NovoCure Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
October 26, 2023

There are 11 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the Novocure Q3 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer 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.

Operator

Please

Speaker 1

go ahead.

Speaker 2

Good morning, and thank you for joining us to review NovaCare's Q3 2023 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle our CEO, Asaf Danvigar and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q and A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com on our 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.

Speaker 2

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 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 ks filed with the SEC today.

Speaker 2

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.

Speaker 3

Thank you, Ingrid, and good morning. At Novocure, our mission is to extend survival in some of the most aggressive forms of cancer through the development of our novel therapy tumor treating fields. This quarter, we made progress on numerous fronts in pursuit of our mission. Before we review the quarter, I would like to address the evolving situation in Israel. NovoCure was founded in Israel.

Speaker 3

And as we've grown, our Israeli DNA has remained an important part of our culture and identity. We have 2 60 colleagues in Israel and hundreds of current and former patients who are affected by the terrorism of October 7 and its horrific aftermath. We are living with grief, shock, fear, anger and sorrow. We will do everything in our power to buttress members of the NovoCure family. Our thoughts and prayers are with everyone affected by these devastating events.

Speaker 3

Shifting back to our quarterly results. Q3 was a period of continued execution at Novocure. We finished the period with 3,639 global active patients on therapy and significantly added to the body of clinical data supporting the use of TT Fields therapy across multiple cancer indications. We also made meaningful progress on our pipeline, including our next series of clinical trials and product development enhancements. This morning, we will begin with an update of our for lung cancer program.

Speaker 3

We will then discuss our other clinical programs and our commercial business. We will close with a review of Q3 Financials. In Q3, we continued to strengthen the foundation of clinical data supporting the use of PKI Field Therapy, especially in our thoracic program. In August, the results of the Phase 3 LUNAR clinical trial in metastatic non small cell lung cancer were published in the journal Lancet Oncology. As a reminder, the LUNAR data showed a statistically significant and clinically meaningful extension in overall survival for patients treated with TT field therapy and the standard of care exhibiting 13.2 months median overall survival compared to 9.9 months for patients treated with standard of care alone.

Speaker 3

The results were more In patients who receive TT field therapy and an immune checkpoint inhibitor, demonstrating 18.5 month median overall survival compared to 10.8 months in patients treated with an immune checkpoint inhibitor alone. Lancet Oncology is one of the premier clinical oncology research journals. We are proud to have the LUNAR data published in this prestigious and impactful platform. In addition to the Lancet publication, Several key post hoc analyses of LUNAR were presented at major medical congresses during the Q3, further illustrating the broad and growing interest in the LUNAR clinical trial. Key among these was an analysis of survival patterns for LUNAR patients with known tumor progression scores, presented at the ISLAC World Conference on Lung Cancer in September.

Speaker 3

This analysis showed that patients treated with TTFields and an ICI with TPS scores greater than 1% exhibited a substantially longer median overall survival compared to those patients treated with an immune checkpoint inhibitor alone. 23.6 months compared to 10.5 months. Further, in patients with low TPS scores between 1% 49%. Median overall survival reached 19 months in the TT Fields Plus ICI arm versus 9.7 months for treated with an ICI alone. While sample sizes are small, these data support the potential of PP fields to materially extend survival In a large subpopulation of non small cell lung cancer patients who may not be prime candidates for immune checkpoint inhibitor monotherapy and who could benefit from the addition of TTFields therapy to their pharmacological therapies.

Speaker 3

The robust extension of survivals demonstrated in LUNAR is key to our ongoing efforts to further explore the capabilities In October, at the European Society of Medical Oncology Conference, we presented health related quality of life data from the LUNAR trial. Consistent with all our previously conducted trials, the use of TTFields in the LUNAR study did not result in an increase in Also in October, at the American Society For Radiation Oncology Annual Meeting, we presented a simulation showing the ability to treat cancerous lung tissue with TTFields regardless of a patient's body mass index. These analyses underscore the applicability of PP fields to treating metastatic non small cell lung cancer and the growing interest in the LUNAR dataset within the oncology community. On the regulatory front, Our teams are on track to submit the final module of our PMA application to the FDA later this year. This comes on the heels of our completed European CE Mark application last quarter.

Speaker 3

The LUNAR trial is an important milestone As it is our 1st randomized clinical trial demonstrating extended survival in the treatment of cancers of the torso. We are now advancing our plans for our next lung cancer clinical trials. These next LUNAR trials will explore the use of TKI fields together with immunotherapies, Which showed immense promise in our first LUNAR trial. Success in these trials will allow us to expand the lung cancer patient populations indicated for TTFields Therapy. Beyond our thoracic program, We have 2 randomized Phase 3 clinical trials nearing major milestones.

Speaker 3

Top line data from the METIS trial is expected late in Q1 2024. Metis is evaluating the use of PT Field's therapy to treat brain metastases for non small cell lung cancer following stereotactic radiosurgery. And in the second half of twenty twenty four, We expect top line data from the PENOVA-three trial. PENOVA-three is evaluating the use of PT Fields therapy together with nab paclitaxel and gemcitabine for the first line treatment of locally advanced pancreatic cancer. In Q3, we also made progress in our PENOVA-four study, which is exploring the use of TTField therapy together with atezolizumab for the treatment of metastatic pancreatic cancer.

Speaker 3

PENOVA-four enrolled its first patient Finally, in the Q3, We announced the top line results from the INNOVATE-three trial in platinum resistant ovarian cancer. INNOVATE-three did not meet its primary endpoint. Platinum resistant ovarian cancer is a difficult to treat condition. And while we are disappointed with the top line results of INNOVATE III, We have gained keen earnings for the design of future trials. Most notably, we saw a promising survival trend in patients who entered the trial after failing a single previous line of platinum therapy compared to those enrolled after failing multiple lines of therapy.

Speaker 3

The benefit observed for women who enrolled in INNOVATE-three earlier in their cancer therapy journey reinforces our understanding The TTPeal's therapy is at its most effective when used early on and informs our plans for future trials. I'd like to close today by reiterating my enthusiasm for the milestones we have reached this year and for those to come in the near future. With 2 Phase 3 trial readouts and our launch in non small cell lung cancer on the docket for 2024, the future is bright for NovoCure and we look forward to the opportunity to treat many more patients suffering from difficult to treat cancers in the coming years. I will now turn to Asaf to discuss our GBM business.

Speaker 4

Thank you, Bill. Our GBM business is the core driver of our financial strength generating $500,000,000 in revenue and free cash flow that are invested In the TT Fields platform, we ended the 3rd quarter with a record 3,639 active patients on therapy. We have had a very successful Optune launch in France and have more than 150 French patients on therapy. We have learned many lessons through our French launch. We built our team in the country over the prior 2 years and focused on building awareness of TT field therapy among French healthcare leaders.

Speaker 4

Early investments planted the seeds for an efficient and effective therapy rollout. And we believe the French launch playbook will serve as a blueprint for future launch success. In the U. S, we continue to see new activities and dialogues emerge following our commercial reorganization. Teams have improved cross functional alignment and are synchronized in addressing the key levers contributing to our growth, including patient starts, patient therapy duration and patient usage.

Speaker 4

All of these inputs are critical to long term growth in active patients and net revenue. Our teams are focused on increasing awareness of the benefits of Tityfills among potential patients and prescribing physicians. In Q3, we finalized our direct to consumer campaign, I Power My Life and expect to introduce the campaign to the market next year. We believe direct to patient messaging will raise awareness of TTField therapy and strengthen the demand from patients following diagnosis. We expect direct to consumer engagement will be instrumental to driving greater demand from patients and caregivers.

Speaker 4

We are also focused on driving awareness among the broader oncology community for treatment of GBM and cancers of the torso. Physician engagement has been strong during recent congresses, especially during the ASTRO earlier this month. Strengthening the foundation of clinical evidence is key to driving greater penetration in our current markets. In July, Doctor. Matthew Ballo published a meta analysis comparing the outcomes reported in 9 studies of over 1400 GBM patients, where TTField therapy was added to TMZ after surgery.

Speaker 4

Doctor. Balow's analysis of real world data confirmed the outcome of our Phase 3 year 14 trial and confirmed the improved outcomes associated with patients using TTField therapy over 75% of the time. Real world analysis of this size reinforce the survival benefit achieved when TTFields therapy is prescribed for GBM and our important tool as we look to reach more patients and physicians. Beyond our efforts to drive demand, we are working to improve ease of use and drive duration of therapy through product development. This month, we launched our next generation arrays in Germany.

Speaker 4

As a reminder, these arrays leverage new materials and a unique design to improve the patient experience. They are lighter, thinner and more flexible than previous versions and have the ability to deliver greater intensity to the tumor site without a corresponding increase in HIT. We are on track to submit a PMA supplement to the FDA for the new arrays later this year. Additionally, we are pleased to announce the hiring of our new Chief Medical Officer, who will join us in January. While we are restricted from sharing the candidate's full details at this time, we are very pleased and look forward to adding His expertise and fresh perspectives to our leadership team.

Speaker 4

Pritesh will also be transitioning from NovoQ. Pritesh plans to stay on at NovoQ for several quarters as an advisor to ensure a smooth transition to the new CMO and the continued success of our teams. I would like to close by addressing the violent events in Israel. It is difficult to describe the emotional impact of the last few weeks. Many of us, including myself, have lost loved ones to this carnage.

Speaker 4

And now all of us have family members and friends who serve in harm's way, Sons and daughters, brothers and sisters, mothers and fathers, the atrocities of war are horrible. It makes me sad that this is our reality today. I hope and pray that the conflict will be resolved swiftly. I will now turn to Ashley to close today's call.

Speaker 5

Thank you, Asaf. The Q3 was a period of consistent execution across multiple verticals. With several clinical readouts, Regulatory filings and commercial launches on the horizon, we are investing in the essential infrastructure to ensure we are prepared to fully leverage growth opportunities in the coming years. We generated $127,000,000 in net revenues in the Q3 and ended September with 3,639 active patients on therapy, an increase of 6% from the same period last year. Our successful launch in France continues to be a tailwind as we had a second straight quarter of strong prescription flow and patient starts.

Speaker 5

The pre commercial engagement and subsequent commercial execution in France have provided a blueprint, which we will leverage in future country launches. We collected $4,000,000 in revenue from France this quarter. But as a reminder, it will take several quarters for the collection cycle to reach full reimbursement level and France will impact the net revenue per active patient in EMEA during this time. In the U. S, we continue to experience a year over year headwind

Speaker 6

due to

Speaker 5

the absence of collections from denied or appealed claims. Last year, we collected $15,000,000 from these claims in the 3rd quarter, which have largely been exhausted at this point. Moving forward, we expect our U. S. Business to more closely track the key drivers of net revenue, active patient starts, duration of therapy and net revenue per active patients per month.

Speaker 5

In Germany, our recovery following defined coverage negotiations continued this quarter. We ended the 3rd quarter with 4 92 active patients on therapy, a 5% increase from Q3 of last year. This quarter, we saw a decrease in prescriptions as our German team focuses on driving higher quality, more readily reimbursable prescriptions and increasing pull through of patient starts and long term active patient growth. Gross margin for the Q3 was 75%. Over the course of the year, we have invested in expanded patient support capacity in anticipation of treating larger patient populations from new indications and geographic regions.

Speaker 5

As we have shared, product development enhancements such as our new arrays will impact our gross margin in the near term. This impact will be felt more acutely in the coming quarters as we roll out the new arrays in our largest markets, beginning with Germany this quarter. We are focused on pursuing opportunities to increase efficiencies and scale within our supply chain and we'll take the steps needed to balance the impact of these product enhancements while maintaining a healthy margin. SG and A expenses were $100,000,000 this quarter. We continue to invest tactically to ensure we are equipped to capture growth opportunities in the future.

Speaker 5

This includes investing in commercial capabilities to increase penetration in GBM, pre commercial activities in non small cell lung cancer, and market access capabilities to reach new patient populations. In addition, we have increased spending in IT and supply chain capacity. Research, development and clinical trial costs for the quarter were $54,000,000 With the conclusion of the LUNAR and INNOVATE III trials, our R and D investment is shifting to our next wave of Phase III clinical trial. This includes the LUNAR-two trial, where we are preparing to engage sites and enroll patients in the coming months. We look forward to updating you on the progress of this and other clinical trials in the coming quarters.

Speaker 5

Cash and short term investments totaled $921,000,000 as of September 30, 2023. Our net loss for the Q3 was $49,000,000 or $0.46 per share and adjusted EBITDA was a negative $29,000,000 We are in a window of investment in preparation with new commercial launches on the horizon and the potential of treating much larger patient population. With these growth opportunities approaching, we are committed to investing tactically to align our near term capital allocation priorities with our long term strategic vision. Our goal is to balance the capacity investments needed to treat more patients while preserving our financial strength and ensuring our ability to invest in value additive opportunities in the future. I'd like to close today by sharing a story about one of our Optune users, Jovan Knutson.

Speaker 5

As you may recall, we highlighted Jovan last October. Jovan was diagnosed with GBM in over 100 miles each way. This summer, Jovan set out to tackle an even greater feat, an 850 mile tour of the Upper Midwest. The logistics associated with the tour of this great length can be daunting with daily checkpoints to reach and supplies to replenish. Jovan worked with our Encompass team to ensure all Joven completed her 850 mile tour in August and we are thankful for the opportunity to support her amazing feat.

Speaker 5

Our mission to extend survival in some of the most aggressive forms of cancer is rooted in patients like Jovaugh. To give the gift of time for patients to be with their loved ones, pursue dreams and achieve amazing feats like Jovan, I'd like to personally congratulate Dravon and thank her for letting us share her story. With that, I'll hand it back to the operator for questions.

Operator

Thank you. One moment for our first question. And our first question comes from Jonathan Chang of Leerink Partners. Please proceed.

Speaker 1

Hi, guys. Thanks for taking my questions. Can you discuss your pancreatic cancer strategy for tumor treating fields? What's the rationale behind the PENOVA-four study and the timelines associated with that? And how should we be thinking about the PENOVA-four study initiating before the PENOVA-three readout next year?

Speaker 1

Thank you.

Speaker 3

So, good morning, Jonathan. This is Bill. I'll start and then turn it over to Ori to describe the details of PENOVA-four. But of course pancreatic cancer is one of the most difficult diagnoses and has proven to be one of the most difficult cancer to treat with many, many failures, of course. Our strategy starts with the fact that we know that we can deliver tumor treating fields to the region of the therapy.

Speaker 3

Many chemotherapies that depend on the circulatory system can't even get to the region because of issues with the stromal tissue and differentiation of pressures. So we start there. Further, we start and have built on a very successful Phase II trial where we showed extremely impressive results in a small sample size for both Locally advanced pancreatic cancer and metastatic pancreatic cancer. In our first PENOVA trial, and I'll remind everyone this is a trial that we expect to read out toward the end of next year, We focused on locally advanced pancreatic cancer. And this is the Stage of the disease where we can completely encompass the extended the disease with our tumor treating fields therapy.

Speaker 3

PENOVA also is a first line trial. So we start at the time of diagnosis in combination with gemcitabine and And so we remain very optimistic and enthusiastic about the design of this trial. And we're preparing for success here in terms of Rolling out the therapy to this patient population. So that's the first element of our pancreatic cancer strategy. And now let me turn it over to Ori to describe the results or to pardon me, not results, but to describe the intent to expand the patient population once we anchor in locally advanced.

Speaker 7

Good morning. So the background for opening the Panuva 4 this time is that we're doing our best To integrate lessons learned through our clinical program and our scientific program and learning from the 2.0 study in newly diagnosed GBM patients and from the LUNAR study results where we have seen An outstanding performance of TTFields when concomitantly used with immune checkpoint inhibitors. We feel that we should not hold off on the next step Also in pancreatic cancer, even prior to reading the results of the PANOVA 3 Starting. So PANOVA-four is for metastatic disease. It will incorporate atezolizumab concomitantly with chemotherapy and PT fields and anti PD L1 And we'll be done in collaboration with Roche for DG Securities.

Speaker 1

Understood. Thanks for taking my questions.

Operator

Thank you. One moment for our next question. And our next question comes from Jason Begner of Piper Sandler. Please proceed. Jason, your line is open.

Operator

One moment for our next question. And our next question comes from Lee Wang of Wells Fargo.

Speaker 8

Good morning. It's Leigh calling in for Larry. Thanks for taking my question. Can you hear me okay?

Speaker 3

You can. Thanks Lee.

Speaker 8

Thanks. I have a few questions starting on the lung side. Is there any update on the chemo B36 trial? On clinicaltrials dot gov, there is a completion date for mid-twenty 24. Can you comment on that?

Speaker 9

Yes. Lee, this is Pritesh. Thank you for that question. We're very excited to have the trial open. The B36 study is a study that's a Phase 2 pilot study that's exploring the use of tumor treating fields in the first line non small cell lung cancer with KEYTRUDA.

Speaker 9

So it's an important So the trial is open and enrolling. One of the aspects of lung cancer that we already know that it's a very competitive space from a trial perspective because of the There are lots of agents and there are lots of trials that are open in this space. So to get rapid enrollment for a Phase 2 study like this can be a challenge. Our teams are focused on ensuring that we do all the education and the support work to make sure that this study continues to enroll because it will be important to help us understand again the role of Tumor Treating Fields in the first line setting.

Speaker 5

Okay. Is there an update on

Speaker 8

the timeline? Is that mid-twenty 24 date on clinicaltrials dot gov? Is that accurate?

Speaker 9

So like with all studies, because they are on a pace of enrollment, I would say that's just an anchor point. As the study enrollment Sort of gets closer to an end date, we will continue to provide updates on that front.

Speaker 8

Okay, got it. And related to that, Is there any way to bridge KEYNOTE-thirty six to your new LUNAR trials in the first line to help expedite patient enrollment and the timeline of development?

Speaker 9

Yes. So that's an interesting question. I think that Anytime we can speed up enrollment, it's really wonderful to take advantage of those opportunities. There are 2 different protocols at the moment. The B36 protocol was ahead of the LUNAR-two study, which is now going to be in an operational setting, so we can start getting Enrollment in LUNAR-two.

Speaker 9

So this study is meant to give us a quicker read of the similar patient population, albeit there are 2 different protocols. So We will look at it as the study enrolls and see if there are any advantages to accelerate our LUNAR-two efforts.

Speaker 8

Okay, thanks. And then just a few questions on the Q3 results. On the call, I think you actually talked about Brett's focusing on high quality prescriptions in Germany. Can you just expand on that? And how do we think about the impact on the prescription volume going forward.

Speaker 8

And rest of world prescription volume was really strong, patient volume as well. And was that just France, the launch or were there other aspects of it?

Speaker 5

Yes, Leigh, this is Ashley. Thanks for the question. So it is patients that we will have you focus on in Germany. So you can see that The patients were up 5% year over year. What that really does reflect is now the new coverage criteria is fully understood Both on our side, but also on the physician side.

Speaker 5

And so over the course of 2023, what we've seen is that physicians have stopped Writing scripts for patients that will not get reimbursed. Those were not scripts that were filled last year nor were they scripts for which we are getting paid. So that's kind of A natural and positive maturation that these messages are understood and everybody in market understands now what we'll get paid for. So I would look at active patient growth, that's the right anchor, and that is really trending well right there in that market. And as you noted, rest of world as well.

Speaker 5

So I would say we saw a stable business in active patients around the rest of the world and then a really strong performance in France as we mentioned with more than 100 patients up there.

Speaker 8

Got it. Thanks. And then if I can squeeze in just one more. You have Azirconvert that's due in November 2025. I think you have the company has the option to redeem at some point this year, but Presumably that's not going to happen at this point.

Speaker 8

How do we think about the redemption or the conversion optionality before maturity?

Speaker 5

Yes. No, it's another great question and one that I as you can imagine, we are getting asked a lot recently. What I will say is reiterate what I mentioned in the script that We have an incredibly strong balance sheet. We have a GBM business, which generates $500,000,000 in revenue and throws off about $100,000,000 in free cash flow. We are an R and D organization.

Speaker 5

So we are committed to investing in these future opportunities and future growth, but we are very astutely looking at How we can both manage our short term goals and ensure that we have a strong balance sheet to get us through our pipeline investments and to get us through successful product launches, while ensuring that we keep our eyes on kind of the long term value creation, which we know is in hand. So what I will say is rest Assured, we are very focused on this and the P and L and free cash flow metrics are something that are in our control And is very much actively being managed, I would say, to ensure that we maintain our strength throughout the journey.

Speaker 8

Okay. So no comment on the redemption or conversion optionality at this point?

Speaker 5

Correct.

Speaker 8

Okay. Thank you.

Operator

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

Operator

Please proceed.

Speaker 10

Hi, good morning. Thanks for taking the questions. Maybe 2 for me. I'm starting with kind of a follow-up from the first question. I'm curious to get your thoughts on PENOVA-three as it's Also using apaclitaxel backbone, which is used in Innovate 3 and maybe just discuss the differences and why you're so confident in PENOVA3 being successful given that with INNOVATE 3, the paclitaxel combination didn't really show much survival benefit.

Speaker 10

And then second question, as you're getting closer to the Medis readout, what are

Speaker 8

how are you kind of

Speaker 10

thinking about the market opportunity there and any overlap that you think you may have in terms of launch benefits given your GBM commercial capabilities? Thanks.

Speaker 3

Sure. So, thank you very much for the question. So let me Comment on the differences between the INNOVATE III study and the PENOVA III study. As we described in the script and other communications, the patient population that was recruited into the INNOVATE study consisted of women who had failed many prior lines of therapy. And we showed a benefit when women entered the study after failing One prior line of therapy, but we were unable to show a benefit after they had failed 3, 4 and up to 5 lines of prior therapy.

Speaker 3

So these were very sick, very brittle. And in fact, these women have Sales I shouldn't say the women have failed, but Phase 3 studies have failed again and again in this particular population. It's also a stage of the disease where the cancer has spread beyond the region that we're able to directly treat with the tumor treating fields, electric fields. I now contrast that with PENOVA-three, as I As I said earlier, this is a study in the first line. So this is after diagnosis.

Speaker 3

It's a study in patients who have locally advanced, Meaning that they have not that the disease has not fully spread throughout the body. So we can treat the full extent of the disease. So I would anchor on these two facts When comparing our ability to derive great benefit and in fact we saw a greater benefit in our Pancreatic Phase 2 compared to the benefit that we saw in our ovarian Phase 2, the benefit that we saw again in our ovarian Phase 2 was with women who were early in their cancer journey, not at the end of the journey. And then that leads to PENOVA-four that Ori just described, Where we know we can treat systemic disease is when we combine with an immunotherapy. This is what we saw in LUNAR where we were treating patients after with metastatic lung cancer after failing platinum therapy.

Speaker 3

And we saw really tremendous results when we combined with an immune checkpoint inhibitor. And in that case, you get the benefit of The antimyotic effect of the tumor treating fields alone where we create immunogenic cell death And then that will turbocharge the effect of the immune checkpoint inhibitor. So that was a lot of discussion, but with Tumor Treating Fields plus chemotherapy, we need to treat early in the disease progression in order to get a really Maximum benefit for patients. And if we have to wait until later in the disease journey,

Speaker 10

Okay. Thanks. And on the Medis readout?

Speaker 3

So in the Metis market, so again, I think we do have an advantage And that we will be using the same commercial infrastructure, So the same oncologists who treat glioblastoma, even though it's a different disease, It's non small cell lung cancer that has metastasized to the brain. These are the same clinicians. And so we would expect to leverage the same commercial infrastructure that's already in place and that will clearly be a benefit for us when we launch that indication.

Speaker 10

Okay. Thank

Speaker 7

you.

Operator

Thank you. One moment for our next question. And our next question comes from Jason Bednar of Piper Sandler. Please proceed. Jason, if your line is muted, please unmute.

Operator

And our next question comes from Vijay Kumar of Evercore ISI. Please proceed.

Speaker 6

Hi, this is Kevin on for Vijay. I noticed that you called out $14,500,000 of denied payments. Just curious on what this means going forward? Is this a change? Are payers becoming more stringent?

Speaker 6

Any color there would be helpful. And were there any denied payment trends historically? Thank you.

Speaker 5

Kevin, yes, this is Ashley. I appreciate the question because it is really So this is not a change. This is not a reflection of any more stringent coverage criteria. And in fact, this Consistent with our messaging here over the prior three quarters and that we had a significant amount of claims from I mean, of revenue from aged claims in our 2022 baseline numbers to the tune of over $40,000,000 year to date in the 1st 9 months, As you noted, about $15,000,000 in this quarter. So that is revenue that was in our year over year comparison in the baseline and is not in the actual

Speaker 7

for 2023. We would not expect it to

Speaker 5

be moving forward, For 2023, we would not expect it to be moving forward because we are now in a position where revenue reflects the base drivers of our business, which is our current active patient volumes and the net revenue that we're able to collect on those patients. So to be very clear, this is not more stringent

Speaker 7

coverage criteria and in fact is a

Speaker 5

factor more of an elevated baseline than it is in

Speaker 6

Thank you. And if I can follow-up, how should we think about the METIS trial as it relates to your GBM business, especially given its focus on the same region. Do you see any Potential impact or change in physician perspectives on optioning, positive or negative from those trial results on your GBM business? Thanks.

Speaker 3

Kevin, another important question. Thank you. Simple answer is no. These are 2 Distinct diseases, even though they may be treated by the same clinicians, our GBM business is now well Established and stable, and we have resounding clinical evidence and commercial experience. In the script, In fact, we called out recent reports of real world evidence And in particular, Ballo's meta analysis of 9 separate real world papers.

Speaker 3

And these are all coming in at exactly the same place, Supporting the results of our original clinical trial and we've reached the point in the world where clinicians also have their in office experience. They have substantial the prescribers have substantial numbers of patients. They see the benefits. They see the extension in survivals in their own practices. So Plus or minus, I don't think there's going to be an effect either way.

Operator

Thank you. At this time, I'd like to turn the conference back Bill Doyle for closing remarks.

Speaker 3

So thank you very much. I want to thank everyone for your continued interest and support in Novocure. The messages I want you to take away from this call are 1st and foremost that we are executing our plan. GBM is a stable business that's providing the financial support for us to invest in our future. We've made exciting clinical progress, 1st and foremost in our thoracic program, where we're preparing to launch around the world, and in the future where we're excited by the imminent prospects of METIS and PENOVA 3 next year.

Speaker 3

So it's an exciting time to be at NovaPure. It's a busy time. We stand with our Israeli colleagues and we couldn't be more appreciative of their hard work during this Incredibly difficult time in that country. So thanks again and we look forward to reporting next quarter.

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