Q3 2022 Novocure Ltd Earnings Call
Yeah.
Good day, and thank you for standing by welcome to the NASDAQ Cure Q3, 2022 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 this SAP.
You will need to press star one on your telephone. 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 another care third quarter 2022 performance I'm joined on the phone by our executive Chairman Bill Doyle, our CEO soft donziger interim CFO after the quarter that 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 dot novocure dot 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 <unk> 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'll now turn the call over to our executive Chairman Bill Doyle.
Thank you Edward and good morning, everyone at <unk>, 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.
Fair into new markets.
Hence our tumor treating fields delivery system 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 a 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 and which currently approximately 40% of newly diagnosed GBM patients receive a prescription for <unk>.
We believe there is room to drive greater adoption of opportune in newly diagnosed GBM given the best in class outcomes demonstrated by our <unk> randomized clinical study.
A growing body of basic and translational science from leading academic research centers.
And ongoing confirmation from real World evidence analysis throughout the globe.
There are three key publications that we would like to highlight this quarter.
First a manuscript by Dr. Shadows, Shams and Charade Patel of MD Anderson Cancer Center, which has been accepted for publication in the journal molecular cell biology reviews, the multiple distinct mechanisms of action of TT fields.
This paper is a comprehensive review of TT fields, and a high impact journal and highlights the fast growing body of scientific research converging to demonstrate the effects of TT fields on cancer growth.
The paper validates the multiple waves the TT fields can disrupt.
Critical cellular processes supports TT fields as a potential backbone therapy for other modalities.
As to our Arsenal of independent support to be used for broader education and awareness.
Second Dr. Shouldnt, Zhou Chen published real World evidence from one of the most reputable hospitals in Shanghai <unk>.
Sean Hospital in the journal of clinical Medicine, Dr. Chen's analysis reproduce the results of the pivotal <unk> study and confirms opportune efficacy and the largest group of patients treated with TT fields in China to date.
Dr. Chen reports, a statistically significant 45% improvement in median overall survival with a P value of less than 1.00, well when comparing TT field plus <unk> to <unk> alone.
Third real world evidence from Dr. <unk> at the West Cancer Center was published in neuro oncology advances underlining the benefits of TT fields, and demonstrating that greater TT fields exposure correlates to improve overall survival, regardless of subgroup or treatment.
Actors.
Publications like these serve to strengthen the underpinnings of research supporting the use of our therapy and provide additional educational resources for practitioners as they learn more about TT fields.
Next I would like to highlight the leadership changes, we announced last month.
And the creation of a new U S central nervous system cancers franchise.
Frank Leonard who most recently served as our Chief Development Officer will lead this new organization is franchise precedent.
Price has succeeded in a number of leadership roles. During his 12 year tenure at <unk> and we believe Frank will drive impactful results in this new role.
The new U S central nervous system cancers franchise, combined sales marketing and medical leadership under one umbrella and strengthens our focus on driving adoption of TT fields for newly diagnosed GBM in our largest and most important market.
It is important to remember that option is still a new therapy to many physicians.
The onus is on Novocure to provide the educational resources needed for prescribing physicians to fully understand the many benefits of TT fields therapy for their patients.
With the creation of the U S. CNS franchise, we have streamlined decision, making and improve coordination across our U S teams with the ultimate goal of increased opportune adoption in GBM.
Continuing the theme of greater TT fields awareness and education in August we introduced a new marketing campaign designed to drive awareness and interest in TT fields in the broader oncology community beyond neuro oncology.
The campaign emphasizes the versatility of the TT fields modality, it's multi mechanistic capabilities and ability to expand the treatment possibilities for patients.
The campaign explains the TT fields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms, including the disruption of mitosis interference with cell motility and migration activation of anti tumor immunity and downregulation of <unk>.
Genes important for DNA damage repair.
One facet of this campaign is the creation of a new tumor treating fields website, which serves as a central educational resource to learn more about our therapy.
The website is now live at Www dot tumor treating fields therapy dot com.
I would encourage all of you to explore this resource.
Before I turn the call over to Scott I'd like to reiterate my excitement for the upcoming pivotal trial Readouts.
For the last 10 years <unk> primary focus has been treating patients with glioblastoma.
The top line Readouts from both the pivotal Luminar and innovate three studies next year should be transformational for our company and potentially April enable tens of thousands of patients to utilize our therapy for treatment of non small cell lung cancer and ovarian cancer.
We look forward to sharing data from these studies with you as soon as possible.
With that I'll turn the call over to SaaS to discuss our clinical and product development updates.
Thank you I would like to Echo Barry's anticipation for the upcoming pivotal readout 2023 will be a very exciting year.
As a reminder, we currently have full phase III pivotal studies approaching completion. This has two readout will be the lunar study evaluating the use of Citi field together with Docetaxel physician's choice checkpoint inhibitor for the treatment of stage four non small cell lung cancer following platinum.
In Australia.
We completed enrollment in this study in the fourth quarter of 2021, which started at 12 month follow up period, we plan to announce top line results from both the primary and powered secondary endpoints early next quarter.
The next phase III data readout will be from the innovate three people can try <unk> Suisse tagging the efficacy of <unk> together with Paclitaxel for the treatment of platinum resistant ovarian cancer.
Cancer is steadily, especially once a patient has become resistant to platinum based therapy.
Enrollment in <unk> was completed in October 2021, we started the 18 months follow up period topline results are expected in the second half of 2023.
Our next top line data release will be from our <unk> study evaluating <unk> 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 concert drugs Mantas continues to enroll well and we have visibility to final patient enrollment.
We will need an additional quarter to reach this milestone given the 12 month follow up period format. This we now expect top line results in Q1 of 2024.
The final readout from our current slate of phase III pivotal trials is the panel suite study evaluating the use of TT fields, together with Nab Paclitaxel and <unk> in locally advanced pancreatic cancer, the five year survival rates for patients with pancreatic cancer is only 10%.
We are hopeful the TT fields can play a part in extending survival for this patient population Panama three remains on track for top line results in 2024.
In addition to our clinical pipeline. We are also exploring avenues to increase the TT fields those delivered to patients as well as improve patient experience through product development TD feels those is defined as the amount of energy delivered to the tissue and one of the key lever to increase dose <unk> field intensity.
Today, we are excited to share the data from our <unk> pilot study.
As a reminder, <unk> is our first study to evaluate the safety and preliminary efficacy often higher intensity array design in 25 patients with recurrent GBM as compared to historical control.
Among those who used opportune as directed with higher intensity arrays for at least one month median progression free survival was four five months versus two two months in our Es 11 trial further notwithstanding the increased TT fields intensity, if 33 patients reported no DTC.
Fields related toxicity.
<unk> III is an important step.
Ongoing product enhancement efforts and supports a much faster development cycle by accelerating the clinical testing of the innovations delivered by our product development team.
Building upon our goal to enhance patient experience NTT flip intensity, we are introducing the flex rate.
As a reminder, the flex array utilizes new materials, which are lighter and more flexible than those used in our current arrays flex arrays also have the potential to deliver higher and more consistent TT fields intensities to the target regions without increasing Keith preclinical research in the Red Juno.
Has shown that increased field intensity and greater time on therapy lead to higher cancer cell kill rate.
We believe the flex arrays have the potential to meaningfully improve patient comfort and improve the efficacy of our therapy. We are on track to treat our first patients we flex arrays in Europe . Later this year pending regulatory approval, we look forward to updating you on this release as well as our.
Plans for broader distribution.
Before I hand, the call over to Ashley I would like to thank all of my normal colleagues for their continued dedication to our mission 2023 could be transformational for novel queue. As soon we may have the opportunity to tweak thousands of additional patients.
Though you will rise to the challenge as you have many times before.
With that I will turn the call over to Ashley to review our financial performance.
Thank you Tom the third quarter of 2022 was another period of consistent commercial execution at the profit from our GBM business.
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 3420 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 for invesco weakening Japanese yen and euro.
With respect to each 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 edge claims will take more time and effort to collect.
As we look ahead to 2023, we expect our net revenue to more closely reflect the core drivers.
Active patients on therapy times, the net revenue earned per activation.
12 months.
Gross margin for the third quarter was 77% <unk>.
Impact to our gross margin from inflationary pressures has been minimal to date and we are working with suppliers to optimize our cost of revenues.
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 agent.
We will continue to invest to explore using our therapy and new cancer indications and in novel combinations.
As well as in product development initiatives designed to improve the efficacy and experience for our patients.
Our net loss for the third quarter was <unk> 25 per share or <unk> $27 million.
Adjusted EBITDA was $4 million and we finished the period with $970 million in cash and short term investments on the balance sheet.
This cash reserve enables us to pursue a number of avenues regret with maximum flexibility.
I'd like to close today by highlighting one of our optima and users.
In July 2021, Javan can obtain with preparing for a backpacking trip when she found herself unable to read or comprehend text messages.
After consulting with physicians and undergoing a battery of scans she was diagnosed with GBM.
Joe Bonn first underwent <unk> surgery at the Mayo Clinic, and then began using up kit.
In the year since your diagnosis Javan disease has not progressed.
Denise can maintain an active lifestyle, while using ttgl's.
Past summer Javan by more than 100 miles to the Mayo clinic for hormone strengthened MRI.
We take our mission very seriously at near the care to extend survival in some of the most aggressive forms of cancer.
Sterling survival means, allowing patients like Joanne the time and ability to continue pursuing their passion, whether thats a long bike ride watching a football game with her husband or getting lunch with her that.
We're proud to play our part and Giovanni journey.
And with that we'll open the call to questions.
As a reminder.
To ask a question. Please press star one one on your telephone please.
Please standby, while we compile the Q&A roster.
Our first question comes from Greg Fraser with <unk>. Your line is now open.
Good morning, folks and thanks for taking the questions.
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 or buy them.
Okay.
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 formal DNA listing in Germany and contracted pricing with all of the large payers you ask specifically, what we should expect in a 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 revenue per patient who started prior to defined coverage and for whom we are no longer being paid.
Consistent with last quarter, but we expect to continue to see an impact for the next five 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 you know as we mentioned last quarter. So it's short term pain for long term gain as we now have four of Airbnb lifting and establish reimbursement pathway and Germany and pricing in Europe in line with our global pricing ASE.
Got it.
Can you talk a bit more about what youre seeing in Japan in terms of demand prescription volume, there and trending down over the last few quarters.
Driving that trend.
Yes, Hi, this is protection 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 a quarter of quarter over quarter grow there.
To 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 our ability to impact patients that can actually received 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 <unk>.
Measure of our growth in Japan.
Got it so that 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, 'twenty finalized 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.
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 have used care reimbursement. Thanks, so much.
Yes, so we have patients today that we're treating in past in France. Those are through clinical trials. Those are they're tied in trial that we have ongoing in France, we don't have any commercial patients outside of that in France today.
Thank you.
Please standby for our next question.
Our next question comes from Jason Wittes with loop capital. Your line is now open hi, Thanks for taking my questions first off.
You're beefing up your infrastructure for GBM sales in the U S. You are 40%.
Should we anticipate that youre 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.
<unk>.
Yes. Good morning, Jason This is bill I'll start off here.
So as you as you point out and I.
I will 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.
Got tier one recommendation per the NCC and guidelines we've established essentially.
Universal pricing and reimbursement for patients in the U S and it really is the core driver of our of our profitable business Thats funding all of the other activities.
That we discussed so that's the that's sort of the big picture.
We believe there are significant opportunities to increase that 40%.
First and foremost as penetration at the academic centers.
This is where the Isps that we've discussed previously.
As well as the.
The TTS the new tumor treating fields campaign that we discussed in the script.
And and also the power of the academic papers that are now coming from independent researchers that are validating the EF 14 clinical trial all of those are important.
For our growth.
And then again.
We have now streamlined our organization to really focus on driving this in and with that I'd like to ask Frank Leonard Who's on the call and as our and as our new franchise President Frank maybe you could just give a little bit of.
Background and 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.
The 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 a focus on increasing the number of GBM patients receiving option.
While allowing the rest of the organization to prepare for the future.
We're really within this new organization focused on two key operational changes.
First we want to streamline the decision making related to the USG GBM business.
To ensure we can get faster implementation of changes that support our prescribers and patients.
Second we also want to build an organization that can prioritize strategic objective for growth, while decentralizing the tactics and execution to the teams that are closest to our customers.
I'd also mentioned just lastly, I wanted to I wanted to highlight that we just returned from the Astro conference in San Antonio and as a reminder, Australia is the largest conference focused on radiation oncology and our radiation oncology prescribers or some of our most engaged and confident customers.
With over 75% to 70 7500 attendees at the conference we had four 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 understand long term potential for tumor treating fields.
Both MGM and then the other solid tumors we're studying.
So we had to.
And excited.
Customer base that was eager to talk to us both about applications in GBM as well as aware of the fact that theres upcoming data releases that will will be meaningful.
Thank you. So so again, maybe maybe to summarize we have a very strong foundation.
In GBM.
It is among our highest priorities to.
To grow in GBM and <unk>.
Hence.
The reorganization to 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 the color if I could just ask one other question then on high intensity arrays.
The 25 patient pilot study was pretty impressive it looks like it doubled.
Congrats on 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.
Yes.
Sure. So again, our focus has been on.
Building first of all developing the array than 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 will announce that when.
When we do have the first patients on these arrays.
And then we will start the regulatory process in the U S next year.
And Jason just for the avoidance of doubt that you have 33 data is on our 14 disk array flex is another kind of leapfrog to generation.
High intensity array that is lighter and more flexible yes, that's a great point so.
We started.
The first trial with <unk>.
Early design that delivered the high intensities.
And we tested those on some of the sickest patients again these were recurrent.
<unk> patients and as you pointed 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.
The initial trial that was those were both important endpoints.
And again I'm, just repeating what Ashley said the flex is is another step forward.
Not only delivers the high intensity, but has a much more comfortable lighter easier to use array.
And so we're we're as excited as can be about this launch.
Great. Thanks for the Emperor ill jump back in queue.
Please standby for our next question.
Our next question comes from Emily <unk> with H C. Wainwright. Your line is now open.
Hi, good morning, Thanks for taking the questions.
Curious how much of a larger sales force would you need to bring <unk> to market for lung cancer are you looking to build like a completely new salesforce for that or do you think there is some synergy with your ongoing sales force in GBS mesothelioma, and then could you maybe provide some background on the <unk> trial, and what's kind of driving the slower.
Thank you.
Sure. So we'll take this in two 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 for cash to describe.
Some of those activities. Thank you Bill I appreciate the question and I'll start off with answering your question first how large of an investment or are we going to be making in the sales.
Sales organizations and we will.
It would 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 and then we're excited about the focus on GBM, while we work on how to structure it 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 adjust.
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.
Web site and the work we're doing on education related to the mechanism of action. This second step we're taking years to understand the marketplace as we await the data working on the patient journey, ensuring we understand how decisions are made how TT fields will insert into the decision making framework and then the last step on this.
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.
Some decisions off of off of that.
And Emily with respect to your question on Medis.
Medicine 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, it's nothing more than that.
Got it thank you.
Please standby for our next question.
Okay.
Our next question comes from Jason Bednar with Piper Sandler Your line is now open.
Hey, there.
Thanks for taking the questions.
<unk>.
Yes.
A few here first time lunar.
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 'twenty three is in like.
Some time in mid January .
And then I think you noted, we'll see primary and secondary endpoints on litter.
Just wondering if you can discuss whether we'll see any hazard ratios when you report those items.
Then finally can you discuss what kind of preparations you're making today.
Just with respect to like submission materials, the FDA FDA and international agencies.
As well as feed your planning with payers to have those conversations start as soon as possible. Once you do have that data fully in hand and the claims.
Thanks, sure. So first and foremost let me just underline theres no change with respect to the the report timing so.
No need to read any tea leaves there.
Secondly, as we've said before our.
First announcement in the 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 with hit the primary and the secondary endpoints.
We do not expect to provide detailed that will compromise our ability to.
To either publish or present the data in the first opportunity that we have in a major medical conference.
And then with with respect to preparation.
I would say that our regulatory capacity is one of our tremendous strengths at <unk>.
Among our strongest core capabilities.
And we are doing everything.
That is possible to do to prepare.
This is will be a PMA supplement that will go in and three.
Sub.
Sub categories, there is 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.
Another question I'll come back to the one Bill you said PMA supplement had been operating under the assumption. This is going to be a full PMA that something's shifted or my my mistake.
And Europe had good catch I'm thinking PMA supplements, because we're so busy doing other PMA supplement, but this is a full new PMA.
Okay. Okay. Thanks, 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.
On the street to reference year end 'twenty, one revenue per patient levels, but I mean.
I think we all can see like what FX is doing across your P&L in <unk>.
<unk> and Germany, they just make it making year end 'twenty, one that just really tough to use is there anything you are willing to reference today as we think about modeling revenue per patient in future quarters and years across your respective markets. Thank you yeah no I appreciate it and it's actually a good question.
Notwithstanding all of the puts and takes year end 2021 sale as a pretty good reference when we roll up to that kind of AFP 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 on tailwind from its claims in the U S. That's benefiting that price when you roll it into the model, but that's being offset by the transition that we're seeing in Germany, and I would say there is a netting to essentially the same place.
Japan of course also had some FX impact, but that prices stable said you look at actually those trends over time, you're seeing the impact of FX.
I would still recommend you look to that.
Q4 exit Asps.
As a good number to model looking moving forward with some puts and takes in each region.
To your year end 'twenty, one global revenue per patient is still how you.
Suggest modeling forward for 'twenty three and beyond.
Yes.
Okay, Alright, thank you very helpful.
Please standby.
Our next question.
And Thats a reminder to ask a question. Please press star one one on your countless times.
Our next question comes from Vijay Kumar with Evercore. Your line is now open.
Hey, guys. Thanks for taking my question.
Actually maybe.
First one is for you did you quantify what the CMS contribution this quarter.
Within the Q and a.
And just based on what Youre seeing right now should we expect revenue growth in fiscal 'twenty three.
Yeah Vijay Thanks for the question, so we've never broken down.
A detailed quantification about what we what we have seen as a benefit throughout 2023 and 2022 from its claims in the U S. That's around $10 million a quarter. If you want a round number that I wouldnt we.
We did have a headwind in the third quarter, where that was down versus Q2, and if you look at consistent occupation trade as you can see that dropping <unk> net revenue in the U S and that is largely the impact of the H claims decreased in the U S.
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 patients on therapy and multiply it by that AFP that we just discussed with Jason and times that by 12 and that we're getting here.
A good estimate.
I guess is in the back payment that headwind for 'twenty three quarter revenues to be declining in 'twenty two.
That's H claims in the U S will be added when in 2023, and when we want you to anchor to that ASC that we just referenced.
Understood.
And.
A couple of questions on lunar given this and the Pms there was some trial design changes.
Do you expect.
There could be an FDA ad com.
For this trial.
We never know whether or not the FDA will.
We will decide that they want.
Netcom 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 in and what the FDA chooses to do.
I think the fact that tumor treating fields has now established in GBM and as 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 the.
And in the community.
Call. They did have an AD com for our very first.
Approval in recurrent GBM, but they did not require an AD com for our second submission in newly diagnosed.
That's helpful and then maybe my last one on this.
So the trial now.
Lunar trial, specifically, we're looking at 12 months of follow up.
Is that mean.
The median overall survival in this trial is less than 12 months or maybe just put that 12 months into context, because I know.
There wasn't a data maturity the trial start enrolling enrolling a while ago.
Or does the 12 months signify.
Again, Vijay that's 12 months from the last patient and it's not an average 12 month follow up so so I don't think there's any issue with respect to this fall uptime.
Understood. Thanks, guys.
Thank you.
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.
Thanks again.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
The conference will begin shortly to raise your hand during Q&A you can dial one one.
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