Q2 2024 Novocure Ltd Earnings Call
Yeah.
Good day and thank you for standing by welcome to the Novocure Q2, 'twenty 'twenty four 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 session you want.
Need to press Star one on your telephone you will then hear an automated message advising your hand, just raised to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today Ingrid Goldberg. Please go ahead.
Good morning.
Thank you for joining us to review <unk> second quarter 2020 for performing.
I'm joined this morning by our executive Chairman Bill Doyle.
CEO of soft on Burger and our CFO Ashley Cordova.
Other members of the executive leadership team will be available for Q&A.
Your reference slides accompanying this earnings release can be found on our website www dot dot com on our Investor Relations page under quarterly report.
Speaker Change: Before we start I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements.
These statements involve a number of risks and uncertainties some of which are beyond our control and are described from time to time in our SEC filings, we do not intend to update publicly any forward looking statement, except as required by law.
Where appropriate we refer to non-GAAP financial measures to evaluate our bedroom, specifically adjusted EBITDA a measure of earnings before interest taxes, depreciation and 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.
These materials can also be accessed from the Investor Relations page of our website.
Following our prepared remarks today, we'll open the line for your questions.
I will now turn the call over to our executive Chairman Bill Doyle.
Thank you Amy and good morning.
Our mission at Melbourne Cure is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor treating fields.
We have built a strong foundation treating glioblastoma and with an anticipated approval.
To treat second line non small cell lung cancer, we are on the threshold of helping many more patients in need.
As we approach this year's milestones the urgency of our mission is even greater for the entire Novocure team.
Entering 2024, we identified three key objectives, which would best position us for success this year and beyond.
One to grow our commercial business in Glioblastoma.
To launch TT field therapy in non small cell lung cancer and three to deliver on the promise of our clinical and product development pipeline.
These objectives are ingrained in our business units and had been rallying point for our global teams.
I am pleased to share that we are making significant progress on all three and with the focus and dedication of the entire Novocure team. We believe we can deliver on all three in 2024.
This morning, we will review our progress on each objective review our financial performance and then open the line for questions.
We ended the second quarter with 3963 active patients on therapy, our highest number of active patients since commencing commercial operations.
Our French GBM launch now in its fifth quarter continues to be a tailwind.
<unk> serves as a blueprint for a successful launch employing our new synchronized commercial structure blueprint, we will leverage and future expansion across the big five EU markets.
Speaker Change: Real world evidence of the benefits of <unk> therapy, as a key resource for engaging with prescribers in June at Astro, Dr. Olivier Bar of the General Hospital, a shock Lindbergh Allen.
Speaker Change: Resent the topline data from the Tiger trial.
<unk> examined TT field therapy, and the routine clinical care of newly diagnosed GBM patients in Germany.
Tiger is the largest perspective non interventional tiki field trial completed to date.
Dr Bar reported a median overall survival of $19 six months.
Speaker Change: And median progression free survival of $10 two months.
Corroborating, the leaving survival outcomes observed in our phase III yet.
<unk> trial.
Speaker Change: Last month in the journal of Neuro oncology.
Dr. Mark Gallardo of the Mayo clinic published updated findings from a post marketing safety analysis of over 25000 TT fields patients Dr.
Dr. <unk>: Dr. <unk> analysis confirmed that TT fields therapy was well tolerated and no signs of additive systemic toxicity were detected in the patient population.
Yes, 14 trial.
In April and the journal BMC cancer.
Speaker Change: Dr. Coon Tucker of northwestern published a qualitative review of key factors driving patient adoption of opportune Geo for the treatment of GBM.
Dr. <unk> team found that the two most influential drivers for adoption or knowledge of opportunity proven survival benefit and the treating physician opinion.
Real world evidence from trials like Tiger.
And Dr. Mark Gallardo and compact cars analyses are important additions to the ever growing body of studies supporting opportunity, though for the treatment of GBM.
And they underline our commitment to generate and share data with physician to support and broaden the adoption of TT fields.
We are also focused on product development to improve the patient experience.
We have rolled out our next generation arrays in our key European markets and patient feedback continues to be positive.
Speaker Change: We submitted a PMA supplement to the FDA in December and expect a decision from the FDA later this year.
After approval, we will commence U S rollout.
Our team is working on improvements to the digital experience for prescribers and patients with the goal of providing dashboards to streamline patient starts and optimize usage and persistence.
We believe our fully align commercial approach supported by real World evidence and digital innovation will help to drive strong commercial performance in the second half of the year.
Our second key objective. This year is the approval and launch of <unk> for the treatment of metastatic non small cell lung cancer.
Regulatory submission had been filed and we are engaged with the authorities in all of our major markets.
As a reminder, prior to our May earnings report, we had recently completed our 100 day meeting with the FDA with no indication that the PMA will be referred to our panel.
To date, our panel has not been requested and our expectations remain unchanged.
Eagerly await the FDA decision later this year.
In Europe, we are waiting for CE Mark approval.
MBR process in Europe has lengthened timelines and we continue to engage with new reviewers at the Rhineland our EU notified body.
While the review process has taken longer than originally projected.
Spector outcome has not changed and we anticipate a final decision in the second half of 2024.
Internally, our German and U S. Lung teams are hired and are preparing to launch immediately following regulatory approval.
We plan to treat patients in the U S and Germany as soon as possible following approval using a named patient reimbursement process with additional country launches expected next year.
Non small cell lung cancer represents the next major step forward in the <unk> story, and we are eager to pursue this opportunity.
We will now review our clinical progress in the quarter.
As Bill mentioned, our third key objective this year is to deliver on the promise of our pipeline.
This quarter, we made significant progress towards achieving that goal across our clinical programs in GBM non small cell lung cancer and pancreatic cancer.
We have reached a key milestone.
Small cell lung cancer program.
Last month, Dr. <unk> Mehta of Baptist Health, South, Florida presented data from the Phase III Metis trial at the Ash annual meeting in Chicago.
<unk> evaluated the use of <unk> therapy with best supportive care for the treatment of brain metastases from non small cell lung cancer.
Betty Smith its primary endpoint, demonstrating a median time to intra continental progression of $21 nine months in the TT field compared.
Compared to 11 three months in the control arm.
Speaker Change: A positive trend in the majority of assessing quality of life scales was also measured and there was no evidence of worsening cognitive function in the <unk>.
Consistent with prior clinical trials TT fields therapy was well tolerated with no additive systemic toxicity final analysis of the Metis trial data is ongoing.
We intend to publish the data in a peer reviewed journal later this year.
Speaker Change: We have expanded our non small cell lung cancer clinical program to include another registrational phase III trial lunar two.
Speaker Change: Two we will explore TT fields views with embolism lab and platinum based chemotherapy in first line metastatic disease. This trial is open and enrolling at initial sites and we are focused on expanding the clinical footprint.
We are also in the process of opening a phase II pilot trial for.
This trial will evaluate immunotherapy treatment in metastatic non small cell lung cancer.
Turning to keynote <unk> <unk> 36, we are evaluating appropriate next steps for this trial given its pace of enrollment and our focus on lunar two.
Our GBM program includes two additional Registrational phase III trials, Trident and keynote <unk> eight.
Trident is exploring the use of Optum Gilles concurrent with chemo radiation.
Right and is successful we will work to expand our label and enable physicians to prescribe TT fields therapy, several months earlier with chemo radiation rather than after chemo radiation as is indicated today.
And is fully enrolled and we'll read out in 2026, one followup is complete.
We are also preparing to open keynote <unk> eight.
The 58 will explore the addition of embolism up two TT fields and team was <unk> in GBM and builds upon the promising results of the two the top phase II trial conducted by Dr. David trend.
Finally, we are nearing an important readout in our country.
The concept program.
In the fourth quarter, we expect to announce the topline data from the phase III Panorama <unk> III trial, which is I think TT fields together with <unk> and Paclitaxel for the treatment of first line locally advanced pancreatic cancer.
We are also currently enrolling patients in our phase II Pan over for trial. This slide is exploring the use of our tests Iliza Mab with TT fields, James Cytarabine and Paclitaxel in metastatic pancreatic cancer.
<unk> cancer is a devastating diagnosis with five year survival rates of 10%.
Speaker Change: We are eager to learn more about the potential benefits of using TT fields in the treatment of this aggressive disease.
So far this year, we have reached one successful phase III readout in matters and are hopeful for a second in panel three.
We are awaiting potential regulatory approvals in lung cancer, and our solid commercial GBM business continues to fuel additional R&D initiatives.
Speaker Change: We are launching several new clinical trials this year that have the potential to expand TT fields us dramatically.
We are pleased with our progress this year and are eager to continue pursuing our goal to deliver the promise of the clinical pipeline.
I look forward to providing further updates later this year.
Speaker Change: <unk> will now review our financial performance for the second quarter.
Thank you Ashok.
The second quarter was a period of consistent execution as we drive towards our three key objectives for 2024.
Our GBM business turned in the best quarter to date, we are laying the groundwork for launch and non small cell lung cancer, and we continue to purposely ambac and clinical research and product innovation.
Speaker Change: Walking down the P&L, we generated $150 million in Q2 net revenue.
Increase of 19% year over year.
Ended the quarter with 3963 active patients on therapy.
An increase of 11% year over year.
Speaker Change: The French market continues to be a tailwind to growth.
Contributed $14 million of net revenue this quarter with 369 active patients.
We also continue to see a benefit in average selling price from improved approval rates in the United States.
Speaker Change: I want to call everyone's attention to two important points on the revenue model.
Speaker Change: Beyond the benefit in period improved approval rates in the U S generated a $5 million benefit in Q2 net revenues from prior period claims.
In addition, we received $3 million in Q2 net revenues from our private payer and the United Kingdom, where payments are not yet breaking.
Speaker Change: We do not expect <unk> to benefit totaling $8 million to recur.
Remove them from baseline expectation when projecting future revenue.
Speaker Change: Gross margin for the second quarter was 77%.
SG&A expenses totaled $94 million in the quarter, a decrease of 5% year over year.
This decrease was primarily driven by lower personnel expenses and support function, which more than offset our continued investment in sales force expansion ahead of a non small cell lung cancer launch.
Research development and clinical trial expenses totaled $55 million in the quarter in line with the same period in 2023.
Speaker Change: Our net loss for the second quarter with $33 million or <unk> 31 per share.
We ended the quarter with cash and short term investments of $951 million.
This quarter, we saw positive adjusted EBITDA of $1 million, an increase of $28 million from the same period in 2023.
While this was in part due to the onetime revenue contributors.
Also saw material benefits from reduced operating expenses, resulting from the strategic restructuring we undertook at the end of 2023.
As we actively invest for growth.
<unk> ability remains a critical goals for asset Novacare and something we are actively driving toward.
I would like to close this morning by highlighting one of our <unk> users laurino jewelry Enzo.
Marino began using <unk> in January 2022, following the bulking surgery.
A father of twin adult sons, and a grandfather of three Marino prides itself on living an active like and was eager to get back on his feet as soon as possible. After his GBM diagnostics.
Marina was able to integrate tumor treating fields therapy into a daily activities quickly and was soon back on the baseball field with the song and playing golf with friends.
Speaker Change: Marino is the embodiment of living each day to the fullest and a great reminder of what's at stake and extending survival for our patients.
It is so fulfilling for our colleagues to be able to help Marino and his family and I'd like to personally thank marino for allowing us to be a part of his journey.
With that we will open the call for your questions.
Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again one moment.
Our first question comes from Jonathan Chang of Leerink Partners. Your line is open.
Hi, guys. Thanks for taking my questions can.
Can you give us an update on the Luna regulatory process in Germany, and the U S. You mentioned, a new process in Europe I believe could you give us additional color on that front and finally could you just confirm your current thinking on timelines in both Europe and the U S. Thank you.
Sure Jonathan Good morning, This is bill.
So as we stated in the.
Prepared remarks.
Our expectations with respect to.
Approvals in Europe, and the U S have not changed.
The FDA timeline also remains unchanged.
Speaker Change: And.
Importantly in the U S. We still believe there will not be a panel we have not received any indication.
Speaker Change: As we mentioned in the 100 day meeting that we had or subsequently.
That the PMA will go to panel.
Speaker Change: In Europe, it's not a new process for us, it's a new process for Europe called the MTR process.
Speaker Change: That has to some degree lengthen the timing from submission to approval for everyone in.
In the medical device space.
Actually we had projected.
At approval in the first half.
We're actively interacting again as we mentioned with our notified body.
And we now expect that to occur in the second half. So that's the only change.
Understood are you able to elaborate on on the <unk> process are there.
Speaker Change: What are the boxes that need to be checked.
Speaker Change: Yes, so we never talk about the specific back and forth other than to say.
It's constructive and again, we don't expect we still expect.
The same outcome, we just expect it to be a little later in the second half.
Understood. Thanks for taking my questions.
Thank you.
Our next question comes from Jason <unk> of Piper Sandler Your line is open.
Okay.
Hi, good morning, nice quarter everyone.
Couple of questions to start from us.
Wanted to focus first and that maybe the commercial side.
The U S active patient number improved sequentially for the first time in a year.
That was good to see can you talk about the sustainability of this type of improvement how do you build upon that going forward.
Speaker Change: Or should we more simply think of this.
Active patient number remaining them around 2200 patients or so going forward.
Speaker Change: Then actually I think you also said that your payer approval rates continued to improve in the U S. How would you have us think about U S revenue in the context of that comment.
Speaker Change: Does your revenue algorithm change near term or revenue per patient change near term and how we calculate and model that out.
Speaker Change: Hi, Jason This is Frank Thank you for the question appreciate the note on the commercial performance. Yes. We are just looking globally before I come to the U S. We're really pleased that we've now approached 4000 patients.
On therapy worldwide and that is a high watermark for us.
Speaker Change: With respect to the U S. What we have been able to do is to to return the active patients to sequential growth from year end as you noted.
Speaker Change: And as a reminder, at the end of last year, we did realign our organization. So that our teams have a focus our commercial teams have a focus not just on driving demand as measured through prescriptions coming in.
Speaker Change: But really have a comprehensive plan to then convert prescriptions to starts and then ensure that the patients can stay on therapy to enjoy the full benefit of the therapy.
Speaker Change: So I think what you have seen in the numbers last two quarters is our ability to tighten up operations and to really ensure that we do maximize the value of each prescription coming through.
And maximize the benefit to the patient.
As you know, we don't give guidance looking out into the future.
So I won't comment specifically on where we see this number going.
But I'll remind you as always that we do believe there are more patients who can benefit from the therapy and as an organization. We're committed in all of our markets.
Ensuring that we drive growth and help the most number of patients possible.
Speaker Change: Great and Jason This is Ashley I'll jump in with some commentary on that net revenue per patient.
It's clearly call out $8 million from this quarter as net revenue, which we believe essentially or I don't like that the one term in nature because fundamentally it's improvement in approval rates is recurring but the benefit in the quarter, we get both the catch up benefit and the yen quarter benefit if you take.
That $8 million out of the Q2 net revenues you can then use that net revenue per active patient.
Number of projecting forward in the model and specifically in the U S, which is where you see the improved benefit from the approval rate.
Speaker Change: That 5 million Youll see the improvement that's about 200 basis points year over year and that is sustainable.
I do believe that the improvements here will endure but you don't get both the catch up and the improvement every quarter maybe important.
Got it okay. That's helpful. Thanks, Frank and makes Ashley.
One clarifying follow up from the prior question.
Speaker Change: Bill did you did you say that CE Mark is now expected later in the second half so basically implying that it's a fourth quarter target.
So I just wanted to check on that if I heard that right and then just wanted to see if you have any updated thoughts or perspective on the regulatory path for for Med is just how youre going to proceed there. Thank you.
Sure. So I did not say late in the <unk>.
Second half for CE Mark.
And then maybe you want to comment on.
The next steps for the matter of submission. Thank you.
So we ranked <unk> evaluating.
And finalized our analysis and preparing for a submission in.
We are planning to do it.
In the near future.
Speaker Change: Let.
Everyone know exactly which department.
FDA.
But we are working on.
Maybe to follow up quick as any is this something we should expect submission before year end is this a 25 just die.
Dynamic just trying to understand.
As we kind of pencil things out from a milestone standpoint, where medicine is going to land.
Speaker Change: So.
But our goal is to try to finalize this year.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Thank you.
Our next question comes from Larry <unk> of Wells Fargo. Your line is open.
Good morning, Thanks for taking the question just.
A follow up on that last response.
A soft when you say our goal is to finalize this year I assume just maybe this is just a little bit of a language barrier, but when you say finalize youre, saying, we plan to submit the metis.
Speaker Change: Application in 2024 in the U S and Europe is that what you meant by finalized this year.
Yes.
Okay.
Okay, and maybe just to follow up on that is what are you guys hearing from clinicians how do they see tumor treating fields.
Fitting into the treatment paradigm and I had a follow up.
Yes. Thanks, Larry This is Frank Thank you for the question.
What I can say is that we.
We unveiled the data from <unk> at <unk>.
In June and.
We really saw across the board strong interest in understanding the data I think I'd also just shared the anecdote that at <unk> This year.
Speaker Change: We saw just broader awareness of tumor treating fields across all of the indications, where we've released data and I think you're really seeing that.
Speaker Change: Strong interest first.
First from the radiation oncology attendee.
Speaker Change: Attendees, but also from the medical oncology attendees.
Strong interest really really focused on the fact that the delay in time to progression is a clinically meaningful endpoint in terms of helping patients with brain Mets. So.
Really pleased with what we saw at <unk> this year and were.
Speaker Change: We're encouraged to move forward with clinicians to help these patients.
Yes.
Speaker Change: And the treatment paradigm what are you hearing.
Well I think that is.
Sorry, I'm not sure I fully understood the question, but I think in terms of.
Speaker Change: Details on.
Yes.
Drugs may be used concurrently or the exact specific patients.
Some of the analysis is still ongoing from the trial and we will we will update you as it becomes available.
Okay, and then on B 36.
Can you.
You provided a little bit of an update in the prepared remarks there.
How many patients have been enrolled what are the options for the next steps and how does that impact how you think about enrollment of lunar two I guess.
Speaker Change: It's taken a long time to enroll <unk> 36, I guess the concern is that it.
It's going to take you know equally long to enroll lunar two.
Thank you very much for that great question I think.
Something is very very important B 36 is not limited to.
Speaker Change: Different aspects, so what we said.
Is that.
Speaker Change: We are just evaluating appropriate next steps will be taken out let me remind you what Pisa 86.
Speaker Change: <unk> phase two study.
First line.
Non small cell lung cancer with monotherapy Perm growth and just to remind you monotherapy pan-broil eight 5%.
Speaker Change: Patients in the U S and it's a trial just being run in the U S and again, it's a phase III trial in our phase II trial.
Speaker Change: The characteristic to lead us with phase III trials and inform us.
Speaker Change: How we need to run phase III trials.
Lunar two is a phase III pivotal trial.
That is exploring TT fields.
Platinum based chemotherapy.
Chemotherapy, which is one of the main foundation in.
Speaker Change: U S patient leased and about 95%. So we are having a very very very different situations.
Got it and just one maybe if I could sneak it in for Ashley with multi tranche financing.
Speaker Change: Are you now more likely to meet the 2025 convert using cash now can you be more specific on the planned uses of the financing.
Speaker Change: Beyond the convert thank you, yes, we're quite confident that we now have been strengthened the balance sheet to pay down that convert so I don't anticipate.
Any challenges there.
Okay, great. Thanks for taking the questions.
Thank you.
Speaker Change: Our next question comes from Jessica Fye of Jpmorgan. Your line is open.
Hey, guys. Good morning, Thanks for taking my questions.
Jessica Macomber Fye: You talked about France, as a nice growth contributor and broke it out for <unk> can.
Jessica Macomber Fye: Can you tell us what France sales were in the first quarter and talk about how we should think of its contribution in the back half.
Then following up on the earlier comments on U S. Net price I think I heard sort of a clean 200 basis point year over year improvement.
Net selling prices are sustainable is that and we will eventually annualize over that and be done or is there more room to run on U S net selling price and if so how much. Thank you.
Yes, Jeff this is actually I can jump in there with a specific modeling questions and then follow up with any color on France.
Speaker Change: In the first quarter, France was about $10 5 million and you saw that second quarter 14, it's always a nice milestone when you cross into being a material market, so France will be broken out for Huron.
Again, congratulations to the entire French team for that it's really an awesome milestone.
So we do continue to see growth there and our growth will moderate as that market matures, but it is approaching.
Jessica Macomber Fye: Approaching a German like sized market now and we expect to continue to perform as we move forward.
If we move over to the U S price all challenged that team always to get better and I know I have a team there that's focused in market on drawing it but we are.
Jessica Macomber Fye: We're approaching approval on almost all patients in the U S. Now so there is not much more room to grow in our commercial payers.
This is a very sustainable improvement, we think we can hold it.
Jessica Macomber Fye: Please after kind of incremental bits that we can get but I want to manage expectations at that net price in the U S. Now is in the range of ammonia price to model moving forward.
Jessica Macomber Fye: This is Frank I'll add just a bit of color on the business in France and repeat what we said during the prepared remarks, which is France is really our blueprint for success in launching.
Speaker Change: We prepared the market with a team at both the business teams. The medical teams, we had clinical trials open in the market in advance of actually getting approval and getting reimbursement.
Jessica Macomber Fye: <unk>.
Jessica Macomber Fye: We are very pleased with the results and we're quite frankly ahead of schedule of where we expect it to be in France in terms of market penetration it's.
It's exciting we're now crossing over a little bit more of a five quarter is a little bit more than a year into the launch and.
Still seeing the excitement from our clinicians and also from the patients who are now coming a year into the therapy. So it's.
Jessica Macomber Fye: It's really our blueprint for success in the future.
Speaker Change: Thank you.
Our next question comes from Vijay Kumar of Evercore ISI. Your line is open.
Vijay Kumar: Hey, guys. Thanks for taking my question.
Vijay Kumar: Couple of modeling related questions.
Jessica Macomber Fye: <unk>.
Speaker Change: Utilizing north of 50 million.
Speaker Change: Is that.
Speaker Change: Have you sized that market opportunity.
Speaker Change: Is this is this.
Speaker Change: Is this expected to continue.
Speaker Change: Strong sequential trends into next year.
Speaker Change: For comparison like what was <unk> revenue base in fiscal 'twenty three.
Vijay Kumar: Yes, I mean, I would anchor you to say Vijay for instance, German life and advising and we expect those to be our two largest European markets and then as we look ahead, we do expect to be able to begin to bring on.
Vijay Kumar: Additionally, they die markets on which will add more revenue it is German like in this opportunity.
Speaker Change: Yes, we continue to expect growth out of all of our markets I will say as it ramps up its.
Speaker Change: It's growing off of a solid base and of course, we have to keep that in mind, but it is a market we expect to be Germany like inside.
Speaker Change: And sorry on the revenue base in fiscal 'twenty, three which was France in fiscal 'twenty three.
Speaker Change: I don't think we broke that out and 23 I will tell you.
Speaker Change: Yes, I mean, if you look at the other EMEA market, which we do break out in our Q D. J divestments of our EBITDA a threat.
Speaker Change: Understood and then.
Speaker Change: Reimbursement work not friends.
Speaker Change: When I look at that.
Speaker Change: Net patient revenue in.
Speaker Change: And the other EMEA region like that's tracking about Germany.
Speaker Change: And when we look at Germany, I think once you had national.
Speaker Change: In our payments kicking.
Speaker Change: Great Scott cut so his friends is there any risk of <unk>.
Speaker Change: Future updates for reimbursement rates or is this all set and done.
Speaker Change: Yes, so the short answer is not unexpected Vijay.
Speaker Change: So long answer I know this is an important distinction is that we have two markets where we go.
Speaker Change: At risk of reimbursement on a named patient basis, how much does the U S and Germany, new hero and lung, that's where we will launch and the other markets its national reimbursement and we do not launch until we have reimbursement secure so that is how we handle France that is how we will handle all other markets outside of the U S and Germany to that revenue is stable and durable.
Speaker Change: Understood. That's helpful. Maybe last question on <unk>.
Speaker Change: On this.
Speaker Change: Canola pancreatic cancer can you maybe high level.
Speaker Change: <unk> had several trials.
Speaker Change: GBM.
Speaker Change: Metastatic brain cancer NFC.
Speaker Change: <unk> when you look at pancreatic cancer.
Speaker Change: Is there anything different about this disease state when you compare versus the others when you've looked at.
Speaker Change: We experienced.
Speaker Change: Early data on pancreatic site.
Speaker Change: How does that compare versus other disease states.
Speaker Change: The thing that sets apart pancreatic opportunity for you guys.
Bill: Sure So Vijay it's bill.
Bill: As we've noted in the past.
Bill: <unk>.
Speaker Change: Tumor treating fields.
Bill: Provides the best opportunity to extend survival when it's used early in the patient journey.
Bill: In many cancer types and this was true in non small cell lung cancer, just because of the way the field has.
Bill: As evolved and we need to start our trials in later lines when the patients are sicker.
Speaker Change: In the case of <unk> three that trial was designed as a first line trial. So number one that is positive with respect to tumor treating fields therapy.
Bill: Currently.
Bill: We know that we are a regional local therapy.
Bill: And that we and we saw this in the phase two.
Bill: <unk> data that when we can treat the full extent of the disease.
Bill: And that means diagnosing it earlier when it has only spread locally we have the best.
Bill: Outcomes and again in this trial <unk> three this trial was in the about 50% of the patients who receive a pancreatic cancer diagnosis, who have locally advanced therapy. So.
Bill: Because it's first line and because it's.
Bill: In the locally advanced population.
Bill: We think the trial is well designed and if we had designed it today, we would have designed it with the same.
Bill: Design. So we're all really looking forward to reporting out the results later this year.
Speaker Change: That's extremely helpful comments from maybe one last follow up on that.
Speaker Change: When you say.
Speaker Change: Given it's a local recently is that.
Speaker Change: Is that how does that does that mean.
Speaker Change: Tumor needs to be fixed.
Speaker Change: Early stage stage, one stage two cancer as against Phase III.
Speaker Change: 50% of patients so at the time of diagnosis are 50% of pancreatic.
Speaker Change: Cancer cases in the first stage one stage two.
Speaker Change: Yes, So let me.
Speaker Change: Our understanding is that.
Speaker Change: In the U S.
Speaker Change: Pancreatic remember, we're not all being scanned for pancreatic cancer every year.
Speaker Change: About 10% of patients are diagnosed.
Speaker Change: Usually by accidental findings when they have pancreatic cancer that is offer.
Speaker Change: They will receive surgery. The remaining 90% are diagnosed pass the point when it's operable.
Speaker Change: Those some.
Speaker Change: But numbers, but 35, 40% are again diagnosed when it has expanded locally and the remaining 40% 45%. It is already systemic in metastatic throughout the body. So.
Speaker Change: <unk> three <unk>.
Speaker Change: Is focused on those patients where the.
Speaker Change: That are not one not operable, but to the pancreatic cancer has not spread into the bones in the brain and the rest of the body.
Speaker Change: That's helpful. So the enrollment criteria, we're looking at those cases, 10% accidental diagnosis in the 35% to 40%.
Speaker Change: Core local correct.
Speaker Change: So that patient a 35% to 40% so the patients who were not operated on.
Speaker Change: And where the diseases again, the term of art here is locally advanced.
Speaker Change: Fantastic Thanks, guys.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Our next question comes from Emily <unk> of HC Wainwright. Your line is open.
Emily: Hi, Good morning, Thanks for taking my question I wanted to follow up on the keynote B 36 study.
Speaker Change: Is there anything that you've seen in that study so far and the patients you've enrolled that kind of gives you more confidence in lunar two.
Speaker Change: And then just kind of following up on other markets for opportunity.
Speaker Change: Are there kind of other countries are you looking at what you think could be similar in size to the France, and Germany markets. So far thanks.
Speaker Change: So I'll take I'll take the first part of the question.
Speaker Change: I think we usually do not comment.
Speaker Change: About findings.
Speaker Change: Running trials.
Speaker Change: As far as I understood. Your question, maybe I misunderstood.
Speaker Change: Oh.
Speaker Change: I just wonder if you have seen anything that gives you confidence and lunar two.
Speaker Change: As I said before.
Speaker Change: 36, <unk> to two completely different trials and that does not in any way change the confidence I have in new night.
Speaker Change: Excellent.
Speaker Change: With respect to new markets.
Speaker Change: We have commented before that up next on the Horizon, we are working in both Italy, and Spain, which are in each country. It's a region by region approach to gaining reimbursement with hospitals and payers.
Speaker Change: And we're making progress in both markets, and we think Italy, and Spain, together as being our next potential France in terms of the market.
Speaker Change: Got it thank you for taking the question.
Speaker Change: Thank you I'm showing no further questions at this time I would like to turn it back to Bill Doyle for closing remarks.
Speaker Change: We entered 2024 with three key objectives for the year and also to position us for the future.
Speaker Change: Those were to grow and return to growth at our GBM business.
Speaker Change: To launch our indications in the U S and Germany in non small cell lung cancer and to deliver on the promise of our clinical and product development pipelines.
Speaker Change: We're very pleased this morning to be able to report progress across all three.
Speaker Change: And we look forward to the balance of the year, where we have significant catalysts.
Speaker Change: So thank you for your continued interest in Novocure. Thanks for all the Novocure employees, who are listening.
Speaker Change: For your dedication.
Speaker Change: It's an exciting time and we will be here.
Speaker Change: For Q3, thank you.
Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect.
Speaker Change: Okay.
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