Q2 2025 Novocure Ltd Earnings Call
Good day, thank you for standing by. Welcome to know second quarter 2025 earnings conference call. At this time, all participants on the list and only mode after the speaker's presentation, there will be a question and answer session to ask a question during the session. You will need to press star 1, 1 on your telephone. You will then hear an automated message advising. Your hand is raised.
Speaker Change: Please note that today's conference may be recorded. I will now hand the conference over to speaker host. Ingrit Goldberg, please go ahead.
Ingrit Goldberg: Good morning and thank you for joining us to review NovaCare second quarter, 2025 performance.
Speaker Change: I'm on the phone this morning with our executive chairman Bill, Doyle CEO, Ashley Cordova, and CFO Kristoff Rahman. Other members of our executive leadership, team will be available for Q&A.
Speaker Change: For your reference slides accompanying, this earnings release can be found on our website. Www.novacare.com on the investor relations page under quarterly reports,
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 form of looking statement except as required, by law.
Speaker Change: Where appropriate, we will refer to non-gaap financial measures to evaluate our business. Specifically adjusted Eva a measure of earnings before interest taxes depreciation amortization, and share based compensation.
We Believe adjusted Eva does an important metric as it removes the impact of earnings attributable to our capital structure tax rate and material non-cash items and best reflects the financial value generated by our business.
Speaker Change: Reconciliations of non-gaap to gaap financial measures are included in our press release earnings flies and our form 10 cue file with the SEC today.
These materials can also be accessed from the investor relations page of our website.
Speaker Change: 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.
Bill Doyle: Thank you, ingrit and good morning.
Bill Doyle: At novocure, our mission is to extend survival for patients diagnosed with some of the most aggressive forms of cancer through the development of tumor, treating Fields, therapy.
Bill Doyle: This quarter, we grew our Commercial Business and advanced our efforts to bring tumor treating Fields, therapy to new patient. Populations.
Bill Doyle: With the first half of 2025 complete, I am pleased to report. We are making good progress on our clinical Regulatory and Commercial milestones.
Bill Doyle: This morning.
Bill Doyle: We will provide details concerning recent pinova, 3 data presentations, at 2 key medical conferences. And we will review the next steps for our upcoming regulatory submissions of pinova 3 in Mattis.
Bill Doyle: We will also discuss our commercial performance in the quarter. And to close, we will review our quarterly financials and open the line for Q&A.
Bill Doyle: While our commercial teams pursue greater penetration in improved indications, we are working intensely to gain approvals in new indications.
Bill Doyle: This quarter, we took important steps towards approval in pancreatic cancer.
Bill Doyle: The 5-year survival rate for patients, diagnosed with pancreatic cancer is only 13% and pancreatic cancer is often associated with debilitating pain.
Speaker Change: For which patients are quickly, escalated to high doses of pain medications.
Speaker Change: Addressing these needs sets, a high threshold for success in pancreatic cancer trials.
Speaker Change: Trial.
Speaker Change: Proved the benefit of TT Fields therapy together with gemcitabine and nabpac with taxol for both of these endpoints.
Speaker Change: In may, we had an exciting Presence at the ASCO annual meeting where data from pova 3 were presented during the Saturday evening. Pancreatic cancer plenary session.
Speaker Change: The pinova 3 findings were concurrently published in the journal of clinical oncology or Joe and earned inclusion in best of ASCO, which will be highlighted at Regional ASCO meetings throughout the year.
Speaker Change: As a reminder, the pinova 3 intent to treat population.
Speaker Change: In unresectable locally Advanced pancreatic cancer patients, treated with TT Fields together with genocide of being in nabla. A taxol saw a median overall survival of 16.2 months.
Speaker Change: 2 months greater than the control arm.
Speaker Change: In the modified intent to treat population of patients who received at least 1 cycle of therapy. Patients on even greater survival benefits of over 3 months.
PT Fields. Patients also saw a benefit in pain-free survival with a median, time to increase pain in the intent to treat group of 15.2 months versus 9.1 months in the control group.
Speaker Change: Following the presentation.
Speaker Change: Session discussing Dr. Brian wilpon of Dana Farber who played the role of objective. Reviewer said TT Fields, plus gem side of being in npap plaxel would be an appropriate option for standard of care.
Dr. Eileen O'Reilly of Memorial Sloan Kettering, Cancer Center commented in the Joe editorial.
That tumor treating Fields together with gemcitabine and napaka taxol serves as a new standard Paradigm in this patient population.
Speaker Change: These Physicians.
Speaker Change: Patients treated with TT fields in gem side of being a napaka taxol. So improved Global health status, significantly improved deterioration free, survival for pain and pancreatic pain and significantly increased time to commencement of opioid use.
Speaker Change: Anova 3, showed TT Fields ability to extend survival.
Speaker Change: Preserve quality of life and delay. Many of the worst symptoms associated with pancreatic cancer.
Speaker Change: These clinical outcomes underscore the importance of TT Fields therapy for these patients.
Speaker Change: And given the extremely limited options for pancreatic cancer. Patients, the feedback from Physicians Kos and advocacy groups following. These presentations has been overwhelmingly positive.
Our teams are working on the FDA PMA submission for pancreatic cancer.
Speaker Change: Earlier this month, we met with the FDA for a pre-submission discussion in anticipation of submitting. Our full PMA package for FDA review.
Speaker Change: We expect to file the PMA with the FDA in the third quarter.
Speaker Change: Concurrently we are working on the regulatory packages for Europe and Japan and expect to file these prior to year end.
Speaker Change: Frame metastases from non small cell. Lung cancer is our next potential indication.
Speaker Change: The metis trial met its primary endpoint demonstrating a, statistically significant Improvement in the time to enterin progression for patients, treated with TT Fields, therapy, and supportive care compared to patients treated with supportive care alone.
Following our initial data presentation at ASCO. Last year, the routine process of cleaning and qualification of the data was completed.
The final analysis of the fully cleaned and qualified data, set confirmed, the statistical, significance of the primary endpoint.
Speaker Change: Improvement in time to Interra progression with updated numerical outcomes.
Patients, treated with TT Fields, therapy, and supportive care, exhibited a risk reduction of 28%.
Speaker Change: With median time to Interra progression of 15 months compared to 7.5 months. In patients, treated with supportive care alone,
with a P value of 0.044.
Speaker Change: And if submitted the manuscript for publication.
Speaker Change: Our teams are also working on the FDA PMA submission for brain, metastases from non small cell, lung cancer.
Speaker Change: We submitted the first 2 pm modules in April.
Speaker Change: We will be meeting with the FDA this quarter prior to submission of the final clinical module, which is on track for submission later this year.
Speaker Change: For both pova 3.
Speaker Change: And Mattis PMA filings. We expect the 9 to 12 months review, following acceptance by the FDA with potential approvals and launches to follow in 2026.
Speaker Change: Our next clinical data readouts are anticipated in the first half of next year.
Speaker Change: The phase 3, tried and trial and newly diagnosed GBM studies. The potential benefits of initiating TT Fields therapy several months earlier in the patient's Journey, concurrent with chemo, radiation rather than after chemo radiation.
Pinova 4 is a phase 2 trial that adds the immunotherapy. As Tesla is anub to TT Fields, gem Saito bean and NAB pack with taxol in the metastatic pancreatic cancer setting.
Speaker Change: Both trials are fully enrolled and we look forward to sharing updates in the near future.
Speaker Change: With that, I'll turn the call over to Ashley to review, our commercial progress in the quarter.
Ashley: Thank you, Bill.
We are squarely focused on execution and I am proud of what the team has delivered so far this year.
Ashley: We have reached multiple Milestones on our path to bring tumor. Treating fields, to more patients, and have additional catalysts on the horizon.
1 of our key areas of focus is the optimum mua launch and non small cell lung cancer.
Ashley: In the second quarter, we received 121 prescriptions for non small cell lung cancer 106 and the US and 15 in Germany, which launched following receipt of the CE mark on April 22nd of this year.
Ashley: We ended the period with 137 optune, Lua, patients globally. 94 from non swasta lung cancer, and 43 from npm.
Ashley: Importantly, we are beginning to build reimbursement experience and recognize 2.4 million dollars in net revenues from Optimum Lua in the quarter of which 1.1 million was from non swallow on cancer.
We are pleased that many of the launch themes. We described last quarter have continued in the US.
Ashley: In Q2, we had 75 unique prescribers of optimum Lua.
Ashley: 41 of those Physicians were entirely new to tumor treating Fields therapy while 34 had previously prescribed.
Ashley: This shows a healthy mix of Physicians recognizing the clinical benefit, and trying tumor treating fields for the first time and repeat prescribers.
Ashley: Additionally, we can continue to see the full label utilized with 58% of prescriptions written together with immune checkpoint Inhibitors and 42% with dosa. Taxol.
Ashley: Importantly, over 93% of the of the patients prescribed Optima with an ICI, had previous ICI exposure.
Ashley: Validating the strong, demand and physician comfort with continued. ICI, use post Platinum failure.
Ashley: 1 theme, we have observed since launch. Is that prior physician experience to tumor, treating Fields, matters.
Ashley: Whether that's firsthand. Prescribing oportun Geo and GBM or Optima for mpm.
Ashley: Or through access to a colleague, with tumor treating Fields experience.
Ashley: Physicians are excited by the clinical outcome, seen in the lunar trial. However, some Physicians have questions on how to incorporate tumor treating Fields into their daily practices.
Ashley: We answered these same questions. When we introduced tumor treating fields to the gvm community.
With this in mind, we have been cultivating peer-to-peer connections so practitioners new to tumor treating Fields can access Physicians with years of opportunity Gogh experience.
Ashley: We have seen promising feedback from these peer-to-peer conversations so far and believe continuing to Foster. These relationships will pay dividends as new indications come to the medical community in the future.
Ashley: We have also learned that many Physicians view, the best use case of Optima, as a replacement for platinum chemo at the first sign of radiological progression rather than explicitly a transition to Second Line treatment.
Ashley: This represents the smoldering progression population. We have referenced throughout our market research.
Ashley: We are tweaking the position messaging around Optum mua to a post Platinum option rather than explicitly second line therapy to better. Align with the way. Doctors view the patient treatment Journey.
Moving outside of the US. In late April, we received the CE, Mark for non swallow on cancer, and launched in Germany with 15 prescriptions in the quarter.
Ashley: We are pleased with the early interactions with prescribers especially pulmonologists who take an outsized role in nonso, lung, cancer, treatment in Germany. Compared to the US.
Ashley: Interests from Physicians has been high and our sales teams have been able to get on calendar, swiftly.
Ashley: We also see similar dynamics of broad label, usage and prior ICI. Exposure in Germany. As we have seen in the US.
Ashley: Japan is the next Market where we expect to launch Optima for non small cell, lung cancer.
We are actively engaged in discussions with Japanese regulators and are hopeful. We will have approval in hand in a matter of months.
Ashley: We Believe Japan will be a strong market for non swallowing cancer as incidents rates are higher in Japan than, in many of our other major markets,
Ashley: Also, single-payer Dynamics can expedite, the revenue ramp timeline once terms are agreed.
Ashley: Similar to what played out in our GBM launched in France, over the past 2 years.
Ashley: We are doing everything in our power to expedite the approval and reimbursement processes in Japan, and look forward to providing more updates later this year.
Ashley: The next step in non swallow. Lung cancer will be translating demand into Topline Revenue growth.
Ashley: We have had some early success in case by case, reimbursement submissions with over 1 million dollars in cash recognized this quarter from naans cancer and are actively engaged with both public and private payers in the US to reach reimbursement terms as soon as possible.
Private payers are focused on updated guidelines from nccn.
Ashley: The nccn, lung cancer panel met earlier this month. And we expect updated guidelines to be published this fall.
Ashley: On the public side, we have submitted our package for LCD reconsideration and are now waiting to hear back from the masks.
Ashley: Once an updated LCD is released and public, and the public comment period is complete. The max will issue a coverage decision.
There isn't a statutory timeline for review. But we estimate, the review will take approximately 9 to 12 months.
Bill Doyle: Turning to our GBM business. We continue to March higher and finished the quarter with 4,194. Optune Geo patients on therapy a 7% increase compared to last year.
Bill Doyle: Each of our key markets, the US Germany, France and Japan increased their patient count year-over-year with all our xus markets, experiencing double digit growth.
Bill Doyle: We are also starting to see early reimbursement success in Spain.
Bill Doyle: While the Spanish Market is fragmented, we are encouraged by the progress.
Bill Doyle: 1 of The Avenues to drive GBM growth is ongoing evidence generation.
Bill Doyle: This quarter and independent retrospective study from the Mayo Clinic was published in the journal of clinical neuroscience.
Bill Doyle: This study followed 374, GBM patients treated at Mayo Clinic locations between 2014 and 2023.
Speaker Change: Academic centers have not historically been the highest adopters of tumor treating Fields therapy. So it's notable to have a leading research institution, like Mayo Clinic, conduct this retrospective study.
Speaker Change: In this real world, study patients, treated with tumor treating Fields therapy, demonstrated a 2-year survival rate of 58% compared to just 41% in patients, not treated with tumor treating fields.
Speaker Change: The Mayo study is another example of confirmatory data, and reaffirms, why optune go is a foundational therapy for GBM patients.
Speaker Change: We believe more real world use data from leading research. Centres like Mayo will be an important lever as we seek to increase adoption and academic centers.
Speaker Change: Before I turn the call over to Kristoff to review. Financials from the quarter, I'd like to express my gratitude to the novocure team for their hard work during this important year.
Speaker Change: The fundamentals of our business continue to strengthen, each quarter.
Speaker Change: Q2 marks the 11th consecutive quarter of active patient growth.
Speaker Change: During that time, we've had 3, positive phase 3 results in new indications.
In the US and Germany and introduced new product enhancements to improve therapy delivery and experience for patients and Physicians.
Speaker Change: Each of these achievements requires the tireless dedication of our teams.
Speaker Change: And I want to applaud your efforts. As we look ahead with urgency to extend survival, for many more patients with some of the most aggressive forms of cancer.
Speaker Change: This is a pivotal period for novocure with an established indication in GBM, the ongoing launch and non swell, lung cancer and 2 additional launches Within Reach.
Speaker Change: The steps we will take this year, set us up for continued growth in both the near and long term.
Kristoff: With that, I will turn the call over to Kristoff.
Kristoff: Thank you, Ashley.
Kristoff: We continue our positive momentum. This quarter with net revenues of 159 million, an increase of 6% from the second quarter of last year.
This increase was primarily driven by year-over-year, active patient growth of 7% in our GBM franchise, including double digit growth. In all our International markets,
Kristoff: The favorable year-over-year impact from exchange rates was 3.8 million in the quarter offset by lower 1-time. Benefits of Prior period claims
Kristoff: We collected 2.4 million from optin lure claims in the quarter, including 1.1 million, from non small sale, lank cancer collections in the period compared to 1.5 million in 0.7 million in q1.
Kristoff: As a reminder, we recognize Revenue by applying estimated future collection rates at the time of billing per US, gaap Standard.
Kristoff: It will take several quarters for us to build a track record of collections to support an estimated rate to recognize Revenue at billing.
Kristoff: In the meantime, non small cell lung cancer collections, reflect approvals and positive outcomes from appeals in the quad.
Kristoff: Gross margin for the second quarter was 74% compared to 77% in Q2 of 2024.
This reduction was primarily driven by the rollout of our HIV rates and the continued launch of non small cell lung cancer prior to establishment of broad reimbursement.
Kristoff: These headwinds are consistent with previous periods and we expect them to decrease, as we lower the production cost of the hfv, erase and establish reimbursement, in non small cell, lung cancer.
We only had a minor impact from terrorists in the quarter of 1.3 million driven by a reduction in pre-term inventory in Q2.
While there are still considerable uncertainty around future terrorists. For import into the us, we currently do not foresee major changes from our expectations of last quarter.
Kristoff: Our most significant exposure Remains the impact of a race into the US from Israel with lesser potential impacts from imports from Mexico and Europe.
Kristoff: Our current estimates indicate that the full year. Pnl impact is, is up to approximately 7 million dollars subject to timing.
Kristoff: Rates and exemptions from these terrorists.
Kristoff: We are continuing to actively explore Avenues to minimize our terrific exposure, where possible
Kristoff: Moving to operating expenses.
Kristoff: Our research and development costs in the quarter were 56 million. An increase of 2% from the second quarter of 2024.
Kristoff: We do not expect R&D expenses to take a material step up this year, as we ramp down spend on some large phase 3, trials and ramp up spent on others.
Kristoff: Sales and marketing expenses. In the quarter were 57 million an increase of 1% from Q2 of last year.
Kristoff: Incremental launch expenses for our non small cell lung cancer indication were mostly offset by lower stock based compensation expenses.
Kristoff: Our thoracic sales forces in the US and Germany are fully staffed and reflected in our year-to-date operating expense.
Kristoff: Looking ahead. We expect models incremental expense, primarily for marketing and in preparation for launch in additional countries.
Kristoff: DNA expenses for the quarter were 44 million and increase of 17% from the second quarter of 2024.
Kristoff: This increase was primarily driven by higher share based, compensation expenses and higher personal and professional service expenses to support the non-smart cell lung, cancer launch in general company buildout, particularly on the Enterprise technology side.
Net loss for the quarter was $40 million with a loss per share of 36 Cents.
Kristoff: Adjusted ibida in the quarter was -10 million.
Kristoff: Our cash and investment balance, at the end of Q2 was 912 million.
Kristoff: We have 560 million in convertible notes, that will come to you later this year, which we intend to retire with cash on the balance sheet.
Kristoff: additionally, we have given notice of intent, to draw the second of 4 tranches of hundred dollar hundred million dollars each from our credit facility, which will close on September 26th 2025
Kristoff: According to the terms of our credit facility, we have an obligation to draw the first 2 tranches.
Kristoff: With the cash and short-term Investments, currently, on the balance sheet and funds available through our credit facility, we believe that we have the capital necessary to retire. The outstanding convertible notes and Bridge to our next revenue streams in new indications.
As Ashley said earlier, in today's call, this is our 11th.
Kristoff: Straight quarter of active patient growth.
Kristoff: With 1 launch ongoing and 2 more on the horizon. We are continuing to build momentum and deliver on the promise of our Innovative Therapies.
Kristoff: We believe we have the talent infrastructure and financial Assets in place to bring new indications to market, gain reimbursement, and reach profitability in the years to come.
Kristoff: I would like to thank you all for joining us on this journey and we look forward to updating you on our progress later this year.
I will now turn the call back to the operator for questions.
Speaker Change: Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star 1, 1 on your telephone and wait for your name to be announced. So we drive questions. Simply press star 1 1. Again please, stand by while we compile the Canon roster,
Speaker Change: our first question coming from the lineup Larry bigsun with Wells, Fargo, your line is now open.
Larry Bigsun: Uh, good morning. Thanks for taking the question.
Larry Bigsun: So so Ashley the second quarter, non small cell lung cancer, prescriptions and patience grew less quarter of a quarter uh in the second quarter than than q1 uh and the number of prescribers actually went down. Um, the US prescriptions increase by only 14 sequential. Why was that? And how should we think about the ramp? The rest of the year? Should we be thinking about, you know, the low end of the 5 to 10 million dollar range? Um, that that you, you know, that we that that that's been discussed before, uh, for for 2025 and I had 1 follow-up.
Speaker Change: Sure, thanks for the question, Larry, I'll start off and then I'll ask Frank to add some additional color. So, I think the theme you should take away. Is that the long launch is on track? We're pleased with the themes. What we're seeing is kind of a consistent ability to get into market and to educate these positions. And I would say, we actually feel like the the launch is progressing as we'd expected and I'm quite comfortable with where expectations are on a full year basis. And with that I'll offering to add some additional color. Yeah. All right I would Echo the note that we're pleased with the overall theme of the launch and specifically what I would say is that you're seeing repeat prescribers. And we've seen, um, in particular prescribers who came on right at the launch are now really building volume with their own practice. And in some instances, we've even seen Physicians, and this is common for devices, have moved towards marketing, access to the device, in their practice in social media. Uh, and so I think, you know, consistent with the device launch. We're getting Physicians comfortable with the device. We're getting into their practice and we're building,
Larry Bigsun: Volume.
Speaker Change: That's helpful. 1 follow-up on the medic data. Um you know how how different were the numbers that you disclosed this morning from what we saw at ASCO last year and why was it another analysis uh required. Thanks for taking the question.
Speaker Change: Sure. So let me, you know, just remind everybody, um, what the medicine trial was studying. Um, so a non small cell lung cancer, uh, brain, metastases are 1 of the, um, really significant markers of deterioration. In the patients about 25% of patients are actually diagnosed with brain mats when they're diagnosed with cancer and, and at least another 25%. So this is a significant unmet need in non small cell, lung cancer. And in fact, the standard of care, uh, is stereotactic Radio surgery followed by supportive care? Um, so in medicine, we studied the addition of tumor, treating fields to supportive care after, uh, stereotactic radius surgery and the endpoint of this study was progression.
You know, very specific and and very binary. Um, in this case and and this is Larry common uh, in other, uh, trials where uh, radiographic review is part of the, um, part of the uh analysis. Um, that a
First read is presented. Uh, and then through the standard cleaning, uh, of data, uh, a final data set is uh, is provided. You know, we're of course delighted that uh the the data considered continue to be very statistically significant and very uh clinically meaningful.
Speaker Change: All right, thank you so much for taking the questions.
Thank you.
Speaker Change: Our next question coming from the lineup, Jason benar with 5% or you let us know. Open
Speaker Change: Hey, good morning. Um I'll I'll double click first and uh the response to Larry's question on long. Um and and anyone feel free to answer, but do you think there's something that you can do that increases the slope and the adoption curve and helps take those scripts and active patients higher than where we're at today. And we we're start now have
Speaker Change: A couple of full quarters of data points here to work with. Um, I hear you on the physician experience is a Medtech like launch, but maybe just talk about how you're thinking about, you know, the progression of uptake, um, and kind of maybe some of your, your own expectations as we look out, you know, balance this year and into future years, and feel free to respond US and Germany as well.
Speaker Change: Yeah, Jason this is Frank. So thank you for the question. I would, you know, just start again with the, the base Baseline for this population which is that there is a high clinical unmet need for second line treatment in stage 4, Non small cell lung cancer. Um, The Physicians are not satisfied with the, uh, with what were the existing treatment options of dose of taxol, or dose of taxol plus, Rama serum.
Speaker Change: Uh, and so we always start with the fact that we still feel very comfortable that we are going into a, a large market. And we see that in the numbers. Um, in our numbers, where we see that 90% of our patients had been previously treated with immune checkpoint Inhibitors. So Physicians, are comfortable. Um, you know, using that full patient population with us and they're accessing both sides of our label. So, you know, that's really where we're, um, you know, where we, we really see the opportunity.
Speaker Change: um to the point of steepening, the curve and really driving this launch now that we have some experience
you know, I I point to, um, our refinement of our marketing messages and our refinement of our targeting of the population,
In that, you know, there are is a very large percentage of patients who start therapy, go on a platinum therapy and either because of um side effects or Adverse Events. They're unable to continue the Platinum therapy. Now they're disease, may not have gone into a full progression. It may be in some cases, even just a clinical progression, where the patient is not feeling as well as they used to.
Speaker Change: And you know, we're going to really lean into that. That message of saying, once the patient is off the Platinum, they are now eligible for tumor treating fields.
Speaker Change: And, and I think that's, that's really going to be an area for success for us. And that's really where we've seen some strong, you know, that's where we've seen Physicians really building up, um, patient, volume. And so we're going to lean into that and we think we have the opportunity to grow faster.
Speaker Change: All right, helpful. Thanks, Frank. And then 1 other 1 looking ahead to Trident. Um, this is a bit of a different trial. You're trying to extend the wear for the indication where you already have approval. I, I don't want to put the cart before the horse here, but can you talk about the maybe the Regulatory and payer path that we should have in mind when we look ahead? If we, if we make the assumption that this is a successful trial is, is this a PMA supplement route? You'd be pursuing, what kind of Hoops do you think you'd have to jump through with payers, uh, anything like,
Speaker Change: That would be helpful as we, we look ahead to early next year.
Speaker Change: Thanks for the question. Jason, this is Ashley. I'll say, I'll just remind everybody that trident is the trial in newly diagnosed GBM, which is studying, the overall survival benefit of starting tumor treating Fields earlier, and the treatment Journey. Concurrent with radiation, rather than waiting to post chemo post chemo radiation, which is the current label the trial reads out and the first half of next year. Um, and we're excited to see, you know, clearly the the data here because first of all it provides a real benefit to extend survival, even further. But as also positions the therapy, um, earlier in the treatment Journey with a with a real potential upside in duration.
Speaker Change: Will be easier than a denovo. PMA, it is, you know, an earlier start of our existing regular of of our existing label and I would say that would extend to pay our Dynamics as well. The the same coverage policies that apply newly diagnosed um, would need to incorporate this data. But I think it is a it's an easier hurdle to, to cross than it is when you're starting with a new indication. So too soon to get specifics because the data will drive those discussions, but we're very hopeful and excited about this trial.
Okay, all right. Well, wait on that then. And then maybe if I could squeeze in 1, more just on the nccn guidelines. Um, how? I don't know if there's any way to handicap it but just how do you think category uh 2A versus 2B versus 3 ultimately influences commercial coverage?
Speaker Change: Yeah, it's probably too soon to handicap other than to say uh you know, anything is helpful and the higher in the category ranking. You could go the more helpful, right? So I think anything, you know, even being on the guidelines in any calculation is is a step up from where we are today, um, with additional Publications. We'll continue to work our way up those guidelines. So I think that's important that it's not kind of where you start is, where you end, certainly publication, volume volume matters here. Um, and whereas eager as everybody is to see those updated guidelines published later. This fall,
Speaker Change: Perfect, thank you.
Speaker Change: Thank you.
Speaker Change: Our next question, coming from the line of Vijay Kumar with EVO isi, your line is now open.
Vijay Kumar: Hey guys. Uh, thanks for taking my question. I had a tool from my side. Um, um, 1 maybe on on, um, ASCO Panola, uh, biller, actually, what, what was the receptionist asked her? If you could just elaborate on the physician feedback in compare contrast this, with the your prior, uh, Podium presentations, uh, at at Asco
Speaker Change: Maybe I'll start is the uh, the longest serving member of the team here. Uh VJ our very first presentation at ASCO, which was the ef11 data. Uh, no 1 came to the presentation, uh, ef4, uh, you know was very well attended, but there was little understanding about the mechanism of action. And, you know, just a lot of questions about, you know, what is this? Uh, new therapy. Um, this was by far the most exciting ASCO that I've attended in 25 years. Uh, we were front and center, uh, on the podium in the plenary session. Um, we were included with all of the latest, uh, um, presentations.
Speaker Change: Um, our discussion, and we mentioned this in the script, who was unfamiliar previously with tumor treating Fields therapy, you know, Dana Farber, physician concluded, that our therapy should be standard of care, um, and ours was the only presentation for which that conclusion was delivered. The others were more study of this more study of that this the side effects. Don't seem to justify the benefit. Um and then we followed that with a uh with a discussion with our uh lead investigator, um, who uh,
Speaker Change: Was a very effective presenter uh and was a very effective. Um,
Speaker Change: Uh, advocate for the standard of care, use of the therapy and that was reflected in, you know, the what I'll call the, you know, the the talk on the floor. Uh, and maybe, maybe I'll turn it over to, uh, to Frank and Ashley, uh, because we were all there but to reflect on some of that I'll call the, you know, the the hubbub. But this is this is highly anticipated uh, at this point. Yeah, I mean the other thing I would add BJ is that we were front page of the ASCO daily news on Sunday, which is a lot of fun. Um, and new for us, and I would also say that that extended into the discussions, we, you know, Asko is 1 event. It's great to see that energy and excitement, but we really needed that to continue on to the ongoing physician dialogue. And, and we've seen that I was at esmo GI and
Speaker Change: Barcelona last month when we were presenting the quality of life data, and I will say, you know, it's a lot of fun to go to these congresses. When Physicians are walking up to you already aware of the data, excited about the data and talking about next steps and where we can go from here.
Speaker Change: That's helpful, then maybe 1, 1 for Kristoff uh, on the revenues here. I think your 10q had some details on on, um,
Speaker Change: You know, there is a CMS backlog, um, you know, payments 1 of us which comes in from time to time what was CMS back pay, is that included as part of this performance obligation? Or how should we think about this uh uh CMS versus the non CMS is is it's more of a recurring feature or should we think of it as a 1-off? Thank you.
Speaker Change: Yeah, so um, I would think of it as a recurring feature. Um, you know, as I said, also in the script we recognize Revenue by applying a estimated future collection rates and uh, we do this by portfolio for commercial portfolio for Medicare for Medicaid. Um, and we do this as best as we can. And so we would typically expect some revenue from prior periods as disclosed in the, in the um queue uh in the range of somewhere between 3 to 5 percentage points. Um, and that's in line with the Q2 of this year. Last year, there was a higher percentage and hence, we called it out.
Speaker Change: I'm sorry. Just on CMS is CMS back with part of this or is it separate?
Speaker Change: Yeah, yeah. It's not really uh, a key Revenue driver of the prior period claims in this quarter.
Speaker Change: Mr. Thank you guys.
Speaker Change: Thank you. Our next question, coming from the line of Jonathan Chang with Ling. Partners Giannis, Nolan.
Jonathan Chang: Hi guys, thanks for taking my questions.
Jonathan Chang: Uh first question, how should we be thinking about your path to profitability? Uh how are you tracking relative to your plans and what are the key levers and is their time frame that we should be modeling around. Um and then second question on the pancreatic cancer opportunity uh are there plans to pursue combinations with other chemo regimens Beyond what's being evaluated uh,
Jonathan Chang: Nova, 3 and 4. Thank you.
Speaker Change: Yeah. Hi Jonathan. It's Kristoff. Um, so on our path to profitability, I would first say look. Um, it's very important for us to, uh, to get to profitability. Um, and as we alluded to, in the past, we have a path to proper ability. Um, we are obviously very conscious of balancing investments in our launches, as well as in future Innovations. So basically R&D uh, with our intent to become profitable in the past, you know, we gave some, um, color around that it, you know, at a revenue level of around, 750 million dollars, we would expect to break, uh, into profitability from an adjusted, evi data perspective and I think that's still a good anchor.
Speaker Change: Um, to think about. Um and I think, you know, we don't really want to uh give you a clear time frame. But I think, you know, with the revenue growth that you have uh, seen in the past that will probably give you some indications of when we think that's going to happen. I would say to your question of, you know, where are we relative to our expectations? Um we are in line with our expectations.
Speaker Change: So to the second question and thank you for that 1. Um
Speaker Change: allow me first to contextualize that, you know,
Speaker Change: An over 3 was the first um, positive trial with OS. And on top of that, the quality of life was positive as well as we saw it at asthma.
Speaker Change: On the top of it, the pain-free survival was very positive and that led to a huge um you know discussion and interest by the investigators. And interestingly when you combine TD field to GNP standard of care, um you don't have added adverse event which means it, it's highly uh, combination more if I may say. So we are actively discussing actively looking into new combinations. And there are a few to come, um, with a number of groups, um, out there.
Bill Doyle: And Jonathan, I'll just remind you that the the next data set, we'll have um, public with pancreatic cancer is our pova 4 data, which comes out in the front half of next year. It's company sponsored looking at a Tesla mab. Um, Jim abraxane napaka, taxol and metastatic things. So, we'll have that in hand and I think that will also inform future directions.
Speaker Change: Got it. Thanks for taking the questions.
Speaker Change: Thank you. Our next question. Coming from the line of Jessica fee with JP Morgan. Elan is now open.
Speaker Change: Hey guys. Good morning. Thanks for taking my questions. Um, 2 questions for me is sort of following up on some of the prior ones. Um first, can you just take us through? Why the metis PMA in the back half of 25?
Speaker Change: Nova, PMA. In the third quarter of 25 given how much longer we've had the meta data relative to pinova.
Speaker Change: And the second 1 is just to clarify the comment on, um, revenue from prior period. Claims. I think you said it was 3 to 5% of Revenue, do we apply that to the 94 million of us optune GS sales this quarter? So like 2.8 to 4.7 or or should I apply that 3 to 5% range to to some other Revenue number. Thank you.
Speaker Change: Jessica. This is Ashley, I'll try to answer both of those and then if we have follow-up, I'll, I'll hand it off to Kristoff. But on the first, it's an easy answer. It's actually the form factor of the submission. So I'll remind you that with medic, we have a modular submission. So modules 1 and 2 went in and April this year to the FDA. Um, this was an important pathway because it's actually the first time this device is under review at the FDA. It is our torso application but at 150 kilohertz, pardon me at 200. Yes. At 150 khz, which is our lung cancer frequency. So those 2 modules need to get through at the FDA through to approval before we're able to submit module 3. So that's simply the gating reason we're in productive discussions. In fact later this quarter, we will have our pre-submission meeting with the FDA that's scheduled for the clinical module, but the pacing of it will actually be dependent on modules 1 and 2 getting through the review process and then that final module will just be the clinical module. So that's, it's a very straightforward and easy answer to the second. I would just remind everybody that this is not new.
Speaker Change: So that this disclosure, you can actually go and look at over the prior kind of years. And I would like we've always seen it in a line of this 3 to 5%. Um,
Speaker Change: And any time it bubbles up above that we call it out on the script. So I would say I wouldn't try to model this anywhere. This is well baked and in our ribbon it has been, you know, since the implementation of 606
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question, coming from the line of Kevin did Jeter with letter to us now open.
Speaker Change: Hey, Greg. Thanks for taking my questions. This morning. Um, I want to follow up on on October specifically the positioning, uh, as more of a
Speaker Change: You know.
Post the Platinum progression uh versus second line, specifically for the nccn guidelines, is there anything you're looking for potentially in the language there to to help you support your positioning? You know in the market and discussions with payers and I guess on a related point, you know, if you had any feedback from payers as to whether they see the distinction as material when they consider potential coverage decisions no problem.
Speaker Change: Problem. Well I'll start just on the to start at the the end with the the payer note, I will say, you know, I think we've seen some initial progress with payers that um you know what I'd really attribute it to again is back to the point that this is an area of high clinical unmet needs and the doctors, see it and the payer see it.
Speaker Change: Um you know, looking at in terms of the positioning and the link of the positioning to nccn um, that we don't necessarily see a, a key link there. We have to fit into the, the guidelines as the nccn has already published them. So we're not trying to influence the way in which they present their guidelines.
Speaker Change: Um, you know, that said what we are doing and, um, we'll begin to see you. You'll begin to see soon is that we're publishing real world evidence around the patient population that we have, uh, you know, treated and you know, really using that to shape physician perception of where to use the device and ultimately over time to then push that, you know, deeper and deeper into the community. This this idea of
Speaker Change: once you're post platinum and you're thinking about what do I do at the first sign? The patient's not doing well.
Speaker Change: Go to optin.
Speaker Change: Great. And then just as a follow-up and
You know, prior calls you've discussed the the potential uh, opportunity for us commercial decisions about an opportunity in Blue. Uh, um, you know, potentially in 2025 based on the, I guess potential timing of of of nccn guideline uh releases is, is that still the right way to think about um you know the pace of dialogue with with major US payers or or you know perhaps into 2026 or more realistic assessment.
Speaker Change: In 2026.
Thanks for taking the questions.
Thank you.
Have a final question. Comes from the line of Emily Butler with HC winright. Yin is now open.
Speaker Change: Hi, good morning. Thanks for taking the questions. Um, could you clarify if the 94 million in US sales, includes the 2.4 million from optin Lua or was that separate? Um, and then in terms of revenues from Germany, would you expect any kind of 1-off reimbursement, um, cases similar to what you're now seeing in the US, um, in the second half of 2025
Speaker Change: So, Emily, the 94 includes all of the revenue inclusive of the Optima. So that's both option, go and do it. And yes, we do. I mean, the US and Germany are the 2 markets that we have the opportunity to go and seek Case by case reimbursement. So it'll follow a similar trajectory in Germany as we're seeing Apollo in the US,
Speaker Change: Okay, makes sense. Um and then I know it's probably still pretty early but are you able to comment at all about efficacy you're seeing in real world cases for lung cancer and how that's kind of related to the lunar child? Particularly in the patients who've had prior immune checkpoint inhibitors
Frank: Um, hi, this is Frank and thank you for the question. I, I would say, you know, we're we're not able to track to overall survival, so we can't comment on a hard clinical endpoint. But what we do see, is that usage of the device is consistent with what we saw in the trial, which is our best proxy to say. These, these patients are using it the same way and, you know, we're um, and as I said, we're seeing Physicians who have have now had patients on from the launch quarter. So we're pretty far into it uh and they're expressing a strong confidence in building. You know, building a practice with more and more patients on the therapy.
Frank: Okay, great. Thank you.
Thank you. And there are no further questions in queue, I will not turn the call back over to Mr. For any closing, remarks.
Speaker Change: No, thank you.
Speaker Change: As we've underlined uh, during the last few quarterly calls, this is a very exciting time at no cure. Uh we are moving from
Speaker Change: A single indication company, treating patients with GBM to a multi-industry.
Speaker Change: With made tremendous progress this year so far, um, all first on the foundation of a very strong.
Speaker Change: And stable business and GBM, uh, and 1 where as Ashley and Kristoff noted. Uh, we now have hit the 11th, successive quarter of active patient growth.
Speaker Change: And from there, uh, we're in the early days, but exciting Days of our Optimum Lua launch in non small cell lung cancer. Uh, and we are furiously busy, uh, at the FDA with both our Medics and our pova 3 filings, uh, with the potential for launches next year, in pancreatic cancer and in brain Mets from non small cell. Lung kids
Speaker Change: We're busy.
Speaker Change: It's exciting and we look forward to keeping you up to date in future calls.
Speaker Change: Ladies and gentlemen, conference for today. Thank you for your participation and you may now disconnect