Q3 2024 Nyxoah SA Earnings Call
Good day, thank you for standing by. Welcome to next chapter, quarter, 2024 earnings conference call. At this time, I'm Opertisence on a Listen Only Mode. Have a discussion with your presentation, do I have a question and answer session?
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We will then hear an automatic message by seeing a hand is ringing. We know that today's conference is being recorded. I will not hand a conference with you speaker. Mikaela Kirkwood, Loic Moreau, Westworld, and Communications Manager. Please go ahead.
Thank you. Good afternoon and good evening, everyone, and I welcome you to our earnings call for the third quarter 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nixella. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and Loic Moreau, Chief Financial Officer.
During the call, we will discuss our operating activities and review our third-quarter financial results released after U.S. market closed today, after which we will host a question-and-answer session.
The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section of the Investor Relations tab of our website.
Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements.
All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.
All forward-looking statements are based upon current available information and the company assumes no obligation to update these statements.
Olivier Taelman: Accordingly, you should not place undue of these risks and uncertainties associated with their business, please refer to the risk factor section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2024. With that, I will now turn over the call to Olivier.
Olivier Taelman: Thank you, Mikaela. Good afternoon and good evening, everyone. And thank you for joining us for our third quarter of 2024 earnings call.
Olivier: 2024 has been an exciting year for NICSOA. In March, we announced our DREAM US pivotal study, achieved its efficacy endpoints with a strong safety profile and demonstrated that Genio has the potential for best-in-class outcomes for obstructive sleep apnea patients.
Subsequently, our regulatory team filed the fourth and final module in our modular TMA submission at the beginning of June. Based on the timing of FDA site inspections, we expect FDA approval will be in the first quarter of 2025.
Olivier: We continue to be highly focused on the U.S. opportunity ahead of our commercial launch and we recently strengthened our balance sheet with 24.6 million euro in new capital raised in October from a single U.S. healthcare dedicated fund.
Olivier: Throughout 2024, we have continued to bolster our U.S. presence in anticipation of Genio's entry into the market with the hiring of executive roles in the U.S.
Olivier: which include the addition of our Chief Medical Officer Dr. Boone, Chief HR, Chief Commercial and Strategy Officers
Olivier: Additionally, I relocated with my family to the U.S. in August to be on the ground during this critical time in the FDA approval and U.S. commercialization process.
Olivier: As you have also seen, we have recently hired John Landry to be our new Chief Financial Officer.
Olivier: John is an experienced U.S.-based public company CFO and brings a wealth of experience as we prepare for the U.S. launch.
Olivier: Loic Moreau, the current CFO, will transition into the newly created role of President-International. In this capacity, Loic will focus on strengthening the company's presence in key international markets.
Olivier: In September, we presented the FullDream dataset at this year's International Surgical Sleep Society, or ISSS, meeting in Miami.
Olivier: To recap DREAM, the study had co-primary endpoints, apnea-hypopnea index, or AHI, is ponderated by the shared criteria, and 12 months, and oxygen desaturation index, or ODI, is ponderated at 12 months.
Olivier: We reached all the endpoints and demonstrated a favourable safety profile.
Olivier: Looking at efficacy, the study shows AHI response rate of 63.5 on an intent-to-treat or ITT base, and a 66.4 on a modified ITT base, with a p-value of 0.002.
Olivier: and an ODI response rate of 71.3 with a p-value less than 0.001.
Olivier: With these strong results, the DREAM study met its primary endpoints of reducing the number of apneas and hypopneas, as well as the number of oxygen desaturation events that occur per hour of sleep.
Speaker Change: know what differentiates DREAM from previous AGENA studies.
Olivier: is that it's the first study where patients were required to sleep at least 60 minutes or more in supine position and demonstrated comparable efficacy to non-supine sleep position with a median 12-month AHI reduction of 70.8% when sleeping on their back.
Olivier: This will be of particular importance in the selection of physicians and the acceptance for patients since in published data it shows that AHI doubles in supine position and people sleep on average between 35-40% of the night on their back.
Olivier: Currently, JINU is the only therapy with clinically proven evidence that it maintains its efficacy irrespective of patient sleeping position.
Olivier: In addition to high efficacy, Genio demonstrated a strong safety profile, driven by a single incision procedure.
Olivier: DREAM safety results included 11 series adverse events, or SAEs, in 10 patients, resulting in an SAE ratio of 8.7%.
Olivier: Out of the 11 SAEs, only 3 were device-related. These safety results compare favorably to existing AGNS therapies.
Olivier: In summary, DREAM data supports our mission to make sleep simple for patients and reinforces our confidence that physicians will embrace Genio as a key treatment option for their oversight.
Olivier: Following the dream result, we submitted the fourth and final module of our PMA in June. We are currently in an interactive review with the FDA, which has already included several U.S. clinical and manufacturing site visits completed without any deficiencies.
Olivier: Based on this progress made, in combination with the latest FDA communication regarding the final site visit timing in Belgium, we anticipate FDA approval first quarter 2025.
Olivier: On our way to commercialization, we are progressing with our reimbursement strategy. In advance of obtaining our own CPT code, we have identified the CPT code that best fits the genial technology and is recognized by payers in the OSA indications.
Olivier: We are now working closely with the American Academy of Otolaryngology, or the AEO,
Olivier: and reimbursement experts, in addition to participating in the FDA-initiated Early Payer Feedback Program to begin the process of educating CMS and other large commercial payers like UnitedHealthcare, Blue Cross Blue Shield, and Apnea to help with obtaining coverage post-FDA approval.
Olivier: Once approved by the FDA, we will have a dedicated team to support pre-authorization efforts at the site level.
Olivier: In anticipation of FDA approval, we continue to actively build our U.S. commercial organization.
Olivier: We have already onboarded our senior commercial leadership team, including the Chief Commercial Officer, the VP of Sales, the Chief Commercial Strategy Officer, and Director of Market Access.
Olivier: Additionally, we have sent out offers for the first wave of territory managers.
Olivier: as well as key marketing and market access personnel with the aim of having the commercial team fully operational by the time of launch.
Olivier: We anticipate the size of the commercial organization will be approximately 50 people at that time.
Olivier: As we think about a commercial loan strategy, it is too prompt.
Olivier: First, we will focus on Tier 1 neprolossal nerve stimulation implanting accounts, where market research suggests that physicians and patients are actively seeking an attractive alternative to currently available therapy.
Olivier: Second, we will focus on driving referrals from sleep physicians who currently manage a high number of patients with moderate to severe OSA who are in need of an alternative treatment.
Olivier: Both of these efforts will be supported by focused DTC investments.
Olivier: We are coming into our US launch with a world of experience from our efforts in Europe, in particular Germany, which has served as a proof-of-concept for the technology and our go-to-market approach.
Olivier: Although the German market size is much smaller than the U.S. market, there are key learnings that has informed of U.S. commercialization strategy.
Olivier: Similar to the U.S. market, the German market is highly concentrated with tier 1 implanting accounts, making up a majority of the market.
Olivier: Of the top 10 accounts, Genial has quickly been embraced by 9 of them.
Olivier: Additionally, we have focused on establishing a referral pathway with top sleep specialists focused on patients who have quit CPAP. By the end of 2024, we will have 15 referral sleep centers across Germany.
Olivier: The RASMAT-NICSOA collaboration should confirm this strategy in the Common Quarters. These activities are being supported by focused DTC efforts.
Olivier: Our entry into the market has resulted in an acceleration of AG&S market growth in the region and we have achieved a 25% overall market share only 24 months after launch.
Olivier: We believe that our approach to the German market and the success we have had in the region can serve as a good proxy for our adoption trajectory in the US.
Olivier: In summary, with strong dream data, a differentiated AG&S system, upcoming regulatory approval and a cash runway that has been extended to mid-2026, I could not be more excited for the future of NICSOA as we move closer to a US commercial launch.
Speaker Change: With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.
Speaker Change: Thank you, Olivier.
Loic Moreau: Good day everyone and thank you for joining us today.
Loic Moreau: Revenue for the third quarter ended September 30, 2020, was 1.3 million euros.
Loic Moreau: The total operating loss for the third quarter was 15 million euros versus 11 million euros in the third quarter of 2023, driven by an acceleration in commercial investments in US.
Loic Moreau: During the third quarter, we secured a loan facility agreement with the European Investment Bank of 37.5 million euros and drew down the first range of 10 million in July.
Loic Moreau: We also raised 24.6 million euros through our ATM program on October 7 from a single US health care dedicated fund.
Loic Moreau: This additional capital provides incremental flexibility as we shift into our U.S. commercialization and extends our cash runway until mid-2026.
Olivier: As of September 30, 2024, cash and financial assets totaled 71 million euros and our monthly cash burn was 5.6 million euros during the quarter.
Speaker Change: September 30, cash position of 71 million euros excludes the proceeds from the 24.6 million raise that we talked about.
Olivier: This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session.
Speaker Change: Thank you. Ladies and gentlemen, if you wish to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced.
Speaker Change: To remove yourself from the queue, simply press star 11 again. Please stand by while we compile the Q&A roster.
Olivier: © transcript Emily Beynon
Olivier: And our first question coming from the lineup, Adam Mather with Piper Stanley, your line is now open.
Adam Mather: Hi, good afternoon, Olivier and Loic, and thank you for taking the questions.
Olivier: I wanted to start with your dream data, which was presented at IFFS a couple months ago. Congrats on the presentation. Olivier, what's been the feedback from the clinician community on the data?
Olivier: you know in particular as it relates to supine versus non-supine, you know, how is that resonating?
Olivier: And then there were three cuts of data from DREAM that were presented on the primary endpoints, intention to treat, modified intention to treat, and per protocol. You know, which of those data sets do you think is most relevant for physicians? And then I had a follow-up. Thanks.
Speaker Change: Thank you, Adam. So let me maybe start by answering the first question, like how did...
Speaker Change: In fact, the audience at ISSS reacted on the published DREAM data and how we differentiate. So, it's clear that we showed published data for patients sleeping 35 to 40% in a supine position.
Olivier: And we know that their AHI is twice as high when they go in the back compared to when they are sleeping in a non-sleeping position.
Olivier: And I have to say there was a lot of positive reaction from physicians on the fact that Doreen is currently the only study to require patients to sleep minimum 60 minutes in a supine position, that it was measured no effect based in a 12-month follow-up visit, and that it resulted, and I think that's the most important topic, in a similar HI reduction compared.
Olivier: to sleeping in a non-sleeping position.
Olivier: I think that is maybe an answer to your first question.
Olivier: Now the next question, also when looking at ITT, modified ITT.
Olivier: I do think that the Modified ITT is the number that resonates most with physicians for the simple reason that in a Modified ITT we include all patients that have reached a 12-month follow-up PSG, and there we see that we have data that are showing a response rate of 66%.
Olivier: Thank you for your time. It was a pleasure.
Speaker Change: So we'll be answering your questions.
Speaker Change: That's helpful, Olivia. Thanks for the color there. And then I feel compelled to ask about reimbursement.
Speaker Change: and sorry to push there, but you know, that's one of the big questions that we get from investors. So, you know, any more color details that you can give us around?
Speaker Change: the CPT code that you're planning to use. And then I think you also have stated you have the expectation that you can onboard U.S. payers pretty quickly after launch. So just talk about the competence there as well. Thanks for taking the question.
Speaker Change: Thank you for this question. I can only confirm that this is a question I get on a regular basis from a lot of investors. So as you know, we are executing a comprehensive reimbursement strategy. In fact, the reimbursement strategy includes a couple of different approaches.
Speaker Change: First, are we using an established CPT code that is recognized by payers for the OSA indication at launch? So that should answer the question, will we have a reimbursement the moment we have FDA approval? In our thinking, the answer is clearly yes.
Speaker Change: In parallel, we are planning to pursue the Gino-specific CPT code over time.
Speaker Change: In order to do this, we are working closely with the AEO, the American Academy of Otolaryngology.
Speaker Change: And we're also very pleased that we can participate in the FDA Early Payer Feedback Program, because it's putting us in closer contact, engaging with CMS, but also major commercial payers, including UnitedHealth, Blue Cross Blue Shield, and Apnea, and being able to educate them on our technology, on the mechanism of action, and also how this is, in fact, already a reimbursed indication for a broad market stimulation in the U.S.
Speaker Change: Thank you for joining us.
Speaker Change: For more information visit www.fema.gov
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of John Block with Stiefel, your line is now open.
Speaker Change: Hey everyone, this is Joe Federico, or John Block. Thanks for taking the questions.
Speaker Change: I guess I'll just start with a two-parter. Just following up on the recent conferences, I think the thought at the time was that the peer-reviewed Dream Data was going to be published kind of in short order following the conferences. Is there any update on the timing of that publication?
Speaker Change: And then I could be wrong, I don't think we ever saw the peer-reviewed better sleep data that was supposed to be published, I guess, a few years ago at this point, but I know it was due to COVID complications, but do you think you could face any challenges there with commercial payers on the reimbursement front, you know, without that breadth of peer-reviewed data?
Speaker Change: So, let me start by maybe answering the first part of the question, the publication strategy. So, yes, indeed, we presented the DREAM study at ISSS in September in Miami, and we anticipate the study being published in the leading medical journal. So, the study is currently being...
Speaker Change: supported by some other PI colleagues. They are doing this in a complete independent way.
Speaker Change: So we can of course not interact or not push them to submit a publication earlier before they feel that they have done appropriate work to submit. I expect that this will be done in the coming weeks because that is based on the latest feedback we get directly from them.
Speaker Change: and Mikaela Kirkwood.
Speaker Change: Second, when you were asking the question on better sleep, so totally correct. And for those who are relatively new to our story and the technology, better sleep was a study done in.
Speaker Change: Australia, in which we have included patients suffering from non-CCC, comparable to the DREAM study, but also patients suffering from CCC. Based on the study data, we were able to have a label expansion.
Speaker Change: expansion already in Europe.
Speaker Change: As you know, we are redoing a study in the U.S. called ACCESS, specifically focused on TCC patients.
Speaker Change: To answer your question, Joe, in going forward, it's clear that we will use all the available evidence including better sleep data, also commercial data on CCC patients in combination with the access data in going forward to also apply for a label expansion for CCC patients in the U.S.
Speaker Change: Thank you for watching!
Speaker Change: Okay, thank you. That's really helpful. And then maybe just a clarifying question. I mean, the language around the FDA approval timeline for Genio seemed to change a little bit. I think last quarter it was...
Speaker Change: I think, you know, a sense of confidence.
Speaker Change: was conveyed in the year-end 24, and it read more leaning towards the 1Q this time around. And so, just to clarify, did you say that was more just the manufacturing inspection, which I think is the third module? If you can just maybe give...
Speaker Change: the change there that would be.
Speaker Change: Thank you for this question, I think it's a very important one. So as you know, we submitted our final model in June, beginning of June to be precise. We made a lot of progress since then, including US clinical site visits, the US manufacturing audit, all the other deficiencies.
Speaker Change: When the FDA investigators or inspectors arrived in Belgium, the FDA had to reschedule the inspection to a later date due to unforeseen circumstances unrelated to NYXOA. We are currently working with the FDA to find a new date for this inspection.
Speaker Change: While we do not control FDA timeline, we know with ease that approval in December is unlikely and therefore staying cautious, we feel confident with the Q1 2025 approval.
Speaker Change: and Mikaela Kirkwood. Thank you.
Speaker Change: Thank you, and our next question coming from the line of Suraj Kalyan with Oppenheimer Hill and is now open.
Suraj Kalyan: Hi Olivier, congrats on all the progress.
Suraj Kalyan: So, Olivier, I know a number of questions have been asked and let me come at it from a different angle regarding your anticipated commercial launch.
Suraj Kalyan: So, Olivier, you guys are making senior leadership changes. Fine. We understand all that. How do you expect your marketing strategy to be different than Inspire?
Suraj Kalyan: And what do you consider as the low-hanging fruit?
Olivier Taelman: First of all, thank you so much, nice hearing you and thank you for the question.
Speaker Change: I would like to push back a little bit on changes.
Speaker Change: in leadership and more related to additions.
Speaker Change: So it's clearly that our focus has shifted to the U.S.
Speaker Change: because that's also where the market opportunity lies and we are definitely strengthening our leadership in the U.S. with the hirings of the chief commercial officer, the chief commercial strategy officer, marketing, but also the recent appointed CFO John that has joined us.
Speaker Change: And while we are doing this, we also make sure that we do not forget international markets.
Speaker Change: So maybe as an introduction and answer as a first part of the question. Now second, from a marketing perspective and from a strategic perspective in the US, how do we want to make a difference? I think we have a two-pronged approach. First, we will focus on tier 1 AG&S implanting accounts.
Speaker Change: As market research strongly suggests that physicians and patients are actively seeking an attractive alternative to current available therapies, so that's I think already the first strategic approach.
Speaker Change: Second, we will work on driving referrals from sleep physicians who currently manage a high number of patients with moderate or severe OSA who are in need for an alternative treatment.
Speaker Change: I think...
Speaker Change: This strategy will overall be supported by a commercial organization of approximately 50 people. We will add it with focused DTC.
Speaker Change: and we will have also, and I think this is really important, the dedicated team supporting pre-authorization efforts.
Speaker Change: when implementing this approach based on our German experience.
Speaker Change: We see that we are able to secure adoption in Tier 1 accounts.
Speaker Change: We see that we are also able, in establishing referrals, lead vendors to start referring patients. And we also saw that this is really demonstrating also an acceleration in market expansion.
Speaker Change: Now, last, and I want to be very complete, Suraj, how do we differentiate? It's clear that we have clinical data that are both strong in efficacy, but also in safety. And I would like to point this out.
Speaker Change: then we are able to reduce HI below 15.
Speaker Change: reducing the cardiovascular risk to patients without OSA. There also we have more than 82% of patients in dream reaching this result.
Speaker Change: And, as I mentioned, safety, we have SAAs below 10%, which is also very favorable if you compare with other AGNS treatments.
Speaker Change: Next to the clinical data differentiation, there is also the product differentiation.
Speaker Change: Thank you very much.
Speaker Change: We are fully scalable, and we also have a single incision, and we learned through market research that these arguments are really resonating very strong with patients in their acceptance criteria and especially with surgeons in their selection of therapies.
Speaker Change: Sorry to be a little bit longer, but I hope I was complete in answering your questions.
Speaker Change: Got it, fair enough. And Olivier, my second question, I'll keep it two-part and hop back in queue. So Olivier, our assumption still is that you all are seeking
Speaker Change: Supine label on Genio. Could you just confirm that that is still...
Speaker Change: you know, on the deck and when do you anticipate to start getting into labeling discussion? And the second part of your question, Olivia, would also love to get your take on the current status of the AG&S market in the U.S.
Speaker Change: And the reason I ask that is, it seems at least based on the numbers right now, you know, utilization for your competitors relatively flattening out. It's basically a push into new sites.
Speaker Change: And as you guys launch Genio, how would you advise us?
Speaker Change: to measure the ROI of Genio's launch, admittedly a few quarters down the line. Thank you for taking my questions.
Speaker Change: Yes so for the label question I can already confirm that the label discussion is ongoing with FDA and it's also clear that based on our dream data we do want to see the supine data reflected in our label.
Speaker Change: I can confirm that based on the data, based on the ongoing discussions, we are going and we would, I see it as more than appropriate to also see this reflected in our label. So that's, I think, the first part of the question.
Speaker Change: When we look at the Hippoglossal Nourish Stimulation Market, I do think if we look in the U.S. specifically that the market is still growing strongly. I was also listening yesterday to what was presented and I'm hearing numbers like over
Speaker Change: in the States.
Speaker Change: Next slide
Speaker Change: So when we will be launching, it's also clear that, of course, we will measure our revenue success. But next to this, there are other parameters, and that is the opening of new sites, that is one. That is also the further expansion of territories, and that is also the uptake.
Speaker Change: of implants that were done by Scythe.
Speaker Change: because I do think, to your point, that it is important that you have...
Speaker Change: a kind of center of excellence approach.
Speaker Change: where you will educate them to make sure and equip them to take an implant at a high volume.
Speaker Change: of course, sea patients.
Speaker Change: to make them better in their quality outcome because they are doing it on a weekly basis.
Speaker Change: It will also reduce the risk of complications because of their experience.
Speaker Change: And I also think it will have a positive overall impact on the healthcare system and the payers if they know that when patients are referred, they will get the highest quality implant as possible. I do think that this is where we will be focused on.
Speaker Change: and we will shoot, if I can use marketing terms, we will shoot more in having a high number of centres of excellence and we will not shoot so broad in having more than 1,000 centres of which the majority is only doing a low number of implants.
Speaker Change: Thank you. Now next question coming from the line of Ross Osborne with Kansas Postal Service. Your line is now open.
Ross Osborne: Hi guys, congrats on the progress and thanks for taking our questions.
Ross Osborne: So maybe starting off on your commercialization strategy for next year, can you walk us through the process of turning on or activating the 31 Tier 1 accounts upon approval? And following up on this, how do you define Tier 1 accounts? Is there a quarterly or annual volume number you can share?
Speaker Change: So, first of all, I would like to be very clear that
Speaker Change: I'm not focusing on 31 accounts, if I misunderstood or if I understood correct. So, what I am saying is, we will first focus on the Hippoglossal.
Speaker Change: implanting accounts for the high-volume Tier 1, not 31, but the Tier 1 accounts. I think that's important and it will be more than 31 accounts just for the record. Well, and then the next thing...
Speaker Change: Also, when we are talking about how to prepare physicians also to do this, we are heavily investing in training and education.
Speaker Change: team that will make sure that we can already onboard physicians right after the moment we have obtained the approval.
Speaker Change: Thank you.
Speaker Change: Okay, great. And then just the second part of that question on, you know, how you define Tier 1 accounts, is there a volume number you can share?
Speaker Change: Yeah, so if we currently look at the market, as you know, we have more than 1,300 AGMF implanting sites in the US.
Speaker Change: Okay, got it. And then lastly, how are you feeling about your ability to meet demand from a supply standpoint?
Speaker Change: of Compine Manufacturing in the U.S.
Speaker Change: several manufacturing lines and based on our forecasting it's also like we will have inventory built and we will have definitely enough supply present to sort of the US and European market.
Speaker Change: Great, thank you for taking our questions. Thank you all.
Speaker Change: Thank you.
Speaker Change: And our last question comes from the line of David Rizkardt with Bear Dylan is Open.
David Rizkardt: Oh great, thanks for taking the questions. I appreciate the comments you gave on reimbursement already, but wondering if you could provide, you know, maybe some some more color on that.
David Rizkardt: well understood, at least it sounds like, by the physician or payer community, is something that you can achieve. I know that.
Speaker Change: On the back end, obviously, you know, whether it be maps or CMS, there's some things that, you know, probably have to be done to make sure that, you know, the code is eligible to be mapped to or to be used. So, just wondering, you know, if you can give us any color on the...
Speaker Change: the back and forth or the conversations that you've had with some of the payers that leads you to believe that you'll be able to utilize this, you know, kind of on day one of the launch next year.
Speaker Change: Yeah.
Speaker Change: Well, first of all, we are fully recognizing the strong work that has been done in this field by having U.S. players covering hypoglossal nerve stimulation, and as I mentioned before, sometimes it's nice to be second and to be able to piggyback a little bit on this hard work that has been done.
Speaker Change: So that's number one. As I mentioned before, most important for the next device is to have...
Speaker Change: a coverage, a coding and a coverage in place right after FDA approval and there we are establishing a CPT code that is recognized by payers for the OSA indication but also the code that is really covering the technology that we are offering including the mechanism of action.
Speaker Change: Thank you.
Speaker Change: As you know, you will see the code once that is at the approval and once you have submitted in fact your first files to payers.
Speaker Change: and many accept and reimburse for your technology.
Speaker Change: So that is step number one. In the meantime, I think we are doing what we have to do in the right order, meaning working closely with the physician association, in our case the American Academy of Otolaryngology.
Speaker Change: Next, with FDA's Early Payer Feedback Program, it gives us a unique opportunity to present and to educate.
Speaker Change: CMS but also major commercial players so that they are prepared what our technology can do, what it can bring and also the clinical data and safety data behind. So I'm feeling really confident that we are making the right steps, that we are making the progress, we feel support.
Speaker Change: from both organizations, AEO, but also the good discussions at the early pair feedback.
Speaker Change: And then I think last, we will also make sure that we help the sites when they work with puritizations to relieve them a little bit from this administrative burden and make sure that the files are complete and fully prepared when they submit to payers. So that's our strategy for now.
Speaker Change: Okay, thanks. Maybe just on the P&L, on the investment that you've talked about, I think in the past you called out maybe this $50 million or so of incremental investment ahead of the launch. Just looking at the difference in OPEX that you have in the quarter, I appreciate that the hiring process is kind of really starting to ramp up. So, from a cadence perspective, I mean, is the fourth quarter of this year a quarter in which we're going to start to see a more substantial sequential step up in kind of the OPEX line associated with?
Speaker Change: a lot of new onboarding, or is that something that might, you know, be pushed closer to the first part of 2025? Thank you.
Speaker Change: Those are the difficult questions I hand over to the CFO.
Speaker Change: Thank you for the question, indeed as you have seen our burn is increasing in Q3, it's now 5.6 million per month.
Speaker Change: We anticipate it will continue in Q4 with the hiring of the first wave of territory managers notably, and continue to ramp up in Q1 and Q2 next year. We then believe that it will reduce with the ramp-up of the sales in the US.
Speaker Change: So with these we have cashed into 2026.
Speaker Change: So that's what we have in mind. So first we see this acceleration and that has started, then it flattens around mid next year and it starts to decrease with the ramp up of sales in the US.
Speaker Change: Any just high-level thoughts on maybe how you kind of quantify what that, you know, Q4 OPEX number looks like? I mean, does it double quarter over quarter? Is it up five to ten million? Just any thoughts that would be helpful.
Speaker Change: I will not give you precise guidance but definitely we will not double the OPEX, far from this.
Speaker Change: And an important point there is we are increasing the commercial investment but at the same time we decrease the clinical and R&D investment because we are shifting from a pure R&D clinical organization to a commercial organization. So that's what you're going to see in the next quarters.
Speaker Change: Thank you and ladies and gentlemen at this time we have no further questions in the Q&A queue. This will conclude today's conference call. Thank you for your participation and you may now disconnect.