Q1 2025 Nyxoah SA Earnings Call
Good day, and thank you for standing by welcome to the Nic So while first quarter 2025 earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question answer session to ask a question. During the session you will need to press star one one.
On your telephone you will then hear an automated message advising your hand is rage to withdraw your question. Please press star one 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 Pearson Dennis Investor Relations Associate. Please go ahead.
Speaker Change: Thank you good morning, everyone and I welcome you to our first quarter of 2025 earnings call participating from the company today will be Olivier.
Speaker Change: She executive officer, and John Landry, Chief Financial Officer.
Speaker Change: During the call we will discuss our operating activities and review our first quarter 2025 financial results.
Speaker Change: For U S market opening today.
Speaker Change: After which we will host a question and answer session.
This 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 on the Investor Relations tab of our website.
Speaker Change: Before we begin I'd 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.
Speaker Change: All forward looking statements are based upon our current estimates and various assumptions.
Speaker Change: These forward looking 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.
Speaker Change: All forward looking statements are based upon current available information and the company assumes no obligation to update these statements.
Speaker Change: Accordingly, you should not place undue reliance on these forward looking statements for a list and description of these risks and uncertainties associated with our business. Please refer to the risk factors section of our form 20-F filed with the Securities and Exchange Commission on March 22025.
Speaker Change: I will now turn the call over to it yet.
Jason: Thank you Jason.
Speaker Change: Good day, everyone and thank you for joining us for first quarter of 2025 earnings call.
Before we start I'd like to welcome Basin, Dennis who recently joined US as our Investor Relations Associate.
Speaker Change: I'd like to focus today's discussion on our path to PMA approval in the United States as.
Speaker Change: As we announced in March.
Speaker Change: <unk> issued an approvable letter for Virginia system.
Speaker Change: <unk> <unk> mcadams metal application substantially meet requirements for marketing in the U S.
Speaker Change: Importantly, the FDA accepted all the biocompatibility testing usability studies clinical data demonstrating safety and effectiveness for continual system just to highlight a few components of our submission.
Following receipt of the approvable letter the FDA will approve the application subject to satisfactory completion of manufacturing facilities metals and control reviews.
Speaker Change: That's the context.
Speaker Change: The AG question validation of one specific manufacturing process with the U S.
Speaker Change: Contract manufacturing site.
Speaker Change: I am pleased to report that our team has successfully completed the validation work and submit it to the required documentation to the FDA.
Speaker Change: This foundation already and has confirmed we have no further questions regarding it.
Speaker Change: As a final step that da snow conducted an onsite inspection of the U S contract manufacturing facility, which we expect to be completed shortly.
Speaker Change: This site already successfully passed an FDA inspection as part of the PMA process with no deficiencies.
Speaker Change: We are confident in our ability to complete this final step in the process.
Speaker Change: And based on this timeline, we continue to expect to receive PMA approval in the second quarter of spending 75.
Speaker Change: In preparation of the U S. Commercial launch we have build a world class team and support of all the U S go to market strategy.
Speaker Change: In addition, we have put in place industry, leading towns with a track record in Neuromodulation and all of obstructive sleep apnea OFC across our sales marketing reimbursement and medical SaaS teams in the U S.
Speaker Change: Our strategy for penetrating the U S market is focused on a two pronged approach.
Speaker Change: First on the smartphone we will target high volume muscle nerve stimulation implanting centers with patients and physicians are actively seeking an alternative solution to current therapy.
Speaker Change: Market research confirmed the significant demand from patients will have written about receiving a base makes that's fallen technology, including an implanted battery, which currently requires a subsequent surgery to replace it.
Speaker Change: Also indicates.
Speaker Change: Issues of eagerly awaiting a compelling alternatives to further next pump the OSA treatment options.
Speaker Change: Consistent with feedback from the 75 U S physicians that already have been trained on the Geneva technology, given that participation in our clinical trials and usability studies and became familiar with <unk> unique features and patient outcomes.
Speaker Change: Second we will develop strong networks with sleep physicians, who manage large populations of moderate to severe OSA patients, but it's also not a stimulation is not yet fully embedded as part of their treatment pathway.
Speaker Change: As a company that prioritize clinical evidence and patient outcome over simplified marketing messages, we believe and secondly, holistic patient expectations and partnering with physicians to find the optimal treatment for each patient as part of our mission and putting patient trials.
Speaker Change: We are ready to launch in the U S. With 50 commercial team members, who are all hired and trained.
Speaker Change: This team is comprised of sales marketing market access professionals, who will be supported by focused direct to consumer DTC initiatives and dedicated reimbursement support.
Speaker Change: We plan to scale of U S commercial team each quarter post FDA approval.
Speaker Change: With the opening of new implant costs.
Speaker Change: Regarding reimbursement we are working closely with the American Academy of Otolaryngology and participating in the Fda's early feedback program.
Speaker Change: UK CNS and major commercial base on the <unk> system and the clinical impact it can have on their OSA patient population.
Speaker Change: We have identified and established CPT code that we plan to utilize at launch.
Speaker Change: The CPT code to be very precise.
Speaker Change: 64568.
Speaker Change: This CPT code has been recognized by commercial and government base for OSA indications and at the same CPT code useful the current FDA approved a DNS technology.
Speaker Change: We expect that pricing will be similar to our AGM as competitors, while we differentiate ourselves with via our unique technology benefits and clinical outcomes.
Speaker Change: Receiving FDA approval will represent the culmination of Regulus clinical research technological innovation and strategic preparation.
Speaker Change: We look forward to launching <unk> in the U S. Upon receipt of FDA approval.
Speaker Change: Evolutionary OSA solution to patients who have been waiting for an alternative that can truly transform the quality of life and long term outcomes.
Speaker Change: With that I'll turn the call over to our CFO, Joe laundry for the financial update.
Olivia we recorded revenue of $1 1 million Euro in the first quarter of 2025 compared to $1 2 million Euro in the first quarter of 2020 for the slight year over year revenue decrease was primarily due to temporary softness in the international HTS market. We also launched our Jennie O $2, one patient software upgrades.
Speaker Change: <unk> is a phased approach, which resulted in certain genotype deferring their purchase until the upgraded patient software what's available to them. We expect these factors will normalize in the upcoming quarters.
Speaker Change: Total operating loss for the first quarter of 2025 was $20 6 million euro versus $12 2 million Euro in the first quarter of 2024, driven by investments in the U S. Commercial organization in preparation for FAA approval and subsequent commercial launch.
Speaker Change: Cash position was 63 million Euro at March 31, 2025, compared to $85 6 million Euro at the end of 2024 with that I'd now like to hand, the call back to Olivier to discuss his thoughts for the remainder of 2025 Olivier. Thank you John.
Speaker Change: What sets and explore our box in the OSA treatment landscape is of patients first approach at a unique therapy, which mitigates the limitation of implantable base makes technologies.
Speaker Change: We have designed the <unk> system with patient comfort and convenience as priorities no implanted Bethany bilateral stimulation for consistent therapy, regardless of patients sleep position under single incision procedures.
Speaker Change: All supported by strong clinical data demonstrating the safety and effectiveness.
Speaker Change: Importantly, we are the only company with clinical data and positional OSA and supine sleep time.
Speaker Change: The U S.
Speaker Change: Not just the largest market opportunity, but also a chance to meaningfully change the standard of care for millions strongly with moderate to severe OSA.
Speaker Change: With our commercial team in place while reimbursement pathway established we are positioned at the starting line with what we believe will be a significant growth trajectory. Once we have FDA approval.
Speaker Change: The enthusiasm we have seen from the clinical community Julien trials.
Speaker Change: Select what we have known all along.
Speaker Change: And physicians, who are looking for meaningful innovation in OSA treatment options all approach.
Speaker Change: Specific limitations that has affected patient adoption and treatment outcomes with existing therapies.
Speaker Change: As we step over to Butch SBA approval, we have never been more confident in <unk> future and our ability to deliver value to patients physicians and shareholders alike with that I would now like to open the line for question and answers.
Speaker Change: As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced.
Withdraw your question. Please press star one one again, please standby, while we compile the Q&A roster.
Speaker Change: Yes.
Jon Block: Our first question comes from the line of Jon Block from Stifel.
Jon Block: Thanks, guys good morning.
Speaker Change: Olivia can you talk about what needs to get done.
At this U S inspection versus the initial award.
Speaker Change: It took place call it earlier in the FDA process.
Speaker Change: Yes, Hello, Joe and thank you for the question so to be very precise we were informed by FDA to do a validation of the specific manufacturing process at the contract manufacturer in the U S.
Speaker Change: You started by doing this at many status and also show protocols and validate certain processes that have been done submitted and accepted by FDA. So that product is off the table.
Speaker Change: As part of the regulatory process of site visits to confirmed that this validation is standard practice OXXO the sample of the validation and that is ongoing as we speak.
Speaker Change: Okay, I think I've got that just one follow up to my first question for clarification. When you see the physical site inspection is ongoing.
Speaker Change: Is that again, it's a physical site inspection. So has that occurred had they been out to the side is there a date for the site inspection I'm, just trying to get as granular as possible, while still being sort of respectful of the process. If you would.
Speaker Change: Yes, so definitely saw the site inspection activity taking place as we speak.
Speaker Change: Normal process oversight inspection is that it can last up to five days, we don't know it's all in the hands of the Inspector that is visiting our contract manufacturers.
Speaker Change: After this he will finish the book you will submit the equal to SBA to the PMA Review Committee and then at that point they could issue.
Speaker Change: <unk> in a pool and that's also why we stay confident that we will obtain the approval by the end of this quarter.
Speaker Change: Okay very helpful. And then just for the second question to shift gears.
Speaker Change: As we think about the market launch and the commercialization can you talk about the company's strategy to have sort of outreach to the E&P.
Speaker Change: I am guessing.
Speaker Change: Got it on the label.
Speaker Change: No contra indication on Triple C might mean, a lot versus the outreach to the sleep dock, where again I'm hypothesizing.
Speaker Change: The supine data might resonate a little bit more because obviously the sleep is the one with the ongoing management.
All of that of that patients so two very different.
Speaker Change: Variables when we think about differentiation in the label that's possible, but can you talk about the outreach on one versus the other and how the company will tackle that thank you.
Speaker Change: Yes, Okay I will try because you are asking several questions at the same point, so let's start with the clinical aspect as I mentioned I always junior was designed to it to the patient focus in subsequent months. So that is one aspect of this and therefore, we are extremely proud that we've been able to demonstrate this robust clinical data show.
Speaker Change: The discontinuation compared towards competition competition is offering to date, how do you compete with the only company that can offer clinical data and showing the effectiveness and Super C position and also helping patients that are suffering from traditional OFC, that's one creating dislocation points when it comes to patient centric focus.
Speaker Change: So thats one aspect linking this to the label because that was the second part of your aspect of course, it will enable submission to FDA we are highlighting this.
Speaker Change: I can not to jump to conclusions yet because we haven't seen the published enables coming from SBA because that goes from the announcement and approval, but it is clear that the discussions and the way we position. The middle case was clearly seized by EMEA. So yes, we do expect that FDA will also built this.
Speaker Change: Enabling so disconcerting supine data traditional overseas and then the last part of the question was CCC basis. As you know we already FCC own label in Northern International markets. We are seeing great results in the markets, where we are commercially available on CCC basins. We are conducting a specific study.
Speaker Change: In the U S called access tweeting dose CCC basins and also we do think it will make sense.
Speaker Change: Next time, we look at the CCC level in the U S and two stocked with CCC would not be reflected as a contra indication in the label that will be issued and going forward, but again, we will have to wait alcahest vehicle to enter final confirmation of this.
Speaker Change: Understood. Thanks for the color guys.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Adam meter from Piper Sandler.
Adam Meter: Hi, Good morning, Olivier and John Thank you for taking the questions.
Adam Meter: The first one for me just on FDA approval process, great to hear you reiterate the Q2 FTE approval expectation.
Adam Meter: And to hear that the final site inspection.
Adam Meter: Ongoing.
Speaker Change: My question is I'm wondering if there's any kind of statutory response time.
Adam Meter: FDA.
Adam Meter: Associated with this process and really I'm, just trying to kind of better understand what's informing the confidence that the.
Adam Meter: U S approval is going to come either later this month or next and then I had a follow up on <unk>. Thanks.
Adam Meter: Yes.
Adam Meter: I see a few of them.
Adam Meter: First of all let me repeat through the final steps. So there is currently an inspection that is taking place one of the inspection is finished then there will be a final support completed and submitted to the FDA PMA Review Committee and at that point SBA has all the information needed to also issuing a poodle.
Adam Meter: As I keep repeating.
Adam Meter: Previous timeline before the end of Q2, we'll see and go to them.
Adam Meter: The FDA approval I'm, just highlighting again the steps that we are facing which will go into as we speak.
Adam Meter: Okay, Okay understood.
Adam Meter: And then for the next question I just wanted to see if there was an update around timing for the Dream Journal publication.
Adam Meter: Just any visibility into when that can be published.
Adam Meter: Indefinitely. So we submitted the publication to a leading industry Journal also there is a clear review process, we have the first acceptance values.
Adam Meter: They like to refer to <unk> in the second level of you. We got some questions already from the <unk> expense. We are honestly in a blessing to if you add all this up I do think that can be focused on the stocks, we should be able to application.
Speaker Change: Okay Fantastic and just one more from me if that's okay, and then I'll hop back into queue for John.
Speaker Change: I just wanted to ask about the pace of Opex spending going forward.
Speaker Change: Any qualitative or quantitative color that youre willing to share as we think about the next couple of quarters as you guys get ready to launch this in the U S would be would be helpful. Thank you.
Speaker Change: Yes, Adam good to hear from you.
Speaker Change: FDA timeline perspective.
Speaker Change: Honestly, we've taken steps to defer costs and the investments until our FDA approval is.
Speaker Change: Achieved and received so we've taken steps in terms of deferring commercial related investments that naturally go hand in hand.
Speaker Change: With revenue and we also have a number of other levers we've pulled in the P&L to extend our cash runway.
Speaker Change: Well into the second quarter of 2026.
Speaker Change: Okay.
Speaker Change: John any finer point around kind of how we should think about.
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: R&D and SG&A kind of going forward I guess.
Speaker Change: The Genesis of the question a lot as it came in a little bit more heavy handed than we were modeling so just trying to kind of.
Speaker Change: I'm wondering if you can kind of oriented <unk> ZIP code for <unk> going forward. Thanks sure absolutely from a from an R&D perspective, I would expect the full year to be probably.
Speaker Change: In line with where we were from 2024 perspective, and then from a sales and marketing perspective, SG&A perspective, overall, I would expect that to be.
Speaker Change: More than double what we had incurred in 2024.
Speaker Change: When you look at it for the full year will be.
Speaker Change: From a timing perspective, the first couple of quarters are probably going to be.
Speaker Change: Little bit heavier than the back quarters of the year.
Speaker Change: That's really good color I appreciate it thank you Youre welcome.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Ross Osborne from Cantor Fitzgerald.
Ross Osborne: Hey, guys. Thanks for taking our questions starting off would be curious to hear how.
Ross Osborne: The commercial launch of <unk> in Dubai is progressing and how youre thinking about the allocation of resources.
The middle East, it's obviously, a large and underserved market, but our focus is likely on the U S. In the near term.
Ross Osborne: Yes.
Ross Osborne: So thank you all for the question. So yes as it creates a debt with general we over the first <unk> company that is confirmed in the Middle East Dubai was the first hospital in Dubai, We a social tool that will be up two successful implants, who started we are opening a second hospital in Dubai and then we are also looking at the Kuwait.
Ross Osborne: And as noted that AAV to go forward. So, yes, I do think great milestone and seeing the middle East and we will see also this AGM as a solution for the patients.
Ross Osborne: Implant is taking place in that location put in place.
Ross Osborne: We are educating some very specific sites spend over the middle east, whether we will be focused intently in quarter two quarter three and beyond.
Speaker Change: Great and then apologies if I missed this any update on the access study in terms of where you stand with implants.
Speaker Change: No absolutely no problem with our northern access as communicated we keep making great progress in enrolling patients. So we are always talking about scoping over b enrollment by Soma, so that timeline hasnt changed.
Speaker Change: Once we have this the next step will be 12 months data. Once we have those data submitted as a PMA supplement and then negotiate any further call discussing shortly with SBA. Although this can expand off label in the U S. I think CPC basis.
Speaker Change: Great. Thanks for taking my questions.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Suraj Kalia from Oppenheimer <unk> company.
Speaker Change: Sure.
Speaker Change: Good morning Olivier John.
Speaker Change: Hey, Olivia so.
Speaker Change: For providing a lot of details.
Speaker Change: You've consistently said that the initial target.
Speaker Change: Junior would be 75 physicians have been trained three.
Speaker Change: 300, or so top sites.
My specific question Olivier is as we understand it.
Speaker Change: 10 or so.
Speaker Change: <unk> already on the shelves.
Speaker Change: These top sites, how do you envision would you all also I should say mandate.
Speaker Change: Require some of the sites to have a certain minimum unit upfront purchases.
Speaker Change: Got it.
Speaker Change: I do think existing inventory would be an issue as you rollout into existing sites the top line.
Speaker Change: Yes, most of that.
Speaker Change: I see it and you and thank you all for <unk>.
Speaker Change: Two questions. If I can refer to decided so first of all I would like to highlight that over the long haul disposal basin FCC's Ags treatment and why do I want to talk to this in the U S. It is just indicating that when you look at high volume sites.
Speaker Change: <unk> implants, or having an incentive standpoint, it will be easily absorb comprehend a couple of weeks. So I don't see an issue of having current exactly of competition because that's the only company that would be a limiting factor wholesale and launching <unk> and going forward.
Speaker Change: First I'll answer the second answer to the question is that when you're working with the 75 surgeons and also with the hospitals. It's also created that.
Speaker Change: We will have to make sure that we've got the <unk> committees.
Speaker Change: <unk> two.
Speaker Change: When parsing. This we also started planning will all the time and also scheduling real time basis and once we are doing this we will make sure that we have available that hospital to treat those patients, but it will not be a strategy that will be a loading shelves even before we identified patients I think the LTE based to stock is also you identified.
Speaker Change: <unk> you have all the data and you make sure Metro police available, including some backups in case that would be a need for more than one product.
Speaker Change: Got it.
Speaker Change: Okay.
Speaker Change: Yes.
Yes.
Speaker Change: Yes.
Speaker Change: As policies for the bank.
Speaker Change: Okay.
Speaker Change: So.
Speaker Change: Maybe if I could send a couple a two part question.
Regions, where your sales force has been hired how would you.
Speaker Change: Just sort of color you can give us there and the second question. The second part of the question Olivia as Jan rollout junior commercially.
Speaker Change: What do you expect to do in terms of DTC.
Speaker Change: How are you expecting to be different that inspire thank you for taking my questions.
Speaker Change: Yes.
Speaker Change: Definitely so Sudan should we have been planning very gasoline that study in the U S market that it starts with heat maps.
Speaker Change: Like level of the high volume sites, we have access to this based on this we also combined with the servicing was up already or experience with our products and we did some photo market research. So we must go to the entire <unk> market in the U S. Using heat mapping and then we sold one building in hiring of sales folks are accordingly, so that's the.
Speaker Change: To the first part of the question the second one on DTC.
Speaker Change: Or what will be different we have a discipline that we will know absolutely low promotional spending to say something maybe a little bit, but we will not have this huge DTC or each as known today by Aegean is competitive we will won't exactly focused we will run into round sweep sites, where they can also to DTC, specifically address and provide space.
Speaker Change: <unk> access to know what would be the best technology available to treat their OSA. Once we have identified these patients and those patients came forward with sleep DOCSIS dental schools, who can further invest in a very focused manner to deny these patients to the <unk> rather than big exposure to discuss.
Speaker Change: With each new England.
Speaker Change: Got it thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of David Ray Scott from Baird.
Speaker Change: Okay, great. Thanks for taking the questions.
Speaker Change: To ask on <unk>.
Speaker Change: 2.1 thank.
Speaker Change: You called out that in Europe with <unk>.
Speaker Change: The rollout there.
Speaker Change: There was some delays in its plan. So when you think about I guess the first part of the question is going to be.
Speaker Change: I'm curious on Jennie O 2.2, or kind of just future software upgrades.
Speaker Change: The U S but.
Speaker Change: When you think about the rollout in the U S and the potential for there to be future maybe updates here I guess, how do you.
Speaker Change: Without that kind of transition and so that you don't have.
Speaker Change: <unk>.
Speaker Change: Our patient warehousing at all on the <unk>.
Clients when new system updates are all now and then.
Speaker Change: Extra conjecture.
Speaker Change: No. Thank you for this question, David and it's a very important to them and I will start and then Joe Mcgoldrick definitely step in.
Speaker Change: Second part of this question on the rollout of <unk> photo Scaleup.
Speaker Change: As I mentioned in the beginning it is so important for <unk> to offer patient centric solutions and the journey of $2. One software upgrade is a clear example of canopy is different compared to our base makes a platform technology.
Speaker Change: Concrete the software upgrades provides the opportunity for a patient to gradually increase stimulation.
Speaker Change: <unk> will result in an improved and an improvement of patient control. So it gives the patient the conflicts and it gives the physician the option to let Julie at rampart stimulation, enabling them also to treat patients that might be sensitive previously when treated with the stimulation and all of sudden become available. So that is one.
Speaker Change: Aspect of the upgrade the second one is also providing the basins with autonomy to increase or decrease stimulation settings within predefined boundaries set by the physician.
Speaker Change: Once you start providing a patient with that autonomy is also increases the compliance of technology based on steel mill and control and they can find the optimal construct so combining those two.
Speaker Change: As long software upgrade is really contributing to our mission and having a patient centric solution.
Speaker Change: Are you old results I'm going to hand, it over to John because I know he's working very closely with our manufacturing team on this and maybe you can provide some more color here.
Speaker Change: Thank you, yes, so to your point David.
Speaker Change: Had a few orders that we didnt ship out this past quarter.
Speaker Change: One of the customers and the customers wanted to have the latest upgraded activation chips for their customers.
Speaker Change: We ship those we have seen low double digit growth in the first quarter.
Speaker Change: 2025 versus first quarter of 2024.
Speaker Change: We're looking to do in the U S. We will have our $2 one available for all these customers. So as we enter the market we won't have a switch from the June year to point out to the $2. One so we'll be ready to roll from that perspective, as we enter into the U S market.
Speaker Change: Okay. Thank you.
Speaker Change: The reimbursement front.
Speaker Change: Consistent on that.
Code Youre going to go after Ed.
Speaker Change: I'm curious what you are.
Maybe on guidance.
Speaker Change: Jim.
Speaker Change: Alright.
Speaker Change: Sure about when the rollout happens.
Speaker Change: Well be able to map to batter or use that code.
Speaker Change: Case by case.
Speaker Change: Maybe a little bit tougher than typical.
Do you expect to have a built out backend kind of reimbursement team to really help streamline.
Speaker Change: Pushing these patients are getting coverage when you also on rollout.
Speaker Change: Thank you.
Speaker Change: Yes. Thanks for the question David Yeah. So short answer we have team market access team, that's dedicated to helping us work through that process. They have a lot of experience specifically in the neuromodulation space. So as we work through the rollout.
Speaker Change: Very specific materials that we're utilizing to help our sales force and then our market access teams navigate and work through the Preauthorization process for these particular patients as they make their way into the facility. So again, we have it.
John: A strong team in place Thats growing and will be well prepared to help with that process. As we entered new accounts in the U S. John and maybe just to folks.
John: On this one it's always nice to be second meaning that there was a lot of heavy lifting done by competition. There is equal to the $6 560, <unk> that is a well established and recognized by payers both government and commercial base for this specific indication, where we also well positioned and so yes, we do feel confident that does that.
John: <unk> also successfully taken and will result in a new generation.
John: Okay. Thank you.
John: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Michael <unk> from Wolfe Research.
John: Yes.
Michael: Hey, good morning, I wanted to follow up on the Triple C discussion and make sure I hear this clearly.
Speaker Change: It sounds like this initial FDA approval will not.
Speaker Change: It sounds like it will have the triple C Contra indication and the FDA is not willing to.
Speaker Change: Not have that with your prelim access data and so we need to follow access through to completion to remove the contra indication is that am I hearing the message correct is that the current expectation.
Speaker Change: No it is not.
Speaker Change: And let me be very precise on this Mike. So you know that there is off label that has enabled but there are also steps in between and <unk>.
Speaker Change: To be very very precise we don't expect to CCC is on label for the simple reason that in the <unk> study, we did not invented CCC basis. So thats I think this is very clear.
Speaker Change: Second thing is when we look at through the CCC.
Speaker Change: In the U S. In access, but also the previous CCC and experience that we are having there is no indication that <unk> is not working for CCC patients and therefore that is also multi one reason that we're pointing to the engine that CCC should be contained indication.
Speaker Change: What we do expect this we expect that in the label, we do not have it on label, but we also expect them to look at it as a complete indication, but simply as an off label indication that this up to the physician's decision whether they would offer this to the efficiencies from that.
Speaker Change: I Hope this answer your question because I won't.
Yes.
Speaker Change: And so.
Speaker Change: Related.
Speaker Change: As you launched this will you be an advocate for the dice procedure ahead of Virginia implant. How are you thinking about that given this labeling expectation for Triple C.
Speaker Change: Yeah. So first of all it is clear that we will never promote anything that has multiple enables that is off label and we will never do this and if you then take it to the next books hoagland physician be soften that ambition, having CCC, yes. They will have to do the does that is currently still the most.
Speaker Change: Traditional and accepted measurements to exclude CCC I also know and we also know that there is some work being done by others also in for example.
Speaker Change: During the final NGL.
Speaker Change: The moment that that would be accepted by base to exclude CCC patients. It's clear that we will also adapt to this but we don't have current data.
Speaker Change: It is also obvious that we will ask to exclude CCC attitude will not actively promote this when launching the product.
Olivia: Thank you Olivia.
Speaker Change: Thank you Mike.
Olivia: Thank you.
Olivia: One moment for our next question.
Speaker Change: Our final question comes from the line of Laura Robot from Degroup Peter Cam.
Laura Robot: Thank you for taking my question.
Speaker Change: First of all I would like to come back on the previous question because you mentioned John.
Speaker Change: Other levers.
Speaker Change: On the cash runway into Q2, so could you elaborate on this and then a second one on the temporary softness in some markets could you provide also a bit more information on this and also your expectations going forward. Thank you.
Speaker Change: Sure. So I'll start with the last piece the temporary softness in the market.
Speaker Change: Some of our competitor in the first quarter also posted a mid single digit decline in the international market.
Speaker Change: Some softness there seasonality, we expect it to be temporary in nature and to recover over the course of the year with regard to some of the other discretionary spending when we build our P&L. We obviously have a number of fixed expenses, but we also have variable expenses. When we look at the variable expenses that are discretionary in nature.
Speaker Change: Whether they are projects or other commercial related items.
Speaker Change: Weighted to launch specifically, we've elected to defer those to be more in line, obviously with an FDA approval timeline as well as to extend some of the other projects.
Speaker Change: Projects that are ongoing that are not essential to either update approval status or Nvidia launched we'll be preparing dose to a later date to extend that cash runway. So.
Speaker Change: So those are some of the nature of the items that we're deferring to extend the runway out.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you at this time I would now like to turn the conference back over to Olivier Tolman, Chief Executive Officer for closing remarks.
Speaker Change: So first of all I would like to thank everyone for attending the call and as we stand on the verge of FDA approval, we have never been more confident in <unk> future and our ability to deliver value to the patients physicians and also shareholders. So thank you again for your time today and your continued support of <unk> and really looking for.
Sure to updating you on our progress in the coming weeks slash months on SBA to be very precise. Thank you all for joining us.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: [music].
Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].