Nyxoah SA ($NYXH)

Good day, and thank you for standing by. Welcome to the Nyxoah First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to turn the conference over to your speaker today, Pearson Dennis. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our first quarter 2026 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter 2026 financial results released after U.S. market closing 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 on the Investor Relations tab of our website. 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. All forward-looking statements are based upon current estimates and various assumptions. 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. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which was filed with the Securities and Exchange Commission on March 26, 2026. With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for our first quarter 2026 earnings call. Let me start with the Q1 2026 overview. The first quarter of '26 marked our second full quarter of U.S. commercialization, and we are encouraged by the strong execution of our U.S. launch. Specifically, we delivered on our commitment to drive 25% sequential U.S. revenue growth in the first quarter of '26 versus the fourth quarter of '25. In the U.S., we are seeing consistent momentum across our key commercial indicators, including surgeon training, account activation, patient prior authorization submissions and procedure volumes. Internationally, our revenue in the first quarter of '26 was consistent with the fourth quarter of '25, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the fourth quarter to the first quarter. On a worldwide basis, I'm pleased to report that we grew our revenue by sequentially by 13% sequentially over the fourth quarter of 2025. Let's now dig in, in the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority. During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our U.S. commercial field presence with an extra 15 sales reps who are now fully operational, enabling us to cover up to 200 high-volume hypoglossal nerve stimulation accounts ending Q2. I'm pleased to report on our U.S. launch key performance indicators as of March 31, 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system. We have activated 34 new accounts in Q1, bringing the total of 91 active accounts out of our 125 targeted accounts. Active accounts are defined as surgeons trained and VAC committee approved. We have 241 new patients submitted under prior-authorization and still pending at the end of Q1. We have trained 50 new sales reps, bringing the total to 40 fully operational sales reps as we enter Q2. 6 months post launch in the accounts where we are already active, we estimate our market share to be between 12% to 14% on average. With the addition of 50 new sales representatives in the U.S. who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AS accounts beginning in Q2. We also recently conducted a market research study of 100 U.S. hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients. All Genio trained surgeons plan to adopt Genio in their practice. The top-sided reasons for adopting Genio were bilateral stimulation, no implanted battery and offering an alternative option. Sleep medicine is the single biggest source of their patient referrals and 84% of surgeons collaborate with sleep medicine colleagues to manage AGNS patients. The result of this market research confirms that our focused launch strategy on high-volume hypoglossal nerve stimulation implant centers in combination with building sleep physician partnerships will drive further Genio adoption. Let me now cover one of the hot topics of Q1, the hypoglossal nerve stimulation reimbursement landscape. In order to provide you with a structured update, I would like to split it up between commercial payers, Medicare and the WISeR program. Starting with commercial payers. They represent approximately 90% of our cases in Q1. Coverage is broad and stable. Genio claims continue to be processed under the CPT code 64568 or even under the CPT code 64582, depending on payer policy and individual case review. For example, UnitedHealthcare recently added CPT 64568 back to their existing AGNS policy in parallel to CPT 64582. So both codes are available for AGS. UnitedHealthcare represents one of several commercial payers, which have both CPT 64568 and the 64582 listed as available codes for AGNS procedures, including Genio. Through the end of the first quarter, we maintained a approval 100% approval rate on reviewed prior authorization submissions. Now moving into the Medicare side, which only represents approximately 10% of our cases in Q1. The year started with coding uncertainty negatively impacting AGNS implants. On February 26, however, CMS provided clarity by issuing AGNS-specific C-codes for facilities. Claims for Genio implantations are submitted under the C-code C8011. This code represents a facility fee mapped to the APC Level 5 at $31,526 in the hospital outpatient setting and $27,563 in the ASC setting. This is equivalent to the existing CPT code 64582 in hospital settings and slightly higher than the CPT code 64582 in the ASC setting. This results also in price parity at facility level for Genio and competition. Next, from a physician fee perspective, claims continue being submitted under CPT64582 at $722. When it comes to the use of modifiers, let me reiterate that it is a physician decision based on the specific surgeon work performed and that Nyxoah is not advising to use of a modifier. As to the newly established WISeR program being an AI-supported prioritization tool rolled out by CMS in six different states since January 1, 2026, we have achieved a 100% approval rate of our submitted Medicare patients. The fact that reimbursement didn't hinder our Q1 launch momentum is the result of the expertise of our market access team, the collaborations with experts in that field, our participation in the FDA early payer feedback program and the proactive education of all our customers. Because of these factors, we expect continuity for '26 and into 2027. As part of the ongoing CPT editorial panel discussion regarding the future of AGNS coding, the panel has indicated that there is no intention to lease any AGNS technology or fund without appropriate coding. For 2028, we understand that there are currently 2 parts to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set. Following the model laid out in the CMS C codes, we learned that competition has chosen to seek its own dedicated code, which we are prepared for as well. Alternatively, specialty societies may seek to engage in a broader exercise to provide further clarity regarding coding in the AGNS space, creating a comprehensive AGNS code set. We will take our lead from the specialty societies, including AAO, [ HNS ] since their actions are driven by the physicians performing these procedures. Let me now move to an international update. Internationally, we are seeing continued growth, and we managed to overcome seasonality versus Q4 '25. This was driven by a strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East and successful entries in the U.K. and the Netherlands. However, we maintained a disciplined financial approach focused on reaching breakeven as demonstrated in Germany, 3 years post launch. With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. For the first quarter of 2026, gross revenue was EUR 6.7 million before EUR 300,000 in deferrals due to the delivery of disposable patches, which are delivered over time, resulting in net revenue of approximately EUR 6.4 million. This represents 13% sequential worldwide growth compared to the fourth quarter of 2025. U.S. net revenue was EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in the fourth quarter of 2025. Our U.S. revenue growth reflects continued expansion in account activation, increasing procedure volumes and growing surgeon adoption. Gross margin in the first quarter of 2026 was 57% as compared to 62% in the first quarter of 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed. Operating expenses were EUR 24.2 million in the first quarter of 2026 as compared to EUR 21.4 million in the first quarter of 2025. The increase in operating expenses was driven by increased investment in the U.S. commercial organization, including sales, marketing and market access functions. Non-GAAP cash operating expenses were EUR 21.7 million in the first quarter of 2026 as compared to EUR 19.5 million in the first quarter of 2025. The increase in non-GAAP cash operating expenses also reflects increased investment in the U.S. commercial organization. As of March 31, 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In the second quarter of 2026, we expect to draw approximately EUR 13.8 million from the second tranche of our European Investment Bank loan. Now let's turn to guidance. We expect U.S. net revenue for the second quarter of 2026 to grow approximately 25% to 30% sequentially over the first quarter of 2026. For the full year 2026, we expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We expect gross margin in the range of 60% to 62%. We expect total operating expenses in the range of EUR 97 million to EUR 99 million. We expect total non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million. Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5% to 8% sequential increase over non-GAAP cash operating expenses of EUR 83.5 million for fiscal year 2025. Strategically, we will focus our investments in supporting our U.S. commercial activities, including sales, marketing and market access as well as key R&D initiatives, including our Genio 2.2 upgrade, which includes a new suite wearable with upgraded software and a low-cost disposable patch to be launched in early 2027. We decreased our total non-GAAP cash operating expenses by EUR 300,000 to EUR 21.7 million from the fourth quarter of 2025 to the first quarter of 2026. We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from the fourth quarter of 2025 and reallocated this capital into our U.S. commercialization efforts. We are applying the same principle for the G&A portion of our SG&A operating expenses, which if we were to break them out separately, you'd be able to see the transition from G&A-related expenses to U.S. commercial activities. Long term, we expect to drive gross margins over 80%, and we will continue to manage our non-GAAP cash operating expenses tightly while investing in growth and gross margin improvement drivers. We believe this disciplined approach will allow us to achieve revenue breakeven below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Thank you, John. As we enter Q2, our priorities remain clear: further execute on the current launch momentum in the U.S. capture greater market share in our targeted high-volume accounts, maintain a disciplined financial approach to OpEx and cash management. Before closing, I would like to thank the Nyxoah employees for their contribution in making Q1 a successful quarter. With that, I would like to open the line for question and answers.

[Operator Instructions] Our first question today will be coming from the line of Adam Meter of Piper Sandler.

Congrats on the solid progress. Two from me. The first one is on the guidance front. I wanted to ask about the full year '26 revenue guidance that you provided, and that is above where the Street is currently sitting. If you look at kind of where you've guided Q2 U.S. revs, it does imply a bit of a step-up in the back half of the year. I know Q4 is typically a seasonally stronger quarter, but maybe just talk about the confidence in achieving the full year outlook, especially in light of the ongoing reimbursement situation and talk about some of the kind of key drivers of the ramp. And any help on quarterly phasing would be appreciated.

So let me start by answering the question. So first of all, as we already communicated, we continued adding salespeople into our -- into the field. So we added 50 new sales reps, bringing the total to 40 salespeople, which enable us to cover 200 out of the 400 high-volume accounts. As you also know, surgeons, when they start implanting, they go through their surgical learning curve. This takes roughly 2 to 4 implants. And then you also see that they are scaling up. What we have learned in Q4 and in Q1 is that we got a lot of positive feedback from surgeons after their first cases. And on top, after seeing the first patient activations, what was confirming the strong away openings that they saw during the surgery gave them even more confidence in start treating immediately more new patients. So that's one aspect. So you have more feet on the street and you also have more experienced surgeons. In parallel, the VAC approvals, you know that we cannot control the time lines. Sometimes it varies from 1 week to 2 weeks all the way up to a couple of months. Also here, we are seeing great progress made, and we have now 91 active accounts already out of the 125 targeted sites with our initial 25 sales reps. So also this is driving an acceleration in adoption. And of course, in the end, there is also the patients and also the patient referral part coming from sleep physicians. I'm extremely pleased also that I was able to announce that we have 241 real patients with a submitted prior authorization file to a commercial payer while exiting entering Q2 exiting Q1. So if you add those leading indicators up, that is giving us confidence of showing continued strong double-digit growth, even further accelerating in the second half of the year. But now John will add some numbers to this as well to answer your question completely.

Excellent. Yes. In terms of where we're at and what we're looking for productivity, we expect in the back half of the year, to your point, we expect to see our revenue growth accelerate given the fact that we have our new training class that's now productive in the second quarter this year and then we will ramp up over the rest of the year. So the sequential growth rate I mentioned, 25% to 30% in the second quarter, we would see that accelerate in the third quarter. probably about the 40 -- low 40% to 45% range and then in the 50% range into the fourth quarter of the year, which, as you know, is a seasonally stronger year, especially in the U.S. as people have fully exhausted their deductibles. So when you run that math, that's what helps provide some of that back-end growth that you'll see in the model to achieve that U.S. revenue target.

And maybe last on this one, let's also not forget that I think we can say that reimbursement is fully clear and supported from both CMS with the C codes and also from commercial payers. So also this is definitely not a hindering factor as we experienced already in Q1, not to be a hindering factor.

Okay. Fantastic. That's a lot of very helpful color. I appreciate all that. For the follow-up, I wanted to switch over to reimbursement, everyone's favorite topic. Olivier, I guess the question is really around kind of the longer-term strategy for Genio and how you're thinking about a permanent CPT code. And I know in your prepared remarks, you mentioned the AMA CPT panel meeting earlier this month. We did see the proposed meeting agenda, and there was a hypoglossal nerve stimulation code on that agenda. But from our vantage point, that actually seemed to kind of describe the competitor device versus Genio. So would you agree or disagree with that assessment? And then just any help that you can give us in terms of pathway forward to kind of a more permanent reimbursement coding solution and time lines for Genio would be appreciated.

So I do think that for 2026, everything is very clear now. CMS has the C codes. We know the WISeR program. There we have obtained 100% approval prior authorization approval ratio. And we also know with commercial payers that we are both covered under the CPT 64568 and 64582. So 2026, I do think is crystal clearing going forward and is completely derisked. Now we were also participating during the editorial CPT panel discussion. And of course, there, we were listening and actively participating in this discussion focused on 2027 and even 2028. So for 2027, we expect no change on the Medicare side. The C-code framework and the physician payment under the CPT 64582 in place and operational. On the commercial side for 2027, just listening to what was discussed and also talking with experts, we do think that the CPT 64568 will be revised and will apply solely to the vagus nerve stimulation, directing all AGNS procedures away from that code and the code would migrate into 64582 code. Now in going to 2028, and that's also touching to the remark that there was a competitor CPT application for a dedicated new CPT code, which is correct. I mean that was part of the agenda of the editorial panel discussion. So for '28, what we are hearing is that there are two roads in going forward. One would be there is the move in the direction of CPT codes, dedicated CPT codes for all reimbursed AGNS technologies. The second road would be that there would be a more comprehensive AGNS coding set where also all reimbursed AGNS technologies would fall over. But that needs to be further clarified. Now when it comes to Genio, when we go to a CPT dedicated code, we intentionally did not yet submit this on the agenda of the editorial panel, but we are well prepared, and we will be submitting this going forward. On the other hand, we will always take a lead from specialty societies, including AGNS since their actions are driven by physicians performing procedures. So the conclusion is 2026, we know that everything is derisked reimbursement-wise. '27, we see it the same way. Medicare side completely clear from the commercial payers, there are coding in place. It might be that everything is more migrated to the 64582 code. And in 2028, I'm sure that editorial panel will continue discussing. They made it already clear that there will be no orphan AGNS technology and whether it evolves into dedicated codes, we will be prepared for this, whether it evolves to a more comprehensive AGNS coding set, we will follow the lead from society in this. I hope this is answering your question.

[Operator Instructions] Our next question will be coming from the line of John Block of Stifel.

Olivier, the first one is the 241 patients submitted under prior authorization at the end of the first quarter of 2026, can you remind us what that number was at the end of the fourth quarter of 2025, sort of apples-to-apples? And then how long does it take to get those patients through the approval process, which I believe you said is still sitting at around 100% from your vantage point?

Yes. So for leaving Q1, as I was saying, 241 -- when we were leaving Q4, we had approximately 116 patients under prior authorization. And how long does it take? I mean commercial payers, they have up to 30 days to come back with the approval. As a reminder, so far, we have a 100% prior authorization approval rate. And then it depends hypoglossal site to hypoglossal site because we are talking about high-volume sites in getting OR time planned, also getting surgical time because it's not only the site that is high-volume site, also the surgeon is a high-volume surgeon doing other procedures as well next to the hypoglossal stimulation of the Genio procedure. So we see that this varies between 1-month to 3 months before those patients are getting implanted.

Okay. That's helpful color. And then maybe just to pivot, John, pro forma for the European second tranche I think you've got about EUR 40 million, call it, cash, the roughly EUR 26 million plus the EUR 14 million. Maybe if you can remind us what the breakeven point for the company is, your views on cash burn going forward? And then just to tack on the gross margin continues to perplex me. When I look at the P&L, when you guys had EUR 4 million in 2023, your gross margin was 62%. And here we are approaching EUR 40 million in 2026, and it can't get out of its own way in the sort of low 60% range plus. So what is preventing gross margins from improving as the company has sort of improved the top line? And then how do we think about it going forward and sort of that inflection that you guys anticipate is going to take place in subsequent years?

Sure. So let me start with gross margin. So with regard to gross margin, we did have some issues with production yields in the quarter due to some turnover and some training issues, which have been all resolved at this point. So we expect to see our gross margins increase going forward beginning in the second quarter and for the rest of the year. I think, as I mentioned on the last call, we have our Genio 2.2 new disposal patch and activation chip, which will be a major step function improvement in our gross margin profile. That will be coming online in early 2027. So that will provide us that uplift from the low 60s to north of 70% at that point in time with that improved patient experience plus significantly cost reduced [ profile ] as well. So that's how we're thinking about gross margin. Then also in terms of the next step-up in gross margin improvement will be driven by the cost reduction on the implants, which we have contractual volume-based pricing as we hit different volume milestones in our contract with our contract manufacturers. So that's the gross margin outlook and that we have a high degree of confidence we'll get to 8-plus percent in our gross margin profile on the back largely of those two initiatives. In terms of cash burn, we're very focused on managing our cash burn. So as you can see, we held our cash operating expenses actually slightly decreased them from the fourth quarter to the first quarter of 2026, and that's reflective of the incremental 15 sales reps that we added in the U.S. So we've been very focused on making sure that we're investing strongly in the U.S. commercialization efforts, reallocating capital to that from other parts of the business and really want to basically extend our cash runway as long as possible while supporting the investments in the U.S. commercial organization, which is the growth engine for us and not sacrificing the improvements in gross margin drivers. So that's how we're thinking about it. As we think about cash operating expenses going forward, we will be -- we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance, but as we're thinking about it, we want to be very mindful of our cash operating expense. That way, we can get to a revenue breakeven point approximately EUR 150 million in revenue, that allows us at that point to have an 80% gross margin, margin plus through tight cash OpEx management that to get to breakeven and knock down the total cash that we need to get to that point to somewhere in the range of EUR 100 million to get there. So that's how we're thinking about it and looking at managing our P&L levers that we have available to us.

[Operator Instructions] Our next question is coming from the line of Suraj Kalia of Oppenheimer.

John, can you hear me all right?

We can hear you, well, Suraj.

Congrats on a strong start to the year. Olivier, I want to follow up on John's question earlier, right? Your Q2 guidance, U.S. guidance is plus 25% to 30%, 241 patients in the queue as of the end. Obviously, you guys are going to add more patients as Q2 works its way. If we assume 100% approval, just the patients at the end of Q1 would imply about $6 million in U.S. revenues, and that's a 50% sequential jump. So maybe you can -- if you could thread the needle for us as to what are your core assumptions here? Also, Olivier, maybe, John, in terms of your Medicare patient funnel, what are your expectations for the full year? And I have a follow-up.

Yes. So Suraj, let me start by commenting on the first part of the question. And I think you're totally correct. So we are seeing a strong ramp-up. And I'm not going into Q2 already, but it's clear that with the patient funnel and the pre-authorization in place and also the spillover from Q4 in Q1 and from Q1 and Q2, we already saw this translated in a very strong April. So that is correct. Now how fast will we continue ramping up further? Again, as I was mentioning, it will all be also defined by the surgical time, the time that we can get because once again, we are working with high-volume sites and high-volume surgeons. But to your point, April already very strong on this one, and it's showing already that the ramp is kicking in. The other part, I will turn it over to John to answer this one.

In terms of the ramp, I think we're looking at, again, stepping up the ramp in the back half of the year with regard to sequential quarter growth. So as we think about it, first -- second quarter, we're looking at 25% to 30% sequential growth and bumping that up to low 40s and then upper 40s, pushing 50% in the fourth quarter to get to our total number for the year. So that's how we're thinking about the staging of that, Suraj. Hope that answers your question.

And then the Medicare percentage that was the last part of the question. So in Q1, it's around 10% to 12%, still not a minority. We also see that this will continue growing and we are scaling up. And I do think that towards year-end, this will also be more in the range of 20%. But our commercial payers will stay predominant, will be the biggest part of the business, but also with the C-coding in place, I do think that is also completely derisked. And we already had the two first [ MACs ] that I were very positive, integrating all the C-codes in their policy as well. So we are looking with a lot of confidence into the next quarters of 2026.

Got it. And Olivier, in terms of Genio and Inspire V, what is the dynamic in the field in terms of selection of the device? Because a lot of sites have these Inspire days booked I guess what I'm trying to understand is, do you all see any early signs of patient selection migrating towards Genio? And by the same token, how do you squeeze your way in with Genio? Is it displacing an Inspire case on these AGNS days? Or help us understand the dynamic as it stands currently?

Okay. So Suraj, that was also one of the reasons we recently conducted a market research study with 100 U.S. AGNS implants also to, in fact, do a sanity check whether our launch strategy and more specifically also the referral strategy is really the right approach and is making sense that impacting -- and it was really to our pleasure to see that I do think we can say that by involving sleep physicians in the management of patients, and that starts with patient selection, so CPAP quitting patients, but it also continues post-surgery in patient management. And what we are doing, we go even one step further. When we train physicians, we do not only train surgeons. We combine this surgeon training together with their sleep physician partners. Now the dynamics between competition and Genio, it's also clear that for now, our investments in DTC are extremely limited. So the majority of patients that are arriving in hospital, they are coming for an AGNS solution, but they are not coming to DTC or Genio at this moment. So where the convert takes place is when they are in the site, and they are explained the different optionalities that currently are, we see that there is already a high percentage that automatically or spontaneously goes to Genio driven by not having an implanted battery, driven also by the bilateral station and software upgrades. So those are the main components that was confirmed in our market research as well. Now going forward, we will continue focusing on sleep medicine involvement. We see also that we did the first therapy and the first patient activation that this is going extremely fast -- that we don't need to search to find the correct titration that in the majority of patients, the settings are exactly the same as they were seen during the surgery. And this is also giving a lot of confidence to sleep physicians also to refer for the patients. So if you combine all this strategy is focused on high-volume implanters. We partner them up with their sleep medicine from the beginning. Then we make sure that there is a clearly defined role in patient phenotyping by sleep physicians before patients are selected after clearing their sleep up. And we make sure the sleep physician is actively involved also in post-surgery patient management. And then, of course, by seeing the first activations, also the ease of finding the correct titration settings, this is giving a lot of confidence. So we will continue with this strategy, and we'll keep our DTC spending very limited.

[Operator Instructions] And our next question will be coming from the line of David Rescott of Baird.

John, I wanted to follow up on the comments around gross margin. I believe you said there was a production yield issue maybe in the quarter that has since been fixed or alleviated. And I guess depending on where you shake out for the year, I guess first part is, is that impact expected to continue into Q2 and then fully revert back in the back half of the year? And I ask that in the context of, again, where you shake out for the full year, you could be somewhere in the mid-60s by the end of the year if you're getting to the upper end of that 60% to 62% range. So just trying to get a sense for what the adjusted maybe cadence looks like as you get through the year on the gross margin? And then I had a follow-up.

Sure. So yes, thanks for the question, David. In terms of the gross margin impact, there will be a slight gross margin impact in Q2 because some of those units that were built in Q1 will run through our P&L in Q2, there will be a slight impact there. The rest of the year, we'll start to see it get back to where essentially we were in Q3, Q4 time frame, which was in the 63%, 64% type range from a gross margin perspective. And then we'll hang out there for the back half of 2026 before we implement the Genio 2.2 disposal patch and activation chip, which will again provide a step function improvement in the first quarter of 2027 up into the low 70s.

Okay. And then I guess just sticking on the P&L here, looking at this adjusted OpEx number for Q1 relative to the guidance for the full year, you annualize the Q1 number, and you're pretty much getting toward that low end of what the full year non-GAAP guide is. So just trying to get a sense for why we shouldn't be anticipating maybe a bigger step-up on a sequential basis as you go through the year on the OpEx line. Is it fair to assume that a lot of this SG&A investment is already in the business? Or is it more of a, hey, we'll step up SG&A as sales increase, but you now have some offsetting factors more on the R&D front? And then as that relates into where you step off when you look into the 2027 time frame?

Sure. Absolutely. So again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. So from the large driver of OpEx growth is really regarding the investments we made in the U.S. commercial organization. Those have largely been made in the first quarter of 2027. So that will run pretty consistent over the course of the year, which leads to the essentially the 4x on Q1 results on the low end of the guide. We will make selected investments over the course of the year, maybe being at the low end to somewhere in the middle of that range from an OpEx perspective. But again, we'll be thoughtful and disciplined in our approach there. And there are a number of items in the business that we made significant investments in 2025 across the board, across a number of supporting functions throughout the organization that we fully expect to leverage in 2026 as the organization scales using the existing infrastructure that's been built out in 2025, which then doesn't require incremental investments here in 2026. So as we think again about 2027, we want to take the same approach into 2027 and try and redeploy as much capital as we can and leverage the noncommercial parts of the organization that have been built out and have the scale and capability to continue to support the business and redeploy that capital into the growth drivers vis-a-vis revenue and/or margin improvement initiatives. That's how we're thinking about it, and we want to be conscientious of that.

I think that was answering the question since the silent. So I don't know, operator, if there are more people lined up for questions.

That concludes today's Q&A session. And this also concludes today's program. You may all disconnect.

Thank you.

Thank you.