Q1 2026 Nyxoah SA Earnings Call

May 12, 2026

Operator: Good day. Thank you for standing by. Welcome to the Nyxoah Q1 2026 Earnings Conference Call. At this time, all participants are on a listen only mode. After the speaker's presentation, there'll be a question and answer session. 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.

Operator: Good day. Thank you for standing by. Welcome to the Nyxoah Q1 2026 Earnings Conference Call. At this time, all participants are on a listen only mode. After the speaker's presentation, there'll be a question and answer session. MUNGAI 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.

Speaker #1: After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star 11 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded.

Speaker #1: I'd now like to turn the conference over to your speaker today, Pearson Dennis. Please go ahead.

Pearson Dennis: Thank you. Good afternoon, everyone. I welcome you to our Q1 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 Q1 2026 financial results released after US 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: The press release can be found in the investor relations section of our website. This call is being recorded and will be archived in the events section under the investor relations tab on our website.

Pearson Dennis: 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.

Speaker #2: 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 #2: 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.

Pearson Dennis: 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 26 March 2026. With that, I will now turn the call over to Olivier.

Speaker #2: 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.

Pearson Dennis: 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 26 March 2026. With that, I will now turn the call over to Olivier.

Speaker #2: For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our form 20F5, which was filed with the Securities and Exchange Commission on March 26, 2026.

Speaker #2: With that, I will now turn the call over to Olivier.

Speaker #3: Thank you, Pearson. Good day, everyone, and thank you for joining us for our first quarter 2026 earnings call. Let me start with a Q1 2026 overview.

Olivier Taelman: Thank you, Pearson. Good day, everyone, and thank you for joining us for Q1 2026 earnings call. Let me start with the Q1 2026 overview. The Q1 2026 marks our second full quarter of US commercialization, and we are encouraged by the strong execution of our US launch. Specifically, we delivered on our commitment to drive 25% sequential US revenue growth in Q1 2026 versus the Q4 2025. In the US, 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 Q1 2026 was consistent with the Q4 2025, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the Q4 to the Q1.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: In the US, we are seeing consistent momentum across our key commercial indicators. Including surgeon training, account activation, patient prior authorization submissions, and procedure volumes.

Olivier Taelman: In the US, 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 Q1 2026 was consistent with the Q4 2025, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the Q4 to the Q1.

Speaker #3: 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.

Speaker #3: On a worldwide basis, I'm pleased to report that we grew our revenue by 13%, sequentially, over the fourth quarter of 2025.

Olivier Taelman: On a worldwide basis, I'm pleased to report that we grew our revenue by 13% sequentially over Q4 2025. Let's now dig in the US commercial update. The US 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 US 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 entering Q2. I'm pleased to report on our US launch key performance indicators as of 31 March 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system.

Speaker #3: Let's now dig in in the US commercial update. The US launch remains the primary driver of our worldwide revenue growth and our key priority.

Speaker #3: During the quarter, we continued to execute on our focused commercial loan strategy and further expanded our US 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 entering Q2.

Olivier Taelman: During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our US 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 entering Q2. I'm pleased to report on our US launch key performance indicators as of 31 March 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system.

Speaker #3: I'm pleased to report on our US 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 Genius system.

Speaker #3: We have activated 34 new accounts in Q1, bringing the total of 91 active accounts out of our 125 targeted accounts. Active accounts, or defined as surgeons trained and VAC committee approved.

Olivier Taelman: 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 authorizations and still pending at the end of Q1. We have trained 15 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 US who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AGNS accounts beginning in Q2.

Speaker #3: 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.

Speaker #3: Six 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 US, who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AGNS accounts beginning in Q2.

Olivier Taelman: 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 US who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AGNS accounts beginning in Q2.

Speaker #3: We also recently conducted a market research study of 100 US hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients.

Olivier Taelman: We also recently conducted a market research study of 100 US 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-cited 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.

Speaker #3: All Genius trained surgeons plan to adopt Genius in their practice. The top-sided reasons for adopting Genius were bilateral stimulation, no implanted battery, and offering an alternative option.

Speaker #3: 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 Genius adoption.

Olivier Taelman: 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.

Speaker #3: Let me know. 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 wider program.

Olivier Taelman: 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 645A2, 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 645A2, so both codes are available for AGNS. UnitedHealthcare represents one of several commercial payers which have both CPT 64568 and the 645A2 listed as available codes for AGNS procedures, including Genio.

Speaker #3: Starting with commercial payers. They represent approximately 90% of our cases in Q1. Coverage is broad and stable. Genius 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.

Speaker #3: For example, UnitedHealthcare recently added CPT 64568 back to their existing AGNS policy in parallel to CPT 64582, so both codes are available for AGNS.

Olivier Taelman: For example, UnitedHealthcare recently added CPT 64568 back to their existing AGNS policy in parallel to CPT 645A2, so both codes are available for AGNS. UnitedHealthcare represents one of several commercial payers which have both CPT 64568 and the 645A2 listed as available codes for AGNS procedures, including Genio.

Speaker #3: UnitedHealthcare represents one of several commercial payers which have both CPT 64568 and 64582 listed as available codes for AGNS procedures, including Genius. To the end of the first quarter, we maintained a 100% approval rate on reviewed prior authorization submissions.

Olivier Taelman: Through the end of Q1, we maintained a 100% approval rate on reviewed prior authorization submissions. 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 26 February, 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 645A2 in hospital settings and slightly higher than the CPT 645A2 in the ASC setting.

Speaker #3: 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.

Speaker #3: On February 26, however, CMS provided clarity by issuing AGNS-specific C codes for facilities. Claims for Genius implantations are submitted under the C code C8011.

Olivier Taelman: 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 645A2 in hospital settings and slightly higher than the CPT 645A2 in the ASC setting.

Speaker #3: 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.

Speaker #3: 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 Genius and competition.

Olivier Taelman: This results also in price parity at facility level for Genio and competition. Next, from a physician fee perspective, claims continue being submitted under CPT 645A2 at 722 dollars. 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 the use of a modifier. As to the newly established WISeR program, being an AI-supported prior authorization tool rolled out by CMS in six different states since 1 January 2026, we have achieved a 100% approval rate of our submitted Medicare patients.

Speaker #3: Next from a physician fee perspective, claims continue being submitted under CPT 64582 at 722 dollars. 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 other modifiers.

Speaker #3: As to the newly established wiser program, being an AI-supported prior authorization 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.

Speaker #3: 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.

Olivier Taelman: 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 Payor Feedback Program, and the proactive education of all our customers. Because of these factors, we expect continuity for 2026 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 leave any AGNS technology orphaned without appropriate coding. For 2028, we understand that there are currently two paths to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set.

Speaker #3: 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 leave any AGNS technology orphaned without appropriate coding.

Olivier Taelman: 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 leave any AGNS technology orphaned without appropriate coding. For 2028, we understand that there are currently two paths to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set.

Speaker #3: For 2028, we understand that there are currently two paths 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.

Olivier Taelman: 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 2025. This was driven by strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East, and successful entries in the UK and the Netherlands.

Speaker #3: 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.

Speaker #3: 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.

Olivier Taelman: Let me now move to an international update. Internationally, we are seeing continued growth, and we managed to overcome seasonality versus Q4 2025. This was driven by strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East, and successful entries in the UK and the Netherlands.

Speaker #3: 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 UK and the Netherlands.

Olivier Taelman: However, we maintained a disciplined financial approach focused on reaching break even, 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.

Speaker #3: However, we maintained a disciplined financial approach focused on reaching break-even as demonstrated in Germany three years post-launch. With that, I will now turn the call over to John for a detailed overview of our financial results.

Speaker #2: Thank you, Olivier. For the first quarter of 2026, gross revenue was 6.7 million euros before 300,000 in deferrals due to the delivery of disposable patches which are delivered over time, resulting in net revenue of approximately 6.4 million.

John Landry: Thank you, Olivier. For Q1 2026, gross revenue was EUR 6.7 million before 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 Q4 2025. US net revenue was EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in Q4 2025. Our US revenue growth reflects continued expansion in account activation, increasing procedure volumes, and growing surgeon adoption. Gross margin in Q1 2026 was 57% as compared to 62% in Q1 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed.

Speaker #2: This represents 13% sequential worldwide growth compared to the fourth quarter of 2025. US net revenue was 4.3 million euros, representing approximately 25% sequential growth compared to 3.4 million euros in the fourth quarter of 2025.

Speaker #2: Our US 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.

John Landry: Our US revenue growth reflects continued expansion in account activation, increasing procedure volumes, and growing surgeon adoption. Gross margin in Q1 2026 was 57% as compared to 62% in Q1 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed.

Speaker #2: The decrease in gross margin was due to production yield issues in the quarter, which have been addressed. Operating expenses were 24.2 million euros in the first quarter of 2026 as compared to 21.4 million in the first quarter of 2025.

John Landry: Operating expenses were EUR 24.2 million in Q1 2026, as compared to EUR 21.4 million in Q1 2025. The increase in operating expenses was driven by increased investment in US commercial organization, including sales, marketing, and market access functions. non-GAAP cash operating expenses were EUR 21.7 million in Q1 2026, as compared to EUR 19.5 million in Q1 2025. The increase in non-GAAP cash operating expenses also reflects increased investment in the US commercial organization. As of 31 March 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In Q2 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.

Speaker #2: The increase in operating expenses was driven by increased investment in the US commercial organization including sales, marketing, and market access functions. Non-GAAP cash operating expenses were 21.7 million euros in the first quarter of 2026 as compared to 19.5 million in the first quarter of 2025.

Speaker #2: The increase in non-GAAP cash operating expenses also reflects increased investment in the US commercial organization. As of March 31, 2026, cash and cash equivalents and financial assets totaled 25.9 million euros.

John Landry: The increase in non-GAAP cash operating expenses also reflects increased investment in the US commercial organization. As of 31 March 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In Q2 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.

Speaker #2: In the second quarter of 2026, we expect to draw approximately 13.8 million euros from the second tranche of our European investment bank loan. Now let's turn to guidance.

Speaker #2: We expect US 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 36 million to 40 million euros.

John Landry: We expect US net revenue for Q2 2026 to grow approximately 25% to 30% sequentially over Q1 2026. For the full year 2026, we expect worldwide net revenue in the range of EUR 36 million to 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 99 million. We expect total non-GAAP cash operating expenses in the range of EUR 88 million to 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.

Speaker #2: We expect gross margin in the range of 60% to 62%. We expect total operating expenses in the range of €97 million to €99 million.

Speaker #2: We expect total non-GAAP cash operating expenses in the range of 88 to 90 million euros. Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5 to 8 percent sequential increase over non-GAAP cash operating expenses of 83.5 million for fiscal year 2025.

John Landry: We expect total non-GAAP cash operating expenses in the range of EUR 88 million to 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.

Speaker #2: Strategically, we will focus our investments in supporting our US 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 sleek wearable with upgraded software and a low-cost disposable patch to be launched in early 2027.

John Landry: Strategically, we will focus our investments in supporting our US 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 sleep wearable with upgraded software and a low-cost disposal 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 Q4 2025 to Q1 2026. We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from Q4 2025 and reallocated this capital into our US commercialization efforts.

Speaker #2: We decreased our total non-GAAP cash operating expenses by 300,000 to 21.7 million euros from the fourth quarter of 2025 to the first quarter of 2026.

John Landry: We decreased our total non-GAAP cash operating expenses by EUR 300,000 to EUR 21.7 million from Q4 2025 to Q1 2026. We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from Q4 2025 and reallocated this capital into our US commercialization efforts.

Speaker #2: We also decreased our non-GAAP cash R&D expenses by €2.9 million sequentially from the fourth quarter of 2025 and reallocated this capital into our US commercialization efforts.

Speaker #2: 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 US commercial activities.

John Landry: 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 US commercial activities. Long term, we expect to drive gross margins over 80%. 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 break even below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Speaker #2: 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.

John Landry: Long term, we expect to drive gross margins over 80%. 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 break even below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Speaker #2: We believe this disciplined approach will allow us to achieve revenue break-even below 150 million euros in revenue. With that, I now like to turn the call back over to Olivier.

Speaker #1: Thank you, John. As we enter Q2, our priorities remain clear: further execute on the current launch momentum in the US, capture greater market share in our targeted high-volume accounts, and maintain a disciplined financial approach to OPEX and cash management.

Olivier Taelman: Thank you, John. As we enter Q2, our priorities remain clear. Further execute on the current launch momentum in the US, 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 Nyxoah employees for their contribution in making Q1 a successful quarter. With that, I would like to open the line for question and answers.

Speaker #1: 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 questions and answers.

Operator: Our first question today will be coming from the line of Adam Maeder of Piper Sandler.

Speaker #3: Remind, if you'd like to ask a question, please press star one on your telephone. You'll then hear the automated message advising your hand is raised.

Speaker #3: We also ask that you please wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster.

Speaker #3: Our first question today will be coming from the line of Adam Meter. Of Piper Sandler, please go ahead.

Operator: Our first question today will be coming from the line of Adam Maeder of Piper Sandler.

Speaker #4: Hi, good afternoon, Olivier and John. Thank you for taking the questions and congrats on the solid progress. Two from me. The first one is on the guidance front.

Adam Maeder: Hi, good afternoon, Olivier and John. Thank you for taking the questions and congrats on the solid progress. Two from me. The first one is on the guidance front. I wanted to ask about the full year 2026 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 US revs, it does imply a bit of a step-up in H2 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. Talk about some of the kind of key drivers of the ramp, and any help on quarterly phasing would be appreciated. Thanks.

Speaker #4: I wanted to ask about the full-year '26 revenue guidance that you provided, which is above where the Street is currently sitting. If you look at where you've guided Q2 U.S. revenue, it does imply a bit of a step up in the back half of the year.

Speaker #4: 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 talked about some of the kind of key drivers of the ramp and any help on quarterly phasing would be appreciated.

Adam Maeder: 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. Talk about some of the kind of key drivers of the ramp, and any help on quarterly phasing would be appreciated. Thanks.

Speaker #4: Thanks.

Speaker #1: Thank you, Adam. So let me start by answering the question. First of all, as we already communicated, we continued adding salespeople into the field.

Olivier Taelman: Thank you, Adam. Let me start by answering the question. First of all, as we already communicated, we continued adding salespeople into our, into the field. 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. On top, after seeing the first patient activations, what was confirming the strong airway openings that they saw during the surgery, gave them even more confidence and start treating immediately more new patients.

Speaker #1: So we added 15 new sales reps bringing the total to 40 salespeople, which enabled us to cover 200 out of the 400 high-volume accounts.

Speaker #1: As you also know, surgeons when they start implanting, they go through their surgical learning curve. This takes roughly two to four implants. And then you also see that they are scaling up.

Speaker #1: 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 airway openings that they saw during the surgery—gave them even more confidence to start treating immediately more new patients.

Olivier Taelman: What we have learned in Q4 and in Q1 is that we got a lot of positive feedback from surgeons after their first cases. On top, after seeing the first patient activations, what was confirming the strong airway openings that they saw during the surgery, gave them even more confidence and start treating immediately more new patients.

Speaker #1: 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 timelines.

Olivier Taelman: That's one aspect. 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 timelines. Sometimes it varies from 1 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. Also this is driving an acceleration in adoption. 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 prioritization file to a commercial payer while exiting, or entering Q2, exiting Q1.

Speaker #1: Sometimes it varies from one to two weeks all the way up to a couple of months. Also here, we are seeing great progress made.

Speaker #1: And we have no 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.

Olivier Taelman: Also this is driving an acceleration in adoption. 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 prioritization file to a commercial payer while exiting, or entering Q2, exiting Q1.

Speaker #1: And of course, in the end, there is also the patients and also the patient referral path coming from sleep physicians. I'm extremely pleased also that I was able to announce that we have 241 real patients with a submitted prioritization file to a commercial payer while exiting or entering Q2, exiting Q1.

Speaker #1: So, if you add those leading indicators up, that has given us confidence of showing continued strong double-digit growth, even further accelerating in the second half of the year.

Olivier Taelman: If you add those leading indicators up, that has given us confidence of showing continued strong double-digit growth, even further accelerating in H2 of the year. Now John will add some numbers to this as well to answer your questions completely.

Speaker #1: But now, John will add some numbers. To this as well, to answer your question completely.

Speaker #4: Excellent, yes. Thanks for the question, Adam. 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.

John Landry: Excellent. Yeah. Thanks for the question, Adam. In terms of where we're at and what we're looking for, productivity, we expect in H2 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 Q2 this year, and then we'll ramp up over the rest of the year. The sequential growth and growth rate I mentioned, 25% to 30% in Q2, we would see that accelerate in Q3 to probably about the 40%, low 40% to 45% range and then 50% range, you know, into the Q4 of the year, which as you know, is a seasonally stronger year, especially in the US, as people have fully exhausted their deductibles.

Speaker #4: And then we'll ramp up over the rest of the year. So the sequential growth rate I mentioned of 25 to 30 percent in the second quarter—we would see that accelerate in the third quarter.

John Landry: The sequential growth and growth rate I mentioned, 25% to 30% in Q2, we would see that accelerate in Q3 to probably about the 40%, low 40% to 45% range and then 50% range, you know, into the Q4 of the year, which as you know, is a seasonally stronger year, especially in the US, as people have fully exhausted their deductibles.

Speaker #4: To probably about the 40, low 40 to 45 percent range. And then in the 50 percent range, into the fourth quarter of the year, which, as you know, is a seasonally stronger year.

Speaker #4: Especially in the US, as people have fully exhausted their deductibles. So when you run that math, that's what helps provide some of that backend.

John Landry: 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 US revenue target.

Speaker #4: Growth that you'll see in the model to achieve that US revenue target.

Speaker #1: And maybe, Adam, last on this one. That's also not to forget that I think we can say that reimbursement now is fully clear and supportive from both CMS with their C codes and also from commercial payers.

Olivier Taelman: Maybe, Adam, last on this one. Let's also not forget that I think we can say that reimbursement now is fully clear and supported from both CMS with their C codes and also from commercial payers. Also this is definitely not a hindering factor, as we experienced already in Q1 not to be a hindering factor.

Speaker #1: So also, this is definitely not a hindering factor, as we experienced already in Q1, not to be a hindering factor.

Adam Maeder: Yes. 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 kind of how you're thinking about, you know, a permanent CPT code. You know, I know in your prepared remarks you mentioned the AMA CPT panel meeting earlier this month. We did see the proposed meeting agenda, there was a hypoglossal nerve stimulation code on that agenda. From our vantage point, that actually seemed to kind of describe the competitor device versus Genio. Would you agree or disagree with that assessment?

Speaker #4: Yes. 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.

Speaker #4: Olivier, I guess the question is really around kind of the longer-term strategy for Geneo and kind of 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.

Adam Maeder: You know, I know in your prepared remarks you mentioned the AMA CPT panel meeting earlier this month. We did see the proposed meeting agenda, there was a hypoglossal nerve stimulation code on that agenda. From our vantage point, that actually seemed to kind of describe the competitor device versus Genio. Would you agree or disagree with that assessment?

Speaker #4: 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.

Speaker #4: 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 timelines for Geneo would be appreciated.

Adam Maeder: Then just any help that you can give us in terms of, you know, pathway forward to kind of a more permanent reimbursement coding solution and timelines would, for Genio, would be appreciated. Thank you.

Speaker #4: Thank you.

Speaker #1: Yeah. No, no. Thank you, Adam, for this. So I do think that for 2026, everything is very clear now. CMS has the C codes.

Olivier Taelman: No, no, thanks, Adam, for this. 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 a 100% prior authorization approval ratio. We also know with commercial payers that we are both covered under the CPT 64568 and 64582. 2026, I do think is crystal clear in going forward, and it's completely de-risked. Now, we were also participating during the CPT Editorial Panel discussions, and of course, there we were listening and actively participating in this discussion focused on 2027 and even 2028. For 2027, we expect no change on the Medicare side.

Speaker #1: We know the WISER program. There, we have obtained our 100% approval in prior authorization approval ratio. And we also know with commercial payers that we are both covered under CPT 61568 and 61582.

Speaker #1: So 2026, I do think is crystal clear in going forward and is completely de-risked. Now, we were also participating during the editorial CPT panel discussion.

Olivier Taelman: Now, we were also participating during the CPT Editorial Panel discussions, and of course, there we were listening and actively participating in this discussion focused on 2027 and even 2028. For 2027, we expect no change on the Medicare side.

Speaker #1: 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.

Speaker #1: The C code framework and the physician payment under the CPT 61582 are 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 61568 will be revised and will apply solely to the vagus nerve stimulation.

Olivier Taelman: The C-code framework and the physician payment under the CPT 64582 are 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, the code would migrate into 64582 coding. In going to 2028, 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. For 2028, what we are hearing is that there are two roads in going forward.

Speaker #1: Directing all AGNS procedures away from that code. And the code would migrate into a 61582 coding. 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.

Olivier Taelman: In going to 2028, 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. For 2028, what we are hearing is that there are two roads in going forward.

Speaker #1: 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.

Speaker #1: 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 under.

Olivier Taelman: 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 follow. 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 CPT Editorial Panel, but we are well-prepared, and we will be submitting this in going forward. On the other hand, we will always take our lead from specialty societies, including AAO-HNS, since their actions are driven by physicians performing the procedures. The conclusion is 2026, we know that everything is de-risked reimbursement-wise. 2027, we see it the same way. Medicare side completely clear.

Speaker #1: But that needs to be further clarified. Now, when it comes to Geneo, when we go to a CPT-dedicated code, we intentionally did not yet submit this on the agenda of the editorial panel.

Olivier Taelman: 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 CPT Editorial Panel, but we are well-prepared, and we will be submitting this in going forward. On the other hand, we will always take our lead from specialty societies, including AAO-HNS, since their actions are driven by physicians performing the procedures. The conclusion is 2026, we know that everything is de-risked reimbursement-wise. 2027, we see it the same way. Medicare side completely clear.

Speaker #1: But we are well prepared, and we will be submitting this going forward. On the other hand, we will always take our lead from specialty societies, including AAO and ANS, since their actions are driven by physicians performing the procedures.

Speaker #1: So the conclusion is 2026, we know that everything is de-risked reimbursement-wise. '27, we see it the same way. Medicare side, completely clear. From the commercial payers, there are codings in place.

Olivier Taelman: From the commercial payers, there are codings in place. It might be that everything is more migrated to the 64582 code. In 2028, I'm sure that CPT 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.

Speaker #1: It might be that everything is more migrated to the 61,582 code. And in 2028, I'm sure that the editorial panel will continue discussing—they made it already clear that there will be no orphan AGNS technology.

Speaker #1: 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 the society in this.

Speaker #1: I hope this is answering your question.

Speaker #4: Perfect. That's very helpful. Thank you.

Adam Maeder: Perfect. That's very helpful. Thank you.

Speaker #3: Thank you. One moment for the next question. Our next question will be coming from the line of Jean-Blanc of Stifel. Please go ahead.

Operator: Thank you. One moment for the next question. Our next question will be coming from the line of Jonathan Block of Stifel. Please go ahead.

Speaker #4: Great. Thanks, guys. And good afternoon. Olivier, the first one is the 241 patients submitted under prior authorization at the end of the first quarter of 2026.

Jonathan Block: Great. Thanks, guys, and good afternoon. Olivier, the first one is the 241 patients submitted under prior authorization at the end of Q1 2026. Can you remind us what that number was at the end of Q4 2025, you know, sort of apples to apples? How long does it take to get those patients through the approval process, which I believe you said, you know, is still sitting at around 100% from your vantage point?

Speaker #4: 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?

Speaker #1: 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?

Olivier Taelman: Yes. For leaving Q1, as I was saying, 241. When we were leaving Q4, we had approximately 116 patients under prior authorization. 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. 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 a high-volume site, also the surgeon is a high-volume surgeon doing other procedures as well, next to the hypoglossal nerve stimulation or the Genio procedure. We see that there's varies between 1 to 3 months before those patients are then implanted.

Speaker #1: 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.

Speaker #1: And then it depends, hypoglossal side to hypoglossal side, 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 a high-volume site.

Olivier Taelman: 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 a high-volume site, also the surgeon is a high-volume surgeon doing other procedures as well, next to the hypoglossal nerve stimulation or the Genio procedure. We see that there's varies between 1 to 3 months before those patients are then implanted.

Speaker #1: Also the surgeon is a high volume surgeon doing other procedures as well next to the hypoglossal nerve stimulation of the Geneo procedure. So we see that this varies between 1 to 3 months before those patients are getting implanted.

Speaker #4: Okay. Thank you. That's helpful color. And then maybe just to pivot John, pro forma for the European second tranche, I think you've got about 40 million euros, call it cash, the roughly 26 plus the 14.

Jonathan Block: Okay. Thank you. That, that's helpful color. Maybe just to pivot, you know, John, pro forma for the European second tranche, I think you've got about EUR 40 million, call it cash, you know, the roughly 26 plus the 14. Maybe if you can remind us what the break-even point for the company is, your views on cash burn going forward? You know, just to tack on, the gross margin continues to perplex me. You know, 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 this sort of low 60% range plus.

Speaker #4: Maybe if you could remind us what the break-even 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.

Jonathan Block: You know, just to tack on, the gross margin continues to perplex me. You know, 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 this sort of low 60% range plus.

Speaker #4: When I look at the P&L, when you guys had €4 million in 2023, your gross margin was 62%. And here we are approaching €40 million in 2026.

Speaker #4: And it can't get out of its own way. And this sort of low 60% range plus. So what is preventing gross margins from improving as the company is sort of improved the top line?

Jonathan Block: You know, what is preventing gross margins from improving as the company's sort of improved the top line? How do we think about it going forward and sort of that inflection that you guys anticipate is gonna take place in subsequent years? Thank you.

Speaker #4: 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?

Speaker #4: Thank you.

John Landry: Sure. Yeah. Thanks for the questions, John. Let me start with gross margin. With regard to gross margin, we did have some issues with production yield in the quarter, due to some turnover and some training issues, which have been all resolved at this point. We expect to see our gross margins increase going forward, beginning Q2 and for the rest of the year. I think, as I mentioned on the last call, we have our Genio 2.2 new disposable patch and activation chip, which will be a major step function improvement in our gross margin profile.

Speaker #1: Sure. Yep. Thanks for the questions, John. So let me start with gross margin. So with regard to gross margin, we did have some issues with production yield in the quarter.

Speaker #1: 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 the second quarter and for the rest of the year.

Speaker #1: I think, as I mentioned on the last call, we have our Geneo 2.2 new disposable patch and activation chip, which will be a major step function improvement in our gross margin profile.

Speaker #1: 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 file.

John Landry: That will be coming online in early 2027, so that will provide us that uplift from the, you know, low 60s to, you know, north of 70% at that point in time, with that improved patient experience plus significantly cost reduced profile. 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.

Speaker #1: So that's how we're thinking about gross margin. Then also in terms of the next step up in gross margin improvement, we'll 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.

Speaker #1: So that's the gross margin outlook. And that we have a high degree of confidence we'll get to 80 plus percent in our gross margin profile on the back, largely of those two initiatives.

John Landry: That's the gross margin outlook, and that we have a high degree of confidence we'll get to 80%+ in our gross margin profile on the backs largely of those two initiatives. In terms of cash burn, we're very focused on, you know, managing our cash burn. As you can see, we held our cash operating expenses. We actually slightly decreased them from Q4 to Q1 of 2026. That's reflective of the incremental 15 sales reps that we added in the US.

Speaker #1: In terms of cash burn, we're very focused on managing our cash burns. So as you can see, we held our cash operating expenses. We actually slightly decreased them from the fourth quarter to the first quarter of 2026.

Speaker #1: And that's reflective of the incremental 15 sales reps that we added in the US. So we've been very focused on making sure that we're investing strongly in the US commercialization efforts.

John Landry: We've been very focused on making sure that we're investing strongly in the US 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 US commercial organization, which is the growth engine for us, and not sacrificing the improvements in gross margin drivers. That's how we're thinking about it. As we think about cash operating expenses going forward, you know, we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance.

Speaker #1: Reallocating capital to that from other parts of the business. And we really want to basically extend our cash runway as long as possible while supporting the investments in the US commercial organization which is the growth engine for us and not sacrifice any improvements in gross margin drivers.

Speaker #1: So that's how we're thinking about it. As we think about cash operating expenses going forward, we'll be we mentioned a 5 to 8 percent sequential increase this year.

John Landry: That's how we're thinking about it. As we think about cash operating expenses going forward, you know, we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance.

Speaker #1: We would expect somewhat similar increases going forward, although not providing guidance. But as we're thinking about it, we want to be very mindful of our cash operating expense.

John Landry: 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 break-even point of approximately EUR 150 million in revenue. That allows us, at that point, to have an 80% gross margin, plus through tight cash OpEx management, allow us to get it to break even and knock down the total cash that we need to get to that point, to somewhere, you know, in the range of EUR 100 million to get there. That's how we're thinking about it and, you know, looking at managing our P&L levers that we have available to us.

Speaker #1: That way, we can get to a revenue break-even point of approximately 150 million in revenue that's allows us at that point to have an 80% gross margin plus through tight cash opex management that allows us to get to break-even.

Speaker #1: And knock down the total cash that we need to get to that point to somewhere in the range of 100 million euros to get there.

Speaker #1: So that's how we're thinking about it. And looking at managing our P&L levers that we have available to us.

Speaker #4: Great. Thanks for the call, guys.

Jonathan Block: Great. Thanks for the color, guys.

Speaker #1: Thanks, Sean.

John Landry: Thanks, Jonathan.

Speaker #3: Thank you.

Olivier Taelman: Thank you.

Speaker #2: Thank you. One moment for the next question. Our next question is coming from the line of Sharjah. Of Oppenheimer, please.

Operator: Thank you. One moment for the next question. Our next question is coming from the line of Suraj Kalia of Oppenheimer. Please go ahead.

Speaker #4: Hi, Olivier. John, can you hear me all right?

Suraj Kalia: Hi, Olivier, John. Can you hear me all right?

Speaker #1: We can hear you well, Subhash.

Olivier Taelman: We can hear you well, Suraj.

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

Speaker #4: Congrats on a strong start to the year. Hey, Olivier, I want to follow up on John's question earlier, right? Your Q2 guidance, US guidance is plus 25 to 30 percent, 241 patients in the queue.

Speaker #4: 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 US revenues.

Speaker #4: 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?

Suraj Kalia: Maybe you can If you could thread the needle for us as to what are your core assumptions here. Also, Olivier, or maybe John, in terms of your Medicare patient funnel, what are your expectations for the full year? I have a follow-up.

Speaker #4: Also, Olivier, or maybe John, in terms of your Medicare patient funnel, what are your expectations for the full year? And I have a follow-up.

Olivier Taelman: Yes. Suraj, let me start by commenting on the first part of the question, and I think you're totally correct. 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 is in place and also the spillover from Q4 in Q1 and from Q1 in Q2, we already saw this translated in a very strong April. That is correct. Now, how fast we will be continue ramping up further? Again, as I was mentioning, it will all be also defined by the surgical time, the OR time that we can get, because once again, we are working with high volume sites and high volume surgeons.

Speaker #1: Yes, so Subhash, let me start by commenting on the first part of the question. And I think you're totally correct. We are seeing a strong ramp-up.

Speaker #1: And I'm not going into Q2 patient funnel, and the prioritization is in place, and also the spillover from Q4 and Q1. And from Q1 and Q2, we already saw this translated in a very strong April.

Speaker #1: 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 OR time that we can get.

Olivier Taelman: That is correct. Now, how fast we will be continue ramping up further? Again, as I was mentioning, it will all be also defined by the surgical time, the OR time that we can get, because once again, we are working with high volume sites and high volume surgeons.

Speaker #1: Because once again, we are working with high-volume sites and high-volume surgeons. But to your point, April is strong already, very strong on this one.

Olivier Taelman: To your point, April is strong 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.

Speaker #1: And it's showing already that the ramp is kicking in. For the other part, I will turn it over to John to answer this one.

Speaker #3: Yeah. In terms of the 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.

John Landry: Yeah. In terms of the ramp, I think, you know, we're looking at, again, stepping up the ramp in H2 with regard to sequential quarter growth. As we think about it, you know, Q1, Q2, we're looking at 25% to 30% sequential growth, then bumping that up to low forties and then, you know, upper forties, pushing 50% in Q4 to get to our total number for the year. That's how we're thinking about the staging of that, Suraj. Hope that answers the question.

Speaker #3: So as we think about it, first, the second quarter, we're looking at 25 to 30 percent sequential growth and bumping that up to low 40s.

Speaker #3: 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.

Speaker #3: Hopefully, that answers the question.

Speaker #1: Yeah. And then the Medicare percentage, that was the last part of the question. So in Q1, it's around 10 to 12 percent, still not a minority.

Olivier Taelman: Yeah. The Medicare percentage, that was the last part of the question. In Q1, it's around 10% to 12%, still more the minority. We also see that this will continue growing and when we are scaling up. I do think that towards year-end, this will also be more in the range of 20%. Our commercial players will stay predominant, will be the biggest part of the business. Also now with the C-code in place, I do think that is also completely de-risked. We already had the two first max that I was very positive integrating all these C-codes in their policy as well. We are looking with a lot of confidence into the next portfolio, to the next quarters of 2026.

Speaker #1: We also see that this will continue growing in when we are scaling up. And I do think that towards year-end, this will also be more in the range of 20%.

Speaker #1: But our commercial players will stay predominant, will be the biggest part of the business. But also now with the C coding, in place, I do think that is also completely de-risked and we already had the two first max that I was very positive integrating all these C codes in there in their policy as well.

Olivier Taelman: Also now with the C-code in place, I do think that is also completely de-risked. We already had the two first max that I was very positive integrating all these C-codes in their policy as well. We are looking with a lot of confidence into the next portfolio, to the next quarters of 2026.

Speaker #1: So we are looking with a lot of confidence into the next progress of 2026.

Speaker #4: Got it. And Olivier, in terms of Genio, an Inspire 5, what is the dynamic in the field in terms of selection of the device?

Suraj Kalia: Got it.

Olivier Taelman: Thank you.

Suraj Kalia: Olivier, in terms of Genio and Inspire five, 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? By the same token, how do you all squeeze your way in with Genio? Is it displacing an Inspire case on these at AGNS days? Help us understand how, you know, the dynamic as it stands currently. Thank you for taking my question.

Speaker #4: 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?

Speaker #4: And by the same token, how do you all squeeze your way in with Genio? Is it displacing an Inspire case on these GNS days?

Speaker #4: Or help us understand the dynamic as it stands currently. Thank you for taking my question.

Speaker #1: Okay. So, Suraj, that was also one of the reasons we recently conducted a market research study with 100 US AGNS implanters, also to, in fact, do a sanity check whether our launch strategy and more specific also the referral strategy is really the right approach and is making sense and impacting.

Olivier Taelman: Suraj, that was also one of the reasons we recently conducted a market research study with 100 US AGNS implanters, also to, in fact, do a sanity check whether our launch strategy, and more specific also the referral strategy, is really the right approach and is making sense and impacting. 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. 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.

Speaker #1: And it was really to our pleasure to see 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.

Olivier Taelman: 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. 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.

Speaker #1: 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.

Speaker #1: Now, the dynamics between competition and Genio—it's also clear that, for now, our investments in VTC are extremely limited. So, the majority of patients that are arriving in hospitals are coming for an AGNS solution.

Olivier Taelman: The dynamic between competition and Genio, it's also clear that for now, our investments in DTC are extremely limited. The majority of patients that are arriving in hospital, they are coming for an AGNS solution, but they are not coming through DTC of Genio at this moment. 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 stimulation and software upgrades. Those are the main components that was confirmed in our market research as well. In going forward, we will continue focusing on sleep medicine involvement.

Speaker #1: But they are not coming through DTC of Genio at this moment. So where the convert takes place is when they are in the site.

Speaker #1: 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 stimulation and software upgrades.

Olivier Taelman: 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 stimulation and software upgrades. Those are the main components that was confirmed in our market research as well. In going forward, we will continue focusing on sleep medicine involvement.

Speaker #1: So, those are the main components that were confirmed in our market research as well. Now, going forward, we will continue focusing on sleep medicine involvement.

Speaker #1: We see also now 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 titrations, that in the majority of our patients, the settings are exactly the same as they were seeing during the surgery.

Olivier Taelman: We see also know 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 our patients, the settings are exactly the same as they were seeing during the surgery. This is also giving a lot of confidence to sleep physicians also to refer for the patients. If you combine all this, strategy is focused on high-volume implanters. We partner them up with their sleep medicine from the beginning. We make sure that there is a clear and defined role in patient phenotyping by sleep physicians before patients are selected after quitting their CPAP. We make sure the sleep physician is actively involved also in post-surgery patient management.

Speaker #1: And this is also giving a lot of confidence to sleep physicians also to refer further patients. So if you combine all this, strategy is focused on high-volume implanters.

Olivier Taelman: If you combine all this, strategy is focused on high-volume implanters. We partner them up with their sleep medicine from the beginning. We make sure that there is a clear and defined role in patient phenotyping by sleep physicians before patients are selected after quitting their CPAP. We make sure the sleep physician is actively involved also in post-surgery patient management.

Speaker #1: We partner them up with their sleep medicine from the beginning. Then we make sure that there is a clear defined role in patient phenotyping by sleep physicians before patients are selected after quitting their CPAP.

Speaker #1: 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 easy of finding the correct titration settings, this is giving a lot of confidence.

Olivier Taelman: Of course, by seeing the first activations, also the ease of finding the correct titration settings, this is giving a lot of confidence. We will continue with this strategy, and we will keep our DTC spending very limited.

Speaker #1: So we will continue with this strategy and we'll keep our DTC spending very limited.

Speaker #4: Thank you.

Suraj Kalia: Thank you.

Olivier Taelman: Thank you.

Speaker #5: One moment for the next question. And our next question will be coming from the line of David Rescott. Of Beard. Your line is open.

Operator: One moment for the next question. Our next question will be coming from the line of David Rescott of Baird. Your line is open.

David Rescott: Great. Thanks for taking the questions. 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. I guess depending on where you shake out for the year, I guess first part is, you know, is that impact expected to continue into Q2 and then fully revert back in H2? I ask that in the context of, again, where you shake out for the full year.

Speaker #6: Great, thanks for taking the questions. 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.

Speaker #6: 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?

Speaker #6: And then fully revert back in the back half of the year? And I asked that in the context of, again, where you shake out for the full year.

David Rescott: You know, you could be somewhere in the mid-sixties by the end of the year if you're getting to the upper end of that 60% to 62% range. Just trying to get a sense for what the adjusted maybe cadence looks like as you get through the year on the gross margin. I had a follow-up.

Speaker #6: 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 percent range.

Speaker #6: 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 line.

Speaker #6: I know I had a follow-up.

John Landry: Sure. Yeah, so thanks for the question, David. In terms of the gross margin impact, there'll be, you know, 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'll be, you know, a slight impact there. You know, the rest of the year, we'll start to see it, you know, get back to where, you know, essentially we were, you know, in, you know, Q3, Q4 timeframe, which was in the 63%, 64% range from a gross margin perspective.

Speaker #1: Sure. So, yeah, so thanks for the question, David. In terms of the gross margin impact, there'll 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.

Speaker #1: So there'll be a slight impact there. The rest of the year will start to see it get back to where essentially we were in Q3, Q4 timeframe, which was in the 63, 64 percent range from a gross margin perspective.

Speaker #1: 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.

John Landry: We'll hang out there for the back half of 2026, before we implement the Genio 2.2, disposal patch and activation share, which will again provide a step function improvement in Q1 2027 up into the low 70s.

David Rescott: Okay. Then I guess just clicking on the P&L here, you know, looking at this adjusted OpEx number for Q1 and relative to the guidance for the full year, you know, you annualize the Q1 number, and you're pretty much getting toward that low end of what the full year non-GAAP guide is. Just trying to get a sense for, you know, 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.

Speaker #6: Okay. And then I guess just sticking on the P&L here, looking at this adjusted OPEX number for Q1 and 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-gap guide is.

Speaker #6: 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.

Speaker #6: 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 to where you step off when you look into the 2027 timeframe?

David Rescott: Is it fair to assume that a lot of this, you know, 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? As that relates into, you know, where you step off when you look into the 2027 timeframe. Thank you.

Speaker #6: Thank you.

Speaker #1: Sure. Absolutely. So again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. So from a large driver of OPEX growth is really regarding the investments we made in the US commercial organization.

John Landry: Sure. Absolutely. Again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. Some of the, you know, large driver of OpEx growth is really regarding, you know, the investments we made in the US commercial organization. Those have largely been made in Q1 of 2027, so that'll 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, you know, somewhere in the middle of that range from an OpEx perspective. Again, we'll be thoughtful and disciplined in our approach there.

Speaker #1: Those have largely been made in the first quarter of 2027. So that'll run pretty consistent over the course of the year, which leads to the essentially the forex on Q1 results on the low end of the guide.

John Landry: 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, you know, somewhere in the middle of that range from an OpEx perspective. Again, we'll be thoughtful and disciplined in our approach there.

Speaker #1: We will make selective 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.

Speaker #1: 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, 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.

John Landry: 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. As we think again about 2027, we wanna take the same approach into 2027 and try and redeploy as much capital as we can and leverage the non-commercial 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-à-vis revenue and/or margin improvement initiatives.

Speaker #1: 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 non-commercial 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-à-vis revenue and/or margin improvement initiatives.

John Landry: As we think again about 2027, we wanna take the same approach into 2027 and try and redeploy as much capital as we can and leverage the non-commercial 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-à-vis revenue and/or margin improvement initiatives.

Speaker #1: So that's how we're thinking about it and want to be conscientious with that. I think that was all for you. The question, since the silence, so I don't know, operator, is there more people lined up for questions?

John Landry: That's how we're thinking about it, and we wanna be conscientious of that.

Olivier Taelman: I think that was answering the question since the silence. I don't know, operator, is there are more people lined up for questions?

Operator: That concludes today's Q&A session.

Speaker #5: That's concludes today's Q&A session. And this also concludes this also concludes today's programming. You may all disconnect.

Olivier Taelman: So then-

Olivier Taelman: Then-

Operator: This also concludes today's programming. You may all disconnect.

Speaker #1: Thank you.

Olivier Taelman: Thank you. Thank you.