Half Year 2026 Nyxoah SA Earnings Call
Operator: Good day, and thank you for standing by. Welcome to Nyxoah's Q2 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. Today's conference is being recorded. I will now hand the conference over to your first speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.
Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star-one-one on your telephone.
Speaker #1: You will then hear an automated message advising your hand is raised. Today's conference is being recorded. I will now hand the conference over to your first speaker today, Pearson Dennis, Investor Relations Associate.
Speaker #1: Please go ahead.
Speaker #2: Thank you. Good afternoon, everyone, and I welcome you to our second quarter 2026 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer.
Pearson Dennis: Thank you. Good afternoon, everyone, and I welcome you to our Q2 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 Q2 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 our current estimates and various assumptions.
Pearson Dennis: Thank you. Good afternoon, everyone, and I welcome you to our Q2 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 Q2 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 our current estimates and various assumptions.
Speaker #2: During the call, we will discuss our operating activities and review our second quarter 2026 financial results, released after U.S. market closing today. Afterward, we will host a question-and-answer session.
Speaker #2: 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.
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 our 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.
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.
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 20F, 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 second quarter 2026 earnings call. Let me start with Q2 highlights.
Olivier Taelman: Thank you, Pearson. Good day, everyone, and thank you for joining us for our Q2 2026 earnings call. Let me start with Q2 highlights. Q2 was a strong quarter for Nyxoah across multiple fronts, and I'm pleased with the progress we are making in the business. First, the strong commercial execution of our US launch delivered a second consecutive quarter of more than 20% sequential US revenue growth. US net revenue was EUR 5.2 million, up 22% over Q1 2026. We also posted another strong quarter of revenue growth in our international business, up 19% over Q1 2026. On a worldwide basis, net revenue was EUR 7.7 million in Q2, representing 21% sequential growth over Q1. Second, before doing a deeper dive on the US commercialization results, let me provide our high-level leading US commercial indicators.
Olivier Taelman: Thank you, Pearson. Good day, everyone, and thank you for joining us for our Q2 2026 earnings call. Let me start with Q2 highlights. Q2 was a strong quarter for Nyxoah across multiple fronts, and I'm pleased with the progress we are making in the business. First, the strong commercial execution of our US launch delivered a second consecutive quarter of more than 20% sequential US revenue growth. US net revenue was EUR 5.2 million, up 22% over Q1 2026. We also posted another strong quarter of revenue growth in our international business, up 19% over Q1 2026. On a worldwide basis, net revenue was EUR 7.7 million in Q2, representing 21% sequential growth over Q1. Second, before doing a deeper dive on the US commercialization results, let me provide our high-level leading US commercial indicators.
Speaker #3: Q2 was a strong quarter for Nyxoah across multiple fronts, and I'm pleased with the progress we are making in the business. First, the strong commercial execution over U.S.
Speaker #3: launch delivered a second consecutive quarter of more than 20% sequential U.S. revenue growth. U.S. net revenue was 5.2 million euros. Up 22% over the first quarter of 2026.
Speaker #3: We also posted another strong quarter of revenue growth in our international business, up 19% over the first quarter of 2026. On a worldwide basis, net revenue was 7.7 million euros, in the second quarter representing 21% sequential growth over the first quarter.
Speaker #3: Second, before doing a deeper dive on the U.S. commercialization results, let me provide our high-level leading U.S. commercial indicators. Our U.S. leading commercial indicators continued to strengthen across the board.
Olivier Taelman: Our US leading commercial indicators continued to strengthen across the board. Entering Q2 with 40 fully trained sales reps, we can cover 200 of the top 400 high-volume hypoglossal nerve stimulation accounts in the US. We have trained 55 new surgeons and activated 89 new accounts in this quarter, doubling our active account base to 180. We entered Q3 with 427 patients actively under prior authorization, a 77% increase over the prior quarter. Our prior authorization approval rate remains at 100% for both commercial payers and patients submitted via the WISeR program. On the reimbursement front, CMS announced meaningful proposed increases for AGNS overall, including Genio specifically. CMS proposed facility reimbursement would increase OPPS facility payment by 12% and ASC, ambulatory surgical centers, by 15% for 2027. These increases would further strengthen the economic value of the Genio procedure for the facilities.
Olivier Taelman: Our US leading commercial indicators continued to strengthen across the board. Entering Q2 with 40 fully trained sales reps, we can cover 200 of the top 400 high-volume hypoglossal nerve stimulation accounts in the US. We have trained 55 new surgeons and activated 89 new accounts in this quarter, doubling our active account base to 180. We entered Q3 with 427 patients actively under prior authorization, a 77% increase over the prior quarter. Our prior authorization approval rate remains at 100% for both commercial payers and patients submitted via the WISeR program. On the reimbursement front, CMS announced meaningful proposed increases for AGNS overall, including Genio specifically. CMS proposed facility reimbursement would increase OPPS facility payment by 12% and ASC, ambulatory surgical centers, by 15% for 2027. These increases would further strengthen the economic value of the Genio procedure for the facilities.
Speaker #3: Entering quarter two, with 40 fully trained sales reps, we can cover 200 of the top 400 high-volume hypoglossal nerve stimulation accounts in the U.S.
Speaker #3: We have trained 55 new surgeons and activated 89 new accounts in this quarter, doubling our active account base to 180. We entered the third quarter with 427 patients actively under prior authorization.
Speaker #3: A 77% increase over the prior quarter. Our prior authorization approval rate remains at 100% for both commercial payers and patients submitted via the Wiser program.
Speaker #3: On the reimbursement front, CMS announced meaningful proposed increases for AGNS overall, including Genio specifically. CMS proposed facility reimbursement would increase OPPS facility payment by 12%, and ASC (ambulatory surgical centers) by 15% for 2027.
Speaker #3: These increases would further strengthen the economic value of the Genio procedure for the facilities. From a financing perspective, we significantly strengthened our balance sheet by securing $110 million during the quarter.
Olivier Taelman: From a financing perspective, we significantly strengthened our balance sheet by securing $110 million during the quarter, taking away the financial overhang. This new capital will provide us with the resources needed to further accelerate Genio US commercialization ramp and implement the growth initiatives focused on increasing the patient funnel. Now digging in deeper into the US commercialization. The US commercial launch remains the primary driver of our long-term company success. Our US-focused strategy remains unchanged and centered on driving strong Genio adoption in the top 400 high-volume AGNS accounts, which represent approximately 70% of the total US AGNS volume. We hired and trained 50 new sales reps in Q1, bringing us to 40 sales territories as of 1 April. Entering Q2, we had access to 200 of the top 400 high-volume AGNS accounts.
Olivier Taelman: From a financing perspective, we significantly strengthened our balance sheet by securing $110 million during the quarter, taking away the financial overhang. This new capital will provide us with the resources needed to further accelerate Genio US commercialization ramp and implement the growth initiatives focused on increasing the patient funnel. Now digging in deeper into the US commercialization. The US commercial launch remains the primary driver of our long-term company success. Our US-focused strategy remains unchanged and centered on driving strong Genio adoption in the top 400 high-volume AGNS accounts, which represent approximately 70% of the total US AGNS volume. We hired and trained 50 new sales reps in Q1, bringing us to 40 sales territories as of 1 April. Entering Q2, we had access to 200 of the top 400 high-volume AGNS accounts.
Speaker #3: Taking away the financial overhang. This new capital will provide us with the resources needed to further accelerate Genio U.S. commercialization ramp and implement growth initiatives focused on increasing the patient funnel.
Speaker #3: No digging in deeper into the U.S. commercialization. The U.S. commercial launch remains the primary driver of our long-term company success. Our U.S.-focused strategy remains unchanged and centered on driving strong Genio adoption in the top 400 high-volume AGNS accounts.
Speaker #3: Which represent approximately 70% of the total U.S. AGNS volume. We hired and trained 15 new sales reps in the first quarter, bringing us to 40 sales territories as of April 1.
Speaker #3: Entering Q2, we had access to 200 of the top 400 high-volume AGNS accounts. Specifically, we trained 55 new surgeons in Q2, bringing the total to 262 surgeons trained on the Genio system.
Olivier Taelman: Specifically, we trained 55 new surgeons in Q2, bringing the total to 262 surgeons trained on the Genio system. We activated 89 new accounts in Q2, roughly doubling our active account base, bringing the total to 180 active high-volume AGNS accounts. Finally, we had 427 patients actively under prior authorization submissions entering Q3 of 2026. This is a 77% increase over the previous quarter. Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio and confirms success of our patient referral pathway by sleep physicians. With 427 patients actively under prior authorization exiting Q2, this gives us firsthand confirmation of increased patient demand and is a key leading indicator for Q3 of the acceleration of our patient pipeline, giving us confidence in continued launch momentum entering Q3. Next, reimbursement.
Olivier Taelman: Specifically, we trained 55 new surgeons in Q2, bringing the total to 262 surgeons trained on the Genio system. We activated 89 new accounts in Q2, roughly doubling our active account base, bringing the total to 180 active high-volume AGNS accounts. Finally, we had 427 patients actively under prior authorization submissions entering Q3 of 2026. This is a 77% increase over the previous quarter. Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio and confirms success of our patient referral pathway by sleep physicians. With 427 patients actively under prior authorization exiting Q2, this gives us firsthand confirmation of increased patient demand and is a key leading indicator for Q3 of the acceleration of our patient pipeline, giving us confidence in continued launch momentum entering Q3. Next, reimbursement.
Speaker #3: We activated 89 new accounts in Q2, roughly doubling our active account base bringing the total to 180 active high-volume AGNS accounts. And finally, we had 427 patients actively under prior authorization submissions entering the third quarter of 2026, this is a 77% increase over the previous quarter.
Speaker #3: Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio, and confirms the success of our patient referral pathway by sleep physicians.
Speaker #3: With 427 patients actively under prior authorization exiting Q2, this gives us firsthand confirmation of increased patient demand and is a key leading indicator for Q3 of the acceleration of our patient pipeline, giving us confidence in continued launch momentum entering Q3.
Speaker #3: Next, reimbursement. There is no full clarity for Genio reimbursement, with the dedicated Medicare C code C8011 for Genio. Our commercial payer coverage remains broad and stable using existing CPT codes, and our market access team continues to execute strong on supporting prior authorization submissions.
Olivier Taelman: There is now full clarity for Genio reimbursement with the dedicated Medicare C code C8011 for Genio. Our commercial payer coverage remains broad and stable using existing CPT codes, and our market access team continues to execute strong on supporting prior authorization submissions. Through our Genio Access Program, we continue to see 100% approval rates of commercial payers, Medicare Advantage, and Medicare patients under the WISeR program. Commercial payers are still the majority of our business, making up approximately 85% of it. The recent direction of CMS proposed rule for 2027 AGNS reimbursement would positively impact the clinical and economic value of the Genio procedure in OPPS and ASCs. Specifically, CMS is proposing to increase hospital outpatient reimbursement for the Genio procedure under C code C8011 from EUR 31,526 to EUR 35,414, or an increase of approximately 12%.
Olivier Taelman: There is now full clarity for Genio reimbursement with the dedicated Medicare C code C8011 for Genio. Our commercial payer coverage remains broad and stable using existing CPT codes, and our market access team continues to execute strong on supporting prior authorization submissions. Through our Genio Access Program, we continue to see 100% approval rates of commercial payers, Medicare Advantage, and Medicare patients under the WISeR program. Commercial payers are still the majority of our business, making up approximately 85% of it. The recent direction of CMS proposed rule for 2027 AGNS reimbursement would positively impact the clinical and economic value of the Genio procedure in OPPS and ASCs. Specifically, CMS is proposing to increase hospital outpatient reimbursement for the Genio procedure under C code C8011 from EUR 31,526 to EUR 35,414, or an increase of approximately 12%.
Speaker #3: To our Genio access program, we continue to see 100% approval rates of commercial payers, Medicare advantage, and Medicare patients under the Wiser program. Commercial payers are still the majority of our business, making up approximately 85% of it.
Speaker #3: The recent direction of the CMS proposed rule for 2027 AGNS reimbursement would positively impact the clinical and economic value of the Genio procedure in both OPPS and ASCs.
Speaker #3: Specifically, CMS is proposing to increase hospital outpatient reimbursement for the Genio procedure under C code C8011 from 31,526 dollars to 35,414 dollars, or an increase of approximately 12%.
Olivier Taelman: CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from EUR 27,563 to EUR 31,722, or an increase of approximately 15%. These proposed increases are amongst the strongest within APC 5465, the level 5 neuromodulation category. Finally, in the upcoming September CPT Editorial Panel meeting, AAO-HNS, supported by Nyxoah as an industry member, will continue the discussion of a comprehensive AGNS coding. Nyxoah did not submit Genio for a dedicated category 1 CPT code on the September CPT Editorial Panel meeting agenda. Let me now focus a little bit more on our recent Investor Day. On 8 July, we had the pleasure of hosting our Investor Day, where we focused on bringing together leading ENT surgeons and sleep physicians alongside independent reimbursement experts. The surgeons shared their firsthand implant experience with Genio, and both surgeons and sleep physicians confirmed strong airway openings on activation.
Olivier Taelman: CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from EUR 27,563 to EUR 31,722, or an increase of approximately 15%. These proposed increases are amongst the strongest within APC 5465, the level 5 neuromodulation category. Finally, in the upcoming September CPT Editorial Panel meeting, AAO-HNS, supported by Nyxoah as an industry member, will continue the discussion of a comprehensive AGNS coding. Nyxoah did not submit Genio for a dedicated category 1 CPT code on the September CPT Editorial Panel meeting agenda. Let me now focus a little bit more on our recent Investor Day. On 8 July, we had the pleasure of hosting our Investor Day, where we focused on bringing together leading ENT surgeons and sleep physicians alongside independent reimbursement experts. The surgeons shared their firsthand implant experience with Genio, and both surgeons and sleep physicians confirmed strong airway openings on activation.
Speaker #3: CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from 27,563 dollars to 31,722 dollars, or an increase of approximately 15%. These proposed increases are amongst the strongest within APC 5465, the Level 5 neuromodulation category.
Speaker #3: Finally, in the upcoming September CPT editorial panel meeting, AAO, HNS, supported by Nyxoah as an industry member, will continue the discussion of a comprehensive AGNS coding.
Speaker #3: As a consequence, Nyxoah did not submit Genio for a dedicated category 1 CPT code on the September CPT editorial panel meeting agenda. Let me know focus a little bit more on our recent investor day.
Speaker #3: On July 8, we had the pleasure of hosting our investor day, where we focused on bringing together leading ENT surgeons and sleep physicians, alongside independent reimbursement experts.
Speaker #3: The surgeons shared their first-hand implant experience with Genio, and both surgeons and sleep physicians confirmed strong airway openings on activation. These real-time experiences are the key drivers behind Genio's adoption in their practice.
Olivier Taelman: These real-time experiences are the key drivers behind Genio's adoption in their practice. The reimbursement experts presented their view of the AGNS reimbursement landscape, confirming the durability of long-term coverage and Genio's strong positioning under every future coding scenario. The event reinforced the two pillars of our US launch, growing physician adoption and a solid reimbursement foundation. For those who missed it, the replay is available on our investor relations website. International. Before turning to the financial, let's look at the international markets. We accelerated revenue in Q2, resulting in a 19% growth quarter-over-quarter. Overall, in H1 2026, we almost doubled our international revenue versus H1 2025, driven by our focused commercial approach in target geographies.
Olivier Taelman: These real-time experiences are the key drivers behind Genio's adoption in their practice. The reimbursement experts presented their view of the AGNS reimbursement landscape, confirming the durability of long-term coverage and Genio's strong positioning under every future coding scenario. The event reinforced the two pillars of our US launch, growing physician adoption and a solid reimbursement foundation. For those who missed it, the replay is available on our investor relations website. International. Before turning to the financial, let's look at the international markets. We accelerated revenue in Q2, resulting in a 19% growth quarter-over-quarter. Overall, in H1 2026, we almost doubled our international revenue versus H1 2025, driven by our focused commercial approach in target geographies.
Speaker #3: The reimbursement experts presented their view of the AGNS reimbursement landscape, confirming the durability of long-term coverage and Genio's strong positioning under every future coding scenario.
Speaker #3: The event reinforced the two pillars of our U.S. launch: growing physician adoption and a solid reimbursement foundation. For those who missed it, the replay is available on our investor relations website.
Speaker #3: International. Before turning to the financial, let's look at the international markets. We accelerated revenue in the second quarter resulting in a 19% growth quarter over quarter.
Speaker #3: Overall, in the first half of 2026, we almost doubled our international revenue versus the first half of 2025, driven by our focused commercial approach in target geographies.
Speaker #3: In Germany specifically, as the largest AGNS market outside the U.S., we first entered this market back in 2023. As our commercial proof of concept.
Olivier Taelman: In Germany specifically, as the largest AGNS market outside the US, we first entered this market back in 2023 as our commercial proof of concept, resulting today in a stable AGNS market share of up to 25% overall, with a market share in our top high-volume accounts of above 50%. In the UK, we entered the market at the same time as competition in late 2024, and in our initial accounts, we are seeing market shares above 50% as well. In the Middle East, Nyxoah is the sole AGNS provider, and we continue to further expand. We recently entered the market in the Netherlands. Our strategy remains unchanged. Exercise financial discipline in these markets with the goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.
Olivier Taelman: In Germany specifically, as the largest AGNS market outside the US, we first entered this market back in 2023 as our commercial proof of concept, resulting today in a stable AGNS market share of up to 25% overall, with a market share in our top high-volume accounts of above 50%. In the UK, we entered the market at the same time as competition in late 2024, and in our initial accounts, we are seeing market shares above 50% as well. In the Middle East, Nyxoah is the sole AGNS provider, and we continue to further expand. We recently entered the market in the Netherlands. Our strategy remains unchanged. Exercise financial discipline in these markets with the goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.
Speaker #3: Resulting today in a stable AGNS market share of up to 25% overall. With a market share in our top high-volume accounts of above 50%.
Speaker #3: In the U.K., we entered the market at the same time as competition in late 2024, and in our initial accounts, we are seeing market shares above 50% as well.
Speaker #3: In the Middle East, Nyxoah is the sole AGNS provider, and we continue to further expand. And we recently entered the market in the Netherlands.
Speaker #3: Our strategy remains unchanged. Exercise financial discipline in these markets, with a goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.
Speaker #3: With that, I will now turn the call over to John for a detailed overview of our financial results.
Olivier Taelman: With that, I will now turn the call over to John for a detailed overview of our financial results.
Olivier Taelman: 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 second quarter of 2026, worldwide net revenue was 7.7 million euros, which represents 21% sequential growth compared to the first quarter of 2026 and compares to 1.3 million euros in net revenue in the second quarter of 2025.
John Landry: Thank you, Olivier Taelman. For Q2 2026, worldwide net revenue was EUR 7.7 million, which represents 21% sequential growth compared to Q1 2026 and compares to EUR 1.3 million in net revenue in Q2 2025. US net revenue was EUR 5.2 million, representing 22% sequential growth over Q1 2026. International net revenue was EUR 2.5 million, representing 19% sequential growth over Q1 2026. For the 6 months ended 30 June 2026, worldwide net revenue was EUR 14 million, compared to EUR 2.4 million for the 6 months ended 30 June 2025, an almost six-fold year-over-year increase, primarily driven by our US commercial launch. Gross margin in Q2 2026 was 60%, compared to 57% in Q1 2026.
John Landry: Thank you, Olivier Taelman. For Q2 2026, worldwide net revenue was EUR 7.7 million, which represents 21% sequential growth compared to Q1 2026 and compares to EUR 1.3 million in net revenue in Q2 2025. US net revenue was EUR 5.2 million, representing 22% sequential growth over Q1 2026. International net revenue was EUR 2.5 million, representing 19% sequential growth over Q1 2026. For the 6 months ended 30 June 2026, worldwide net revenue was EUR 14 million, compared to EUR 2.4 million for the 6 months ended 30 June 2025, an almost six-fold year-over-year increase, primarily driven by our US commercial launch. Gross margin in Q2 2026 was 60%, compared to 57% in Q1 2026.
Speaker #2: U.S. net revenue was 5.2 million euros, representing 22% sequential growth over the first quarter of 2026. International net revenue was 2.5 million euros, representing 19% sequential growth over the first quarter of 2026.
Speaker #2: For the six months ended June 30, 2026, worldwide net revenue was 14 million euros, compared to 2.4 million euros for the six months ended June 30, 2025, and almost sixfold year-over-year increase primarily driven by our U.S.
Speaker #2: commercial launch. Gross margin in the second quarter of 2026 was 60%, compared to 57% in the first quarter of 2026. Research and development expenses were 9.5 million euros in the second quarter of 2026, compared to 10.1 million in the second quarter of 2025, due to a decrease in product development expenses.
John Landry: Research and development expenses were EUR 9.5 million in Q2 2026, compared to EUR 10.1 million in Q2 2025, due to a decrease in product development expenses. SG&A expenses were EUR 15.6 million in Q2 2026, compared to EUR 10.7 million in Q2 2025. This increase was primarily driven by the continued build-out of our US commercial organization. Total operating loss for Q2 2026 was EUR 20.6 million, and remained relatively flat compared to EUR 19.9 million in Q2 2025. Please note that our operating expenses in Q2 2026 included a one-time non-cash share-based compensation charge of approximately EUR 900,000 due to the repricing of employee equity incentive awards. Non-GAAP cash operating expenses were EUR 21.8 million, or essentially flat compared to EUR 21.7 million in Q1 2026.
John Landry: Research and development expenses were EUR 9.5 million in Q2 2026, compared to EUR 10.1 million in Q2 2025, due to a decrease in product development expenses. SG&A expenses were EUR 15.6 million in Q2 2026, compared to EUR 10.7 million in Q2 2025. This increase was primarily driven by the continued build-out of our US commercial organization. Total operating loss for Q2 2026 was EUR 20.6 million, and remained relatively flat compared to EUR 19.9 million in Q2 2025. Please note that our operating expenses in Q2 2026 included a one-time non-cash share-based compensation charge of approximately EUR 900,000 due to the repricing of employee equity incentive awards. Non-GAAP cash operating expenses were EUR 21.8 million, or essentially flat compared to EUR 21.7 million in Q1 2026.
Speaker #2: SG&A expenses were 15.6 million euros in the second quarter of 2026, compared to 10.7 million euros in the second quarter of 2025. This increase was primarily driven by the continued build-out of our U.S.
Speaker #2: commercial organization. Total operating loss for the second quarter of 2026 was 20.6 million euros, and remained relatively flat compared to 19.9 million euros in the second quarter of 2025.
Speaker #2: Please note that our operating expenses in the second quarter of 2026 included a one-time, non-cash, share-based compensation charge of approximately €900,000 due to the repricing of employee equity incentive awards.
Speaker #2: Non-GAAP cash operating expenses were 21.8 million euros, or essentially flat compared to 21.7 million euros in the first quarter of 2026. Non-GAAP cash operating expenses increased from 19.8 million euros in the second quarter of 2025, primarily due to the investments in our U.S.
John Landry: Non-GAAP cash operating expenses increased from EUR 19.8 million in Q2 2025, primarily due to the investments in our US commercial organization. During Q2 2026, we secured $110 million in aggregate financing via a $95 million equity raise and the drawdown of the second tranche of our EIB loan in the amount of $15 million. This additional cash removes the near-term financial overhang that had been a concern for investors and gives us the capital to scale our US commercial business. As of 30 June 2026, cash and cash equivalents plus financial assets totaled approximately EUR 97.8 million. Now I'll turn to guidance. For the full year 2026, our full year revenue guidance remains unchanged, and we continue to expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We continue to expect gross margin in the range of 60% to 62%.
John Landry: Non-GAAP cash operating expenses increased from EUR 19.8 million in Q2 2025, primarily due to the investments in our US commercial organization. During Q2 2026, we secured $110 million in aggregate financing via a $95 million equity raise and the drawdown of the second tranche of our EIB loan in the amount of $15 million. This additional cash removes the near-term financial overhang that had been a concern for investors and gives us the capital to scale our US commercial business. As of 30 June 2026, cash and cash equivalents plus financial assets totaled approximately EUR 97.8 million. Now I'll turn to guidance. For the full year 2026, our full year revenue guidance remains unchanged, and we continue to expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We continue to expect gross margin in the range of 60% to 62%.
Speaker #2: commercial organization. During the second quarter of 2026, we secured 110 million dollars in aggregate financing via a 95 million dollar equity raise and the drawdown of the second tranche of our EIB loan in the amount of 15 million dollars.
Speaker #2: This additional cash removed the near-term financial overhang that had been a concern for investors and gives us the capital to scale our U.S. commercial business.
Speaker #2: As of June 30, 2026, cash and cash equivalents, plus financial assets totaled approximately 97.8 million euros. Now I'll turn to guidance. For the full year 2026, our full-year revenue guidance remains unchanged, and we continue to expect worldwide net revenue in the range of 36 million euros to 40 million euros.
Speaker #2: We continue to expect gross margin in the range of 60% to 62%. We now expect total operating expenses in the range of 99 million to 102 million euros, an increase of 1 million due to the one-time share-based compensation charge recorded in the second quarter.
John Landry: We now expect total operating expenses in the range of EUR 99 million to EUR 102 million, an increase of EUR 1 million due to the one-time share-based compensation charge recorded in Q2. We continue to expect total Non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash items such as depreciation, amortization, and share-based compensation expense. We continue to target long-term gross margins above 80% and believe our disciplined approach to operating expenses supports revenue breakeven below EUR 150 million in revenue. With that, I'll now turn the call back over to Olivier Taelman.
John Landry: We now expect total operating expenses in the range of EUR 99 million to EUR 102 million, an increase of EUR 1 million due to the one-time share-based compensation charge recorded in Q2. We continue to expect total Non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash items such as depreciation, amortization, and share-based compensation expense. We continue to target long-term gross margins above 80% and believe our disciplined approach to operating expenses supports revenue breakeven below EUR 150 million in revenue. With that, I'll now turn the call back over to Olivier Taelman.
Speaker #2: We continue to expect total non-GAAP cash operating expenses in the range of 88 million euros to 90 million euros. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash items such as depreciation, amortization, and share-based compensation expense.
Speaker #2: We continue to target long-term gross margins above 80% and believe our discipline approach to operating expenses supports revenue break-even below 150 million in revenue.
Speaker #2: With that, I'll now turn the call back over to Olivier.
Speaker #3: Thank you, John. As we enter the second half of 2026, our priorities remain clear. First, accelerate investment in our U.S. commercial organization in quarter three, by further expanding from 40 to 55 territories and implement growth initiatives focused on increasing the patient funnel.
Olivier Taelman: Thank you, John. As we enter the H2 of 2026, our priorities remain clear. First, accelerate investment in our US commercial organization in Q3 by further expanding from 40 to 55 territories, implement growth initiatives focused on increasing the patient funnel. Second, continue to execute on our focused US launch strategy, targeting the top 400 high-volume AG and ASAC accounts. Third, maintain a disciplined financial approach to OPEX and direct investments towards revenue growth drivers. Before closing, I would like to thank all Nyxoah employees for their contribution in making Q2, once more, a successful one. With that, I would now like to open the line for Q&A.
Olivier Taelman: Thank you, John. As we enter the H2 of 2026, our priorities remain clear. First, accelerate investment in our US commercial organization in Q3 by further expanding from 40 to 55 territories, implement growth initiatives focused on increasing the patient funnel. Second, continue to execute on our focused US launch strategy, targeting the top 400 high-volume AG and ASAC accounts. Third, maintain a disciplined financial approach to OPEX and direct investments towards revenue growth drivers. Before closing, I would like to thank all Nyxoah employees for their contribution in making Q2, once more, a successful one. With that, I would now like to open the line for Q&A.
Speaker #3: Second, continue to execute on our focused U.S. loan strategy, targeting the top 400 high-volume AGNS accounts. And third, maintain a disciplined financial approach to OPEX, and direct investments towards revenue growth drivers.
Speaker #3: Before closing, I would like to thank all the Nyxoah employees for their contribution in making the second quarter once more a successful one. With that, I would now like to open the line for Q&A.
Speaker #1: Thank you. Ladies and gentlemen, can I grab a question at this time? You will need to press star 11 on your telephone, and wait for your name to be announced.
Operator: Thank you. Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To remove yourself from the queue, simply press star one one again. One moment for our first connection. Our first question coming from the line of Adam Maida with Piper Sandler. Your line is now open.
Operator: Thank you. Ladies and gentlemen, if you'd like to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To remove yourself from the queue, simply press star one one again. One moment for our first connection. Our first question coming from the line of Adam Maida with Piper Sandler. Your line is now open.
Speaker #1: Doing with yourself on the phone, simply press star 11 again. One moment for our first question. Our first question coming from the line of Adam Mater with Piper Sandler.
Speaker #1: Your line is now open.
Kyle Winborn: Hi, this is Kyle Winborn on for Adam. Thanks for taking our questions, congrats on the progress. I guess first I just wanted to ask about the quarterly cadence, if we could, with the revenue guidance. Is there any additional color you can give us on how you expect the remainder of the year to break out, between Q3 and Q4? Obviously, understanding amidst the ramp for the launch that it should continue to grow sequentially. Just anything you can help us with there, maybe you could just talk through your confidence level of achieving the guidance.
Kyle Winborne: Hi, this is Kyle Winborne on for Adam. Thanks for taking our questions, congrats on the progress. I guess first I just wanted to ask about the quarterly cadence, if we could, with the revenue guidance. Is there any additional color you can give us on how you expect the remainder of the year to break out, between Q3 and Q4? Obviously, understanding amidst the ramp for the launch that it should continue to grow sequentially. Just anything you can help us with there, maybe you could just talk through your confidence level of achieving the guidance.
Speaker #4: Hi, this is Kyle Winborn on for Adam. Thanks for taking our questions and congrats on the progress. I guess, first, I just wanted to ask about the quarterly cadence, if we could, with the revenue guidance.
Speaker #4: Is there any additional color you can give us on how you expect the remainder of the year to break out, kind of between Q3 and Q4?
Speaker #4: Obviously, understanding, amidst the ramp for the launch, that it should kind of continue to grow sequentially. Just anything you can kind of help us with there? And maybe you could just talk through your confidence level of achieving the guidance?
Speaker #3: Sure. Absolutely. I'll start with that part. First, Kyle, I guess, with regard to what we see in the funnel with regard to new surgeon trainings, VAC committee approvals, as well as the number of pre-authorization patients that are in that position entering Q3, we're comfortable with the guidance for the full year of 36 million to 40 million euros.
John Landry: Sure, absolutely. I'll start with that part. First, Kyle, I guess with regard to what we see in the funnel with regard to new surgeon training, VAC committee approvals, as well as the number of pre-authorization patients that are in that position entering Q3. We're comfortable with the guidance for the full year of EUR 36 million to 40 million, which reflects, based on our H1 revenue, a range of EUR 22 million to 26 million for the H2 of 2026. We would expect that revenue in the US to grow sequentially from Q2 to Q3, then again from Q3 to Q4. From an international perspective, we expect it to be consistent in the H2 of the year as compared to the H1 of the year.
John Landry: Sure, absolutely. I'll start with that part. First, Kyle, I guess with regard to what we see in the funnel with regard to new surgeon training, VAC committee approvals, as well as the number of pre-authorization patients that are in that position entering Q3. We're comfortable with the guidance for the full year of EUR 36 million to 40 million, which reflects, based on our H1 revenue, a range of EUR 22 million to 26 million for the H2 of 2026. We would expect that revenue in the US to grow sequentially from Q2 to Q3, then again from Q3 to Q4. From an international perspective, we expect it to be consistent in the H2 of the year as compared to the H1 of the year.
Speaker #3: Which reflects, based on our first half revenue range of 22 to 26 million euros for the second half of 2026, we would expect that revenue in the U.S.
Speaker #3: to grow sequentially from Q2 to Q3. And then, again, from Q3 to Q4, and then from an international perspective, we expect it to be consistent in the back half of the year as compared to the first half of the year.
Speaker #4: Okay, great. That's helpful. And then maybe just as my second question, on the access study, and we talked about this a bit on the investor day, just wanted to kind of check in to make sure, like, everything kind of went well.
Kyle Winborn: Okay, great. That's helpful. Maybe just as my second question, on the ACCESS study, we talked about this a bit on the Investor Day. Just wanted to check in to make sure everything went well. I think you were planning to wrap patient follow-up shortly after the Investor Day, which would've been a couple of weeks ago. Just to confirm if you're still expecting initial data, I think you were saying at or around the ISSS meeting. If you're still on track for the PMA supplement for Q4 label expansion early next year. Thanks.
Kyle Winborne: Okay, great. That's helpful. Maybe just as my second question, on the ACCESS study, we talked about this a bit on the Investor Day. Just wanted to check in to make sure everything went well. I think you were planning to wrap patient follow-up shortly after the Investor Day, which would've been a couple of weeks ago. Just to confirm if you're still expecting initial data, I think you were saying at or around the ISSS meeting. If you're still on track for the PMA supplement for Q4 label expansion early next year. Thanks.
Speaker #4: I think you were planning to wrap patient follow-up shortly after the investor day, which would have been a couple of weeks ago, and just to kind of confirm if you're still expecting initial data.
Speaker #4: I think you were saying at or around the ISSS meeting. And if you're still on track for the PMA supplement for Q4, label expansion early next year.
Speaker #4: Thanks.
Speaker #3: Thank you for the question. I'm happy to also share here some very positive news. We are finalizing the 12-month data as we speak.
Olivier Taelman: Thank you for the question. I'm happy to also share here some very positive news. We are finalizing the 12-month data as we speak, and we are preparing for the PMA supplement submission. For ISSS, we just received the news that the podium presentation has been accepted for the CCC data. We will release all the CCC data during the ISSS Congress on podium. I invite everyone to attend and to be present. When it comes to the submission, also there, we stay fully on plan. We are finalizing our 12-month data. We are planning to get them submitted end of Q3, latest beginning Q4. There is the 180 days FDA review, and we accept, as we disclosed already previously, somewhere during the end of Q1, maybe beginning Q2, latest in 2027, a positive result and also CCC as a tool of label.
Olivier Taelman: Thank you for the question. I'm happy to also share here some very positive news. We are finalizing the 12-month data as we speak, and we are preparing for the PMA supplement submission. For ISSS, we just received the news that the podium presentation has been accepted for the CCC data. We will release all the CCC data during the ISSS Congress on podium. I invite everyone to attend and to be present. When it comes to the submission, also there, we stay fully on plan. We are finalizing our 12-month data. We are planning to get them submitted end of Q3, latest beginning Q4. There is the 180 days FDA review, and we accept, as we disclosed already previously, somewhere during the end of Q1, maybe beginning Q2, latest in 2027, a positive result and also CCC as a tool of label.
Speaker #3: And we are preparing for the PMA supplement submission. For ISSS, we just received the news that the podium presentation has been accepted. For the CCC data, we will release all the CCC data during the ISSS Congress on podium.
Speaker #3: I invite everyone to attend and to be present. And then when it comes to the submission, also there, we stay fully on plan. So we are finalizing our 12-month data.
Speaker #3: We are planning to get them submitted end of Q3, latest beginning Q4. Then there is the 180 days FDA review, and we accept, as we disclosed already previously, somewhere during the end of Q1, maybe beginning Q2, latest in 2027, a positive result and also CCC added to our label.
Kyle Winborn: Great. Thank you, guys.
Kyle Winborne: Great. Thank you, guys.
Speaker #4: Great. Thank you guys.
Speaker #1: Thank you. Our next question in queue, coming from the line of Suraj Kaliya with Oppenheimer. Your line is now open.
Operator: Thank you. Our next question in queue coming from the line of Suraj Kalia with Oppenheimer. Your line is now open.
Operator: Thank you. Our next question in queue coming from the line of Suraj Kalia with Oppenheimer. Your line is now open.
Olivier Taelman: Hi, Suraj.
Olivier Taelman: Hi, Suraj.
Speaker #3: Hi, Suraj.
Speaker #4: Hey, Olivier, can you hear me all right?
Suraj Kalia: Hey, Olivier. Can you hear me all right?
Suraj Kalia: Hey, Olivier. Can you hear me all right?
Speaker #3: Yes, no, we can. Hello, good afternoon.
Olivier Taelman: Yes. Now we can. Hello. Good afternoon.
Olivier Taelman: Yes. Now we can. Hello. Good afternoon.
Speaker #4: Good afternoon. Hey, so Olivier, in terms of your prior authorization cadence, you know, the numbers that you give exiting the quarter, how should we think about the cadence of these prior auths?
Suraj Kalia: Good afternoon. Hey, Olivier, in terms of your prior authorization cadence, the numbers that you give exiting the quarter, how should we think about the cadence of these prior auths? We can reverse-engineer some of the implants, US implants, that are being done in the quarter. I'm more curious in terms of how much time are you all seeing for prior authorization from start to finish. If there's a specific cadence as the quarter progresses, just so that we can map it out for the next few quarters.
Suraj Kalia: Good afternoon. Hey, Olivier, in terms of your prior authorization cadence, the numbers that you give exiting the quarter, how should we think about the cadence of these prior auths? We can reverse-engineer some of the implants, US implants, that are being done in the quarter. I'm more curious in terms of how much time are you all seeing for prior authorization from start to finish. If there's a specific cadence as the quarter progresses, just so that we can map it out for the next few quarters.
Speaker #4: I mean, we can reverse engineer some of the implants U.S. implants that are being done in the quarter. I'm more curious in terms of how much time are you all seeing for prior authorization from start to finish?
Speaker #4: You know, and if there is a specific cadence as the quarter progresses, just so that we can map it out for the next few quarters.
Olivier Taelman: Yes. This is a very interesting question. First of all, with 427 submitted prior authorizations entering Q3, just to give some color, this is a significant increase of 77% compared to the number of prior authorizations we had entering Q2. In absolute numbers, entering Q3, 427. If we go back in time, entering Q2, we had 241. That being said, next question is, how fast can a prior authorization result into an actual implant? I'm sure if you do the math on sales, we end with approximately 240 devices that were sold. If you then calculate Q1, we had roughly 240 prior authorizations that were transferred in Q2. Is this exact science? No, it's not. Ballpark, we see that the majority, as we consistently communicated, that we transfer will also result in actual implants in the next quarter.
Olivier Taelman: Yes. This is a very interesting question. First of all, with 427 submitted prior authorizations entering Q3, just to give some color, this is a significant increase of 77% compared to the number of prior authorizations we had entering Q2. In absolute numbers, entering Q3, 427. If we go back in time, entering Q2, we had 241. That being said, next question is, how fast can a prior authorization result into an actual implant? I'm sure if you do the math on sales, we end with approximately 240 devices that were sold. If you then calculate Q1, we had roughly 240 prior authorizations that were transferred in Q2. Is this exact science? No, it's not. Ballpark, we see that the majority, as we consistently communicated, that we transfer will also result in actual implants in the next quarter.
Speaker #3: Yes, and this is a very interesting question. So, first of all, with 427 submitted prioritizations entering Q3—just to give some color—this is a significant increase of 77% compared to the number of prioritizations we had entering Q2.
Speaker #3: In absolute numbers, entering Q3, 427. If we go back in time, entering Q2, we had 241. Now, that being said, the next question is: how fast can a prioritization result in an actual implant?
Speaker #3: And I'm sure if you do the math on sales, so we end with approximately 240 devices that were sold. And if you then calculate Q1, we had roughly 240 prioritizations that were transferred in Q2.
Speaker #3: So is this exact science? No, it's not. But ballpark, we see that the majority, as we consistently communicated, that we transfer will also result in actual implants in the next quarter.
Speaker #3: I hope this is answering the question, Suraj.
Olivier Taelman: I hope this is answering the question, Suraj.
Olivier Taelman: I hope this is answering the question, Suraj.
Speaker #4: Got it. And Olivier, our math is suggesting in Q2 you did roughly 240 implants? And I'm curious, out of the 180 active sites, what do you think this translates into for your share?
Suraj Kalia: Got it. Olivier, our math is suggesting in Q2 you all did roughly 240 implants. I'm curious, out of the 180 active sites, what do you think this translates into your share? Are the 240 just in a certain subset of those active sites, really, and the remaining really have to, even though they are active, have to really start contributing? Any additional color would be great. Thank you.
Suraj Kalia: Got it. Olivier, our math is suggesting in Q2 you all did roughly 240 implants. I'm curious, out of the 180 active sites, what do you think this translates into your share? Are the 240 just in a certain subset of those active sites, really, and the remaining really have to, even though they are active, have to really start contributing? Any additional color would be great. Thank you.
Speaker #4: Are the 240 just in, you know, in a certain subset of those active sites really? And the remaining really have to, even though they are active, you know, have to really start contributing.
Speaker #4: Any additional color would be great. Thank you.
Speaker #3: Yes, so that's another very interesting question. We were talking about having, on average, a 15% market share in the sites where we are present. When we exited Q1, we could see that overall we were maintaining this 15%, but note that we opened 89 new sites in Q2, which are fresh, and are gaining their first experience.
Olivier Taelman: Yes. Another very interesting question. We were talking about having on average 15% market share in the sites where we are present when we exited, in fact, Q1. We can see that overall we are maintaining this 15%, Note that we have opened 89 new sites in Q2, which are fresh, which are gaining their first experience. We can also report that the longest-standing accounts are showing market shares above 15%, I'm even happy to share that our top account is passing already the 44% of market share, This is really promising. If you see how fast we are opening new accounts, then also if you see all the longest-standing accounts due to reordering and confidence in Genio are showing stronger growth in market share than the 15%.
Olivier Taelman: Yes. Another very interesting question. We were talking about having on average 15% market share in the sites where we are present when we exited, in fact, Q1. We can see that overall we are maintaining this 15%, Note that we have opened 89 new sites in Q2, which are fresh, which are gaining their first experience. We can also report that the longest-standing accounts are showing market shares above 15%, I'm even happy to share that our top account is passing already the 44% of market share, This is really promising. If you see how fast we are opening new accounts, then also if you see all the longest-standing accounts due to reordering and confidence in Genio are showing stronger growth in market share than the 15%.
Speaker #3: But we can also report that the longest standing accounts are showing market shares above 15%. And I'm even happy to share that our top account is passing already the 44% of market share.
Speaker #3: And this is really promising. If you see how fast we are opening new accounts, and then also if you see how the longest-standing accounts, due to reordering and confidence in Genio, are showing stronger growth in market share than the 15%.
Suraj Kalia: Got it. Hey, Olivier, one last question. Forgive me. Did I hear you correctly, you all have not paired with Inspire for the C code submission for the September editorial meeting?
Suraj Kalia: Got it. Hey, Olivier, one last question. Forgive me. Did I hear you correctly, you all have not paired with Inspire for the C code submission for the September editorial meeting?
Speaker #4: Got it. Hey, Olivier, one last question. Forgive me. Did I hear you correctly? You'll have not paired with Inspire for the C code submission for the September editorial meeting?
Speaker #3: Yes, this was correct. So we are very transparent in this. We participate as an industry partner. We are also supporting the discussions, led by the AAO-HNS.
Olivier Taelman: Yes, this was correct. We are very transparent in this. We participate as an industry partner. We are supporting also the discussions, the lead of the AAO-HNS, they are talking about a comprehensive coding. For September, we continue to support this approach, we did not submit it for a dedicated code.
Olivier Taelman: Yes, this was correct. We are very transparent in this. We participate as an industry partner. We are supporting also the discussions, the lead of the AAO-HNS, they are talking about a comprehensive coding. For September, we continue to support this approach, we did not submit it for a dedicated code.
Speaker #3: And they are talking about a comprehensive coding. So for September, we continue to support this approach, and we did not submit it for a dedicated code.
Speaker #4: Got it. Thank you.
Suraj Kalia: Got it. Thank you.
Suraj Kalia: Got it. Thank you.
Speaker #1: Thank you. Our next question, coming from the line of David Riscard with Baird. Your line is now open.
Operator: Thank you. Our next question coming from the line of David Rescott with Baird. Your line is now open.
Operator: Thank you. Our next question coming from the line of David Rescott with Baird. Your line is now open.
David Rescott: Oh, great. Thanks for taking the questions. I wanted to ask about the new center adds, the trained new physicians that you have. I think you pretty much doubled the account base in Q2, that's a pretty significant step-up of course, trying to get a sense out of the line of sight accounts, high-volume accounts that you've laid out there. Maybe how or why or what, I guess, we should be thinking about on a go-forward basis, at least in the back half of the year, as it relates to the number of new centers you're expecting to bring on per quarter. Maybe what that sets you up for into 2027. Then, from a utilization perspective, where or again, how would you expect utilization to track in the near to intermediate term?
David Rescott: Oh, great. Thanks for taking the questions. I wanted to ask about the new center adds, the trained new physicians that you have. I think you pretty much doubled the account base in Q2, that's a pretty significant step-up of course, trying to get a sense out of the line of sight accounts, high-volume accounts that you've laid out there. Maybe how or why or what, I guess, we should be thinking about on a go-forward basis, at least in the back half of the year, as it relates to the number of new centers you're expecting to bring on per quarter. Maybe what that sets you up for into 2027. Then, from a utilization perspective, where or again, how would you expect utilization to track in the near to intermediate term?
Speaker #4: Great. Thanks for taking the questions. I wanted to ask about, you know, the new center ads, the train new physicians that you have. I think you pretty much doubled the account base in Q2.
Speaker #4: And, you know, that's a pretty significant step up, of course. But trying to get a sense out of the, you know, line of sight accounts, high volume accounts that you've laid out out there, you know, maybe how or why or what, I guess, we should be thinking about on a go-forward basis, at least in the back half of the year, as it relates to the, you know, number of new centers you're expecting to bring on per quarter?
Speaker #4: Maybe what that sets you up for into 2027? And then, you know, from a utilization perspective, you know, where or, again, how would you expect utilization to kind of track in the, you know, near to intermediate term?
Olivier Taelman: Yeah. No, David, thank you for the question. First of all, we have a focused launch strategy focused on the top 400 high-volume AGNS accounts in the US. To your point, we showed very strong results in Q2 by doubling the number of active accounts, bringing it to 180. To answer your question, we have to link this also with the number of territory managers or sales reps that we are having, we have 40 entering Q2. I communicated already a couple of times that on average, our sales reps, they have five of those high-volume accounts. With 40 reps, it's easy mathematics. You can cover up to 200 high-volume sites. Today, exiting Q2, we already have 180 who are active.
Olivier Taelman: Yeah. No, David, thank you for the question. First of all, we have a focused launch strategy focused on the top 400 high-volume AGNS accounts in the US. To your point, we showed very strong results in Q2 by doubling the number of active accounts, bringing it to 180. To answer your question, we have to link this also with the number of territory managers or sales reps that we are having, we have 40 entering Q2. I communicated already a couple of times that on average, our sales reps, they have five of those high-volume accounts. With 40 reps, it's easy mathematics. You can cover up to 200 high-volume sites. Today, exiting Q2, we already have 180 who are active.
Speaker #3: Yeah. So no, David, thank you for the question. And first of all, we have a focused launch strategy focused on the top 400 high volume AGNS accounts in the U.S.
Speaker #3: To your point, we showed very strong results in Q2 by doubling the number of active accounts, bringing it to 180. And to answer your question, we have to link this also with the number of territory managers or sales reps that we are having.
Speaker #3: And we have 40 entering Q2. So I communicated already a couple of times that on average, our sales reps, they have five of those high volume accounts.
Speaker #3: So with 40 reps, it's easy mathematics. You can cover up to 200 high volume sites. Today, exiting Q2, we already have 180 who are active.
Speaker #3: Now, in going forward, we did also are hiring again a new cohort of 15 sales reps. So that will bring our total to 55.
Olivier Taelman: Now in going forward, we also are hiring again a new cohort of 15 sales reps, that will bring our total to 55. You do the same math, you see that we can go in Q3, Q4, up to 225 to 230 implanting high-volume accounts with our current sales force. That's one thing that we are doing. Now, the next thing, also asking on productivity in our strategy, the strategy is going deep, therefore I'm extremely pleased also to see that we capture overall, in all our accounts, an average already of 15% market share. I think more important is that we can see the accounts that were opened up already in Q4 or early Q1, that they are already going beyond the 15% market share, that we already have a top account where we go above 40% market share.
Olivier Taelman: Now in going forward, we also are hiring again a new cohort of 15 sales reps, that will bring our total to 55. You do the same math, you see that we can go in Q3, Q4, up to 225 to 230 implanting high-volume accounts with our current sales force. That's one thing that we are doing. Now, the next thing, also asking on productivity in our strategy, the strategy is going deep, therefore I'm extremely pleased also to see that we capture overall, in all our accounts, an average already of 15% market share. I think more important is that we can see the accounts that were opened up already in Q4 or early Q1, that they are already going beyond the 15% market share, that we already have a top account where we go above 40% market share.
Speaker #3: You do the same math. So you see that we can go in quarter three, quarter four, up to 225 to 230 implanting high volume accounts with our current sales force.
Speaker #3: So that's one thing that we are doing. Now, the next thing, also asking on productivity in our strategy, the strategy is going deep. And therefore, I'm extremely pleased also to see that we capture overall in all our accounts an average already of 15% market share, but I think more important is that we can see the accounts that were opened up already in Q4 or early Q1, that they are already going beyond this 15% market share and that we already have top account where we go above 40% market share.
Speaker #3: I mean, all this is confirming that facilities, surgeons, and patients are embracing genu. And I think that is the key takeaway message. We are growing extremely fast in the volume of accounts.
Olivier Taelman: All this is confirming that facilities, surgeons, and patients are embracing Genio, I think that is the key takeaway message. We are growing extremely fast in the volume of accounts. We also have more than 262 surgeons trained. Again, showing the excitement of surgeons. What to expect in the H2, the growth will be more or less reaching 225 to 230 accounts in the H2 of 2026. Then as we continue investing in hiring more salespeople, this also goes hand-in-hand with having more accounts that we will open. It's not our strategy to open 1,000 accounts. Our strategy stays to get as fast as we can to the 400 high-volume implanting accounts that we see across US.
Olivier Taelman: All this is confirming that facilities, surgeons, and patients are embracing Genio, I think that is the key takeaway message. We are growing extremely fast in the volume of accounts. We also have more than 262 surgeons trained. Again, showing the excitement of surgeons. What to expect in the H2, the growth will be more or less reaching 225 to 230 accounts in the H2 of 2026. Then as we continue investing in hiring more salespeople, this also goes hand-in-hand with having more accounts that we will open. It's not our strategy to open 1,000 accounts. Our strategy stays to get as fast as we can to the 400 high-volume implanting accounts that we see across US.
Speaker #3: We also have more than 262 surgeons trained. I mean, again, showing the excitement of surgeons. So what to expect in the second half? The growth will be more or less reaching 225 to 230 accounts.
Speaker #3: In the second half of '26, and then as we continue investing in hiring more salespeople, this goal also goes hand in hand with having more accounts that we will open.
Speaker #3: But it's not our strategy to open 1,000 accounts. Our strategy stays to get as fast as we can to the 400 high volume implanting accounts that we see across the U.S.
Speaker #4: Okay. That's helpful. Maybe just thinking about this, you know, the other pieces of the guide for the year. You know, to hit the gross margin line, it's a pretty significant step up in the back half of the year.
David Rescott: Okay, that's helpful. Maybe just thinking about this, the other pieces of the guide for the year. To hit the gross margin line, it's a pretty significant step-up in the back half of the year. Can you help us think through the moving pieces and your level of confidence behind hitting that? When you think about this, EUR 88 to 90 million of non-GAAP OpEx expense in the back half of the year, where should we be thinking about the bigger incremental dollar spend coming from in the H2 of the year? Meaning, what are you more so expecting to invest behind to drive this broader sales growth versus what's already baked into the core of the business? Thank you.
David Rescott: Okay, that's helpful. Maybe just thinking about this, the other pieces of the guide for the year. To hit the gross margin line, it's a pretty significant step-up in the back half of the year. Can you help us think through the moving pieces and your level of confidence behind hitting that? When you think about this, EUR 88 to 90 million of non-GAAP OpEx expense in the back half of the year, where should we be thinking about the bigger incremental dollar spend coming from in the H2 of the year? Meaning, what are you more so expecting to invest behind to drive this broader sales growth versus what's already baked into the core of the business? Thank you.
Speaker #4: So can you help us think through the moving pieces and your level of confidence behind hitting that? And then when you think about this, you know, 88 to 90 million dollars of non-GAAP OPEX expense in the back half of the year, you know, where I guess, you know, should we be thinking about the bigger incremental dollar spend coming from in the second half of the year, meaning what I guess, you know, are you more so expecting to invest behind to drive this broader sales growth versus what's already kind of baked into the core of the business?
Speaker #4: Thank you.
Speaker #3: Yeah, sure, absolutely, David. So for the back half of the year, from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up.
John Landry: Yep, sure. Absolutely, David. For the H2 of the year, from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up. These are smaller in nature. For one example, the ES, which is a component of the device that's going to be removed in the H2 of the year in the US, that's going to help drive gross margin up to those levels. We continue to increase our yields over the course of the year as we continue to produce products. Those are the near-term drivers for 2026 in the H2 of the year.
John Landry: Yep, sure. Absolutely, David. For the H2 of the year, from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up. These are smaller in nature. For one example, the ES, which is a component of the device that's going to be removed in the H2 of the year in the US, that's going to help drive gross margin up to those levels. We continue to increase our yields over the course of the year as we continue to produce products. Those are the near-term drivers for 2026 in the H2 of the year.
Speaker #3: These are smaller in nature. For one example, the ES, which is a component of the device that's going to be removed in the second half of the year in the U.S.
Speaker #3: So that's going to help drive gross margin up to those levels. And we continue to increase our yields over the course of the year as we continue to produce products.
Speaker #3: So those are the near-term drivers. For 2026 in the back half of the year, in terms of OPEX spread, I would anticipate in the third quarter, you'll see a bit of a sequential step up from the second quarter, but more of the expenditures will be coming in the fourth quarter when we have a full quarter's worth of U.S.
John Landry: In terms of OpEx spread, I would anticipate in Q3, you'll see a bit of a sequential step-up from Q2, but more of the expenditures will be coming in Q4, when we have a full quarter's worth of US sales rep expansion baked into that full quarter. A bit of step-up Q3 expense-wise, but more of it in Q4 to get to that full year 88 to 90 number, cash OpEx.
John Landry: In terms of OpEx spread, I would anticipate in Q3, you'll see a bit of a sequential step-up from Q2, but more of the expenditures will be coming in Q4, when we have a full quarter's worth of US sales rep expansion baked into that full quarter. A bit of step-up Q3 expense-wise, but more of it in Q4 to get to that full year 88 to 90 number, cash OpEx.
Speaker #3: sales rep expansion baked into that fourth quarter. So a bit of a step up Q3 expense-wise, but more of it in Q4 to get to that full year 88 to 90 number cash OPEX.
Speaker #4: Okay. Thank you.
David Rescott: Okay, thank you.
David Rescott: Okay, thank you.
Speaker #3: You're welcome.
John Landry: You're welcome.
John Landry: You're welcome.
Speaker #2: Thank you. And again, as a reminder, to ask a question, please press star 11. Our next question in queue coming from the line of John Block with Stifel.
Operator: Thank you. Again, as a reminder, to ask a question, please press *11. Our next question in queue coming from the line of John Blagg with Stifel. Your line is now open.
Operator: Thank you. Again, as a reminder, to ask a question, please press *11. Our next question in queue coming from the line of John Blagg with Stifel. Your line is now open.
Speaker #2: Yolanda is now open.
Speaker #5: Hey, everyone. Joe Federico on for John. Thanks for taking the question. Maybe just to circle back to reimbursement for a second. I know you mentioned that you have not submitted you know, for a dedicated code.
Joseph Federico: Hey, everyone. Joseph Federico on for John. Thanks for taking the question. Maybe just to circle back to reimbursement for a second. I know you mentioned that you have not submitted for a dedicated code. Your competitor seemingly has submitted an application for review at the panel next month. Can you maybe just give us a sense of what your strategy would be in the range of outcomes, if their package is approved or denied, or just where are you thinking you go from there?
Joe Federico: Hey, everyone. Joe Federico on for John. Thanks for taking the question. Maybe just to circle back to reimbursement for a second. I know you mentioned that you have not submitted for a dedicated code. Your competitor seemingly has submitted an application for review at the panel next month. Can you maybe just give us a sense of what your strategy would be in the range of outcomes, if their package is approved or denied, or just where are you thinking you go from there?
Speaker #5: And your competitor seemingly has, submitted an application for review at the panel next month. Can you maybe just, you know, give us a sense of what your strategy would be like in the range of outcomes if they're, you know, packages approved or denied or just what where are you thinking you go from there?
Olivier Taelman: Definitely, Joe. First of all, I would like to start by pointing out that today, the environment for hypoglossal nerve stimulation reimbursement is stable and supportive, and that with Genio, we have a dedicated code, the C8011, that is in place. Also for commercial payers, we see that there is clarity on the CPT codes that they are using, and we are also seeing that we have 100% prior authorization. That is the starting base. Next, I think that the discussions that are ongoing in the Editorial Panel are extremely constructive. We see that the AAO-HNS is really taking the lead and is also trying to find and to discuss together with AMA, finding the most optimal solution for AGNS in the future, coming to a comprehensive coding as part of this strategy.
Speaker #3: Yeah. So definitely, Joe. So first of all, I would like to start by pointing out that today, the environment for reversal nerve stimulation reimbursement is stable and supportive.
Olivier Taelman: Definitely, Joe. First of all, I would like to start by pointing out that today, the environment for hypoglossal nerve stimulation reimbursement is stable and supportive, and that with Genio, we have a dedicated code, the C8011, that is in place. Also for commercial payers, we see that there is clarity on the CPT codes that they are using, and we are also seeing that we have 100% prior authorization. That is the starting base. Next, I think that the discussions that are ongoing in the Editorial Panel are extremely constructive. We see that the AAO-HNS is really taking the lead and is also trying to find and to discuss together with AMA, finding the most optimal solution for AGNS in the future, coming to a comprehensive coding as part of this strategy.
Speaker #3: And that with genu, we have a dedicated code. The C8011. That is in place. Also, for commercial payers, we see that there is clarity on the CPT codes that they are using and we are also seeing that we have 100% prior authorization.
Speaker #3: So that is the starting base. Next, I do think that the discussions that you are that are ongoing in the editorial panel are extremely constructive.
Speaker #3: We see that the AAO/ANS is really taking the lead. And is also trying to find and to discuss together with AMA finding the most optimal solution for AGNS in the future.
Speaker #3: And coming to a comprehensive coding is part of this strategy. If that strategy is followed, the first comprehensive coding clarity would be effective in play January 1st, 2029.
Olivier Taelman: If that strategy is followed, the first comprehensive coding clarity would be effective in play 1 January 2029. Now, going back to competition, yes, they went and they submitted in September for a dedicated code. They also did the same thing in April. Just as a reminder, in April, this was rejected, so they have resubmitted. Our strategy with Genio stays and remains unchanged. We support the AAO-HNS, and we do want to follow and give our full support in also going to a comprehensive AGNS coding, because there is a coding in play, there is no risk at all. In moving forward, we will see how the future will further evolve.
Olivier Taelman: If that strategy is followed, the first comprehensive coding clarity would be effective in play 1 January 2029. Now, going back to competition, yes, they went and they submitted in September for a dedicated code. They also did the same thing in April. Just as a reminder, in April, this was rejected, so they have resubmitted. Our strategy with Genio stays and remains unchanged. We support the AAO-HNS, and we do want to follow and give our full support in also going to a comprehensive AGNS coding, because there is a coding in play, there is no risk at all. In moving forward, we will see how the future will further evolve.
Speaker #3: Now, going back to competition, yes, they went and they submitted in September for a dedicated code. They also did the same thing in April.
Speaker #3: Just as a reminder, in April, this was rejected. So they have resubmitted. Our strategy within genu stays and remains unchanged. We support the AAO/ANS.
Speaker #3: And we do want to follow and give our full support in also going to a comprehensive AGNS coding. Because there is a coding in play, there is no risk at all.
Speaker #3: And in moving forward, we will see how the future will further evolve.
Speaker #5: Okay. That's really helpful color. And then maybe just a quick follow-up. Just on, you know, you mentioned the 40 trained sales reps entering the quarter.
Joseph Federico: Okay, that's really helpful color. Maybe just a quick follow-up just on, you mentioned the 40 trained sales reps entering the quarter and that the plan is to add the next tranche of 15. Maybe just as we sit in August, how's that hiring progressing? When do you think those additional reps will be trained and in the field being fully productive?
Joe Federico: Okay, that's really helpful color. Maybe just a quick follow-up just on, you mentioned the 40 trained sales reps entering the quarter and that the plan is to add the next tranche of 15. Maybe just as we sit in August, how's that hiring progressing? When do you think those additional reps will be trained and in the field being fully productive?
Speaker #5: And that the plan is to add, you know, the next tranche of 15. Maybe just as we sit in August, how is that hiring progressing?
Speaker #5: And then, you know, when do you think those additional reps will be trained and like in the field being fully productive?
Olivier Taelman: Yes. As I mentioned also in earlier calls, we have a high demand of salespeople who want to join Nyxoah, and this has continued. We are currently actively doing the interview process. We expect that we have all 15 onboarded definitely by the end of Q3. We will start doing their training beginning Q4 so that we can still get them active selling even during Q4, and definitely have a full selling and trained sales force of 55 people going in 1 January 2027.
Olivier Taelman: Yes. As I mentioned also in earlier calls, we have a high demand of salespeople who want to join Nyxoah, and this has continued. We are currently actively doing the interview process. We expect that we have all 15 onboarded definitely by the end of Q3. We will start doing their training beginning Q4 so that we can still get them active selling even during Q4, and definitely have a full selling and trained sales force of 55 people going in 1 January 2027.
Speaker #3: Yes. So as I mentioned also in earlier calls, we have a high demand of salespeople who want to join Nyxoah. And this has continued.
Speaker #3: So the interview process. So we expect that we have all 15 onboarded definitely by the end of quarter three. We will start doing their training beginning Q4 so that we can still get them active selling even during Q4.
Speaker #3: And definitely have a full selling and trained salesforce of 55 people going in January 1st, 2027.
Speaker #5: Great. Thank you.
Joseph Federico: Great. Thank you.
Joe Federico: Great. Thank you.
Operator: Thank you. At this time, we have no further questions from the Q&A queue. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation, you may now disconnect.
Operator: Thank you. At this time, we have no further questions from the Q&A queue. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation, you may now disconnect.
Speaker #2: Thank you. At this time, we have no further questions in the Q&A queue. Please and gentlemen, this concludes today's conference call. We thank you for your participation.
