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Investor releaseQuarter not tagged2026-08-06

Nyxoah Q2 Earnings Call Highlights

MarketBeat
Interested in Nyxoah SA? Here are five stocks we like better. Revenue surged as the U.S. launch expanded: Second-quarter worldwide revenue rose 21% sequentially to €7.7 million, including €5.2 million from the U.S. First-half revenue reached €14 million, nearly six times the prior-year period. Nyxoah significantly expanded its commercial footprint: Active U.S. accounts doubled to 180, while patients under prior authorization increased 77% to 427, with a reported 100% approval rate. The company plans to add 15 sales representatives and expects further sequential U.S. revenue growth in the second half. 2026 guidance was largely maintained: Revenue guidance remains €36 million–€40 million and gross-margin guidance 60%–62%; operating-expense guidance rose by €1 million due to a one-time equity-compensation charge. Proposed 2027 Medicare reimbursement rates for Genio procedures would increase 12%–15%. Nyxoah (NASDAQ:NYXH) reported second-quarter worldwide net revenue of €7.7 million, up 21% sequentially from the first quarter, as its U.S. commercial launch continued to expand. U.S. net revenue reached €5.2 million, a 22% increase from the prior quarter, while international revenue rose 19% sequentially to €2.5 million. For the first six months of 2026, worldwide revenue totaled €14 million, compared with €2.4 million in the first half of 2025. Chief Financial Officer John Landry said the nearly six-fold increase was driven primarily by the company’s U.S. commercial launch. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Executive Officer Olivier Taelman said Nyxoah doubled its active U.S. account base during the quarter, activating 89 new high-volume accounts and ending the period with 180 active accounts. The company trained 55 new surgeons in the quarter, bringing its total number of trained surgeons to 262. Nyxoah entered the third quarter with 427 patients actively under prior authorization, up 77% from 241 patients entering the second quarter. Taelman said the company has maintained a 100% prior-authorization approval rate for commercial payers, Medicare Advantage and Medicare patients submitted through the WISeR program. → 3 Drone Stocks That Should Soar After the Summer Slump “Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are em…Read full document

Interested in Nyxoah SA? Here are five stocks we like better. Revenue surged as the U.S. launch expanded: Second-quarter worldwide revenue rose 21% sequentially to €7.7 million, including €5.2 million from the U.S. First-half revenue reached €14 million, nearly six times the prior-year period. Nyxoah significantly expanded its commercial footprint: Active U.S. accounts doubled to 180, while patients under prior authorization increased 77% to 427, with a reported 100% approval rate. The company plans to add 15 sales representatives and expects further sequential U.S. revenue growth in the second half. 2026 guidance was largely maintained: Revenue guidance remains €36 million–€40 million and gross-margin guidance 60%–62%; operating-expense guidance rose by €1 million due to a one-time equity-compensation charge. Proposed 2027 Medicare reimbursement rates for Genio procedures would increase 12%–15%. Nyxoah (NASDAQ:NYXH) reported second-quarter worldwide net revenue of €7.7 million, up 21% sequentially from the first quarter, as its U.S. commercial launch continued to expand. U.S. net revenue reached €5.2 million, a 22% increase from the prior quarter, while international revenue rose 19% sequentially to €2.5 million. For the first six months of 2026, worldwide revenue totaled €14 million, compared with €2.4 million in the first half of 2025. Chief Financial Officer John Landry said the nearly six-fold increase was driven primarily by the company’s U.S. commercial launch. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Executive Officer Olivier Taelman said Nyxoah doubled its active U.S. account base during the quarter, activating 89 new high-volume accounts and ending the period with 180 active accounts. The company trained 55 new surgeons in the quarter, bringing its total number of trained surgeons to 262. Nyxoah entered the third quarter with 427 patients actively under prior authorization, up 77% from 241 patients entering the second quarter. Taelman said the company has maintained a 100% prior-authorization approval rate for commercial payers, Medicare Advantage and Medicare patients submitted through the WISeR program. → 3 Drone Stocks That Should Soar After the Summer Slump “Doubling our active account base to 180 high-volume AGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio,” Taelman said, referring to the company’s Genio system for obstructive sleep apnea. The company began the quarter with 40 fully trained sales representatives covering 200 of the 400 highest-volume U.S. hypoglossal nerve stimulation accounts. Nyxoah plans to add 15 representatives, expanding to 55 territories. Taelman said the company expects to have the new hires onboarded by the end of the third quarter, trained in early fourth quarter and fully deployed entering 2027. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Nyxoah expects its current salesforce capacity to support approximately 225 to 230 active high-volume accounts in the second half of 2026. Rather than pursuing broad account expansion, Taelman said the company’s strategy remains focused on reaching the top 400 high-volume U.S. implanting accounts. In response to an analyst question, Taelman said the company’s active accounts averaged approximately 15% market share, while its more established accounts were above that level. Its top account had surpassed 44% market share, he said. Nyxoah said reimbursement clarity for Genio includes dedicated Medicare C-code C8011, while commercial coverage remains stable through existing CPT codes. Commercial payers represented approximately 85% of the business during the quarter, according to Taelman. The Centers for Medicare & Medicaid Services has proposed increases to 2027 reimbursement for the procedure. Under the proposal, hospital outpatient reimbursement for Genio under C-code C8011 would rise 12% to $35,414 from $31,526. Reimbursement for ambulatory surgical centers would increase 15% to $31,722 from $27,563. Nyxoah did not submit an application for a dedicated Category 1 CPT code at the upcoming September CPT Editorial Panel meeting. Instead, the company said it supports the American Academy of Otolaryngology-Head and Neck Surgery’s effort toward a comprehensive coding approach for hypoglossal nerve stimulation. Taelman said a comprehensive coding outcome, if pursued, would first become effective on Jan. 1, 2029. Second-quarter gross margin was 60%, up from 57% in the first quarter. Research and development expense declined to €9.5 million from €10.1 million a year earlier, while selling, general and administrative expense rose to €15.6 million from €10.7 million, largely reflecting the expansion of the U.S. commercial organization. Operating loss was €20.6 million, compared with €19.9 million in the prior-year quarter. Operating expenses included an approximately €900,000 one-time, non-cash share-based compensation charge related to the repricing of employee equity incentive awards. Non-GAAP cash operating expenses were €21.8 million, essentially unchanged from €21.7 million in the first quarter, but up from €19.8 million in the second quarter of 2025 due to investment in the U.S. commercial organization. During the quarter, Nyxoah secured $110 million in financing, consisting of a $95 million equity raise and a $15 million drawdown under the second tranche of its European Investment Bank loan. Cash, cash equivalents and financial assets totaled about €97.8 million as of June 30. Full-year 2026 worldwide revenue guidance was maintained at €36 million to €40 million. Gross-margin guidance remained 60% to 62%. Total operating-expense guidance increased by €1 million to €99 million to €102 million because of the one-time share-based compensation charge. Non-GAAP cash operating-expense guidance remained €88 million to €90 million. Landry said the revenue outlook implies €22 million to €26 million of revenue in the second half of 2026. The company expects U.S. revenue to rise sequentially in both the third and fourth quarters, while international revenue is expected to remain consistent with first-half levels. Taelman said Nyxoah is finalizing 12-month data from its ACCESS study and plans to submit a PMA supplement by the end of the third quarter or, at the latest, early in the fourth quarter. The company expects to present CCC data during the International Sleep Surgery Society Congress after receiving acceptance for a podium presentation. Nyxoah expects an FDA decision on the supplement around the end of the first quarter of 2027, or the beginning of the second quarter at the latest. International revenue nearly doubled in the first half of 2026 compared with the first half of 2025, according to Taelman. In Germany, Nyxoah said it has achieved stable overall market share of up to 25%, with share above 50% at its top high-volume accounts. The company also cited market share above 50% in its initial U.K. accounts, continued expansion in the Middle East, where it is the sole AGNS provider, and a recent entry into the Netherlands. Nyxoah said it intends to maintain financial discipline internationally while pursuing growth and break-even operations in those markets, a milestone it said it has already achieved in Germany. Nyxoah SA, headquartered in Mont-Saint-Guibert, Belgium, is a medical technology company focused on neuromodulation therapies for sleep‐disordered breathing. Established in 2018, the company's primary offering is the Genio® system, a minimally invasive bilateral hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA). By electrically stimulating the genioglossus muscle, the device helps maintain airway patency during sleep, reducing apnea events and improving overall sleep quality. The Genio system comprises a small, implantable stimulator positioned submentally and an external activation unit worn by the patient. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Nyxoah Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-06

Nyxoah SA (NYXH) (Q2 2026) Earnings Call Highlights: US Revenue Surges 22% Sequentially, $110M ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nyxoah SA (NASDAQ:NYXH) delivered a second consecutive quarter of more than 20% sequential US revenue growth, with US net revenue reaching EUR5.2 million, up 22% from Q1 2026. The company significantly strengthened its balance sheet by securing $110 million in financing during the quarter, removing the near-term financial overhang and providing capital to accelerate its US commercialization ramp. Nyxoah SA (NASDAQ:NYXH) saw strong commercial execution in the US, doubling its active account base to 180 and training 55 new surgeons, bringing the total to 262 trained surgeons. The company reported a 77% increase in patients actively under prior authorization, reaching 427 entering Q3, a key leading indicator for continued launch momentum. CMS proposed meaningful reimbursement increases for the Genio procedure, including a 12% increase for hospital outpatient payments and a 15% increase for ambulatory surgical centers for 2027. International revenue grew 19% sequentially, with the company nearly doubling its first-half 2026 international revenue compared to the first half of 2025, and achieving break-even in Germany. Nyxoah SA (NASDAQ:NYXH) continues to incur significant operating losses, with a total operating loss of EUR20.6 million in Q2 2026, remaining relatively flat year-over-year. SG&A expenses increased substantially to EUR15.6 million in Q2 2026, up from EUR10.7 million in Q2 2025, driven by the continued buildout of the US commercial organization. The company recorded a one-time non-cash share-based compensation charge of approximately EUR900,000 in Q2 2026 due to the repricing of employee equity incentive awards. Nyxoah SA (NASDAQ:NYXH) chose not to submit Genio for a dedicated Category 1 CPT code for the September CPT editorial panel meeting, instead supporting a comprehensive AGNS coding approach, which may delay potential coding clarity. The company's gross margin, while improved to 60% in Q2, remains well below its long-term target of above 80%, indicating ongoing production and scaling challenges. The company expects a significant step-up in operating expenses in the second half of 2026, particularly in Q4, as it expands its US sales force from 40 to 55 territories. Warning! G…Read full document

This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nyxoah SA (NASDAQ:NYXH) delivered a second consecutive quarter of more than 20% sequential US revenue growth, with US net revenue reaching EUR5.2 million, up 22% from Q1 2026. The company significantly strengthened its balance sheet by securing $110 million in financing during the quarter, removing the near-term financial overhang and providing capital to accelerate its US commercialization ramp. Nyxoah SA (NASDAQ:NYXH) saw strong commercial execution in the US, doubling its active account base to 180 and training 55 new surgeons, bringing the total to 262 trained surgeons. The company reported a 77% increase in patients actively under prior authorization, reaching 427 entering Q3, a key leading indicator for continued launch momentum. CMS proposed meaningful reimbursement increases for the Genio procedure, including a 12% increase for hospital outpatient payments and a 15% increase for ambulatory surgical centers for 2027. International revenue grew 19% sequentially, with the company nearly doubling its first-half 2026 international revenue compared to the first half of 2025, and achieving break-even in Germany. Nyxoah SA (NASDAQ:NYXH) continues to incur significant operating losses, with a total operating loss of EUR20.6 million in Q2 2026, remaining relatively flat year-over-year. SG&A expenses increased substantially to EUR15.6 million in Q2 2026, up from EUR10.7 million in Q2 2025, driven by the continued buildout of the US commercial organization. The company recorded a one-time non-cash share-based compensation charge of approximately EUR900,000 in Q2 2026 due to the repricing of employee equity incentive awards. Nyxoah SA (NASDAQ:NYXH) chose not to submit Genio for a dedicated Category 1 CPT code for the September CPT editorial panel meeting, instead supporting a comprehensive AGNS coding approach, which may delay potential coding clarity. The company's gross margin, while improved to 60% in Q2, remains well below its long-term target of above 80%, indicating ongoing production and scaling challenges. The company expects a significant step-up in operating expenses in the second half of 2026, particularly in Q4, as it expands its US sales force from 40 to 55 territories. Warning! GuruFocus has detected 5 Warning Signs with NYXH. Is NYXH fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide additional color on how you expect the remainder of the year to break out between Q3 and Q4, and your confidence level in achieving the full-year revenue guidance? A: CFO John Landry confirmed the company is comfortable with the full-year guidance of EUR36 million to EUR40 million, which implies a second-half revenue range of EUR22 million to EUR26 million. He expects U.S. revenue to grow sequentially from Q2 to Q3 and again from Q3 to Q4, while international revenue is expected to remain consistent in the back half of the year compared to the first half. Q: On the DREAM study, are you still on track for initial data at the ISSS meeting and the PMA supplement for label expansion? A: CEO Olivier Taelman provided positive updates, stating the company is finalizing the 12-month data and preparing for the PMA supplement submission. The CCC data has been accepted for a podium presentation at the ISSS Congress. The submission is planned for end of Q3 or beginning of Q4, with an expected FDA review period of 180 days, leading to a potential positive result and CCC label expansion by end of Q1 or beginning of Q2 2027. Q: How should we think about the cadence of prior authorizations from start to finish, and how quickly do they convert to actual implants? A: CEO Olivier Taelman noted that entering Q3, the company had 427 patients under prior authorization, a 77% increase from the 241 entering Q2. He explained that while it's not an exact science, the majority of prior authorizations typically convert to actual implants in the following quarter, as evidenced by approximately 240 devices sold in Q2, which aligns with the roughly 240 prior authorizations transferred from Q1. Q: Out of the 180 active sites, what does the approximately 240 implants in Q2 translate to in terms of market share, and are the remaining sites contributing? A: CEO Olivier Taelman stated that the company maintains an average 15% market share in sites where it is present, despite opening 89 new sites in Q2. Importantly, the longest-standing accounts are showing market shares above 15%, with the top account already exceeding 44% market share, demonstrating growing confidence and reordering in Genio. Q: Can you confirm that Nyxoah did not pair with Inspire for the C code submission for the September editorial meeting, and what is the strategy? A: CEO Olivier Taelman confirmed this is correct. Nyxoah participates as an industry partner supporting the AAO-HNS led discussion on comprehensive AGNS coding. The company did not submit for a dedicated code in September, choosing to support the comprehensive coding approach instead. Q: What should we expect in terms of new center additions per quarter in the back half of the year, and how will utilization track? A: CEO Olivier Taelman explained that with 40 sales reps covering approximately 5 high-volume accounts each, the company can cover up to 200 sites. With 180 active accounts exiting Q2 and plans to hire 15 additional reps (bringing total to 55), the company expects to reach 225-230 accounts in the second half of 2026. The strategy remains focused on going deep in the TOP400 high-volume accounts rather than expanding to 1,000 accounts. Q: Can you help us think through the moving pieces to hit the gross margin guidance, and where will the incremental OpEx spend come from in the second half? A: CFO John Landry explained that gross margin improvements will be driven by ongoing projects, including the removal of a component (ES) from the device in the second half and continued yield improvements. Regarding OpEx, he anticipates a sequential step-up in Q3, with more significant expenditures in Q4 when the full quarter's worth of U.S. sales rep expansion is baked in, to reach the full-year cash OpEx guidance of EUR88-90 million. Q: What is your strategy regarding the reimbursement coding landscape, given that your competitor has submitted for a dedicated code in September? A: CEO Olivier Taelman stated that the current reimbursement environment is stable and supportive, with Genio having a dedicated C-code (C8011) and 100% prior authorization approval. He noted that the AAO-HNS is leading constructive discussions with AMA on comprehensive AGNS coding, which could be effective January 1, 2029. Nyxoah's strategy remains unchanged, supporting the comprehensive coding approach, and the company sees no risk given the existing coding in place. Q: How is the hiring of the next tranche of 15 sales reps progressing, and when will they be fully productive? A: CEO Olivier Taelman stated that there is high demand from salespeople wanting to join Nyxoah. The company expects to have all 15 onboarded by the end of Q3, with training beginning in Q4. This will allow them to start selling during Q4, with a fully trained sales force of 55 people in place by January 1, 2027. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-05

Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results

GlobeNewswire
REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026 Mont-Saint-Guibert, Belgium – August 5, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the second quarter and first half of 2026. Financial and Operating Highlights Financials Leading U.S. commercial indicators U.S. reimbursement landscape Hosted investor day on July 8 – Link to the replay “The doubling of active accounts in Q2 and the strong acceleration of our patient pipeline, demonstrate the growing acceptance and excitement around Genio by physicians and patients,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. “With a dedicated Genio C-code for Medicare patients and another quarter of 100% prior-authorization approval for commercial and WISeR patients, we are confident that the current reimbursement landscape supports our accelerating U.S. revenue growth. The recent closing of our $110 million financing provides the capital needed to further invest in Genio’s U.S. commercial organization in the second half of 2026.” Results for the Three and Six Months Ended June 30, 2026 Revenue Net revenue in the second quarter of 2026 was €7.7 million, compared to €1.3 million in the second quarter of 2025. Net revenue in the first half of 2026 was €14.0 million, as compared to €2.4 million for the first half of 2025. The increases in net revenue were primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets. Cost of Goods Sold Cost of goods sold was €3.1 million for the second quarter of 2026, resulting in gross profit of €4.6 million and a gross margin of 60% for the second quarter of 2026, compared to cost of goods sold of €0.5 million in the second quarter of 2025, resulting in gross profit of €0.9 million and a gross margin of 63% in the second quarter of 2025. The increase in cost of goods sold was primarily driven by an increase in revenue. The decrease in gross ma…Read full document

REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026 Mont-Saint-Guibert, Belgium – August 5, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the second quarter and first half of 2026. Financial and Operating Highlights Financials Leading U.S. commercial indicators U.S. reimbursement landscape Hosted investor day on July 8 – Link to the replay “The doubling of active accounts in Q2 and the strong acceleration of our patient pipeline, demonstrate the growing acceptance and excitement around Genio by physicians and patients,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. “With a dedicated Genio C-code for Medicare patients and another quarter of 100% prior-authorization approval for commercial and WISeR patients, we are confident that the current reimbursement landscape supports our accelerating U.S. revenue growth. The recent closing of our $110 million financing provides the capital needed to further invest in Genio’s U.S. commercial organization in the second half of 2026.” Results for the Three and Six Months Ended June 30, 2026 Revenue Net revenue in the second quarter of 2026 was €7.7 million, compared to €1.3 million in the second quarter of 2025. Net revenue in the first half of 2026 was €14.0 million, as compared to €2.4 million for the first half of 2025. The increases in net revenue were primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets. Cost of Goods Sold Cost of goods sold was €3.1 million for the second quarter of 2026, resulting in gross profit of €4.6 million and a gross margin of 60% for the second quarter of 2026, compared to cost of goods sold of €0.5 million in the second quarter of 2025, resulting in gross profit of €0.9 million and a gross margin of 63% in the second quarter of 2025. The increase in cost of goods sold was primarily driven by an increase in revenue. The decrease in gross margin was primarily due to a higher mix of U.S. revenue. Cost of goods sold in the first half of 2026 was €5.8 million, as compared to €0.9 million for the first half of 2025, resulting in gross profit of €8.2 million and a gross margin of 59% in the first half of 2026, compared to gross profit of €1.5 million and a gross margin of 63% in the first half of 2025. The decrease in gross margin was primarily due to production yield issues in the first quarter of 2026 and higher mix of U.S. revenue. Research and Development For the second quarter of 2026, research and development expenses were €9.5 million, versus €10.1 million for the second quarter of 2025. For the first half of 2026, research and development expenses were €18.3 million, versus €19.0 million for the first half of 2025. The decreases in research and development expenses were primarily due to a decrease in product development expenses. Selling, General and Administrative For the second quarter of 2026, selling, general and administrative expenses were €15.6 million, versus €10.7 million for the second quarter of 2025. For the first half of 2026, selling, general and administrative expenses were €31.0 million, versus €23.1 million for the first half of 2025. The increases in selling, general and administrative expenses were primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions. Operating Loss Total operating loss for the second quarter of 2026 was €20.6 million, versus €19.9 million in the second quarter of 2025. Total operating loss for the first half of 2026 was €41.1 million, versus €40.5 million in the first half of 2025. The increases in operating loss reflect increased net revenue offset by increased investments to support the build-out of the Company’s U.S. commercial organization. Cash PositionCash and cash equivalents and financial assets totaled €97.8 million at June 30, 2026, compared to €48.0 million at December 31, 2025. Financial Guidance for the full year 2026 The Company continues to expect worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million. The Company continues to expect gross margin for the full year 2026 to be in the range of 60% to 62%. The Company now expects total operating expenses for the full year 2026 to be in the range of €99 million to €102 million. This increase of approximately €1 million is due to the one-time share-based compensation expense of approximately €0.9 million associated with the repricing of employee equity incentive arrangements recorded in the second quarter. The Company continues to expect non-GAAP cash operating expenses for the full year 2026 to be in the range of €88 million to €90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash expenses such as depreciation, amortization, and share-based compensation. Conference call and webcast presentation Company management will host a conference call to discuss financial results on Wednesday, August 5, 2026, beginning at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2 Earnings Call Webcast. For those not planning to ask a question to management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q2 2026 Earnings Call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. Non-GAAP financial measuresThis press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expense items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company's operating performance and for planning purposes, including the preparation of the Company's annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company's future results will be unaffected by unusual or non-recurring items. The Company's definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and receipt of approval from the FDA in August 2025. For more information, please visit http://www.nyxoah.com. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited) (in thousands) Non-GAAP Financial Measures The following table contains a reconciliation of GAAP operating expenses to non-GAAP cash operating expenses for the three and six months ended June 30, 2026 and 2025, respectively. Contacts: NyxoahJohn Landry, [email protected] Rémi RenardHead of Investor Relations & Corporate Communication [email protected] Attachment ENGLISH_Nyxoah_Q2 2026 Earnings PR_FINAL

TranscriptFY2026 Q22026-08-05

FY2026 Q2 earnings call transcript

Earnings source - 54 paragraphs
Operator

Good day. Thank you for standing by. Welcome to Nyxoah's second quarter 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.

Pearson Dennis

Thank you. Good afternoon, everyone. 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. During the call, we will discuss our operating activities and review our second quarter 2026 financial results released after U.S. market closing today, after which we will host a question-and-answer session. The press release can be found on the investor relations section of our website. This call is being recorded and will be archived in the events section on the investor relations tab of our website. Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions.

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. The company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which was filed with the Securities and Exchange Commission on March 26th, 2026. With that, I will now turn the call over to Olivier.

Olivier Taelman

Thank you, Pearson. Good day, everyone. Thank you for joining us for the second quarter 2026 earnings call. Let me start with Q2 highlights. Q2 was a strong quarter for Nyxoah across multiple fronts. I'm pleased with the progress we are making in the business. First, the strong commercial execution of our U.S. launch delivered a second consecutive quarter of more than 20% sequential U.S. revenue growth. U.S. net revenue was EUR 5.2 million, up 22% over the first quarter of 2026. 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 EUR 7.7 million in the second quarter, representing 21% sequential growth over the first quarter. Second, before doing a deeper dive on the U.S. commercialization results, let me provide our high-level leading U.S. commercial indicators.

Olivier Taelman

Our U.S. leading commercial indicators continued to strengthen across the board. 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. 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, 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

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 U.S. commercialization ramp and implement the growth initiatives focused on increasing the patient funnel. 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, which represent approximately 70% of the total U.S. AGNS volume. We hired and trained 50 new sales reps in the first quarter, bringing us to 40 sales territories as of April 1st. Entering Q2, we have access to 200 of the top 400 high-volume AGNS accounts.

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 the third quarter 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 first-hand 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

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. 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 $31,526 to $35,414, or an increase of approximately 12%.

Olivier Taelman

CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from $27,563 to $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. 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 now focus a little bit more on our recent Investor Day. On July 8th, 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 first-hand implant experience with Genio, and both surgeons and sleep physicians confirmed strong airway openings on activation.

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 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. 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. 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.

Olivier Taelman

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, 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 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. 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 a goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.

Olivier Taelman

With that, I will now turn the call over to John for a detailed overview of our financial results.

John Landry

Thank you, Olivier. For the second quarter of 2026, worldwide net revenue was EUR 7.7 million, which represents 21% sequential growth compared to the first quarter of 2026 and compares to EUR 1.3 million in net revenue in the second quarter of 2025. U.S. net revenue was EUR 5.2 million, representing 22% sequential growth over the first quarter of 2026. International net revenue was EUR 2.5 million, representing 19% sequential growth over the first quarter of 2026. For the six months ended June 30, 2026, worldwide net revenue was EUR 14 million compared to EUR 2.4 million for the six months ended June 30, 2025, an almost six-fold year-over-year increase, primarily driven by our U.S. commercial launch. Gross margin in the second quarter of 2026 was 60%, compared to 57% in the first quarter of 2026.

John Landry

Research and development expenses were EUR 9.5 million in the second quarter of 2026 compared to EUR 10.1 million in the second quarter of 2025, due to a decrease in product development expenses. SGA expenses were EUR 15.6 million in the second quarter of 2026 compared to EUR 10.7 million in the second quarter of 2025. This increase was primarily driven by the continued build-out of our U.S. commercial organization. Total operating loss for the second quarter of 2026 was EUR 20.6 million and remained relatively flat compared to EUR 19.9 million in the second quarter of 2025.

John Landry

Please note that our operating expenses in the second quarter of 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 the first quarter of 2026.

John Landry

Non-GAAP cash operating expenses increased from EUR 19.8 million in the second quarter of 2025, primarily due to the investments in our U.S. commercial organization. During the second quarter of 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 U.S. commercial business. As of June 30th, 2026, cash and cash equivalents plus financial assets totaled approximately EUR 97.8 million. 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%-62%.

John Landry

We now expect total operating expenses in the range of EUR 99 million-EUR 102 million, an increase of EUR 1 million due to the one-time share-based compensation charge recorded in the second quarter. We continue to expect total non-GAAP cash operating expenses in the range of EUR 88 million-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. I'll now turn the call back over to Olivier.

Olivier Taelman

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 40-55 territories and implement growth initiatives focused on increasing the patient funnel. Second, continue to execute on our focused U.S. loan strategy, targeting the top 400 volume AGNS 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 the second quarter once more a successful one. With that, I would now like to open the line for Q&A.

Operator

Thank you. Ladies and gentlemen, if you would 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. You'll listen now, please.

Kyle Winborne

Hi, this is Kyle Winborne 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. 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? Obviously understanding amidst the ramp for the launch that it should kind of continue to grow sequentially. Just anything you can help us with there, and maybe you can just talk through your confidence level of achieving the guidance?

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-EUR 40 million, which reflects, based on our first-half revenue, a range of EUR 22 million-EUR 26 million for the second half of 2026. We would expect that revenue in the U.S. 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 back half of the year as compared to the first half of the year.

Kyle Winborne

Okay, great. That's helpful. Then 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.

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. 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 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. 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 Winborne

Great. Thank you guys.

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.

Suraj Kalia

Hey, Olivier. Can you hear me all right?

Olivier Taelman

Yes. No, we can. Hello. Good afternoon.

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, 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, and if there's 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 quarter three, 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 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

I hope this is answering the question, Suraj.

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.

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%, but 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%, and 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, 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?

Olivier Taelman

Yes, this was correct. We are very transparent in this. We participate as an industry partner. We are supporting also the discussion, the lead of the AAO-HNS, and they are talking about a comprehensive coding. For September, we continue to support this approach, and we did not submit it for a dedicated code.

Suraj Kalia

Got it. Thank you.

Operator

Thank you. Our next question coming from the line of David Briscoe with Baird. Your line is now open.

David Briscoe

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, but 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 kind of track in the 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 U.S. 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. Going forward, we also are hiring again a new cohort of 15 sales reps.

Olivier Taelman

That will bring our total to 55. You do the same math, you see that we can go in quarter three, quarter four, up to 225 to 230 implanted high-volume accounts with our current sales force. That's one thing that we are doing. 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, and that we already have a top account where we go above 40% market share.

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 second half, the quote will be more or less reaching 225-230 accounts in the second half of 2026. As we continue investing in hiring more salespeople, this goal 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 U.S.

David Briscoe

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 million-EUR 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 second half of the year? Meaning, what 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? Thank you.

John Landry

Yep, sure. Absolutely, David. For the back half of the year, from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up. These are small 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. 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 back half of the year. In terms of OpEx spread

John Landry

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. sales rep expansion baked into that fourth quarter. A bit of step-up Q3 expense-wise, but more of it in Q4 to get to that full year EUR 88 million-EUR 90 million number.

David Briscoe

Okay, thank you.

Olivier Taelman

You're welcome.

Operator

Thank you. Again, as a reminder, to ask a question, please press star one one. Our next question in queue coming from the line of John Block with Stifel. Your line is now open.

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 like in the range of outcomes if their package is approved or denied, or just 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 do 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.

Olivier Taelman

If that strategy is followed, the first comprehensive coding clarity would be effective in play January 1st, 2029. 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.

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?

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 quarter three. 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 January 1st, 2027.

Joe Federico

Great. Thank you.

Operator

Thank you. At this time, we have no further questions in the Q&A queue. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation, and you may now disconnect.

Investor releaseQuarter not tagged2026-08-04

Earnings To Watch: Nyxoah SA (XBRU:NYXH) Q2 2026 -- GF Value Sees 5209% Upside

GuruFocus.com

This article first appeared on GuruFocus. Nyxoah SA (XBRU:NYXH) is set to release its Q2 2026 earnings on Aug 5, 2026. The consensus estimate for Q2 2026 revenue is 7.60 million, and the earnings are expected to come in at -0.39 per share. The full year 2026's revenue is expected to be $37.38 million and the earnings are expected to be $-1.18 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 5 Warning Signs with XBRU:NYXH. Is XBRU:NYXH fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Nyxoah SA (XBRU:NYXH) have increased from $30.83 million to $37.38 million for the full year 2026, and from $69.26 million to $73.73 million for 2027. Earnings estimates have also improved, rising from $-1.81 per share to $-1.18 per share for the full year 2026, and from $-1.36 per share to $-0.85 per share for 2027. In the previous quarter of 2026-03-31, Nyxoah SA's (XBRU:NYXH) actual revenue was $6.37 million, which beat analysts' revenue expectations of $6.00 million by 6.15%. Nyxoah SA's (XBRU:NYXH) actual earnings were $-0.37 per share, which beat analysts' earnings expectations of $-0.50 per share by 25.45%. After releasing the results, Nyxoah SA (XBRU:NYXH) was down by -4.79% in one day. Based on the one-year price targets offered by 4 analysts, the average target price for Nyxoah SA (XBRU:NYXH) is $5.35 with a high estimate of $8.30 and a low estimate of $2.50. The average target implies an upside of 327.32% from the current price of $1.25. Based on GuruFocus estimates, the estimated GF Value for Nyxoah SA (XBRU:NYXH) in one year is $66.47, suggesting an upside of 5209.11% from the current price of $1.25. Based on the consensus recommendation from 8 brokerage firms, Nyxoah SA's (XBRU:NYXH) average brokerage recommendation is currently 2.00, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-27

Nyxoah to Release Second Quarter 2026 Financial Results on August 5, 2026

GlobeNewswire
Nyxoah to Release Second Quarter 2026 Financial Results on August 5, 2026 Mont-Saint-Guibert, Belgium – July 27, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the second quarter of 2026 on Wednesday, August 5, 2026. Company management will host a conference call to discuss financial results that day beginning at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q2 2026 Earnings Call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in…Read full document

Nyxoah to Release Second Quarter 2026 Financial Results on August 5, 2026 Mont-Saint-Guibert, Belgium – July 27, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the second quarter of 2026 on Wednesday, August 5, 2026. Company management will host a conference call to discuss financial results that day beginning at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q2 2026 Earnings Call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and receipt of approval from the FDA in August 2025. For more information, please visit http://www.nyxoah.com. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts:NyxoahJohn Landry, [email protected] Rémi RenardHead of Investor Relations & Corporate [email protected] Attachment ENGLISH_2Q26_Earnings_Call_Announcement

Investor releaseQuarter not tagged2026-07-07

Nyxoah Announces Preliminary Results for the Second Quarter of 2026

GlobeNewswire
Nyxoah Announces Preliminary Results for the Second Quarter of 2026 Continued U.S. launch momentum drives second quarter global preliminary net revenue of €7.7 millionCMS proposes 2027 OPPS and ASC payment increase of 12% and 15% respectively Mont-Saint-Guibert, Belgium – July 7, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported certain preliminary unaudited second quarter 2026 financial and operating results. Second Quarter 2026 – Preliminary Sales and Market Metrics Financials Leading U.S. commercial indicators Reimbursement US Liquidity "We closed Q2 with clear U.S. momentum: the scaling of our U.S. sales force allowed us to double the number of active accounts to 180 high-volume HGNS accounts and deliver a second consecutive quarter of over 20% sequential U.S. revenue growth. Additionally, the recent CMS proposed reimbursement increases in both hospital outpatient and ambulatory surgical centers are among the strongest within APC 5465 (Level 5 Neuromodulation) and, if approved, support continued economic value for the Genio procedure,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “With $110 million in new financing, the financial overhang is now behind us, and we are positioned to accelerate Genio's U.S. commercial ramp and drive toward profitability." Revenue Guidance for the Full Year 2026 The Company continues to expect global net revenue for the full year 2026 to be in the range of €36 million to €40 million. The preliminary, unaudited revenue results and cash, cash equivalents and financial assets described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for the second quarter of 2026, including in its Quarterly Report on Form 6-F. Upcoming Investor and Analyst Day The Company will be hosting an Investor and Analyst Day on Wednesday, July 8, 2026, in New York. The event will be held at the offices of Bank of America and will run from 10:00 AM to 12:30 PM ET (16:00 to 18:30 CET). The event will be webcast live for those unable to attend in person, with a replay available shortly afterwards. Participants joining via the webcast will be able to ask questions durin…Read full document

Nyxoah Announces Preliminary Results for the Second Quarter of 2026 Continued U.S. launch momentum drives second quarter global preliminary net revenue of €7.7 millionCMS proposes 2027 OPPS and ASC payment increase of 12% and 15% respectively Mont-Saint-Guibert, Belgium – July 7, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported certain preliminary unaudited second quarter 2026 financial and operating results. Second Quarter 2026 – Preliminary Sales and Market Metrics Financials Leading U.S. commercial indicators Reimbursement US Liquidity "We closed Q2 with clear U.S. momentum: the scaling of our U.S. sales force allowed us to double the number of active accounts to 180 high-volume HGNS accounts and deliver a second consecutive quarter of over 20% sequential U.S. revenue growth. Additionally, the recent CMS proposed reimbursement increases in both hospital outpatient and ambulatory surgical centers are among the strongest within APC 5465 (Level 5 Neuromodulation) and, if approved, support continued economic value for the Genio procedure,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “With $110 million in new financing, the financial overhang is now behind us, and we are positioned to accelerate Genio's U.S. commercial ramp and drive toward profitability." Revenue Guidance for the Full Year 2026 The Company continues to expect global net revenue for the full year 2026 to be in the range of €36 million to €40 million. The preliminary, unaudited revenue results and cash, cash equivalents and financial assets described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for the second quarter of 2026, including in its Quarterly Report on Form 6-F. Upcoming Investor and Analyst Day The Company will be hosting an Investor and Analyst Day on Wednesday, July 8, 2026, in New York. The event will be held at the offices of Bank of America and will run from 10:00 AM to 12:30 PM ET (16:00 to 18:30 CET). The event will be webcast live for those unable to attend in person, with a replay available shortly afterwards. Participants joining via the webcast will be able to ask questions during the event. Event details Date: Wednesday, July 8, 2026 Time: 10:00 AM to 12:30 PM ET (16:00 to 18:30 CET) Location: Bank of America Tower at One Bryant Park, 1111 Avenue of the Americas, New York, NY Registration and webcast access: https://www.netroadshow.com/events/login/1PeTHmohOsvcptHhJ0ULn0T429N8JKb3IuZtL About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. For more information, please visit http://www.nyxoah.com/. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: NyxoahJohn Landry, [email protected] Rémi RenardHead of Investor Relations & Corporate [email protected] Attachment ENGLISH_Nyxoah Prelim Earnings PR Q2

Investor releaseQuarter not tagged2026-05-20

Nyxoah Welcomes the Flemish Investors Federation (VFB) at LégiaPark following Q1 2026 Results and U.S. Commercial Momentum

GlobeNewswire
Nyxoah Welcomes the Flemish Investors Federation (VFB) at LégiaPark following Q1 2026 Results and U.S. Commercial Momentum Mont-Saint-Guibert, Belgium – May 20, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today participated in an exclusive afternoon organized at LégiaPark, the life sciences innovation campus in Liège, Belgium. The event, which took place at LégiaPark alongside neighbouring listed company Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), brought together up to 40 investors and members of the press for a comprehensive update on both companies. Olivier Taelman, Chief Executive Officer of Nyxoah, walked attendees through the strong commercial progress of the Genio® system in the United States, less than a year after FDA approval in August 2025. He also revisited Nyxoah's recently announced LégiaPark investment, a large manufacturing facility designed to scale industrial capacity in line with the Company's growth ambitions. Stijn Van Rompay, Chief Executive Officer of Hyloris, then presented Hyloris' strategy, broad pipeline of innovative drug candidates and its 2025 highlights, before guiding attendees through the company's R&D facilities and illustrating the depth of the life sciences ecosystem developing on the LégiaPark campus. “Welcoming the VFB community at LégiaPark today was an opportunity to share the tangible progress Nyxoah is delivering in the United States, less than a year after FDA approval, and to demonstrate the strength of the Belgian industrial footprint we are building to support our growth,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. Located on the heights of Liège, LégiaPark is establishing itself as a benchmark life sciences cluster in Wallonia, now home to two Belgian-listed companies on a single campus. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular como…Read full document

Nyxoah Welcomes the Flemish Investors Federation (VFB) at LégiaPark following Q1 2026 Results and U.S. Commercial Momentum Mont-Saint-Guibert, Belgium – May 20, 2026, 10:05 pm CET / 4:05 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today participated in an exclusive afternoon organized at LégiaPark, the life sciences innovation campus in Liège, Belgium. The event, which took place at LégiaPark alongside neighbouring listed company Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), brought together up to 40 investors and members of the press for a comprehensive update on both companies. Olivier Taelman, Chief Executive Officer of Nyxoah, walked attendees through the strong commercial progress of the Genio® system in the United States, less than a year after FDA approval in August 2025. He also revisited Nyxoah's recently announced LégiaPark investment, a large manufacturing facility designed to scale industrial capacity in line with the Company's growth ambitions. Stijn Van Rompay, Chief Executive Officer of Hyloris, then presented Hyloris' strategy, broad pipeline of innovative drug candidates and its 2025 highlights, before guiding attendees through the company's R&D facilities and illustrating the depth of the life sciences ecosystem developing on the LégiaPark campus. “Welcoming the VFB community at LégiaPark today was an opportunity to share the tangible progress Nyxoah is delivering in the United States, less than a year after FDA approval, and to demonstrate the strength of the Belgian industrial footprint we are building to support our growth,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. Located on the heights of Liège, LégiaPark is establishing itself as a benchmark life sciences cluster in Wallonia, now home to two Belgian-listed companies on a single campus. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and received approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. For more information, please visit http://www.nyxoah.com/. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts:NyxoahJohn Landry, [email protected] Rémi RenardHead of Investor Relations & Corporate [email protected] Attachment ENGLISH_Nyxoah Event with VFB Press Release

Investor releaseQuarter not tagged2026-05-13

Nyxoah Q1 Earnings Call Highlights

MarketBeat
Interested in Nyxoah SA? Here are five stocks we like better. Nyxoah’s U.S. Genio launch is gaining traction, with first-quarter 2026 worldwide net revenue up 13% sequentially and U.S. revenue rising about 25% to EUR 4.3 million. The company added 15 sales reps, bringing its U.S. field force to 40, and reported 91 active accounts plus 207 surgeons trained. Reimbursement remains strong and is a major focus, with management saying commercial coverage is broad and stable and that reviewed prior authorization submissions were approved at a 100% rate. The company also said Medicare claims received 100% approval under CMS’ WISeR program and noted recent coding clarity for hypoglossal nerve stimulation procedures. Nyxoah expects accelerating growth but margins were pressured in Q1, guiding for 25% to 30% sequential U.S. revenue growth in Q2 and full-year 2026 worldwide net revenue of EUR 36 million to EUR 40 million. Gross margin fell to 57% due to production yield issues, though management expects improvement later in 2026 and further margin expansion in 2027. Nyxoah (NASDAQ:NYXH) reported 13% sequential worldwide net revenue growth in the first quarter of 2026, driven primarily by continued adoption of its Genio system in the United States, where the company is in its second full quarter of commercialization. Chief Executive Officer Olivier Taelman said the company delivered on its commitment to generate 25% sequential U.S. revenue growth from the fourth quarter of 2025 to the first quarter of 2026. He cited momentum across surgeon training, account activation, prior authorization submissions and procedure volumes. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority,” Taelman said. Nyxoah said U.S. net revenue totaled EUR 4.3 million in the first quarter, up about 25% from EUR 3.4 million in the fourth quarter of 2025. Worldwide gross revenue was EUR 6.7 million before EUR 300,000 in deferrals related to disposable patches delivered over time, resulting in net revenue of about EUR 6.4 million. → MercadoLibre Boldly Invests in Growth: Discount Deepens Taelman said Nyxoah expanded its U.S. commercial field presence by adding 15 sales representatives, bringing the company to 40 fully operational sales reps entering the second quarter. That footprint…Read full document

Interested in Nyxoah SA? Here are five stocks we like better. Nyxoah’s U.S. Genio launch is gaining traction, with first-quarter 2026 worldwide net revenue up 13% sequentially and U.S. revenue rising about 25% to EUR 4.3 million. The company added 15 sales reps, bringing its U.S. field force to 40, and reported 91 active accounts plus 207 surgeons trained. Reimbursement remains strong and is a major focus, with management saying commercial coverage is broad and stable and that reviewed prior authorization submissions were approved at a 100% rate. The company also said Medicare claims received 100% approval under CMS’ WISeR program and noted recent coding clarity for hypoglossal nerve stimulation procedures. Nyxoah expects accelerating growth but margins were pressured in Q1, guiding for 25% to 30% sequential U.S. revenue growth in Q2 and full-year 2026 worldwide net revenue of EUR 36 million to EUR 40 million. Gross margin fell to 57% due to production yield issues, though management expects improvement later in 2026 and further margin expansion in 2027. Nyxoah (NASDAQ:NYXH) reported 13% sequential worldwide net revenue growth in the first quarter of 2026, driven primarily by continued adoption of its Genio system in the United States, where the company is in its second full quarter of commercialization. Chief Executive Officer Olivier Taelman said the company delivered on its commitment to generate 25% sequential U.S. revenue growth from the fourth quarter of 2025 to the first quarter of 2026. He cited momentum across surgeon training, account activation, prior authorization submissions and procedure volumes. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority,” Taelman said. Nyxoah said U.S. net revenue totaled EUR 4.3 million in the first quarter, up about 25% from EUR 3.4 million in the fourth quarter of 2025. Worldwide gross revenue was EUR 6.7 million before EUR 300,000 in deferrals related to disposable patches delivered over time, resulting in net revenue of about EUR 6.4 million. → MercadoLibre Boldly Invests in Growth: Discount Deepens Taelman said Nyxoah expanded its U.S. commercial field presence by adding 15 sales representatives, bringing the company to 40 fully operational sales reps entering the second quarter. That footprint allows the company to cover 200 of the 400 high-volume hypoglossal nerve stimulation accounts beginning in the second quarter, he said. As of March 31, the company reported several launch metrics: 207 surgeons trained on the Genio system, including 62 trained during the first quarter. 91 active accounts out of 125 targeted accounts, after activating 34 new accounts in the quarter. 241 new patients submitted under prior authorization and still pending at quarter-end. An estimated 12% to 14% average market share in accounts where Nyxoah is already active. → MP Materials Is Quietly Building a Rare Earth Powerhouse Taelman said active accounts are defined as having trained surgeons and value analysis committee approval. In the question-and-answer portion of the call, he said the company had about 116 patients under prior authorization at the end of the fourth quarter of 2025, compared with 241 at the end of the first quarter. He said commercial payers have up to 30 days to respond, and procedures are generally performed one to three months after approval depending on operating room and surgeon availability. Nyxoah executives spent a significant portion of the call discussing reimbursement for hypoglossal nerve stimulation procedures. Taelman said commercial payers represented about 90% of the company’s first-quarter cases, while Medicare represented about 10%. For commercial payers, Taelman said coverage is “broad and stable,” with Genio claims processed under CPT code 64568 or CPT code 64582 depending on payer policy and case review. He noted that UnitedHealthcare recently added CPT 64568 back to its hypoglossal nerve stimulation policy alongside CPT 64582. Taelman said Nyxoah maintained a 100% approval rate on reviewed prior authorization submissions through the end of the first quarter. He also said the company achieved a 100% approval rate for submitted Medicare patients under CMS’ WISeR program, an AI-supported prior authorization tool being rolled out in six states since Jan. 1, 2026. On Medicare, Taelman said CMS provided clarity on Feb. 26 by issuing hypoglossal nerve stimulation-specific C codes for facilities. Claims for Genio implantations are submitted under C code C8011, which Taelman said maps to APC level 5 at EUR 31,526 in the hospital outpatient setting and EUR 27,563 in the ambulatory surgery center setting. Physician fee claims continue to be submitted under CPT 64582 at $722, he said. Looking beyond 2026, Taelman said the CPT Editorial Panel has indicated it does not intend to leave any hypoglossal nerve stimulation technology without appropriate coding. He said the company sees two potential paths for 2028: dedicated CPT codes for different technologies or a comprehensive coding set for hypoglossal nerve stimulation. Nyxoah will take its lead from specialty societies, including AAO-HNS, he said. Internationally, Taelman said first-quarter revenue was consistent with the fourth quarter of 2025, which he described as a strong result given the typical sequential decline from the fourth quarter to the first quarter. Growth was supported by performance in Germany, continued therapy adoption in the Middle East and entries into the U.K. and the Netherlands. Taelman also said the company remains focused on a disciplined financial approach, pointing to Germany as an example where Nyxoah reached break-even three years after launch. Chief Financial Officer John Landry said gross margin was 57% in the first quarter, down from 62% in the first quarter of 2025. He attributed the decline to production yield issues during the quarter, which he said have been addressed. During the Q&A session, Landry said some impact from the issue will continue into the second quarter as units produced in the first quarter flow through the income statement. He said gross margin should return to the 63% to 64% range in the back half of 2026. Nyxoah expects full-year gross margin of 60% to 62%. Landry said the company expects a step-up in margin in early 2027 with the Genio 2.2 upgrade, including a new disposable patch and activation chip. He said the upgrade is expected to move gross margin into the low 70% range, with longer-term gross margins expected to exceed 80% as implant cost reductions take effect. Nyxoah guided for second-quarter U.S. net revenue growth of approximately 25% to 30% sequentially from the first quarter. For full-year 2026, the company expects worldwide net revenue of EUR 36 million to EUR 40 million. Landry said sequential U.S. growth is expected to accelerate in the second half of the year, with growth in the low-40% to 45% range in the third quarter and in the 50% range in the fourth quarter. He said the fourth quarter is typically seasonally stronger in the U.S. as patients have exhausted deductibles. Operating expenses were EUR 24.2 million in the first quarter, compared with EUR 21.4 million a year earlier. Non-GAAP cash operating expenses were EUR 21.7 million, compared with EUR 19.5 million in the prior-year period. Landry said the increase reflected investment in the U.S. commercial organization, including sales, marketing and market access. Nyxoah ended the quarter with EUR 25.9 million in cash, cash equivalents and financial assets. The company expects to draw approximately EUR 13.8 million from the second tranche of its European Investment Bank loan in the second quarter. Landry said Nyxoah believes it can reach revenue break-even below EUR 150 million in revenue while managing operating expenses and investing in growth. Nyxoah SA, headquartered in Mont-Saint-Guibert, Belgium, is a medical technology company focused on neuromodulation therapies for sleep‐disordered breathing. Established in 2018, the company's primary offering is the Genio® system, a minimally invasive bilateral hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA). By electrically stimulating the genioglossus muscle, the device helps maintain airway patency during sleep, reducing apnea events and improving overall sleep quality. The Genio system comprises a small, implantable stimulator positioned submentally and an external activation unit worn by the patient. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Nyxoah Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Investor releaseQuarter not tagged2026-05-13

Nyxoah SA (NYXH) Q1 2026 Earnings Call Highlights: Strong U.S. ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nyxoah SA (NASDAQ:NYXH) achieved a 25% sequential U.S. revenue growth in Q1 2026 compared to Q4 2025, indicating strong execution of their U.S. launch. The company trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the GENIOS system, enhancing their market presence. Nyxoah SA (NASDAQ:NYXH) maintained a 100% approval rate on reviewed prior authorization submissions, showcasing effective market access strategies. The company expanded its U.S. commercial field presence with 15 additional sales reps, enabling coverage of up to 200 high-volume accounts. International revenue remained consistent with Q4 2025, avoiding the typical sequential decline, and showing strong performance in markets like Germany and the Middle East. Gross margin decreased to 57% in Q1 2026 from 62% in Q1 2025 due to production yield issues, which have been addressed. Operating expenses increased to EUR 24.2 million in Q1 2026 from EUR 21.4 million in Q1 2025, driven by investments in the U.S. commercial organization. The company faces ongoing challenges with Medicare, which only represents approximately 10% of their cases, due to initial coding uncertainties. Despite the growth, Nyxoah SA (NASDAQ:NYXH) is still not at break-even, with a revenue target of EUR 150 million needed to achieve this. The company anticipates a slight gross margin impact in Q2 2026 due to units built in Q1 running through the P&L, delaying full margin recovery. Warning! GuruFocus has detected 4 Warning Signs with NYXH. Is NYXH fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the confidence in achieving the full-year 2026 revenue guidance, especially considering the ongoing reimbursement situation? A: Olivier Talman, CEO: We have added 50 new sales reps, bringing the total to 40, which allows us to cover 200 out of 400 high-volume accounts. Surgeons are gaining experience, and we have 91 active accounts out of 125 targeted sites. We also have 241 patients submitted for prioritization, which gives us confidence in achieving strong double-digit growth, especially in the second half of the year. John Landry, CFO, added that revenue growth is expected to accelerate in the back half of the year, w…Read full document

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nyxoah SA (NASDAQ:NYXH) achieved a 25% sequential U.S. revenue growth in Q1 2026 compared to Q4 2025, indicating strong execution of their U.S. launch. The company trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the GENIOS system, enhancing their market presence. Nyxoah SA (NASDAQ:NYXH) maintained a 100% approval rate on reviewed prior authorization submissions, showcasing effective market access strategies. The company expanded its U.S. commercial field presence with 15 additional sales reps, enabling coverage of up to 200 high-volume accounts. International revenue remained consistent with Q4 2025, avoiding the typical sequential decline, and showing strong performance in markets like Germany and the Middle East. Gross margin decreased to 57% in Q1 2026 from 62% in Q1 2025 due to production yield issues, which have been addressed. Operating expenses increased to EUR 24.2 million in Q1 2026 from EUR 21.4 million in Q1 2025, driven by investments in the U.S. commercial organization. The company faces ongoing challenges with Medicare, which only represents approximately 10% of their cases, due to initial coding uncertainties. Despite the growth, Nyxoah SA (NASDAQ:NYXH) is still not at break-even, with a revenue target of EUR 150 million needed to achieve this. The company anticipates a slight gross margin impact in Q2 2026 due to units built in Q1 running through the P&L, delaying full margin recovery. Warning! GuruFocus has detected 4 Warning Signs with NYXH. Is NYXH fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the confidence in achieving the full-year 2026 revenue guidance, especially considering the ongoing reimbursement situation? A: Olivier Talman, CEO: We have added 50 new sales reps, bringing the total to 40, which allows us to cover 200 out of 400 high-volume accounts. Surgeons are gaining experience, and we have 91 active accounts out of 125 targeted sites. We also have 241 patients submitted for prioritization, which gives us confidence in achieving strong double-digit growth, especially in the second half of the year. John Landry, CFO, added that revenue growth is expected to accelerate in the back half of the year, with sequential growth rates increasing from 25%-30% in Q2 to 40%-50% in Q4. Q: What is the strategy for obtaining a permanent CPT code for Genio, and how does it relate to the recent AMA CPT panel meeting? A: Olivier Talman, CEO: For 2026, reimbursement is clear with CMS C codes and commercial payer coverage under CPT codes 64568 and 64582. For 2027, we expect no change on the Medicare side, and commercial codes may migrate to 64582. By 2028, there could be dedicated CPT codes for all AGNS technologies or a comprehensive AGNS coding set. We are prepared for both scenarios and will follow the lead of specialty societies. Q: Can you provide details on the 241 patients submitted under prior authorization and the approval process timeline? A: Olivier Talman, CEO: At the end of Q1 2026, we had 241 patients submitted, up from 116 at the end of Q4 2025. Commercial payers have up to 30 days to approve, and we have maintained a 100% prior authorization approval rate. The timeline for getting patients through the approval process varies from one to three months, depending on surgical scheduling and site volume. Q: What are the expectations for gross margin improvement, and how does it relate to production yield issues? A: John Landry, CFO: We experienced production yield issues in Q1, which have been resolved. We expect gross margins to improve starting in Q2 and continue throughout the year. The Genio 2.2 upgrade in early 2027 will further enhance margins, moving them from the low 60s to north of 70%. Long-term, we aim for gross margins over 80% through cost reductions and volume-based pricing with contract manufacturers. Q: How does the dynamic between Genio and Inspire 5 play out in terms of device selection at sites? A: Olivier Talman, CEO: Our strategy involves partnering with sleep physicians for patient selection and management. Most patients arrive at hospitals seeking AGNS solutions, not specifically Genio. Once at the site, they are informed of their options, and many choose Genio due to its features like no implanted battery and bilateral stimulation. We focus on high-volume implanters and involve sleep physicians from the start, which has been effective in driving adoption. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-13

Nyxoah Reports First Quarter 2026 Financial and Operating Results

GlobeNewswire
REGULATED INFORMATION Nyxoah Reports First Quarter 2026 Financial and Operating Results Strong Genio launch in the U.S. drove 25% sequential quarterly U.S. revenue growth Continued clarity around HGNS and Genio reimbursement in the U.S. Mont-Saint-Guibert, Belgium – May 12, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2026. Q1 2026 Financial and Operating Highlights Financials U.S. net revenue first quarter 2026 was €4.3 million (gross revenue was €4.5 million), 25% sequential growth over net revenue fourth quarter 2025 Global net revenue first quarter 2026 was €6.4 million (gross revenue was €6.7 million), 13% sequential growth over net revenue fourth quarter 2025 Leading U.S. commercial indicators 62 new surgeons trained in Q1, bringing the total to 207 surgeons trained 34 new accounts activated in Q1, bringing the total to 91 active high-volume accounts 241 patients submitted under prior authorization and still pending at the end of Q1 U.S. reimbursement landscape – further clarified Medicare issued new C-Codes covering Genio and clarified facility and physician payments Commercial payers continued reimbursement under existing CPT codes 100% prior-authorization approval obtained on reviewed submissions with commercial payers and WISeR program As of March 31, 2026, cash, cash equivalents and financial assets amounted to €25.9 million. In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan. “Our first quarter revenue results reflect strong execution of our U.S. launch. The 25% sequential quarterly revenue growth was driven by continued strong activity in existing sites, and high growth in new site openings. We continue to see a consistent reimbursement landscape and had a 100% approval rate on closed U.S. prior authorization submissions as of the end of Q1 2026. Reimbursement did not hinder our first quarter results,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Entering our third full quarter of U.S. commercialization, we remain focused on further expanding account activation, treating more pat…Read full document

REGULATED INFORMATION Nyxoah Reports First Quarter 2026 Financial and Operating Results Strong Genio launch in the U.S. drove 25% sequential quarterly U.S. revenue growth Continued clarity around HGNS and Genio reimbursement in the U.S. Mont-Saint-Guibert, Belgium – May 12, 2026, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2026. Q1 2026 Financial and Operating Highlights Financials U.S. net revenue first quarter 2026 was €4.3 million (gross revenue was €4.5 million), 25% sequential growth over net revenue fourth quarter 2025 Global net revenue first quarter 2026 was €6.4 million (gross revenue was €6.7 million), 13% sequential growth over net revenue fourth quarter 2025 Leading U.S. commercial indicators 62 new surgeons trained in Q1, bringing the total to 207 surgeons trained 34 new accounts activated in Q1, bringing the total to 91 active high-volume accounts 241 patients submitted under prior authorization and still pending at the end of Q1 U.S. reimbursement landscape – further clarified Medicare issued new C-Codes covering Genio and clarified facility and physician payments Commercial payers continued reimbursement under existing CPT codes 100% prior-authorization approval obtained on reviewed submissions with commercial payers and WISeR program As of March 31, 2026, cash, cash equivalents and financial assets amounted to €25.9 million. In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan. “Our first quarter revenue results reflect strong execution of our U.S. launch. The 25% sequential quarterly revenue growth was driven by continued strong activity in existing sites, and high growth in new site openings. We continue to see a consistent reimbursement landscape and had a 100% approval rate on closed U.S. prior authorization submissions as of the end of Q1 2026. Reimbursement did not hinder our first quarter results,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Entering our third full quarter of U.S. commercialization, we remain focused on further expanding account activation, treating more patients in active accounts and maintaining operating discipline to deliver sustainable revenue growth in the U.S.” Results for the Three Months Ended March 31, 2026 Revenue Gross revenue for the first quarter of 2026 was €6.7 million before €0.3 million of deferred revenue mainly related to disposable patches which are delivered over time. Net revenue was €6.4 million, compared to €1.1 million in the first quarter of 2025. The increase in net revenue was primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets. Cost of Goods Sold Cost of goods sold was €2.7 million for the first quarter of 2026, resulting in a gross profit of €3.6 million and a gross margin of 57%, compared to cost of goods sold of €0.4 million and a gross margin of 62% in the first quarter of 2025. The increase in cost of goods sold was driven by higher volumes associated with the U.S. commercialization. The decrease in gross margin reflects production yield issues which have been addressed. Research and Development For the first quarter of 2026, research and development expenses were €8.8 million, versus €9.0 million for the first quarter of 2025. The decrease in research and development expenses reflects reduced investments in clinical study costs such as DREAM and ACCCESS. Selling, General and Administrative For the first quarter of 2026, selling, general and administrative expenses were €15.4 million, versus €12.4 million for the first quarter of 2025. The increase in selling, general and administrative expenses was primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions. Operating Loss Total operating loss for the first quarter of 2026 was €20.5 million, versus €20.6 million in the first quarter of 2025. The change in operating loss reflects increased net revenue offset by increased commercial investments to support U.S. launch activities, as well as continued investment in research and development. Cash Position Cash, cash equivalents and financial assets amounted to approximately €25.9 million at March 31, 2026. In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan. Financial Guidance for the Second Quarter of 2026 and Full Year 2026 The Company expects U.S. net revenue for the second quarter of 2026 to grow sequentially by approximately 25-30% over the first quarter of 2026. The Company expects worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million. The Company expects the gross margin for the full year 2026 to be in the range of 60% to 62%. The Company expects total operating expenses for the full year 2026 to be in the range of €97 million to €99 million. The Company expects non-GAAP cash operating expenses for the full year 2026 to be in the range of €88 million to €90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash expenses such as depreciation, amortization, and share-based compensation. Conference call and webcast presentation Company management will host a conference call to discuss financial results on Tuesday, May 12, 2026, beginning at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2026 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q1 2026 Earnings Call Q&A Link. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. Non-GAAP financial measures This press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expenses items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company's operating performance and for planning purposes, including the preparation of the Company's annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company's future results will be unaffected by unusual or non-recurring items. The Company's definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. For more information, please visit http://www.nyxoah.com/. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited) (in thousands) For the Three Months Ended March 31, Non-GAAP Financial Measures The following tables contain a reconciliation of GAAP operating expenses to non-GAAP cash operating expenses for the three months ended March 31, 2026 and 2025, respectively. Contacts: Nyxoah John Landry, CFO [email protected] Rémi Renard Head of Investor Relations & Corporate Communication [email protected] Attachment ENGLISH_Earnings PR 1Q26

TranscriptFY2026 Q12026-05-12

FY2026 Q1 earnings call transcript

Earnings source - 74 paragraphs
Operator

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.

Pearson Dennis

Thank you. Good afternoon, everyone. I welcome you to our first quarter 2026 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter 2026 financial results released after U.S. market closing today. 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.

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 file, which was filed with the Securities and Exchange Commission on March 26th, 2026. With that, I will now turn the call over to Olivier.

Olivier Taelman

Thank you, Pearson. Good day, everyone, and thank you for joining us for first quarter 2026 earnings call. Let me start with the Q1 2026 overview. The first quarter of 2026 marks our second full quarter of U.S. commercialization, and we are encouraged by the strong execution of our U.S. launch. Specifically, we delivered on our commitment to drive 25% sequential U.S. revenue growth in the first quarter of 2026 versus the fourth quarter of 2025. In the U.S., we are seeing consistent momentum across our key commercial indicators, including surgeon training, account activation, patient prior authorization submissions, and procedure volumes. Internationally, our revenue in the first quarter of 2026 was consistent with the fourth quarter of 2025, 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.

Olivier Taelman

On a worldwide basis, I'm pleased to report that we grew our revenue by 13% sequentially over the fourth quarter of 2025. Let's now dig in the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority. During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our U.S. commercial field presence with an extra 15 sales reps who are now fully operational, enabling us to cover up to 200 high-volume hypoglossal nerve stimulation accounts entering Q2. I'm pleased to report on our U.S. launch key performance indicators as of March 31st, 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system.

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 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. Six months post-launch, in the accounts where we are already active, we estimate our market share to be between 12%-14% on average. With the addition of 50 new sales representatives in the U.S. who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume HGNS accounts beginning in Q2.

Olivier Taelman

We also recently conducted a market research study of 100 U.S. hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients. All Genio-trained surgeons plan to adopt Genio in their practice. The top-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 HNS 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.

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 64582, depending on payer policy and individual case review. For example, UnitedHealthcare recently added CPT 64568 back to their existing HGNS policy in parallel to CPT 64582, so both codes are available for HGNS. UnitedHealthcare represents one of several commercial payers which have both CPT 64568 and the 64582 listed as available codes for HGNS procedures, including Genio.

Olivier Taelman

Through the end of the first quarter, 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 HGNS implants. On February 26th, however, CMS provided clarity by issuing HGNS-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 EUR 31,526 in the hospital outpatient setting, and EUR 27,563 in the ASC setting. This is equivalent to the existing CPT code 64582 in hospital settings and slightly higher than the CPT code 64582 in the ASC setting.

Olivier Taelman

This results also in price parity at facility level for Genio and competition. From a physician fee perspective, claims continue being submitted under CPT 64582 at $722. When it comes to the use of modifiers, let me reiterate that it is a physician decision based on the specific surgeon work performed and that Nyxoah is not advising to use of a modifier. As to the newly established WISeR program, being an AI-supported prior authorization tool rolled out by CMS in six different states since January 1st, 2026, we have achieved a 100% approval rate of our submitted Medicare patients.

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 Payer Feedback Program, and the proactive education of all our customers. Of these factors, we expect continuity for 2026 and into 2027. As part of the ongoing CPT Editorial Panel discussion regarding the future of HGNS coding, the panel has indicated that there is no intention to leave any HGNS technology orphaned without appropriate coding. 2028, we understand that there are currently two paths to support continued coding being dedicated CPT codes for the different HGNS technologies or creating a comprehensive HGNS coding set. Following the model laid out in the CMS C codes, we learned that competition has chosen to seek its own dedicated code, which we are prepared for as well.

Olivier Taelman

Alternatively, specialty societies may seek to engage in a broader exercise to provide further clarity regarding coding in the HGNS space, creating a comprehensive HGNS 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. 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 U.K. and the Netherlands. 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.

John Landry

Thank you, Olivier. For the first quarter of 2026, gross revenue was EUR 6.7 million before EUR 300,000 in deferrals due to the delivery of disposable patches, which are delivered over time, resulting in net revenue of approximately EUR 6.4 million. This represents 13% sequential worldwide growth compared to the fourth quarter of 2025. U.S. net revenue was EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in the fourth quarter of 2025. Our U.S. revenue growth reflects continued expansion in account activation, increasing procedure volumes, and growing surgeon adoption. Gross margin in the first quarter of 2026 was 57% as compared to 62% in the first quarter of 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed.

John Landry

Operating expenses were EUR 24.2 million in the first quarter of 2026, as compared to EUR 21.4 million in the first quarter of 2025. The increase in operating expenses was driven by increased investment in U.S. commercial organization, including sales, marketing, and market access functions. Non-GAAP cash operating expenses were EUR 21.7 million in the first quarter of 2026, as compared to EUR 19.5 million in the first quarter of 2025. The increase in non-GAAP cash operating expenses also reflects increased investment in the U.S. commercial organization. As of March 31st, 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In the second quarter of 2026, we expect to draw approximately EUR 13.8 million from the second tranche of our European Investment Bank loan. Now let's turn to guidance.

John Landry

We expect U.S. net revenue for the second quarter of 2026 to grow approximately 25%-30% sequentially over the first quarter of 2026. For the full year 2026, we expect worldwide net revenue in the range of EUR 36 million-EUR 40 million. We expect gross margin in the range of 60%-62%. We expect total operating expenses in the range of EUR 97 million-EUR 99 million. We expect total non-GAAP cash operating expenses in the range of EUR 88 million-EUR 90 million. Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5%-8% sequential increase over non-GAAP cash operating expenses of EUR 83.5 million for fiscal year 2025.

John Landry

Strategically, we will focus our investments in supporting our U.S. commercial activities, including sales, marketing, and market access, as well as key R&D initiatives, including our Genio 2.2 upgrade, which includes a new sleep wearable with upgraded software and a low-cost disposable patch to be launched in early 2027. We decreased our total non-GAAP cash operating expenses by EUR 300,000 to EUR 21.7 million from the Q4 2025 to the Q1 2026. We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from the Q4 2025 and reallocated this capital into our U.S. commercialization efforts.

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 U.S. commercial activities. Long term, we expect to drive gross margins over 80%, and we will continue to manage our non-GAAP cash operating expenses tightly while investing in growth and gross margin improvement drivers. We believe this disciplined approach will allow us to achieve revenue breakeven below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Olivier Taelman

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

Operator

To 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. We also ask that you please wait for your name and company to be announced before proceeding with your question, and one moment while we compile the Q&A roster. Our first question today will be coming from the line of Adam Maeder of Piper Sandler. Please go ahead.

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 U.S. revs, it does imply a bit of a step-up in the back half of the year. I know Q4 is typically a seasonally stronger quarter, but maybe just talk about the confidence in achieving the full year outlook, especially in light of the ongoing reimbursement situation and talk about some of the kind of key drivers of the ramp and any help on quarterly phasing would be appreciated. Thanks.

Olivier Taelman

Thank you, Adam. Let me start by answering the question. First of all, as we already communicated, we continued adding salespeople into the field. We added 15 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 two-four implants, 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.

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 one to two weeks all the way up to a couple of months. 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. 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.

Olivier Taelman

If you add those leading indicators up, that is giving us confidence of showing continued strong double-digit growth even further accelerating in the second half of the year. Now John will add some numbers to this as well to answer your question completely.

John Landry

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, and then we'll ramp up over the rest of the year. The sequential growth and growth rate I mentioned, 25% to 30% in the second quarter. We would see that accelerate in the third quarter to probably about the 40%, low 40% to 45% range, and then in 50% range, you know, into the fourth quarter of the year, which as you know, is a seasonally stronger year, especially in the U.S., as people have fully exhausted their deductibles.

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 U.S. revenue target.

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.

Adam Maeder

Okay. Fantastic. That's a lot of very helpful color. I appreciate all that. For the follow-up, I wanted to switch over to reimbursement, everyone's favorite topic. Olivier, I guess the question is really around kind of the longer-term strategy for Genio and 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, and 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?

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.

Olivier Taelman

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 Model. There we have obtained a 100% approval, 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, 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.

Olivier Taelman

The CPT 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 hypoglossal nerve stimulation, directing all HNS procedures away from that code, and the code would migrate into a 64582 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. I mean, that was part of the agenda of the CPT Editorial Panel discussion. For 28, what we are hearing is that there are two roads in going forward.

Olivier Taelman

One would be there is the move in the direction of CPT codes, dedicated CPT codes for all universe HGNS technologies. The second road would be that there would be a more comprehensive HGNS coding set where also all reimbursed HGNS technologies would follow. That needs to be further clarified. 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.

Olivier Taelman

From the commercial payers, there are codings in place. It might be that everything is more migrated to the CPT 645A2 code. In 2028, I'm sure that CPT Editorial Panel will continue discussing. They made it already clear that there will be no orphan HGNS technology, and whether it evolves into dedicated codes, we will be prepared for this. Whether it evolves to a more comprehensive HGNS coding set, we will follow the lead from society in this. I hope this is answering your question.

Adam Maeder

Perfect. That's very helpful. Thank you.

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.

Jonathan Block

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. Can you remind us what that number was at the end of the fourth quarter of 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?

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 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 this varies between one to three months before those patients are then implanted.

Jonathan Block

Okay. Thank you. 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 could remind us what the break-even point for the company is, your views on cash burn going forward. Then, 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%, here we are approaching EUR 40 million in 2026, it can't get out of its own way in this sort of low 60% range plus.

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.

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 the second quarter and for the rest of the year. I think, as I mentioned on the last call, we have our Genio two point two new disposable patch and activation chip, which will be a major step function improvement in our gross margin profile.

John Landry

That'll be coming online in early 2027, 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. That's how we're thinking about gross margin. 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. That's the gross margin outlook, and that we have a high degree of confidence we'll get to 8%+ in our gross margin profile on the backs largely of those two initiatives.

John Landry

In terms of, in terms of cash burn, we're very focused on managing our cash burn. 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, that's reflective of the incremental 15 sales reps that we added in the U.S. We've been very focused on making sure that we're investing strongly in the U.S. commercialization efforts, reallocating capital to that from other parts of the business and really want to basically extend our cash runway as long as possible while supporting the investments in the U.S. commercial organization, which is the growth engine for us, not sacrificing the improvements in gross margin drivers. That's how we're thinking about it.

John Landry

As we think about cash operating expenses going forward, you know, we mentioned a 5%-8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance. 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.

John Landry

That's how we're thinking about it and, you know, looking at managing our P&L levers that we have available to us.

Jonathan Block

Great. Thanks for the color, guys.

John Landry

Thanks, John.

Olivier Taelman

Thank you.

Operator

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

Suraj Kalia

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

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, U.S. guidance is +25%-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 U.S. revenues, and that's a 50% sequential jump. 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.

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 and Q2, we already saw this translated in a very strong April. That is correct. How fast we will 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.

Olivier Taelman

To your point, April started 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.

John Landry

Yeah. In terms of the, in terms of the ramp, I think, you know, we're looking at, again, stepping up the ramp in the back half of the year with regard to sequential quarter growth. As we think about it, you know, first-second quarter, we're looking at 25%-30% sequential growth, then bumping that up to low 40s and then, you know, upper 40s pushing 50% in the fourth quarter 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.

Olivier Taelman

Yeah. Then the Medicare percentage, that was the last part of the question. In Q1, it's around 10%-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 coding in place, I do think that is also completely de-risked. We already had the two first MACs 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.

Suraj Kalia

Got it. Olivier, in terms of Genio and Inspire V, what is the dynamic in the field in terms of selection of the device? A lot of sites have these Inspire days booked. I guess what I'm trying to understand is, do you see any early signs of patient selection migrating towards Genio? By the same token, how do you squeeze your way in with Genio? Is it displacing an Inspire case on these HNS days? Help us understand how, you know, the dynamic as it stands currently. Thank you for taking my question.

Olivier Taelman

Suraj, that was also one of the reasons we recently conducted a market research study with 100 U.S. HGNS 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.

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 HGNS 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.

Olivier Taelman

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 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.

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'll keep our DTC spending very limited.

Suraj Kalia

Thank you.

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 the back half of the year? I ask 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-60%s by the end of the year if you're getting to the upper end of that 60%-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 have a follow-up.

John Landry

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, so 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.

John Landry

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 70%s.

David Rescott

Okay. 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. So 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.

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.

John Landry

Sure. Absolutely. Again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. The, you know, large driver of OpEx growth is really regarding, you know, the investments we made in the U.S. commercial organization. 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 essentially the 4x on Q1 results on the low end of the guide. We will make selective 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.

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 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, be they be revenue and/or margin improvement initiatives.

John Landry

That's how we're thinking about it, and we want to 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.

Olivier Taelman

So then-

Operator

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

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook