This article first appeared on GuruFocus .
Release Date: November 05, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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U.S. net revenue reached EUR6.7 million in Q3 2026, up 29% sequentially, accelerating from 22% growth in Q2.
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Global net revenue was EUR9.2 million, up 19% sequentially, with international revenue growing 42% year-over-year.
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Gross margin improved to 63.1% in Q3 2026 from 60.5% in Q3 2025, driven by higher device volume.
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The AXIS U.S. pivotal study met co-primary efficacy and safety endpoints in CCC patients, with AHI responder rate of 77.2% and ODI responder rate of 87.7%, and zero device/procedure-related serious adverse events.
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CMS finalized 2027 reimbursement increases: hospital outpatient rate up ~11% to $35,072 and ambulatory surgical center rate up ~13% to $31,283, strengthening the economic value of the Genio procedure.
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The company trained 80 new surgeons in Q3, bringing the total to 342, and activated 53 new accounts, reaching 233 active accounts.
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Nyxoah SA submitted a PMA supplement to the FDA to expand the Genio indication to include CCC patients, a population representing about one in four OSA patients evaluated for therapy.
Negative Points
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Full-year 2026 revenue guidance was reduced to EUR33-35 million, down from previous expectations, due to a slower U.S. launch ramp.
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Total operating loss was EUR21.9 million in Q3 2026, reflecting continued cash burn as the company invests in commercial infrastructure.
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Cash and equivalents declined to EUR77.1 million at September 30, 2026, from EUR97.8 million at June 30, 2026.
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The company pre-announced Q3 revenue and adjusted guidance, which may raise concerns about visibility and execution.
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U.S. revenue growth, while strong sequentially, is still below the historical ramp for a new technology, according to the revised guidance.
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The PMA supplement for CCC indication is still under FDA review, with no guarantee of approval.
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The company faces competition from established hypoglossal nerve stimulation therapy providers, and market adoption may take time.
Q & A Highlights
Q: With the updated guidance and what appears to be a new guidance philosophy, where should expectations head into 2027, and can you provide any first look at the cadence of sequential growth? A: CEO Liam Kelly expressed pleasure with U.S. launch momentum, noting an annualized Q3 run rate of nearly EUR27 million ($31 million), which he called best-in-class. He highlighted a 260 basis point year-over-year gross margin expansion and a $2.5 million reduction in cash burn. While declining to provide specific 2027 guidance until the Q4 report, he pointed to new center activations, more doctors trained, and 55 productive sales reps as reasons investors should feel confident in the company's ability to achieve its 2027 targets, with focus on U.S. execution and continued international growth.
Q: What are you most excited to tackle in your new role, and what drew you to this opportunity? A: CEO Liam Kelly said he is most excited about Genio's opportunity to penetrate the U.S. market, calling it an inflection point for the company's growth. He cited bilateral stimulation as a key differentiator and the anticipated PMA approval for CCC patients, which would address roughly one in four patients currently untreatable and improve workflow. He noted customer enthusiasm for a new technology option and believes the market can support multiple players, which historically expands rather than contracts medical device markets, ultimately benefiting patients.
Q: What drove the decision to adjust full-year 2026 revenue guidance to EUR33 million to EUR35 million? A: CEO Liam Kelly explained that while the company is disappointed to adjust guidance, the new range reflects U.S. revenues more in line with historical ramps for a new technology as physicians and centers build experience with Genio. He emphasized that the foundations remain strong, with growing numbers of trained surgeons and active accounts, positive physician feedback, and the potential CCC label expansion. He also clarified it is not the company's intent to systematically pre-announce revenue on a quarterly basis.
Q: Can you provide an update on the AXIS U.S. Pivotal study results and the CCC PMA supplement submission? A: CEO Liam Kelly reported that the AXIS U.S. Pivotal study met its co-primary efficacy and safety endpoints in complete concentric collapse (CCC) patients. At 12 months, the AHI responder rate was 77.2% and the ODI responder rate was 87.7%, both highly statistically significant, with zero device- and procedure-related serious adverse events. The full 12-month data was presented at the International Surgical Sleep Society Annual Meeting in October. Nyxoah has submitted a PMA supplement to the FDA to expand Genio's U.S. indication to include CCC patients, who are currently contraindicated for unilateral hypoglossal nerve stimulation.
Q: What were the key U.S. commercial launch metrics as of September 30, 2026? A: CEO Liam Kelly reported that Nyxoah trained 80 new surgeons in Q3, bringing the total to 342 trained surgeons. The company activated 53 new accounts in the quarter, reaching 233 active Genio accounts. Additionally, 447 patients were actively undergoing prior authorization in the Genio access program entering Q4 2026. The company has 55 sales reps and will focus on driving deeper utilization within existing accounts rather than solely activating new ones.
Q: What is the reimbursement outlook following CMS's final rule on 2027 reimbursement for the Genio procedure? A: CEO Liam Kelly stated that CMS published its final rule on 2027 reimbursement, with hospital outpatient reimbursement under C-code C8011 increasing approximately 11% from $31,526 to $35,072, and ambulatory surgical center reimbursement increasing approximately 13% from $27,563 to $31,283. He noted these facility increases strengthen the economic value of the Genio procedure, while CMS and commercial payer coverage remain broad and stable.
Q: Can you review the third quarter 2026 financial results, including revenue, gross margin, and operating loss? A: Interim CFO Loic Moreau reported Q3 2026 net revenue of EUR9.2 million, up 365% year over year and 19% sequentially. U.S. net revenue was EUR6.7 million, up 29% sequentially, while international net revenue was EUR2.5 million, up 42% year over year. Gross margin improved to 63.1% from 60.5% a year ago, driven by spreading cost of goods sold over higher device volumes. Total operating loss was EUR21.9 million versus EUR24.4 million in Q3 2025, as spending shifts from clinical and R&D toward commercial infrastructure.
Q: What is the company's cash position and full-year 2026 guidance for gross margin? A: Interim CFO Loic Moreau reported that cash, cash equivalents, and financial assets totaled EUR77.1 million as of September 30, 2026, compared to EUR97.8 million at June 30, 2026. For full-year 2026, the company expects global net revenue of EUR33 million to EUR35 million and gross margin in the range of 60% to 62%. He reiterated the company's commitment to disciplined spending and reducing cash burn quarter over quarter.
Q: How is the international business performing, and what is the strategy in those markets? A: CEO Liam Kelly reported that international revenue grew 42% compared to Q3 2025, reaching EUR2.5 million, and continues to perform in line with expectations. He noted the company executes in focused markets with a disciplined approach, maintaining solid growth internationally while prioritizing the U.S. launch as the primary growth driver.
Q: What are the company's top priorities for the coming quarters under your leadership? A: CEO Liam Kelly outlined three priorities: first, deliver against the updated 2026 revenue guidance by driving utilization in existing U.S. accounts while continuing to train new doctors and expand into new accounts; second, advance the CCC label expansion through FDA review of the PMA supplement; and third, maintain financial discipline while investing behind the highest-return, highest-growth opportunities. He emphasized refocusing Nyxoah from an R&D and clinical development organization into a commercially-centric organization.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
