Nyxoah Q1 Earnings Call Highlights

Key Points

• 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.

“The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority,” Taelman said.

U.S. launch continues to scale

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.

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.

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.

Reimbursement remains a key investor focus

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.

International revenue holds steady

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.

Margins pressured by production yield issue

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.

Guidance calls for accelerating growth

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.

About Nyxoah NASDAQ: NYXH

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.

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