Nyxoah Q4 Earnings Call Highlights

Key Points

• Nyxoah received U.S. FDA approval for Genio on Aug. 8, 2025 and began U.S. commercialization (first implants/revenue in Sept 2025); by Dec. 31 the company had trained 145 surgeons across 125 high‑volume accounts and completed 120 VAC submissions with 57 approvals and no rejections.
• In Feb. 2026 CMS issued interim C‑codes (C8011–C8013) for airway genioglossus nerve stimulation, with C8011 reimbursed in the hospital outpatient setting at $31,526, creating parity with competitors while surgeon billing is expected to continue under CPT 64582; Nyxoah expects dedicated AGNS CPT codes likely around 2028.
• Q4 2025 net revenue was EUR 5.6 million (up from EUR 1.3M YoY) with ~EUR 3.5 million from the U.S. launch and full‑year net revenue of EUR 10 million (+122% YoY); the company ended 2025 with EUR 48 million in cash, burning ~EUR 20 million per quarter (runway into Q1 2027) and expects ~25% sequential U.S. revenue growth in Q1–Q2 2026 while expanding the U.S. salesforce to 40 reps.

Nyxoah NASDAQ: NYXH used its fourth-quarter and full-year 2025 earnings call to outline the first results from the U.S. launch of its Genio hypoglossal nerve stimulation system, discuss the evolving reimbursement environment for the category, and provide initial growth expectations for early 2026. Management repeatedly characterized 2025 as a “transformative year,” highlighted by U.S. FDA approval and initial commercial execution.

U.S. launch milestones and early commercial indicators

Chief Executive Officer Olivier Taelman said Nyxoah built its U.S. commercial foundation ahead of FDA approval by hiring and training a field team and preparing market access and account targeting plans focused on the “top 400 highest volume” hypoglossal nerve stimulation (HGNS) accounts in the U.S. Taelman said the company hired and trained its first 25 U.S. sales representatives in early 2025.

Nyxoah received U.S. FDA approval for Genio on Aug. 8, 2025 and began actively launching the product, with “first implants and revenue as early as September 2025,” according to Taelman. He said the fourth quarter represented the first full quarter of U.S. commercialization and that the company tracked leading indicators tied to account access and physician readiness.

As of Dec. 31, 2025, Taelman said Nyxoah’s team was focused on 125 of the top 400 U.S. accounts. Within that group, the company trained 145 surgeons across 125 high-volume accounts. Nyxoah completed 120 Value Analysis Committee (VAC) submissions and had received 57 VAC approvals by quarter-end, with “no VAC rejections to date,” he said.

In Q&A, Taelman said the remaining VAC submissions were in process and that additional approvals began coming through in the first quarter of 2026, noting that timelines vary by hospital. He also said that after expanding the sales force in early 2026, the company expected its additional representatives to add coverage and expand account reach.

Reimbursement updates and CMS coding clarity

Management devoted a significant portion of the call to reimbursement, particularly Medicare facility billing for “airway genioglossus nerve stimulation” (AGNS). Taelman said Genio reimbursement had been consistent across Medicare and “many large commercial payers” and noted that in Q4 commercial payers represented about 90% of Genio business while Medicare represented about 10%.

Taelman addressed recent discussion in the market about coding practices as the category matures. He said that in February 2026, CMS established new interim C-codes for AGNS used by facilities billing traditional Medicare patients, including codes C8011, C8012, and C8013, which apply to external power devices such as Genio.

Taelman added that CMS indicated the new C-code C8011 used for a Genio implant would be reimbursed in the hospital outpatient department at $31,526, which he said was in line with 2026 coverage for CPT code 64582. “This also means that there is no reimbursement difference between the Genio system and competition,” he said.

For surgeon billing, Taelman said the introduction of the C-codes does not change how surgeons bill their physician fee and that, given recent CMS guidance, Nyxoah expects surgeons will elect to use CPT 64582 for their physician fee. For commercial payers, he said claims continue to be processed under CPT 64582 or 64568, depending on payer policies and case specifics, and that Nyxoah has seen “strong prior authorization outcomes” to date.

Taelman said Nyxoah remains engaged with specialty societies and coding authorities to support “long-term dedicated AGNS CPT codes.” In Q&A, he also said the company expects dedicated coding for Genio “most likely somewhere beginning 2028,” while emphasizing that the facility fee under the interim C-code has been clarified and that physician billing is expected to remain similar to prior practice.

Clinical data and pipeline updates

Taelman highlighted publication of the DREAM pivotal study in the Journal of Clinical Sleep Medicine, which he said demonstrated Genio’s efficacy in both supine and non-supine positions and is reflected in the product’s labeling. He said this positioning differentiates Genio from competitors.

Looking ahead, Taelman said Nyxoah expects 12-month data from its ACCCESS study evaluating complete concentric collapse, with an aim to submit a PMA supplement that could support a U.S. label expansion. In response to an analyst question, Taelman said that by the end of June 2026 the company expects to have 12-month data for all patients, with about 30 days for analysis, leading to a view of results by the end of July and preparation of the PMA supplement submission. He said regulatory timelines drive the expectation for a potential approval timeframe in the first quarter of 2027.

Financial results: revenue growth driven by U.S. launch

Chief Financial Officer John Landry reported that fourth-quarter 2025 gross revenue was EUR 6.3 million before EUR 0.7 million of revenue deferrals, resulting in net revenue of EUR 5.6 million, compared with EUR 1.3 million in the fourth quarter of 2024. Landry said the increase was driven by the U.S. commercial launch, which contributed approximately EUR 3.5 million of net revenue in Q4 2025.

Gross margin was 64% in the fourth quarter, Landry said. Total operating loss for Q4 2025 was EUR 18.6 million, compared with EUR 18.3 million in Q4 2024, which Landry said remained relatively stable year over year “despite significant commercial investments” for the U.S. launch.

For the full year, Landry reported gross revenue of EUR 11 million before EUR 1 million of revenue deferrals, resulting in net revenue of EUR 10 million, up from EUR 4.5 million in 2024, representing 122% year-over-year growth. Full-year gross margin was 63%. Total operating loss for 2025 was EUR 83.5 million, compared with EUR 58.8 million in 2024, reflecting what Landry described as accelerated U.S. commercialization activities.

Nyxoah ended 2025 with EUR 48 million in cash, cash equivalents, and financial assets. In Q&A, Landry said Nyxoah was burning approximately EUR 20 million per quarter in the near term and stated that capital raised in the fourth quarter via a PIPE and convertible debt provided additional runway “into the first quarter of 2027,” with burn expected to decline as U.S. revenue traction improves.

2026 priorities: salesforce expansion, revenue growth outlook, and margin initiatives

Landry said Nyxoah expects U.S. net revenue in both the first and second quarters of 2026 to grow 25% sequentially, attributing the outlook to continued surgeon training, additional VAC approvals, and growing surgeon adoption. International revenue, he said, is expected to follow typical seasonal patterns.

Taelman said Nyxoah increased its sales force by 15 representatives and three sales directors in the first quarter of 2026, bringing the U.S. team to 40 sales reps covering 200 of the top 400 accounts. He said surgeon training demand remains strong, with trainings occurring “almost every weekend” and waiting lists for training.

On profitability drivers, Landry said gross margin should increase slightly through 2026 due to higher volume and overhead absorption, with a larger step-up expected in early 2027 with the launch of the next-generation disposable patch activation chip (Genio 2.2), which he said could improve patient experience and “significantly reduce” disposable patch costs. Landry also said Nyxoah does not provide specific OpEx guidance, but expects R&D-related expenses to decline sequentially over 2026 as certain pre-commercial investments fall off, while SG&A run rates increase in the second half of the year due to the expanded U.S. sales organization.

Taelman added that the company is expanding its internal manufacturing footprint to strengthen its competitive position and improve gross margins.

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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