Nyxoah’s Earnings Call Shows Rapid Growth, Rising Risks

Nyxoah Sa ((BE:NYXH)) has held its Q4 earnings call. Read on for the main highlights of the call.

Nyxoah’s latest earnings call struck a cautiously optimistic tone, as management balanced strong early U.S. launch momentum and robust growth metrics against sizable operating losses and a fast cash burn. Investors heard a story of differentiated technology and accelerating adoption, but also one that depends heavily on flawless U.S. execution and timely reimbursement progress.

FDA Approval Unlocks Full U.S. Commercial Launch

Genio secured U.S. FDA approval on August 8, 2025, enabling Nyxoah to run its first full commercial quarter in the U.S. during Q4. Management highlighted that the company entered this phase with an established stateside commercial team and structured launch plan, positioning Genio as a new player in hypoglossal nerve stimulation.

Explosive Revenue Growth From a Small Base

Full‑year 2025 net revenue more than doubled to EUR 10.0 million from EUR 4.5 million in 2024, a 122% year‑over‑year jump. Q4 2025 underscored the inflection, with net revenue of EUR 5.6 million versus EUR 1.3 million a year earlier, translating to roughly 331% growth and signaling rapid early adoption.

U.S. Launch Quickly Becomes the Growth Engine

U.S. commercialization emerged as the main growth driver in Q4, contributing about EUR 3.5 million of net revenue in the quarter. Management commentary referenced roughly $4.5 million in U.S. sales, underlining that the new market is already accounting for a substantial share of group revenue.

Healthy Gross Margins With Room to Improve

Nyxoah reported a 64% gross margin in Q4 2025 and 63% for the full year, levels more typical of a mature medtech business than an early launch. Management expects modest margin improvement in 2026 and a step‑change toward about 70% after Genio 2.2 and cheaper disposable patches roll out in 2027.

Commercial Traction Evident in Training and Access

By December 31, 2025, Nyxoah had trained 145 surgeons across 125 targeted high‑volume accounts, illustrating a broadening clinical footprint. The company had also submitted 120 value analysis committee requests and secured 57 approvals with no rejections, suggesting hospitals are receptive to adopting Genio.

Reimbursement Wins Bring Parity With Competitors

Genio achieved reimbursement consistency across commercial insurers, which account for about 90% of business, and Medicare, which makes up roughly 10%. CMS introduced interim C‑codes in February 2026 and set a hospital outpatient facility fee of $31,526, effectively bringing facility reimbursement in line with a key competitor.

Sales Force Expansion Deepens U.S. Account Coverage

Nyxoah expanded its U.S. sales force from 25 representatives at launch to 40, adding 15 reps and three sales directors in Q1 2026. This build‑out broadened coverage from around 125 to about 200 of the top 400 hypoglossal nerve stimulation accounts, accelerating surgeon outreach and account activation.

International and Operational Base Strengthen Fundamentals

International markets, especially Germany, continued to contribute revenue and Germany reached profitability, providing a stabilizing base outside the U.S. Management is also scaling manufacturing capacity to support higher volumes and unlock further gross margin improvements as Genio adoption grows.

Near‑Term Growth Outlook Signals Continued Momentum

Management guided for U.S. net revenue to increase about 25% sequentially in both Q1 and Q2 2026, driven by more trained surgeons, additional VAC approvals and growing usage in activated centers. This trajectory, if achieved, would maintain the company’s strong growth profile into the mid‑2026 timeframe.

Operating Loss Widens on Heavy U.S. Investment

The cost of scaling in the U.S. is high, with full‑year 2025 operating loss rising to EUR 83.5 million from EUR 58.8 million in 2024, a roughly 42% increase. Management framed this as deliberate spending on commercial infrastructure and market access, but it leaves the company firmly in loss‑making territory for now.

Cash Burn and Runway Raise Financing Questions

Nyxoah ended 2025 with EUR 48 million in cash, cash equivalents and financial assets, while signaling near‑term cash burn of about EUR 20 million per quarter. On that pace, the firm has a runway only into early 2027, making sustained revenue ramp or supplemental funding a critical variable for shareholders.

Coding and Physician Fees Remain a Moving Target

While the facility fee is now well defined, physician payment levels and the long‑term coding structure are still evolving. A competitor is pushing for a dedicated code effective early 2028, and management acknowledged that shifting coding practices could influence relative reimbursement and physician economics over time.

Revenue Deferrals Blur Short‑Term Top‑Line Picture

About EUR 1.0 million of revenue was deferred in 2025, including EUR 0.7 million in Q4, largely tied to disposable patches delivered over time. These deferrals mean reported net revenue trails underlying activity, adding a layer of complexity to short‑term growth comparisons and modeling.

Limited Unit Disclosure Clouds Adoption Visibility

Management chose not to disclose implant counts, instead emphasizing revenue figures and average selling price references. For investors, this limits visibility into how much product is implanted versus sitting on shelves, making it harder to judge underlying utilization trends and the depth of the installed base.

U.S. Market Becomes Central to Growth Story

The call underscored that Nyxoah’s growth case now rests heavily on the U.S. launch, with international markets acting as supportive but secondary contributors. U.S. execution, from reimbursement dynamics to salesforce productivity, will largely determine whether the company can scale fast enough to offset ongoing investment.

Account Penetration Still in Early Innings

Despite progress, activation is nascent, with only 57 VAC approvals in place out of 125 priority accounts and 400 target centers overall by year‑end. This early stage of penetration highlights both the significant remaining opportunity and the operational work still required to embed Genio broadly in high‑volume sleep centers.

Guidance Points to Sustained Growth and Margin Upside

Management expects U.S. net revenue to climb roughly 25% quarter‑over‑quarter in Q1 and Q2 2026, supported by 40 sales reps covering about 200 top accounts and 145 trained surgeons. Gross margins, already in the low‑60s, are projected to improve through 2026 and approach around 70% after Genio 2.2 and lower‑cost patches roll out in early 2027, while clinical milestones are aimed at enabling a U.S. label expansion around that time.

Nyxoah’s earnings call painted a picture of a company transitioning from clinical stage to commercial contender, with strong growth, attractive margins and promising reimbursement progress. Yet the story remains high risk, as widened losses, limited cash runway and execution questions put pressure on management to convert early traction into sustainable, profitable scale.