Nyxoah SA Q1 FY2026 earnings call

U.S. Commercial Launch Progress

• 2026 marks the second full quarter of U.S. commercialization, meeting the management commitment to deliver 25% sequential U.S. revenue growth year-over-year, with consistent momentum across all key performance indicators.
• Expanded U.S. commercial field capacity by adding 15 fully trained new sales reps in Q1, bringing the total to 40 operational reps and enabling coverage of 200 high-volume hypoglossal neurostimulation (AGNS) accounts entering Q2 2026, out of 400 total high-volume target accounts.
• As of quarter-end: 207 total trained Genio system surgeons (62 new in Q1), 91 total active accounts (34 new in Q1, active = surgeon trained + VAC committee approved) out of 125 initial targeted accounts, 241 pending prior authorization patient submissions, and an average estimated 12%-14% market share in already active accounts 6 months post-launch.
• A recent market research study of 100 U.S. AGNS implanters confirmed 88% of ENTs see value in multiple AGNS options for patients, 100% of Genio-trained surgeons plan to adopt the system, and top adoption drivers are bilateral stimulation, no implanted battery, and the alternative option it provides.

Reimbursement Update

• Commercial Payers (90% of Q1 cases): Coverage is broad and stable, with Genio claims processed under existing CPT codes; 100% of reviewed prior authorization submissions have been approved to date.
• Medicare (10% of Q1 cases): CMS issued clear coding guidance in February 2026, assigning Genio the facility C-code C9790, which provides price parity with competing AGNS devices at the facility level; the WISER Medicare prior authorization program also holds a 100% approval rate for submitted Genio cases.
• Long-term coding outlook: The CPT editorial panel has confirmed no AGNS technology will be left without appropriate coding for 2028, with two possible pathways (dedicated CPT codes for each AGNS technology or a single comprehensive AGNS coding set); management is prepared for either outcome and will align with leading specialty society guidance.

International Operations

• International revenue avoided the typical Q4 to Q1 seasonal decline, with growth driven by deeper penetration in existing German accounts, continued adoption in the Middle East, and successful new market entry in the UK and Netherlands. Management maintains a disciplined financial approach focused on reaching breakeven, demonstrated by Germany's performance 3 years post-launch.

Nyxoah operates two primary geographic segments: the U.S. and International. For Q1 2026, worldwide gross revenue was €6.7 million, with €300 thousand in deferrals leading to net revenue of €6.4 million, a 13% sequential increase from Q4 2025. The U.S. segment generated net revenue of €4.3 million, representing 67.2% of total worldwide net revenue, and delivered 25% sequential growth from Q4 2025. The International segment generated the remaining €2.1 million of net revenue (32.8% of total net revenue), with revenue flat sequentially relative to Q4 2025, a strong performance that avoided the typical Q1 seasonal decline. Overall gross margin for Q1 2026 was 57%, down from 62% in Q4 2025 due to temporary production yield issues. Q1 2026 operating expenses totaled €24.2 million, up from €21.4 million in Q4 2025, driven by increased U.S. commercial investment. Non-GAAP cash operating expenses were €21.7 million in Q1 2026, up from €19.5 million in Q4 2025, also reflecting higher U.S. commercial spending.

• Full year 2026 worldwide net revenue guidance is set to a range of €36 million to €40 million.
• Full year 2026 U.S. net revenue is expected to grow 25% to 30% sequentially in Q2 2026, with growth accelerating to the low 40% to 45% range in Q3 and mid-50% range in Q4 2026 (driven by seasonal strength and expanding coverage/adoption).
• Full year 2026 gross margin guidance is 60% to 62%, with gross margin expected to return to the 63% to 64% range in the back half of 2026 after temporary Q1 production issues and a small residual Q2 impact.
• Full year 2026 total operating expenses are expected to range from €97 million to €99 million, with total non-GAAP cash operating expected to range from €88 million to €90 million, representing a 5% to 8% sequential increase over 2025 non-GAAP cash operating expenses.
• Long-term, management expects gross margins to exceed 80% and achieve revenue breakeven at below €150 million in total revenue.

• VAC approval timelines for new active accounts are outside of management's control, and can range from 1-2 weeks to multiple months, potentially slowing adoption and revenue ramp.
• Surgical scheduling constraints at high-volume target sites and with high-volume surgeons can delay implantation of approved pending patients, slowing near-term revenue growth even with strong prior authorization approval rates.
• Uncertainty around long-term CPT coding for AGNS procedures, which will not be finalized for 2028 until regulatory and industry processes are completed, though management has confirmed no technology will be left without appropriate coding.
• Sustained gross margin improvement is dependent on hitting volume-based pricing milestones with contract manufacturers and the successful launch of the Genio 2.2 platform in early 2027, which could be delayed or underdeliver on expected cost savings.

Q: Analyst Adam Maeder (Piper Sandler) asks why full-year 2026 revenue guidance is above Street consensus, what drives the expected back-half revenue acceleration, and whether reimbursement remains a headwind. / A: Management explains that the addition of 15 new sales reps expands coverage to 200 high-volume accounts, and existing trained surgeons are moving past their learning curve and scaling procedure volumes after positive early patient outcomes. There are already 91 active accounts out of the initial 125 targets, with 241 pending prior authorization patients driving future growth. Reimbursement is now fully de-risked and clear for 2026 from both CMS and commercial payers, so it is no longer a headwind. Sequential U.S. growth is expected to accelerate from 25-30% in Q2 to low 40s% in Q3 and mid-50s% in Q4, aligned with the guidance range.

Q: Maeder follows up on long-term CPT coding strategy, noting the competitor's dedicated CPT code application on the recent CPT panel agenda, and asks for clarity on Genio's timeline and pathway. / A: Management confirms 2026 and 2027 reimbursement are fully de-risked: 2026 has clear CMS C-codes and commercial payer coverage, and 2027 will see no change to the Medicare framework, with commercial codes likely migrating to a single existing AGNS CPT code that will cover Genio. For 2028, two pathways are under discussion (dedicated codes for all AGNS technologies or a comprehensive AGNS coding set). Nyxoah is prepared to submit a dedicated code if that pathway moves forward, but will align its strategy with leading specialty societies like AAO-HNS, and the CPT panel has confirmed no AGNS technology will be orphaned without coding.

Q: Analyst Jonathan Block (Stifel) asks why gross margins have not improved with revenue scale, when they were 62% at lower revenue levels, and asks for clarification on cash burn and breakeven. / A: Management explains Q1 2026 gross margin was depressed by temporary production yield issues from staff turnover and training, which have now been fully resolved. The Genio 2.2 platform, launching in early 2027 with a lower-cost disposable patch and activation chip, will deliver a step function improvement to gross margins pushing them above 70%, with additional volume-based pricing improvements from contract manufacturers expected to push long-term gross margins over 80%. Management is tightly controlling cash operating expenses, reallocating R&D and G&A capital to U.S. commercial growth rather than making large incremental increases, and expects to hit breakeven at €150 million in revenue with a total cash need of €100 million to reach that point.

Q: Analyst Suraj Kalia (Oppenheimer) asks about the device selection dynamic between Genio and competitor Inspire in active sites, and how Genio gains procedure volume. / A: Management reports that the majority of patients currently arrive at sites seeking an AGNS solution, not specifically Genio, as DTC marketing spend remains very limited. Conversion to Genio happens in-clinic when patients are presented with available options, and a high share of patients spontaneously choose Genio driven by its key differentiators: no implanted battery, bilateral stimulation, and capability for software upgrades, which was confirmed in recent market research. Nyxoah's strategy of co-training surgeons and their sleep medicine partner physicians, and engaging sleep doctors in patient selection and post-operative management, is driving referrals and adoption, and this approach will continue.