Nyxoah’s Earnings Call Contradictions: Sequential Revenue Forecasts and PMA Timeline Shifts Raise Questions

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Date of Call: Aug 5, 2026

Financials Results

• Revenue: €7.7M, up 21% sequentially over Q1 2026, and up from €1.3M in Q2 2025; H1 2026 revenue €14M vs €2.4M in H1 2025
• Gross Margin: 60%, compared to 57% in Q1 2026

Guidance:

• Full-year 2026 worldwide net revenue expected in the range of €36M to €40M.
• Full-year gross margin expected in the range of 60% to 62%.
• Full-year total operating expenses expected in the range of €99M to €102M.
• Full-year total non-GAAP cash operating expenses expected in the range of €88M to €90M.
• Long-term gross margins targeted above 80%.
• Revenue break-even targeted below €150M in revenue.

Business Commentary:

Revenue Growth and Commercial Execution:

• NEXA reported worldwide net revenue of €7.7 million in Q2 2026, representing 21% sequential growth compared to Q1 2026 and a significant increase from €1.3 million in Q2 2025.
• U.S. net revenue was €5.2 million, up 22% sequentially, while international revenue grew 19% over the previous quarter.
• The revenue growth was driven by strong commercial execution, particularly in the U.S. launch, which delivered a second consecutive quarter of more than 20% sequential U.S. revenue growth.

Commercialization and Market Expansion:

• The company trained 55 new surgeons and activated 89 new accounts, doubling the active account base to 180 high-volume AG&S accounts in the U.S.
• NEXA's U.S. commercialization efforts resulted in a 77% increase in patients under prior authorization, reaching 427 patients entering Q3.
• Growth was supported by a focused strategy on the top 400 high-volume AG&S accounts, representing approximately 70% of U.S. AG&S volume.

Reimbursement and Financial Strengthening:

• CMS proposed a 12% increase in OPPS facility payment and a 15% increase in ASC reimbursement for the Genio procedure in 2027.
• NEXA strengthened its balance sheet by securing $110 million in financing, removing financial overhang and providing resources for commercialization.
• The financial support and favorable reimbursement trends are expected to enhance the economic value of the Genio procedure and support further market penetration.

International Revenue and Market Positioning:

• International revenue grew 19% quarter-over-quarter, and for the first half of 2026, it was almost six-fold compared to the same period in 2025.
• In Germany, NEXA achieved a stable market share of up to 25% overall, with shares in top accounts exceeding 50%.
• The growth strategy in international markets focuses on financial discipline, with a goal of breaking even in the international business, which has been achieved in Germany.

Sentiment Analysis:

Overall Tone: Positive

• CEO stated 'Q2 was a strong quarter for Nixola across multiple fronts' and 'I'm pleased with the progress we are making in the business.' U.S. revenue grew 22% sequentially, and the company secured €110M in financing, 'taking away the financial overhang.' Management expressed comfort with full-year revenue guidance and noted strong market share gains and adoption momentum.

Q&A:

• Question from Kyle Winborn (Piper Sandler): Could you provide additional color on the quarterly cadence for the revenue guidance and your confidence level in achieving it?
  Response: Management is comfortable with the full-year guidance of €36M to €40M, expects U.S. revenue to grow sequentially each quarter in H2, and international revenue to be consistent with H1.

• Question from Kyle Winborn (Piper Sandler): Can you provide an update on the Access study timeline and data, including the PMA supplement and label expansion?
  Response: The company is finalizing 12-month data and preparing for PMA supplement submission, targeting submission end of Q3/latest Q4 2026, with FDA review expected to conclude by Q1/Q2 2027, and is on plan.

• Question from Suraj Kalia (Oppenheimer): What is the cadence and conversion rate of prior authorizations to actual implants, and how should we model this going forward?
  Response: With 427 prior authorizations entering Q3 (up 77% from Q2), management expects the majority to result in implants in the next quarter.

• Question from Suraj Kalia (Oppenheimer): What is the utilization and market share dynamics within the active accounts?
  Response: The company maintains an average market share of 15% in accounts where it is present, with newer accounts showing strong growth and the top account exceeding 44% market share.

• Question from Suraj Kalia (Oppenheimer): Did the company not submit for a dedicated CPT code for Genio at the September CPT Editorial Panel meeting?
  Response: Confirmed they did not submit for a dedicated code, supporting the AAO-HNS-led discussion on comprehensive AGNS coding instead.

• Question from David Prescott (Baird): What is the expected trajectory for new high-volume account additions and utilization/penetration in H2 and into 2027?
  Response: The company plans to expand coverage to 225-230 high-volume accounts in H2 2026, with continued hiring to reach the target of 400 accounts, and expects strong market share growth as accounts mature.

• Question from David Prescott (Baird): What drives the expected gross margin improvement in H2 and the higher non-GAAP OPEX, and what is the confidence level?
  Response: Gross margin will improve from component changes (e.g., removal of ES cost) and yield gains. OPEX will see a sequential step-up in Q3 but a larger increase in Q4 due to full-quarter impact of sales force expansion, with confidence supported by ongoing cost projects.

• Question from John Pluck (Stifel): What is the reimbursement strategy and outlook given the competitor's submission for a dedicated CPT code?
  Response: The company supports the AAO-HNS comprehensive coding approach, sees no risk due to existing C-code, and believes the environment is stable and supportive for Genio reimbursement.

• Question from John Pluck (Stifel): How is the hiring and training for the additional 15 sales reps progressing?
  Response: The company expects all 15 reps onboarded by end of Q3 2026, with training beginning in Q4 to ensure they are productive by January 1, 2027.

Contradiction Point 1

Full-Year Revenue Guidance and Quarterly Phasing

It involves differing expectations regarding the sequential growth rate of U.S. revenue in Q4, impacting the quarterly financial outlook.

Kyle Winborn (Piper Sandler) asks about the key factors driving the company's recent financial performance? - Kyle Winborn (Piper Sandler)

2026Q2: It expects U.S. revenue to grow sequentially from Q2 to Q3 and again from Q3 to Q4 - Olivier Talman(CEO)

Can you provide details on the revenue outlook for the remaining quarters and your confidence level in meeting full-year revenue guidance? - Adam Maeder (Piper Sandler)

2026Q1: Expects U.S. revenue growth to accelerate sequentially: ... Q4 (low 50%+) - John Landry(CFO)

Contradiction Point 2

Prior Authorization Conversion Timeline

Contradiction on the expected timeline from prior authorization to implant, affecting the predictability of revenue recognition.

Suraj Kalia (Oppenheimer) - Suraj Kalia (Oppenheimer)

2026Q2: The majority of these [427 authorizations] will result in implants in the next quarter - Olivier Talman(CEO)

What is the typical timeline from prior authorization to implantation? - Jonathan Block (Stifel)

2026Q1: The time from authorization to implant varies between 1 to 3 months, depending on surgeon and hospital scheduling. - Olivier Taelman(CEO)

Contradiction Point 3

Gross Margin Trajectory

Contradiction on the expected gross margin progression through the year, impacting financial performance expectations.

What were the key factors driving your performance in the quarter? - David Prescott (Baird)

2026Q2: Gross margin improvement in H2 will come from ongoing projects... and increased yield from production. - John Landry(CFO)

What are the key factors and your confidence level in achieving the gross margin and non-GAAP OPEX guidance for the second half? - Jonathan Block (Stifel)

2026Q1: Margin is expected to increase beginning in Q2, reaching the 63%-64% range in H2 2026. - John Landry(CFO)

Contradiction Point 4

Access Study Data Submission & FDA Review Timeline

Timeline for PMA supplement submission and expected FDA decision date shifted forward, affecting product label expansion and market strategy.

Kyle Winborn (Piper Sandler) - Kyle Winborn (Piper Sandler)

2026Q2: PMA supplement submission is on plan for end of Q3/beginning of Q4. The FDA review period is 180 days, with a positive outcome expected by end of Q1 or beginning of Q2 2027. - Olivier Talman(CEO)

What is the current status of the Access study's progress toward initial data at the ISSS meeting and the PMA supplement submission for Q4 label expansion in early 2027? - Adam Meader (Piper Sandler)

2025Q4: The data will be available by end of June 2026. Analysis will take up to 30 days, with the PMA supplement submission expected to be completed by Q1 2027 for potential approval. - Olivier Talman(CEO)

Contradiction Point 5

Strategy & Outlook for Dedicated CPT Code

Shift from pursuing a separate dedicated CPT code to supporting a comprehensive coding initiative, reflecting a change in market strategy.

"Suraj Kalia (Oppenheimer)" - Suraj Kalia (Oppenheimer)

2026Q2: Confirmed that NEXA did not submit Genio for a dedicated Category 1 CPT code at the September meeting. The company continues to support the AAO-HNS-led discussion on comprehensive AG&S coding... - Olivier Talman(CEO)

Did NEXA not submit Genio for a dedicated Category 1 CPT code at the September CPT Editorial Panel meeting? - John Block (Stifel)

2025Q4: The company is following the same pathway as competitors to obtain a dedicated CPT code, likely effective around 2028. - Olivier Talman(CEO)

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