FDA Approval Will Unlock New Sleep Market Opportunities

Key Takeaways

• Imminent U.S. approval and unique technology position Nyxoah for strong adoption and rapid revenue growth in a large, underserved market.
  
• Robust reimbursement channels, global expansion, and ongoing product innovation set the stage for sustained earnings growth and improved operating leverage.
  
• Persistently high spending, international market softness, regulatory reliance, execution risks, and uncertain reimbursement threaten Nyxoah's revenue growth, profitability, and capital needs.

Catalysts

A medical technology company, develops and commercializes solutions to treat obstructive sleep apnea (OSA).

• Imminent FDA approval of Genio in the U.S. is set to unlock a large new addressable market, benefiting from rising OSA prevalence due to aging and obesity trends, directly supporting top-line revenue expansion.
  
• Patient and physician demand for minimally invasive, alternative therapies to CPAP is high, and Genio's unique technology (no battery, single incision, supine and positional OSA data) differentiates Nyxoah in a rapidly growing market, possibly driving higher adoption rates and accelerating revenue growth.
  
• Expansion of established reimbursement pathways, including a well-recognized CPT code already accepted by both government and commercial payers, is likely to support swift commercialization and quicker realization of revenues and margin improvement in the U.S. post-launch.
  
• Ongoing clinical studies and product upgrades (e.g., Genio 2.1/2.2, ACCCESS study for label expansion) demonstrate long-term investment in product innovation, paving the way for broader indications, label enhancements, and future earnings growth.
  
• Entry into new and underserved geographies (such as the Middle East) alongside the U.S. rollout aligns with the global trend for better sleep disorder treatments, setting up a multi-year period of double-digit revenue growth and eventual operating leverage.

Nyxoah Future Earnings and Revenue Growth

Assumptions

• Analysts are assuming Nyxoah's revenue will grow by 195.2% annually over the next 3 years.
• Analysts are not forecasting that Nyxoah will become profitable in next 3 years. To represent the Analyst Price Target as a Future PE Valuation we will estimate Nyxoah's profit margin will increase from -1597.5% to the average BE Medical Equipment industry of 4.0% in 3 years.
• If Nyxoah's profit margin were to converge on the industry average, you could expect earnings to reach €4.5 million (and earnings per share of €0.1) by about August 2028, up from €-69.7 million today.
• In order for the above numbers to justify the analysts price target, the company would need to trade at a PE ratio of 155.4x on those 2028 earnings, up from -3.0x today. This future PE is greater than the current PE for the BE Medical Equipment industry at 36.4x.
• Analysts expect the number of shares outstanding to grow by 7.0% per year for the next 3 years.
• To value all of this in today's terms, we will use a discount rate of 7.0%, as per the Simply Wall St company report.

Nyxoah Future Earnings Per Share Growth

Risks

• Nyxoah is experiencing persistent operating losses with a total operating loss of €20.6 million in Q1 2025 (versus €12.2 million in Q1 2024) and its cash position declining from €85.6 million at year-end 2024 to €63 million at March 31, 2025, raising the risk that continued high R&D and commercialization spending-especially with SG&A expected to more than double in 2025-could outpace near-term revenue growth and threaten net margins, cash burn, or necessitate dilutive capital raises.
  
• Temporary softness in the international HGNS (Hypoglossal Nerve Stimulation) market-with both Nyxoah and its competitor posting year-over-year declines-hints at possible broader industry headwinds or market saturation outside the U.S., which could constrain revenue growth if these trends persist.
  
• Nyxoah's dependence on successful U.S. FDA approval and subsequent commercial rollout is a major risk; any regulatory delays, unexpected negative findings during ongoing inspections, or failure to secure anticipated labeling (especially for indications like CCC) could significantly delay or reduce U.S. market revenue, impacting top-line growth and earnings prospects.
  
• Although Genio's product upgrades are intended to drive differentiation, the need to manage software rollouts to avoid delays in implants (as seen in Europe) highlights potential execution risk-future software transitions or product updates could disrupt sales cycles or cause revenue volatility unless carefully managed.
  
• Despite plans to leverage existing CPT codes for reimbursement, there is an underlying risk that actual payer uptake, coverage decisions, and potential pricing pressures-especially in a cost-constrained U.S. healthcare system-could delay or limit broad market penetration, impacting both revenue ramp and longer-term net margin expansion.

Valuation

• The analysts have a consensus price target of €12.8 for Nyxoah based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of €18.6, and the most bearish reporting a price target of just €7.0.
  
• In order for you to agree with the analyst's consensus, you'd need to believe that by 2028, revenues will be €112.2 million, earnings will come to €4.5 million, and it would be trading on a PE ratio of 155.4x, assuming you use a discount rate of 7.0%.
  
• Given the current share price of €5.63, the analyst price target of €12.8 is 56.0% higher.
  
• We always encourage you to reach your own conclusions though. So sense check these analyst numbers against your own assumptions and expectations based on your understanding of the business and what you believe is probable.