FDA And Payer Challenges Will Constrain Rollout Yet Hint Potential

Key Takeaways

• Long-term growth relies on US adoption, yet clinician hesitancy, payers' pricing pressures, and larger competitors' innovation could hinder revenue and margin expansion.
  
• High initial investments and exposure to operational, supply chain, and regulatory risks may prolong operating losses and challenge Nyxoah's path to sustained profitability.
  
• Heavy upfront investment, regulatory hurdles, reimbursement uncertainty, and competitive or market volatility threaten Nyxoah's ramp-up pace, margin sustainability, and revenue visibility.

Catalysts

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

• Although Nyxoah is poised to benefit from the increasing prevalence and diagnosis of obstructive sleep apnea, the final FDA approval and commercial success in the US remain contingent on establishing broad physician and patient adoption, which could be hampered if competing therapies improve or if clinicians remain hesitant to switch from established treatments, potentially suppressing long-term revenue growth.
  
• While aging demographics and greater awareness of sleep apnea are expanding the addressable market, growing scrutiny and cost sensitivity from both public and private payers could result in downward pricing pressure or more restrictive reimbursement, thereby limiting the company's ability to achieve anticipated margin expansion in the US and internationally.
  
• Despite progressing with a next-generation product pipeline and securing strong clinical data-particularly with unique features like bilateral stimulation and positional OSA outcomes-Nyxoah faces the ongoing risk of new, less-invasive or technologically advanced alternatives being introduced by larger competitors, which could erode the company's future revenue streams.
  
• Although the commercial team is fully built and well-planned for US market entry, Nyxoah's high upfront investments in sales, marketing, and reimbursement support, coupled with slower-than-expected normalization of European and international demand due to temporary market softness or delayed product upgrades, may extend the company's operating losses and delay the path to consistent earnings.
  
• While Nyxoah's focus on minimally invasive, patient-friendly devices aligns with broad industry trends, the company's reliance on contract manufacturing and complex regulatory pathways leaves it exposed to potential supply chain disruptions, increased compliance requirements or regulatory hurdles, all of which could drive up operating expenses and compress future earnings.

Nyxoah Future Earnings and Revenue Growth

Assumptions

• This narrative explores a more pessimistic perspective on Nyxoah compared to the consensus, based on a Fair Value that aligns with the bearish cohort of analysts.
• The bearish analysts are assuming Nyxoah's revenue will grow by 179.2% annually over the next 3 years.
• The bearish 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 €3.8 million (and earnings per share of €0.09) by about August 2028, up from €-69.7 million today. The analysts are largely in agreement about this estimate.
• In order for the above numbers to justify the price target of the more bearish analyst cohort, the company would need to trade at a PE ratio of 100.4x 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 36.5x.
• 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 6.99%, as per the Simply Wall St company report.

Nyxoah Future Earnings Per Share Growth

Risks

• Nyxoah continues to operate at a significant operating loss, which has widened from 12.2 million euros in Q1 2024 to 20.6 million euros in Q1 2025, largely driven by upfront investments in the U.S. commercial launch-if top-line revenue does not ramp up rapidly post-approval, sustained losses could pressure earnings and cash flow.
  
• The company's ability to secure broad insurance reimbursement in the critical U.S. market remains contingent on successful navigation of payer processes and continued clinical evidence generation; any delays or setbacks in reimbursement or if coverage is more restrictive than anticipated may suppress long-term revenue growth and net margins.
  
• Nyxoah's commercial rollout is being staged with a modest salesforce and targeted DTC initiatives rather than broad campaigns-if awareness and physician adoption ramp slower than expected, or if competitors maintain stronger patient or provider loyalty, sales growth could materially lag projections, impacting overall revenue.
  
• The company relies on a key contract manufacturing site in the U.S., currently under FDA inspection for PMA approval; any future regulatory, supply chain, or process validation challenges could disrupt product availability and delay expansion, thereby threatening both revenue momentum and profitability.
  
• Market softness in the international HGNS segment and company admissions about deferred purchases around software upgrades highlight susceptibility to cyclical and launch-related demand swings; if these types of volatility persist long term, Nyxoah's revenue trajectory and ability to maintain or expand net margins may be at risk.

Valuation

• The assumed bearish price target for Nyxoah is €7.0, which represents the lowest price target estimate amongst analysts. This valuation is based on what can be assumed as the expectations of Nyxoah's future earnings growth, profit margins and other risk factors from analysts on the more bearish end of the spectrum.
  
• 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 bearish analysts, you'd need to believe that by 2028, revenues will be €95.0 million, earnings will come to €3.8 million, and it would be trading on a PE ratio of 100.4x, assuming you use a discount rate of 7.0%.
  
• Given the current share price of €5.67, the bearish analyst price target of €7.0 is 19.0% 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.