Gold prices steady ahead of Fed decision; weekly weakness noted
On Monday, Stifel analysts adjusted their outlook on Nyxoah SA (NASDAQ:NYXH), reducing the price target from $15.00 to $14.00 while sustaining a Buy rating on the stock. The company’s shares, currently trading at $6.04, have declined over 43% in the past year. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value assessment, with analysts maintaining targets between $13.83 and $17.05. The revision follows the company’s receipt of an "approvable" letter from regulators in late March, which indicated a delay in full approval for its Genio system, a device designed to treat sleep apnea.
The analysts at Stifel have updated their financial model for Nyxoah, removing any anticipated U.S. sales contributions for the second and third quarters of 2025. This change is based on the expectation that the U.S. Food and Drug Administration’s full approval for Genio may not occur until the third quarter of 2025. Consequently, the firm’s estimates for U.S. sales in 2026 have been lowered from €27 million to €18 million, suggesting a market share of approximately 2.0%. InvestingPro data shows the company maintains a strong financial position with more cash than debt and a healthy current ratio of 4.56, though it’s currently burning through cash rapidly. Get access to 8 more exclusive InvestingPro Tips and comprehensive financial analysis through the Pro Research Report.
Despite the delay, Stifel remains optimistic about Nyxoah’s prospects. The analysts predict that the Genio system will contribute to an increase in the sleep apnea industry’s utilization growth to mid-single-digit percentages, up from zero percent this year. This growth is expected despite the revised launch schedule and lower initial sales projections. InvestingPro forecasts indicate a 3.13% revenue growth for FY2025, though the company is not expected to be profitable this year.
Stifel anticipates that Nyxoah’s product labeling will offer competitive advantages over Inspire Medical (TASE:BLWV)’s offerings, particularly due to the lack of contraindications related to sleeping position and cardiac conditions. Previous research conducted by Stifel suggests that over half of non-academic medical centers are eager to receive training on the Genio system within approximately six months of its commercial availability, indicating a potentially rapid adoption rate compared to Inspire’s initial market entry. The company currently maintains a gross profit margin of 65.67%, demonstrating strong operational efficiency despite its pre-profit stage.
In other recent news, Nyxoah has been actively engaging with the FDA regarding the approval of its Genio system, designed to treat obstructive sleep apnea. The company received an "Approvable Letter" from the FDA, indicating that while approval is near, specific conditions must be met. Stifel analysts have maintained a Buy rating on Nyxoah shares, adjusting their price target to $15, and anticipate a potential U.S. approval by the second quarter of 2025. Meanwhile, H.C. Wainwright analyst Edward White also maintained a Buy rating with a $17 target, noting that Nyxoah’s fourth-quarter sales for the Genio system were €1.3 million, excluding deferred revenues.
Oppenheimer also reaffirmed an Outperform rating with a $13 price target, emphasizing the importance of resolving the FDA’s requirements for Nyxoah’s manufacturing process. Recent quarterly revenue reports showed figures below expectations, but Nyxoah’s gross margins were better than anticipated. Stifel projects that Nyxoah could achieve $10 million in U.S. Genio sales in the second half of 2025, potentially capturing 2% of the market share. Additionally, Nyxoah has launched the Genio system in the UK and announced its introduction to the Middle Eastern market, highlighting its international expansion efforts. The company’s management continues discussions with the FDA to resolve outstanding issues surrounding the PMA application for the Genio system.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.