On Tuesday, H.C. Wainwright maintained a positive outlook on Nyxoah SA (NASDAQ:NYXH), reiterating a Buy rating and a $18.00 price target for the company's stock. The endorsement follows Nyxoah's announcement on July 1 that it has completed the submission of the final module for its Premarket Approval (PMA) application for the Genio system to the U.S. Food and Drug Administration (FDA).
Genio, a unique hypoglossal neurostimulation device, is designed to treat moderate-to-severe Obstructive Sleep Apnea (OSA) by providing bilateral stimulation without the need for an internal battery, which also allows for full-body MRI compatibility. The system is already CE-Mark validated in Europe, indicating it meets high safety, health, and environmental protection requirements.
The company's confidence in Genio is bolstered by the positive 12-month data from its DREAM study, which was released on March 19, 2024. The study aimed to support the marketing authorization of Genio in the U.S. and showed a statistically significant reduction in both Apnea Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates among patients who had failed or refused CPAP therapy and did not have complete concentric collapse (CCC) of the soft palate.
The DREAM study reported a 63.5% AHI responder rate and a 71.3% ODI responder rate on an intent to treat (ITT (NYSE:ITT)) basis, with a median 12-month AHI reduction of 70.8%. These results are comparable to those of Inspire's STAR trial, despite Inspire not being rated by H.C. Wainwright.
H.C. Wainwright forecasts Genio sales of €7.2 million in 2024, limited to European markets. However, with potential U.S. market entry, projections for 2026 sales soar to €116.5 million. The firm's steadfast Buy rating and $18 price target reflect these optimistic sales forecasts and the potential for Genio to gain traction in the sleep apnea treatment market.
In other recent news, Nyxoah SA continues to make significant strides in the medical technology sector with its hypoglossal nerve stimulation device, Genio. The company's revenue streams have seen impressive growth, with a 225% year-over-year increase in 1Q24, primarily driven by its operations in Germany. Analysts anticipate that the company's strategic focus on the U.S. market, pending FDA approval, will further bolster its financial performance.
Analysts from firms such as Cantor Fitzgerald and Piper Sandler maintain an "Overweight" rating on Nyxoah, with price targets ranging from $17.00 to $20.00. However, H.C. Wainwright and Oppenheimer have recently adjusted their price targets for Nyxoah to $18.00 and $15.00 respectively. These adjustments come in the wake of Nyxoah's recent public offering in the United States and its first-quarter 2024 revenue report.
Moreover, Nyxoah is on the cusp of a major breakthrough with its final PMA module submission scheduled for the second quarter of 2024, which could lead to FDA approval and U.S. commercial launch between late 2024 and early 2025. The company is also expanding its salesforce and building out its reimbursement team in anticipation of U.S. market entry.
InvestingPro Insights
As Nyxoah SA (NASDAQ:NYXH) continues to make headway with its Genio system, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, Nyxoah holds more cash than debt on its balance sheet, a reassuring sign of financial stability. Additionally, analysts anticipate sales growth in the current year, aligning with H.C. Wainwright's positive sales forecast for Genio in European markets.
Despite the optimism surrounding its sales growth, Nyxoah is not expected to be profitable this year, and the stock has experienced significant price fluctuations recently. Over the last three months, the price has dropped considerably, yet there has been a large price uptick over the last six months. The company's market cap currently stands at $248.93M USD, and it's trading at a high revenue valuation multiple with a Price/Book ratio of 2.7 as of the last twelve months ending Q1 2024.
For those interested in deeper analysis, InvestingPro provides additional insights, including the fact that the stock's Relative Strength Index (RSI) suggests it is in oversold territory, which could indicate a potential rebound. For investors seeking to make informed decisions, there are 11 additional InvestingPro Tips available, offering a comprehensive view of Nyxoah's financial and market standing. To access these tips and enhance your investment strategy, visit https://www.investing.com/pro/NYXH and use the coupon code PRONEWS24 for up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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