Nyxoah Sa ((BE:NYXH)) has held its Q2 earnings call. Read on for the main highlights of the call.
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Nyxoah’s recent earnings call for Q2 2025 was marked by a mix of optimism and caution. The company celebrated a significant milestone with the FDA approval of its Genio system, which has set a positive trajectory for its launch in the U.S. market. However, the call also highlighted challenges, including increased operating losses, a reduced cash position, and a patent lawsuit, which have tempered the overall outlook.
FDA PMA Approval for Genio System
Nyxoah achieved a major breakthrough with the FDA PMA approval for its Genio system, making it the first and only bilateral hypoglossal nerve stimulation (HGNS) device approved in the U.S. for treating obstructive sleep apnea (OSA). This approval marks a pivotal moment for the company, opening up significant opportunities in the U.S. market.
Significant Revenue Growth
The company reported impressive revenue growth, with Q2 2025 revenues reaching EUR 1.3 million, a 73.8% increase from EUR 800,000 in Q2 2024. This growth underscores the positive reception and potential of the Genio system in the market.
Successful U.S. Launch Strategy
Nyxoah has initiated a focused launch strategy in the U.S., deploying over 50 commercial professionals. The company has already achieved several VAC and pre-authorization approvals in the first week, indicating a strong start in establishing its presence.
High Patient Satisfaction and Compliance
The DREAM study, published in the Journal of Clinical Sleep Medicine, highlighted high patient satisfaction and compliance rates, with scores of 90% and 85.9%, respectively. These results reinforce the efficacy and acceptance of the Genio system among patients.
Increased Operating Loss
Despite the positive developments, Nyxoah reported an increased operating loss of EUR 19.9 million for Q2 2025, compared to EUR 13.3 million in Q2 2024. This increase is attributed to the heightened commercial investments required for the U.S. launch.
Decreased Cash Position
The company’s cash position has decreased from EUR 63 million at the end of March 2025 to EUR 43 million at the end of June 2025. This reduction reflects the financial demands of scaling operations and expanding into new markets.
Patent Lawsuit from Inspire Medical
Inspire Medical has initiated a patent lawsuit against Nyxoah, presenting a legal challenge that the company plans to vigorously defend. This lawsuit adds a layer of complexity to Nyxoah’s operational landscape.
Forward-Looking Guidance
Looking ahead, Nyxoah’s leadership remains optimistic about the Genio system’s potential, supported by the FDA approval and positive study results. The company is focused on expanding its U.S. operations, with a team targeting key implanting centers and building referral networks. Despite financial challenges, Nyxoah is poised to leverage its current momentum to drive future growth.
In summary, Nyxoah’s Q2 2025 earnings call reflected a blend of promising advancements and notable challenges. While the FDA approval and revenue growth signal a positive trajectory, increased losses and legal hurdles present obstacles that the company must navigate. Investors and stakeholders will be keenly watching how Nyxoah manages these dynamics in the coming quarters.