Nyxoah Sa’s Earnings Call: Progress Amid Challenges

Nyxoah Sa ((BE:NYXH)) has held its Q1 earnings call. Read on for the main highlights of the call.

Nyxoah Sa’s recent earnings call paints a picture of cautious optimism. The company is making strides towards FDA approval and is gearing up for a U.S. market launch with innovative strategies. However, it faces challenges such as a slight decline in revenue, an increased operating loss, and a decreased cash position.

PMA Approval Progress

Nyxoah has made significant progress towards obtaining PMA approval for its Genio system. The company received an approvable letter from the FDA, indicating that the application substantially meets U.S. marketing requirements. The FDA has no further questions regarding manufacturing validation, and the final on-site inspection is anticipated to be completed soon.

U.S. Commercial Launch Preparations

In preparation for the U.S. launch of Genio, Nyxoah has assembled a commercial team of 50 members. The strategy is focused on targeting high-volume hypoglossal nerve stimulation centers and establishing networks with sleep physicians to ensure a successful market entry.

Reimbursement and Pricing Strategy

Nyxoah plans to utilize the established CPT code 64568 for reimbursement, which is recognized for OSA indications. The company expects pricing to be similar to competitors but aims to differentiate itself through the unique benefits of its technology.

Genio 2.1 Software Upgrade

The launch of the Genio 2.1 patient software upgrade marks a significant enhancement, offering increased patient autonomy and comfort. This upgrade allows for gradual stimulation increases and more personalized settings, improving the overall patient experience.

Middle East Market Entry

Nyxoah has successfully entered the Middle East market, with initial Genio implants conducted in Dubai. The company plans to expand its presence further into Kuwait and Saudi Arabia, signaling a strategic move to broaden its global footprint.

Revenue Decline

In the first quarter of 2025, Nyxoah reported a revenue of €1.1 million, a slight decrease from €1.2 million in the same period of 2024. This decline is attributed to temporary softness in the international HGNS market and deferred purchases due to the Genio 2.1 software upgrade.

Increased Operating Loss

Nyxoah’s operating loss increased to €20.6 million in Q1 2025 from €12.2 million in Q1 2024. This increase is primarily due to investments in the U.S. commercial organization in anticipation of FDA approval and the subsequent commercial launch.

Decreased Cash Position

The company’s cash position decreased to €63 million as of March 31, 2025, from €85.6 million at the end of 2024. This necessitates careful cash management and deferred spending to ensure financial stability.

Forward-Looking Guidance

Nyxoah is optimistic about obtaining full PMA approval for the Genio system by the second quarter of 2025. The company is preparing for a U.S. commercial launch with plans to scale operations each quarter following FDA approval. Financially, Nyxoah is aligning its pricing strategy with competitors while leveraging its unique technological advantages.

In summary, Nyxoah Sa’s earnings call reflects a balanced outlook with promising developments towards FDA approval and strategic market expansions. Despite facing financial challenges, the company is poised for growth with its innovative strategies and market entry plans.