Nyxoah SA (NYXH) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges

GuruFocus News

Thu, May 15, 2025, 1:09 AM 4 min read

Nyxoah SA (NASDAQ:NYXH) received an approvable letter from the FDA for its Genio system, indicating substantial compliance with US marketing requirements.
The company successfully completed the validation of a specific manufacturing process required by the FDA, with no further questions from the agency.
Nyxoah SA (NASDAQ:NYXH) has built a strong US commercial team in preparation for the anticipated FDA approval and market launch.
The company has identified and established a CPT code for reimbursement, which is recognized by both commercial and government payers.
Nyxoah SA (NASDAQ:NYXH) is the first AGNS company to implant in the Middle East, marking a significant milestone in expanding its market presence.

Negative Points

Nyxoah SA (NASDAQ:NYXH) reported a slight year-over-year revenue decrease in Q1 2025, attributed to temporary softness in the international AGNS market.
The company experienced an increase in total operating loss, driven by investments in the US commercial organization ahead of FDA approval.
Nyxoah SA (NASDAQ:NYXH) saw a decrease in its cash position from 85.6 million at the end of 2024 to 63 million as of March 31, 2025.
There are concerns about potential delays in implants due to the rollout of the Genio 2.1 software upgrade, which led to deferred purchases.
The FDA approval process for the Genio system still requires a final on-site inspection, which introduces uncertainty in the timeline for market entry.

Q & A Highlights

Warning! GuruFocus has detected 4 Warning Signs with NYXH.

Q: Olivier, can you talk about what needs to get done at this US inspection versus the initial one that took place earlier in the FDA process? A: Yes, Jon. We were informed by the FDA to validate a specific manufacturing process at our US contract manufacturers. This involves administrative tasks and protocol validation, which have been submitted and accepted by the FDA. The ongoing site inspection is a standard practice to confirm this validation.

Q: As we think about the market launch and commercialization, can you discuss the company's strategy for outreach to ENT and sleep doctors? A: Our strategy involves targeting high-volume hypoglossal nerve stimulation centers and developing networks with sleep physicians managing moderate to severe OSA patients. We emphasize our clinical data showing effectiveness in sleep position and positional OSA, which we expect to be reflected in our FDA labeling.

Q: Is there any statutory response time from the FDA associated with the approval process, and what informs your confidence in receiving US approval by Q2? A: The final steps include completing the ongoing site inspection and submitting a report to the FDA PMA review committee. We remain confident in obtaining FDA approval by the end of Q2, based on the progress and steps completed so far.

Q: Can you provide an update on the Dream Journal publication timing? A: We have submitted the publication to a leading industry journal and are currently in the second level of review. We expect the publication to be out before summer starts.

Q: How do you plan to manage OpEx spending as you prepare for the US launch? A: We have deferred some commercial-related investments until FDA approval is received. We expect R&D spending to be in line with 2024 levels, while SG&A expenses will be more than double compared to 2024, with heavier spending in the first half of the year.

Q: How is the commercial launch of Genio in Dubai progressing, and how are you allocating resources in the Middle East? A: We are the first AGNS company to implant in the Middle East, starting with Dubai. We are expanding to other regions like Kuwait and Saudi Arabia, with training and education in place for further implants in Q2 and Q3.

Q: Regarding the CCC discussion, will the initial FDA approval include the CCC contraindication? A: We do not expect CCC to be on label due to the lack of CCC patients in the Dream study. However, we also do not expect it to be a contraindication. It will likely be an off-label indication, leaving the decision to the physician.

Q: Can you elaborate on the temporary softness in the AGNS market and your expectations going forward? A: We observed a single-digit decline in the international market, similar to our competitors, due to seasonality. We expect this softness to be temporary and anticipate recovery over the course of the year.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

Terms and Privacy Policy

Your Privacy Choices

Utah Privacy Notice

More Info