Nyxoah(NYXH) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company recorded revenue of €1.1 million in Q1 2025, a decrease from €1.2 million in Q1 2024, primarily due to temporary softness in the international HD and S market [16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization [17] - Cash position was €63 million as of March 31, 2025, down from €85.6 million at the end of 2024 [17] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade commercially via a phased approach, which led to certain Genio sites deferring their purchases until the upgrade was available [16] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch of the GENEOS system, with a focus on high-volume hypoglossal nerve stimulation implanting centers [11] - Market research indicates significant demand from patients and physicians for alternatives to current therapies, particularly in the OSA treatment landscape [11][12] Company Strategy and Development Direction - The company aims to penetrate the U.S. market as a smart follower, targeting high-volume centers and developing strong networks with sleep physicians [11][12] - The strategy includes a focus on clinical evidence and patient outcomes, differentiating itself from competitors through unique technology benefits [18] - The company plans to scale up its U.S. commercial team each quarter post-FDA approval [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving PMA approval in Q2 2025, following successful validation of a specific manufacturing process and ongoing site inspection by the FDA [9][20] - The company believes it is positioned for significant growth once FDA approval is obtained, with a strong commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for OSA indications, which is recognized by commercial and government payers [14][77] - The company is actively working with the American Academy of Otolaryngology to educate payers on the GENEOS system's clinical impact [13] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which has been completed and accepted [22][26] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][36] Question: What is the strategy for outreach to ENT and sleep doctors? - The company plans to differentiate its approach based on clinical data and patient-centric focus, targeting both ENT and sleep physicians [27][29] Question: Is there a statutory response time from the FDA? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [35][36] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [39] Question: What is the pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, with expectations for R&D and SG&A spending to increase [41][43] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted the GENEOS system in Dubai and is expanding into other Middle Eastern markets [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline for completion by summer [50] Question: Will there be a reimbursement team to streamline coverage? - The company has a dedicated market access team to assist with the reimbursement process as they enter new accounts in the U.S. [76] Question: Will CCC be a contraindication in the initial FDA approval? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [81] Question: How will the company promote the DICE procedure? - The company will not promote off-label uses and will rely on traditional methods to exclude CCC patients [84]