Beyond Air(XAIR) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $1.1 million, compared to $0.4 million a year ago, indicating significant growth [24] - Gross profit loss was $0.2 million for Q3 2025, an improvement from a loss of $0.4 million in the same period last year [24] - Net loss attributed to common stockholders was $13 million, or a loss of $0.15 per share, compared to a net loss of $16.2 million, or a loss of $0.50 per share, in Q3 2024 [27] - Net cash burn for the quarter was $7.6 million, over 30% lower than the previous quarter [28] - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of $10.9 million [29] Business Line Data and Key Metrics Changes - The commercial team signed six new hospital contracts and renewed two contracts during the quarter [8] - Positive feedback from existing customers on the LungFit PH device is driving new engagements [10] - The company is enhancing its marketing efforts and customer engagement processes [10] Market Data and Key Metrics Changes - The LungFit PH received CE Mark approval, allowing marketing in the EU and other countries, which triggered a $1 million milestone payment from Getz Healthcare [14] - Getz Healthcare is ahead of schedule in securing market authorization in Australia [15] - The company is seeing high distributor interest in various global markets, including the Middle East [15] Company Strategy and Development Direction - The company aims to strengthen its commercial infrastructure and customer engagement to drive revenue growth [9] - Plans to submit a PMA supplement for the next-generation LungFit PH system are underway, with expectations for significant market share growth [12][17] - The company is focusing on expanding its presence in international markets, anticipating that ex-U.S. markets will become larger than the U.S. market in the long term [77] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing momentum in revenue growth and customer engagement [9] - The company is preparing for potential challenges with the FDA regarding the PMA submission process [41][72] - Management believes that the updated LungFit PH is poised to capture significant market share in both the U.S. and global markets [16][78] Other Important Information - Research and development expenses decreased to $3 million from $6.8 million year-over-year, primarily due to reduced salaries and stock-based compensation [25] - SG&A expenses also decreased to $7.7 million from $9.8 million year-over-year [26] - The company is committed to improving profitability while enhancing patient care through nitric oxide therapies [23] Q&A Session Summary Question: Impact of CE Mark on revenues - Management indicated that the CE Mark will have a small impact in the March quarter, with more significant effects expected in subsequent quarters [34] Question: Changes in commercial organization - Management highlighted a cultural shift and improved customer service as key drivers of recent progress [46][48] Question: PMA submission timeline - Management noted uncertainty regarding the timeline for FDA review due to potential staffing changes at the agency [41] Question: Annualized contract revenue update - Management refrained from providing specific updates on annualized contract revenue but indicated positive growth trends [55] Question: Importance of U.S. vs. ex-U.S. markets - Management expects ex-U.S. markets to become larger than the U.S. market in the long term, driven by the unique advantages of the LungFit PH system [77] Question: Hospital contract turnaround times - Management confirmed that most contracts lead to customer engagement within 30 to 45 days, with some exceptions [85][89] Question: Long-term debt status - Management clarified that the company has $11.5 million in long-term debt, with payments starting in October 2026 [92] Question: Next-gen device PMA submission - Management indicated that the next-gen device PMA submission would likely cover both NICU and cardiac indications [95]