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Beyond Air(XAIR) - 2025 Q4 - Earnings Call Transcript
2025-06-17 21:32
Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3,700,000 compared to $1,200,000 for the same period last year [5][19] - The company anticipates revenue of at least $1,700,000 for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12,000,000 and $16,000,000 [6][21] - The net loss attributed to common stockholders for the fiscal year was $46,600,000, or a loss of $0.69 per share, compared to a net loss of $60,200,000, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [8] - The company has established a solid customer base across key target regions in the US, with 45 hospitals either installed or using the LungFit system [68] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2,000,000,000 lives [11] - Initial shipments of LungFit PH to international customers have begun, with expectations for meaningful contributions to financial results starting in the latter half of fiscal 2026 [12] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market, overcoming barriers to entry and enhancing customer confidence through increased usage [7] - The introduction of LungFit PH2, a next-generation system, is expected to significantly impact market share and logistics within hospitals [10] - The company is focused on cost reduction efforts, having reduced operating expenses from over $17,000,000 to just above $7,000,000 in the current quarter, translating to a 58% reduction [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets for the upcoming quarter and fiscal year, citing strong customer interest and flexibility in contract structures [66] - The company is optimistic about the potential for international growth, although it acknowledges the longer tender processes outside the US [31][59] Other Important Information - The company received orphan drug designation from the FDA for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company announced the appointment of Bob Goodman to the board of directors, bringing extensive commercial leadership experience [16] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to US hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the US takes longer [31] Question: What is the expected timeline for FDA approval of LungFit 2.0? - Management refrained from providing a specific timeline, noting the current upheaval at the FDA [40] Question: What factors could lead to achieving the higher end of the revenue guidance range? - Management mentioned that securing large contracts and regulatory approvals could significantly impact revenue [42] Question: How is the company addressing potential geopolitical impacts on supply and sales? - Management stated that the majority of manufacturing is in the US, and geopolitical issues have minimal impact on costs [53] Question: How does LungFit 2.0 expand the market? - Management noted that the new system would allow access to every hospital wanting to use nitric oxide, significantly increasing market reach [82]
Beyond Air® Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-06-17 20:01
Revenues increased 220% to $3.7 million, compared with $1.2 million for the fiscal year ended March 31, 2024 Expect to report revenue of at least $1.7 million for quarter ending June 30, 2025, and introducing revenue guidance of $12-$16 million for the full fiscal year 2026 Submitted PMA supplement for second-generation LungFit® PH to FDA International distribution partnerships now provide access to markets representing over 2 billion lives, with LungFit® PH actively shipping to Europe, Australia, and the ...
Beyond Air Schedules Fiscal Year End 2025 Financial Results Conference Call and Webcast
Globenewswire· 2025-05-20 12:00
Core Insights - Beyond Air, Inc. is set to report its financial results for the fiscal fourth quarter and full year ending March 31, 2025, on June 17, 2025 [1] - The company specializes in medical devices and biopharmaceuticals, focusing on nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [3][4] Financial Reporting - The financial results will be discussed in a conference call and webcast scheduled for June 17, 2025, at 4:30 PM Eastern Time [1][2] - The conference call can be accessed via domestic and international phone lines, with a conference ID provided for participants [2] Company Overview - Beyond Air has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating neonates with hypoxic respiratory failure [3] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] - A partnership with The Hebrew University of Jerusalem is focused on pre-clinical programs for autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [4]