Beyond Air, Inc. Q3 FY2025 earnings call

• Sequential quarterly revenue growth driven by new hospital signings (6 new starts) and renewals (2, including a 3-year renewal).
• New Chief Commercial Officer joined 7 months ago, bringing new energy. Strong customer feedback on LungFit PH device.
• Partnerships in place: Healthcare Links and TrillaMed to supplement sales. Upgraded marketing and presence at respiratory conferences.
• PMA supplement for LungFit PH label expansion to cardiac surgery in discussion with FDA. Next-gen LungFit PH transport capable system submission to FDA imminent.
• LungFit PH received CE Mark in December, allowing marketing in EU and other countries. Getz Healthcare milestone payment of $1 million to be received in March. Getz ahead of schedule in Australia.
• Beyond Cancer Phase 1b trial for UNO in late-stage cancer with anti-PD-1 therapy anticipated to have top-line data by end of 2025. NeuroNOS appointed Professor Roger Kornberg to Scientific Advisory Board; meeting with FDA later in 2025 to plan human studies starting in 2026.

For the fiscal third quarter of 2025, revenue was $1.1 million compared to $0.4 million in the same quarter of the previous year. Gross profit was a $0.2 million loss vs. a $0.4 million loss in the prior year. Cost of revenue included $0.3 million in onetime costs to upgrade devices and $0.5 million in noncash headwinds. R&D expenses were $3 million, down from $6.8 million in the prior year. SG&A expenses were $7.7 million vs. $9.8 million previously. Other expense was $2.4 million vs. $0.3 million prior. Net loss was $13 million or $0.15 per share. Net cash burn was $7.6 million, 30% lower than the prior quarter. Cash, cash equivalents, and marketable securities as of December 31, 2024, were $10.9 million, sufficient to support operating plans through spring 2026 if revenue estimates are met and costs controlled.

• Will provide revenue guidance for fiscal 2026 on the fiscal 2025 year-end call in June.
• Anticipate cash burn to continue lower trend but not to same magnitude as current quarter due to onetime costs for next-gen LungFit PH submission to FDA.
• Cash, cash equivalents, and marketable securities sufficient to support operating plans through spring 2026 if revenue estimates are met and costs controlled.

• Uncertainty in FDA approval timelines for PMA supplements and next-gen product submissions.
• Variability in market adoption and timing of contract start-ups in both U.S. and international markets.
• Dependence on ability to control costs and meet internal revenue estimates to sustain cash sufficiency.

Q: How should we think about timing of CE Mark impacting revenues?

A: Takes a bit, small impact in June, significant pickup in September/December and beyond. Shipping in first half of 2025.

Q: Changes to commercial organization and what's working well?

A: New Chief Commercial Officer drove cultural shift, improved customer service, better attitude, and superior customer support due to resolved issues with original product version.

Q: Timing of PMA submission for next-gen device and its impact?

A: Uncertain due to FDA flux; will know more after submission. Next-gen product is transport capable, smaller, lighter, and people are excited about it.

Q: View on U.S. vs ex-U.S. geographies for LungFit PH long term?

A: Ex-U.S. expected to be much bigger in 5 years due to ability to make product from ambient air, solving issues with cylinder-based systems in many countries; impact on fiscal '26/'27 not massive, but beyond fiscal '28, trend will shift.

Q: Hospital contracting seasonality and contract start times?

A: Little seasonality, contracts can start at any time; most hospitals start within 30-45 days of signing, though some rare cases have longer delays.

Q: Balance sheet and debt structure?

A: Debt with 8% royalty on net sales, no scheduled payments until October 2026, structure company friendly.