Executive summary highlights: Beyond Air reported a modest quarterly revenue gain in QQ3 2025, with revenue of $1.072 million, up sequentially and year over year as commercial execution accelerates. The quarter featured six new hospital starts and two contract renewals in the U.S., signaling progress in hospital adoption of LungFit PH amidst a ramp of commercial capabilities and partnerships. However, profitability remains a challenge near term, as gross profit was negative by $0.215 million and the company posted a net loss of $13.03 million for the quarter, driven by ongoing R&D and SG&A investments plus one-time costs associated with upgrading devices and preparing PMA submissions. Management outlined a constructive outlook driven by CE Mark-enabled ex-U.S. expansion, continued U.S. market share gains, and the next-generation LungFit PH system targeting FDA submission. The company asserted cash runway through spring 2026 provided internal revenue milestones hold and cost discipline is maintained.
Key catalysts include: (1) CE Mark normalization in EU and other markets with milestone payments (Getz Healthcare), (2) US PMA submission for the transport-capable LungFit PH, (3) continued commercial momentum with new hospital signings and distributor partnerships, and (4) Beyond Cancer and NeuroNOS programs that could diversify long-term growth. While management remains optimistic about multi-quarter revenue growth, the near-term path to profitability hinges on successful FDA interactions, continued revenue ramp, and expense discipline. The June guidance update for fiscal 2026 will be a critical read on the trajectory toward profitability and scale.