Beyond Air Reports 107% Revenue Growth, Awaits FDA Decision on Second-Generation LungFit PH System
核心洞察
Beyond Air reported fiscal year 2026 revenue of $7.7 million, a 107% increase year-over-year driven by growing demand for its LungFit PH (搜索) inhaled nitric oxide system.
The company's second-generation LungFit PH (搜索) system is under FDA review with a PMA supplement seeking expanded labeling for use during patient transport by air and ground.
If approved, the expanded label could increase the U.S. addressable market approximately fourfold to $400 million and surpass $1 billion worldwide.
Beyond Air, Inc. (搜索) (NASDAQ: XAIR) announced financial results for its fiscal fourth quarter and full year ended March 31, 2026, reporting a 107% year-over-year revenue increase to $7.7 million, as the commercial-stage medical device and biopharmaceutical company advances its second-generation LungFit PH (搜索) system through FDA review.
"We are encouraged by the market interest in the second-generation LungFit PH (搜索) system, which is currently under FDA review," said Robert Goodman, Chief Executive Officer of Beyond Air. "Subject to FDA approval, the system is designed to provide a smaller footprint, reduced weight, simplified operation, longer service intervals and expanded operational flexibility."
Regulatory Milestone and Market Expansion Potential
The PMA supplement for the second-generation LungFit PH (搜索) was submitted to the U.S. FDA (搜索) in June 2025 and seeks expanded labeling that would permit use during patient transport by air and ground. If approved, Beyond Air estimates the total addressable U.S. market for the LungFit platform could increase by approximately fourfold to roughly $400 million, with the worldwide market opportunity exceeding $1 billion.
The current first-generation LungFit PH (搜索) system is already FDA-approved and CE Marked for the treatment of term and near-term neonates with hypoxic respiratory failure (搜索). The device is a cylinder-free, phasic flow nitric oxide generator that produces NO from ambient air on demand, eliminating the need for large, high-pressure NO cylinders in the hospital setting.
Commercial Momentum
Beyond Air reported strong customer retention exceeding 90% alongside new hospital customer wins during fiscal 2026. The company secured a national group purchasing agreement for inhaled nitric oxide therapy with a leading U.S. group purchasing organization, marking the third major GPO engagement and significantly broadening access to healthcare providers.
The global distribution network for LungFit PH (搜索) expanded throughout fiscal 2026 and now covers more than 45 countries, positioning the company for continued international commercial expansion pending applicable regulatory approvals.
Financial Performance
For the fiscal year ended March 31, 2026, revenue reached $7.7 million, compared with $3.7 million in the prior fiscal year. Gross profit improved to $0.3 million from a gross loss of $1.7 million in fiscal 2025, attributed primarily to sales growth.
Research and development expenses decreased 39% to $10.2 million from $16.9 million, driven by reduced employee expenses following prior restructuring activities and lower development costs associated with the Gen 2 device and PMA supplement. Selling, general and administrative expenses declined 27% to $19.1 million from $26.0 million.
Net loss attributable to common stockholders narrowed to $33.2 million, or $4.01 per share, compared with $46.6 million, or $13.77 per share, in the prior fiscal year. Net cash burn, excluding financing inflows, was $19.1 million for the fiscal year.
As of March 31, 2026, the company reported cash, cash equivalents, restricted cash, and marketable securities of $17.3 million, with total long-term debt outstanding of $21.6 million and $18.2 million remaining under its equity line of credit.
Leadership and Governance Updates
Robert Goodman was appointed Chief Executive Officer in March 2026, bringing what the company describes as a distinguished track record of leadership across the life sciences industry. Dan Moorhead joined as Chief Financial Officer in January 2026 with more than 20 years of finance leadership experience. Bob Carey assumed the role of Chairman of the Board, reflecting a continued focus on strengthening governance.
Nasdaq Compliance and Corporate Actions
Nasdaq granted the company's request to continue listing, subject to regaining compliance with the Bid Price Rule by July 31, 2026. Following stockholder approval at a June 18 special meeting, the Board approved a 1-for-20 reverse stock split, expected to enable the company to regain compliance ahead of the deadline. The company is also transitioning its fiscal year-end from March 31 to December 31.
Financial Guidance
Beyond Air issued revenue guidance of $8 million for calendar year 2026, representing approximately 15% growth compared with calendar year 2025. For calendar year 2027, the company projects revenue of $16–$18 million, representing more than 110% year-over-year growth at the midpoint, including the anticipated commercial launch of the second-generation LungFit PH (搜索) system.
"Fiscal 2026 was a year of meaningful transition for Beyond Air, marked by significant progress in strengthening the foundation of our LungFit PH (搜索) commercial program," Goodman said. "Our fiscal 2026 performance, including the 107% revenue growth, strong customer retention of over 90% and new hospital customer wins, reflect that focus and positions us for what we believe could be an important inflection point for the business."