Beyond Air (NASDAQ:XAIR) reported record quarterly revenue of $2.3 million for the period ended September 30, 2026, as sales of its LungFit PH system grew and the company prepared for a potential launch of a second-generation device pending regulatory approval.
Revenue rose approximately 28% from $1.8 million a year earlier and 31% from the June quarter, Chief Financial Officer Dan Moorhead said. The company reaffirmed its calendar-year revenue guidance of $8 million for 2026 and $16 million to $18 million for 2027.
The 2026 outlook excludes revenue from the second-generation LungFit PH. The 2027 forecast includes anticipated sales of the device, subject to Food and Drug Administration approval, but assumes no second-generation revenue in the first quarter, Chief Executive Officer Robert Goodman said.
FDA Review and Launch Plans
Beyond Air’s premarket approval supplement for the second-generation LungFit PH remains under FDA review. The company expects to complete its audit readiness process in mid-December, after which the system would remain subject to FDA inspections and final approval, Goodman said. He emphasized that the timing and outcome depend on the agency.
The proposed system is smaller and lighter than the current version, with simplified operation, longer service intervals and greater operational flexibility, according to Goodman. The company is also seeking expanded FDA labeling to permit use during patient transport by air and ground.
In response to an analyst’s question about the potential timing of a decision, Goodman said the company expects the audit to follow its readiness announcement and anticipates hearing back within a few weeks after the audit. He said an early-2027 timeline was “right around where we’re pointing at,” while noting that the decision rests with the FDA.
Goodman said testing related to transport, including altitude testing, had been completed and documented as part of the supplement. He also said the company had conducted additional repeatability and stability testing during its audit preparations and had encountered no surprises.
Commercial Pipeline and Sales
Beyond Air’s first-generation LungFit PH business benefited from new hospital accounts and renewals, Goodman said. The company’s international distribution partnerships cover more than 40 countries, and international sales during the quarter were among its highest to date.
Goodman said the U.S. pipeline had more than doubled after the company cleaned up older deals and applied greater rigor to its definition of the pipeline. He attributed an improving win rate partly to the product’s ease of use, customer references and fewer competitors in the field.
The company has a couple hundred units in use across dozens of hospitals and additional sites, Goodman said. He put the average deal size at approximately $250,000 and said unit volume and international business were driving revenue growth. International direct sales generate immediately recognized revenue, while the U.S. business generally uses a subscription model, he said.
Goodman added that the second-generation device could allow Beyond Air to compete for larger deals. He described adding it to existing group purchasing organization agreements as a relatively simple update.
Quarterly Financial Results
Gross margin improved to approximately 8% from negative 16% a year earlier. Beyond Air reported gross profit of $200,000, compared with a gross loss of $300,000 in the prior-year quarter.
Research and development expenses fell to $1.6 million from $2.5 million, primarily because most second-generation LungFit PH development is complete, Moorhead said. Selling, general and administrative expenses declined to $4.6 million from $4.9 million, as lower stock-based compensation costs were partially offset by higher sales staff salaries.
Other expense increased to $2.2 million from $600,000, primarily because of higher interest expense and a charge for scrap materials. Net loss attributable to Beyond Air common stockholders was $7.8 million, or $3.76 per basic and diluted share, compared with $7.9 million, or $24.98 per share, a year earlier.
As of September 30, the company reported $18.5 million in cash equivalents, restricted cash and marketable securities. That total included $4.8 million in restricted cash, $2.7 million held by NeuroNOS and $700,000 held by Beyond Cancer, Moorhead said.
Other Development Programs
Beyond Air’s LungFit GO received FDA Breakthrough Device Designation during the quarter for the treatment of nontuberculous mycobacterial pulmonary disease. Goodman said the company does not currently plan to allocate resources to further LungFit GO development in 2027, as it prioritizes LungFit PH commercialization.
The company also entered into a definitive agreement during the quarter under which UNIVO Pharmaceutical Industries would acquire Beyond Air’s controlling interest in NeuroNOS Israel. Beyond Air is evaluating potential development partnerships and other strategic arrangements for Beyond Cancer, Goodman said.
Beyond Air is changing its fiscal year-end from March 31 to December 31, effective at the end of 2026. It expects to report results for the nine-month transition period on a Form 10-K/T, Moorhead said.
About Beyond Air (NASDAQ:XAIR)
Beyond Air, Inc. is a medical technology and biopharmaceutical company focused on developing nitric oxide (NO) therapies and delivery systems for respiratory diseases and other serious medical conditions. Its platform is designed to generate NO from ambient air at the point of care, potentially reducing reliance on traditional high-pressure gas cylinders. The company’s primary product family is LungFit, a series of compact NO delivery systems intended for use in hospital and clinical settings. LungFit PH is designed to deliver inhaled nitric oxide to term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
