Aug 13, 2026 earnings call — Gen II LungFit PH approval and commercial launch prep
Reaffirmed calendar 2026 revenue guidance of $8 million and advanced Gen II LungFit PH toward potential FDA approval, with quarterly revenue of $1.8 million.
Revenue $0.0B (est $0.0B) · EPS $-11.00 (est $-10.80)
Key quotes
"As it relates to the Gen II LungFit system in the U.S., which remains under review at the FDA, we continue to believe this to be the most important near-term catalyst for the company."
"We strengthened our balance sheet through an up to $30 million financing, regained compliance with Nasdaq's listing requirements, and continue to expand the commercial foundation supporting LungFit PH."
"During the quarter, we entered into a national group purchasing agreement with a leading U.S. GPO, becoming the third major national GPO to partner with Beyond Air."
Analyst Q&A 2
Use of financing and hospital contracting
Q (Jillian Weiss · Rodman & Renshaw): They asked what the new financing will be used for and where the biggest investment will be over the next quarters. They also asked whether contracting is picking up and if hospitals might spend remaining budgets toward year-end.
A: Management said the financing is mostly for operations and device work: they are building pilots on the Gen II device now and plan to build many more devices after FDA clearance to drive commercial rollout in 2027 and beyond, and the funds will also cover cash burn. They added that contracting has picked up, commercial activity accelerated, and pipelines doubled over the last five or six months, though sales cycles remain long.
"So it's really an operations function, but a lot of it is on the device." — Daniel Moorhead (CFO)
PMA supplement status and revenue outlook
Q (Yale Jen · Laidlaw & Company): He asked for an update on the PMA supplement interactions with the FDA and the expected timing for a decision. He also asked how confident management is that revenue will be stronger in the second half to support the $8 million full-year outlook.
A: They said they have begun submitting paperwork to the FDA, the FDA is reviewing it, pilot and engineering builds are being finished, and the process has moved into the audit phase with good, quick communication from the FDA. They would not give an exact date but said the decision is expected in H2 and likely Q4; they reaffirmed the $8 million revenue guidance for calendar 2026, expecting about $3.7 million in H1 and around $4.3 million in H2, and said they are confident because of pipeline wins, recent quarter wins, and rising international sales.
"We've begun to submit paperwork to the FDA." — Robert Goodman (CEO)