Beyond Air, Inc. Q4 FY2026 earnings call

Strategic Focus and Core Priorities

• Under new CEO Robert Goodman, the company has narrowed its strategic focus to prioritize the LungFit PH platform, with nearly all capital and operational resources allocated to this core business, and a disciplined approach to non-core programs.
• Management believes the upcoming second-generation OneFit Gen 2 system, if approved, will be a transformative inflection point for the company, expanding access and driving significant revenue growth.

Commercial Progress

• Revenue grew more than 107% year-over-year in the current smaller addressable market, supported by a 90% customer renewal rate that reflects high product and service satisfaction among existing customers.
• Beyond Air secured a national purchasing agreement with one of the top three U.S. group purchasing organizations (GPOs) for inhaled nitric oxide therapy, joining existing agreements with Premier and Vizion. This expands the company's access to a substantial portion of the U.S. hospital market, building a foundation for future adoption growth.
• The company now holds regulatory clearance for LungFit PH in over 45 countries, building out a global distribution network for long-term international growth, even as commercialization remains in early stages.

Regulatory and Product Development

• The PMA supplement for the Gen 2 OneFit system was submitted to the FDA in June 2025, and the review process is proceeding at the expected pace, with management on track for potential approval in the second half of calendar 2026.
• The Gen 2 platform addresses key limitations of the first-generation product: it adds approved labeling for ground and air transport outside the hospital (not included in the current label), features a smaller footprint, reduced weight, simplified operation, and four-times longer service intervals between maintenance.
• If approved, Gen 2 is expected to expand the U.S. total addressable market approximately fourfold to $400 million, and grow the global addressable market to over $1 billion.

Corporate Update

• The company is transitioning its fiscal year end from March 31 to December 31 to align with calendar year reporting.
• The NASDAQ Hearings Panel granted Beyond Air's request to continue listing on the NASDAQ exchange, subject to regaining compliance with the minimum bid price requirement by July 31, 2026. A 1-for-20 reverse stock split has been approved to meet this requirement.

Beyond Air operates a single core product segment focused on its LungFit PH inhaled nitric oxide therapy platform. For the full fiscal year 2026, total segment revenue grew 107% year-over-year to $7.7 million, up from $3.7 million in fiscal 2025. Gross profit improved by $2 million to a positive $300,000, a swing from a $1.7 million gross loss in the prior year, demonstrating early operating leverage as revenue scales. R&D expenses for the segment decreased 39% year-over-year to $10.2 million (from $16.9 million in FY2025), and SG&A expenses decreased 27% to $19.1 million (from $26 million in FY2025). There are no separate reportable product segments.

This is the first time Beyond Air has provided calendar year guidance following its fiscal year end transition:

• Calendar year 2026 revenue guidance is set at $8 million, representing approximately 15% growth over calendar 2025. No revenue from the Gen 2 launch is included in this guidance, as the launch is expected to occur late in the year.
• Calendar year 2027 revenue guidance is $16 million to $18 million, representing over 110% year-over-year growth at the midpoint of the range. This guidance assumes FDA approval and commercial launch of the Gen 2 system during 2027, in line with current planning assumptions. Approximately half or more of 2027 U.S. revenue is expected to come from Gen 2 sales.

• Final FDA approval timing and outcome for the Gen 2 OneFit system is subject to FDA discretion, and actual approval may differ from the company's current expected timeline.
• Beyond Air is not yet compliant with NASDAQ's minimum bid price requirement, and must regain compliance by July 31, 2026 to maintain its listing, even with the approved reverse split.
• The company reported a net loss of $33.2 million in fiscal 2026, and has $17.3 million in cash/equivalents and $21.6 million in long-term debt as of March 31, 2026, requiring continued capital access to fund operations and the Gen 2 launch.
• All forward-looking statements, including revenue guidance and growth projections, are subject to risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings.

Q: What is the current status of FDA questions and review progress for the Gen 2 PMA supplement?

A: The review process remains fully on track. All required testing (software, ventilator, cybersecurity, altitude, etc.) requested by the FDA has been completed, and final documentation is being wrapped up shortly. The FDA has been highly communicative throughout the process, and upcoming pre-approval audits are scheduled for the next couple of months. All interactions to date align with the expected timeline for H2 2026 approval.

Q: Does the $8 million 2026 calendar year guidance include the recently reported $1.9 million quarter, and does it include any Gen 2 revenue?

A: The $8 million covers all four calendar quarters of 2026, including the $1.9 million in revenue from the January-March 2026 period. No Gen 2 revenue is included in this guidance, because launch is expected late in the year, with all Gen 2 revenue growth accounted for in the 2027 guidance.

Q: What share of 2027 U.S. revenue is expected to come from Gen 2, and how many new hospital accounts are needed to hit the 2027 guidance?

A: Gen 2 is expected to make up about half or slightly more of 2027 U.S. revenue, with existing first-generation recurring business making up the remainder. Because Gen 2 targets larger hospitals and has a higher average deal size than the current generation product, the company only needs to add 50% to 70% more total accounts to double U.S. revenue, rather than doubling the number of accounts.

Q: How critical are the new GPO agreements to hitting the 2027 guidance, and what key differences does Gen 2 have compared to the first-generation LungFit PH?

A: GPO agreements are very critical, as the three major U.S. GPOs cover approximately 7,000 hospitals, including large integrated delivery networks. The latest GPO, signed in April 2026, already has ongoing hospital evaluations underway. Key Gen 2 differences include FDA-approved transport capability (opening the 4x larger TAM), four-times longer maintenance intervals that lower customer and COGS burdens, a smaller lighter form factor, and simpler operation, while retaining the same core unlimited nitric oxide delivery and fast start-stop benefits of the first-generation product.