Beyond Air, Inc. Q4 FY2025 earnings call

• Revenue grew 220% to $3.7 million for FY 2025 compared to $1.2 million the prior year, all from U.S. sales with hospitals driving growth.
• Commercial team secured new hospital contracts and renewals in FY 2025; 3 new hospital starts and 3 renewals in Q4 2025.
• Partnered with Vanderbilt University Medical Center as the first luminary site for LungFit PH to optimize products and showcase technology.
• Submitted a PMA supplement for LungFit PH2, a smaller, lighter system designed for air/ground transport with enhanced features.
• Beyond Cancer received Israel regulatory approval for phase 1b trial of UNO with anti-PD-1 therapy.
• Neuronass' lead therapy BA-102 granted orphan drug designation by FDA, and completed $2M equity financing for preclinical development.
• Appointed Bob Goodman to board of directors; progress on LungFitGo program for lung infection therapy.

For the fiscal year ended 03/31/2025, Beyond Air reported a 220% increase in revenue to $3.7 million compared to $1.2 million in the prior year. All growth came from U.S. sales, with the majority from hospitals signed in the back half of the year. The revenue contribution from LungFit PH was the primary driver of this growth.

• Projected revenue of at least $1.7 million for Q2 2025 ending 06/30/2025, representing >45% sequential and >145% YOY growth.
• Full fiscal year 2026 revenue guidance: $12 million to $16 million.
• Cost reduction efforts led to operating expenses reduced from over $17M to ~$7M over 6 quarters, with further cash burn reduction expected as R&D on next-gen device wraps up.

• Uncertainty in FDA approval timeline for LungFit PH2 PMA supplement; FDA timelines for PMAs are variable and depend on interactions with the agency.
• Geopolitical impacts on costs: low single-digit percentage impact on COGS due to tariffs on some imported parts.
• FDA's ability to set timelines for PMA supplements, as clock stops during discussions with FDA, affecting approval timing.

Q: About LungFit 2.0, is its approval assumed in FY 2026 guidance and selling dynamics?

A: FY 2026 guidance does not include LungFit PH2. Promotion of Gen 2 awaits FDA approval; some hospitals inquire about Gen 2 but focus is on Gen 1 now.

Q: Timeline for LungFit PH2 PMA approval and launch dynamics?

A: Can't give exact timing; will interact with FDA in coming months, prep for launch involves inventory build-up and manufacturing scale-up post-approval.

Q: Impact of geopolitical issues on operations?

A: Tariffs on imported parts have low single-digit percentage impact on COGS; Israel and Ukraine sales are small but provide upside; manufacturing is mostly U.S.-based.

Q: Confidence in FY 2026 guidance?

A: Confident due to ongoing international expansion, flexible contract models like purchase of system plus consumables, and increasing hospital volume usage.

Q: Difference in sales process for LungFit 2.0 vs 1.0?

A: Not marketing Gen 2 yet; Gen 2 expands the market by making nitric oxide delivery easier for ambulances, helicopters, etc., reaching more hospitals.