8-K: Beyond Air Reports 34% Revenue Increase in Fiscal Q3 2025, Receives CE Mark for LungFit PH

Beyond Air announces a 34% revenue increase compared to the previous quarter and the receipt of CE Mark for LungFit PH in Europe.

Summary

• Beyond Air reported its fiscal third quarter 2025 financial results, showing a 34% increase in revenue compared to the previous quarter, reaching $1.1 million.
• The company received CE Mark for LungFit PH in Europe and market authorization in Australia, with international shipments expected to begin later in 2025.
• A $1 million milestone payment from Getz Healthcare, Beyond Air's Asia-Pacific partner, was triggered by the CE Mark certification and is payable in the fiscal fourth quarter of 2025.
• The company's cash burn for the quarter was $7.6 million, excluding financing and debt extinguishment impacts.
• As of December 31, 2024, Beyond Air had $10.9 million in cash, cash equivalents, and marketable securities, with $11.8 million in total debt outstanding.
• The company anticipates double-digit sequential quarterly revenue growth for the foreseeable future.
• Topline data from the Phase 1b trial (combination therapy) are anticipated late in calendar 2025 or early-2026.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to revenue growth, CE Mark approval, and expansion into new markets. However, concerns remain regarding profitability and cash burn.

Positives

• The company experienced a 34% increase in revenue compared to the previous quarter.
• CE Mark for LungFit PH was received, allowing marketing in the European Union and other countries recognizing the certification.
• Market authorization was received in Australia, expanding the commercial reach.
• A $1 million milestone payment from Getz Healthcare was triggered.
• Partnerships with two distributors in the Middle East were signed, with initial shipments expected in the first half of calendar year 2025.
• NeuroNOS appointed Professor Roger D. Kornberg to its Scientific Advisory Board (SAB).

Negatives

• Cost of revenue exceeded revenue, primarily driven by depreciation of LungFit devices and one-time upgrade costs to systems.
• The company reported a net loss of $13.333 million for the quarter ended December 31, 2024.
• Cash burn in the fiscal quarter ended December 31, 2024, excluding the impacts of financing and the extinguishment of debt, was $7.6 million.

Risks

• The company's future performance is subject to risks related to raising additional capital, regulatory approvals, competition, and dependence on collaborators.
• The company's cash, cash equivalents, and marketable securities, along with its cash conservation strategy and anticipated revenue growth are expected to provide sufficient cash runway to support current operating plans well into calendar 2026.

Future Outlook

The company expects to continue generating double-digit sequential quarterly revenue growth for the foreseeable future and anticipates a faster commercial ramp-up in Europe and other regions compared to the U.S.

Management Comments

• 'We expect to continue generating double digit sequential quarterly revenue growth for the foreseeable future,' said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
• Mr. Lisi concluded that they anticipate a faster commercial ramp-up in these regions compared to what they experienced in the U.S., with the advantage of real-world customer experience and feedback from their U.S. program, combined with their distribution partners established sales teams and customer networks.

Industry Context

The announcement highlights Beyond Air's progress in the medical device and biopharmaceutical industry, particularly in the nitric oxide therapy space. The CE Mark for LungFit PH positions the company to compete in the European market, while partnerships in the Middle East and Asia-Pacific region further expand its global reach.

Comparison to Industry Standards

• The company's revenue growth of 34% quarter-over-quarter is a positive sign, but the cost of revenue exceeding revenue raises concerns about profitability.
• Compared to companies like Mallinckrodt, which also offers nitric oxide therapy (INOmax), Beyond Air's LungFit PH offers a cylinder-free alternative, potentially providing a competitive advantage.
• The company's focus on expanding into new markets through partnerships is a common strategy in the medical device industry, similar to companies like Medtronic and Stryker.

Stakeholder Impact

• Shareholders may be positively impacted by the revenue growth and expansion into new markets.
• Employees may benefit from the company's growth and expansion.
• Patients may benefit from the availability of LungFit PH in new markets.
• The company's suppliers may see increased demand for their products and services.

Next Steps

• Commence international shipments of LungFit PH later in 2025.
• Continue the cardiac surgery PMA supplement review at the FDA.
• Submit the LungFit PH transport-ready PMA supplement to the FDA.
• Advance clinical trials for the treatment of severe lung infections and solid tumors.
• Continue development of treatments for autism spectrum disorder (ASD) and other neurological disorders.

Key Dates