Oct 8, 2026, 8:40 AM ETHealthcare
Beyond Air — Q3 2026 Earnings Summary
Financial Performance
- Preliminary, unaudited revenue for the quarter ended September 30, 2026, was approximately $2.3 million.
- Revenue represents a 30% sequential increase compared to the quarter ended June 30, 2026.
- Revenue represents a 27% year-over-year increase compared to the same quarter in the prior year.
- The $2.3 million figure is the highest quarterly revenue reported to date.
- Actual results remain subject to financial closing procedures and independent audit review.
Guidance and Future Outlook
- Reaffirmed revenue guidance of $8 million for calendar year 2026, excluding revenue from the second-generation LungFit PH system.
- Reaffirmed revenue guidance of $16 million to $18 million for calendar year 2027, which includes anticipated revenue from the second-generation system pending FDA approval.
- Full financial results for the quarter ended September 30, 2026, are scheduled for reporting in November 2026.
- Management expects demand for the LungFit PH platform to increase significantly following FDA approval of the second-generation system.
Business Segments and Product Lines
- Performance reflects continued adoption of the first-generation LungFit PH system.
- The second-generation LungFit PH system remains under FDA review via a PMA supplement process.
- The first-generation system has been refined through enhancements for ease of use and reliability.
- The second-generation system is expected to add transport capability, qualifying Beyond Air as a single-source nitric oxide provider, a standard across most U.S. hospital systems.
- LungFit PH is a cylinder-free, phasic flow generator approved for the treatment of term and near-term neonates with hypoxic respiratory failure.
- The system can generate NO from ambient air at concentrations ranging from 1 ppm to 80 ppm and potentially above 80 ppm for severe acute or chronic lung infections.
Market and Competitive Landscape
- The cylinder-free technology offers advantages over large, high-pressure NO cylinders, including reduced inventory and storage requirements and improved safety by eliminating NO2 purging steps.
- Beyond Air intends to offer NO treatment in the home setting by eliminating cylinders.
- The company aims to become the single-source nitric oxide provider for U.S. hospital systems.
Risks and Challenges
- Final revenue for the quarter may differ materially from the preliminary $2.3 million figure due to financial closing procedures or adjustments.
- Achieving revenue guidance depends on assumptions regarding demand, hospital adoption, and pricing that may not be realized.
- FDA approval of the PMA supplement for the second-generation LungFit PH system is not guaranteed and may not occur in a timely manner.
- Risks include market acceptance of products, competition in the nitric oxide market, and the ability to obtain necessary financing to fund operations and satisfy debt obligations.
- There is a risk regarding the ability to maintain the listing of common stock on The Nasdaq Stock Market.
Management Commentary and Tone
- CEO Robert Goodman stated that strong revenue growth reflects continued adoption of LungFit PH and the value hospitals see in cylinder-free nitric oxide technology.
- Management expressed pleasure with the progress of the ongoing PMA supplement process.
- The first-generation system is described as having a strong track record and being a trusted system among hospital customers.
Other Key Points
- Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on nitric oxide for respiratory illnesses, neurological disorders, and solid tumors.
- The company holds FDA approval and CE Mark for the first-generation LungFit PH system.
- The press release includes a standard "Forward-Looking Statements" disclaimer regarding risks and uncertainties.
- Investor Relations contact is Corey Davis, Ph.D., of LifeSci Advisors, LLC.