Are things picking up on the contracting side, and do you expect hospitals to be more willing to spend remaining budgets heading into year-end?

Yes, contracting activity has significantly picked up, with the commercial pipeline doubling over the last five to six months. This indicates increased interest and potential for new opportunities. “Yes, we've noticed a lot of pickup with contracting. Actually, our commercial functions really picked up a lot of that pace with a number of different new opportunities in front of us. Pipelines actually doubled over the last five or six months.”

Can you provide an update on the PMA supplement application for the Gen 2 LungFit PH system, specifically regarding interactions with the FDA and any remaining submissions?

The company has had significant activity and progress with the FDA, submitting paperwork for review. They are finishing engineering and pilot builds for validation. The process is moving towards a desk audit, and communication with the FDA team has been very positive and responsive. “So yes, we've had a lot of activity and a lot of progress with the PMA supplement. So we've begun to submit paperwork to the FDA. They're already reviewing the paperwork, as Dan touched on.”

Given that we are already in the midst of Q3, should we expect the potential FDA decision for Gen 2 LungFit PH to likely be in Q4?

While the company avoids pinpointing an exact date due to the nature of medical device approvals (no PDUFA date), they reaffirm the H2 2026 timeline. Given the current timing, a Q4 2026 decision is more likely, but still within the stated second half of the calendar year. “Yes, you know, I mean, what we're trying not to do is pinpoint an exact date, and only Yale. The only reason for that, as you know, is it's not like with pharmaceuticals where you have a PDUFA date. Right. it's a medical device, we have to give a range. And yes, to your point, yes, we're now a month into Q3, so likely that would be a Q4 period.”

XAIR

Beyond Air (XAIR) Q1 FY27 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q1 FY27)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

Beyond Air Q1 FY27 — Strengthening Foundation for Gen 2 LungFit PH Launch

Beyond Air is positioning for its next growth phase, strengthening its financial foundation and expanding commercial reach ahead of the anticipated FDA approval and launch of its second-generation LungFit PH system. While Q1 FY27 revenue remained flat, the company reported improved gross margins and significant progress in market access and pipeline development, reaffirming its full-year revenue guidance.

Highlights

Strengthened balance sheet with up to $30 million financing, including $10 million in upfront gross proceeds.
Regained compliance with NASDAQ's listing requirements.
Gross margin improved to 13% for Q1 FY27, up from 9% in the prior year, marking the third consecutive quarter of positive gross profit.
Entered into a national group purchasing agreement with a third major U.S. GPO, expanding market access.
Commercial pipeline doubled over the last five to six months.

Concerns

Revenue for Q1 FY27 was $1.8 million, effectively flat compared to the prior quarter.
Net loss attributable to common stockholders was $7.9 million, or $11 per basic and diluted share, compared to $7.7 million or $30.67 per share in the prior year.

Guidance & targets

Category	Target	Timeline	Confidence
Calendar Year 2026 Revenue	$8 million high materiality	CY2026 · FY26	High
Calendar Year 2027 Revenue	$16 million to $18 million high materiality	CY2027 · FY27	High
Gen 2 LungFit PH FDA Approval	Second half of calendar year 2026 high materiality	H2 CY2026 · FY26	Medium

Deals & partnerships

Leading U.S. GPO National group purchasing agreement

This is the third major national GPO to partner with Beyond Air, alongside existing agreements with Premier and Vizion, expanding commercial reach for LungFit PH.

Multiple international partners Global distribution network expansion

Beyond Air is expanding its international distribution network through new and existing commercial partnerships, supported by its strengthened financial position.

Risks & headwinds

FDA approval timing and outcome for Gen 2 LungFit PH Second half of calendar year 2026

Timing and outcome of the review remain subject to the FDA approval process.

Mitigation:Ongoing positive interactions with the FDA, submission of required paperwork, and preparation for commercial launch.

What to watch in Q2 FY27

Gen 2 LungFit PH FDA Approval

Q4 CY2026

Current Under review, on track for H2 CY2026

Target Approval decision

Why it matters

FDA approval is the most important near-term catalyst for the company, enabling the commercial launch of the second-generation system and driving significant future revenue growth.

We continue to believe this to be the most important near-term catalyst for the company. We submitted our PMA supplement to the FDA in June of 2025, and based off of our interactions with the FDA to date, we continue to believe we are on track for a potential approval in the second half of this calendar year, although the timing and outcome of the review remain subject to the FDA approval process.

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Q&A highlights

Can you provide more detail on how the recent financing capital will be used, specifically for the Gen 2 LungFit PH launch and commercial rollout, and where the biggest investments will be?

The capital will primarily be used for operations, including building pilot devices for the Gen 2 system and scaling up device production upon FDA clearance for commercial launch in 2027 and beyond. It will also absorb some of the company's cash burn during this period.

“It really is a lot for operations. So what we have going right now is we have the pilots, which are being built on the Gen 2 device, in the near term and then upon FDA clearance, we'd be building a lot more devices and gaining commercial steam for 2027 and beyond.”

asked by Jillian Weiss · answered by Daniel Moorhead

2 min read 6 chapters

Detailed narrative

Financial Strengthening and NASDAQ Compliance

Beyond Air has significantly strengthened its financial position through a recent financing of up to $30 million, securing $10 million in upfront gross proceeds. This capital infusion has also enabled the company to regain compliance with NASDAQ's listing requirements, providing greater financial flexibility for future operations and strategic initiatives, particularly the planned commercial launch of the second-generation LungFit PH system.

Commercial Expansion and Market Access

The company continues to expand its commercial footprint by deepening relationships with hospitals and health systems. During the quarter, Beyond Air secured a national group purchasing agreement with a third major U.S. GPO, complementing existing agreements with Premier and Vizion. These partnerships collectively provide access to a substantial portion of U.S. hospitals, forming a critical component of the commercial strategy for LungFit PH.

International Distribution Network Growth

Beyond Air is actively expanding its global distribution network, with partnerships already in place covering over 40 countries. The strengthened financial position from the recent equity raise is expected to better support these international partners in bringing LungFit PH to market in various regions. This international expansion is identified as a key growth center for the company.

Second-Generation LungFit PH FDA Review Progress

The second-generation LungFit PH system remains under review by the FDA, with the PMA supplement submitted in June 2025. Management reports positive and frequent interactions with the FDA, indicating that the review process is on track for a potential approval in the second half of calendar year 2026. The company is actively preparing for a commercial launch pending this critical regulatory milestone.

Disciplined Capital Allocation and Operational Focus

Beyond Air maintains a disciplined approach to capital allocation, primarily dedicating resources to the LungFit PH program. The recent financing is earmarked to support operations, including the building of pilot devices for the Gen 2 system and covering cash burn during the pre-launch phase. This strategic investment aims to ensure a robust commercial rollout post-FDA clearance.

Confidence in H2 2026 Revenue Growth

Despite flat revenue in Q1 FY27, management expressed strong confidence in achieving its reaffirmed $8 million revenue guidance for calendar year 2026, implying significant growth in the second half. This confidence is attributed to a doubled commercial pipeline, recent wins in the current quarter, and immediate revenue recognition from international tenders, which are expected to contribute meaningfully to H2 numbers.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.