Beyond Air, Inc. (XAIR): Business Model Canvas [Dec-2025 Updated]

You're looking at a company that perfectly embodies the high-risk, high-reward disruptor narrative. Honestly, the numbers for the fiscal year ended March 31, 2025, show the classic cash burn: revenue hit $3.7 million, while R&D alone was $16.9 million, and Cost of Revenue was $5.4 million. That's a lot of capital going out the door, but the proprietary technology-generating inhaled nitric oxide on-demand-is finally gaining traction in U.S. NICUs and through global partners. To see exactly how this innovative tech translates into a scalable business, check out the full Business Model Canvas breakdown below; it maps out the path from hospital sales to future home-use potential.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Key Partnerships

You're looking at how Beyond Air, Inc. (XAIR) builds out its commercial reach and R&D muscle through external relationships. Honestly, for a company in this stage, these partnerships are the engine for scaling the LungFit platform and advancing the biopharma pipeline.

The access to large U.S. hospital systems is cemented by a major contract. Beyond Air, Inc. secured a national group purchasing agreement (GPO) with Premier, Inc., effective July 15, 2025. This is big because Premier is a healthcare improvement company serving approximately two-thirds of all U.S. healthcare providers. This agreement gives Premier's network access to special pricing for the LungFit PH system and the disposable NO2 Smart Filters.

To get this done, Beyond Air, Inc. leaned on a strategic ally. The negotiation of the Premier contract was supported by HealthCare Links, a consulting group that specializes in national GPO access and alignment. This kind of specialized help is key to streamlining entry into Integrated Delivery Networks (IDNs) across the U.S.

Here's a quick look at the scope of the U.S. access point:

Internationally, the focus is on leveraging established medical device infrastructure through distribution partners. As of March 11, 2025, Beyond Air, Inc.'s international commercial footprint for LungFit PH spanned 18 countries, following recent agreements covering France, Romania, Turkey, and Morocco. While you mentioned 34 countries, the latest reported number shows strong expansion from the initial approvals in the U.S., European Union, Australia, Thailand, Saudi Arabia, Taiwan, and New Zealand.

The global distribution network, as of early 2025, looked like this:

• International commercial footprint: 18 countries (as of March 2025)
• Recent additions included: France, Romania, Turkey, and Morocco
• Regulatory approvals noted in: United States, European Union, Australia, Thailand, Saudi Arabia, Taiwan, and New Zealand

On the R&D side, the NeuroNOS program, focused on Autism Spectrum Disorder (ASD) and other neurological conditions, relies on a deep research collaboration. Beyond Air, Inc. licensed commercial rights for neuronal nitric oxide synthase (nNOS) inhibitor candidates from The Hebrew University of Jerusalem via its technology transfer company, Yissum. The plan was to initiate a first-in-human study in 2025, though other filings suggest a 2026 target for the related Phelan-McDermid Syndrome indication. This subsidiary, NeuroNOS, secured an initial $2 million in equity financing as of March 2025 to accelerate preclinical development.

The academic partner brings significant research weight to this effort. The Hebrew University of Jerusalem serves 24,000 students from 80 countries and produces about a third of Israel's civilian research.

Finally, for product optimization, Beyond Air, Inc. established a clinical collaboration with Vanderbilt University Medical Center (VUMC), naming it the Company's first luminary site on March 31, 2025. This partnership is specifically aimed at further optimizing the LungFit products and exploring new ways to enhance hospital-based nitric oxide therapy. To be fair, VUMC's status as a leading academic center, which saw a record year of heart transplants in 2024, makes it an ideal site for this kind of workflow refinement.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Key Activities

You're hiring before product-market fit is fully proven, so the Key Activities have to be laser-focused on scaling what works and de-risking the pipeline. Here's the quick math on what Beyond Air, Inc. is actively driving as of late 2025, based on their latest reported figures.

Commercialization and direct sales of LungFit PH system in the U.S.

The direct sales effort for the LungFit PH system in the U.S. is the current revenue engine. You saw a significant jump in fiscal year 2025, which management is banking on to continue accelerating.

• Fiscal Year 2025 revenue grew by 220% to $3.7 million, up from $1.2 million in Fiscal Year 2024.
• The company reported that the total number of customers increased by over 60% during the fiscal second quarter of 2025 (ended September 30, 2024).
• As of June 17, 2025, the LungFit PH system was installed and in regular use at more than 45 hospitals nationwide.
• The annualized contracted revenue stood at $3.5 million as of October 1, 2024.
• Guidance for Fiscal Year 2026 revenue is set between $12 million and $16 million.

Research and Development (R&D) for LungFit PRO/GO and the next-gen LungFit PH2.

R&D spending shows a clear trend toward cost discipline while advancing the next generation of hardware and the biopharma pipeline. The focus is on getting the next-gen device through the FDA pipeline.

For the fiscal year ended March 31, 2025, R&D expenses were $16.9 million, a decrease of $7.5 million compared to the prior fiscal year. For the most recent reported quarter (Q3 FY2026, ended September 30, 2025), R&D expenses were $4.6 million.

Manufacturing and supply chain management for the LungFit system and Smart Filters.

Supply chain management is critical, especially as the company scales from a low base. The cost structure reflects this investment in infrastructure needed to support future revenue.

For the fiscal year ended March 31, 2025, the Cost of Revenue was $5.4 million. This was driven by depreciation of LungFit devices and one-time upgrade costs. Commercial demand growth was evidenced by a more than 100% increase in filters shipped quarter over quarter leading up to June 2025.

Securing and maintaining global regulatory approvals (FDA, CE Mark, etc.).

Regulatory milestones are key value drivers, unlocking both domestic label expansion and international revenue streams. The company has successfully expanded its approved footprint.

• LungFit PH is approved for commercial use in the United States, European Union, Australia, Thailand, and New Zealand.
• The CE Mark was received approximately 15 weeks before March 11, 2025.
• International distribution agreements, as of June 2025, provide access to markets representing over 2 billion lives.
• The FDA accepted the PMA supplement for the cardiac surgery indication for filing in late-December 2024.

Advancing clinical trials for pipeline indications like severe lung infections and oncology.

Clinical trial advancement is currently focused on the biopharma pipeline through subsidiaries, with specific indications targeted for nitric oxide therapy beyond PPHN.

For the oncology indication (BA-101), a Phase 1b trial is planned to enroll up to 20 subjects to evaluate UNO + anti-PD-1 combination therapy. For the neurological indication (BA-102), the company announced plans to start first-in-human clinical trials in the United States in 2026.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Key Resources

You're looking at the core assets that make Beyond Air, Inc. (XAIR) tick as of late 2025. These aren't just ideas; they are tangible, protected, and in-use components of their strategy.

The foundation is definitely the proprietary technology enabling cylinder-free nitric oxide (NO) delivery.

• Proprietary LungFit Ionizer technology uses patented Ionizer™ technology to generate NO from ambient air.
• The system operates using the equivalent power of a 60-watt lightbulb.
• The first-generation LungFit PH system, which eliminated the need for bulky gas cylinders, received FDA approval in 2022.
• The original LungFit PH has market authorization in the United States, European Union, Australia, Thailand, and New Zealand.
• The system is designed to deliver NO doses for PPHN treatment in a range from 0.5 ppm - 80 ppm.

The installed base acts as a crucial validation layer, showing real-world utility and providing reference sites. As of the fiscal year ended March 31, 2025, the LungFit PH system was installed and in regular use at over 45 hospitals nationwide. This commercial traction supported a reported FY 2025 revenue of $3.7 million.

To give you a sense of the early commercial velocity, during the fiscal second quarter of 2025 (ended September 30, 2024), the number of hospital contracts increased by 60%, with annualized contracted revenue reaching $3.5 million as of October 1, 2024. The company is also moving forward with the second-generation device, having submitted a premarket approval (PMA) supplement for the LungFit PH II in mid-2025.

The Intellectual Property (IP) portfolio is centered around this core generation method, though a specific count of patents isn't immediately available in the latest filings. Still, the protection of the patented Ionizer™ technology is a key barrier to entry for competitors.

The pipeline assets in the subsidiaries represent future value drivers, moving Beyond Air, Inc. (XAIR) beyond just neonatal care into oncology and neurology. Here's a look at the key designations as of late 2025:

The R&D expenses for the fiscal year ended March 31, 2025, were $16.9 million, showing the investment supporting these pipeline assets. Despite this investment, the company recorded a net loss of $46.6 million for FY 2025, though this was an improvement from the $60.2 million loss in FY 2024. The cash position as of March 31, 2025, was $6.9 million.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Value Propositions

You're looking at the core reasons why hospitals choose Beyond Air, Inc. (XAIR)'s LungFit PH over the old way of doing things. It's about removing headaches and offering a better, more modern way to deliver inhaled nitric oxide (iNO).

Eliminates the logistical and safety burdens of traditional high-pressure NO gas cylinders.

The LungFit PH system is designed as a cylinder-free generator. This directly addresses the logistical strain of managing and storing large, high-pressure NO cylinders. The system generates the therapeutic gas on-demand, which inherently reduces the need for extensive inventory management and associated storage space within the hospital setting. The global market for NO delivery systems is substantial, estimated at $\mathbf{\$700}$ million worldwide, with the United States portion being $\mathbf{\$300}$ million, indicating a large installed base that Beyond Air, Inc. (XAIR) is targeting for replacement.

Generates inhaled nitric oxide (iNO) on-demand from ambient air.

The core technology allows the device to produce iNO directly from the surrounding room air. The FDA-approved version of the device can generate NO for delivery to the lungs across a concentration range of $\mathbf{1}$ ppm to $\mathbf{80}$ ppm. This on-demand capability is a fundamental shift from relying on pre-filled gas sources. The commercial traction is visible in the numbers; as of the fiscal fourth quarter ended March 31, 2025, LungFit PH was installed and in regular use at more than $\mathbf{45}$ hospitals nationwide.

Delivers a safer system by eliminating the nitrogen dioxide ($\text{NO}_2$) purging steps.

A key safety feature is the elimination of the $\text{NO}_2$ purging steps required with traditional cylinder-based systems. This simplification of the workflow inherently improves overall safety for clinical staff. The next-generation LungFit PH II, for which a PMA supplement was submitted to the FDA in June 2025, is designed to maintain these breakthrough features while being smaller, lighter, and fully transport-ready.

Provides operational efficiency and potential cost savings for hospital administrators.

Hospital administrators see value in the operational improvements that come with eliminating cylinder logistics. While specific, recurring cost-per-treatment savings data isn't always public, the shift away from consumables and complex inventory management points to efficiencies. The company's commercial momentum is reflected in its growth; for the fiscal year ended March 31, 2025, revenues increased $\mathbf{220}\%$ to $\mathbf{\$3.7}$ million compared to the prior fiscal year. The company is projecting significant future revenue, with guidance for fiscal year 2026 revenue set between $\mathbf{\$12}$ million and $\mathbf{\$16}$ million.

The operational adoption is evidenced by customer growth:

• Number of hospital contracts increased by $\mathbf{60}\%$ in fiscal Q2 2025 (ended September 30, 2024).
• $\mathbf{6}$ new U.S. hospital starts were reported in fiscal Q3 2025 (ended December 31, 2024).

Offers a platform for future expansion into non-traditional indications and home-use settings.

Beyond Air, Inc. (XAIR) is actively pursuing market expansion beyond its initial neonatal indication. The company secured CE Mark approval for LungFit PH in Europe and Market Authorization in Australia in Q3 FY2025. Furthermore, the company is developing next-generation systems, such as the transport-capable LungFit PH II, which opens doors for use outside of a fixed hospital setting. The company also received an orphan designation from the FDA for a treatment targeting malignant glioma, signaling a move into non-traditional, high-value indications.

Here's a quick look at the market access and product evolution supporting this expansion:

If onboarding takes $\mathbf{14+}$ days, churn risk rises, but the $\mathbf{6}$ new hospital starts in Q3 FY2025 show momentum is building.

Finance: draft $\mathbf{13}$-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Customer Relationships

You're building out the customer relationship strategy for a device company like Beyond Air, Inc. (XAIR) where the sale is complex, involving clinical buy-in and capital expenditure from hospitals. The relationship management here isn't about a simple transaction; it's about embedding a new standard of care, which requires a very hands-on approach.

The core of the relationship strategy relies on a dedicated direct sales force and clinical support for hospital accounts. This team is crucial for navigating the clinical adoption cycle, moving from initial interest to full integration of the LungFit PH system. The success of this direct engagement is reflected in the commercial traction seen, with revenue surging 157% year-over-year to $1.8 million in fiscal Q1 2026 (quarter ended June 30, 2025). Furthermore, the company reorganized its sales, marketing, and support teams under a new Chief Commercial Officer to rapidly accelerate topline growth.

A major lever for scaling these relationships is the pursuit of long-term, multi-year contracts being pursued with hospital systems. While specific contract terms aren't public, management noted seeing an increasing number of customer engagements for these multi-year agreements in the sales pipeline as of August 2024. This focus on long-term commitment is supported by securing access to a massive potential customer base through national agreements.

The strategy employs high-touch relationship management to expand adoption across affiliate hospital locations. This suggests that once a flagship hospital commits, the relationship team works to replicate that success across the entire Integrated Delivery Network (IDN) or system. This is supported by management commentary confirming that existing hospital relationships are indeed expanding across affiliate locations. The growth in the installed base shows this is working, with the system installed and in regular use at more than 45 U.S. hospitals as of March 31, 2025.

Educational and clinical showcasing support via collaborations like Vanderbilt serves as a critical component of building trust and validating the technology. Beyond Air, Inc. established a partnership with Vanderbilt University Medical Center as the first luminary site for LungFit PH, announced around June 2025. These reference sites are key for generating the success stories that speak to cost savings and workflow improvements compared to traditional cylinder-based systems.

The scale of market access achieved through these relationship and contracting efforts is substantial, as shown in the table below, reflecting the reach available to the commercial team as of late 2025:

The company is actively leveraging partnerships to streamline entry into these large systems, having partnered with firms like Healthcare Links to focus on expanding access through Group Purchasing Organizations (GPOs) and IDNs across the United States. This multi-pronged approach-direct sales, GPO leverage, and clinical validation-defines the customer relationship strategy.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Channels

You're looking at how Beyond Air, Inc. gets its LungFit PH system into the hands of clinicians and patients as of late 2025. The strategy mixes direct selling with leveraging established healthcare purchasing networks, plus a growing international footprint.

The core U.S. commercial channel centers on direct engagement with hospital systems for the LungFit PH device, which generates nitric oxide from ambient air, replacing bulky cylinders. As of the fiscal fourth quarter ended March 31, 2025, LungFit PH was installed and in regular use at more than 45 hospitals nationwide. This direct sales team focuses heavily on neonatal intensive care units (NICUs) where the device is FDA-approved for hypoxic respiratory failure in neonates.

Access to a wider set of U.S. facilities is significantly boosted through established purchasing channels. Specifically, Beyond Air, Inc. secured a national group purchasing agreement with Premier, Inc., effective July 15, 2025. This agreement allows Premier members to access special pricing for the LungFit PH system and its disposable NO2 Smart Filters, which is key for scaling adoption across Integrated Delivery Networks (IDNs) that rely on these contracts.

Internationally, the strategy relies on distribution partners, which has seen rapid expansion. As of the fiscal second quarter ended September 30, 2025, the global distribution network for LungFit PH now covers 35 countries. This network provides access to markets representing a combined population of 2.8 billion people. This is up from 18 countries reported earlier in the year.

Here's a look at the geographic reach as of late 2025:

The pipeline for future channels involves moving beyond the hospital setting with the LungFit GO product. Beyond Air, Inc. planned to initiate a U.S. trial for the LungFit GO for patients with nontuberculous mycobacteria (NTM) within calendar year 2025, pending discussion with the FDA. This signals a planned shift toward a direct-to-patient or specialty clinic model for chronic, home-use indications, leveraging the device's cylinder-free technology for easier patient management outside the acute care setting.

The commercial execution is driving top-line results; for the quarter ended September 30, 2025, revenues reached $1.8 million, a 128% increase year-over-year. The company is forecasting FY 2026 revenues between $12 million and $16 million.

Key channel activities include:

• Direct sales team focused on U.S. hospitals and NICUs.
• Access via U.S. Group Purchasing Organizations (GPOs) and IDNs, notably the Premier, Inc. national agreement.
• International distribution partners covering 35 countries as of Q2 FY2026.
• Planned U.S. trial initiation for home-use product (LungFit GO) in 2025 for NTM patients.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Customer Segments

You're looking at the core groups Beyond Air, Inc. (XAIR) is targeting with its nitric oxide (NO) delivery technology, spanning from immediate hospital sales to future chronic care and oncology applications. Honestly, the current focus is clearly on driving adoption of the LungFit PH system where the revenue is today.

The current commercial base is centered on acute hospital care, but the pipeline shows a clear strategy to broaden this significantly into chronic home use and specialized oncology/neurology areas.

Here's a breakdown of the segments and the associated real-life numbers we have as of late 2025:

The financial performance in Fiscal Year 2025 supports this segment focus, showing a clear ramp-up in the core hospital business.

• FY2025 Total Revenues: $3.7 million
• FY2026 Revenue Guidance: $12 million to $16 million
• FY2025 Net Loss: $46.6 million
• Expected FY2025 Net Cash Burn: Less than $30 million
• Cash, Cash Equivalents, and Marketable Securities (as of March 31, 2025): $6.9 million

For the current PPHN segment, the value proposition is the cylinder-free, on-demand generation of NO, which addresses logistical constraints directly. The device can generate NO at concentrations ranging from 1 ppm to 80 ppm.

The future segments rely on label expansion and new indications:

• LungFit PRO for severe acute lung infections could use NO concentrations at or above 80 ppm.
• The NeuroNOS program is advancing a pre-clinical program for Autism Spectrum Disorder (ASD).

The aggregate contracted revenue through fiscal year 2027 stands at more than $7 million, which is a direct reflection of the current customer segment pipeline health.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Cost Structure

You're looking at the cost side of Beyond Air, Inc.'s (XAIR) business as they push for commercial scale with the LungFit® PH system. For a company in this growth stage, the cost structure is heavily weighted toward future revenue generation, meaning high upfront investment in R&D and sales infrastructure.

The major cost drivers for Beyond Air, Inc. during the fiscal year ended March 31, 2025, show a clear focus on both product refinement and market penetration. You can see the key figures broken down below:

High Research and Development (R&D) spending is a core component of the cost structure, reflecting the biopharmaceutical and medical device nature of Beyond Air, Inc.'s operations. For the fiscal year ended March 31, 2025, R&D expenses totaled $16.9 million. This spending is essential to support the pipeline, even as it decreased from the $24.4 million spent in the prior fiscal year. This R&D investment is directly tied to advancing their technology platform.

Significant Selling, General, and Administrative (SG&A) costs are necessary for commercial expansion. For FY2025, SG&A expenses were $26.0 million. This spending supports the growing field team and the infrastructure needed to support the LungFit® PH system, which was installed in over 45 U.S. hospitals by mid-2025. This figure was down from $37.3 million in FY2024, showing management's focus on operational efficiency alongside growth.

The Cost of Revenue for device manufacturing, depreciation, and upgrades was $5.4 million for the fiscal year ended March 31, 2025. This figure exceeding the year's total revenue of $3.7 million is common when a company is scaling device deployment, as depreciation on the installed base contributes significantly to this line item.

Beyond Air, Inc. incurs specific costs for clinical trials and regulatory submissions for new indications. A key cost driver in 2025 was the work supporting the submission of the PMA supplement for the second-generation LungFit® PH device to the FDA in June 2025. Furthermore, costs are allocated to advancing their pipeline, including the solid tumor program utilizing UNO technology, where the Phase 1a trial monotherapy portion was completed.

Regarding capital conservation efforts, the company had a stated goal to keep the net cash burn below $30 million for FY2025. However, the actual reported cash burn, excluding financing and debt extinguishment impacts, for the fiscal year ended March 31, 2025, was $44.1 million. To address this, Beyond Air, Inc. secured new financing later in 2025, including up to $32 million in potential proceeds from Streeterville Capital, LLC, which included a $12 million promissory note and a $20 million Equity Line of Credit Agreement, aiming to provide runway into calendar 2027.

• The actual net cash burn for FY2025 was $44.1 million.
• The stated capital conservation goal for FY2025 was less than $30 million.
• The company ended Q2 FY2026 (September 30, 2025) with a cash balance of $10.7 million.
• The quarterly net cash burn in Q2 FY2026 was significantly reduced to $4.7 million.

Finance: draft 13-week cash view by Friday.

Beyond Air, Inc. (XAIR) - Canvas Business Model: Revenue Streams

Beyond Air, Inc. generates revenue primarily through the commercialization of its LungFit PH system, which is the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use. This revenue structure is built around system sales and the subsequent recurring sales of necessary components.

Sales of the LungFit PH device (system sales) to hospitals form a core component of the revenue base. As of the fiscal quarter ended September 30, 2025, the number of hospital contracts for the LungFit PH system increased by 60% over the course of the second fiscal quarter of 2025, building upon an existing base of over 45 U.S. hospitals where the system has been deployed. The company is seeing an increasing number of customer engagements for multi-year contracts.

Recurring revenue from the sale of disposable NO2 Smart Filters (consumables) supports the system sales, providing a stream of ongoing revenue as the devices are used clinically. While a specific dollar breakdown between system sales and consumables is not explicitly detailed in the latest reports, the overall revenue growth reflects the combined uptake of the system and its associated supplies.

International unit sales and milestone payments from distribution partners are becoming an increasingly important segment. As of September 30, 2025, Beyond Air, Inc. expanded its global LungFit PH distribution network to 35 countries, which represents a combined population of 2.8 billion people. This expansion is driven by recent regulatory approvals in select markets, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador.

The company's recent financial performance underscores this commercial activity. Total revenue for the fiscal year ended March 31, 2025, was $3.71 million, marking a significant 219.67% growth compared to the prior fiscal year. For the quarter ended September 30, 2025, revenue reached $1.82 million, a 128% increase year-over-year.

Future revenue from new indications (PRO/GO) and the second-generation system represents the next phase of growth. Beyond Air, Inc. anticipates the launch of its second-generation LungFit PH device prior to the end of calendar 2026. Furthermore, the company is advancing regulatory initiatives, including an ongoing FDA submission for the LungFit PH in cardiac surgery, which would unlock a new labeled indication.

Here's the quick math on recent and projected revenue performance:

The expansion of the commercial footprint is also tracked through key operational metrics:

• Number of U.S. hospitals adopting LungFit PH: Over 45.
• Number of countries with distribution network expansion (as of Sep 30, 2025): 35.
• Combined population covered by international markets: 2.8 billion people.
• Anticipated launch of second-generation system: Prior to end of calendar 2026.

The company is actively pursuing regulatory milestones that will directly impact future revenue realization, such as the FDA review for the cardiac surgery indication.

Finance: draft 13-week cash view by Friday