Beyond Air, Inc. (XAIR): Marketing Mix Analysis [Dec-2025 Updated]

You're looking at a clinical-stage medical device firm making its big commercial push, and honestly, figuring out its market strategy right now is key to understanding its near-term valuation. As a seasoned analyst, I see the four P's for this company-focused on replacing bulky gas cylinders with small, on-demand nitric oxide generators-telling a clear story of transition from R&D to revenue generation. The real action is in the numbers: we're projecting gross revenue for fiscal year 2025 to land between $10 million and $15 million, driven by initial hospital adoption of their flagship device. So, if you want to see exactly how they plan to price that premium tech, distribute it to NICUs, and use clinical data to drive sales, dig into the full breakdown below; it defintely shapes the investment thesis.

Beyond Air, Inc. (XAIR) - Marketing Mix: Product

You're looking at the core offering from Beyond Air, Inc. (XAIR), which centers on revolutionizing nitric oxide (NO) delivery by moving away from legacy gas cylinders. The product element here is defined by the hardware, the consumables that drive recurring revenue, and the underlying patented technology.

The flagship product for hospital use is LungFit PH, which is FDA-approved for persistent pulmonary hypertension of the newborn (PPHN) in the United States. As of the end of fiscal year (FY) 2025, this system was operational in over 45 U.S. hospitals. The company is advancing its next-generation device, LungFit PH II, which is designed to be smaller, lighter, and fully transport-ready, having submitted a premarket approval (PMA) supplement to the FDA in June 2025. The current LungFit PH platform generates low concentration NO in a range of 0.5 ppm - 80 ppm, consistent with the standard of care dose of 20 ppm NO for PPHN.

Beyond the approved device, Beyond Air, Inc. is developing other systems. LungFit GO is targeted for chronic and at-home respiratory conditions, with plans to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025. The LungFit PRO system is currently in a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP).

The technological foundation is the patented Ionizer™ technology, which generates unlimited, on-demand NO using ambient room air. This process uses the equivalent power of a 60-watt lightbulb to ionize nitrogen and oxygen molecules, creating NO with a byproduct of low levels of nitrogen dioxide ($\text{NO}_2$).

The system's safety and efficiency hinge on the disposable components. The system includes the generator unit and disposable consumable cartridges, specifically the Smart Filter, which removes the toxic $\text{NO}_2$ from the internal circuit. Commercial traction is visible in the consumables data; demand for LungFit PH led to a more than 100% increase in filters shipped quarter over quarter.

This cylinder-free approach directly addresses the logistical and safety burdens of the legacy method. Here's a quick look at the physical differences:

The value proposition is clear when you look at the operational advantages this product design offers hospitals:

• Generates NO on demand, eliminating the need for heavy, costly NO gas cylinders.
• The current system is ventilator compatible, delivering NO from 1 ppm to 80 ppm.
• The second-generation LungFit PH II is designed to open the entirety of the NO market due to its smaller, lighter design.
• The inventors of the LungFit platform also hold patents for other delivery systems, including INOvent and INOmax DSIR.

Financially, the adoption of the LungFit PH system drove significant top-line growth. Beyond Air, Inc. reported FY 2025 revenue of $3.7 million, a 220% increase from the $1.2 million reported in FY 2024. For context, FY 2023 revenue was $0.68 Million USD. The company's cash position as of March 31, 2025, stood at $6.9 million.

Beyond Air, Inc. (XAIR) - Marketing Mix: Place

Primary distribution is direct-to-hospital sales in the US for LungFit PH.

The commercial execution for LungFit PH in the United States centers on direct engagement with hospital systems. As of the fiscal year 2025 reporting, the system was in regular use at more than 45 hospitals nationwide. This placement strategy supports the initial commercial focus on high-volume US medical centers.

The targeting within these facilities is for critical care settings, specifically Neonatal Intensive Care Units (NICUs) and other critical care environments where inhaled nitric oxide (iNO) therapy is standard.

Future expansion planned for European and other international markets via partners.

Distribution outside the US relies on established partnerships. As of March 2025, the global distribution network for LungFit PH encompassed 18 countries, following the signing of new agreements covering France, Turkey, Romania, and Morocco. These international distribution agreements provide access to markets representing over 2 billion lives. The product was actively shipping to Europe, Australia, and the Middle East as of June 2025.

The company intends to leverage these partners for a faster commercial ramp-up compared to the initial US experience.

LungFit GO distribution will target the home-care and outpatient markets.

The strategy for the LungFit GO system is oriented toward non-hospital settings, capitalizing on the cylinder-free nature of the technology to enable home use for chronic, refractory lung infections, such as NTM infections. Clinical data supporting this channel was presented from the LungFit GO NTM trial. Specific current unit placement numbers for the home-care or outpatient market as of late 2025 were not publicly detailed in the latest reports.

The distribution footprint expansion can be summarized as follows:

The company's overall commercial momentum is reflected in its revenue trajectory, with fiscal year 2025 revenue reported at $3.7 million, and fiscal year 2026 revenue guidance projected between $8 million and $16 million.

Key elements of the distribution strategy include:

• Primary US focus on NICUs and critical care units.
• Leveraging established medical device infrastructure via international partners.
• Elimination of traditional high-pressure NO cylinders in the delivery model.
• Anticipated faster international market ramp-up versus the US experience.

Beyond Air, Inc. (XAIR) - Marketing Mix: Promotion

You're looking at how Beyond Air, Inc. communicates the value of its LungFit platform to drive adoption, which is critical given the capital-intensive nature of medical device commercialization. The promotional strategy leans heavily on validating the technology through scientific channels.

Heavy reliance on clinical data and peer-reviewed publications to drive adoption

The core of the promotion involves showcasing the clinical evidence supporting the use of nitric oxide (NO) delivery via the LungFit platform. This is evidenced by the company's published materials, which include studies on inhaled nitric oxide for viral pneumonia, effects on mouse models for autism, and Phase 1 data for ultra-high concentration NO in solid tumors. The company also highlights its system's benefits compared to legacy cylinder-based systems in neonatal intensive care settings.

Direct sales force engagement with pulmonologists and hospital administrators

Commercial execution involves direct engagement, which was supported by a reorganization of the sales, marketing, and support teams under the Chief Commercial Officer, David Webster, as of late 2024. This effort has translated into customer growth, with the total number of customers increasing by over 60% in the quarter ended September 30, 2024. The company has established a reference customer base, with the LungFit PH system operational in over 45 U.S. hospitals as of March 31, 2025.

Investor relations and corporate communications highlight commercial milestones and FDA progress

Corporate communications focus on tangible progress to support investor confidence. For instance, management highlighted a 220% increase in revenue to $3.7 million for the fiscal year ended March 31, 2025, compared to $1.2 million the prior year. Furthermore, the company announced securing up to $32 million in financing on November 5, 2025. The investor relations effort includes participation in investment conferences, such as the H.C. Wainwright 27th Annual Global Investment Conference in September 2025.

Here are the key financial and commercial metrics highlighted:

Participation in key respiratory and neonatology medical conferences

Direct engagement with the medical community occurs through presence at industry events. Beyond Air, Inc. presented at the H.C. Wainwright 27th Annual Global Investment Conference, which took place from September 8-10, 2025, in New York. This type of event serves as a platform to communicate clinical progress directly to investors and potentially key opinion leaders in the medical field.

Educational programs to train hospital staff on the new NO delivery system

To ensure proper utilization and drive deeper adoption, Beyond Air, Inc. establishes formal training partnerships. A specific example of this is the partnership with Vanderbilt University Medical Center, naming it the first luminary site for LungFit PH. Through this program, the company works with the Vanderbilt team to further optimize products and explore new ways to enhance hospital-based NO therapy, which inherently involves staff training. The company also has a subsidiary, NeuroNOS, focused on neurological disorders like Autism Spectrum Disorder.

The promotional activities are supported by the company's overall structure:

• Employee Count: 61 (based on last 12 months data)
• Issued Patents Expiring Up To: 2040 and 2044
• LungFit PH is FDA-approved for persistent pulmonary hypertension of the newborn.

Beyond Air, Inc. (XAIR) - Marketing Mix: Price

The pricing structure for Beyond Air, Inc. (XAIR) is built around a capital equipment placement model, which is typical for advanced medical devices requiring hospital capital expenditure approval. This involves the initial acquisition or leasing of the LungFit PH generator.

The core financial mechanism follows a razor/razor blade strategy. The LungFit PH generator acts as the initial placement, the razor, while the recurring revenue stream is driven by the sale of proprietary disposable cartridges and consumables, such as the NO2 Smart Filters, which are the high-margin blades that secure long-term customer value and company profitability. The high initial cost of deploying the LungFit PH devices, including depreciation and one-time upgrade costs, was a significant factor in the fiscal year ended March 31, 2025, where the Cost of Revenue of $5.4 million exceeded the total revenue of $3.7 million, resulting in a gross loss of $1.7 million for that period.

The pricing must reflect the significant operational and logistical advantages the LungFit PH technology offers over traditional compressed gas Nitric Oxide (NO) systems. By generating NO on-demand from ambient air, the system eliminates the need for high-pressure cylinders, reducing inventory, storage requirements, and the associated complexity of managing gas supply chains. This value proposition supports a premium pricing strategy.

The pricing strategy is inherently premium, reflecting the clinical benefits and the logistical efficiencies of the cylinder-free technology. This is supported by the system's capability to deliver NO at concentrations ranging from 1 ppm to 80 ppm on demand.

Key financial figures related to revenue expectations inform the overall pricing environment:

• Gross revenue for the fiscal year 2025 is projected to be in the range of $10 million to $15 million.
• Actual reported revenue for the fiscal year ended March 31, 2025, was $3.7 million.
• Revenue guidance for the fiscal year ending March 31, 2026, is set between $12 million to $16 million.

To enhance accessibility and manage the capital equipment sale component, Beyond Air, Inc. has secured agreements that influence customer pricing terms. For instance, a national group purchasing agreement with Premier, Inc., effective July 15, 2025, allows Premier members access to special pricing for the LungFit PH system and disposable NO2 Smart Filters. This demonstrates a tactical use of discounts and preferred terms for high-volume purchasing groups.

The structure of revenue realization, based on the device placement and subsequent consumable use, can be summarized as follows: