Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 751

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 751
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 and the level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for
our approved product and product candidates. We expect to experience pricing pressures in connection with the sale of any of our approved
product and product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations
and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical
procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new
products.

Accordingly, the certification
or approval of our product and product candidates for insurance coverage and reimbursement by governmental and private payors may impact
our ability to generate revenues.

34

We face intense competition and rapid technological
change and the possibility that our competitors may discover, develop or commercialize therapies that are similar, more advanced or more
effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize LungFit®
PH and our product candidates.

We are working on PPHN which is
a highly competitive market. A delivery system with a generator of NO has never been commercialized anywhere in the world, and market
acceptance at an appropriate price is proving to be a somewhat difficult and lengthy process. The biotechnology, pharmaceutical and medical
device industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, medical device companies,
public and private universities and research organizations actively engaged in the research and development of products that may be similar
to our approved product or our product candidates. We are aware of several companies currently developing and selling NO therapies for
various indications such as hypoxic respiratory failure (HRF). For example, Mallinckrodt commercializes INOMAX® (nitric
oxide) for inhalation, which is approved for use to treat newborns suffering from HRF-PPHN in the U.S., Canada, Australia, Mexico and
Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery system called NOxBOX®. The
Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar product in Europe, called KINOX™,
together with their delivery platform called SoKINOX™, for the treatment of pulmonary hypertension of the newborn. In Europe, EKU,
International Biomedical, Cahouet and ITC each have a device that delivers nitric oxide