Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 47

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 47
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MA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries. According
to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $261.4 million in
2024 (down from $303.2 million in 2023) for the United States, Canada, Japan, Mexico and Australia, with ~90% in the United States. Outside
of the U.S. there are multiple market participants which translates to considerably lower relative sales than in the U.S. We believe
the U.S. sales potential of LungFit® PH to be approximately $350 million and worldwide sales potential to be approximately
$700 million or greater. We initiated the first phase of our commercial launch in July 2022 (the limited launch phase to introduce Lungfit®
PH and Beyond Air to hospitals), and entered into phase 2 (target initial market share gains in certain geographies) with an expanded
commercial presence during the spring of 2023 in the U.S. We recently entered the final phase of our launch process where we will equip
our commercial organization to become the market leader in the U.S. in a few years. Since receiving CE Mark in late November, 2024, we
have received regulatory approvals in Australia, New Zealand, Hong Kong and Thailand with our partner Getz Healthcare and are awaiting
approvals in several other countries in South East Asia. Additionally, we have signed new distribution agreements covering France, India,
Italy, Japan, Morocco, Saudi Arabia, and Turkey, among others. We anticipate significant contribution to revenues in fiscal 2026 and
beyond from these and future partnerships.

LungFit®
PRO for the treatment of viral lung infections in hospitalized patients

Viral
Community-Acquired Pneumonia (including COVID-19)

Viral
pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (“RSV”) and influenza virus. However,
newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing
to the overall burden of adult viral pneumonia. COVID-19 is an infectious disease caused by SARS-CoV-2, that resulted in a global pandemic,
causing millions of hospitalizations and over 7 million deaths worldwide reported as of January 2024, according