Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (NO) generators and delivery systems. The company's flagship product, LungFit PH, received premarket approval (PMA) from the FDA in June 2022 for the treatment of persistent pulmonary hypertension of the newborn (PPHN).
Financials
In the fiscal year ended March 31, 2024, Beyond Air reported annual revenue of $1.159 million, a significant increase from the prior year's zero revenue. However, the company incurred a net loss of $60.2 million, or $1.82 per share, during the same period. The company's annual operating cash flow was negative $56.015 million, and its annual free cash flow was negative $61.76 million.
The company's fourth quarter of fiscal 2024 saw a sequential revenue growth of more than 20%, indicating positive momentum. Beyond Air's management has revised its fiscal year 2025 revenue guidance to greater than $10 million, down from the previous range of $12 million to $16 million, citing delays in reaching certain milestones.
Business Overview
One of the key drivers of Beyond Air's growth is the successful commercialization of its LungFit PH system in the United States. The company has reported that more than 50 hospitals in the U.S. have used LungFit PH to treat over 1,100 patients, totaling more than 75,000 hours of therapy. Importantly, every hospital that has used LungFit PH and had their contract conclude has renewed with the company, and the number of multi-year contracts has increased by over 100% since the last earnings call.
New Leadership
To further drive growth, Beyond Air has appointed David Webster as its new Chief Commercial Officer, effective July 8th. Webster's extensive experience in bringing products to market in the hospital setting and building commercial teams is expected to be instrumental in accelerating the adoption of LungFit PH.
Expanding Indications
Beyond Air is also focused on expanding the indications for LungFit PH. The company has submitted a PMA supplement to the FDA for the expansion of the LungFit PH label to include certain cardiac surgeries, and it expects a decision from the agency in the fourth quarter of calendar 2024. If approved, this would open up a new market opportunity for the company, as there are currently no nitric oxide products approved for cardiac surgery in the United States.
International Expansion
Internationally, Beyond Air continues to work towards obtaining CE Mark certification for LungFit PH in the European Union. While the company does not have clarity on the updated timing, the CE Mark approval would trigger a milestone payment from its partner, Getz Healthcare, which has signed an agreement to commercialize LungFit PH in several countries in the Asia-Pacific region, excluding Japan.
Recent Developments
In addition to the LungFit PH program, Beyond Air has two other initiatives that do not utilize the LungFit platform. Through its majority-owned affiliate, Beyond Cancer, Ltd., the company is developing a novel therapy using ultra-high concentration nitric oxide (UNO) to target solid tumors. The Beyond Cancer program has recently reported positive data from its Phase 1a clinical trial, and it is now preparing to initiate a Phase 1b combination study with anti-PD-1 therapy.
Furthermore, Beyond Air's subsidiary, NeuroNOS, is focused on developing a selective neuronal nitric oxide synthase (nNOS) inhibitor for the treatment of autism spectrum disorder (ASD) and other neurological conditions. This program is expected to progress from preclinical to a Phase 1 first-in-human clinical trial by early 2025.
Liquidity
To preserve capital and extend its cash runway, Beyond Air has implemented a plan that includes a 20% reduction in headcount, with most of the moves occurring in the June 2024 quarter. The company had cash, cash equivalents, and marketable securities of $34.5 million as of March 31, 2024, and it recently raised $14.6 million in net proceeds from a security purchase agreement with Roth Capital and Laidlaw.
Geographic Breakdown
In terms of geographic breakdown, Beyond Air's revenue is currently primarily generated in the United States, as the company focuses on the commercialization of LungFit PH in its home market. However, the company's partnerships in Asia-Pacific and its pursuit of CE Mark certification in Europe suggest that it is positioning itself for potential international expansion in the future.
Conclusion
Overall, Beyond Air is navigating a path towards sustainable growth, leveraging the successful commercialization of LungFit PH, expanding its product indications, and diversifying its pipeline with promising initiatives in oncology and neurology. The company's focus on preserving capital and the appointment of a seasoned commercial leader are positive steps in its journey to deliver long-term value for shareholders.