Beyond Air(US:XAIR)2023-06-22 23:01Financial Data and Key Metrics Changes - Revenue for the fiscal year ended March 31, 2023, was zero, unchanged from the previous fiscal year, but management expressed confidence that this would be the last time they report zero revenue [82] - Selling, general and administrative expenses increased to $34.7 million from $18.4 million, primarily due to investments in Beyond Cancer and the U.S. commercial launch [83] - GAAP net loss for the fiscal year was $59.4 million, compared to a net loss of $43.2 million for the previous year, with a loss per share of $1.86 [92] Business Line Data and Key Metrics Changes - The company is in phase 2 of the commercial launch for LungFit PH, expanding its commercial team and aiming to increase market share [9][74] - The company has conducted over 150 in-person demonstrations of LungFit PH, receiving positive feedback and optimizing the system [73] - Management expects annual contract signings to be measured in the millions over the next six months [75] Market Data and Key Metrics Changes - The market for nitric oxide in hospitals is estimated to be around $350 million to $400 million, with approximately 1,000 hospitals as potential customers [45] - The company anticipates that the customer base and commercial function being established will support future launches of LungFit PRO [76] Company Strategy and Development Direction - The company is focusing on expanding its commercial operations and increasing its market share, with plans to grow its team over the next 18 to 24 months [106] - The company is preparing for a pivotal study for LungFit PRO in the first half of 2025 and a pilot study for LungFit GO in the second half of 2024 [84][69] - The company is also exploring new programs, including a focus on autism spectrum disorder through nNOS inhibitors [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving CE Mark and FDA submission for LungFit PH, indicating a positive regulatory outlook [77] - The company is optimistic about the feedback from hospitals and the potential for future growth, emphasizing the importance of building a solid foundation during the initial phases of the commercial launch [72][75] - Management acknowledged supply chain challenges but noted improvements in training and logistics [101] Other Important Information - The company secured debt financing of up to $40 million, which is expected to strengthen its position for executing its strategy [70] - The company has completed multiple studies with no serious adverse events attributed to nitric oxide, reinforcing the safety of its products [85] Q&A Session Summary Question: What was accomplished in phase 1 of the LungFit PH launch? - Management indicated that several contracts were signed, and positive clinical feedback was received, setting a foundation for future growth [100][101] Question: How will the commercial sales force expand? - The company plans to expand its team to around 70 to 80 people over the next 18 to 24 months, including sales reps and clinical specialists [106] Question: What is the expected revenue from contracts? - Management stated that contracts are expected to convert into revenue gradually, with a slow build-up anticipated over the next several quarters [124]