Beyond Air(XAIR) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for the fiscal year ended March 31, 2020, was $1.4 million, a decrease from $7.7 million in fiscal 2019 [40] - Research and development expenses increased to $10.6 million from $3.9 million in fiscal 2019 [41] - General and administrative expenses rose to $8.9 million compared to $6.9 million in fiscal 2019 [41] - The net loss to common shareholders was $20.5 million or $1.78 per share, compared to a net loss of $6.6 million or $0.77 per share in fiscal 2019 [41] - As of March 31, 2020, the company had cash, cash equivalents, and restricted cash of $25.5 million, sufficient to fund operations beyond the next 12 months [42] Business Line Data and Key Metrics Changes - The company is focused on its LungFit system, which is designed to generate nitric oxide from ambient air and deliver it to patients, differentiating it from traditional cylinder-based systems [12][13] - The LungFit PH system is being developed for persistent pulmonary hypertension of the newborn and is a key focus area for the company [27] - The LungFit HOME program aims to allow patients to self-administer nitric oxide therapy, with a pilot study planned for 20 patients by the end of 2020 [30][31] Market Data and Key Metrics Changes - The market for the LungFit PH system is estimated to be over $300 million in the U.S. and more than $600 million worldwide [29] - The company anticipates significant opportunities in treating hospitalized patients diagnosed with COVID-19 using the LungFit system [18] Company Strategy and Development Direction - The company aims to obtain FDA clearance for the LungFit system in the first half of 2021, which is expected to position it favorably against traditional delivery systems [12][28] - The company is preparing for a pivotal trial for bronchiolitis treatment, with plans to initiate this study in the fourth quarter of 2021 at the earliest [26] - The company is also exploring the potential of high-concentration nitric oxide in treating various solid tumors, with promising preclinical data [34][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the LungFit system and its ability to address unmet medical needs, particularly in the context of COVID-19 [47][49] - The ongoing COVID-19 pandemic has impacted timelines for clinical programs, but the team is working diligently to resume normal activities [49] - Management highlighted the importance of safety and efficacy in developing therapies during the pandemic, emphasizing the need for rapid deployment of treatments [16] Other Important Information - The company entered into a $25 million line of credit available for three years, with the first tranche of $5 million already drawn [43] - A new common stock purchase agreement for up to $40 million was established, extending until May 2023 [44] Q&A Session Summary Question: Number of patients treated under the U.S. COVID study and the Canadian study - The U.S. study will enroll 20 patients, and stage one of the Canadian study will involve 10 patients [53] Question: Timing for the U.S. study - Exact timing for completion is uncertain due to the current environment and competition for patients [56] Question: PPHN PMA submission timeline - The submission is targeted for the end of September, pending completion of logistical challenges [58][59] Question: Safety concerns regarding higher doses of nitric oxide - The FDA has requested starting with 80 parts per million for safety reasons, but the company has not observed safety issues at higher concentrations in previous studies [74][75] Question: Insights from the third bronchiolitis pilot study - The study confirmed that higher concentrations of nitric oxide are necessary for efficacy, and adjustments were made to improve the treatment process [71][72] Question: Future steps if U.S. and Canadian data are positive - If data is favorable, the next step would likely be a pivotal trial, but this will depend on discussions with regulatory agencies [83]