Financial Data and Key Metrics Changes - Revenue for the fiscal quarter ended 06/30/2025 increased by 157% to $1,800,000 compared to $700,000 for the same period last year [5][15] - Gross profit increased to $200,000 from a loss of $300,000 for the same period last year, reflecting the increase in revenues [15] - Net loss attributed to common stockholders was $7,700,000 or a loss of $1.53 per share, compared to a net loss of $12,200,000 or a loss of $5.32 per share for the same period last year [19] Business Line Data and Key Metrics Changes - The company reported a 50% sequential increase in revenue over the quarter ended 03/31/2025 [5] - More than 55% of contracts are multi-year contracts, indicating a stable revenue stream [8] - The first quarter of international revenues was recorded, expanding the company's reach to over 30 countries and covering more than 2 billion lives [8][9] Market Data and Key Metrics Changes - The company has been added to the Premier Network, providing access to nearly 3,000 hospitals [10] - The company anticipates growth in international markets, with expectations of significant revenue contributions in fiscal year 2027 [10][66] Company Strategy and Development Direction - The company is focused on overcoming barriers to entry in the nitric oxide market with the LungFit PH system and plans to introduce LungFit PH2 in calendar year 2026, pending regulatory clearance [6][14] - The company is assessing the best path forward for its Beyond Cancer program and expects to communicate more details once a clinical trial site is secured [12] - The company aims to maintain a strong focus on cost reduction in SG&A, R&D, and supply chain management [16] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed revenue guidance of $12,000,000 to $16,000,000 for fiscal year 2026, indicating confidence in achieving this target [7] - Management noted that while the Premier agreement will not have a major impact this fiscal year, it is expected to significantly contribute in the following fiscal year [26] - The company is optimistic about the growth potential in both domestic and international markets, with ongoing training and support for distribution partners [66] Other Important Information - The company reported a net cash burn of $4,700,000, which is more than 60% lower than the first quarter of the previous fiscal year [20] - As of 06/30/2025, the company had cash, cash equivalents, and marketable securities of $6,500,000, which is expected to support operations into calendar year 2026 [21] Q&A Session Summary Question: How should we think about the various growth drivers coming together this year? - Management indicated that while they are confident in their guidance, they need to see more growth opportunities materialize throughout the fiscal year [25][28] Question: Are there certain countries we should be listening for in terms of international growth? - Management noted that initial sales to distribution partners are for demonstration and training purposes, with hospital wins expected towards the end of the fiscal year [30][32] Question: How long does it take to go from initial contact with a customer to closing a deal? - Management stated that it typically takes anywhere from four to twelve months to close deals, depending on the hospital system [36][38] Question: How should expenses be modeled in relation to revenue growth? - Management explained that expenses will increase in proportion to revenue growth, with some fluctuations expected in the upcoming quarters [41][42] Question: How is the Premier agreement facilitating engagement efforts? - Management confirmed that being part of the Premier network removes significant barriers, allowing for more effective discussions with hospitals [46][48] Question: Can you provide insights on sales so far this quarter? - Management refrained from commenting on quarterly estimates but reiterated confidence in their fiscal year guidance [52][53] Question: What is the current expectation for PMA filings? - Management emphasized that their focus is on the second-generation machine, which is deemed more important than the cardiac indication at this time [56][58]

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3,700,000 compared to $1,200,000 for the same period last year [5][19] - The company anticipates revenue of at least $1,700,000 for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12,000,000 and $16,000,000 [6][21] - The net loss attributed to common stockholders for the fiscal year was $46,600,000, or a loss of $0.69 per share, compared to a net loss of $60,200,000, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [8] - The company has established a solid customer base across key target regions in the US, with 45 hospitals either installed or using the LungFit system [68] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2,000,000,000 lives [11] - Initial shipments of LungFit PH to international customers have begun, with expectations for meaningful contributions to financial results starting in the latter half of fiscal 2026 [12] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market, overcoming barriers to entry and enhancing customer confidence through increased usage [7] - The introduction of LungFit PH2, a next-generation system, is expected to significantly impact market share and logistics within hospitals [10] - The company is focused on cost reduction efforts, having reduced operating expenses from over $17,000,000 to just above $7,000,000 in the current quarter, translating to a 58% reduction [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets for the upcoming quarter and fiscal year, citing strong customer interest and flexibility in contract structures [66] - The company is optimistic about the potential for international growth, although it acknowledges the longer tender processes outside the US [31][59] Other Important Information - The company received orphan drug designation from the FDA for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company announced the appointment of Bob Goodman to the board of directors, bringing extensive commercial leadership experience [16] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to US hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the US takes longer [31] Question: What is the expected timeline for FDA approval of LungFit 2.0? - Management refrained from providing a specific timeline, noting the current upheaval at the FDA [40] Question: What factors could lead to achieving the higher end of the revenue guidance range? - Management mentioned that securing large contracts and regulatory approvals could significantly impact revenue [42] Question: How is the company addressing potential geopolitical impacts on supply and sales? - Management stated that the majority of manufacturing is in the US, and geopolitical issues have minimal impact on costs [53] Question: How does LungFit 2.0 expand the market? - Management noted that the new system would allow access to every hospital wanting to use nitric oxide, significantly increasing market reach [82]

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3.7 million compared to $1.2 million for the same period last year [5][19] - The company anticipates revenue of at least $1.7 million for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12 million and $16 million [6][21] - The net loss attributed to common stockholders was $46.6 million, or a loss of $0.69 per share, compared to a net loss of $60.2 million, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [7] - The company has established a solid customer base across key target regions in the U.S. [7] - The company has shipped more than a dozen units of LungFit PH to customers outside the U.S. recently, with expectations for meaningful contributions to financial results starting in the back half of fiscal 2026 [12] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2 billion lives [11] - The company has signed several new international distribution partnerships in countries including India, Italy, and Ukraine [11] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market by overcoming barriers to entry and enhancing customer confidence through increased usage [6] - The company is focused on reducing operating expenses and cash burn while preparing for the launch of its next-generation LungFit PH2 system [22] - The collaboration with Vanderbilt University Medical Center is intended to optimize LungFit products and enhance hospital-based nitric oxide therapy [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and highlighted the potential for significant growth driven by new contracts and international expansion [6][66] - The company is optimistic about the upcoming FDA approval of LungFit PH2, which is expected to have a major impact on market share and logistics within hospitals [10] - Management noted that geopolitical factors have not significantly impacted operations, as most manufacturing occurs in the U.S. [51] Other Important Information - The company has received orphan drug designation for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company completed a $2 million equity financing to accelerate the preclinical development of its small molecule drug for autism [15] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to U.S. hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the U.S. takes longer [30] Question: What is the expected timeline for FDA approval of LungFit PH2? - Management refrained from providing a specific timeline but noted that the FDA's average review time is around 180 days [78] Question: How does the company view the competitive landscape following a peer's new offering? - Management stated that they have not seen significant changes in contract negotiations due to the new offering from a competitor [84]