Company Project Progress - The collaboration project with the Gates Foundation has advanced, with the development of ultrasound equipment's gestational age and fetal position functions completed and now entering clinical validation and confirmation stages. Three new automatic measurement functions in obstetrics are in the clinical data collection and performance optimization phase, which may impact the product launch timeline [1] Project Development - The overseas capacity layout has deepened, with a new facility in the U.S. (covering 1,940 square meters) fully certified as of July 2025. The company plans to flexibly arrange domestic and overseas capacity based on order demand, which is expected to enhance supply chain resilience in the long term. The main structure of the second-phase industrial building has been capped, and internal decoration is underway, with production capacity expected to ramp up in phases after launch [2] Strategic Advancement - The internationalization strategy is being continuously promoted, with plans to drive growth in international markets through product iteration upgrades and expanding local construction overseas, particularly in patient monitoring and ultrasound imaging businesses [3]

Financial Data and Key Metrics Changes - Revenues for Q4 2025 were $4.9 million, a decrease from $31 million in Q4 2024, primarily due to lower unit sales [13] - Full year revenues for 2025 were $27.5 million, down from $41.8 million in 2024, driven by reduced sales to the largest customer [16] - Gross profit for Q4 2025 was $1.9 million, or 38.8% of revenues, compared to $7.1 million, or 54.2% in Q4 2024 [14] - Net loss for Q4 2025 was $3.2 million, or a loss of $0.19 per share, compared to net income of $1.5 million, or $0.09 per diluted share in Q4 2024 [15] - Full year net loss for 2025 was $7.7 million, or a loss of $0.47 per share, compared to net income of $6.6 million, or $0.41 per diluted share in 2024 [18] Business Line Data and Key Metrics Changes - The company shipped 14 units in Q4 2025, with 8 in the U.S. and 6 internationally, with no sales to the largest customer [5][22] - Utilization across the Fair Deal Agreement program increased substantially, with treatments up more than eightfold year-over-year and the number of patients treated increasing by over 250% [6] Market Data and Key Metrics Changes - International sales were strong in Q4 2025, with shipments to China and a growing demand in Asia, particularly in Taiwan and South Korea [7][28] - The company expects international markets to remain a significant part of its growth strategy, with Brazil clearance anticipated in 2026 [28] Company Strategy and Development Direction - The introduction of new CPT codes for SRT and IG-SRT technology is expected to enhance physician reimbursement and support broader adoption [4][20] - The company aims to achieve full-year profitability in 2026, supported by a diversified customer base and expanding international opportunities [8][19] - A disciplined approach to scaling the sales organization is being implemented, with plans to hire additional sales representatives [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about entering 2026 with greater clarity and control over the business, emphasizing the positive impact of new reimbursement codes [20] - The company is focused on educating physicians about the new reimbursement codes to drive adoption and growth [5][8] Other Important Information - The company ended 2025 with $22.1 million in cash and cash equivalents, unchanged from the previous year, and no outstanding debt [18] - Research and development expenses for 2025 increased to $7.8 million, primarily due to higher costs related to billing and reimbursement efforts [17] Q&A Session Summary Question: Guidance on revenue growth excluding the largest customer - Management confirmed that projections for 2026 do not include expectations from the largest customer, as they are reevaluating their model moving forward [22][23] Question: Update on TDI and FDA approval - Management indicated ongoing efforts with the FDA regarding TDI but could not provide a timeline for approval [25] Question: International demand outlook - Management highlighted strong demand in China and growth in Taiwan, with expectations for further expansion in Asia and South America [27][28] Question: Reaction to reimbursement and system mix - Management noted a shift towards outright purchases and leasing options due to improved reimbursement clarity, with a stronger focus on SRT technology [37][41] Question: Interest from private equity-backed groups - Increased interest from private equity groups was noted, with a reevaluation of acquisition strategies due to clearer reimbursement pathways [42]

Core Viewpoint - The company, Edan Instruments, forecasts a net profit attributable to shareholders of between 284 million to 332 million yuan for 2025, representing a year-on-year growth of 75% to 105% [1] Group 1: Financial Performance - The company expects steady growth in overall operating revenue for 2025, particularly with double-digit growth in international markets, especially in patient monitoring and ultrasound imaging sectors [1] - Non-recurring gains and losses are anticipated to impact net profit by approximately 14 million yuan, mainly from government subsidies, which is a decrease of around 4 million yuan compared to the previous year [1] Group 2: Strategic Initiatives - The company continues to focus on its development strategy of "innovation, platform-based, and internationalization," enhancing its global business layout and service capabilities in overseas markets [1] - Edan Instruments is accelerating new product development and optimizing its marketing system while advancing its overseas manufacturing strategy and localizing operations [2] - The company has made significant progress in collaboration with the Gates Foundation, with the handheld ultrasound device project entering clinical validation and confirmation stages [2] Group 3: Operational Developments - A new facility of 1940 square meters has been added to enhance the company's business layout in North America, which has received comprehensive certifications including MDSAP and California FDB medical device production licenses [2] - The company has been operating in the U.S. market for over 15 years and aims to improve supply chain resilience and overall service capabilities [2] - The second phase of the industrial building is nearing completion, with internal renovations ongoing, and production capacity will be adjusted based on order growth [3]

Group 1: Financial Performance - In the first three quarters of 2025, the company achieved total revenue of 1.45 billion CNY, a year-on-year increase of 5% [2] - The net profit attributable to shareholders reached 257 million CNY, showing a significant year-on-year growth of nearly 50% [2] - In Q3 2025, total revenue was 530 million CNY, representing a year-on-year increase of approximately 16% and a quarter-on-quarter increase of about 8% [3] Group 2: Market Performance - Domestic market revenue for the first three quarters was 530 million CNY, a decline of around 4% [2] - International market revenue reached 910 million CNY, with a year-on-year growth of 10.7%, contributing over 60% to total revenue [3] - In Q3 2025, domestic revenue was 176 million CNY, up 18% year-on-year, while international revenue was 357 million CNY, reflecting a growth of about 15% [3] Group 3: Strategic Initiatives - The company is collaborating with the Gates Foundation, receiving payments of 2.568 million USD and 1.547 million USD for project development [4] - Future plans include product upgrades and expanding local operations to maintain stable growth in overseas markets [3] Group 4: Contract Liabilities and R&D - Q3 contract liabilities increased significantly due to enhanced order acquisition capabilities, expected to convert into revenue and profit [5] - R&D expenses decreased while maintaining research intensity, attributed to the application of advanced technologies and efficient management practices [6][7] Group 5: Production and Sales Structure - The new facility in the U.S. spans 1,940 square meters and has received necessary certifications, focusing initially on monitoring and obstetric products [8] - The domestic sales structure includes 28 offices, ensuring comprehensive coverage and effective service support [9] - The international market employs a national agency sales model, with plans to establish subsidiaries in mature regions [10] Group 6: Product Performance - The i500 device, a key product, has shipped around 300 units and over 300,000 reagent units since the beginning of the year, supporting future growth in blood gas business [11] - The overall gross margin for the first three quarters was approximately 58%, with domestic gross margin at 64% and international gross margin at 55% [12]

Core Insights - Butterfly Network reported a record gross margin of 63.7% and a revenue growth of 9.0% year-over-year for Q2 2025, although revenue slightly missed analyst expectations at $23.4 million [1][2] - The company narrowed its losses with non-GAAP earnings per share of $(0.03), better than the expected $(0.05) [1] - Management revised its full-year revenue guidance down to $91 million to $95 million for FY2025, indicating a shift from earlier expectations of approximately 20% year-on-year growth [1][10] Financial Performance - Revenue for Q2 2025 was $23.4 million, up 8.8% from $21.5 million in Q2 2024 [2] - Gross margin improved by 5.1 percentage points from 58.6% in Q2 2024 to 63.7% in Q2 2025 [2][6] - Product revenue increased by 25% to $14.2 million, while software and services revenue remained flat at $6.8 million [5] Strategic Developments - Butterfly Network focuses on handheld ultrasound devices using Ultrasound-on-Chip technology, targeting a wide range of healthcare providers [3] - The company is expanding clinical partnerships and launching new AI-driven software, including the iQ3 device and upcoming P5 chip [4][7] - Recent pilot programs, such as Butterfly HomeCare, have shown promising results in reducing hospital readmissions [8] Future Outlook - The updated revenue guidance suggests approximately 13% growth for FY2025, down from previous estimates [10] - Despite the reduced revenue outlook, the company expects adjusted EBITDA losses to improve to between $32 million and $37 million for FY2025 [10] - Key areas to monitor include the uptake of new AI-driven software, international expansion, and progress in securing additional hospital contracts [11]