Financial Data and Key Metrics Changes - Total revenue for the first quarter was $19.4 million, representing a 52% increase year over year [18] - Gross margin improved to 45.7% from 32.9% in the prior year period, marking seven consecutive quarters of gross margin expansion [18][9] - Cost per fit decreased approximately 20% compared to the prior year, while adjusted revenue per fit increased approximately 20% [18] Business Line Data and Key Metrics Changes - The company accepted over 4,200 prescriptions for the Assure system, an increase of 51% year over year [8] - The conversion rate improved to approximately 47% from an adjusted 40% in the prior year period [19] Market Data and Key Metrics Changes - The in-network patient mix increased from approximately 70% at the time of the IPO to nearly 80% [10][22] - The company estimates its current market share to be around 12% [61] Company Strategy and Development Direction - The company is focused on expanding its sales organization to penetrate existing accounts and target new prescribers [9] - A new commercial strategy includes an expanded clinical specialist role to complement sales territory managers [10][66] - The company aims to build clinical evidence supporting the Assure system, with a significant study expected to be presented at the American Heart Association Scientific Sessions [14][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 70% gross margins in the coming years due to the attractive unit economics of the rental model [18][19] - The company anticipates steady revenue growth driven by increased prescriptions and improved revenue cycle management capabilities [22][20] Other Important Information - Cash and cash equivalents totaled $201.2 million as of July 31, 2025, expected to be sufficient for reaching cash flow breakeven [22] - The company raised its fiscal year 2026 revenue guidance to $88 million, a 47% increase compared to fiscal year 2025 [22] Q&A Session Summary Question: What is driving the confidence to raise guidance? - Management noted a strong Q1 performance and expressed optimism for the rest of the year, indicating comfort with the updated guidance [26] Question: What is being done to improve the in-network mix? - Management highlighted efforts to engage more payers and expand sales territories in high-demand areas, expecting gradual increases in the in-network mix [28][29] Question: What is the expected increase in the conversion rate? - Management indicated a target increase of about 2.5 to 3 points in the conversion rate, driven by improvements in in-network patient mix and sales strategies [56] Question: What is the current market share and how long to achieve category leadership? - Management estimated current market share at around 12% and emphasized the importance of expanding sales coverage to achieve category leadership [61] Question: What does the expanded clinical specialist role entail? - The expanded role will allow sales representatives to focus on acquiring new accounts while clinical specialists manage existing accounts, starting in high-performing territories [66] Question: What are the key endpoints of the FDA post-approval study? - The study includes endpoints such as shock success rate and patient compliance, with results expected to significantly enhance the company's clinical data credibility [71][73] Question: How are compliance rates evolving? - Management reported a median daily wear time of over 23 hours, indicating strong patient compliance with the Assure system [78] Question: What is the pace of OpEx investments for the year? - Management indicated a steady and measured approach to OpEx investments, focusing on high-quality hires and supporting new territory managers [80]

Financial Data and Key Metrics Changes - Total revenue for Q1 2026 was $19.4 million, representing a 52% increase year over year [17] - Gross margin improved to 45.7% from 32.9% in the prior year period, marking seven consecutive quarters of gross margin expansion [8][17] - Cost per fit decreased approximately 20% compared to the prior year, while adjusted revenue per fit increased approximately 20% [17] Business Line Data and Key Metrics Changes - The company accepted over 4,200 prescriptions for the Assure system, an increase of 51% year over year [8] - The conversion rate improved to approximately 47% from an adjusted 40% in the prior year period, driven by enhancements in prescription fill rate, bill rate, and collections performance [18] Market Data and Key Metrics Changes - The in-network patient mix increased from approximately 70% at the time of the IPO to nearly 80% [10][20] - The company is targeting a gradual increase in the in-network mix as it engages with more payers, which is expected to positively impact revenue per fitting [28] Company Strategy and Development Direction - The company is focused on expanding its sales organization to penetrate existing accounts and attract new prescribers, particularly in regions with high WCD prescription volumes [9] - A new commercial strategy includes an expanded clinical specialist role to support sales territory managers, aimed at enhancing account penetration [10][64] - The company aims to build clinical evidence supporting the Assure system, with a significant milestone achieved in the FDA post-approval study, expected to be the largest study published in the WCD category [12][70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 70% gross margins in the coming years, supported by the rental model's volume and depreciation leverage [18] - The company anticipates steady revenue growth and improvements in profitability as it continues to enhance its revenue cycle management processes [19][21] - Management highlighted the ongoing need for WCD therapy, noting that only 14% of eligible U.S. patients currently receive it, indicating significant market expansion potential [13][15] Other Important Information - Cash and cash equivalents totaled $201.2 million as of July 31, 2025, with expectations that this will be sufficient to reach cash flow breakeven and profitability [20] - The company raised its fiscal year 2026 revenue guidance to $88 million, reflecting a 47% increase compared to fiscal year 2025 [20][21] Q&A Session Summary Question: What is driving the confidence to raise guidance? - Management noted a strong Q1 performance and expressed optimism about the rest of the year, indicating that it is still early in the fiscal year [25] Question: What is being done to improve the in-network mix? - The company is gradually increasing the in-network mix by engaging more payers, with a focus on territories with known WCD demand and good payer coverage [28] Question: What is the current status of payer additions? - Management described the process as a "sawtooth curve," indicating that payer additions will not be linear but will continue to increase over time [32] Question: What is the expected increase in conversion rate for the year? - Guidance reflects a 2.5 to 3-point increase in the conversion rate, with ongoing improvements expected as the commercial team expands [53] Question: What is the size and focus of the FDA post-approval study? - The study includes approximately 24,000 to 25,000 patients, focusing on endpoints such as shock success rate and patient compliance, which will provide significant clinical data [68][70]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $17.2 million, representing a 71% increase year-over-year [9][24] - For fiscal year 2025, total revenue reached $59.8 million, a 115% increase compared to fiscal year 2024 [24] - Gross margin improved to 44.3% in Q4 2025 from 13.9% in the prior year [10][25] - Fiscal year 2025 gross margin was 40.5%, up from 1.3% in fiscal year 2024 [11][25] - GAAP net loss for Q4 2025 was $51.1 million, compared to a loss of $22.3 million in the prior year [29] - Adjusted EBITDA loss for Q4 2025 was $20.3 million, compared to a loss of $16.5 million in the prior year [29] Business Line Data and Key Metrics Changes - The Assure system generated over 3,900 prescriptions in Q4 2025, a 43% increase year-over-year [9] - Revenue growth was driven by a higher mix of in-network patients and improvements in revenue cycle management capabilities [24][25] Market Data and Key Metrics Changes - Covered lives for the Assure system now total over 285 million health plan members in the U.S. [13] - The company is targeting geographies with high volumes of WCD prescriptions and strong in-network payer coverage [12] Company Strategy and Development Direction - The company aims to expand its commercial team and enhance revenue cycle management capabilities [11][12] - Plans to nearly double sales coverage over the next few years, increasing from approximately 80 sales territories [12] - The company is focused on continuous innovation and has over 365 patent assets [14][15] - The goal is to make the Assure system the standard of care for patients at risk of sudden cardiac arrest [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant operating leverage and gross margin expansion over the next few years [11][30] - The company expects revenue of $85 million for fiscal year 2026, a 42% increase compared to fiscal year 2025 [30] - Management highlighted the underutilization of WCD therapy, indicating a significant market opportunity [16][17] Other Important Information - The company is not subject to competitive bidding due to the Assure system being a class III medical device [26] - The company is focused on building clinical evidence to support the safety and efficacy of the Assure system [15][84] Q&A Session Summary Question: Guidance for fiscal year 2026 and underlying assumptions - Management indicated that revenue growth will be driven by sales territory productivity, expansion plans, and penetration of existing accounts [33][35] Question: Margin expansion potential - Management noted that margin expansion is expected due to increasing volumes and improved revenue per fit [37][38] Question: Sole source contract with a provider network - Management explained that the contract allows for better patient management and smoother revenue cycle processes [40][42] Question: Seasonality considerations for fiscal year 2026 - Management stated that prescription growth is expected to average 40% per quarter, with higher conversion rates in the first half of the year [44][45] Question: Competitive response and guidance - Management clarified that the guidance reflects normal scaling and territory ramp-up, with no significant competitive issues [48][50] Question: Conversion rate drivers - Management identified fill rate, claim conversion, and in-network patient mix as key drivers of the conversion rate [59][61] Question: Plans for randomized trials - Management is focused on executing the post-approval study and leveraging the data from the registry [83][85]