Financial Data and Key Metrics Changes - The company reported net sales of $27.3 million for Q3 2025, representing a 63% year-over-year growth [7] - Gross margin improved to 55.5%, up 212 basis points from 53.4% in Q3 2024 and up 167 basis points sequentially from 53.8% in Q2 2025 [10] - Total operating expenses increased to $32.2 million, a 62% rise compared to $19.9 million in Q3 2024 [13] - The company has approximately $274 million in cash and investments as of September 30, 2025, indicating strong capitalization for future initiatives [14] Business Line Data and Key Metrics Changes - The growth in revenue was driven by 5,334 new patient starts in Q3, which grew 68% year-over-year [8] - A low 30% of new patient starts were reimbursed through the pharmacy channel, significantly higher than the high single-digit percentage in Q3 2024 [8][9] - Approximately 70% of new patient starts came from individuals previously using multiple daily injections, indicating market expansion [12] Market Data and Key Metrics Changes - The company has over 80% of insured lives in the U.S. covered under formulary agreements with major pharmacy benefit managers (PBMs) [8] - The pharmacy mix of new patient starts is projected to be between 27% to 29% for the full year 2025, up from prior guidance of 25% to 28% [14][15] Company Strategy and Development Direction - The company aims to disrupt the diabetes management industry with innovative products like the iLet and the upcoming Mint patch pump [6][18] - The focus remains on driving adoption of the iLet as a pharmacy benefit at the health plan level [9] - The company is committed to building a robust pipeline of innovative solutions to transform diabetes management [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business direction, citing strong demand for the iLet and positive real-world outcomes [10][11] - The company anticipates continued gross margin expansion due to increased scale and manufacturing volume leverage [10][16] - Management acknowledged potential variability in pharmacy mix due to seasonal dynamics and ongoing adoption efforts [15] Other Important Information - The company received a special 510(k) clearance for updates to the iLet, improving usability and reducing alert fatigue [22] - Remediation efforts related to an FDA Form 483 are underway, with expectations to complete by Q2 2026 [24][26] - Over 25% of new patient starts in Q3 were from type 2 diabetes patients, consistent with prior quarters [27] Q&A Session Summary Question: What is driving the momentum in revenue growth? - Management indicated that the success is due to the unique positioning of the iLet as a new category of device, with increasing adoption over time [32] Question: Can you elaborate on the patient demographics for new starts? - The remaining 30% of new patients are coming from competitive pump systems, with a consistent split among primary competitors [37] Question: What is the impact of the FDA Form 483? - Management stated that they are aggressively addressing the issues raised and have implemented new systems to align with FDA standards [45][46] Question: What are the growth drivers for next year? - Continued understanding of the iLet, pharmacy adoption, and high retention rates from the pharmacy installed base are expected to drive growth [56][58] Question: What is the timeline for the biohormonal system? - Management refrained from providing specific timelines but confirmed that they are working towards initiating a feasibility trial [66]