Financial Data and Key Metrics Changes - For the full year 2024, Beta Bionics reported net sales of $65.1 million, representing a 443% year-over-year growth, with a gross margin of 55.1% [22][46] - In Q4 2024, net sales reached $20.4 million, a 145% increase from $8.4 million in Q4 2023, with a gross margin of 57.2% [22][35] Business Line Data and Key Metrics Changes - The company saw an increase of approximately 13,000 new users adopting their technology in 2024, including over 4,000 new users in Q4 alone [18] - The gross margin for the full year was 55.1%, up from 52.6% in the prior year, reflecting improved cost discipline and better manufacturing overhead leverage [46] Market Data and Key Metrics Changes - Approximately 70% of new patient starts in Q4 2024 came from users previously using multiple daily injections (MDI) [33] - The pharmacy channel mix for new patient starts increased to a low teens percentage in Q4 2024, compared to a mid single-digit percentage earlier in the year [42] Company Strategy and Development Direction - Beta Bionics aims to simplify diabetes management through its Eyelet Bionic pancreas, which reduces the complexity of insulin delivery for both patients and providers [10][14] - The company is focusing on expanding its pharmacy channel, which is expected to enhance user access to the Eyelet with minimal out-of-pocket costs [39][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, projecting total revenue for 2025 to be between $80 million and $85 million, driven by strong adoption and recurring revenue from existing users [48] - The company anticipates that the pharmacy channel will continue to grow, with over 20% of new patient starts expected to be reimbursed through this channel in 2025 [49] Other Important Information - The company completed its initial public offering and raised approximately $26 million in net proceeds, strengthening its cash position for future investments [48][47] - Beta Bionics is advancing its innovation pipeline, including a patch pump program and a biohormonal pump program, with commercialization expected by the end of 2027 [25][29] Q&A Session Summary Question: Guidance on pharmacy percentages and Q1 revenue - Management noted that they have visibility on pharmacy mix due to a recent agreement with Prime Therapeutics and are seeing early traction in 2025 [61] - They did not confirm specific revenue numbers for Q1 but indicated that the revenue weighting for 2025 would be consistent with 2024 [62] Question: Market conditions and commercial team performance - Management did not observe a slowdown in the market towards the end of the year and expressed confidence in their commercial strategy [63] Question: Update on the patch pump - Management reiterated that the timeline for the patch pump remains consistent, with commercialization expected by the end of 2027 [71] Question: Competitor's new algorithm and ease of use - Management expressed confidence in the Eyelet's unique learning and adaptation capabilities, differentiating it from competitors' offerings [76][80]

Table of Contents As filed with the Securities and Exchange Commission on January 23, 2025. Registration No. 333-284147 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BETA BIONICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3841 47-5386878 (I.R.S. Employer ...