Beta Bionics (BBNX) Registration Filing summary

Company overview and business model

• Commercial-stage medical device company focused on improving diabetes management for insulin-requiring patients using adaptive closed-loop algorithms.

• Flagship product, the iLet Bionic Pancreas, is FDA-cleared for type 1 diabetes (T1D) in patients six and older; automates all insulin dosing without carb counting.

• iLet integrates with leading CGM devices (Dexcom G6/G7, Abbott FreeStyle Libre 3 Plus) and is designed for ease of use, requiring only body weight for initialization.

• Business model includes recurring revenue from single-use products (cartridges, infusion sets) and a multi-channel reimbursement strategy (DME and pharmacy benefit plans).

• Pipeline includes a patch pump and a bihormonal iLet (insulin and glucagon), with plans to expand into insulin-dependent type 2 diabetes (T2D).

Financial performance and metrics

• Revenue for the nine months ended September 30, 2024 was $44.7M, up from $3.6M in the prior year period; annual revenue for 2023 was $12.0M.

• Net loss for the nine months ended September 30, 2024 was $36.6M, compared to $25.3M in the prior year period; accumulated deficit as of September 30, 2024 was $278.6M.

• Gross margin for the nine months ended September 30, 2024 was 54%, up from 34% in the prior year period.

• As of December 31, 2024, cash, cash equivalents, and short-term investments were approximately $103.6M.

• Majority of new patient starts (67% as of September 30, 2024) came from patients previously using multiple daily injections (MDI).

Use of proceeds and capital allocation

• Estimated net proceeds from the IPO and concurrent private placement are $114.4M, based on an assumed IPO price of $15.00 per share.

• Proceeds will fund: (i) development of the bihormonal iLet through regulatory submissions and glucagon approval; (ii) development and manufacturing of the patch pump; (iii) expansion of sales and manufacturing infrastructure, working capital, and general corporate purposes.

• Funds are expected to support operations through the first half of 2028.