Dive Brief:

• Beta Bionics is aiming to raise around $114.4 million to fund development of its iLet automated insulin delivery system, the company said in an updated securities filing last week.
• The update, which comes weeks after Beta Bionics first filed its initial public offering paperwork, reveals that the company is aiming to sell stock publicly for $14 to $16 per share and close a $17 million private placement at the same time.
• Beta Bionics also provided preliminary fourth-quarter results. The company estimated that its install base surpassed 15,000 by the end of last year, leading to sales of more than $20 million in the fourth quarter.

Dive Insight:

The Food and Drug Administration cleared iLet for use in Type 1 diabetes in the U.S. in 2023. The device combines a pump with software that calculates insulin dosing, eliminating the need for users to manually adjust settings or count their consumption of carbohydrates. 

Beta Bionics plans to sell 7.5 million shares to public investors. Concurrently, Beta Bionics plans to sell around 1.1 million shares to a fund run by Wellington Management, which invested in the company late last year. If Beta Bionics hits the midpoint of its price range, the parallel public and private financings will give it $114.4 million.

The company plans to spend around $50 million to develop a bihormonal configuration of iLet and bring it to market in the U.S. The bihormonal version will enable the automated delivery of insulin and glucagon. While the current device can only lower blood sugar when it is too high, the bihormonal product could raise blood sugar when it is too low by delivering glucagon.

Beta Bionics has allocated another $50 million to bringing a patch pump to the U.S. market. The device will adhere to the skin and deliver insulin without tubing. Beta Bionics is aiming to launch the product by the end of 2027.

Currently, Beta Bionics relies on the tubed, insulin-only version of iLet for sales. The company included its preliminary fourth-quarter results in the updated IPO filing, telling potential investors that it expects net sales of $20.2 million and $20.6 million. Beta Bionics posted net sales of $8.4 million in the fourth quarter of 2023. Net sales across the first nine months of 2024 were $44.7 million.

The accelerating sales reflect the growth of Beta Bionics’ installed base. The company ended September with 11,214 customers. The company estimates its install base to range from 15,150 to 15,310 as of Dec. 31, 2024.

Between 67% and 70% of the new patients previously administered multiple daily injections of insulin to manage their diabetes, up from 55% in the fourth quarter of 2023. Beta Bionics said a higher percentage of patients switching from daily injections “indicates that the iLet’s value proposition is resonating with patients who have historically chosen to not wear an insulin pump.”

Medtronic, Tandem and Insulet sell rival insulin pumps and, according to Beta Bionics, collectively hold 96% market share. Persuading people to switch from injections to iLet would enable Beta Bionics to grow sales without needing to win market share from Medtronic, Tandem and Insulet. The company estimates two-thirds of people with Type 1 diabetes in the U.S. still use injections.