Beta Bionics Inc
NASDAQ:BBNX
Beta Bionics Inc
Beta Bionics, Inc. is a commercial-stage medical device company. The company is headquartered in Irvine, California and currently employs 279 full-time employees. The company went IPO on 2025-01-30. The firm's product, the iLet Bionic Pancreas (iLet), is an insulin delivery device cleared by the United States Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. iLet is used for the treatment of Type 1 diabetes (T1D). The firm's solutions include iLet for Adults, iLet for Children, Bionic Circle App and iLet Simulator. The firm is in the early stages of developing an insulin pump that is designed to adhere directly to the skin and administer insulin without the need for tubing, commonly known in the diabetes industry as a patch pump. The company is also in the early stages of developing a bihormonal configuration of the iLet.
Beta Bionics, Inc. is a commercial-stage medical device company. The company is headquartered in Irvine, California and currently employs 279 full-time employees. The company went IPO on 2025-01-30. The firm's product, the iLet Bionic Pancreas (iLet), is an insulin delivery device cleared by the United States Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. iLet is used for the treatment of Type 1 diabetes (T1D). The firm's solutions include iLet for Adults, iLet for Children, Bionic Circle App and iLet Simulator. The firm is in the early stages of developing an insulin pump that is designed to adhere directly to the skin and administer insulin without the need for tubing, commonly known in the diabetes industry as a patch pump. The company is also in the early stages of developing a bihormonal configuration of the iLet.
Revenue Beat: Beta Bionics delivered Q3 net sales of $27.3 million, up 63% year-over-year and ahead of expectations.
Strong Patient Growth: New patient starts reached a record 5,334 in Q3, growing 68% year-over-year, with about 70% converting from multiple daily injections.
Pharmacy Channel Expansion: Low 30s percent of new patient starts went through the pharmacy channel in Q3, much higher than the prior year and above internal expectations.
Margin Expansion: Gross margin rose to 55.5% in Q3, up 212 basis points year-over-year and 167 basis points sequentially, driven by higher pharmacy mix and manufacturing scale.
Raised Guidance: Full year 2025 revenue guidance increased to over $96.5 million (from $88–93 million), and full-year gross margin guidance raised to 54–55%.
Innovation Progress: Key pipeline milestones reached, including special 510(k) clearance for iLet software updates, progress on Mint patch pump, and completion of a bridging trial for the bihormonal system.
FDA Reporting Update: Recent FDA Form 483 led to changes in complaint reporting, causing an increase in reported complaints, but management emphasized this does not reflect higher adverse events.
Solid Cash Position: Company ended Q3 with $274 million in cash and investments, funding key initiatives and targeting free cash flow generation ahead of diabetes peers.
