Highlights

  • Second quarter 2026 net sales were $32,013 thousand, compared with $23,238 thousand, an increase of 38% from the second quarter of 2025.
  • Net loss was $23,403 thousand, or $0.53 per share, compared with a net loss of $16,869 thousand in the prior-year quarter.
  • Cash, cash equivalents and investments were $225.2 million at June 30, 2026, and six-month net cash used in operations was $38,454 thousand.
  • Management reiterated 2026 revenue guidance of $131 million to $136 million and gross margin guidance of 58.5% to 59.5%.

Beta Bionics (NASDAQ: BBNX) shares were trading at USD 21.41 on October 27, 2026, up 4.39%, with a relative volume at time of 2.55. The medical device company received an FDA Warning Letter in January 2026, began enrolling adults with type 2 diabetes in a pivotal trial in July 2026, and filed its quarterly report for the second quarter of 2026 on July 29, 2026.

Beta Bionics is incorporated in Delaware and lists its principal executive offices in Irvine, California. It is a commercial-stage medical device company that designs, develops and commercializes insulin delivery solutions for insulin-requiring people with diabetes. Its product, the iLet, is cleared by the U.S. Food and Drug Administration to use adaptive closed-loop algorithms to determine insulin doses. It is developing a tubeless patch pump called Mint and a bihormonal system. Its fiscal year ends December 31.

Second Quarter Results

Net sales for the three months ended June 30, 2026 were $32,013 thousand, compared with $23,238 thousand a year earlier. Gross profit was $18,902 thousand, compared with $12,503 thousand. Management said on its call that gross margin was 59.0%.

Operating expenses totaled $44,480 thousand, compared with $32,375 thousand. Sales and marketing expense was $24,640 thousand. Loss from operations was $25,578 thousand, compared with $19,872 thousand. Net loss was $23,403 thousand, compared with $16,869 thousand, and net loss per share was $0.53.

For the six months ended June 30, 2026, net sales were $59,639 thousand, compared with $40,877 thousand, and the net loss was $45,298 thousand, compared with $45,525 thousand. Pharmacy benefit plan channel sales represented 37% of net sales for the six months, compared with 21% a year earlier. Accumulated deficit was $415,235 thousand at June 30, 2026.

Liquidity, Cash Flow and Regulatory Matters

The company stated that it has incurred operating losses since inception and expects to incur expenses and operating losses for the foreseeable future as it advances commercialization of the iLet and development of Mint and the bihormonal system. At June 30, 2026, it had cash, cash equivalents and short-term and long-term investments of $225.2 million.

For the six months ended June 30, 2026, net cash used in operating activities was $38,454 thousand, compared with $33,569 thousand. Net cash provided by financing activities was $2,424 thousand, compared with $211,161 thousand in the prior-year period, which included initial public offering proceeds.

In January 2026, the company received a Warning Letter from the FDA after an inspection of its Irvine facility from June 9, 2025 through June 26, 2025. The letter cited deficiencies in the company's responses to a June 2025 Form 483 and non-conformities in its Quality Management System, Medical Device Reporting, and Correction and Removals. The company said it has responded to the FDA and continues to work to address the observations.

Pipeline and Outlook

Subject to FDA 510(k) clearance as an alternate controller enabled pump, the company expects to fully commercialize Mint by the end of the second quarter of 2027. In July 2026, it began enrolling adults with type 2 diabetes in a pivotal trial, with a goal of expanding the iLet's indications around mid-year 2027, subject to FDA clearance. It initiated an additional Phase 2a feasibility trial of the bihormonal system in the first quarter of 2026.

On the call, management reiterated full-year 2026 revenue guidance of $131 million to $136 million. It raised gross margin guidance to 58.5% to 59.5% from 57.5% to 59.5%, and it expects 37% to 39% of new patient starts to be reimbursed through the pharmacy channel for the full year. Management said new patient starts increased between 10% and 20% compared with the first quarter of 2026.