IRVINE, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. (Nasdaq: BBNX), a pioneering leader in the development of advanced diabetes management solutions, today reported its financial results for the quarter ended June 30, 2026 and updated its full year guidance for the year ending December 31, 2026.
Second Quarter 2026 Financial Highlights & Key Metrics
-- Net sales of $32.0 million, up 38% compared to $23.2 million in the
second quarter of 2025.
-- Durable Medical Equipment (DME) channel net sales of $20.4 million,
up 9% compared to $18.6 million in the second quarter of 2025.
-- Pharmacy Benefit Plan $(PBP)$ channel net sales of $11.6 million, up
153% compared to $4.6 million in the second quarter of 2025.
-- Gross margin of 59.0%, up 524 basis points compared to 53.8% in the
second quarter of 2025.
-- New patient starts increased by at least 10% but less than 20%
sequentially versus the first quarter of 2026.
-- 69% of new patient starts came from multiple daily injections
(MDI).
-- High 30s percentage of new patient starts reimbursed through the
PBP channel.
-- Loss from operations of $25.6 million, or negative 80% of sales, compared
to $19.9 million or negative 86% of sales in the second quarter of 2025.
-- Net loss of $23.4 million, or negative 73% of sales, compared to $16.9
million or negative 73% of sales in the second quarter of 2025.
-- Adjusted EBITDA(1) of negative $17.7 million, or negative 55% of sales,
compared to negative $14.5 million or negative 63% of sales in the second
quarter of 2025.
-- $225.2 million in cash, cash equivalents, short and long-term investments
as of June 30, 2026.
((1) () See "Non-GAAP Financial Measures" below for additional information. A reconciliation of the non-GAAP financial measure to its most directly comparable GAAP financial measure can be found in Table D.
Recent Strategic Highlights
-- In July, initiated enrollment for a pivotal trial studying the iLet in
adults with type 2 diabetes in the U.S.
-- Beta Bionics expects to expand iLet's indications for use to
adults with type 2 diabetes in the U.S. around mid-year 2027,
subject to regulatory clearance by the FDA.
-- Announced updated expectations to fully commercialize Mint, Beta Bionics'
patch pump in development, by the end of the second quarter of 2027,
subject to regulatory clearance by the U.S. Food and Drug Administration
(FDA).
-- The company expects Mint manufacturing capacity to meet
anticipated demand at full launch.
-- Published a near real-time real-world data dashboard publicly available
on the company's website, setting a new standard for data transparency in
the Automated Insulin Delivery category.
-- In its most recent Phase 2a feasibility trial in New Zealand initiated in
the first quarter of 2026 for the bihormonal system in development, the
company identified opportunities to improve the glucagon asset's
excipient profile and the bihormonal dosing algorithm, with improvements
expected to take less than one year prior to initiating additional
feasibility trials.
2026 Full Year Guidance
-- Estimated total revenue of approximately $131 million to $136 million (no
change versus previous guidance).
-- Estimated 37% to 39% of new patient starts reimbursed through the PBP
channel (no change versus previous guidance).
-- Estimated gross margin of 58.5% to 59.5% (previously 57.5% to 59.5%).
Webcast & Conference Call Details
Beta Bionics will host a conference call and concurrent webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time), to review the company's second quarter 2026 performance. The link to the webcast will be available on the Company's website in the "Investors--Events & Presentations" section at https://investors.betabionics.com, and will be archived there for future replay. To access the live call by phone, please use the following link, which will provide you with dial-in details and a personal pin: https://register-conf.media-server.com/register/BI3bd9f03fbd0f42bcb9f566c242240033
Non-GAAP Financial Measures
Beta Bionics, Inc. (the "Company") prepares and presents the Company's financial statements in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The Company believes adjusted EBITDA as a non-GAAP measure is useful in evaluating the Company's operating performance and uses adjusted EBITDA to evaluate ongoing operations and for internal planning and forecasting purposes. The Company believes that this non-GAAP financial measure, when taken together with the corresponding GAAP financial measures, provide meaningful supplemental information regarding the Company's performance by excluding certain items that may not be indicative of the Company's business, results of operations, or outlook. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. In addition, other companies, including companies in the Company's industry, may calculate similarly-titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of the Company's non-GAAP financial measures as tools for comparison. A reconciliation is provided below for adjusted EBITDA to the most directly comparable financial measure stated in accordance with GAAP in Table D below.
The Company calculates adjusted EBITDA as net loss adjusted to exclude (i) depreciation expense, (ii) stock-based compensation expense, (iii) interest income, (iv) income tax expense, (v) change in fair value of warrant liabilities, (vi) litigation settlement and other related expense, and (vii) quality system remediation (previously labeled "Other non-recurring" in the Form 10-K for the year ended December 31, 2025), which relates to one-time remediation efforts in response to the FDA Form 483 and Warning Letter, including contractor support and various updates to the quality system.
Some of the limitations of adjusted EBITDA include: (i) adjusted EBITDA does not properly reflect capital commitments to be paid in the future and (ii) although depreciation and amortization expense are non-cash charges, the underlying assets may need to be replaced and adjusted EBITDA does not reflect these capital expenditures. The Company's adjusted EBITDA may not be comparable to similarly titled measures of other companies because they may not calculate adjusted EBITDA in the same manner as the Company calculates the measure, limiting its usefulness as a comparative measure. In evaluating adjusted EBITDA, you should be aware that in the future the Company will incur expenses similar to the adjustments in this presentation. The Company's presentation of adjusted EBITDA should not be construed as an inference that the Company's future results will be unaffected by these expenses or any unusual or non-recurring items. When evaluating the Company's performance, you should consider adjusted EBITDA alongside other financial performance measures, including the Company's net loss and other GAAP results.
Investors are encouraged to review the related GAAP financial measures and the reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure, and not to rely on any single financial measure to evaluate the Company's business. This non-GAAP measure has limitations as an analytical tool and should not be construed as an inference that the Company's future results will be unaffected by unusual or non-recurring items. Therefore, this non-GAAP financial measure should be considered in addition to, not as a substitute for, or in isolation from, measures prepared in accordance with GAAP.
About Beta Bionics
Beta Bionics, Inc. is a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. The iLet Bionic Pancreas is the first FDA-cleared insulin delivery device that autonomously determines every insulin dose and offers the potential to substantially improve overall outcomes across broad populations of PWD. To learn more, visit www.betabionics.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Beta Bionics, Inc. (the "Company") regarding its clinical and regulatory development plans for the iLet and other product candidates; the markets and market opportunities for the iLet, Mint, the bihormonal system and other product candidates, if approved; the timing, likelihood or success of its business strategy, including commercialization as well as plans and objectives of management for future operations; its anticipated growth and other measures of future operating results and financial performance, including 2026 full year guidance regarding estimates of revenue, new patient starts reimbursed through the PBP channel and gross margin; the design, results, and timing of its research and development efforts and planned trials for the iLet in adults with type 2 diabetes; the design, results and timing of its research and development efforts and feasibility trials for the bihormonal system in
development, including the expected timelines with respect to improvements to the glucagon asset's excipient profile and the bihormonal dosing algorithm; and the timing or certainty of the FDA's approval of Mint, the timing or certainty of the commercialization of Mint and related updates and the Company's manufacturing capacity at launch. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, future results from the Company's ongoing and future studies and clinical trials, the Company's ability to obtain adequate financing to fund its product development and other expenses, risks that real-world data or future results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the Company's relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry, future expenditures and the potential impacts of global macroeconomic conditions. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission, including the section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Beta Bionics, Inc.
Statements of Operations and Comprehensive Loss (unaudited)
Table A
Three Months Ended Six Months Ended
(In thousands,
except number of
shares and per
share data) June 30, June 30,
2026 2025 2026 2025
---------------- ---------------- ---------------- ----------------
Net sales $ 32,013 $ 23,238 $ 59,639 $ 40,877
Cost of sales 13,111 10,735 24,300 19,403
Gross profit 18,902 12,503 35,339 21,474
Gross margin 59.0% 53.8% 59.3% 52.5%
Operating
expenses:
Research and
development 10,240 8,873 20,596 16,463
Sales and
marketing 24,640 15,623 45,375 29,025
General and
administrative 9,600 7,879 19,217 14,500
Total operating
expenses 44,480 32,375 85,188 59,988
Loss from
operations (25,578) (19,872) (49,849) (38,514)
Other income
(expense):
Interest income 2,177 3,005 4,553 5,441
Other expense (2) (2) (2) (2)
Change in fair
value of warrant
liabilities -- -- -- (12,450)
Total other income
(expense), net 2,175 3,003 4,551 (7,011)
Net loss $ (23,403) $ (16,869) $ (45,298) $ (45,525)
Other
comprehensive
income (loss):
Unrealized gain
(loss) on
short-term and
long-term
investments (294) (91) (793) 84
Comprehensive loss $ (23,697) $ (16,960) $ (46,091) $ (45,441)
Net loss per share
attributable to
common
stockholders,
basic and
diluted $ (0.53) $ (0.39) $ (1.02) $ (1.23)
Weighted-average
common shares
outstanding,
basic and
diluted 44,545,293 43,390,652 44,554,141 37,087,726
============ ============ ============ ============
Beta Bionics, Inc.
Balance Sheets (unaudited)
Table B
(In thousands, except number of shares) June 30, December 31,
2026 2025
Assets
Current assets:
Cash and cash equivalents $ 44,318 $ 31,576
Restricted cash,
current 100 100
Short-term investments 136,171 187,549
Accounts receivable, net 18,053 17,118
Inventories 23,918 21,722
Prepaid expenses and other current
assets 8,474 9,840
Total current assets 231,034 267,905
Property and equipment, net 10,748 8,600
Operating lease right-of-use asset 5,816 6,627
Long-term investments 44,648 45,431
Other long-term assets 141 180
Total assets $ 292,387 $ 328,743
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 5,351 $ 4,998
Accrued expenses and other current
liabilities 17,194 22,431
Operating lease liabilities 1,591 1,938
Deferred revenue 1,881 1,557
Total current liabilities 26,017 30,924
Operating lease liabilities, net of
current portion 4,921 5,365
Deferred revenue, net of current
portion 3,454 3,297
Other long-term liabilities 1,629 1,547
Total liabilities 36,021 41,133
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value,
10,000,000 shares authorized; no
shares issued and outstanding at
June 30, 2026 and December 31, 2025 -- --
Common stock, $0.0001 par value,
700,000,000 shares authorized;
44,981,606 and 44,360,873 issued
and outstanding at June 30, 2026
and December 31, 2025,
respectively 5 4
Additional paid-in capital 671,986 657,140
Accumulated other comprehensive
income (loss) (390) 403
Accumulated deficit (415,235) (369,937)
Total stockholders' equity 256,366 287,610
Total liabilities and stockholders'
equity $ 292,387 $ 328,743
Beta Bionics, Inc.
Net Sales by Channel (unaudited)
Table C
Three Months Ended Six Months Ended
(In thousands) June 30, June 30,
2026 2025 2026 2025
---------------- ---------------- ---------------- ----------------
DME channel:
iLet((1) $ 12,651 $ 13,414 $ 22,740 $ 23,042
Single-use
products 7,762 5,230 14,596 9,429
Total DME channel 20,413 18,644 37,336 32,471
PBP channel:
iLet((1) 221 205 686 711
Single-use
products 11,379 4,389 21,617 7,695
Total PBP channel 11,600 4,594 22,303 8,406
-------- -------- -------- --------
Total net sales $ 32,013 $ 23,238 $ 59,639 $ 40,877
((1) iLet includes the over-time recognition software
updates and mobile app access.
Beta Bionics, Inc.
Reconciliation of GAAP versus Non-GAAP Financial Results
(unaudited)
Table D
Three Months Ended Six Months Ended
(In thousands) June 30, June 30,
2026 2025 2026 2025
---------------- ---------------- ---------------- ----------------