Beta Bionics Reports Third Quarter 2025 Financial Results and Raises Full Year 2025 Guidance

Rhea-AI Summary

Beta Bionics (Nasdaq: BBNX) reported third quarter 2025 results and raised full‑year guidance. Q3 net sales $27.3M (+63% YoY) with DME sales $21.0M (+45%) and PBP sales $6.2M (+178%). Gross margin was 55.5% (up 212 bps). Installed customer base reached 29,419 users (+162% YoY) with 5,334 new patient starts (+68%), ~70% from MDI. Loss from operations was $17.0M; net loss $14.2M; adjusted EBITDA was negative $12.2M. Cash and investments totaled $274.0M as of Sept 30, 2025. Management completed a glucagon PK/PD trial, expects a New Zealand feasibility trial in Q4 2025, and received Special 510(k) updates for iLet on Sept 29, 2025. Full‑year 2025 revenue guidance raised to greater than $96.5M.

Positive

• Net sales of $27.3M (+63% YoY)
• PBP channel sales of $6.2M (+178% YoY)
• Installed base 29,419 users (+162% YoY)
• Gross margin 55.5% (up 212 bps)
• Cash and investments $274.0M
• Raised full‑year revenue guidance to >$96.5M

Negative

• Loss from operations $17.0M (−63% of sales)
• Net loss $14.2M (−52% of sales)
• Adjusted EBITDA negative $12.2M (−45% of sales)

Insights

Financial Analyst

Revenue grew strongly and guidance was raised; margin and reimbursement progress support constructive near‑term outlook.

Net sales rose to $27.3 million, up 63% year‑over‑year, driven by DME and a 178% increase in the PBP channel, which reduced patient up‑front cost and expanded access through pharmacy benefit coverage.

Gross margin improved to 55.5% and operating loss narrowed as a share of sales, while adjusted EBITDA loss also improved; these changes show better unit economics but the company remains loss‑making in absolute terms and depends on sustained adoption and reimbursement trends.

Key items to watch: execution of pharmacy benefit manager relationships and conversion of formulary agreements into plan‑level coverage, full PK/PD data from the completed glucagon trial and the planned New Zealand feasibility trial in Q4 2025, and the company’s ability to convert growing starts (5,334 new patient starts) into profitable scale; monitor cash runway given $274.0 million in liquidity and quarterly operating losses for the next 6–12 months.

IRVINE, Calif., Oct. 28, 2025 (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 September 30, 2025 and raised its full year guidance for the year ending December 31, 2025.

Third Quarter 2025 Financial Results & Key Metrics

• Net sales of $27.3 million, up 63% compared to $16.7 million in the third quarter of 2024.
  • Durable Medical Equipment (DME) channel net sales of $21.0 million, up 45% compared to $14.5 million in the third quarter of 2024.
  • Pharmacy Benefit Plan (PBP) channel net sales of $6.2 million, up 178% compared to $2.2 million in the third quarter of 2024.
• Gross margin of 55.5%, up 212 basis points compared to 53.4% in the third quarter of 2024.
• Installed customer base (calculated as all new patient starts over a rolling four-year period) of 29,419 users, up 162% compared to 11,214 in the third quarter of 2024.
• 5,334 new patient starts, up 68% compared to 3,180 new patient starts in the third quarter of 2024.
  • 70% of new patient starts came from multiple daily injections (MDI).
  • Low 30s percentage of new patient starts reimbursed through the PBP channel.
• Loss from operations of $17.0 million, or negative 63% of sales, compared to $11.0 million or negative 66% of sales in the third quarter of 2024.
• Net loss of $14.2 million, or negative 52% of sales, compared to $9.7 million or negative 58% of sales in the third quarter of 2024.
• Adjusted EBITDA⁽¹⁾ of negative $12.2 million, or negative 45% of sales, compared to negative $8.7 million or negative 52% of sales in the third quarter of 2024.
• $274.0 million in cash, cash equivalents, short-term investments, and long-term investments as of September 30, 2025.

⁽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 E.

Recent Strategic Highlights

• As of July 1, 2025, Beta Bionics has effective formulary agreements in place with all the major pharmacy benefit managers (PBMs) that operate in the United States.
  • For the PBMs with whom Beta Bionics has an effective formulary agreement in place, Beta Bionics is actively working with the health plans that partner with those PBMs to drive coverage of iLet under their pharmacy benefit.
  • For plans that cover the iLet Bionic Pancreas under their pharmacy benefit, this decision significantly reduces the potentially large up-front cost of the pump for both the patient and the plan, while easing the administrative burden for the physician when prescribing the iLet Bionic Pancreas.
• In September 2025, Beta Bionics completed the glucagon pharmacokinetic (PK)-pharmacodynamic (PD) trial in Canada.
  • The completion of the trial enables Beta Bionics to bridge previous bihormonal clinical data, which tested prior formulations of glucagon in three pre-pivotal inpatient and six pre-pivotal outpatient clinical trials, to Beta Bionics’ glucagon asset developed by Xeris Pharmaceuticals for use in the bihormonal system in development.
  • Full PK/PD results are in-line with management expectations and Beta Bionics believes such results are supportive of the continued development of the glucagon asset for use in the bihormonal system in development.
  • In the fourth quarter of 2025, Beta Bionics expects to initiate a feasibility trial in New Zealand to test the bihormonal system, including the pump and dosing algorithms, in humans for the first time with the new glucagon asset.
• On September 29, 2025, Beta Bionics received Special 510(k) clearance for iLet feature updates.
  • Updates are intended to improve the user experience on the iLet, including a more seamless cartridge change process and the elimination of redundant low glucose alerts.
    
    

2025 Full Year Guidance

• Estimated total revenue of greater than $96.5 million (previously $88 million to $93 million).
• Estimated 27% to 29% of new patient starts reimbursed through the PBP channel (previously 25% to 28%).
• Estimated gross margin of 54% to 55% (previously 52% to 55%).
  
  

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 third quarter 2025 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/BI0b27b735377640268ec22270324ddd73

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 E below.

The Company calculates adjusted EBITDA as net loss adjusted to exclude (i) depreciation and amortization expense, (ii) stock-based compensation expense, (iii) interest income, (iv) provision for state taxes, (v) change in fair value of warrant liabilities, and (vi) litigation settlement and other related expense.

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 regulatory development plans for the iLet and other product candidates; the markets and market opportunities for the iLet and other product candidates, if approved; the timing, likelihood or success of its business strategy, including commercialization and its multi-channel reimbursement strategy, 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 2025 full year guidance regarding revenue, new patient starts through the PBP channel and gross margin; and its expectation to initiate a feasibility trial in New Zealand by year-end 2025 to test the bihormonal configuration of the iLet in humans for the first time with the new glucagon asset. 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 September 30, 2025. 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								Nine Months Ended
(In thousands, except number of shares and per share data)		September 30,								September 30,
		2025				2024				2025				2024
Net sales		$	27,253			$	16,705			$	68,130			$	44,684
Cost of sales			12,134				7,791				31,537				20,485
Gross profit			15,119				8,914				36,593				24,199
Gross margin			55.5	%			53.4	%			53.7	%			54.2	%
Operating expenses:
Research and development			8,195				5,141				24,658				16,970
Sales and marketing			16,045				9,645				45,070				26,282
General and administrative			7,922				5,105				22,422				13,161
Total operating expenses			32,162				19,891				92,150				56,413
Loss from operations			(17,043	)			(10,977	)			(55,557	)			(32,214	)
Other income (expense):
Interest income			2,833				826				8,274				2,958
Other income (expense), net			1				(4	)			(1	)			(2	)
Change in fair value of warrant liabilities			—				419				(12,450	)			(7,390	)
Total other income (expense), net			2,834				1,241				(4,177	)			(4,434	)
Net loss		$	(14,209	)		$	(9,736	)		$	(59,734	)		$	(36,648	)
Other comprehensive income (loss):
Unrealized gain (loss) on short-term investments			205				79				289				(79	)
Comprehensive loss		$	(14,004	)		$	(9,657	)		$	(59,445	)		$	(36,727	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.33	)		$	(1.46	)		$	(1.52	)		$	(5.86	)
Weighted-average common shares outstanding, basic and diluted		43,634,006				6,660,493				39,293,798				6,264,162
Beta Bionics, Inc.
Balance Sheets (unaudited)
Table B
(In thousands, except number of shares)										September 30,				December 31,
										2025				2024
Assets
Current assets:
Cash and cash equivalents										$	38,485			$	30,432
Short-term investments											190,202				73,143
Accounts receivable, net											11,539				11,996
Inventories, net											20,373				13,320
Prepaid expenses and other current assets											9,427				4,032
Total current assets											270,026				132,923
Property and equipment, net											7,385				4,776
Operating lease right-of-use asset											7,024				6,645
Restricted cash											100				100
Deferred offering costs											—				5,051
Long-term investments											45,328				—
Other long-term assets											183				150
Total assets										$	330,046			$	149,645
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable										$	4,461			$	2,852
Accrued expenses and other current liabilities											17,605				15,828
Operating lease liabilities											1,980				1,529
Deferred revenue											1,342				939
Total current liabilities											25,388				21,148
Operating lease liabilities, net of current portion											5,707				5,726
Deferred revenue, net of current portion											2,986				1,860
Warrant liabilities											—				44,898
Other long-term liabilities											1,205				—
Total liabilities											35,286				73,632
Commitments and contingencies
Convertible preferred stock (Series A, A-2, B, B-2, C, D and E), par value of $0.0001 per share; no and 34,966,547 shares authorized at September 30, 2025 and December 31, 2024, respectively; no and 17,228,954 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively; liquidation preference of $0 and $355,162 at September 30, 2025 and December 31, 2024, respectively											—				321,373
Stockholders’ equity (deficit):
Class A common stock, par value of $0.0001 per share; no and 5,790,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; no and 2,939,085 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively											—				1
Class B common stock, par value of $0.0001 per share; no and 70,000,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; no and 3,679,790 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively											—				—
Class C common stock, par value of $0.0001 per share; no and 96,910 shares authorized at September 30, 2025 and December 31, 2024, respectively; no and 48,918 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively											—				—
Preferred stock, par value of $0.0001 per share; 10,000,000 and no shares authorized at September 30, 2025 and December 31, 2024, respectively; no shares issued or outstanding at September 30, 2025 and December 31, 2024											—				—
Common stock, par value of $0.0001 per share; 700,000,000 and no shares authorized at September 30, 2025 and December 31, 2024, respectively; 43,991,598 and no shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively											4				—
Additional paid-in capital											650,873				51,311
Accumulated other comprehensive income											354				65
Accumulated deficit											(356,471	)			(296,737	)
Total stockholders’ equity (deficit)											294,760				(245,360	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)										$	330,046			$	149,645
Beta Bionics, Inc.
Net Sales by Channel (unaudited)
Table C
		Three Months Ended								Nine Months Ended
(In thousands)		September 30,								September 30,
		2025				2024				2025				2024
DME channel:
iLet(1)		$	14,175			$	11,042			$	37,217			$	33,105
Single-use products			6,840				3,420				16,269				7,740
Total DME channel			21,015				14,462				53,486				40,845
PBP channel:
iLet(1)			148				1,228				859				1,748
Single-use products			6,090				1,015				13,785				2,091
Total PBP channel			6,238				2,243				14,644				3,839
Total net sales		$	27,253			$	16,705			$	68,130			$	44,684
(1)iLet includes the over-time recognition software updates and mobile app access.
Beta Bionics, Inc.
Key Business Metrics (unaudited)
Table D
		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2025				2024				2025				2024
New patient starts(1)			5,334				3,180				14,121				8,910
New patient starts from MDI as a percentage of total new patient starts			70	%			69	%			70	%			67	%
Installed customer base(2)			29,419				11,214				29,419				11,214
(1)In the three months ended September 30, 2024 a high-single digit percentage of our new patient starts were reimbursed through the PBP channel. In the three months ended September 30, 2025 a low 30s percentage of our new patient starts were reimbursed through the PBP channel.
(2)The installed customer base represents all new patient starts, over a rolling four-year period basis. This period reflects our in-warranty customer base under the typical four-year reimbursement cycle and helps us understand the total number of patients using the iLet.
Beta Bionics, Inc.
Reconciliation of GAAP versus Non-GAAP Financial Results (unaudited)
Table E
		Three Months Ended								Nine Months Ended
(In thousands)		September 30,								September 30,
		2025				2024				2025				2024
Net loss		$	(14,209	)		$	(9,736	)		$	(59,734	)		$	(36,648	)
Add:
Depreciation expense			386				333				1,036				919
Stock-based compensation expense			4,478				1,976				12,081				4,832
Interest income			(2,833	)			(826	)			(8,274	)			(2,958	)
Income tax expense (benefit)			(1	)			—				1				2
Litigation settlement and other related expense			—				—				200				—
Change in fair value of warrant liabilities			—				(419	)			12,450				7,390
Adjusted EBITDA		$	(12,179	)		$	(8,672	)		$	(42,240	)		$	(26,463	)

Investor Relations:
Blake Beber
Head of Investor Relations
ir@betabionics.com

Media and Public Relations:
Karen Hynes
Vice President of Marketing
media@betabionics.com

Source: Beta Bionics, Inc.

FAQ

What were Beta Bionics (BBNX) Q3 2025 net sales and YoY change?

Beta Bionics reported $27.3 million in Q3 2025 net sales, a +63% increase versus Q3 2024.

How did Beta Bionics raise its full‑year 2025 revenue guidance for BBNX?

The company raised 2025 revenue guidance to greater than $96.5 million (previously $88–$93M).

What is Beta Bionics’ installed customer base and new patient starts in Q3 2025 (BBNX)?

Installed customer base was 29,419 users (+162% YoY) with 5,334 new patient starts (+68% YoY) in Q3 2025.

How much cash did Beta Bionics (BBNX) hold at Sept 30, 2025?

Beta Bionics held $274.0 million in cash, cash equivalents, and investments as of Sept 30, 2025.

What clinical and regulatory milestones did Beta Bionics announce in Q3 2025?

The company completed a glucagon PK/PD trial in Canada, plans a Q4 2025 New Zealand feasibility trial for the bihormonal system, and received Special 510(k) clearance for iLet feature updates on Sept 29, 2025.

What were Beta Bionics’ Q3 2025 profitability metrics (losses and adjusted EBITDA) for BBNX?

Q3 2025 loss from operations was $17.0M, net loss $14.2M, and adjusted EBITDA was negative $12.2M.

What portion of new patient starts came from MDI and PBP in Q3 2025 for BBNX?

About 70% of new patient starts came from multiple daily injections (MDI); low‑30s percentage of new starts were reimbursed through the PBP channel.