Beta Bionics Announces Third Quarter 2026 Financial Results and Updates Full Year 2026 Guidance

The updated revenue outlook includes potential fourth-quarter deferrals as prospective iLet users could wait for Mint.

Rhea-AI Summary

Beta Bionics (Nasdaq: BBNX) reported third-quarter 2026 net sales of $35.5 million, up 30% from a year earlier. Gross margin rose to 57.3% from 55.5%, while net loss widened to $24.4 million from $14.2 million. Cash and investments totaled $373.6 million at September 30.

The company estimates 2026 revenue of approximately $124 million to $126 million, previously $121 million to $126 million, including potential fourth-quarter revenue deferral of up to $8.5 million. Mint received FDA clearance; Beta Bionics expects a full U.S. launch in the first quarter of 2027. It withdrew the 3D Intelligence regulatory application and intends to resubmit in mid-fourth-quarter 2026 with additional simulator validation data. Enrollment in the iLet type 2 diabetes pivotal trial is complete. A public stock offering raised approximately $161.3 million in net proceeds.

18 points · 2 major

MixediHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

1 major · 13 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointPublic stock offering completed, raising approximately $161.3 million in net proceeds. 15% of market cap
• Major point. Forward-looking: it has not happened yet and may not happen.Mint received FDA clearance; the company expects full U.S. commercial launch in first-quarter 2027.
• Moderate pointThird-quarter net sales increased 30% year over year to $35.5 million.
• Moderate pointThird-quarter gross margin increased to 57.3% from 55.5% a year earlier.
• Moderate point. Forward-looking: it has not happened yet and may not happen.2026 revenue guidance is approximately $124 million–$126 million, previously $121 million–$126 million.
• Moderate pointiLet type 2 diabetes pivotal trial completed enrollment in the United States.
• Moderate point. Forward-looking: it has not happened yet and may not happen.iLet type 2 indication expansion remains expected around mid-year 2027, subject to FDA clearance.
• Moderate point. Forward-looking: it has not happened yet and may not happen.3D Intelligence commercialization expected in first-half 2027, potentially fourth-quarter 2026, subject to FDA clearance.

10 minor points

• Minor pointPBP channel sales rose 118% year over year to $13.6 million in the third quarter.
• Minor pointDME channel sales increased 4% year over year to $21.9 million in the third quarter.
• Minor pointCash and investments totaled $373.6 million at September 30, 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Mint manufacturing capacity is anticipated to produce at least 1.5 million total disposable units during 2027.
• Minor pointNew patient starts increased by a mid-single digit percentage versus second-quarter 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.Fully-closed loop pivotal trial planned for fourth-quarter 2026 in adults with type 1 and type 2 diabetes.
• Minor point. Forward-looking: it has not happened yet and may not happen.Senseonics integration agreement covers iLet and Mint with Eversense 365; integrated iLet launch expected fourth-quarter 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.2027 Mint revenue is expected by the company to recapture any fourth-quarter 2026 revenue lost.
• Minor pointNine-month net sales increased to $95.144 million from $68.130 million a year earlier.
• Minor pointNine-month gross margin increased to 58.5% from 53.7% a year earlier.

Negative

• Major pointCommon stock offering issued shares, diluting existing holders.
• Moderate pointThird-quarter net loss widened to $24.4 million from $14.2 million a year earlier.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Fourth-quarter revenue deferral could reach up to $8.5 million as prospective iLet users await Mint.
• Moderate point3D Intelligence application withdrawn; additional simulator validation data planned for a revised submission in mid-fourth-quarter 2026.
• Minor pointThird-quarter operating loss widened to $26.6 million from $17.0 million a year earlier.

8 minor points

• Minor pointThird-quarter adjusted EBITDA, a non-GAAP earnings measure, deteriorated to negative $18.9 million from negative $12.2 million.
• Minor pointThird-quarter research and development expense rose to $11.975 million from $8.195 million a year earlier.
• Minor pointThird-quarter sales and marketing expense rose to $25.124 million from $16.045 million a year earlier.
• Minor pointThird-quarter general and administrative expense rose to $9.841 million from $7.922 million a year earlier.
• Minor pointThird-quarter loss per share widened to $0.52 from $0.33 a year earlier.
• Minor pointNine-month net loss widened to $69.651 million from $59.734 million a year earlier.
• Minor pointNine-month operating loss widened to $76.458 million from $55.557 million a year earlier.
• Minor pointNine-month adjusted EBITDA deteriorated to negative $54.280 million from negative $42.240 million a year earlier.

News Explained

The release reports 54,362,972 shares issued and outstanding at September 30, 2026, versus 44,360,873 at December 31, 2025; the higher share count reduces existing holders’ percentage ownership absent offsetting changes.

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Market move: BBNX -13.04% vs previous close. 3Q26 earnings report

$18.50 – $22.29 Day Range

$1.00B Mkt Cap at Last Price

On Oct 27, the day this news came out, the latest delayed price for BBNX is 13.04% below the previous close. Our momentum scanner has recorded 44 alerts for this stock so far that day. The latest delayed price is $18.60. Relative volume is above average at 1.5x the average.

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Key Figures

Net sales: $35.5 million; up 30% PBP channel net sales: $13.6 million; up 118% Gross margin: 57.3%; up 179 basis points +4 more

Net sales

$35.5 million; up 30%

Q3 2026 versus Q3 2025

PBP channel net sales

$13.6 million; up 118%

Q3 2026 versus Q3 2025

Gross margin

57.3%; up 179 basis points

Q3 2026 versus Q3 2025

Net loss

$24.4 million

Q3 2026, versus $14.2 million in Q3 2025

Cash, cash equivalents and investments

$373.6 million

As of September 30, 2026

2026 revenue guidance

$124 million to $126 million

Previously $121 million to $126 million

Potential Q4 revenue deferral

Up to $8.5 million

Potential impact in Q4 2026

Previous Earnings Reports

2 past events · Latest: Jul 29

Same Type 2 events

1. Jul 29

   Q2 earnings

   24h Move

   -5.9%

   Reported 38% sales growth and raised full-year gross-margin guidance.

2. Apr 21

   Q1 earnings

   24h Move

   -0.6%

   Reported 57% sales growth and raised full-year revenue guidance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

adjusted ebitda, 510(k), gaap, continuous glucose monitoring, +1 more

5 terms

adjusted ebitda financial

"Adjusted EBITDA(1) of negative $18.9 million"

Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.

510(k) regulatory

"the Company has withdrawn its 510(k) application for 3D Intelligence"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

gaap financial

"in accordance with U.S. Generally Accepted Accounting Principles (GAAP)"

GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.

View in glossary

continuous glucose monitoring medical

"Eversense® 365 continuous glucose monitoring system"

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

closed-loop technical

"advanced adaptive closed-loop algorithms"

A closed-loop system automatically measures its own output and feeds that information back to adjust inputs, operating without the need for constant human intervention — like a thermostat that senses room temperature and turns the heater on or off to keep a set point. Investors pay attention because closed-loop products often deliver more consistent performance, lower operational costs, and stronger regulatory or competitive advantages, which can improve revenue prospects, margins and risk profiles for companies that make or use them.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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IRVINE, Calif., Oct. 27, 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 September 30, 2026 and updated its full year guidance for the year ending December 31, 2026.

Third Quarter 2026 Financial Highlights & Key Metrics

• Net sales of $35.5 million, up 30% compared to $27.3 million in the third quarter of 2025.
  • Durable Medical Equipment (DME) channel net sales of $21.9 million, up 4% compared to $21.0 million in the third quarter of 2025.
  • Pharmacy Benefit Plan (PBP) channel net sales of $13.6 million, up 118% compared to $6.2 million in the third quarter of 2025.
• Gross margin of 57.3%, up 179 basis points compared to 55.5% in the third quarter of 2025.
• New patient starts increased by a mid-single digit percentage versus the second 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 $26.6 million, or negative 75% of sales, compared to $17.0 million or negative 63% of sales in the third quarter of 2025.
• Net loss of $24.4 million, or negative 69% of sales, compared to $14.2 million or negative 52% of sales in the third quarter of 2025.
• Adjusted EBITDA⁽¹⁾ of negative $18.9 million, or negative 53% of sales, compared to negative $12.2 million or negative 45% of sales in the third quarter of 2025.
• $373.6 million in cash, cash equivalents, short and long-term investments as of September 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

• Announced FDA clearance of Mint™ and expectations for full U.S. commercial launch of Mint in the first quarter of 2027, with anticipated manufacturing capacity to produce at least 1.5 million total disposable units in the full year 2027.
• Completed public offering of common stock, raising approximately $161.3 million in net proceeds to the Company.
• Unveiled 3D Intelligence™ as the Company’s next-generation insulin dosing algorithm.
  • Following recent interactions with the U.S. Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application for 3D Intelligence.
  • Beta Bionics will provide, in a revised 510(k), additional simulator validation data. The company intends to submit this revised 510(k) in mid-Q4 2026.
  • The Company expects to commercialize 3D Intelligence in the United States as iLet 3D™ and Mint 3D™ in the first half of 2027, with the potential for an earlier launch in the fourth quarter of 2026, subject to regulatory clearance by the FDA.
• Completed enrollment for the U.S. pivotal trial studying the iLet in adults with type 2 diabetes.
  • Company reiterates expectations to expand iLet’s indications for use to adults with type 2 diabetes in the United States around mid-year 2027, subject to regulatory clearance by the FDA.
• In the fourth quarter of 2026, the Company intends to initiate a pivotal trial studying a next-generation fully-closed loop (FCL) algorithm in adults with type 1 and type 2 diabetes.
  • The FCL algorithm in development is characterized by the complete removal of a meal announcement feature, with the only required input being the user’s body weight at pump initialization.
• Announced agreement to integrate the iLet and Mint with Senseonics’ Eversense® 365 continuous glucose monitoring system.
  • Commercial launch of the integrated iLet and Eversense 365 system expected in the fourth quarter of 2026.
    
    

2026 Full Year Guidance

• Estimated total revenue of approximately $124 million to $126 million (previously $121 million to $126 million).
  • Revenue guidance reflects a potential revenue deferral impact of up to $8.5 million in the fourth quarter of 2026 as new prospective iLet users could choose to await the launch of Mint.
  • During the full year 2027, the Company expects Mint to recapture any revenue lost in the fourth quarter of 2026.
• 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% (no change versus previous guidance).
  
  

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 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/BIb765a5e68b554419b9df996402991220

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. Beta Bionics’ proprietary insulin dosing algorithm is the first FDA-cleared algorithm 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 Mint, 3D Intelligence, iLet 3D, Mint 3D and the FCL algorithm in development; the potential regulatory clearance by the FDA of 3D Intelligence, iLet 3D, Mint 3D and the iLet in adults with type 2 diabetes, and the timing thereof; the timing or certainty of U.S. commercial launch of Mint, iLet 3D and Mint 3D; the Company’s anticipated manufacturing timeline and capacity of production of Mint at commercial launch and during 2027; the timing of submission of a new 510(k) application for 3D Intelligence; the design, results, and timing of its research and development efforts for the iLet in adults with type 2 diabetes and the FCL algorithm in development; expectations of the Company regarding the integration of iLet and Mint with the Eversense 365 system, and the timing or certainty of commercial launch of such integrated iLet; and the Company’s anticipated growth and other measures of future operating results and financial performance, including 2026 full year guidance regarding estimates of revenue, including revenue deferral and revenue recapture, new patient starts reimbursed through the PBP channel and gross margin. 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, the Company’s ability to manufacture and scale production of its products and manage its supply chain, the Company’s ability to obtain adequate reimbursement and payer coverage for its products, 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 U.S. Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 24, 2026, as updated by its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, filed with the SEC on October 27, 2026, and other filings that Beta Bionics may make from time to time with the SEC. 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,
		2026				2025				2026				2025
Net sales		$	35,505			$	27,253			$	95,144			$	68,130
Cost of sales			15,174				12,134				39,474				31,537
Gross profit			20,331				15,119				55,670				36,593
Gross margin			57.3	%			55.5	%			58.5	%			53.7	%
Operating expenses:
Research and development			11,975				8,195				32,571				24,658
Sales and marketing			25,124				16,045				70,499				45,070
General and administrative			9,841				7,922				29,058				22,422
Total operating expenses			46,940				32,162				132,128				92,150
Loss from operations			(26,609	)			(17,043	)			(76,458	)			(55,557	)
Other income (expense):
Interest income			2,258				2,833				6,811				8,274
Other (expense) income, net			(2	)			1				(4	)			(1	)
Change in fair value of warrant liabilities			—				—				—				(12,450	)
Total other income (expense), net			2,256				2,834				6,807				(4,177	)
Net loss		$	(24,353	)		$	(14,209	)		$	(69,651	)		$	(59,734	)
Other comprehensive income (loss):
Unrealized gain (loss) on short-term and long-term investments			(487	)			205				(1,280	)			289
Comprehensive loss		$	(24,840	)		$	(14,004	)		$	(70,931	)		$	(59,445	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.52	)		$	(0.33	)		$	(1.54	)		$	(1.52	)
Weighted-average common shares outstanding, basic and diluted		46,541,997				43,634,006				45,224,038				39,293,798
Beta Bionics, Inc.
Balance Sheets (unaudited)
Table B
(In thousands, except number of shares)										September 30,				December 31,
										2026				2025
Assets
Current assets:
Cash and cash equivalents										$	81,551			$	31,576
Restricted cash, current											100				100
Short-term investments											158,653				187,549
Accounts receivable, net											20,667				17,118
Inventories, net											22,971				21,722
Prepaid expenses and other current assets											9,004				9,840
Total current assets											292,946				267,905
Property and equipment, net											11,764				8,600
Operating lease right-of-use asset											5,401				6,627
Long-term investments											133,436				45,431
Other long-term assets											212				180
Total assets										$	443,759			$	328,743
Liabilities & Stockholders’ Equity
Current liabilities:
Accounts payable										$	4,682			$	4,998
Accrued expenses and other current liabilities											24,656				22,431
Operating lease liabilities											1,452				1,938
Deferred revenue											2,046				1,557
Total current liabilities											32,836				30,924
Operating lease liabilities, net of current portion											4,649				5,365
Deferred revenue, net of current portion											3,480				3,297
Other long-term liabilities											1,411				1,547
Total liabilities											42,376				41,133
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value, 700,000,000 shares authorized; 54,362,972 and 44,360,873 issued and outstanding at September 30, 2026 and December 31, 2025, respectively											5				4
Additional paid-in capital											841,843				657,140
Accumulated other comprehensive income (loss)											(877	)			403
Accumulated deficit											(439,588	)			(369,937	)
Total stockholders’ equity											401,383				287,610
Total liabilities and stockholders’ equity										$	443,759			$	328,743
Beta Bionics, Inc.
Net Sales by Channel (unaudited)
Table C
		Three Months Ended								Nine Months Ended
(In thousands)		September 30,								September 30,
		2026				2025				2026				2025
DME channel:
iLet(1)		$	11,563			$	14,175			$	34,303			$	37,217
Single-use products			10,334				6,840				24,930				16,269
Total DME channel			21,897				21,015				59,233				53,486
PBP channel:
iLet(1)			(37	)			148				649				859
Single-use products			13,645				6,090				35,262				13,785
Total PBP channel			13,608				6,238				35,911				14,644
Total net sales		$	35,505			$	27,253			$	95,144			$	68,130
(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								Nine Months Ended
(In thousands)		September 30,								September 30,
		2026				2025				2026				2025
Net loss		$	(24,353	)		$	(14,209	)		$	(69,651	)		$	(59,734	)
Add:
Depreciation expense			892				386				2,186				1,036
Stock-based compensation expense			6,715				4,478				19,137				12,081
Interest income			(2,258	)			(2,833	)			(6,811	)			(8,274	)
Income tax expense (benefit)			2				(1	)			4				1
Litigation settlement and other related expense			66				—				201				200
Quality system remediation(1)			30				—				654				—
Change in fair value of warrant liabilities			—				—				—				12,450
Adjusted EBITDA		$	(18,906	)		$	(12,179	)		$	(54,280	)		$	(42,240	)
(1)Amounts presented reflect the same category of expenses previously labeled "Other non-recurring" in our Form 10-K for the year ended December 31, 2025. These expenses relate to our one-time remediation efforts in response to the FDA Form 483 and Warning Letter, including contractor support and the various updates to our quality system to meet FDA expectations.

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

Media and Public Relations:
Felicia Sanborn
Vice President of Marketing
media@betabionics.com

Source: Beta Bionics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Beta Bionics' updated 2026 guidance?

Beta Bionics estimates 2026 revenue of approximately $124 million to $126 million, versus $121 million to $126 million previously. Estimated gross margin remains 58.5% to 59.5%. The estimated share of new patient starts reimbursed through the Pharmacy Benefit Plan channel remains 37% to 39%.

When does Beta Bionics expect to launch Mint?

Beta Bionics expects the full U.S. commercial launch of Mint in the first quarter of 2027, following FDA clearance. Anticipated manufacturing capacity is at least 1.5 million total disposable units for the full year 2027.

What will Beta Bionics' planned fully-closed loop trial study?

Beta Bionics intends to initiate a pivotal trial of its next-generation fully-closed loop algorithm in adults with type 1 and type 2 diabetes in the fourth quarter of 2026. The algorithm under development removes meal announcements, with body weight at pump initialization as the only required input.

What share of Beta Bionics' new patients used injections before starting treatment?

69% of third-quarter 2026 new patient starts came from multiple daily injections. A percentage in the high 30s of new patient starts was reimbursed through the Pharmacy Benefit Plan channel.