Beta Bionics Reports First Quarter 2025 Financial Results and Raises Annual Guidance for Full Year 2025

Rhea-AI Summary

Beta Bionics (BBNX) reported strong Q1 2025 financial results and raised its annual guidance. Net sales reached $17.6 million, up 36% year-over-year, driven by growth in both DME and PBP channels. The company's installed customer base grew 291% to 19,151 users, with 3,853 new patient starts (48% increase). Despite revenue growth, the company reported increased losses with operating loss of $18.6 million and net loss of $28.7 million. Beta Bionics completed an IPO raising $206 million and secured Prime Therapeutics coverage for its iLet Bionic Pancreas. The company raised its 2025 guidance, now expecting revenue of $82-87 million and PBP channel patient starts of 22-25%. The company maintains $295.5 million in cash and investments.

Positive

• Net sales increased 36% YoY to $17.6 million
• Installed customer base grew 291% to 19,151 users
• New patient starts increased 48% to 3,853
• Successful IPO raised $206 million in net proceeds
• Prime Therapeutics added iLet Bionic Pancreas to national commercial formulary
• Strong cash position of $295.5 million
• Raised annual revenue guidance to $82-87 million

Negative

• Operating loss increased to $18.6 million (106% of sales) from $9.5 million
• Net loss widened to $28.7 million (162% of sales) from $12.4 million
• Gross margin declined 482 basis points to 50.9%
• Adjusted EBITDA worsened to negative $15.5 million (88% of sales)

Insights

Financial Analyst

Beta Bionics delivers strong 36% revenue growth, raises 2025 guidance despite wider losses, with cash runway secured from recent IPO.

Beta Bionics posted impressive commercial momentum in Q1 2025 with net sales climbing 36% year-over-year to $17.6 million. The standout performer was their Pharmacy Benefit Plan channel, which surged 360% to $3.8 million, while their traditional Durable Medical Equipment channel grew a solid 14% to $13.8 million.

The company's installed customer base expanded dramatically to 19,151 users (up 291%), with 3,853 new patient starts in Q1 alone (up 48%). Particularly encouraging is that 71% of these new starts came from patients previously using multiple daily injections rather than competitive pump systems, indicating the iLet Bionic Pancreas is successfully expanding the overall diabetes technology market.

This rapid growth comes with expected scaling investments. Operating losses widened to $18.6 million (negative 106% of sales) from $9.5 million a year ago. Gross margin compressed to 50.9%, down 482 basis points year-over-year. However, the company maintains a robust financial position with $295.5 million in cash and investments, substantially reinforced by their recent $206 million IPO proceeds.

Management's decision to raise full-year 2025 revenue guidance to $82-87 million (from $80-85 million) signals confidence in accelerating commercial momentum through the remainder of the year. The projected increase in PBP channel utilization to 22-25% of new starts suggests this more efficient reimbursement pathway is gaining significant traction.

Medical Technology Expert

Beta Bionics gains key formulary access, advances bihormonal system development, and reveals upcoming patch pump innovation.

The addition of the iLet Bionic Pancreas to Prime Therapeutics' national commercial formulary represents a significant milestone for market access and commercialization. This formulary placement transforms the economics of adoption by shifting from a substantial upfront device cost to a more accessible monthly supply model covered under pharmacy benefits. For diabetes technology, this approach directly addresses two persistent adoption barriers: patient affordability and physician administrative burden.

The initiation of the glucagon pharmacokinetic-pharmacodynamic bridging trial marks important progress toward Beta Bionics' differentiated bihormonal approach. While current automated insulin delivery systems only modulate insulin delivery, a dual-hormone system utilizing both insulin and glucagon would more closely mimic normal pancreatic function. The company's mention of leveraging data from nine previous pre-pivotal trials using earlier glucagon formulations indicates substantial clinical groundwork for this innovative approach.

The upcoming investor event's planned demonstration of "the patch pump in development" reveals Beta Bionics is expanding beyond their current form factor. This product line extension could potentially address the growing segment of patients who prefer tubeless insulin delivery systems, broadening the company's addressable market. The scheduled presentation of new real-world data will provide crucial insights into how the iLet system performs in everyday clinical practice beyond controlled trial settings.

With 71% of new patient starts coming from multiple daily injections rather than pump conversions, the iLet system is demonstrating its ability to expand the overall insulin pump market rather than merely capturing share from competitors – a key metric for long-term growth potential in the diabetes technology sector.

IRVINE, Calif., May 06, 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 March 31, 2025 and raised its annual guidance for the year ending December 31, 2025.

First Quarter 2025 Financial Results & Key Metrics

• Net sales of $17.6 million, up 36% compared to $12.9 million in the first quarter of 2024.
  • Durable Medical Equipment (DME) channel net sales of $13.8 million, up 14% compared to $12.1 million in the first quarter of 2024.
  • Pharmacy Benefit Plan (PBP) channel net sales of $3.8 million, up 360% compared to $0.8 million in the first quarter of 2024.
• Gross margin of 50.9%, down 482 basis points compared to 55.7% in the first quarter of 2024.
• Installed customer base (calculated as all new patient starts over a rolling four-year period) of 19,151 users, up 291% compared to 4,901 in the first quarter of 2024.
• 3,853 new patient starts, up 48% compared to 2,597 new patient starts in the first quarter of 2024.
  • 71% of new patient starts came from multiple daily injections (MDI).
  • Low 20s percentage of new patient starts reimbursed through the PBP channel.
• Loss from operations of $18.6 million, or negative 106% of sales, compared to $9.5 million or negative 73% of sales in the first quarter of 2024.
• Net loss of $28.7 million, or negative 162% of sales, compared to $12.4 million or negative 96% of sales in the first quarter of 2024.
• Adjusted EBITDA⁽¹⁾ of negative $15.5 million, or negative 88% of sales, compared to negative $7.8 million or negative 60% of sales in the first quarter of 2024.
• $295.5 million in cash, cash equivalents, short-term investments, and long-term investments as of March 31, 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

• On January 31, 2025, completed upsized initial public offering and concurrent private placement, raising approximately $206.0 million in net proceeds to the company.
• Announced that effective February 1, 2025, Prime Therapeutics has added the iLet Bionic Pancreas and associated monthly supplies to its largest national commercial formulary.
  • Beta Bionics is actively working with the health plans that partner with Prime Therapeutics to drive coverage of iLet under their pharmacy benefit, per Prime’s recommendation to the health plans.
  • 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.
• Initiated enrollment in March for the glucagon pharmacokinetic-pharmacodynamic bridging trial in Canada.
  • The trial is intended to enable 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 candidate developed by Xeris Pharmaceuticals for use in the bihormonal configuration of the iLet.
• Announced an investor event on June 22, 2025, to be hosted in conjunction with the 85th Scientific Sessions of the American Diabetes Association.
  • Agenda to include updates on commercial and financial performance, a demonstration of the patch pump in development, a review of the adaptive closed-loop algorithm, and new real-world data.

2025 Full Year Guidance

• Estimated total revenue of approximately $82 million to $87 million (previously $80 million to $85 million).
• Estimated 22% to 25% of new patient starts reimbursed through the PBP channel (previously greater than 20%).
• Estimated gross margin of 50% to 53% (previously at least 50%).
  

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 first 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. You may also access the live call by dialing (888) 596-4144, passcode is 8363701.

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 and (v) change in fair value of warrant liabilities.

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 our 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 our business strategy, including commercialization and our multi-channel reimbursement strategy, as well as plans and objectives of management for future operations; our 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 the potential benefits of the addition of the iLet to Prime Therapeutics’ national commercial formulary. 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 March 31, 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 March 31,
(In thousands, except number of shares and per share data)
		2025				2024
Net sales	$	17,639			$	12,933
Cost of sales		8,668				5,732
Gross profit		8,971				7,201
Gross margin		50.9	%			55.7	%
Operating expenses:
Research and development		7,590				5,479
Sales and marketing		13,402				7,663
General and administrative		6,621				3,512
Total operating expenses		27,613				16,654
Loss from operations		(18,642	)			(9,453	)
Other income (expense):
Interest income		2,436				1,139
Other income		—				4
Change in fair value of warrant liabilities		(12,450	)			(4,139	)
Total other expense, net		(10,014	)			(2,996	)
Net loss	$	(28,656	)		$	(12,449	)
Other comprehensive income (loss):
Unrealized gain (loss) on short-term investments		175				(132	)
Comprehensive loss	$	(28,481	)		$	(12,581	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.93	)		$	(2.07	)
Weighted-average common shares outstanding, basic and diluted	30,714,769					6,021,882
Beta Bionics, Inc.
Balance Sheets (unaudited)
Table B
(In thousands, except number of shares)	March 31,				December 31,
		2025				2024
Assets
Current assets:
Cash and cash equivalents	$	42,454			$	30,432
Short-term investments		189,019				73,143
Accounts receivable, net		9,060				11,996
Inventories, net		15,730				13,320
Prepaid expenses and other current assets		5,652				4,032
Total current assets		261,915				132,923
Property and equipment, net		5,515				4,776
Operating lease right-of-use asset		6,344				6,645
Restricted cash		100				100
Deferred offering costs		—				5,051
Long-term investments		64,004				—
Other long-term assets		146				150
Total assets	$	338,024			$	149,645
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable	$	3,454			$	2,852
Accrued expenses and other current liabilities		10,565				15,828
Operating lease liabilities		1,524				1,529
Deferred revenue		949				939
Total current liabilities		16,492				21,148
Operating lease liabilities, net of current portion		5,450				5,726
Deferred revenue, net of current portion		2,330				1,860
Warrant liabilities		—				44,898
Total liabilities		24,272				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 March 31, 2025 and December 31, 2024, respectively; no and 17,228,954 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively; liquidation preference of no and $355,162 at March 31, 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 March 31, 2025 and December 31, 2024, respectively; no and 2,939,085 shares issued and outstanding at March 31, 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 March 31, 2025 and December 31, 2024, respectively; no and 3,679,790 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		—				—
Class C common stock, par value of $0.0001 per share; no and 96,910 shares authorized at March 31, 2025 and December 31, 2024, respectively; no and 48,918 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		—				—
Preferred stock, par value of $0.0001 per share; 10,000,000 and no shares authorized at March 31, 2025 and December 31, 2024, respectively; no shares issued or outstanding at March 31, 2025 and December 31, 2024		—				—
Common stock, par value of $0.0001 per share; 700,000,000 and no shares authorized at March 31, 2025 and December 31, 2024, respectively; 43,353,890 and no shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		4				—
Additional paid-in capital		638,901				51,311
Accumulated other comprehensive income		240				65
Accumulated deficit		(325,393	)			(296,737	)
Total stockholders’ equity (deficit)		313,752				(245,360	)
Total liabilities, convertible preferred stock and stockholders’ deficit	$	338,024			$	149,645
Beta Bionics, Inc.
Net Sales by Channel (unaudited)
Table C
(In thousands)	Three Months Ended March 31,
		2025				2024
DME channel:
iLet(1)	$	9,628			$	10,373
Single-use products		4,199				1,732
Total DME channel		13,827				12,105
PBP channel:
iLet(1)		506				291
Single-use products		3,306				537
Total PBP channel		3,812				828
Total net sales	$	17,639			$	12,933
(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 March 31,
		2025				2024
New patient starts(1)		3,853				2,597
New patient starts from MDI as a percentage of total new patient starts		71	%			66	%
Installed customer base(2)		19,151				4,901
(1)In the month ended March 31, 2024 a mid-single digit percentage of our new patient starts were reimbursed through the PBP channel. In the month ended March 31, 2025 a low 20s 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
(In thousands)	Three Months Ended March 31,
		2025				2024
Net loss	$	(28,656	)		$	(12,449	)
Add:
Depreciation expense		303				287
Stock-based compensation expense		2,804				1,357
Interest income		(2,436	)			(1,139	)
Provision for state taxes		—				—
Change in fair value of warrant liabilities		12,450				4,139
Adjusted EBITDA	$	(15,535	)		$	(7,805	)

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) Q1 2025 earnings results?

Beta Bionics reported Q1 2025 net sales of $17.6 million (up 36% YoY) but increased net losses of $28.7 million. The company's installed customer base grew 291% to 19,151 users.

How much cash does Beta Bionics (BBNX) have after its IPO?

As of March 31, 2025, Beta Bionics had $295.5 million in cash, cash equivalents, and investments, including approximately $206 million raised from its IPO in January 2025.

What is Beta Bionics' (BBNX) revenue guidance for 2025?

Beta Bionics raised its 2025 revenue guidance to $82-87 million, up from the previous guidance of $80-85 million.

How many new patients started using Beta Bionics' (BBNX) products in Q1 2025?

Beta Bionics reported 3,853 new patient starts in Q1 2025, a 48% increase from 2,597 in Q1 2024, with 71% coming from multiple daily injections.

What was Beta Bionics' (BBNX) gross margin in Q1 2025?

Beta Bionics reported a gross margin of 50.9% in Q1 2025, down 482 basis points from 55.7% in Q1 2024.