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

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 $(DME.AU)$ channel net sales of $13.8 million, 
             up 14% compared to $12.1 million in the first quarter of 2024. 
 
          -- Pharmacy Benefit Plan $(PBP.AU)$ 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 
             $(MDI.AU)$. 
 
          -- 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

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