2/17/2026

speaker
Operator

good day and thank you for standing by welcome to the beta bionics inc q4 and full year 2025 earnings conference call and webcast at this time all participants are in a listen-only mode please be advised that today's conference is being recorded after the speaker's presentation there will be a question and answer session to ask a question please press star 1 1 on your telephone and wait for your name to be announced to withdraw your question please press star 1 1 again I would now like to hand the conference over to your speaker today, Blake Bieber, Head of Investor Relations.

speaker
Blake Bieber
Head of Investor Relations

Good afternoon, and thank you for tuning in to Beta Bionic's fourth quarter and full year 2025 earnings call. Joining me for today's call are Chief Executive Officer Sean Saint and Chief Financial Officer Stephen Feider. Both the replay of this call and the press release discussing our fourth quarter and full year 2025 results will be available on the Investor Relations section of our website. The replay will be available for approximately one year following the conclusion of this call. Information recorded on this call speaks only as of today, February 17, 2026. Therefore, if you are listening to any replay, time sensitive information may no longer be accurate. Also on our website is our supplemental fourth quarter 2025 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates. Before we begin, we would like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance, and operating plans. Please refer to the cautionary statements in the press release we issued earlier today for a detailed explanation of the inherent limitations of such forward-looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward-looking statements. Please note that the forward-looking statements made during this call speak only as of today's date and we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law. Today's discussion will also include references to non-GAAP financial measures with respect to our performance, namely adjusted EBITDA. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution independently or superior to results prepared in accordance with GAAP. please refer to our earnings release and supplemental earnings presentation on the investor relations section of our website for reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measure. With that, I'd now like to turn the call over to Sean.

speaker
Sean Saint
Chief Executive Officer

Thanks, Blake. Good afternoon, everyone, and thank you for joining. With this call, we're officially turning the page on our first full year as a public company. It's been an exciting year to say the least, And I want to take a brief moment to reflect on it before we dive into the details of our Q4 and full year 2025 performance. Beta Bionics exists to deliver solutions to people with diabetes that reduce burden, expand access, and ultimately improve outcomes at the population level. We believe that in doing so, we can, for the first time, begin to lower the average A1C of people living with diabetes in the U.S. Our performance over the last year is strongly indicative that we're on the right track. On our first earnings call, we shared our key targets for the full year 2025. And as we'll highlight in more detail shortly, we outperformed substantially on each of those metrics. Close to 20,000 new users adopted our technology in 2025, more than doubling our installed base entering the year, which now stands above 35,000 total users that have adopted the islet since launch. We added those users with what we believe is a substantially smaller sales force than our competitors. which we believe on a per-territory basis made our sales reps potentially the most productive in the durable pumps market in 2025. That goes to show you the power of our fully adaptive algorithm, our robust ecosystem of digital tools to support our users, their caregivers, and their providers, and ultimately our team's ability to execute and deliver results. We continued to lead from the front on our pharmacy channel strategy for durable pumps and established formulary agreements with all the major pharmacy benefit managers, or PBMs, operate in the U.S. We were also effective at driving adoption of those formulary agreements at the individual plan level, which is a critical step in the process that ultimately enabled many of our users to access the islet and its related consumables for significantly lower out-of-pocket costs. We also believe our gross margin profile is already the strongest in the durable pump space, as evidenced by our performance this year, especially considering the success that we've seen in the pharmacy channel which had a short-term dilutive effect on gross margin in 2025. On the R&D side of the business, we took meaningful steps in the development of Mint, our patch-pump program, which we unveiled to the world at our first Investor and Analyst Day in June. We also completed our first clinical trials as a drug company, executing a PKPD trial for our glucagon asset and a first in-human feasibility trial for the entirety of our bi-hormonal system in development. I'm proud of all we've accomplished in 2025 and I look forward to 2026 as another year of relentless execution on our key objectives that we believe will ultimately position us to revolutionize diabetes care in the years to come. We have lots of ground to cover on today's call, beginning with our fourth quarter and full year 2025 results. Stephen will then provide some additional detail on our fourth quarter performance before introducing our guidance for the full year 2026. I'll wrap up the call with regulatory and pipeline updates, and then we'll take Q&A. Starting with a brief overview of full year 2025 performance, I'm proud to announce that we delivered $100.3 million in net sales, which grew 54% year over year. Our gross margin of 55.4% expanded slightly year over year, while our percentage of new patient starts through pharmacy grew to a high 20s percentage for the full year 2025 relative to a high single digit percentage in the prior year. To put it simply, these are excellent results. The iOLED is winning with its unmatched automation. Our highly transparent and inclusive real-world efficacy and safety outcomes are excellent and available for the world to see in our latest corporate presentation. Beyond the product, we're quickly innovating the business model for durable insulin pumps and we're remaining disciplined in our execution and cost control. Diving into Q4 results, specifically, we generated $32.1 million in net sales, which represents 57% growth year over year. Q4 revenue growth was driven by a few items. Number one, we delivered 5,592 new patient starts in the quarter, which grew 37% year over year. Number two is our growing installed base of users accessing their monthly supplies for the islet through the pharmacy channel, whom we're retaining at a high level. Number three is modest favorability in stocking revenue that we saw in both the DME and pharmacy channels relative to the prior quarters and year. In pharmacy in particular, we saw a modest pull forward of about $1 million of stocking orders from Q1 into Q4 ahead of price increases that were implemented at the end of the year in that channel. In Q4, a low 30s percentage of our new patient starts were reimbursed through the pharmacy channel, increasing slightly relative to the prior quarter and substantially relative to the low teens percentage we saw in Q4 of the prior year. Our gross margin in Q4 was 59%, expanding 179 basis points year over year. Gross margin expansion is being driven by the benefits of increased scale and manufacturing volume leverage, greater contribution of high margin revenue from our growing pharmacy installed base, and continued cost discipline. With that, I'll hand the call over to Steven to provide some additional color on our fourth quarter performance and introduce our full year 2026 guidance. Steven?

Disclaimer

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