Beta Bionics, Inc.

Good afternoon, and welcome to the Beta Bionics third quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session, and instructions will follow at that time. As a reminder, please be advised that today's conference is being recorded. I would like to hand the conference over to Blake Bieber, head of investor relations. Please go ahead.

Good afternoon, and thank you for tuning in to Beta Bionics third quarter 2025 earnings call. Joining me for today's call are Chief Executive Officer Sean Saint and Chief Financial Officer Steven Feider. Both the replay of this call and the press release discussing our third quarter 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, October 28, 2025. Therefore, if you are listening to any replay, any time sensitive information may no longer be accurate. Also on our website is our supplemental third 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, as well as our SEC filings, including our Form 10-Q filed 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 press release and supplemental earnings presentation on the investor relations section of our website for a reconciliation of non-GAAP measures to their most directly comparable GAAP financial measure. With that, I'd now like to turn the call over to Sean.

Thanks, Blake. Good afternoon, everyone, and thank you for joining. We're proud to share with you all today the details of our strong performance in the third quarter, as well as discuss our updated annual projections for the full year 2025. Starting with our performance in the third quarter, we continue to make key advances across our business, both commercially and in our innovation pipeline. Demand for the islet, both in existing practices as well as new practices, continues to exceed our expectations. And in the third quarter, we saw a record number of both new patient starts as well as the percentage of those new patient starts going through the pharmacy channel. The ILS automation and adaptation continue to set a new standard for our industry, simplifying and alleviating the burden of managing diabetes for our users, their caregivers, and their healthcare providers. But we're not stopping there. And we're continuing to push the envelope on key innovations to our pipeline that I believe will enable beta bionics to disrupt ourselves in the future. and deliver even more life-changing solutions to people with diabetes and the community that supports them. During today's call, I'll begin by covering our Q3 results, which exceeded our expectations across the board. Stephen will then discuss our Q3 performance and updated full-year 2025 guidance in more detail. Lastly, I'll share some exciting updates across our innovation pipeline, including ILIT and some new features we recently rolled out, MINT, which is our patch pump in development, and lastly, our biohormonal system in development. Let's begin with an overview of our Q3 2025 performance. I'm pleased to share that we delivered $27.3 million in net sales, which grew 63% year-over-year. Q3 revenue growth was predominantly driven by 5,334 new patient starts in the quarter, which grew 68% year-over-year, as well as our growing installed base of users accessing their monthly supplies for the islet through the pharmacy channel. In Q3, a low 30s percentage of our new patient starts were reimbursed through the pharmacy channel, which is significantly higher than the high single-digit percentage we saw in Q3 of the prior year and increasing sequentially compared to the high 20s percentage we saw in Q2 of this year. As of the end of Q3, Beta Bionics has greater than 80% of insured lives in the U.S. covered under formulary agreements with pharmacy benefit managers, or PBMs, including all the major PBMs that operate in the U.S. However, Patients covered under those formulary agreements do not yet benefit from the pharmacy channel until the health plans that partner with those PBMs adopt the islet for reimbursement under their pharmacy benefit, which is why the over 80% of covered lives under PBM agreements differs from the low 30% of our new patient starts that actually benefited from accessing the islet and its consumables through the pharmacy channel during the quarter. Driving adoption of the islet as a pharmacy benefit at the health plan level remains a core focus of ours, and that is why we share the percentage of new patient starts going through the pharmacy as the right KPI to use to measure our progress in that channel, not just the PBM Covered Lives percentage, which does not account for pull-through at the health plan level. Shifting now to gross margin, our gross margin in the quarter was 55.5% of 212 basis points compared to 53.4% in Q3 of 2024, and up 167 basis points sequentially relative to 53.8% in Q2 of this year. Last quarter, we guided towards sequential gross margin expansion in Q3 of this year relative to the prior quarter, citing benefits of increased scale and manufacturing volume leverage, greater contribution of high margin revenue from our growing pharmacy installed base, and continued cost discipline. We delivered in all those areas in Q3, and expect that each of those factors will continue to provide a tailwind to gross margin in Q4, as Steven will discuss in more detail shortly. Looking ahead, I'm confident in the direction this business is headed in. The islet's highly differentiated, fully adaptive, closed-loop algorithm is producing phenomenal real-world outcomes, and those outcomes are resonating with users, caregivers, providers, and payers. We're expanding availability for the islet and the pharmacy channel, enabling more people with diabetes to access insulin pump therapy with minimal to no upfront out-of-pocket costs. The 20 new territories we onboarded toward the end of Q1 of this year have hit the ground running, and they're validating our strategy to remain disciplined and highly selective in our Salesforce hiring as we look forward. With that, I'll hand the call over to Stephen to provide some additional color on our third quarter performance and full year 2025 guidance, and later wrap up the call with some important updates on our pipeline. Stephen?