Beta Bionics, Inc.

Good afternoon, and welcome to the Beta Bionics second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll 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 now like to turn the conference over to Blake Beaver, head of investor relations. Please go ahead.

Thank you. Good afternoon and thank you for tuning in to Beta Bionic's second 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 second 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, July 29, 2025. Therefore, if you are listening to the replay, any time sensitive information may no longer be accurate. Also on our website is our supplemental second 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'd 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 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 reconciliation of non-GAAP measures to their most directly comparable GAAP financial measure. Now, I'd like to turn the call over to Sean for some opening remarks.

Thanks, Blake. Good afternoon, everyone, and thank you for joining us for our second quarter 2025 earnings call. We're excited to share with you all today our financial results for the second quarter, as well as positive updates to our full year guidance for 2025. Starting with our performance in the second quarter, our team continues to execute at the highest level across all aspects of our business, and we made key advances commercially, clinically, and in our innovation pipelines. We continue to see robust demand for the islet, and our efforts to expand the islet's commercial reach resulted in a record number of new patient starts in the quarter in both the DME and pharmacy channels, and a record percentage of those new patient starts going through the pharmacy channel. In late June, we hosted our first Investor and Analyst Day, where we talked about the islet's place on the continuum of user engagement from hybrid to fully closed loop, and the continuum of system adaptation from static to adapted algorithms. The islet demands the least engagement from the user and delivers the most automated adaptation of any AID system, setting a new standard for our industry. We also highlighted the superior clinical outcomes of the islet with our real-world data through the first two years of islet's launch. We demonstrated that the islet drove meaningful changes from baseline HbA1c to follow-up glucose management indicator, or GMI, which is a proxy for A1c. Regardless of our user's baseline A1c group, prior therapy, or a level of engagement with the islet. We also shared outcomes for users treated by endocrinologists or primary care practices, and the outcomes were virtually the same. We're extremely proud of those data and believe that islet is the only pump on the market that's capable of producing those results across such a wide range of users and clinicians. It's important to remind you all that if we had a user's baseline A1C and at least three weeks of CGM data uploaded to our cloud, they were included in our real-world results. We've noticed a trend in our industry of sub-segmented data in ways that make it appear more favorable, sometimes in dramatic fashion. And we encourage everyone to read the fine print on these data sets to get a better sense of how populations are being sub-segmented in a way that skews the results. Beta Bionics is committed to providing fair and honest representations of our real-world data. And when we do sub-segment our data, we do it to highlight the performance of our system in our hardest users, not our easiest ones. In this way, we are not only setting a new standard with our technology, but also with our approach to sharing real-world results. In Q2, we also made some key strides in our innovation pipeline, which I'll dive into in more detail on later in the call. I've never been more confident that we're building a highly differentiated business that is poised to achieve success over the short, medium, and long term. Our team's dedication to our mission of delivering life-changing solutions that simplify and alleviate the burden of managing diabetes is stronger than ever. And we want to thank our community of users, healthcare providers, and caregivers in our Bionic universe that inspire us every day to achieve our mission. For today's call, I'll cover our Q2 results, which exceeded our expectations across the board. Stephen will provide some additional color on our performance in the quarter while highlighting positive updates to our annual guidance for the full year 2025. I'll discuss the recent CMS proposal for the 2026 Durable Medical Equipment Payment System, which has implications for durable insulin pumps and beta bionics. Lastly, I'll wrap up the call with key updates across our innovation pipeline, including MINT, which is our patch pump program, and then our biohormonal system. Starting with a brief overview of our Q2 2025 financial performance, I'm proud to announce that we delivered $23.2 million in net sales, which grew 54% year over year. In Q2, we saw 4,934 new patients adopt the islet, growing 57% versus the prior year. a high 20s percentage of those new patient starts were reimbursed through the pharmacy channel, which is substantially higher than the mid-single-digit percentage we saw in Q2 of the prior year and increasing relative to the low 20s percentage we saw in Q1 of this year. As a reminder, we believe the best metric to measure pharmacy coverage is the percentage of total new patient starts that were reimbursed through pharmacy, as opposed to percent of lives covered under formulary arrangements with pharmacy benefit managers, or PBMs. which doesn't account for adoption by the underlying health plans or the underlying logistics required to utilize this channel. As of July 1st, Beta Bionics has effective formulary agreements in place with all the major PBMs that operate in the U.S. While we're proud of that accomplishment, it does not yet mean that all of those patients are benefiting from the pharmacy channel. We'll continue to work with the health plans that partner with those PBMs to expand adoption of the islet under the pharmacy benefit, as we've been successfully doing over the last two years. Shifting now to gross margin. Our gross margin in the quarter was 53.8%, up slightly relative to 53.7% in Q2 of 2024. There are a few moving pieces that impacted our gross margin in Q2 that Steven will address in detail shortly. But overall, our gross margin in Q2 is indicative of our continued cost discipline across the business, as well as our ability to extract leverage from our fixed manufacturing overhead as we continue to build scale. As I mentioned earlier, these Q2 results exceeded our expectations across the board, and I'm proud of what our teams accomplished. There are a number of drivers to point to when it comes to our strong performance, and we expect all of them to continue to contribute to our performance going forward. The first driver to call out is the market's deepening appreciation for our highly differentiated, fully adaptive closed-loop algorithm. At the Investor and Analyst Day, we showed that the ILID delivered an average baseline A1C to follow-up GMI decline of 1.6% in the real world, a result that we believe is unique in the history of insulin pumping and even diabetes management more broadly. And we're generating those results in our true real-world population, meaning our entire user base for whom we have baseline A1C and at least three weeks of CGM data. This isn't a fractional, advantaged subsegment of our data. This is a representative, real-world population. With each quarter, we see the islet growing into new accounts and penetrating deeper into existing accounts, and there's still substantial runway. In Q2, we launched an update for the Bionic Portal, our healthcare provider portal, which now allows providers to access real-time clinical outcomes for their patients that are using the islet. The updated portal facilitates collaboration between providers in the clinic enhances the connection that providers have with their islet patients between visits, and enriches communications between providers and their patients during visits to the clinic. Initial feedback from islet prescribers has been overwhelmingly positive, and we're already seeing the Bionic Portal drive more rapid adoption of the islet at the provider and clinic level. As you may recall, in the second half of 2024, we launched three new products, including integration with Abbott's Freestyle Libre 3 Plus CGM, Color Islet, and the Bionic Circle remote monitoring app. These product launches continue to gain traction in Q2, and we expect their contribution to continue to grow in the second half of the year. In Q1, we expanded our sales force by 20 territories to bring our total territory count to 63. Those 20 incremental territories began selling in earnest in Q2. The last driver I'll mention is we're continuing to expand our pharmacy channel presence, enabling more people with diabetes to access insulin pump therapy with minimal to no upfront out-of-pocket costs. What I hope you all take away from this is that we're positioning Beta Bionic's core business for success today and tomorrow, all while making key advances in our innovation pipeline, which I'm excited to share with you in more detail later on during the call. But for now, I'll hand the call over to Stephen to provide some additional color on our second quarter results and discuss our increased full-year guidance for 2025. Stephen?