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Image source: The Motley Fool. Wednesday, July 29, 2026 at 4:30 p.m. ET Head of Investor Relations - Blake Beber Chief Executive Officer - Sean Saint Chief Financial Officer - Stephen Feider Operator: Good afternoon and welcome to the Beta Bionics Second Quarter 2026 Earnings Conference Call. Please be advised that today's conference will be recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. Blake Beber: Good afternoon, and thank you for joining Beta Bionics Second Quarter 2026 Earnings Call. With me on 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 second quarter 2026 results will be available on the Investor Relations section of our website. Information recorded on this call speaks only as of today, July 29, 2026. Therefore, if you are listening to a replay, any time-sensitive information may no longer be accurate. Also on our website is our supplemental second quarter 2026 earnings presentation and uploaded 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. With that, I'd now like to hand the call over to Sean. Sean Saint: Thanks, Blake. Good afternoon, everyone, and thank you for joining. Getting down to business, today we're going to cover our financial results for the second quarter, updated guidance for the full year of 2026, and some recent developments in our innovation pipeline. Starting with a brief overview of our Q2 performance, we delivered $32 million in net sales, which grew approximately 38% year-over-year. Q2 revenue growth was driven predominantly by growth in new patient starts, as well as our growing installed base of users who continued to access their monthly supplies for the iLet through the pharmacy channel and who we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel was a high 30s percentage, similar to the prior quarter. Our gross margin was 59%, expanding 524 basis points year-over-year. Before I hand the call to Stephen, I want to highlight a very important update for Q2. We published our real-world data on our company website, and it's publicly available for all to see. This data is refreshed continuously and openly in near real-time, without filters or fine print. If an iLet user has a provider-reported baseline A1C and at least 2 weeks of data uploaded to our cloud, they are represented on that dashboard. No exclusions applied. Too often in our industry, it has become the norm to publish real-world data that doesn't show the whole picture. Selective populations, optimized settings, no baseline comparators, short time periods, strict exclusion criteria. These are all ways that real-world data in our industry has become disconnected from the real-world experience and unrepresentative of population health statistics. I don't want that point to be missed. Any data set can be sub-segmented to show how well a system worked in a narrow set of users, and then marketed as what that system is capable of. However, Beta Bionics believes that all people with diabetes deserve great clinical outcomes with minimal work required. So we're setting a new standard in data transparency. The data you see isn't what our system is capable of in a narrow set of users. The data you see is what our system, in fact, does across our broad population. We believe that this is the right way to share real-world data because we're making it easier for healthcare providers, people with diabetes, payers, investors, and anyone else who's interested to evaluate our outcomes with confidence. We have received very positive feedback on the dashboard and we view that feedback as a reflection of the positive experience that the iLet is delivering on the market today. With that, I'll hand the call over to Stephen to provide some additional detail on our second quarter performance and our full year 2026 guidance. Stephen? Stephen Feider: Thanks, Sean. Our revenue performance was mainly driven by new patient starts and the recurring revenue generated from our growing pharmacy installed base. New patient starts increased more than 10%, but less than 20% compared to the prior quarter, consistent with our expectations. We continued to expand the insulin pump market as approximately 69% of our new patient starts came from people utilizing multiple daily injections prior to starting on iLet. A high 30s percentage of our new patient starts in Q2 accessed iLet through the pharmacy channel, consistent with our expectations, and we continue to retain our pharmacy installed base at a high level. Moving on to gross margin, Q2 gross margin was 59.0%, declining 45 basis points relative to the prior quarter and increasing 524 basis points relative to Q2 2025. Our gross margin exceeded our expectations, primarily driven by the high margin recurring revenue generated from our pharmacy installed base and a lower than expected warranty rate. Importantly, Q2 did not benefit from the kind of 1-time tailwind that benefited Q1, so we view 59% as a clean read on our underlying gross margin profile and a solid base for continued expansion. Total operating expenses in the second quarter were $44.5 million, an increase of 37% year-over-year. The increase in sales and marketing expense compared to both the prior quarter and the prior year was driven by the continued expansion of our field sales organization and increased marketing investments. In Q2, we achieved our previously stated goal of expanding by at least 20 sales territories in 2026. We expect these new sales territories to contribute more meaningfully to new patient starts in the second half of the year. On R&D expenses, the increase relative to the prior year is driven by the Mint and bihormonal projects. The increase in G&A expenses relative to the prior year is driven by continued efforts to scale the company in support of commercial growth and pipeline initiatives. As of June 30, 2026, we have approximately $225 million in cash, cash equivalents, and short and long-term investments. We believe we are sufficiently capitalized to fund all of our key initiatives and remain well positioned to generate free cash flow well ahead of historical diabetes peers. I'd now like to discuss our updated full year 2026 guidance. We are reiterating our guidance for total revenue of $131 million to $136 million, as well as our expectation that 37% to 39% of our new patient starts will be reimbursed through the pharmacy channel. On gross margin, we are raising our full-year outlook to 58.5% to 59.5%, up from our prior guidance of 57.5% to 59.5%. This updated outlook reflects our strong first half performance, the underlying gross margin profile I discussed earlier, and our expectation for continued contributions from our pharmacy installed base, along with the increasing manufacturing scale throughout the year. As we set our guidance, we also considered the benefit from 1-time tailwinds in Q1, while recognizing that neither Q1 nor Q2 were impacted by meaningful one time headwinds. Although we do not currently expect any notable headwinds in the second half of the year, we believe it is prudent for our outlook to reflect a variety of potential outcomes. To briefly comment on operating expenses, we expect a modest increase in operating expenses in the second half of the year relative to the first half, driven primarily by higher sales and R&D expenses. The sales expense increase reflects the impact of the sales territories we added during the first half of 2026, which will carry their full cost in the second half of 2026. We do not expect to further expand our field sales organization during the second half of the year. Sean, back to you. Sean Saint: Thanks, Stephen. To wrap up the call, I'll briefly touch on our remediation efforts regarding the FDA warning letter we received in late January, and then highlight some key updates in our innovation pipeline. Regarding the warning letter, the company has made considerable progress in remediating the systems that we believe were central to the agency's concerns. As we have previously stated, the 2 major focus points of the warning letter, the complaints handling system, primarily our definition of reportable complaints, as well as our post-market surveillance systems, are both heavily revised and we believe will meet the agency's expectations. Now, turning to our pipeline, starting with Mint, our patch pump in development. We recently updated our expected timeline to achieve full commercial launch by the end of the second quarter of 2027, subject to regulatory clearance by the FDA. This reflects the FDA's initial feedback on our Mint ACE Pump 510(k) submission, as well as the significant progress we've made in manufacturing readiness. We recently retired our manual manufacturing line, built out a new cleanroom, and now have our semi-automated production line operating in that cleanroom. This marks an important milestone in preparing for commercial scale. As our launch plan is built around these semi-automated lines, we believe we're well positioned to support anticipated demand at full launch and as adoption grows over time. We remain confident in our path to FDA clearance and in our ability to manufacture Mint at scale. We believe Mint has the potential to redefine the patch pump category and become the leading automated insulin delivery platform in the market. And we're excited by the progress we're making towards bringing it to people living with diabetes. Additionally, we're excited to really begin having a more in-depth discussion as to what constitutes a good patch pump, or in other words, what users want in a patch pump. We think it's impossible to have this conversation with only 1 product on the market. It's only when 2 or more products exist that true comparisons can begin to happen. We're excited for Mint's potential to thrive in that conversation, given our confidence in the architectural decisions that we've made, including the 2-part design and importantly, the steel cannula. For our bihormonal system in development, in Q1, we initiated a Phase 2a feasibility trial to stress test and iterate the system. During that trial, we identified 2 key opportunities to improve the system, 1 focusing on the glucagon asset's excipient profile and the other focusing on the dosing algorithms. Beta Bionics is in a unique position here. We're defining what bihormonal glucose management is all about. Is it about greater time in range or complete freedom from hypoglycemia or somewhere in between? It's this conversation that we are exploring, which is our responsibility as the developers of the fundamental technology. We expect these iterations to take less than 1 year prior to initiating additional Phase 2a trials. We continue to believe the bihormonal system has the potential to be a transformative innovation for people with diabetes, which is why our commitment to the program has never been stronger. Lastly, on our innovation pipeline, I want to cover 2 opportunities where the iLet is already being used today by providers and patients, albeit off-label. The first opportunity is in Type 2 diabetes, where we estimate that greater than 30% of our new patient starts in Q2 were Type 2. We recently gained alignment with the FDA in a pivotal trial design that may enable indication expansion for the iLet to include adults with Type 2 diabetes. The pivotal trial is being conducted on real-world iLet users with Type 2 diabetes, and we initiated enrollment in July. We ultimately expect to expand iLet's indications for use to include adults with Type 2 diabetes in the U.S. around mid-year 2027, subject to regulatory clearance by the FDA. The second opportunity I want to highlight is pursuing a fully closed-loop indication. I've discussed in the past that a meaningful proportion of iLet users choose to operate the device off-label in a fully closed-loop manner, meaning they announce less than 1 meal per day on average. We've highlighted the clinical outcomes associated with the use of the iLet in a fully closed-loop manner and those are available in our most recent Corporate Presentation on the Investor Relations site. In the coming quarters, we intend to initiate a fully closed-loop pivotal trial in Type 1 and Type 2 diabetes and pursue the indication formally with the FDA. However, we are not committing to a specific timeline for commercialization at this time. I want to leave you all with 1 key message from today's call. We believe we're building the foundation for a category-leading diabetes technology company. Our commercial business continues to gain momentum. The iLet is resonating with customers and delivering outstanding clinical outcomes. Our pharmacy strategy is working. And with our expanded field organization, we expect to continue increasing awareness and adoption. Looking ahead, the opportunity becomes even more compelling. We expect Mint to launch in less than 1 year, pairing a differentiated patch pump with what we believe is the most advanced insulin dosing algorithm available. Around mid-year '27, we expect to expand the algorithm's indication for use to adults with Type 2 diabetes. And beyond that, we plan to raise the bar with our bihormonal system. We believe the years ahead represent the most exciting chapter in Beta Bionics' history, and the team is committed to bringing these life-changing solutions to people with diabetes. I want to close today with a heartfelt thank you to our team. As you've seen in today's call, we have a lot of initiatives going on as a company. We believe we have a category-leading product pipeline with a fraction of the resources. Said another way, we believe we're doing more with less, and that is all about our team. I just want to remind each of them that I appreciate it, as does the broader community of people with diabetes. You guys rock. With that, I'd like to thank you all for joining today's call, which will now open for Q&A. Felipe Lamar: Hey, it's Felipe on for Rich. Just starting with the live portal data, I mean, that's a huge feat. You're maybe the first one to actually put live patient data up online for providers to see. I guess, like, what are you doing to make sure that prescribing physicians are seeing that data? And then just 1 follow-up. Sean Saint: Yes, great question, Felipe. We are absolutely telling the healthcare provider community about this. They've always been able to see their own clinics in our healthcare provider portal, so they've had access to this for a while. But in this new portal on the website, you can see the entirety of our user base. But absolutely we're showing them that with our field sales team, but it's absolutely as much about users and others being able to come and take a look at that data there, people who don't have access to our healthcare provider portal. So I'd actually say it's primarily for different audiences. Felipe Lamar: Great. And then, on Mint, some of your competitors have nitpicked the steel cannula. I guess, can you remind us, like, what percent of patients on durable pumps, or if you have an idea of what percent of patients on durable pumps are using steel cannulas versus maybe soft cannulas and why that maybe isn't really a problem for a patch pump? Sean Saint: Yes, that's a good question. I do have an idea of what that mix is with durable pumps. For Beta Bionics, that mix, and I'm not going to give specifics, but I will say for Beta Bionics, that mix is quite a bit more heavy toward the steel cannula side of things. We believe in the durability of those systems. We believe in the comfort of those systems. And I think if you go back and look at the evolution into, "soft cannulas", they weren't about comfort. I think there's an underlying expectation that steel must be more -- more uncomfortable. But the reality is that a steel cannula is a much smaller system. It's a much smaller diameter system. And in our case, we're looking at the size of an insulin needle, right? Like a traditional insulin pen needle. So what I would encourage you to do is look at somebody taking an injection with an insulin pen and look at the reaction versus a person inserting a "soft cannula" of any description, whether it be an infusion set or 1 of the patch pumps that may be available, and then tell me what the reaction was. So there's a lot of things that go into these decisions, but we are firmly convinced that our system is going to be an advantaged system from user experience. I want to be real careful here because I don't want to make any claims, but that being said, we have all the beliefs in the world of it. And we look forward to being able to talk in more detail about that. And as I said on the prepared remarks, having that head-to-head comparison, right? Right now, people are criticizing this decision of ours. But what we look forward to is a day when somebody has tried the competition, tried us, and then we just ask them, which 1 did you prefer? And we know where the answer lies, because, newsflash, we've used both. Matthew O'Brien: Just for starters, Sean, maybe just on the -- Sean or Stephen, on the pharmacy side of things here in Q2, I know the new patient start numbers were good through the pharmacy, but the supplies number was a little bit lighter than expected. Can you talk about that dynamic? And what I'm really trying to get at is during the back half of the year, should we expect more of the revenue coming from DME for the full year guide and then maybe starting to flip more aggressively towards the supply side as we head into '27? And then I do have a follow-up. Stephen Feider: This is Stephen. Hey, Matt. The softness that you're seeing in pharmacy supply revenue in the second quarter is driven by what I call a stocking dynamic from our pharmacy customers. And what I mean by this is that our pharmacy customers ended the second quarter with less pharmacy supply inventory on their shelf than they did at the end of Q1. So the patient demand for pharmacy supplies was consistent with our expectation. The retention on the product is still strong. The new patient starts going through that channel were in line with our expectations. But the actual revenue can be pretty dramatically impacted based on ordering patterns from the pharmacy customers. And that's what drove that dynamic. So nothing notable about the actual business and performance from patients. Matthew O'Brien: Okay. I appreciate that. And then, Sean, 1 of your competitors that's coming into the patch market has kind of put a bogey out there of being able to supply about 10,000 patients when they launch. Is that a guidepost we can use for Beta, or do you think we should anchor to something less than that or even more than that? Sean Saint: Yes, I'm not going to comment at this time on our actual expectations or specifics to our supply or expected supply. Yes, sorry, it's just something we haven't commented on as of yet. Stephen Feider: What we can reiterate that we've said in the past is we have our own expectations by the end of Q2 '27 for Mint in terms of what demand will be. And we are anticipating the ability to be able to fulfill that level of demand. So embedded in our full commercial launch guidance is, again, our expectation of demand and feeling confident that we will be able to fill that. Now, in the event that demand massively exceeds our expectations, then we could be wrong. But the commercial launch that we're describing is not slowly dripping this product into the market. It's at that time, it's the full launch. Patrick Wood: I'll keep it to 1. You always get all this clinical data and see a ton of it. And I'm sure people appreciate you putting it out there. I'm curious, particularly for the Type 2 patients, have you been surprised by anything in relation to how they've been using iLet, whether it's units or having more patients who are not exactly basal, but let's say higher up the acuity curve rather than somebody using a huge amount of units further down. Is there anything you could learn from the data in that Type 2 cohort that surprised you at all in terms of how patients are using it? I hope the question is clear. Sean Saint: Let me clarify, in terms of how they're using it, are you referring primarily to meal announcements, which of course for us is essentially the only interaction that you have, but you did refer to units. I'm not sure if you mean units per day. Yes, can you clarify, please? Patrick Wood: Yes, just total amounts of units used. You can kind of infer, I guess, obviously Type 2 being essentially a progressive condition, how far down the curve they are. Does that make any sense? Sean Saint: Oh, yes. So I think what you're trying to get at is, there's, I think, an expectation of Type 2 that the farther down the curve you are the more insulin you use. You're probably trying to get an idea of whether or not we're getting the early stage or late stage Type 2... Patrick Wood: You got it. Sean Saint: Got it. It's a great question, and I don't have off the top of my head average units per day in our Type 2 population. But what I can say is that the iLet has -- we've made a number of design architecture decisions on the product, 1 of which is our cartridge, which is about 180 units. And that decision has been acceptable to our user base, of course. So that means sort of 1 of 2 things. One, either the -- the average units per day is comparatively low or it means that despite the heavier usage that you're traditionally -- you're used to in seeing, our cartridge change procedure is quite acceptable in that group. So -- but with all that being said, I have an idea of it and it's not insane. I mean, yes, I don't want to comment specifically. I'm not sure it's, I find it more interesting to talk about our meal announcement, um, behavior on iLet users than I do total daily dose. Stephen Feider: Patrick, congrats on the new gig. Sean Saint: Oh, yes. Stephen Feider: Really nice to have you covering us. Jordan Bernstein: Jordan on for Jon here. Just thinking about as the year progresses on new customer starts, nice beat here relative to our model in 2Q. As we think over to 3Q, should we think about that being a step up from 2Q, but maybe a steeper slope 3Q to 4Q? In any color, that would be much appreciated. Stephen Feider: Hey, Jordan. Yes, Q3 will be a step up from Q2, but the specifics of where new patient starts will end up or what's embedded in the guidance in terms of new patient starts relative to prior quarters, I don't want to comment on. But yes, we're expecting a step up. We added more than 20 new territories in the first half of the year. Most of those territories start generating demand for the business. And our new territories start generating demand for the business in roughly 1 quarter. And again you'd expect that to make an impact in the third and fourth quarter. Jordan Bernstein: Makes sense. And then my follow-up is just on that pharmacy dynamic that you were discussing before on the stocking and there seems to be some less pharmacy supply on the shelf. Is that something that you'd call industry-wide or company-specific, just kind of in the context of a new competitor entering that channel here throughout the year trying to figure out if you could provide some more color on that? Stephen Feider: It's very company specific is the short answer. If you even look at the history of our pharmacy revenue and as related specifically to supply, the pharmacy stocking dynamic has fluctuated from quarter to quarter, sometimes semi-dramatically, and it's not fully predictable. And so we generally comment proactively if there's a major impact to pharmacy or from stocking. But point is, you could have another company selling something similar or 1 of our competitors selling something similar to similar customers and our performance wouldn't necessarily dictate what their particular performance was in terms of stocking in the exact same quarter. So it's very company specific. Michael Kratky: Can you talk about what ultimately prompted your strategic decision to pursue the pivotal trial of iLet in Type 2? It seems like you've been getting good traction there without it. And then just as a follow-up, can you confirm whether we should expect Mint to also be commercially available for Type 2 as part of that mid-2027 expected timeline? Sean Saint: Yes, great question, Mike. So we've been commenting for a number of quarters that we had Type 2 plans, we just weren't really commenting on them. And exactly to your point, we have had quite a bit of success in the Type 2 space. And for that reason, we didn't feel it was the right thing to do to go and run a traditional trial in that space with the expense and the timeline and everything else. So we had already seen the outcomes that we were getting in Type 2. So there was a process of working with the agency to kind of compromise on the right data that was required for iLet specifically in order to get that indication. And as we commented in prepared remarks, we did come to an agreement on that. We are looking at our current iLet users, but enrolling them in a trial. So that's really what that was about. But why did we do it at any level? Because we're having a ton of success, but we'd love more. And certainly being able to comment on that and sell it publicly is something that we'd like to be able to do. We've achieved the level of success we have without doing that. So it was the right thing to do for us and it's a pretty modest investment considering how we've chosen to do it. And yes, Mint and Type 2. Let me make sure I don't get this wrong. Mint itself, the submission on Mint is an ACE pump submission. The pump side of things have historically been approved for people with insulin-dependent diabetes mellitus, right? It's the algorithms that have been specific to Type 1 or Type 2. So to the extent we get a Type 2 indication on our algorithm, that algorithm will be paired with Mint, and yes, Mint at that time would carry a Type 2 indication as well. The Mint system writ large, meaning Mint hardware, with the iLet algorithm. Mathew Blackman: Maybe, Sean and Stephen, just from a high level, how did the quarter play out on pumps shipped? I know you said in line with expectations, but I think you probably appreciate there's a lot of background noise in med tech and utilization with coverage changes and perhaps macro headwinds. Just wondering, are you seeing or hearing any of this and the fields that bleeding into diabetes at all? And then I've got 1 follow-up. Stephen Feider: I'll just reiterate that we did think the quarter's new patient starts performance and revenue performance in line with expectations. There was nothing that we saw about Q2 market dynamics-wise or traction with our product that changed our guidance. So I suppose in that respect, everything was, again, consistent with what we expected, and that includes anything related to public policy that may be a perceived headwind. We're just not seeing any of that. Mathew Blackman: Okay, I appreciate that. And then, Stephen, I'm going to push a little bit, reflecting on your scripted comments, but also in response to 1 of the questions asked, as we think about the 3Q and 4Q case, and I appreciate you don't guide quarterly, but given that you are onboarding and have onboarded new reps, and I think you said it takes about a quarter for them to ramp to productivity. As we think about just the pump shipped cadence, is it potentially going to be a little bit more heavily weighted to the fourth quarter than prior years, or no, last year is still a good proxy for how we think about the shape of the back half of the year? Stephen Feider: Yes, sorry. Mathew Blackman: You want me to go at it again? Stephen Feider: No, no, Sean just clarified the question for me. Yes, so shoot, now I can't remember. I can't remember. Can you restate the question, Matt? Mathew Blackman: I'll give it another shot. So I think historically, recently, this year you told us to use 2025 as sort of a guidepost from a cadence standpoint, percent pumps shipped per quarter or revenue per quarter. And so I know you don't guide quarterly for the third and the fourth quarter. This year is a little bit different. You've onboarded a bunch of new territories. It takes a little of time for them to ramp to productivity. So my question is, as we think about the third and fourth quarter, the shape of the third and fourth quarter for 2026, is 2025 still the right guidepost to use in terms of how we should think about the rest of the year playing out? Or no, maybe it's a little bit more fourth quarter weighted just given the dynamics of bringing on a sales force, incremental sales force, and driving productivity gains as they work through the back half of the year. Stephen Feider: Got you. Yes, the shape that we saw in 2025, generally consistent with what we're expecting in 2026, there's 2 primary factors driving that. One is that the sales territories that we added in the first half of 2026, we expect, and history would suggest this for us, or validate this, I should say, that the territories will start to get more productive in their second, third, and quarters beyond, meaning the fourth quarter they've had a longer tenure, they've been at Beta Bionics for longer, and thus we would expect them to be more productive. In addition, fourth quarter tends to be seasonally more favorable relative to Q3. Now that seasonality is muted for reasons that we've explained in the past, driven by the pharmacy dynamic. But those are kind of the contributing factors, I would say, for how we would see the new patient starts growth in the back half of the year. Maggie Starker: This is Maggie on for Jeff. I was wondering what you guys are seeing on the competitive front at present. One newer company that has come to market with a fairly sizable sales force just in the past 6 to 12 months and then another company that is newly independent and has made improvements on their own front. Are you guys seeing any sort of pause from physicians, anything from your field sales rep, that it's getting harder to win across accounts? Sean Saint: Yes, great question, Maggie. No, I don't really think so. I mean, I think that, we're obviously aware of the 2 competitors that you mentioned or alluded to. In 1 case, actually I would say in both cases, they represent pretty different products to what Beta Bionics is offering. And I think this is a really important point that I don't want to be missed. We've been continuing to educate the market on what iLet is over the last several years. And it does represent a highly differentiated offering as compared to what some of those other companies are doing, especially the ones that are more on the side where settings are important. And you can see that in some of the sub-segmented data that I referred to in my prepared remarks. If you're talking quite a bit about your outcomes and the settings required to get that, that's exactly what we're not doing. And that's why we see Beta Bionics as a sort of a population health tool, something everybody can get or most people can get a good result with. Those other products you mentioned are a little bit the other end of that spectrum. They require quite a bit of aggressive interaction. And -- so said another way, the target iLet patient is not necessarily a person who would really be striving for a system like that in general. And we also think that over time though, people who actually think they want that kind of system will ultimately realize they don't love managing their diabetes and pivot more our way. But that's a long way of answering the question and saying no, we're not really seeing -- they're not pulling our target patient away from us in any way. Not seeing it. Michael Polark: I'm curious for color on the 20 new sales territories. Are these folks opening portions of the country that previously were not open for iLet? Or are you splitting geographies going deeper in key places? What's the -- those 20? How are they focused and what is similar or different to the mandate for the existing rep base? Sean Saint: Yes. Good question, Mike. So the way I would describe it is this. Beta Bionics really hasn't had much what we call white space, meaning areas without a sales rep at all for quite a while at this point. So from that perspective, all of these new territories do represent territory cuts. However, it is also true that if you're a rep with a large territory, especially geographically large territory, you're going to have a very hard time getting to some of your target accounts, right? You're going to be focused more in, the large city nearest your home, for example. So from that perspective, this will ultimately be -- will ultimately result in stores that never had a rep visit them starting to visit them at this point, which looks more like a new territory. Where that overlaps is when you cut a territory to the extent that a particular account that was previously writing is now in a new territory's area, that rep is incentivized to go visit that account first. They were previously writing. They want to shore up that account. They want to make sure they don't stop. That can be a disruptive experience for that account, and we want to make sure we don't provide that. So they're going to start there and they're going to then expand into sort of new store sales, if you will. So it falls somewhere in between just a complete territory cut where the previous territory was completely visited, which wasn't true for us, and a net new territory, which it really isn't there either. Hopefully that's helpful. Michael Polark: Follow-up on that, and then I have a proper follow-up. Has the splitting happened in Q2 or is that a 2H project? Sean Saint: Yes, it's happened in Q2, or in the first half of the year. Michael Polark: The follow-up maybe for Stephen, in your prepared remarks you mentioned, lower warranty expense is 1 of the gross margin good guys. I just want to understand that dynamic. Is there something to read there positively about retention or that's an over read? I would welcome any further color on that mention. Stephen Feider: The reason warranty expense has gone down or the warranty rate has gone down is we made the screen stronger. So when we first launched the iLet, it was shipping with a version of a certain screen strength. And then we've since upgraded the screen to what's called Gorilla Glass 3 to get technical, and now the screen is breaking far less frequently. So that's the impact on gross margin. A second order impact of that could certainly be retention, although that's a little hard to measure, meaning like the screen's breaking less often, patients are happier, how less often are they attriting? I don't know exactly what that metric is, but yes, absolutely. It's a better patient experience if the iLet is breaking less frequently, and that did have a favorable impact on gross margin. Stephanie ELGHAZI: I wanted to follow up on the new patient starts this quarter. It looks like the quarter-over-quarter growth of mid-teens at the midpoint that you shared is below the typical historical trend, Q1 to Q2. Is there anything to call out there, or is it just hard to call history a trend given the initial launch period? Stephen Feider: Well, I'm not sure I exactly agree with your math necessarily, you're calling this particular quarter down relative to a trend in the past. But again, this particular new patient start quarter met our expectations, and I guess I'll just leave it there. Stephanie ELGHAZI: Got it. And then on the Mint manufacturing capacity and being able to meet demand at the launch, just any progress you can share on the confidence you have driving that, and just where you're at now with getting ready for that capacity and what may be left to do. Sean Saint: Yes, definitely understand what you're trying to get at. I think that in general, we've provided a number of updates lately that are the reasons for our upgraded confidence here. Obviously, we talked about the submission of our 510(k). We talked about our cleanroom construction. We've talked about our semi-automated lines being up and running so much so that we've retired our manual lines. In the past, you've heard me talk about our progression from manual to semi-automated. That would be our launch configuration and followed by fully automated lines that would come on in the future. Those are a very long lead item. So, without getting into the exact details of our production rates and our yields and everything else, I think I'll just say that, trying to give a little bit of color today on where we are and obviously we see the underlying numbers and we -- based on the timelines to launch here, we're feeling good. We're seeing what we need to see at this stage. This is not our first product launch ever and we're seeing what we need to see to be able to continue to make that statement. So hopefully, that's helpful. Jeffrey Cohen: Just 1 follow-up on manufacturing. Can you hypothesize with us regarding margins and how you may think that plays out on Mint and how that might compare to iLet with the increased efficiency and the automation? Stephen Feider: Yes, just so I make sure I don't answer the wrong question, Jeff, you're asking about Mint gross margin profile after we launch it? Jeffrey Cohen: Yes, what you would anticipate, yes. Stephen Feider: Got you, thank you. Well, without giving you a specific number for gross margin that we're targeting or an outlook that we're targeting, I'll just say this. Manufacturing cost was very much embedded in the design of Mint, meaning the ability to manufacture and the corresponding cost, so like you mean the reliability of it, yields and the corresponding cost of the actual device itself. And that's why we've done the 2-part architecture where we have a reusable portion of the device, which is replaced every 2 years. And that's where all the expensive components live. And then the actual component of Mint that gets thrown away every time a patient changes his or her insulin is actually quite inexpensive in terms of the bill of materials, because all it is batteries, cannula, the syringe, and the adhesive with, of course, a few other components. But again, all the expensive components in the reusable portion. So at any level of real scale, meaning millions of parts manufactured or millions of Mints manufactured annually, our gross margin profile on Mint, we believe will be advantaged relative to the patch pump competition. And again, that's because of our design. And so that gives you some directional sense as to what kind of gross margin profile we're talking about. And also embedded in that too, is the CapEx associated with getting the Mint production capacity to the level that's required. It's reasonably CapEx light, especially the first phase of Mint's manufacturing development, where it's semi-automated. That is very CapEx light. There's more labor costs, of course, that's the trade off. But then as Mint capacity grows in the future and we move to full automation, more CapEx, but still reasonably light relative to numbers you're familiar with from our competition and then labor costs, it drops out of it. So hear from all this, that cost is very much at the forefront of all decision making. User experience being number 1, but cost right there in the Mint design. And that's part of how we're going to be building a profitable market leading company. Felipe Lamar: Hey guys, sorry, it's Felipe. Just 1 follow-up. This is like the second or third quarter that multiple durable pump players are moving into the pharmacy channel, so I'm just wondering if you could give us an update. Are you seeing any changes? You're the furthest along of those players. Are you seeing any changes in your conversations with the PBMs? Are PBMs more open to coverage, I guess, like what kind of changes are you seeing? Sean Saint: Yes, great question. I think that multiple players moving in here definitely helps everybody. It becomes -- the conversations become more normal at some level. It becomes -- nobody wants to do anything out of the ordinary, right? So the more of us do it, the more -- it's going to be easier for those that follow. We did pave this road a little bit, at least on the tubed pump side, and that's okay. But yes, I mean, we're happy to have everybody. I think that ultimately the pharmacy channel benefits people with diabetes, and yes, it is getting a little easier to do as we do it and as we provide a roadmap to have it done. Are the conversations evolving? Mildly. I guess there's just a little bit more -- a little bit more understanding of what it is that we're doing. But beyond that, no. There's no seismic shift here. Stephen Feider: Yes, I think maybe 1 other point I'd add is we've always desired to have the iLet reimbursed in the pharmacy channel as the predominant reimbursement strategy in the long term. And I think what actually helps that strategy is other tubed insulin pump companies moving towards pharmacy. And in order for that vision that I've just described to be fulfilled, I don't think it can just be Beta Bionics being the only company that's prioritizing pharmacy or preferring pharmacy as their reimbursement path. And so, yes, maybe it creates, like, in the short run, a small bit of negotiation over time with the PBMs and the decision makers at the PBMs because there's more pump companies. But, look, we like our differentiation and our ability to win those discussions. And then in the long term, this is absolutely healthy for a company like us that wants our product to be reimbursed in pharmacy. And that goes for iLet and Mint, of course. Frank Takkinen: I'll follow up on the pharmacy channel questions in slightly different context. I know we've talked about in the past 1 of the gating factors to getting Mint broadly adopted and having that unconstrained launch is really the pharmacy channel contracting. Can you remind us and walk us through how that process will go once you have that approval or if you need the approval prior to those contracting discussions, and then how should we think about that kind of impacting the launch cadence? Stephen Feider: Hey, Frank. Yes, look, iLet's position with pharmacy PBMs, meaning the relationships we have, the contracts that we have, and then the underlying health plans is absolutely the runway that will help us get coverage for Mint significantly faster than if we didn't already have iLet on the market. So in some cases, these are the exact same agreements with the PBMs, with the underlying plans, with an amendment to add a new NDC code. In other cases, it's a new agreement, but the point is we've already convinced Chief Medical Officers or the decision makers at these respective accounts of the merits of iLet clinically and the users and what their experience is on the device. And so there's no new sales process from 0. All we have to do is convince them that what our hardware is, why it's differentiated, why they should cover what the predicate is. And so that's -- I can't really understate how important that is for us to be able to have coverage that we'll feel good about at launch. Now, I guess CFO answer here. The other side of this is like, what I don't want you to hear is that we will have the level of pharmacy coverage that our patch pump competitor will have on day 1. That will take us time. And I think it's actually really helpful that road has already been paved that we can follow, but we will not right out of the gate have the same level of coverage that they have. But I think, look, there's other -- I'm just going to take a quick moment to make the point how set up Beta Bionics is for Mint and how -- I guess, well positioned the company is and this plan that we've laid out years ago, how well it's playing out. And pharmacy coverage is only 1 part of that. But you think like a company like us with a proven algorithm, proven in terms of clinically, that has confidence from healthcare providers, has confidence from patients, truly differentiated in terms of what its value proposition is. We talked about pharmacy reimbursement and how we've already become experts in that particular area that matters. We have a commercial infrastructure in place, a brand that's well recognized, and this is all exactly how you would draw up a launch for a product like Mint. And, I guess, so if you can't tell, we're kind of -- we're excited about it. And I guess, Frank, just coming back to the pharmacy point, I appreciate you asking. Sean Saint: Small follow-up, just a very specific answer to your question, Frank, and I love Stephen's answer there. In answer to your specific question, do we need approval prior to signing these agreements? The answer is sometimes. But we don't need it to go out and start doing the work. And part of that work, as Stephen said, was laid by iLet. Additional work is being done now. I'll leave it at that. Frank Takkinen: Okay, that's helpful. And then just a big picture question, and not sure if you'll be comfortable commenting on this or not, but I'll try. How should we think about the leverage profile coming back into the model? Obviously, investment is first and foremost today, and we're seeing OpEx going to grow at about the same rate of sales, if not sometimes a little bit faster. When should we see that lines cross where that revenue growth starts to really outpace the OpEx investment? Stephen Feider: I love the question. As you know, I haven't communicated a specific number for where we start generating free cash flow. So I'm not going to today. But look, what's become the expectation for diabetes med tech companies in particular in terms of what revenue scale or what revenue is required in order for you to start generating free cash? Don't use that when you're thinking about Beta Bionics. We're in a different universe in terms of what our expectations are for ourselves and what revenue level is required. And I guess just also hear that profit and free cash flow generation and returning that to shareholders is just a core principle that are in Sean and I in building companies. And yes, I guess you're just going to have to take my word for it and look at our history and what we've done. But I won't particularly -- pick a particular level, we'll start generating free cash, at least for the moment. Sean Saint: I'll just say I appreciate everybody's time and understanding today and willingness to dig in. We're excited and hope everybody sees that in our comments today. With that, I'll close it. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of approximately 38% year-over-year was driven by new patient starts and high retention within the growing pharmacy-based installed base. Gross margin expansion of 524 basis points year-over-year to 59% was attributed to high-margin recurring pharmacy revenue and lower-than-expected warranty rates due to hardware durability improvements. Management launched a real-time, unfiltered public data dashboard to set a new industry standard for transparency, countering the 'selective populations' and 'optimized settings' often used in competitor data. Approximately 69% of new patient starts transitioned from multiple daily injections, indicating the iLet system is successfully expanding the total addressable insulin pump market. The company achieved its 2026 goal of adding at least 20 sales territories in the first half of the year, focusing on increasing account penetration in previously underserved geographies. Management reported significant progress in remediating the FDA warning letter, specifically regarding complaint handling and post-market surveillance systems. The Mint patch pump commercial launch is now targeted for the end of Q2 2027, supported by a transition from manual to semi-automated manufacturing lines to meet anticipated demand. Full-year 2026 gross margin guidance was raised to 58.5%–59.5%, reflecting confidence in manufacturing scale and the clean margin profile established in the first half of the year. Type 2 diabetes indication expansion for the iLet is expected around mid-year 2027, following a pivotal trial design agreement with the FDA that utilizes real-world users. Operating expenses are expected to increase modestly in the second half of 2026 as the full cost of the expanded sales force and R&D for bihormonal projects are realized. Bihormonal system development is undergoing iterations to glucagon excipients and dosing algorithms, with additional Phase 2a trials expected to initiate within one year. The company retired its manual manufacturing line in favor of a new cleanroom and semi-automated production line to prepare for the Mint patch pump launch. Warranty expenses decreased due to a hardware upgrade to Gorilla Glass 3, which significantly reduced screen breakage rates and improved the user experience. Management noted that while Q1 benefited from one-time tailwinds, Q2 represents a 'clean read' of the underlying business performance with no major one-time headwinds expected in the second half. A meaningful proportion of users are operating the iLet off-label in a 'fully closed-loop' manner, prompting plans for a formal pivotal trial to seek FDA clearance for this use case. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management defended the steel cannula choice, noting it is smaller in diameter than soft cannulas and offers superior durability and comfort based on internal testing. They anticipate that head-to-head user experience comparisons following the Mint launch will validate their architectural decisions over competitor soft-cannula systems. A perceived softness in pharmacy supply revenue was attributed to a 'stocking dynamic' where customers ended Q2 with lower inventory levels compared to Q1. Management clarified that patient demand and retention remained strong and consistent with expectations despite these fluctuating ordering patterns. New sales territories typically require one quarter to begin generating demand, suggesting a steeper growth contribution in Q3 and Q4. The company does not plan further sales force expansion in the second half of 2026, focusing instead on driving productivity from the 20 territories added in the first half. Existing iLet contracts and PBM relationships provide a 'runway' that will allow for faster coverage of Mint via NDC code amendments or new agreements. Management acknowledged that while they have a head start, achieving the same level of coverage as established patch pump competitors will take time post-launch.

IRVINE, Calif., July 29, 2026 (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 June 30, 2026 and updated its full year guidance for the year ending December 31, 2026. Second Quarter 2026 Financial Highlights & Key Metrics Net sales of $32.0 million, up 38% compared to $23.2 million in the second quarter of 2025. Gross margin of 59.0%, up 524 basis points compared to 53.8% in the second quarter of 2025. New patient starts increased by at least 10% but less than 20% sequentially versus the first quarter of 2026. Loss from operations of $25.6 million, or negative 80% of sales, compared to $19.9 million or negative 86% of sales in the second quarter of 2025. Net loss of $23.4 million, or negative 73% of sales, compared to $16.9 million or negative 73% of sales in the second quarter of 2025. Adjusted EBITDA(1) of negative $17.7 million, or negative 55% of sales, compared to negative $14.5 million or negative 63% of sales in the second quarter of 2025. $225.2 million in cash, cash equivalents, short and long-term investments as of June 30, 2026. (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 D. Recent Strategic Highlights In July, initiated enrollment for a pivotal trial studying the iLet in adults with type 2 diabetes in the U.S. Announced updated expectations to fully commercialize Mint, Beta Bionics’ patch pump in development, by the end of the second quarter of 2027, subject to regulatory clearance by the U.S. Food and Drug Administration (FDA). Published a near real-time real-world data dashboard publicly available on the company’s website, setting a new standard for data transparency in the Automated Insulin Delivery category. In its most recent Phase 2a feasibility trial in New Zealand initiated in the first quarter of 2026 for the bihormonal system in development, the company identified opportunities to improve the glucagon asset’s excipient profile and the bihormonal dosing algorithm, with improvements expected to take less than one year prior to initiating additional feasibility trials. 2026 Full Year Guidance Estimated total revenue of approximately $131 million to $136 million (no change versus previous guidance). Estimated 37% to 39% of new patient starts reimbursed through the PBP channel (no change versus previous guidance). Estimated gross margin of 58.5% to 59.5% (previously 57.5% to 59.5%). 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 second quarter 2026 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. To access the live call by phone, please use the following link, which will provide you with dial-in details and a personal pin: https://register-conf.media-server.com/register/BI3bd9f03fbd0f42bcb9f566c242240033 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 D below. The Company calculates adjusted EBITDA as net loss adjusted to exclude (i) depreciation expense, (ii) stock-based compensation expense, (iii) interest income, (iv) income tax expense, (v) change in fair value of warrant liabilities, (vi) litigation settlement and other related expense, and (vii) quality system remediation (previously labeled “Other non-recurring” in the Form 10-K for the year ended December 31, 2025), which relates to one-time remediation efforts in response to the FDA Form 483 and Warning Letter, including contractor support and various updates to the quality system. 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 its clinical and regulatory development plans for the iLet and other product candidates; the markets and market opportunities for the iLet, Mint, the bihormonal system and other product candidates, if approved; the timing, likelihood or success of its business strategy, including commercialization as well as plans and objectives of management for future operations; its anticipated growth and other measures of future operating results and financial performance, including 2026 full year guidance regarding estimates of revenue, new patient starts reimbursed through the PBP channel and gross margin; the design, results, and timing of its research and development efforts and planned trials for the iLet in adults with type 2 diabetes; the design, results and timing of its research and development efforts and feasibility trials for the bihormonal system in development, including the expected timelines with respect to improvements to the glucagon asset’s excipient profile and the bihormonal dosing algorithm; and the timing or certainty of the FDA’s approval of Mint, the timing or certainty of the commercialization of Mint and related updates and the Company’s manufacturing capacity at launch. 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 June 30, 2026. 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. Investor Relations:Blake BeberHead of Investor [email protected] Media and Public Relations: Felicia SanbornVice President of [email protected] Source: Beta Bionics, Inc.

Interested in Beta Bionics, Inc.? Here are five stocks we like better. Q2 sales rose 38% year over year to $32 million, supported by new iLet patient starts and recurring pharmacy-channel supply revenue. Gross margin improved to 59.0%, prompting Beta Bionics to raise its full-year margin outlook to 58.5%–59.5% while reaffirming revenue guidance of $131 million–$136 million. The company expanded its sales force by at least 20 territories and reported strong patient retention, while maintaining approximately $225 million in cash and investments. Management expects operating expenses to rise modestly in the second half but believes it is sufficiently capitalized to fund key initiatives. Mint’s commercial launch is now targeted for the end of Q2 2027, subject to FDA clearance, as manufacturing preparations advance. Beta Bionics also began a pivotal Type 2 diabetes trial for iLet and continues development of fully closed-loop and bi-hormonal systems. Beta Bionics (NASDAQ:BBNX) reported second-quarter 2026 net sales of $32 million, up approximately 38% from a year earlier, as new patient starts and recurring pharmacy-channel supply revenue supported growth for its iLet insulin-delivery system. Chief Executive Officer Sean Saint said the company’s installed base continued to access monthly iLet supplies through pharmacies and that patient retention remained high. New patient starts reimbursed through the pharmacy channel represented a high-30% percentage of total starts, consistent with the first quarter. → This Tiny AI Supplier Could Be More Important Than the Chipmakers The company also published continuously updated real-world iLet data on its website. Saint said the dashboard includes users with a provider-reported baseline A1C and at least two weeks of cloud-uploaded data, without exclusions. He described the initiative as an effort to provide broader transparency around clinical outcomes for the iLet user population. Second-quarter gross margin was 59.0%, up 524 basis points from the prior-year quarter but down 45 basis points sequentially. Chief Financial Officer Stephen Feider said margin exceeded the company’s expectations, supported by higher-margin recurring revenue from the pharmacy installed base and a lower-than-expected warranty rate. → Refiner Stocks Are Near Record Highs—Can Iran-Driven Margins Keep Them There? Feider said the second quarter did not receive the one-time tailwind that benefited first-quarter results and characterized the 59% figure as a “clean read” on Beta Bionics’ underlying gross-margin profile. Total operating expenses rose 37% year over year to $44.5 million. The increase reflected continued expansion of the field sales organization, greater marketing investment, research and development spending on the Mint patch pump and bi-hormonal programs, and general and administrative investments to support commercial growth and pipeline development. → Innovative ETF Strategies That Are Paying Off This Summer Beta Bionics added at least 20 sales territories during the first half, achieving its stated goal for 2026. The company expects the territories to contribute more meaningfully to new patient starts in the second half. Feider said new patient starts increased more than 10% but less than 20% from the first quarter, while approximately 69% of new starts came from people who previously used multiple daily injections rather than insulin pumps. As of June 30, the company had approximately $225 million in cash equivalents and short- and long-term investments. Feider said management believes Beta Bionics is sufficiently capitalized to fund its key initiatives and is positioned to generate free cash flow ahead of historical diabetes-device peers, though he did not provide a specific timetable. Beta Bionics reiterated its 2026 revenue guidance of $131 million to $136 million and maintained its expectation that 37% to 39% of new patient starts will be reimbursed through the pharmacy channel. The company raised its full-year gross-margin outlook to 58.5% to 59.5%, from previous guidance of 57.5% to 59.5%. Management cited first-half performance, continued contributions from pharmacy-based recurring revenue, and increasing manufacturing scale. Feider said the company expects a modest increase in second-half operating expenses relative to the first half, primarily due to sales and R&D costs. The sales expense increase will reflect the full-period cost of territories added in the first half, though Beta Bionics does not expect to expand its field sales organization further during the second half. In response to questions on pharmacy supply revenue, Feider said second-quarter softness reflected inventory stocking behavior by pharmacy customers rather than patient-demand trends. He said patient demand, retention and pharmacy-channel new starts remained in line with expectations, while ordering patterns can materially affect reported pharmacy supply revenue from quarter to quarter. Beta Bionics updated its expected timeline for a full commercial launch of Mint, its patch pump in development, to the end of the second quarter of 2027, subject to FDA clearance. Saint said the timeline reflects initial FDA feedback on the company’s Mint ACE Pump 510(k) submission and progress in manufacturing readiness. The company has retired its manual manufacturing line, built a new clean room and begun operating semi-automated production lines there. Saint said the launch plan is based on semi-automated lines and that Beta Bionics believes it will be able to meet its anticipated demand at full launch. Management emphasized Mint’s two-part design, in which the reusable portion contains more expensive components while the disposable portion includes items such as batteries, a cannula, syringe and adhesive. During the question-and-answer session, Saint said the company expects Mint’s gross-margin profile at meaningful scale to be advantaged relative to patch-pump competitors, although he did not provide specific margin targets. The company said its existing iLet relationships with pharmacy benefit managers and health plans should provide a foundation for Mint coverage discussions. However, management cautioned that Mint will not have the same level of pharmacy coverage as established patch-pump competitors immediately at launch. Beta Bionics said it estimates that more than 30% of second-quarter new patient starts were patients with Type 2 diabetes, where iLet is currently used off-label. The company gained alignment with the FDA on a pivotal-trial design that could support an expanded iLet indication for adults with Type 2 diabetes. Enrollment began in July, and the company expects a potential U.S. indication expansion around midyear 2027, subject to FDA clearance. Saint said Mint hardware would be available for Type 2 diabetes if the iLet algorithm receives the Type 2 indication, as the Mint system would pair the hardware with the algorithm. The company also plans to initiate a pivotal trial for a fully closed-loop iLet indication in Type 1 and Type 2 diabetes in coming quarters. A fully closed-loop system would require users to announce fewer than one meal per day on average, according to Saint. Beta Bionics did not commit to a commercialization timeline for that program. For its bi-hormonal system, the company initiated a Phase IIa feasibility trial during the first quarter. Saint said the trial identified opportunities to improve the glucagon asset’s excipient profile and the dosing algorithms. Beta Bionics expects those iterations to take less than one year before initiating additional Phase IIa trials. Finally, Saint said the company has made “considerable progress” in remediating systems related to the FDA warning letter received in late January. He said Beta Bionics has heavily revised its complaint-handling and post-market surveillance systems and believes the changes will meet the agency’s expectations. Beta Bionics, a clinical-stage medical device company headquartered in Boston, Massachusetts, is focused on revolutionizing the management of type 1 diabetes through automated insulin delivery solutions. The company's flagship product, the iLet Bionic Pancreas system, is designed to simplify glycemic control by automatically adjusting insulin dosing in response to continuous glucose monitoring data. By integrating advanced algorithmic control with wearable infusion pumps, the iLet aims to reduce the daily burden of diabetes management and improve clinical outcomes for patients. At the core of Beta Bionics' offering is its proprietary bionic pancreas software, which can operate in both insulin-only and dual‐hormone modes. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Beta Bionics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Image source: The Motley Fool. Tuesday, April 21, 2026 at 4:30 p.m. ET Chief Executive Officer — Sean Saint Chief Financial Officer — Stephen Feider Head of Investor Relations — Blake Beber Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good afternoon, and welcome to the Beta Bionics, Inc. First Quarter 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' 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 now like to hand the conference over to Blake Beber, Head of Investor Relations. You may begin, sir. Blake Beber: Good afternoon, and thank you for tuning in to Beta Bionics, Inc.’s first quarter 2026 earnings call. Joining me on 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 first quarter 2026 results will be available on the Investor Relations section of our website. Information recorded on this call speaks only as of today, 04/21/2026. Therefore, if you are listening to the replay, any time‑sensitive information may no longer be accurate. Also on our website are our supplemental first quarter 2026 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; we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law. With that, I would now like to turn the call over to Sean. Sean Saint: Thanks, Blake. Good afternoon, everyone, and thank you for joining. I am pleased to share with you today our financial results for the first quarter as well as positive updates to our full‑year guidance for 2026. In Q1, the company continued to progress rapidly across our key initiatives—both commercially, in terms of driving adoption of the islet and expanding pharmacy channel access, and developmentally, in terms of advancing our Mint patch pump program and our bihormonal program. Our teams continue to execute relentlessly to deliver life‑changing solutions to the diabetes community today and over the long term. Diving into a brief overview of our Q1 performance, we delivered $27.6 million in net sales, which grew 57% year over year. Q1 revenue growth was driven predominantly by growth in new patient starts, as well as our growing installed base of users who continued to obtain their monthly supplies for the islet through the pharmacy channel, and whom we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel grew to the high‑30s percentage compared to the low‑30s percentage in Q4 and the low‑20s percentage in Q1 2025. Our gross margin was 59.5%, expanding over 860 basis points year over year. Stephen will discuss our gross margin dynamics shortly in more detail. I wanted to highlight this exceptional performance as evidence that the pharmacy business model is working, as is our ability to drive leverage in manufacturing costs as we scale. I am proud of these results and eager to build on them as we progress throughout the year. With that, I will hand the call over to Stephen to provide some additional color on our first quarter performance and our full‑year 2026 guidance. Stephen? Stephen Feider: Thanks, Sean. Our Q1 performance exceeded our expectations across the board. Revenue performance was mainly driven by new patient starts and the recurring revenue generated from our growing pharmacy installed base. Q1 revenue saw modest contribution from pharmacy and DME stocking, but the stocking benefit in Q1 declined relative to Q4 in both channels. I would now like to highlight some of our Q1 commercial metrics. New patient starts declined more than 10% but less than 20% compared to Q4 2025, consistent with our expectations given typical seasonal demand patterns from Q4 to Q1. A high‑30s percentage of our new patient starts in Q1 accessed islet through the pharmacy channel. The increase compared to the prior quarter exceeded our expectations. It is important to note that most pharmacy plan changes occur at the beginning and midpoint of the calendar year; thus, we do not expect an uptick from Q1 to Q2. Our pharmacy strategy continues to deliver strong financial results for the business, driven by the advantaged recurring revenue model, low out‑of‑pocket costs for patients, a streamlined process for health care providers, and our ability to retain patients utilizing the product. Lastly, we continue to expand the insulin pump market, as approximately 70% of our new patient starts came from people with diabetes using multiple daily injections prior to starting the islet. Moving on to gross margin. Q1 gross margin was 59.5%, representing an increase of 52 basis points relative to the prior quarter and an increase of 864 basis points relative to the prior year. The primary driver here is our pharmacy installed base, which generates high‑margin recurring revenue and where we continue to see strong user retention. Previously, I have shared a simple way to think about how the pharmacy channel impacts our overall gross margin. The framework I introduced was that when our pharmacy installed base in a given quarter exceeds three times the number of new patient starts through pharmacy in that same quarter, the pharmacy channel generates higher gross margin than the DME channel and becomes accretive to our overall gross margin. We crossed that threshold in Q1, and we expect further gross margin expansion as our pharmacy installed base continues to grow. The other key driver of strong margin performance this quarter was lower cost of materials for the islet relative to the prior quarter and year. We also benefited from a couple of one‑time gross margin tailwinds in the quarter, including higher‑than‑planned islet production and modest contribution from pharmacy islet revenue. While we do not expect those one‑time tailwinds to repeat, I expect our core gross margin to remain a key area of strength going forward and an important driver of our ability to generate free cash flow at an earlier stage as compared to our diabetes peers. Total operating expenses in the first quarter were $40.7 million, an increase of 47% compared to $27.6 million in 2025. The increase in sales and marketing expenses relative to the prior year was driven by expansion of our field sales team, which we made excellent progress on in Q1 towards our previously stated goal of expanding by at least 20 sales territories in 2026. Newly onboarded territories generally take at least a quarter to begin contributing meaningfully to sales; we are excited for those additions to take shape throughout the year. On R&D expenses, the increase relative to the prior year is driven by the Mint and bihormonal projects. The increase in G&A expenses relative to the prior year is driven by continued efforts to scale the company in support of commercial growth and pipeline initiatives. As of 03/31/2026, we had approximately $240 million in cash, cash equivalents, and short‑ and long‑term investments. We believe we are sufficiently capitalized to fund all of our key initiatives and remain well positioned to generate free cash flow well ahead of historical diabetes peers. We feel that all of the key indicators that we monitor suggest we are building a sustainably successful and profitable business, including strong product‑market fit, solid sales force productivity, growing pharmacy traction, healthy gross margins, and continued operational discipline. I would now like to discuss our revised full‑year 2026 guidance, which we are raising across the board. We now project total revenue for the year to be $131 million to $136 million, up from our prior guidance of $130 million to $135 million. On pharmacy mix, we now expect 37% to 39% of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of 36% to 38%. Our increased revenue and pharmacy mix guidance reflects our higher expectations for new patient starts driven by strong Q1 performance and the success we have had in onboarding new sales territories; we are on track toward our goal of adding at least 20 territories in 2026. On gross margin, we are raising our outlook to 57.5% to 59.5% for the full year versus our prior guidance of 55.5% to 57.5%. Our gross margin outlook reflects the strong performance in Q1 normalized for one‑time tailwinds and our expectation of continued contribution from our pharmacy installed base along with increasing leverage from manufacturing scale over the course of the year. To briefly comment on operating expenses, we expect year‑over‑year growth to accelerate for the remainder of the year compared to Q1, driven by continued expansion of the sales force, increased investment in brand and direct‑to‑consumer marketing, and spending related to Mint and our bihormonal programs. With that, I will hand the call back over to Sean. Sean Saint: Thanks, Stephen. To wrap up the call, I will briefly touch on our remediation efforts regarding the FDA warning letter we received in late January, and then highlight the progress we are making in our innovation pipeline. Regarding the warning letter, the company is continuing to take this matter very seriously. Our teams and leadership are conducting thorough systemic reviews of our quality management system and instituting corrective actions that we believe address the agency's observations. The company is responding quickly to the agency's concerns, and we have been providing periodic updates to the FDA regarding changes to our processes and documentation we believe address many of the FDA's concerns as stated in the warning letter. One example of our progress thus far is our efforts to remediate old complaints under our new complaint handling system and definitions for reportable complaints. We recently completed that work well ahead of schedule, which we believe is a good representation of our organization's commitment to resolving the warning letter in an effective and timely manner. We still have work to do in other areas to fully address the agency's concerns, and we look forward to continuing to work together with the FDA to resolve this. Now for the pipeline. Let us start with a quick update on Mint, our patch pump in development. In Q1, we continued to advance Mint toward our goal of an unconstrained commercial launch by 2027. We remain confident in our ability to gain FDA clearance for Mint, manufacture the product at scale, and ultimately realize the opportunity to make Mint the market‑leading product in automated insulin delivery that we believe it has the potential to be. For our bihormonal system in development, in Q1 we initiated a Phase 2a feasibility trial to stress test and iterate the system. Our Phase 2a trials have helped us to identify further areas for system optimization in preparation for the more advanced stages of development inclusive of a Phase 2b feasibility trial and Phase 3 pivotal trials. I am excited by our continued progress with the bihormonal system as it represents what we believe has the potential to be a transformative innovation for people with diabetes. Our industry talks a lot about moving towards fully closed‑loop algorithms, which the industry generally defines as algorithms that do not require any engagement from the user. Another topic that is always top of mind for the industry is health outcomes. The ADA's glycemic goals for most nonpregnant adults with diabetes are less than 7% A1c and greater than 70% time in range, which the vast majority of people with diabetes are not achieving today. When we look at the body of evidence of insulin‑only fully closed‑loop algorithms, we believe that they will not enable the majority of people with diabetes to achieve the ADA's glycemic goals. But bihormonal may be different. We believe that the existing body of evidence of bihormonal fully closed‑loop algorithms shows the potential for the majority of people with diabetes to achieve the ADA's glycemic goals. That is such a big reason why bihormonal has game‑changing potential for the industry at large and why our commitment to the program has never been stronger. At the end of Q1, we also launched a key new feature called Bionic Insights within our health care provider portal. This is a one‑of‑its‑kind intelligent data analytics and reporting feature within the industry. Bionic Insights surfaces clinically relevant indicators, user activities, and system events and packages them into actionable insights that help health care providers make more informed and personalized treatment recommendations for their patients. Early feedback on the feature has been overwhelmingly positive, and we are extremely excited by its potential to further improve experiences and outcomes with islet. Lastly, on our innovation pipeline, I want to cover type 2 diabetes. In Q1, we continued to see some health care providers prescribe islet to their type 2 patients off label. We estimate that 25% to 30% of our new patient starts in Q1 were from type 2. While we are not committing to a specific timeline, we remain eager to pursue the type 2 diabetes indication through the FDA. I want to leave you all with one key message from today's call: we are building a business that we believe is uniquely positioned to succeed over the short, medium, and long term, fueled by our exceptional commercial product, pharmacy channel strategy, operational efficiency, and what we believe to be the most innovative pipeline in the diabetes industry. We are excited and motivated to deliver. Thank you all for joining today's call. We will now open the call for questions. Operator: Thank you. To ask a question, please press star 1-1 on your telephone, then wait for your name to be announced. To withdraw your question, please press star 1-1 again. Our first question comes from the line of Mike Kratky with Leerink Partners. Your line is open. Mike Kratky: Hi, everyone. Thanks for taking my questions, and congrats on the strong quarter. To start, it was really encouraging to see the high‑30s percent of new starts through the pharmacy channel, but your updated guidance of 37% to 39% seems to suggest it could hang out there over the next few quarters. Is there any fundamental reason driving that assumption, or anything you are seeing from a competitive standpoint that may be tempering expectations there? And then, on the ongoing sales force expansion, any additional color you can provide in terms of what inning we are in and how far along you are? Stephen Feider: Hey, Mike. Appreciate the question, and happy belated birthday, by the way. Nothing notable about the calendar year other than the biggest step‑ups in pharmacy coverage happen at the start of the year and at the middle of the year—so January and July. The other important note about pharmacy reimbursement is that while we feel like the business is highly predictable in areas like revenue, this particular area is not perfectly predictable. It is B2B sales with a long sales cycle, and our guidance acknowledges both of those points. In terms of competitive pressure we are feeling as it relates to the pharmacy channel—none at all that is dampening guidance in any way. If anything, the move from our tube pump competitors to the pharmacy channel makes payers and PBMs more inclined to want to move insulin pumps, particularly tubed insulin pumps, to pharmacy reimbursement. We actually do not see that move from our competitors as bad at all. On the sales force expansion, I do not want to speak specifically to the number. As you can imagine based on the prepared remarks, we are not in the ninth inning—meaning there is more expansion to happen. Most of the expansion of the field sales force will happen in the first half of the year. A lot of it happened in the first quarter, and then you will see some in the second quarter as well, and that will round out most of what we expect to expand by. Operator: Our next question comes from the line of David Roman with Goldman Sachs. Your line is open. David Roman: Thank you. I appreciate your taking the question here. Maybe I will start with the ADA guideline changes that went into effect in December regarding AID therapy. Could you give us some perspective on what you are observing in the field as it relates to prescribing patterns? I know you talked about Beta Bionics, Inc. contributing to expansion of the overall pump market. Help us understand a little bit more what you are seeing both on the type 1 and type 2 side from an underlying demand perspective. And then, you obviously continue to get a ton of questions around GLP‑1s, especially given the oral dynamic—any perspective there? For my follow‑up, you talked about accelerating OpEx growth through the year. How are you thinking about overall investment and cost to serve? We see one of your competitors very aggressively going down the DTC path, a lot of people hiring reps, but revenue expectations look similar across the space. Are you seeing a higher customer acquisition cost as the market becomes more competitive, and how are you thinking about that OpEx versus growth trade‑off? Sean Saint: David, this is Sean. Good question. I do not think the ADA guideline changes, while helpful, are really impacting prescribing patterns on a daily basis yet. Things like that take time to filter out. I do not think we have ever seen the industry just react to a shift, and the guideline evolutions were relatively subtle. The last quarter has been relatively stable in terms of prescribing patterns and narrative. On GLP‑1s, I think they are a phenomenal class of drugs and are helping a ton of people. When you talk about type 1 and also insulin‑dependent type 2—insulin‑managed type 2 specifically—not really a huge impact there. Orals are a continued evolution of that drug class and a great evolution, but going from a once‑a‑week injectable to an oral is probably not what kicks it over into a drug that people taking four injections per day or who are on a pump will utilize. That is not the reason it was not helping them, in my view, and I do not think oral will change that. It is another helpful evolution for that class. I will let Stephen take the investment question. Stephen Feider: First, with regard to our sales and marketing growth for the rest of the year and what we are expecting in OpEx: as I alluded to earlier, you will see our sales and marketing spend grow into the second quarter because of expansions of our field sales team—that is why you saw the uptick in sales and marketing in Q1 2026 relative to Q4 2025. This also embeds some investment that we are making in direct‑to‑consumer advertising—not at the same level as some of our competitors, but notable investments nonetheless. In terms of customer acquisition cost, that is a really good point. When you look at our P&L, our sales and marketing costs in Q1 2026 are 75% of our revenue. That is not an efficient business at scale, and so our customer acquisition cost needs to go down—and it will. The primary ways it will go down are: building an installed base, particularly in pharmacy, where we generate high‑gross‑margin recurring revenue from selling supplies; and readying this business in terms of brand recognition and building a customer‑forward brand in anticipation of the Mint product. For those reasons, I am comfortable that we are building a profitable business in the medium and long term that will start generating free cash way earlier than diabetes peers. I acknowledge that the customer acquisition cost today, acknowledging we are getting many of our new patients from the pharmacy channel and we are building a brand, does not look perfectly economical at this exact moment. Operator: Thank you. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open. Frank Takkinen: Great. Thank you for taking the question. I wanted to start with one on gross margin. Obviously a really strong performance in Q1. Could you help quantify some of the benefits you called out related to the higher islet production and anything else you mentioned that may have contributed to Q1? Extrapolating that out, it feels like gross margin is trending toward the higher end of the guided range today. Is there something in there tempering that expectation? And then, related to cash burn, any seasonal considerations we should think about from Q1 through Q4—was cash burn a little higher in Q1—and how should we model the burn profile throughout the year? Stephen Feider: Hey, Frank. Appreciate the question. On gross margin, yes, there were one‑time tailwinds in Q1 that brought the gross margin up from what its current run rate is. I do not want to quantify specifically what that impact was, but it was relatively small yet notable. To your guidance question—does our Q1 actual performance make the guidance look conservative? Maybe, but I would reiterate two points: Q1 did have some one‑time favorability, and cost of sales can have discrete and semi‑unpredictable one‑time charges that can occur unfavorably in any given quarter, which in short‑run periods makes gross margin semi‑difficult to predict. Our guidance embeds openness to that. Stepping back, gross margin is a high point for our business with massive room for upside in the medium and long term. We are demonstrating cost favorability in our ability to manufacture more efficiently quarter over quarter, and the pharmacy business model is absolutely working. I even alluded to the pharmacy revenue model having a higher gross margin as of this quarter than the DME revenue model, and this is still early days—so more upside to come. On cash burn, I think cash burn for us is going to approximate adjusted EBITDA for the rest of the year. We burned about $25 million in Q1, which was higher than our adjusted EBITDA of around $17 million. The reason is we paid cash bonuses in Q1—there was a big change in our accrued expenses—and there were working capital differences between Q4 quarter‑end and Q1 quarter‑end, notably inventory, accounts receivable, and accounts payable. Those totaled about $4 million of impact. That bridges the gap between the $25 million of burn and adjusted EBITDA. Operator: Thank you. Our next question comes from the line of Jonathan Block with Stifel. Your line is open. Jonathan Block: Great. Thanks, guys. Good afternoon. Maybe I will go with a couple of modeling questions. First, I think the Street was about 44% or 45% in 2026 sales in 1H prior to the print. It sort of lands around $31 million for Q2 2026. You mentioned this year would be more front‑end weighted relative to 2025 for a handful of reasons. Is that the right cadence to think about for the model, or anything else to call out as we think about the balance of the year on the top line? And then, on gross margin, going into this year I think you alluded to GM increasing sequentially throughout 2026. There was material upside to Q1 2026—good problem to have. You do not want to quantify the one‑timers, but help us out: as we think about GM going forward, now that you are already at the upper band of your revised guidance, what are the key upside or downside factors for GM or COGS from here over the next handful of quarters? Stephen Feider: I will reiterate the guidance I gave on the last call, which is that 2026 will have more revenue weighting in the first half for the calendar year period than what we saw in 2025. I am not going to specifically comment on a Q2 revenue number; we do not provide quarterly revenue guidance. Based on what I said, you can get a good sense for a tight range. On gross margin, without quantifying the extent of the Q1 one‑timers or giving a run‑rate Q1 GM, relative to the normalized Q1 GM we are still expecting an uptick quarter over quarter. There is nothing notable about Q1 that changes the slope for the rest of the year; Q1 had a big number for reasons I have explained. Operator: Our next question comes from the line of Felipe Raul Lamar with Truist Securities, on for Richard Newitter. Your line is open. Felipe Raul Lamar: Hi. It is Felipe on for Rich. Just to follow up on the pharmacy channel: you mentioned more competitors trying to enter with durable pumps into the channel potentially accelerating the shift. Could you dig into that and give any context on conversations you have been having with your PBM partners? And then, if you could remind us why you expect economics in the channel to hold over the long term—there are misconceptions around multiple players in the channel and potential downward trends in economics—any clarity would be helpful. Thank you. Sean Saint: Yeah, Felipe, it is Sean. Beyond saying that the more companies accessing this channel, the more normal it becomes, the less one‑off these conversations are. The more of us that have success through this channel, the more future entrants will also have that success—and that success brings more success with other payers. The more payers that start to pay, the more those who choose not to become outliers. This is a snowball rolling down a hill, and multiple players accessing this channel is a positive for all of us. We are happy to see that and believe it ultimately makes our entire industry healthier. Frankly, we are happy to have started that snowball rolling in the durable pump space. On why we expect economics to hold: insulin pumps are a non‑commoditized market. In the pharmacy channel, commoditized markets can enter a race to the bottom where a payer may only need to offer one product and scripts can be changed between products without the provider’s approval. That is not the case in insulin pumping. When you write a script for an islet, the pharmacy must deliver an islet specifically; you need a new script for something else. It is the definition of a non‑commoditized market. That limits the ability to create downward price pressure. Because of the nature of automated insulin delivery and unique algorithms, that will not change anytime soon given the clinical trials required. Today we are still looking at a very differentiated market, and we think islet is one of the more differentiated products out there. Operator: Next question comes from the line of Jeffrey Johnson with Baird. Your line is open. Jeffrey Johnson: Thanks, guys. Can you hear me okay? Sorry, I am in the back of the car—hopefully not too much noise here. Sean, staying on the pharmacy point, any updated thoughts on rebates and how you are thinking about rebate dollars you might provide the channel over the next few years? How do you balance staying at tier three in some contracts and buying down the copay versus trying to move up to a tier two but having to chase added rebate dollars as you compete against bigger peers in the pharmacy channel? Sean Saint: Great question, Jeff. Starting with the non‑commoditization point, we see a lot of durability of pricing for the foreseeable future. On the tier two versus tier three question, there are two fundamental differences: the rebate required to obtain tier two versus tier three, and the copay that the user is asked to pay when their product is covered at either tier. Most companies, Beta Bionics, Inc. included, have copay assistance programs that are transparent to the user and ensure we control that copay at a particular level—currently $25 or less per month. That makes it a math problem for us. We balance the rebate required to move between tiers with the reduction in copay when we do it. The outcome tells us whether a tier two or tier three positioning would be more advantageous for Beta Bionics, Inc., and we will pick that. Our patients will always pay the $25 copay or less that we control. It is really a win‑win for us and our users. Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Matthew O'Brien with Sandler. Your line is open. Matthew O'Brien: Good afternoon. Thanks for taking the questions. First, as I look at the model, it looks like type 2 growth in Q1 was meaningfully higher than type 1. Is type 2 really carrying you right now for overall patient growth on a year‑over‑year basis? Are you still growing type 1 in the double‑digit range? And are you exposed in the intermediate term by not having a type 2 indication given how well you are doing there? And then I have a follow‑up on R&D. Stephen Feider: Is type 2 growth driving growth for the business? I need to be a little careful—we do not have the indication, so you will hear Sean and me be cautious. Yes, the fact that 25% to 30% of our new users are coming to us with type 2 diabetes is a large part of our growth. But our type 1 growth is not shrinking, and the applicability for our product in type 1 is not dwindling. The math will show that type 2 is a larger growth contributor for us this quarter than type 1, but not because the type 1 market for our product is shrinking. Are we exposed by not having a type 2 indication? Health care providers will prescribe what they want, but the fact that we cannot promote our product for type 2—and we do not and legally cannot—does hinder our growth. It is an indication we desire and will ultimately need in order to win at the level we desire in the medium and long term. If we had the ability to market ourselves for that area, it would help us. Matthew O'Brien: Thanks. And on the R&D spike in Q1 versus Q4—timing issues aside—is it fair to say the big bump was related more to Mint than bihormonal, which feels earlier‑stage? Are you sensing Mint timing is on track or potentially a little earlier than expected internally? Sean Saint: Thanks, Matt. I am not going to comment on the split between bihormonal and Mint spending. Both projects continue to move forward and both will see upticks in spending over the next period of time, so that was true for both. On Mint, not a lot I can share right now. The notable point is that we have been sharing the same timeline for quite a while and it has not slipped. We have been reiterating it consistently. We want to be predictable. No additional updates except reiterating our timeline of an unconstrained launch by 2027. Operator: Our next question comes from the line of Jeffrey Scott Cohen with Ladenburg Thalmann & Company. Your line is open. Jeffrey Scott Cohen: Hi, Blake and Sean. Afternoon. First, you called out lower cost of materials in Q1. That was one‑time favorable, but was any of that deflationary in nature, or was it scale related as far as sheer scale? And second, on the bihormonal program, what might we see during 2026 as far as any data or publications related to the Phase 2a or Phase 2b feasibility studies? Stephen Feider: The primary driver of the lower cost per unit and cost of materials is simply volume—so, scale. The more components we are able to purchase at larger scale, the lower the cost per component. Sean Saint: On bihormonal publications, we do not really intend to publish a lot of this information; there is not a benefit to us to do that. As things complete, our cadence has been to let you know that things are done, not so much to tell you what is coming up. 2026 should bring meaningful updates, but I am not going to call out exactly what those are at this point. We probably will not publish the results of these trials for various reasons. I will note that in the past we have published quite a few studies over the last 20‑odd years on this product with really strong results. I would encourage you to reread some of the work we published in the 2010s. Operator: Our next question comes from the line of Mathew Blackman with TD Cowen. Your line is open. Mathew Blackman: Thank you. Can you hear me okay? I appreciate you taking my questions. Stephen, on the new disclosure for new patient adds—you said a greater than 10% but less than 20% quarter‑over‑quarter decline. Would you have us be in the middle of that range as a reasonable launching point to model off of? Stephen Feider: Totally appreciate why you would want to know that. Unfortunately, what we said in the prepared remarks is what we prefer to disclose in terms of extent, so I will not comment further. Mathew Blackman: Understood. And on the sales force expansion—you are adding 20 territories—but relative to expansions over the last several years, how similar or different is this? Is this white space fill‑in versus splitting territories and going deeper? Is execution any different than what you have tackled successfully in prior years? Sean Saint: I am not going to comment on size beyond what we have said. It is both. Technically, “white space” would be an area without a rep, and we do not really have white space—there is a rep covering everywhere in the country. That said, there are areas that essentially get no rep visiting—no feet on the ground historically—so we are putting reps in those spaces. It is not technically white space, but for all intents and purposes it is. We are also adding people in areas that were well covered. We tend to find good people and put them where we can. We will not just take whoever is available and drop them into an MSA; we want good people in every place, and that governs where and when we add. Operator: Our next question comes from the line of Analyst with Bank of America, on for Travis Steed. Your line is open. Analyst: Hey, this is Grace on for Travis. Thanks for taking the questions. On the 2026 revenue guidance, I think it implies about $33 million of year‑over‑year dollar growth versus about $35 million in 2025. Is this conservatism in the guide, or what do you think it takes from the pipeline or other parts of the business to accelerate revenue growth on a dollar basis going forward? And any directional color on new patient starts relative to 2025 or seasonally throughout 2026—maybe how DTC advertising spend will help leverage new patient starts this year? Stephen Feider: Your math is correct on the implied year‑over‑year growth. The puts that could allow us to exceed revenue guidance—guidance we set with confidence—include: islet continuing to build confidence with health care providers as clinical results resonate and patients have unique and great experiences on the device, which drives same‑store sales; and new‑store sales as we add new sales territories. Most of the places where these new reps are going do not prescribe islet today. Turning on those providers by making them aware of the benefits of automation and the great clinical outcomes we have could represent upside versus what is embedded in guidance. We do not guide new patient starts specifically, but to reiterate, Q1 is the weakest quarter seasonally. We expect an uptick in new patient starts—and revenue—in Q2. The Q1 to Q2 jump is the largest seasonal step change in the calendar year, and you will see that in our results. Operator: Our next question comes from the line of Analyst with Wolfe Research. Your line is open. Analyst: Hi. Thank you for taking the questions. On competition, there was a competitor who did a recent IPO and another who launched a nationwide product. Have you seen any changes in the competitive environment, and where do you see the most opportunity today? Sean Saint: Good question. IPOs do not have any bearing on market dynamics from our perspective. On the nationwide product launch, sure, you hear about it. That particular product, while very good, is quite similar to some other products on the market. I believe it increases competition among those products. It is quite different from what we offer. Generally, the same person looking at a product like ours is not looking at that one, so the impact to us is more muted. Increased competition at the margin can dilute everybody a bit, which is unfortunate, but I would not say it impacts us much. There has not been a big, meaningful product launch changing the narrative recently; things are relatively stable. For Beta Bionics, Inc., our job is to continue to get the word out. We offer a meaningfully differentiated product, which also means it is new and different and health care providers are not as familiar with it as with others. Historically we have been doing this with a smaller sales force and in a smaller portion of the market—the tubed pump market. We like where we are. We are taking meaningful share of new patient starts every quarter, especially considering our sales force size and the segment we play into. That is exactly what we need to do now: get information on our differentiated islet system and algorithm out there, get providers familiar, and set up to bring that more nationally with an added sales force and ultimately to the entire market with our Mint program. We believe we are doing the right things to set up long‑term success. No recent evolutions of the market that materially change our view. Operator: Ladies and gentlemen, I am showing no further questions in the queue. That concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Beta Bionics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Beta Bionics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $511,411!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,238,736!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 199% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of April 21, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Beta Bionics BBNX Q1 2026 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Net Sales: $27.6 million, a 57% year-over-year increase. Gross Margin: 59.5%, expanding 860 basis points year-over-year. Operating Expenses: $40.7 million, a 47% increase compared to Q1 2025. Cash Equivalents and Investments: Approximately $240 million as of March 31, 2026. New Patient Starts: Declined more than 10% but less than 20% compared to Q4 2025. Pharmacy Channel Reimbursement: High 30s percentage of new patient starts in Q1. Full-Year Revenue Guidance: Raised to $131 million to $136 million. Full-Year Gross Margin Guidance: Raised to 57.5% to 59.5%. Warning! GuruFocus has detected 4 Warning Signs with BBNX. Is BBNX fairly valued? Test your thesis with our free DCF calculator. Release Date: April 21, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Beta Bionics Inc (NASDAQ:BBNX) reported a 57% year-over-year growth in net sales, reaching $27.6 million in Q1 2026. The company's gross margin expanded by 860 basis points year-over-year to 59.5%, indicating strong operational efficiency. The pharmacy channel strategy is proving successful, with a high 30s percentage of new patient starts being reimbursed through this channel. Beta Bionics Inc (NASDAQ:BBNX) has approximately $240 million in cash equivalents and investments, indicating strong financial positioning. The company is expanding its sales force, aiming to add at least 20 new sales territories in 2026, which is expected to drive future growth. New patient starts declined by more than 10% but less than 20% compared to Q4 2025, reflecting typical seasonal demand patterns. Total operating expenses increased by 47% year-over-year, driven by sales and marketing expansion and R&D investments. The company received an FDA warning letter in January, requiring ongoing remediation efforts to address quality management concerns. There is uncertainty regarding the timeline for obtaining FDA clearance for the Mint patch pump and bihormonal system. The company faces competitive pressures in the pharmacy channel, although it currently sees no significant impact on its guidance. Q: It was encouraging to see the high 30%'s of new starts through the pharmacy channel, but your updated guidance of 37% to 39% seems to suggest it could hang out there over the next few quarters. Is there any fundamental reason driving that assumption or anything you're seeing from a competitive standpoint that may be tempering expectations? A: Stephen Feider, CFO: The biggest step-ups in pharmacy coverage happen at the start and middle of the year, so January and July. The business is highly predictable in areas like revenue, but pharmacy reimbursement isn't perfectly predictable due to its B2B nature and long sales cycle. We don't see competitive pressure dampening guidance; in fact, competitors moving to the pharmacy channel makes payers more inclined to shift insulin pumps to pharmacy reimbursement. Q: In terms of the ongoing sales force expansion, any additional color you can provide in terms of what inning we're in there or how far along you are? A: Stephen Feider, CFO: We are not in the ninth inning, meaning there's more expansion to happen. Most of the expansion of the field sales force will happen in the first half of the year, with a lot in the first quarter and some in the second quarter, rounding out most of what we expect to expand by. Q: Could you give us some perspective on what you're observing in the field as it relates to prescribing patterns, especially with the ADA guideline changes regarding AID therapy? A: Sean Saint, CEO: The ADA guideline changes, while helpful, are not significantly impacting prescribing patterns on a daily basis. Such changes take time to filter out, and the guideline evolutions were relatively subtle. The last quarter has been stable in terms of prescribing patterns and narrative. Q: Can you help quantify some of the benefits related to the higher iLet production and other factors that contributed to Q1's strong gross margin performance? A: Stephen Feider, CFO: There were one-time tailwinds in Q1 that brought the gross margin up from its current run rate. While I won't quantify the impact, it was relatively small but notable. Our guidance acknowledges potential one-time charges that can affect gross margin unpredictably in any given quarter. Q: Is type 2 growth driving the growth for the business, and are you exposed by not having a type 2 indication? A: Stephen Feider, CFO: Type 2 is a large part of our growth, with 25% to 30% of new users having type 2 diabetes. However, our type 1 growth is not shrinking. While we cannot promote our product for type 2, healthcare providers prescribe it based on their knowledge, and having the indication would help us win at the level we desire in the medium and long-term. Q: What might we see during 2026 as far as any data or publications related to the 2a or 2b trials for the bihormonal system? A: Sean Saint, CEO: We don't intend to publish a lot of this information as there's no benefit to us. We will inform when things are completed but won't publish results for various reasons. Historically, we've published data on our formative studies, which have shown great outcomes. Q: Have you seen any changes in the competitive environment with a competitor's recent IPO and another's nationwide product launch? A: Sean Saint, CEO: IPOs don't impact market dynamics from our perspective. The nationwide product launch is similar to existing products and competes more with them than with us. Increased competition dilutes everyone slightly, but it doesn't significantly impact us. Our focus is on getting the word out about our differentiated product. Q: Can you provide any directional color on new patient starts relative to 2025 or seasonally throughout 2026? A: Stephen Feider, CFO: We don't guide to new patient starts specifically, but Q1 is the weakest quarter seasonally. We expect an uptick in new patient starts and revenue in the second quarter, which is the largest seasonal step change in the calendar year. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Revenue growth of 57% year-over-year was primarily driven by new patient starts and high retention within the growing installed base of pharmacy-reimbursed users. Gross margin expansion was fueled by the pharmacy business model reaching a critical scale threshold where the pharmacy installed base exceeds 3x new starts through the pharmacy channel, contributing to a raised full-year gross margin outlook of 57.5% to 59.5%. The pharmacy channel is now generating higher gross margins than the traditional DME channel, validating the company's shift toward a high-margin recurring revenue model. Market expansion remains a core driver, with approximately 70% of new patient starts transitioning from multiple daily injections rather than switching from other pump brands. Management attributes operational leverage to increased manufacturing scale and lower material costs, despite seasonal Q1 demand patterns that typically see a sequential dip in new starts. Off-label use in type 2 diabetes patients accounted for 25% to 30% of new patient starts in Q1, highlighting significant organic demand ahead of formal FDA indication efforts. Full-year 2026 revenue guidance was raised to $131 million–$136 million, reflecting higher expectations for new patient starts and successful sales territory onboarding. The company is on track to expand its field sales team by at least 20 territories in 2026, with most hiring occurring in the first half of the year to drive second-half productivity. Gross margin guidance was increased to 57.5%–59.5%, assuming continued pharmacy channel contribution and manufacturing efficiencies, though normalized for one-time Q1 tailwinds. The Mint patch pump program remains on schedule for an unconstrained commercial launch by the end of 2027, serving as a key future catalyst for market share gains. Bihormonal system development is advancing through Phase IIa trials, with management focusing on system optimization to enable fully closed-loop outcomes that meet ADA glycemic goals. Management is actively remediating an FDA warning letter from January 2026, having already completed the remediation of old complaints under a new complaint handling system ahead of schedule. Q1 gross margins benefited from one-time tailwinds, including higher-than-planned production and modest pharmacy stocking, which are not expected to repeat in future quarters. Operating expense growth is expected to accelerate for the remainder of the year due to increased investments in direct-to-consumer marketing and R&D for the Mint and bihormonal programs. Cash burn in Q1 reached $25 million, exceeding adjusted EBITDA due to seasonal bonus payments and working capital shifts in inventory and accounts receivable. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management expects pharmacy mix to remain stable in Q2 as major plan changes typically occur in January and July. Competitors moving to the pharmacy channel is viewed as a positive 'snowball effect' that makes payers more inclined to adopt pharmacy reimbursement for tubed pumps. Management argues the market is non-commoditized because automated insulin delivery algorithms are unique and scripts are not easily switchable by payers. The company uses a 'math problem' approach to balance rebates for Tier 2 versus Tier 3 positioning, ensuring patient co-pays remain at $25 or less regardless of the tier. Current sales and marketing spend at 75% of revenue is acknowledged as inefficient at scale, but management expects this to decline as the pharmacy installed base grows. Investments are being front-loaded to build brand recognition in anticipation of the Mint patch pump launch. Management views GLP-1s as complementary or irrelevant for intensive insulin-dependent patients, noting that oral versions are unlikely to change the needs of those requiring multiple daily injections. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

IRVINE, Calif., April 21, 2026 (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, 2026 and raised its full year guidance for the year ending December 31, 2026. First Quarter 2026 Financial Highlights & Key Metrics Net sales of $27.6 million, up 57% compared to $17.6 million in the first quarter of 2025. Durable Medical Equipment (DME) channel net sales of $16.9 million, up 22% compared to $13.8 million in the first quarter of 2025. Pharmacy Benefit Plan (PBP) channel net sales of $10.7 million, up 181% compared to $3.8 million in the first quarter of 2025. Gross margin of 59.5%, up 864 basis points compared to 50.9% in the first quarter of 2025. New patient starts declined by at least 10% but less than 20% sequentially versus the fourth quarter of 2025. 70% of new patient starts came from multiple daily injections (MDI). High 30s percentage of new patient starts reimbursed through the PBP channel. Loss from operations of $24.3 million, or negative 88% of sales, compared to $18.6 million or negative 106% of sales in the first quarter of 2025. Net loss of $21.9 million, or negative 79% of sales, compared to $28.7 million or negative 162% of sales in the first quarter of 2025. Adjusted EBITDA(1) of negative $17.7 million, or negative 64% of sales, compared to negative $15.5 million or negative 88% of sales in the first quarter of 2025. $239.5 million in cash, cash equivalents, short and long-term investments as of March 31, 2026. (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 D. Recent Strategic Highlights In March 2026, launched Bionic Insights™ feature within the Bionic Reports healthcare provider portal. Intelligent data analytics and reporting feature designed to help healthcare providers make more informed, personalized treatment recommendations for people living with diabetes. In Q1 2026, initiated a Phase 2a feasibility trial in New Zealand for the bihormonal system in development, including the glucagon asset, pump, and dosing algorithms. 2026 Full Year Guidance Estimated total revenue of approximately $131 million to $136 million (previously $130 million to $135 million). Estimated 37% to 39% of new patient starts reimbursed through the PBP channel (previously 36% to 38%). Estimated gross margin of 57.5% to 59.5% (previously 55.5% to 57.5%) 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 2026 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. To access the live call by phone, please use the following link, which will provide you with dial-in details and a personal pin: https://register-conf.media-server.com/register/BI9e198d2306384b3c88c83ffa25a93bcc. 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 D below. The Company calculates adjusted EBITDA as net loss adjusted to exclude (i) depreciation expense, (ii) stock-based compensation expense, (iii) interest income, (iv) income tax expense, (v) change in fair value of warrant liabilities, (vi) litigation settlement and other related expense, and (vii) other non-recurring expense. 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 its clinical and regulatory development plans for the iLet and other product candidates; the markets and market opportunities for the iLet, the bihormonal system and other product candidates, if approved; the timing, likelihood or success of its business strategy, including commercialization and its multi-channel reimbursement strategy, as well as plans and objectives of management for future operations; its anticipated growth and other measures of future operating results and financial performance, including 2026 full year guidance regarding estimates of revenue, new patient starts reimbursed through the PBP channel and gross margin; and the design, results and timing of its research and development efforts and feasibility trials for the bihormonal system in development. 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, 2026. 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. Investor Relations: Blake Beber Head of Investor Relations [email protected] Media and Public Relations: Felicia Sanborn Vice President of Marketing [email protected] Source: Beta Bionics, Inc.

Beta Bionics reported Q1 net sales of $27.6 million, up 57% year-over-year, driven by new patient starts and a rising base of recurring pharmacy users, and raised its full-year 2026 outlook (total revenue $131M–$136M, pharmacy mix 37%–39%, gross margin 57.5%–59.5%). Gross margin expanded sharply to 59.5% (up 864 basis points YoY) as the pharmacy installed base crossed the company’s accretion threshold, making high-margin recurring supply revenue a primary profit driver. Operating expenses climbed to $40.7 million as the company scales sales and R&D, but cash and investments remain about $240 million; management is remediating an FDA warning letter while progressing the Mint patch-pump toward a planned commercial launch by end‑2027 and running a phase IIa trial for its bi-hormonal system. Interested in Beta Bionics, Inc.? Here are five stocks we like better. Beta Bionics (NASDAQ:BBNX) reported first-quarter 2026 net sales of $27.6 million, up 57% year-over-year, as management cited growth in new patient starts, a rising base of recurring pharmacy users, and continued expansion of pharmacy channel access for its iLet insulin delivery system. Chief Executive Officer Sean Saint said the company “continued to progress rapidly” in commercial adoption of iLet and in expanding pharmacy channel access, while also advancing development programs including its Mint patch pump and a bi-hormonal system. Saint attributed Q1 revenue growth primarily to “growth in new patient starts” and the company’s “growing installed base of users” obtaining monthly supplies through the pharmacy channel, which he said the company has retained “at a high level.” → Credo Stock Flashes Strong Bullish Signal—Upswing Just Starting CFO Stephen Feider said revenue exceeded internal expectations and included only “modest contribution” from pharmacy and durable medical equipment (DME) stocking. He added that the stocking benefit declined from Q4 in both channels. Feider noted that new patient starts fell seasonally versus Q4 2025 by “more than 10%, but less than 20%,” consistent with typical Q4-to-Q1 patterns. He also said that about 70% of new patient starts came from people previously using multiple daily injections, which he characterized as evidence the company is expanding the insulin pump market. → Allbirds Exits Shoes, Pivots to AI With NewBird Rebrand The company highlighted increasing pharmacy reimbursement for new users. Saint said the portion of new patient starts reimbursed through the pharmacy channel rose to a high-30s percentage in Q1, compared with a low-30s percentage in Q4 and a low-20s percentage in the prior-year quarter. Feider said the Q1 increase exceeded expectations but cautioned against assuming continued sequential improvement. “Most pharmacy plan changes occur at the beginning and midpoint of the calendar year,” he said, adding that the company does not expect an uptick from Q1 to Q2. → Amazon Stock Up 30%: Is AMZN Still a Buy Before Earnings? On competition, Feider told Leerink Partners’ Mike Kratky that the company was not seeing competitive pressure in the pharmacy channel that would dampen expectations. Feider said moves by tubed pump competitors toward pharmacy reimbursement could make payers and pharmacy benefit managers “more inclined” to shift pumps into pharmacy coverage. In a separate discussion about long-term pharmacy economics, Saint told Truist’s Philippe that insulin pumps remain a “non-commoditized market,” arguing that prescriptions are product-specific and cannot be substituted without a new script, which he said limits “downward price pressure.” Beta Bionics posted a 59.5% gross margin in Q1, which Saint said demonstrated the pharmacy business model is working and that the company is gaining manufacturing leverage as it scales. Feider said the margin was up 52 basis points sequentially and 864 basis points year-over-year. Feider attributed margin improvement primarily to the growing pharmacy installed base that generates high-margin recurring supply revenue. He reiterated a framework that pharmacy becomes accretive to overall gross margin when the pharmacy installed base in a quarter exceeds three times the number of new patient starts through pharmacy in that quarter, adding that the company crossed that threshold in Q1 and expects further expansion as the installed base grows. He also cited lower iLet material costs versus the prior quarter and year and said the company benefited from “a couple of one-time gross margin tailwinds,” including higher-than-planned iLet production and modest contribution from pharmacy iLet revenue. While he said those tailwinds are not expected to repeat, Feider described gross margin as a key area of strength going forward. For full-year 2026, the company raised its outlook across several metrics: Total revenue: $131 million to $136 million (previously $130 million to $135 million) Pharmacy mix of new patient starts: 37% to 39% (previously 36% to 38%) Gross margin: 57.5% to 59.5% (previously 55.5% to 57.5%) Feider said the higher revenue and pharmacy mix outlook reflect stronger expectations for new patient starts, supported by Q1 performance and progress onboarding new sales territories. On profitability, he said the gross margin outlook reflects Q1 performance “normalized for one-time tailwinds,” continued contribution from the pharmacy installed base, and increasing manufacturing leverage over the year. Total operating expenses were $40.7 million in Q1, up 47% from $27.6 million in the prior-year quarter. Feider said the year-over-year increase in sales and marketing was driven by expansion of the field sales team, and he reiterated the company’s goal to add at least 20 sales territories in 2026. He said newly onboarded territories generally take at least a quarter to contribute meaningfully to sales. R&D expense growth was driven by the Mint patch pump and bi-hormonal programs, while G&A expense growth reflected scaling the organization to support commercial growth and pipeline initiatives. Looking ahead, Feider said operating expense growth is expected to accelerate versus Q1, driven by continued sales force expansion, higher brand and direct-to-consumer marketing investment, and spending tied to Mint and the bi-hormonal program. As of March 31, 2026, Feider said the company had approximately $240 million in cash, cash equivalents, and investments. Saint said the company continues to take seriously the FDA warning letter received in late January. He said Beta Bionics is conducting “thorough, systemic reviews” of its quality management system and implementing corrective actions it believes address the agency’s observations, while providing periodic updates to the FDA. Saint cited one example of progress: remediation of older complaints under a new complaint-handling system and revised definitions for reportable complaints, which he said was completed “well ahead of schedule.” On the pipeline, Saint said Mint remains on track toward the company’s goal of an “unconstrained commercial launch by the end of 2027,” and he reiterated confidence in FDA clearance and scaling manufacturing. For the company’s bi-hormonal system, Saint said Beta Bionics initiated a phase IIa feasibility trial in Q1 to “stress test and iterate the system,” with work informing preparation for a phase IIb feasibility trial and phase III pivotal trials. Saint also said the company launched a new feature called Bionic Insights within its healthcare provider portal near the end of Q1, describing it as an intelligent data analytics and reporting tool designed to surface clinically relevant indicators and actionable insights. He said early feedback has been “overwhelmingly positive.” Regarding type 2 diabetes, Saint said the company continues to see some off-label prescribing and estimated 25% to 30% of Q1 new patient starts were from people with type 2 diabetes. Feider added that while the company does not have a type 2 indication and cannot promote the product for that use, the lack of an indication “does hinder our growth,” and management views it as an indication the company wants to pursue through the FDA without committing to a timeline. Beta Bionics, a clinical-stage medical device company headquartered in Boston, Massachusetts, is focused on revolutionizing the management of type 1 diabetes through automated insulin delivery solutions. The company's flagship product, the iLet Bionic Pancreas system, is designed to simplify glycemic control by automatically adjusting insulin dosing in response to continuous glucose monitoring data. By integrating advanced algorithmic control with wearable infusion pumps, the iLet aims to reduce the daily burden of diabetes management and improve clinical outcomes for patients. At the core of Beta Bionics' offering is its proprietary bionic pancreas software, which can operate in both insulin-only and dual‐hormone modes. The article "Beta Bionics Q1 Earnings Call Highlights" was originally published by MarketBeat.