And now I'd like to hand the conference over to Blake Beber, Head of Investor Relations. Please go ahead, sir.

Good afternoon, and thank you for joining Beta Bionics' third 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 third quarter 2026 results will be available on the investor relations section of our website. Information recorded on this call speaks only as of today, October 27, 2026. If you are listening to a replay of this call, any time sensitive information may no longer be accurate. Also on our website is our supplemental third 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'd like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance, and operating plans, and speak only as of today's date. 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. 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.

Thanks, Blake, and thanks everyone for joining. Q3 is usually a somewhat boring quarter in diabetes with summer vacations and a lull of news after ADA. Today, we're going to do our best to spice it up a little bit with some great updates. So let's dive in. In September, we received FDA clearance for mint, our transformative patch pump, which we expect to fully commercialize in the U.S. in Q1 of 2027. I feel this will ultimately prove to be the largest milestone achieved by the company to this point, and what an incredible effort it has been from the team to get that product designed, developed, and cleared by the FDA in a matter of about three years, which we believe is the fastest ever timeline from concept to clearance for an automated insulin delivery, or AID, patch pump. We believe that Mint will be a game changer for people with diabetes. Starting in Q1 of next year, the only fully adaptive and most advanced insulin dosing algorithm in the U.S. can power the smallest AID patch in the U.S., a patch pump that never requires recharging, integrates with industry-leading continuous glucose monitors, and can be controlled by iOS and Android smartphones. We designed Mint around the user experience, and the feedback we've gathered across our development program keeps reinforcing that. One recent example is from a survey of 30 active users of a competitive patch pump. all 30 rated mint insertion as less painful. Delivering life-changing solutions that simplify and alleviate the burden of managing diabetes is critical. We strongly believe that mint will deliver on that promise. In September, we completed a public offering raising approximately $161 million in net proceeds. This capital strengthens our balance sheet and provides flexibility to support the commercialization of mint, invest in our operations, and pursue future growth opportunities. Moving now to a brief overview of our Q3 performance. We delivered a record quarter of $35.5 million in net sales, which grew approximately 30% year over year. Q3 revenue growth was driven by growth in new patient starts and our growing installed base of users in the pharmacy channel, who we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel was in the high 30s. Our gross margin was over 57%, expanding 179 basis points year over year. Later, I'll give more detail around our new algorithm, 3D intelligence, and other projects in our innovation pipeline. But first, I'll hand the call over to Stephen to provide some additional detail on our third quarter performance and our updated full-year 2026 guidance. Stephen? Thanks, Sean.

Our revenue performance was mainly driven by new patient starts and the recurring revenue generated from our growing pharmacy install base. New patient starts increased a mid-single-digit percentage 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 islet. A high 30s percentage of our new patients accessed islet through the pharmacy channel, consistent with our expectations. Moving on to gross margin. Q3 gross margin was 57.3%, down 178 basis points quarter over quarter, and up 179 basis points year over year. Gross margin was below our expectations, primarily reflecting a lower contribution from higher margin DME islet revenue due to distributor stocking dynamics. DME islet sales, a high margin revenue source, declined quarter over quarter even as DME new patient starts increased. Distributors supplied more islets to patients than they purchased from Beta Bionics, which means the DME distributors ended Q3 with lower islet inventory than at the end of Q2. This reflects normal variability in distributor ordering rather than weaker patient demand. At the same time, increased distributor stocking of lower margin DME supplies, meaning infusion sets and cartridges, largely offset the revenue impact from DME islets, but created an unfavorable mix for gross margin. We expect revenue mix to normalize in Q4 and are maintaining our full year gross margin guidance. Meanwhile, continued growth and strong retention of our pharmacy install base support a growing stream of high margin recurring supply revenue. Total operating expenses in the third quarter were $46.9 million, an increase of 46% year over year. The increase in sales and marketing expense compared to the prior year is driven by expansion of our field sales organization and marketing investments. The increase in R&D expenses relative to the prior year is driven predominantly by the mint and bi-hormonal 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 September 30, 2026, we had approximately $374 million in cash, cash equivalents, and short and long-term investments. The capital raise was primarily intended to fund capital expenditures for mint manufacturing and strengthen our balance sheet. We will continue to spend with discipline and expect to achieve positive free cash flow well ahead of historical diabetes peers. I'd now like to discuss our updated full year 2026 guidance. We are increasing the lower end of our revenue guidance and now expect to generate total revenue of $124 million to $126 million, up from our prior guidance of $121 million to $126 million. The updated guidance reflects our expectation to generate $29 million to $31 million of revenue in the fourth quarter. Our previous guidance reflected a potential revenue deferral impact of up to $10 million in the fourth quarter as new prospective ILIT users could choose to await the launch of Mint. While we are seeing some evidence of this occurring in the fourth quarter, it is not happening at the rate that we initially expected when Mint received clearance. Thank you for joining us. reflects our expectation that the unfavorable revenue mix in Q3 will reverse in Q4, along with continued strong retention of our pharmacy install base and the high-margin recurring supply revenue it generates. We expect a modest increase in operating expenses in the fourth quarter compared to the prior quarter, driven primarily by higher R&D expenses supporting our fully closed-loop pivotal study, which Sean will describe in more detail momentarily. We expect fourth quarter capital expenditures in the low to mid single digit millions as we expand mint manufacturing ahead of the full U.S. launch in Q1 2027. Sean, back to you.

Thanks, Stephen. I discussed our mint update in detail earlier, and now I want to cover some other important updates in our innovation pipeline. First, 3D intelligence, the next generation insulin delivery algorithm we unveiled in September. Thank you for joining us today. While this is disappointing, we remain confident in 3D intelligence potential. We are working to address the FDA's feedback and intend to submit the revised 510 in mid-Q4, 2026. For clarity, the remaining questions were just that, questions on approaches that we took. We do not believe there were any concerns with the algorithm itself, and the resubmitted 510 is on the exact same algorithm with no changes, but with additional validation activities completed. Our current expectation is to launch 3D intelligence in the U.S. as ILIT3D and MINT3D around mid-2027, subject to FDA clearance. Depending on the timing and resubmission and FDA clearance, a launch as early as the fourth quarter of 2026 remains possible. Together, these products would expand our automated insulin delivery platform, offering patients and clinicians greater choice in both algorithm options and device form factors. Regarding our real-world pivotal trial on adults with type 2 diabetes, we have completed enrollment and expect that study will enable us to expand our algorithms indication for use to include adults with type 2 diabetes in the U.S. around mid-year 2027, subject to regulatory clearance by the FDA. In Q3, we continued to see off-label prescribing of the islet for people with type 2 diabetes, and we estimate greater than 30% of our new patient starts in the quarter were type 2. With the Pivotal study completing enrollment, we are one step closer to potentially offering that community the means to access our algorithm on-label. Another exciting update on the algorithm front is that in the coming weeks, we are expected to initiate a Pivotal trial in the U.S. studying our next-generation, fully closed-loop algorithm in adults with Type 1 and Type 2 diabetes. Our next-generation fully closed-loop algorithm in development completely removes the meal announcement feature for users and represents a potential next step forward for the entire automated insulin delivery industry, and certainly the potential to further alleviate the burden of managing diabetes in a significant way. In the effort to maximize choice for our users wherever we can, we continue to advance our integrations with leading continuous glucose monitors. In Q4, we expect to launch our integration of ILIT with Senseonics ever since 365, and are committed to integrating mint with Eversense 365 in the future. We continue to refine our bi-hormonal system. The drug reformulation is complete and additional phase 2A trials are in the works. Assuming these trials proceed as planned, we believe the program is back on track and will continue to provide updates as we progress. We communicated a lot of updates today, and the collection of those updates go to show the foundation we've built and the steps that we're continuing to take toward building a category-leading diabetes technology company. This company is executing across the board at the highest level, and we have the team and the roadmap to deliver for the diabetes community. With that, I'd like to thank you all for joining today's call, and we'll now open it up for Q&A.

Certainly, ladies and gentlemen, if you do have a question at this time, please press star 11 on your telephone. If your question has been answered and you'd like to remove yourself from the queue, simply press star 11 again. Our first question for today comes from the line of Matthew O'Brien from Piper Sandler. Your question, please.

Afternoon. Thanks for taking the questions. Sean, maybe for starters on 3D, that's probably going to get the most attention today. Can you elaborate a little bit more on some of the additional questions that they had? Was it simplistically just validation testing they wanted you to do or because it's three different algos or three different options for the patient, is it more just patient-specific kind of testing, making sure they know what they're doing, just anything more you can talk about as far as the delay there, and then I do have a follow-up.

Yeah, great question, Matt. Thank you. Your last portion of the question there alluded to the fact that it may be like a human factors type thing, and that's not it at all. Primarily for us, in this particular submission, simulation is a huge part of it, and simulation is a relatively new area for diabetes algorithms. We're all getting a lot better at it. The FDA offers a guidance document on what they believe they want for a simulation. But like many guidance documents, we're all still learning to interpret it perfectly. So it's around that. It's around the validation of our simulator, not the results of it, not the algorithm itself, not what we do, but just ensuring that we can trust the output of the simulator. So again, not proposing that there is a problem. Instead, more proposing that we want to make sure that there isn't. Hopefully that's helpful. But again, it's not a human factors thing. It's not an output thing. It's not an outcomes thing. It's none of those things. It's just ensuring we did the right work to validate our simulator.

Got it. Thanks for that. And then I really don't want to make a mountain out of a molehill here, but the commentary that Stephen had on deferrals coming in lighter than expected, you can't overread that as, hey, you know what, we don't The patch was not as much interest in the patch as maybe we thought. That's why we're not seeing as much deferral. Like, hey, you guys are a durable pump company. We like you guys. We like your algo. Is there anything to read into that commentary? Thank you.

No, that's a really good question, too. I think it reflects a little bit more on an understanding of exactly how informed people are. and our fear was based on, you know, of course, we've done market research, we've asked our users who would prefer mint, et cetera, and frankly, we're, I'll say, very surprised and at some level scared by the answers and that people love the mint product. If everybody had perfect information, then you know likely we would have seen more waiting but the reality is that most people are not wandering through their lives wondering when mint is coming out right they're just not that familiar with it so um because the the awareness of the product is a little lower um you know that the um pauses were also a bit lower but again I don't mean that in a negative way like you know these are people who haven't seen their healthcare providers and certainly their healthcare providers are not in the business of pushing mint at this point so um But it was very hard for us to know who would know about it, who was following along, etc. And we intended to be conservative on that. Got it. Thanks so much. Yep. Thanks, Matt.

Thank you. And our next question comes from the line of Lawrence Peterson from Wells Fargo. Your question, please.

Good afternoon. Thanks for taking the question. First, I just wanted to start on Mint. When do you expect the first commercial shipments of Mint to occur? Do you need to wait for 3D to be cleared? And how should we think about the ramp through 27? And I had one follow-up.

Yeah. You know, Larry, I think we've said, you know, probably all we're prepared to say on when the first commercial shipment will be just in the first quarter here. No, I don't think we need to wait for 3D, although the sooner we get it, the sooner we will be able to launch 3D on Mint, which is obviously a big deal for us just because, you know, we have a huge degree of confidence in each one of those products, but they are independent so we can ship without it. And great question on the ramp throughout the year. It's not exactly like this, but I think a good mental model is that we start, let's just say, near zero, and we add capability throughout the year. From a modeling perspective, model it as basically linear from now through the end of the year, averaging out at what we previously stated, which is at least 1.5 million units for the year. Is that helpful?

That's very helpful. and just for my follow-up, when MIM was approved, you lowered the 26 guidance by 10 million. That's obviously 8.5 million now and you expect to recover that next year. I think consensus was about 180 million when MIM was cleared. So I just want to ask the obvious question. It sounds like you're comfortable with about 190 million in sales next year. Can you confirm that and just talk about maybe the shape of revenues next year? Thank you.

Yeah, reiterating What you just said, Larry, we've communicated that any deferral that we would see from prospective Mint users who would have otherwise purchased Islet in 2026, we expect to more than make up for that deferral in 2027. So your math is accurate. So now we're expecting the benefit into 2027 from 2026 deferral for at least $8.5 million from where Thank you.

And our next question comes from the line of Chris Pasquale from Barclays. Your question, please.

Yeah, thanks for taking the questions. I was hoping you could talk a little bit about your fully closed-loop algorithm and what we might see there that differs from what other companies in the space are working on. are you guys approaching that project differently, do you think, given your history of having a more kind of hands-off algorithm to begin with? Just love any comments there on how you're taking maybe a little bit of a different angle.

Yeah, Chris, I would say that, you know, we do, okay, let me take a moment to define a term here, which we do rarely. You know, hybrid closed loop, of course, means including interaction from the patient, Fully closed loop means not needing to interact to require anything from the patient, meaning meal announcements, for example. And then there's a concept of forced fully closed loop, which is probably not a marketing term that we'll continue with, but it's descriptive. And what it means is not being able to meal announce, right? Purely a fully closed loop system. and that's the direction we're going with this particular product. It is based on sort of a sub-segment of the 3D algorithm and importantly it's going to be studied in both type 1 and type 2 diabetes. Said another way that we do believe that there's a huge cross-section of people that can benefit from an algorithm like that and part of that by the way is in the primary care space where it's more difficult to train on some of these things. Training becomes quite a bit easier when you're not forced to discuss at any level meal announcements when the product just handles it. I think when you compare the different you know, development paths that different companies have followed. They're either a sub-segment of users or they're maintaining a lot of the complexity of the previous device. We've tried to take a slightly different perspective, which is to include everybody, Type 1 and Type 2, while making this massively simpler device that can be used by anybody in any position. Said another way, we think it's the most, you know, commercially viable of the different you know, architectures that are being studied right now. Now, with that being said, that's not for everybody. And, you know, I think what we've seen lately from Beta Bionics is in terms of 3D, in terms of forcefully closed loop, et cetera, we have a pretty robust algorithm development team here, you know, in terms of our type two submission that we're talking about. And, you know, this is not our last bite at the apple.

That's helpful. And then I was just hoping you'd comment on the Type 2 trial and which we should expect from here. When could that data be available? Is that going to line up with ADA next year, or could it come sooner when we would actually see that readout?

Yeah, the first time we'll plan to communicate the data readout from the trial, again, acknowledging this is a real-world observational trial. is at the time when we get the clearance, which will be simultaneous with us having the label and then, in effect, commercially launching it. So I can't be more specific on your timeline relative to ADA other than, you know, what the public guidance that we've communicated, which is we expect this in the first half of next year. Okay, thanks.

Thank you. And our next question comes from the line of Mike Kratke from Lyric. Your question, please.

Hey, everyone. This is Sam on for Mike. So maybe just turning back to the men adoption ramp, could you just provide some more color on the degree to which capacity is currently in place to produce the 1.5 million units you expect, any meaningful additional commercial milestones that need to take place ahead of the launch to really hit the ground running, and then, you know, to what degree you could potentially expand beyond the capacity should outsized demand arise?

Yeah, all good questions. Let me start with the current and the rest of the team. So, I'm going to give you a little bit about our current capacity. As I answered earlier, I think with Larry, for modeling purposes, we should assume sort of near zero at this stage. But, you know, the reality is not quite near zero, of course. Well, it's effectively zero because the line is not up, validated and ready to go. It's extremely close to that. But we will start with a baseline level of production with a single manufacturing line. I'll, you know, give one additional piece of color here. We're hiring for that line now, and I'm not going to give an exact number, but meaningfully all the way through hiring a full four shifts for that line. Four shifts are what we believe are required to run the line effectively 24-7. And again, to keep that line up and operating at that level, we're near there. Opportunities for expansion beyond that, which are required throughout the year, are to replicate that line additional times. I'm not going to state how many or talk about cycle times today. and then opportunities for outperformance are primarily replicating additional lines. And then there's all your little ankle biters that that pull away from your production capacity. Right. Those are yield. Those are uptime of the line. And then production capacity, meaning cycle time, which I'm not going to state, but If we can ever improve cycle time of the lime, that obviously improves output of each and every lime. So those are the kinds of things we'll be looking at in order to improve production capacity should it be necessary. Awesome.

And then I just had a quick follow-up maybe on that point. You know, can you just kind of provide a little bit more color on mince expected production? Gross Margin Impact in 27. Obviously, I think you mentioned it was going to be dilutive, but just, you know, the volume milestones needed to achieve accretion and, you know, when you expect that could occur.

Perfect. Yes. So, yes, Mint's gross margin will be dilutive in 2027. Where we have the analyst models currently, the cell site analyst models currently, we are comfortable with. And I'm not, I won't give any specific guidance on 2027 yet, but just acknowledging again that we've communicated our expectations with cell site analysts, and we have the models in a reasonably good place for 2027. Over the next three years, and this is the exciting thing, over the next three years, the cost characteristics of Mint and the design decisions that we've made for Mint allow us to have, within three years, a gross margin outcome for that product that we expect to exceed our current patch pump incumbent. And again, at the scale that we're talking about at that particular time period, the reason that we have the ability to achieve that level of gross margin or that gross margin profile is because of the design decisions, meaning we have a durable component, which is where kind of the meat of the product lives, sort of the expensive components that last two years. And then the disposable component, which we call mint, that patients use whenever they're done with their 200-unit cartridge or up to three days plus 12 hours. That is much, much more cost-effective to make than what we're familiar with in the patch pump world. So super exciting gross margin profile and profit outlook for Beta Bionics in that regard. And I appreciate you asking about it.

Awesome. Thanks, guys.

Thank you. And our next question comes from the line of Michael Pollark from Wolf Research. Your question, please.

Hey, good afternoon. A couple follow-ups on 3D intelligence update. Just on timing quickly so I understand it, you're submitting more data back to FDA. It could be still possible you get that approval by the end of this year. I just want to make sure I understand that. That's only, say, 45 days. Sounds quick. And then the bigger question was just about the validation of the simulator. Is it specific to the more aggressive or the more conservative versions of the algorithm, or it's not about one of the three at all. It's about how you tested and framed the system. I wanted to just understand if it was about one nudge of the algorithm or not. Thank you.

Great questions, Mike. So, yeah, that would be quick. There's no question about it. So, you know, we did announce in the prepared remarks that we'll be resubmitting this year We were very far through this submission and unfortunately we just ran out of time. So there's a possibility that the agency sort of picks up the new submission and looks at it as a continuation and picks up right where they left off. And if they were to do that, there's, I would say, even a decent possibility that we could be looking at a clearance this year. They are not by any means obligated to do that and the statutory numbers absolutely put us into next year. So that, I think, is the most likely scenario and what we're preparing everybody for with our guidance. But if they were then to turn around and give it to us this year, I didn't want everybody to look at us and say, hey, what gives? You said it was Q4, then it was first half. Now it's Q4 again. Technically, that remains on the table. So we wanted to be honest about that. But again, the guidance itself is that we're likely to see this next year. On the second half of your question, The questions were very much specific to the simulator itself. They have nothing to do with individual modes of the algorithm, so I want to be clear. It's not that the simulator said, here's the output, and they said, ooh, that's concerning. That's not it. For any one particular mode, that's not it. What it was was, hey, really interesting simulator guys were not You know, you haven't provided enough data for us to believe it yet. We like what you showed us. We like the outcome, but we don't believe it yet. That's what validation of the sim itself is about. So, again, the outcome of the simulator, the outcome of the modes, 3D itself, all that's good, we believe. but that's all hinged upon our simulator being believable, which is what validation of the sim is about. So no, not specific to modes, not even specific to the simulator, specific to the way we validated the simulator.

Thanks, Sean.

Yep. Thank you. And our next question comes from the line of Steve Lichman from William Player. Your question, please.

Thank you. Hi, guys. Sean, can you talk about how you see pharmacy coverage building in 2027 for Mint? I think you've said you'll start at the high 30s, 40% pharmacy mix you're at today. What are your latest views on what happens with prospective customers who don't get pharmacy coverage as well? You're still assuming most purchase islet?

I'm going to kick that one to Stephen, actually.

Hey, Steve. Pharmacy coverage expectations for 2027 for mint are at the time of launch, we expect roughly 40% of all lives in the country to be covered for mint, growing to around 50% by the end of the year. So that's just the crisp way of communicating what expectation we have.

And for those that don't have pharmacy coverage and therefore won't be able to get mint, you're still assuming most will purchase islet, or what are your latest thoughts on that?

Well, there's a few different permutations of this, all of which will likely happen. Certainly people who would prefer mint, who don't have insurance coverage for mint, in some cases are going to buy islet. I would actually use a data point that we even have internally today to kind of prove that our particular value proposition of islet will continue to win with many patients who would prefer to wear a tubeless pump. We actually surveyed several hundred or a little over 300 of our users and asked them a question of knowing what you know about mint and assuming no difference in your out-of-pocket cost each month, would you prefer to switch to mint right now? And almost 90% of those patients said yes. Now, that's a relatively small sample, but I think it proves that what we're selling, meaning the islets differentiation, will continue to win even up against other patch pump form factors. So I think that people will certainly fall into the category of, okay, I'm not covered for mint, and I suppose I would prefer to be on a Beta Bionics product, and if I could choose, I'd prefer mint, but I'm still going to purchase islet. There will certainly be some of those people. Now, will there be some deferrals of patients who will otherwise wait to get mint before they start on islet? Absolutely. And quantifying that right now is a little bit difficult, candidly. We've had FDA clearance for our product for five, six weeks, and we have sort of good experience in understanding what the patient demand is like for eyelid in spite of there being mint clearance. But I think that that will be different, of course, when we actually launch it commercially rather than it just existing as a future product. So sorry to not give you a precise mathematical answer on that. I have a hard time not doing that as a finance guy, but I don't exactly know how each of those categories will get bucketed.

I appreciate the call, Steven. Just quickly, any update on the fully automated manufacturing timeline?

Probably no update on the timelines for that. I suppose I'll say that as we've discussed in the past that we have a lineup in operating. We have additional lines being constructed at this time. and we are working at this stage on our more fully automated manufacturing lines for the future. I think we've probably said in the past that we, you know, that was a future item. We are thinking about that now and doing the actual work now, but I'm not going to provide exact timelines on it.

Got it. Thanks, Sean.

Thank you. And our next question comes from the line of Jeffrey Cohen from Lederberg, Darwin. Your question, please.

Oh, good afternoon. Thanks for taking the question. So just two brief ones. I missed it, Steven. Q3 pharmacy composition was what percent that you called out earlier in the call?

A high 30s percentage of our new patient starts went through pharmacy in the third quarter.

Got it. I guess when it comes to the Mint line, the 46 million capex that you called out, was that specific to one line? And the anticipation sounded like that would be somewhat linear as Mint rolls out and rolls up as opposed to a sub-function. Any further color on that?

Yeah, so the Lotus mid-single-digit capex that we'll have in Q4... and then much of the CapEx that we'll spend in 2027 is associated with our automated or semi-automated manufacturing line. And that's actually more than one line. When I say line, I mean it's our semi-automated and manual manufacturing operation. So those, yeah, it's not one individual line. Now, there's a separate project that Sean just kind of alluded to a moment ago of making the manufacturing for Mint more fully automated. And that has its own CapEx profile that I can get into if you'd like, but that's more in future years, although we'll start to see some of that CapEx incurred in 27. But, yeah, I think that answers your question.

Okay. Most of this commentary is related to Mint, not specific to Islet when you're talking about CapEx and automation.

That's right. That's right. Yeah, the CapEx for Islet manufacturing is behind us.

Got it. Perfect.

Thanks for taking the questions.

Yeah.

Thank you. And our next question comes from the line of Jeff Johnson from RW Baird. Your question, please.

Yeah, thanks, guys. Good afternoon. Maybe two algo questions if I could, Sean. One, just on type 2, if you're using real-world data there and you won't have the 3D algos out until later this year or probably early next year, Will you get type 2 on 3D or how are you going to restrict use to just the standard islet algo and the type 2 adult patients that you're targeting for mid-year approval there? Just the mechanics of how that type 2 approval will come across from an algo perspective.

Yeah, that's a really good question, Jeff. And frankly, we're not exactly sure yet. So as you've alluded to, our real-world evidence study obviously studies people, you know, type 2 users using the current algorithm as it sits today. that is one of the modes available in 3D because we know it and love it and users know it and love it. So at a minimum, we would expect that we can get Type 2 indication for that mode of the algorithm. But remember that we're also getting 3D, well, we hope to be getting 3D cleared through, primarily through simulation data. And assuming that that's the case, we may be able to apply the same level of thought to get this in a wider, fully, on all of 3D, if you will. But to be 100% honest with you, we're not sure yet. This is going to be a conversation that we have to have with the agency once we get into it.

One thing I need to add here, I was answering a Type 2 question earlier that Chris asked, and I just fact-checked myself looking at my notes. I had communicated in the response to the question that the Type 2 indication was a first half timeline. We're calling that a mid-2027 timeline. are indication in commercial launch for type 2, not a first half timeline. So go ahead and put the second part of your question.

Yeah, just the second question is just on the forced FCL decision. I'm a little surprised you're doing that on the T1 side, I guess. I mean, Sean, you know more than any of us the alpha response there issues and concerns that if you can't interact with your pump at all, does that increase in T1, at least the risk of hypo in a fully closed loop or a forced fully closed loop? So I guess my question is, What's going to be your bar on what is acceptable from an increase in hypo risk from baseline to forced FCL or just any other thoughts you can give us on doing the forced FCL pathway in T1?

Yeah. So the first is, I mean, I don't think that forced FCL should result in a higher level of hypos. Now, as with anything, diabetes is a tough beast. There are always going to be individual users that have one experience or another, but I don't think as a general statement, forced FCL should be a higher level of hypo. In fact, I think it should probably be lower. But additionally to that, there's unquestionably an enormous group of type 1s today that aren't getting access to you know AAD generally that absolutely has lower risks of hypo than you know MDI that absolutely has lower risk of hypos than what you might call standard of care and you know we need to make sure that they have access to that and by providing a simpler system that's both simpler to use, simpler to train, simpler to understand from the healthcare provider standpoint we're doing exactly that so Paradoxically, the reason we're doing this is actually to limit hypo in the population, to improve outcomes in the population. And we do that by getting products like this out to more people.

Understood. Thank you.

Thank you.

Thank you. And our next question comes from the line of Jonathan Bach from Stiefel. Your question, please.

Great, guys. Thanks. Good afternoon. maybe just a couple of quick cleanups and then one on 3D. In terms of the cleanups, Stephen, are we now thinking new customer starts down, call it slightly less than 30%, 3Q to 4Q sequentially? And then I might have missed it, but did you have any timing on FCL in terms of approval? And then I'll just ask the one on 3D.

Yeah, John, more like down 20%. New patient starts in 4Q relative to Q3. And then do you want to take the other one?

This is approval timeline. We haven't provided timing on that as of yet. Just start timing for the trial, which is relatively imminent. I don't remember the exact wording that we used. Okay.

And then just on 3D, and I'm sorry if I'm missing something or I don't mean to beat it up, but Sean, why did you withdraw the 3D intelligence filing rather than just answer the agency's questions? I'm not sure if that's sort of simulator related, but I just didn't have my arms around that. And just to be perfectly clear, Still with the new approach that you're taking, this is still going to have sort of the three options, if you would, in terms of, I mean, these are my words, but original, enhanced, and maybe importantly, the conservative option, if I've got that correct.

Yeah, none of that has changed. And that's a really important clarification on why we withdrew. The simple fact is that we got to the end of the 90-day review period, and some of these questions kind of came up near the end, and that's okay. That happens sometimes. And we just didn't have the time to get through them. So, you know, when you get into a situation like that, at times you can get into a situation where the agency is like, all right, look, I'm at the end of my time. I have to close this file. So I can either, you know, quote, disapprove it or you can pull it. And it's just kind of a procedural thing. Like what everybody always does is pull it, answer the question and resubmit. But, you know, we would have loved to have answered the questions within the bounds of the previous file, but we were just at the end of the time. So we didn't really have that opportunity, unfortunately. But that is actually the point of why we say there is still a chance to of getting clearance for this in Q4 because, again, if we pick up where we were, then, you know, potentially that's actually possible because, again, look, we acknowledge it. It sounds bad. It's not as bad as it is. It was just literally we ran out of time to answer all the questions. It wasn't a problem per se.

Understood. Thanks, guys.

You know, actually, let me say one other thing on that. I'm not a MDUFA expert here, but My understanding is that the agency has a certain number of their files that they're supposed to close within their statutory 90 days. And then, you know, they're allowed to go beyond with a few. So we do see 510ks to go beyond. It happens rarely, but it does happen. Most of them, they're going to try and close. So that's just what happened here, you know. But if people are like, oh, geez, I've seen them go beyond. That's absolutely right. But most of them do not. And they try and meet their metrics on that. So we try and help them do that.

Thank you. And our next question comes from the line of Matthew Blackman from TD Cowan. Your question, please.

Good afternoon, everybody. Can you hear me okay?

Yeah, I got you, Matt. How are you doing?

Doing well, thanks, Sean. Question for you. I was actually hoping for maybe let's call it a State of the Union on the Salesforce, obviously ahead of the Mint rollout, but particularly given your comments about needing to drive awareness of Mint earlier in the call. So just anything you're willing to share on just, again, the state of the union on the Salesforce, how the new reps have been ramping, to the extent you want to talk, perhaps not, just about the strategy you have in terms of the Mint rollout, who you're going to target out of the gate, et cetera. Just, again, any sort of updated thoughts on the Salesforce ahead of a pretty important commercial launch.

Yeah. Yeah. Well, let me start with the, you know, the awareness that we discussed earlier. You know, the Salesforce, while they absolutely talk to users every day, primarily are calling on healthcare providers, right? So what we weren't sure about was the likelihood of a user who's, you know, not seeing their healthcare provider, et cetera, you know, just sort of at home hearing about Mint in some way. Are they following us on socials? Are they checking out our website every day. Hard to predict how often that happens. But we don't think we have a problem getting the word out about Mint to healthcare providers, which is what our Salesforce is primarily engaged in doing. That was what the expansion was all about. It was about preparing us for that moment when we have Mint readiness, which we're nearly upon now. So Salesforce ramp. You know, I would say that you can see it in the numbers at some level. You know, it's absolutely sort of decelerated, and that's absolutely expected. We did a really good job, I think, of getting the word out on Islet with our previous, you know, somewhat smaller group of reps, and we've had now three years, three-plus years, to get the word out there. Getting more reps in the field doesn't really inform too many more health care providers about islet that weren't informed about it before. However, you are going to start to slowly increase the rate of scripts, and that's exactly what we see. However, on the cusp of a major launch, as you alluded to, we want to make darn sure that we can get that word out to as many healthcare providers as possible quickly with the number of times you have to visit them for them to be comfortable, again, in a short period of time. So we really needed to do this expansion prior to the launch of Mint to do that. Hopefully that's some additional color for you.

Yeah, I appreciate it. Thanks so much.

Thank you. And our next question comes from the line. That's Stephanie Algazi from B of A. Your question, please.

Hi. Thanks for taking the question. I wanted to ask on the process for getting mint on formulary and how that factors into the revenue for mint next year. And is that process all factored into that 40% covered lives you mentioned for mint at launch? or is the, I guess, immediately addressable patient opportunity smaller because of that?

Hey, Stephanie, yeah, great question. Look, you can hear it, I'm sure, in Sean and I's voice as we talk about the business that we are hugely excited for the upcoming mid-launch, massive milestone for our company and, you know, allows us to compete in a very different way. So if you're an investor or you're an analyst looking at the opportunity to I think you're naturally asking, first, is there demand for the product? And I hope we've convinced you yes by showing what the differentiation of it is. Then you're asking, can we manufacture the product? And I think Sean went into a lot of detail today that illustrates that. But then you're getting to a really important point, which is how can you guys be sure that Mint will be covered or the market access, the insurance coverage on the product? And again, reiterating that we expect 40% insurance coverage at launch, growing to at least around 50%. by the end of 2027. Yeah, so we're in a good position to do that for a couple reasons, to obtain that coverage, that 40% number at launch for a couple reasons, and very notable ones. Number one is that Mint is considered a patch pump for reimbursement purposes, meaning it is a Medicare Part D product, or at least that's the reimbursement designation. There's a nerd level term here called the GPI code for the product that governs whether the product is considered a disposable product. Mint is. On both MediSpan and First Data Bank, we are considered that distinction. So by default, we are considered a patch pump, which makes the reimbursement process dramatically easier than taking a tubed pump, which is considered Medically reimbursed and achieving pharmacy coverage for it, which is what we have done historically. But in this case with mint, it's a lot easier. So that's number one is it is considered a patch pump, which makes the reimbursement process much easier. Number two is we know how to do this. So we have the capability. There's three large PBMs that represent over 80% of all lives in the country. There's 100 underlying health plans associated with those PBMs that combined make up roughly 90% of all lives in the country. We have relationships with these decision makers at these accounts. We know how to do this. We have a market access team. We've laid all the groundwork associated with the Mint reimbursement launch. are the Mint launch for reimbursement purposes with everything we've learned from Islet reimbursement. So I could go on and on about individual accounts and details underlying this, but that's why I have confidence in these numbers we're promising here for Mint launch. And that is a very important item, going back to my first point, if you're buying into the success and the outcome associated with Mint.

Thank you. And our next question comes from the line of Richard Newitter from Truist Securities. Your question, please.

Hi, thanks. Excuse me. Thanks for taking the question. Just maybe going back to one that was asked earlier, I think, you know, lots of permutations as to where kind of the demand could eventually be sourced from for men. One of the things I was curious on is any quantification you could put around the existing islet users in the pharmacy channel currently and, you know, what you think that mix will look like as a percentage of the total mint install base when we're maybe looking back at the end of 27. Is it reasonable to think that your existing islet conversions could represent, I don't know, what, 30%, 25% of whatever install base of mint users you have by the end of next year? I'm just trying to get a sense for what's converting existing islet in-channel, in-pharmacy channel users and kind of what's truly incremental.

Yeah, Rich, fair question. I'm not going to give you the numeric answer for what I ultimately believe and I have modeled, but I'll give you a directional sense of what I think will happen here. I do think that many islet users, for reasons I've communicated earlier, are going to prefer to wear mint for reasons I hope that are clear to you all. I do also believe that much of our insurance coverage that we will have on mint will come from the existing contracts that we have on ILIT and added amendments or relationships and wins that we've already had associated with ILIT when we're trying to achieve coverage for Mint. What does that ultimately look like in terms of what percentage of the new patients we have next year on Mint? Well, it's important that you know this first, is that we will likely be prioritizing, to the extent where there's constraints on manufacturing capacity relative to demand, we will likely be prioritizing new users to Beta Bionics. And so that point, I think, certainly at the start of our initial launch, where we're more likely to be capacity constrained, that will... Thank you. Thank you. Thank you. I do think that it's plausible that we will see some of that conversion. I also think it's plausible that people who purchased Islet and are purchasing supplies through DME for Islet will also convert to Mint. Now, important to remember there that that's not a bad thing for us at all, financially. So patients who are purchasing islet supplies from us in DME, we're generating directionally around $70 a month. And Mint's reimbursement will be somewhere in the neighborhood of six times the amount of revenue per month per patient than what we're getting for that islet patient in DME. So there's a little bit of a mouthful there without, again, giving you the direct number, but I hope that's helpful.

Yeah, no, it is. And maybe... Just another one, you know, just going back to churn and type two, anything you're seeing in the market, you've been asked this question, I'm sure, in the wake of 2Q results from a competitor of yours. Anything you've noticed on type two and churn retention that's worth calling out?

Yeah, we're not seeing any notable change in David Henderson, Mark Hopman, Mike Mensinger, Stephen Feider, Our type two retention on the product is actually just slightly better than our type one retention. I'm not advertising that as like some grand difference between the two or some like incredible characteristic of our business. I'm just answering the question, but there's no massive difference, but there is some discernible difference between type two and type one in terms of retention on our product and type two is slightly better. And I have thoughts on why that could be, but just wanting to get you the direct answer.

Okay, thank you.

Thank you. And our next question is a follow-up from the line of Stephanie Algassi from B of A. Your question, please.

Thank you. Sorry I missed my follow-up earlier, but I just wanted to ask on the market, given there will be multiple patch or tubeless options in the market next year, I'm just curious how you're thinking about potential market expansion versus share-taking, and I guess how do you think about your competitive positioning and anything you'd be willing to say on your expected share capture potential on new patient starts with Mint. Thank you.

Yeah. You know, Stephanie, we're still in our infancy compared to some of the larger incumbents here. So when we think about that question, we think primarily about designing the right product. And whether we take share or whether we expand the market, you know, we do better either way. and we do that by designing a better product in both cases. So I'm not trying to be, you know, obfuscatory here. The answer is both, of course. You know, in the past, there have been people who have chosen, you know, patch pumps for good reasons. They like that format and those are people that we're giving an additional option to today with a product, or not today, but soon, with a product that we believe has additional benefits. There are other people that have chosen not to move to patch pumps today or any pump today because they didn't find the product that best met the needs for something they were looking for. And we believe that we're doing that as well. But I couldn't necessarily tell you exactly what portion of our expectation is from expansion versus share taking. For us, it's not really that important a distinction. So hopefully that's helpful. Actually, I'll also say that I think it just illustrates the fact that what we've done is we've focused on making the best product that we can. And I think everybody's heard us talk about this for the last year or so. Mint absolutely represents the right architecture as far as we're concerned. We think we've given users the right options. We think we've given them the right features, the right architecture. is it 100% perfect for all users? No, but that's never going to be the case. What we think we've done is made a product that's most applicable to most users, which is exactly what Beta Bionics has always been engaged in, right? We're trying to improve the outcome for more people with diabetes, and you do that by making a product that more people will use, that the lion's share of people will use, and that's what we're doing. And we think we've done a pretty good job of it, and we're really excited for 2027 to hopefully show the world that.

That's it for questions.

Anything else you want to say in closing? Maybe just reiterating what I just said, which is, you know, 2027 is going to be a fun year. We're really excited for Mint. I think you hear that in our voices. You hear that in the plans we're making. We do believe it's a great product. And look, I'm personally wearing it right now, and I'm loving it. I hope to bring that experience to a hell of a lot more people. So thanks, everybody, for joining today. We really appreciate your time, and I look forward to catching up with each one of you.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.