Beta Bionics, Inc.

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

Good afternoon, and thank you for tuning in to Beta Bionics third quarter 2025 earnings call. Joining me for today's call are Chief Executive Officer Sean Saint and Chief Financial Officer Steven Feider. Both the replay of this call and the press release discussing our third quarter 2025 results will be available on the investor relations section of our website. The replay will be available for approximately one year following the conclusion of this call. Information recorded on this call speaks only as of today, October 28, 2025. Therefore, if you are listening to any replay, any time sensitive information may no longer be accurate. Also on our website is our supplemental third quarter 2025 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates. Before we begin, we would like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance, and operating plans. Please refer to the cautionary statements in the press release we issued earlier today, as well as our SEC filings, including our Form 10-Q filed today, for a detailed explanation of the inherent limitations of such forward-looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward-looking statements. Please note that the forward-looking statements made during this call speak only as of today's date and we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law. Today's discussion will also include references to non-GAAP financial measures with respect to our performance, namely adjusted EBITDA. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution independently or superior to results prepared in accordance with GAAP. Please refer to our earnings press release and supplemental earnings presentation on the investor relations section of our website for a reconciliation of non-GAAP measures to their most directly comparable GAAP financial measure. With that, I'd now like to turn the call over to Sean.

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

Thanks, Sean. Approximately 70% of our 5,334 new patient starts in Q3 came from people with diabetes that used multiple daily injections prior to starting the islet, which is an important representation of how much the islet is expanding the market for insulin pumps and addressing an unmet need. We believe the islet is a game changer given its unique simplicity and ease of use, powered by the most advanced adaptive algorithm available. Given its simplicity, we're able to reach a broader group of patients and providers that were previously inaccessible to existing automated insulin delivery players, and we're seeing that in our results. Turning to gross margin, the improvements we saw in our Q3 gross margin relative to the prior year and the prior quarter are driven by two primary factors. Number one, growth in the pharmacy install base, which generates high margin recurring revenue and where we continue to see strong patient retention. And number two, lower cost per unit from higher manufacturing volumes, driven by growth in patient demand. Shifting to operating expenses. Total operating expenses in the third quarter were $32.2 million, an increase of 62% compared to $19.9 million in the third quarter of 2024. The increase in sales and marketing expenses relative to the prior year is driven by expansion of our field sales team, which still stands at 63 sales territories, exiting Q3. The increase in R&D expenses relative to the prior year is driven by the mint and bi-hormonal programs. The increase in G&A expenses relative to the prior year is driven by new costs related to operating as a public company. Let's discuss cash. As of September 30, 2025, we have approximately $274 million in cash, cash equivalents, and short and long-term investments. We are sufficiently capitalized to fund all of our key initiatives and positioned to begin generating free cash flow well ahead of historical diabetes peers. Turning to our updated full year 2025 guidance, we are raising guidance across the board. We project total revenue for the full year of 2025 will be greater than $96.5 million, up from our prior guidance of $88 to $93 million. This means we project sales of at least $28.5 million in Q4 2025. For the full year 2025, we now expect 27 to 29 percent of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of 25 to 28 percent. This implies that we project our pharmacy mix as a percentage of new patient starts in Q4 to be similar to the mix we saw in Q3. I want to point out a couple of factors that could create variability to the upside or downside in our pharmacy mix of new patient starts in Q4. On one hand, we continue to drive more adoption of the islet under the pharmacy benefit at the health plan level, which pushes pharmacy mix higher. On the other hand, new patient starts in the DME channel tend to be strong in Q4 because many people have hit their out-of-pocket maximum and can receive their pump and supplies at no cost until year-end. Taking those dynamics together, we expect Q4 pharmacy mix as a percentage of new patient starts to be similar to Q3, but recognize there is potential for that mix to trend higher or lower based on those dynamics. Moving on to gross margin, we are raising our outlook to 54% to 55% gross margin for the full year 2025 versus our prior guidance of 52% to 55%. This means we project Q4 gross margin to be in line with or improve slightly relative to Q3. We are increasing guidance at the low end and midpoint of the range for a couple of reasons. Number one, embedded in our revenue guidance raise and pharmacy mixed guidance raise is a raise in our expectations for new patient starts, and that increased scale should generate a lower per unit cost through manufacturing volume leverage. And number two, we expect to benefit from our growing pharmacy install base, where the large number of new pharmacy users year-to-date, combined with the strong retention of those users, produces high-margin recurring revenue in Q4 and beyond. We continue to contemplate the impact of existing and potential tariffs on our full-year gross margin guidance. We are aware of recent initiatives focused on reevaluating the application of tariffs on our industry and do not have a reason at this time to believe that duty-free exemptions from custom components of the island and its consumables are in any jeopardy. With that, I'll hand the call back to Sean to discuss updates in our innovation pipeline. Sean?

Thanks, Stephen. As I've stated before, our goal with our pipeline programs is to disrupt the industry and disrupt ourselves. Let's start with an update on Mint, our patch pump in development. We've spoken at length in the past about the key advantages of Mint's two-piece design architecture, where we believe we've chosen a design that creates an advantaged user experience relative to other patch pumps currently on the market and in development. Our design choices spanning from a patch change experience that doesn't require phone interaction to eliminating the need for recharging and to enabling firmware over-the-air updates are all in service of user experience. Add those advantages to our industry-leading algorithm, which has been shown to produce excellent clinical outcomes independent of user engagement, and we believe that Mint will be a true game changer when it commercializes. In Q3, we continued to execute according to plan on our Mint timelines, and remain highly confident in our ability to gain 510K clearance for the product as well as manufacture it at scale. Our goal remains to commercialize mint with an unconstrained commercial launch by the end of 2027, meaning we expect to be able to fully support demand for the product by that time. Shifting to our bi-hormonal pump program, in September, we completed our pharmacokinetic, pharmacodynamic, or PKPD, bridging trial for our glucagon assets. Full results from that trial are in line with our expectations, and we believe such results are supportive of the continued development of our glucagon asset for use in our biohormonal system and development. In Q4 of this year, we expect to initiate a feasibility trial of our biohormonal system to test it in humans for the first time with our glucagon asset before progressing the asset to any larger scale studies. As a reminder, the PKPD study was the first in human trial for our glucagon asset, and But the bi-hormonal system also includes our bi-hormonal pump and algorithm for insulin and glucagon dosing. And we're yet to test that system using our glucagon asset in humans, such that we believe the best strategy is to run at least one bi-hormonal system feasibility trial before progressing to pivotal trials. There is no change to our expectations that we'll conduct concurrent pivotal trials to fulfill the requirements for a 505B2 NDA with a chronic drug indication for glucagon and the ACE and IAGC 510Ks for the pump and algorithm respectively. We continue to be extremely excited by the biohormonal system's ability to transform clinical outcomes for people with diabetes, but more importantly, the ability to transform the way people experience their diabetes and shift their mindset from diabetes being a disease that they manage to simply a disease that they have. To highlight another recent win in our pipeline, on September 29th, we received a special 510K clearance for certain feature updates for the islet. These updates focused on improving the usability of the pump. We introduced an improved workflow for the cartridge change process to make it more seamless for the user and eliminated redundant low-glucose alerts to ensure our users are focusing on the alerts that matter most while reducing alert fatigue. These updates are illustrative of both the intent we have in listening to feedback from our users, as well as the speed with which we operate in an effort to ensure our users' needs are consistently met every day. There's one more update that I'd like to discuss on the regulatory front. In late June, the FDA issued a Form 483 following an inspection. The Form 483 is primarily related to our customer complaint handling system, and our criteria for reporting complaints to the FDA, which are ultimately reflected in the FDA's manufacturer and user facility device experience database, also known as the MOD database. The result of the FDA's inspection is not unusual in our industry, as numerous precedents the agency has set for our peers at similar stages would suggest. We believe that in those instances, Beta Bionics and our peers likely developed similar definitions for what constitutes a reportable complaint prior to the FDA's feedback. and each company has successfully taken the steps required to align reporting with the FDA's standards. We are no different, and our remediation efforts to the Form 483 are straightforward and well underway. Regarding the change to the criteria for reporting complaints to the FDA, we revised our definition of what complaints are reportable to better align with the broader industry standards. Our revised standard operating procedure for reportable complaints took effect in late July, which resulted in the notable increase in reportable complaints in August and September. To cite some examples of how our definition of reportable complaints has changed, prior to the 43, we were not reporting complaints such as the device's screen cracking or a hypo or hyperglycemic event that did not require medical intervention. We now report these types of complaints to the FDA given they could result in an adverse event if ignored. I want to make something abundantly clear. While the number of complaints we have reported to the FDA increased, most notably in August and September after the new system went live, this is not the result of a change to the underlying complaint or adverse event rate relative to our installed base. In terms of what to expect going forward, since we received the Form 483 in June, we've submitted monthly progress reports to the agency. We're confident that our new complaint handling system and reporting system meets or exceeds the expectations laid out by the agency in their Form 43 observations. As part of this process, we will be applying the new reporting criteria to all historical complaints we have received since the IELTS launched. That remedial filing process started very recently. As such, we expect to see the number of mod entries relative to our installed base increase considerably from October to November. and remain elevated until we have completed the remediation process, as both current and historical complaints will layer on top of each other. We expect to complete the remediation process by the end of Q2 2026, at which time the number of mod entries relative to our installed base will fall as historical reports are no longer being submitted. Shifting the topic of type 2 diabetes. In Q3, we continued to see some healthcare providers prescribed ILIT to their type 2 diabetes patients off-label. We estimate that over 25% of our new patient starts in Q3 were from type 2, which is consistent with the prior quarter. While we're not committing to a specific timeline, we remain eager to pursue the type 2 diabetes label through the FDA. To conclude the prepared remarks portion of today's call, I want to highlight the key points that we hope you take away from our discussion. Number one, the islet's differentiation is resonating wider and deeper in the market. Number two, Our commercial strategy is working, and we're continuing to execute relentlessly toward the goal of making ILIT the new standard of care. Lastly, we're aiming to build the most innovative pipeline in the industry with the goal of disrupting the industry and ourselves, and we continue to make progress on each key pipeline initiative every day. This is a business that we believe is set up for sustainable success over the near, medium, and long term, and we're excited to continue sharing updates with you all as we continue to execute. With that, thank you all for tuning in, and we'll now open the call for Q&A.

Thank you. If you'd like to ask a question, please press star 1-1. If your question hasn't answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Mike Kratke with Lewink Partners. Your line is open.

Hi, everyone. Thanks for taking our questions. The fact that you're creeping up on $100 million in revenue for the year and at a much higher rate of pharmacy mix than we'd been expecting is super impressive, so congrats on the ongoing execution. Just to that point, can you share some additional color on what's driving that momentum you're seeing What factors really seem to be contributing to that demand? And can you talk about the cadence of new starts throughout the third quarter, specifically that's shaping your assumptions on the fourth quarter?

Yeah, Mike, first of all, thanks a lot for that. Appreciate it. In terms of what's driving the quarter, I mean, frankly, I don't think it's anything different than it's been driving our success all along. You know, we do see the islet as a new category of device, and fundamentally that takes a bit of time, right? We're not launching just another insulin pump here. We're launching an insulin pump that you have to think a little differently about. And that takes time. And necessarily, we're going to see increased adoption as the world gets it more and more over time. And I think we just saw that continuing. But I don't think there's any particular initiative that I could point to uniquely in Q3 that really impacted the quarter. Stephen, can you comment further?

Yeah, cadence and demand, I'll just address that briefly, was generally consistent across the entire quarter. So nothing really to read into in terms of timing of demand and where it was relative to the upcoming quarter.

Understood. And maybe just one quick follow-up. In terms of things that are out of your control, how does the government shutdown impact your assumptions on timing for the Mint launch, if at all?

I would say it doesn't. currently have an impact on our expectations for timing. We reiterated those earlier in the call. Yeah, I'll leave it at that.

Understood. Thanks very much.

Thank you. Our next question comes from David Roman with Goldman Sachs. Your line is open.

Thank you. Good afternoon, everyone. I appreciate your taking the questions here. Maybe I'll just start with a further question on kind of what you're seeing in the underlying market dynamics. You talked about the 70% of patients coming from MDI converts. Can you maybe give us a flavor on the remaining 30% of the patients, whether that's coming from conversions from patients who are coming up for renewal? It looks to be a big bolus of renewal patients coming to market. Is that conversions from different pump therapies? Maybe just help us understand the balance of the growth drivers there and how you see that unfolding through the rest of 25 and into 26.

Yeah, thanks, David. This is Steven here. In terms of the remaining 30% that are coming to us from competitive pump systems, they're coming roughly one-third, one-third, one-third from the three primary competitors. And in terms of the outlook in the future, there's nothing that – look, that bifurcation of our demand coming from – 70% coming from injections and the other 30% coming from competitive pumps, that's been pretty consistent over the last four to eight quarters. And there's nothing that we see in our business that would imply that the future will look any differently. I would say there's still a the market for insulin pumps in both type and type one and type two is still very underpenetrated. I want you to remind you of those percentages. And so the the large opportunity that still exists for a company like ours with a new and differentiated system remains an MDI. And I expect most of our demand will continue to come from there.

That's very helpful. And I appreciate your reiterating the timelines around the Mint full commercialization by the end of 2027. But can you maybe just remind us of the different steps that need to take place between now and then? For example, have you finished human factor testing? And what types of updates will you be able to provide us along the way?

Yeah, I don't think we're going to provide any additional information on where we are at the moment. I mean, we would reiterate that you know, generically the three main steps that we need to look for here are 510K clearance, followed by manufacturing readiness, followed by launch. We've talked about those in the past, but I don't want to get into the details of exactly where our internal program is, lest people read more or less into them than they deserve. So, for the moment, we'll reiterate our timelines, and we reserve the right, of course, at all times to update you as we know more. Great. Thank you very much.

Thank you. Our next question comes from Matt O'Brien with Piper Sandler. Your line is open.

Afternoon. Thanks for taking the questions. Can you hear me okay? I have some technical issues this evening.

Loud and clear.

You got this, Matt. All right. All right. Great. Appreciate the questions. Maybe just starting with the 20 new territories that you added in Q1, Um, maybe if you can just tease out the impact that those 20 territories are having here in Q3, because you don't typically see such a meaningful step up here in the third quarter versus, um, you know, Q4 based on seasonality. So maybe talk about how those, those, um, those reps are ramping and then, you know, kind of what's left for that group or that cohort, you know, as we think about, you know, maybe the next 18 months.

Yeah. All right. So the new territories that we added at the start of the year are absolutely growing in their maturity and increasing in productivity. But the entire sales force on balance also is. So if you looked at even just the quarter over quarter growth in new patient starts from Q2 to Q3, we saw an 8% uptake. And yes, that's Uh, that is driven in large part by the new, the 20 new territories that we added in the start of the year, but the Island is still new to almost every territory nationwide. And so we're continuing to see an uptake in new store sales, same store sales across the entire country. Okay.

And then, you know, maybe talk a little bit, you know, I wanted to ask a little bit more about mint, but just maybe talk a little bit more about the four 83, cause that's a little bit of new information. and how serious that is, your remediation efforts. It sounds like you're kind of on track already. So maybe just try to frame up the 483 for us, not that they're ever great to see, not that you take them for granted, but just how this one falls in terms of seriousness and then your ability to respond quickly. Thank you.

Yeah, great question, Matt. I mean, it's tough to put a qualifier on something like that. I mean, obviously the FDA issues 43s when they find something to be important. But I think with a 43, as long as you're aggressive with dealing with the problem, you don't have a big problem. And we've certainly been that. We're... you know, very far along in our remediation efforts. New systems are fully in place at this time. And what we're seeing now, as we stated on the prepared remarks, is just the implementation of those systems and, you know, sort of remediating past complaints. But the new systems are in place at this time, and no, we don't foresee any ongoing challenges at all. Stephen, you got anything to add to that?

Sure. Yeah, I think, look, the FDA interpretation or the interpretation of the rules for what's considered a reportable complaint and what's considered a non-reportable complaint actually leaves a lot of room for interpretation. And so we were interpreting before the 43 observation, we were interpreting the rules a particular way that we had a lot of confidence in and we're not apologetic about. However, when the FDA did their observation, they disagreed with our interpretation, which is totally fine. They asked us to remediate and use the new definition, and we, of course, complied. And now, you know, to us, this is a very benign issue as long as we actually do what we say we're going to do. And so we're bringing it to your attention because we feel it's important to be transparent. There may be some misinformation out there about why we've seen an uptake in um, reportable complaints in the mod database. We don't see it as an issue at all. And we kind of on brand for us to just, you know, answer the mail. And so hence why we brought it up today.

Understood. Thanks so much.

Thank you. Our next question comes from Travis deed with bank of America securities. Your line is open.

Hi, this is Stephanie Piazzolla on for Travis. Thanks for taking the question and congrats on a good quarter. Maybe just wanted to follow up again on the increased complaints being reported. Maybe you can just elaborate more on the real-world performance and feedback and retention that you're seeing despite some of the complaints received. And if you could clarify, it sounds like you've made good progress on the remediation already, but some things will continue through Q2 of next year, if I heard that right. So maybe we can just clarify what's going to be outstanding through then. Thanks.

Yeah. First of all, I wouldn't read anything in to the word complaint in this case. The insulin pump industry is, if you look at the complaint rates that all insulin pump companies receive, it's somewhat shocking at some level. And the primary reason for that is that definition that Stephen alluded to earlier, where really anything, you know, anybody calls in with a problem with your product or an experience issue and it gets reflected as a complaint, which is fine. Those are the rules. But I don't want anybody to hear, and I don't believe it's true, that there's any complaint with a product that, I don't know, those are our words here. Anyway, I wouldn't read too much into it. Second half of that question is,

I think, I don't know, I think it kind of answered Stephanie. Was there a part that we missed? Yeah, I forgot the second half of her question.

It was just that you mentioned you made good progress on the remediation effort. Oh, yeah, right. But that's something that will continue through next year.

Yeah, sorry you wanted details on that. Absolutely. So what it is specifically, and I think we said this, but I'll give just a little more clarity. When, you know, over time, we receive calls, right? Everybody receives calls, and you have to decide whether or not those get reflected as reportable complaints to the agency. So what we're doing at this point is we're going back through all of those calls we've received, you know, since the dawn of time, and reporting the ones that now qualify under the new definition as reportable events that did not prior. Does that make more sense?

Yes, got it, thank you.

And we'll be done with that process by Q2 of next year.

Okay, understood.

But again, the systems are now in place. Everything is working as it should at this point. We just have to go back and do all that catch-up work, that's all.

Okay, got it. And then you talked about some of the positive growth drivers that you have this year and are going to continue into Q4. maybe just thinking a little bit ahead to next year, how we can think about some of those continuing and then any headwinds that we should keep in mind for next year as well. Thank you.

Yeah, I'll start with that one and then Stephen can add anything that he may want to. The primary growth driver that I listed was obviously additional understanding what ILIT is. Again, I think there's When you look at data on adoption from healthcare providers, it really takes quite a number of years, in fact. So I think that we expect that tailwind to continue over time as people start to understand ILIT better, as we develop more and more of our own real-world evidence and get that evidence out there, showing the world how well ILIT really is working in a real-world setting. So those continue, obviously. The other tailwind that I'll mention is obviously pharmacy adoption. There's a lot of reasons that pharmacy adoption is better for the business. It makes it easier to adopt dial it, easier to script dial it. Obviously with the expansion of that, that's certainly going to be a tailwind. And we hope that the expansion of pharmacy adoption itself continues more in the next year as well.

And this year, and by the way, thanks for the compliment, Stephanie, on the results. We're definitely happy with them. Yes. The uptake that we've seen in pharmacy this particular year, meaning now in the low 30s percentage of our new patient starts, it's way exceeded even our internal expectations. And what it's really doing for next year's financials that's great is that we're retaining those patients at a very, very high level. And because of that, it's high margin recurring revenue now that we have in this pharmacy install base, which is the design of the whole program. And that's the intention of the whole program to move to a subscription like revenue stream. And you're going to see that in our financials. And you've already been seeing that and even like the gross margin profile that we now, again, have this high margin revenue that we've generated from our growing pharmacy installed base.

Thank you. Our next question comes from Michael Polark with Wolf Research. Your line is open.

Hey, good afternoon. Thank you. First topic for me was the The 510K clearances you mentioned, different cartridge change process and elimination of redundant low-glucose alerts. I guess I'd just be curious, the cartridge change process, what improved? How was it before? How is it now? And what kind of was the root cause, if you will, of too many low-glucose alerts? Is that a software fix or another change? Oh, right.

Yeah, so on the first part, the cartridge change process, these are really just subtleties in the process, different screens and whatnot, user experience stuff. They're not huge, but we think meaningful. On the low glucose alert, so I want to make sure that one's really clear. With a system like an insulin pump, you can get, for example, an urgent low, a low a very low, there's all different kinds of alerts and they can stack on top of one another and require you to clear each one individually and what have you. Or you can look at it and take the most severe of those alerts and only, only deal with that one, for example. Um, so it's sort of related to that. It's just like, do you really have to clear, you know, four alerts at all in effect till you're low? That seems pointless, right? Um, does that make sense?

Yeah, understood. Um, the other one is just, uh, Maybe kind of a look into 26 as well, a reminder on what's a good way to think about Salesforce expansion as you roll into next year? Any soft circle for a number of territories that you would hope to add? Thank you.

Yeah, of course. Good question, Mike. Yes, of course, we have our internal expectation of how many new sales territories we're going to expand and win next year. But I'm not going to talk about a forecast for 2026 that gives any indication as to what our revenue is going to look like. So unfortunately, I'm not going to share that number.

Understood. Thank you.

Thank you. Our next question comes from Frank Takanan with Lake Street Capital Markets. Your line is open.

Great. Thanks for taking the questions. Congrats on a really solid quarter. Just a curiosity question versus my model, and I could be unique in how I modeled it this quarter, but it feels like the A bigger portion of outperformance, you outperformed on both my DME and PBM expectations. A bigger portion for me was related to DME. Was this just a modeling discrepancy on my side, or was DME maybe a little bit stronger than you anticipated? Any specifics on maybe where the pumps were placed, which geographies, maybe didn't have health plans set up, or anything to kind of call out that maybe drove that DME being a little stronger than my expectations?

Yeah, good question, Frank. The Outperformance in DME, of course, is just mostly driven by new patient starts exceeding expectations, but there actually was some favorability from stocking dynamics in Q3 relative to Q2, and that created favorability in DME revenue in Q3 relative to Q2. There actually, and you didn't ask about this, but there's actually the inverse impact we saw in the pharmacy supply kit revenue. There was an unfavorable stocking dynamic in or had an unfavorable impact on revenue in Q3 relative to Q2. And what I mean by this in the case of DME is that the DME customers ended their quarter with more inventory on their shelves in Q3 than they did in Q2, creating again, what I would call a favorable stocking dynamic in Q3.

Got it. Okay. That's helpful. Thank you for that. And then maybe on, uh, the bi-hormonal timeline? I know you guys are talking about the feasibility study, but how should we maybe think about when you guys might formalize a cleaner timeline, kind of similar to how you've talked about patch end of 2027? Will you do that with the bi-hormonal pump in the near future? How should we think about that?

Yeah, Frank, you know, look, we'd love nothing more than to give you a solid timeline on the bi-hormonal product. But we obviously have internal expectations on that that we have not shared. However, given the complexity of that particular product being, you know, having to get both CDRH and CDR on the same page in terms of what a pivotal clinical trial looks like and all the requirements around the drug, and frankly, our own evolution into a drug company as well, I think it would be a little bit premature to start putting timelines out on that now. because, you know, frankly, they could evolve as we learn. And as we get the agency, both halves of the agency onto the same page with what it is that we're doing here. So not just yet, but please be assured that we're working toward getting, most importantly, the product out the door as soon as we possibly can. But of course, the next step will be to help you all understand the timelines on that as soon as we can. But in the meantime, hopefully you do see that we continue to make progress on the product, including, as I said, the completion of PKPD and the soon implementation of the new feasibility trial, which we're excited about.

Perfect. Cool. Thanks for the call. Thank you. Our next question comes from Jeff Johnson with Baird. Your line is open.

Yeah, thanks. Good evening, guys. So, Sean, maybe on the bi-hormonal question there, even if you can't put a timeline out there, which I understand, can you just remind us, you know, we're so accustomed to 510K pathways here in the diabetes space. We know kind of six-month review processes. We know these tend to be 13, 26-week trials, things like that. Once you do start a pivotal, how long would a pivotal for a bi-hormonal run as far as, you know, from... in a single patient. I know it takes a while to enroll in first patient in, last patient in, and all that. We'd have to estimate. But I guess my question is more, how long would the study last on a per patient visit or per patient basis? And then how do we think about, you know, the review timeline once you do get that data and submit it to the agencies, how long a review process could last?

Yeah, great question, Jeff. The ICH guidelines dictate that for a chronic drug indication, we need a year's worth of data. on an individual patient. So to your point, plus enrollment, etc. But the trial itself will run at least a year on, you know, at least one, well, not at least one, on a number of patients. And then, you know, timelines for enrollment, timelines review of that data, you know, early interactions with the agency, but then the actual NDA submission itself, I believe, is a year.

One year on that too, yeah. Okay, that helps. Thanks. I'm not a pharma guy, so the number is strong there. But also then, Stephen, maybe can you just maybe quantify for us the stocking headwind in pharmacy and the stocking tailwind in DME at all and how much of that was on supply side? Just as we look at the supply revenue this quarter on a per patient basis in the pharmacy channel, it came down about 10%, 12% or so sequentially this and we keep trying to wrestle with how much of that is attrition versus stocking dynamics and all that. So just maybe help us quantify, especially in the pharmacy channel, maybe what that stocking headwind was in the quarter.

Yeah, of course. I have two parts to this answer. First part is that I'm not going to quantify the exact dollar amount of the stocking impact in DME versus pharmacy, but the two offset one another nearly dollar for dollar. in the quarter. So net neutral stocking impact with, again, favorability in DME, unfavorability in pharmacy. And then on your point about attrition and retention, while I'm not going to share retention rate or attrition rate, even though I know we get asked about it consistently, and this is for reasons that I think we've been very clear about, most notably that the competition doesn't share attrition or retention rates. I do want to point to one output of your model, Jeff, and I guess any investor or analyst that has as a model, that I would sort of maybe alleviate maybe your feeling on that question. So the metric that I want to point your attention to is the number of pharmacy supply kits per pharmacy patient per quarter. And so the math there, how to do the math to get to that metric is you'll take the pharmacy revenue, pharmacy supply revenue, I should say, in the given quarter, Divide that by the price of each pharmacy supply kit, which you know is roughly $450 because that's what we've said. And then divide that again by your belief of what the pharmacy installed base is. So that's, again, it's pharmacy revenue in the given quarter divided by the price, $450, and then divided again by the pharmacy installed base. And what you're going to find when you run that metric in this quarter and in all the most recent quarters is that that metric is well in excess of $300. And that's regardless of what attrition rate or retention rate assumption you use in your model, no matter how low you would choose the attrition rate to be. And what does that say? If it's above three, well, remember that a patient only uses one pharmacy supply kit per month. And so they would use three per quarter. So by very virtue of that number, which is, again, an output in your model, by that being above three, I think that illustrates why there's not retention or attrition issue at the business. So I guess I, hopefully that was, that was helpful, but again, I won't, I'm not going to talk specifically about attrition or retention, the number for reasons that we've communicated in the past.

Yeah, no, that math is helpful. That's exactly how we run it in our model. I guess it's just, you know, we're trying to understand the 40% decline we've seen in per patient per pharmacy running over the last two and a half quarters.

So I think the other thing to remember is that you're going to see, like, again, big deviations in that metric from quarter to quarter, meaning, yeah, you did see a downtake in it this quarter. You've also seen uptakes in the same metric if you looked over trending over quarter to quarter. And what that really points out is that there are fluctuations in in pharmacy stocking, and it does have a material impact on our revenue in a given quarter. But really, the reason why this is so much fluctuation is just think about how much our pharmacy demand has changed. We've gone from our guidance being low teens or low double-digit percentage up to now we're in the low 30s. And so pharmacy customers don't really know how much to order to keep up with demand, and that's a part of why you're seeing big fluctuations.

Understood. Thank you.

Thank you. Our next question comes from Richard Newiter with Truist Securities. Your line is open.

Hi. Thanks for taking the questions, and congrats on the quarter. Maybe just on the pharmacy channel and the percentage here, so you're obviously exceeding your expectations, our model, and I think consensus, too. You're on track to exit at a low 30%. Let's just think through where this percentage could reasonably get to or where we should not be, what threshold we shouldn't be exceeding before you potentially are on commercial with a patch. Is this something that could be 50% exiting 2026? Or what's the threshold that we should be thinking about or put some bookends around it as we fine-tune our models? Because clearly you're exceeding where we all had you on a trajectory?

Yeah, I appreciate the question. Frankly, the frustrating answer for us and you is that we don't know. We're doing something nobody's ever done before, and that's push a durable pump through the pharmacy channel. To your point, we've exceeded our own expectations on what we can do there. We hope that those exceedances continue and that we can get even farther than even we think we can, but it's very hard for us to make a prediction on that, and I don't think we're frankly in any better position to do it than than anybody else. We're just forced with going out and actually doing the work. So I'm sorry, we can't make that prediction. But what I will tell you is that we'll try and make that number as high as we absolutely can.

Okay, fair enough. And then just on type two indication, I think, Sean, you've talked in the past, you know, that it's not something that you necessarily, it's precluding you from moving that percentage higher. It was a little flat this quarter. I'm just curious, anything you're seeing that we have multiple players out there with an official indication and data, and you mentioned you're not going to commit to precisely the strategy and timing of what you're going to do to ultimately secure an indication, but if you could elaborate on you know, how you're thinking about that and what your options are. Thanks.

Yeah, you know, the first thing I would say is that I wouldn't look at it as flat. The percentage was the same, and our new patient start, you know, obviously base grew. I don't think there's any benefit to beta bionics to grow that 30% or, you know, roughly 30 to roughly 25, excuse me, to, you know, something much larger. I mean, we need to grow our total new patient starts. and to your point, you know, we're not really outselling it. So, um, it kind of is what it is on a percentage basis and that's okay. Um, you know, there's some, some other things that go into the dynamic as to whether or not we would, we would make the decision to, to invest in that or when we make the decision to invest in that is what I should say. Um, that I probably just can't get into at this stage, um, because they result or they relate to some, you know, internal product pipeline stuff. But, um, Yeah, I don't know. I would say that, you know, we're doing as well as anybody effectively in that channel, and we don't even have the indication. So, yeah, I'll leave it at that. Okay, thank you.

Thank you. Our next question comes from John Block with Stiefel. Your line is open.

Great, guys. Thanks. Good afternoon. Anything to call out regarding just the competitive landscape? You know, there's really been a good amount of focus there with a new entrant, but your competitive wins as a percent of ads actually ticked up a bit Q over Q and obviously had a huge growth rate if we look at it year over year. So just any color you can provide there with the landscape may be changing or maybe not.

Thanks. Hey, Jeff. Yeah, I appreciate the question. Short answer is no. It is a highly competitive industry. It's competitive not only just for recruiting the right type of sales reps, but every account has a lot of different sales reps that are trying to sell and get the attention of the HCP at that given account. But we're confident in what we have. We have a highly differentiated product, the easiest system on the market, we believe, to use for doctors, for patients, compelling solution with the pharmacy reimbursement. And so I don't see the market or the competitive landscape as meaningfully different than it was, you know, semi-recently. And we feel confident.

Okay, Stephen.

Sorry, that was John. My bad.

All good. All good. Stephen, maybe I'll stick with you. You know, I'm struggling with the guidance from Gross-Martin's in a good way. And I know you gave some reasons. You sort of said, hey, it implies flattish to slightly up GM's Q over Q for 4Q. But your pharmacy mix is largely consistent, or the assumption is, with 3Q. And we've seen a lot of scale, right, throughout 2025 when you just look at your sequential gross margin improvement despite pharmacy ramping as an overall percentage. So can you just tell me why like that improving scale dynamic wouldn't resonate as much if you would in 4Q25? Or is this maybe just leaving a little bit of wiggle room considering you really don't know the percentage DME versus pharmacy because of the deductible metric you brought up earlier? Thanks for your time. Of course.

On the high end of the range, the gross margin guidance for Q4 is actually in line with the increase that we're guiding to in Q4 revenue. So the increase in scale and the benefit that we would get the gross margin is actually sort of in line, again, with the revenue increase quarter over quarter. But on the low end of the range, you're right, that may seem a little surprising to you that we're guiding to that low. Really, it just comes down to lack of predictability around the pharmacy reimbursement channel. There is a world where in Q4 we out outperform our expectations in pharmacy, which actually creates in terms of new patient starts. And what would that do is it would create a short term headwind to revenue and gross margin. And, you know, that that's one reason. And the second is that cost of sales. Well, look, we like said the guidance philosophy around here is for metrics like this. We like to set expectations at a level that we have a high degree of confidence in. And with cost of sales, there can at times be things that are semi unpredictable that could come up and be a one time charge. I'm not suggesting I see any of those in Q4, but, you know, that can happen. And so, hence, we like to be, you know, I guess a little cautious with, you know, large uptakes in gross margin guidance for that reason.

Oh, good. Thanks for the call.

Thank you. Our next question comes from Jeffrey Cohen with Leidenberg Thalman and Company. Your line is open.

Oh, hey. Thanks for taking our questions. Congrats on a strong quarter. Just one for us, if you could maybe talk about your Special 510K. Was this software only and was this uploaded to all the units out there and does that help or would that help in mid-development or some of those updates being embedded into mid now?

Yeah, it's a software upgrade and As with all of our software upgrades, that's something that all of our users get a chance to download and use. And in fact, we always like to push people to our newest software. I would say that part of those software upgrades are related to Mint and some not. Some of the way we do the alerts and alarms certainly will be reflected in Mint. Cartridge change process, of course, has nothing to do with Mint whatsoever. So yes and no. But as with anything, Betabionics considers ourselves to be primarily a user innovation, a user experience company, I should say. And to the extent that those user experience things are applicable to Mint, we'll absolutely reflect them in that. Yeah.

Okay, perfect. Thanks for taking our question.

Thank you. Our next question comes from David Roman with Goldman Sachs. Your line is open.

Thank you. I appreciate your taking the follow-up. And I hate to focus on the 483, but the mod dynamic has become such a distraction for investors, intro quarter. And as we think about the kind of remediation process here, that does have the potential just to create some noise for people out there counting up mod reports, which is sort of like a meaningless metric, but it does get a lot of attention. So can you maybe just help us frame how we should think about those reports when we see them? how to interpret the remediation filings and just maybe help us kind of calm the obsession with counting mod entries?

Great question. Well, look, you know, from our perspective, this is something that every company in the diabetes space has gone through at one time or another. I think, as Steven alluded to, the guidelines associated with what constitutes a complaint or a report, I should say, are unclear at best, and we've all had to align our understandings with that of the agency. For anybody who really wants to dig in, I guess I encourage you to. You can go to the mod database, that's the whole point of the thing, and you can look what's being submitted, in our case, the case of any other company out there. You can look at rates. We've been fairly transparent with what our installed base is, et cetera, and you can compare those things, and we think we compare favorably. You know, in terms of how to think through it beyond that, I'd say that's hard to say. You know, we don't see an underlying problem in our data here. The 43 itself had nothing to do with the actual complaints being received or the number of them. It had to do solely with the definition of the reports being filed as complaints, and that's all. So hopefully that's clear.

Very appreciate your taking the additional question. No problem. Not at all.

Thank you. I'm sure no further questions at this time. I'd like to turn the call back over to Sean for any closing remarks.

All right. Thanks, everyone. As usual, we enjoyed discussing a strong quarter with you today. We appreciate your work to understand our business, and I guess we look forward to seeing you all next quarter. Thank you. Thanks, everyone.

Thank you for your participation. You may now disconnect. Good day.