Beta Bionics, Inc. (NASDAQ:BBNX) Q1 2025 Earnings Call Transcript

Beta Bionics, Inc. (NASDAQ:BBNX) Q1 2025 Earnings Call Transcript May 10, 2025

Operator: Good afternoon, and welcome to the Beta Bionics First Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. And instructions will follow at that time. As a reminder, please be advised that today’s conference is being recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. Please go ahead.

Blake Beber: Thank you. Good afternoon, and thank you for joining Beta Bionics first quarter 2025 earnings call. Joining me on the call today are Sean Saint, Beta Bionics President and Chief Executive Officer; and Stephen Feider, Chief Financial Officer. Both the replay of this call and the press release discussing our first 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, May 6, 2025. Therefore, if you are listening to this replay, any time-sensitive information may no longer be accurate. Also on our website is our supplemental first quarter 2025 earnings presentation and updated corporate presentation.

We encourage you to reference 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 of future events, our product pipeline, developmental time lines, 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 financial 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 financial measures to their most directly comparable GAAP financial measure. With that, I’ll now turn the call over to Sean.

Sean Saint : Good afternoon, everyone, and thank you for joining us for our first quarter 2025 earnings call. We’re excited to discuss with you all today our results for the first quarter of 2025 and updates regarding our annual guidance for the full year. As I highlighted in detail on our Q4 and full year earnings call in March, 2024 was a tremendous momentum building year for Beta Bionics, where our efforts to expand iLet’s commercial reach while advancing our innovation pipeline set the company up for success over the short, medium and long term. We are building a highly differentiated company that is difficult to compare to traditional insulin pumps from the industry business models from our first-of-its-kind adaptive closed-loop algorithm, which takes over set up in dosing, to our pay-as-you-go pharmacy business model, which we pioneered for durable insulin pumps to our innovation pipeline, which includes a further differentiated patch pump and the bi-hormonal pump that we hope will transform the way people think about managing their diabetes, plus it could give us a second new business model based on our glucagon license.

We appreciate our business is quite different from others in our industry and appreciate everyone’s efforts towards learning about these differences. We firmly believe the business model and product evolutions we’re pioneering are the right path forward for Beta Bionics and our customers, and we are confident that you will see that play out in our performance over time. The momentum that we saw in 2024 carried into the first quarter of 2025, driven by robust demand for the iLet and our team’s unwavering commitment to delivering life-changing solutions that simplify and alleviate the burden of managing diabetes. I want to thank our team for their efforts through which we generated Q1 results that exceeded our expectations across the board, and that gives us a great deal of confidence in our ability to meet or potentially exceed our updated projections for the remainder of the year.

Specifically, we’ve increased our 2025 annual guidance for revenue, percent of new patient starts reimbursed through pharmacy channel and gross margin, which Stephen will discuss in greater detail. On today’s call, I’ll discuss our Q1 results. Following that, Stephen will give us some additional details as I’ll highlight our increased annual guidance for the full year 2025 and the conviction we have in our ability to meet or potentially exceed those targets. And lastly, I’ll provide updates on our innovation pipeline. Starting with a brief overview of our Q1 2025 financial performance, I’m happy to announce that we delivered $17.6 million in net sales, which grew 36% year-over-year. This was fueled by growth in our new patient starts, which we — where we saw 3,853 new patients adopt the iLet in Q1, up 48% year-over-year.

Low 20s percentage of those new patient starts were reimbursed through the pharmacy channel in Q1, which is meaningfully higher than the mid-single-digit percent we saw in Q1 of 2024 and the low-teens percentage we saw in Q4 of 2024. Notably, we’ve already achieved our previous guidance of greater than 20% of new patient starts through pharmacy. As a reminder, we believe the best metric to measure pharmacy coverage is the percentage of new patient starts that are reimbursed through pharmacy as opposed to percentage of lives covered, which only accounts for formulary arrangements with pharmacy benefit managers or PBMs and doesn’t account for adoption by the underlying health plans or the underlying logistics required to utilize this channel.

Shifting now to gross margin. Our gross margin in the quarter was 50.9%, down relative to 55.7% in Q1 of 2024, which is primarily attributable to the substantial year-over-year increase we delivered in the percentage of new patient starts going through the pharmacy channel. As I’ll highlight in more detail shortly, this meaningful expansion of pharmacy adoption goes well for our medium- to long-term outlook for gross margin expansion. I want to emphasize that our pharmacy model is a pay-as-you-go model that essentially eliminates the revenue we generate for the iLet itself, but maximizes reimbursement we get for iLet supplies on a monthly basis. This model is starkly different from the DME channel or other pharmacy channel business models that focus more on collecting a large upfront payment for the pump itself, but much less payment for monthly supplies.

You can’t have your cake and eat it too, meaning maximize both upfront payments — for the pump itself as well as the monthly payments for supplies. That’s a very difficult recipe for driving meaningful pharmacy adoption. As such, we’ve chosen the pay-as-you-go model that maximizes supply revenue because we believe it generates the most lifetime customer value while also being the most powerful pharmacy benefit model for health plans to adopt as evidenced by our rapid growth in new patient starts being reimbursed through the pharmacy in recent quarters. Said differently, we’re willing to weather the slight near-term headwinds that come with our pharmacy model so that we can benefit much more from the medium- to long-term tailwinds that we expect it to generate relative to other models.

As I mentioned earlier, we’re proud of our Q1 results. They are a reflection of the market’s deepening appreciation for our highly differentiated adaptive closed-loop algorithm and recent product launches from Q3 to Q4 of 2024, including Libre 3 Plus Integration, Color iLet and our Bionic Circle remote monitoring app, all of which contributed meaningfully to our performance in Q1. Q1 tends to be seasonally weaker period for diabetes technology adoption as patients’ deductibles reset, yet our new patient starts only experienced a slight sequential decline in Q1. That’s certainly a credit to all those factors I just mentioned, but it’s also important to highlight that our — increasing pharmacy mix enables people with diabetes to access our pump with minimal to no upfront out-of-pocket costs, which also certainly helped our ability to drive new patient starts in the quarter.

Regardless of which pharmacy business model the industry decides to pursue, I think we can all agree that decreased out-of-pocket costs are good for patients, and it’s encouraging to see us all working toward that same goal. With that, I’ll turn the call over to Stephen to provide some additional color regarding our first quarter results and to discuss our increased full year guidance for 2025. Stephen?

Stephen Feider : Thanks, Sean. Diving deeper into our Q1 performance, approximately 71% of our 3,853 new patient starts in Q1 came from people with diabetes that use multiple daily injections prior to starting the iLet. This metric reinforces our belief that the iLet is addressing an unmet need in the market and meaningfully expanding the market for insulin pumps. Q1 results saw traction from our product launches in Q3 and Q4 of 2024, including the Libre 3 Plus Integration, Color iLet and Bionic Circle as well as our growth in pharmacy mix, which makes it easier for patients to access our pump. With these dynamics in play, we’re able to partially offset some of the seasonal headwinds to new patient starts that the industry tends to see in Q1 relative to Q4.

Let’s shift to pharmacy dynamics. In Q1, a low 20s percentage of our new patient starts were reimbursed through the pharmacy, which exceeded our expectations as we saw faster uptick by the underlying health plans that partner with Prime Therapeutics as their PBM, plus we continue to make progress in driving adoption by health plans within other existing PBM partnerships. The pharmacy channel is our preferred reimbursement channel, given it is meaning accretive to our financials over a four-year period relative to the DME channel, and it substantially lowers out-of-pocket cost for patients. Turning now to gross margin. In Q1, our gross margin was 50.9%, down compared to 55.7% in the first quarter of 2024. The decline relative to the same quarter of the prior year can be attributed predominantly to our rapidly increasing pharmacy mix as a percentage of new patient starts, which we just discussed.

Reflecting on our Q1 gross margin performance, we’re pleased with the strong result we delivered despite the substantial uptick in pharmacy adoption because it’s reflective of our continued cost discipline, which bodes well for our gross margin outlook for the remainder of 2025 and beyond. Shifting now to operating expenses. Total operating expenses in the first quarter were $27.6 million, an increase of 66% compared to the $16.7 million in the first quarter of 2024. This increase in operating expenses was primarily attributable to expansion of our field sales team as well as the new costs related to operating as a public company. Let’s talk about cash. As of March 31, 2025, we ended the quarter with $295.5 million in cash, cash equivalents, and short- and long-term investments.

We remain confident in our ability to generate positive free cash flow at an earlier stage relative to what historical precedents in our peer group may suggest. Here are a few reasons for this confidence. Number one, our gross margin profile is attractive relative to our scale. We have designed our device to be manufactured efficiently and expect to see future reductions in the cost to produce an iLet, stemming predominantly from greater leverage on our fixed overhead costs as we scale. Number two is our pay-as-you-go pharmacy revenue model, which we’ve now discussed extensively and are confident it is financially accretive relative to DME in the medium and long term. Our most powerful lever on profitability is price. Number three is simply that this management team has a track record of operating efficiently.

The Beta Bionics management team and I appreciate the way to earn this efficient operator title and the public’s trust is by delivering results, and that’s what we intend to do in the coming quarters and years. Now turning to our 2025 annual guidance. We are increasing guidance across the board. We now project that net sales for the full year of 2025 will be $82 million to $87 million, up from our prior guidance of $80 million to $85 million. We now expect 22% to 25% of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of greater than 20%. Allow me to remind you what the increase in pharmacy guidance means for revenue over the next four years. The raise from 20% to 23.5% new patient starts through pharmacy, which is the midpoint of our updated guidance, will likely generate a roughly $1 million headwind in 2025 revenue.

This roughly $1 million headwind is baked into our updated 2025 annual revenue guidance of $82 million to $87 million. From 2025 through 2028, we’d expect the same increase in pharmacy guidance to result in up to a potentially $8 million net tailwind to cumulative revenue that goes directly to our bottom line, assuming no attrition and inclusive of the $1 million potential headwind in 2025. In terms of how to think about the revenue cadence for the remainder of the year, we still expect the relative weighting of new patient starts and revenue across each quarter to be similar to the relative weighting we saw across each quarter in 2024. We anticipate new patient starts in the second quarter will increase sequentially relative to the first quarter, driven by continued traction of our recent product launches, plus the 20 sales territories we added in the first quarter to bring our total number of territories up to 63.

We expect the percentage of new patient starts reimbursed to the pharmacy in Q2 will be at least as strong as Q1, with additional growth coming in the back half of the year. Our formulary agreement with Prime Therapeutics went into effect on February 1, and we saw faster-than-expected traction of iLet pharmacy within the health plans that partner with Prime. While these efforts to expand pharmacy adoption will continue throughout the year, both with Prime partner health plans as well as health plans that partner with other PBMs we have agreements with, we don’t expect the rate of pharmacy increase in any given quarter for the remainder of the year to be as pronounced as the rate — of increase we saw in Q1. Moving on now to gross margin. We are raising our outlook to 50% to 53% gross margin for the full year 2025 versus our prior guidance of at least 50%.

Despite the larger-than-expected increase in pharmacy mix, we are raising our gross margin outlook for a number of reasons. Number one, embedded in our revenue guidance raise is a raise in our expectations for new patient starts, and that increased scale will allow us to gain more leverage on our fixed overhead costs. Number two, we saw an incremental decrease in our bill of materials for the iLet relative to the prior quarter and expect that Q1 run rate should sustain throughout the year. And number three, we’ll benefit from our growing pharmacy installed base, where the bolus of new pharmacy users we onboarded in Q1 should produce high-margin pharmacy supply revenue for the balance of the year. So the takeaway here is that while the outperformance in pharmacy was an unexpected headwind to our gross margin outlook for the year, we expect to be able to more than offset that headwind, and we are raising guidance as a result.

Moving on to tariffs. Custom components for the iLet and its consumables are exempt from tariffs under the Nairobi protocol. We do have some non-custom components that we source from China, such as our device chargers. But overall, we expect the impact of tariffs on our business to be minimal, and their impact is contemplated in our updated gross margin guidance for the year. In terms of how to think about gross margin cadence for the remainder of the year, we expect gross margin to increase slightly throughout the year as continued increases in new patient starts through the pharmacy are more than offset by the combination of, number one, the leverage we gained on fixed overhead manufacturing costs from increased volumes; and number two, our growing pharmacy installed base.

With that, I’ll hand the call back to Sean to discuss our innovation pipeline.

Sean Saint : Thanks, Stephen. Before I jump into our innovation pipeline, I want to dive a little deeper into our algorithm and the advantaged position it holds in the market. Let’s first acknowledge that an FDA-approved AID system in the market today, including the iLet, must first deliver great outcomes. Given this is table stakes, a core belief of ours is that ease of use is the metric that people with diabetes care about the most when they think about their approach to treating their diabetes. We saw that — we saw the importance of no fingerstick calibration, continuous glucose monitors, and the role that particular ease-of-use innovation played in accelerating CGM penetration. And we believe that the iLet is simply similarly redefining the metrics that matter most for insulin pumps.

We believe this because not only are we seeing tremendous traction for the iLet since launch, but now the pump industry at large is touting ease of use as the next frontier of innovation, whether that’s by trying to simplify pump setup, meal announcements and carb counting or trying to eliminate meal announcements altogether, which the industry would define as fully closed-loop. In terms of where the industry is today, the ease-of-use innovations that we’ve seen from traditional hybrid closed-loop systems are incremental steps in the right direction, but we still believe the iLet is far ahead. And that’s because the iLet does something that we believe no other pump can do. It adapts to each user and learns their insulin requirements. It’s one thing to pre-populate a pump’s initial settings based on a new — on a few inputs.

It’s another thing entirely to do what the iLet does, which is autonomously determine initial insulin dosing based on weight alone, and then the pump actually adapts to the user and continuously adjust those doses over time based on what that — specific user needs at that time. With other pumps, the burden of adjusting pump settings and finding the right doses is on the provider and the patient. With the iLet, the burden is on the pump itself to do that. The same logic applies to fixed insulin dosing or fixed carb counts for different food items. The burden is still on the provider to educate the user and on the user to learn what fixed insulin dose to give or fixed carb count to select and what works best for them over time. With the iLet, the pump will learn and adapt to what a usual meal is for you.

That’s the key to revolutionizing ease of use, adaptation and learning. It’s important to note that Beta Bionics has worked hard to bring easier products — to use in the market. But as we said earlier, outcomes can’t be sacrificed in the process. We’re proud of our clinical and real-world data, and we have chosen to arm our sales force with real-time access to our real-world patient outcomes. Using our iPads, reps can select a particular clinic as well as criteria like previous therapy and see how those de-identified users are doing in real time. They can do this on a population level or a clinical level. We arm our sales force with that data because we’re proud of it. And we’re penetrating deeper into new and existing clinics because our data is resonating with prescribers.

We look forward to presenting a comprehensive update of our real-world evidence through the iLet’s first two years of launch at our ADA investor event in June. Now let’s dig into our innovation pipeline. I’m extremely excited by our pipeline and the ability it may have to disrupt the industry and ourselves. In Q1, we continue to make progress on our patch pump towards our goal of commercialization by the end of 2027, and we remain confident in that target. We believe our patch pumps two part reusable and disposable design may make for a more seamless patch change process versus fully disposable patches, and that, plus the integration of our adaptive closed-loop algorithm with the patch has the potential to transform the user experience for patch pumps.

We’re excited to show you all a demonstration of the patch at our ADA investor event in June, where we will dive deeper into the product design and the user experience advantages I mentioned. Shifting to our bi-hormonal pump program. In Q1, we began enrolling what I would refer to as our bridging study for our glucagon candidate, which is successful, would allow us to bridge all of our previous bi-hormonal clinical data, including three pre-pivotal inpatient and six pre-pivotal outpatient trials to our new formulation of glucagon. This study is designed to assess the pharmacokinetics and pharmacodynamics, typically referred to as PK/PD of our glucagon candidate. Beyond the PK/PD study, we’re planning to conduct concurrent pivotal trials to fulfill the requirements for a 505(b)(2) NDA with a chronic drug indication or glucagon and the ACE and IAGC 510(k)s for the pump and algorithm, respectively.

I want to remind everyone that if we’re successful in getting the bi-hormonal system to market, we believe it could have not only the ability to transform clinical outcomes for people with diabetes, but more importantly, the ability to transform the way people think about managing their diabetes as well as produce a larger lifetime customer value to Beta. Beyond the patch and bi-hormonal programs, I want to provide a few other updates. Starting with our digital innovation. We recently launched a pilot of our updated health care provider portal, which allows clinics to see a full view of all the iLet patients they treat in the clinic, to collaborate between providers in the clinic and to simplify communication and connection between health care providers and iLet users during and between their visits to the clinic.

Our mission is to simplify and alleviate the burden of managing diabetes and the vision for our new health care provider portal is to do just that. Over time, we’ll be adding features that we expect will empower providers to understand the outcomes that the iLet is driving across their entire patient base and to quickly identify and triage patients that may need additional support. To briefly touch on the type 2 label expansion opportunity, we’ve shared that there are some health care providers that decide to prescribe iLet to their type 2 patients off-label. We continue to see this in Q1 and estimate that approximately 20% to 25% of our new patient starts in the quarter were type 2. We look forward to pursuing the type 2 label to the FDA, but we also recognize the importance that ease of use and pharmacy reimbursement can have in driving type 2 adoption by patients and the providers who manage them, most of which are primary care providers.

Now to touch on CGM integrations, we will support the 15-day Dexcom G7 sensor at launch. We are currently integrated with Dexcom G6 and G7 and Abbott Freestyle Libre 3 Plus, making us the most advantaged pump for CGM integrations in the U.S. today, and we intend to retain that advantage when the 15-day G7 launches. To summarize what we hope you’ll take away from the call today, we are seeing positive momentum across our business, both commercially and in our pipeline. We’ve updated our annual guidance accordingly and are confident in our ability to meet or potentially exceed those increased targets across the board. We have a number of compelling short-, medium- and long-term initiatives that we expect will ultimately deliver life-changing solutions to a much larger group of people with diabetes.

We’re committed to building a business that delivers durable value to the diabetes community and in doing so to our shareholders as well. And we’re excited to continue sharing updates with you all each quarter as we progress in our journey. With that, operator, please open the call for Q&A.

Q&A Session

Operator: [Operator Instructions] Your first question comes from the line of Matthew O’Brien with Piper Sandler. Please go ahead.

Matthew O’Brien : Hey, good afternoon. Thanks for taking my question. Would love to start on the pharmacy side because that number was pretty eye-popping as far as what we saw here in Q1. Just between the new access that you received, new sales force you received or you’ve gotten recently, just maybe talk a little bit about — just thinking about the sales force, I’m not sure that was that big of a contributor. But just what we’re seeing on the underlying side in terms of the dynamics of the pharmacy channel on your business and the decision to increase the outlook there specifically here in Q1?

Sean Saint : Yeah, Matt, thanks for the question. I think that what we’re seeing there is we’re just having greater success with in effect, what we’re selling to the plans themselves. As we shared in prepared remarks, step one is get the contract to the PBM, but the traditionally more difficult step is to convince the underlying plans to adopt your — the plan that you’ve laid out or the contract you’ve laid up with the PBM. And frankly, we’re just seeing that happen faster than we expected. And I think that’s a testament to signing those contracts in a way that makes it advantaged for the plans to want to do this. And that happened pretty aggressively in the first quarter, primarily based on the Prime contract specifically. But that obviously gives us — increased confidence going into the back half of the year.

Stephen Feider : And there’s nothing onetime about the success that we had in pharmacy in the first quarter. So again, it was a low 20s percentage of our new patient starts reimbursed through the pharmacy in Q1, and we increased the guidance to 22% to 25% for the year. And so — we’re just pointing out that like what we saw in Q1, we expect to sustain through the rest of the year with some slight uptick.

Matthew O’Brien : Got it. And then, Stephen, you did a really nice job running through the financial benefit that you’re going to get from that upside here in Q1. Can you talk about, again, the patient adds? I mean, that was way higher than what — what we’ve been modeling here, especially in the seasonally soft quarter. Just some of the successes that you’re having in terms of adding new patients and then the contribution from these new reps and potentially even layering on in terms of adoption because you’re still fairly new in the rollout of the product.

Stephen Feider : Yeah. Good question, Matt, and thanks for the compliment there. So yeah, we saw a 4% reduction in our new patient starts from Q4 to Q1. And I think that’s Matt, what you’re alluding to. So again, Q4 to Q1, 4% reduction. But seasonally, you would expect in diabetes, the decrease to be quite more — quite a bit similar significant than that. And so I think it’s really just a product of 2 things that are resonating with our product. Number one, we had some new product launches that went into effect in Q3 and Q4, notably the Color iLet, the Libre 3 integration and the Bionic Circle. So those certainly create some benefit for us that we’re selling better things now, and we had — we were able to do that for the entire quarter.

And then the second is we have a maturing sales force. So we have a sales force that now we exited Q1 with 63 sales territories, but a lot of those — 20 of those 63 are brand new in the first quarter. But even of the 43 that existed prior to that, they were maturing — they’re more mature and we’re developing traction across the entire country. So again, of those 20 that — those 20 new territories that we added in the first quarter, really, there was no contribution to new patient starts from those incremental 20. So it’s again, most of the results that we saw in Q1 were from the existing 43 we already had.

Matthew O’Brien : Got it, thank you.

Operator: Your next question comes from the line of Mike Kratky with Leerink Partners. Please go ahead.

Mike Kratky : Hey, good morning. Thanks for taking my questions. Stephen, maybe just wanted to start on the guidance. Can you help frame to what extent your new guidance assumes a raise in new starts for the year relative to your prior expectations? Any color on the magnitude of that would be helpful. And then I have one follow-up.

Stephen Feider : Can you say that again, Mike?

Mike Kratky : Yeah. I might have missed this, but I think you said in your comments that your new guidance in terms of revenue assumes a raise in your new starts overall for the year. And yes, just curious on the magnitude of that. And maybe just to ask the follow-up upfront, how does that assume any new shifts in competition, either between new players or new combos that could come to market?

Stephen Feider : Yeah, got you. Okay. So yes, we increased our revenue guidance by $2 million at the bottom end, high end of the range. But we also dramatically increased our pharmacy guidance, which means that in 2025, we increased our new patient starts expectations by above what we — what our revenue guidance implies because we have to sell more new patient starts in order to make up for that revenue delta that has now created in the short run — from pharmacy. So I guess maybe just to confirm your point, Mike, yeah, we called — we increased our revenue guidance, but the actual implied increase in new patient starts guidance is higher than what again — what we’re communicating in terms of revenue. In terms of competitive pressure, I don’t know, Sean, do you want to comment on that part?

Sean Saint : Sure. I mean I don’t think that the way we do our guidance generally doesn’t consider relative share between the different players. But what I will say is that we’re obviously quite cognizant of competitive launches within the space, and we did allude to that in the call. And at this point, we don’t see anything on the horizon that we’re particularly concerned about. Everybody is doing well. There’s good products out there now and getting better. But for the moment, we believe that the iLet remains a differentiated algorithm that what — that does a fairly unique thing. And that’s exactly why we’ve been leaning into sharing our real-world results of the iLet and how it’s working in the field as broadly as we possibly can.

And I would add to what Stephen said earlier about tailwinds in Q1 is, as we mentioned, our sales reps are now in a position to be sharing how well the iLet is doing from baseline A1c to follow GMI, and that message is very much resonating. And again, we just don’t see anything on the market — or excuse me, on the horizon that really risks that in any way.

Mike Kratky : Understood. Thanks very much. And maybe if I can just sneak one more in. In terms of the type 2 side, super helpful color. Can you talk about what type of traction you’re seeing among endos versus PCPs for those patients?

Sean Saint : Mike, I think we probably prefer not to comment on that at this time specifically. What we will say is that a significant number of the type 2 population is managed in the primary care space. And we do believe that being applicable in the primary care space is a very different challenge than in the endocrinology space, primarily based on the fact that primary care providers are somewhat less familiar with the setup and management of a traditional insulin pump. And that, we believe, positions us uniquely in the primary care space specifically, having nothing to do with the type 2 opportunity specifically because, again, we don’t have that indication at this point.

Mike Kratky : Got it. Thanks so much.

Operator: Your next question comes from the line of Matthew Blackman with Stifel. Please go ahead.

Mathew Blackman : Hi, good afternoon. Thanks for taking my questions. I’ve got 2. Maybe to start, Sean or Stephen, you both, I think, echoing what Matt said, tackled that pharmacy mix impact well. So I appreciate that color. I think the one question I have still is, why are you confident in this now explicit 22% to 25% range? What kind of visibility do you have on that mix? And how much control do you have over whether a pharmacy — a script goes through DME or through pharmacy? And then I’ve got one follow-up on the sales force.

Stephen Feider : Yeah. We have pretty good visibility. So we signed I think I’ll just remind you kind of the framework of how this works for us for you to ultimately get coverage turned on for a patient to be able to be reimbursed through the pharmacy channel. First, you have to sign PBM contracts and then there’s some selling that gets done at the plan level and all those decisions get made at a future date. So there’s really like three stages to turning on pharmacy coverage. And because we are in discussions like — with PBMs, with plans involving both of those elements of the process, we actually do have like some pretty good visibility. Now that said, there can be slight deviations from quarter-to-quarter because our sample size is relatively small.

But with the reason that we see we’re forecasting some upward momentum in the pharmacy adoption through the rest of the year is because we’re aware of some information for like when we expect certain plans to turn on the iLet as a pharmacy benefit. And so I would say our visibility is actually reasonably strong.

Mathew Blackman : Really appreciate that.

Sean Saint : Part of Matt’s question there was how do we control which channel the script goes through.

Stephen Feider : Yeah, yeah. So every single prescription for the iLet ends up getting sent to Beta Bionics and at which time Beta Bionics then checks to see if a patient is covered in the pharmacy benefit. And if they are — so we have a tool that allows us to do that. If they are covered in the pharmacy benefit, we send the patient to get reimbursed through pharmacy and that prescription is filled through a mail order pharmacy. If the patient is not covered in pharmacy, we then send them to DME. So that just reiterates my — the points that we’ve now said on the call, and it’s a good question. But this is why when we say that the pharmacy is our preferred channel and that we send every patient that we can through the pharmacy. We actually do control all those — that patient volume. And so every patient who is covered in pharmacy benefits from it. So again, we check all the patients for pharmacy, if they’re covered, we send them there.

Mathew Blackman : Got it. Thank you for that. And the question I have on the sales force, you sort of touched on it a little bit, but up to 63 from 43 at the end of ’24. Just to be clear, are all those 20 incremental territories now up and running in the second quarter? And then a couple of follow-ups. I don’t think so, but okay. So thank you on the yes. I doubt there was any, but was there any 1Q dislocation with the expansion of the sales force with maybe the existing territories? And the final question is, how are you thinking about layering in these new territories as those reps ramp to productivity? Are they layered in, in the back half of ’25? Or is it really in 2026, a 9- to 12-month productivity curve that we should start to visibly see them contribute to the top line? Thank you.

Stephen Feider : Yeah. So dislocation, Matt, sorry to clarify, but what do you mean by the dislocation point? I just want to make sure I don’t misanswer that.

Mathew Blackman : Yeah. So sometimes when you expand the sales force, there is eyes get taken off the balls, things slip though the cracks. Now typically, that’s when you’re slicing up territories, which you’re not doing here. But any time I think in med tech, we hear sales force expansion, you automatically think the worst.

Stephen Feider : So no dislocation. Look, on balance, what you said is true about the net the 20 new territories are on — are being added to areas where there wasn’t already an existing sales rep. But sometimes there are certain new places where we did cut a territory, let’s say. And so that — statement isn’t always true. In terms of like the time to productivity, we’ll start seeing our — this new 20 sales territories start generating revenue immediately in the second quarter. So, now the time to productivity, I’ve never formally answered that question in terms of like when we expect the territory to become fully productive, and I won’t answer that here. But I — but it doesn’t take quarters for a territory to kind of get up and running so that they start creating any demand at all. Now these territories are now in place, they’re trained and they’re actually selling for us in the second quarter.

Mathew Blackman : Thank you, Stephen. I’ll get back to queue.

Stephen Feider : Good questions, Matt.

Operator: Your next question comes from the line of Travis Steed with Bank of America. Please go ahead.

Travis Steed : Hey, thanks a lot for taking the question. Congrats on the quarter. I guess the first question I had is now that you’re at kind of 63 territories, the awareness of iLet is getting out there. Any change in kind of what you’re seeing within your doctors and prescribers in the uptake of iLet. How they’re using it and also like seeing penetration move like within your own doctors and also kind of adding new prescribers. Just kind of curious how the awareness of the product is kind of playing out? And then I had a follow-up.

Sean Saint : Yeah. Great question, Travis. I think what we’re seeing evolve is that when you first launch a product, you’re necessarily going to get niched in some level, right? Nobody ever launched a product in this industry and somebody just looked at it and said, yeah, I’m going to use that on absolutely everybody. It hasn’t happened one time that I’m aware of, and I’ve been in the industry a while. So they’re going to find that area where they need to try it out. And I think iLet was no different, right? And we know that at some level, we get used on some of the harder patients. And patients have previously been unable to be successful on other therapies. But what we’ve been able to do, and we’ve alluded to this several times now is share that success of the average A1c drop from X to Y.

I think on the last call, we shared what we considered our fully closed-loop experience and the shocking reductions in GMI that we saw on that. And when we can share that on a clinic-by-clinic basis or a doctor-by-doctor basis and say, doctor, this is your experience with the iLet, say, holy smokes, it’s really working well. And there’s no real reason that if it’s working well on my harder patients, it really shouldn’t work at least as well on my easier ones. And so I think there’s an understanding of that going on. But at the same time, as we increase our sales force size, we increase the accounts that we’re calling on, we’re going to see that also start the other direction in those new accounts, right? So we say, okay, well, now it’s my first time using the iLet.

I understand it’s out there, but I haven’t tried it before, and then they try it on some of the harder patients. And then we have to get that physician or account to move down the spectrum or what have you and get iLet to be more broadly accepted. But I think we’re clearly seeing that at some level. And again, the clinical data that we’re able to share does indicate it. And as we mentioned, we are — we’re excited to share that real-world evidence data more broadly at our Analyst Day in June at ADA. And I will remind everybody that the majority of people in the United States, roughly 80% have an A1c over 7%, so not meeting A1c goal. And historically, these are the people that we’ve considered to be the harder patients. So frankly, being niche to an 80% group is something that we’re very happy to start with.

And if we progress into the entire population, well that’s just even better.

Travis Steed : Great. And then, Sean, I guess the follow-up one would be on the patch pump. I’m not sure if there’s any milestones you could share on progress you’re making there. I just wanted to make sure there’s nothing else on that. And then Steve, on the modeling question, we’re putting in the DME revenue and patient revenue in the models, and it looks like there was a tick down in revenue per patient in the DME side this quarter versus the prior few quarters. I’m not sure if there’s something to call out there. We can follow up offline if there’s something that we’re missing.

Sean Saint : Yeah, I’ll take those one at a time and Travis, that’s fast work on that second one. That’s good fast math. I like that. I’m going to let Stephen take that one. On the patch pump, no, I’m sorry, we won’t share any additional color on that project. We did reiterate our prior guidance of commercial launch by the end of 2027. And then as I mentioned, we look forward to sharing that product in more detail at the Analyst Day in June, so we can get a little hands-on with it and see how it works, and what the intent is and provide some more color around my statement today, which is that we do expect it to, on balance, be an easier user experience as compared to a fully disposable form factor. So yes, looking forward to that one. Stephen?

Stephen Feider : Yeah. And just to be clear, at that ADA event that Sean just referenced, we’re — we’ll do a full demonstration of it. So it’s not just some slides with like some updated visuals. We intend to show you exactly what the merits of it are.

Sean Saint : Exactly.

Stephen Feider : So in terms of why you’re seeing that trend, Travis, so the distributors ended Q4 with more inventory, DME inventory on their shelf than they did in Q1. So said another way, there was lumpy — a little bit of lumpiness, which there’s nothing to read into here, but it’s just so it kind of happens in the nature of the industry that we’re in. But there was a larger spread between new patient starts and number of iLets sold to distributors in Q4 than what there was in Q1. So that’s really the reason.

Sean Saint : Timing aspect of orders.

Stephen Feider : Yeah, timing aspect of orders. And there’s nothing — I wouldn’t call like a prediction of what we’ll see in the next quarters either. I think we’ll just sort of experience a little lumpiness like that. That will get minimized as the revenue for our business sense grows over time. But for the time being, yes, it did make an impact in the comparative periods.

Travis Steed : Is there likely a catch-up next quarter? So it’s like if it’s under this quarter, it goes higher next quarter? Or is that too simplistic?

Stephen Feider : Not always true. I mean there’s a world where distributors end — end Q2 with the same level of inventory that they did at the end of Q1, in which case, we wouldn’t see any difference there for comparing the two periods. But if — at the end of Q2, distributors end the quarter with a similar inventory level they did from Q4, then yes, there’s some tailwind in Q2.

Travis Steed : Okay, thank you.

Stephen Feider : Yes.

Operator: Your next question comes from the line of Johnson Jeff [ph] with Baird. Please go ahead.

Unidentified Analyst: Thank you.Good afternoon, guys. Just a couple of quick follow-up questions, if I could. First one, just on the hold on, sorry — I feel like I’m losing my chain of thought here just I’m sitting in the airport. I know I’m trying to remember what I was going to ask hold on. I know what it was. Just on the gross margin line. So you came in a little bit below. Obviously, that’s the move to pharmacy. So much of the value of your patients is in year two, three and four . Do you have any on the 19,000 pumps that you’ve placed so far, any early indication on attrition rates? So far, your pump supply revenue seems to be coming in a little bit better than we had expected. It would suggest to me maybe the attrition rate is a little lower than I had been modeling. But just any early indication on the attrition rate would be helpful.

Stephen Feider : Yeah, sure. Look, you’re not going to love my answer here, so just a disclaimer. But we won’t be sharing the actual attrition rate in the pharmacy channel or in the DME channel for that matter for a few reasons, including the competition doesn’t. But I guess just embedded in the statement, we have perfect access to that information. So I know what our attrition rate is every month, of course, in both channels, DME and pharmacy. And embedded in my statements of the pharmacy being our preferred revenue channel is my understanding of the attrition rate and my confidence that it’s accretive to Beta Bionics financially in the medium and long term because of that. And so I guess I’ll just have to leave it there that, yes, we’re seeing strong attrition at the moment or strong retention, I guess.

Unidentified Analyst: All right, fair. There are some noise in the background. So I’ll drop there. Thanks.

Stephen Feider : Thanks, Jeff.

Operator: Your next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen : Hi, gentlemen. Thanks for taking our questions. I guess we wanted to focus on clinical work for two questions. Firstly, on the bridging study. Can you talk about what we may see this year? You did mention inpatient and outpatient numbers as far as the study is ongoing. And then secondly, could you talk about the time line and expected size on this label expansion trial for type 2?

Sean Saint : All right. There’s a couple of questions embedded in that, Jeff. Let me start with the bridging study. The bridging study is primarily a pharmacokinetic, pharmacodynamic study or PK/PD. So as such, we won’t have device outcomes from that because what we’re looking at is the way that our glucagon candidate impacts blood sugar over time as compared to historical glucagon. So the idea why it’s considered bridging is that if this glucagon candidate reacts or causes the body to react in the same way as previous glucagons that we used in our formative trials than we can expect the device to work in the same way as well. So that’s — that basically says all the data to date can be bridged to the new glucagon. That being said, that trial has begun.

We didn’t state anything beyond that, and I won’t at this time. But I will say that historically, we’ve shared that the cadence here is going to be a bridging study followed by pivotal trials, and there is more than one, but they’re anyway similar, followed by the NDA and 510(k)s on that product. And so this gives us an idea of where we’re at, at that point. And then timeline on any type 2 label expansion, I think we’re going to continue to not comment on that one for any number of reasons. But primarily, we’re – well, yes, maybe just leave it at that.

Jeffrey Cohen : Okay. Perfect. And one more brief one for us. As far as the size of the commercial organization, you update us quarterly. Are you planning on more adds throughout Q2 to Q4 for this year? Or is this an annualized decision when you talk about adding 20 in the first quarter?

Stephen Feider : Yeah. I’m going to not share an expectation or communicate an expectation on whether we’ll expand the size of the field team through the remainder of the year, but we’ll continue to share at the end of each quarter how many territories we have.

Jeffrey Cohen : Super. Okay. Thanks for taking our question.

Stephen Feider : Yeah, Jeff.

Operator: [Operator Instructions]

Stephen Feider : Looks like we have one more from Brooks, right?

Operator: Yes. Your final question comes from the line of Brooks O’Neil with Lake Street Capital Markets.

Brooks O’Neil : Thank you very much. Congratulations on a terrific first quarter. I just have a couple to finish up here. First is you guys are the only ones integrated with Abbott Libre 3. I’m just curious if you’d comment on whether you see any meaningful impact on new patient starts that’s tied to the Abbott Libre 3 device.

Sean Saint : It’s a great question, Brooks. Now I’ll take a page from Stephen’s playbook and say I’ll probably frustrate you with my answer. Given that we are partnered with multiple CGM players, I think it’s our policy to not discuss the relative weighting of our CGM adoptions between those players. Said another way, we’re going to let the CGM guys battle it out, and we’re going to be very happy to support all of them. With that being said, we’re extremely thankful to Abbott for partnering with us on the Libre 3, certainly one great sensor as is the Dexcom, and it certainly matters to our business as does the Dexcom sensor. So if that was a middle-of-the-road answer, then I got it right.

Stephen Feider : And just to reiterate what I said earlier, I mean, Q1 was a strong quarter, partially because we had some new product launches and one of those new product launches was Libre 3 in the fourth quarter. So that did contribute to a strong quarter.

Brooks O’Neil : Sure. That’s helpful, Steve. Thanks a lot. Last question I had was, you talked quite a bit about the pharmacy and the economics and dynamics. And I’m just curious, when you say that for you guys, you’re highly confident that it’s going to be meaningfully accretive in the medium and long term, and you comment that the patients’ out-of-pocket is meaningfully lower. On one level, I assume that means that the payers are paying more and yet you comment that they’re very enthusiastic about adoption. And I’m just — I would love to get any color you can offer in terms of how that dynamic works out because in my experience, the payers are pretty sensitive to their out-of-pocket costs.

Stephen Feider : Yeah. Understood. So yeah, it is meaningfully accretive to Beta Bionics in the medium and long term. And at month 11, we actually generate in the aggregate a larger amount of revenue in the pharmacy channel than the DME channel, like if you just compare, again, cumulative revenue from a patient who would start in DME versus pharmacy. So what does that mean? Yes. That means that a payer over the course of a four-year period would pay more for the iLet in pharmacy than they would in DME. However, here’s why the payers like it. There’s two primary reasons. Number one, in DME, patients do find a way at times to switch from pump to pump, and it’s left to the DME distributors and the — or not the DME distributors, but the DME payers to police this four-year warranty element of their business, meaning preventing patients from getting another pump in DME, if they’ve gotten one within the last four years.

Well, that’s actually kind of a challenging system for DME payers to police. And so they found ways to do it, but patients also find different ways sort of around that mechanism. So that’s the first reason is it’s avoid this sort of system that I think is maybe frustrating for the payers to police themselves. The second is that, look, I think it’s well known that having patients on insulin pumps, in particular, AID, automated insulin delivery pumps does great things for patient outcomes — for patient health outcomes. And so payers actually believe that having more patients on a — and this is true, I think, in the data that having more patients on insulin pumping reduces a patient’s overall cost to the system for someone that has diabetes.

And so payers, again, want more patients on insulin pumping, and they see a path to more patients using them if these products can be made at a lower cost and an easier system to access, which is the pharmacy reimbursement system. So for those two reasons, we found that payers are certainly welcoming the pay-as-you-go business model in the pharmacy channel relative to DME.

Brooks O’Neil : Great. It’s a good explanation, Stephen. I appreciate it. And it’s good to hear that the payers are actually doing the right thing in this case.

Stephen Feider : Yeah. Every partners Brooks. And good question, Brooks.

Brooks O’Neil : Thank you very much.

Stephen Feider : Looks like we have one more.

Operator: Your last question comes from the line of Kelly Close with Close Concerns. Please go ahead.

Kelly Close: Thank you. We were wondering, as you think about the type 2 market, do you think there’s more opportunity in the number of patients who are already on basal and maybe they’re on GLP-1, but they still can really use more help with their glycemic management or the ones who maybe are actually on MDI, but that’s such a challenging thing for clinicians to manage and they would benefit so much more from pump therapy, especially pump therapy that’s easier and so much more convenient. Thanks so much.

Sean Saint : Great question, Kelly. Definitely a perspective, and we’ll see how this plays out over the long run. I think — first of all, I’m not a physician. But if I were, I think I would be looking at potential users who most closely matched the current users of a particular technology because it’s closer to what I’m familiar with, meaning I’ll translate that. Obviously, there’s a huge percentage of type 2 users today who are on intensive insulin therapy and those patients are really being managed just the way type 1s are, as we know. So that’s a natural entry of pumps into the type 2 space. What they can additionally do in the basal only or in the GLP-1 or what have you, at least at some level remains to be seen. And I think we’re interested to see that.

But the intensive insulin therapy market in type 2 is quite large today. And I think certainly would benefit by the entry of a product that is effectively specifically designed for users like that for the reasons you mentioned, Kelly, that it is a very difficult therapy to follow MDI. So I would probably start on that end, but we shall see what ends up happening. Thanks for the —

Kelly Close: Thanks.

Operator: That concludes our Q&A session. I will now turn the call back over to Sean Saint for closing remarks. Please go ahead.

Sean Saint : Well, thanks, everybody, today. We really appreciate your time on our Q1 2025 earnings call. And we hope we put up some good numbers this quarter, and we look forward to keeping that going headed forward. So thank you.

Operator: Ladies and gentlemen, that concludes today’s call. Thank you all for joining. You may now disconnect.