Beta Bionics, Inc.

Good afternoon and welcome to the Beta Bionics first quarter 2025 earnings conference call. At this time, all participants are in listen only mode. After the speakers presentations, 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 Bieber, head investors relations. Please go ahead.

Thank you. Good afternoon and thank you for joining Beta Bionics first

quarter 2025 earnings call. Joining me on the call today for Sean St., Beta Bionics president and chief executive officer and Stephen Fider, chief financial officer. Both the replay of this call and the press release discussing our first quarter 2025 results. 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 6th, 2025. Therefore, if you're listening to this replay, anytime since this 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 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 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 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.

Hey, 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. For our efforts to expand the ILS 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 of endosing, 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 evolution for 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 demands of the islet and our team's delivering commitment to delivering life changing solutions that simplify and alleviate the burden of managing diabetes. We wanna 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 25 annual guidance for revenue, percentage of patients starts to reimburse through pharmacy panel 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 well as highlight our increased annual guidance for the full year 2025 and the conviction we have on 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 going 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 patients parts, which we, where we saw 3,853 new patients adopt the islet in Q1 of 48% year over year. A low 20s percentage of those new patient starts were reimbursed through the pharmacy channel in Q1, which is meaningfully higher than the mid single 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 patients 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 lives covered, which only accounts for formulary arrangements with pharmacy benefit managers or PVMs and doesn't account for adoption by the underlying health plans or the underlying logistics required to utilize this channel. Shifting down to gross margin, our gross margin in the quarter was .9% down relative to .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 bodes well for a medium to long-term outlook for gross margin expansion. I wanna emphasize that our pharmacy model is a pay as you go model that essentially eliminates the revenue we generate for the islet itself, but maximizes reimbursement we get for islet 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 palatable pharmacy benefit model for health plans to adopt, as evidenced by our rapid growth and 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 expected 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 and Q4 of 2024, including Libre 3 Plus implementation, Color Islet, and our Bionic Circle remote monitoring app, all of which contributed meaningfully to our performance in Q1. Q1 tends to be seasonally weaker, and we're purited 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 -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 -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? 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 used multiple daily injections prior to starting the iLIT. This metric reinforces our belief that the iLIT is addressing unmet need in the market and meaningfully expanding the market for insulin pumps. Q1 results felt traction from our product launches in Q3 and Q4 of 2024, including the Libre 3 Plus integration, color iLIT, 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 uptake 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 meanly accretive to our financials over a four-year period relative to the DME channel, and it substantially lowers -of-pocket costs for patients. Turning now to gross margin. In Q1, our gross margin was 50.9%, down compared to .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 uptake 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 31st, 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 and 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 islet stemming predominantly from greater leverage on fixed overhead costs as we scale. Number two is our -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 BetaBionics 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 to $87 million up from our prior guidance of 80 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 .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 to $87 million. From 2025 through 2028, we'd expect the same increase in pharmacy guidance for resulting 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 to reimburse the pharmacy in Q2 will be at least as strong as Q1, with additional growth coming in the back half of the year. Our formula agreement with Prime Therapeutics went into effect on February 1st, and we saw faster than expected traction of Islet & Pharmacy within the health plans that partner with Prime. While these efforts to expand pharmacy adoption will continue throughout the year, both with Prime partnered 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 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 Islet relative to the prior quarter, and expect that Q1 run rates should sustain throughout the year. And number three, we'll benefit from our growing pharmacy install base, where the bolus 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 outlook performance in pharmacy was an unexpected headwind during the 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 Islet 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 gain on fixed overhead manufacturing costs from increased volumes, and number two, our growing pharmacy install base. With that, I'll hand the call back to Sean to discuss our innovation pipeline.

Thanks, Stephen. Before I jump into our innovation pipeline, I want to dive a little deeper into our algorithm and the advantage position it holds in the market. Let's first acknowledge that an FDA approved AID system in the market today, including the Islet, 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 the importance of no finger stick calibration continue with glucose monitors, and the role that particular ease of use innovation played in accelerating CGM penetration. And we believe that the Islet is similarly redefining the metrics that matter most for insulin pumps. We believe this because not only are we seeing tremendous traction for the Islet 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 Islet is far ahead, and that's because the Islet does something that we believe no other pump can do, adapts to each user and learns their insulin requirements. It's one thing to pre-populate a pump's initial settings based on a few inputs. It's another thing entirely to do what the Islet does, which is autonomously determine initial insulin dosing based on weight alone, and then the pump actually adapts to the user and continuously adjusts 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 Islet, 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 Islet, 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 the beta bionics has worked hard to bring easier products to use to 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 clinic 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 IELTS 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 process 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 PKPD, of our glucagon candidate. Beyond the PKPD study, we're planning to conduct concurrent pivotal trials to fulfill the requirements for a 505b2 NDA with a chronic drug indication of glucagon and the ACE and IAGC 510ks for the pump and algorithm respectively. I wanna 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 wanna provide a few other updates. Starting with our digital innovation, we recently launched a pilot of our updated healthcare provider portal, which allows clinics to see a full view of all the ILOID patients they treat in the clinic, to collaborate between providers in the clinic, and to simplify communication and connections between healthcare providers and ILOID 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 healthcare 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 ILOID 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 two label expansion opportunity, we've shared that there's some healthcare providers that decide to prescribe ILOID to their type two 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 two. We look forward to pursuing the type two label to the FDA, but we also recognize the importance that ease of use and pharmacy reimbursement can have in driving type two 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 Avid Freestyle Libre 3+, making us the most advantage pump for CGM integrations in the US 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.

At this time, I would like to remind everyone in order to ask a question, press star then the number one in your telephone keypad. You will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Matthew O'Brien with Piper Sandler. Please go ahead.

Good afternoon. Thanks for taking the questions. Would love to start on the pharmacy side because that number was pretty eye-popping as far as what we saw here in Q1. You know, 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, let's just think about the sales force. I'm not sure that was that big of a contributor, but just, you know, what we're seeing on the underlying side in terms of dynamics of the pharmacy channel on your business and, you know, the decision to increase the outlook there specifically here in Q1.

Yeah, on that, thanks for the question. I think that what we're seeing there is we're just having greater success with, you know, in effect what we're selling to the plans themselves. As we shared and prepared remarks, step one is get the contract to the PVM, but the traditionally more difficult step is to convince the underlying plans to adopt your plan that you've laid out or the contract you've laid out with the PVM. 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 advantage 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, excuse me, increased confidence going into the back half of the year.

And there's nothing one time about the success that we had in pharmacy in the first quarter. So again, there 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 uptake.

Got it. And then, you know, Stephen, you did a really nice job running through the financial benefit that you're gonna get from that upside here in Q1. Can you talk about, again, the patient ads? I mean, that was way higher than 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. Thanks.

Yeah,

thanks.

Yeah, good questions, 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 a bit more significant than that. And so I think it's really just a product of two 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 Islet, the Libre3 integration, and the Bionic Circle. So those certainly create some benefit for us that we're selling better things now, and 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 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 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.

Got it, thank you.

Yeah. Your next question comes from the line of Mike Kratky with

Learing Partners. Please go ahead.

Hey everyone, thanks for taking our questions. Steven, maybe just wanted to start on the guidance. Can you help bring to what extent your new guidance assumes it raised in new starts for the year relative to your prior expectations? Any color on the magnitude of that would be helpful, and then have one follow up.

Can you say that again, Mike?

Yeah, I might've 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 yeah, just curious on the magnitude of that, and maybe just to ask the follow up up front, you know, how does that assume any new shifts in competition, either between new players or new combos that could come to market?

Yeah, gotcha, okay. So yeah, we increased our revenue guidance by two million at the bottom and 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 our revenue guidance implies, because we have to sell more new patient starts in order to make up for that revenue delta that's now created in the short run from pharmacy. So I guess maybe just to confirm your point, Mike, yeah, 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 wanna comment on that part?

Sure, I mean, I don't think that, you know, 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. You know, everybody's doing well, you know, there's good products out there now and getting better. But for the moment, we believe that the islet remains a differentiated algorithm that does what, that does a fairly unique thing. And that's exactly why we've been leaning into sharing our real world results of the islet 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 islet is doing from baseline A1C to follow up GMI, and that message is very much resonating. And again, you know, we just don't see anything on the market, or excuse me, on the horizon, that really risks that in any way.

Understood, thanks very much. And maybe if I can just sneak one more in. In terms of the tracking side, super helpful color. Can you talk about what type of traction you're

seeing among endos versus PCPs for those patients?

Mike, I think we'd probably prefer not to comment on that at this time specifically. What we will say is that, you know, a significant number of the type two population is managing 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 two opportunity specifically because again, you know, we don't have that, we don't have that indication at this point.

Got it, thanks very much.

Thanks

Mike. Your next question comes from the line of Matthew Blackman with Stiefel. Please go ahead.

Good afternoon everybody, thanks for taking our questions. I've got two, maybe to start Sean or Steven, you both I think echoing what Matt said, tackled that pharmacy mix impact well, so 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 Salesforce.

Yeah, we have pretty good visibility. So, you know, we sign, 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 to 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, you know, we are in discussions like with PBMs with plans, you know, 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, you know, from quarter to quarter because our sample size is relatively small. But, you know, the reason that we see or 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 iLIT as a pharmacy benefit. And so I would say our visibility is actually reasonably strong. I really appreciate that. Part of

Matt's question there was how do we control which channel the script goes through? Yeah, yeah. So every

single prescription for the iLIT ends up getting sent to Betabionics and at which time Betabionics then checks to see if a patient is covered in the pharmacy benefit. And if they, 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 the points that we've now set 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.

Got it, thank you for that. And the question I have on the Salesforce, you've 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 in a couple of followups? I don't think so, but okay, so thank you on the yes. I doubt there was any, but was there any one queue dislocation with the expansion of the Salesforce 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 nine to 12 month productivity curve that we should start to visibly see them contribute to the top line? Thanks so much.

Yeah, so dislocation, Matt, sorry to clarify, but what do you mean by the dislocation point? I just wanna make sure I don't miss answer that. Yeah,

so sometimes when you expand the Salesforce, there is the eyes get taken off the balls, things slip through the cracks. And now typically that's when you're slicing up territories, which you're not doing here, but anytime I think in MedTech, we hear Salesforce expansion,

we automatically

think the worst.

So no dislocation. Look on balance, what you said is true about the 20 new territories are being added to areas where there wasn't already an existing sales rep, but sometimes there's certain 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 this new 20 sales territory 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 a territory to become fully productive, and I won't answer that here, 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. Great, thank you, Stephen, I'll get back to you. Good questions, Matt. Thanks, Matt.

Your next question comes from the line of Siravistid with Bank of America. Please go ahead.

Hey, thanks for taking the question and congrats on the quarter. I guess the first question I have is, now that you're kind of 63 territories, the awareness of iLed is getting out there. Any change in kind of what you're seeing within your doctors and prescribers in the uptake of iLed, how they're using it, and also like seeing penetration move, you know, like within your own doctors and also kind of adding new prescribers. Just kind of curious how the awareness of the products kind of playing out in the meta follow-up.

Yeah, great question, Travis. I think what we're seeing evolve is that, you know, when you first launch a product, you're necessarily gonna 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 gonna 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 gonna find that area where they need to try it out. And I think iLed was no different, right? And we know that at some level, we get used on some of the harder patients. And, you know, patients previously been unable to be successful in other therapies. But what we've been able to do, and we've alluded to this several times now, is share that success of, you know, 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, say, doctor, this is your experience with iLed. 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 Salesforce size, we increase the accounts that we're calling on, we're gonna 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 iLed. 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 iLed 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're excited to share that real world evidence data more broadly at our Analyst Day in June at EVA. 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 niched, 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. Great, thanks

for that. 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 the progress you're making there. Just wanted to make sure there's nothing else on that. And then even a modeling question, we are putting in the DME revenue and patient revenue in the models. And it looks like there was a tick down in revenue for patients in the DME side this quarter versus the prior few quarters. I'm not sure if there was something to call out there. We can follow up offline if there's something that we're missing.

Yeah, let's 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 gonna let Stephen take that one. On the patch pump, no, I'm sorry. We won't share any additional color in that project. We did reiterate our prior guidance of commercial launch by the end of 2027. 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 yeah, looking forward to that one. Stephen?

Yeah, and just to be clear, at that ADA event that Sean just referenced, we'll do a full demonstration of it so it's not just some slides with some updated visuals. We intend to show you exactly what the merits of it are. 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 a little bit of lumpiness, which there's nothing to read into here, but it's just so it happens the nature of the industry that we're in. But there was a larger spread between new patient starts and number of islets sold to distributors in Q4 than what there was in Q1. So that's really the reason. Okay, thanks for that.

Just the streaming aspect of orders.

Yeah, I mean, 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 grows over time. But for the time being, yeah, it did make an impact in the comparative periods.

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?

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

then

yeah, there's some

tailwind in Q2. Okay, thank you.

Yep. Your next question comes from the line of Jonathan Jeff with

Baird, please go ahead.

Thank you, good afternoon guys. Just a couple of quick follow up questions if I could. First one, just on the, hold on, sorry. Feel like I'm losing my train of thought here, just I'm sitting in the airport. What was I, I know, I'm trying to remember what I

was even gonna ask here, hold on.

I'm sorry. Oh, 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. You know, 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 rates are a little lower than I had been modeling. But just any early indication on the attrition rate would be helpful,

thanks. Yeah, sure. Look, you're not gonna 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 that 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, 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 antibiotics financially in the medium and long term because of that. And so I guess I'll just have to leave it there. Yeah, we're seeing strong attrition at the moment, or strong retention, I guess.

All right, fair enough. And there's some noise in the background, so I'll drop there, thanks. Someone,

you do not go. All right, thanks,

Jeff.

Your next question comes from the line of Jeffrey Cohen with Levenberg-Feldman, please go ahead.

All right, Sean, thanks for taking our questions. I guess we wanted to focus on clinical work for our two questions. Firstly, on the bridging study, can we talk about what we may see this year? You did mention inpatient and outpatient members as far as the study's ongoing. And then secondly, could you talk about the timeline and expected size on this

label expansion trial for type two?

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 PKPD. 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, that we can expect the device to work in the same way as well. So 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 gonna be a bridging study followed by pivotal trials, and there is more than one, but they're anyway similar, followed by the NDA and 510Ks on the product. And so this gives us an idea of where we're at at that point. And then timeline on any type two label expansion, I think we're gonna continue to not comment on that one for any number of reasons, but primarily we're, well, yeah, maybe just leave it at that.

Okay, perfect, and one more brief one for us. As far as the size of the commercial organization, will you update us quarterly? Are you planning on more answer out of Q2 to Q4 for this year, or is this an annualized decision when you talk about adding 20 in the first quarter?

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.

Super, okay, I got it, thanks for taking our questions. Yeah, Jeff, as

always.

Again, if you would like to ask a question, press star one in your telephone KPUT.

Looks like we have one more from Brooks, right?

Yes, your final question comes from the line of Brooks O'Neill with Lake Street Capital Markets, please go ahead.

Thank you very much, and congratulations on a terrific first quarter. I just have a couple of questions for you, 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.

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 gonna let the CGM guys battle it out and we're gonna 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.

And just to reiterate what I said

earlier, 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.

Sure, that's helpful, Stephen, 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 gonna be meaningfully a creative 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. 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.

Yeah, understood. So yeah, it is meaningfully a creative debate about onyx in the medium and long term. And at month 11, we actually generate in the aggregate 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 islet 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, 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 avoids sort of this 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 a pay as you go business model in the pharmacy channel relative to DME.

Great, it's a good explanation, Steve, and I appreciate it and it's good to hear that the payers are actually doing the right thing in this case.

Yeah, they've been great partners, Brooks. Yeah, they have been, and good question, Brooks.

Thank

you very much.

It looks like we have one more.

Your last question comes from the line of Kelly Close with Close Concerns, please go ahead.

Well, 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.

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 market, 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 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 is. So I would probably start on that end, but we shall see what ends up happening.

And thanks for the question.

That concludes

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

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. Thanks everybody.

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

Please wait. The conference will begin shortly.