Good afternoon, and welcome to the Beta Bionics First Quarter 2026 Earnings Conference Call. The operator provided instructions on how to queue for questions. As a reminder, please be advised that today's conference is being recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. You may begin, sir.

Good afternoon, and thank you for tuning into Beta Bionics First Quarter 2026 Earnings Call. Joining me on today's call are Chief Executive Officer, Sean Saint; and Chief Financial Officer, Stephen Feider. Both the replay of this call and the press release discussing our first quarter 2026 results will be available on the Investor Relations section of our website. Information recorded on this call speaks only as of today, April 21, 2026. Therefore, if you are listening to the replay, any time-sensitive information may no longer be accurate. Also on our website is our supplemental first quarter 2026 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates. Before we begin, we would like to remind you that today's discussion will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect management's expectations about future events, our product pipeline, development timelines, financial performance and operating plans. Please refer to the cautionary statements in the press release we issued earlier today for a detailed explanation of the inherent limitations of such forward-looking statements. These documents contain and identify important factors that may cause actual results to differ materially from current expectations expressed or implied by our forward-looking statements. Please note that the forward-looking statements made during this call speak only as of today's date, and we undertake no obligation to update them to reflect subsequent events or circumstances, except to the extent required by law. With that, I'd now like to turn the call over to Sean.

Thanks, Blake. Good afternoon, everyone, and thank you for joining. We're pleased to share with you all today our financial results for the first quarter as well as positive updates to our full year guidance for 2026. In Q1, the company continued to progress rapidly across our key initiatives, both commercially in terms of driving adoption of the iLet and expanding pharmacy channel access and developmentally in terms of advancing our Mint patch pump program and our bihormonal program. Our teams continue to execute relentlessly to deliver life-changing solutions to the diabetes community today and over the long term. Diving into a brief overview of our Q1 performance, we delivered $27.6 million in net sales, which grew 57% year-over-year. Q1 revenue growth was driven predominantly by growth in new patient starts as well as our growing installed base of users who continue to access their monthly supplies for the iLet through the pharmacy channel and who we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel grew to a high 30s percentage compared to a low 30s percentage in Q4 and a low 20s percentage in Q1 2025. Our gross margin was 59.5%, expanding over 860 basis points year-over-year. Stephen will discuss our gross margin dynamics shortly in more detail, but I wanted to highlight this exceptional performance as evidence that the pharmacy business model is working as is our ability to drive leverage in manufacturing costs as we scale. I'm proud of these results and eager to build on them as we progress throughout the year. With that, I'll hand the call over to Stephen to provide some additional color on our first quarter performance and our full year 2026 guidance. Stephen?

Thanks, Sean. Our Q1 performance exceeded our expectations across the board. Revenue performance was mainly driven by new patient starts and the recurring revenue generated from our growing pharmacy installed base. Q1 revenue saw a modest contribution from pharmacy and DME stocking, but the stocking benefit in Q1 declined relative to Q4 in both channels. I'd now like to highlight some of our Q1 commercial metrics. New patient starts declined more than 10%, but less than 20% compared to Q4 2025, consistent with our expectations given typical seasonal demand patterns from Q4 to Q1. A high 30s percentage of our new patient starts in Q1 accessed iLet through the pharmacy channel. The increase compared to the prior quarter exceeded our expectations. It is important to note that most pharmacy plan changes occur at the beginning and midpoint of the calendar year. Thus, we do not expect an uptick from Q1 to Q2. Our pharmacy strategy continues to deliver strong financial results for the business, driven by the advantaged recurring revenue model, low out-of-pocket cost for patients, a streamlined process for health care providers and our ability to retain patients utilizing the product. Lastly, we continue to expand the insulin pump market as approximately 70% of our new patient starts came from people with diabetes using multiple daily injections prior to starting the iLet. Moving on to gross margin. Q1 gross margin was 59.5%, representing an increase of 52 basis points relative to the prior quarter and an increase of 864 basis points relative to the prior year. The primary driver here is our pharmacy installed base, which generates high-margin recurring revenue and where we continue to see strong user retention. Previously, I've shared a simple way to think about how the pharmacy channel impacts our overall gross margin. The framework I introduced was that when our pharmacy installed base in a given quarter exceeds 3x the number of new patient starts through pharmacy in that same quarter, the pharmacy channel generates higher gross margin than the DME channel and becomes accretive to our overall gross margin. We crossed that threshold in Q1, and we expect further gross margin expansion as our pharmacy installed base continues to grow. The other key driver of strong margin performance this quarter was lower cost of materials for the iLet relative to the prior quarter and year. We also benefited from a couple of one-time gross margin tailwinds in the quarter, including higher-than-planned iLet production and modest contribution from pharmacy iLet revenue. While we don't expect those one-time tailwinds to repeat, I expect our core gross margin to remain a key area of strength going forward and an important driver of our ability to generate free cash flow at an earlier stage as compared to our diabetes peers. Total operating expenses in the first quarter were $40.7 million, an increase of 47% compared to $27.6 million in the first quarter of 2025. The increase in sales and marketing expenses relative to the prior year was driven by expansion of our field sales team, which we made excellent progress on in Q1 towards our previously stated goal of expanding by at least 20 sales territories in 2026. Newly onboarded territories generally take at least a quarter to begin contributing meaningfully to sales. So we're excited for those additions to take shape throughout the year. On R&D expenses, the increase relative to the prior year is driven by the Mint and bihormonal projects. The increase in G&A expenses relative to the prior year is driven by continued efforts to scale the company in support of commercial growth and pipeline initiatives. As of March 31, 2026, we have approximately $240 million in cash, cash equivalents and short- and long-term investments. We believe we are sufficiently capitalized to fund all of our key initiatives and remain well positioned to generate free cash flow well ahead of historical diabetes peers. We feel that all of the key indicators that we monitor suggest we are building a sustainably successful and profitable business, including strong product market fit, solid sales force productivity, growing pharmacy traction, healthy gross margins and continued operational discipline. I'd now like to discuss our revised full year 2026 guidance, which we're raising across the board. We now project total revenue for the year to be $131 million to $136 million, up from our prior guidance of $130 million to $135 million. On pharmacy mix, we now expect 37% to 39% of our new patient starts to be reimbursed through the pharmacy channel versus our prior guidance of 36% to 38%. Our increased revenue and pharmacy mix guidance reflects our higher expectations for new patient starts, driven by strong Q1 performance and the success we've had in onboarding new sales territories, where we're on track toward our goal of adding at least 20 territories in 2026. On gross margin, we are raising our outlook to 57.5% to 59.5% for the full year versus our prior guidance of 55.5% to 57.5%. Our gross margin outlook reflects the strong performance in Q1 normalized for one-time tailwinds and our expectation of continued contribution from our pharmacy installed base, along with increasing leverage from manufacturing scale over the course of the year. To briefly comment on operating expenses, we expect year-over-year growth to accelerate for the remainder of the year compared to Q1, driven by continued expansion of the sales force, increased investment in brand and direct-to-consumer marketing and spending related to Mint and our bihormonal programs. With that, I'll hand the call back over to Sean.

Thanks, Stephen. To wrap up the call, I'll briefly touch on our remediation efforts regarding the FDA warning letter we received in late January and then highlight the progress we're making in our innovation pipeline. Regarding the warning letter, the company is continuing to take this matter very seriously. Our teams and leadership are conducting thorough systemic reviews of our quality management system and instituting corrective actions that we believe address the agency's observations. The company is responding quickly to the agency's concerns, and we've been providing periodic updates to the FDA regarding changes to our processes and documentation that we believe address many of the FDA's concerns as stated in the warning letter. One example of our progress thus far is our efforts to remediate old complaints under our new complaint handling system and definitions for reportable complaints. We recently completed that work well ahead of schedule, which we believe is a good representation of our organization's commitment to resolving the warning letter in an effective and timely manner. We still have work to do in other areas to fully address the agency's concerns, and we look forward to continuing to work together with the FDA to resolve this. Now for the pipeline. Let's start with a quick update on Mint, our patch pump in development. In Q1, we continued to advance Mint toward our goal of an unconstrained commercial launch by the end of 2027. We remain confident in our ability to gain FDA clearance for Mint, manufacture the product at scale and ultimately realize the opportunity to make Mint the market-leading product in automated insulin delivery that we believe it has the potential to be. For our bihormonal system in development, in Q1, we initiated a Phase IIa feasibility trial to stress test and iterate the system. Our Phase IIa trials have helped us to identify further areas for system optimization and preparation for the more advanced stages of development, inclusive of a Phase IIb feasibility trial and Phase III pivotal trials. I'm excited by our continued progress with the bihormonal system as it represents what we believe has the potential to be a transformative innovation for people with diabetes. Our industry talks a lot about moving toward fully closed-loop algorithms, which the industry generally defines as algorithms that don't require any engagement from the user. Another topic that's always top of mind for the industry is health outcomes. The ADA's glycemic goals for most nonpregnant adults with diabetes is less than 7% A1c and greater than 70% time in range, which the vast majority of people with diabetes aren't achieving today. When we look at the body of evidence of insulin-only fully closed-loop algorithms, we believe that they will not enable the majority of people with diabetes to achieve the ADA's glycemic goals, but bihormonal may be different. We believe that the existing body of evidence of bihormonal fully closed-loop algorithms shows the potential for the majority of people with diabetes to achieve the ADA's glycemic goals. That is such a big reason why bihormonal has game-changing potential for the industry at large and why our commitment to the program has never been stronger. At the end of Q1, we also launched a key new feature called Bionic Insights within our health care provider portal. This is a one-of-its-kind intelligent data analytics and reporting feature within the industry. Bionic Insights surfaces clinically relevant indicators, user activities and system events and packages them into actionable insights that help health care providers make more informed and personalized treatment recommendations for their patients. Early feedback on the feature has been overwhelmingly positive, and we're extremely excited by its potential to further improve experiences and outcomes with iLet. Lastly, on our innovation pipeline, I want to cover type 2 diabetes. In Q1, we continued to see some health care providers prescribe iLet to their type 2 patients off-label. We estimate that 25% to 30% of our new patient starts in Q1 were from type 2. While we're not committing to a specific timeline, we remain eager to pursue the type 2 diabetes indication through the FDA. I want to leave you all with one key message from today's call. We are building a business that we believe is uniquely positioned to succeed over the short, medium and long term, fueled by our exceptional commercial product, pharmacy channel strategy, operational efficiency and what we believe to be the most innovative pipeline in the diabetes industry. We're excited and motivated to deliver. Thank you all for joining today's call. We'll now open up the call for Q&A.

The operator provided instructions on how to queue for questions. Our first question comes from the line of Mike Kratky with Leerink Partners.

Congrats on the strong quarter. I guess to start, it was really encouraging to see the high 30s percent of new starts through the pharmacy channel, but your updated guidance of 37% to 39% seems to suggest it could hang out there over the next few quarters. So is there any fundamental reason driving that assumption or anything you're seeing from a competitive standpoint that may be tempering expectations there?

Mike, I appreciate the question, and happy belated birthday, by the way. I forgot that; I missed that. So nothing notable about the calendar year other than the biggest step-ups in pharmacy coverage happened at the start of the year and at the middle of the year, so January and July. And the other thing that's important to note about pharmacy reimbursement is that while we feel like the business is highly predictable in areas like revenue, this particular area isn't perfectly predictable. It's B2B sales, long sales cycle. And so our guidance acknowledges both of those factoids that I just shared there. In terms of competitive pressure that we're feeling as it relates to the pharmacy channel, none at all that's dampening guidance in any way. Actually, if anything, the move from our competitors, our tubed pump competitors to the pharmacy channel makes payers and PBMs more inclined to want to move insulin pumps or tubed insulin pumps in particular, to a pharmacy reimbursement. So we actually don't see that move that we're seeing from our competitors to be bad at all.

Awesome. Very much appreciate that. And maybe just separately, in terms of the ongoing sales force expansion, any additional color you can provide in terms of what inning we're in there or how far along you are there?

Yes. I don't want to speak specifically to the number as you can imagine based on the prepared remarks. We are not in the ninth inning, meaning there's more expansion to happen. But most of the expansion of the field sales force will happen in the first half of the year. So a lot of it happened in the first quarter, and then you'll see some in the second quarter as well, and that will round out most of what we expect to expand by.

The operator provided instructions on how to queue for questions. Our next question comes from the line of David Roman with Goldman Sachs.

Maybe I'll just start with the ADA guideline changes that I think went into effect in December regarding AID therapy. And could you give us some perspective on what you're observing in the field as it relates to prescribing patterns? I know you talked about in your prepared remarks, Beta contributing to expansion of the overall pump market. But help us understand a little bit more what you're seeing both on the type 1 and type 2 side from an underlying demand perspective.

Yes, David, this is Sean. Good question. I don't think that the ADA guideline changes, while helpful, are really impacting prescribing patterns on a daily basis. Things like that take time to filter out. I don't think we've ever seen the industry just react to a shift. And I think also the guideline evolutions were relatively subtle. Beyond that, I'm really not sure what I can add in terms of evolutions. I mean I think the last quarter has been relatively stable in terms of prescribing patterns, narrative, et cetera. I just don't have anything to add at the moment.

Okay. Maybe just to clarify there. We obviously continue to get a ton of questions around GLP-1s, especially given the oral dynamic. So maybe just any perspective there? And then just for my follow-up here, you talked, Stephen, I think, about accelerating OpEx growth through the year. How are you thinking about just overall investment in cost to serve here? Because as we look across the space, you have one of your competitors very aggressively going down the DTC path. You have a lot of people out there hiring reps, but it looks like, generally speaking, revenue expectations are pretty similar for most of the players here. So are you just seeing a higher customer acquisition cost as the market becomes more competitive? And how you're thinking about just that OpEx versus growth trade-off?

Well, let me take the first part of that, the GLP-1-based question. And I'll just say that, look, I mean, I think in many ways, this is sort of an asked and answered point on GLP-1s. I think they're a phenomenal class of drugs. I think they are helping a ton of people. I think when you talk about certainly type 1 and also insulin-dependent type 2, intensive insulin managed type 2 specifically, not really a huge impact there. Obviously, orals, I think, are a continued evolution of that drug class. It's a great evolution for those. But when you consider that we were going from a once-a-week injectable to an oral, probably not the thing that kicks it over into a class of drug that people taking four injections per day or on a pump are utilizing. That's not the reason it wasn't helping them is my point. I don't think oral is going to be the change there. But again, another evolution of that drug class that's helpful for them. I'm going to let Stephen take the second half of that investment question.

Yes, sure. First, David, I'll comment on our sales and marketing growth for the rest of the year and what we're expecting in OpEx. As I mentioned in response to Mike's question, you'll see our sales and marketing spend increase into the second quarter because we're expanding our field sales team, which is why sales and marketing rose in Q1 '26 relative to Q4 '25. We are also investing in direct-to-consumer advertising, not at the same level as some competitors, but making notable investments. Regarding customer acquisition cost, that's a good point. In Q1 '26 our sales and marketing costs were 75% of revenue, which is not efficient at scale. Customer acquisition cost needs to come down, and it will. The primary ways it will decline are by building an installed base, particularly in pharmacy, where we generate high gross margin recurring revenue from selling supplies, and by strengthening brand recognition and building a customer-first brand in anticipation of the Mint product. For those reasons I'm comfortable we are building a profitable business over the medium to long term that will start generating free cash much earlier than our diabetes peers. I acknowledge that customer acquisition cost today is high, given that many of our new patients come from the pharmacy channel and we're building a brand, so our current sales and marketing model does not look perfectly economical at this exact moment.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets.

I wanted to start with gross margin. Q1 was clearly a really strong performance. Could you quantify the benefits you mentioned from higher iLet production and any other factors that contributed to Q1? And when you extrapolate that forward, it seems gross margin is trending toward the higher end of the guided range. Is there anything that might temper that expectation?

Frank, I appreciate the question. As I mentioned in the prepared remarks, there were one-time tailwinds in Q1 that lifted gross margin above its current run rate. I don't want to quantify the impact specifically, but it was relatively small yet notable. Regarding guidance, you asked whether Q1's performance makes the guidance look conservative. Maybe, but I want to emphasize two points. First, Q1 did include one-time favorability. Second, cost of sales can include discrete and semi-unpredictable one-time charges that may occur unfavorably in any quarter, which makes gross margin difficult to predict in the short run. Acknowledging that, just as we had a favorable one-time item in Q1, I'm not forecasting similar results going forward, but our guidance allows for that possibility. That said, gross margin is a strong point for our business and there is significant upside over the medium and long term. I hope the quarter's results show we are achieving cost favorability and improving manufacturing efficiency quarter over quarter. The pharmacy business model is working; the pharmacy revenue model has a higher gross margin this quarter than the DME model, and it is still in an early stage. There is more upside to come in the long term, and those factors explain why guidance is set the way it is.

Got it. Very helpful. And then maybe just for my second one, related to cash burn, any seasonal considerations we should think about with the cash burn from Q1, Q2, Q3 and Q4? You saw a little higher cash burn in Q1. Just kind of trying to understand how we should model the burn profile throughout the end of the year.

For sure. I think cash burn for us is going to approximate adjusted EBITDA for the rest of the year. Q1 cash burn exceeded adjusted EBITDA because we burned about $25 million in Q1 versus adjusted EBITDA of around $17 million. That was primarily because we paid cash bonuses in Q1, which caused a big change in accrued expenses, and there were working capital differences between the Q4 and Q1 quarter-ends—notably inventory, accounts receivable, and accounts payable—that totaled about $4 million, which helps bridge the gap between the $25 million burn and the adjusted EBITDA number.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Jon Block with Stifel.

Maybe I'll go with a couple of modeling questions. But the first one, Stephen, I think the Street was about 44% to 45% of 2026 sales in the first half prior to the earnings print. It landed around $31 million for Q2 2026. I'm curious: you mentioned this year would be more front-end weighted relative to 2025 for a handful of reasons. When we look at that first-half weighting, or even more specifically the $31 million for Q2, is that the right cadence to use for the model, or is there anything else to call out as we think about the balance of the year on the top line?

Yes, I'll reiterate the guidance I gave on the last call that you just alluded to, Jon: in the first half of 2026 we'll have a larger share of revenue for the calendar year than we did in the first half of 2025. I'm not going to specifically comment on the number you shared for Q2 guidance. We don't want to give quarterly revenue guidance. But based on what I just told you, I think you can get a good sense of that number or at least a tight range for it. So I'll leave it there.

Yes. Fair enough. So maybe I'll take a different shot and go to gross margin. Going into this year, I think what you alluded to was gross margin would increase sequentially throughout 2026. And obviously, there was material upside to 1Q '26, right, sort of like a good problem to have. You don't want to quantify the one-timers. But just help us out like when we think about gross margin going forward, now that you're already at the upper band of your revised guidance for GM, what are the like the, call it, the upside or downside for GMs or COGS from here as we think about the next handful of quarters?

Yes. I appreciate the question, but I'm not quantifying the extent of the one-time items we saw in Q1 to give you a run-rate Q1 gross margin. Relative to that run-rate, we still expect gross margin to tick up quarter over quarter. There was nothing else notable about Q1, and we're not pulling down gross margin or changing the slope for the rest of the year in our outlook. Q1 simply had a big number for reasons I have explained.

Okay, sorry, if I can just clarify there. We're still up sequentially from the normalized first-quarter 2026 gross margin number. You're not going to quantify it, but logically it has to be about a 200 basis point tailwind if we're up sequentially and still reach the revised range.

Yes. Without commenting on specifically the 200 basis points tailwind, bingo.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Richard Newitter with Truist Securities.

It's Felipe on for Rich. Just a follow-up on the pharmacy channel. I think you had mentioned that more competitors trying to enter with durable pumps into the channel is potentially going to accelerate the shift over. So I'm just wondering if you could dig into that and maybe give any context on the conversations that you've been having with your PBM partners? And then just one follow-up.

Yes, Felipe, it's Sean. Really, beyond just saying that the more companies access this channel, the more normal it becomes and the less one-off these conversations are, the more of us who have success through this channel, the more future people accessing it will also have that success. That success brings more success with other payers, and as more payers start to pay, those who choose not to will become outliers. I think this is definitely a snowball rolling down a hill, and multiple players accessing this channel are a positive for all of us. We're more than happy to see that, and I think it ultimately makes our entire industry much healthier. Frankly, we're happy to have started that snowball rolling in the durable pump space.

And then if you could just remind us why you expect economics in the channel to hold over the long term? I think there are a lot of misconceptions around multiple players in the channel and potential trends downward in economics. Just any clarity around that would be helpful.

Yes, that's a good question. The primary reason is that insulin pumps are not a commoditized market. In the pharmacy channel you see many commoditized markets enter a race to the bottom because a payer only needs to offer one product and products are easily switchable, and prescriptions can sometimes be changed between products without approval of the health care provider. That is not the case with insulin pumping. When you write a prescription for an iLet, the payer or whoever must deliver an iLet specifically needs to obtain a new prescription to supply something else. That is the definition of a non-commoditized market. So there are real limits to downward price pressure in a market like the one we have today. Because of the nature of automated insulin delivery and the unique algorithms we provide, that situation is unlikely to change soon given the clinical trials and other requirements needed to develop these pumps. As of today, we still see a very differentiated market, and we believe iLet is one of the more differentiated products out there. Does that help?

Super helpful.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Jeff Johnson with Baird.

Yes. So Sean, staying on the pharmacy point, do you have any updated thoughts on rebates and how you're thinking about rebate dollars you might provide to the channel over the next few years? How do you balance staying at Tier 3 in some of your contracts and buying down the co-pay versus trying to move up to Tier 2 and having to chase added rebate dollars as you compete against one of your bigger peers in the pharmacy channel? So, rebates versus buying down co-pays, what's your outlook there over the next few years?

Yes. Great question, Jeff. You're absolutely right, and that builds on Felipe's question. First, when you look at the market not becoming commoditized, payers have limited ability to create downward price pressure, so we see pricing remaining durable for the foreseeable future. Second, the Tier 2 versus Tier 3 issue really comes down to two things: the rebate required to obtain Tier 2 versus Tier 3, and the co-pay the patient pays when their product is covered at either tier. Most companies, including Beta Bionics, offer co-pay assistance programs that are transparent to the patient and let us control the co-pay at a set level. Currently we believe we're at $25 or less per month. That makes it a simple math problem: we balance the rebate required to move between tiers against the reduction in co-pay. From that calculation we determine whether Tier 2 or Tier 3 positioning is more advantageous for Beta Bionics, and we will always choose that while ensuring our patients pay the $25 or less co-pay we control. It's a win-win for us and our users.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Matthew O'Brien with Piper Sandler.

The first one is a little convoluted, so forgive me. But I don't have perfect information here. But as I look at the model, it looks like the type 2 growth that we saw in Q1 was meaningfully higher than on the type 1 side. And so I'm just wondering, is the math there about right? Type 2 is really kind of carrying you right now as far as overall patient growth on a year-over-year basis. Are you still growing type 1 somewhere in the double-digit range? And then are you exposed in the intermediate term by not having a type 2 indication, just given how well you're doing there? And then I do have a follow-up.

All right. Yes. So is type 2 growth driving the growth for the business? Look, type 2 has been strong, but I have to be a little careful here because, of course, we don't have the indication. You will always hear Sean and me when we're talking about type 2 a little hesitant to say too much. But yes, the fact that 25% to 30% of our new users are coming to us with type 2 diabetes is a large part of our growth. Is our type 1 growth shrinking, or is the type 1 market or the applicability for our product in type 1 shrinking? No, it is not. The math will show that type 2 is a growth contributor for us and was a larger contributor than type 1 in this particular quarter, but that is not because the market for our product in type 1 is dwindling. We're as confident as we've ever been. Are we exposed by not having a type 2 indication? I do think health care providers will prescribe what they want. That said, the fact that we cannot promote our product for type 2, and we do not and, of course, legally, we cannot, does hinder our growth. It's an indication we desire and will ultimately need in order to win at the level we want in the medium and long term. The fact that the product has been prescribed as it has in type 2 is largely a result of doctors being educated about what insulin pumps are available. If we had the ability to market ourselves for that area, it would absolutely help us.

Got it. Apologies for that long question, and I think here comes another long one. Regarding the R&D spike we saw in Q1 versus Q4, and I know there are some timing issues, is it fair to say, I still think the bihormonal work is earlier stage versus Mint, that the big bump we saw, which was much higher than what we were modeling, was really related to Mint? And are you sensing that your Mint timing is, you don't have to give it to us, but just that it's on track versus what you were expecting or maybe even potentially a little bit earlier than what you were expecting internally?

Yes. Thanks for the question, Matt. It's Sean. I'm not going to comment on how we're splitting spending between bihormonal and Mint. Both projects continue to move forward and both will see increased spending over the coming period. So I think that was true for both, but I'm not going to quantify where the lion's share fell. In terms of Mint, I don't have much to share right now. The notable point I'll reiterate is that we've been sharing the same timeline for quite a while and it hasn't slipped. We've been continually reiterating it for a long time, and that's what you want to see from us. We're not moving it around. We want to be predictable, and that's what we've been. With that said, no additional updates, except reiterating our timeline for an unconstrained launch by the end of '27.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann & Company.

So I guess, firstly, you did call out lower cost of materials in Q1 that was one-time favorable. But anything related to deflation or scale as a function of that or too small to tell?

Can you say the last part of your question related to inflation or scale? Or what did you say?

So Q1 cost of materials was some of that deflationary in a sense? Or was some of that scale related as sheer scale?

Yes. The primary driver of the lower cost per unit and the cost of materials is simply just volume. So yes, scale. The more components we're able to purchase at a larger scale, the lower cost per component.

Okay. Got it. And then secondly, I want to follow up on the bihormonal. What might we see during 2026 as far as any data or publications related to the IIa or the IIb trials, feasibility studies?

Yes, Jeff, that's a great question. Frankly, I don't think we really intend to publish a lot of this information. There's not really a benefit to us to do that. So what we will do is, I don't know about publishing, but as things complete, our cadence here has been to let you know that things are done, not so much to tell you what's coming up. We'll continue to follow that path. 2026 should bring some meaningful updates, but I'm not going to call out exactly what those are at this point. But I will reiterate now we probably won't publish the results of these trials for various reasons. I just don't think there's a benefit. What I will say, and I alluded to this in our prepared remarks, is that in the past, we really have published data on this. There have been quite a few studies published by Beta Bionics on our formative studies over the last 20-odd years on this product. And there's a lot there, and there's some really, I think, phenomenal results to be looked at. So that, I think, sets a line as to kind of where we'd like to see things sort of at a minimum. But there I don't know to say they're great outcomes from my perspective. So I would encourage you to go take a read of some of the stuff we published in the teens.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Mathew Blackman with TD Cowen.

Maybe start, and I apologize, I've been jumping around calls. But Stephen, I just want to get a feel for the new disclosure on new patient adds. I know we can pick whatever number we want, but would you have us be sort of in that middle of that range? Is that a reasonable sort of launching point to model off of that greater than 10%, but less than 20% quarter-over-quarter decline? Is being in the middle of that a fair point to sort of model that new patient number off of?

Totally appreciate why you want to know that. Unfortunately, what we said in the prepared remarks is what we'd prefer to disclose in terms of the extent. So I'm sorry, Matt, but I won't comment any further.

Okay. And then just remind us again on the sales force expansion, I know we talked a little bit about it, but we know you're adding 20 territories. But just relative to the expansions you've done over the last several years, how similar or how different is this versus those expansions? Is this a lot of white space that you're filling in? Or are you now sort of splitting territories going deeper into areas, geographies so that you can really pound away at accounts? And if so, is the execution of the sales force expansion any different than what you've tackled successfully in prior years? And that's all I had.

Yes, Matt, this is Sean. I'm not going to comment on the size of the expansion, but I will say yes. And of course, it's both of those things. I would say technically, white space would be an area that you consider you don't have a rep, and we don't really have white space. There's a rep covering everywhere in the country. That being said, there are absolutely areas of the country that get essentially no rep visits. We never actually put a foot on the ground in those areas. So we are putting reps in those spaces. So it's not technically white space, but for all intents and purposes it is. But then also they're replacing people at some stage. We're adding people in areas where we're well covered. It's just all those things. We tend to find good people and put them where we can to some extent. You're not just going to say, well, I'm going to take whoever is available and pick a particular MSA and just find a person. We want to make sure that we get good people in every place. So that governs to some extent where and when we add.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Travis Steed with Bank of America.

This is Grace on for Travis. I just wanted to start the first one, maybe about the 2026 revenue guidance. I think it's implying about $33 million of year-over-year dollar growth. You did like $35 million in 2025. Just wondering if this is sort of a level of conservatism in the guide or what sort of do you think it takes from the pipeline or other parts of the business to accelerate revenue growth going forward on a dollar basis?

Yes, understood. This is Stephen. Thanks for the question and for dialing in. Your math is correct about what the guidance implies year-over-year. What could allow us to exceed our revenue guidance are a few things: the iLet building confidence among health care providers, particularly endocrinologists around the country, because the clinical results continue to resonate; patients having strong experiences on the device and telling their providers, which drives same-store sales; and new sales growth from territories we've recently added and will add in the second quarter. Most of the places where new sales reps are going do not prescribe the iLet today, so if we can convert those providers by educating them about the benefits of automation and our strong clinical outcomes, and that exceeds what we’ve assumed in the guidance, that would be upside to the numbers we’ve guided to.

Awesome. And then maybe just a follow-up on any directional color that you can sort of help with on new patient starts relative maybe to 2025 or seasonally throughout the year of 2026 and maybe how that DTC advertising spend is going to help leverage the new patient starts in 2026.

Of course. We don't provide guidance on new patient starts specifically, but I want to reiterate that Q1 is the weakest quarter seasonally. We expect an uptick in new patient starts and a corresponding increase in revenue in the second quarter. Beyond that, I'll point you to our full-year revenue guidance, which reflects our expectations for new patient starts. The Q1-to-Q2 increase is the largest seasonal step change we expect in the year, and we believe you will see that in our results.

The operator provided instructions on how to queue for questions. Our next question comes from the line of Ryan Schiller with Wolfe Research.

Just one for me on competition. There was a competitor who did a recent IPO and another competitor who launched a nationwide product launch. Have you seen any changes in the competitive environment? And maybe where do you see the most opportunity today?

Yes, good question. I mean, IPOs don't really have any bearing whatsoever on the actual market dynamics as far as we're concerned. We're well aware of that, of course, but no impact from our perspective. Regarding the nationwide product launch by the other competitor, you certainly hear about it and there's definitely news out there. I would point out that that particular product, while being a very good product, is quite similar to some of the other products on the market, and I do believe it's increasing competition with those other products. It's quite a bit different from what we offer, and in general the same person who's looking at a product like ours is not looking at that one. So I would say the impact to us is more muted. It's true that increased competition always, at the margin, is going to dilute everybody just a little bit. That's unfortunate, but I wouldn't say it impacts us all that much. Beyond that, that product has been known and available at some level for a while. Nothing really has changed the narrative out there. There hasn't been a big or meaningful product launch that we're aware of for quite a while at this point. Things are relatively stable. For a company like Beta Bionics, our job is to continue to get the word out. We are offering a meaningfully differentiated product. That also means it's new and different, and health care providers are not nearly as familiar with it as some of our competitors. That's our job today. We've been doing it historically with a smaller sales force. We've been operating in a smaller portion of the market, the tubed pump market. With all that said, I think we really like where we're at. We've taken meaningful share of the new patient starts every quarter, especially considering our sales force and the smaller portion of the market that we play in, which is doing exactly what we need to do now. It's getting the information on our differentiated iLet system with our new algorithm out there, getting health care providers familiar, and setting us up to then bring that more nationally with an added sales force and ultimately to the entire market with our Mint program. I think we're doing the right things to set ourselves up for long-term success. But those are long-term statements, and I suppose I started with, yes, no recent evolution of the market that we're aware of. So thank you.

Ladies and gentlemen, I'm showing no further questions in the queue. And that concludes today's conference call. Thank you for your participation. You may now disconnect.