Beta Bionics Q1 2026 Earnings Call - Pharmacy Channel Pivot Drives Margin Expansion and Guidance Raise
Summary
Beta Bionics delivered a standout first quarter, characterized by a massive 57% year-over-year revenue surge to $27.6 million. The real story, however, isn't just the top-line growth; it is the structural shift toward the pharmacy channel. By moving more new patient starts through pharmacies rather than traditional DME channels, the company has unlocked a high-margin, recurring revenue model that saw gross margins jump 860 basis points year-over-year to 59.5%. This efficiency gain has given management enough confidence to raise their full-year 2026 guidance across revenue, pharmacy mix, and gross margin targets.
While the company navigates an ongoing FDA warning letter remediation, leadership is looking past immediate regulatory hurdles toward a high-stakes pipeline. With the Mint patch pump targeting a late 2027 launch and a bi-hormonal system in Phase IIa trials, Beta Bionics is positioning itself as a premium, non-commoditized player in the automated insulin delivery market. Despite higher operating expenses driven by an aggressive sales force expansion into 20 new territories, the company maintains a strong cash position of $240 million, betting that their differentiated technology will outpace the broader market's move toward commoditization.
Key Takeaways
- Revenue grew 57% year-over-year to $27.6 million, driven by new patient starts and a growing recurring pharmacy base.
- Gross margins expanded significantly by 860 basis points year-over-year to 59.5%, fueled by the higher-margin pharmacy channel.
- The company raised its full-year 2026 revenue guidance to a range of $131 million to $136 million.
- Pharmacy reimbursement for new patient starts reached the high 30% range, exceeding prior expectations.
- Management raised full-year gross margin guidance to 57.5%-59.5%, up from 55.5%-57.5%.
- The company is aggressively expanding its sales force, aiming to add at least 20 new territories in 2026.
- Beta Bionics reported $240 million in cash and short-term investments, stating they are well-capitalized for future initiatives.
- Remediation of the FDA warning letter is underway, with management noting that work on old complaints was completed ahead of schedule.
- The Mint patch pump program remains on track for a target commercial launch by the end of 2027.
- Bi-hormonal system development has entered Phase IIa feasibility trials to optimize the system for future pivotal studies.
- Approximately 25%-30% of new patient starts in Q1 were from Type 2 diabetes patients, despite the lack of an official indication.
- Management views the insulin pump market as non-commoditized due to unique algorithms, which protects against aggressive downward pricing pressure.
Full Transcript
Operator: Good afternoon, and welcome to the Beta Bionics first quarter 2026 earnings conference call. At this time, all participants are on a listen only mode. After the speaker’s presentation, there will be a question and answer session, and instructions will follow at that time. As a reminder, please be advised that today’s conference is being recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. You may begin, sir.
Blake Beber, Head of Investor Relations, Beta Bionics: Good afternoon, and thank you for tuning in to 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 21st 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.
David Roman, Analyst, Goldman Sachs1: 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 bi-hormonal 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 continued 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 and 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?
David Roman, Analyst, Goldman Sachs2: 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 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% 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 advantage recurring revenue model, low out-of-pocket costs for patients, a streamlined process for healthcare 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 three times 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 bi-hormonal projects. The increase in G&A expenses relative to the prior year is driven by continued efforts to scale the company in support of commercial growth and pipeline initiatives. As of March 31, 2026, we have approximately $240 million in 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-$136 million, up from our prior guidance of $130 million-$135 million. On pharmacy mix, we now expect 37%-39% of our new patient starts to be reimbursed through the pharmacy channel, versus our prior guidance of 36%-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%-59.5% for the full year versus our prior guidance of 55.5%-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 bi-hormonal programs. With that, I’ll hand the call back over to Sean.
David Roman, Analyst, Goldman Sachs1: 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 bi-hormonal system and 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 bi-hormonal 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 towards 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 non-pregnant adults with diabetes is less than 7% A1C and greater than 70% time and 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. Bi-hormonal may be different. We believe that the existing body of evidence of bi-hormonal, 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 bi-hormonal 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 healthcare provider portal.
This is one-of-a-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 healthcare 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 healthcare providers prescribe iLet to their type 2 patients off-label. We estimate that 25%-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.
Operator: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Mike Kratky with Leerink Partners. Your line is open.
Mike Kratky, Analyst, Leerink Partners: Hi, everyone. Thanks for taking my questions, and congrats on the strong quarter. I guess to start, it was really encouraging to see the high 30s% of new starts through the pharmacy channel, but your updated guidance of 37%-39% seems to suggest it could hang out there over the next few quarters. Is there any fundamental reason driving that assumption or anything you’re seeing from a competitive standpoint that may be tempering expectations there?
David Roman, Analyst, Goldman Sachs1: Hey, Mike, appreciate the question, and happy belated birthday, by the way. Forgot that I missed that. Nothing notable about the calendar year other than the biggest step-ups in pharmacy coverage happen at the start of the year and at the middle of the year, so January and July. 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. We actually don’t see that move that we’re seeing from our competitors to be bad at all.
Mike Kratky, Analyst, Leerink Partners: Awesome. I very much appreciate that. 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?
David Roman, Analyst, Goldman Sachs1: Yeah. 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. A lot of it happened in the first quarter, and then you’ll see some in the second quarter as well, and that’ll round out most of what we expect to expand by.
Mike Kratky, Analyst, Leerink Partners: Awesome. Thanks again, Stephen.
David Roman, Analyst, Goldman Sachs1: Of course.
Operator: Our next question comes from the line of David Roman with Goldman Sachs. Your line is open.
David Roman, Analyst, Goldman Sachs: Thank you. I appreciate your taking the question here. Maybe I’ll just start with the ADA guideline changes that I think went into effect in December regarding AID therapy. 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?
David Roman, Analyst, Goldman Sachs1: Yeah. 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 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.
David Roman, Analyst, Goldman Sachs: Okay. Maybe just to clarify there, we obviously continue to get a ton of questions around GLP-1s, especially given the oral dynamic. 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. It looks like, generally speaking, revenue expectations are pretty similar for most of the players here. 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?
David Roman, Analyst, Goldman Sachs1: Well, let me take the first part of that, the GLP-1-based question. I’ll just say that, look, 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 and 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 4 injections per day or in 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. 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.
David Roman, Analyst, Goldman Sachs2: Yeah, sure. First thing, David, I’m going to comment on is with regards to our sales and marketing growth for the rest of the year and what we’re expecting in OpEx. As I just alluded to in Mike’s question, you’ll see our sales and marketing spend grow here into the second quarter because of expansions of our field sales team, and that’s why you saw the uptick in sales and marketing in Q1 2026 relative to Q4 2025. That’s what we’re anticipating, and this also embeds some investment that we’re making in direct-to-consumer advertising. Not at the same level as some of our competitors, but we are making notable investments there. In terms of the customer acquisition cost, I think that’s a really good point.
I think when you look at our P&L, for example, our sales and marketing costs in Q1 2026 are 75% of our revenue. That’s not an efficient business at scale, of course. Our sales and marketing costs or our customer acquisition cost needs to go down, and it will. The ways that it’ll go down primarily are building an install base, in particular in pharmacy, where we generate a high gross margin, recurring revenue from selling supplies in the pharmacy. The second one is that we are readying this business in terms of the brand recognition and building a customer first or customer forward brand in anticipation of the Mint product.
Yeah, for those two reasons, I’m comfortable that we are building a profitable business in the medium long term that will just start generating free cash way earlier than what we’ve seen in any diabetes peers. I acknowledge that the customer acquisition cost today for a business like us, acknowledging we’re getting a lot of our new patients from pharmacy channel, and we’re building a brand that it doesn’t look like a perfectly economical sales and marketing model at this exact moment.
David Roman, Analyst, Goldman Sachs: Understood. Well, just not yet.
David Roman, Analyst, Goldman Sachs2: Yeah
David Roman, Analyst, Goldman Sachs: I appreciate all the perspective.
Operator: Thank you. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open.
Frank Takkinen, Analyst, Lake Street Capital Markets: Great. Thank you for taking the question. Wanted to start with one on gross margin. Obviously, a really strong performance in Q1. Was hoping maybe you can help quantify some of the benefits you called out related to the higher iLet production and anything else that you mentioned on what may have contributed to Q1. Extrapolating that out to, it feels like gross margin is trending towards the higher end of the guided range today. Is there something in there tempering that expectation?
David Roman, Analyst, Goldman Sachs2: Hey, Frank. Appreciate the question. With gross margin, yes, as I mentioned on the prepared remarks, there were one-time tailwinds that we had in Q1 that brought the gross margin up from what its current run rate is. I don’t want to quantify specifically what that impact was, but it was relatively small but notable. That is the first point. The second thing you asked about is relative to our guidance. Doesn’t your Q1 actual performance look, these are my words, not yours, but you’re alluding to, like, doesn’t this look like sort of conservative based on what the Q1 performance is? I would say maybe, but I just want to acknowledge two key points. Number one is just reiterating that Q1 did have some one-time favorability in it.
Then the second point is that cost of sales generally has sometimes discrete and semi-unpredictable one-time charges that can happen unfavorably in any given quarter. In short-run periods, makes gross margin somewhat difficult to predict. Acknowledging that similar to how we had a favorability of a one-time charge in Q1, I’m not at all forecasting any future result of that nature for us. I am saying that our guidance embeds the openness to that. I think, look, gross margin is a very high point for our business. There is massive room for upside in gross margin in the long term for the company. I hope what you’re seeing in just the results even this quarter is that we’re demonstrating cost favorability in our ability to manufacture costs more and more efficiently quarter over quarter. The pharmacy business model is absolutely working.
I even alluded to today that the pharmacy business unit or the pharmacy revenue model has a higher gross margin as of this quarter than even the DME revenue model. This is in its early state, so more upside to come in gross margin in the long term. There’s sort of your answer too on why guidance is set the way it is.
Frank Takkinen, Analyst, Lake Street Capital Markets: Got it. Very helpful. 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? Just a little higher cash burn in Q1 and just kind of trying to understand how we should model the burn profile throughout the end of the year.
David Roman, Analyst, Goldman Sachs2: For sure. Yeah, I think cash burn for us is going to sort of approximate adjusted EBITDA for the rest of the year. The reason Q1 cash burn exceeded. We burned about $25 million in Q1. That was higher than what our adjusted EBITDA was of around $17 million. The reason for that is, transparently, we paid cash bonuses in Q1, so there was a big change in our accrued expenses. Then the second thing is there was some working capital differences between Q4 quarter end and Q1 quarter end, notably inventory, accounts receivable and accounts payable. Those totaled about $4 million of impact. That’ll kind of get you closer, bridging the gap between that $25 million of burn and the adjusted EBITDA number.
Frank Takkinen, Analyst, Lake Street Capital Markets: Got it. Very helpful. Thanks for taking the questions.
Operator: Thank you. Our next question comes from the line of Jonathan Block with Stifel. Your line is open.
Jonathan Block, Analyst, Stifel: Great. Thanks, guys. Good afternoon. Maybe I’ll go with a couple modeling questions, but the first one, Stephen, I think the street was about 44%-45% in 2026 sales in 1H, prior to tonight’s print. It sort of landed around $31 million for 2Q 2026. Just curious, you mentioned this year would be more front-end weighted relative to 2025 for a handful of reasons. But when we look at that 1H weighting, or maybe even more specifically, the $31 million for 2Q, is that the right cadence to think about for the model or anything else to call out as we think about the balance of the year on the top line?
David Roman, Analyst, Goldman Sachs2: Yeah, I’ll reiterate the guidance that I gave on the last call that you just alluded to, John, which is that the first half of 2026 will have more revenue in terms of weighting for the calendar year period than what we saw in the first half of 2025. I’m sorry, I’m not going to specifically comment on the number you shared in terms of 2Q2 guidance. That’s not a number. We don’t want to give quarterly revenue guidance. Based on what I just told you, I think you can kind of get a really good sense as to what that number is or at least a tight range for it. I’ll leave it there.
Jonathan Block, Analyst, Stifel: Yep, fair enough. 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. Obviously there was material upside to 1Q 2026, 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, call it the upside or downside for GMs or COGS from here as we think about the next handful of quarters?
David Roman, Analyst, Goldman Sachs2: Yeah. Again, I appreciate the question, and I’m not quantifying the extent of the one-timer that we saw, or the one-timers that we saw in Q1 to give you the run rate Q1 gross margin. Relative to the run rate Q1 gross margin, we are still expecting an uptick quarter over quarter in gross margin. There was nothing, I guess, notable about Q1 or we’re not calling down gross margin or a different slope for the rest of the year in terms of the outlook. It’s just that Q1 had a big number for reasons that I’ve now explained.
Jonathan Block, Analyst, Stifel: Okay. Sorry if I can just clarify there. We’re up sequentially off the normalized 1Q 2026 GM number. You’re not going to quantify it, but logically it’s got to be about a 200 basis points tailwind if you’re up sequentially and still get to the revised range.
David Roman, Analyst, Goldman Sachs2: Yeah, without commenting on specifically the 200 basis points tailwind. Bingo.
Jonathan Block, Analyst, Stifel: Fair enough. I’ll take the rest offline. Thanks, guys.
David Roman, Analyst, Goldman Sachs2: All right. Yep.
Operator: Our next question comes from the line of Richard Newitter with Truist Securities. Your line is open.
David Roman, Analyst, Goldman Sachs4: Hi, it’s Philippe on for Rich. Just to 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. 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. Just one follow-up. Thank you.
David Roman, Analyst, Goldman Sachs1: Yeah, Philippe, it’s Sean. Really beyond just saying that the more companies that are accessing this channel, the more normal it becomes, the less
The less one-off these conversations are, the more of us that have success through this channel, the more future people accessing it will also have that success. That success brings more success with other payers. The more payers that start to pay, the more that the ones who choose not to become outliers. I think this is definitely a snowball rolling down a hill, and multiple payers accessing this channel are a positive for all of us. Yeah. We’re more than happy to see that. I think it ultimately makes our entire industry quite a bit more healthy. Frankly, we’re happy to have started that snowball rolling in the durable pump space.
Matthew O’Brien, Analyst, Piper Sandler: If you could just remind us why you expect economics in the channel to hold over the long term. 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. Thank you.
David Roman, Analyst, Goldman Sachs1: Yeah, that’s a good question. The primary reason for the moment is that insulin pumps are a non-commoditized market. When you look at the pharmacy channel, there are plenty of examples of commoditized markets getting into a race to the bottom because you’re in a situation where a particular payer really only needs to offer one of those products because they’re easily switchable. In fact, you’ll see situations where scripts can be changed between different products without the approval of the healthcare provider. That is not the case in insulin pumping. When you write a script for an iLet, the payer, well, whoever must deliver an iLet specifically, and you need to get a new script for something else. It is the definition of a non-commoditized market. That really limits the ability to create downward price pressure in a market like we have today.
Because of the nature of automated insulin delivery and the unique algorithms that we’re all providing, that really isn’t going to change anytime soon given the clinical trials, et cetera, et cetera, that are required to go into these pumps. As of today anyway, we are still looking at a very differentiated market. Of course, we think iLet being one of the more differentiated products out there. Does that help?
Matthew O’Brien, Analyst, Piper Sandler: Too helpful. Thanks for taking the questions.
David Roman, Analyst, Goldman Sachs1: You got it.
Operator: Thank you. Our next question comes from the line of Jeff Johnson with Baird. Your line is open.
Jeff Johnson, Analyst, Baird: Hey, thanks, guys. Can you hear me okay? Sorry, I’m in the back of the car. Hopefully not too much noise here.
David Roman, Analyst, Goldman Sachs1: We got you, Jeff. You sound all right.
Jeff Johnson, Analyst, Baird: Yeah, good, thanks. Sean, just maybe staying on that pharmacy point. I think any updated thoughts you have on rebates maybe, and how you’re thinking about rebate dollars you might provide the channel here over the next few years, handful of years anyway. How do you balance kind of staying at tier three in some of your contracts and buying down the co-pay versus maybe trying to move up to a tier two, but having to chase some added rebate dollars as you compete against maybe one of your bigger peers in the pharmacy channel there. Just rebates versus buying down co-pays and that. Just what’s your outlook there over the next few years? Thanks.
David Roman, Analyst, Goldman Sachs1: Yeah, great question, Jeff. You’re absolutely right. That is very much building on Felipe’s question. I would start with, when you just look at the non-commoditization of the market, limiting the ability generally of payers to create the downward price pressure. We see a lot of durability of pricing here for the foreseeable future. That’s one aspect of your question. The second, frankly, is very different, and that’s the tier two versus tier three argument or well, argument. Let me just be clear on that. Tier two versus tier three has two fundamental differences, and really only the two. They are the rebate required to obtain tier two versus tier three, and the co-pay that the user is asked to pay when their particular product is covered at either tier two or tier three.
Most companies, Beta Bionics certainly included, we have co-pay assistance programs, which are transparent to the user, which ensure that we control that co-pay at a particular level. Currently, I believe we’re at $25 or less per month. What that means, though, is that it’s a math problem for us. We just balance the rebate required to move between tiers with the reduction in co-pay that we would get when we do it. Out of that, it’s a very simple math problem to tell us whether or not a tier two or a tier three positioning would be more advantage for Beta Bionics. We will always pick that, keeping in mind that our patients will always pay the $25 co-pay or less that we control. It’s really a win-win for us and our users.
Jeff Johnson, Analyst, Baird: Fair enough. Appreciate the thoughts.
David Roman, Analyst, Goldman Sachs1: Thanks, Jeff.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Matthew O’Brien with Piper Sandler. Your line is open.
Matthew O’Brien, Analyst, Piper Sandler: Good afternoon. Thanks for taking the questions. The first one’s a little convoluted, so forgive me. 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. 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? Are you exposed, in the intermediate term by not having a type 2 indication, just given how well you’re doing there? I do have a follow-up.
David Roman, Analyst, Goldman Sachs1: All right.
David Roman, Analyst, Goldman Sachs2: Yeah. Is Type 2 driving the growth for the business? Look, I have to be a little careful here because, of course, we don’t have the indication. You’re going to always hear Sean and I, when we’re talking about Type 2, a little hesitant to say too much. Yes, the fact that 25%-30% of our new users are coming to us with Type 2 diabetes, that 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, yes, Type 2 is a growth contributor for us, and it’s a larger growth contributor than what Type 1 in this particular quarter was.
It’s not because the market for our product in Type 1 is dwindling or anything of that nature. We’re as confident as we’ve ever been. Are we exposed by not having a Type 2 indication? I do think healthcare providers will prescribe what they want. That said, the fact that we cannot promote our product for Type 2, and we do not, because, of course, legally we cannot, that does hinder our growth, yes. It’s an indication that we desire, that we’ll ultimately need in order to win at the level that we desire to in the medium and long term. The fact that the product is prescribed the way that it has been in Type 2 is really just a product of doctors being educated about what insulin pumps are out there.
if we had the ability to market ourselves for that particular area, absolutely, it would help us.
Matthew O’Brien, Analyst, Piper Sandler: Got it. Apologies for that long question. I think here comes another long one. Just the R&D spike that we saw in Q1 versus Q4, and I know there’s some timing issues there, but I still think the bi-hormonal work is still kind of earlier stage versus Mint. Is it fair to say the big bump that we saw is much higher than what we were modeling, was really related to Mint? And then, are you sensing that your Mint timing is-- you don’t have to give it to us, but just it’s on track versus what you were expecting? Or maybe even potentially a little bit earlier than what you were expecting internally? Thanks.
David Roman, Analyst, Goldman Sachs1: Yeah. Thanks for the question, Matt. It’s Sean. Look, I’m not going to comment on the split between where we’re spending our money between bi-hormonal and Mint. What I will say is that both products or both projects continue to move forward, and both will see upticks in spending over the next period of time. I think at some level, that was true on both. I’m not going to quantify where the lion’s share fell. Then in terms of Mint, not really a lot I can share right now. I think the notable point that maybe I’ll sort of reiterate is that we’ve been sharing the timeline we’ve been sharing for quite a while. It hasn’t slipped. We’ve been continually reiterating it now for forever, I think. I think that’s what you want to see from us, right? We’re not moving it all around.
We want to be predictable, and that’s what we’ve been. With that being said, no really additional updates except for reiterating our timeline on constrained launch by the end of 2027.
Matthew O’Brien, Analyst, Piper Sandler: Got it. Thanks so much.
Operator: Thank you. Our next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann & Co. Inc. Your line is open.
Jeffrey Cohen, Analyst, Ladenburg Thalmann & Co. Inc.: Hi, Blake and Sean. Good afternoon. I guess firstly, you did call out lower cost of materials in Q1 that was one-time favorable. Anything related to deflation or scale as a function of that, or too small to tell?
David Roman, Analyst, Goldman Sachs1: Can you say the last part of your question related to inflation or scale? What did you say?
Jeffrey Cohen, Analyst, Ladenburg Thalmann & Co. Inc.: Q1 cost of materials, was some of that deflationary in the sense, or was some of that scale related as far as?
David Roman, Analyst, Goldman Sachs1: Oh, yeah.
Jeffrey Cohen, Analyst, Ladenburg Thalmann & Co. Inc.: shared scale?
David Roman, Analyst, Goldman Sachs1: Yeah. The primary driver of the lower cost per unit and the cost of materials is simply just volume. Yes, scale. The more components we’re able to purchase, the larger scale, the lower cost per component.
Jeffrey Cohen, Analyst, Ladenburg Thalmann & Co. Inc.: Okay. Got it. Secondly, I want to follow up on the bi-hormonal. What might we see during 2026 as far as any data or publications related to the phase IIa or the phase IIb trials feasibility studies?
David Roman, Analyst, Goldman Sachs1: Yeah. 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. 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 us some meaningful updates, but I’m not going to call out exactly what those are at this point. 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’s been quite a few studies published by Beta Bionics on our formative studies over the last 20-odd years on this product. There’s a lot there, and there’s some really, I think, phenomenal results to be looked at. That, I think, sets a line as to where we’d like to see things at a minimum. I don’t know what to say. They’re great outcomes from my perspective. I would encourage you to go take a re-read of some of the stuff we published in the teens.
Jeffrey Cohen, Analyst, Ladenburg Thalmann & Co. Inc.: Got it. Thanks for taking the questions.
David Roman, Analyst, Goldman Sachs1: Yeah, you got it, Jeff. Thank you.
Operator: Our next question comes from the line of Mathew Blackman with TD Cowen. Your line is open.
Mathew Blackman, Analyst, TD Cowen: All right. Thank you, guys. Can you hear me okay?
David Roman, Analyst, Goldman Sachs1: Yeah we can, Matt.
Mathew Blackman, Analyst, TD Cowen: All right. Appreciate you taking my questions. Maybe to start, I apologize. I’ve been jumping around calls. 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?
David Roman, Analyst, Goldman Sachs2: Totally appreciate why you’d want to know that. Unfortunately, what we’ve said in the prepared remarks is what we’d prefer to disclose in terms of the extent. I’m sorry, Matt, but I won’t comment any further.
Mathew Blackman, Analyst, TD Cowen: Okay. 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? If so, is the execution of the sales force expansion any different than what you’ve tackled successfully in prior years? That’s all I had. Thanks.
David Roman, Analyst, Goldman Sachs1: Yeah, Matt. This is Sean. I’m not going to comment on size of the expansion, and this is probably an unsatisfying answer, but I’m going to say yes. Of course, it’s both of those things. I would say technically, white space would be an area that you kind of consider that you don’t have a rep. 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 visiting. We never actually put a foot on the ground in that area. We are putting reps in those spaces. It’s not technically white space, but for all intents and purposes, it is. They’re replacing people at some stage. We’re adding people in areas that we’re well-covered. It’s just all those things.
We tend to find good people and put them where we can at some level. You’re not just going to say, "Well, I’m going to take whoever’s available and, I don’t know, pick a particular MSA and just find a person." We want to make sure that we get good people in every place. That governs to some extent where and when we add.
Mathew Blackman, Analyst, TD Cowen: Got it. Appreciate it. Thank you so much.
Operator: Thank you. Our next question comes from the line of Travis Steed with Bank of America. Your line is open.
David Roman, Analyst, Goldman Sachs3: Hey, this is Grace on for Travis. Thanks for taking the questions. 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?
David Roman, Analyst, Goldman Sachs2: Yeah, understood. Hey, this is Stephen. Thanks for the question and for dialing in. Yes, your math is correct in terms of what the guidance kind of implies year-over-year growth-wise. The upside on what could go right for the business that would allow us to exceed the revenue guidance, which we do set, of course, as we have confidence in what we guide to, is the iLet builds confidence from the healthcare providers from endocrinologists around the country. The clinical results that we get from our product, they continue to resonate with healthcare providers. Patients have unique and great experiences on the device, tell their healthcare providers, other healthcare providers about it, or their healthcare provider about it, and we start to build confidence and traction in same-store sales. The other thing that’s an upside on the business is the new store sales.
David Roman, Analyst, Goldman Sachs1: As Sean just alluded to, we added a lot of new sales territories already. We’ll continue to add more of them in the second quarter. Most of the places where these new sales reps are going do not prescribe the iLet today. Turning on those particular healthcare providers by making them aware of the benefits of automation, the great clinical outcomes that we have from our product, if that exceeds our expectations or what’s embedded in the guidance, that would be another upside to the numbers that we’ve guided to.
David Roman, Analyst, Goldman Sachs3: Awesome. Thank you. 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. Thanks for taking the question.
David Roman, Analyst, Goldman Sachs2: Of course. We don’t guide to new patient starts specifically, but the only point I’ll kind of communicate to you all and is just to reiterate that Q1 is the weakest quarter seasonally. We absolutely expect an uptick in new patient starts and then of course revenue to coincide in the second quarter. Other than that, I think I’ll just leave it to our full year guidance as it relates to revenue, which I think kind of embeds what our expectations are on new patient starts. The Q1 to Q2 jump is the largest seasonal step change that we think happens in the calendar year, and you’ll see that we believe in our results.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Ryan Schiller with Wolfe Research. Your line is open.
David Roman, Analyst, Goldman Sachs0: Hi, thank you for taking the questions. 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? Maybe where do you see the most opportunity today?
David Roman, Analyst, Goldman Sachs1: Yeah, good question. IPOs don’t really have any bearing whatsoever on the actual market dynamics as far as we’re concerned. Yes, we’re well aware of that, of course, but no impact from our perspective on the nationwide product launch of the other competitor. Look, sure, at some level you hear about it. There’s definitely news out there. I would point out that particular product is, while being a very good product, quite similar to some of the other products on the market, and I do believe it’s increasing competition with those other products quite a bit. Quite a bit different from what we offer. In general, the same person who’s looking at our product like ours is not looking at that one. I would say more muted impact to us.
However, it’s true that increased competition always at the margin is going to dilute everybody just a little bit. I’d say that’s unfortunate, but I wouldn’t say that it impacts us all that much. Beyond that, and then that project of course has been known and available at some level for a while. Nothing really that’s changed the narrative out there. There hasn’t been a big product launch, a 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. That also means it’s different. It also means healthcare 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. Frankly, we’ve been doing it in a, I don’t want to call it a niche exactly, but a smaller portion of the market, meaning the tube pump market. With all that being said, I think we like where we’re at. We’re taking meaningful share of the new patient starts every quarter, especially when considering our sales force, especially when considering the smaller portion of the market that we play into, 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 the healthcare providers familiar, and setting us up to then bring that more nationally with an added sales force, and then 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 here. Those are long-term statements, and I suppose I started with no recent evolutions of the market that we’re aware of. Thank you.
Operator: Thank you. Ladies and gentlemen, I’m showing no further questions in the queue. That concludes today’s conference call. Thank you for your participation. You may now disconnect.