Beta Bionics BBNX Q1 2026 Earnings Transcript

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Date

Tuesday, April 21, 2026 at 4:30 p.m. ET

Call participants

• Chief Executive Officer — Sean Saint
• Chief Financial Officer — Stephen Feider
• Head of Investor Relations — Blake Beber

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Risks

• Management stated, "we cannot promote our product for type 2—and we do not and legally cannot—does hinder our growth," confirming inability to directly market islet for type 2 represents a constraint on addressable growth until an approved indication is obtained.
• Operational expense growth is expected to "accelerate for the remainder of the year compared to Q1," linked to continued sales force expansion, brand and direct-to-consumer marketing, and ongoing investments in pipeline programs, which may pressure near-term profitability.
• One-time gross margin tailwinds contributed to Q1 results, with management cautioning, "we do not expect those one-time tailwinds to repeat," signaling normalization could reduce future margin outperformance.
• "We still have work to do in other areas to fully address the agency's concerns," referencing the ongoing FDA warning letter remediation, indicating potential risk if further regulatory requirements arise.

Takeaways

• Revenue -- $27.6 million, reflecting 57% year-over-year growth, primarily attributed to new patient starts and an expanding installed user base obtaining monthly supplies through the pharmacy channel.
• Gross margin -- 59.5%, an increase of 52 basis points sequentially and 864 basis points year over year, driven by pharmacy installed base growth, lower cost of materials, and one-time gross margin tailwinds.
• Pharmacy channel penetration -- High-30s percentage of new patient starts accessed the islet through the pharmacy channel, up from low-30s percentage in Q4 and low-20s percentage in Q1 2025.
• New patient starts -- Declined more than 10% but less than 20% quarter over quarter, described by management as seasonally typical from Q4 to Q1.
• Recurring revenue model -- Approximately 70% of new patient starts were previously on multiple daily injections, indicating expansion of the insulin pump market through adoption of the islet.
• Operating expenses -- $40.7 million, a 47% increase year over year, with growth linked to field sales expansion, research and development on Mint and bihormonal programs, and increased general and administrative expenses for commercial scaling.
• Cash position -- $240 million in cash, cash equivalents, and investments at quarter end, with management stating this provides adequate funding for all key initiatives and positions the company ahead of peers in anticipated free cash flow generation.
• Full-year 2026 guidance increase -- Revenue outlook raised to $131 million-$136 million (prior: $130 million-$135 million), pharmacy mix to 37%-39% of new patient starts (prior: 36%-38%), and gross margin to 57.5%-59.5% (prior: 55.5%-57.5%).
• Field sales team expansion -- The company remains on schedule to add at least 20 sales territories in 2026, with new territories expected to contribute meaningfully later in the year.
• Product pipeline progress -- Mint patch pump targeted for unconstrained commercial launch by 2027, and Phase 2a bihormonal system feasibility trial initiated, with system optimization ongoing in preparation for further clinical milestones.
• Bionic Insights launch -- Introduction of a new analytics and reporting tool in the health care provider portal, designed to enhance treatment personalization and support clinical decision-making.
• Type 2 diabetes new patient mix -- An estimated 25%-30% of new patient starts were from type 2 diabetes, despite the absence of explicit regulatory indication for this segment.
• FDA warning letter remediation -- Management reports timely completion of corrective actions for legacy complaint handling and ongoing collaboration with the agency, while noting further remediation work remains.

Summary

Beta Bionics (NASDAQ:BBNX) raised full-year 2026 revenue, pharmacy channel, and gross margin guidance following Q1 performance and sales territory expansion. The pharmacy channel now anchors gross margin improvement, as the installed base delivers high-margin recurring revenue and outpaces direct-to-market equipment economics on a scalable basis. Strategic product development continues, with Mint advancing toward a 2027 commercial launch and bihormonal feasibility trials underway to position the portfolio for differentiated clinical outcomes. The Bionic Insights analytics platform has launched to enhance provider engagement, and 25%-30% of new patient starts originated from type 2 diabetes, although regulatory marketing restrictions remain a gating factor.

• Management reiterated that gross margin benefits in Q1 partially resulted from temporary factors not expected to recur, which may temper sequential improvement despite overall margin strength.
• Sales and marketing expenses accounted for 75% of revenue in Q1 as territory and direct-to-consumer expansion efforts accelerated, with management projecting improved efficiency as the base scales and recurring revenue increases.
• Leadership confirmed the FDA warning letter is being addressed with expedited corrective actions, highlighting remediation of old complaints as one tangible example, but acknowledged ongoing work is required for full compliance.
• No significant competitive changes impacting market dynamics or guidance were identified; the company asserts its differentiated islet system remains well positioned within the evolving insulin pump landscape.
• Cash burn in Q1 was approximately $25 million, higher than adjusted EBITDA, due to seasonal bonuses and working capital fluctuations; expectations are for cash burn to align closely with adjusted EBITDA for the remainder of the year.

Industry glossary

• DME: Durable medical equipment; refers to medical devices such as insulin pumps that are reimbursed under specific insurance channels and require periodic stocking.
• PBM: Pharmacy benefit manager; third-party administrators managing prescription drug benefits on behalf of insurers, responsible for reimbursement channels like the pharmacy model referenced throughout the call.
• Bionic Insights: Beta Bionics' analytics and reporting feature, providing clinicians actionable insights and event analysis for enhanced patient care decisions.

Full Conference Call Transcript

Operator: Good afternoon, and welcome to the Beta Bionics, Inc. First Quarter 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session, and instructions will follow at that time. As a reminder, please be advised that today's conference is being recorded. I would now like to hand the conference over to Blake Beber, Head of Investor Relations. You may begin, sir.

Blake Beber: Good afternoon, and thank you for tuning in to Beta Bionics, Inc.’s 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, 04/21/2026. Therefore, if you are listening to the replay, any time‑sensitive information may no longer be accurate. Also on our website are 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; we undertake no obligation to update them to reflect subsequent events or circumstances except to the extent required by law. With that, I would now like to turn the call over to Sean.

Sean Saint: Thanks, Blake. Good afternoon, everyone, and thank you for joining. I am pleased to share with you 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 islet 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 continued to obtain their monthly supplies for the islet through the pharmacy channel, and whom we continue to retain at a high level. The percentage of new patient starts that were reimbursed through the pharmacy channel grew to the high‑30s percentage compared to the low‑30s percentage in Q4 and the 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.

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 am proud of these results and eager to build on them as we progress throughout the year. With that, I will hand the call over to Stephen to provide some additional color on our first quarter performance and our full‑year 2026 guidance. Stephen?

Stephen Feider: 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 would 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 islet 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 costs 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 islet. 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 have 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 islet 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 islet production and modest contribution from pharmacy islet revenue. While we do not 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 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; we are 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 03/31/2026, we had 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 would now like to discuss our revised full‑year 2026 guidance, which we are 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 have had in onboarding new sales territories; we are 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 will hand the call back over to Sean.

Sean Saint: Thanks, Stephen. To wrap up the call, I will briefly touch on our remediation efforts regarding the FDA warning letter we received in late January, and then highlight the progress we are 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 have been providing periodic updates to the FDA regarding changes to our processes and documentation 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 us 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 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 2a feasibility trial to stress test and iterate the system. Our Phase 2a trials have helped us to identify further areas for system optimization in preparation for the more advanced stages of development inclusive of a Phase 2b feasibility trial and Phase 3 pivotal trials.

I am 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 towards fully closed‑loop algorithms, which the industry generally defines as algorithms that do not require any engagement from the user. Another topic that is always top of mind for the industry is health outcomes. The ADA's glycemic goals for most nonpregnant adults with diabetes are less than 7% A1c and greater than 70% time in range, which the vast majority of people with diabetes are not 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 are extremely excited by its potential to further improve experiences and outcomes with islet. Lastly, on our innovation pipeline, I want to cover type 2 diabetes. In Q1, we continued to see some health care providers prescribe islet 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 are 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 are excited and motivated to deliver. Thank you all for joining today's call. We will now open the call for questions.

Operator: Thank you. To ask a question, please press star 1-1 on your telephone, then wait for your name to be announced. To withdraw your question, please press star 1-1 again. Our first question comes from the line of Mike Kratky with Leerink Partners. Your line is open.

Mike Kratky: Hi, everyone. Thanks for taking my questions, and congrats on the strong quarter. 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. Is there any fundamental reason driving that assumption, or anything you are seeing from a competitive standpoint that may be tempering expectations there? And then, on the ongoing sales force expansion, any additional color you can provide in terms of what inning we are in and how far along you are?

Stephen Feider: Hey, Mike. Appreciate the question, and happy belated birthday, by the way. 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 important note about pharmacy reimbursement is that while we feel like the business is highly predictable in areas like revenue, this particular area is not perfectly predictable. It is B2B sales with a long sales cycle, and our guidance acknowledges both of those points. In terms of competitive pressure we are feeling as it relates to the pharmacy channel—none at all that is dampening guidance in any way.

If anything, the move from our tube pump competitors to the pharmacy channel makes payers and PBMs more inclined to want to move insulin pumps, particularly tubed insulin pumps, to pharmacy reimbursement. We actually do not see that move from our competitors as bad at all. On the sales force expansion, I do not 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 is more expansion to happen. 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 will see some in the second quarter as well, and that will round out most of what we expect to expand by.

Operator: Our next question comes from the line of David Roman with Goldman Sachs. Your line is open.

David Roman: Thank you. I appreciate your taking the question here. Maybe I will start with the ADA guideline changes that went into effect in December regarding AID therapy. Could you give us some perspective on what you are observing in the field as it relates to prescribing patterns? I know you talked about Beta Bionics, Inc. contributing to expansion of the overall pump market. Help us understand a little bit more what you are seeing both on the type 1 and type 2 side from an underlying demand perspective. And then, you obviously continue to get a ton of questions around GLP‑1s, especially given the oral dynamic—any perspective there? For my follow‑up, you talked about accelerating OpEx growth through the year.

How are you thinking about overall investment and cost to serve? We see one of your competitors very aggressively going down the DTC path, a lot of people hiring reps, but revenue expectations look similar across the space. Are you seeing a higher customer acquisition cost as the market becomes more competitive, and how are you thinking about that OpEx versus growth trade‑off?

Sean Saint: David, this is Sean. Good question. I do not think the ADA guideline changes, while helpful, are really impacting prescribing patterns on a daily basis yet. Things like that take time to filter out. I do not think we have ever seen the industry just react to a shift, and the guideline evolutions were relatively subtle. The last quarter has been relatively stable in terms of prescribing patterns and narrative. On GLP‑1s, I think they are a phenomenal class of drugs and are helping a ton of people. When you talk about type 1 and also insulin‑dependent type 2—insulin‑managed type 2 specifically—not really a huge impact there.

Orals are a continued evolution of that drug class and a great evolution, but going from a once‑a‑week injectable to an oral is probably not what kicks it over into a drug that people taking four injections per day or who are on a pump will utilize. That is not the reason it was not helping them, in my view, and I do not think oral will change that. It is another helpful evolution for that class. I will let Stephen take the investment question.

Stephen Feider: First, with regard to our sales and marketing growth for the rest of the year and what we are expecting in OpEx: as I alluded to earlier, you will see our sales and marketing spend grow into the second quarter because of expansions of our field sales team—that is why you saw the uptick in sales and marketing in Q1 2026 relative to Q4 2025. This also embeds some investment that we are making in direct‑to‑consumer advertising—not at the same level as some of our competitors, but notable investments nonetheless. In terms of customer acquisition cost, that is a really good point.

When you look at our P&L, our sales and marketing costs in Q1 2026 are 75% of our revenue. That is not an efficient business at scale, and so our customer acquisition cost needs to go down—and it will. The primary ways it will go down are: building an installed base, particularly in pharmacy, where we generate high‑gross‑margin recurring revenue from selling supplies; and readying this business in terms of brand recognition and building a customer‑forward brand in anticipation of the Mint product. For those reasons, I am comfortable that we are building a profitable business in the medium and long term that will start generating free cash way earlier than diabetes peers.

I acknowledge that the customer acquisition cost today, acknowledging we are getting many of our new patients from the pharmacy channel and we are building a brand, does not look perfectly economical at this exact moment.

Operator: Thank you. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open.

Frank Takkinen: Great. Thank you for taking the question. I wanted to start with one on gross margin. Obviously a really strong performance in Q1. Could you help quantify some of the benefits you called out related to the higher islet production and anything else you mentioned that may have contributed to Q1? Extrapolating that out, it feels like gross margin is trending toward the higher end of the guided range today. Is there something in there tempering that expectation? And then, related to cash burn, any seasonal considerations we should think about from Q1 through Q4—was cash burn a little higher in Q1—and how should we model the burn profile throughout the year?

Stephen Feider: Hey, Frank. Appreciate the question. On gross margin, yes, there were one‑time tailwinds in Q1 that brought the gross margin up from what its current run rate is. I do not want to quantify specifically what that impact was, but it was relatively small yet notable. To your guidance question—does our Q1 actual performance make the guidance look conservative? Maybe, but I would reiterate two points: Q1 did have some one‑time favorability, and cost of sales can have discrete and semi‑unpredictable one‑time charges that can occur unfavorably in any given quarter, which in short‑run periods makes gross margin semi‑difficult to predict. Our guidance embeds openness to that.

Stepping back, gross margin is a high point for our business with massive room for upside in the medium and long term. We are demonstrating cost favorability in our ability to manufacture more efficiently quarter over quarter, and the pharmacy business model is absolutely working. I even alluded to the pharmacy revenue model having a higher gross margin as of this quarter than the DME revenue model, and this is still early days—so more upside to come. On cash burn, I think cash burn for us is going to approximate adjusted EBITDA for the rest of the year. We burned about $25 million in Q1, which was higher than our adjusted EBITDA of around $17 million.

The reason is we paid cash bonuses in Q1—there was a big change in our accrued expenses—and there were 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 bridges the gap between the $25 million of burn and adjusted EBITDA.

Operator: Thank you. Our next question comes from the line of Jonathan Block with Stifel. Your line is open.

Jonathan Block: Great. Thanks, guys. Good afternoon. Maybe I will go with a couple of modeling questions. First, I think the Street was about 44% or 45% in 2026 sales in 1H prior to the print. It sort of lands around $31 million for Q2 2026. You mentioned this year would be more front‑end weighted relative to 2025 for a handful of reasons. 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? And then, on gross margin, going into this year I think you alluded to GM increasing sequentially throughout 2026. There was material upside to Q1 2026—good problem to have.

You do not want to quantify the one‑timers, but help us out: as we think about GM going forward, now that you are already at the upper band of your revised guidance, what are the key upside or downside factors for GM or COGS from here over the next handful of quarters?

Stephen Feider: I will reiterate the guidance I gave on the last call, which is that 2026 will have more revenue weighting in the first half for the calendar year period than what we saw in 2025. I am not going to specifically comment on a Q2 revenue number; we do not provide quarterly revenue guidance. Based on what I said, you can get a good sense for a tight range. On gross margin, without quantifying the extent of the Q1 one‑timers or giving a run‑rate Q1 GM, relative to the normalized Q1 GM we are still expecting an uptick quarter over quarter.

There is nothing notable about Q1 that changes the slope for the rest of the year; Q1 had a big number for reasons I have explained.

Operator: Our next question comes from the line of Felipe Raul Lamar with Truist Securities, on for Richard Newitter. Your line is open.

Felipe Raul Lamar: Hi. It is Felipe on for Rich. Just to follow up on the pharmacy channel: you mentioned more competitors trying to enter with durable pumps into the channel potentially accelerating the shift. Could you dig into that and give any context on conversations you have been having with your PBM partners? And then, if you could remind us why you expect economics in the channel to hold over the long term—there are misconceptions around multiple players in the channel and potential downward trends in economics—any clarity would be helpful. Thank you.

Sean Saint: Yeah, Felipe, it is Sean. Beyond saying that the more companies accessing this channel, the more normal it becomes, the less one‑off these conversations are. The more of us that have success through this channel, the more future entrants will also have that success—and that success brings more success with other payers. The more payers that start to pay, the more those who choose not to become outliers. This is a snowball rolling down a hill, and multiple players accessing this channel is a positive for all of us. We are happy to see that and believe it ultimately makes our entire industry healthier. Frankly, we are happy to have started that snowball rolling in the durable pump space.

On why we expect economics to hold: insulin pumps are a non‑commoditized market. In the pharmacy channel, commoditized markets can enter a race to the bottom where a payer may only need to offer one product and scripts can be changed between products without the provider’s approval. That is not the case in insulin pumping. When you write a script for an islet, the pharmacy must deliver an islet specifically; you need a new script for something else. It is the definition of a non‑commoditized market. That limits the ability to create downward price pressure. Because of the nature of automated insulin delivery and unique algorithms, that will not change anytime soon given the clinical trials required.

Today we are still looking at a very differentiated market, and we think islet is one of the more differentiated products out there.

Operator: Next question comes from the line of Jeffrey Johnson with Baird. Your line is open.

Jeffrey Johnson: Thanks, guys. Can you hear me okay? Sorry, I am in the back of the car—hopefully not too much noise here. Sean, staying on the pharmacy point, any updated thoughts on rebates and how you are thinking about rebate dollars you might provide the channel over the next few years? How do you balance staying at tier three in some contracts and buying down the copay versus trying to move up to a tier two but having to chase added rebate dollars as you compete against bigger peers in the pharmacy channel?

Sean Saint: Great question, Jeff. Starting with the non‑commoditization point, we see a lot of durability of pricing for the foreseeable future. On the tier two versus tier three question, there are two fundamental differences: the rebate required to obtain tier two versus tier three, and the copay that the user is asked to pay when their product is covered at either tier. Most companies, Beta Bionics, Inc. included, have copay assistance programs that are transparent to the user and ensure we control that copay at a particular level—currently $25 or less per month. That makes it a math problem for us. We balance the rebate required to move between tiers with the reduction in copay when we do it.

The outcome tells us whether a tier two or tier three positioning would be more advantageous for Beta Bionics, Inc., and we will pick that. Our patients will always pay the $25 copay or less that we control. It is really a win‑win for us and our users.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Matthew O'Brien with Sandler. Your line is open.

Matthew O'Brien: Good afternoon. Thanks for taking the questions. First, as I look at the model, it looks like type 2 growth in Q1 was meaningfully higher than type 1. Is type 2 really carrying you right now for overall patient growth on a year‑over‑year basis? Are you still growing type 1 in the double‑digit range? And are you exposed in the intermediate term by not having a type 2 indication given how well you are doing there? And then I have a follow‑up on R&D.

Stephen Feider: Is type 2 growth driving growth for the business? I need to be a little careful—we do not have the indication, so you will hear Sean and me be cautious. 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. But our type 1 growth is not shrinking, and the applicability for our product in type 1 is not dwindling. The math will show that type 2 is a larger growth contributor for us this quarter than type 1, but not because the type 1 market for our product is shrinking. Are we exposed by not having a type 2 indication?

Health care providers will prescribe what they want, but the fact that we cannot promote our product for type 2—and we do not and legally cannot—does hinder our growth. It is an indication we desire and will ultimately need in order to win at the level we desire in the medium and long term. If we had the ability to market ourselves for that area, it would help us.

Matthew O'Brien: Thanks. And on the R&D spike in Q1 versus Q4—timing issues aside—is it fair to say the big bump was related more to Mint than bihormonal, which feels earlier‑stage? Are you sensing Mint timing is on track or potentially a little earlier than expected internally?

Sean Saint: Thanks, Matt. I am not going to comment on the split between bihormonal and Mint spending. Both projects continue to move forward and both will see upticks in spending over the next period of time, so that was true for both. On Mint, not a lot I can share right now. The notable point is that we have been sharing the same timeline for quite a while and it has not slipped. We have been reiterating it consistently. We want to be predictable. No additional updates except reiterating our timeline of an unconstrained launch by 2027.

Operator: Our next question comes from the line of Jeffrey Scott Cohen with Ladenburg Thalmann & Company. Your line is open.

Jeffrey Scott Cohen: Hi, Blake and Sean. Afternoon. First, you called out lower cost of materials in Q1. That was one‑time favorable, but was any of that deflationary in nature, or was it scale related as far as sheer scale? And second, on the bihormonal program, what might we see during 2026 as far as any data or publications related to the Phase 2a or Phase 2b feasibility studies?

Stephen Feider: The primary driver of the lower cost per unit and cost of materials is simply volume—so, scale. The more components we are able to purchase at larger scale, the lower the cost per component.

Sean Saint: On bihormonal publications, we do not really intend to publish a lot of this information; there is not a benefit to us to do that. As things complete, our cadence has been to let you know that things are done, not so much to tell you what is coming up. 2026 should bring meaningful updates, but I am not going to call out exactly what those are at this point. We probably will not publish the results of these trials for various reasons. I will note that in the past we have published quite a few studies over the last 20‑odd years on this product with really strong results.

I would encourage you to reread some of the work we published in the 2010s.

Operator: Our next question comes from the line of Mathew Blackman with TD Cowen. Your line is open.

Mathew Blackman: Thank you. Can you hear me okay? I appreciate you taking my questions. Stephen, on the new disclosure for new patient adds—you said a greater than 10% but less than 20% quarter‑over‑quarter decline. Would you have us be in the middle of that range as a reasonable launching point to model off of?

Stephen Feider: Totally appreciate why you would want to know that. Unfortunately, what we said in the prepared remarks is what we prefer to disclose in terms of extent, so I will not comment further.

Mathew Blackman: Understood. And on the sales force expansion—you are adding 20 territories—but relative to expansions over the last several years, how similar or different is this? Is this white space fill‑in versus splitting territories and going deeper? Is execution any different than what you have tackled successfully in prior years?

Sean Saint: I am not going to comment on size beyond what we have said. It is both. Technically, “white space” would be an area without a rep, and we do not really have white space—there is a rep covering everywhere in the country. That said, there are areas that essentially get no rep visiting—no feet on the ground historically—so we are putting reps in those spaces. It is not technically white space, but for all intents and purposes it is. We are also adding people in areas that were well covered. We tend to find good people and put them where we can.

We will not just take whoever is available and drop them into an MSA; we want good people in every place, and that governs where and when we add.

Operator: Our next question comes from the line of Analyst with Bank of America, on for Travis Steed. Your line is open.

Analyst: Hey, this is Grace on for Travis. Thanks for taking the questions. On the 2026 revenue guidance, I think it implies about $33 million of year‑over‑year dollar growth versus about $35 million in 2025. Is this conservatism in the guide, or what do you think it takes from the pipeline or other parts of the business to accelerate revenue growth on a dollar basis going forward? And any directional color on new patient starts relative to 2025 or seasonally throughout 2026—maybe how DTC advertising spend will help leverage new patient starts this year?

Stephen Feider: Your math is correct on the implied year‑over‑year growth. The puts that could allow us to exceed revenue guidance—guidance we set with confidence—include: islet continuing to build confidence with health care providers as clinical results resonate and patients have unique and great experiences on the device, which drives same‑store sales; and new‑store sales as we add new sales territories. Most of the places where these new reps are going do not prescribe islet today. Turning on those providers by making them aware of the benefits of automation and the great clinical outcomes we have could represent upside versus what is embedded in guidance. We do not guide new patient starts specifically, but to reiterate, Q1 is the weakest quarter seasonally.

We expect an uptick in new patient starts—and revenue—in Q2. The Q1 to Q2 jump is the largest seasonal step change in the calendar year, and you will see that in our results.

Operator: Our next question comes from the line of Analyst with Wolfe Research. Your line is open.

Analyst: Hi. Thank you for taking the questions. On competition, there was a competitor who did a recent IPO and another who launched a nationwide product. Have you seen any changes in the competitive environment, and where do you see the most opportunity today?

Sean Saint: Good question. IPOs do not have any bearing on market dynamics from our perspective. On the nationwide product launch, sure, you hear about it. That particular product, while very good, is quite similar to some other products on the market. I believe it increases competition among those products. It is quite different from what we offer. Generally, the same person looking at a product like ours is not looking at that one, so the impact to us is more muted. Increased competition at the margin can dilute everybody a bit, which is unfortunate, but I would not say it impacts us much. There has not been a big, meaningful product launch changing the narrative recently; things are relatively stable.

For Beta Bionics, Inc., our job is to continue to get the word out. We offer a meaningfully differentiated product, which also means it is new and different and health care providers are not as familiar with it as with others. Historically we have been doing this with a smaller sales force and in a smaller portion of the market—the tubed pump market. We like where we are. We are taking meaningful share of new patient starts every quarter, especially considering our sales force size and the segment we play into.

That is exactly what we need to do now: get information on our differentiated islet system and algorithm out there, get providers familiar, and set up to bring that more nationally with an added sales force and ultimately to the entire market with our Mint program. We believe we are doing the right things to set up long‑term success. No recent evolutions of the market that materially change our view.

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

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