Beta Bionics (BBNX) Q4 2025 Earnings Transcript

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DATE

Tuesday, Feb. 17, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

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

TAKEAWAYS

• Net Sales -- $100.3 million for the year, up 54% year over year, reflecting significant growth in product adoption.
• Q4 Revenue -- $32.1 million, increasing 57% year over year, driven by 5,592 new patient starts and favorable pharmacy channel dynamics.
• Gross Margin -- 55.4% for the year, up modestly, and 59% in Q4, higher by 179 basis points year over year, attributed to improved scale and pharmacy channel leverage.
• Sales Force Productivity -- Newly added users in 2025 doubled the installed base to over 35,000 using a sales force of 63 territories, which management claims delivered leading per-territory productivity in the sector.
• Pharmacy Channel Penetration -- High-twenties percentage of full-year new patient starts and low-thirties percentage of Q4 new patient starts, both sharply higher than prior periods.
• Q4 Patient Mix -- 69% of new starts were users converting from multiple daily injections, demonstrating the device’s reach beyond traditional pump users.
• Operating Expenses (Q4) -- $35.1 million, up 42%, with increases attributed to sales force expansion, R&D on Mint and bihormonal programs, and new public-company G&A costs.
• Liquidity -- $265 million in cash, equivalents, and investments as of year-end, positioned to fund all planned initiatives.
• 2026 Guidance -- Revenue expected between $130 million and $135 million; gross margin targeted at 55.5%-57.5%; pharmacy channel to account for 36%-38% of new patient starts.
• Sales Force Expansion -- At least 20 new territories to be added in 2026, with the majority of hires planned in the first half, supporting broader market coverage.
• Product Innovation -- Mint patch pump on track for unconstrained commercial launch by 2027; Phase 2a feasibility complete for bihormonal system with no safety signals observed.
• Pharmacy Revenue Model -- In the pharmacy channel, iLET is provided without upfront cost and generates approximately $450 in monthly recurring revenue per active user.
• Q4 Inventory Dynamics -- $1 million in stocking orders pulled forward from Q1 into Q4 in the pharmacy channel ahead of supply price increases, impacting quarterly comparisons.
• Type 2 Diabetes Uptake -- 25%-30% of Q4 new patient starts were type 2 diabetes patients, with sequential growth cited, predominately via off-label use.
• Pricing Actions -- A low single-digit percentage price increase was taken for pharmacy channel supply sales, with DME pricing held stable.

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RISKS

• CEO Saint disclosed, "we received from the FDA in late January" relating to complaint handling, MDR definitions, late filings, and corrective and preventative action procedures at the Irvine facility.
• Saint stated, "an elevated MDR rate would be present" through Q2 due to backdated remediation of previously non-reportable complaints, with full compliance targeted by end of Q2.
• Feider warned, "Q1 to decline sequentially from Q4 2025," with a larger drop than prior years, citing fewer product launches and muted pharmacy coverage expansion versus Q1 2025.
• Management acknowledged that a higher-than-anticipated share of new starts in the pharmacy channel "creates a short-term headwind on revenue" and "a short-term drag on our gross margin profile."

SUMMARY

Beta Bionics (NASDAQ:BBNX) reported robust year-over-year revenue and gross margin expansion, driven by continued adoption of its iLET platform and growth within the pharmacy distribution channel, despite a relatively small sales force. Detailed guidance for 2026 projects sustained top-line growth, further pharmacy adoption, and significant sales force expansion weighted early in the year, though the company signaled greater Q1 seasonality than in prior years. Regulatory remediation efforts following an FDA warning letter on quality systems, MDR, and complaint handling are ongoing but do not alter internal timelines for key launches such as Mint. Management outlined that upcoming operating cost increases will fund both commercial and advanced R&D initiatives, especially for Mint and the bihormonal platform, while reaffirming the company's ample cash position and industry-leading transparency for performance reporting and channel metrics.

• Management stated industry norms will drive a shift away from specific quarterly new patient starts reporting in favor of product-level, channel, and trend-based disclosures.
• Saint clarified that updated MDR practices now match FDA expectations, noting that legacy late filings stemmed from retrospective changes in definitional criteria rather than new adverse events.
• Feider explained Q4 seasonality effects are diminishing as pharmacy channel adoption changes patient purchasing patterns, yet Q1 remains a relative low due to deductible resets.
• Company guidance anticipates revenue in 2026 will be more weighted toward the first half compared to prior years, with key future growth drivers linked to territory expansion pace and pharmacy mix swings.
• Mint’s coverage strategy leverages existing PBM relationships formed through iLET, with expectations that commercial terms for Mint will mirror or extend current agreements.
• Real-world iLET efficacy and safety data, including rates of hypoglycemia, align with or surpass clinical trial benchmarks and meet or exceed established ADA guidelines, per CEO data references.

INDUSTRY GLOSSARY

• iLET: Beta Bionics, Inc.'s automated insulin delivery system for people with insulin-requiring diabetes, central to company sales and development strategy.
• DME Channel: The durable medical equipment reimbursement pathway for insulin pumps, distinct from pharmacy channel, often with higher patient up-front costs and different seasonality.
• PBM: Pharmacy Benefit Manager, entities contracting to administer pharmacy benefits and negotiate formulary access for devices like iLET and Mint.
• MDR: Medical Device Report, regulatory notification required for certain adverse events or complaints as defined by FDA.
• CAPA: Corrective and Preventative Action system, a regulated process for resolving quality, safety, or compliance issues identified during product lifecycle.
• Phase 2a / 2b: Early- and mid-stage clinical trial phases for device-drug development, used here for the bihormonal system assessing feasibility, iteration, and readiness for pivotal studies.

Full Conference Call Transcript

Sean T. Saint, and Chief Financial Officer, Stephen H. Feider. Both the replay of this call and the press release discussing our fourth quarter and full year 2025 results will be available on the Investor Relations section of our website. The replay will be available for approximately one year following the conclusion of this call. Information recorded on this call speaks only as of today, 02/17/2026. Therefore, if you are listening to any replay, time-sensitive information may no longer be accurate. Also on our website is our supplemental fourth quarter 2025 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. Today's discussion will also include references to non-GAAP financial measures with respect to our performance, namely adjusted EBITDA. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting

Operator: periods. Any non-GAAP information presented should not be considered as

Blake Beber: a substitution independently or superior results prepared in accordance with GAAP. Please refer to our earnings release and supplemental earnings presentation on the Investor Relations section of our website for a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measure. With that, I would now like to turn the call over to Sean. Thanks, Blake. Good afternoon, everyone, and thank you for joining. With this call, we are officially turning the page on our first full year as a public company. It has been an exciting year to say the least,

Sean T. Saint: and I want to take a brief moment to reflect on it before we dive into the details of our Q4 and full year 2025 performance. Beta Bionics, Inc. exists to deliver solutions to people with diabetes that reduce burden, expand access, and ultimately improve outcomes at the population level. We believe that in doing so, we can, for the first time, begin to lower the average A1C of people living with diabetes in the U.S. Our performance over the last year is strongly indicative that we are on the right track.

On our first earnings call, we shared our key targets for the full year 2025, and as we will highlight in more detail shortly, we outperformed substantially on each of those metrics. Close to 20,000 new users adopted our technology in 2025, more than doubling our installed base entering the year, which now stands above 35,000 total users that have adopted the iLET since launch. We added those users with what we believe is a substantially smaller sales force than our peers, which we believe, on a per-territory basis, made our sales reps potentially the most productive in the durable pumps market in 2025.

That goes to show you the power of our fully adaptive algorithm, our robust ecosystem of digital tools to support our users, their caregivers, and their providers, and ultimately, our team's ability to execute and deliver results. We continue to lead from the front on our pharmacy channel strategy for durable pumps, establishing formulary agreements with all the major pharmacy benefit managers, or PBMs, that operate in the U.S. We were also effective at driving adoption of those formulary agreements at the individual plan level, which is a critical step in the process that ultimately enabled many of our users to access the iLET and its related consumables for significantly lower out-of-pocket costs.

We also believe our gross margin profile is already the strongest in the durable pump space, as evidenced by our performance this year, considering the success that we have seen in the pharmacy channel, which had a short-term dilutive effect on gross margin in 2025. On the R&D side of the business, we took meaningful steps in the development of Mint, our patch pump program, which we unveiled to the world at our first Investor and Analyst Day in June. We also completed our first clinical trials as a drug company, executing a PK/PD trial for our glucagon asset and a first-in-human feasibility trial for the entirety of our bihormonal system in development.

I am proud of all we have accomplished in 2025, and I look forward to 2026 as another year of relentless execution on our key objectives that we believe will ultimately position us to revolutionize diabetes care in the years to come.

Blake Beber: We have lots of ground to cover on today's call, beginning with our fourth quarter and

Sean T. Saint: full year 2025 results. Stephen will then provide some additional detail on our fourth quarter performance before introducing our guidance for full year 2026. I will wrap up the call with regulatory and pipeline updates. Then we will take Q&A. Starting with a brief overview of full year 2025 performance, I am proud to announce that we delivered $100,300,000 in net sales, which grew 54% year over year. Our gross margin of 55.4% expanded slightly year over year while our percentage of new patient starts through pharmacy grew to a high-twenties percentage for the full year 2025, relative to a high single-digit percentage in the prior year. To put it simply, these are excellent results.

The iLET is winning with its unmatched automation. Our highly transparent and inclusive real-world efficacy and safety outcomes are excellent and available for the world to see in our latest corporate presentation. Beyond the product, we are quickly innovating the business model for durable insulin pumps, and we are remaining disciplined in our execution and cost control. Diving into Q4 results specifically, we generated $32,100,000 in net sales, which represents 57% growth year over year. Q4 revenue growth was driven by a few items. Number one, we delivered 5,592 new patient starts in the quarter, which grew 37% year over year.

Number two is our growing installed base of users accessing their monthly supplies for the iLET through the pharmacy channel, whom we are retaining at a high level. Number three is modest favorability in stocking revenue that we saw in both the DME and pharmacy channels relative to the prior quarters and year. In pharmacy in particular, we saw a modest pull forward of about $1,000,000 of stocking orders from Q1 into Q4, ahead of price increases that were implemented at the end of the year in that channel.

In Q4, a low-thirties percentage of our new patient starts were reimbursed through the pharmacy channel, increasing slightly relative to the prior quarter and substantially relative to the low-teens percentage we saw in Q4 of the prior year. Gross margin in Q4 was 59%, an expanding 179 basis points year over year. Gross margin expansion is being driven by the benefits of increased scale and manufacturing volume leverage, greater contribution of high-margin revenue from our growing pharmacy installed base, and continued cost discipline. With that, I will hand the call over to Stephen to provide some additional color on our fourth quarter performance and introduce our full year 2026 guidance. Stephen?

Stephen H. Feider: Thanks, Sean. Our Q4 revenue, pharmacy mix, and gross margin results exceeded our guidance across the board. While we do not guide on this metric, our 5,592 new patient starts grew 5% sequentially relative to the prior quarter, which was in line with the lower end of our expectation for the quarter. While Q4 remains the strongest quarter seasonally for new patient starts in the diabetes market, as it has been for us since we launched the iLET, we believe its relative strength compared to the other quarters is diminishing.

We believe that historically, Q4’s relative strength was predicated on people with diabetes who waited to purchase an insulin pump until they met their out-of-pocket maximums for the year and before their deductibles reset in the new year. By waiting until their out-of-pocket maximums are reached, patients could save as much as $1,000 to $2,000 on a pump they purchase later in the year through the DME channel. Since 2023, the majority of new pump users in the U.S. have acquired their device through the pharmacy channel, where the majority of users can initiate and maintain therapy for under $50 per month.

Said another way, we believe that over the past few years, people with diabetes who may have previously waited until Q4 to adopt a new pump are waiting less frequently than they used to. Our pharmacy channel strategy

Blake Beber: enables us to compete for those new users and is a key reason why we have seen great adoption of the

Stephen H. Feider: iLET throughout the year. In Q4, approximately 69% of our new patient starts came from people with diabetes that used multiple daily injections prior to starting the iLET, which is an important representation of how much the iLET is expanding the market for insulin pumps and addressing an unmet need. Moving on to gross margin. Q4 gross margin was 59%. The improvement we saw in our Q4 gross margin relative to the prior year and the prior quarter was driven by two primary factors. Number one, growth in the pharmacy installed base, which generates high-margin recurring revenue where we continue to see strong patient retention.

And number two, lower cost per unit from higher manufacturing volumes driven by growth in patient demand. Total operating expenses in the fourth quarter were $35,100,000, an increase of 42% compared to $24,700,000 in 2024. The increase in sales and marketing expenses relative to the prior year is driven by the expansion of our field sales team, which still stands at 63 territories exiting Q4. The increase in R&D expenses 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 new costs related to operating as a public company.

As of 12/31/2025, we have approximately $265,000,000 in cash, cash equivalents, and short- and long-term investments. We are sufficiently capitalized to fund all our key initiatives and remain well positioned to begin generating free cash flow well ahead of historical diabetes peers. I would now like to introduce our full year 2026 guidance. Starting with revenue, we expect to generate $130,000,000 to $135,000,000 of revenue in 2026. On our channel mix, we expect 36% to 38% of our new patient starts to be reimbursed through the pharmacy channel. Lastly, we expect gross margin to be between 55.5% and 57.5%. Our revenue guidance contemplates our expectations for the iLET to expand the pump market

Blake Beber: while taking market share,

Stephen H. Feider: stable and strong patient retention in both the DME and pharmacy channels, stable pricing in the DME channel, and a low single-digit increase in price for supplies sold through the pharmacy channel. Other key variables that may impact our revenue performance relative to our guidance include the percentage of new patient starts in the pharmacy channel and the rate at which we expand our sales force throughout the year. Our gross margin guidance contemplates our continued cost discipline, improved leverage of manufacturing overhead at greater scale, and continued contribution of high-margin revenue from the growing pharmacy install base.

Another key variable that could impact our gross margin performance is our pharmacy mix of new patient starts, which, with meaningful changes from one quarter to the next, can have a material impact on our near-term gross margin. A quick comment on operating expenses and CapEx. For 2026, we expect OpEx and CapEx to increase as a percentage of revenue

Blake Beber: relative to the prior year.

Stephen H. Feider: We expect both sales and marketing and R&D spend to accelerate on a year-over-year basis driven by sales force expansions as well as Mint and bihormonal costs, respectively. We expect G&A spend to increase slightly year over year to support the organization as it scales. CapEx spend will accelerate predominantly related to Mint. In terms of revenue cadence, we expect Q1 to decline sequentially from Q4 2025. As I mentioned earlier, the growth of the pharmacy channel is muting traditional seasonality in the insulin pump market. Q4 remains the strongest quarter on a relative basis, even if its relative strength is diminishing. Q1 also continues to be the softest quarter on a relative basis due to annual deductible resets.

While many patients do not wait for their medical deductibles to be met before purchasing an insulin pump, a portion still do.

Sean T. Saint: As a result,

Stephen H. Feider: the pool of patients initiating therapy through the medical benefit is typically larger in the back half of the year, especially relative to Q1.

Blake Beber: In 2025,

Stephen H. Feider: we were able to partially offset this typical Q1 seasonality headwind for two primary reasons. Number one, we were still benefiting from momentum generated by our late 2024 product launches, including Color iLET, Bionic Circle, and the Libre 3 Plus integration. Number two, we meaningfully expanded pharmacy coverage in Q1 2025 through our agreement with Prime Therapeutics. That expansion allowed significantly more patients to access iLET earlier in the year with minimal out-of-pocket costs, driving incremental new patient starts. While we continue to view iLET as highly competitive in the market, we do not expect Q1 2026 to benefit from the same level of tailwinds.

We did not have comparable product launches in late 2025, and although we anticipate incremental growth in pharmacy coverage from Q4 2025 to Q1 2026, we do not expect a similar step-change pharmacy coverage expansion as we experienced in Q1 2025. Stepping back from Q1, we expect full year 2026 revenue to be slightly more weighted towards the first half of the year compared to 2025. In 2025, we experienced a significant increase in the percentage of new patient starts flowing through the pharmacy channel. That mix shift was dilutive to revenue in the first half, but became accretive in the back half of the year.

In 2026, we again expect the pharmacy mix to increase with that growth weighted towards the front half of the year. However, we expect the magnitude of the shift to be more modest

Blake Beber: than what we saw in early 2025.

Stephen H. Feider: As a result, we expect a modestly higher revenue weighting in 2026 relative to the prior year. Beyond pharmacy mix, the other key variable that could influence revenue cadence throughout the year is the pace at which we expand our sales force. In 2026, we plan to add at least 20 new sales territories, up from the 63 territories we had at the end of 2025. We expect to expand throughout the year as we identify high-quality sales reps in priority markets. Going forward, however, we will no longer provide specific quarter-end territory counts in order to better align our disclosure practices with those of our peers.

With that in mind, I would like to address our approach to the new patient starts disclosure going forward.

Blake Beber: Since our IPO, we have provided exact new patient starts figures

Stephen H. Feider: to support the investment community in understanding the complexity of our traditional DME channel model versus our innovative pay-as-you-go model in pharmacy. We now feel, at this stage, that the investment community has a strong understanding of our dual-channel business model. Therefore, to better align our disclosure practices with industry peers, we will no longer provide an exact quarterly new patient starts figure. That said, we remain committed to an industry-leading level of transparency, and we will continue to provide our quarterly revenue by product and channel, our mix of new patient starts going through the pharmacy channel, and quantitative trend-based commentary on new patient starts each quarter.

Again, this is more disclosure and transparency than we typically see in the insulin pump space. We will continue to evaluate our disclosure strategy to align with industry practices while maintaining a leaning level of transparency in line with our brand. Shifting back to our 2026 guidance, regarding the trajectory of gross margin throughout the year, we expect Q1 gross margin to decline relative to the levels we saw in 2025, driven by two factors. Number one is Q1 demand tends to be seasonally lighter, which translates to lighter manufacturing volume. Number two is we expect to see an increase in our mix of new patient starts in the pharmacy channel in Q1, as discussed earlier.

Beyond Q1, we expect gross margin to sequentially improve

Blake Beber: in each quarter throughout the year as we drive more leverage from greater scale.

Stephen H. Feider: And we generate more and more high-margin revenue from our growing pharmacy installed base. Before I hand the call back to Sean, I want to say how proud I am of this team. In just our second full year on the market, we scaled past $100,000,000 in revenue, pioneered pharmacy reimbursement for a tubed insulin pump, and made significant progress across our R&D programs. We did all that while operating with a level of cost discipline the industry simply has not seen. Energy and enthusiasm at Beta Bionics, Inc. are at their highest since joining the company. The team is filled with competitive people, all focused on winning and doing their very best for people living with diabetes.

I am excited. With that, I will hand the call back to Sean.

Sean T. Saint: Thanks, Stephen. Before I get into the innovation pipeline, I would like to address the warning letter that we received from the FDA in late January related to observations made by the agency following the inspection of our Irvine facility in June 2025. After that inspection, the agency issued us a Form 483, which we highlighted on our previous earnings call. We take the FDA's observations very seriously, and following issuance of Form 483, we immediately began remediation efforts to directly address the observations. We were disappointed to receive a warning letter, but I remain proud of the incredible work our teams are doing to address the agency's concerns and confident in our ability to resolve them.

We look forward to working together with the FDA to evolve and strengthen our quality systems and processes. I want to briefly highlight those key issues and discuss our remediation efforts in the spirit of transparency to instill confidence in the work we are doing to address the agency's concerns and ultimately close out the warning letter. First, the agency had several findings concerning our complaint handling system. Specifically, they found that our definitions of complaints that rose to the level of medical device report, or MDR, were not consistent with their expectations.

This alignment is a hard thing to do without direct feedback from the FDA, and many companies have had to work through the exact issue with the agency to get it resolved. I would like to highlight an example of what I am talking about. In the agency's view, a reportable hypoglycemia event includes those that are self-treated with glucose drinks or candies. By contrast, prior to receiving feedback from the agency, our definition of a reportable hypoglycemia event included those requiring third-party assistance, which was aligned to the ADA's definition of severe hypoglycemia.

The FDA's view that self-treated hypoglycemia should also be reported is not codified, and without direct feedback from the agency and through our collaboration, Beta Bionics, Inc. has aligned our definition of reportability with the expectations of the agency, and the warning letter seems to confirm that the agency agrees with our new criteria. These criteria often vary meaningfully between different companies in the industry, so one of the most important things that we are staying mindful of is collaboratively establishing and implementing practices that the agency agrees with specifically in the context of Beta Bionics, Inc.

Another finding in the warning letter is that certain MDRs that were previously filed or caused to be filed by this change in definition were filed after the 30-day deadline. In many cases, these late filings were caused by the change in reportability definitions. Specifically, when we remediated old complaints that were previously not reportable and later became reportable, the 30-day time clock had already expired, causing a number of late reports. Beta Bionics, Inc. believes that both our new definition as well as our new complaint handling system will eliminate this problem in the future.

We previously discussed that while we remediate our old complaints, an elevated MDR rate would be present, and this remediation would last through Q2 of this year. We are on track with this remediation and reiterate our intention to have all of our old filings fully compliant by the end of Q2. Additionally, findings in the warning letter relate to our procedures for tracking, trending, and analyzing our complaint data to ensure our product meets expectations in the field. I want to be clear on this one. We certainly had procedures, and they had been previously audited as acceptable.

But as with most things, the more you use them, the more you can identify areas for improvement, and that is what happened here. We have been working on those improvements since June and are confident through our collaboration with the agency that we will sufficiently address their observations. Another typical area that the agency had feedback on was our CAPA, corrective and preventative action, system. Again, while we had a CAPA system, the agency found areas where we could have opened a CAPA and did not, or could have done a better job with what we call VOE, or verification of effectiveness, which is the process to ensure that changes we make through the CAPA process worked.

The agency's feedback was crucial to our understanding of where our CAPA process needed to evolve, and this is another area that we have devoted a lot of attention towards remediating as it relates to the agency's observations. And lastly, the agency had feedback on our corrections and removals procedure. In today’s day and age, companies like Beta Bionics, Inc. are in the advantageous position to be able to push out software updates to our products easily with firmware-over-the-air updates. This is a benefit to our users as it allows the product to get better without users having to send it to us.

However, the FDA takes a broad view of what constitutes a safety change, and their feedback was that there were certain software updates that we had made where we should have filed a corrections and removals report. Beta Bionics, Inc. must now file all the required reports, and to be clear, these reports have to do with changes previously made to the software, and no additional changes that we are currently aware of are required. We expect the agency will be satisfied with our response to their concerns here. As many of you may have noticed, there have been several warning letters recently issued in the diabetes space.

From the limited public information available, these letters generally seem to have to do with issues concerning quality systems, indicating how challenging it can be to get these systems fully aligned with the FDA's expectations without direct feedback from the agency. While these findings are serious, we also believe that they are straightforward, and that our remediation of the systemic issues found is well underway. I am proud of our team's response to both the 483 and the subsequent warning letter, and as we previously stated, we do not believe this warning letter impacts any of our previously shared timelines. Now for the fun stuff. Let us start with an update on Mint, our patch pump in development.

I spoke earlier about our leadership in the durable pump space, propelled by our differentiated algorithm, pharmacy channel strategy, and excellent gross margin profile. We expect that Mint will enable us to extend our leadership into the broader automated insulin delivery market beyond just the durable segment. We expect Mint to be a game-changing product with an advantaged user experience, from both form factor and algorithm standpoint, relative to other patch pumps on the market or in development. Our efforts in the pharmacy channel with iLET have been critical in terms of our ability to form key relationships with PBMs and payers that we will leverage to build coverage for Mint.

In many cases, we expect that existing contracts for iLET will be amended to incorporate Mint. And in other cases where we do not yet have coverage for the iLET in pharmacy, we expect to be able to generate coverage for Mint given mechanisms for patch pump coverage already exist for the majority of payers. On gross margin, we expect Mint's design will eventually enable us to drive industry-leading gross margins for any automated insulin delivery system at scale. In Q4, we continued to make great progress on Mint, which is tracking well towards key internal milestones on the way to unconstrained commercial launch by 2027.

Our work in Q4 continued to boost our confidence in the product's merit and, ultimately, our ability to potentially obtain FDA clearance and manufacture at scale. For the bihormonal system in development, in Q4, we completed our first-in-human feasibility trial in New Zealand. This was our first time testing the entirety of the bihormonal system inclusive of our glucagon asset in humans, which represents a key milestone for the program. The trial was highly informative to our go-forward development strategy, and we continue to observe no safety signals for the glucagon asset.

As we have progressed this development program, we have also gotten greater feedback from the agency on our regulatory path to approval for the system, which can be described in development phases. We are currently in Phase 2a for the program, meaning we are conducting feasibility trials in small groups of patients to stress test the system's capabilities and iterate it accordingly. The first-in-human feasibility trial was just completed as part of Phase 2a, and we will be initiating another Phase 2a feasibility trial in the first half of this year to stress test and iterate the system further in preparation for the more advanced stages of development.

Following the completion of our upcoming Phase 2a trial, we expect to progress to Phase 2b, which we anticipate will be a much more robust feasibility trial that will enable us to advance to concurrent Phase 3 pivotal trials. This pathway does not represent a change to our development program, but rather it provides increased specificity to the expected requirements for our system to ultimately gain NDA approval for the glucagon asset and 510(k) approvals for the pump and algorithm.

We continue to be extremely excited by the bihormonal system’s potential to transform clinical outcomes for people with diabetes, but more importantly, the potential to transform the way people experience their diabetes and shift their mindset from diabetes being a disease that they manage to simply a disease that they have. Lastly, on our innovation pipeline, I want to cover type 2 diabetes. In Q3, we continued to see some health care providers prescribe iLET to their type 2 patients off label. We estimate that 25% to 30% of our new patient starts in Q4 were from type 2, increasing slightly relative to the prior quarter.

While we are not committing to a specific timeline, we remain eager to pursue the type 2 diabetes label through the FDA. To conclude our prepared remarks, I want to highlight the key message from today's call. It has been about two and a half years since we launched the iLET, and in that time, Beta Bionics, Inc. has emerged as a leader in the durable insulin pump space. Our product is exceptional, and it is changing lives. Our real-world evidence strategy is setting the gold standard for transparency in our industry, enabled by the iLET’s automation, which has been shown to improve clinical outcomes regardless of our users' baseline A1C or engagement with the product.

Our pharmacy channel strategy is making durable insulin pumps more accessible for our users than they have ever been. Our digital solutions are delivering users, their caregivers, and their providers the information and support they need to generate the best outcomes possible on our product. Our product is breaking the molds of what has historically been believed to be possible in durable pumping, and we are delivering financial results that we are proud of. But the work does not stop here. We are working to expand our capabilities to the broader automated insulin delivery market with Mint, and with the bihormonal system, we are looking to redefine how people experience their diabetes and the outcomes they can achieve.

This cohesive strategy is what defines our business and what we believe will drive our ability to succeed over the short, medium, and long term. Stay tuned. With that, thank you all for joining today's call, and we will now open the floor to Q&A.

Operator: Thank you. Press 11 again. One moment for questions. Our first question comes from David Roman with Goldman Sachs. You may

Sean T. Saint: Thanks. Good afternoon. This is Felipe Raul Lamar on for David. I want to start with the top line. Last year, you delivered north of 20% upside to your initial sales guidance for the year, despite stronger pharmacy conversion than initially anticipated. As we think about the forecast for this year, given the increasingly recurring nature of the business, our model only contemplates pretty modest new patient growth to be able to hit the high end of your guidance. I guess, could you talk a bit more about the level of conservatism still in guidance moving forward and any additional color you can give on the outlook for new patient starts embedded in this initial guidance?

Stephen H. Feider: Yeah. Hey, Felipe. This is Stephen. I appreciate the question. Hey, Stephen. Look. I do not want to call the guidance for 2026 conservative, so I am not going to use that word. I think and also, I am not going to speak to exactly the new patient starts that are embedded in the guidance. But we do, of course, have confidence in hitting the guidance that we have communicated, and then the one little extra color I would add as it relates to the revenue guidance is anytime that we have dramatically outsized performance in the pharmacy channel, meaning the percentage of new patient starts that get reimbursed in pharmacy, it creates a short-term headwind on revenue.

And so we do have to embed in our revenue guidance, knowing that we need to continue to beat or to hit the revenue guidance that we communicate.

Blake Beber: We have to be ready for the idea, the fact that

Stephen H. Feider: we could massively outperform on our pharmacy new patient starts percentage. And because of that revenue headwind, we do embed that in our 2026 revenue guide.

Felipe Raul Lamar: The gross margin guidance for the year came in a little bit light of what we were expecting given the underlying leverage seen in the back half of the year. Wondering how much of that maybe comes from your rate of pharmacy conversion

Michael K. Polark: versus underlying the direction of travel for underlying gross margins would be helpful.

Stephen H. Feider: Yeah. The point you just alluded to is really the reason for the gross margin guidance being where it is, besides the fact that, again, we like to have confidence in any particular guidance that we communicate.

Blake Beber: But in the event that we outperform on the percentage of new patient starts growth,

Stephen H. Feider: from 2025 to 2026,

Blake Beber: that, again, creates a short-term revenue headwind, but it also creates a short-term drag on our gross margin profile.

Stephen H. Feider: Because, again, in the pharmacy business model, as you know, we give away the iLET for free, and then we charge a monthly recurring revenue

Blake Beber: we generate monthly recurring revenue of around $450 for all patients that continue using the product in the pharmacy channel.

Stephen H. Feider: But, in the event that we massively outperform our guidance in 2026 in terms of pharmacy new patient starts, that can create, again, will create a short-term drag on gross margin and, hence, we are guiding gross margin where we have

Michael K. Polark: Thanks, Stephen. Thank you.

Operator: Our next question comes from Michael K. Polark with Wolfe Research. You may proceed.

Michael K. Polark: Good afternoon. Thank you for taking the questions. I am curious on the fourth quarter, just with all the focus on your starts performance up 5% sequentially, have you developed a view as to what the pump market in the U.S. starts were up, how that performed quarter over quarter? Do you have a number by chance? Obviously, your peers are still mostly to report. I am curious if you developed a thing.

Blake Beber: Yeah. Good—hey, Mike. I appreciate the question. For the reasons that you stated, because our

Stephen H. Feider: competitors have not

Blake Beber: really published their earnings, we do not have a particular perspective on

Stephen H. Feider: what our market share was in the fourth quarter and how it, what, you know, how that performed relative to Q3. So I am sorry. I do not have a take on that yet. I mean, I will wait to

Blake Beber: see our competitors' numbers.

Michael K. Polark: Fair enough. For the follow-up, maybe about 2026. I heard 20 new sales territories to be created, invested in. You know, that is over 30% growth in territories. I know it will be done over the course of the year. I know you are not going to be too precise, but can you maybe comment first half, second half centric? You know, I think I am interested in what the formal guidance has considered for the timing of those incremental territories. Thank you.

Blake Beber: Of course. The guidance is at least 20 territories we will be expanding by in 2026.

Stephen H. Feider: And there will be a large expansion in the first half of the year.

Blake Beber: I do not want to say that there will not be an expansion at some level in the second half, but much of that expansion is in the first half of the year.

Michael K. Polark: Thank you.

Operator: Thank you. Our next question comes from Mathew Blackman with TD Cowen. You may proceed.

Mathew Blackman: Good afternoon, everybody. Can you hear me okay?

Sean T. Saint: Yeah. We got you, Matt.

Operator: Great. Appreciate you taking my questions. I just want to start. I want to make sure I

Michael K. Polark: call

Operator: so correct me if I have gotten some of this wrong, but it sounds like Q1 will be down more than, let’s call it, roughly 14% quarter-over-quarter decline that you saw in 2025 versus Q4 2024.

Travis Steed: Then it sounded like 2026 should be modestly higher than

Michael K. Polark: like

Travis Steed: 41% of the full year revenue we saw in 2025. Did I capture all of that correctly? Maybe start there.

Michael K. Polark: I am sorry, Matt. Can you—you cut out a little on our end. I

Stephen H. Feider: hope it is not us, but can you repeat the second half of your question there? What I heard was

Operator: Sure.

Travis Steed: What I heard was I think my headset cut out. So, yeah, let me do it again. I apologize. It sounded like your commentary for the first quarter was that it will be down more than, I think, the roughly, let’s call it, 14% you were down in 2025 versus 2024. But then you expect that 2026 should be modestly higher than the first half revenue you saw in 2025. Did I capture that commentary correctly?

Blake Beber: You—yeah. You did, directionally. So I am going to repeat some of that back to you.

Stephen H. Feider: What we did say is that there is seasonality to the business, and this is with regards to the step change from Q4 to Q1. So there is seasonality to the insulin pump business. The biggest step change that we see in terms of seasonality in our business is from Q4 to Q1, and you should expect a reduction in revenue and new patient starts

Blake Beber: from Q4 2025 to Q1 2026. And that step change, that reduction, should be larger than what you saw

Stephen H. Feider: for both new patient starts and revenue than what you saw last year. So from, again, Q4 2024 to Q1 2025, that reduction, you should see a larger reduction from Q4 2025 to Q1 2026. And the reason for that is that there were product launches

Blake Beber: that were unique in Q4 2024, and notably the Color iLET, which created a lot of pent-up demand

Stephen H. Feider: in Q4 2024 and Q1 2025. That kind of obfuscated traditional seasonality. Again, we launched a Color iLET that was smaller, a massively different form factor. And then the second thing is that we did see a very large uptick in the percentage of new patient starts going through the pharmacy channel

Blake Beber: from Q4 2024 to Q1 2025, which created also this demand

Stephen H. Feider: improvement in those comparative periods. And we will not see the same from Q4 2025 to Q1 2026. So that is the first part of your answer—yes, and for all those reasons, I think that were important to share. The second part is, in the prepared remarks, I was just commenting on the weighting of revenue.

Blake Beber: We expect the weighting of revenue

Stephen H. Feider: to be more heavily weighted towards first half 2026 than what we saw first half 2025 weighting to be.

Blake Beber: Meaning, first half 2025 revenue divided by total year 2025 revenue—that percentage—that will be lower in 2025 than what we will see in 2026. Got it. Okay. I appreciate that.

Travis Steed: I guess the other question I wanted to ask—I do not know if you have this handy, but even if just directionally, thinking about the sales territory expansion in 2026, is there a way to, you know, roughly quantify how much of the addressable market you were able to cover in 2025, how much incremental the 20 territories would give you, again, even just directionally? And I guess maybe most important, how much of a rate limiter do you think that has been in terms of iLET adoption? And thanks so much. Appreciate it.

Blake Beber: Yeah.

Stephen H. Feider: Alright. Another good question. I think that the right number of territories in the U.S. for an insulin pump company—and this is kind of a wide range because I want to reserve the right to change as we sort of grow here—is somewhere between 120 to 180 sales territories. That is like when you have the level of

Blake Beber: sort of adoption that, in particular, like, let’s say, our patch pump competitor has, I think it is probably on the higher end of that.

Stephen H. Feider: But the point is, I think in order to cover all of the endocrinologists and high-prescribing primary care doctors in the country, you need somewhere between 120 to 180. And so for

Blake Beber: most of last year, as you know, we had 63 territories. So, obviously, the simple math is we had, you know, half to a third of the country covered. Now the reality is that our territories tended to be a little wider or a little larger. We were probably covering actually more than 33% to 50% of the entire country, but that gives you a directional understanding of, you know, how much of the country generally we were sort of addressing and then what 20 incremental territories does.

Travis Steed: Great. Really appreciate it. Thank you.

Operator: Thank you. Our next question comes from Jonathan Block with Stifel. You may proceed.

Blake Beber: Great. Thanks, guys. Good afternoon. Maybe just to pick up

Michael K. Polark: on that thread or to pull that thread a little bit. Maybe you guys can just talk to why are 20 reps the right number? Right? It takes you to the low 80s. But, Stephen, you just talked about a number 120 plus. So when I think about exiting 2026, I mean, you are that much closer to Mint, that much closer to type 2 label

Sean T. Saint: as a possibility. So maybe just talk about

Michael K. Polark: why the organization, with the balance sheet you have, would not push a little bit harder and faster when we think about the number of reps that you are unloading or plan to unload this year?

Stephen H. Feider: Yeah. Good question. And, Sean, I will start here and just tell—if you want to jump in and add a little more. Look. We, of course, have confidence in

Blake Beber: the product that we are offering. And so, you know, expansion is absolutely the intention of the company, and

Stephen H. Feider: we are underpenetrated in terms of, you know, doctors that are aware of what the iLET is and

Blake Beber: you know, having a sales rep that is communicating to them what the great clinical outcomes are for their patients. So that absolutely is true. But I also did say that we are going to expand by at least 20. So I do not want us to, you know, just anchor on, you know, on 20 as, you know, on the low end of that and say that is the only amount that will be—or that is the, like, you know, the amount that we will be limited to in 2026 in terms of expansion. And then the last point I would make is that, you know, we are anticipating, as you know, from our R&D

Stephen H. Feider: pipeline, we are anticipating future products. And Sean mentioned them

Blake Beber: in his prepared remarks. And I think, you know, embedded in sort of our plan for the sales force expansion is—you know, being a little cagey here—is sort of anticipation of future time when we have

Stephen H. Feider: another product on the market. So there is that as well.

Sean T. Saint: I will just add to that, Jon, that

Blake Beber: you know, we always believe in being deliberate.

Sean T. Saint: Right? I mean, I do not think that you can realistically launch a product, come out of the gate, hire 200 people, and field 200 fully trained people and expect that your manufacturing line can produce that many—you know, the whole bit. Right? There are so many systems, etc., that have to scale along with the number of reps. And there are a lot of opportunities to get it wrong. You know, Beta Bionics, Inc. is playing the long game here, and I do not think anybody needs us to take over the world on day one. So we are going to do this deliberately and conservatively at some level. We are going to get it right.

Michael K. Polark: Great. Thanks for that. That is helpful. Maybe just to shift, and I guess I will go there. You know, there is this hypoglycemia concerns or chatter, and it is out there. Maybe it is more Wall Street than Main Street, etc. But, you know, Sean, any data or metrics that you plan to share with the Street that might be forthcoming? And then maybe just to add on to that, I am curious in the real world or out in the field,

Jeffrey D. Johnson: what are your reps hearing or any blowback? And has that evolved in the past three or six months? Thanks for your time.

Sean T. Saint: Yeah. Fair question, Jon. First of all, in terms of data, I would point you to our current corporate deck on the website, which does speak to this. Look. You know, our best information on the iLET—and, of course, we see all of our data in our cloud—it is, etc. I will just say a few things. First of all, it is consistent with our clinical trial.

Stephen H. Feider: Right?

Sean T. Saint: We are seeing the same or even slightly lower rates of hypoglycemia that we saw in our clinical trial. It was clearly acceptable at that time. Number one. Number two, those rates of hypoglycemia seem to be roughly one-quarter to one-third of the ADA guidelines for hypoglycemia. So we are meeting that metric by 4x. Again, I will point you to our data on the corporate deck as well. But what I am telling you is, to the best of our knowledge, yes, we hear the narrative. No, we do not see some outsized hypo problem with any description. It is a true statement that people with diabetes do occasionally get low. They get low on every system.

And in fact, if you look at severe hypoglycemic events, it is roughly an order of magnitude worse than it is with iLET or other AID systems. But I do want to highlight a difference. And I believe I have talked about this before. And it is, you know, at this point what we call the Tesla effect. You know, people—there are car crashes every day. But when a Tesla crashes, it is national news. I think the data at this point is clear. Teslas are safer than the average driver. Full self-driving, of course, is what I am referring to. And yet,

Blake Beber: excuse me, and yet,

Sean T. Saint: it is national news when something happens. We do believe that there is a version of that is happening with the iLET. We have provided an increased level of automation than the world has ever seen with insulin pumps. There is very, very little to do for the user of an iLET. However, lows do still happen.

When a person chooses their dose, gives that dose, goes for a walk, gets low, they think, “Wow, I probably should not have done that.” When a user utilizes the iLET, does not choose a dose at any level, and then goes for a walk and gets low, they think, “Look at what this thing did to me.” So I think that is where that is coming from, and I think it is somewhat natural that Beta Bionics, Inc. will live that world because we are the tip of the spear in terms of automation in insulin pumps here. But, again, I will focus back on what I started my response with.

All of the data that we have published, all the data we are aware of, do not indicate any level of outsized hypo problem with the iLET.

Jeffrey D. Johnson: Very helpful. Thanks for the color, guys.

Sean T. Saint: Thank you.

Operator: Thank you. Our next question comes from Matthew Oliver O'Brien with Piper Sandler. You may proceed.

Matthew Oliver O'Brien: Afternoon. Thanks for taking the questions, and congrats on getting to $100,000,000 in sales so quickly. Maybe just to follow up on—you're welcome. Maybe follow up on Felipe’s question to start with. Just on the guide, even, you know,

Michael K. Polark: the

Matthew Oliver O'Brien: you go to the midpoint of the range, the absolute dollar number is actually lower in 2026 versus 2025. And you are getting the benefit of all these pharmacy patients from a revenue perspective here in 2026 versus 2025. So is there something else that is contemplated in here that we should be thinking about? I do not know if it is, you know, potential impact to the warning letter or competition or higher attrition because more pharmacy, anything like that specifically to call out here in terms of, you know, this initial guide versus what you kind of did on an absolute basis last year?

Stephen H. Feider: Hey, Matt. Good question, and I appreciate the congrats.

Blake Beber: In short, no.

Stephen H. Feider: There are not—there is no odd characteristics of the competitive

Blake Beber: landscape that we are particularly afraid of. We are not seeing any elements of our pharmacy business model where there is attrition that is trending any different than what we have seen. And, by the way, we have had great retention on the product.

Operator: We are just

Blake Beber: you know, setting a guide that we have confidence in and we feel good about.

Matthew Oliver O'Brien: Okay. Very fair. And then on the gross margin side, I mean, the number in Q4 is eye-popping as far as how well you did on the gross margin side. For the range that you gave for the rest of your—sorry, for 2026, you know, it just implies a pretty big step down in the first half of this year. I am just wondering if there is something maybe even in the back half that you are contemplating. I do not know. Is that—hey, we could start to see some Mint sales. Is that something that is—and then just to be specific on Mint, do you still expect to be second to market as far as patch pumps still?

Thank you.

Stephen H. Feider: Yeah. I will let you answer the question on Mint.

Blake Beber: But, yeah, as it relates to—

Stephen H. Feider: Sorry. I just lost my train of thought. Can you take the Mint question—the Mint part?

Sean T. Saint: Yeah. Sure. And to be clear, when you said “you can take the question,” I do not think he meant you. I think he meant me. Alright. So on Mint, you know, I do not recall exactly the statements we have made in the past on order of release. And I, frankly, Matt, do not remember the exact details of when all of our competitors are currently saying their products come to market. What we are doing today is reiterating our timeline of an unconstrained launch by 2027. So that is what I will commit to.

But I am not going to call our shot on exactly what position that puts us in because, frankly, we do not have visibility to what others are doing. And thanks for the eye-popping comment, by the way.

Operator: Steve.

Stephen H. Feider: Yeah. And in terms of the gross margin—the gross margin guide for the year—yeah,

Blake Beber: obviously, 59% in Q4 is a great number.

Stephen H. Feider: I think something notable about

Blake Beber: Q4 gross margin was that

Stephen H. Feider: we did not see a big uptick in the percentage of

Blake Beber: pharmacy new patient starts from Q3 to Q4 2025. But remembering that

Blake Beber: that particular metric for us is only so predictable. So, obviously, we do guide to that metric in 2026, but in the event that it outperforms our expectations, which it has the possibility to do, we have to be, you know, ready for a short-term headwind on our gross margin profile.

Stephen H. Feider: And so, hence,

Blake Beber: that is embedded in the guide. But there is nothing competitive about, you know, the product, or there is no, like, new problem, or we are not seeing an uptick in warranty

Stephen H. Feider: rates or anything of that nature. It is just, again, simply us being careful in the event that, you know, a particular metric

Blake Beber: outperforms what we have communicated.

Operator: Got it. Thank you.

Operator: Thank you. Next question comes from Mike Kratky with Leerink Partners. You may proceed.

Mike Kratky: Everyone, thanks for taking our questions. Maybe just to start, you know, now that we are more than halfway through the first quarter, can you share any qualitative or quantitative commentary around what you have seen so far year to date in terms of new starts and if that is aligned with your expectations on seasonality and your outlook for the sequence from Q4 to Q1?

Blake Beber: Yeah.

Stephen H. Feider: Yeah. I guess I am going to kind of repeat

Blake Beber: something I already had communicated. So, sorry, this is just a regurgitation, Mike. Although I do certainly appreciate the question. So as it relates to the first quarter,

Blake Beber: there absolutely is seasonality in the insulin pump business.

Stephen H. Feider: And where we see the largest step change in seasonality is from the fourth quarter to the first quarter.

Blake Beber: And so you should expect, or expect, a reduction in

Stephen H. Feider: revenue and new patient starts from Q4 2025 to Q1 2026, and you should expect that reduction in new patient starts in particular to be larger than what we saw

Blake Beber: in the—what we saw in last year's reduction. So last year's reduction was a 6% reduction, and for reasons that I have already communicated regarding new product launches and the

Stephen H. Feider: change in pharmacy adoption,

Blake Beber: you should expect our reduction to be in excess of that 6%.

Mike Kratky: Understood. Thanks, Stephen. And just a follow-up. You know, I think one thing that stood out in the guidance is that 36% to 38% of expected pharmacy mix. So, you know, to get to the upper end of that range exiting this year in the low thirties, is it fair to think that you could be above 40%? And what needs to happen in order to achieve that?

Blake Beber: Yeah. Look. I do not want to call it, like, a number above our guide. Obviously, we guide to the 36% to 38% for a reason, but what would have to happen for us to outperform that—and, by the way, that is, of course, possible—is, first of all, we need PBM agreements, which we have almost over 80% of all lives in the country covered under a PBM agreement. So, for the most part, that is a green checkbox. And then next, we need the underlying health plans associated with those PBMs.

Stephen H. Feider: We need an underlying agreement with those, and that is where the lion's share of the work still is left to grow our pharmacy adoption from where it is today

Blake Beber: to becoming

Stephen H. Feider: mostly or all a pharmacy-reimbursed product. But in terms of specifics, I mean, we have some Medicaid contracts, or some Medicaid programs, or states where we are seeing Medicaid coverage, and we can continue to grow more of those state adoptions for Medicaid. And then, you know, underlying plan agreements, again, associated with the already existing PBM contract that we have. It absolutely is possible for us to outperform the guide.

Sean T. Saint: Understood. Thanks very much. We will remind everybody that the things do tend to be a little front-half weighted. They do happen throughout the year, but it does tend to occur a little heavier in the front half of the year.

Operator: Thank you.

Operator: Our next question comes from

Operator: Richard Newitter with Truist Securities. You may proceed.

Operator: Hey. This is Felipe on for Rich. I guess, just to follow up on Mint,

Michael K. Polark: you guys are clearly

Frank James Takkinen: guiding to a step-up of CapEx spend for the platform and other things. So I am just wondering if you could maybe just give any update on, like, where you are at on the checklist before submission. Any color would be helpful.

Sean T. Saint: Yeah. Sorry, Felipe. I do not think we are going to go beyond what we have said in prepared remarks in terms of exact status and Mint at this point. I am

Operator: sorry.

Frank James Takkinen: No, no, no problem. And then just to follow up on pharmacy, you know, you guys have a bunch of competitors now that are durable competitors who are starting to make progress in the channel. I am just wondering, one, how you are seeing any impact to your contract—like, conversations with PBMs? And then, two, I guess, like, if there are more low-cost durable pump options, how does that maybe potentially impact you competitively on the go forward? Thanks so much.

Sean T. Saint: I would like to start this one, and maybe you could provide some color, Stephen. I would say that the conversations are evolving slightly in that you are right—there are more people out there, more durable pump companies now knocking on the doors. And from my perspective, that is a positive because it is providing an expectation that this is exactly how these things are covered. Beta Bionics, Inc. was, you know, the company to go out and start this conversation, and we were pretty successful doing it.

Blake Beber: But

Sean T. Saint: everybody following along—it is just a bit of a tidal wave of momentum that is going to help the entire industry move there.

Michael K. Polark: And

Sean T. Saint: to the extent that pharmacy is a competitive advantage, we love that. But the reality is, it is an improved business model to allow, you know, these companies to operate better and a better experience for our users. So we are happy to have pioneered that, and we are happy to have more momentum moving in that direction. So that is the color. Stephen, anything to add to that?

Blake Beber: I think well said.

Operator: Thank you.

Operator: Our next question comes from Jeffrey D. Johnson with Baird. You may proceed.

Jeffrey D. Johnson: Yes. Thanks. Good afternoon, guys. You have got me to go

Jeffrey Scott Cohen: to the territory question. I know a few questions that I have here on it. But, you know, as we track some of the metrics for you guys, it does look like you maybe—and I will stress the word maybe—hired 40 or so new sales reps that would cover about 20 territories just in the last couple months. And, again, you know, our visibility of it is not clear on that by any means. But I guess, Sean, I would love to hear you—and I do have one follow-up question then—but I would love to hear from you how much of that was maybe backfilling reps?

We have actually lost one or two of your reps that we have talked to over the last year, year and a half. So it feels like maybe there has been a little bit of rep departure, but how much of that was backfilling reps versus hiring and expanding territories over the last couple months?

Sean T. Saint: Yeah, Jeff. Thanks for the question. I am not going to comment on exactly how many people we have hired recently. Just not going to do it. What I will say is we are always hiring backfills at some level. In any group of, you know, like I said, 63 territories to 126 people, whatever that is, you are going to have turnover for multiple reasons. Some for performance, some for, you know, other jobs that were offered, what have you. And you are always going to be backfilling. So there is some of that going on at all times.

I am not going to comment on exactly how many we may have hired outside of that group, or even in that group, recently.

Jeffrey Scott Cohen: Yeah. Fair enough. And—Stephen, go ahead.

Stephen H. Feider: Understood. Yeah. No. Stephen, maybe clarifying for you. You talked about $1,000,000 pull forward in the PBM channel—or the pharmacy channel, I am sorry—from Q1 into Q4. I think it is—I cannot remember the conversation with you or else over the last month or so as we kind of were trying to calibrate our 2026 model. It sounded like there was going to be maybe $10,000,000 to $12,000,000 in additional stocking in 2026, mostly in supplies, some in pump. Is that still the right number to be thinking about as a component of your revenue guidance for 2026? And how would that $10,000,000 to $12,000,000—if we are ballpark accurate—compare to maybe total stocking you saw in 2025?

Blake Beber: Yeah. I actually do not—I do not think I have ever communicated any particular number on what the stocking dynamic would be for 2026 in terms of dollars. So the $10,000,000 to $12,000,000 actually is not—

Stephen H. Feider: it is not, it would not be even directionally accurate. So in terms of—

Blake Beber: yeah. I guess that number is not accurate, and I do not really want to comment on

Operator: it. Okay. Thanks.

Operator: Thank you. Our next question comes from Travis Steed with Bank of America Securities. You may proceed.

Travis Steed: Hey. Thanks for taking the question. I guess, just want to make sure we have got Street models in the right place. I see $27,000,000 in Street models for Q1.

Blake Beber: Taking all the comments you have given, is that kind of the right place to be? Or does that need to move one way or the other? Yeah. That is directionally accurate.

Travis Steed: Okay. And then gross margin, I think at 54 in Q1, is that the right place to be roughly as well?

Stephen H. Feider: I do not want to comment specifically on any quarterly guidance as it relates to margin.

Travis Steed: Okay. Thank you. And there were some comments on stepping up

Blake Beber: OpEx as a percent of sales in 2026. Just wanted to—trying to think about how much of that is R&D, sales and marketing versus G&A, and how much of that is pipeline versus kind of sales force expansion, and any color on how that kind of rolls out. Yeah. I do not want to—I am not going to give you numeric

Stephen H. Feider: answers for how much to expand

Blake Beber: sales or each of those particular line items, but the most notable expansions

Stephen H. Feider: in terms of OpEx will be, number one, to sales and marketing for reasons that we discussed already with the sales force expansion, but we are also going to see a pretty dramatic uptick in investments in marketing, notably some direct-to-consumer advertising, and some marketing branding for direct-to-patient initiatives. And then the second thing relates to—the other line item to comment on is with regards to R&D investments. And

Blake Beber: there are various projects that Sean outlined in his prepared remarks that we are working on.

Stephen H. Feider: And as a result of those particular projects, notably the bihormonal program and Mint, you will see an uptick in R&D expense in

Blake Beber: 2026. That is pretty meaningful from 2025. And then G&A will show a very mild increase.

Operator: Okay. Thanks a lot. Yep. Good question. Thanks, Travis.

Operator: Thank you. Our next question comes from Frank Takkinen with Lake Street Capital Markets. You may proceed.

Sean T. Saint: Great. Thank you for taking the questions. I have one follow-up on pharmacy channel starts related to the 36% to 38% guidance. How should we think about that cadencing? Is there an element of DME having more pronounced seasonality in Q1, potentially resulting in that pharmacy channel start number actually starting higher in Q1 and then kind of staying flat throughout the year? Or is that not

Frank James Takkinen: a phenomenon that occurs?

Sean T. Saint: Want me to take that one? Sure. Yeah. That is a really good question. Unfortunately, it layers a couple things on top of one another that make it a little bit hard to answer. So let me talk about seasonality for a quick moment. Historically, seasonality in DME was a question of, you know, early in the year, you have this big co-pay. Eventually, you start meeting your co-pays; it gets cheaper to get a pump. So people were waiting to get that pump till later in the year. Now, with pharmacy being available all year round with certain competitors, we think that the waiting aspect has gone away.

Instead of waiting for one pump, you would just get a different pump right now. So that decreases the vast increases at the end of the year that we see. However—and this is associated with your question—Q1, you are still going to see a drop because you do still see resets of deductibles. So people who would have come to you in, let’s say, December, been able to get the pump for relatively zero out-of-pocket cost, may, in January, have a higher out-of-pocket cost. So that is why the pronounced drop in January. Excuse me. Sorry. And I am losing my question. Hold me up. Yeah. Any—I guess, Frank, does that make sense? Yeah. That is sort of helpful.

I think the—really, that concept of just DME starting at a higher—or, sorry, pharmacy starting at a higher percent of total

Michael K. Polark: in Q1 and then kind of staying flat, or, like, how does that

Sean T. Saint: new pharmacy start trend throughout the—Right. Alright. Thanks for the reminder, Frank. So pharmacy coverage goes up earlier in the first half—or more in the first half of the year—than it does the second half of the year. Right? So that is going to be one layer. Additionally, you are right. Likely a higher percentage in Q1, holding everything else constant, would go through pharmacy because of the DME decisions being made. So those two things layer in. But, again, it is not unlike seasonality we have talked about in the past. There is more than one thing causing that. I think it becomes kind of hard to predict. But, directionally, yes.

You should probably see a higher per—well, anyway, those two things are on top of one another. Hopefully, that makes sense. Yeah. That is great. Thanks. And then just one quick follow-up. Just can you talk about the Phase 2b a little bit more? I heard the prepared remarks, but maybe what are you looking for exactly in that Phase 2b before kicking off the pivotal? Yeah. From Beta Bionics, Inc.’s side, the Phase 2b is primarily about confidence that when we get into the pivotal, we are going to have success.

You know, over the course of Beta Bionics, Inc.’s history with the bihormonal trial—and this has been true all the way from, I do not know, 2007 till now—all of the trials that we have run, all of the formative trials that we have run that we now call 2a trials, were very, very small. And, you know, we have published a bunch in the past. I will not rehash it now. It can be very difficult to extrapolate the results of a, you know, several-hundred-patient, year-long clinical trial from a very short, small-N trial.

So it is a bit of a diligence item to walk before you run and just step up and make sure we are not going to get to an enormous trial and really fail. So that is primarily what that is about. And the agency would have slightly different words for that. I think at the end of the day, it would be similar reasoning. Okay. That is helpful. Thanks for taking the questions.

Operator: Thank you.

Operator: Our next question comes from Danielle Antalffy with UBS. You may proceed.

Travis Steed: Hey. Good afternoon, guys. Thanks so much for

Kelly Close: taking the question. Just a question here on type 2. And less about the timeline for approval, etc., but just at a high level, how you guys think about that market as you already see adoption of iLET in type 2. We hear that is the very pump for type 2 patients. So go-to-market strategy in that patient population probably a little bit different than type 1, particularly given where these patients are managed. So I am just curious about how you guys are thinking about that ahead of a potential FDA approval there and, you know, sort of really getting after that. Thanks so much.

Sean T. Saint: Yeah. Good question, Danielle. And I think you just identified the right point there, which is where the patients are managed. And I think what I will illustrate—and I think you know this from your very question—is that in the endocrinology space, the health care providers have proved to be quite mature and understanding of what the iLET is and other products are. And they know where they can be utilized. And that is exactly what we are seeing across the different devices. In the primary care space, that is probably going to be less true.

And so I think it does become more important that, you know, type 2 indications are there by the time we start to market meaningfully in the primary care space, which we have already said that we do not have a primary care sales force at this point. So, and the way we intend to do that is a little bit different. But I do agree that a type 2 indication is, you know, going to be extremely important there because—well, for the reasons that you implied. So we are aware of that dynamic.

Operator: Thank you.

Blake Beber: And, Danielle, thanks for launching coverage on us. Great work.

Kelly Close: Thanks for all the help.

Operator: Thank you. And as a reminder, to ask a question, please press—Our next question comes from Jeffrey Scott Cohen with Ladenburg Thalmann and Company.

Jeffrey Scott Cohen: Hi. Thanks for taking the questions. I wonder if you could dive into R&D a little bit as far as 2026,

Jeffrey Scott Cohen: with regard to cadence or throughout the year. I know you called out just an incremental increase across the board.

Blake Beber: Yeah. So, yeah, I want to speak specifically on what timing of the investments you will see in R&D, but generally, Jeff, you can expect

Stephen H. Feider: consistent investments, consistent pattern of investments throughout the year. There may be some

Blake Beber: lumpiness when we, you know, say, start trials or the like. But I would not model anything, you know, more heavily, significantly heavily weighted in one quarter or another.

Jeffrey Scott Cohen: Okay. Thanks. That is helpful. And do you recall maybe taking some pricing in the pharmacy channel? Any plans for the DME channel, or what are you expecting on pricing throughout the year?

Blake Beber: Yeah. As we alluded to, we took a small or a low single-digit price increase in pharmacy for our supply revenue, and then no change to your modeling for DME revenue price.

Jeffrey Scott Cohen: Perfect. Thanks for taking our questions.

Blake Beber: Yeah. Appreciate it, Jeff.

Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

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