Q4 2025 Beta Bionics Inc Earnings Call

February 17, 2026

Operator: Good day, and thank you for standing by. Welcome to the Beta Bionics Inc. Q4 and full year 2025 earnings conference call and webcast. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question-and-answer session. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. I would now like to hand the conference over to your speaker today, Blake Beber, Head of Investor Relations.

Speaker #1: At this time, all participants are in a listen-only mode. This call is being recorded. After the speakers' presentation, there will be a question-and-answer session. To ask a question, please press *11 on your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press *11 again. I would now like to hand the conference over to your speaker today, Blake Beber, Head of Investor Relations.

Speaker #2: Good afternoon, and thank you for tuning in to Beta Bionics' fourth quarter and full year 2025 earnings call. Joining me for today's call are Chief Executive Officer Sean Saint and Chief Financial Officer Stephen Feider.

Blake Beber: Good afternoon, and thank you for tuning in to Beta Bionics' Q4 and Full Year 2025 Earnings Call. Joining me for 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 Q4 and full year 2025 results will be available on the investor relations section of our website. The replay will be available for approximately 1 year following the conclusion of this call. Information recorded on this call speaks only as of today, 17 February 2026. Therefore, if you are listening to any replay, time-sensitive information may no longer be accurate. Also on our website is our supplemental Q4 2025 earnings presentation and updated corporate presentation. We encourage you to refer to those documents for a summary of key metrics and business updates.

Speaker #2: 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.

Speaker #2: 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, February 17, 2026.

Speaker #2: 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.

Speaker #2: 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.

Blake Beber: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Blake Beber: Today's discussion will also include references to non-GAAP financial measures with respect to our performance, namely Adjusted EBITDA. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution, independently, or superior to 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'd now like to turn the call over to Sean.

Speaker #2: We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution, independently or superior to results prepared in accordance with GAAP.

Speaker #2: 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.

Speaker #2: With that, I'd now like to turn the call over to Sean.

Speaker #3: Thanks, Blake. Good afternoon, everyone, and thank you for joining. With this call, we're officially turning the page on our first full year as a public company.

Sean Saint: Thanks, Blake. Good afternoon, everyone, and thank you for joining. With this call, we're officially turning the page on our first full year as a public company. It's been an exciting year, to say the least, 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 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 US. Our performance over the last year is strongly indicative that we're on the right track.

Speaker #3: It's been an exciting year, to say the least, 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.

Speaker #3: Beta Bionics 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.

Speaker #3: Our performance over the last year is strongly indicative that we're on the right track. On our first earnings call, we shared our key targets for the full year 2025, and as we'll highlight in more detail shortly, we outperformed substantially on each of those metrics.

Sean Saint: On our first earnings call, we shared our key targets for the full year 2025, and as we'll 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 competitors, 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.

Speaker #3: 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.

Speaker #3: We added those users with what we believe is a substantially smaller sales force than our competitors, which we believe, on a per-territory basis, made our sales reps potentially the most productive in the durable pumps market in 2025.

Speaker #3: 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.

Speaker #3: We continue to lead from the front on our pharmacy channel strategy for durable pumps, and have established formulary agreements with all the major pharmacy benefit managers, or PBMs, that operate in the U.S.

Sean Saint: We continued to lead from the front on our pharmacy channel strategy for durable pumps and established formulary agreements with all the major pharmacy benefit managers, or PBMs, that operate in the US. 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, especially considering the success that we've seen in the pharmacy channel, which had a short-term dilutive effect on gross margin in 2025.

Speaker #3: 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 Eyelet and its related consumables for significantly lower out-of-pocket costs.

Speaker #3: We also believe our gross margin profile is already the strongest in the durable pump space, as evidenced by our performance this year—especially considering the success that we've seen in the pharmacy channel, which had a short-term dilutive effect on gross margin in 2025.

Speaker #3: 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.

Sean Saint: 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 bi-hormonal system and development. I'm proud of all we've 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. We have lots of ground to cover on today's call, beginning with our Q4 and full year 2025 results.

Speaker #3: We also completed our first clinical trials as a drug company, executing a PKPD trial for our glucagon asset and a first-in-human feasibility trial for the entirety of our bihormonal system in development.

Speaker #3: I'm proud of all we've 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.

Speaker #3: We have lots of ground to cover on today's call, beginning with our fourth quarter and full year 2025 results. Stephen will then provide some additional detail on our fourth quarter performance before introducing our guidance for the full year 2026.

Sean Saint: Stephen will then provide some additional detail on our Q4 performance before introducing our guidance for full year 2026. I'll wrap up the call with regulatory and pipeline updates, and then we'll take Q&A. Starting with a brief overview of full year 2025 performance, I'm proud to announce that we delivered $100.3 million 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 20s percentage for the full year of 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.

Speaker #3: I'll wrap up the call with regulatory and pipeline updates, and then we'll take Q&A. Starting with a brief overview of full-year 2025 performance, I'm proud to announce that we delivered $100.3 million in net sales, which grew 54% year over year.

Speaker #3: Our gross margin of 55.4% expanded slightly year over year, while our percentage of new patient starts through pharmacy grew to a high-20s percentage for the full year 2025, relative to a high single-digit percentage in the prior year.

Speaker #3: To put it simply, these are excellent results. The Eyelet 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.

Sean Saint: 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're quickly innovating the business model for durable insulin pumps, and we're remaining disciplined in our execution and cost control. Diving into Q4 results, specifically, we generated $32.1 million 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're retaining at a high level.

Speaker #3: Beyond the product, we're quickly innovating the business model for durable insulin pumps, and we're remaining disciplined in our execution and cost control. Diving into Q4 results specifically, we generated $32.1 million in net sales, which represents 57% growth year over year.

Speaker #3: 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.

Speaker #3: Number two is our growing installed base of users, accessing their monthly supplies for the iLet through the pharmacy channel, whom we're retaining at a high level.

Speaker #3: 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.

Sean Saint: Number three is modest favorability and 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 million 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 30s 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. Our gross margin in Q4 was 59%, expanding 179 basis points year-over-year.

Speaker #3: In pharmacy, in particular, we saw a modest pull-forward of about $1 million of stocking orders from Q1 into Q4, ahead of price increases that were implemented at the end of the year in that channel.

Speaker #3: In Q4, a low 30% 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.

Speaker #3: Our gross margin in Q4 was 59%, expanding 179 basis points year over year. Gross margin expansion is being driven by the benefits of increased scale in manufacturing volume, leverage, greater contribution of high-margin revenue from our growing pharmacy installed base, and continued cost discipline.

Sean Saint: 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'll hand the call over to Stephen to provide some additional color on our fourth quarter performance and introduce our full year 2026 guidance. Stephen?

Speaker #3: With that, I'll hand the call over to Stephen to provide some additional color on our fourth quarter performance and introduce our full-year 2026 guidance.

Speaker #3: Stephen?

Speaker #2: Thanks, Sean. Our Q4 revenue, pharmacy mix, and gross margin results exceeded our guidance across the board. While we don't 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.

Stephen Feider: Thanks, Sean. Our Q4 revenue, pharmacy mix, and gross margin results exceeded our guidance across the board. While we don't 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 purchased later in the year through the DME channel.

Stephen Feider: 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 purchased later in the year through the DME channel. Since 2023, the majority of new pump users in the US 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 enables us to compete for those new users and is a key reason why we've seen great adoption of the iLet throughout the year.

Speaker #2: Since 2023, the majority of new pump users in the US have acquired their device through the pharmacy channel, where the majority of users can initiate and maintain therapy for under $50 per month.

Speaker #2: 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.

Speaker #2: Our pharmacy channel strategy enables us to compete for those new users and is a key reason why we've seen great adoption of the iLet throughout the year.

Speaker #2: In Q4, approximately 69% of our new patient starts came from people with diabetes who used multiple daily injections prior to starting the iLet. This is an important representation of how much the iLet is expanding the market for insulin pumps and addressing an unmet need.

Stephen Feider: 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 install base, which generates high margin recurring revenue and 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.

Speaker #2: 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.

Speaker #2: Number one, growth in the pharmacy installed base, which generates high-margin, recurring revenue and 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.

Speaker #2: Total operating expenses in the fourth quarter were $35.1 million, an increase of 42% compared to $24.7 million in the fourth quarter of 2024.

Stephen Feider: Total operating expenses in the fourth quarter were $35.1 million, an increase of 42% compared to $24.7 million in the fourth quarter of 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 bi-hormonal 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 31 December 2025, we have approximately $265 million 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.

Speaker #2: 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.

Speaker #2: The increase in R&D expenses relative to the prior year is driven by the iLet and by hormonal projects. The increase in G&A expenses relative to the prior year is driven by new costs related to operating as a public company.

Speaker #2: As of December 31, 2025, we have approximately $265 million 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.

Speaker #2: I'd now like to introduce our full-year 2026 guidance. Starting with revenue, we expect to generate $130 million to $135 million of revenue in 2026.

Stephen Feider: I'd now like to introduce our full year 2026 guidance. Starting with revenue. We expect to generate $130 million to $135 million 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 continue to expand the pump market while taking market share, 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.

Speaker #2: 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%.

Speaker #2: Our revenue guidance contemplates our expectations for the iLet to continue to expand the pump market while taking market share. We expect stable and strong patient retention in both the DME and pharmacy channels.

Speaker #2: 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 Salesforce throughout the year.

Stephen Feider: 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 growing pharmacy install base. Another key variable that could impact our gross margin performance is our pharmacy mix of new patient starts, where 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 relative to the prior year.

Speaker #2: 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 our growing pharmacy install base.

Speaker #2: Another key variable that could impact our gross margin performance is our pharmacy mix of new patient starts, where meaningful changes from one quarter to the next can have a material impact on our near-term gross margin.

Speaker #2: A quick comment on operating expenses and CapEx. For 2026, we expect OPEX and CapEx to increase as a percentage of revenue relative to the prior year.

Speaker #2: We expect both sales and marketing and R&D spend to accelerate on a year-over-year basis, driven by Salesforce expansions as well as MINT and by hormonal costs, respectively.

Stephen 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, while 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.

Speaker #2: 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.

Speaker #2: As I mentioned earlier, while 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.

Speaker #2: 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.

Speaker #2: As a result, the pool of patients initiating therapy through the medical benefit is typically larger in the back half of the year, especially relative to Q1.

Stephen Feider: As a result, the pool of patients initiating therapy through the medical benefit is typically larger in the back half of the year, especially relative to Q1. In Q1 of 2025, we were able to partially offset this typical Q1 seasonality headwind for 2 primary reasons. Number 1, 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 2, 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.

Speaker #2: In Q1 of 2025, 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 Eyelet, Bionic Circle, and the Libre 3 Plus integration.

Speaker #2: 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.

Speaker #2: While we continue to view Eyelet as highly competitive in the market, we do not expect Q1 2026 to benefit from the same level of tailwinds.

Speaker #2: We do 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 in pharmacy coverage expansion as we experienced in Q1 2025.

Stephen Feider: 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 in 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 the first half of 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.

Speaker #2: Stepping back from Q1, we expect full-year 2026 revenue to be slightly more weighted toward the first half of the year compared to 2025.

Speaker #2: In the first half of 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.

Speaker #2: 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 than what we saw in early 2025.

Stephen Feider: However, we expect the magnitude of the shift to be more modest than what we saw in early 2025. As a result, we expect a modestly higher revenue weighting in the first half of 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'd like to address our approach to the new patient starts disclosure going forward.

Speaker #2: As a result, we expect a modestly higher revenue weighting in the first half of 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 Salesforce.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: With that in mind, I'd like to address our approach to the new patient starts disclosure going forward. Since our IPO, we have provided exact new patient starts figures 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.

Stephen Feider: Since our IPO, we have provided exact new patient starts figures 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 leading level of transparency in line with our brand.

Stephen Feider: We will continue to evaluate our disclosure strategy to align with industry practices while maintaining a leading 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 the second half of 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 in each quarter throughout the year as we drive more leverage from greater scale, and we generate more and more high-margin revenue from our growing pharmacy install base.

Speaker #2: 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 the second half of 2025, driven by two factors.

Speaker #2: 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.

Speaker #2: Beyond Q1, we expect gross margin to sequentially improve in each quarter throughout the year, as we drive more leverage from greater scale, and we generate more and more high-margin revenue from our growing pharmacy install base.

Speaker #2: 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 million in revenue, pioneered pharmacy reimbursement for a tubed insulin pump, and made significant progress across our R&D programs.

Stephen Feider: 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 million 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 hasn't seen. Energy and enthusiasm at Beta Bionics 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'm excited. With that, I'll hand the call back to Sean.

Speaker #2: We did all that while operating with a level of cost discipline the industry simply hasn't seen. Energy and enthusiasm at Beta Bionics are their highest since joining the company.

Speaker #2: The team is filled with competitive people, all focused on winning and doing their very best for people living with diabetes. I'm excited. With that, I'll hand the call back to Sean.

Speaker #1: Thanks, Stephen. Before I get into the innovation pipeline, I'd 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 of 2025.

Sean Saint: Thanks, Stephen. Before I get into the innovation pipeline, I'd 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 of 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 the issuance of the 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.

Speaker #1: After that inspection, the agency issued us a Form 43, which we highlighted on our previous earnings call. We take the FDA's observations very seriously and, following issuance of the Form 43, we immediately began remediation efforts to directly address the observations.

Speaker #1: 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.

Speaker #1: 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 a spirit of transparency, and to instill confidence in the work we're doing to address the agency's concerns and ultimately close out the warning letter.

Sean Saint: I want to briefly highlight those key issues and discuss our remediation efforts in the spirit of transparency, and to instill confidence in the work we're 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'd like to highlight an example of what I'm talking about. In the agency's view, a reportable hypoglycemia event includes those that are self-treated with glucose drinks or candies.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: I'd like to highlight an example of what I'm talking about. In the agency's view, a reportable hypoglycemia event includes those that are self-treated with glucose drinks or candies.

Speaker #1: By contrast, prior to receiving feedback from the agency, our definition of a reportable hypoglycemia event included only those requiring third-party assistance, which was aligned to the ADA's definition for severe hypoglycemia.

Sean Saint: By contrast, prior to receiving feedback from the agency, our definition of a reportable hypoglycemia event included only 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 isn't codified to us without direct feedback from the agency and through our collaboration. Beta Bionics has aligned our definition of reportability with the expectations of the agency, and the warning letter seemed 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're staying mindful of is collaboratively establishing and implementing practices that the agency agrees with, specifically in the context of Beta Bionics.

Speaker #1: The FDA's view that self-treated hypoglycemia should also be reported isn't codified to us without direct feedback from the agency and through our collaboration. Beta Bionics has aligned our definition of reportability with the expectations of the agency, and the warning letter seemed to confirm that the agency agrees with our new criteria.

Speaker #1: These criteria often vary meaningfully between different companies in the industry. So one of the most important things that we're staying mindful of is collaboratively establishing and implementing practices that the agency agrees with, specifically in the context of Beta Bionics.

Speaker #1: 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.

Sean Saint: 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 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're on track with this remediation and reiterate our intention to have all of our old filings fully compliant by the end of Q2.

Speaker #1: 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.

Speaker #1: Beta Bionics 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.

Speaker #1: We're 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.

Sean Saint: 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's what happened here. We've 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 or Corrective and Preventative Action system.

Speaker #1: 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's what happened here.

Speaker #1: We've been working on those improvements since June, and are confident, through our collaboration with the agency, that we will have sufficiently addressed their observations.

Speaker #1: Another typical area that the agency had feedback on was our CAPA, or 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.

Sean Saint: Again, while we had a CAPA system, the agency found areas where we could have, 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 was another area that we've devoted a lot of attention towards remediating as it relates to the agency's observations. Lastly, the agency had feedback on our corrections and removals procedure. In today's day and age, companies like Beta Bionics are in the advantageous position to be able to push out software updates to our products easily with firmware over-the-air updates.

Speaker #1: The agency's feedback was crucial to our understanding of where our CAPA process needed to evolve, and this was another area that we've devoted a lot of attention toward remediating, as it relates to the agency's observations.

Speaker #1: And lastly, the agency had feedback on our corrections and removals procedure. In today's day and age, companies like Beta Bionics are in the advantageous position to be able to push out software updates to our products easily with firmware over-the-air updates.

Speaker #1: 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 removal report.

Sean Saint: 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 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.

Speaker #1: Beta Bionics must now file all the required reports, and to be clear, these reports have to do with changes previously made to the software. No additional changes that we are currently aware of are required.

Speaker #1: 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.

Speaker #1: 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.

Sean Saint: 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'm proud of our team's response to both the 43 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's 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.

Speaker #1: 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'm 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.

Speaker #1: Now for the fun stuff. Let's 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.

Speaker #1: 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 a form factor and algorithm standpoint, relative to other patch pumps on the market or in development.

Sean Saint: 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 advantage user experience from both a 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'll 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 don't 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.

Speaker #1: Our efforts in the pharmacy channel with ILIT 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.

Speaker #1: In many cases, we expect that existing contracts for ILIT will be amended to incorporate Mint, and in other cases where we don't yet have coverage for the ILIT 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.

Speaker #1: 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 continue to make great progress on Mint, which is tracking well towards key internal milestones on the way to unconstrained commercial launch by the end of 2027.

Sean Saint: 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 the end of 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 our bihormonal system and 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.

Speaker #1: 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.

Speaker #1: For our 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.

Speaker #1: 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've progressed this development program, we've also gotten greater clarity from the agency on our regulatory path to approval for the system.

Sean Saint: As we've progressed this development program, we've also gotten greater clarity from the agency on our regulatory path to approval for the system, which can be described in development phases. We're currently in phase IIa 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 IIa, and we'll be initiating another phase IIa 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 IIa trial, we expect to progress to phase IIb, which we anticipate will be a much more robust feasibility trial that will enable us to advance to concurrent phase III pivotal trials.

Speaker #1: Which can be described in development phases. We're 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.

Speaker #1: The first in-human feasibility trial was just completed as part of Phase 2A. We'll 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.

Speaker #1: 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.

Speaker #1: This pathway doesn't 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.

Sean Saint: This pathway doesn't 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 healthcare 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.

Speaker #1: 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.

Speaker #1: Lastly, on our innovation pipeline, I want to cover type 2 diabetes. In Q3, we continued to see some healthcare providers prescribe ILIT to their type 2 patients off-label.

Speaker #1: We estimate that 25% to 30% of our new patient starts in Q4 were from type 2, increasing slightly relative to the prior quarter.

Speaker #1: While we're 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.

Sean Saint: While we're 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's been about 2.5 years since we launched the iLet, and in that time, Beta Bionics has emerged as a leader in the durable insulin pump space. Our product is exceptional, and it's 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've ever been.

Speaker #1: It's been about two and a half years since we launched the ILIT, and in that time, Beta Bionics has emerged as a leader in the durable insulin pump space.

Speaker #1: Our product is exceptional, and it's changing lives. Our real-world evidence strategy is setting the gold standard for transparency in our industry. Enabled by the ILIT’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've ever been.

Speaker #1: 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.

Stephen Feider: ... 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 is historically believed to be possible in durable pumping, and we're delivering financial results that we're proud of. But our work doesn't stop here. We're working to expand our capabilities to the broader automated insulin delivery market with Mint, and with the bi-hormonal system, we're 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'll now open the floor to Q&A.

Sean Saint: ... 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 is historically believed to be possible in durable pumping, and we're delivering financial results that we're proud of. But our work doesn't stop here. We're working to expand our capabilities to the broader automated insulin delivery market with Mint, and with the bi-hormonal system, we're 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'll now open the floor to Q&A.

Speaker #1: Our product is breaking the molds of what has historically been believed to be possible in durable pumping, and we're delivering financial results that we're proud of.

Speaker #1: But our work doesn't stop here. We're working to expand our capabilities to the broader automated insulin delivery market with Mint and with the bihormonal system.

Speaker #1: We're 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.

Speaker #1: Stay tuned. With that, thank you all for joining today's call, and we'll now open the floor to Q&A.

Speaker #2: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from David Roman with Goldman Sachs. You may proceed.

Speaker #2: One moment for questions. Our first question comes from David Roman with Goldman Sachs. You may proceed.

Speaker #3: Thanks. Good afternoon. This is Phil on for David. I want to start with the top line. Last year, you delivered north of 20 percent upside to your initial sales guidance for the year.

[Analyst] (Goldman Sachs): Thanks. Good afternoon. This is Phil 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, you know, despite stronger pharmacy conversion than initially anticipated. As we think about the forecast for this year, you know, 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 that's still in guidance moving forward, and any additional color you can give on the outlook for new patient starts embedded in this initial guidance?

Phil Coover: Thanks. Good afternoon. This is Phil 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, you know, despite stronger pharmacy conversion than initially anticipated. As we think about the forecast for this year, you know, 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 that's still in guidance moving forward, and any additional color you can give on the outlook for new patient starts embedded in this initial guidance?

Speaker #3: 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.

Speaker #3: I guess could you talk a bit more about the level of conservatism that's still in guidance moving forward, and any additional color you can give on the outlook for new patient starts embedded in this initial guidance?

Speaker #4: Yeah. Hey, Phil. This is Steven. Appreciate the question. Okay. I don't want to call the guidance for 2026 conservative, so I'm not going to use that word.

Stephen Feider: Yeah. Hey, Phil, this is Stephen. Appreciate the question. Look, I don't want to call the guidance for 2026 conservative, so I'm not going to use that word. I think - and also, I'm 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've 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, we need to continue to beat, to, to hit the revenue guidance that we communicate.

Speaker #4: I think, and also, I'm 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've communicated.

Speaker #4: 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.

Speaker #4: 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. We have to be ready for the fact that we could massively outperform on our pharmacy new patient starts percentage.

Stephen Feider: We have to be ready for the idea, the fact that we could massively outperform on our pharmacy new patient starts percentage. And because of that revenue headwind, you know, we do embed that in our 2026 revenue guide.

Speaker #4: And because of that revenue headwind, we do embed that in our 2026 revenue guide.

Speaker #3: That's fair enough. 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.

[Analyst] (Goldman Sachs): Fair enough. 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 versus underlying the direction of travel for underlying gross margins would be helpful.

Phil Coover: Fair enough. 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 versus underlying the direction of travel for underlying gross margins would be helpful.

Speaker #3: Wondering how much of that maybe comes from your rate of pharmacy conversion versus underlying the direction of travel for underlying gross margins would be helpful.

Speaker #4: 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.

Stephen 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. But in the event that we outperform on the percentage of new patient starts growth from 2025 to 2026, that again creates a short-term revenue headwind, but it also creates a short-term drag on our gross margin profile. 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. We generate monthly recurring revenue of around $450 for all patients that continue using the product in the pharmacy channel.

Speaker #4: But in the event that we outperform on the percentage of new patient starts growth from 2025 to 2026, that, again, creates a short-term revenue headwind, but it also creates a short-term drag on our gross margin profile because, again, in the pharmacy business model, as you know, we give away the ILIT for free, and then we charge a monthly recurring revenue we generate monthly recurring revenue of around $450 for all patients that continue using the product in the pharmacy channel.

Speaker #4: 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're guiding gross margin where we have.

Stephen 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're guiding Gross Margin where we have.

Speaker #3: Thanks, Steve.

[Analyst] (Goldman Sachs): Thanks, Steve.

Phil Coover: Thanks, Steve.

Speaker #2: Thank you. Our next question comes from Michael Pollock with Wolfe Research. You may proceed.

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

Speaker #5: Hey, good afternoon. Thank you for taking the questions. I'm curious on the fourth quarter. Just with all the focus on your starts performance of 5% sequentially, have you developed a view as to what the pump market in the U.S. starts were up?

Michael Polark: Good afternoon. Thank you for taking the questions. I'm curious, in 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 US starts were up, how that performed Q over Q? Do you have a number by chance? Obviously, your peers are still mostly to report. I'm curious if you've developed an opinion.

Speaker #5: How did that perform Q over Q? Do you have a number, by chance? Obviously, your peers are still mostly to report. I'm curious if you've developed an opinion.

Speaker #4: Yeah. Hey, Mike. I appreciate the question. For the reasons that you stated, because our competitors haven't really published their earnings, we don't have a particular perspective on what our market share was in the fourth quarter and how it and how that performed relative to Q3.

Stephen Feider: Yeah, good. Hey, Mike, I appreciate the question. For the reasons that you stated, because our competitors haven't really published their earnings, we don't have a particular perspective on what our market share was in Q4 and how it, and what, you know, how that performed relative to Q3. So I'm sorry, I don't have a take on that yet. I'm gonna. I'll wait to see our competitors' numbers.

Speaker #4: I'm sorry. I don't have a take on that yet. I'll wait to see our competitors' numbers.

Michael Polark: Fair enough. For the follow-up, maybe about 26, I heard 20 new sales territories to be created, invested in, you know, that's over 30% growth in territories. I know it will be done over the course of the year. I know you're not going to be too precise, but can you maybe comment, 1H, 2H centric? You know, I think, I'm interested in what the formal guidance-

Speaker #3: Fair enough. For the follow-up—maybe about 26—I heard 20 new sales territories to be created, invested in; that's over 30% growth in territories.

Speaker #3: I know it will be done over the course of the year. I know you're not going to be too precise, but can you maybe comment?

Speaker #3: 1H, 2H-centric, I think I'm interested in what the formal guidance has considered for the timing of those incremental territories. Thank you.

Stephen Feider: Mm-hmm

Michael Polark: ... has considered for the timing of those incremental territories.

Stephen Feider: Yes.

Michael Polark: Thank you.

Speaker #4: Of course. The guidance is at least 20 territories. We will be expanding by 2026, and there will be a large expansion in the first half of the year.

Stephen Feider: Of course. The guidance is at least 20 territories. We will be expanding in 2026, and there will be a large expansion in the first half of the year. I don't want to say that there won't be an expansion at some level in the second half, but much of that expansion is in the first half of the year.

Speaker #4: I don't want to say that there won't be an expansion at some level in the second half, but there's much of that expansion is in the first half of the year.

Speaker #3: Thank you.

Michael Polark: Thank you.

Speaker #2: Thank you. Our next question comes from Matthew Blackman with TD Cowen. You may proceed.

Operator: Thank you. Our next question comes from Matthew Blackman with D.D. Cowan. You may proceed.

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

Speaker #6: Good afternoon, everybody. Can you hear me okay?

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

Speaker #3: Yeah, we got you, Matt.

Stephen Feider: Yeah, we got you, Matt.

Speaker #6: Great. Appreciate you taking my questions. I just want to start I want to make sure I call. So correct me if I've gotten some of this wrong, but it sounds like 1Q will be down more than let's call it roughly 14% quarter over quarter decline that you saw in 2025 versus 4Q24.

Matthew Blackman: Great. Appreciate you taking my questions. I just want to make sure. So correct me if, if I've 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. But then it sounded like first half of 2026 should be modestly higher than something like 41% of the full year revenue we saw in the first half of 2025. Did I capture all of that correctly? Maybe start there.

Mathew Blackman: Great. Appreciate you taking my questions. I just want to make sure. So correct me if, if I've 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. But then it sounded like first half of 2026 should be modestly higher than something like 41% of the full year revenue we saw in the first half of 2025. Did I capture all of that correctly? Maybe start there.

Speaker #6: But then, it sounded like the first half of 2026 should be modestly higher than something like 41% of the full-year revenue we saw in the first half of 2025.

Speaker #6: Did I capture all of that correctly? Maybe start there.

Stephen Feider: I'm sorry, Matt, can you—you cut out a little on our end. I hope it's not us, but can you repeat the second half of your question there? What I heard was-

Speaker #4: I'm sorry, Matt. Can you are you cut out a little on our end? I hope it's not us, but can you repeat the second half of your question there?

Stephen Feider: I'm sorry, Matt, can you—you cut out a little on our end. I hope it's not us, but can you repeat the second half of your question there? What I heard was-

Speaker #4: What I heard was what I heard was.

Matthew Blackman: Sure, sure, sure.

Mathew Blackman: Sure, sure, sure.

Stephen Feider: What I heard was,

Matthew Blackman: Yeah. No, I think, I, I think my headset cut out. So, yeah, let me do it again. I apologize. It sounded like your commentary for Q1 was that it'll be down more than, I think, the roughly, let's call it 14% you were down in Q1 of 2025 versus Q4 of 2024. But then you expect the first half of 2026 should be modestly higher than the first half revenue you saw in 2025. Did I capture that commentary correctly?

Mathew Blackman: Yeah. No, I think, I, I think my headset cut out. So, yeah, let me do it again. I apologize. It sounded like your commentary for Q1 was that it'll be down more than, I think, the roughly, let's call it 14% you were down in Q1 of 2025 versus Q4 of 2024. But then you expect the first half of 2026 should be modestly higher than the first half revenue you saw in 2025. Did I capture that commentary correctly?

Speaker #6: Sure. Yeah. No, 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'll be down more than, I think, the roughly—let's call it 14%—you were down in the first quarter of '25 versus the fourth quarter of '24.

Speaker #6: But then you expect the first half of 2026 should be modestly higher than the first half revenue you saw in 2025. Did I capture that commentary correctly?

Stephen Feider: Yeah, you did directionally. So I'm going to repeat some of that back to you. 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 from Q4 2025 to Q1 2026. And that step change or that reduction should be larger than what you saw for both new patient starts and revenue, than what you saw last year.

Speaker #4: Yeah, you did directionally. So I'm going to repeat some of that back to you. What we did say is that the there is seasonality to the business, and this is with regards to the step change from Q4 to Q1.

Speaker #4: 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.

Speaker #4: And you should expect a reduction in revenue and new patient starts from Q4 '25 to Q1 '26. And that step change or that reduction should be larger than what you saw for both new patient starts and revenue than what you saw last year.

Speaker #4: So from, again, 2024 to Q4 2024 to Q1 2025, that reduction, you should see a larger reduction from Q4 2025 to Q1 '26. And the reason for that is that there's product launches that were unique in Q4 2024.

Stephen Feider: So from, again, 2024 to 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's product launches that were unique in Q4 2024, and notably the Color iLet, which created a lot of pent-up demand in Q4 2024 and Q1 2025. That kind of obfuscated traditional seasonality. Again, we launched a Color iLet that was smaller, 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 from Q4 2024 to Q1 2025, which created also this demand improvement in those comparative periods. And we won't see the same from Q4 2025 to Q1 2026.

Speaker #4: And notably, the Color iLet, which created a lot of pent-up demand in Q4 '24 and Q1 '25, that kind of obfuscated traditional seasonality. Again, we launched a Color iLet that was smaller, massively different form factor.

Speaker #4: 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 from Q4 2024 to Q1 '25, which created also this demand improvement in its comparative periods.

Speaker #4: And we won't see the same from Q4 '25 to Q1 '26. So that's the first part of your answer—yes. And for all those reasons, I think that were important to share.

Stephen Feider: So that's the first part of the of your answer is, is yes, and for all those reasons I think that were important to share. The second part is I was in, in the prepared remarks, I was just commenting on the weighting of revenue, and we expect the weighting of revenue to be more heavily weighted towards first half 2026 than what we saw first half 2025 weighting to be. Meaning first half 2025 revenue divided by total year 2025 revenue, that percentage, that will be lower in 2025 than what we'll see in 2026.

Speaker #4: The second part is, I was in the prepared remarks. I was just commenting on the weighting of revenue. We expect the weighting of revenue to be more heavily weighted towards the first half of 2026 than what we saw for the first half of 2025 weighting. Meaning, first half '25 revenue divided by total year '25 revenue—so, that percentage.

Speaker #4: That will be lower in '25 than what we'll see in '26.

Speaker #6: Got it. Okay, I appreciate that. I guess the other question I wanted to ask—I don't know if you have this handy, but even if just directionally—thinking about the sales territory expansion in '26, is there a way to even roughly quantify how much of the addressable market you were able to cover in 2025, and how much incremental that 20 territories would give you?

Matthew Blackman: Got it. Okay. I appreciate that. I guess the other question I wanted to ask. I don't know if you have this handy, but even if just directionally, thinking about the sales territory expansion in 2026, is there a way to even 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's been, in terms of iLet adoption?

Mathew Blackman: Got it. Okay. I appreciate that. I guess the other question I wanted to ask. I don't know if you have this handy, but even if just directionally, thinking about the sales territory expansion in 2026, is there a way to even 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's been, in terms of iLet adoption?

Speaker #6: Again, even just directionally. And I guess maybe most important, how much of a rate limiter do you think that's been in terms of ILIT adoption?

Stephen Feider: Mm-hmm.

Speaker #6: And thanks so much. Appreciate it.

Matthew Blackman: Thanks so much. Appreciate it.

Mathew Blackman: Thanks so much. Appreciate it.

Speaker #4: Yeah, all right. Well, another good question. I think that the right number of territories in the US 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.

Stephen Feider: Yeah. All right. Well, another good question. I think that the right number of territories in the US 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's like when you have the level of sort of adoption that in particular, like, let's say our patch pump competitor has. I think it's probably on the higher end of that. But 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. So for most of last year, as you know, we had 63 territories.

Speaker #4: That's like when you have the level of sort of adoption that, in particular, let's say our patch pump competitor has. I think it's probably on the higher end of that.

Speaker #4: But 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.

Speaker #4: And so for most of last year, as you know, we had 63 territories. So obviously, the simple math is we had half to a third of the country covered.

Stephen Feider: So obviously, the simple math is we had, you know, 1/2 to 1/3 of the country covered. Now, the reality is that our territories tended to be a little wider or a little larger, so 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.

Speaker #4: Now, the reality is that our territories tended to be a little wider, or a little larger. So we were probably covering actually more than 33% to 50% of the entire country.

Speaker #4: But that gives you a directional understanding of how much of the country generally we were sort of addressing and then what 20 incremental territories does.

Speaker #6: Great. Really appreciate it. Thank you.

Matthew Blackman: Great. Really appreciate it. Thank you.

Mathew Blackman: Great. Really appreciate it. Thank you.

Speaker #7: Thank you. Our next question comes from John Block with Stifel. You may proceed.

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

Speaker #8: Great. Thanks, guys. Good afternoon. Maybe just to pick up 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?

Jonathan Block: Great. Thanks, guys. Good afternoon. Maybe just to pick up on that thread or to pull that thread a little bit. Maybe you guys can just talk to why 20 reps are the right number, right? It takes you to the low 80s, but Stephen, you just talked about a number, 120+. So when I think about exiting 2026, I mean, you're that much closer to Mint, you're that much closer to Type 2 label, as a possibility. So maybe just talk about why the organization with the balance sheet you have wouldn't push a little bit harder and faster, just when we think about the number of reps that you're onboarding or plan to onboard this year.

Jon Block: Great. Thanks, guys. Good afternoon. Maybe just to pick up on that thread or to pull that thread a little bit. Maybe you guys can just talk to why 20 reps are the right number, right? It takes you to the low 80s, but Stephen, you just talked about a number, 120+. So when I think about exiting 2026, I mean, you're that much closer to Mint, you're that much closer to Type 2 label, as a possibility. So maybe just talk about why the organization with the balance sheet you have wouldn't push a little bit harder and faster, just when we think about the number of reps that you're onboarding or plan to onboard this year.

Speaker #8: It takes you to the low 80s, but Steven, you just talked about a number—120 plus. So, when I think about exiting 2026, I mean, you're that much closer to mint.

Speaker #8: You're that much closer to type 2 label. As a possibility, so maybe just talk about why the organization with the balance sheet you have wouldn't push a little bit harder and faster just when we think about the number of reps that you're unloading or plan to unload this year.

Speaker #4: Yeah, good question. And, Sean, I'll start here, and if you want to jump in and add a little more. Look, we, of course, have confidence in the product that we're offering.

Stephen Feider: Yeah, good question. And Sean, I, I'll start here and just tell me if you want to jump in-

Operator: Yeah.

Sean Saint: Yeah.

Stephen Feider: and add a little more. Look, we, of course, have confidence in the product that we're offering. And so, you know, expansion is absolutely the intention of the company, and we, you know, we are underpenetrated in terms of, you know, doctors that are aware of what the iLet is and, you know, having a sales rep that's communicating to them what the great clinical outcomes are for their patients. So that absolutely is true. But I also did say that we're going to expand by at least 20.

Speaker #4: And so, expansion is absolutely the intention of the company. And we are underpenetrated in terms of doctors that are aware of what the ILIT is and having a sales rep that's communicating to them what the great clinical outcomes are for their patients.

Speaker #4: So that absolutely is true. But I also did say that we are going to expand by at least 20. So I don't want us to just anchor on 20 as on the low end of that and say that's the only amount that we'll be or that's the amount that we will be limited to.

Stephen Feider: So I don't want us to, you know, just anchor on, you know, on 20 as like, you know, on the low end of that and say that's, that's the only amount that we'll be-- or that's 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, from our R&D pipeline, we are anticipating future products, and Sean mentioned them in his prepared remarks. And I think, you know, embedded in sort of like our, our plan for the sales force expansion is, being a little cagey here is sort of anticipation of a future time when we have, when we have another product on the market. So there's, there's that as well.

Speaker #4: In 2026, in terms of expansion—and then, the last point I would make is that we are anticipating, as you know from our R&D pipeline, future products.

Speaker #4: And Sean mentioned them in this prepared remarks. And I think embedded in sort of like our plan for the Salesforce expansion is being a little cagey here is sort of anticipation of future time when we have another product on the market.

Speaker #4: So there's that as well.

Speaker #8: I'll just add to that, John, that we always believe in being deliberate, right? I mean, I don't 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—the whole bit, right?

Sean Saint: I'll just add to that, John, that, you know, we always believe in being deliberate, right? I mean, I don't 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, you know, your manufacturing line can produce that many, you know, the whole bit, right? There's so many systems, et cetera, that have to scale along with the number of reps, and there's a lot of opportunities to get it wrong. You know, Beta Bionics is playing the long game here, and I don't think anybody needs us to take over the world on day one. So we're going to do this deliberately and, and conservatively at some level, and we're going to get it right.

Speaker #8: There's so many systems, etc., that have to scale along with the number of reps. And there's a lot of opportunities to get it wrong.

Speaker #8: Betabionics is playing the long game here. And I world on day one. So we're going to do this deliberately. And conservatively at some level.

Speaker #8: And we're going to get it right. Great. Thanks for that. That's helpful. Maybe just to shift, and I guess I'll go there. There is this hypoglycemia concern or chatter.

Jonathan Block: Great. Thanks for that. That's, that's helpful. Maybe just to shift, and I guess I'll go there. You know, there is this hypoglycemia concerns or chatter, and, and it's out there, and maybe it's more Wall Street than Main Street, et cetera. 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'm curious, in the real world or out in the field, what are your reps hearing or any blowback, and has that evolved in the past three or six months? Thanks for your time.

Jon Block: Great. Thanks for that. That's, that's helpful. Maybe just to shift, and I guess I'll go there. You know, there is this hypoglycemia concerns or chatter, and, and it's out there, and maybe it's more Wall Street than Main Street, et cetera. 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'm curious, in the real world or out in the field, what are your reps hearing or any blowback, and has that evolved in the past three or six months? Thanks for your time.

Speaker #8: And it's out there. And maybe it's more Wall Street than Main Street. Etc. But Sean, any data or metrics that you plan to share with the street that might be forthcoming?

Speaker #8: And then maybe just to add on to that, I'm curious, in the real world or out in the field, what are your reps hearing or any blowback?

Speaker #8: And has that evolved in the past three or six months? Thanks for your time.

Speaker #4: Yeah, fair question, John. Well, first of all, in terms of data, I would point you to our current corporate deck on the website, which does speak to this.

Sean Saint: Yeah, fair question, John. Well, 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, et cetera. I'll just say a few things. First of all, it's consistent with our, our clinical trial, right? We're 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 1/3, 1/4 to 1/3 of the ADA guidelines for hypoglycemia. So we're meeting that, that metric by 4x. Again, I'll point you to our, our data on the, the corporate deck as well.

Speaker #4: Look, our best information on the ILIT—and of course, we see all of our data in our cloud, etc. I'll just say a few things.

Speaker #4: First of all, it's consistent with our clinical trial, right? We're seeing the same or even slightly lower rates of hypoglycemia that we saw in our clinical trial that was clearly acceptable at that time.

Speaker #4: Number one. Number two, those rates of hypoglycemia seem to be roughly one-third, one-quarter to one-third of the ADA guidelines for hypoglycemia. So we're meeting that metric by 4X.

Speaker #4: Again, I'll point you to our data on the corporate deck as well. But what I'm telling you is, to the best of our knowledge, yes, we hear the narrative.

Sean Saint: But what I'm telling you is, to the best of our knowledge, yes, we hear the narrative. No, we don't see some outsized hypo problem of 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's 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've talked about this before, and it's, 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's 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'm referring to. And yet, excuse me.

Speaker #4: No, we don't see some outsized hypo problem, if any description. It is a true statement that people with diabetes do occasionally get low. They get low on every system.

Speaker #4: And in fact, if you look at severe hypoglycemic events, it's roughly an order of magnitude worse than it is with ILIT or other AID systems.

Speaker #4: But I do want to highlight a difference. And I believe I've talked about this before. And at this point, what we call the Tesla effect.

Speaker #4: People, there are car crashes every day. But when a Tesla crashes, it's national news. I think the data at this point is clear. Teslas are safer.

Speaker #4: Then the average driver—full self-driving, of course, is what I’m referring to—and yet, excuse me, and yet, that's national news when something happens.

Sean Saint: And yet, that's national news when something happens. We do believe that there is a, a version of that that's happening with the iLet. We've 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.

Speaker #4: We do believe that there is a version of that that's happening with the ILIT. We've provided an increased level of automation than the world has ever seen with insulin pumps.

Speaker #4: There is very, very little to do for the user of an ILIT. However, those do still happen. When a person chooses their dose, gives that dose, goes for a walk and gets low, they think, wow, I probably shouldn't have done that.

Sean Saint: When a person chooses their dose, gives that dose, goes for a walk, and gets low, they think, "Wow, I probably shouldn't have done that." When a user utilizes the iLet, doesn't choose a dose of 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's where that's coming from, and I think it's somewhat natural that Beta Bionics will live that world because we are the tip of the spear in terms of automation and insulin pumps here. But again, I'll focus back on what I started my response with. All of the data that we've published, all the data we are aware of, do not indicate any level of outsized hypo problem with the iLet.

Speaker #4: When a user utilizes the iLet, doesn't 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.'

Speaker #4: So I think that's where that's coming from. And I think it's somewhat natural that Beta Bionics will live in that world because we are the tip of the spear in terms of automation and insulin pumps here.

Speaker #4: But again, I'll focus back on what I started my response with. All of the data that we've published—all the data we are aware of—do not indicate any level of outsized hypo problem with the iLet.

Speaker #8: Very helpful. Thanks for the color, guys.

Jonathan Block: Very helpful. Thanks for the color, guys.

Jon Block: Very helpful. Thanks for the color, guys.

Speaker #4: Thank you.

Sean Saint: Thank you.

Speaker #6: Thank you. Our next question comes from Matthew O'Brien with Piper Sandler. You may proceed.

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

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

Speaker #8: Afternoon. Thanks for taking the questions—and congrats on getting to $100 million in sales so quickly. Maybe just to follow up on—oh, you’re welcome.

Matthew O'Brien: Afternoon. Thanks for taking the questions, and congrats on getting to $100 million in sales so quickly. You know, maybe just to follow up on... Oh, you're welcome. Maybe just to follow up on Phil's questions to start with. Just on the guide, even you know, that, that if you go to the midpoint of the range, the absolute dollar number is actually lower in 2026 versus 2025, and you're getting the benefit of all these pharmacy patients, from a revenue perspective here in 2026 versus 2025. So is there something else that's contemplated in here that we should be thinking about? I don't know if it's, you know, potential impact of the Warning Letter or competition or higher attrition because more pharmacy.

Speaker #8: Maybe to follow up on Phil's questions to start with. Just on the guide, even if you go to the midpoint of the range, the absolute dollar number is actually lower in 26 versus 25.

Speaker #8: And you're getting the benefit of all these pharmacy patients from a revenue perspective here in '26 versus '25. So is there something else that's contemplated in here that we should be thinking about?

Speaker #8: I don't know if it's 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 this initial guide versus what you kind of did on an absolute basis last year?

Matthew O'Brien: Anything like that specifically to call out here, in terms of, you know, this, this initial guide versus what you kind of did on an absolute basis last year?

Speaker #6: Hey, Matt. Good question, and I appreciate the congrats. In short, no, there's no odd characteristics of the competitive landscape that we're particularly afraid of.

Stephen Feider: ... Hey, Matt, good question, and I appreciate the congrats. In short, no, there's no odd characteristics of the competitive landscape that we're particularly afraid of. We're not seeing any elements of our pharmacy business model where there's attrition that's trending any different than what we've seen. And by the way, we've had great retention on the product. We're just, you know, setting a guide that we have confidence in and we feel good about.

Speaker #6: We're not seeing any elements of our pharmacy business model where there's attrition that's trending any different than what we've seen. And by the way, we've had great retention on the product.

Speaker #6: We're just setting a guide that we have confidence in. And we feel good about.

Speaker #8: 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 '26, it just implies a pretty big step down in the first half of this year.

Matthew O'Brien: Okay, very fair. And then on the, 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. You know, for the range that you gave for the rest of... or sorry, for 2026, you know, it just, it just implies a pretty big, you know, step down in the first half of this year. So I'm just wondering, you know, if there's something maybe even in the back half that you're contemplating. I don't know. Is that, is that, hey, we could start to see some Mint sales? Is that something that's... And then just to be specific on Mint, do you still expect to be second to, to market as far as patch pumps go? Thank you.

Speaker #8: So I'm just wondering if there's something, maybe even in the back half, that you're contemplating. I don't know. Is that, hey, we could start to see some mid-sales?

Speaker #8: Is that something that's—and then, just to be specific on Mint, do you still expect to be second to market as far as patch pumps go?

Speaker #8: Thank you.

Speaker #6: Yeah. I'll let you answer the question on mint. But yeah, as it relates to or sorry, I just lost my train of thought. Can you take the mint question, the mint part?

Stephen Feider: Yeah, I'll let you answer the, the question on Mint. But yeah, as it relates to... Oh, sorry, I just lost my train of thought. Can you take the Mint question, the Mint part?

Sean Saint: Yeah, sure. To be clear, when he said, "You can take the question," I don't think he meant you. I think he meant me. All right. On Mint, you know, I don't recall exactly the statements we've made in the past on order of release, and I frankly, Matt, don't remember the exact details of when all of our competitors are currently saying their products come to market. What we're doing today is reiterating our timeline of an unconstrained launch by the end of 2027. So that's what I'll commit to. But I'm not going to call our shot on exactly what position that puts us in, 'cause frankly, we don't have visibility to what others are doing. And thanks for the eye-popping comment by the way, Steve.

Speaker #4: Yeah, sure. And to be clear, when you said you can take the question, I don't think he meant you—I think he meant me.

Speaker #4: All right. So on Mint, I don't recall exactly the statements we've made in the past on order of release. And I, frankly, Matt, don't remember the exact details of when all of our competitors are currently saying their products come to market.

Speaker #4: What we're doing today is reiterating our timeline of an unconstrained launch by the end of '27. So that's what I'll commit to. But I'm not going to call our shot on exactly what position that puts us in because, frankly, we don't have visibility to what others are doing.

Speaker #4: And thanks to the eye-popping comment by Steve.

Stephen Feider: Yeah, and in terms of the gross margin, the gross margin guide for the year, yeah, obviously, 59% in Q4 is a great number. I think something notable about Q4 gross margin was that we didn't see a big uptick in the percentage of pharmacy new patient starts from Q3 to Q4 2025. But, remembering that 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. And so hence, that's embedded in the guide.

Speaker #6: Yeah. And in terms of the gross margin, the gross margin guide for the year—yeah, obviously, 59% in Q4 is a great number. I think something notable about Q4 gross margin was that we didn't see a big uptick in the percentage of pharmacy new patient starts from Q3 to Q4 2025.

Speaker #6: But remembering that 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 ready for a short-term headwind on our gross margin profile.

Speaker #6: And so, hence, that's embedded in the guide. But there’s nothing competitive about the product, or there’s no new problem, or they’re not seeing an uptick in warranty rates or anything of that nature.

Stephen Feider: But there's nothing competitive about, you know, the product or there's no like, new problem or we're not, we're not seeing an uptick in warranty rates or anything of that nature. It's just, again, simply us being careful in the event that, you know, a particular metric outperforms what we've communicated.

Speaker #6: It's just, again, simply us being careful in the event that a particular metric outperforms what we've communicated.

Speaker #8: Got it. Thank you.

Matthew O'Brien: Got it. Thank you.

Speaker #6: Thank you. Our next question comes from Mike Cracky with Bearing Partners. You may proceed.

Operator: Thank you. Our next question comes from Mike Krajcie with Hering Partners. You may proceed.

Speaker #9: Hey, everyone. Thanks for taking our questions. Maybe just to start, now that we're more than halfway through the first quarter, can you share any qualitative or quantitative commentary around what you've seen so far, year to date, in terms of new starts?

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

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

Speaker #9: And if that's aligned with your expectations on seasonality and your outlook for the sequence from Q4 to Q1?

Speaker #10: Yeah. Yeah, I guess I'm going to kind of repeat something I already had communicated. So sorry, this is just a regurgitation, Mike, although I do certainly appreciate the question.

Stephen Feider: Yeah. Yeah, I guess I'm, I'm going to kind of repeat something I already had communicated, so sorry, this is just a regurgitation, Mike, although I, I do certainly appreciate the question. So, as it relates to the first quarter, there absolutely is seasonality in the insulin pump business, and where we see the largest step change in seasonality is from the fourth quarter to the first quarter. And so you should expect your respect to-- expect a reduction in 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 in what we saw in the last year's reduction. So last year's reduction was a 6% reduction.

Speaker #10: So, as it relates to the first quarter, there absolutely is seasonality in the insulin pump business. And where we see the largest step change in seasonality is from the fourth quarter to the first quarter.

Speaker #10: And so you should expect your expect a reduction in 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 in what we saw in the last year's reduction.

Speaker #10: So, last year's reduction was a 6% reduction. And for reasons that I've already communicated, regarding new product launches and the change in pharmacy adoption, you should expect our reduction to be in excess of that 6%.

Stephen Feider: And, for reasons that I've already communicated, regarding new product launches and the change in pharmacy adoption, you should expect our reduction to be in excess of that 6%.

Speaker #9: Understood. Thanks, Steven. And just to follow up, I think one thing that stood out in the guidance is that 36% to 38% of expected pharmacy mix.

Mike Krajcie: Understood. Thanks, Stephen. And just to 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 30s, is it fair to think that you could be above 40%, and what needs to happen in order to achieve that?

Mike Kratky: Understood. Thanks, Stephen. And just to 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 30s, is it fair to think that you could be above 40%, and what needs to happen in order to achieve that?

Speaker #9: So to get to the upper end of that range, exiting this year in the low 30s, is it fair to think that you could be above 40%?

Speaker #9: And what needs to happen in order to achieve that?

Speaker #10: Yeah. Look, I don't want to call 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?

Stephen Feider: Yeah, look, I don't want to call it like a number above our guide. I 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... Well, first of all, we need PBM agreements, which we have most, almost, over 80% of all lives in the country covered under a PBM agreement. So for the most part, that's a green checkbox. And then the next, we need the underlying health plans associated with those PBMs.

Speaker #10: And by the way, that is, of course, possible as well, first of all, we need PBM agreements, which we have almost over 80% of all lives in the country covered under a PBM agreement.

Speaker #10: So for the most part, that's a green checkbox. Then next, we need the underlying health plan associated with those PBMs. We need an underlying agreement with those.

Stephen Feider: We need an underlying agreement with, with those, and that's where the lion's share of the work still is left to grow our pharmacy adoption from where it is today, you know, to, to becoming, mostly a ph-- mostly or all a, a pharmacy reimbursed product. But in like, in terms of specifics, I mean, we have some Medicaid contracts or some Medicaid programs or states where we're seeing Medicaid coverage, and we can continue to grow more of those, those state adoptions for Medicaid. And then, you know, underlying plan agreements, again, associated with the already existing PBM contracts that we have. But it absolutely is possible for us to outperform the guide.

Speaker #10: And that's where the lion's share of the work still is left to grow our pharmacy adoption from where it is today to becoming mostly or all a pharmacy reimbursed product.

Speaker #10: But in terms of specifics, I mean, we have some Medicaid contracts or some Medicaid programs where we're— or states where we're seeing Medicaid coverage, and we can continue to grow more of those.

Speaker #10: Those state adoptions for Medicaid and then underlying plan agreements, again, associated with the already existing PBM contracts that we have. But it absolutely is possible for us to outperform the guide.

Speaker #9: Understood. Thanks very much.

Mike Krajcie: Understood. Thanks very much.

Mike Kratky: Understood. Thanks very much.

Sean Saint: We'll remind everybody that these 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.

Speaker #4: We'll remind everybody that the these 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.

Speaker #6: Thank you. Our next question comes from Richard Newitter with True Securities. You may proceed.

Operator: ... Thank you. Our next question comes from Richard Newitter with Truist Securities. You may proceed.

[Analyst] (Truist Securities): Hey, this is Philippe on for Rich. I guess just to follow up on Mint, you guys are clearly got into a step up in CapEx spend for the platform and investing. So I'm just wondering if you could maybe just give any update on, like, where are you at on the checklist before submission? Any color would be helpful.

Felipe Lamar: Hey, this is Philippe on for Rich. I guess just to follow up on Mint, you guys are clearly got into a step up in CapEx spend for the platform and investing. So I'm just wondering if you could maybe just give any update on, like, where are you at on the checklist before submission? Any color would be helpful.

Speaker #11: Hey, this is Felipe on for Rich. I guess just to follow up on Mint, you guys are clearly guiding to a step up with CapEx spend for the platform and are resting.

Speaker #11: So I'm just wondering if you could maybe just give any update on where you're at on the checklist before submission, and any color would be helpful.

Speaker #10: Yeah. Sorry, Felipe. I don't think we're going to go beyond what we've said and prepared remarks in terms of exact status of mint at this point.

Sean Saint: Yeah, sorry, Philippe. I don't think we're gonna go beyond what we've said in prepared remarks in terms of exact status of Mint at this point. I'm sorry.

Speaker #10: I'm sorry.

Speaker #11: No, no problem. And then, just to follow up on pharmacy—you guys have a bunch of competitors now that are durable competitors who are starting to make progress in the channel.

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

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

Speaker #11: So I'm just wondering, one, how are you seeing any impact here—your contract conversations with PBMs? And then two, I guess if there are more low-cost, durable pump options, how does that maybe potentially impact you competitively going forward?

Speaker #11: Thanks so much.

Sean Saint: I'd like to start this one, and maybe you could provide some color, Stephen. I would say that the conversations are evolving slightly, and that you're right. There's more people out there, more durable pump companies now knocking on the doors. And from my perspective, that's a positive because it's providing an expectation that this is exactly how these things are covered. Beta Bionics was, you know, the company to go out and start this conversation, and we were pretty successful doing it. But with everybody following along, it's just a bit of a tidal wave of momentum that's gonna help the entire industry move there. And, you know, to the extent that pharmacy is a competitive advantage, we love that.

Speaker #10: I'd like to start this one, and maybe you could provide some color, Steven. I would say that the conversations are evolving slightly, in that you're right.

Speaker #10: There's more people out there, more durable pump companies now knocking on the doors. And from my perspective, that's a positive because it's providing an expectation that this is exactly how these things are covered.

Speaker #10: Betabionics was the company to go out and start this conversation. And we were pretty successful doing it. But with everybody following along, it's just a bit of a tidal wave of momentum that's going to help the entire industry move there.

Speaker #10: And to the extent that pharmacy is a competitive advantage, we love that. But the reality is it's an improved business model to allow these companies to operate better in a better experience for our users.

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

Speaker #10: So, we're happy to have pioneered that, and we're happy to have more momentum moving in that direction. So that's the— But Steven, anything to add to that?

Stephen Feider: I think, well said.

Speaker #11: I think well said.

Speaker #10: All right.

Sean Saint: All right.

Speaker #6: Thank you. Our next question comes from Jeff Johnson with Baird. You may proceed.

Operator: Thank you. Our next question comes from Jeff Johnson with Baird. You may proceed.

Speaker #11: Yeah, thanks. Good afternoon, guys. I don't mean to go back into the territory question—I know a few questions have been asked here on it. But as we track some of the metrics for you guys, it does look like you've maybe—and I'll stress the word maybe—hired 40 or so new sales reps that would cover about 20 territories.

Jeff Johnson: Yeah, thanks. Good afternoon, guys. Let me go back to the territory and question. I know a few questions have been asked here on it, but you know, as we track some of the metrics for you guys, it does look like you maybe, and I'll stress the word maybe, hired 40 or so new sales reps that would cover about 20 territories, just in the last couple of months. And again, you know, our visibility isn't clear on that by any means. But I guess, Sean, I'd love to hear from you, and I do have one follow-up question then, but I'd love to hear from you. How much of that was maybe backfilling reps? We've actually lost one or two of your reps that we've talked to over the last year, year and a half.

Jeffrey Johnson: Yeah, thanks. Good afternoon, guys. Let me go back to the territory and question. I know a few questions have been asked here on it, but you know, as we track some of the metrics for you guys, it does look like you maybe, and I'll stress the word maybe, hired 40 or so new sales reps that would cover about 20 territories, just in the last couple of months. And again, you know, our visibility isn't clear on that by any means. But I guess, Sean, I'd love to hear from you, and I do have one follow-up question then, but I'd love to hear from you. How much of that was maybe backfilling reps? We've actually lost one or two of your reps that we've talked to over the last year, year and a half.

Speaker #11: Just in the last couple of months. And again, our visibility isn't clear on that by any means. But I guess, Sean, I'd love to hear from you.

Speaker #11: And I do have one follow-up question then. But I'd love to hear from you, how much of that was maybe backfilling reps? We've actually lost one or two of your reps that we've talked to over the last year, year and a half.

Jeff Johnson: So, it feels like maybe there's 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?

Speaker #11: So it feels like maybe there's been a little bit of rep departure. But how much of that was backfilling reps versus hiring and expanding territories over the last couple of months?

Jeffrey Johnson: So, it feels like maybe there's 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?

Speaker #10: Yeah, Jeff, thanks for the question. I'm not going to comment on exactly how many people we've hired recently. Just not going to do it.

Sean Saint: Yeah, Jeff, thanks for the question. I'm not gonna comment on exactly how many people we've hired recently. Yeah, just not gonna 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, 126 people or whatever that is, you're gonna have turnover for multiple reasons. Some for performance, some for, you know, other jobs that were offered, what have you, and you're always gonna be backfilling. So there is some of that going on at all times, but I'm not gonna comment on exactly how many we may have hired outside of that group or even in that group recently.

Speaker #10: What I will say is, we are always hiring backfills at some level. In any group of, like I said, 63 territories, 126 people, or whatever that is, you're going to have turnover for multiple reasons.

Speaker #10: Some for performance, some for other jobs that were offered, what have you. And you're always going to be backfilling. So there is some of that going on at all times.

Speaker #10: But I'm not going to comment on exactly how many we may have hired outside of that group, or even in that group, recently.

Speaker #11: Yeah, fair enough. And Steven, maybe to clarify—yeah.

Jeff Johnson: Yeah, fair enough. And Stephen, maybe a clarifying-

Jeffrey Johnson: Yeah, fair enough. And Stephen, maybe a clarifying-

Sean Saint: Sorry, go ahead.

Speaker #10: I'm sorry. Go ahead.

Jeff Johnson: Understood. Yeah, no, Stephen, maybe clarifying for you. You talked about $1 million pull forward in the PBM channel or the pharmacy channel, I'm sorry, from Q1 into Q4. I think as... I can't remember it was a conversation with you or someone else over the last month or so, as we kind of were trying to pipe rate our 2026 model. It sounded like there was gonna be maybe $10 to 12 million in additional stocking in 2026, mostly in supplies, some in pumps. Is that still the right number to be thinking about as a component of your revenue guidance for 2026? And how would that $10 to 12, if we're ballpark accurate, compare to maybe total stocking you saw in 2025? Thanks.

Jeffrey Johnson: Understood. Yeah, no, Stephen, maybe clarifying for you. You talked about $1 million pull forward in the PBM channel or the pharmacy channel, I'm sorry, from Q1 into Q4. I think as... I can't remember it was a conversation with you or someone else over the last month or so, as we kind of were trying to pipe rate our 2026 model. It sounded like there was gonna be maybe $10 to 12 million in additional stocking in 2026, mostly in supplies, some in pumps. Is that still the right number to be thinking about as a component of your revenue guidance for 2026? And how would that $10 to 12, if we're ballpark accurate, compare to maybe total stocking you saw in 2025? Thanks.

Speaker #11: Understood. Yeah. No, Steven, maybe just to clarify for you—you talked about the $1 million pull forward in the PBM channel, or was it in the pharmacy channel? I'm sorry.

Speaker #11: From Q1 into Q4, I think—I can't remember if the conversation was with you or someone else over the last month or so, as we kind of were trying to titrate our 26 model.

Speaker #11: It sounded like there was going to be maybe 10 to 12 million in additional stocking in 2026, mostly in supplies, some in pumps. Is that still the right number to be thinking about as a component of your revenue guidance for '26?

Speaker #11: And how would that 10 to 12, if we're ballpark accurate, compare to maybe total stocking you saw in 2025? Thanks.

Speaker #10: Yeah. I actually don't think I've ever communicated any particular number on what the stocking dynamic would be for 2026 in terms of dollars. So the 10 to 12 million actually isn't it's not it wouldn't be even directionally accurate.

Stephen Feider: Yeah, I actually don't, I don't think I've ever communicated any particular number on what the stocking dynamic would be for 2026 in terms of dollars. So, the $10 to 12 million actually isn't, it's not, it's not, it wouldn't be even directionally accurate. So in terms of... Yeah, I guess that number is not accurate, and I don't really want to comment on it.

Speaker #10: So in terms of, yeah, I guess that number is not accurate. And I don't really want to comment on it.

Jeff Johnson: Okay, thanks.

Jeffrey Johnson: Okay, thanks.

Speaker #11: Okay. Thanks.

Speaker #6: Thank you. Our next question comes from Travis Feed with Bank of America Securities. You may proceed.

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've got the street models in the right place. I see $27 million in street models for Q1. Taking all the comments you've given, is that kind of the right place to be, or does that need to move one way or the other?

Speaker #12: Hey, thanks for taking the question. I guess I just want to make sure we've got the street models in the right place. I see $27 million in street models for Q1.

Speaker #12: Taking all the comments you've given, is that kind of the right place to be? Or does that need to move one way or the other?

Stephen Feider: Yeah, that's directionally accurate.

Speaker #10: Yeah, that's directionally accurate.

Stephen Feider: Yeah, that's directionally accurate.

Speaker #12: Okay. And then, gross margin—I think that 54 in Q1—is that the right place to be, roughly, as well?

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

Stephen Feider: I don't want to comment specifically on any quarterly guidance as it relates to margin.

Speaker #10: I don't want to comment specifically on any quarterly guidance as it relates to margin.

Stephen Feider: I don't want to comment specifically on any quarterly guidance as it relates to margin.

Speaker #12: Okay. Thank you. And there were some comments on stepping up OPEX as a percent of sales in '26. Just wanted to try to think about how much of that's R&D, sales and marketing versus GNA and trying to think how much of that's pipeline versus kind of sales-first expansion and kind of any color on how that kind of rolls out.

Travis Steed: Okay, thank you. And there were some comments on stepping up OpEx as a percent of sales in 2026. Just wanted to try to think about how much of that's R&D, sales, and marketing versus G&A, and trying to think how much of that's pipeline versus kind of sell-through expansion and kind of any color of how that kind of rolls out.

Speaker #10: Yeah. I don't want to—I'm not going to give you numeric answers for how much to expand sales on each of those particular line items.

Stephen Feider: ... Yeah. I don't wanna—I'm not gonna give you numeric answers for how much to expand sales or each of those particular line items. But the most notable expansions 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're also, we're 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 is, or the other line item to comment on, is with regards to R&D investments. And there's various projects that Sean outlined in his prepared remarks that we're working on.

Speaker #10: But the most notable expansions in terms of OPEX will be, number one, to Sales and Marketing, for reasons that we discussed already with the Salesforce expansion.

Speaker #10: But we're 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.

Speaker #10: And then the second thing relates, or the other line item to comment on, is with regards to R&D investments. And there's various projects that Sean outlined in his prepared remarks that we're working on.

Speaker #10: And as a result of those particular projects, notably the Bihormonal program and Mint, you will see an uptick in R&D expense in 2026. That's pretty meaningful from '25.

Stephen Feider: And as a result of those particular projects, notably the bi-hormonal program and Mint, you will see an uptick in R&D expense in 2026. That's pretty meaningful from 2025. And then G&A will show a very mild increase.

Speaker #10: And then GNA will be at will show a very mild increase.

Speaker #12: Okay. Thanks a lot.

Daniela Antalffy: Okay. Thanks a lot.

Travis Steed: Okay. Thanks a lot.

Speaker #10: Yep. Good questions. Thanks, Travis.

Stephen Feider: Yep, good question. Thanks, Travis.

Speaker #6: Thank you. Our next question comes from Frank Dickinson with Lakeview Capital Markets. You may proceed.

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

Frank Takkinen: Great. Thank you for taking the question. I had 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 a phenomenon that occurs?

Speaker #13: Great, thank you for taking the questions. I had one follow-up on pharmacy channel starts related to the 36% to 38% guidance. How should we think about that cadencing?

Speaker #13: 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?

Speaker #13: Or is that not a phenomenon that occurs?

Speaker #10: Want me to say that one? Yeah. That's a really good question. Unfortunately, it layers a couple of things on top of one another. They make it a little bit hard to answer.

Sean Saint: Want me to take that one?

Frank Takkinen: Sure.

Sean Saint: Yeah, that's a really good question. It unfortunately 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 copay. Eventually, you start meeting your copays, and 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.

Speaker #10: So let me talk about seasonality for a quick moment. Historically, seasonality in DME was a question of early in the year, you have this big copay.

Speaker #10: Eventually, you start meeting your copays, and it gets cheaper to get a pump. So people were waiting to get that pump till later in the year.

Speaker #10: 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.

Speaker #10: 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're still going to see a drop, because you do still see resets of deductibles.

Sean Saint: However, and this is associated with your question, Q1, you're still gonna see a drop because you do still see resets of deductibles. So people who would have come to you in, let's say, December and been able to get the pump for relatively zero out-of-pocket costs, may, in January, have a higher out-of-pocket cost. So that's why the pronounced drop in January. Excuse me. Sorry. And I'm losing my question. Help me out. I guess, Frank, does that make sense?

Speaker #10: So people who would have come to you in, let's say, December and been able to get the pump for relatively low out-of-pocket costs may, in January, have a higher out-of-pocket cost.

Speaker #10: So that's why the pronounced drop in January. Excuse me, sorry. And I'm losing my question—help me out. Yeah, I guess, Frank, does that make sense?

Speaker #13: Yeah. That's sort of helpful. I think the really the concept of just DME starting at a higher or sorry, pharmacy starting at a higher percent of total starts in Q1 and then kind of staying flat or how does that pharmacy start trend throughout the year?

Frank Takkinen: Yeah, that's sort of helpful. I think really the concept of just DME starting at a higher, or sorry, pharmacy-

Sean Saint: Oh, right

Frank Takkinen: ... starting at a higher percent of total starts in Q1 and then kind of staying flat, or like, how does that, that-

Sean Saint: Right. Okay

Frank Takkinen: Pharmacy start trend throughout the year?

Sean Saint: So, sorry, thanks, 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's gonna be one layer. Additionally, you're 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's not unlike seasonality we've talked about in the past. There's more than one thing causing that, so I think it becomes kind of hard to predict. But directionally, yes, you should probably see a higher pers-- Well, anyway, those two things are on top of one another. Hopefully, that makes sense.

Speaker #10: Sorry. 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?

Speaker #10: So that's going to be one layer. Additionally, you're right. Likely, a higher percentage in Q1—holding everything else constant—would go through pharmacy because of the DME decisions being made.

Speaker #10: So those two things layer in. But again, it's not unlike seasonality we've talked about in the past. There's more than one thing causing that.

Speaker #10: So, I think it becomes kind of hard to predict. But directionally, yes, you should probably see a higher—well, anyway, those two things are on top of one another.

Speaker #10: Hopefully, that makes sense.

Speaker #13: Yeah, that's great, thanks. And then just one quick follow-up: can you talk about the Phase 2b a little bit more? I heard the prepared remarks, but maybe just—what exactly are you looking for in that Phase 2b before kicking off the pivotal?

Frank Takkinen: Yeah, that's 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 just maybe what are you looking for exactly in that phase 2B before kicking off the pivotal?

Speaker #10: Yeah. From Beta Bionics' side, the Phase 2b is primarily about confidence that when we get into the pivotal, we're going to have success.

Sean Saint: Yeah. From Beta Bionics side, the Phase 2B is primarily about confidence that when we get into the pivotal, we're gonna have success. You know, over the course of Beta Bionics' history with the bihormonal trial, and this has been true all the way from, I don't know, 2007 till now, all of the trials that we've run, all the formative trials that we've run, that we now call 2A trials, were very, very small. And, you know, we've published a bunch in the past, I won't 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.

Speaker #10: Over the course of Beta Bionics' history with the bihormonal trial—and this has been true all the way from, I don't know, 2007 till now—all of the trials that we've run, all of the formative trials that we run, that we now call 2A trials, were very, very small.

Speaker #10: And we've published a bunch of them in the past. I won't rehash it now. It can be very difficult to extrapolate the results of a several-hundred-patient, year-long clinical trial from a very short, small-end trial.

Speaker #10: So it's a bit of a diligence item to walk before you run and just step up and make sure we're not going to get to an enormous trial and really fail.

Sean Saint: So it's a bit of a diligence item to walk before you run and just step up and make sure we're not gonna get to an enormous trial and really fail. So that's primarily what that's about. And the agency would have slightly different words for that, but I think at the end of the day, it would be similar reasoning.

Speaker #10: So that's primarily what that's about. And the agency would have slightly different words for that. But I think at the end of the day, it would be a similar reasoning.

Speaker #13: Okay. That's helpful. Thanks for taking the questions.

Frank Takkinen: Okay, that's helpful. Thanks for taking the questions.

Speaker #6: Thank you. Our next question comes from Danielle Antapi with UBS. You may proceed.

Operator: Thank you. Our next question comes from Daniela Antalffy with UBS. You may proceed.

Daniela Antalffy: Hey, good afternoon, guys. Thanks so much for taking the question. Just a question here on type 2, and less about the timeline for approval, et cetera, 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 it's a very good 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'm just curious about, you know, 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.

Danielle Antalffy: Hey, good afternoon, guys. Thanks so much for taking the question. Just a question here on type 2, and less about the timeline for approval, et cetera, 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 it's a very good 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'm just curious about, you know, 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.

Speaker #14: Hi. Good afternoon, guys. Thanks so much for taking the question. Just a question here on type two. And less about the timeline for approval, etc.

Speaker #14: 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 at the very pump for type 2 patients.

Speaker #14: So go-to-market strategy in that patient population probably a little bit different than type one, particularly given where these patients are managed. So I'm just curious about how you guys are thinking about that ahead of a potential FDA approval there and sort of really getting after that.

Speaker #14: Thanks so much.

Sean Saint: Yeah, good question, Daniela. I think you just identified the right point there, which is where the patients are managed. I think what I'll illustrate, and I think you know this from your very question, is that in the endocrinology space, the healthcare 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's exactly what we're seeing across the different devices. In the primary care space, that's probably going to be less true. So I think it does become more important that you know, Type 2 indications there by the time we start to market meaningfully in the primary care space, which we've already said that we don't have a primary care sales force at this point.

Speaker #10: 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'll illustrate—and I think you know this from your very question—is that in the endocrinology space, the healthcare providers have proved to be quite mature and understanding of what the iLet is and what other products are.

Speaker #10: And they know where they can be utilized. And that's exactly what we're seeing. Across the different devices. In the primary care space, that's probably going to be less true.

Speaker #10: And so I think it does become more important that type two indications there by the time we start to market meaningfully in the primary care space, which we've already said that we don't have a primary care sales force at this point.

Speaker #10: So, the way we intend to do that is a little bit different. But I do agree that a Type 2 indication is going to be extremely important there because, well, for the reasons that you implied.

Sean Saint: So, 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're, we're aware of that dynamic.

Speaker #10: So, we're aware of that dynamic.

Speaker #14: Thank you.

Jeff Johnson: Thank you.

Danielle Antalffy: Thank you.

Speaker #13: And Danielle, thanks for launching coverage on us. Great work.

Stephen Feider: Daniela, thanks for launching coverage on us. Great work.

Jeff Johnson: Thanks for all the help.

Jeffrey Johnson: Thanks for all the help.

Speaker #14: Thanks for all the help.

Speaker #13: Thank you. And as a reminder, to ask a question, please press star-1-1 on your telephone. Our next question comes from Jeffrey Cohen with Ladenburg Thalmann & Company.

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone. Our next question comes from Jeffrey Cohen with Ladenburg Thalmann & Company. You may proceed.

Speaker #13: You may proceed.

Jeffrey Cohen: Hi, thanks for taking the questions. I wonder if you could dive into R&D a little bit as far as, 2026 with regard to cadence or throughout the year. I know you had called out just an incremental increase across the board.

Speaker #15: Hello, thanks for taking the questions. I wonder if you could dive into R&D a little bit as far as '26 with regard to cadence or throughout the year.

Speaker #15: I know you had called out just an incremental increase across the board.

Stephen Feider: Yeah. So I don't want to speak specifically on what timing of the investments you'll see in R&D, but generally, Jeff, you can expect consistent investments, consistent pattern of investments throughout the year. There may be some lumpiness when we, you know, say, start trials or the like, but I wouldn't model anything, you know, more heavily, significantly heavily weighted in one quarter or another.

Speaker #13: Yeah, so I don't want to speak specifically on what timing of the investments you'll see in R&D, but generally, Jeff, you can expect consistent investments or a consistent pattern of investments throughout the year.

Speaker #13: There may be some lumpiness when we, say, start trials or the like, but I wouldn't model anything more significantly heavily weighted in one quarter or another.

Speaker #15: Okay, thanks. That's helpful. And you had called out maybe taking some pricing in the pharmacy channel. Any plans for the DMA channel, or what are you expecting on pricing throughout the year?

Jeffrey Cohen: Okay, thanks. That's helpful. You called out maybe taking some pricing in the pharmacy channel. Any plans for the DME channel, or what are you expecting on pricing throughout the year?

Speaker #13: 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.

Stephen Feider: 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 Cohen: Perfect. Thanks for taking our questions.

Speaker #15: Perfect. Thanks for taking our questions.

Stephen Feider: Yeah, appreciate it, Jeff.

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

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