Beta Bionics, Inc.

Previous wording

We are a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. Diabetes is a chronic condition that requires ongoing insulin management, and despite advances in care, many PWD continue to struggle to achieve optimal outcomes. Despite decades of innovation, a significant unmet need remains. Our product, the iLet, is the first insulin delivery device cleared by the U.S. Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. We believe this represents a significant advancement over currently available insulin delivery options by offering a differentiated combination of improved glycemic control and a simplified experience for users and caregivers.

Current wording

We are a commercial-stage medical device company engaged in the design, development, and commercialization of innovative solutions to improve the health and quality of life of insulin-requiring people with diabetes (PWD) by utilizing advanced adaptive closed-loop algorithms to simplify and improve the treatment of their disease. Diabetes is a chronic condition that requires ongoing insulin management, and despite advances in care, many PWD continue to struggle to achieve optimal outcomes. Despite decades of innovation, a significant unmet need remains. Our product, the iLet, is the first insulin delivery device cleared by the U.S. Food and Drug Administration (FDA) to utilize adaptive closed-loop algorithms to autonomously determine every insulin dose without requiring a user to count carbohydrate intake. We believe this represents a significant advancement over currently available insulin delivery options by offering a differentiated combination of improved glycemic control and a simplified experience for users and caregivers. Our mission is to simplify and alleviate the burden of managing diabetes with life-changing solutions. Our vision is to make diabetes easier, for everyone, every day. Our goal is to establish the iLet as the standard of care for insulin delivery.

Previous wording

Our initial commercialization efforts for the iLet are in type 1 diabetes (T1D), an indication for which we received FDA clearance in patients six and older in May 2023, in the United States. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.9 million people with T1D currently in the United States, all of whom require daily insulin replacement to manage their disease. We believe that one of the principal causes of suboptimal outcomes as it relates to disease management is the complexity of the user experience with most currently available insulin pumps and hybrid closed-loop systems, which has kept the majority of PWD from adopting them despite the improved disease management they can offer. We believe that approximately one-third of people with T1D in the United States utilize insulin pumps or hybrid closed-loop systems to receive their daily insulin, while the majority receive their daily insulin via MDI, which is less complex, but often less effective, and has been shown to be associated with higher HbA1c levels. Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 69% and 71% of the iLet’s adoption during the six months ended June 30, 2026 and 2025, respectively, came from PWD who were previously utilizing MDI.

Current wording

Our initial commercialization efforts for the iLet are in type 1 diabetes (T1D), an indication for which we received FDA clearance in patients six and older in May 2023, in the United States. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.9 million people with T1D currently in the United States, all of whom require daily insulin replacement to manage their disease. We believe that one of the principal causes of suboptimal outcomes as it relates to disease management is the complexity of the user experience with most currently available insulin pumps and hybrid closed-loop systems, which has kept the majority of PWD from adopting them despite the improved disease management they can offer. We believe that approximately one-third of people with T1D in the United States utilize insulin pumps or hybrid closed-loop systems to receive their daily insulin, while the majority receive their daily insulin via MDI, which is less complex, but often less effective, and has been shown to be associated with higher HbA1c levels. Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 69% and 70% of the iLet’s adoption during the nine months ended September 30, 2026 and 2025, respectively, came from PWD who were previously utilizing MDI.

Previous wording

By contrast, PBP reimbursement requires the user and insurance carrier to make a small upfront payment and reimbursement, respectively, for the iLet, allowing for a potentially higher rate of adoption by PWD. The insurance carrier then makes larger reimbursement payments for the purchase of single-use products, with the user’s payments for the single-use products being generally consistent with what the user would likely pay for single-use products in DME reimbursement. As a result, we recognize a small amount of revenue at or around the date the iLet is sold in the PBP channel and we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to then start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the six months ended June 30, 2026 and 2025, PBP channel sales represented 37% and 21% of net sales, respectively.

Current wording

By contrast, PBP reimbursement requires the user and insurance carrier to make a small upfront payment and reimbursement, respectively, for the iLet, allowing for a potentially higher rate of adoption by PWD. The insurance carrier then makes larger reimbursement payments for the purchase of single-use products, with the user’s payments for the single-use products being generally consistent with what the user would likely pay for single-use products in DME reimbursement. As a result, we recognize a small amount of revenue at or around the date the iLet is sold in the PBP channel and we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to then start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the nine months ended September 30, 2026 and 2025, PBP channel sales represented 38% and 21% of net sales, respectively.

Previous wording

In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team. We are developing Mint, a next-generation, tubeless insulin patch pump designed to provide the same adaptive closed-loop automation of the iLet in a discreet, wearable format. The device features a two-part design, including a reusable controller that houses the electronics and adaptive algorithm paired with a disposable cartridge. The system will be waterproof, smartphone-controlled through iOS and Android applications, and designed for efficient large-scale manufacturing with reduced environmental waste. We expect Mint to expand the addressable insulin delivery market, particularly among people seeking a tubeless form factor reimbursed through the pharmacy channel. Subject to receiving FDA 510(k) clearance as an alternate controller enabled (ACE) pump, we expect to fully commercialize Mint by the end of the second quarter of 2027.

Current wording

In addition to our commercialized product and to maintain our competitive position in the marketplace, we intend to continue investing in disruptive technologies through our experienced research and development team.

Previous wording

We are also in the early stages of developing a first-of-its-kind bihormonal system of the iLet, which combines automated delivery of insulin and glucagon, the BG-raising hormone that protects against low blood sugar, or hypoglycemia, with adaptive closed-loop algorithms where all doses of both hormones are autonomously determined. As part of our development plans, in September 2025, we completed a clinical trial in Canada assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (also referred to as the glucagon asset, and referred to herein as the PK-PD Trial). The completion of the PK-PD Trial enables us to bridge our previous bihormonal clinical data to our glucagon product candidate. We believe that the results from the PK-PD Trial are supportive of the continued development of our glucagon product candidate for use in our bihormonal system of the iLet. In the fourth quarter of 2025, we completed our first-in-human Phase 2a feasibility trial in New Zealand evaluating the integrated bihormonal system, including the glucagon formulation, pump, and dosing algorithms. In the first quarter of 2026, we initiated an additional Phase 2a feasibility trial to further evaluate the system, including the glucagon formulation, pump, and dosing algorithms. Based on the results from this feasibility work, we identified opportunities to improve the system, including the glucagon asset’s excipient profile and dosing algorithms. We are also pursuing the development of the iLet for expanded patient populations and indications, including people with type 2 diabetes (T2D). In July 2026, we began enrolling adults with T2D in a pivotal trial in the United States, with the goal of expanding the iLet’s indications for use to include adults with T2D around mid-year 2027, subject to regulatory clearance by the FDA.

Current wording

We are in the early stages of developing a first-of-its-kind bihormonal system of the iLet, which combines automated delivery of insulin and glucagon, the BG-raising hormone that protects against low blood sugar, or hypoglycemia, with adaptive closed-loop algorithms where all doses of both hormones are autonomously determined. As part of our development plans, in September 2025, we completed a clinical trial in Canada assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (also referred to as the glucagon asset, and referred to herein as the PK-PD Trial). The completion of the PK-PD Trial enables us to bridge our previous bihormonal clinical data to our glucagon product candidate. We believe that the results from the PK-PD Trial are supportive of the continued development of our glucagon product candidate for use in our bihormonal system of the iLet. In the fourth quarter of 2025, we completed our first-in-human Phase 2a feasibility trial in New Zealand evaluating the integrated bihormonal system, including the glucagon formulation, pump, and dosing algorithms. In the first quarter of 2026, we initiated an additional Phase 2a feasibility trial to further evaluate the system, including the glucagon formulation, pump, and dosing algorithms. Based on the results from this feasibility work, we identified opportunities to improve the system, including the glucagon asset’s excipient profile and dosing algorithms. During the third quarter of 2026, we continued our efforts to reformulate the glucagon asset and refine the dosing algorithms. We are also pursuing the development of the iLet for expanded patient populations and indications, including people with type 2 diabetes (T2D). In October 2026, we completed enrollment of adults with T2D in a pivotal trial in the United States, with the goal of expanding the iLet’s indications for use to include adults with T2D around mid-year 2027, subject to regulatory clearance by the FDA. Also, in the fourth quarter of 2026, we intend to initiate a pivotal trial studying a next-generation fully-closed loop (FCL) algorithm in adults with type 1 and type 2 diabetes.

Previous wording

We have a Device License Agreement with Boston University (BU) that requires ongoing royalty payments and other financial obligations related to products incorporating BU-licensed technology. Under the agreement, we are required to pay (i) quarterly royalties in the mid-single-digit percentage range based on net sales of licensed products by us and our affiliates, (ii) quarterly royalties in the low double-digit percentage range based on net sales by sublicensees, which are creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments in the low double-digit percentage range based on certain non-royalty sublicensing revenue. We are also responsible for reimbursing BU for patent-related costs and may be required to pay an assignment fee in the event of a sale of substantially all assets related to the licensed technology. During the six months ended June 30, 2026, we continued to incur royalty and license-related costs under this agreement which were recorded as cost of sales or operating expenses, as applicable, and expect these costs to increase as sales volumes grow.

Current wording

We have a Device License Agreement with Boston University (BU) that requires ongoing royalty payments and other financial obligations related to products incorporating BU-licensed technology. Under the agreement, we are required to pay (i) quarterly royalties in the mid-single-digit percentage range based on net sales of licensed products by us and our affiliates, (ii) quarterly royalties in the low double-digit percentage range based on net sales by sublicensees, which are creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments in the low double-digit percentage range based on certain non-royalty sublicensing revenue. We are also responsible for reimbursing BU for patent-related costs and may be required to pay an assignment fee in the event of a sale of substantially all assets related to the licensed technology. During the nine months ended September 30, 2026, we continued to incur royalty and license-related costs under this agreement which were recorded as cost of sales or operating expenses, as applicable, and expect these costs to increase as sales volumes grow.

Previous wording

We have a Control Algorithm license agreement with BU covering automated control system technology incorporated into the iLet. Under the financial terms of the agreement, we are required to pay BU (i) quarterly royalties of a mid-single-digit percentage based on net sales by us and our affiliates, (ii) quarterly royalties of a low double-digit percentage based on net sales by sublicensees, in each case of (i) and (ii) creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments of a low double-digit percentage of certain non-royalty sublicensing revenue received from sublicensees. We are also responsible for reimbursing patent-related costs and are required to make a one-time change-of-control payment of $65,000 if such an event occurs. During the six months ended June 30, 2026, we continued to incur royalty and license-related costs under this agreement and expect these costs to increase as sales volumes grow.

Current wording

We have a Control Algorithm license agreement with BU covering automated control system technology incorporated into the iLet. Under the financial terms of the agreement, we are required to pay BU (i) quarterly royalties of a mid-single-digit percentage based on net sales by us and our affiliates, (ii) quarterly royalties of a low double-digit percentage based on net sales by sublicensees, in each case of (i) and (ii) creditable against a minimum annual royalty amount, and (iii) quarterly lump-sum payments of a low double-digit percentage of certain non-royalty sublicensing revenue received from sublicensees. We are also responsible for reimbursing patent-related costs and are required to make a one-time change-of-control payment of $65,000 if such an event occurs. During the nine months ended September 30, 2026, we continued to incur royalty and license-related costs under this agreement and expect these costs to increase as sales volumes grow.

Previous wording

We are pursuing a multi-channel coverage and reimbursement strategy to maximize access to the iLet within the T1D population, provide flexibility for PWD in choosing their device and provide PWD with advantageous coverage and reimbursement terms. We are working with payors to establish coverage and reimbursement under both the DME and PBP channels as we believe this strategy increases access and optimizes the potential for better medical outcomes for PWD through the adoption of the iLet. The DME and PBP channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. When considering the overall economics over the lifetime of each iLet, sales through the DME channel generally result in higher upfront cash flows from the large, upfront payment and reimbursement for the iLet, but lead to lower cash flows over time as the user purchases the necessary single-use products. By contrast, sales through the PBP channel generally result in lower upfront cash flows from the small payment and reimbursement for the iLet, but lead to higher cash flows over time as the user purchases the necessary single-use products. This is because single-use products under the PBP channel are sold at a much higher per unit cost than under the DME. As a result of a small amount of revenue recognized at or around the date the iLet is sold in the PBP channel, we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the six months ended June 30, 2026 and 2025, PBP channel sales represented 37% and 21%, respectively, of net sales. When comparing sales through the DME and PBP channels, we expect sales through the PBP channel will have a more favorable economic impact on our financial results over the lifetime of the iLet. To the extent that our mix of channel reimbursement fluctuates, our financial results may vary from period to period.

Current wording

We are pursuing a multi-channel coverage and reimbursement strategy to maximize access to the iLet within the T1D population, provide flexibility for PWD in choosing their device and provide PWD with advantageous coverage and reimbursement terms. We are working with payors to establish coverage and reimbursement under both the DME and PBP channels as we believe this strategy increases access and optimizes the potential for better medical outcomes for PWD through the adoption of the iLet. The DME and PBP channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. When considering the overall economics over the lifetime of each iLet, sales through the DME channel generally result in higher upfront cash flows from the large, upfront payment and reimbursement for the iLet, but lead to lower cash flows over time as the user purchases the necessary single-use products. By contrast, sales through the PBP channel generally result in lower upfront cash flows from the small payment and reimbursement for the iLet, but lead to higher cash flows over time as the user purchases the necessary single-use products. This is because single-use products under the PBP channel are sold at a much higher per unit cost than under the DME. As a result of a small amount of revenue recognized at or around the date the iLet is sold in the PBP channel, we absorb initial negative gross margin. iLet sales in the PBP channel are generally expected to start generating cumulative positive gross margin for us following the third month the user utilizes the iLet and continues to purchase single-use products. For the nine months ended September 30, 2026 and 2025, PBP channel sales represented 38% and 21%, respectively, of net sales. When comparing sales through the DME and PBP channels, we expect sales through the PBP channel will have a more favorable economic impact on our financial results over the lifetime of the iLet. To the extent that our mix of channel reimbursement fluctuates, our financial results may vary from period to period.

Previous wording

The medical device industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products, treatment techniques or technologies. We expect our business to be impacted by the introduction of new diabetes devices and treatments by us or our competitors. In order to maintain our competitive position in the marketplace, we intend, through our experienced research and development team, to continue investing in disruptive technologies, such as a patch pump and a bihormonal system of the iLet, as well as pursuing the development of the iLet for expanded patient populations and indications such as people with T2D.

Current wording

The medical device industry is intensely competitive, subject to rapid change and highly sensitive to the introduction of new products, treatment techniques or technologies. We expect our business to be impacted by the introduction of new diabetes devices and treatments by us or our competitors. In order to maintain our competitive position in the marketplace, we intend, through our experienced research and development team, to continue investing in disruptive technologies, such as a bihormonal system of the iLet, as well as pursuing the development of the iLet and Mint, our patch pump, for expanded patient populations and indications such as people with T2D.

Previous wording

The medical devices we manufacture are subject to laws and regulation by numerous regulatory bodies, including the FDA. The laws and regulations govern, among other things, the research and development, design, testing, manufacture, packaging, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting, distribution and import and export of medical devices. Any adverse event involving any products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency actions, which could include warning letters, inspection, mandatory recalls or other enforcement actions. For example, in January 2026, we received a Warning Letter (“Warning Letter”) from the FDA following inspection of our facility in Irvine, California that occurred from June 9, 2025 through June 26, 2025. In the Warning Letter, the FDA cited deficiencies in the response letters we sent to the FDA following the FDA’s issuance of a Form 483, List of Inspectional Observations (“Form 483”) in June 2025. The Warning Letter highlights non-conformities observed by the FDA in relation to our Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483. We have responded to the FDA regarding the Warning Letter and continue to work to address the FDA’s observations. In the future, we also intend to pursue additional products, such as Mint, our patch pump, and a bihormonal system of the iLet, as well as pursue the development of the iLet for expanded patient populations and indications such as people with T2D, which will increase our expenses and subject us to increased regulatory-related risks.

Current wording

The medical devices we manufacture are subject to laws and regulation by numerous regulatory bodies, including the FDA. The laws and regulations govern, among other things, the research and development, design, testing, manufacture, packaging, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting, distribution and import and export of medical devices. Any adverse event involving any products that we distribute could result in future corrective actions, such as recalls or customer notifications, or regulatory agency actions, which could include warning letters, inspection, mandatory recalls or other enforcement actions. For example, in January 2026, we received a Warning Letter (“Warning Letter”) from the FDA following inspection of our facility in Irvine, California that occurred from June 9, 2025 through June 26, 2025. In the Warning Letter, the FDA cited deficiencies in the response letters we sent to the FDA following the FDA’s issuance of a Form 483, List of Inspectional Observations (“Form 483”) in June 2025. The Warning Letter highlights non-conformities observed by the FDA in relation to our Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483. We have responded to the FDA regarding the Warning Letter and continue to work to address the FDA’s observations. In the future, we also intend to pursue additional products, such as a bihormonal system of the iLet, as well as pursue the development of the iLet and Mint, our patch pump, for expanded patient populations and indications such as people with T2D, which will increase our expenses and subject us to increased regulatory-related risks.

Previous wording

Our research and development expenses include engineering and clinical trial activities for the iLet, regulatory efforts, personnel costs such as salaries, bonuses, stock-based compensation and benefits, payments under third-party license agreements, supplies, development prototypes, design and testing services, depreciation and allocated facilities and information technology expenses, all of which are expensed as incurred. We track research and development expenses by individual product candidate. We expect research and development expenses to increase significantly for the foreseeable future as we advance clinical development, pursue new products and indications including the bihormonal system, Mint, our patch pump, and potential T2D use, expand technical and operational staffing, make required payments under license arrangements, and establish commercial scale manufacturing capabilities.

Current wording

Our research and development expenses include engineering and clinical trial activities for the iLet and Mint, our patch pump, regulatory efforts, personnel costs such as salaries, bonuses, stock-based compensation and benefits, payments under third-party license agreements, supplies, development prototypes, design and testing services, depreciation and allocated facilities and information technology expenses, all of which are expensed as incurred. We track research and development expenses by individual product candidate. We expect research and development expenses to increase significantly for the foreseeable future as we advance clinical development, pursue new products and indications including the bihormonal system and potential T2D use, enhance the iLet and Mint, expand technical and operational staffing, make required payments under license arrangements, and establish commercial scale manufacturing capabilities.

Previous wording

Net sales for the three months ended June 30, 2026 was $32.0 million, compared to $23.2 million for the three months ended June 30, 2025. The increase in net sales of $8.8 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For the three months ended June 30, 2026, single-use products accounted for 60% of net sales, up from 41% for the three months ended June 30, 2025.

Current wording

Net sales for the three months ended September 30, 2026 were $35.5 million, compared to $27.3 million for the three months ended September 30, 2025. The increase in net sales of $8.2 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For the three months ended September 30, 2026, single-use products accounted for 68% of net sales, up from 47% for the three months ended September 30, 2025.

Previous wording

For the three months ended June 30, 2026, 64% of net sales were generated through the DME channel and 36% through the PBP channel, compared to 80% and 20%, respectively, for the three months ended June 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage enabled through contracts with PBMs and their affiliated health plans, resulting in a higher proportion of new patient starts being reimbursed through this channel.

Current wording

For the three months ended September 30, 2026, 62% of net sales were generated through the DME channel and 38% through the PBP channel, compared to 77% and 23%, respectively, for the three months ended September 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage enabled through contracts with PBMs and their affiliated health plans, resulting in a higher proportion of new patient starts being reimbursed through this channel.

Previous wording

Net sales for the six months ended June 30, 2026 was $59.6 million, compared to $40.9 million for thesix months ended June 30, 2025. This increase in net sales of $18.7 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For thesix months ended June 30, 2026, single-use products accounted for 61% of net sales, up from 42% for thesix months ended June 30, 2025.

Current wording

Net sales for the nine months ended September 30, 2026 were $95.1 million, compared to $68.1 million for thenine months ended September 30, 2025. This increase in net sales of $27.0 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base, and growth in new patient starts. For thenine months ended September 30, 2026, single-use products accounted for 63% of net sales, up from 44% for thenine months ended September 30, 2025.

Previous wording

For thesix months ended June 30, 2026, 63% of net sales were generated through the DME channel and 37% through the PBP channel, compared to 79% and 21%, respectively, for thesix months ended June 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage, resulting in a larger percentage of new patient starts reimbursed through this channel.

Current wording

For thenine months ended September 30, 2026, 62% of net sales were generated through the DME channel and 38% through the PBP channel, compared to 79% and 21%, respectively, for thenine months ended September 30, 2025. The shift toward the PBP channel was driven by expanded pharmacy benefit coverage, resulting in a larger percentage of new patient starts reimbursed through this channel.

Previous wording

Cost of sales for the three months ended June 30, 2026 was $13.1 million, compared to $10.7 million for the three months ended June 30, 2025. This increase of $2.4 million was primarily attributable to increased volumes of single-use products and pharmacy iLets.

Current wording

Cost of sales for the three months ended September 30, 2026 was $15.2 million, compared to $12.1 million for the three months ended September 30, 2025. This increase of $3.1 million was primarily attributable to increased volumes of single-use products and iLets sold through the PBM channel.

Previous wording

Cost of sales for thesix months ended June 30, 2026 was $24.3 million, compared to $19.4 million for thesix months ended June 30, 2025. This increase of $4.9 million was primarily attributable to increased volumes of single-use products and pharmacy iLets.

Current wording

Cost of sales for thenine months ended September 30, 2026 was $39.5 million, compared to $31.5 million for thenine months ended September 30, 2025. This increase of $8.0 million was primarily attributable to increased volumes of single-use products and iLets sold through the PBM channel.

Previous wording

Gross profit for the three months ended June 30, 2026 was $18.9 million, compared to $12.5 million for the three months ended June 30, 2025. Gross margin was 59% for the three months ended June 30, 2026, compared to 54% in the three months ended June 30, 2025. Gross profit increased by $6.4 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Current wording

Gross profit for the three months ended September 30, 2026 was $20.3 million, compared to $15.1 million for the three months ended September 30, 2025. Gross margin was 57% for the three months ended September 30, 2026, compared to 55% in the three months ended September 30, 2025. Gross profit increased by $5.2 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Previous wording

Gross profit for the six months ended June 30, 2026 was $35.3 million, compared to $21.5 million for the six months ended June 30, 2025. Gross margin was 59% for the six months ended June 30, 2026, compared to 53% in the six months ended June 30, 2025. Gross profit increased by $13.8 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Current wording

Gross profit for the nine months ended September 30, 2026 was $55.7 million, compared to $36.6 million for the nine months ended September 30, 2025. Gross margin was 59% for the nine months ended September 30, 2026, compared to 54% in the nine months ended September 30, 2025. Gross profit increased by $19.1 million, primarily driven by higher sales volume. Gross margin improved year over year due to increased production scale, lower warranty expense and improved cost absorption.

Previous wording

Research and development expenses for the three months ended June 30, 2026 was$10.2 million, compared to $8.9 million for the three months ended June 30, 2025. The increase of $1.3 million was primarily attributable to a net increase of $1.5 million in payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities. This increase was partially offset by lower materials and clinical trial-related expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates, primarily due to the timing of development activities and the completion of certain milestones.

Current wording

Research and development expenses for the three months ended September 30, 2026 were $12.0 million, compared to $8.2 million for the three months ended September 30, 2025. The increase of $3.8 million was primarily attributable to a net increase of $3.1 million in materials, engineering and clinical trial-related expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates. The remaining increase is attributable to payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities.

Previous wording

Research and development expenses for thesix months ended June 30, 2026 was$20.6 million, compared to $16.5 million for thesix months ended June 30, 2025. The increase of $4.1 million was primarily attributable to a net increase of $3.0 million in payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities. The remaining increase is primarily attributable to higher materials and engineering expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates, partially offset by lower clinical trial-related expenses due to the timing of trial activities and completion of certain prior studies.

Current wording

Research and development expenses for thenine months ended September 30, 2026 were$32.6 million, compared to $24.7 million for thenine months ended September 30, 2025. The increase of $7.9 million was primarily attributable to a net increase of $4.2 million in materials, engineering and clinical trial-related expenses incurred in the development of Mint, our patch pump, the bihormonal system of the iLet and incremental software and product updates. The remaining increase is attributable to payroll-related expenses, including stock-based compensation, driven by an increase in headcount focused on supporting our innovation activities.

Previous wording

External research and development costs primarily include expenses incurred with third parties such as clinical research organizations conducting the clinical trials and engineering and product development consulting services associated with our development of the iLet.

Current wording

External research and development costs primarily include expenses incurred with third parties such as clinical research organizations conducting the clinical trials and engineering and product development consulting services associated with our development of the iLet and Mint, our patch pump.

Previous wording

Sales and marketing expenses for the three months ended June 30, 2026 was $24.6 million, compared to $15.6 million for the three months ended June 30, 2025. The increase of $9.0 million was primarily attributable to an increase of $6.0 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes healthcare provider (HCP)-related marketing and training and travel-related costs to support our business growth.

Current wording

Sales and marketing expenses for the three months ended September 30, 2026 were $25.1 million, compared to $16.0 million for the three months ended September 30, 2025. The increase of $9.1 million was primarily attributable to an increase of $6.2 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes healthcare provider (HCP)-related marketing and travel-related costs to support our business growth.

Previous wording

Sales and marketing expenses for the six months ended June 30, 2026 was $45.4 million, compared to $29.0 million for the six months ended June 30, 2025. The increase of $16.4 million was primarily attributable to an increase of $11.3 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes HCP-related marketing and training and travel-related costs to support our business growth.

Current wording

Sales and marketing expenses for the nine months ended September 30, 2026 were $70.5 million, compared to $45.1 million for the nine months ended September 30, 2025. The increase of $25.4 million was primarily attributable to an increase of $17.5 million in payroll-related costs, including salaries and wages, sales incentive bonuses, and stock-based compensation due to an increase in headcount of our sales force and customer care team in connection with the expansion of our sales territories within the United States. The remaining increase includes HCP-related marketing and training and travel-related costs to support our business growth.

Previous wording

General and administrative expenses for the three months ended June 30, 2026 was $9.6 million, compared to $7.9 million for the three months ended June 30, 2025. The increase of $1.7 million was primarily attributable to an increase of $1.4 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases in software-related expenses and legal fees. These increases were partially offset by a decrease in accounting and other professional service fees.

Current wording

General and administrative expenses for the three months ended September 30, 2026 were $9.8 million, compared to $7.9 million for the three months ended September 30, 2025. The increase of $1.9 million was primarily attributable to a $2.1 million increase in software-related expenses, professional service fees and payroll-related expenses, including stock-based compensation, due to an increase in headcount. These increases were partially offset by a decrease in legal fees.

Previous wording

General and administrative expenses for the six months ended June 30, 2026 was $19.2 million, compared to $14.5 million for the six months ended June 30, 2025. The increase of $4.7 million was primarily attributable to an increase of $2.7 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases in software-related expenses, quality remediation expenses, and legal fees. These increases were partially offset by a decrease in accounting and other professional service fees.

Current wording

General and administrative expenses for the nine months ended September 30, 2026 were $29.1 million, compared to $22.4 million for the nine months ended September 30, 2025. The increase of $6.7 million was primarily attributable to an increase of $3.7 million in payroll-related expenses, including stock-based compensation, due to an increase in headcount, as well as increases of $3.5 million in software-related expenses, quality remediation expenses, and professional service fees. These increases were partially offset by a decrease in accounting and legal fees.

Previous wording

Total other income (expense), net for the three months ended June 30, 2026 was $2.2 million of income, compared to $3.0 million of income for the three months ended June 30, 2025. This change of $0.8 million was primarily attributable to lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Current wording

Total other income (expense), net for the three months ended September 30, 2026 was $2.3 million of income, compared to $2.8 million of income for the three months ended September 30, 2025. This change of $0.6 million was primarily attributable to lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Previous wording

Total other income (expense), net for the six months ended June 30, 2026 was $4.6 million of income, compared to $7.0 million of expense for the six months ended June 30, 2025. This change of $11.6 million was primarily attributable to the absence of a loss from the change in fair value of warrant liabilities in the current period, as the warrants were remeasured and net exercised in connection with the Company’s IPO in January 2025, partially offset by lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Current wording

Total other income (expense), net for the nine months ended September 30, 2026 was $6.8 million of income, compared to $4.2 million of expense for the nine months ended September 30, 2025. This change of $11.0 million was primarily attributable to the absence of a loss from the change in fair value of warrant liabilities in the current period, as the warrants were remeasured and net exercised in connection with our IPO in January 2025, partially offset by lower interest income on investments, reflecting a reduction in invested balances as IPO proceeds were used to fund operating activities.

Previous wording

Net sales generally increased across the periods presented, primarily driven by continued growth in new patient starts and higher sales of both iLets and supplies. The quarterly trend reflects continued commercial adoption of the iLet and growth in the Company’s installed base, with seasonal decreases in net sales in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Current wording

Net sales generally increased across the periods presented, primarily due to higher sales volumes, driven by continued growth in new patient starts and the installed base, which resulted in higher sales of both iLets and supplies. The quarterly trend reflects continued commercial adoption of the iLet and growth in our installed base, with seasonal decreases in net sales in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Previous wording

Cost of sales generally increased across the periods presented, primarily driven by higher sales volume, including increased pharmacy channel iLet sales, and higher product warranty costs, partially offset by improved manufacturing efficiencies. Consistent with seasonal sales trends, cost of sales decreased in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Current wording

Cost of sales generally increased across the periods presented, primarily driven by higher sales volume, including increased pharmacy channel iLet sales, partially offset by improved manufacturing efficiencies. Cost of sales increased in the third quarter of 2026 compared to the second quarter of 2026, primarily due to higher sales volume and a less favorable product mix within the DME channel, reflecting a higher contribution from DME supplies and a lower contribution from DME iLets. Consistent with seasonal sales trends, cost of sales decreased in the first quarters of 2026 and 2025 compared to the immediately preceding fourth quarters.

Previous wording

Gross margin generally improved across the periods presented, driven by material cost savings, increased production volumes, and improved manufacturing cost absorption. Gross margin remained relatively consistent at approximately 59% from the fourth quarter of 2025 through the second quarter of 2026.

Current wording

Gross margin generally improved across the periods presented through the second quarter of 2026, driven by lower material costs, increased production volumes, and improved manufacturing cost absorption. Gross margin decreased to 57.3% in the third quarter of 2026 from approximately 59% in the second quarter of 2026, primarily due to unfavorable product mix within the DME channel.

Previous wording

The proportion of new patient starts reimbursed through the PBP remained in the high-30% range in the second quarter of 2026, consistent with the first quarter of 2026. The higher PBP mix compared to prior-year periods reflects expanded pharmacy benefit coverage enabled through contracts with PBMs and their affiliated health plans, resulting in a higher proportion of new patient starts being reimbursed through this channel.

Current wording

The proportion of new patient starts reimbursed through the PBP remained in the high-30% range in the third quarter of 2026, consistent with the first and second quarter of 2026.

Previous wording

Research and development expenses generally increased over the periods presented, reflecting the timing of various clinical trial-related expenses, as well as increased engineering, materials, third-party consulting and payroll-related costs to support ongoing product development and enhancement efforts, including Mint, our patch pump, bihormonal system of the iLet and incremental software and product updates.

Current wording

Research and development expenses generally increased over the periods presented, reflecting the timing of various clinical trial-related expenses, as well as increased engineering, materials, third-party consulting and payroll-related costs to support ongoing product development and enhancement efforts, including Mint, our patch pump, the bihormonal system, and incremental software and product updates.

Previous wording

Sales and marketing expenses increased across the periods presented, primarily driven by higher payroll-related costs associated with expansion of the sales force and customer care team, as well as increased marketing and education efforts.

Current wording

Sales and marketing expenses increased across the periods presented, primarily driven by higher payroll-related costs associated with expansion of the sales force and customer care team, as well as increased marketing efforts.

Previous wording

General and administrative expenses generally increased over the periods presented, primarily due to higher payroll-related costs, public company expenses, including audit, legal and insurance services, and increased operational overhead to support business growth.

Current wording

General and administrative expenses generally increased over the periods presented, primarily due to higher payroll-related costs to support growth.

Previous wording

Adjusted EBITDA fluctuated across the periods presented, reflecting the impact of revenue seasonality, continued investment in operating expenses, and changes in gross margin. Adjusted EBITDA improved through the second half of 2025 as revenue growth, improving gross margins and operating leverage more than offset increases in operating expenses, but declined in the first half of 2026 compared to the fourth quarter of 2025 primarily due to seasonal factors and higher operating expenses to support continued commercial growth. Variability across prior periods was also impacted by discrete items, including a milestone payment to Xeris in the fourth quarter of 2024 and quality system remediation expenses in the fourth quarter of 2025 and first half of 2026.

Current wording

Adjusted EBITDA fluctuated across the periods presented, reflecting the impact of revenue seasonality, continued investment in operating expenses and changes in gross margin. Adjusted EBITDA improved through the second half of 2025 as revenue growth, improved gross margins and operating leverage more than offset increases in operating expenses. Adjusted EBITDA declined in the first quarter of 2026 compared to the fourth quarter of 2025, remained relatively consistent in the second quarter of 2026, and declined further in the third quarter of 2026, primarily reflecting continued investment in operating expenses to support commercial growth. Variability across the periods presented was also impacted by discrete items, including a milestone payment to Xeris in the fourth quarter of 2024 and quality system remediation expenses beginning in the fourth quarter of 2025 and continuing through 2026.

Previous wording

Since our inception, we have incurred significant operating losses. To date, research and development, market development and commercial launch activities have accounted for a significant portion of our overall operating expenses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the commercialization of our iLet, including future development of Mint, our patch pump, and the bihormonal system of the iLet.

Current wording

Since our inception, we have incurred significant operating losses. To date, research and development, market development and commercial launch activities have accounted for a significant portion of our overall operating expenses. We expect to incur significant expenses and operating losses for the foreseeable future as we advance the commercialization of Mint, our patch pump, and further develop the bihormonal system of the iLet.

Previous wording

To date, we have funded our operations primarily through equity financings, including our IPO completed in January 2025, as well as revenue generated from the sale of the iLet and related single-use products. We have also received payments under collaboration agreements and government grants. As of June 30, 2026, we had cash, cash equivalents and short-term and long-term investments of $225.2 million.

Current wording

To date, we have funded our operations primarily through equity financings, including our IPO completed in January 2025 and our follow-on public offering in September 2026, as well as revenue generated from the sale of the iLet and related single-use products. We have also received payments under collaboration agreements and government grants. As of September 30, 2026, we had cash, cash equivalents and short-term and long-term investments of $373.6 million.

Previous wording

Net cash used in operating activities was $38.5 million for the six months ended June 30, 2026, compared to $33.6 million for the six months ended June 30, 2025. The increase in net cash used of $4.9 million was primarily driven by the impact of a $12.5 million non-cash adjustment from the change in fair value of warrant liabilities in the prior year period, which did not recur in the current period due to the net exercise of warrant liabilities upon our IPO in January 2025, partially offset by higher stock-based compensation expense, a favorable change in amortization of premiums and discounts on investments, higher depreciation expense, and a lower net loss in the current period. Working capital activity was relatively consistent year-over-year, as favorable changes in prepaid expenses and other current assets due to timing of payments on software licenses and prepaid inventory, were mostly offset by higher cash outflows from accrued expenses and other current liabilities due to timing of services incurred and accounts payable due to timing of vendor payments, mainly on inventory and progress billings on capital purchases.

Current wording

Net cash used in operating activities was $50.7 million for the nine months ended September 30, 2026, compared to $42.3 million for the nine months ended September 30, 2025. The increase in net cash used of $8.4 million was primarily driven by a higher net loss in the current period and the absence of a $12.5 million non-cash adjustment for the change in fair value of warrant liabilities recorded in the prior-year period, as the warrants were net exercised in connection with our IPO in January 2025. These impacts were partially offset by higher stock-based compensation expense, favorable changes in the amortization of premiums and discounts on investments and higher depreciation expense. Working capital activity also partially offset the increase in cash used, primarily due to favorable changes in inventories and prepaid expenses and other current assets reflecting the timing of payments on software licenses and prepaid inventory, partially offset by unfavorable changes in accounts receivable and accounts payable, with the increase in accounts receivable primarily reflecting higher sales activity late in the quarter for amounts not yet due, and the change in accounts payable reflecting the timing of vendor payments on inventory and capital purchases.

Previous wording

Net cash provided by investing activities was $48.8 million for the six months ended June 30, 2026, compared to net cash used of $172.9 million for the six months ended June 30, 2025. The increase of $221.7 million of cash provided by investing activities was primarily driven by reduced investment activity in the current period following the deployment of IPO proceeds in the prior year period. Specifically, purchases of short-term investments decreased by $190.8 million and proceeds from maturities and redemptions of short-term investments increased by $45.0 million. These increases in cash provided were partially offset by a $13.7 million increase in purchases of long-term investments as part of our cash management strategy and a $0.3 million increase in purchases of property and equipment to support further development of Mint, our patch pump.

Current wording

Net cash used in investing activities was $65.3 million for the nine months ended September 30, 2026, compared to net cash used of $163.5 million for the nine months ended September 30, 2025. The decrease of $98.1 million in net cash used in investing activities was primarily driven by a $192.8 million decrease in purchases of short-term investments and a $20.0 million increase in proceeds from maturities and redemptions of short-term investments. These decreases in cash used were partially offset by a $113.4 million increase in purchases of long-term investments, primarily from investing a portion of the proceeds from our September 2026 follow-on public offering, and a $1.3 million increase in purchases of property and equipment to support further development of Mint.