Beta Bionics, Inc.

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. T1D is an autoimmune disorder that often develops during childhood or adolescence, but can occur at any age, and arises from a person’s immune system attacking and destroying the insulin-producing beta cells in the pancreas. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.8 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. These systems require PWD to set and to periodically adjust several insulin pump parameters, to quantify daily carbohydrate intake, and to frequently calculate proper doses of insulin for their pump to deliver. We believe this complexity, and the constant engagement that is required in order to enjoy the full therapeutic benefits that these systems can offer, limits their uptake to a subset of PWD and to subspecialty healthcare providers (HCPs). 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. This is based on our internal estimates factoring epidemiologic data from government and leading industry organizations such as the CDC (to establish the overall size of the T1D population) and industry sales data from public filings and disclosures made by the leading device manufacturers (Medtronic, Tandem and Insulet, who collectively hold approximately 96% market share) and aggregated by third-party data service providers (to provide independent estimates of both overall device penetration of various diabetes populations). Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 71% and 66% of the iLet’s adoption through six months ended June 30, 2025 and 2024, 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. T1D is an autoimmune disorder that often develops during childhood or adolescence, but can occur at any age, and arises from a person’s immune system attacking and destroying the insulin-producing beta cells in the pancreas. According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.8 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. These systems require PWD to set and to periodically adjust several insulin pump parameters, to quantify daily carbohydrate intake, and to frequently calculate proper doses of insulin for their pump to deliver. We believe this complexity, and the constant engagement that is required in order to enjoy the full therapeutic benefits that these systems can offer, limits their uptake to a subset of PWD and to subspecialty healthcare providers (HCPs). 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. This is based on our internal estimates factoring epidemiologic data from government and leading industry organizations such as the CDC (to establish the overall size of the T1D population) and industry sales data from public filings and disclosures made by the leading device manufacturers (Medtronic, Tandem and Insulet, who collectively hold approximately 96% market share) and aggregated by third-party data service providers (to provide independent estimates of both overall device penetration of various diabetes populations). Our initial commercial results suggest that the iLet’s value proposition is resonating strongly within the MDI population as approximately 70% and 67% of the iLet’s adoption through nine months ended September 30, 2025 and 2024, respectively, came from PWD who were previously utilizing MDI.

Previous wording

The durable machine equipment (DME) and pharmacy benefit plans (PBP) reimbursement channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. DME reimbursement requires the user and insurance carrier to make a large, upfront payment and reimbursement, respectively, for the iLet, which is typically in the thousands of dollars. In order to use the iLet, the user must purchase our single-use products, which are generally sold in a 30-day supply.

Current wording

The durable medical equipment (DME) and pharmacy benefit plans (PBP) reimbursement channels for the iLet and its single-use products entail different payment outlays and therefore differentially impact PWD and our financial results. DME reimbursement requires the user and insurance carrier to make a large, upfront payment and reimbursement, respectively, for the iLet, which is typically in the thousands of dollars. In order to use the iLet, the user must purchase our single-use products, which are generally sold in a 30-day supply.

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, 2025 and 2024, PBP channel sales represented 21% and 6% 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, 2025 and 2024, PBP channel sales represented 21% and 9% 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 in the early stages of developing an insulin pump that adheres directly to the skin and administers insulin without the need for tubing, commonly known in the diabetes industry as a “patch pump.” We are also in the early stages of developing a first-of-its-kind bihormonal configuration 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, we are conducting a clinical trial to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of our glucagon product candidate (the PK-PD Trial). The PK-PD Trial is intended to enable us to bridge our previous bihormonal clinical data, which tested prior formulations of glucagon in three pre-pivotal inpatient and six pre-pivotal outpatient clinical trials, to our glucagon product candidate. In March 2025, we began enrolling patients into the PK-PD Trial in Canada. The clinical trial is currently ongoing. Preliminary PD data are supportive of continued development of the glucagon candidate. We expect to have full results from the PK-PD Trial in the second half of 2025, which will inform the go-forward development strategy for our glucagon product candidate. We also intend to pursue the development of the iLet for expanded patient populations and indications, such as people with type 2 diabetes (T2D), as we believe the size and composition of this population make it a compelling opportunity.

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. We are in the early stages of developing an insulin pump that adheres directly to the skin and administers insulin without the need for tubing, commonly known in the diabetes industry as a “patch pump.” 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, which tested prior formulations of glucagon in three pre-pivotal inpatient and six pre-pivotal outpatient clinical trials, 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. We also intend to pursue the development of the iLet for expanded patient populations and indications, such as people with type 2 diabetes (T2D), as we believe the size and composition of this population make it a compelling opportunity.

Previous wording

In connection with entering into Phase 3 of the collaboration, under the Clinical Supply Agreement, we will incur development and manufacturing costs, including ordering clinical materials and technical transfer, development, and testing of the product, totaling $5.1 million. As of June 30, 2025, we have completed the first payment of $1.5 million. The payment was initially recognized in prepaid expense and other current assets in the unaudited condensed balance sheets and a portion of the payment was expensed related to the services completed.

Current wording

In connection with entering into Phase 3 of the collaboration, under the Clinical Supply Agreement, we will incur development and manufacturing costs, including ordering clinical materials and technical transfer, development, and testing of the product, totaling $5.1 million. As of September 30, 2025, we have completed payments totaling $2.5 million. The payments were initially recognized in prepaid expense and other current assets in the unaudited condensed balance sheets and a portion of the payment was expensed related to the services completed.

Previous wording

As a medical device company, our revenue and results of operations may be impacted by the failure to obtain adequate coverage or reimbursement for our current and future products from third-party payors, as well as changes in reimbursement structures in line with our strategy.

Current wording

As a medical device company, our revenue and results of operations may be impacted if we are unable to secure sufficient coverage or reimbursement from third-party payors for our current or future products, or if reimbursement structures change under our multi-channel strategy.

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 six months ended June 30, 2025 and 2024, PBP channel sales represented 21% and 6%, 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 nine months ended September 30, 2025 and 2024, PBP channel sales represented 21% and 9%, 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 bihormonal configuration 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 patch pump and 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.

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 action, which could include inspection, mandatory recall or other enforcement action. In the future, we also intend to pursue additional products, such as a patch pump and bihormonal configuration 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 action, which could include inspection, mandatory recall or other enforcement action. In the future, we also intend to pursue additional products, such as a patch pump and 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.

Previous wording

Our research and development expenses primarily consist of engineering and research expenses related to the iLet clinical trials, regulatory expenses and personnel-related expenses, such as salaries, bonuses, stock-based compensation expense and benefits for our employees in the research and development function. We also incur research and development expenses for payments made under third-party licensing agreements, supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trial costs, and other indirect costs. We expense research and development costs as incurred. In the first quarter of 2025, we began to track research and development expenses by individual product candidate.

Current wording

Our research and development expenses primarily consist of engineering and research expenses related to the iLet clinical trials, regulatory expenses and personnel-related expenses, such as salaries, bonuses, stock-based compensation expense and benefits for our employees in the research and development function. We also incur research and development expenses for payments made under third-party licensing agreements, supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trial costs, and other indirect costs. We expense research and development costs as incurred. We track research and development expenses by individual product candidate.

Previous wording

Investigational devices in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly for the foreseeable future as we advance our current clinical development activities, develop the bihormonal configuration of the iLet, develop the patch pump, and if we pursue the development of the iLet for expanded patient populations and indications such as people with T2D. We expect our research and development expenses to also increase significantly for the foreseeable future as we hire and retain additional personnel, including research, clinical, development, manufacturing, regulatory and scientific personnel; remit payments to third parties through license arrangements; and develop, establish and validate our commercial-scale and manufacturing process.

Current wording

Investigational devices in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly for the foreseeable future as we advance our current clinical development activities, develop the bihormonal system of the iLet, develop the patch pump, and if we pursue the development of the iLet for expanded patient populations and indications such as people with T2D. We expect our research and development expenses to also increase significantly for the foreseeable future as we hire and retain additional personnel, including research, clinical, development, manufacturing, regulatory and scientific personnel; remit payments to third parties through license arrangements; and develop, establish and validate our commercial-scale and manufacturing process.

Previous wording

Net sales for the three months ended June 30, 2025 was $23.2 million, compared to $15.0 million for the three months ended June 30, 2024. The increase in net sales of $8.2 million was primarily driven by an increase in the number of single-use products sold, which increased proportionally with the expansion of our installed customer base. For the three months ended June 30, 2025, single-use products accounted for 41% of net sales, up from 21% as of the three months ended June 30, 2024.

Current wording

Net sales for the three months ended September 30, 2025 was $27.3 million, compared to $16.7 million for the three months ended September 30, 2024. The increase in net sales of $10.6 million was primarily driven by an increase in the number of single-use products sold, which increased proportionally with the expansion of our installed customer base, and growth in New Patient Starts. For the three months ended September 30, 2025, single-use products accounted for 47% of net sales, up from 27% as of the three months ended September 30, 2024. For the three months ended September 30, 2025, there were 5,334 New Patient Starts, up from 3,180 for the three months ended September 30, 2024.

Previous wording

For the three months ended June 30, 2025, 80% of net sales were generated through the DME channel and 20% through the PBP channel, compared to 95% and 5%, respectively, in the prior-year period. The increase in PBP channel sales 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, 2025, 77% of net sales were generated through the DME channel and 23% through the PBP channel, compared to 87% and 13%, respectively, in the prior-year period. The increase in PBP channel sales 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, 2025 was $40.9 million, compared to $28.0 million for thesix months ended June 30, 2024. This increase in net sales of $12.9 million was primarily driven by an increase in the number of single-use products sold, correlated to the growth in our installed base. For thesix months ended June 30, 2025, single-use products accounted for 42% of net sales, up from 19% of net sales as of thesix months ended June 30, 2024.

Current wording

Net sales for the nine months ended September 30, 2025 was $68.1 million, compared to $44.7 million for thenine months ended September 30, 2024. This increase in net sales of $23.4 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, 2025, single-use products accounted for 44% of net sales, up from 22% of net sales as of thenine months ended September 30, 2024. For the nine months ended September 30, 2025, there were 14,121 New Patient Starts, up from 8,910 for thenine months ended September 30, 2024.

Previous wording

For thesix months ended June 30, 2025, 79% of net sales were generated through the DME channel and 21% through the PBP channel, compared to 94% and 6%, respectively, for thesix months ended June 30, 2024. 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, 2025, 79% of net sales were generated through the DME channel and 21% through the PBP channel, compared to 91% and 9%, respectively, for thenine months ended September 30, 2024. 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, 2025 was $10.7 million, compared to $7.0 million for the three months ended June 30, 2024. The $3.8 million increase was primarily driven by higher volumes of single-use products and pharmacy iLets.

Current wording

Cost of sales for the three months ended September 30, 2025 was $12.1 million, compared to $7.8 million for the three months ended September 30, 2024. The $4.3 million increase was primarily driven by higher volumes of single-use products and pharmacy iLets.

Previous wording

Cost of sales for thesix months ended June 30, 2025 was $19.4 million, compared to $12.7 million for thesix months ended June 30, 2024. This increase of $6.7 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, 2025 was $31.5 million, compared to $20.5 million for thenine months ended September 30, 2024. This increase of $11.0 million was primarily attributable to increased volumes of single-use products and pharmacy iLets.

Previous wording

Gross profit for the three months ended June 30, 2025 was $12.5 million, compared to $8.1 million for the three months ended June 30, 2024. Gross margin was 54% for the three months ended June 30, 2025, compared to 54% in the three months ended June 30, 2024. The $4.4 million increase in gross profit was driven by higher sales volume.

Current wording

Gross profit for the three months ended September 30, 2025 was $15.1 million, compared to $8.9 million for the three months ended September 30, 2024. Gross margin was 55% for the three months ended September 30, 2025, compared to 53% in the three months ended September 30, 2024. The $6.2 million increase in gross profit was driven by higher sales volume.

Previous wording

Research and development expenses for the three months ended June 30, 2025 was $8.9 million, compared to $6.4 million for the three months ended June 30, 2024. The increase of $2.5 million was primarily attributable to a $1.0 million increase in engineering, materials, and clinical trial related expenses incurred for the development of our patch pump, bihormonal configuration of the iLet and incremental software and product updates. The remaining increase is attributable to a net increase of $1.4 million in payroll-related expenses, including stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan, driven by an increase in headcount primarily with our tech transfer team focused on supporting our innovation activities, and $0.1 million in allocated facilities-related expenses driven by an increase in headcount.

Current wording

Research and development expenses for the three months ended September 30, 2025 was $8.2 million, compared to $5.1 million for the three months ended September 30, 2024. The increase of $3.1 million was primarily attributable to a net increase of $1.9 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 attributable to increase in materials and clinical trial related expenses incurred for the development of our patch pump, bihormonal system of the iLet and incremental software and product updates.

Previous wording

Research and development expenses for thesix months ended June 30, 2025 was$16.5 million, compared to $11.8 million for thesix months ended June 30, 2024. The increase of $4.6 million was primarily attributable to a $2.1 million increase in engineering, materials, and clinical trial related expenses incurred for the development of our patch pump, bihormonal configuration of the iLet and incremental software and product updates. The remaining increase is attributable to a net increase of $2.2 million in payroll-related expenses, including stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan, driven by an increase in headcount primarily with our tech transfer team focused on supporting our innovation activities, and $0.3 million in allocated facilities-related expenses driven by an increase in headcount.

Current wording

Research and development expenses for thenine months ended September 30, 2025 was$24.7 million, compared to $17.0 million for thenine months ended September 30, 2024. The increase of $7.7 million was primarily attributable to a net increase of $4.1 million in payroll-related expenses, including stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan, driven by an increase in headcount focused on supporting our innovation activities. The remaining increase is attributable to materials and clinical trial related expenses incurred for the development of our patch pump, bihormonal system of the iLet and incremental software and product updates.

Previous wording

Sales and marketing expenses for the three months ended June 30, 2025 was $15.6 million, compared to $9.0 million for the three months ended June 30, 2024. The increase of $6.6 million was primarily attributable to an increase of $4.2 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 HCP-related marketing, training and professional education.

Current wording

Sales and marketing expenses for the three months ended September 30, 2025 was $16.0 million, compared to $9.6 million for the three months ended September 30, 2024. The increase of $6.4 million was primarily attributable to an increase of $4.3 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.

Previous wording

Sales and marketing expenses for the six months ended June 30, 2025 was $29.0 million, compared to $16.6 million for the six months ended June 30, 2024. The increase of $12.4 million was primarily attributable to an increase of $7.9 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, training and professional education.

Current wording

Sales and marketing expenses for the nine months ended September 30, 2025 was $45.1 million, compared to $26.3 million for the nine months ended September 30, 2024. The increase of $18.8 million was primarily attributable to an increase of $12.2 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 travel-related costs to support our business growth and HCP-related marketing and training.

Previous wording

General and administrative expenses for the three months ended June 30, 2025 was $7.9 million, compared to $4.5 million for the three months ended June 30, 2024. The increase of $3.3 million was primarily attributable to an increase of $2.2 million in payroll-related expenses, driven by an increase in headcount following the Company's initial public offering as well as increased stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan. The remaining increase is partially attributable to professional fees, including legal and accounting services of $0.5 million primarily related to operating as a public company.

Current wording

General and administrative expenses for the three months ended September 30, 2025 was $7.9 million, compared to $5.1 million for the three months ended September 30, 2024. The increase of $2.8 million was primarily attributable to an increase of $1.8 million in payroll-related expenses, driven by an increase in headcount following the Company's initial public offering as well as increased stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan. The remaining increase is partially attributable to professional fees, including legal and accounting services of $1.0 million primarily related to operating as a public company.

Previous wording

General and administrative expenses for the six months ended June 30, 2025 was $14.5 million, compared to $8.1 million for the six months ended June 30, 2024. The increase of $6.4 million was primarily attributable to an increase of $3.7 million in payroll-related expenses, driven by an increase in headcount following the Company's initial public offering as well as increased corporate bonus incentives provided to management level employees and stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan. The remaining increase is partially attributable to professional fees, including legal and accounting services, and increased insurance premiums primarily related to operating as a public company.

Current wording

General and administrative expenses for the nine months ended September 30, 2025 was $22.4 million, compared to $13.2 million for the nine months ended September 30, 2024. The increase of $9.2 million was primarily attributable to an increase of $5.5 million in payroll-related expenses, driven by an increase in headcount following the Company's initial public offering as well as increased corporate bonus incentives provided to management level employees and stock-based compensation related to RSUs granted on March 15, 2025 to eligible employees under the 2025 Plan. The remaining increase is partially attributable to professional fees, including legal and accounting services, software-related expenses, and increased insurance premiums primarily related to operating as a public company.

Previous wording

Total other income (expense), net for the three months ended June 30, 2025 was $3.0 million income, compared to ($2.7) million expense for the three months ended June 30, 2024. This increase of $5.7 million was attributable to a $3.7 million decrease in expense from the change in fair value of our warrant liabilities due to changes in inputs associated with the fair value measurement immediately prior to our initial public offering, which were converted into shares of common stock upon IPO effectiveness. This was partially offset by a $2.0 million increase in interest income from our short-term and long-term investments due to the investment of our IPO proceeds during the first quarter of 2025.

Current wording

Total other income (expense), net for the three months ended September 30, 2025 was $2.8 million income, compared to $1.2 million income for the three months ended September 30, 2024. This increase of $1.6 million was attributable to a $2.0 million increase in interest income from our short-term and long-term investments due to the investment of our IPO proceeds during the first quarter of 2025. This was partially offset by a $0.4 million decrease in expense from the change in fair value of our warrant liabilities based on the fair value measurement at the end of the third quarter of 2024, which were converted into shares of common stock upon IPO effectiveness at the end of the first quarter of 2025.

Previous wording

Total other expense, net for thesix months ended June 30, 2025 was $7.0 million, compared to $5.7 million for thesix months ended June 30, 2024. This increase of $1.3 million was attributable to a $4.6 million increase in expense from the change in fair value of our warrant liabilities due to changes in inputs associated with the fair value measurement immediately prior to our initial public offering compared to June 30, 2024. This was partially offset by a $3.3 million increase in interest income from our short-term and long-term investments due to the investment of our IPO proceeds during the first quarter of 2025.

Current wording

Total other expense, net for thenine months ended September 30, 2025 was $4.2 million, compared to $4.4 million for thenine months ended September 30, 2024. This increase of $0.2 million was attributable to a $5.3 million increase in interest income from our short-term and long-term investments due to the investment of our IPO proceeds during the first quarter of 2025. This was partially offset by a $5.1 million increase in expense from the change in fair value of our warrant liabilities due to changes in inputs associated with the fair value measurement immediately prior to our initial public offering compared to September 30, 2024.

Previous wording

Quarterly net sales increased from the third quarter of 2023 through the fourth quarter of 2024, driven primarily by growth in our installed customer base as more patients adopted the iLet. This growth also contributed to higher recurring sales of single-use products, which are replaced every 2–3 days. Net sales declined in the first quarter of 2025, primarily due to seasonal factors and an unfavorable product mix. Net sales increased in the second quarter of 2025, benefiting from favorable seasonality and continued growth in both iLets and supplies.

Current wording

Net sales increased in the second and third quarters of 2025, benefiting from favorable seasonality and continued growth in new patients starts leading to higher net sales of both iLets and supplies. This followed a decline in the first quarter of 2025, primarily due to seasonal factors. From the fourth quarter of 2023 through the fourth quarter of 2024, net sales had steadily increased, driven primarily by growth in our installed customer base as more patients adopted the iLet. This expansion also contributed to higher recurring sales of single-use products, which are replaced every 2–3 days.

Previous wording

Quarterly cost of sales increased from the third quarter of 2023 through the fourth quarter of 2024, reflecting higher iLet sales and a growing installed base, which drove increases in material cost and royalties expense. Cost of sales declined in the first quarter of 2025, primarily due to product mix and lower volume. Cost of sales increased again in the second quarter of 2025, largely due to increased volume, particularly in pharmacy iLet sales, and higher product warranty costs.

Current wording

Cost of sales increased in the second and third quarters of 2025, largely due to increased volume, particularly in pharmacy iLet sales, and higher product warranty costs. This followed a decline in the first quarter of 2025, primarily due to product mix and lower volume. From the fourth quarter of 2023 through the fourth quarter of 2024, cost of sales had steadily increased, reflecting higher iLet sales and a growing installed base, which drove increases in material cost and royalties expense.

Previous wording

Gross margin improved from the second quarter through the fourth quarter of 2023, driven by net sales growth. However, gross margin declined from the fourth quarter of 2023 through the first quarter of 2025, reflecting a shift in channel mix. A higher proportion of new patient starts were reimbursed through the pharmacy benefit (PBP) channel, which recognizes less revenue upfront compared to the DME channel. Specifically, PBP-reimbursed starts accounted for a mid-single-digit percentage of new patients in the third quarter of 2023, increasing to the low teens in the fourth quarter of 2024, the low twenties in the first quarter of 2025, and the high twenties in the second quarter of 2025. Gross margin increased in the second quarter of 2025 due to higher volumes and improved cost absorption.

Current wording

Gross margin improved from the first quarter of 2025 to the third quarter of 2025, reflecting higher sales volumes and improved manufacturing cost absorption. Margins also strengthened as production volumes increased and fixed costs were absorbed more efficiently. Gross margin decreased from the fourth quarter of 2024 to the first quarter of 2025 driven by a shift in channel mix toward the PBP channel—which recognizes less revenue upfront compared to the DME channel. Prior to that, gross margin increased from the fourth quarter of 2023 to the fourth quarter of 2024 due to higher sales volumes and improved manufacturing cost absorption. PBP-reimbursed patient starts represented a low-30% share of new patients in the third quarter of 2025, compared to the high-20% range in the second quarter of 2025, the low-20% range in the first quarter of 2025, and the low-teens in the fourth quarter of 2024. Although the mix shift toward the PBP channel continues, the adverse margin impact was more than offset by higher unit volumes and improved manufacturing efficiencies during the period.

Previous wording

Our quarterly research and development expenses increased in all periods presented, except the third quarter of 2024 and first quarter of 2025, primarily due to increases in engineering, third-party consulting costs and payroll-related expenses incurred to support our continued research and development efforts to enhance our existing product and develop new products.

Current wording

Our quarterly research and development expenses increased in all periods presented, except the third quarter of 2024 and first and third quarters of 2025, primarily due to increases in engineering, materials, third-party consulting costs and payroll-related expenses incurred to support our continued research and development efforts to enhance our existing product and develop new products.

Previous wording

Our quarterly Adjusted EBITDA increased from the third quarter 2023 to the fourth quarter of 2023 primarily due to an increase in Net Sales and Gross Profit. Our quarterly Adjusted EBITDA decreased from the fourth quarter of 2023 to the third quarter of 2024 primarily due to increases in Sales & Marketing and Research & Development expenses. The decrease in Adjusted EBITDA from the third quarter of 2024 to the fourth quarter of 2024 was primarily driven by a $3.0 million milestone payment made to Xeris in the fourth quarter of 2024 for the achievement of certain developmental milestones. The decrease in Adjusted EBITDA from the fourth quarter of 2024 to the first quarter of 2025 was primarily driven by an increase in the change in fair value of warrant liabilities and an increase in stock compensation expenses as a result of additional headcount. Adjusted EBITDA improved from the first quarter of 2025 to the second quarter of 2025 due to higher revenue, improved margins and increased operating leverage despite continued headcount increases.

Current wording

Adjusted EBITDA improved from the first quarter of 2025 to the third quarter of 2025 due to higher revenue, improved margins, and increased operating leverage despite continued headcount increases. The decrease from the fourth quarter of 2024 to the first quarter of 2025 was primarily driven by an increase in the change in fair value of warrant liabilities and higher stock compensation expenses resulting from additional headcount. The decline from the third quarter of 2024 to the fourth quarter of 2024 was primarily due to a $3.0 million milestone payment made to Xeris for the achievement of certain developmental milestones. Prior to that, adjusted EBITDA continued to decrease from the fourth quarter of 2023 to the third quarter of 2024, primarily due to increases in sales and marketing and research and development expenses.

Previous wording

In thesix months ended June 30, 2024, a mid-single digit percentage of our new patient starts were reimbursed through the PBP channel. In the six months ended June 30, 2025, a mid-twenties percentage of our new patient starts were reimbursed through the PBP channel. The increase in new patient starts through the pharmacy benefit pathway reflects enhanced formulary access and broader pharmacy coverage for iLet. These improvements are primarily attributable to the execution of contracts with key PBMs.

Current wording

In the nine months ended September 30, 2025, a high-twenties percentage of our new patient starts were reimbursed through the PBP channel. In thenine months ended September 30, 2024, a mid-single digit percentage of our new patient starts were reimbursed through the PBP channel. The increase in new patient starts through the pharmacy benefit pathway reflects enhanced formulary access and broader pharmacy coverage for iLet. These improvements are primarily attributable to the execution of contracts with key PBMs.

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 the patch pump and bihormonal configuration 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 our iLet, including future development of the patch pump and bihormonal system of the iLet.

Previous wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock, raising an aggregate of approximately $356.6 million of gross proceeds, including net proceeds of approximately $101.7 million from the issuance and sale of our Series D convertible preferred stock in August 2023 and approximately $59.7 million from the issuance and sale of our Series E convertible preferred stock in November 2024. In January 2025, we completed our initial public offering and a concurrent private placement, pursuant to which we received aggregate net proceeds of approximately $190.4 million and approximately $15.6 million, respectively, in each case after deducting underwriting discounts, commissions, and other offering expenses. We have also received payments in connection with collaboration agreements and government grants, receiving $6.1 million to date from these types of arrangements, as well as from the sale of the iLet and single-use products utilized with the iLet from our contracts with customers. As of June 30, 2025, we had cash, cash equivalents and short-term and long-term investments of $280.9 million.

Current wording

To date, we have funded our operations primarily with proceeds from the sale of our convertible preferred stock, raising an aggregate of approximately $356.6 million of gross proceeds, including net proceeds of approximately $101.7 million from the issuance and sale of our Series D convertible preferred stock in August 2023 and approximately $59.7 million from the issuance and sale of our Series E convertible preferred stock in November 2024. In January 2025, we completed our initial public offering and a concurrent private placement, pursuant to which we received aggregate net proceeds of approximately $190.4 million and approximately $15.6 million, respectively, in each case after deducting underwriting discounts, commissions, and other offering expenses. We have also received payments in connection with collaboration agreements and government grants, receiving $6.1 million to date from these types of arrangements, as well as from the sale of the iLet and single-use products utilized with the iLet from our contracts with customers. As of September 30, 2025, we had cash, cash equivalents and short-term and long-term investments of $274.0 million.

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $33.6 million, primarily resulting from our net loss of $45.5 million and net cash used by changes in our operating assets and liabilities of $8.0 million. This was partially offset by non-cash charges of $19.9 million, including $12.5 million attributable to the change in fair value of our warrant liabilities as a result of the remeasurement, $7.6 million in stock-based compensation expense due to increase in headcount, $0.6 million in amortization of operating lease right-of-use asset, $0.6 million in depreciation expense, $0.2 million in provision for excess and obsolete inventory and $0.2 million in provision for net realizable value of inventory, partially offset by the $1.7 million in accretion of discount on short-term investments. Changes in our operating assets and liabilities for the six months ended June 30, 2025 are primarily attributable to a $4.4 million increase in inventories from the growth in commercial sales, a $3.6 million increase in prepaid expenses and other current assets attributable to directors and officers insurance premiums, prepaid material components, and software license renewals, a $2.6 million decrease in accrued expenses and other current liabilities due primarily to the payout of the 2024 corporate bonus offset by the six months of accrual for 2025 corporate bonus based on company goals, and a $0.6 million decrease in operating lease liabilities. These decreases to cash were offset by a $.6 million decrease in accounts receivable due to additional collections offset by revenue recognized from sales, a $0.5 million increase to accounts payable, a $1.0 million increase to other long-term liabilities, and a $1.0 million increase in deferred revenue.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $42.3 million, primarily resulting from our net loss of $59.7 million and net cash used by changes in our operating assets and liabilities of $7.7 million. This was partially offset by non-cash charges of $25.1 million, including $12.4 million attributable to the change in fair value of our warrant liabilities as a result of the remeasurement, $12.1 million in stock-based compensation expense due to increased headcount to support growing demand, $1.0 million in depreciation expense, $0.9 million in amortization of operating lease right-of-use asset, $0.4 million in provision for excess and obsolete inventory, and $0.3 million in provision for net realizable value of inventory, partially offset by $2.0 million in accretion of discount on short-term investments. Changes in our operating assets and liabilities for the nine months ended September 30, 2025 are primarily attributable to a $7.7 million increase in inventories, reflecting higher production levels to support anticipated future demand as commercial sales continue to grow, a $5.4 million increase in prepaid expenses and other current assets attributable to directors and officers insurance premiums, prepaid material components, and software license renewals, and a $0.9 million decrease in operating lease liabilities. These decreases to cash were offset by a $1.6 million increase in accrued expenses and other current liabilities due primarily to the payout of the 2024 corporate bonus offset by the nine months of accrual for 2025 corporate bonus based on company goals, a $0.4 million decrease in accounts receivable due to additional collections offset by revenue recognized from sales, a $1.6 million increase to accounts payable due to the timing of invoices processed and payments made to vendors, a $1.2 million increase to other long-term liabilities related to the increase of the warranty liability as a result of higher volume of sales, and a $1.5 million increase in deferred revenue due to increased sales ofperformance obligations that were not yet satisfied.

Previous wording

During the six months ended June 30, 2024, net cash used in operations was $24.4 million, primarily attributable to our net loss of $26.9 million and net cash used by changes in our operating assets and liabilities of $7.6 million. The net cash used by changes in our operating assets and liabilities was partially offset by non-cash charges of $10.1 million, including $7.8 million attributable to the change in the fair value of our warrant liabilities during the year, $2.9 million in stock-based compensation expense due to increase in headcount, $0.6 million in depreciation expense and $0.6 million in amortization of operating lease right-of-use asset, partially offset by the $1.7 million in accretion of discount on short-term investments. For six months ended June 30, 2024, net cash used from changes in our operating assets and liabilities was primarily attributable to a $4.6 million increase in accounts receivable due to an increase in commercial sales of the iLet, a $6.3 million increase in inventories from the growth in commercial sales, and $0.9 million increase in prepaid expenses and other current assets attributable to prepaid material components, software license renewals and clinical supply purchases, and a $0.5 million decrease in operating lease liabilities. These decreases to cash were offset by a $1.5 million increase in accounts payable, a $2.1 million increase in accrued expenses and other current liabilities due primarily to the payout of the 2023 corporate bonus net with the accrual for 2024 corporate bonus based on company goals, and a $1.1 million increase in deferred revenue.

Current wording

During the nine months ended September 30, 2024, net cash used in operations was $34.0 million, primarily attributable to our net loss of $36.6 million and net cash used by changes in our operating assets and liabilities of $10.2 million. The net cash used by changes in our operating assets and liabilities was partially offset by non-cash charges of $11.5 million, including $7.4 million attributable to the change in the fair value of our warrant liabilities during the year, $4.8 million in stock-based compensation expense due to increased headcount to support growing demand, $0.9 million in depreciation expense and $0.8 million in amortization of operating lease right-of-use asset, partially offset by the $2.2 million in accretion of discount on short-term investments and $0.2 million adjustment to excess and obsolete inventory. For nine months ended September 30, 2024, net cash used from changes in our operating assets and liabilities was primarily attributable to a $3.1 million increase in accounts receivable due to an increase in commercial sales of the iLet, a $9.9 million increase in inventories, reflecting higher production levels to support anticipated future demand as commercial sales continue to grow, a $1.7 million increase in prepaid expenses and other current assets attributable to prepaid material components, software license renewals and clinical supply purchases, a $1.3 million increase deferred offering costs related to the Series E financing, and a $0.7 million decrease in operating lease liabilities. These decreases to cash were offset by a $1.6 million increase in accounts payable due to the timing of invoices processed and payments made to vendors, a $3.2 million increase in accrued expenses and other current liabilities primarily due to the accrual for the 2024 corporate bonus based on company goals, net with the payout of the 2023 corporate bonus, and a $1.7 million increase in deferred revenue due to increased sales ofperformance obligations that were not yet satisfied.

Previous wording

During the six months ended June 30, 2025, net cash used in investing activities was $172.9 million, primarily attributable to $190.8 million in purchases of short-term investments and $31.1 million in purchases of long-term investments based on the proceeds received from our IPO in January 2025 as well as $2.1 million in additional investment in property and equipment for additional manufacturing equipment. These decreases to cash are offset by $51.0 million in proceeds from maturities and redemptions of short-term investments.

Current wording

During the nine months ended September 30, 2025, net cash used in investing activities was $163.5 million, primarily attributable to $236.8 million in purchases of short-term investments and $45.3 million in purchases of long-term investments based on the proceeds received from our IPO in January 2025 as well as $3.4 million in additional investment in property and equipment for additional manufacturing equipment. These decreases to cash are offset by $122.0 million in proceeds from maturities and redemptions of short-term investments.

Previous wording

During the six months ended June 30, 2024, net cash provided by investing activities was $10.9 million, primarily attributable to $32.0 million in proceeds from maturities and redemptions of short-term investments, offset by $20.2 million in purchases of short-term investments and $0.9 million in additional investment in property and equipment for additional manufacturing equipment.

Current wording

During the nine months ended September 30, 2024, net cash provided by investing activities was $26.2 million, primarily attributable to $56.0 million in proceeds from maturities and redemptions of short-term investments, offset by $27.0 million in purchases of short-term investments and $2.8 million in additional investment in property and equipment for additional manufacturing equipment.

Previous wording

During thesix months ended June 30, 2025, net cash provided by financing activities was $211.2 million, primarily attributable to the net proceeds of $195.4 million received from our IPO,$15.6 million from the private placement, and $0.1 million from stock option exercises.

Current wording

During thenine months ended September 30, 2025, net cash provided by financing activities was $213.8 million, primarily attributable to the net proceeds of $195.4 million received from our IPO,$15.6 million from the private placement, and $2.8 million from stock option exercises.

Previous wording

the cost of obtaining and maintaining FDA marketing authorization or clearance for other future indications or other product candidates, including for the iLet for T1D using both insulin and glucagon (a bihormonal configuration), the iLet for T2D and the patch pump;

Current wording

the cost of obtaining and maintaining FDA marketing authorization or clearance for other future indications or other product candidates, including for the iLet for T1D using both insulin and glucagon (a bihormonal system), the iLet for T2D and the patch pump;