TANDEM DIABETES CARE INC

Previous wording

This Quarterly Report contains forward-looking statements within the meaning of the federal securities laws, which statements are subject to considerable risks and uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this Quarterly Report, other than statements of historical fact, are forward-looking statements. You can identify forward-looking statements by the use of words such as “may,” “will,” “could,” “anticipate,” “expect,” “intend,” “believe,” “continue” or the negative of such terms, or other comparable terminology. Forward-looking statements also include the assumptions underlying or relating to such statements. In particular, forward-looking statements contained in this Quarterly Report may relate to, among other things, our future or assumed financial condition, results of operations, liquidity, trends impacting our financial results, the impact of our foreign currency forward hedging contracts, business forecasts and plans, research and product development plans, product pipelines, development timelines, manufacturing plans, strategic plans and objectives, capital needs and financing plans, product launches, geographic expansion, distribution plans, production capacity, clinical trials, regulatory approvals, competitive position and the impact of changes in the competitive environment, supply chain, and the businesses of our contract manufacturers and suppliers, integration of acquisitions and partner technologies, cybersecurity threats, macroeconomic pressures or uncertainties, and the application of accounting guidance. We caution you that the foregoing list may not include all of the forward-looking statements made in this Quarterly Report.

Current wording

This Quarterly Report contains forward-looking statements within the meaning of the federal securities laws, which statements are subject to considerable risks and uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this Quarterly Report, other than statements of historical fact, are forward-looking statements. You can identify forward-looking statements by the use of words such as “may,” “will,” “could,” “anticipate,” “expect,” “intend,” “believe,” “continue” or the negative of such terms, or other comparable terminology. Forward-looking statements also include the assumptions underlying or relating to such statements. In particular, forward-looking statements contained in this Quarterly Report may relate to, among other things, our future or assumed financial condition, results of operations, liquidity, trends impacting our financial results, the impact of our foreign currency forward hedging contracts, business forecasts and plans, research and product development plans, product pipelines, development timelines, manufacturing plans, strategic plans and objectives, capital needs and financing plans, product launches, geographic expansion, distribution plans, production capacity, clinical trials, regulatory approvals, competitive position and the impact of changes in the competitive environment, supply chain, the businesses of our contract manufacturers and suppliers, integration of acquisitions and partner technologies, cybersecurity threats, macroeconomic pressures or uncertainties, and the application of accounting guidance. We caution you that the foregoing list may not include all of the forward-looking statements made in this Quarterly Report.

Previous wording

Tandem Diabetes Care is a global leader in insulin delivery and diabetes technology, specializing in the design, development, and commercialization of advanced solutions that reduce the burden of diabetes management. We serve nearly 500,000 people living with diabetes in more than 25 countries worldwide. Our strategy is to offer flexibility and choice in intelligent insulin delivery systems through an accessible portfolio of market-leading pumps, applications and insights. In support of this strategy, our Tandem pump platforms include t:slim X2 and Tandem Mobi (Mobi), both of which feature Control-IQ+ advanced hybrid closed-loop technology.

Current wording

Tandem Diabetes Care is a global leader in insulin delivery and diabetes technology, specializing in the design, development, and commercialization of advanced solutions that reduce the burden of diabetes management. We serve nearly 500,000 people living with diabetes in more than 25 countries worldwide. We offer flexibility and choice in intelligent insulin delivery systems through an accessible portfolio of market-leading pumps, applications, and insights.

Previous wording

We develop our diabetes technology solutions using a consumer-focused approach. This has resulted in a differentiated insulin pump portfolio, including the t:slim X2 insulin pump (t:slim X2) and Tandem Mobi (Mobi), which provide users with distinct easy-to-use features and functionality. The t:slim X2 is an all-in-one system that features a slim, sleek, user-friendly color touchscreen and holds up to 300 units of insulin. Mobi is designed for people who seek even greater discretion and flexibility, and includes features such as expanded pump-control from a mobile application, inductive charging, and an on-pump button that can be used for bolusing and other actions. Our insulin pumps offer the option to detach in addition to Bluetooth connectivity and are typically used as part of an Automated Insulin Delivery (AID) system.

Current wording

Our Tandem pump platforms include t:slim X2 and Tandem Mobi (Mobi), both of which offer distinct, easy-to-use features and Control-IQ+ advanced hybrid closed-loop technology. The t:slim X2 is an all-in-one system that features a slim, sleek, user-friendly color touchscreen and holds up to 300 units of insulin. Mobi is designed for people who seek even greater discretion and flexibility, and includes features such as expanded pump-control from a mobile application, inductive charging, and an on-pump button that can be used for bolusing and other actions. Our insulin pumps offer the option to detach and are typically used as part of an Automated Insulin Delivery (AID) system.

Previous wording

Our insulin pumps are compatible for use with industry-leading CGM sensors from Abbott and Dexcom. When used as an AID system, the CGM sensor data powers our Control-IQ+ technology. Results from four independent pivotal studies using Control-IQ technology have been published in the New England Journal of Medicine since 2019. Control-IQ+ launched in 2025 and is our third and newest AID algorithm, which is available globally and indicated for people ages 2+ (type 1). In the United States, it is also indicated for use in pregnancy complicated by type 1 diabetes as well as people 18+ living with type 2 diabetes. This hybrid closed loop algorithm increases a user’s time in targeted glycemic range (70-180 mg/dL) by predicting and helping to prevent the frequency and/or duration of hyperglycemic and/or hypoglycemic events. It is the only predictive algorithm featuring AutoBolus corrective bolusing. Control-IQ+ also offers an easy set-up feature and settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.

Current wording

Our insulin pumps are compatible for use with industry-leading continuous glucose monitoring (CGM) sensors from Abbott and Dexcom. When used as an AID system, the CGM sensor data powers our Control-IQ+ technology. Results from four independent pivotal studies using Control-IQ technology have been published in the New England Journal of Medicine since 2019. Control-IQ+, which launched in 2025 and is our third and newest AID algorithm. Its indications include use by people with type 1 diabetes ages 2+, as well as for use in pregnancy complicated by type 1 diabetes, and for people 18+ living with type 2 diabetes. This hybrid closed loop algorithm increases a user’s time in targeted glycemic range (70-180 mg/dL) by predicting and helping to prevent the frequency and/or duration of hyperglycemic and/or hypoglycemic events. It is the only predictive algorithm featuring AutoBolus corrective bolusing. Control-IQ+ also offers an easy set-up feature and settings for sleep and exercise activities that adjust the algorithm parameters to better match the different physiological needs during these activities.

Previous wording

As part of our ecosystem of diabetes solutions, we also offer a web-based data management platform, Tandem Source, that provides users, their caregivers and their healthcare providers with a fast, easy and visual way to display diabetes therapy management data from our pumps and compatible CGM sensors. Tandem Source also provides us with data that we can analyze to reveal patterns, trends, outcomes and associations that can be used for product development and in the analysis of clinical outcomes data.

Current wording

As part of our ecosystem of diabetes solutions, we also offer a web-based data management platform, Tandem Source, that provides users, their caregivers, and their healthcare providers with a fast, easy, and visual way to display diabetes therapy management data from our pumps and compatible CGM sensors. When an individual pump user consents, Tandem Source also provides us with data that we can analyze to reveal patterns, trends, outcomes, and associations that can be used for product development and in the analysis of clinical outcomes data.

Previous wording

In support of this strategy, we continue to drive innovation in our Tandem pump platforms. This includes a novel, extended-wear infusion site option for Mobi that will transform the pump into a tubeless patch device. In the second quarter 2026, we submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for Tandem Mobi tubeless capability. In addition, our pipeline also includes a next-generation Mobi patch pump that leverages the technology acquired with the Sigi Patch Pump to deliver further miniaturization. Our development efforts also include extended-wear infusion set technology, dual glucose-ketone sensor compatibility, and algorithm advancement in pursuit of offering fully closed loop technology.

Current wording

In support of this strategy, we continue to drive innovation in our Tandem pump platforms. This includes a novel, extended-wear infusion site option for Mobi that will transform the pump into a tubeless patch device. In the second quarter 2026, we submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for Mobi tubeless capability. In addition, our pipeline includes a next-generation Mobi patch pump that leverages the technology acquired with the Sigi Patch Pump to deliver further miniaturization. Our development efforts also include extended-wear infusion set technology, dual glucose-ketone sensor compatibility, and algorithm advancement in pursuit of offering fully closed loop technology.

Previous wording

In the United States, we are pursuing a multi-channel coverage and reimbursement strategy, enhancing coverage and reimbursement through both the durable medical equipment (DME) and pharmacy channels. We believe this strategy will improve access and optimize the potential for better medical outcomes for people living with diabetes, while reducing the overall economic burden of diabetes care. This also provides our customers with flexibility in how they use their insurance benefits to simplify onboarding and provide them with the most advantageous reimbursement terms.

Current wording

In the United States, we are transitioning coverage from the durable medical equipment (DME) benefit,where we have been reimbursed historically, to the pharmacy benefit. We believe this strategy will improve access and optimize the potential for better medical outcomes for people living with diabetes, while reducing the overall economic burden of diabetes care.

Previous wording

Through the medical benefit, pumps were historically reimbursed upfront, separate from the ongoing supply purchases. In 2025, we began contracting for customers to receive their pumps and supplies through a pharmacy benefit with the same upfront reimbursement structure as a medical benefit, but are evolving to an alternative pay-as-you-go reimbursement structure in 2026. This would eliminate the upfront pump reimbursement. Under this model, customers would no longer incur a significant upfront cost when a patient initiates pump therapy, thus reducing the initial financial burden and supporting broader patient access. With a lower upfront cost, this model is expected to increase adoption of our products by reducing a barrier for patients when evaluating pump therapy. Overall, we anticipate higher revenue in this model over the four-year life of each customer compared to the current medical benefit structure.

Current wording

Through the medical benefit, pumps were historically reimbursed upfront, separate from the ongoing supply purchases. In 2025, we began contracting for customers to receive their pumps and supplies through a pharmacy benefit with the same upfront reimbursement structure as a medical benefit. In the first quarter of 2026, we renegotiated our pharmacy benefit contracts to a pay-as-you-go reimbursement structure, eliminating the upfront pump reimbursement. Under this model, customers no longer incur a significant upfront cost when initiating pump therapy, which reduces their initial financial burden. With a lower upfront cost, this model is expected to support broader patient access and increase adoption of our products by reducing a barrier for patients when evaluating pump therapy. Overall, we anticipate higher revenue per customer under the pay-as-you-go reimbursement structure compared to the current medical benefit structure over a four-year period.

Previous wording

•Any adverse event involving 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. Any action by regulatory bodies against us, and any regulatory challenges we encounter, could have a negative impact on our product sales and harm our reputation.

Current wording

•Any adverse event involving products that we distribute could result in future corrective actions, such as recalls, customer notifications or regulatory agency action, which could include inspection, mandatory recall or other enforcement action. Any action by regulatory bodies against us, and any regulatory challenges we encounter, could have a negative impact on our product sales and harm our reputation.

Previous wording

•Seasonality in the United States is associated with annual insurance deductibles and coinsurance requirements of the insurance plan benefit used by our customers and the customers of our distributors. In the United States, we typically experience a higher volume of pump shipments in the second half of the year due to the nature of these reimbursement dynamics under the medical benefit. As we expand our access through the pharmacy benefit with no upfront reimbursement for an insulin pump, we anticipate there will be less of a seasonal impact on the business in future periods related to insurance deductibles and coinsurance requirements. Other factors that may impact sales across the year include the timing of seasonal holidays, particularly in our international markets.

Current wording

•Seasonality in the United States is associated with annual insurance deductibles and coinsurance requirements of the insurance plan benefit used by our customers and the customers of our distributors. In the United States, we typically experience a higher volume of pump shipments in the second half of the year due to the nature of these reimbursement dynamics under the medical benefit. As we expand our access through the pharmacy benefit with no upfront reimbursement for an insulin pump, we anticipate there will be less of a seasonal impact on the business in future periods related to insurance deductibles and coinsurance requirements. Other factors that may impact worldwide sales across the year include the timing of seasonal holidays, particularly in our international markets.

Previous wording

•In periods following new product launches, particularly with new hardware platforms, our cost of sales may increase on a per unit basis until the new products achieve manufacturing scale and operating expenses may be elevated by increased sales and marketing spending to support the product launches.

Current wording

•In periods following new product launches, our cost of sales may increase on a per unit basis until the new products achieve manufacturing scale and operating expenses may be elevated by increased sales and marketing spending to support the product launches.

Previous wording

•In 2026, our primary focus is to continue increasing our sales through the pharmacy benefit with improved scalability of operations, expanded coverage and a change in the reimbursement model. Our pharmacy contracts are structured as pay-as-you-go with reimbursement for the ongoing supply purchases only, at a price premium to the DME model. Under this model, in 2026, we began experiencing a decrease in sales and gross profit when pumps are shipped. As pharmacy utilization scales, we expect the decrease in sales from pharmacy pump shipments to be offset by an increase in supply sales and gross profit from both our existing installed base and new customers.

Current wording

•In 2026, our primary focus is to continue increasing our sales through the pharmacy benefit with improved scalability of operations, expanded coverage, and a change in the reimbursement model. Our pharmacy contracts are structured as pay-as-you-go with reimbursement for the ongoing supply purchases only, at a price premium to the DME model. Under this model, in 2026, we began experiencing a decrease in sales and gross profit when pumps are shipped with no upfront reimbursement. As pharmacy utilization scales, we expect the decrease in sales from pharmacy pump shipments to be offset by an increase in supply sales and gross profit from both our existing installed base and new customers.

Previous wording

•We depend on a limited number of third-party suppliers for certain components and products. Their inability to provide an adequate supply of components or products could harm our business. For example, one of our key infusion set suppliers has recently experienced supply challenges, which has impacted our overall inventory levels and supply sales, and we expect inventory constraints to persist through 2026. If we are unable to obtain sufficient quantities of such supplies or other necessary components to meet demand on a timely basis going forward, we could lose additional customer orders, our reputation may be harmed, and our business could suffer.

Current wording

•We depend on a limited number of third-party suppliers for certain components and products. Their inability to provide an adequate supply of components or products could harm our business. For example, one of our key infusion set suppliers has recently experienced supply challenges, which has impacted our overall inventory levels and supply sales, and we currently expect inventory constraints to persist through early 2027. If we are unable to obtain sufficient quantities of such supplies or other necessary components to meet demand on a timely basis going forward, we could lose additional customer orders, our reputation may be harmed, and our business could suffer.

Previous wording

For the three months ended June 30, 2026, we shipped more than 33,000 pumps worldwide. Sales were $254.6 million, which included $75.3 million of international sales. Sales were $240.7 million for the three months ended June 30, 2025, which included $70.5 million of international sales. Overall, the increase was primarily driven by an improvement in price, favorable channel mix and increased pump volumes, while supply sales were impacted by an inventory constraint relating to a key supplier.

Current wording

For the three months ended September 30, 2026, we shipped approximately 33,000 pumps worldwide. Sales were $283.7 million, which included $92.6 million of international sales. Sales were $249.3 million for the three months ended September 30, 2025, which included $73.6 million of international sales. Overall, the increase was primarily driven by increased volumes, favorable channel mix and improved pricing, even with a continued inventory constraint relating to a key supplier.

Previous wording

For the second quarter 2026, sales in the United States increased primarily due to favorable channel dynamics with the increased adoption of the new pharmacy channel business model. The adoption of this model resulted in a decrease in pump average selling prices that was more than offset by a corresponding increase in supply prices. This change in reimbursement structure was effective beginning in the first quarter 2026. Pump shipments grew to more than 22,000 pumps in the second quarter 2026 compared to approximately 21,000 pumps for the second quarter 2025. Supply sales increased although volumes were impacted by the constraint in inventory. Sales through the pharmacy channel accounted for 10% and 3% of sales in the United States for the second quarter 2026 and 2025, respectively.

Current wording

For the third quarter 2026, sales in the United States increased primarily due to increased volumes and favorable channel dynamics with the increased adoption of the new pharmacy channel business model. As expected with the new pricing model, this adoption resulted in a decrease in pump average selling prices, which was more than offset by a corresponding increase in supply prices. This change in reimbursement structure was effective beginning in the first quarter 2026. Pump shipments increased to nearly 23,000 pumps in the third quarter 2026 compared to more than 20,000 pumps for the third quarter 2025. Sales through the pharmacy channel accounted for 15% and 5% of sales in the United States for the third quarter 2026 and 2025, respectively.

Previous wording

For the second quarter 2026, total international sales increased primarily due to improved average selling prices, an increase in pump shipments, and favorable changes in foreign exchange rates, offset by lower supply sales due to the inventory constraint. Pump shipments were approximately 11,000 pumps in the second quarter 2026 compared to approximately 9,000 pumps for the second quarter 2025. Direct sales to customers accounted for 13% and 4% of international sales in the second quarter 2026 and 2025, respectively.

Current wording

For the third quarter 2026, total international sales increased primarily due to higher volumes and improved average selling prices, partially offset by unfavorable foreign currency impacts. Pump shipments increased to nearly 11,000 pumps in the third quarter 2026 compared to more than 9,000 pumps for the third quarter 2025. Direct sales to customers accounted for 18% and 3% of international sales in the third quarter 2026 and 2025, respectively.

Previous wording

Our cost of sales for the six months ended June 30, 2026 was $220.2 million, resulting in gross profit of $281.6 million, compared to cost of sales of $230.8 million and gross profit of $244.3 million for the same period in 2025. The gross margins for the six months ended June 30, 2026 and 2025 were 56% and 51%, respectively. This increase in gross margin was primarily driven by favorable pricing from the increase in U.S. pharmacy sales and direct international sales, as well as efficiencies gained in both manufacturing and non-manufacturing costs.

Current wording

Our cost of sales for the three months ended September 30, 2026 was $123.3 million, resulting in gross profit of $160.4 million, compared to cost of sales of $115.0 million and gross profit of $134.3 million for the same period in 2025. The gross margins for the three months ended September 30, 2026 and 2025 were 57% and 54%, respectively. This increase in gross margin was primarily driven by favorable pricing from the increase in U.S. pharmacy sales and direct international sales.

Previous wording

Selling, General and Administrative Expenses. SG&A expenses were $111.6 million for the three months ended June 30, 2026, compared to $109.6 million for the same period in 2025. The increase in SG&A expenses was primarily driven by $7.8 million in commercial investments in our U.S. sales infrastructure, costs to support direct operations in Europe, marketing activities, and other initiatives to create future efficiencies. The increase was partially offset by a $5.8 million decrease in stock-based compensation expense.

Current wording

Selling, General and Administrative Expenses. SG&A expenses were $113.9 million for the three months ended September 30, 2026, compared to $108.4 million for the same period in 2025. The increase in SG&A expenses was primarily driven by $8.6 million in commercial investments in our U.S. sales infrastructure, costs to support direct operations in Europe, marketing activities, and other initiatives to create future efficiencies. The increase was partially offset by a $3.1 million decrease in stock-based compensation expense.

Previous wording

Research and Development Expenses. R&D expenses were $46.9 million for the three months ended June 30, 2026, compared to $48.1 million for the same period in 2025. The decrease in R&D expenses was primarily driven by a reduction of stock-based compensation expense by $3.4 million, partially offset by an increase in clinical trial expense.

Current wording

Research and Development Expenses. R&D expenses were $48.8 million for the three months ended September 30, 2026, compared to $48.7 million for the same period in 2025. R&D expenses for the three months ended September 30, 2026 increased due to investments in R&D operations offset by a $1.7 million reduction in stock-based compensation expense compared to the same period in 2025.

Previous wording

Total other income (expense), net for the three months ended June 30, 2026 was a loss of $6.9 million, compared to a loss of $5.9 million for the same period in 2025. The increase in other income (expense), net was primarily driven by the increase in loss on equity investment and interest expense, offset by an increase in interest income earned on our cash equivalents and short-term investments.

Current wording

Total other income (expense), net for the three months ended September 30, 2026 was a loss of $5.3 million, compared to a loss of $2.3 million for the same period in 2025. The increase in other income (expense), net was primarily driven by the increase in loss on equity investment and interest expense, partially offset by an increase in interest income earned on our cash equivalents and short-term investments.

Previous wording

We recognized income tax expense of $1.0 million on a pre-tax loss of $40.5 million for the six months ended June 30, 2026, compared to income tax expense of $3.1 million on a pre-tax loss of $179.8 million for the six months ended June 30, 2025. Income tax expense for the six months ended June 30, 2026 was primarily attributable to state and foreign income tax expense as a result of current taxable income in certain jurisdictions.

Current wording

We recognized income tax benefit of $0.6 million on a pre-tax loss of $7.7 million for the three months ended September 30, 2026, compared to income tax benefit of $4.0 million on a pre-tax loss of $25.1 million for the three months ended September 30, 2025. Income tax benefit for the three months ended September 30, 2026, was primarily attributable to a discrete benefit related to amending prior period tax returns, partially offset by state and foreign income tax expense as a result of current taxable income in certain jurisdictions.

Previous wording

For the six months ended June 30, 2026, we shipped nearly 63,000 pumps worldwide. Sales were $501.8 million, which included $161.6 million of international sales. Sales were $475.1 million for the six months ended June 30, 2025, which included $154.3 million of international sales. Overall, the increase was primarily driven by an improvement in price, favorable channel mix and increased pump volumes, while supply sales were impacted by an inventory constraint relating to a key supplier.

Current wording

For the nine months ended September 30, 2026, we shipped approximately 96,000 pumps worldwide. Sales were $785.5 million, which included $254.3 million of international sales. Sales were $724.4 million for the nine months ended September 30, 2025, which included $227.9 million of international sales. Overall, the increase was primarily driven by an improvement in price, favorable channel mix, and increased volumes. Supply sales were impacted by an inventory constraint relating to a key supplier.

Previous wording

For the six months ended June 30, 2026, sales in the United States increased due to favorable channel dynamics with the increased adoption of the new pharmacy channel business model, where the decrease in pump average selling prices was more than offset by a corresponding increase in supply prices. This change in reimbursement structure was effective beginning in the first quarter of 2026. Pump shipments exceeded 41,000 in the six months ended June 30, 2026 compared to more than 38,000 pumps in the six months ended June 30, 2025. Supply sales increased although volumes were impacted by the constraint in inventory, Sales within the pharmacy channel accounted for 8% and 2% of the Company’s U.S. sales for the six months ended June 30, 2026 and 2025, respectively.

Current wording

For the nine months ended September 30, 2026, sales in the United States increased primarily due to favorable channel dynamics with the increased adoption of the new pharmacy channel business model, where the decrease in pump average selling prices was more than offset by a corresponding increase in supply prices. This change in reimbursement structure was effective beginning in the first quarter 2026. Pump shipments exceeded 64,000 pumps in the nine months ended September 30, 2026 compared to approximately 59,000 pumps in the nine months ended September 30, 2025. Sales within the pharmacy channel accounted for 10% and 3% of the Company’s U.S. sales for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

For the six months ended June 30, 2026, total international sales increased primarily due to improved average selling prices, favorable changes in foreign exchange rates, and in increase in pump shipments, partially offset by a decrease in supplies volumes. International sales for the six months ended June 30, 2026 also included a one-time benefit for the transition to direct servicing of rental customers in Switzerland. Pump shipments were more than 21,000 in the six months ended June 30, 2026 compared to 20,000 pumps in the six months ended June 30, 2025. Direct sales to customers, including the one-time benefit in Switzerland, accounted for 12% and 4% of international sales for the six months ended June 30, 2026 and 2025, respectively.

Current wording

For the nine months ended September 30, 2026, total international sales increased primarily due to improved average selling prices, favorable changes in foreign exchange rates, and an increase in pump shipments, partially offset by lower supplies volumes. International sales for the nine months ended September 30, 2026 also included a one-time benefit for the transition to direct servicing of rental customers in Switzerland. Pump shipments exceeded 32,000 pumps in the nine months ended September 30, 2026 compared to approximately 30,000 pumps in the nine months ended September 30, 2025. Direct sales to customers, including the one-time benefit in Switzerland, accounted for 14% and 4% of international sales for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

Our cost of sales for the three months ended June 30, 2026 was $109.8 million, resulting in gross profit of $144.8 million, compared to cost of sales of $114.8 million and gross profit of $125.9 million for the same period in 2025. The gross margins for the three months ended June 30, 2026 and 2025 were 57% and 52%, respectively. This increase in gross margin was primarily driven by favorable pricing from the increase in U.S. pharmacy sales and direct international sales, as well as efficiencies gained in both manufacturing and non-manufacturing costs.

Current wording

Our cost of sales for the nine months ended September 30, 2026 was $343.5 million, resulting in gross profit of $442.0 million, compared to cost of sales of $345.8 million and gross profit of $378.6 million for the same period in 2025. The gross margins for the nine months ended September 30, 2026 and 2025 were 56% and 52%, respectively. This increase in gross margin was primarily driven by favorable pricing from the increase in U.S. pharmacy sales and direct international sales, as well as efficiencies gained in manufacturing costs.

Previous wording

Our operating expenses for the six months ended June 30, 2026 were $312.8 million, compared to $417.0 million for the six months ended June 30, 2025. The decrease was primarily driven by a reduction of one-time charges incurred in the six months ended June 30, 2025, including $75.2 million in IPR&D charges (see Note 13, “Acquisitions”), $20.0 million in litigation and settlement expenses (see Note 2, “Intangible Assets Subject to Amortization”) and $11.2 million in operating lease impairment charges and restructuring charges related to relocation of certain R&D activities.

Current wording

Our operating expenses for the nine months ended September 30, 2026 were $475.6 million, compared to $574.1 million for the nine months ended September 30, 2025. The decrease was primarily driven by a reduction of one-time charges incurred in the nine months ended September 30, 2025, including $75.2 million in IPR&D charges (see Note 13, “Acquisitions”), $20.0 million in litigation and settlement expenses (see Note 2, “Summary of Significant Accounting Policies - Intangible Assets Subject to Amortization”), and $14.0 million in operating lease impairment charges and restructuring charges related to relocation of certain R&D activities.

Previous wording

Selling, General and Administrative Expenses. SG&A expenses were $219.8 million for the six months ended June 30, 2026, compared to $223.4 million for the same period in 2025. After one-time costs, the increase in SG&A expenses was primarily driven by a $17.4 million increase from commercial investments in sales infrastructure, including sales force expansion in the United States, costs to support direct operations in Europe, marketing activities, and other initiatives to create future efficiencies in operations. The increase was offset by a $12.1 million decrease in stock-based compensation expense.

Current wording

Selling, General and Administrative Expenses. SG&A expenses were $333.8 million for the nine months ended September 30, 2026, compared to $331.9 million for the same period in 2025. After one-time facility impairment and restructuring costs, the increase in SG&A expenses was primarily driven by a $27.9 million increase from commercial investments in sales infrastructure, including sales force expansion in the United States, costs to support direct operations in Europe, marketing activities, and other initiatives to create future efficiencies in operations. The increase was partially offset by a $15.1 million decrease in stock-based compensation expense.

Previous wording

Research and Development Expenses. R&D expenses were $93.0 million for the six months ended June 30, 2026, compared to $98.3 million for the same period in 2025. After one-time costs, the decrease in R&D expenses was primarily driven by a $6.6 million decrease in stock-based compensation expense. The decrease was partially offset by an increase in clinical trial expense.

Current wording

Research and Development Expenses. R&D expenses were $141.8 million for the nine months ended September 30, 2026, compared to $147.0 million for the same period in 2025. After one-time restructuring costs related to relocation of certain R&D activities, the decrease in R&D expenses was primarily driven by an $8.3 million decrease in stock-based compensation expense, partially offset by increased expenses due to investments in R&D operations.

Previous wording

Acquired In-Process Research and Development (IPR&D) Expenses. We did not incur any IPR&D expenses for the six months ended June 30, 2026. Acquired IPR&D expenses were $75.2 million for the six months ended June 30, 2025, which represented costs associated with the revised AMF purchase agreement (see Note 13, “Acquisitions”).

Current wording

Acquired In-Process Research and Development (IPR&D) Expenses. We did not incur any IPR&D expenses for the nine months ended September 30, 2026. Acquired IPR&D expenses were $75.2 million for the nine months ended September 30, 2025, which represented costs associated with the amended AMF purchase agreement (see Note 13, “Acquisitions”).

Previous wording

Litigation and Settlement Expense. We did not incur any litigation and settlement expense for the six months ended June 30, 2026. Litigation and settlement expenses of $20.0 million for the six months ended June 30, 2025 related to the Settlement Agreement with Roche.

Current wording

Litigation and Settlement Expense. We did not incur any litigation and settlement expense for the nine months ended September 30, 2026. Litigation and settlement expenses of $20.0 million for the nine months ended September 30, 2025 related to the Settlement Agreement with Roche.

Previous wording

Total other income (expense), net for the six months ended June 30, 2026 was a $9.3 million loss, compared to $7.1 million for the same period in 2025. The increase in other expense, net was primarily driven by an increase in loss on equity investment offset by an increase in interest income earned on our cash equivalents and short-term investments.

Current wording

Total other income (expense), net for the nine months ended September 30, 2026 was a $14.6 million loss, compared to a loss of $9.4 million for the same period in 2025. The increase in other income (expense), net was primarily driven by the increase in loss on equity investment and interest expense, partially offset by an increase in interest income earned on our cash equivalents and short-term investments.

Previous wording

We recognized income tax expense of $0.5 million on a pre-tax loss of $20.7 million for the three months ended June 30, 2026, compared to income tax benefit of $5.3 million on a pre-tax loss of $57.7 million for the three months ended June 30, 2025. Income tax expense for the three months ended June 30, 2026, was primarily attributable to state and foreign income tax expense as a result of current taxable income in certain jurisdictions.

Current wording

We recognized income tax expense of $0.4 million on a pre-tax loss of $48.2 million for the nine months ended September 30, 2026, compared to an income tax benefit of $0.8 million on a pre-tax loss of $205.0 million for the nine months ended September 30, 2025. Income tax expense for the nine months ended September 30, 2026 was primarily attributable to state and foreign income tax expense as a result of current taxable income in certain jurisdictions.

Previous wording

As of June 30, 2026, we had $456.0 million in cash and cash equivalents and short-term investments. We believe that our cash and cash equivalents, short-term investments, and future cash flows from operations will be sufficient to fund our ongoing core business activities for at least the next twelve months. We also believe our current liquidity position provides flexibility to support our longer-term operating objectives.

Current wording

As of September 30, 2026, we had $443.1 million in cash and cash equivalents and short-term investments. We believe that our cash and cash equivalents, short-term investments, and future cash flows from operations will be sufficient to fund our ongoing core business activities for at least the next twelve months. We also believe our current liquidity position provides flexibility to support our longer-term operating objectives.

Previous wording

The following table shows a summary of our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table shows a summary of our cash flows for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Operating Activities. Net cash used in operating activities was $23.6 million for the six months ended June 30, 2026, compared to $27.8 million of cash used in the same period in 2025. For the six months ended June 30, 2026, net loss was $41.6 million, net non-cash adjustments were $55.8 million, and the change in working capital balances was a decrease of $37.8 million, including a $7.0 million cash outflow for the annual payment related to the Roche Settlement Agreement. For the six months ended June 30, 2025, net loss was $183.0 million, net non-cash adjustments were $151.8 million, and the change in working capital balances was an increase of $3.4 million.

Current wording

Operating Activities. Net cash used in operating activities was $24.4 million for the nine months ended September 30, 2026, compared to $19.5 million of cash used in the same period in 2025. For the nine months ended September 30, 2026, net loss was $48.6 million, net non-cash adjustments were $87.1 million, and the change in working capital balances was a decrease of $62.8 million, including a $7.0 million cash outflow for the annual payment related to the Roche Settlement Agreement. For the nine months ended September 30, 2025, net loss was $204.1 million, net non-cash adjustments were $184.1 million, and the change in working capital balances was an increase of $0.5 million.

Previous wording

Investing Activities. Net cash used in investing activities was $282.8 million for the six months ended June 30, 2026, which primarily consisted of $260.5 million in purchases of short-term investments, $81.4 million in purchases of equity investments and $10.3 million in purchases of property and equipment, partially offset by $69.5 million in proceeds from maturities and redemptions of short-term investments. Net cash provided by investing activities was $67.3 million for the six months ended June 30, 2025, which primarily consisted of $146.4 million in proceeds from maturities and redemptions of short-term investments, offset by $43.5 million paid for IPR&D, $26.5 million in purchases of short-term investments, and $9.2 million in purchases of property and equipment.

Current wording

Investing Activities. Net cash used in investing activities was $264.8 million for the nine months ended September 30, 2026, which primarily consisted of $290.5 million in purchases of short-term investments, $81.4 million in purchases of equity investments, and $15.0 million in purchases of property and equipment, partially offset by $122.1 million in proceeds from maturities and redemptions of short-term investments. Net cash provided by investing activities was $87.9 million for the nine months ended September 30, 2025, which primarily consisted of $200.6 million in proceeds from maturities and redemptions of short-term investments, offset by $43.5 million paid for IPR&D, $56.0 million in purchases of short-term investments, and $13.3 million in purchases of property and equipment.

Previous wording

Financing Activities. Net cash provided by financing activities was $276.3 million for the six months ended June 30, 2026, which consisted of net proceeds of $291.2 million from the issuance of the 2032 Notes, partially offset by $15.3 million used to pay the cost of the 2032 Capped Call Transactions. In addition, $0.5 million was used in payments for tax withholdings related to the issuance of common stock under our stock plans, net of proceeds received from common stock issuances for the period. Net cash used in financing activities was $44.4 million for the six months ended June 30, 2025, which consisted of $40.8 million used to pay the principal of the 2025 Notes and $3.6 million used in payments for tax withholdings related to the issuance of common stock under our stock plans, net of proceeds received from common stock issuances for the period.

Current wording

Financing Activities. Net cash provided by financing activities was $269.3 million for the nine months ended September 30, 2026, which consisted of net proceeds of $291.2 million from the issuance of the 2032 Notes, partially offset by $15.3 million used to pay the cost of the 2032 Capped Call Transactions. In addition, $4.5 million was used to pay off the principal balance of a promissory note and $2.1 million was used in payments for tax withholdings related to the issuance of common stock under our stock plans, net of proceeds received from common stock issuances for the period. Net cash used in financing activities was $46.0 million for the nine months ended September 30, 2025, which consisted of $40.8 million used to pay the principal of the 2025 Notes and $5.2 million used in payments for tax withholdings related to the issuance of common stock under our stock plans, net of proceeds received from common stock issuances for the period.

Previous wording

•fluctuations in costs, gross and operating margins; and

Current wording

•fluctuations in costs and gross and operating margins; and