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Item 2 — Management's Discussion and Analysis
Tandem Diabetes Care, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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You should read the following discussion and analysis together with our financial statements and related notes in Part I, Item 1 of this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (Quarterly Report).
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.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
Our forward-looking statements are based on our management’s current assumptions and expectations about future events and trends, which affect or may affect our business, strategy, operations or financial performance. Although we believe that these forward-looking statements are based upon reasonable assumptions, they are subject to numerous known and unknown risks and uncertainties and are made in light of information currently available to us. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below in the section entitled “Risk Factors” in this Quarterly Report, as well as in the other public filings we make with the Securities and Exchange Commission. You should read this Quarterly Report with the understanding that our actual future financial condition and results may be materially different from and worse than what we expect.
Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for our management to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Forward-looking statements speak only as of the date they were made, and we undertake no obligation to update or review any forward-looking statement because of new information, future events or other factors except as required by law.
We qualify all of our forward-looking statements by these cautionary statements.
Overview
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.
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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.
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.
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.
Our Strategy & Future Technology
Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs, personal preferences and affordability. Our strategy is to redefine global leadership in insulin delivery solutions through commercial excellence, patient-first reimbursement choices, and a differentiated device portfolio. We strive to offer all people with insulin-dependent diabetes flexibility and choice in their intelligent insulin delivery systems, through our portfolio of market-leading pumps, applications, and insights that improve outcomes and reduce the daily burden of living with diabetes.
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.
Third-Party Reimbursement
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.
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.
Internationally, insurance reimbursement models may vary by geography. In markets where we have direct operations, we are responsible for all reimbursement, tender application and fulfillment activities. Otherwise, that responsibility lies with our distributors.
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Trends and Uncertainties Impacting Financial Results
Our financial condition and operating results have historically fluctuated on a quarterly or annual basis. We expect periodic fluctuations will continue based on a number of trends and uncertainties, including the following:
Regulatory Approvals and Actions
•Sales of new products are subject to local government regulations. The requirements and timelines to receive regulatory clearance can vary substantially from country to country and delays may impact our ability to expand our worldwide customer base and bring products to market in a competitive timeframe. These delays, or failure to receive regulatory approval, could adversely impact our sales and results of operations.
•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.
Markets, Seasonality, Competition, and Product Launches
•We expect our business to be impacted by the introduction of new diabetes devices and treatments by us or our competitors. The success of our products is variable and we believe it correlates to market acceptance, anticipated product launches and commercial availability.
•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.
•Regulatory approval and/or upcoming launches of new Tandem or competing products could also adversely impact timing of purchasing decisions.
•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.
Reimbursement
•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.
•We generally have had broad insurance coverage for our products through third-party payors. Our sales and results of operations may be impacted by the failure to secure or retain adequate coverage consistent with current reimbursement levels, changes in reimbursement structures, or availability of affordable options for our customers.
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Supply Chain
•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.
Macroeconomic Factors
•Global economic and market uncertainty, such as recessionary concerns, changes in discretionary spending, and increased interest rates, have impacted our customers’ purchasing decisions and the buying patterns of our distributors.
•High inflation, fluctuations in foreign currency valuations, uncertainty regarding tariffs and trade relations, and the effects of other macroeconomic factors and concerns have disrupted and may continue to disrupt our relationships with suppliers, third-party manufacturers, healthcare providers, distributors, and our existing or potential customers, as well as impact our cost structure as more of our business is exposed to foreign currency fluctuations.
Components of Results of Operations
Sales
We offer products for people with insulin-dependent diabetes, including a portfolio of hardware platforms, single-use insulin cartridges and infusion sets, data management platforms, and mobile applications. Our primary customers are the end users of our products, non-exclusive distribution partners whose level of service varies based on geography, the healthcare professionals who prescribe our products, and the healthcare systems or payors who provide insurance coverage and access to our products. Our sales may fluctuate from period to period. See also “Trends and Uncertainties Impacting Financial Results” above.
Cost of Sales
Cost of sales primarily consists of raw materials, labor costs, manufacturing overhead expenses, reserves for expected warranty costs, product training costs, royalties, and freight. Manufacturing overhead expenses include expenses relating to quality assurance, manufacturing engineering, material procurement, inventory control, facilities, equipment, information technology, and operations supervision and management. When taking into consideration the differences in reimbursement levels and cost structure, pumps have historically had a higher gross profit and gross margin percentage than our pump-related supplies on a per unit basis. Therefore, the percentage of pump sales relative to total sales has had a significant impact on our overall gross margin percentage. Under the pay-as-you-go model through the pharmacy benefit in the United States, our overall gross profit and gross margin percentage may be negatively impacted when pumps are shipped during the initial stages of this new model, but that impact may be partially or fully offset by the anticipated benefit from higher profits for our recurring sale of supplies.
Selling, General and Administrative
Our SG&A expenses primarily consist of salary, cash-based incentive compensation, fringe benefits, and non-cash stock-based compensation for our sales, marketing and administrative functions in the United States and select international markets, which also includes our clinical, customer support, technical services, insurance verification and regulatory affairs personnel. Our sales territories are generally maintained by sales representatives and field clinical specialists, and supported by managed care liaisons, additional sales management, and other customer support personnel. Other significant SG&A expenses typically include costs of technology infrastructure for customer sales and support, commercialization activities associated with new product launches, travel, trade shows, outside legal fees, independent auditor fees, outside consultant fees, insurance premiums, facilities costs, and information technology costs.
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Research and Development
Our R&D activities primarily consist of engineering and research programs associated with our hardware, software, and digital health products under development, as well as activities associated with our core technologies and processes. R&D expenses are primarily related to employee compensation, including salary, cash-based incentive compensation, fringe benefits, and non-cash stock-based compensation. We also incur R&D expenses for supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trials, payments under our licensing, development and commercialization agreements, and other indirect costs.
Acquired In-process Research and Development
Acquired IPR&D reflects costs of external research and development projects acquired directly in a transaction other than a business combination, which do not have an alternative future use.
Litigation and Settlement Expense
Litigation and settlement expense reflects costs of litigation and settlement in conjunction with the Settlement Agreement with Roche entered into during the second quarter of 2025.
Other Income and Expense, Net
Other income and expense primarily consist of interest earned on our cash equivalents and short-term investments, income or loss from equity method investment, foreign currency transaction gains and losses, and interest expense, which includes the amortization of debt issuance costs related to our convertible senior notes.
Income Tax Expense (Benefit)
Due to the full valuation allowance against our domestic and foreign deferred tax assets, our consolidated tax provision or benefit in any period is a result of current taxable income or losses generated in the jurisdictions in which we operate as well as reserves established for current period tax uncertainties.
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Results of Operations
Three Months Ended June 30, Six Months Ended June 30,
(in thousands, except percentages) 2026 2025 2026 2025
Sales:
United States $ 179,292 $ 170,209 $ 340,135 $ 320,841
International 75,268 70,469 161,646 154,259
Total sales 254,560 240,678 501,781 475,100
Cost of sales 109,780 114,823 220,213 230,838
Gross profit 144,780 125,855 281,568 244,262
Gross margin 57 % 52 % 56 % 51 %
Operating expenses:
Selling, general and administrative 111,642 109,596 219,829 223,449
Research and development 46,930 48,118 92,965 98,333
Acquired in-process research and development expenses — — — 75,217
Litigation and settlement expense — 19,951 — 19,951
Total operating expenses 158,572 177,665 312,794 416,950
Operating loss (13,792) (51,810) (31,226) (172,688)
Other income (expense), net:
Interest income and other income, net 1,225 (632) 4,851 3,561
Interest expense (2,450) (1,905) (4,654) (3,767)
Loss from equity method investment (5,641) (3,375) (9,506) (6,917)
Total other income (expense), net (6,866) (5,912) (9,309) (7,123)
Loss before income taxes (20,658) (57,722) (40,535) (179,811)
Income tax expense (benefit) 510 (5,322) 1,026 3,145
Net loss $ (21,168) $ (52,400) $ (41,561) $ (182,956)
Comparison of the Three Months Ended June 30, 2026 and 2025
Sales
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.
Sales by product in the United States were as follows (in thousands):
Three Months Ended June 30,
2026 2025
Pump $ 83,002 $ 85,467
Supplies and other 96,290 84,742
Total Sales in the United States $ 179,292 $ 170,209
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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.
International sales by product were as follows (in thousands):
Three Months Ended June 30,
2026 2025
Pump $ 31,650 $ 26,404
Supplies and other 43,618 44,065
Total International Sales $ 75,268 $ 70,469
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.
Cost of Sales and Gross Profit
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.
Operating Expenses
Our operating expenses for the three months ended June 30, 2026 were $158.6 million, compared to $177.7 million for the three months ended June 30, 2025. The decrease was primarily driven by a one-time litigation and settlement charge of $20.0 million incurred in the second quarter 2025 (see Note 2, “Intangible Assets Subject to Amortization”).
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.
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.
Litigation and Settlement Expense. We did not incur any litigation and settlement expenses for the three months ended June 30, 2026. Litigation and settlement expenses of $20.0 million for the three months ended June 30, 2025 related to the Settlement Agreement with Roche.
Other Income (Expense), Net
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.
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Income Tax Expense (Benefit)
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.
Comparison of the Six Months Ended June 30, 2026 and 2025
Sales
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.
Sales by product in the United States were as follows (in thousands):
Six Months Ended June 30,
2026 2025
Pump $ 160,943 $ 157,608
Supplies and other 179,192 163,233
Total Sales in the United States $ 340,135 $ 320,841
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.
International sales by product were as follows (in thousands):
Six Months Ended June 30,
2026 2025
Pump $ 64,135 $ 56,354
Supplies and other 97,511 97,905
Total International Sales $ 161,646 $ 154,259
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.
Cost of Sales and Gross Profit
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.
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Operating Expenses
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.
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.
Six Months Ended June 30,
2026 2025
Selling, general and administrative 219,829 214,562
Non-recurring facility impairment costs — 6,697
Restructuring costs — 2,190
Total SG&A expenses $ 219,829 $ 223,449
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.
Six Months Ended June 30,
2026 2025
Research and development $ 92,965 $ 96,053
Restructuring costs — 2,280
Total R&D expenses $ 92,965 $ 98,333
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”).
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.
Other Income (Expense), Net
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.
Income Tax Expense (Benefit)
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.
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Liquidity and Capital Resources
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.
Our historical cash outflows have primarily been associated with cash used for operating activities such as R&D activities, sales, marketing and commercialization of our products worldwide, expansion of clinical and customer support organizations, the acquisition of intellectual property, equity investments and asset acquisitions, capital expenditures and debt service costs.
Historically, our principal sources of cash have included cash collected from product sales, private and public offerings of equity securities, exercises of employee stock awards, and debt financing. We expect to rely primarily on product sales to fund our material cash requirements in both the short and long term.
The following table shows a summary of our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):
Six Months Ended June 30,
2026 2025
Net cash provided by (used in):
Operating activities $ (23,576) $ (27,774)
Investing activities (282,784) 67,316
Financing activities 276,315 (44,401)
Effect of foreign exchange rate changes on cash 2,229 (263)
Net decrease in cash and cash equivalents $ (27,816) $ (5,122)
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.
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.
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.
Our liquidity position and capital requirements are subject to fluctuation based on a number of factors. In particular, our cash inflows and outflows are principally impacted by the following:
•our ability to generate sales, the timing of those sales, the quantity of pumps sold through the pharmacy channel under the pay-as-you-go reimbursement model, the mix of products sold and the collection of receivables from period to period;
•contractual debt obligations, including periodic interest payments;
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•the timing of any additional financings, and the net proceeds raised from such financings;
•the timing and amount of proceeds from the issuance of equity awards pursuant to employee stock plans;
•fluctuations in costs, gross and operating margins; and
•fluctuations in working capital, including changes in accounts receivable, inventories, accounts payable, employee-related liabilities, and operating lease liabilities.
Both our primary short-term and long-term capital needs are expected to include expenditures related to:
•support of our commercialization efforts related to our current and future products;
•expansion of our commercial resources for our growing installed customer base;
•research and product development efforts, including clinical trial costs;
•acquisitions, including strategic investments, equity method investments and future contingent payments associated with acquisitions;
•leasing or licensing of equipment, technology, intellectual property and other assets;
•additional facilities leases and related tenant improvements;
•investments for the development, improvement and acquisition of manufacturing, testing and packaging equipment to support business growth and increase capacity;
•payments under licensing, development and commercialization agreements; and
•integration costs related to acquisitions of businesses, products and technologies.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements and accompanying notes as of the date of the financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about our financial condition and results of operations that are not readily apparent from other sources. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies Involving Management Estimates and Assumptions,” included in our Annual Report.
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