Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: 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, 2025 (Quarterly Report).
+Added: 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 September 30, 2025 (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.
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We are a global insulin delivery and diabetes technology company focused on the design, development and commercialization of technology solutions that reduce the burden of diabetes management.
−Removed: We consider our primary addressable market to be people who live with type 1 diabetes, and recently expanded our U.S.
−Removed: addressable market to include people living with type 2 diabetes who require intensive insulin therapy.
−Removed: We sell to customers in approximately 25 countries worldwide, with the majority of our sales derived from customers in the United States.
+Added: We consider our primary addressable market to be people who live with type 1 diabetes, and we expanded our U.S.
+Added: addressable market this year to include people living with type 2 diabetes who require intensive insulin therapy.
+Added: We sell to customers in approximately 25 countries worldwide, and the majority of our sales come from customers in the United States.
Our goal is to address the individual needs of people with insulin-dependent diabetes and their care team, by offering flexibility and choice in intelligent insulin delivery systems, through an accessible portfolio of market-leading pumps, applications, and insights.
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The Tandem Mobi insulin pump is the world’s smallest durable automated insulin delivery (AID) system.
−Removed: At approximately half the size of our t:slim X2 pump, Tandem Mobi is designed for people who seek even greater discretion and flexibility, and includes features such as expanded pump-control from our iOS mobile application, inductive charging, and an on-pump button that can be used for bolusing and other actions.
+Added: At approximately half the size of our t:slim X2 pump, Tandem 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.
In the first half of 2024, we scaled the commercial release of Tandem Mobi in the United States.
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Control-IQ+ is an advanced hybrid-closed loop feature designed to help increase a user’s time in their targeted glycemic range.
−Removed: Multiple studies, including four publications in the New England Journal of Medicine with the most recent in March 2025 , have demonstrated that use of Control-IQ+ technology, and its predecessor Control-IQ technology, provide people across all demographics with improved clinical outcomes that are both immediate and sustained.
+Added: Multiple studies, including four publications in the New England Journal of Medicine , the most recent appearing in March 2025, demonstrate that both Control-IQ+ technology and its predecessor, Control-IQ technology, are associated with improved, immediate and sustained clinical outcomes for people living with type 1 or type 2 diabetes across diverse demographics.
The t:slim X2 was the first pump in the industry on which remote software updates were made commercially available in the United States and is now also available in the countries we serve worldwide.
This feature allows our customers to update their pump software independently.
−Removed: We believe this offering is a competitive advantage that allows us to bring our customers clinical and lifestyle enhancements within their warranty cycle without having to purchase a new pump.
+Added: We believe this offering is a competitive advantage, allowing us to bring our customers clinical and lifestyle enhancements within their warranty cycle without having to purchase a new pump.
These enhancements generally include new developments in our AID technology, CGM integrations and mobile app features.
For more than a decade we have offered our customers, their caregivers and healthcare providers a data management application to provide a fast, easy and visual way to display diabetes therapy management data from our pumps and integrated CGMs.
−Removed: In the second quarter of 2023, we expanded our digital technology solutions with the launch of Tandem Source in the United States.
−Removed: In the second quarter of 2024, we began the launch of Tandem Source outside the United States.
+Added: Since the launch of Tandem Source, we have enhanced and expanded our digital technology solutions, and will continue to scale into additional countries.
In addition to displaying diabetes therapy management data, Tandem Source is also designed to serve as a portal for supplies reordering and pump software updates.
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Our goal is to redefine global leadership in insulin delivery with an accessible portfolio of transformational devices, applications and services that reduce the daily burden of living with diabetes.
−Removed: In support of this strategy, our portfolio of future technologies includes enhancing the features and capabilities of our t:slim X2 and Tandem Mobi insulin pump platforms, including adding a tubeless infusion site option for Tandem Mobi users.
−Removed: Our development efforts also include Sigi, our ergonomic and rechargeable patch pump, in addition to extended wear infusion technology and algorithm advancement in pursuit of offering fully closed loop technology.
+Added: In support of this strategy, our portfolio of future technologies includes enhancing the features and capabilities of our t:slim X2 and Tandem Mobi insulin pump platforms, including adding a tubeless, extended-wear infusion site option for Tandem Mobi users.
+Added: Our pipeline also includes a next-generation patch pump that incorporates our Sigi Patch Pump technology, and we anticipate marketing it as the next generation Tandem Mobi.
+Added: In addition, our development efforts include extended-wear infusion set technology, dual glucose-ketone sensor integration, and algorithm advancement in pursuit of offering fully closed loop technology.
Pump Reimbursement Cycle
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At December 31, 2024, we had more than 480,000 users in our in-warranty installed base, approximately one-third of whom live outside the United States.
−Removed: The ordering patterns of, and levels of inventory carried by, our distributors outside the United States for pumps and supplies have historically been highly variable from period to period due to a number of factors, including summer vacations, the timing of product launches, expansion into new geographies and variability due to supply chain logistics, particularly during the global pandemic.
+Added: The ordering patterns of, and levels of inventory carried by, our distributors outside the United States for pumps and supplies have historically been highly variable from period to period due to a number of factors, including summer vacations, the timing of product launches, expansion into new geographies and variability due to supply chain logistics.
This also influences the timing in which renewal eligibility begins for existing customers, which may not initially be consistent with trends in the United States market.
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Reimbursement
−Removed: • In 2025, we began implementing a multi-channel managed care strategy.
−Removed: Historically, our insulin pump products have generally been considered durable medical equipment (DME) with an expected lifespan of at least four years.
−Removed: In addition to insulin pumps, we sell single-use products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body.
−Removed: Because of the DME classification, our pumps and supplies are typically reimbursed through a medical benefit.
−Removed: In the first quarter of 2025, we began serving Tandem Mobi customers through the pharmacy channel on a scaled basis, and are preparing to serve t:slim X2 customers for their cartridges and infusion sets beginning in the fourth quarter of 2025.
+Added: • In 2025, we began implementing a multi-channel managed care strategy in the United States, which provides the opportunity for reimbursement through a pharmacy benefit as an alternative to a medical benefit.
+Added: This strategic expansion supports broader access and flexibility in reimbursement pathways for our customers.
+Added: Historically, our products have been offered through a medical benefit.
+Added: Pumps are generally reimbursed upfront, separate from the ongoing supply purchases.
+Added: In the first quarter of 2025, we began contracting for Tandem Mobi customers to receive their pumps and supplies through a pharmacy benefit with the same upfront reimbursement structure as a medical benefit.
+Added: In the third quarter of 2025, we began contracting for existing t:slim X2 customers to receive their supplies through a pharmacy benefit.
• We generally have had broad insurance coverage for our current products from third-party payors.
18 unchanged sentences
Cost of Sales
−Removed: Cost of sales includes raw materials, labor costs, manufacturing overhead expenses, product training costs, royalties, freight, reserves for expected warranty costs, costs of supporting our digital health platforms, scrap and charges for excess and obsolete inventories.
+Added: 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.
6 unchanged sentences
Litigation and Settlement Expense
−Removed: Litigation and settlement expense reflects costs of litigation and settlement in conjunction with a cross-license agreement with F.
−Removed: Hoffmann-La Roche AG and its subsidiaries, entered into during the second quarter of 2025.
+Added: Litigation and settlement expense reflects costs of litigation and settlement in conjunction with the Roche Cross-License Agreement, entered into during the second quarter of 2025.
Research and Development
4 unchanged sentences
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.
−Removed: Other Income and Expense
+Added: 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 investments, 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)
−Removed: Because the Company maintains a full valuation allowance against its net deferred tax assets, income tax expense (benefit) is expected to primarily consist of current federal, state and foreign cash tax expense (benefit) as a result of taxable income (loss) anticipated or incurred in those jurisdictions.
+Added: Due to the valuation allowance on domestic and foreign deferred tax assets, the Company's domestic and foreign tax provisions consist of cash tax expense incurred in each of the jurisdictions in which the Company operates.
Results of Operations
Three Months Ended
−Removed: June 30, Six Months Ended June 30,
+Added: September 30, Nine Months Ended September 30,
(in thousands, except percentages) 2025 2024 2025 2024
8 unchanged sentences
Litigation and settlement expense
−Removed: 19,951 — 19,951 —
Research and development 48,715 51,107 147,048 146,677
3 unchanged sentences
Other income (expense), net:
−Removed: Interest income and other income (expense), net (632) 2,824 3,561 8,138
+Added: Interest income and other income, net
+Added: 2,509 5,344 6,070 13,482
Interest expense (2,065) (1,865) (5,832) (5,555)
7 unchanged sentences
Net loss $ (21,165) $ (23,251) $ (204,121) $ (96,780)
−Removed: Comparison of the Three Months Ended June 30, 2025 and 2024
−Removed: For the three months ended June 30, 2025, we shipped more than 30,000 pumps worldwide.
+Added: Comparison of the Three Months Ended September 30, 2025 and 2024
+Added: For the three months ended September 30, 2025, we shipped approximately 30,000 pumps worldwide.
Sales were $249.3 million, which included $73.6 million of sales outside the United States.
−Removed: Sales were $221.9 million for the three months ended June 30, 2024, which included $65.2 million of sales outside the United States.
−Removed: For the three months ended June 30, 2024, we recognized incremental pump sales of $0.2 million as a result of Tandem Choice fulfillment.
+Added: Sales were $244.0 million for the three months ended September 30, 2024, which included $72.3 million of sales outside the United States.
Sales by product in the United States were as follows (in thousands):
Three Months Ended
+Added: September 30,
Pump $ 84,785 $ 86,722
2 unchanged sentences
Total Sales in the United States $ 175,631 $ 171,650
−Removed: Pump and supply sales in the United States increased due to growth in volumes and average selling prices.
−Removed: Pump shipments increased to approximately 21,000 in the second quarter of 2025, compared to approximately 20,000 in the second quarter of 2024.
−Removed: Sales in the second quarter of 2024 included $0.2 million in sales from Tandem Choice fulfillment, for which there was no comparable adjustment in 2025.
+Added: For the third quarter of 2025, sales in the United States increased primarily due to improved average selling prices across all products, partially offset by a slight decrease in pump shipments.
+Added: Pump shipments were more than 20,000 in the third quarter of 2025 compared to nearly 21,000 pumps for the third quarter of 2024.
+Added: Sales in the third quarter of 2024 included $1.0 million in incremental sales from Tandem Choice fulfillments, for which there was no comparable adjustment in 2025.
Sales by product outside the United States were as follows (in thousands):
Three Months Ended
+Added: September 30,
Pump $ 25,329 $ 28,077
1 unchanged sentence
Total Sales Outside the United States $ 73,622 $ 72,321
−Removed: For the second quarter of 2025, total sales outside the United States increased primarily due to growth in supply volumes, improved average selling prices, geographical mix, and favorable changes in foreign exchange rates.
−Removed: Pump shipments decreased slightly to approximately 9,000 pumps for the second quarter of 2025 compared to nearly 10,000 pumps in the second quarter of 2024.
+Added: For the third quarter of 2025, total sales outside the United States increased primarily due to favorable changes in foreign exchange rates and higher supply volumes, partially offset by lower pump volumes.
+Added: Pump shipments decreased to more than 9,000 pumps for the third quarter of 2025 compared to nearly 11,000 pumps for the third quarter of 2024.
+Added: The decrease in pump shipments was attributable to distributor destocking in anticipation of the initiation of direct sales activities in select countries, expected to begin in the first quarter of 2026.
Cost of Sales and Gross Profit
−Removed: Our cost of sales for the three months ended June 30, 2025 was $114.8 million, resulting in gross profit of $125.9 million, compared to cost of sales of $109.1 million and gross profit of $112.8 million for the same period in 2024.
−Removed: The gross margins for the three-month periods ended June 30, 2025 and 2024 were 52% and 51%, respectively.
−Removed: This increase in gross margin was primarily driven by improvement in average selling prices, partially offset by the impact of less favorable product mix and non-manufacturing costs.
+Added: Our cost of sales for the three months ended September 30, 2025 was $115.0 million, resulting in gross profit of $134.3 million, compared to cost of sales of $119.3 million and gross profit of $124.7 million for the same period in 2024.
+Added: The gross margins for the three-month periods ended September 30, 2025 and 2024 were 54% and 51%, respectively.
+Added: This increase in gross margin was primarily driven by improved average selling prices and reduced non-manufacturing costs, partially offset by the impact of less favorable product mix.
Operating Expenses
−Removed: Our operating expenses for the three months ended June 30, 2025 were $177.7 million, compared to $143.6 million for the three months ended June 30, 2024.
−Removed: The $34.1 million increase was primarily driven by $20.0 million in litigation and settlement expenses.
−Removed: Additionally, operating expenses increased due primarily to higher employee-related expenses.
+Added: Our operating expenses for the three months ended September 30, 2025 were $157.2 million, compared to $150.7 million for the three months ended September 30, 2024.
Selling, General and Administrative Expenses.
−Removed: SG&A expenses were $109.6 million for the three months ended June 30, 2025, compared to $94.2 million for the same period in 2024.
−Removed: The increase was driven by commercial investments in the sales infrastructure, including sales force expansion in the United States, costs to support direct operations in Europe and initiatives to create future efficiencies in operations.
−Removed: Litigation and Settlement Expense.
−Removed: Litigation and settlement expenses of $20.0 million for the three months ended June 30, 2025 related to a Settlement, Mutual Release and Cross-License Agreement with F.
−Removed: Hoffmann-La Roche AG and its subsidiaries (the “Cross-License Agreement”) (see Intangible Assets Subject to Amortization, Note 2, “Summary of Significant Accounting Policies”).
−Removed: We did not incur any legal settlement expenses for the three months ended June 30, 2024.
+Added: SG&A expenses were $108.4 million for the three months ended September 30, 2025, compared to $99.6 million for the same period in 2024.
+Added: Expenses increased $9.1 million from commercial investments in the sales infrastructure, including sales force expansion in the United States, costs to support direct operations in Europe and initiatives to create future efficiencies in operations, as well as $2.0 million in restructuring costs.
+Added: The increase was partially offset by a $2.3 million decrease in stock-based compensation expense.
Research and Development Expenses .
−Removed: R&D expenses decreased to $48.1 million for the three months ended June 30, 2025, from $49.3 million for the same period in 2024.
−Removed: The decrease in R&D expenses was primarily due to lower employee-related expenses as a result of restructuring activities that occurred in the first quarter of 2025.
+Added: R&D expenses were $48.7 million for the three months ended September 30, 2025, compared to $51.1 million for the same period in 2024.
+Added: The decrease in R&D expenses was primarily due to a $2.4 million decrease in stock-based compensation expense and $0.5 million decrease in other employee benefits and expenses, partially offset by $0.8 million in restructuring costs.
Other Income (Expense), Net
−Removed: Total other income (expense), net for the three months ended June 30, 2025 was a $5.9 million loss, compared to $1.0 million of income for the same period in 2024.
−Removed: Other expense, net for the three months ended June 30, 2025 primarily consisted of $4.3 million of unrealized losses on foreign currency remeasurements, $3.4 million loss on equity investment and $1.9 million of interest expense which included the amortization of debt issuance costs related to our convertible senior notes, partially offset by $3.4 million of interest income earned on our cash equivalents and short-term investments.
−Removed: Other income, net for the three months ended June 30, 2024 was $1.0 million of income, primarily consisting of $5.3 million of interest income earned on our cash equivalents and short-term investments, partially offset by $2.0 million impairment on a strategic investment in a private company, and $1.8 million of interest expense which included the amortization of debt issuance costs.
−Removed: Income Tax Expense
−Removed: We recognized income tax benefit of $5.3 million on a pre-tax loss of $57.7 million for the three months ended June 30, 2025, compared to income tax expense of $1.1 million on a pre-tax loss of $29.7 million for the three months ended June 30, 2024.
−Removed: Income tax benefit and expense for the three months ended June 30, 2025 and 2024, respectively, was primarily attributable to federal, state and foreign income tax benefit and expense as a result of current taxable income in certain jurisdictions.
−Removed: Comparison of the Six Months Ended June 30, 2025 and 2024
−Removed: For the six months ended June 30, 2025, we shipped approximately 59,000 pumps worldwide.
+Added: Total other income (expense), net for the three months ended September 30, 2025 was a loss of $2.3 million, compared to income of $3.5 million for the same period in 2024.
+Added: Other expense, net for the three months ended September 30, 2025 primarily consisted of a $2.7 million loss on equity investment, $2.1 million of interest expense which included the amortization of debt issuance costs related to our convertible senior notes, and $0.7 million of realized losses on foreign currency transactions.
+Added: This was partially offset by $3.2 million of interest income earned on our cash equivalents and short-term investments.
+Added: Other income, net for the three months ended September 30, 2024 was income of $3.5 million, primarily consisting of $5.6 million of interest income earned on our cash equivalents and short-term investments, partially offset by $1.9 million of interest expense which included the amortization of debt issuance costs.
+Added: Income Tax Expense (Benefit)
+Added: We recognized income tax benefit of $4.0 million on a pre-tax loss of $25.1 million for the three months ended September 30, 2025, compared to income tax expense of $0.6 million on a pre-tax loss of $22.6 million for the three months ended September 30, 2024.
+Added: Income tax benefit for the three months ended September 30, 2025, was due to a reduction in domestic cash tax expense as a result of the passage of the One Big Beautiful Bill Act (“OBBBA”) in July 2025.
+Added: The OBBBA included various provisions with multiple effective dates, including, but not limited to, immediate expensing of domestic research and development expenditures.
+Added: The impacts of the OBBBA are reflected in our results for the quarter ended September 30, 2025.
+Added: Additionally, certain foreign cash tax expenses were reduced in the current period.
+Added: Income tax expense for the three months ended September 30, 2024 was primarily attributable to state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
+Added: Comparison of the Nine Months Ended September 30, 2025 and 2024
+Added: For the nine months ended September 30, 2025, we shipped more than 88,000 pumps worldwide.
Sales were $724.4 million, which included $227.9 million of sales outside the United States.
−Removed: Sales were $413.6 million for the six months ended June 30, 2024, which included $127.1 million of sales outside the United States.
−Removed: For the six months ended June 30, 2024, we deferred $1.0 million of pump sales as the result of Tandem Choice.
+Added: Sales were $657.6 million for the nine months ended September 30, 2024, which included $199.4 million of sales outside the United States.
Sales by product in the United States were as follows (in thousands):
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
Pump $ 242,393 $ 230,187
Supplies and other 254,079 227,888
−Removed: Net revenue deferred for Tandem Choice program
+Added: Net revenue recognized for Tandem Choice program
Total Sales in the United States $ 496,472 $ 458,122
Pump and supply sales in the United States increased primarily due to growth in shipment volumes and increased average selling prices.
−Removed: Pumps shipments increased to over 38,000 for the six months ended June 30, 2025, compared to nearly 36,000 for the six months ended June 30, 2024.
−Removed: Sales in the first half of 2024 were reduced by $1.0 million from net sales deferrals related to Tandem Choice, for which there were no comparable adjustments for the same period in 2025.
+Added: Pumps shipments were approximately 59,000 in the nine months ended September 30, 2025.
+Added: For the nine months ended September 30, 2024, there was a negligible net impact to our revenues as a result of Tandem Choice.
+Added: There were no comparable Tandem Choice adjustment for the same period in 2025.
Sales by product outside the United States were as follows (in thousands):
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
Pump $ 81,683 $ 79,774
1 unchanged sentence
Total Sales Outside the United States $ 227,881 $ 199,433
−Removed: For the six months ended June 30, 2025, both pumps and pump-related supply sales increased due to a year-over-year increase in shipment volumes and average selling prices, with pump shipments growing to over 20,000 pumps in the six months ended June 30, 2025, compared to approximately 19,000 in the six months ended June 30, 2024.
+Added: For the nine months ended September 30, 2025, pump sales increased due to a year-over-year increase in average selling prices and favorable changes in foreign currency exchange rates.
+Added: Pump shipments were approximately 30,000 in the nine months ended September 30, 2025.
+Added: For the nine months ended September 30, 2025, pump-related supply sales increased due to a year-over-year increase in volumes shipped, improved average selling prices and favorable changes in foreign currency exchange rates.
Cost of Sales and Gross Profit
−Removed: Our cost of sales for the six months ended June 30, 2025 was $230.8 million , resulting in gross profit of $244.3 million, compared to cost of sales of $206.1 million and gross profit of $207.5 million for the same period in 2024.
−Removed: The gross margins for the six-month periods ended June 30, 2025 and 2024 were 51% and 50%, respectively.
−Removed: This increase in gross margin was primarily driven by improved average selling prices, partially offset by the impact of less favorable product mix.
+Added: Our cost of sales for the nine months ended September 30, 2025 was $345.8 million , resulting in gross profit of $378.6 million, compared to cost of sales of $325.4 million and gross profit of $332.1 million for the same period in 2024.
+Added: The gross margins for the nine months ended September 30, 2025 and 2024 were 52% and 51%, respectively.
+Added: This increase in gross margin was primarily driven by improved average selling prices and reduced non-manufacturing costs, partially offset by the impact of less favorable product mix.
Operating Expenses
−Removed: Our operating expenses for the six months ended June 30, 2025 were $417.0 million, compared to $279.9 million for the six months ended June 30, 2024.
−Removed: The $137.1 million increase was primarily driven by a $75.2 million charge to IPR&D in connection with the revised AMF purchase agreement (see Note 13, “Acquisitions”) and a $20.0 million litigation and settlement expense, as well as costs related to operating lease impairment and restructuring charges related to relocation of certain research and development activities and sales force expansion.
+Added: Our operating expenses for the nine months ended September 30, 2025 were $574.1 million, compared to $430.7 million for the nine months ended September 30, 2024.
+Added: The $143.4 million increase was primarily driven by a $75.2 million charge to IPR&D in connection with the revised AMF purchase agreement (see Note 13, “Acquisitions”), a $20.0 million litigation and settlement expense, costs related to our international and domestic sales force expansions, and certain operating lease impairment and restructuring charges recognized during 2025.
Selling, General and Administrative Expenses.
−Removed: SG&A expenses, including one-time charges for non-recurring facility impairment costs of $6.7 million and restructuring costs of $2.2 million, were $223.4 million for the six months ended June 30, 2025, compared to $184.3 million for the same period in 2024.
+Added: SG&A expenses, including one-time charges for non-recurring facility impairment costs of $6.7 million and restructuring costs of $4.2 million, were $331.9 million for the nine months ended September 30, 2025, compared to $284.0 million for the same period in 2024.
After one-time costs, the remaining increase was largely driven by commercial investments in sales infrastructure, including sales force expansion in the United States, costs to support direct operations in Europe and initiatives to create future efficiencies in operations.
−Removed: Six Months Ended
+Added: Nine Months Ended September 30, 2025
Selling, general and administrative
5 unchanged sentences
Litigation and Settlement Expense.
−Removed: Litigation and settlement expenses of $20.0 million for the six months ended June 30, 2025 related to the Cross-License Agreement.
−Removed: We did not incur any legal settlement expenses for the six months ended June 30, 2024.
+Added: Litigation and settlement expenses of $20.0 million for the nine months ended September 30, 2025 related to the Roche Cross-License Agreement.
+Added: We did not incur any litigation and settlement expenses for the nine months ended September 30, 2024.
Research and Development Expenses .
−Removed: R&D expenses, including one-time charges for non-recurring restructuring costs of $2.3 million, increased to $98.3 million for the six months ended June 30, 2025, from $95.6 million for the same period in 2024.
−Removed: After one-time costs, R&D expenses were relatively flat compared to the prior year.
−Removed: Six Months Ended
+Added: R&D expenses were $147.0 million for the nine months ended September 30, 2025, compared to $146.7 million for the same period in 2024.
+Added: The current period includes $3.1 million of non-recurring restructuring costs.
+Added: Excluding these costs, the decrease was primarily due to lower stock-based compensation expense of $1.9 million.
+Added: Nine Months Ended September 30, 2025
Research and development
4 unchanged sentences
Acquired In-Process Research and Development (IPR&D) Expenses.
−Removed: 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”).
−Removed: We did not incur any IPR&D expenses for the six months ended June 30, 2024.
+Added: Acquired IPR&D expenses were $75.2 million for the nine months ended September 30, 2025, which represented costs associated with the revised AMF purchase agreement (see Note 13, “Acquisitions”).
+Added: We did not incur any IPR&D expenses for the nine months ended September 30, 2024.
Other Income (Expense), Net
−Removed: Total other income (expense), net for the six months ended June 30, 2025 was a $7.1 million loss, compared to $3.2 million for the same period in 2024.
−Removed: Other expense, net for the six months ended June 30, 2025 primarily consisted of $6.9 million loss on equity investment and $3.8 million of interest expense which included the amortization of debt issuance costs related to our convertible senior notes, and $4.3 million unrealized loss from foreign currency remeasurement, offset by $7.9 million of interest income earned on our cash equivalents and short-term investments.
−Removed: Other income, net for the six months ended June 30, 2024 primarily consisted of $10.8 million of interest income earned on our cash equivalents and short-term investments, partially offset by $3.7 million of interest expense which included the amortization of debt issuance costs, and $1.3 million loss on debt extinguishment.
−Removed: Income Tax Expense
−Removed: We recognized income tax expense of $3.1 million on a pre-tax loss of $179.8 million for the six months ended June 30, 2025, compared to income tax expense of $4.3 million on a pre-tax loss of $69.3 million for the six months ended June 30, 2024.
−Removed: Income tax expense for the six months ended June 30, 2025 and 2024 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
+Added: Total other income (expense), net for the nine months ended September 30, 2025 was a $9.4 million loss, compared to a net income of $6.7 million for the same period in 2024.
+Added: Other expense, net for the nine months ended September 30, 2025 primarily consisted of $9.6 million loss on equity investment, $5.8 million of interest expense which included the amortization of debt issuance costs related to our convertible senior notes, and $5.0 million realized loss from foreign currency transactions, offset by $11.1 million of interest income earned on our cash equivalents and short-term investments.
+Added: Other income, net for the nine months ended September 30, 2024 primarily consisted of $16.7 million of interest income earned on our cash equivalents and short-term investments, partially offset by $5.6 million of interest expense which included the amortization of debt issuance costs.
+Added: Income Tax Expense (Benefit)
+Added: We recognized income tax benefit of $0.8 million on a pre-tax loss of $205.0 million for the nine months ended September 30, 2025, compared to income tax expense of $4.9 million on a pre-tax loss of $91.9 million for the nine months ended September 30, 2024.
+Added: Income tax benefit for the nine months ended September 30, 2025 was due to a reduction in domestic cash tax expense as a result of the passage of the OBBBA legislation in July 2025.
+Added: The OBBBA included various provisions with multiple effective dates, including, but not limited to, immediate expensing of domestic research and development expenditures.
+Added: The impacts of the OBBBA are reflected in our results for the nine months ended September 30, 2025.
+Added: Additionally, certain foreign cash tax expenses were reduced in the current period.
+Added: Income tax expense for the nine months ended September 30, 2024 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
Liquidity and Capital Resources
−Removed: At June 30, 2025, we had $315.4 million in cash and cash equivalents and short-term investments.
+Added: At September 30, 2025, we had $319.1 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 12 months.
1 unchanged sentence
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.
−Removed: We expect to rely on these sources of cash, primarily from product sales, to fund our material cash requirements in both the short and long term.
−Removed: The following table shows a summary of our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
−Removed: Six Months Ended June 30,
+Added: We expect to rely primarily on product sales to fund our material cash requirements in both the short and long term.
+Added: The following table shows a summary of our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):
+Added: Nine Months Ended September 30,
Net cash provided by (used in):
6 unchanged sentences
Operating Activities .
−Removed: Net cash used in operating activities was $27.8 million for the six months ended June 30, 2025, compared to $13.3 million used in the same period in 2024.
−Removed: 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.
−Removed: For the six months ended June 30, 2024, net loss was $73.5 million, net non-cash adjustments were $63.8 million and the change in working capital balances was a decrease of $3.6 million.
+Added: Net cash used in operating activities was $19.5 million for the nine months ended September 30, 2025, compared to $13.5 million cash provided in the same period in 2024.
+Added: 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.
+Added: For the nine months ended September 30, 2024, net loss was $96.8 million, net non-cash adjustments were $98.8 million and the change in working capital balances was an increase of $11.5 million.
Investing Activities .
−Removed: 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.
−Removed: Net cash used in investing activities was $8.6 million for the six months ended June 30, 2024, which primarily consisted of $177.7 million in purchases of short-term investments, and $10.9 million in purchases of property and equipment, offset by $180.1 million in proceeds from maturities and redemptions of short-term investments.
+Added: 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 $56.0 million in purchases of short-term investments, $43.5 million paid for IPR&D, and $13.3 million in purchases of property and equipment.
+Added: Net cash used in investing activities was $28.5 million for the nine months ended September 30, 2024, which primarily consisted of $251.4 million of purchases of short-term investments, and $16.2 million in purchases of property and equipment, offset by $239.0 million in proceeds from maturities and redemptions of short-term investments.
Financing Activities.
−Removed: Net cash used in financing activities was $44.4 million for the six months ended June 30, 2025, which consisted of $40.6 million used to pay the principal of the 2025 Notes and 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.
−Removed: Net cash provided by financing activities was $10.6 million for the six months ended June 30, 2024, which primarily consisted of net proceeds of $306.9 million from the issuance of the 2029 Notes which was partially offset by $246.1 million used in the repurchase of 2025 Notes, $30.0 million used in the repurchase and retirement of common stock and $15.8 million used to purchase Capped Call Options related to the 2029 Notes.
+Added: 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 portion of the 2025 Notes and 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.
+Added: Net cash provided by financing activities was $6.1 million for the nine months ended September 30, 2024, which primarily consisted of net proceeds of $306.9 million from the issuance of the 2029 Notes which was partially offset by $246.1 million used in the repurchase of 2025 Notes, $30.0 million used in the repurchase and retirement of common stock and $15.8 million used to purchase Capped Call Options related to the 2029 Notes.
In addition, $9.0 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.
25 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.