Tandem Diabetes Care Announces Third Quarter 2025 Financial Results

Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended September 30, 2025 and reaffirmed full year 2025 guidance.

Third Quarter 2025 and Recent Highlights

• Achieved record third quarter sales both in the United States (U.S.) and internationally
• Demonstrated year-over-year and sequential gross margin improvement
• Progressed multi-channel initiative by:
  • Increasing pharmacy benefit coverage for Tandem Mobi to more than 40% of U.S. lives
  • Introducing t:slim X2 supplies through a pharmacy benefit
• Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for extended wear use of the SteadiSet Infusion Set
• Filed a 510(k) with the FDA for Android mobile control of the Tandem Mobi insulin delivery system
• Began global commercial rollout of t:slim X2 pump integration with the FreeStyle Libre 3 Plus CGM sensor

"Tandem delivered a strong third quarter performance marked by record quarterly sales, significant gross margin improvement, and meaningful progress on our key strategic initiatives," said John Sheridan, president and chief executive officer. "We are beginning to see the positive impact of our business transformation, which strengthens our ability to achieve Tandem's near- and longer-term goals, while continuing our commitment to improve the lives of people with diabetes."

Third Quarter 2025 Results Compared to Third Quarter 2024

• Sales ⁽¹⁾: Worldwide sales increased to $249.3 million, which included sales outside the United States of $73.6 million. This is compared to worldwide sales of $244.0 million, which included sales of $72.3 million outside the United States.
  
  
  
  Non-GAAP worldwide sales⁽²⁾ of increased to $249.3 million, which included sales outside of the United States of $73.6 million. This is compared to worldwide sales of $242.9 million, which included sales of $72.3 million outside the United States.
  
  
  
  Shipments in the United States were more than 20,000 pumps. Shipments outside the United States were more than 9,000 pumps.
  
  
  
  
• Gross profit ⁽¹⁾: GAAP gross profit was $134.3 million, compared to $124.7 million. GAAP gross margin was 54%, compared to 51%.
  
  
  
  Non-GAAP gross profit⁽²⁾ was $134.3 million, compared to $124.3 million. Non-GAAP gross margin⁽²⁾ was 54%, compared to 51%.
  
  
  
  
• Operating loss: GAAP operating loss was $22.9 million, or negative 9% of sales, compared to $26.1 million, or negative 11% of sales.
  
  
  
  Non-GAAP operating loss⁽²⁾ was $22.9 million, or negative 9% of sales, compared to $26.5 million or negative 11% of sales.
  
  
  
  
• Net loss: GAAP net loss was $21.2 million, compared to net loss of $23.3 million.
  
  
  
  Non-GAAP net loss⁽²⁾ was $21.2 million, compared to net loss of $23.6 million.
  
  
  
  Adjusted EBITDA⁽²⁾ was $2.8 million, or 1% of sales, compared to $4.0 million, or 2% of sales.
  
  

2025 Financial Guidance

For the year ending December 31, 2025, the Company is reaffirming its 2025 financial guidance as follows:

• Sales for the full year are estimated to be approximately $1.0 billion.
  • Sales in the United States of approximately $700 million.
  • Sales outside the United States of approximately $300 million, which reflects a $10 million headwind associated with the Company's preparation for direct commercial operations in select countries in 2026.
• Gross margin is estimated to be approximately 53% to 54% of sales for the full year.
• Adjusted EBITDA margin is estimated to be approximately negative 5% of sales for the full year, recast in the second quarter of 2025 from approximately 3%. The change was made to align with views expressed by the staff of the U.S. Securities and Exchange Commission to include an acquired in-process research and development (IPR&D) charge that occurred in the first quarter of 2025, which had an estimated impact of negative 8 percentage points.
• Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $115 million. This includes:
  • Approximately $95 million non-cash, stock-based compensation expense.
  • Approximately $20 million depreciation and amortization expense.

Non-GAAP Financial Measures

Certain non-GAAP financial measures are presented in this press release to provide information that may assist investors in understanding the Company's financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important operating performance indicators because they exclude items that are unrelated to, and may not be indicative of, the Company's core operating results. These non-GAAP financial measures, as calculated, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent, and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. To the extent the Company uses such non-GAAP financial measures in the future, we expect they will be calculated using a consistent method from period to period and, if not, an explanation will be provided. A reconciliation of each of the historical GAAP financial measures to the most directly comparable historical non-GAAP financial measures has been provided in Table D "Reconciliation of GAAP versus Non-GAAP Financial Results" attached to this press release.

In the first quarter of 2025, the Company included an adjustment for IPR&D expense in its non-GAAP financials and provided guidance based on this practice. Beginning in the second quarter of 2025, the Company no longer included an adjustment for IPR&D expense in its non-GAAP results to align with views expressed by the staff of the U.S. Securities and Exchange Commission and 2025 results. The Company's guidance has been revised accordingly.

The accounting treatment for Tandem Choice, which was in effect from September 2022 through December 2024, had a high degree of complexity. When the program originally launched, the Company began deferring a portion of sales for each eligible t:slim X2 pump shipped in the United States. When a customer elected to participate in Tandem Choice upon the launch of Tandem Mobi in 2024, the Company recognized the existing deferral, incremental fees received and the associated costs of providing the new insulin pump at the time of fulfillment. Historical non-GAAP financial measures are presented in this press release to facilitate better comparisons of the Company's operating results across the reporting periods. Tandem Choice will not impact any financial measures for the year ending December 31, 2025.

Conference Call

The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link (https://register-conf.media-server.com/register/BIc606fdd6dfdd4cec879c519f6530a5c6) and you will be provided with dial-in details, including a personal pin.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company's pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ+ advanced hybrid closed-loop technology. Tandem Diabetes Care is headquartered in San Diego, California. For more information, visit tandemdiabetes.com.

Tandem Diabetes Care, the Tandem logo, Control-IQ, Control-IQ+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements include statements regarding, among other things, the Company's projected financial results and the ability to achieve other operational and commercial goals. The Company's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, the Company's ability to achieve projected financial results will be impacted by market acceptance of the Company's products; products marketed and sold or under development by competitors; the Company's ability to establish and sustain operations to support international sales, including expanding into additional geographies; changes in reimbursement rates or insurance coverage for the Company's products; the Company's ability to meet increasing operational and infrastructure requirements from higher customer interest and a larger base of existing customers; the Company's ability to successfully commercialize its products; the Company's ability to develop and launch new products; risks associated with the regulatory approval process outside the United States for new products; the potential that newer products, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, may render the Company's products obsolete or less desirable, or may otherwise negatively impact the purchasing trends of customers; reliance on third-party relationships, such as outsourcing and supplier arrangements; global economic conditions; and other risks identified in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other documents that the Company files with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

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