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Tandem Diabetes Care Announces Second Quarter 2025 Financial Results and Provides 2025 Annual Guidance

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended June 30, 2025 and provided full year 2025 guidance.

Second Quarter 2025 Highlights

• Achieved record second quarter sales both in the United States (U.S.) and internationally.
• Demonstrated year-over-year and sequential gross margin improvement.
• Initiated an early access program for the t:slim X2鈩� insulin pump with Control-IQ+ technology integrated with Abbott鈥檚 FreeStyle Libre庐 3 Plus continuous glucose monitoring sensor in the U.S.
• Progressed multichannel initiative to include t:slim X2 supplies as a pharmacy benefit beginning in Q4 2025.
• Received CE Mark for the Tandem Mobi insulin delivery system with Control-IQ+ technology.
• Filed a 510(k) with the U.S. Food and Drug Administration for extended wear use of the SteadiSet Infusion Set.
• Completed feasibility study to advance the development of a fully-closed loop automated insulin delivery system.

鈥淚n the second quarter, we increased U.S. pump shipments while strengthening our business model and improving operational efficiency,鈥� said John Sheridan, president and chief executive officer. 鈥淟ooking at the remainder of the year, we are advancing our product development and commercial initiatives, which positions us well for sustained double-digit growth and enhanced profitability.鈥�

Second Quarter 2025 Results Compared to Second Quarter 2024

• Sales ⁽¹⁾: Worldwide sales increased to $240.7 million, which included sales outside the United States of $70.5 million. This is compared to worldwide sales of $221.9 million, which included sales of $65.2 million outside the United States.
  
  Shipments in the United States grew to approximately 21,000 pumps. Shipments outside the United States were approximately 9,000 pumps.

• Gross profit ⁽¹⁾: GAAP gross profit was $125.9 million, compared to $112.8 million. GAAP gross margin was 52%, compared to 51%.

• Operating loss: GAAP operating loss was $51.8 million, or negative 22% of sales, compared to $30.8 million, or negative 14% of sales.
  
  Non-GAAP operating loss⁽²⁾ was $31.9 million, or negative 13% of sales, compared to $30.9 million or negative 14% of sales.

• Net loss: GAAP net loss was $52.4 million, compared to net loss of $30.8 million.
  
  Non-GAAP net loss⁽²⁾ was $32.4 million, compared to $30.9 million.
  
  Adjusted EBITDA⁽²⁾ was negative $1.8 million, or negative 1% of sales, compared to negative $1.9 million, or negative 1% of sales.

2025 Financial Guidance

鈥淲e expect to reach $1 billion in worldwide 2025 sales, which is a significant milestone for our company,鈥� said Leigh Vosseller, executive vice president and chief financial officer. 鈥淥ur narrowed guidance reflects insights gained in the first half of the year, including our U.S. growth expectations as we progress our commercial transformation, increased benefit from accelerated pharmacy channel initiatives and greater contributions from international sales."

For the year ending December 31, 2025, the Company is providing 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鈥檚 preparation for direct commercial operations in select countries.
• Gross margin is estimated to be approximately 53% to 54% of sales for the full year.
• Adjusted EBITDA margin⁽¹⁾ is being recast from approximately 3% to approximately negative 5% of sales for the full year, which has been updated to include a negative 8 percentage point impact for an acquired in-process research and development (鈥淚PR&D鈥�) charge that occurred in the first quarter of 2025. 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.
• 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鈥檚 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鈥檚 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 鈥淩econciliation of GAAP versus Non-GAAP Financial Results鈥� 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鈥檚 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鈥檚 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 , and will be archived for 30 days. To access the call by phone, please use this link () 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鈥檚 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 鈥渇orward-looking statements鈥� 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鈥檚 projected financial results and the ability to achieve other operational and commercial goals. The Company鈥檚 actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, the Company鈥檚 ability to achieve projected financial results will be impacted by market acceptance of the Company鈥檚 products; products marketed and sold or under development by competitors; the Company鈥檚 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鈥檚 products; the Company鈥檚 ability to meet increasing operational and infrastructure requirements from higher customer interest and a larger base of existing customers; the Company鈥檚 ability to successfully commercialize its products; the Company鈥檚 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鈥檚 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鈥檚 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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Source: Tandem Diabetes Care, Inc.