0001438133FALSE00014381332025-05-162025-05-16

 

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Delaware

001-36189

20-4327508

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer  Identification No.)

12400 High Bluff Drive

92130

San Diego

California

(Zip Code)

(Address of principal executive offices)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 8.01 Other Events.

On May 16, 2025, Tandem Diabetes Care, Inc. (the Company) received CE mark approval for the Tandem Mobi insulin delivery system with Control-IQ+ technology.

The Company intends to pursue additional regulatory and pre-commercial activities, such as securing in-country registrations and reimbursement for Tandem Mobi in EU markets, with plans to begin EU commercial launches by the end of 2025.

This report 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. These forward-looking statements relate to the Company’s plans to secure in-country registrations and reimbursement and begin EU commercial launches of Tandem Mobi by the end of 2025. These forward-looking statements are subject to numerous risks and uncertainties, including failure to obtain and maintain any required regulatory authorization, clearance or certification in foreign jurisdictions will prevent us from marketing our products in international markets; in EU countries, the pricing, reimbursement and rebates of health products is subject to governmental control, and in such countries, there can be considerable pressure by governments and other stakeholders on prices, as well as reimbursement and rebates; international trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, and operating results; risks related to the competitive landscape; other risks associated with commercializing our products outside of the United States; and other risks identified under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed 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 report. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this report because of new information, future events or other factors.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 19, 2025