MiniMed Group (MMED) gets early FDA clearance and books $157M Flex pump charge

Rhea-AI Filing Summary

MiniMed Group, Inc. announced that the U.S. Food and Drug Administration has cleared the MiniMed Flex™, a next-generation, discreet, smartphone-controlled insulin pump. The clearance came several months earlier than anticipated and will allow earlier commercialization of this key product.

Development of MiniMed Flex™ was funded in part by affiliates of Blackstone Life Sciences Advisors L.L.C. Under their agreement, during the first two years following U.S. regulatory approval and commercial launch, Blackstone will receive the greater of a mid-to-high single digit royalty percentage on applicable net sales or a minimum payment of $157 million. MiniMed expects to recognize a one-time charge of $157 million in the fourth quarter of fiscal year 2026 related to these future payments.

Positive

• Early FDA clearance of MiniMed Flex™ several months ahead of expectations enables earlier commercialization of a next-generation, smartphone-controlled insulin pump.
• Structured funding partnership with Blackstone supported development of MiniMed Flex™, allowing MiniMed to advance a key product with external capital participation.

Negative

• Material $157 million accounting charge is expected in the fourth quarter of fiscal year 2026 related to future payments owed to Blackstone under the MiniMed Flex™ funding agreement.
• Royalty/minimum payment obligation of at least $157 million over the first two years after U.S. approval and launch will reduce MiniMed’s economic take from MiniMed Flex™ sales in that period.

Insights

Medical devices and capital allocation analyst

Early FDA clearance accelerates MiniMed Flex™ launch but triggers a sizable $157M charge.

The early U.S. FDA clearance for MiniMed Flex™, a discreet, smartphone-controlled insulin pump, is a meaningful regulatory milestone that allows commercialization to start sooner than the company had anticipated. This can help MiniMed enter or expand in the insulin pump market with a next-generation product.

The Blackstone funding structure shifts some development risk to affiliates of Blackstone Life Sciences Advisors L.L.C. but adds a material economic obligation. For the first two years after U.S. approval and commercial launch, Blackstone earns the greater of a mid-to-high single digit royalty on applicable net sales or a minimum of $157 million.

MiniMed expects a one-time charge of $157 million in the fourth quarter of fiscal year 2026 tied to future payments under this arrangement. That charge will weigh on reported earnings for that period, while ongoing royalties will depend on actual MiniMed Flex™ net sales over the initial two-year commercialization window.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 25, 2026

MiniMed Group, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-43183	33-3985981
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

18000 Devonshire St.

Northridge, CA 91325

(Address of principal executive offices) (Zip Code)

(763) 514-4000

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of exchange on which registered
Common Stock, $0.01 par value		MMED		The Nasdaq Stock Market LLC

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. ¨

Item 7.01. Regulation FD Disclosure

On March 18, 2026, MiniMed Group, Inc. (“MiniMed”) announced that the U.S. Food and Drug Administration (the “FDA”) has cleared the MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump. The clearance of the MiniMed Flex by the FDA was several months earlier than anticipated, and will facilitate the earlier commercialization of this key MiniMed product.

The research and development of the MiniMed Flex was funded in part by affiliates of Blackstone Life Sciences Advisors L.L.C. (“Blackstone”). Under the research and development agreement between MiniMed and Blackstone, in exchange for funding the development of the MiniMed Flex, during the first two years following regulatory approval in the U.S. and commercial launch of the MiniMed Flex, Blackstone will earn the greater of: (i) mid-to-high single digit royalty percentage of applicable net sales, and (ii) a specified minimum payment of $157 million for this product. MiniMed is expected to recognize a one-time charge of $157 million in the fourth quarter of fiscal year 2026 related to the series of future payments due to Blackstone for this product.

Forward-Looking Statements Disclaimer

This filing contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to MiniMed’s anticipated financial results for the fourth quarter of fiscal year 2026 and for fiscal year 2027. These risks and uncertainties are described in MiniMed’s filings with the U.S. Securities and Exchange Commission. In some cases, you can identify these statements by forward-looking words or expressions, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “going to,” “will,” and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. MiniMed does not undertake to update its forward-looking statements or any of the information contained in this filing, including to reflect future events or circumstances.

SIGNATURES

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.

	MiniMed Group, Inc.
Date: March 25, 2026	By:	/s/ Chad Spooner
	Name:	Chad Spooner
	Title:	Executive Vice President & Chief Financial Officer

EXHIBIT INDEX

Exhibit Number		Description
104		Cover Page Interactive Data File (embedded with the Inline XBRL document).

FAQ

What did MiniMed Group (MMED) announce about the MiniMed Flex insulin pump?

MiniMed announced that the U.S. FDA has cleared the MiniMed Flex™, a next-generation discreet, smartphone-controlled insulin pump. The clearance came several months earlier than anticipated, allowing earlier commercialization of this key diabetes product in the United States.

How is Blackstone involved in funding MiniMed Flex for MiniMed Group (MMED)?

Affiliates of Blackstone Life Sciences Advisors L.L.C. helped fund research and development of MiniMed Flex™. In return, they receive either a mid-to-high single digit royalty on applicable net sales or a minimum payment of $157 million over the first two years after U.S. approval and commercial launch.

What financial impact will the Blackstone agreement have on MiniMed Group (MMED)?

MiniMed expects to record a one-time $157 million charge in the fourth quarter of fiscal year 2026. This reflects the series of future payments due to Blackstone under the MiniMed Flex™ funding agreement, affecting reported earnings in that quarter.

Over what period can Blackstone earn payments from MiniMed Flex sales at MiniMed Group (MMED)?

For the first two years following U.S. regulatory approval and commercial launch of MiniMed Flex™, Blackstone will earn the greater of a mid-to-high single digit royalty on applicable net sales or a minimum payment of $157 million tied to this product.

Why are MiniMed Group (MMED) earnings for fiscal 2026 and 2027 flagged as risky in this disclosure?

The company notes forward-looking statement risks related to anticipated financial results for the fourth quarter of fiscal year 2026 and fiscal year 2027. Outcomes may differ materially, and the disclosure points investors to MiniMed’s SEC filings for detailed risk descriptions.

What type of product is MiniMed Flex from MiniMed Group (MMED)?

MiniMed Flex™ is described as a next-generation, discreet insulin pump that can be controlled by a smartphone. This design aims to modernize insulin delivery for people with diabetes, combining pump therapy with mobile control features.

Filing Exhibits & Attachments

3 documents

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 2.9 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 33.4 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 21.8 KB