8-K
Medtronic plc (MDT)
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): December 15, 2021
_____________________________
Medtronic plc
(Exact name of Registrant as Specified in its Charter)
_____________________________
| Ireland | 1-36820 | 98-1183488 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission<br><br>File Number) | (IRS Employer<br><br>Identification No.) |
20 On Hatch, Lower Hatch Street
Dublin 2, Ireland
(Address of principal executive offices) (Zip Code)
+353 1 438-1700
(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 each exchange on which registered |
|---|---|---|
| Ordinary shares, par value $0.0001 per share | MDT | New York Stock Exchange |
| 0.00% Senior Notes due 2022 | MDT/22B | New York Stock Exchange |
| 0.375% Senior Notes due 2023 | MDT/23B | New York Stock Exchange |
| 0.000% Senior Notes due 2023 | MDT/23C | New York Stock Exchange |
| 0.25% Senior Notes due 2025 | MDT/25 | New York Stock Exchange |
| 0.000% Senior Notes due 2025 | MDT/25A | New York Stock Exchange |
| 1.125% Senior Notes due 2027 | MDT/27 | New York Stock Exchange |
| 0.375% Senior Notes due 2028 | MDT/28 | New York Stock Exchange |
| 1.625% Senior Notes due 2031 | MDT/31 | New York Stock Exchange |
| 1.00% Senior Notes due 2031 | MDT/31A | New York Stock Exchange |
| 0.750% Senior Notes due 2032 | MDT/32 | New York Stock Exchange |
| 2.250% Senior Notes due 2039 | MDT/39A | New York Stock Exchange |
| 1.50% Senior Notes due 2039 | MDT/39B | New York Stock Exchange |
| 1.375% Senior Notes due 2040 | MDT/40A | New York Stock Exchange |
| 1.75% Senior Notes due 2049 | MDT/49 | New York Stock Exchange |
| 1.625% Senior Notes due 2050 | MDT/50 | New York Stock Exchange |
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 December 15, 2021, Medtronic plc (the “Company”) issued a press release announcing it had received a warning letter from the U.S. Food and Drug Administration (FDA) following an inspection of its Northridge, California, facility. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company is providing the following additional details related to the warning letter.
The Company does not expect an impact to the total company organic revenue growth and adjusted earnings per share guidance for the third quarter or full fiscal year 2022 that it issued on November 23, 2021.
Given the potential impact on Diabetes business drivers, including uncertainty on the timing of U.S. Diabetes product approvals, the Company is adjusting its expectations for its Diabetes business organic revenue. The Company now expects Diabetes declines in the high-single digit range for the third fiscal quarter and the mid-single digits range for the full fiscal year 2022, down modestly from previous guidance of mid- and low-single digit declines, respectively.
At this time, depending on a range of potential scenarios, the Company has modeled preliminary impact to total company fiscal year 2023 revenue growth in the range of less than 0.5 percentage points to approximately 1 percentage point of growth, and intends to give full fiscal year 2023 guidance on its fiscal fourth quarter earnings call in May 2022.
The Company is expeditiously addressing the concerns raised in the warning letter and working with the FDA to ensure these actions are comprehensive and effective.
The information in this Item 7.01 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
This Current Report on Form 8-K 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 difficulties and delays inherent in the development, testing, approval, manufacturing, marketing and sale of medical products, government regulation and general economic conditions and other risks and uncertainties described in the Company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the Company, as filed with the U.S. Securities and Exchange Commission. In some cases, you can identify these statements by forward-looking words, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “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. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this Current Report on Form 8-K, including to reflect future events or circumstances.
Item 9.01 Exhibits
Exhibit Number Description
99.1 Press release of Medtronic plc dated December 15, 2021
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.
| Medtronic plc | ||
|---|---|---|
| By | /s/ Karen L. Parkhill | |
| Date: December 15, 2021 | Karen L. Parkhill | |
| Executive Vice President and Chief Financial Officer |
Document
NEWS RELEASE
Contacts:
Pamela Reese Ryan Weispfenning
Public Relations Investor Relations
+1-818-576-3398 +1-763-505-4626
FOR IMMEDIATE RELEASE
Medtronic Diabetes receives FDA warning letter
DUBLIN ― December 15, 2021 ― Medtronic plc (NYSE:MDT) today announced it received a warning letter from the U.S. Food and Drug Administration (FDA) on December 9 for the company’s Northridge, California, facility, the headquarters for its Diabetes Business. The warning letter was issued following an inspection that concluded in July 2021 related to recalls of the MiniMed™ 600 series insulin infusion pump, and a remote controller device for MiniMed™ 508 and Paradigm™ pumps.
The warning letter focuses on the inadequacy of specific medical device quality system requirements at the Northridge facility in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
“We are committed to fully resolving all observations as effectively and quickly as possible. Nothing is more important to us than providing the highest quality products to people living with diabetes,” said Sean Salmon, executive vice president and president of the Diabetes business at Medtronic.
To ensure the most effective response to the warning letter, Medtronic will apply resources from across the company and utilize external experts. The company is implementing a range of
corrective actions and process improvements related to the observations, and will continue reviewing these actions with the FDA.
Medtronic is not recommending any action by patients or their healthcare providers as a result of this warning letter.
“Every day millions of people living with diabetes around the world rely on the innovations we deliver, and Medtronic remains deeply committed to ensuring their safety and well-being,” said Salmon.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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