SEC Info - Insulet Corp. - ‘8-K’ for 10/17/22

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Insulet Corp. – ‘8-K’ for 10/17/22

On: Monday, 10/17/22, at 8:30am ET · For: 10/17/22 · Accession #: 1145197-22-52 · File #: 1-33462

  As Of               Filer                 Filing    For·On·As Docs:Size

10/17/22  Insulet Corp.                     8-K:7,9    10/17/22   11:193K

Current Report — Form 8-K

Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                      HTML     42K 
 2: EX-99.1     Miscellaneous Exhibit                               HTML     18K 
 6: R1          Cover                                               HTML     45K 
 9: XML         IDEA XML File -- Filing Summary                      XML     11K 
 7: XML         XBRL Instance -- podd-20221017_htm                   XML     22K 
 8: EXCEL       IDEA Workbook of Financial Reports                  XLSX      8K 
 4: EX-101.LAB  XBRL Labels -- podd-20221017_lab                     XML     67K 
 5: EX-101.PRE  XBRL Presentations -- podd-20221017_pre              XML     33K 
 3: EX-101.SCH  XBRL Schema -- podd-20221017                         XSD     10K 
10: JSON        XBRL Instance as JSON Data -- MetaLinks               11±    16K 
11: ZIP         XBRL Zipped Folder -- 0001145197-22-000052-xbrl      Zip     21K

‘8-K’ — Current Report

This is an HTML Document rendered as filed. [ Alternative Formats ]

iX: C: C:

podd-20221017

i 0001145197 i FALSE00011451972022-10-172022-10-17

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM i 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): i October 17, 2022

i INSULET CORPORATION

(Exact Name of Registrant as Specified in Charter)

i Delaware

i 001-33462

i 04-3523891

(State or Other Jurisdiction
of Incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

i 100 Nagog Park

i Acton

i Massachusetts

i 01720

(Address of Principal Executive Offices, including Zip Code)


			Registrant’s telephone number, including area code:			i (978)			i 600-7000

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 (see General Instruction A.2. below):


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


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


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


i ☐			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			i ☐
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 accounting standards provided pursuant to Section 13(a) of the Exchange Act			☐

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

i Common Stock, $0.001 Par Value Per Share

i PODD

i The NASDAQ Stock Market, LLC



Item 7.01						Regulation FD Disclosure

On October 17, 2022, Insulet Corporation (the “Company”) issued a voluntary Medical Device Correction notice for its Omnipod DASH® Personal Diabetes Manager (“PDM”) relating to the Omnipod DASH PDM battery. Insulet will replace the PDMs for all current Omnipod DASH users globally due to reported issues which may occur if the PDM battery is charged to full capacity or for extended periods of time. The Company currently estimates an aggregate charge in the range of $35 million to $45 million with the majority impacting cost of revenue in the third quarter of 2022 and the remainder primarily impacting operating expenses in the fourth quarter of 2022 and fiscal year 2023.

Additionally, excluding the related charges, the Company is not changing its annual gross margin or adjusted operating margin guidance provided on August 4, 2022.

This voluntary Medical Device Correction notice does not affect the Omnipod DASH Pods, the Omnipod® Insulin Management System, or the Omnipod® 5 Automated Insulin Delivery System.

A copy of the notice sent to customers in the United States is attached as exhibit 99.1 to this Form 8-K. The notice is also posted on the Company’s website at www.omnipod.com/insulet-alerts.

The information in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section. The information in this Current Report shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.


Item 9.01						Financial Statements and Exhibits


			(d)			Exhibits.


Exhibit No.						Description

99.1						Voluntary Medical Device Correction Notice
104						Cover Page Interactive Date File (formatted as Inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report to be signed on its behalf by the undersigned thereunto duly authorized.