What changed in this filing

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Item 9A. Controls and Procedures

2022-03-01 compared with 2021-03-05 · 47 added, 14 removed, 240 unchanged (20% of the section changed)

8 unchanged sentences

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

As we are no longer an emerging growth company and adapted our system of internal controls over financial reporting pursuant to Section 404(a) of the Sarbanes-Oxley Act, we did not identify any material weakness in our internal control over financing reporting at December 31, 2020.

As we are no longer an emerging growth company and adapted our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act, we did not identify any material weakness in our internal control over financing reporting at December 31, 2021.

Management’s Report on Internal Control over Financial Reporting and Attestation Report of the Registered Public Accounting Firm

2 unchanged sentences

Based on our evaluation under this framework, our management concluded that our internal control over financial reporting was effective as of December 31, 2021.

As a “smaller reporting company” and a “non-accelerated filer,” we are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002.

As a result, Ernst & Young LLP, our independent registered public accounting firm, has not audited or issued an attestation report with respect to the effectiveness of our internal control over financial reporting as of December 31, 2020.

Attestation Report of the Registered Public Accounting Firm

Ernst & Young LLP, the independent registered public accounting firm that audited the Company’s financial statements, has also audited the Company’s internal control over financial reporting as of December 31, 2021.

Ernst & Young LLP’s attestation report on the Company’s internal control over financial reporting appears directly below.

Report of Independent Registered Public Accounting Firm

To the Shareholders and the Board of Directors of Senseonics Holdings, Inc.

Opinion on Internal Control over Financial Reporting

We have audited Senseonics Holdings Inc.’s internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).

In our opinion, Senseonics Holdings, Inc.

(the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2021 and 2020, the related consolidated statements of operations and comprehensive loss, changes in stockholder’s equity (deficit) and cash flows for each of the three years in the period ended December 31, 2021, and the related notes and our report dated March 1, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ Ernst & Young LLP

March 1, 2022

Other Information

On March 3, 2021, the Board of Directors of the Company adopted an amendment to the Company’s Amended and Restated Bylaws (the “Bylaw Amendment”), to add a new Section 47, which provides that, unless the Company consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States of America shall be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable

We will file a definitive Proxy Statement for our 2022 Annual Meeting of Stockholders, or the 2022 Proxy Statement, with the SEC, pursuant to Regulation 14A, not later than 120 days after the end of our fiscal year.

13 unchanged sentences

(a)(1) Financial Statements.

The response to this portion of Item 15 is set forth under Part II, Item 8 above.

Our Consolidated Financial Statements are listed in the “Index to Consolidated Financial Statements” under Part II, Item 8 of this Annual Report on Form 10-K.

(a)(2) Financial Statement Schedules.

1 unchanged sentence

(a)(3) Exhibits

The exhibits listed below are filed as part of this Annual Report on Form 10-K, or are incorporated herein by reference, in each case as indicated below.

Description of Document

11 unchanged sentences

001-37717) filed on November 9, 2020).

Bylaw Amendment

Bylaw Amendment (incorporated by reference to Exhibit 3.7 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed on March 5, 2021).

Registration Rights Agreement by and among the Registrant and certain of its stockholders, dated as of December 7, 2015 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

6 unchanged sentences

001-37717) filed on January 30, 2018).

Description of Document

Second Supplemental Indenture, dated July 25, 2019, between the Registrant and U.S.

1 unchanged sentence

001-37717) filed on July 27, 2019).

Description of Document

Indenture, dated July 25, 2019, between the Registrant and U.S.

37 unchanged sentences

333-198168) filed on December 10, 2015).

Description of Document

Form of Indemnification Agreement between the Registrant and its directors and executive officers (incorporated by reference to Exhibit 10.9 to the Registrant’s Current Report on Form 8-K (File No.

333-198168) filed on December 10, 2015).

Description of Document

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Timothy T.

37 unchanged sentences

001-37717), filed with the Commission on June 5, 2019).

Description of Document

Amended and Restated Employment Agreement, by and between Senseonics, Incorporated and Nick B.

1 unchanged sentence

0101-37717) filed with the Commission on March 16, 2020).

Description of Document

Registration Rights Agreement, dated as of April 21, 2020, by and between the Company and Highbridge Tactical Credit Master Fund, L.P.

33 unchanged sentences

001-37717) filed with the Commission on November 9, 2020).

First Amendment to Collaboration and Commercialization Agreement, by and between the Subsidiary and Ascensia Diabetes Care Holdings AG, dated as of March 31, 2021 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on August 9, 2021).

Form of Securities Purchase Agreement by and between the Company and certain purchases named therein, dated as of January 17, 2021 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on January 19, 2021).

Description of Document

Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Registrant's Current Report on Form 8-K (File No.

3 unchanged sentences

Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002.

Description of Document

Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a- 14(b) and 15d-14(b) promulgated under the Securities Exchange Act of 1934 and 18 U.S.C.

11 unchanged sentences

Indicates management contract or compensatory plan.

Certain portions of this exhibit, indicated by asterisks, have been omitted pursuant to Item 601(b)(10) of Regulation S-K because they are not material and would likely cause competitive harm to the registrant if publicly disclosed.

Certain portions of this exhibit, indicated by asterisks, have been omitted because they are not material and are the type that the registrant treats as private and confidential.

Form 10-K Summary.

29 unchanged sentences

March 1, 2022

/s/ Peter Justin Klein, M.D., J.D.

March 5, 2021

Peter Justin Klein, M.D., J.D.

/s/ Douglas Prince

13 unchanged sentences

March 1, 2022

/s/JOHN MAROTTA

March 1, 2022

/s/SHARON LARKIN

March 1, 2022

Sharon Larkin

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures