What changed in this filing

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Item 9A. Controls and Procedures

2023-03-16 compared with 2022-03-01 · 39 added, 119 removed, 168 unchanged (48% 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, 2022 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(b) of the Sarbanes-Oxley Act, we did not identify any material weakness in our internal control over financing reporting at December 31, 2021.

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, 2022.

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, 2022.

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

This Annual Report does not include an attestation report with respect to the effectiveness of our internal control over financial reporting as of December 31, 2022 due to the Company’s SOX 404(b) exemption based on Smaller Reporting Company status.

Other Information

24 unchanged sentences

001-37717) filed on March 23, 2016).

Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on March 23, 2016).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.3 to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended June 30, 2018 (File No.

001-37717) filed on August 8, 2018)

Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on August 18, 2020).

Certificate of Amendment to Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on October 26, 2020).

Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No.

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

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 August 18, 2020).

Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on November 8, 2022).

Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on March 23, 2016).

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.

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

Base Indenture, dated January 30, 2018, between the Registrant and U.S.

Bank National Association, as Trustee (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

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

First Supplemental Indenture, dated January 30, 2018, between the Registrant and U.S.

Bank National Association, as Trustee (including the form of 5.25% convertible senior subordinated notes due 2023) (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K (File No.

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

Description of Document

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

Bank National Association, as Trustee (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K (File No.

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

Amendment to Bylaws of Senseonics Holdings, Inc.

(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).

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

3 unchanged sentences

001-37717), filed with the Commission on July 29, 2019).

Description of Document

Registration Rights Agreement, dated as of July 25, 2019, by and among the Company, the Subsidiary and Jefferies LLC (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 July 29, 2019).

Registration Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.1 to Amendment No.

1 unchanged sentence

001-37717), filed with the Commission on August 31, 2020).

Registration Rights Agreement, dated as of August 9, 2020, by and between the Registrant and certain purchasers named therein (incorporated herein by reference to Exhibit 4.2 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Investor Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.4 to Amendment No.

1 unchanged sentence

001-37717), filed with the Commission on August 31, 2020).

Investor Rights Agreement, dated as of August 9, 2020, by and between the Registrant and PHC Holding Corporation (incorporated herein by reference to Exhibit 4.4 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717), filed with the Commission on August 31, 2020).

Description of Senseonics Holdings, Inc.

1 unchanged sentence

001-37717) filed on March 16, 2020).

Registration Rights Agreement, by and between Senseonics Holdings, Inc.

and PHC Holdings Corporation, dated as of March 13, 2023 (incorporated herein by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on March 15, 2023).

Lease Agreement, dated as of February 4, 2008, by and between Senseonics, Incorporated and Seneca Meadows Corporate Center III Limited Partnership, as amended by the First Amendment to Lease, dated as of September 25, 2012 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

9 unchanged sentences

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

2015 Equity Incentive Plan of Senseonics, Incorporated (incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K (File No.

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

Amended and Restated 2015 Equity Incentive Plan, (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-8 (File No.

4 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.

3 unchanged sentences

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

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Mukul Jain, dated as of July 30, 2015 (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report on Form 8-K (File No.

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

Executive Employment Agreement by and between Senseonics, Incorporated and Mirasol Panlilio, dated as of August 10, 2015 (incorporated by reference to Exhibit 10.12 to the Registrant’s Current Report on Form 8-K (File No.

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

Form of Secured Promissory Note issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of July 31, 2014 and December 23, 2014 (incorporated by reference to Exhibit 10.15 to the Registrant’s Current Report on Form 8-K (File No.

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

Form of Secured Promissory Note issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of December 7, 2015 (incorporated by reference to Exhibit 10.16 to the Registrant’s Current Report on Form 8-K (File No.

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

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Mukul Jain, dated as of August 12, 2017.

Amended and Restated Executive Employment Agreement by and between Senseonics, Incorporated and Kenneth L.

Horton, dated as of October 1, 2017.

Description of Document

Form of Replacement Warrant to Purchase Common Stock issued to Oxford Finance LLC by Senseonics, Incorporated, dated as of December 7, 2015 (incorporated by reference to Exhibit 10.17 to the Registrant’s Current Report on Form 8-K (File No.

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

Form of Warrant to Purchase Preferred Stock issued by Senseonics, Incorporated in bridge loan financings (incorporated by reference to Exhibit 10.18 to the Registrant’s Current Report on Form 8-K (File No.

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

Form of 2016 Employee Stock Purchase Plan (incorporated by reference to Exhibit 4.10 to the Registrant’s Registration Statement on Form S-8 (File No.

2 unchanged sentences

333-198168) filed on March 15, 2019).

Letter Agreement, by and among the Registrant, Senseonics, Incorporated and Stephen P.

DeFalco, dated June 20, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on June 21, 2016) .

Restricted Stock Award Grant Notice and Restricted Stock Award Agreement, by and between the Registrant and Stephen P.

DeFalco, dated June 20, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed on June 21, 2016) .

Form of Warrant to Purchase Stock issued by the Registrant to Oxford Finance LLC and Silicon Valley Bank, dated as of June 30, 2016 (incorporated by reference to Exhibit 10.5 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed on August 9, 2016) .

Open Market Sales Agreement, dated November 27, 2019, by and between the Registrant and Jefferies LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No.

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

001-37717), filed with the Commission on July 29, 2019).

Executive Employment Agreement, by and between Senseonics, Incorporated and Francine Kaufman, effective as of May 4, 2019 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-37717) filed with the Commission on May 9, 2019).

Senseonics Holdings, Inc.

4 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.

Tressler , effective as of November 12, 2019 (incorporated herein by reference to Exhibit 10.32 to the Registrant’s Annual Report on Form 10-K (File No.

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

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

(incorporated herein by reference to Exhibit 10.2 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

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

(incorporated herein by reference to Exhibit 10.3 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Loan and Security Agreement among Wilmington Savings Fund Society, SCB as collateral agent, Highbridge Tactical Credit Master Fund, L.P., the Company and the Subsidiary, dated as of April 21, 2020 (incorporated herein by reference to Exhibit 10.4 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Note Purchase and Exchange Agreement among Wilmington Savings Fund Society, SCB, as collateral agent, Highbridge Tactical Credit Master Fund, L.P., the Company and the Subsidiary, dated as of April 21, 2020 (incorporated herein by reference to Exhibit 10.5 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Form of Note representing the Registrant’s Secured Promissory Second Lien Notes (incorporated herein by reference to Exhibit 10.7 to Amendment No.

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-37717) filed with the Commission on April 28, 2020).

Form of Warrant to Purchase Common Stock issued to Highbridge Tactical Credit Master Fund, L.P.

5 unchanged sentences

001-37717) filed with the Commission on August 31, 2020).

Stock Purchase Agreement, dated as of August 9, 2020, by and between the Registrant and certain purchasers named therein (incorporated herein by reference to Exhibit 10.2 to Amendment No.

1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on August 31, 2020).

Equity Line Agreement by and between the Company and Energy Capital, LLC dated as of November 9, 2020 (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 November 9, 2020).

Warrant to purchase common stock of the Company by and between the Company and Energy Capital, LLC, dated as of November 9, 2020 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

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

Side Letter Agreement by and between the Company and certain purchasers named therein, dated as of November 9, 2020 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

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

Collaboration and Commercialization Agreement, by and between the Subsidiary and Ascensia Diabetes Care Holdings AG, dated as of August 9, 2020 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

2 unchanged sentences

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.

Second Amendment to Collaboration and Commercialization Agreement, by and between Senseonics Incorporated and Ascensia Diabetes Care Holdings AG, dated as of June 21, 2022 (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, 2022).

2023 Commercial Equity Plan, dated as of January 10, 2023 (incorporated herein by reference to Exhibit 4.1 to the Registration Statement on Form S-3 (File No.

33 3-269177 filed with the Commission on January 10, 2023)

Securities Purchase Agreement, by and between Senseonics Holdings, Inc.

and PHC Holdings Corporation, dated as of March 13, 2023 (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 March 15, 2023).

Exchange Agreement, by and between Senseonics Holdings, Inc.

and PHC Holdings Corporation, dated as of March 13, 2023 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on March 15, 2023).

Form of Warrant to Purchase Common Stock issued to PHC Holdings Corporation (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on March 15, 2023).

L etter from Ernst & Young LLP dated March 15, 2022 to the Securities and Exchange Commission regarding change in certifying accountant (incorporated herein by reference to Exhibit 16.1 to the Registrant’s Current Report on Form 8-K (File No.

001-37717) filed with the Commission on March 15, 2022).

Description of Document

1 unchanged sentence

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

Consent of KPMG LLP, independent registered public accounting firm.

Consent of Ernst & Young LLP, independent registered public accounting firm.

25 unchanged sentences

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Timothy T.

Goodnow, Ph.D., and Nick B.

Tressler, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Senseonics Holdings, Inc., and any or all amendments (including post-effective amendments) thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Goodnow, Ph.D., and Rick Sullivan, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Senseonics Holdings, Inc., and any or all amendments (including post-effective amendments) thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

5 unchanged sentences

(Principal Executive Officer)

/s/ RICK SULLIVAN

Chief Financial Officer

March 15, 2023

Nick Tressler

Rick Sullivan

(Principal Financial Officer and Principal Accounting Officer)

7 unchanged sentences

March 15, 2023

/s/ Douglas Prince

/s/ Douglas S.

March 15, 2023

Douglas Prince

/s/ DOUGLAS ROEDER

/s/ Douglas A.

March 15, 2023

Douglas Roeder

/s/ FRANCINE KAUFMAN, M.D.

9 unchanged sentences

March 15, 2023

/s/SHARON LARKIN

March 15, 2023

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