Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of disclosure controls and procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and other procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our management, with the participation of our chief executive officer and our chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on that evaluation, our chief executive officer and our chief financial officer concluded that our disclosure controls and procedures were effective, at the reasonable assurance level, as of the end of the period covered by this Annual Report on Form 10-K.
Changes in internal control over financial reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Management assessed our internal control over financial reporting as of December 31, 2022 based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Management’s assessment included evaluation of elements such as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment.
Based on this assessment, management has concluded that our internal control over financial reporting was effective as of the end of the fiscal year to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external reporting purposes in accordance with U.S. GAAP. We reviewed the results of management’s assessment with the audit committee of our board of directors.
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Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
Item 11. Executive Compensation
The information required by this Item is incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
T he information required by this Item is incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item is incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
Item 14. Principal Accountant Fees and Services
The information required by this Item is incorporated by reference to our definitive proxy statement for our 2023 annual meeting of stockholders to be filed with the SEC within 120 days of the fiscal year ended December 31, 2022.
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PART IV
Item 15. Exhibit and Financial Statement Schedules
(a) 1. Financial Statements:
The following consolidated financial statements of the Company are set forth in Part II, Item 8:
Report of Independent Registered Public Accounting Firm (PCAOB ID 248 )
Consolidated Balance Sheets as of December 31, 2022 and 2021
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2022 and 2021
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2022 and 2021
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
Notes to Consolidated Financial Statements
2. Financial Statement Schedules:
[All financial statement schedules are omitted as the required information is inapplicable or the information is presented in the consolidated financial statements or related notes.]
3. Exhibits:
See the response to Item 15(b) below.
(b) Exhibits:
EXHIBIT INDEX
Exhibit
No.
Description
3.1
Amended and Restated Certificate of Incorporation of CVRx, Inc. (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 7, 2021)
3.2
Amended and Restated By-Laws of CVRx, Inc. (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed on July 7, 2021)
4.1
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
4.2*
Warrant to Purchase Stock, dated as of September 12, 2014, issued by the Company to Life Science Loans, LLC (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.3*
Warrant to Purchase Stock, dated as of September 12, 2014, issued by the Company to Silicon Valley Bank (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
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4.4*
Warrant to Purchase Stock, dated as of July 21, 2015, issued by the Company to Life Science Loans, LLC (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.5*
Warrant to Purchase Stock, dated as of July 21, 2015, issued by the Company to Silicon Valley Bank (incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.6*
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC (incorporated by reference to Exhibit 4.7 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.7*
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC (incorporated by reference to Exhibit 4.8 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.8*
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC (incorporated by reference to Exhibit 4.9 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.9*
Warrant to Purchase Stock, dated as of May 31, 2016, issued by the Company to Oxford Finance LLC (incorporated by reference to Exhibit 4.10 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.10
Warrant to Purchase Series G Convertible Preferred Stock, dated as of September 28, 2018, issued by the Company to Biosense Webster, Inc. (incorporated by reference to Exhibit 4.12 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.11
Warrant to Purchase Shares of Series G Preferred Stock (Loan A), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Credit II LLC on February 6, 2020 (incorporated by reference to Exhibit 4.13 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.12
Warrant to Purchase Shares of Series G Preferred Stock (Loan B), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Credit II LLC on February 6, 2020 (incorporated by reference to Exhibit 4.14 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.13
Warrant to Purchase Shares of Series G Preferred Stock (Loan C), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation, as assigned to Horizon Funding Trust 2019-1 on February 18, 2020 (incorporated by reference to Exhibit 4.15 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.14
Warrant to Purchase Shares of Series G Preferred Stock (Loan D), dated as of September 30, 2019, issued by the Company to Horizon Technology Finance Corporation as assigned to Horizon Funding Trust 2019-1 on February 18, 2020 (incorporated by reference to Exhibit 4.16 to the Company’s Registration Statement on Form S-1 filed on June 4, 2021)
4.15
Description of the Company’s Common Stock (incorporated by reference to Exhibit 4.16 to the Company’s Annual Report on Form 10-K filed on February 22, 2022)
10.1
Lease, dated October 13, 2008, by and between the Company and Duke Realty Limited Partnership (incorporated by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
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10.2
First Lease Amendment, dated November 30, 2010, by and between the Company and Duke Realty Limited Partnership (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.3*
Second Lease Amendment, dated October 22, 2012, by and between the Company and Duke Realty Limited Partnership (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.4*
Lease Amending Agreement No. 3, dated April 21, 2016, by and between the Company and AX CROSSTOWN VI L.P. (incorporated by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.5
Lease Amending Agreement No. 4, dated May 18, 2020, by and between the Company and AX CROSSTOWN VI L.P. (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.6
Eighth Amended and Restated Investors’ Rights Agreement, dated July 1, 2020, by and among the Company and the holders listed therein (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.7#
2001 Stock Incentive Plan, as amended and restated (incorporated by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.8#
Form of Stock Option Agreement (Employees/Officers) pursuant to 2001 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-8 filed on July 1, 2021)
10.9#
Form of Stock Option Agreement (Non-Employee Directors) pursuant to 2001 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-8 filed on July 1, 2021)
10.10#
2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.11#
Form of Stock Option Agreement (Employees/Officers) pursuant to 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-8 filed on July 1, 2021)
10.12#
Form of Stock Option Agreement (Non-Employee Directors) pursuant to 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-8 filed on July 1, 2021)
10.13#
Form of Non-Plan Stock Option Agreement (incorporated by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-8 filed on July 1, 2021)
10.14
Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.14 to the Company’s Annual Report on Form 10-K filed on February 22, 2022)
10.15#
Form of Executive Officer Employment Agreement (incorporated by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
10.16
Form of Indemnification Agreement between the Company and its directors and officers (incorporated by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1/A filed on June 23, 2021)
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10.17*
Loan and Security Agreement, dated as of October 31, 2022, among the Company, Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, and the other lenders from time to time party thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 1, 2022)
10.18
Equity Distribution Agreement, dated as of November 4, 2022, by and between the Company and Piper Sandler & Co. (incorporated by reference to Exhibit 1.2 to the Company’s Registration Statement on Form S-3 filed on November 4, 2022)
31.1 †
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 †
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 †
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2 †
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Company’s Annual Report on Form 10-K filed on February 22, 2022)
23.1 †
Consent of Grant Thornton LLP, independent registered public accounting firm
101.INS †
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH †
Inline XBRL Taxonomy Extension Schema Document
101.CAL †
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF †
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB †
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE †
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104 †
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
†
Filed herewith.
#
Indicates management contract or compensatory plan.
*
Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K under the Securities Act. The Company agrees to furnish supplementally any omitted exhibits and schedules to the SEC upon request.
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Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on behalf by the undersigned, thereunto duly authorized.
Date: February 10, 2023
CVRX, INC.
By:
/s/ Nadim Yared
Name:
Nadim Yared
Title:
President and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Date: February 10, 2023
Signature
Title
Date
/s/ Nadim Yared
President and Chief Executive Officer (Principal Executive Officer)
February 10, 2023
Nadim Yared
/s/ Jared Oasheim
Chief Financial Officer (Principal Financial and Accounting Officer)
February 10, 2023
Jared Oasheim
/s/ Ali Behbahani
Director
February 10, 2023
Ali Behbahani
/s/ Kevin Hykes
Director
February 10, 2023
Kevin Hykes
/s/ John Nehra
Director
February 10, 2023
John Nehra
/s/ Joseph Slattery
Director
February 10, 2023
Joseph Slattery
/s/ Mudit Jain
Director
February 10, 2023
Mudit Jain
/s/ Kirk Nielsen
Director
February 10, 2023
Kirk Nielsen
/s/ Martha Shadan
Director
February 10, 2023
Martha Shadan
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