UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-40545

CVRx, Inc.

(Exact name of registrant as specified in its charter)

Delaware

41-1983744

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

9201 West Broadway Avenue

Suite 650

Minneapolis, MN 55445

(Address of Principal Executive Offices)

(763) 416-2840

(Registrant’s telephone number)

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

Title of each class

Trading Symbol(s)

Name of each exchange

on which registered

Common stock,

par value $0.01 per share

CVRX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒	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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of April 25, 2022, there were 20,500,177 shares of the registrant’s common stock, par value $0.01 per share outstanding.

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		Page

Part I	Financial Information

Item 1.	Financial Statements	5

	Condensed Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021 (Unaudited)	5

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2022 and 2021 (Unaudited)	6

	Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three months ended March 31, 2022 and 2021 (Unaudited)	7

	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2022 and 2021 (Unaudited)	8

	Notes to Condensed Consolidated Financial Statements (Unaudited)	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	28

Item 4.	Controls and Procedures	29

Part II	Other Information

Item 1.	Legal Proceedings	30

Item 1A.	Risk Factors	30

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30

Item 3.	Defaults Upon Senior Securities	30

Item 4.	Mine Safety Disclosures	30

Item 5.	Other Information	30

Item 6.	Exhibits	30

Exhibit Index

Signatures

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CVRx, Inc.

Quarterly Report on Form 10-Q

For the quarterly period ended March 31, 2022

Cautionary Note on Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including statements regarding our future results of operations and financial position, business strategy, the impact of the ongoing and global COVID-19 pandemic on our business, financial results and financial position, clinical trial results, prospective products, product approvals, research and development costs, timing and likelihood of success, and the plans and objectives of management for future operations.

In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, the important factors discussed in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021, which are summarized below. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Summary Risk Factors

Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include, but are not limited to, the following:

●

we have a history of significant losses, which we expect to continue, and we may not be able to achieve or sustain profitability;

●

our principal stockholders, management and directors (four of whom are affiliated with our principal stockholders) own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval;

●

we have a limited history operating as a commercial company and are highly dependent on a single product, Barostim, and the failure to obtain market acceptance in the U.S. for Barostim would negatively impact our business, liquidity and results of operations;

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●

we have limited commercial sales experience marketing and selling Barostim, and if we are unable to establish and maintain sales and marketing capabilities, we will be unable to successfully commercialize Barostim or generate sustained and increasing product revenue;

●

we must demonstrate to physicians and patients the merits of Barostim;

●

if third-party payors do not provide adequate coverage and reimbursement for the use of Barostim, our revenue will be negatively impacted;

●

our industry is competitive; if our competitors, many of which are large, well-established companies with substantially greater resources than us and have a long history of competing in the heart failure market, are better able to develop and market products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim, our business will be adversely impacted;

●

if we fail to receive access to hospitals, our sales may decrease;

●

we are dependent upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers, making us vulnerable to supply shortages, loss or degradation in performance of the suppliers and price fluctuations, which could harm our business;

●

manufacturing risks may adversely affect our ability to manufacture our product and could reduce our gross margin and profitability;

●

a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide, including the outbreak of the novel strain of coronavirus disease, COVID-19, could adversely affect our business;

●

we may face product liability claims that could be costly, divert management’s attention and harm our reputation;

●

we may in the future become involved in lawsuits to protect or enforce our intellectual property, which could be expensive and time consuming, and ultimately unsuccessful, and could result in the diversion of significant resources, thereby hindering our ability to effectively commercialize our existing or future products;

●

if we fail to retain our key executives or recruit and hire new employees, our operations and financial results may be adversely affected while we attract other highly qualified personnel; and

●

we will continue to obtain long-term clinical data regarding the safety and efficacy of our products, which could impact future adoption and regulatory approvals.

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PART I —FINANCIAL INFORMATION

Item 1. Financial Statements

CVRx, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)


	March 31,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	131,177	$	142,072
Accounts receivable, net		3,673		2,560
Inventory		5,261		3,880
Prepaid expenses and other current assets		2,090		2,585
Total current assets		142,201		151,097
Property and equipment, net		1,656		1,425
Operating lease right-of-use asset		522		—
Other non-current assets		26		26
Total assets	$	144,405	$	152,548
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,607	$	510
Accrued expenses		4,985		5,398
Total current liabilities		6,592		5,908
Operating lease liability, non-current portion		304		—
Other long-term liabilities		706		681
Total liabilities		7,602		6,589
Commitments and contingencies (Notes 5 and 10)
Stockholders’ equity:
Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2022 and December 31, 2021; 20,486,971 and 20,399,337 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively		205		204
Additional paid-in capital		541,547		540,707
Accumulated deficit		(404,745)		(394,754)
Accumulated other comprehensive loss		(204)		(198)
Total stockholders’ equity		136,803		145,959
Total liabilities and stockholders’ equity	$	144,405	$	152,548

The accompanying notes are an integral part of these condensed consolidated financial statements.

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CVRx, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)


	Three months ended
	March 31,
	2022		2021
Revenue	$	4,076	$	2,860
Cost of goods sold		949		867
Gross profit		3,127		1,993
Operating expenses:
Research and development		2,258		1,750
Selling, general and administrative		10,777		4,460
Total operating expenses		13,035		6,210
Loss from operations		(9,908)		(4,217)
Interest expense		—		(601)
Other expense, net		(57)		(3,792)
Loss before income taxes		(9,965)		(8,610)
Provision for income taxes		(26)		(17)
Net loss		(9,991)		(8,627)
Cumulative translation adjustment		(6)		(4)
Comprehensive loss	$	(9,997)	$	(8,631)
Net loss per share, basic and diluted	$	(0.49)	$	(23.92)
Weighted-average common shares used to compute net loss per share, basic and diluted		20,453,341		360,675

The accompanying notes are an integral part of these condensed consolidated financial statements.

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CVRx, INC.

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(In thousands, except share data)

(Unaudited)


											Accumulated		Total
	Convertible						Additional				other		stockholders’
	preferred stock			Common stock			paid-in		Accumulated		comprehensive		(deficit)
	Shares		Amount	Shares		Amount	capital		deficit		loss		equity
Balances as of December 31, 2021	—	$	—	20,399,337	$	204	$	540,707	$	(394,754)	$	(198)	$	145,959
Exercise of stock options	—		—	87,634		1		47		—		—		48
Employee stock compensation	—		—	—		—		793		—		—		793
Net loss for the three months ended March 31, 2022	—		—	—		—		—		(9,991)		—		(9,991)
Cumulative translation adjustment	—		—	—		—		—		—		(6)		(6)
Balances as of March 31, 2022	—	$	—	20,486,971	$	205	$	541,547	$	(404,745)	$	(204)	$	136,803

Balances as of December 31, 2020	223,541,754	$	329,983	360,412	$	4	$	58,624	$	(351,676)	$	(190)	$	(293,238)
Exercise of stock options	—		—	4,862		—		2		—		—		2
Employee stock compensation	—		—	—		—		61		—		—		61
Net loss for the three months ended March 31, 2021	—		—	—		—		—		(8,627)		—		(8,627)
Cumulative translation adjustment	—		—	—		—		—		—		(4)		(4)
Balances as of March 31, 2021	223,541,754	$	329,983	365,274	$	4	$	58,687	$	(360,303)	$	(194)	$	(301,806)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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CVRx, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

Three months ended

March 31,

Cash flows from operating activities:

SEC Form 10-Q filed by CVRx Inc.