Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 02, 2024 | Jun. 30, 2023 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-40545 | ||
Entity Registrant Name | CVRx, Inc | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 41-1983744 | ||
Entity Address, Address Line One | 9201 West Broadway Avenue | ||
Entity Address, Address Line Two | Suite 650 | ||
Entity Address, City or Town | Minneapolis | ||
Entity Address, State or Province | MN | ||
Entity Address, Postal Zip Code | 55445 | ||
City Area Code | 763 | ||
Local Phone Number | 416-2840 | ||
Title of 12(b) Security | Common stock, | ||
Trading Symbol | CVRX | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 190 | ||
Entity Common Stock, Shares Outstanding | 20,927,729 | ||
Auditor Name | GRANT THORNTON LLP | ||
Auditor Firm ID | 248 | ||
Auditor Location | Minneapolis, Minnesota | ||
Entity Central Index Key | 0001235912 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 90,569 | $ 106,194 |
Accounts receivable, net of allowances of $508 and $679, respectively | 7,551 | 5,504 |
Inventory | 10,983 | 6,957 |
Prepaid expenses and other current assets | 2,987 | 4,223 |
Total current assets | 112,090 | 122,878 |
Property and equipment, net | 1,763 | 1,698 |
Operating lease right-of-use asset | 1,349 | 334 |
Other non-current assets | 27 | 27 |
Total assets | 115,229 | 124,937 |
Current liabilities: | ||
Accounts payable | 1,884 | 1,719 |
Accrued expenses | 5,980 | 6,369 |
Total current liabilities | 7,864 | 8,088 |
Long-term debt | 29,222 | 6,747 |
Operating lease liability, non-current portion | 1,160 | 117 |
Other long-term liabilities | 1,036 | 805 |
Total liabilities | 39,282 | 15,757 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value, 200,000,000 authorized as of December 31, 2023 and 2022; 20,879,199 and 20,663,736 shares issued and outstanding as of December 31, 2023 and 2022, respectively, respectively | 209 | 207 |
Additional paid-in capital | 553,326 | 545,362 |
Accumulated deficit | (477,381) | (436,182) |
Accumulated other comprehensive loss | (207) | (207) |
Total stockholders' equity | 75,947 | 109,180 |
Total liabilities and stockholders' equity | $ 115,229 | $ 124,937 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets [Abstract] | ||
Allowance for accounts receivable, net | $ 508 | $ 679 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 20,879,199 | 20,663,736 |
Common stock, shares outstanding | 20,879,199 | 20,663,736 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Revenue | $ 39,295 | $ 22,469 |
Cost of goods sold | 6,256 | 4,999 |
Gross profit | 33,039 | 17,470 |
Operating expenses: | ||
Research and development | 11,633 | 9,952 |
Selling, general and administrative | 64,509 | 50,045 |
Total operating expenses | 76,142 | 59,997 |
Loss from operations | (43,103) | (42,527) |
Interest expense | (1,799) | (165) |
Other income, net | 3,850 | 1,373 |
Loss before income taxes | (41,052) | (41,319) |
Provision for income taxes | (147) | (109) |
Net loss | (41,199) | (41,428) |
Cumulative translation adjustment | (9) | |
Comprehensive loss | $ (41,199) | $ (41,437) |
Net loss per share, basic | $ (1.99) | $ (2.02) |
Net loss per share, diluted | $ (1.99) | $ (2.02) |
Weighted-average common shares used to compute net loss per share, basic | 20,754,375 | 20,532,838 |
Weighted-average common shares used to compute net loss per share, diluted | 20,754,375 | 20,532,838 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders Equity - USD ($) $ in Thousands | Common stock | Additional paid-in capital | Accumulated deficit | Accumulated and other comprehensive loss | Total |
Balances, Beginning at Dec. 31, 2021 | $ 204 | $ 540,707 | $ (394,754) | $ (198) | $ 145,959 |
Balances, Beginning (in shares) at Dec. 31, 2021 | 20,399,337 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | $ 2 | 182 | 184 | ||
Exercise of stock options (in shares) | 150,509 | ||||
Proceeds from Employee Stock Purchase Plan | $ 1 | 586 | 587 | ||
Proceeds from Employee Stock Purchase Plan (shares) | 113,890 | ||||
Employee stock compensation | 3,887 | 3,887 | |||
Net Income (Loss) | (41,428) | (41,428) | |||
Cumulative translation adjustment | (9) | (9) | |||
Balances, Ending at Dec. 31, 2022 | $ 207 | 545,362 | (436,182) | (207) | 109,180 |
Balances, Ending (in shares) at Dec. 31, 2022 | 20,663,736 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | $ 1 | 727 | 728 | ||
Exercise of stock options (in shares) | 144,187 | ||||
Proceeds from Employee Stock Purchase Plan | $ 1 | 934 | 935 | ||
Proceeds from Employee Stock Purchase Plan (shares) | 71,276 | ||||
Employee stock compensation | 6,303 | 6,303 | |||
Net Income (Loss) | (41,199) | (41,199) | |||
Balances, Ending at Dec. 31, 2023 | $ 209 | $ 553,326 | $ (477,381) | $ (207) | $ 75,947 |
Balances, Ending (in shares) at Dec. 31, 2023 | 20,879,199 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (41,199) | $ (41,428) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 6,303 | 3,887 |
Depreciation of property and equipment | 522 | 412 |
Loss on disposal of equipment | 4 | 0 |
Amortization of deferred financing costs and loan discount | 154 | 25 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,047) | (2,944) |
Inventory | (4,026) | (3,077) |
Prepaid expenses and other current assets | 1,273 | (1,634) |
Accounts payable | 165 | 1,209 |
Accrued expenses | (170) | 873 |
Net cash used in operating activities | (39,021) | (42,677) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (591) | (685) |
Net cash used in investing activities | (591) | (685) |
Cash flows from financing activities: | ||
Proceeds from the exercise of common stock options | 728 | 184 |
Proceeds from Employee Stock Purchase Plan | 935 | 587 |
Proceeds from debt financing | 22,500 | 7,500 |
Debt financing costs | (179) | (778) |
Net cash provided by financing activities | 23,984 | 7,493 |
Effect of currency exchange on cash and cash equivalents | 3 | (9) |
Net change in cash and cash equivalents | (15,625) | (35,878) |
Cash and cash equivalents at beginning of period | 106,194 | 142,072 |
Cash and cash equivalents at end of period | 90,569 | 106,194 |
Supplemental Information: | ||
Cash paid for interest | 1,396 | 59 |
Cash paid for income taxes | $ 4 | $ 5 |
Business Organization
Business Organization | 12 Months Ended |
Dec. 31, 2023 | |
Business Organization [Abstract] | |
Business organization | 1. Business organization CVRx, Inc. (the “Company”) was incorporated in Delaware and is headquartered in Minneapolis, Minnesota. We have developed and is marketing a medical device, Barostim, for heart failure (“HF”) and resistant hypertension. We are focused on the sale of our product in the U.S. and Europe. Management expects that operating losses and negative cash flows from operations could continue in the foreseeable future. There is no assurance that we will generate sufficient product sales to produce positive earnings or cash flows. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Statement presentation and basis of consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and with the applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy, which was closed during 2023. All intercompany balances and transactions have been eliminated in consolidation. JOBS Act accounting election We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, we have elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. Use of estimates Preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. Cash and cash equivalents Cash and cash equivalents include highly liquid investments with an original maturity of three months or less. As of December 31, 2023 and 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of December 31, 2023 and 2022, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits. Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the standard generally being net 30 days. We evaluate the collectability of our accounts receivable based on known collection risks and historical experience. In circumstances where we are aware of a specific customer's inability to meet its financial obligations to us, we record a specific allowance for bad debts against amounts due to reduce the carrying amount of accounts receivable to the amount we reasonably believe will be collected. ASU 2016-13 became effective for us for interim and annual periods beginning January 1, 2023. We have determined that the adoption of ASU 2016-13 did not have a material impact on our results of operations, cash flows, or financial position as we do not have a history of credit losses. Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. We regularly review inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate. Leases Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses and operating lease liability – non-current portion in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. We used the incremental borrowing rate based on information readily available at the time of recognition to determine the present value of the lease payments. The determination of our incremental borrowing rate requires management judgement based on information available at lease commencement. Revenue recognition We sell our products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. Our revenue consists primarily of the sale of our Barostim, which consists of two implantable components: a pulse generator and a stimulation lead. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers Stock-Based Compensation We recognize equity-based compensation expense for awards of equity instruments to employees and non-employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 718, Compensation—Stock Compensation Recent accounting pronouncements In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 12 Months Ended |
Dec. 31, 2023 | |
Selected Balance Sheet Information [Abstract] | |
Selected balance sheet information | 3. Selected balance sheet information Inventory consists of the following at: December 31, December 31, (in thousands) 2023 2022 Raw material $ 4,714 $ 2,390 Work-in-process 654 1,033 Finished goods 5,615 3,534 $ 10,983 $ 6,957 Property and equipment, net consists of the following at: December 31, December 31, (in thousands) 2023 2022 Office furniture and equipment $ 402 $ 350 Lab equipment 2,721 2,684 Computer equipment and software 776 618 Leasehold improvements 98 95 Capital equipment in process 554 231 4,551 3,978 Less: Accumulated depreciation and amortization 2,788 2,280 $ 1,763 $ 1,698 three five years Accrued expenses consist of the following at: December 31, December 31, (in thousands) 2023 2022 Clinical trial and other professional fees $ 277 $ 1,733 Bonuses 3,335 2,303 Paid time off 770 960 Customer rebates 411 256 Operating lease liability, current portion 231 222 Taxes 125 120 Other 831 775 $ 5,980 $ 6,369 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt [Abstract] | |
Debt | 4. Debt Innovatus Loan Agreement On October 31, 2022, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Innovatus Life Sciences Fund I, LP, as the collateral agent and a lender, under which we may borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of term loans. On the closing date, we borrowed the minimum amount of $7.5 million under the Loan Agreement. On March 10, 2023, we borrowed the $7.5 million remaining under the first tranche of the Loan Agreement. On December 15, 2023, we borrowed an additional $15.0 million under the second tranche of the Loan Agreement. The Loan Agreement initially requires interest only payments through November 2027, followed by three monthly principal and interest payments. A final payment of $1.4 million, equal to 4.5% of the original borrowed principal, is due in January 2028. The term loans advanced pursuant to the Loan Agreement (collectively, the “Term Loans”) bear interest at a floating rate per annum equal to the sum of (a) the greater of (i) the prime rate and (ii) 5.50% plus (b) 2.65%. The Term Loans are secured by substantially all of our personal property. We have the option to draw down up to $20.0 million between September 1, 2024 and December 15, 2024 if we achieve trailing three months revenue of $9.0 million prior to June 30, 2024. A performance covenant takes effect at the earlier of September 30, 2025 or the third tranche funding, requiring that we achieve 50% of the trailing twelve months revenue target set in the Board-approved revenue plan in effect for such period. The Loan Agreement requires the payment of certain penalties if the Term Loans are paid off prior to maturity for any reason, including pursuant to an acceleration clause, and includes various restrictive covenants, including a restriction on the payment of dividends or making other distributions or payments on our capital stock, subject to limited exceptions. We were in compliance with these covenants as of December 31, 2023. In connection with the Loan Agreement, we recorded $1.0 million of debt issuance costs and discounts as a reduction of long-term debt. The annual principal maturities of debt under the Loan Agreement are as follows: December 31, (in thousands) 2023 2024 $ — 2025 — 2026 — 2027 — 2028 20,000 2029 10,000 30,000 Less: Unamortized debt costs and discounts (778) Long-term debt $ 29,222 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | 5. Leases We lease 31,505 square feet of office space in Minneapolis, Minnesota, which houses our principal executive offices and our manufacturing facility. We lease this space under an operating lease agreement that commenced December 1, 2008 and was scheduled to expire August 31, 2024. On April 21, 2023, we extended the operating lease for our office space in Minneapolis, Minnesota for an additional 49 consecutive months through August 31, 2028. On November 7, 2023, we expanded our existing office space with the addition of 7,615 square feet of property adjacent to our principal executive offices and our manufacturing facility. The term on this expanded property is for 57 consecutive months that will run concurrently with the term on the existing lease. We intend to add new facilities as we grow, and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations. Our operating lease agreement includes an option to renew for one additional period of three years. The exercise of the lease renewal option is at our sole discretion and was not included in the lease term for the calculation of the ROU asset and lease liability, as it is not reasonably certain of exercise. In addition to base rent, we also pay our proportionate share of operating expenses, as defined in the lease. These payments are made monthly and are adjusted annually to reflect actual charges incurred for operating expenses, such as common area maintenance, taxes and insurance. The following table presents the lease balances within the consolidated balance sheets: December 31, (in thousands) 2023 Right-of-use assets: Operating lease right-of-use asset $ 1,349 Operating lease liabilities: Accrued expenses 231 Operating lease liability, non-current portion 1,160 Total operating lease liabilities $ 1,391 Maturities of our lease liability for our operating lease are as follows as of December 31, 2023: December 31, (in thousands) 2023 2024 315 2025 350 2026 362 2027 374 2028 223 Total undiscounted lease payments 1,624 Less: imputed interest (233) Present value of lease liability $ 1,391 As of December 31, 2023, the remaining lease term was 4.7 years, and the weighted average discount rate was 6.7%. The operating cash outflows from our operating lease were $0.4 million for each of the years ended December 31, 2023 and 2022. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' equity | 6. Stockholders’ equity We have common stock warrants exercisable for 716,131 shares of common stock upon conversion at a weighted average exercise price of $2.39 per share. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | 7. Stock-based compensation Summary of plans and activity In June 2001, our Board of Directors and stockholders established the 2001 Stock Incentive Award Plan (“2001 Plan”). Under the 2001 Plan, as amended, 2,674,749 shares of common stock had been reserved for the issuance of incentive stock options granted to employees, non-employee directors, consultants or independent contractors. Options granted under the 2001 Plan have vesting terms that range from the date of grant to four years and expire within a maximum term of 10 years from the grant date. In 2021, our Board of Directors and stockholders established the 2021 Equity Incentive Plan (“2021 Plan”). The number of shares of common stock initially reserved for issuance under the 2021 Plan was 1,854,490 newly reserved shares in addition to the 600,737 shares that remained available for issuance under the 2001 Plan. The shares available for issuance under the 2021 Plan automatically increase on the first day of each year, commencing January 1, 2022, and ending on (and including) January 1, 2031, in an amount equal to 5% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The annual increase resulted in an additional 1,033,186 shares being reserved for issuance under the 2021 Plan as of January 1, 2023. The 2021 Plan provides for the issuance of stock options, stock appreciation rights, restricted stock awards, stock unit awards and other stock-based awards and cash incentive awards to employees, consultants and non-employee directors of the Company and its subsidiaries. Awards granted under the 2021 Plan will have such vesting schedules and other terms as determined by the Compensation Committee and stock options and stock appreciation rights have a maximum term of 10 years from the grant date. No further awards can be made under the 2001 Plan following the adoption of the 2021 Plan. As of December 31, 2023, there were 1,671,202 shares available for future issuance under the 2021 Plan. Options are granted at exercise prices not less than the fair market value (as determined by the Board of Directors) of our common stock on the date of grant. During the years 2008 through the IPO, the Board of Directors authorized the grant of stock options for the purchase of shares of common stock to the employers of certain non-employee directors. The options were not granted under the 2001 Plan or the 2021 Plan, but terms are substantially the same as our standard form of option agreement for non-employee directors as they have an exercise price not less than the fair market value on the grant date and vest over 48 months from the date of grant. The following is a summary of stock option activity: Weighted Number Average Aggregate of Exercise Intrinsic Options Price Value (in thousands) Balance as of December 31, 2021 2,749,441 $ 7.93 $ 16,262 Granted 1,486,805 $ 8.14 Cancelled / Forfeited (328,902) $ 7.96 Exercised (150,509) $ 1.22 Balance as of December 31, 2022 3,756,835 $ 8.28 $ 36,616 Granted 1,161,926 $ 14.20 Cancelled / Forfeited (285,729) $ 10.52 Exercised (144,187) $ 5.05 Balance as of December 31, 2023 4,488,845 $ 9.77 $ 97,266 Options exercisable as of December 31, 2023 2,450,327 $ 7.27 $ 59,295 As of December 31, 2023, stock options outstanding included 8,559 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of December 31, 2023, the weighted average remaining contractual life was 7.3 years. For options exercisable as of December 31, 2023, the weighted average remaining contractual life was 6.3 years. Our Board of Directors and stockholders also established an Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock initially reserved for issuance under the ESPP was 278,170. The shares available for issuance under the ESPP automatically increase on the first day of each year, commencing January 1, 2022, and ending on (and including) January 1, 2031, in an amount equal to 1% of the total number of shares of our common stock outstanding on the last day of the calendar month before the date of each automatic increase, or such lesser number of shares as determined by the Board of Directors. The annual increase resulted in an additional 206,637 shares being reserved for issuance under the ESPP as of January 1, 2023. The ESPP permits certain of our U.S. employees to purchase shares of our common stock at a price per share not less than 85% of the l ower of (i) the closing market price per share of our common stock on the first day of the applicable purchase period or (ii) the closing market price per share of our common stock on the purchase date at the end of the applicable six-month purchase period. The first purchase date under the ESPP was June 30, 2022. For the year ended December 31, 2023, 71,276 shares of common stock were purchased under the ESPP for $0.9 million of employee contributions. As of December 31, 2023, there were 503,634 shares available for issuance under the ESPP. Stock-based compensation expense We use the Black-Scholes option pricing model to determine the fair value of stock options and ESPP purchase rights on the grant date. We measure stock-based compensation expense based on the grant date fair value of the award and recognizes compensation expense over the requisite service period, which is generally the vesting period for stock options and the offering period for ESPP purchase rights. The amount of stock-based compensation expense recognized for stock option awards during a period is based on the portion of the awards that are ultimately expected to vest. The amount of stock-based compensation expense recognized for ESPP purchase rights during a period is based on the estimated purchase rights as of the grant date. We account for forfeitures as they occur. The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the years ended December 31, 2023 and 2022. December 31, 2023 2022 Weighted average fair value of options granted $ 10.65 $ 4.72 Expected term (in years) — non-officer employees 5.5 to 6.1 5.3 to 6.1 Expected term (in years) — officer employees 2.5 to 6.1 3.2 to 6.1 Expected volatility 77.2% to 79.6 % 56.3% to 60.4 % Expected dividend yield — % — % Risk-free interest rate 3.40% to 4.89 % 1.75% to 4.18 % The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the years ended December 31, 2023 and 2022. December 31, 2023 2022 Weighted average fair value per ESPP purchase right $ 5.64 $ 1.95 Expected term (in years) 0.5 0.5 Expected volatility 76.2% to 84.6 % 51.3% to 62.9 % Expected dividend yield — % — % Risk-free interest rate 4.77% to 5.53 % 0.22% to 2.52 % We review these assumptions on a periodic basis and adjust them, as necessary. We utilize the simplified method to develop the estimate of the expected term for stock option awards and ESPP purchase rights. The expected volatility is based upon observed volatility of comparable public companies. The expected dividend yield is assumed to be zero, as we have never paid dividends and have no current plans to do so. The risk-free interest rate is based on the yield on U.S. Treasury securities for a period approximating the expected term of the options being valued. The following table presents the components and classification of stock-based compensation expense for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Stock options $ 5,901 $ 3,664 Employee Stock Purchase Plan 402 223 Total stock-based compensation expense 6,303 3,887 Selling, general & administrative $ 5,073 $ 3,304 Research & development 1,152 519 Cost of goods sold 78 64 $ 6,303 $ 3,887 As of December 31, 2023, unrecognized compensation expense related to unvested stock-based compensation arrangements was $13.4 million. As of December 31, 2023, the related weighted average period over which the expense is expected to be recognized is approximately 2.4 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes [Abstract] | |
Income taxes | 8. Income taxes As of December 31, 2023 and 2022, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position. The components of our provision for income taxes are as follows for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Current Federal and state $ — $ — Foreign 147 109 Total provision for income taxes $ 147 $ 109 The reconciliation of taxes at the federal statutory rate to our provision for income taxes are as follows for the periods indicated: Year Ended December 31, 2023 2022 Tax at federal statutory rate 21.0 % 21.0 % Permanent differences (4.3) (2.1) Research and development ("R&D") tax credit 1.4 0.8 Uncertain tax position (0.3) (0.3) State, net of federal benefit 2.6 (0.5) Deferred rate change 0.4 0.3 Change in valuation allowance (21.2) (19.5) Total (0.4) % (0.3) % Significant components of net deferred tax assets were as follows for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Deferred tax assets Net operating loss carryforwards $ 89,173 $ 82,050 R&D tax credits 9,664 9,072 Capitalized R&D expenses 8,963 8,412 Non-qualified stock options 1,473 752 Start-up costs 680 894 Accrued vacation 179 212 Property and equipment 59 144 Other 361 300 Total deferred tax assets 110,552 101,836 Valuation allowance (110,552) (101,836) Net deferred tax assets $ — $ — As of December 31, 2023, we had federal and state net operating loss carryforwards (“NOLs”) of approximately $389.9 million and $7.3 million, respectively. The federal NOLs began expiring in 2021 and the state NOLs began expiring in 2020. As of December 31, 2023, we had federal and state tax credit carryforwards of approximately $9.8 million and $2.0 million, respectively. The federal tax credit carryforwards began expiring in 2021 and the state tax credits will begin expiring in 2028. Utilization of NOLs may be subject to an annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. We have not performed a detailed analysis to determine whether an ownership change has occurred. Such a change of ownership would limit our utilization of the NOLs and could be triggered by subsequent sales of securities by us or our stockholders. The changes to our gross unrecognized tax benefits were as follows for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Gross unrecognized tax benefits at beginning of year $ 2,046 $ 1,939 Gross increases: Prior year tax positions 12 4 Current year tax positions 185 113 Gross decreases: Prior year tax positions (22) (10) Gross unrecognized tax benefits at end of year $ 2,221 $ 2,046 All of these unrecognized tax benefits, if recognized, would impact the effective tax rate before taking consideration of the valuation allowance. The amount of unrecognized tax benefits subjected to the valuation allowance was $1.7 million and $1.6 million for the years ended December 31, 2023 and 2022, respectively. We recognized approximately $0.1 million of interest or penalties for each of the years ended December 31, 2023 and 2022. As of December 31, 2023 and 2022, total accrued interest and penalties were $0.5 million and $0.4 million, respectively. We recognize accrued interest and penalties related to unrecognized tax positions as a component of income tax expense. We do not expect a significant change in the amount of unrecognized tax benefits in the next year. We are subject to U.S. federal income tax as well as income tax of multiple state and foreign jurisdictions. Tax years from 2004 through present remain open for audit under the applicable statute of limitations due to the carryover of the unused NOLs and tax credit carryforwards. We do not have any tax audits or other proceedings pending. |
Loss Per Share
Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Loss Per Share [Abstract] | |
Loss Per Share | 9. Loss Per Share Basic and diluted net loss per share attributable to common stockholders was calculated for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2023 2022 Numerator: Net loss $ (41,199) $ (41,428) Denominator: Weighted average common shares outstanding — basic and diluted 20,754,375 20,532,838 Net loss per share attributable to common stockholders — basic and diluted $ (1.99) $ (2.02) Our potentially dilutive securities, which include stock options and warrants to purchase shares of common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders, as the effect would be to reduce the net loss per share attributable to common stockholders. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. We excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Year Ended December 31, 2023 2022 Options to purchase common stock 4,488,845 3,756,835 Warrants to purchase common stock 716,131 716,131 5,204,976 4,472,966 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and contingencies | 10. Commitments and contingencies From time to time, we may have certain contingent liabilities that arise in the ordinary course of business. We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual or disclosure as of December 31, 2023 or December 31, 2022. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Employee Benefit Plans [Abstract] | |
Employee benefit plans | 11. Employee benefit plans We sponsor a voluntary defined-contribution employee retirement plan (the “401(k) plan”) for its U.S. employees. The 401(k) plan provides that each participant may contribute pre-tax or post-tax compensation up to the statutory limit allowable. Under the 401(k) plan, each participant is fully vested in his or her deferred salary contributions when contributed. We do not provide matching contributions to employees. |
Segment, Geographic Information
Segment, Geographic Information and Revenue Disaggregation | 12 Months Ended |
Dec. 31, 2023 | |
Segment, Geographic Information and Revenue Disaggregation [Abstract] | |
Segment, geographic information and revenue disaggregation | 12. Segment, geographic information and revenue disaggregation Our chief operating decision maker is our Chief Executive Officer. The Chief Executive Officer reviews financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of allocating resources and evaluating financial performance. We have one business activity and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, we have determined that we have a single reportable and operating segment structure. We and our Chief Executive Officer evaluate performance based primarily on revenue in the geographic locations in which the Company operates. We derive all our revenues from sales to customers in Europe and the U.S. The following table provides revenue by country for each location accounting for more than 10% of the total revenue for the periods indicated: Year ended December 31, (in thousands) 2023 2022 U.S. $ 35,111 $ 18,021 Germany 3,690 3,477 Other countries 494 971 $ 39,295 $ 22,469 As of December 31, 2023 and 2022, long-lived assets were located primarily in the U.S. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent events | 13. Subsequent events On January 31, 2024, we announced that our Board of Directors appointed Kevin Hykes as President and Chief Executive Officer, effective February 12, 2024 to succeed Nadim Yared, who previously announced his plans to retire upon the appointment of his successor. In connection with a transition and consulting agreement we entered into with Mr. Yared, we also modified certain terms and conditions of Mr. Yared’s stock options granted under the 2001 Plan and 2021 Plan, however, the impact of this modification on the amount of stock-based compensation expense cannot yet be quantified. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Statement presentation and basis of consolidation | Statement presentation and basis of consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and with the applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy, which was closed during 2023. All intercompany balances and transactions have been eliminated in consolidation. |
JOBS Act accounting election | JOBS Act accounting election We are an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, we have elected to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. |
Use of estimates | Use of estimates Preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents Cash and cash equivalents include highly liquid investments with an original maturity of three months or less. As of December 31, 2023 and 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of December 31, 2023 and 2022, a majority of our cash and cash equivalents were maintained with two financial institutions in the U.S., and our current deposits are likely in excess of insured limits. |
Accounts Receivable | Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the standard generally being net 30 days. We evaluate the collectability of our accounts receivable based on known collection risks and historical experience. In circumstances where we are aware of a specific customer's inability to meet its financial obligations to us, we record a specific allowance for bad debts against amounts due to reduce the carrying amount of accounts receivable to the amount we reasonably believe will be collected. ASU 2016-13 became effective for us for interim and annual periods beginning January 1, 2023. We have determined that the adoption of ASU 2016-13 did not have a material impact on our results of operations, cash flows, or financial position as we do not have a history of credit losses. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. We regularly review inventory quantities in consideration of actual loss experiences, projected future demand and remaining shelf life to record a provision for excess and obsolete inventory when appropriate. |
Leases | Leases Operating leases are included in operating lease right-of-use (“ROU”) asset, accrued expenses and operating lease liability – non-current portion in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. We used the incremental borrowing rate based on information readily available at the time of recognition to determine the present value of the lease payments. The determination of our incremental borrowing rate requires management judgement based on information available at lease commencement. |
Revenue recognition | Revenue recognition We sell our products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. Our revenue consists primarily of the sale of our Barostim, which consists of two implantable components: a pulse generator and a stimulation lead. Under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers |
Stock-Based Compensation | Stock-Based Compensation We recognize equity-based compensation expense for awards of equity instruments to employees and non-employees based on the grant date fair value of those awards in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification Topic 718, Compensation—Stock Compensation |
Recent accounting pronouncements | Recent accounting pronouncements In November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Selected Balance Sheet Information [Abstract] | |
Schedule of Inventory | Inventory consists of the following at: December 31, December 31, (in thousands) 2023 2022 Raw material $ 4,714 $ 2,390 Work-in-process 654 1,033 Finished goods 5,615 3,534 $ 10,983 $ 6,957 |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following at: December 31, December 31, (in thousands) 2023 2022 Office furniture and equipment $ 402 $ 350 Lab equipment 2,721 2,684 Computer equipment and software 776 618 Leasehold improvements 98 95 Capital equipment in process 554 231 4,551 3,978 Less: Accumulated depreciation and amortization 2,788 2,280 $ 1,763 $ 1,698 |
Schedule of Accrued Expenses | Accrued expenses consist of the following at: December 31, December 31, (in thousands) 2023 2022 Clinical trial and other professional fees $ 277 $ 1,733 Bonuses 3,335 2,303 Paid time off 770 960 Customer rebates 411 256 Operating lease liability, current portion 231 222 Taxes 125 120 Other 831 775 $ 5,980 $ 6,369 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt [Abstract] | |
Schedule of Annual Principal Maturities of Debt | The annual principal maturities of debt under the Loan Agreement are as follows: December 31, (in thousands) 2023 2024 $ — 2025 — 2026 — 2027 — 2028 20,000 2029 10,000 30,000 Less: Unamortized debt costs and discounts (778) Long-term debt $ 29,222 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of lease balances within the balance sheets | The following table presents the lease balances within the consolidated balance sheets: December 31, (in thousands) 2023 Right-of-use assets: Operating lease right-of-use asset $ 1,349 Operating lease liabilities: Accrued expenses 231 Operating lease liability, non-current portion 1,160 Total operating lease liabilities $ 1,391 |
Maturities of lease liability | Maturities of our lease liability for our operating lease are as follows as of December 31, 2023: December 31, (in thousands) 2023 2024 315 2025 350 2026 362 2027 374 2028 223 Total undiscounted lease payments 1,624 Less: imputed interest (233) Present value of lease liability $ 1,391 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Schedule of Stock Option Activity | The following is a summary of stock option activity: Weighted Number Average Aggregate of Exercise Intrinsic Options Price Value (in thousands) Balance as of December 31, 2021 2,749,441 $ 7.93 $ 16,262 Granted 1,486,805 $ 8.14 Cancelled / Forfeited (328,902) $ 7.96 Exercised (150,509) $ 1.22 Balance as of December 31, 2022 3,756,835 $ 8.28 $ 36,616 Granted 1,161,926 $ 14.20 Cancelled / Forfeited (285,729) $ 10.52 Exercised (144,187) $ 5.05 Balance as of December 31, 2023 4,488,845 $ 9.77 $ 97,266 Options exercisable as of December 31, 2023 2,450,327 $ 7.27 $ 59,295 |
Recognized Stock-Based Compensation Expense | The following table presents the components and classification of stock-based compensation expense for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Stock options $ 5,901 $ 3,664 Employee Stock Purchase Plan 402 223 Total stock-based compensation expense 6,303 3,887 Selling, general & administrative $ 5,073 $ 3,304 Research & development 1,152 519 Cost of goods sold 78 64 $ 6,303 $ 3,887 |
ESPP | |
Schedule of Assumptions Used to Determine the Grant-Date Fair Value of Stock Options | The following table provides the weighted average fair value of ESPP purchase rights and the related assumptions used in the Black-Scholes option pricing model for the years ended December 31, 2023 and 2022. December 31, 2023 2022 Weighted average fair value per ESPP purchase right $ 5.64 $ 1.95 Expected term (in years) 0.5 0.5 Expected volatility 76.2% to 84.6 % 51.3% to 62.9 % Expected dividend yield — % — % Risk-free interest rate 4.77% to 5.53 % 0.22% to 2.52 % |
Employee Stock Option | |
Schedule of Assumptions Used to Determine the Grant-Date Fair Value of Stock Options | The following table provides the weighted average fair value of options granted to employees and the related assumptions used in the Black-Scholes option pricing model for the years ended December 31, 2023 and 2022. December 31, 2023 2022 Weighted average fair value of options granted $ 10.65 $ 4.72 Expected term (in years) — non-officer employees 5.5 to 6.1 5.3 to 6.1 Expected term (in years) — officer employees 2.5 to 6.1 3.2 to 6.1 Expected volatility 77.2% to 79.6 % 56.3% to 60.4 % Expected dividend yield — % — % Risk-free interest rate 3.40% to 4.89 % 1.75% to 4.18 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes [Abstract] | |
Components of Provision for Income Taxes | The components of our provision for income taxes are as follows for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Current Federal and state $ — $ — Foreign 147 109 Total provision for income taxes $ 147 $ 109 |
Reconciliation of Taxes at the Federal Statutory Rate | Year Ended December 31, 2023 2022 Tax at federal statutory rate 21.0 % 21.0 % Permanent differences (4.3) (2.1) Research and development ("R&D") tax credit 1.4 0.8 Uncertain tax position (0.3) (0.3) State, net of federal benefit 2.6 (0.5) Deferred rate change 0.4 0.3 Change in valuation allowance (21.2) (19.5) Total (0.4) % (0.3) % |
Components of Net Deferred Tax Assets | Year Ended December 31, (in thousands) 2023 2022 Deferred tax assets Net operating loss carryforwards $ 89,173 $ 82,050 R&D tax credits 9,664 9,072 Capitalized R&D expenses 8,963 8,412 Non-qualified stock options 1,473 752 Start-up costs 680 894 Accrued vacation 179 212 Property and equipment 59 144 Other 361 300 Total deferred tax assets 110,552 101,836 Valuation allowance (110,552) (101,836) Net deferred tax assets $ — $ — |
Changes to Gross Unrecognized Tax Benefits | The changes to our gross unrecognized tax benefits were as follows for the periods indicated: Year Ended December 31, (in thousands) 2023 2022 Gross unrecognized tax benefits at beginning of year $ 2,046 $ 1,939 Gross increases: Prior year tax positions 12 4 Current year tax positions 185 113 Gross decreases: Prior year tax positions (22) (10) Gross unrecognized tax benefits at end of year $ 2,221 $ 2,046 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Loss Per Share [Abstract] | |
Basic and Diluted Net Loss per Share | Basic and diluted net loss per share attributable to common stockholders was calculated for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2023 2022 Numerator: Net loss $ (41,199) $ (41,428) Denominator: Weighted average common shares outstanding — basic and diluted 20,754,375 20,532,838 Net loss per share attributable to common stockholders — basic and diluted $ (1.99) $ (2.02) |
Antidilutive Securities Excluded from Computation of Earnings Per Share | Year Ended December 31, 2023 2022 Options to purchase common stock 4,488,845 3,756,835 Warrants to purchase common stock 716,131 716,131 5,204,976 4,472,966 |
Segment, Geographic Informati_2
Segment, Geographic Information and Revenue Disaggregation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Segment, Geographic Information and Revenue Disaggregation [Abstract] | |
Schedule of Segment Reporting | We derive all our revenues from sales to customers in Europe and the U.S. The following table provides revenue by country for each location accounting for more than 10% of the total revenue for the periods indicated: Year ended December 31, (in thousands) 2023 2022 U.S. $ 35,111 $ 18,021 Germany 3,690 3,477 Other countries 494 971 $ 39,295 $ 22,469 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information [Abstract] | ||
Raw material | $ 4,714 | $ 2,390 |
Work-in-process | 654 | 1,033 |
Finished goods | 5,615 | 3,534 |
Total inventory | $ 10,983 | $ 6,957 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,551 | $ 3,978 |
Less: Accumulated depreciation and amortization | 2,788 | 2,280 |
Property and equipment, net | $ 1,763 | 1,698 |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 3 years | |
Office furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 402 | 350 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,721 | 2,684 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 776 | 618 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 98 | 95 |
Capital equipment in process | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 554 | $ 231 |
Selected Balance Sheet Inform_5
Selected Balance Sheet Information (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Selected Balance Sheet Information [Abstract] | ||
Depreciation | $ 522 | $ 412 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information (Schedule of Accrued Expenses) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information [Abstract] | ||
Clinical trial and other professional fees | $ 277 | $ 1,733 |
Bonuses | 3,335 | 2,303 |
Paid time off | 770 | 960 |
Customer rebates | 411 | 256 |
Operating lease liability, current portion | $ 231 | $ 222 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Total accrued expenses | Total accrued expenses |
Taxes | $ 125 | $ 120 |
Other | 831 | 775 |
Total accrued expenses | $ 5,980 | $ 6,369 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) $ in Thousands | 12 Months Ended | ||||
Dec. 15, 2023 USD ($) | Mar. 10, 2023 USD ($) | Oct. 31, 2022 USD ($) item | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | |||||
Proceeds from debt financing | $ 22,500 | $ 7,500 | |||
Loan and Security Agreement | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 50,000 | ||||
Proceeds from debt financing | $ 7,500 | ||||
Variable interest rate (as a percent) | 5.50% | ||||
Interest rate ( as a percent) | 2.65% | ||||
Percentage of trailing twelve months revenue goal | 50% | ||||
Number of monthly payments of principal plus interest | item | 3 | ||||
Final payment | $ 1,400 | ||||
Percentage of final payment on original principal | 4.50% | ||||
Debt issuance costs and discounts | $ 1,000 | ||||
Loan and Security Agreement | Tranche One | |||||
Debt Instrument [Line Items] | |||||
Proceeds from debt financing | $ 7,500 | ||||
Loan and Security Agreement | Tranche Two | |||||
Debt Instrument [Line Items] | |||||
Proceeds from debt financing | $ 15,000 | ||||
Loan and Security Agreement | Draw down from September 1, 2024 to December 15, 2024 | |||||
Debt Instrument [Line Items] | |||||
Proceeds from debt financing | 20,000 | ||||
Three months of trailing revenue | $ 9,000 |
Debt (Maturities of debt) (Deta
Debt (Maturities of debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Long-Term Debt, Fiscal Year Maturity [Abstract] | ||
2028 | $ 20,000 | |
2029 | 10,000 | |
Total | 30,000 | |
Less: Unamortized debt costs and discounts | (778) | |
Long-term debt | $ 29,222 | $ 6,747 |
Leases (Details)
Leases (Details) $ in Thousands | 12 Months Ended | |||
Nov. 07, 2023 ft² | Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Apr. 21, 2023 | |
Right-of-use assets: | ||||
Operating lease right-of-use asset | $ 1,349 | $ 334 | ||
Operating lease liabilities: | ||||
Accrued expenses | $ 231 | $ 222 | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses | Accrued expenses | ||
Operating lease liability, non-current portion | $ 1,160 | $ 117 | ||
Present value of lease liability | $ 1,391 | |||
Remaining lease term | 4 years 8 months 12 days | |||
Discount rate | 6.70% | |||
Operating cash outflows | $ 400 | $ 400 | ||
Office space in Minneapolis, Minnesota | ||||
Lessee, Lease, Description [Line Items] | ||||
Area of land leased | ft² | 31,505 | |||
Lessee, Operating Lease, Renewal Term | 3 years | 49 years | ||
Additional area of land leased | ft² | 7,615 | |||
Additional renewal term option | 57 years | |||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true |
Leases (Maturities of lease lia
Leases (Maturities of lease liability) (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
2024 | $ 315 |
2025 | 350 |
2026 | 362 |
2027 | 374 |
2028 | 223 |
Total undiscounted lease payments | 1,624 |
Less: imputed interest | (233) |
Present value of lease liability | $ 1,391 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - Warrants to purchase common stock | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Temporary Equity [Line Items] | |
Preferred stock warrants converted to common stock warrants at IPO | shares | 716,131 |
Preferred stock warrants converted to common stock warrants at IPO, Weighted Average Exercise Price | $ / shares | $ 2.39 |
Stock-Based Compensation (Narra
Stock-Based Compensation (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Jun. 30, 2001 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2008 | Jan. 01, 2023 | Jul. 02, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected dividend yield | 0% | ||||||
Proceeds from Employee Stock Purchase Plan | $ 935 | $ 587 | |||||
2001 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Reserved for future issuance | 2,674,749 | ||||||
Number of shares available for grant | 600,737 | ||||||
Vesting Period | 4 years | ||||||
2001 Plan | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting Period | 10 years | ||||||
ESPP | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Reserved for future issuance | 206,637 | 278,170 | |||||
Number of shares available for grant | 503,634 | ||||||
Shares issued/purchased under ESPP | 71,276 | ||||||
Annual incremental percentage | 1% | ||||||
Minimum Percentage | 85% | ||||||
Proceeds from Employee Stock Purchase Plan | $ 900 | ||||||
2021 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Reserved for future issuance | 1,671,202 | 1,854,490 | 1,033,186 | ||||
Annual incremental percentage | 5% | ||||||
2021 | Maximum | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share based payment award, term | 10 years | ||||||
Employee Stock Option [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected dividend yield | 0% | 0% | |||||
Employee Stock Option [Member] | Employers of certain non-employee directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting Period | 48 months |
Stock-Based Compensation (Summa
Stock-Based Compensation (Summary of Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Stock Option [Member] | |||
Aggregate Intrinsic Value | |||
Weighted average remaining contractual term, outstanding (in years) | 7 years 3 months 18 days | ||
Weighted average remaining contractual life, exercisable (in years) | 6 years 3 months 18 days | ||
Employee Stock Option [Member] | Employers of certain non-employee directors | |||
Number of Options | |||
Outstanding as of Beginning of period (in shares) | 3,756,835 | 2,749,441 | |
Granted (in shares) | 1,161,926 | 1,486,805 | |
Cancelled / Forfeited (in shares) | (285,729) | (328,902) | |
Exercised (in shares) | (144,187) | (150,509) | |
Balance as of End of period (in shares) | 4,488,845 | 3,756,835 | |
Options exercisable as of June 30, 2023 (in shares) | 2,450,327 | ||
Weighted Average Exercise Price | |||
Outstanding as of Beginning of period (in dollars per share) | $ 8.28 | $ 7.93 | |
Granted (in dollars per share) | 14.20 | 8.14 | |
Cancelled / Forfeited (in dollars per share) | 10.52 | 7.96 | |
Exercised (in dollars per share) | 5.05 | 1.22 | |
Balance as of End of period (in dollars per share) | 9.77 | $ 8.28 | |
Options exercisable as of June 30, 2023 (in dollars per share) | $ 7.27 | ||
Aggregate Intrinsic Value | |||
Aggregate intrinsic value | $ 97,266 | $ 36,616 | $ 16,262 |
Options exercisable as of June 30, 2023 | $ 59,295 | ||
Options not granted under the 2001 or 2021 Plans | |||
Number of Options | |||
Balance as of End of period (in shares) | 8,559 |
Stock-Based Compensation (Assum
Stock-Based Compensation (Assumptions Used in Determine the Grant Date Fair Value of Stock Options) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted | $ 1.95 | |
Expected term (in years) | 6 months | |
Expected dividend yield | 0% | |
Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted | $ 10.65 | $ 4.72 |
Expected volatility, Minimum | 77.20% | 56.30% |
Expected volatility, Maximum | 79.60% | 60.40% |
Expected dividend yield | 0% | 0% |
Risk-free interest rate, Minimum | 3.40% | 1.75% |
Risk-free interest rate, Maximum | 4.89% | 4.18% |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted | $ 5.64 | |
Expected term (in years) | 6 months | |
Expected volatility, Minimum | 76.20% | 51.30% |
Expected volatility, Maximum | 84.60% | 62.90% |
Risk-free interest rate, Minimum | 4.77% | 0.22% |
Risk-free interest rate, Maximum | 5.53% | 2.52% |
Non officer employees | Employee Stock Option | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 3 months 18 days |
Non officer employees | Employee Stock Option | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Officer employees | Employee Stock Option | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 2 years 6 months | 3 years 2 months 12 days |
Officer employees | Employee Stock Option | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation (Recog
Stock-Based Compensation (Recognized Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 6,303 | $ 3,887 |
Unrecognized compensation expense | $ 13,400 | |
Weighted average period | 2 years 4 months 24 days | |
Employee Stock Option | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 5,901 | 3,664 |
ESPP | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 402 | 223 |
Selling, general & administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 5,073 | 3,304 |
Research & development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,152 | 519 |
Cost of goods sold | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 78 | $ 64 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense | $ 147 | $ 109 |
Unrecognized tax benefits that are subjected to a valuation allowance | 1,700 | 1,600 |
Unrecognized tax benefits, income tax penalties and interest expense | 100 | |
Unrecognized tax benefits, Income tax penalties and interest accrued | 500 | $ 400 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 389,900 | |
Tax credit carryforwards | 9,800 | |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 7,300 | |
Tax credit carryforwards | $ 2,000 |
Income Taxes (Components of Pro
Income Taxes (Components of Provision for Income Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes [Abstract] | ||
Provision for income taxes, federal and state | $ 0 | $ 0 |
Provision for income taxes, foreign | 147 | 109 |
Total provision for income taxes | $ 147 | $ 109 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Taxes at the Federal Statutory Rate) (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes [Abstract] | ||
Tax at federal statutory rate | 21% | 21% |
Permanent differences | (4.30%) | (2.10%) |
Research and development ("R&D") tax credit | 1.40% | 0.80% |
Uncertain tax position | (0.30%) | (0.30%) |
State, net of federal benefit | 2.60% | (0.50%) |
Deferred rate change | 0.40% | 0.30% |
Change in valuation allowance | (21.20%) | (19.50%) |
Total | (0.40%) | (0.30%) |
Income Taxes (Components of Net
Income Taxes (Components of Net Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Taxes [Abstract] | ||
Net operating loss carryforwards | $ 89,173 | $ 82,050 |
R&D tax credits | 9,664 | 9,072 |
Capitalized R&D expenses | 8,963 | 8,412 |
Non-qualified stock options | 1,473 | 752 |
Start-up costs | 680 | 894 |
Accrued vacation | 179 | 212 |
Property and equipment | 59 | 144 |
Other | 361 | 300 |
Total deferred tax assets | 110,552 | 101,836 |
Valuation allowance | (110,552) | (101,836) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Changes to Gross
Income Taxes (Changes to Gross Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes [Abstract] | ||
Gross unrecognized tax benefits at beginning of year | $ 2,046 | $ 1,939 |
Gross increases: Prior year tax positions | 12 | 4 |
Gross increases: Current year tax positions | 185 | 113 |
Gross decreases: Prior year tax positions | (22) | (10) |
Gross unrecognized tax benefits at end of year | $ 2,221 | $ 2,046 |
Loss Per Share (Basic and Dilut
Loss Per Share (Basic and Diluted Net Loss per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||
Net Income (Loss) | $ (41,199) | $ (41,428) |
Denominator: | ||
Weighted average common shares outstanding - basic | 20,754,375 | 20,532,838 |
Weighted average common shares outstanding - diluted | 20,754,375 | 20,532,838 |
Net loss per share attributable to common stockholders - basic | $ (1.99) | $ (2.02) |
Net loss per share attributable to common stockholders - diluted | $ (1.99) | $ (2.02) |
Loss Per Share (Antidilutive Se
Loss Per Share (Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Excluded potential common shares from the computation of diluted net loss per share | 5,204,976 | 4,472,966 |
Employee Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Excluded potential common shares from the computation of diluted net loss per share | 4,488,845 | 3,756,835 |
Warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Excluded potential common shares from the computation of diluted net loss per share | 716,131 | 716,131 |
Commitments and Contingencies (
Commitments and Contingencies (Narrative) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies [Abstract] | ||
Contingent liabilities accrual amount | $ 0 | $ 0 |
Segment, Geographic informati_3
Segment, Geographic information and revenue disaggregation (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | |
Segment Reporting Information [Line Items] | ||
Total revenues | $ 39,295 | $ 22,469 |
Number of segments | segment | 1 | |
U.S. | ||
Segment Reporting Information [Line Items] | ||
Total revenues | $ 35,111 | 18,021 |
Germany | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 3,690 | 3,477 |
Other countries | ||
Segment Reporting Information [Line Items] | ||
Total revenues | $ 494 | $ 971 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (41,199) | $ (41,428) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |