Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 24, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 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 Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 20,815,635 | |
Entity Central Index Key | 0001235912 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 82,993 | $ 106,194 |
Accounts receivable, net of allowances of $506 and $679, respectively | 6,372 | 5,504 |
Inventory | 10,887 | 6,957 |
Prepaid expenses and other current assets | 3,345 | 4,223 |
Total current assets | 103,597 | 122,878 |
Property and equipment, net | 1,723 | 1,698 |
Operating lease right-of-use asset | 1,058 | 334 |
Other non-current assets | 26 | 27 |
Total assets | 106,404 | 124,937 |
Current liabilities: | ||
Accounts payable | 1,133 | 1,719 |
Accrued expenses | 6,274 | 6,369 |
Total current liabilities | 7,407 | 8,088 |
Long-term debt | 14,294 | 6,747 |
Operating lease liability, non-current portion | 916 | 117 |
Other long-term liabilities | 960 | 805 |
Total liabilities | 23,577 | 15,757 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value, 200,000,000 authorized as of September 30, 2023 and December 31, 2022; 20,813,612 and 20,663,736 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 208 | 207 |
Additional paid-in capital | 551,045 | 545,362 |
Accumulated deficit | (468,218) | (436,182) |
Accumulated other comprehensive loss | (208) | (207) |
Total stockholders' equity | 82,827 | 109,180 |
Total liabilities and stockholders' equity | $ 106,404 | $ 124,937 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Condensed Consolidated Balance Sheets [Abstract] | ||
Allowance for accounts receivable, net | $ 506 | $ 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 | 20,813,612 | 20,663,736 |
Common stock, shares outstanding | 20,813,612 | 20,663,736 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||
Revenue | $ 10,511,000 | $ 6,186,000 | $ 27,990,000 | $ 15,293,000 |
Cost of goods sold | 1,691,000 | 1,340,000 | 4,536,000 | 3,490,000 |
Gross profit | 8,820,000 | 4,846,000 | 23,454,000 | 11,803,000 |
Operating expenses: | ||||
Research and development | 2,696,000 | 2,293,000 | 9,392,000 | 6,906,000 |
Selling, general and administrative | 15,652,000 | 12,679,000 | 47,504,000 | 35,945,000 |
Total operating expenses | 18,348,000 | 14,972,000 | 56,896,000 | 42,851,000 |
Loss from operations | (9,528,000) | (10,126,000) | (33,442,000) | (31,048,000) |
Interest expense | (499,000) | 0 | (1,220,000) | 0 |
Other income (expense), net | 1,056,000 | 328,000 | 2,734,000 | 237,000 |
Loss before income taxes | (8,971,000) | (9,798,000) | (31,928,000) | (30,811,000) |
Provision for income taxes | (40,000) | (32,000) | (108,000) | (81,000) |
Net loss | (9,011,000) | (9,830,000) | (32,036,000) | (30,892,000) |
Cumulative translation adjustment | (21,000) | (8,000) | (1,000) | (21,000) |
Comprehensive loss | $ (9,032,000) | $ (9,838,000) | $ (32,037,000) | $ (30,913,000) |
Net loss per share, basic | $ (0.43) | $ (0.48) | $ (1.55) | $ (1.51) |
Net loss per share, diluted | $ (0.43) | $ (0.48) | $ (1.55) | $ (1.51) |
Weighted-average common shares used to compute net loss per share, basic | 20,801,350 | 20,576,838 | 20,730,024 | 20,512,254 |
Weighted-average common shares used to compute net loss per share, diluted | 20,801,350 | 20,576,838 | 20,730,024 | 20,512,254 |
Condensed Consolidated Statem_2
Condensed 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 | $ 1 | 80 | 81 | ||
Exercise of stock options (in shares) | 121,945 | ||||
Proceeds from Employee Stock Purchase Plan | $ 1 | 294 | 295 | ||
Proceeds from Employee Stock Purchase Plan (shares) | 57,681 | ||||
Employee stock compensation | 2,822 | 2,822 | |||
Net loss | (30,892) | (30,892) | |||
Cumulative translation adjustment | (21) | (21) | |||
Balances, Ending at Sep. 30, 2022 | $ 206 | 543,903 | (425,646) | (219) | 118,244 |
Balances, Ending (in shares) at Sep. 30, 2022 | 20,578,963 | ||||
Balances, Beginning at Jun. 30, 2022 | $ 206 | 542,967 | (415,816) | (211) | 127,146 |
Balances, Beginning (in shares) at Jun. 30, 2022 | 20,576,149 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | 7 | 7 | |||
Exercise of stock options (in shares) | 2,814 | ||||
Employee stock compensation | 929 | 929 | |||
Net loss | (9,830) | (9,830) | |||
Cumulative translation adjustment | (8) | (8) | |||
Balances, Ending at Sep. 30, 2022 | $ 206 | 543,903 | (425,646) | (219) | 118,244 |
Balances, Ending (in shares) at Sep. 30, 2022 | 20,578,963 | ||||
Balances, Beginning at Dec. 31, 2022 | $ 207 | 545,362 | (436,182) | (207) | 109,180 |
Balances, Beginning (in shares) at Dec. 31, 2022 | 20,663,736 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | $ 1 | 518 | $ 519 | ||
Exercise of stock options (in shares) | 115,455 | 115,455 | |||
Proceeds from Employee Stock Purchase Plan | 452 | $ 452 | |||
Proceeds from Employee Stock Purchase Plan (shares) | 34,421 | ||||
Employee stock compensation | 4,713 | 4,713 | |||
Net loss | (32,036) | (32,036) | |||
Cumulative translation adjustment | (1) | (1) | |||
Balances, Ending at Sep. 30, 2023 | $ 208 | 551,045 | (468,218) | (208) | 82,827 |
Balances, Ending (in shares) at Sep. 30, 2023 | 20,813,612 | ||||
Balances, Beginning at Jun. 30, 2023 | $ 208 | 549,150 | (459,207) | (187) | 89,964 |
Balances, Beginning (in shares) at Jun. 30, 2023 | 20,750,910 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options | 363 | 363 | |||
Exercise of stock options (in shares) | 62,702 | ||||
Employee stock compensation | 1,532 | 1,532 | |||
Net loss | (9,011) | (9,011) | |||
Cumulative translation adjustment | (21) | (21) | |||
Balances, Ending at Sep. 30, 2023 | $ 208 | $ 551,045 | $ (468,218) | $ (208) | $ 82,827 |
Balances, Ending (in shares) at Sep. 30, 2023 | 20,813,612 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (32,036) | $ (30,892) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 4,713 | 2,822 |
Depreciation of property and equipment | 393 | 284 |
Loss on disposal of equipment | 4 | 0 |
Amortization of deferred financing costs and loan discount | 114 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (868) | (2,737) |
Inventory | (3,930) | (2,184) |
Prepaid expenses and other current assets | 902 | (479) |
Accounts payable | (586) | 766 |
Accrued expenses | 112 | 584 |
Net cash used in operating activities | (31,182) | (31,836) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (422) | (606) |
Net cash used in investing activities | (422) | (606) |
Cash flows from financing activities: | ||
Proceeds from the exercise of common stock options | 519 | 81 |
Proceeds from Employee Stock Purchase Plan | 452 | 295 |
Proceeds from debt financing | 7,500 | 0 |
Debt financing costs | (67) | 0 |
Net cash provided by financing activities | 8,404 | 376 |
Effect of currency exchange on cash and cash equivalents | (1) | (21) |
Net change in cash and cash equivalents | (23,201) | (32,087) |
Cash and cash equivalents at beginning of period | 106,194 | 142,072 |
Cash and cash equivalents at end of period | 82,993 | 109,985 |
Supplemental Information: | ||
Cash paid for interest | 979 | 0 |
Cash paid for income taxes | $ 4 | $ 4 |
Business Organization
Business Organization | 9 Months Ended |
Sep. 30, 2023 | |
Business Organization [Abstract] | |
Business organization | 1. Business organization CVRx, Inc. (the “Company”) was incorporated in Delaware and is headquartered in Minneapolis, Minnesota. The Company has developed and is marketing a medical device, Barostim, for heart failure (“HF”) and resistant hypertension. The Company is focused on the sale of its 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 the Company will generate sufficient product sales to produce positive earnings or cash flows. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) applicable to interim financial statements. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company’s statements of financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole or any other future period. The condensed consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy. All intercompany balances and transactions have been eliminated in consolidation. JOBS Act accounting election The Company is an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, the Company has 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 condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 September 30, 2023 and December 31, 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of September 30, 2023 and December 31, 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. Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company regularly reviews 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 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 The Company sells its products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. The Company’s revenue consists primarily of the sale of its 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 ASC Topic 718, Compensation—Stock Compensation our equity-based compensation awards granted to employees on a straight-line basis over the associated service period, which is generally the period in which the related services are received. |
Selected Balance Sheet Informat
Selected Balance Sheet Information | 9 Months Ended |
Sep. 30, 2023 | |
Selected Balance Sheet Information [Abstract] | |
Selected balance sheet information | 3. Selected balance sheet information Inventory consists of the following at: September 30, December 31, (in thousands) 2023 2022 Raw material $ 4,875 $ 2,390 Work-in-process 1,173 1,033 Finished goods 4,839 3,534 $ 10,887 $ 6,957 Property and equipment, net consists of the following at: September 30, December 31, (in thousands) 2023 2022 Office furniture and equipment $ 402 $ 350 Lab equipment 2,685 2,684 Computer equipment and software 772 618 Leasehold improvements 98 95 Capital equipment in process 425 231 4,382 3,978 Less: Accumulated depreciation and amortization 2,659 2,280 $ 1,723 $ 1,698 Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three Accrued expenses consist of the following at: September 30, December 31, (in thousands) 2023 2022 Bonuses $ 2,366 $ 2,303 Paid time off 1,212 960 Clinical trial and other professional fees 892 1,733 Customer rebates 382 256 Employee Stock Purchase Plan 280 — Operating lease liability, current portion 170 222 Taxes 103 120 Other 869 775 $ 6,274 $ 6,369 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt [Abstract] | |
Debt | 4. Debt Innovatus Loan Agreement On October 31, 2022, the Company 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 the Company may borrow, subject to the Company’s achievement of certain milestones, up to a total of $50.0 million in a series of term loans. On the closing date, the Company borrowed the minimum amount of $7.5 million under the Loan Agreement. On March 10, 2023, the Company borrowed the $7.5 million remaining under the first tranche of the Loan Agreement , with $4.0 million received on March 13, 2023, and $3.5 million received on March 15, 2023 In connection with the Loan Agreement, the Company recorded $0.8 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: September 30, (in thousands) 2023 2023 $ — 2024 — 2025 — 2026 — 2027 10,000 2028 5,000 15,000 Less: Unamortized debt costs and discounts (706) Long-term debt $ 14,294 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | 5. Leases We lease 23,890 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. 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 condensed consolidated balance sheets: September 30, December 31, (in thousands) 2023 2022 Right-of-use assets: Operating lease right-of-use asset $ 1,058 $ 334 Operating lease liabilities: Accrued expenses 170 222 Operating lease liability, non-current portion 916 117 Total operating lease liabilities $ 1,086 $ 339 Maturities of our lease liability for our operating lease are as follows as of September 30, 2023: September 30, (in thousands) 2023 2023, remainder $ 59 2024 223 2025 255 2026 262 2027 270 2028 161 Total undiscounted lease payments 1,230 Less: imputed interest (144) Present value of lease liability $ 1,086 As of September 30, 2023, the remaining lease term was 4.9 years and the discount rate was 5.0%. The operating cash outflows from our operating lease were $0.3 million for each of the nine months ended September 30, 2023 and 2022. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity [Abstract] | |
Stockholders' equity | 6 . Stockholders’ equity Common Stock Warrants The Company has 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 | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | 7. Stock-based compensation Summary of plans and activity In June 2001, the Company’s 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, the Company’s 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 the Company’s 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 September 30, 2023, there were 1,724,683 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 the Company’s common stock on the date of grant. During the years 2008 through the initial public offering (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 the Company’s 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, 2022 3,756,835 $ 8.28 $ 36,616 Granted 1,086,876 14.06 Cancelled / Forfeited (264,160) 10.42 Exercised (115,455) 4.50 Balance as of September 30, 2023 4,464,096 $ 9.66 $ 37,331 Options exercisable as of September 30, 2023 2,311,211 $ 7.05 $ 25,374 As of September 30, 2023, stock options outstanding included 8,796 options that were not granted under the 2001 Plan or the 2021 Plan. For options outstanding as of September 30, 2023, the weighted average remaining contractual life was 7.5 years. For options exercisable as of September 30, 2023, the weighted average remaining contractual life was 6.4 years. The Company’s 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 the Company’s 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 the Company’s U.S. employees to purchase shares of the Company’s common stock at a price per share not less than 85% of the l ower of (i) the closing market price per share of the Company’s common stock on the first day of the applicable purchase period or (ii) the closing market price per share of the Company’s common stock on the purchase date at the end For the nine months ended September 30, 2023, 34,421 shares of common stock were purchased under the ESPP for $0.5 million of employee contributions. Stock-based compensation expense The Company uses the Black-Scholes option pricing model to determine the fair value of stock options and ESPP purchase rights on the grant date. The Company measures 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. The Company accounts 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 nine months ended September 30, 2023 and 2022: September 30, 2023 2022 Weighted average fair value of options granted $ 10.59 $ 4.56 Expected term (in years) — non-officer employees 5.5 to 6.1 5.5 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 58.6 % Expected dividend yield — % — % Risk-free interest rate 3.40% to 4.61 % 1.75% to 3.97 % 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 nine months ended September 30, 2023 and 2022: September 30, 2023 2022 Weighted average fair value per ESPP purchase right $ 9.01 $ 2.85 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 % The Company reviews these assumptions on a periodic basis and adjusts them, as necessary. The expected term of a stock option award was determined based on the Company’s analysis of historical exercise behavior while taking into consideration various participant demographics and option characteristics. The expected term of an ESPP purchase right is based on the offering period. We utilize the simplified method to develop the estimate of the expected term. The expected volatility is based upon observed volatility of comparable public companies. The expected dividend yield is assumed to be zero, as the Company has never paid dividends and has 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: Three Months Ended Nine months ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Stock options $ 1,419 $ 866 $ 4,403 $ 2,657 Employee Stock Purchase Plan 113 63 310 165 Total stock-based compensation expense $ 1,532 $ 929 $ 4,713 $ 2,822 Selling, general & administrative $ 1,290 $ 785 $ 3,728 $ 2,402 Research & development 221 132 927 367 Cost of goods sold 21 12 58 53 $ 1,532 $ 929 $ 4,713 $ 2,822 As of September 30, 2023, unrecognized compensation expense related to unvested stock-based compensation arrangements was $14.1 million. As of September 30, 2023, the related weighted average period over which the expense is expected to be recognized is approximately 2.5 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Taxes [Abstract] | |
Income taxes | 8. Income taxes As of September 30, 2023 and December 31, 2022, a valuation allowance was recorded against all deferred tax assets due to the Company’s cumulative net loss position. Provision for income taxes for the three months ended September 30, 2023 and 2022 was $40,000 and $32,000, respectively. Provision for income taxes for the nine months ended September 30, 2023 and 2022 was $108,000 and $81,000, respectively. As of December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOLs”) of approximately $361.0 million and $6.2 million, respectively. The federal NOLs began expiring in 2021 and the state NOLs began expiring in 2020. As of December 31, 2022, the Company had federal and state tax credit carryforwards of approximately $9.3 million and $1.8 million, respectively. The federal tax credit carryforwards began expiring in 2021 and the state tax credit carryforwards 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 and similar state provisions. The Company has not performed a detailed analysis to determine whether an ownership change has occurred. Such a change of ownership would limit the Company’s utilization of the NOLs and could be triggered by subsequent sales of securities by the Company or its stockholders. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 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): Three Months Ended Nine months ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net loss $ (9,011) $ (9,830) $ (32,036) $ (30,892) Denominator: Weighted average common shares outstanding — basic and diluted 20,801,350 20,576,838 20,730,024 20,512,254 Net loss per share attributable to common stockholders — basic and diluted $ (0.43) $ (0.48) $ (1.55) $ (1.51) The Company’s 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. The Company 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: Nine months ended September 30, 2023 2022 Options to purchase common stock 4,464,096 3,723,499 Warrants to purchase common stock 716,131 716,131 5,180,227 4,439,630 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and contingencies | 10. Commitments and contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business. The Company accrues 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 September 30, 2023 or December 31, 2022. |
Employee Benefit Plans
Employee Benefit Plans | 9 Months Ended |
Sep. 30, 2023 | |
Employee Benefit Plans [Abstract] | |
Employee benefit plans | 11. Employee benefit plans The Company sponsors 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. The Company does not provide matching contributions to employees. |
Segment, Geographic Information
Segment, Geographic Information and Revenue Disaggregation | 9 Months Ended |
Sep. 30, 2023 | |
Segment, Geographic Information and Revenue Disaggregation [Abstract] | |
Segment, geographic information and revenue disaggregation | 12. Segment, geographic information, and revenue disaggregation The chief operating decision maker for the Company is the 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. The Company has 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, the Company has determined that it has a single reportable and operating segment structure. The Company and its Chief Executive Officer evaluate performance based primarily on revenue in the geographic locations in which the Company operates. The Company derives all its 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 (in thousands): Three months ended Nine months ended September 30, September 30, 2023 2022 2023 2022 U.S. $ 9,579 $ 5,039 $ 24,818 $ 12,035 Germany 802 933 2,819 2,744 Other countries 130 214 353 514 $ 10,511 $ 6,186 $ 27,990 $ 15,293 As of September 30, 2023 and December 31, 2022, long-lived assets were located primarily in the U.S. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Statement presentation and basis of consolidation | Statement presentation and basis of consolidation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) applicable to interim financial statements. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company’s statements of financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole or any other future period. The condensed consolidated financial statements include the accounts of CVRx, Inc., its wholly owned subsidiary, CVRx Switzerland LLC, and its sales branch in Italy. All intercompany balances and transactions have been eliminated in consolidation. |
JOBS Act accounting election | JOBS Act accounting election The Company is an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As a result, the Company has 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 condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 September 30, 2023 and December 31, 2022, cash equivalents consisted of money market funds, which are stated at cost and approximate fair value. Additionally, as of September 30, 2023 and December 31, 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. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. The Company regularly reviews 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 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 The Company sells its products primarily through a direct sales force and to a lesser extent through a combination of sales agents and independent distributors. The Company’s revenue consists primarily of the sale of its 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 ASC Topic 718, Compensation—Stock Compensation our equity-based compensation awards granted to employees on a straight-line basis over the associated service period, which is generally the period in which the related services are received. |
Selected Balance Sheet Inform_2
Selected Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Selected Balance Sheet Information [Abstract] | |
Schedule of Inventory | Inventory consists of the following at: September 30, December 31, (in thousands) 2023 2022 Raw material $ 4,875 $ 2,390 Work-in-process 1,173 1,033 Finished goods 4,839 3,534 $ 10,887 $ 6,957 |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following at: September 30, December 31, (in thousands) 2023 2022 Office furniture and equipment $ 402 $ 350 Lab equipment 2,685 2,684 Computer equipment and software 772 618 Leasehold improvements 98 95 Capital equipment in process 425 231 4,382 3,978 Less: Accumulated depreciation and amortization 2,659 2,280 $ 1,723 $ 1,698 |
Schedule of Accrued Expenses | Accrued expenses consist of the following at: September 30, December 31, (in thousands) 2023 2022 Bonuses $ 2,366 $ 2,303 Paid time off 1,212 960 Clinical trial and other professional fees 892 1,733 Customer rebates 382 256 Employee Stock Purchase Plan 280 — Operating lease liability, current portion 170 222 Taxes 103 120 Other 869 775 $ 6,274 $ 6,369 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt [Abstract] | |
Schedule of Annual Principal Maturities of Debt | The annual principal maturities of debt under the Loan Agreement are as follows: September 30, (in thousands) 2023 2023 $ — 2024 — 2025 — 2026 — 2027 10,000 2028 5,000 15,000 Less: Unamortized debt costs and discounts (706) Long-term debt $ 14,294 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of lease balances within the balance sheets | The following table presents the lease balances within the condensed consolidated balance sheets: September 30, December 31, (in thousands) 2023 2022 Right-of-use assets: Operating lease right-of-use asset $ 1,058 $ 334 Operating lease liabilities: Accrued expenses 170 222 Operating lease liability, non-current portion 916 117 Total operating lease liabilities $ 1,086 $ 339 |
Maturities of lease liability | Maturities of our lease liability for our operating lease are as follows as of September 30, 2023: September 30, (in thousands) 2023 2023, remainder $ 59 2024 223 2025 255 2026 262 2027 270 2028 161 Total undiscounted lease payments 1,230 Less: imputed interest (144) Present value of lease liability $ 1,086 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 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, 2022 3,756,835 $ 8.28 $ 36,616 Granted 1,086,876 14.06 Cancelled / Forfeited (264,160) 10.42 Exercised (115,455) 4.50 Balance as of September 30, 2023 4,464,096 $ 9.66 $ 37,331 Options exercisable as of September 30, 2023 2,311,211 $ 7.05 $ 25,374 |
Recognized Stock-Based Compensation Expense | The following table presents the components and classification of stock-based compensation expense for the periods indicated: Three Months Ended Nine months ended September 30, September 30, (in thousands) 2023 2022 2023 2022 Stock options $ 1,419 $ 866 $ 4,403 $ 2,657 Employee Stock Purchase Plan 113 63 310 165 Total stock-based compensation expense $ 1,532 $ 929 $ 4,713 $ 2,822 Selling, general & administrative $ 1,290 $ 785 $ 3,728 $ 2,402 Research & development 221 132 927 367 Cost of goods sold 21 12 58 53 $ 1,532 $ 929 $ 4,713 $ 2,822 |
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 nine months ended September 30, 2023 and 2022: September 30, 2023 2022 Weighted average fair value per ESPP purchase right $ 9.01 $ 2.85 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 % |
Stock options | |
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 nine months ended September 30, 2023 and 2022: September 30, 2023 2022 Weighted average fair value of options granted $ 10.59 $ 4.56 Expected term (in years) — non-officer employees 5.5 to 6.1 5.5 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 58.6 % Expected dividend yield — % — % Risk-free interest rate 3.40% to 4.61 % 1.75% to 3.97 % |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 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): Three Months Ended Nine months ended September 30, September 30, 2023 2022 2023 2022 Numerator: Net loss $ (9,011) $ (9,830) $ (32,036) $ (30,892) Denominator: Weighted average common shares outstanding — basic and diluted 20,801,350 20,576,838 20,730,024 20,512,254 Net loss per share attributable to common stockholders — basic and diluted $ (0.43) $ (0.48) $ (1.55) $ (1.51) |
Antidilutive Securities Excluded from Computation of Earnings Per Share | Nine months ended September 30, 2023 2022 Options to purchase common stock 4,464,096 3,723,499 Warrants to purchase common stock 716,131 716,131 5,180,227 4,439,630 |
Segment, Geographic Informati_2
Segment, Geographic Information and Revenue Disaggregation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Segment, Geographic Information and Revenue Disaggregation [Abstract] | |
Schedule of Segment Reporting | The Company derives all its 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 (in thousands): Three months ended Nine months ended September 30, September 30, 2023 2022 2023 2022 U.S. $ 9,579 $ 5,039 $ 24,818 $ 12,035 Germany 802 933 2,819 2,744 Other countries 130 214 353 514 $ 10,511 $ 6,186 $ 27,990 $ 15,293 |
Selected Balance Sheet Inform_3
Selected Balance Sheet Information (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information [Abstract] | ||
Raw material | $ 4,875 | $ 2,390 |
Work-in-process | 1,173 | 1,033 |
Finished goods | 4,839 | 3,534 |
Total inventory | $ 10,887 | $ 6,957 |
Selected Balance Sheet Inform_4
Selected Balance Sheet Information (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,382 | $ 3,978 |
Less: Accumulated depreciation and amortization | 2,659 | 2,280 |
Property and equipment, net | $ 1,723 | 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 | 2,685 | 2,684 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 772 | 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 | $ 425 | $ 231 |
Selected Balance Sheet Inform_5
Selected Balance Sheet Information (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Selected Balance Sheet Information [Abstract] | ||||
Depreciation | $ 137 | $ 127 | $ 393 | $ 284 |
Selected Balance Sheet Inform_6
Selected Balance Sheet Information (Schedule of Accrued Expenses) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Selected Balance Sheet Information [Abstract] | ||
Bonuses | $ 2,366 | $ 2,303 |
Paid time off | 1,212 | 960 |
Clinical trial and other professional fees | 892 | 1,733 |
Customer rebates | 382 | 256 |
Employee stock purchase plan | 280 | |
Operating lease liability, current portion | 170 | 222 |
Taxes | 103 | 120 |
Other | 869 | 775 |
Total accrued expenses | $ 6,274 | $ 6,369 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) $ in Thousands | 9 Months Ended | |||||
Mar. 15, 2023 USD ($) | Mar. 13, 2023 USD ($) | Mar. 10, 2023 USD ($) | Oct. 31, 2022 USD ($) item | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Debt Instrument [Line Items] | ||||||
Proceeds from debt financing | $ 7,500 | $ 0 | ||||
Loan and Security Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 50,000 | |||||
Proceeds from debt financing | $ 3,500 | $ 4,000 | $ 7,500 | $ 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 | $ 700 | |||||
Percentage of final payment on original principal | 4.50% | |||||
Debt issuance costs and discounts | $ 800 | |||||
Loan and Security Agreement | Draw down from September 1, 2023 to December 15, 2023 | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from debt financing | 30,000 | |||||
Three months of trailing revenue | 5,750 | |||||
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 | Sep. 30, 2023 | Dec. 31, 2022 |
Long-Term Debt, Fiscal Year Maturity [Abstract] | ||
2027 | $ 10,000 | |
2028 | 5,000 | |
Total | 15,000 | |
Less: Unamortized debt costs and discounts | (706) | |
Long-term debt | $ 14,294 | $ 6,747 |
Leases (Details)
Leases (Details) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2023 USD ($) ft² | Sep. 30, 2022 USD ($) | Apr. 21, 2023 | Dec. 31, 2022 USD ($) | |
Right-of-use assets: | ||||
Operating lease right-of-use asset | $ 1,058 | $ 334 | ||
Operating lease liabilities: | ||||
Accrued expenses | $ 170 | $ 222 | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses | Accrued expenses | ||
Operating lease liability, non-current portion | $ 916 | $ 117 | ||
Present value of lease liability | $ 1,086 | $ 339 | ||
Remaining lease term | 4 years 10 months 24 days | |||
Discount rate | 5% | |||
Operating cash outflows | $ 300 | $ 300 | ||
Office space in Minneapolis, Minnesota | ||||
Lessee, Lease, Description [Line Items] | ||||
Area of land leased | ft² | 23,890 | |||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |||
Lessee, Operating Lease, Renewal Term | 3 years | 49 months |
Leases (Maturities of lease lia
Leases (Maturities of lease liability) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2023, remainder | $ 59 | |
2024 | 223 | |
2025 | 255 | |
2026 | 262 | |
2027 | 270 | |
2028 | 161 | |
Total undiscounted lease payments | 1,230 | |
Less: imputed interest | (144) | |
Present value of lease liability | $ 1,086 | $ 339 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) - Warrants to purchase common stock | 9 Months Ended |
Sep. 30, 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 | 9 Months Ended | |||
Jul. 02, 2021 | Jun. 30, 2001 | Sep. 30, 2023 | Sep. 30, 2022 | Jan. 01, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expected dividend yield | 0% | ||||
Proceeds from Employee Stock Purchase Plan | $ 452 | $ 295 | |||
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 | 278,170 | 206,637 | |||
Number of shares available for grant | 540,489 | ||||
Shares issued/purchased under ESPP | 34,421 | ||||
Annual incremental percentage | 1% | ||||
Minimum Percentage | 85% | ||||
Expected dividend yield | 0% | 0% | |||
Proceeds from Employee Stock Purchase Plan | $ 500 | ||||
2021 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Reserved for future issuance | 1,854,490 | 1,724,683 | 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 | ||||
Options to purchase common stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expected dividend yield | 0% | 0% | |||
Options to purchase common stock | 2001 Plan | |||||
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) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | |
Number of Options | ||
Outstanding as of Beginning of period (in shares) | 3,756,835 | |
Granted (in shares) | 1,086,876 | |
Cancelled / Forfeited (in shares) | (264,160) | |
Exercised (in shares) | (115,455) | |
Balance as of End of period (in shares) | 4,464,096 | |
Options exercisable as of June 30, 2023 (in shares) | 2,311,211 | |
Weighted Average Exercise Price | ||
Outstanding as of Beginning of period (in dollars per share) | $ / shares | $ 8.28 | |
Granted (in dollars per share) | $ / shares | 14.06 | |
Cancelled / Forfeited (in dollars per share) | $ / shares | 10.42 | |
Exercised (in dollars per share) | $ / shares | 4.50 | |
Balance as of End of period (in dollars per share) | $ / shares | 9.66 | |
Options exercisable as of June 30, 2023 (in dollars per share) | $ / shares | $ 7.05 | |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value | $ | $ 37,331 | $ 36,616 |
Options exercisable as of June 30, 2023 | $ | $ 25,374 | |
Weighted average remaining contractual term, outstanding (in years) | 7 years 6 months | |
Weighted average remaining contractual life, exercisable (in years) | 6 years 4 months 24 days | |
Options not granted under the 2001 or 2021 Plans | ||
Number of Options | ||
Balance as of End of period (in shares) | 8,796 |
Stock-Based Compensation (Assum
Stock-Based Compensation (Assumptions Used in Determine the Grant Date Fair Value of Stock Options) (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted | $ 10.59 | $ 4.56 |
Expected volatility, Minimum | 77.20% | 56.30% |
Expected volatility, Maximum | 79.60% | 58.60% |
Expected dividend yield | 0% | 0% |
Risk-free interest rate, Minimum | 3.40% | 1.75% |
Risk-free interest rate, Maximum | 4.61% | 3.97% |
ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted | $ 9.01 | $ 2.85 |
Expected term (in years) | 6 months | 6 months |
Expected volatility, Minimum | 76.20% | 51.30% |
Expected volatility, Maximum | 84.60% | 62.90% |
Expected dividend yield | 0% | 0% |
Risk-free interest rate, Minimum | 4.77% | 0.22% |
Risk-free interest rate, Maximum | 5.53% | 2.52% |
Non officer employees | Stock options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 6 months |
Non officer employees | Stock options | 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 | Stock options | 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 | Stock options | 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 1,532 | $ 929 | $ 4,713 | $ 2,822 |
Unrecognized compensation expense | 14,100 | $ 14,100 | ||
Weighted average period | 2 years 6 months | |||
Stock options | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 1,419 | 866 | $ 4,403 | 2,657 |
ESPP | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 113 | 63 | 310 | 165 |
Selling, general & administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 1,290 | 785 | 3,728 | 2,402 |
Research & development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 221 | 132 | 927 | 367 |
Cost of goods sold | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 21 | $ 12 | $ 58 | $ 53 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | |||||
Income tax expense | $ 40,000 | $ 32,000 | $ 108,000 | $ 81,000 | |
Federal | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating loss carryforwards | $ 361,000,000 | ||||
Tax credit carryforwards | 9,300,000 | ||||
State | |||||
Operating Loss Carryforwards [Line Items] | |||||
Operating loss carryforwards | 6,200,000 | ||||
Tax credit carryforwards | $ 1,800,000 |
Loss Per Share (Basic and Dilut
Loss Per Share (Basic and Diluted Net Loss per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||
Net loss | $ (9,011) | $ (9,830) | $ (32,036) | $ (30,892) |
Denominator: | ||||
Weighted average common shares outstanding - basic | 20,801,350 | 20,576,838 | 20,730,024 | 20,512,254 |
Weighted average common shares outstanding - diluted | 20,801,350 | 20,576,838 | 20,730,024 | 20,512,254 |
Net loss per share attributable to common stockholders - basic | $ (0.43) | $ (0.48) | $ (1.55) | $ (1.51) |
Net loss per share attributable to common stockholders - diluted | $ (0.43) | $ (0.48) | $ (1.55) | $ (1.51) |
Loss Per Share (Antidilutive Se
Loss Per Share (Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 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 | 5,180,227 | 4,439,630 |
Options 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 | 4,464,096 | 3,723,499 |
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 | Sep. 30, 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | |
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 10,511 | $ 6,186 | $ 27,990 | $ 15,293 |
Number of segments | segment | 1 | |||
U.S. | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 9,579 | 5,039 | $ 24,818 | 12,035 |
Germany | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 802 | 933 | 2,819 | 2,744 |
Other countries | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 130 | $ 214 | $ 353 | $ 514 |