☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 45-1306615 | |||||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||
2210 Faraday Ave., Suite 100, Carlsbad, CA | 92008 | |||||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
Common Stock, par value | AFIB | The Nasdaq Stock Market LLC |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||||||||||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||||||||||||
Emerging growth company | ☒ |
Class of Common Stock | Outstanding Shares as of August 2, 2023 | |||||||||||
29,259,086 |
Page | ||||||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
(in thousands, except share and per share amounts) | (unaudited) | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 23,055 | $ | 25,584 | |||||||
Marketable securities, short-term | 31,461 | 44,863 | |||||||||
Restricted cash, short-term | 7,002 | 5,764 | |||||||||
Accounts receivable | 7,670 | 21,085 | |||||||||
Inventory | 15,671 | 13,327 | |||||||||
Employer retention credit receivable | — | 4,703 | |||||||||
Prepaid expenses and other current assets | 2,444 | 2,541 | |||||||||
Total current assets | 87,303 | 117,867 | |||||||||
Property and equipment, net | 7,245 | 9,221 | |||||||||
Right-of-use assets, net | 3,533 | 3,872 | |||||||||
Intangible assets, net | 1,483 | 1,583 | |||||||||
Other assets | 731 | 897 | |||||||||
Total assets | $ | 100,295 | $ | 133,440 | |||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 5,492 | $ | 4,721 | |||||||
Accrued liabilities | 9,759 | 9,686 | |||||||||
Contingent consideration, short-term | — | 1,800 | |||||||||
Operating lease liabilities, short-term | 466 | 319 | |||||||||
Warrant liability | 2,504 | 3,346 | |||||||||
Total current liabilities | 18,221 | 19,872 | |||||||||
Operating lease liabilities, long-term | 3,679 | 4,103 | |||||||||
Long-term debt | 34,634 | 34,434 | |||||||||
Other long-term liabilities | 20 | 12 | |||||||||
Total liabilities | 56,554 | 58,421 | |||||||||
Commitments and contingencies (Note 12) | |||||||||||
Stockholders' equity | |||||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 6,666 shares of the preferred stock, designated as Series A Common Equivalent Preferred Stock, are issued and outstanding as of June 30, 2023 and December 31, 2022 | — | — | |||||||||
Common stock, $0.001 par value; 260,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 29,206,570 and 28,554,656 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | 29 | 29 | |||||||||
Additional paid-in capital | 597,578 | 594,173 | |||||||||
Accumulated deficit | (552,975) | (518,314) | |||||||||
Accumulated other comprehensive loss | (891) | (869) | |||||||||
Total stockholders' equity | 43,741 | 75,019 | |||||||||
Total liabilities and stockholders' equity | $ | 100,295 | $ | 133,440 |
June 30, 2020 | December 31, 2019 | |||||||
(unaudited) | ||||||||
ASSETS: | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 24,295 | $ | 9,452 | ||||
Marketable securities | 5,037 | 62,351 | ||||||
Restricted cash | 150 | 150 | ||||||
Accounts receivable | 860 | 263 | ||||||
Inventory | 12,266 | 8,424 | ||||||
Deferred offering costs | 2,506 | — | ||||||
Prepaid expenses and other current assets | 1,323 | 1,816 | ||||||
Total current assets | 46,437 | 82,456 | ||||||
Property and equipment, net | 7,584 | 4,427 | ||||||
Right-of-use asset, net | 2,005 | 2,341 | ||||||
Intangible assets, net | 3,890 | 4,110 | ||||||
Goodwill | 12,026 | 12,026 | ||||||
Other assets | 87 | 95 | ||||||
Total assets | $ | 72,029 | $ | 105,455 | ||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 9,084 | $ | 3,882 | ||||
Accrued liabilities | 7,036 | 10,076 | ||||||
Contingent consideration, short-term | 3,500 | 8,200 | ||||||
Operating lease liabilities, short-term | 882 | 833 | ||||||
Common and preferred stock warrant liability | 10,791 | 8,919 | ||||||
Total current liabilities | 31,293 | 31,910 | ||||||
Operating lease liabilities, long-term | 1,594 | 2,054 | ||||||
Long-term debt | 38,558 | 38,244 | ||||||
Contingent consideration, long-term | 4,000 | 5,700 | ||||||
Total liabilities | 75,445 | 77,908 | ||||||
Commitments and contingencies (Note 11) | ||||||||
C onvertible preferred stock | ||||||||
Series A convertible preferred stock, $0.001 par value; 3,848,696 shares authorized as of each of June 30, 2020 and December 31, 2019; 391,210 shares issued and outstanding as of each of June 30, 2020 and December 31, 2019; liquidation preference of $3,245 as of each of June 30, 2020 and December 31, 2019 | 3,059 | 3,059 | ||||||
Series B convertible preferred stock, $0.001 par value; 30,032,100 shares authorized as of each of June 30, 2020 December 31, 2019; 3,088,444 shares issued and outstanding as of each of June 30, 2020 and December 31, 2019; liquidation preference of $41,294 as of each of June 30, 2020 and December 31, 2019 | 40,685 | 40,685 | ||||||
Series C convertible preferred stock, $0.001 par value; 48,184,000 shares authorized as of each of June 30, 2020 and December 31, 2019; 4,499,921 shares issued and outstanding as of each of June 30, 2020 and December 31, 2019; liquidation preference of $75,000 as of each of June 30, 2020 and December 31, 2019 | 74,575 | 74,575 | ||||||
Series D convertible preferred stock, $0.001 par value; 90,000,000 shares authorized as of each of June 30, 2020 and December 31, 2019; 8,593,360 and 8,200,297 issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation preference of $157,348 and $136,675 as of June 30, 2020 and December 31, 2019, respectively | 142,236 | 135,039 | ||||||
Stockholders’ deficit | ||||||||
Common stock, $0.001 par value; 260,000,000 shares authorized as of each of June 30, 2020 and December 31, 2019; 775,403 and 695,902 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 1 | 1 | ||||||
Additional paid-in capital | 36,355 | 33,252 | ||||||
Accumulated deficit | (300,325 | ) | (259,034 | ) | ||||
Accumulated other comprehensive loss | (2 | ) | (30 | ) | ||||
Total stockholders’ deficit | (263,971 | ) | (225,811 | ) | ||||
Total liabilities, convertible preferred stock and stockholders’ deficit | $ | 72,029 | $ | 105,455 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||
(in thousands, except share and per share amounts) | (unaudited) | |||||||||||||||||||||||||
Revenue | $ | 5,289 | $ | 4,076 | $ | 9,458 | $ | 7,757 | ||||||||||||||||||
Cost of products sold | 8,063 | 9,697 | $ | 14,852 | $ | 16,638 | ||||||||||||||||||||
Gross profit | (2,774) | (5,621) | $ | (5,394) | $ | (8,881) | ||||||||||||||||||||
Operating expenses (income): | ||||||||||||||||||||||||||
Research and development | 6,799 | 7,935 | 12,916 | 15,938 | ||||||||||||||||||||||
Selling, general and administrative | 9,284 | 14,143 | 18,849 | 28,528 | ||||||||||||||||||||||
Goodwill impairment | — | — | — | 12,026 | ||||||||||||||||||||||
Restructuring | 463 | — | 475 | 949 | ||||||||||||||||||||||
Change in fair value of contingent consideration | (77) | 948 | 123 | 955 | ||||||||||||||||||||||
Gain on sale of business | (2,072) | (43,575) | (3,279) | (43,575) | ||||||||||||||||||||||
Total operating expenses (income) | 14,397 | (20,549) | 29,084 | 14,821 | ||||||||||||||||||||||
Income (loss) from operations | (17,171) | 14,928 | (34,478) | (23,702) | ||||||||||||||||||||||
Other income (expense): | ||||||||||||||||||||||||||
Loss on debt extinguishment | — | (7,947) | — | (7,947) | ||||||||||||||||||||||
Change in fair value of warrant liability | (604) | — | 842 | — | ||||||||||||||||||||||
Interest income | 824 | 27 | 1,676 | 51 | ||||||||||||||||||||||
Interest expense | (1,395) | (1,290) | (2,701) | (2,701) | ||||||||||||||||||||||
Total other expense, net | (1,175) | (9,210) | (183) | (10,597) | ||||||||||||||||||||||
(Loss) income before income taxes | (18,346) | 5,718 | (34,661) | (34,299) | ||||||||||||||||||||||
Income tax benefit | — | — | — | — | ||||||||||||||||||||||
Net (loss) income | $ | (18,346) | $ | 5,718 | $ | (34,661) | $ | (34,299) | ||||||||||||||||||
Other comprehensive income (loss) | ||||||||||||||||||||||||||
Unrealized gain (loss) on marketable securities | (8) | 18 | 4 | (39) | ||||||||||||||||||||||
Foreign currency translation adjustment | (85) | (387) | (26) | (553) | ||||||||||||||||||||||
Comprehensive income (loss) | $ | (18,439) | $ | 5,349 | $ | (34,683) | $ | (34,891) | ||||||||||||||||||
Basic net income (loss) per common share | $ | (0.63) | $ | 0.16 | $ | (1.20) | $ | (1.22) | ||||||||||||||||||
Diluted net income (loss) per common share | $ | (0.63) | $ | 0.16 | $ | (1.20) | $ | (1.22) | ||||||||||||||||||
Basic weighted average shares outstanding | 29,039,732 | 28,339,362 | 28,902,808 | 28,229,338 | ||||||||||||||||||||||
Diluted weighted average shares outstanding | 29,039,732 | 28,349,429 | 28,902,808 | 28,229,338 | ||||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenue | $ | 1,134 | $ | 734 | $ | 2,717 | $ | 1,521 | ||||||||
Costs and operating expenses: | ||||||||||||||||
Cost of products sold | 2,663 | 2,435 | 5,857 | 4,611 | ||||||||||||
Research and development | 8,176 | 5,247 | 16,149 | 9,624 | ||||||||||||
Selling, general and administrative | 9,125 | 6,927 | 19,360 | 11,020 | ||||||||||||
Change in fair value of contingent consideration | 635 | — | (1,584 | ) | — | |||||||||||
Total costs and operating expenses | 20,599 | 14,609 | 39,782 | 25,255 | ||||||||||||
Loss from operations | (19,465 | ) | (13,875 | ) | (37,065 | ) | (23,734 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Change in fair value of warrant liability and embedded derivative | (2,453 | ) | (1,446 | ) | (1,872 | ) | (605 | ) | ||||||||
Loss on debt extinguishment | — | (1,398 | ) | — | (1,398 | ) | ||||||||||
Interest income | 95 | 143 | 370 | 208 | ||||||||||||
Interest expense | (1,370 | ) | (13,769 | ) | (2,724 | ) | (19,511 | ) | ||||||||
Total other expense, net | (3,728 | ) | (16,470 | ) | (4,226 | ) | (21,306 | ) | ||||||||
Net loss | $ | (23,193 | ) | $ | (30,345 | ) | $ | (41,291 | ) | $ | (45,040 | ) | ||||
Other comprehensive income (loss) | ||||||||||||||||
Unrealized (loss) gain on marketable securities | (14 | ) | 6 | (41 | ) | 7 | ||||||||||
Foreign currency translation adjustment | 96 | 2 | 69 | (12 | ) | |||||||||||
Comprehensive loss | $ | (23,111 | ) | $ | (30,337 | ) | $ | (41,263 | ) | $ | (45,045 | ) | ||||
Net loss per common share, basic and diluted | $ | (32.24 | ) | $ | (45.70 | ) | $ | (58.16 | ) | $ | (68.21 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 719,421 | 663,972 | 709,961 | 660,333 | ||||||||||||
(in thousands, except share amounts) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders' Equity | |||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2023 | 6,666 | $ | — | 28,894,080 | $ | 29 | $ | 595,864 | $ | (534,629) | $ | (798) | $ | 60,466 | |||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | (8) | (8) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (85) | (85) | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | 267,328 | — | 1,689 | — | — | 1,689 | |||||||||||||||||||||||||||||||||||||||
Employee stock purchase plan shares issued | — | — | 45,162 | — | 25 | — | — | 25 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | (18,346) | — | (18,346) | |||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2023 (unaudited) | 6,666 | $ | — | 29,206,570 | $ | 29 | $ | 597,578 | $ | (552,975) | $ | (891) | $ | 43,741 |
Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock | Series D Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2020 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 8,593,360 | $ | 142,236 | 710,841 | $ | 1 | $ | 34,993 | $ | (277,132 | ) | $ | (84 | ) | $ | (242,222 | ) | ||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | — | — | (14 | ) | (14 | ) | ||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | — | — | — | — | — | — | 96 | 96 | ||||||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | — | — | — | — | — | — | 64,562 | — | 205 | — | — | 205 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | — | — | 1,157 | — | — | 1,157 | ||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | — | (23,193 | ) | — | (23,193 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2020 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 8,593,360 | $ | 142,236 | 775,403 | $ | 1 | $ | 36,355 | $ | (300,325 | ) | $ | (2) | $ | (263,971 | ) | |||||||||||||||||||||||||||||||
(in thousands, except share amounts) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders' Equity | |||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2022 | 6,666 | $ | — | 28,279,065 | $ | 28 | $ | 587,889 | $ | (518,715) | $ | (440) | $ | 68,762 | |||||||||||||||||||||||||||||||||
Unrealized gain on marketable securities | — | — | — | — | — | — | 18 | 18 | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (387) | (387) | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | 70,135 | — | 2,540 | — | — | 2,540 | |||||||||||||||||||||||||||||||||||||||
Net income | — | — | — | — | — | 5,718 | — | 5,718 | |||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2022 (unaudited) | 6,666 | $ | — | 28,349,200 | $ | 28 | $ | 590,429 | $ | (512,997) | $ | (809) | $ | 76,651 | |||||||||||||||||||||||||||||||||
Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock | Series D Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||
Balance as of March 31, 2019 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | — | $ | — | 656,654 | $ | 1 | $ | 30,709 | $ | (176,690 | ) | $ | 7 | $ | (145,973 | ) | |||||||||||||||||||||||||||||||
Unrealized gain on marketable securities | — | — | — | — | — | — | — | — | — | — | — | — | 6 | 6 | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | — | — | — | — | — | — | 2 | 2 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for cash, net of issuance costs of $274 | — | — | — | — | — | — | 2,309,959 | 38,226 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for 2018 Convertible Notes and 2019 Convertible Notes | — | — | — | — | — | — | 4,108,478 | 68,476 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 6,837 | — | 803 | — | — | 803 | ||||||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | — | — | — | — | — | — | 8,469 | — | 57 | — | — | 57 | ||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | — | (30,345 | ) | — | (30,345 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2019 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 6,418,437 | $ | 106,702 | 671,960 | $ | 1 | $ | 31,569 | $ | (207,035 | ) | $ | 15 | $ | (175,450 | ) | |||||||||||||||||||||||||||||||
(in thousands, except share amounts) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders' Equity | |||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2022 | 6,666 | $ | — | 28,554,656 | $ | 29 | $ | 594,173 | $ | (518,314) | $ | (869) | $ | 75,019 | |||||||||||||||||||||||||||||||||
Unrealized gain on marketable securities | — | — | — | — | — | — | 4 | 4 | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (26) | (26) | |||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | 3,218 | — | 4 | — | — | 4 | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | 603,534 | — | 3,376 | — | — | 3,376 | |||||||||||||||||||||||||||||||||||||||
Employee stock purchase plan shares issued | — | — | 45,162 | — | 25 | — | — | 25 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | (34,661) | — | (34,661) | |||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2023 (unaudited) | 6,666 | $ | — | 29,206,570 | $ | 29 | $ | 597,578 | $ | (552,975) | $ | (891) | $ | 43,741 |
Series A | Series B | Series C | Series D | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||
Convertible Preferred Stock | Convertible Preferred Stock | Convertible Preferred Stock | Convertible Preferred Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2019 | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 8,200,297 | $ | 135,039 | 695,902 | $ | 1 | $ | 33,252 | $ | (259,034) | $ | (30) | $ | (225,811) | |||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | — | — | — | — | — | — | (41 | ) | (41 | ) | ||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | — | — | — | — | — | — | 69 | 69 | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for the Biotronik Asset Purchase | — | — | — | — | — | — | 273,070 | 5,000 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for the contingent consideration related to the Rhythm Xience Acquisition | — | — | — | — | — | — | 119,993 | 2,197 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | — | — | — | — | — | — | 64,562 | — | 205 | — | — | 205 | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 14,939 | — | 2,898 | — | — | 2,898 | ||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | — | (41,291 | ) | — | (41,291 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2020 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 8,593,360 | $ | 142,236 | 775,403 | $ | 1 | $ | 36,355 | $ | (300,325) | $ | (2) | $ | (263,971 | ) | ||||||||||||||||||||||||||||||||
(in thousands, except share amounts) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total Stockholders' Equity | |||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2021 | 6,666 | $ | — | 27,957,223 | $ | 28 | $ | 584,613 | $ | (478,698) | $ | (217) | $ | 105,726 | |||||||||||||||||||||||||||||||||
Unrealized loss on marketable securities | — | — | — | — | — | — | (39) | (39) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | (553) | (553) | |||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | 35,478 | — | 66 | — | — | 66 | |||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | 262,273 | — | 5,568 | — | — | 5,568 | |||||||||||||||||||||||||||||||||||||||
Employee stock purchase plan shares issued | — | — | 94,226 | — | 182 | — | — | 182 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | (34,299) | — | (34,299) | |||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2022 (unaudited) | 6,666 | $ | — | 28,349,200 | $ | 28 | $ | 590,429 | $ | (512,997) | $ | (809) | $ | 76,651 | |||||||||||||||||||||||||||||||||
Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock | Series D Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders’ Deficit | ||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||
Balance as of December 31, 2018 | 388,558 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | — | $ | — | 656,654 | $ | 1 | $ | 30,150 | $ | (161,995) | $ | 20 | $ | (131,824) | |||||||||||||||||||||||||||||||||
Unrealized gain on marketable securities | — | — | — | — | — | — | — | — | — | — | — | — | 7 | 7 | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | — | — | — | — | — | — | — | (12 | ) | (12 | ) | ||||||||||||||||||||||||||||||||||||||||
Issuance of Series A preferred stock for cashless warrant exercise | 2,652 | — | — | — | — | — | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for cash, net of issuance costs of $274 | — | — | — | — | — | — | 2,309,959 | 38,226 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Issuance of Series D convertible preferred stock for 2018 Convertible Notes and 2019 Convertible Notes | — | — | — | — | — | — | 4,108,478 | 68,476 | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | — | — | — | — | — | — | — | — | 6,837 | — | 1,362 | — | — | 1,362 | ||||||||||||||||||||||||||||||||||||||||||
Stock option exercises | — | — | — | — | — | — | — | — | 8,469 | — | 57 | — | — | 57 | ||||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | — | (45,040 | ) | — | (45,040 | ) | ||||||||||||||||||||||||||||||||||||||||
Balance as of June 30, 2019 (unaudited) | 391,210 | $ | 3,059 | 3,088,444 | $ | 40,685 | 4,499,921 | $ | 74,575 | 6,418,437 | $ | 106,702 | 671,960 | $ | 1 | $ | 31,569 | $ | (207,035) | $ | 15 | $ | (175,450) | |||||||||||||||||||||||||||||||||
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(in thousands) | (unaudited) | ||||||||||
Cash flows from operating activities | |||||||||||
Net loss | $ | (34,661) | $ | (34,299) | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation expense | 2,473 | 3,145 | |||||||||
AcQMap Systems converted to sales | 238 | 110 | |||||||||
Sales-type lease gain | (310) | (57) | |||||||||
Amortization of intangible assets | 100 | 320 | |||||||||
Non-cash stock-based compensation expense | 3,639 | 5,613 | |||||||||
(Accretion of discounts) amortization of premiums on marketable securities, net | (1,037) | 264 | |||||||||
Amortization of debt issuance costs | 212 | 641 | |||||||||
Amortization of operating lease right-of-use assets | 339 | 321 | |||||||||
Loss on debt extinguishment | — | 7,947 | |||||||||
Goodwill impairment | — | 12,026 | |||||||||
Gain on sale of business, net | (3,279) | (43,575) | |||||||||
Direct costs paid related to sale of business | — | (2,488) | |||||||||
Change in fair value of warrant liability | (842) | — | |||||||||
Loss on disposal of property and equipment | 277 | — | |||||||||
Change in fair value of contingent consideration | 123 | 955 | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | (204) | 1,037 | |||||||||
Inventory | (2,344) | 1,101 | |||||||||
Employer retention credit receivable | 4,703 | — | |||||||||
Prepaid expenses and other current assets | 432 | (3,592) | |||||||||
Other assets | 452 | 223 | |||||||||
Accounts payable | 824 | 236 | |||||||||
Accrued liabilities | (1,963) | (386) | |||||||||
Operating lease liabilities | (277) | (203) | |||||||||
Other long-term liabilities | 8 | (45) | |||||||||
Net cash used in operating activities | (31,097) | (50,706) | |||||||||
Cash flows from investing activities | |||||||||||
Proceeds from sale of business | 17,000 | 50,000 | |||||||||
Purchases of available-for-sale marketable securities | (33,880) | — | |||||||||
Sales of available-for-sale marketable securities | — | 13,099 | |||||||||
Maturities of available-for-sale marketable securities | 48,250 | 27,787 | |||||||||
Purchases of property and equipment | (984) | (1,718) | |||||||||
Net cash provided by investing activities | 30,386 | 89,168 | |||||||||
Cash flows from financing activities | |||||||||||
Repayment of debt | — | (44,550) | |||||||||
Penalty fees paid for early prepayment of debt | — | (1,074) | |||||||||
Borrowing under new debt | — | 35,000 | |||||||||
Payment of debt issuance costs | — | (624) | |||||||||
Proceeds from the exercise of stock options | 4 | 66 | |||||||||
Repurchase of common shares to pay employee withholding taxes | (263) | (45) | |||||||||
Proceeds from employee stock purchase plan | 25 | 182 | |||||||||
Payment of contingent consideration | — | (598) | |||||||||
Net cash used in financing activities | (234) | (11,643) | |||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (346) | (323) | |||||||||
Net change in cash, cash equivalents and restricted cash | (1,291) | 26,496 | |||||||||
Cash, cash equivalents and restricted cash, at the beginning of the period | 31,348 | 24,221 | |||||||||
Cash, cash equivalents and restricted cash, at the end of the period | $ | 30,057 | $ | 50,717 | |||||||
Supplemental disclosure of cash flow information: | |||||||||||
Cash paid for interest | $ | 2,458 | $ | 2,073 |
Supplemental disclosure of noncash investing and financing activities: | |||||||||||
Accounts receivable from sale of business | $ | 3,381 | $ | — | |||||||
Change in unrealized (gain) loss on marketable securities | $ | (4) | $ | 39 | |||||||
Change in unpaid purchases of property and equipment | $ | (54) | $ | 42 | |||||||
Contingent consideration escrow release | $ | — | $ | 157 | |||||||
Net book value on AcQMap system sales-type leases | $ | 238 | $ | 110 | |||||||
Amount of debt proceeds allocated to warrant liability | $ | — | $ | 3,379 | |||||||
Unpaid transaction costs from sale of business | $ | — | $ | 429 | |||||||
Unpaid debt issuance costs | $ | — | $ | 177 | |||||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (41,291 | ) | $ | (45,040 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation expense | 978 | 1,142 | ||||||
Amortization of intangible assets | 220 | — | ||||||
Stock-based compensation expense | 2,898 | 1,362 | ||||||
Accretion of discounts/(amortization of premiums) on marketable securities, net | 5 | (19 | ) | |||||
Amortization of debt issuance costs | 314 | 17,309 | ||||||
Amortization of right-of-use | 336 | 312 | ||||||
Loss on debt extinguishment | — | 1,398 | ||||||
Change in fair value of warrant liability and embedded derivative | 1,872 | 605 | ||||||
Change in fair value of contingent consideration | (1,584 | ) | — | |||||
Changes in operating assets and liabilities, net of effect from business combination: | ||||||||
Accounts receivable | (597 | ) | (280 | ) | ||||
Inventory | (3,616 | ) | (1,961 | ) | ||||
Prepaid expenses and other current assets | 666 | (43 | ) | |||||
Other assets | 8 | (12 | ) | |||||
Accounts payable | 5,286 | 1,682 | ||||||
Accrued liabilities | 155 | 1,810 | ||||||
Operating lease liabilities | (411 | ) | (349 | ) | ||||
Net cash used in operating activities | (34,761 | ) | (22,084 | ) | ||||
Cash flows from investing activities | ||||||||
Purchases of available-for-sale | — | (22,208 | ) | |||||
Sales of available-for-sale | 17,095 | — | ||||||
Maturities of available-for-sale | 40,000 | 8,100 | ||||||
Purchases of property and equipment | (4,445 | ) | (316 | ) | ||||
Cash paid, net of cash acquired for the Rhythm Xience Acquisition | — | (3,000 | ) | |||||
Net cash provided by (used in) investing activities | 52,650 | (17,424 | ) | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of debt and warrants | — | 77,000 | ||||||
Repayment of debt | — | (15,000 | ) | |||||
Payment of issuance and extinguishment costs related to debt | — | (2,332 | ) | |||||
Payment of contingent consideration | (2,619 | ) | — | |||||
Proceeds from issuance of convertible preferred stock, net of issuance costs | — | 38,226 | ||||||
Payment of deferred offering costs | (701 | ) | — | |||||
Proceeds from stock options exercises | 205 | 57 | ||||||
Net cash (used in) provided by financing activities | (3,115 | ) | 97,951 | |||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 69 | (12 | ) | |||||
Net change in cash, cash equivalents and restricted cash | 14,843 | 58,431 | ||||||
Cash, cash equivalents and restricted cash, at the beginning of the period | 9,602 | 9,775 | ||||||
Cash, cash equivalents and restricted cash, at the end of the period | $ | 24,445 | $ | 68,206 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Cash paid for income taxes | $ | — | $ | — | ||||
Cash paid for interest | $ | 2,376 | $ | 1,168 | ||||
Supplemental disclosure of noncash investing and financing activities: | ||||||||
Issuance of Series D convertible preferred stock for 2018 Convertible Notes and 2019 Convertible Notes | $ | — | $ | 68,476 | ||||
Issuance of Series D convertible preferred stock for Biotronik asset purchase | $ | 5,000 | $ | — | ||||
Issuance of Series D convertible preferred stock for Rhythm Xience Acquisition | $ | 2,197 | $ | — | ||||
Change in unrealized (gain) loss on marketable securities | $ | 41 | $ | (7 | ) | |||
Warrants issued in conjunction with OrbiMed debt | $ | — | $ | 872 | ||||
Right-of-use | $ | — | $ | 2,978 | ||||
Unpaid purchases of property and equipment | $ | 55 | $ | 77 | ||||
Unpaid deferred offering costs | $ | 1,805 | $ | — |
June 30, 2023 | December 31, 2022 | ||||||||||
(unaudited) | |||||||||||
Cash and cash equivalents | $ | 23,055 | $ | 25,584 | |||||||
Restricted cash | 7,002 | 5,764 | |||||||||
Total cash, cash equivalents and restricted cash | $ | 30,057 | $ | 31,348 |
June 30, 2020 | December 31, 2019 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 24,295 | $ | 9,452 | ||||
Restricted cash | 150 | 150 | ||||||
Total cash, cash equivalents and restricted cash | $ | 24,445 | $ | 9,602 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Disposables | $ | 1,122 | $ | 730 | $ | 2,179 | $ | 1,512 | ||||||||
Systems | — | — | $ | 520 | — | |||||||||||
Service/Other | 12 | 4 | 18 | 9 | ||||||||||||
Total | $ | 1,134 | $ | 734 | $ | 2,717 | $ | 1,521 | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Disposables | $ | 3,914 | $ | 3,334 | $ | 7,340 | $ | 6,545 | |||||||||||||||
Systems | 691 | 346 | 691 | 346 | |||||||||||||||||||
Service/Other | 684 | 396 | 1,427 | 866 | |||||||||||||||||||
Total revenue | $ | 5,289 | $ | 4,076 | $ | 9,458 | $ | 7,757 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
United States | $ | 3,125 | $ | 2,037 | $ | 5,373 | $ | 4,060 | |||||||||||||||
Outside the United States | 2,164 | 2,039 | 4,085 | 3,697 | |||||||||||||||||||
Total revenue | $ | 5,289 | $ | 4,076 | $ | 9,458 | $ | 7,757 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
United States | $ | 559 | $ | 221 | $ | 1,328 | $ | 456 | ||||||||
Europe | 575 | 513 | 1,389 | 1,065 | ||||||||||||
Total Revenue | $ | 1,134 | $ | 734 | $ | 2,717 | $ | 1,521 | ||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
(unaudited) | |||||||||||
Trade accounts receivable | $ | 4,289 | $ | 4,085 | |||||||
Earnouts receivable from Medtronic | 3,381 | 17,000 | |||||||||
Total accounts receivable | $ | 7,670 | $ | 21,085 |
Fair Value Measurements as of June 30, 2023 | |||||||||||||||||||||||||||||||||||||||
Fair Value Measured at June 30, 2020 (unaudited) | (unaudited) | ||||||||||||||||||||||||||||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Fair Value at June 30, 2020 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | ||||||||||||||||||||||||||||||||
Assets included in: | Assets included in: | ||||||||||||||||||||||||||||||||||||||
Cash and cash equivalents | Cash and cash equivalents | ||||||||||||||||||||||||||||||||||||||
Money market securities | $ | 21,544 | $ | — | $ | — | $ | 21,544 | Money market securities | $ | 20,196 | $ | — | $ | — | $ | 20,196 | ||||||||||||||||||||||
Marketable securities at fair value | Marketable securities at fair value | ||||||||||||||||||||||||||||||||||||||
U.S. treasury securities | — | 5,037 | — | 5,037 | U.S. treasury securities | — | 10,942 | — | 10,942 | ||||||||||||||||||||||||||||||
Commercial paper | Commercial paper | — | 19,265 | — | 19,265 | ||||||||||||||||||||||||||||||||||
Yankee debt securities | Yankee debt securities | — | 1,254 | — | 1,254 | ||||||||||||||||||||||||||||||||||
Total fair value | $ | 21,544 | $ | 5,037 | $ | — | $ | 26,581 | Total fair value | $ | 20,196 | $ | 31,461 | $ | — | $ | 51,657 | ||||||||||||||||||||||
Liabilities included in: | Liabilities included in: | ||||||||||||||||||||||||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 7,500 | $ | 7,500 | |||||||||||||||||||||||||||||||
Common and preferred stock warrant liability | — | — | 10,791 | 10,791 | |||||||||||||||||||||||||||||||||||
Warrant liability | Warrant liability | $ | — | $ | — | $ | 2,504 | $ | 2,504 | ||||||||||||||||||||||||||||||
Total fair value | $ | — | $ | — | $ | 18,291 | $ | 18,291 | Total fair value | $ | — | $ | — | $ | 2,504 | $ | 2,504 | ||||||||||||||||||||||
Fair Value Measured at December 31, 2019 | |||||||||||||||||||||||||||||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Fair Value at December 31, 2019 | ||||||||||||||||||||||||||||||||||||
Assets included in: | |||||||||||||||||||||||||||||||||||||||
Cash and cash equivalents | |||||||||||||||||||||||||||||||||||||||
Money market securities | $ | 8,901 | $ | — | $ | — | $ | 8,901 | |||||||||||||||||||||||||||||||
Marketable securities at fair value | |||||||||||||||||||||||||||||||||||||||
Corporate debt securities | — | 28,224 | — | 28,224 | |||||||||||||||||||||||||||||||||||
Asset-backed securities | — | 17,121 | — | 17,121 | |||||||||||||||||||||||||||||||||||
U.S. treasury securities | — | 5,032 | — | 5,032 | |||||||||||||||||||||||||||||||||||
Commercial paper | — | 11,974 | — | 11,974 | |||||||||||||||||||||||||||||||||||
Total fair value | $ | 8,901 | $ | 62,351 | $ | — | $ | 71,252 | |||||||||||||||||||||||||||||||
Liabilities included in: | |||||||||||||||||||||||||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 13,900 | $ | 13,900 | |||||||||||||||||||||||||||||||
Common and preferred stock warrant liability | — | — | 8,919 | 8,919 | |||||||||||||||||||||||||||||||||||
Total fair value | $ | — | $ | — | $ | 22,819 | $ | 22,819 | |||||||||||||||||||||||||||||||
Fair Value Measurements as of December 31, 2022 | |||||||||||||||||||||||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | Total | ||||||||||||||||||||
Assets included in: | |||||||||||||||||||||||
Cash and cash equivalents | |||||||||||||||||||||||
Money market securities | $ | 22,700 | $ | — | $ | — | $ | 22,700 | |||||||||||||||
Marketable securities at fair value | |||||||||||||||||||||||
U.S. treasury securities | — | 26,897 | — | 26,897 | |||||||||||||||||||
Commercial paper | — | 14,764 | — | 14,764 | |||||||||||||||||||
Yankee debt securities | — | 3,202 | — | 3,202 | |||||||||||||||||||
Total fair value | $ | 22,700 | $ | 44,863 | $ | — | $ | 67,563 | |||||||||||||||
Liabilities included in: | |||||||||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 3,346 | $ | 3,346 | |||||||||||||||
Contingent consideration | — | — | 1,800 | 1,800 | |||||||||||||||||||
Total fair value | $ | — | $ | — | $ | 5,146 | $ | 5,146 |
Contingent Consideration | Warrant Liability | ||||||||||
Balance, December 31, 2022 | $ | 1,800 | $ | 3,346 | |||||||
Change in fair value | 123 | (842) | |||||||||
Accrued final contingent consideration payment(1) | $ | (1,923) | $ | — | |||||||
Balance, June 30, 2023 (unaudited) | $ | — | $ | 2,504 |
Common and Preferred Stock Warrant Liability | Contingent Consideration | Total | |||||||||||
Balance, December 31, 2019 | $ | 8,919 | $ | 13,900 | $ | 22,819 | |||||||
Payment of contingent consideration | — | (2,619 | ) | (2,619 | ) | ||||||||
Issuance of preferred stock for contingent consideration | — | (2,197 | ) | (2,197 | ) | ||||||||
Change in fair value | 1,872 | (1,584 | ) | 288 | |||||||||
Balance, June 30, 2020 (unaudited) | $ | 10,791 | $ | 7,500 | $ | 18,291 | |||||||
June 30, | ||||||||
(unaudited) | ||||||||
Risk-free interest rate | ||||||||
Expected | ||||||||
Expected volatility |
June 30, 2020 | December 31, 2019 | |||
(unaudited) | ||||
Risk-free interest rate | 0.20% | 1.60% | ||
Expected term in years | 1.0 - 2.0 | 1.0 - 2.0 | ||
Expected volatility | 18.3% | 11.8% |
Six Months Ended June 30, 2023 | |||||
(unaudited) | |||||
Percentage of Product Net Sales Earnout accrued as of June 30, 2023 | $ | 3,381 | |||
Transaction costs | (102) | ||||
Gain on sale of business, net | $ | 3,279 |
Accounts receivable, net | $ | 3 | ||
Prepaid expenses and other current assets | 8 | |||
Property and equipment, net | 3 | |||
Intangible assets | 4,360 | |||
Goodwill | 12,026 | |||
Contingent consideration | (13,400 | ) | ||
Cash consideration | $ | 3,000 | ||
June 30, 2023 (unaudited) | |||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||||||||||
Available-for-sale securities - short-term: | |||||||||||||||||||||||
U.S. treasury securities | $ | 10,943 | $ | 1 | $ | (2) | $ | 10,942 | |||||||||||||||
Commercial paper | 19,265 | — | — | 19,265 | |||||||||||||||||||
Yankee debt securities | 1,256 | — | (2) | 1,254 | |||||||||||||||||||
Total available-for-sale securities - short-term | 31,464 | 1 | (4) | 31,461 | |||||||||||||||||||
Total available-for-sale securities | $ | 31,464 | $ | 1 | $ | (4) | $ | 31,461 |
June 30, 2020 (unaudited) | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | |||||||||||||
Available-for-sale securities - short-term : | ||||||||||||||||
U.S. treasury securities | $ | 5,033 | $ | 4 | $ | — | $ | 5,037 | ||||||||
Total available-for-sale | $ | 5,033 | $ | 4 | $ | — | $ | 5,037 | ||||||||
December 31, 2019 | ||||||||||||||||
Amortized | Gross Gains | Gross Losses | Fair | |||||||||||||
Available-for-sale securities - short-term: | ||||||||||||||||
Corporate debt securities | $ | 28,204 | $ | 20 | $ | — | $ | 28,224 | ||||||||
Asset-backed securities | 17,108 | 13 | — | 17,121 | ||||||||||||
U.S. treasury securities | 5,020 | 12 | — | 5,032 | ||||||||||||
Commercial paper | 11,974 | — | — | 11,974 | ||||||||||||
Total available-for-sale | $ | 62,306 | $ | 45 | $ | — | $ | 62,351 | ||||||||
December 31, 2022 | |||||||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | ||||||||||||||||||||
Available-for-sale securities - short-term: | |||||||||||||||||||||||
U.S. treasury securities | $ | 26,906 | $ | 3 | $ | (12) | $ | 26,897 | |||||||||||||||
Commercial paper | 3,200 | 2 | — | 3,202 | |||||||||||||||||||
Yankee debt securities | 14,764 | — | — | 14,764 | |||||||||||||||||||
Total available-for-sale securities - short-term | 44,870 | 5 | (12) | 44,863 | |||||||||||||||||||
Total available-for-sale securities | $ | 44,870 | $ | 5 | $ | (12) | $ | 44,863 |
June 30, 2020 | December 31, 2019 | June 30, 2023 | December 31, 2022 | ||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||
Raw materials | $ | 6,468 | $ | 5,492 | Raw materials | $ | 10,452 | $ | 9,179 | ||||||||||
Work in process | 1,353 | 1,605 | Work in process | 2,189 | 2,025 | ||||||||||||||
Finish goods | 4,445 | 1,327 | |||||||||||||||||
Finished goods | Finished goods | 3,030 | 2,123 | ||||||||||||||||
Total inventory | $ | 12,266 | $ | 8,424 | Total inventory | $ | 15,671 | $ | 13,327 | ||||||||||
Total Maturities | |||||
Six months ending December 31, 2023 | $ | 414 | |||
Year ending December 31, 2024 | 524 | ||||
Year ending December 31, 2025 | 194 | ||||
Total maturities of customer sales-type leases | $ | 1,132 |
June 30, 2023 | December 31, 2022 | ||||||||||
(unaudited) | |||||||||||
Medical diagnostic equipment | $ | 15,289 | $ | 14,826 | |||||||
Furniture and fixtures | 452 | 432 | |||||||||
Office equipment | 1,561 | 1,556 | |||||||||
Laboratory equipment and software | 5,226 | 5,148 | |||||||||
Leasehold improvements | 608 | 580 | |||||||||
Construction in process | 1,691 | 2,166 | |||||||||
Total property and equipment | 24,827 | 24,708 | |||||||||
Less: accumulated depreciation | (17,582) | (15,487) | |||||||||
Property and equipment, net | $ | 7,245 | $ | 9,221 |
June 30, 2020 | December 31, 2019 | |||||||
(unaudited) | ||||||||
Medical diagnostic equipment | $ | 7,180 | $ | 5,492 | ||||
Furniture and fixtures | 388 | 159 | ||||||
Office equipment | 1,377 | 1,321 | ||||||
Laboratory equipment and software | 3,380 | 2,807 | ||||||
Leasehold improvements | 595 | 507 | ||||||
Construction in process | 102 | 306 | ||||||
Total property and equipment | 13,022 | 10,592 | ||||||
Less: accumulated depreciation | (5,438 | ) | (6,165 | ) | ||||
Property and equipment, net | $ | 7,584 | $ | 4,427 | ||||
Intangible Assets | |||||
Balance, December 31, 2022 | $ | 1,583 | |||
Amortization expense | (100) | ||||
Balance, June 30, 2023 (unaudited) | $ | 1,483 |
June 30, 2023 | Estimated Useful Life (in years) | Weighted Average Remaining Life (in years) | Intangible Assets | Accumulated Amortization | Balance | ||||||||||||||||||||||||
(unaudited) | |||||||||||||||||||||||||||||
Licensed intangibles | 10.0 | 7.4 | $ | 2,000 | $ | (517) | $ | 1,483 | |||||||||||||||||||||
Total intangible assets | $ | 2,000 | $ | (517) | $ | 1,483 |
Goodwill | Intangible Assets | |||||||
Balance at December 31, 2019 | $ | 12,026 | $ | 4,110 | ||||
Amortization expense | — | (220 | ) | |||||
Balance at June 30, 2020 (unaudited) | $ | 12,026 | $ | 3,890 | ||||
December 31, 2022 | Estimated Useful Life (in years) | Weighted Average Remaining Life (in years) | Intangible Assets | Accumulated Amortization | Balance | ||||||||||||||||||||||||
Licensed intangibles | 10.0 | 7.9 | 2,000 | (417) | 1,583 | ||||||||||||||||||||||||
Total intangible assets | $ | 2,000 | $ | (417) | $ | 1,583 |
Estimated Useful Life (in years) | Weighted Average Remaining Life (in years) | Intangible Assets | Accumulated Amortization | June 30, 2020 | ||||||||||||
(unaudited) | ||||||||||||||||
Developed technology | 10 | 9.1 | $ | 4,200 | $ | (390 | ) | $ | 3,810 | |||||||
Trademarks and trade names | 0.5 | — | 60 | (60 | ) | — | ||||||||||
Customer-related intangible | 5 | 4 | 100 | (20 | ) | 80 | ||||||||||
Total | $ | 4,360 | $ | (470 | ) | $ | 3,890 | |||||||||
Estimated Useful Life (in years) | Weighted Average Remaining Life (in years) | Intangible Assets | Accumulated Amortization | December 31, 2019 | ||||||||||||||||
Developed technology | 10 | 9.5 | $ | 3,600 | $ | (180 | ) | $ | 3,420 | |||||||||||
In-process technology | indefinite | 600 | — | 600 | ||||||||||||||||
Trademarks and trade names | 0.5 | — | 60 | (60 | ) | — | ||||||||||||||
Customer-related intangible | 5 | 4.5 | 100 | (10 | ) | 90 | ||||||||||||||
Total | $ | 4,360 | $ | (250 | ) | $ | 4,110 | |||||||||||||
Total Amortization | |||||||||||||||||||||||
Six months ending December 31, 2023 | $ | 100 | |||||||||||||||||||||
Year ending December 31, 2024 | 200 | ||||||||||||||||||||||
Year ending December 31, 2025 | 200 | ||||||||||||||||||||||
Year ending December 31, 2026 | 200 | ||||||||||||||||||||||
Year ending December 31, 2027 | 200 | ||||||||||||||||||||||
Thereafter | 583 | ||||||||||||||||||||||
Total future amortization | $ | 1,483 |
Developed Technology | Customer-Related Intangible | Total Amortization | |||||||||||
Six months ending December 31, 2020 | $ | 210 | $ | 10 | $ | 220 | |||||||
Year ending December 31, 2021 | 420 | 20 | 440 | ||||||||||
Year ending December 31, 2022 | 420 | 20 | 440 | ||||||||||
Year ending December 31, 2023 | 420 | 20 | 440 | ||||||||||
Year ending December 31, 2024 | 420 | 10 | 430 | ||||||||||
Thereafter | 1,920 | 0 | 1,920 | ||||||||||
Total | $ | 3,810 | $ | 80 | $ | 3,890 | |||||||
June 30, 2020 | December 31, 2019 | June 30, 2023 | December 31, 2022 | ||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||
Biotronik Asset Acquisition - accrued purchase price | $ | — | $ | 5,000 | |||||||||||||||
Payroll and related expenses | 3,869 | 3,785 | |||||||||||||||||
Compensation and related expenses | Compensation and related expenses | $ | 5,327 | $ | 6,919 | ||||||||||||||
Professional fees | 1,850 | 188 | Professional fees | 261 | 126 | ||||||||||||||
Deferred revenue | 88 | 311 | Deferred revenue | 342 | 326 | ||||||||||||||
Sales and use tax | Sales and use tax | 304 | 639 | ||||||||||||||||
Clinical studies | Clinical studies | 371 | 390 | ||||||||||||||||
Clinician Council payable | Clinician Council payable | 240 | 216 | ||||||||||||||||
Accrued royalties | Accrued royalties | 234 | 159 | ||||||||||||||||
Accrued restructuring | Accrued restructuring | 173 | 45 | ||||||||||||||||
Accrued contingent consideration payment | Accrued contingent consideration payment | 1,923 | — | ||||||||||||||||
Other | 1,229 | 792 | Other | 584 | 866 | ||||||||||||||
Total accrued liabilities | $ | 7,036 | $ | 10,076 | Total accrued liabilities | $ | 9,759 | $ | 9,686 | ||||||||||
June 30, 2023 | December 31, 2022 | ||||||||||
(unaudited) | |||||||||||
2022 Credit Agreement(1) | $ | 36,750 | $ | 36,776 | |||||||
Total outstanding debt, gross | 36,750 | 36,776 | |||||||||
Less: Unamortized debt discount and fees | (2,116) | (2,342) | |||||||||
Total outstanding debt, long-term | $ | 34,634 | $ | 34,434 |
June 30, 2020 | December 31, 2019 | |||||||
(unaudited) | ||||||||
2019 Credit Agreement (1) | $ | 44,550 | $ | 44,550 | ||||
Total debt, gross | 44,550 | 44,550 | ||||||
Less: Unamortized debt discount and fees | (5,992 | ) | (6,306 | ) | ||||
Total long-term debt | $ | 38,558 | $ | 38,244 | ||||
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Operating cash flows from operating leases | $ | 281 | $ | 365 | |||||||
Weighted average remaining lease term – operating leases (in years) | 4.4 | 3.3 | |||||||||
Weighted average discount rate – operating leases | 6.9% | 7.0% |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Operating cash flows used in operating leases | $ | 507 | $ | 477 | ||||
Right-of-use | $ | — | $ | 2,978 | ||||
Weighted-average remaining lease term – operating leases | 1.8 years | 2.3 years | ||||||
Weighted-average discount rate – operating leases | 7.0 | % | 7.0 | % |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Operating leases | |||||||||||||||||||||||
Operating lease cost | $ | 252 | $ | 246 | $ | 503 | $ | 493 | |||||||||||||||
Variable lease cost | 81 | 63 | 162 | 140 | |||||||||||||||||||
Total operating lease expense | $ | 333 | $ | 309 | $ | 665 | $ | 633 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Operating leases | ||||||||||||||||
Operating lease cost | $ | 216 | $ | 216 | $ | 432 | $ | 432 | ||||||||
Variable lease cost | 92 | 40 | 165 | 104 | ||||||||||||
Total rent expense | $ | 308 | $ | 256 | $ | 597 | $ | 536 | ||||||||
Six months ending December 31, 2020 | $ | 507 | ||
Year ending December 31, 2021 | 1,044 | |||
Year ending December 31, 2022 | 1,074 | |||
Year ending December 31, 2023 | 51 | |||
Year ending December 31, 2024 | 51 | |||
Total | 2,727 | |||
Less: present value discount | (251 | ) | ||
Operating lease liabilities | $ | 2,476 | ||
Six months ending December 31, 2023 | $ | 49 | |||
Year ending December 31, 2024 | 1,159 | ||||
Year ending December 31, 2025 | 1,151 | ||||
Year ending December 31, 2026 | 1,185 | ||||
Year ending December 31, 2027 | 1,221 | ||||
Total | 4,765 | ||||
Less: present value discount | (620) | ||||
Operating lease liabilities | $ | 4,145 |
Exercise Price | Expiration Date | June 30, 2023 | December 31, 2022 | |||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||
Warrants issued in 2015 | $ | 5.25 | 1/30/25 | 3,808 | 3,808 | |||||||||||||||||||||
Warrants issued with 2018 Convertible Notes | $ | 0.10 | 6/7/28 | 346,689 | 346,689 | |||||||||||||||||||||
Warrants issued with 2018 Term Loan | $ | 16.67 | 7/31/28 | 26,998 | 26,998 | |||||||||||||||||||||
Warrants issued with 2019 Credit Agreement | $ | 16.67 | 5/20/29 | 419,992 | 419,992 | |||||||||||||||||||||
Warrants issued with 2022 Credit Agreement | $ | 1.11 | 6/30/30 | 3,779,018 | 3,779,018 | |||||||||||||||||||||
Total Warrants | 4,576,505 | 4,576,505 |
Equity Upon Exercise | Exercise | Expiration | June 30, 2020 | December 31, 2019 | ||||||||||||||||
(unaudited) | ||||||||||||||||||||
Warrants issued in 2015 | Common Stock | $ | 5.25 | 1/30/25 | 7,616 | 7,616 | ||||||||||||||
Warrants issued with 2018 Convertible Notes | Common Stock | $ | 0.10 | 6/7/28 | 501,946 | 501,946 | ||||||||||||||
Warrants issued with 2018 Term Loan | Series D convertible preferred | | $ | 16.67 | 7/31/28 | 26,998 | 26,998 | |||||||||||||
Warrants issued with 2019 Credit Agreement | Series D convertible preferred | | $ | 16.67 | 5/20/29 | 419,992 | 419,992 | |||||||||||||
Total Warrants | 956,552 | 956,552 | ||||||||||||||||||
Series | Conversion Price | |||
Series A convertible preferred stock | $ | 8.295 | ||
Series B convertible preferred stock | $ | 13.370 | ||
Series C convertible preferred stock | $ | 16.667 | ||
Series D convertible preferred stock | $ | 16.667 |
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Risk-free interest rate | 3.91% - 4.27% | 1.76% - 3.35% | |||||||||
Expected dividend yield | — | — | |||||||||
Expected term in years | 5.5 - 5.6 | 5.5 - 6.0 | |||||||||
Expected volatility | 75% - 85% | 75% - 90% |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Risk-free interest rate | 0.90% | 2.0% - 2.1 % | ||||||
Expected dividend yield | — | — | ||||||
Expected term in years | 7.0 | 6.38 - 10.00 | ||||||
Expected volatility | 70.0% | 80.0% |
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic (in | |||||||||||||
Outstanding as of December 31, 2019 | 2,041,205 | $ | 9.52 | 7.7 | $ | 7,857 | ||||||||||
Options granted | 867,031 | 14.81 | ||||||||||||||
Option exercised | (111,936 | ) | 7.73 | |||||||||||||
Options forfeited | (200,213 | ) | 12.01 | |||||||||||||
Outstanding as of June 30, 2020 (unaudited) | 2,596,087 | $ | 11.17 | 7.8 | $ | 17,816 | ||||||||||
Options vested and exercisable as of June 30, 2020 (unaud i ted) | 1,138,429 | $ | 8.34 | 6.1 | $ | 11,037 | ||||||||||
Stock Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Life (in years) | Aggregate Intrinsic Value (in thousands) | ||||||||||||||||||||
Outstanding as of December 31, 2022 | 2,898,821 | $ | 6.83 | 6.9 | $ | 79 | |||||||||||||||||
Options granted | 735,580 | 1.30 | |||||||||||||||||||||
Options exercised | (3,218) | 1.34 | $ | 1 | |||||||||||||||||||
Options forfeited | (269,868) | 9.30 | |||||||||||||||||||||
Outstanding as of June 30, 2023 (unaudited) | 3,361,315 | $ | 5.43 | 4.9 | $ | 53 | |||||||||||||||||
Options vested and exercisable as of June 30, 2023 (unaudited) | 2,216,938 | $ | 7.49 | 3.1 | $ | 45 |
Number of Shares | Weighted Average Grant Price | ||||||||||
Unvested as of December 31, 2022 | 1,659,898 | $ | 4.17 | ||||||||
Granted | 1,795,520 | 1.33 | |||||||||
Forfeited | (257,446) | 5.26 | |||||||||
Vested | (774,950) | 2.53 | |||||||||
Unvested as of June 30, 2023 (unaudited) | 2,423,022 | $ | 2.47 |
Number of Shares | Weighted Average Grant Price | |||||||
Unvested as of December 31, 2019 | — | $ | — | |||||
Granted | 14,945 | 14.81 | ||||||
Vested | (14,945 | ) | 14.81 | |||||
Unvested as of June 30, 2020 (unaudited) | — | $ | — | |||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Cost of products sold | $ | 153 | $ | 225 | $ | 228 | $ | 451 | |||||||||||||||
Research and development | 336 | 554 | 682 | 1,068 | |||||||||||||||||||
Selling, general and administrative | 1,245 | 1,802 | 2,729 | 4,094 | |||||||||||||||||||
Total stock-based compensation | $ | 1,734 | $ | 2,581 | $ | 3,639 | $ | 5,613 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Cost of products sold | $ | 58 | $ | 54 | $ | 166 | $ | 106 | ||||||||
Research and development | 167 | 150 | 378 | 292 | ||||||||||||
Selling, general and administrative | 932 | 599 | 2,354 | 964 | ||||||||||||
Total stock-based compensation | $ | 1,157 | $ | 803 | $ | 2,898 | $ | 1,362 | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Net income (loss) | $ | (18,346) | $ | 5,718 | $ | (34,661) | $ | (34,299) | |||||||||||||||
Net income allocated to participating securities | — | (1,197) | — | — | |||||||||||||||||||
Net income (loss) available to common stockholders | $ | (18,346) | $ | 4,521 | $ | (34,661) | $ | (34,299) | |||||||||||||||
Basic weighted average number of shares outstanding | 29,039,732 | 28,339,362 | 28,902,808 | 28,229,338 | |||||||||||||||||||
Dilutive effect of stock options | — | 10,067 | — | — | |||||||||||||||||||
Diluted weighted average number of shares outstanding | 29,039,732 | 28,349,429 | 28,902,808 | 28,229,338 | |||||||||||||||||||
Basic net income (loss) per common share | $ | (0.63) | $ | 0.16 | $ | (1.20) | $ | (1.22) | |||||||||||||||
Diluted net income (loss) per common share | $ | (0.63) | $ | 0.16 | $ | (1.20) | $ | (1.22) |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||||||
(unaudited) | (unaudited) | |||||||||||||||||||||||||||||||
Shares issuable upon: | ||||||||||||||||||||||||||||||||
Conversion of Series A Common Equivalent Preferred Stock | 6,665,841 | 6,665,841 | 6,665,841 | 6,665,841 | ||||||||||||||||||||||||||||
Exercise of common stock warrants | 4,576,505 | 4,576,505 | 4,576,505 | 4,576,505 | ||||||||||||||||||||||||||||
Exercise of stock options | 2,216,938 | 3,915,381 | 2,216,938 | 3,925,448 | ||||||||||||||||||||||||||||
Vesting of RSUs and RSAs | 2,423,022 | 1,767,655 | 2,423,022 | 1,767,655 | ||||||||||||||||||||||||||||
Issuance of shares under 2020 ESPP | 61,361 | — | 61,361 | — | ||||||||||||||||||||||||||||
Total potentially dilutive securities | 15,943,667 | 16,925,382 | 15,943,667 | 16,935,449 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Shares issuable upon conversion of Series A Preferred Stock | 391,210 | 391,210 | ||||||
Shares issuable upon conversion of Series B Preferred Stock | 3,088,444 | 3,088,444 | ||||||
Shares issuable upon conversion of Series C Preferred Stock | 4,499,921 | 4,499,921 | ||||||
Shares issuable upon conversion of Series D Preferred Stock | 8,593,360 | 6,418,437 | ||||||
Shares issuable upon exercise of stock options | 2,596,087 | 1,751,616 | ||||||
Shares issuable upon exercise of common stock warrants | 509,562 | 509,562 | ||||||
Shares issuable upon exercise of preferred stock warrants | 446,990 | 446,990 | ||||||
Total | 20,125,574 | 17,106,180 | ||||||
As of June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Acutus | |||||||||||
U.S. | 27 | 37 | |||||||||
Outside the U.S. | 51 | 38 | |||||||||
Total Acutus net system placements | 78 | 75 |
As of June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Acutus Direct | ||||||||
US | 20 | 8 | ||||||
Europe | 18 | 18 | ||||||
Total Acutus Direct | 38 | 26 | ||||||
Biotronik | — | — | ||||||
Total net system placements | 38 | 26 | ||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Acutus Direct | ||||||||||||||||
US | 7 | 1 | 10 | 3 | ||||||||||||
Europe | — | 2 | 1 | 2 | ||||||||||||
Total Acutus Direct | 7 | 3 | 11 | 5 | ||||||||||||
Biotronik | — | — | — | — | ||||||||||||
Total net system placements | 7 | 3 | 11 | 5 | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
(unaudited) | (unaudited) | ||||||||||||||||||||||
Procedure volumes | 584 | 481 | 1,035 | 948 |
Three Months Ended June 30, | Change | Three Months Ended June 30, | Change | ||||||||||||||||||||||||||||||||||||
(dollars in thousands) | 2020 | 2019 | $ | % | (dollars in thousands) | 2023 | 2022 | $ | % | ||||||||||||||||||||||||||||||
(Unaudited) | (unaudited) | ||||||||||||||||||||||||||||||||||||||
Revenue | $ | 1,134 | $ | 734 | $ | 400 | 54 | % | $ | 5,289 | $ | 4,076 | $ | 1,213 | 30 | % | |||||||||||||||||||||||
Costs of products sold(2) | Costs of products sold(2) | 8,063 | 9,697 | (1,634) | (17) | % | |||||||||||||||||||||||||||||||||
Gross profit | Gross profit | (2,774) | (5,621) | 2,847 | (51) | % | |||||||||||||||||||||||||||||||||
Costs and operating expenses: | |||||||||||||||||||||||||||||||||||||||
Costs of products sold (1) | 2,663 | 2,435 | 228 | 9 | % | ||||||||||||||||||||||||||||||||||
Research and development (1) | 8,176 | 5,247 | 2,929 | 56 | % | ||||||||||||||||||||||||||||||||||
Selling, general and administrative (1) | 9,125 | 6,927 | 2,198 | 32 | % | ||||||||||||||||||||||||||||||||||
Operating expenses (income): | Operating expenses (income): | ||||||||||||||||||||||||||||||||||||||
Research and development(2) | Research and development(2) | 6,799 | 7,935 | (1,136) | (14) | % | |||||||||||||||||||||||||||||||||
Selling, general and administrative(2) | Selling, general and administrative(2) | 9,284 | 14,143 | (4,859) | (34) | % | |||||||||||||||||||||||||||||||||
Restructuring | Restructuring | 463 | — | 463 | 100% | ||||||||||||||||||||||||||||||||||
Change in fair value of contingent consideration | 635 | — | 635 | NM | Change in fair value of contingent consideration | (77) | 948 | (1,025) | (108) | % | |||||||||||||||||||||||||||||
Total operating expenses | 20,599 | 14,609 | 5,990 | 41 | % | ||||||||||||||||||||||||||||||||||
Loss from operations | (19,465 | ) | (13,875 | ) | (5,590 | ) | 40 | % | |||||||||||||||||||||||||||||||
Gain on sale of business | Gain on sale of business | (2,072) | (43,575) | 41,503 | (95) | % | |||||||||||||||||||||||||||||||||
Total operating expenses (income) | Total operating expenses (income) | 14,397 | (20,549) | 34,946 | (170) | % | |||||||||||||||||||||||||||||||||
Income (loss) from operations | Income (loss) from operations | (17,171) | 14,928 | (32,099) | (215) | % | |||||||||||||||||||||||||||||||||
Other income (expense): | Other income (expense): | ||||||||||||||||||||||||||||||||||||||
Change in fair value of warrant liability and embedded derivative | (2,453 | ) | (1,446 | ) | (1,007 | ) | 70 | % | |||||||||||||||||||||||||||||||
Loss on debt extinguishment | — | (1,398 | ) | 1,398 | (100 | %) | Loss on debt extinguishment | — | (7,947) | 7,947 | (100) | % | |||||||||||||||||||||||||||
Change in fair value of warrant liability | Change in fair value of warrant liability | (604) | — | (604) | 100% | ||||||||||||||||||||||||||||||||||
Interest income | 95 | 143 | (48 | ) | (34 | %) | Interest income | 824 | 27 | 797 | 2952 | % | |||||||||||||||||||||||||||
Interest expense | (1,370 | ) | (13,769 | ) | 12,399 | (90 | %) | Interest expense | (1,395) | (1,290) | (105) | 8 | % | ||||||||||||||||||||||||||
Total other expense, net | (3,728 | ) | (16,470 | ) | 12,742 | (77 | %) | ||||||||||||||||||||||||||||||||
Net loss | $ | (23,193 | ) | $ | (30,345 | ) | $ | 7,152 | (24 | %) | |||||||||||||||||||||||||||||
Total other income (expense), net | Total other income (expense), net | (1,175) | (9,210) | 8,035 | (87) | % | |||||||||||||||||||||||||||||||||
(Loss) income before income taxes | (Loss) income before income taxes | $ | (18,346) | $ | 5,718 | $ | (24,064) | (421) | % | ||||||||||||||||||||||||||||||
Income tax benefit | Income tax benefit | $ | — | $ | — | $ | — | * | |||||||||||||||||||||||||||||||
Net (loss) income | Net (loss) income | $ | (18,346) | $ | 5,718 | $ | (24,064) | (421) | % | ||||||||||||||||||||||||||||||
Other comprehensive income (loss) | Other comprehensive income (loss) | ||||||||||||||||||||||||||||||||||||||
Unrealized gain (loss) on marketable securities | (14 | ) | 6 | (20 | ) | NM | Unrealized gain (loss) on marketable securities | (8) | 18 | (26) | (144) | % | |||||||||||||||||||||||||||
Foreign currency translation adjustment | 96 | 2 | 94 | NM | Foreign currency translation adjustment | (85) | (387) | 302 | (78) | % | |||||||||||||||||||||||||||||
Comprehensive loss | $ | (23,111 | ) | $ | (30,337 | ) | $ | 7,226 | (24 | %) | |||||||||||||||||||||||||||||
Comprehensive income (loss) | Comprehensive income (loss) | $ | (18,439) | $ | 5,349 | $ | (23,788) | (445) | % |
Three Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Disposables | $ | 3,914 | $ | 3,334 | |||||||
Systems | 691 | 346 | |||||||||
Service/Other | 684 | 396 | |||||||||
Total revenue | $ | 5,289 | $ | 4,076 |
Three Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Cost of products sold | $ | 58 | $ | 54 | ||||
Research and development | 167 | 150 | ||||||
Selling, general and administrative | 932 | 599 | ||||||
Total stock-based compensation | $ | 1,157 | $ | 803 | ||||
Three Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
United States | $ | 3,125 | $ | 2,037 | |||||||
Outside the United States | 2,164 | 2,039 | |||||||||
Total revenue | $ | 5,289 | $ | 4,076 |
Three Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Cost of products sold | $ | 153 | $ | 225 | |||||||
Research and development | 336 | 554 | |||||||||
Selling, general and administrative | 1,245 | 1,802 | |||||||||
Total stock-based compensation | $ | 1,734 | $ | 2,581 |
Three Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Acutus Direct | ||||||||
Disposables | $ | 899 | $ | 705 | ||||
Systems | — | — | ||||||
Service/Other | 12 | 4 | ||||||
Total Acutus direct revenue | 911 | 709 | ||||||
Distribution agreements | 223 | 25 | ||||||
Total revenue | $ | 1,134 | $ | 734 | ||||
Three Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Acutus Direct | ||||||||
United States | $ | 544 | $ | 221 | ||||
Europe | 367 | 488 | ||||||
Total Acutus direct revenue | 911 | 709 | ||||||
Distribution Agreements | ||||||||
United States | 15 | — | ||||||
Europe | 208 | 25 | ||||||
Total revenue through distribution | 223 | 25 | ||||||
Total revenue | $ | 1,134 | $ | 734 | ||||
Six Months Ended June 30, | Change | Six Months Ended June 30, | Change | ||||||||||||||||||||||||||||||||||||
2020 | 2019 | $ | % | ||||||||||||||||||||||||||||||||||||
(dollars in thousands) | (dollars in thousands) | 2023 | 2022 | $ | % | ||||||||||||||||||||||||||||||||||
(Unaudited) | (unaudited) | ||||||||||||||||||||||||||||||||||||||
Revenue | $ | 2,717 | $ | 1,521 | $ | 1,196 | 79 | % | $ | 9,458 | $ | 7,757 | $ | 1,701 | 22 | % | |||||||||||||||||||||||
Costs of products sold(2) | Costs of products sold(2) | 14,852 | 16,638 | (1,786) | (11) | % | |||||||||||||||||||||||||||||||||
Gross profit | Gross profit | (5,394) | (8,881) | 3,487 | (39) | % | |||||||||||||||||||||||||||||||||
Costs and operating expenses: | |||||||||||||||||||||||||||||||||||||||
Costs of products sold (1) | 5,857 | 4,611 | 1,246 | 27 | % | ||||||||||||||||||||||||||||||||||
Research and development (1) | 16,149 | 9,624 | 6,525 | 68 | % | ||||||||||||||||||||||||||||||||||
Selling, general and administrative (1) | 19,360 | 11,020 | 8,340 | 76 | % | ||||||||||||||||||||||||||||||||||
Operating expenses (income): | Operating expenses (income): | ||||||||||||||||||||||||||||||||||||||
Research and development(2) | Research and development(2) | 12,916 | 15,938 | (3,022) | (19) | % | |||||||||||||||||||||||||||||||||
Selling, general and administrative(2) | Selling, general and administrative(2) | 18,849 | 28,528 | (9,679) | (34) | % | |||||||||||||||||||||||||||||||||
Goodwill impairment | Goodwill impairment | — | 12,026 | (12,026) | (100) | % | |||||||||||||||||||||||||||||||||
Restructuring | Restructuring | 475 | 949 | (474) | (50) | % | |||||||||||||||||||||||||||||||||
Change in fair value of contingent consideration | (1,584 | ) | — | (1,584 | ) | NM | Change in fair value of contingent consideration | 123 | 955 | (832) | (87) | % | |||||||||||||||||||||||||||
Total operating expenses | 39,782 | 25,255 | 14,527 | 58 | % | ||||||||||||||||||||||||||||||||||
Gain on sale of business | Gain on sale of business | (3,279) | (43,575) | 40,296 | (92) | % | |||||||||||||||||||||||||||||||||
Total operating expenses (income) | Total operating expenses (income) | 29,084 | 14,821 | 14,263 | 96 | % | |||||||||||||||||||||||||||||||||
Loss from operations | (37,065 | ) | (23,734 | ) | (13,331 | ) | 56 | % | Loss from operations | (34,478) | (23,702) | (10,776) | 45 | % | |||||||||||||||||||||||||
Other income (expense): | Other income (expense): | ||||||||||||||||||||||||||||||||||||||
Change in fair value of warrant liability and embedded derivative | (1,872 | ) | (605 | ) | (1,267 | ) | 209 | % | |||||||||||||||||||||||||||||||
Loss on debt extinguishment | — | (1,398 | ) | 1,398 | (100 | %) | Loss on debt extinguishment | — | (7,947) | 7,947 | (100) | % | |||||||||||||||||||||||||||
Change in fair value of warrant liability | Change in fair value of warrant liability | 842 | — | 842 | 100% | ||||||||||||||||||||||||||||||||||
Interest income | 370 | 208 | 162 | 78 | % | Interest income | 1,676 | 51 | 1,625 | 3186 | % | ||||||||||||||||||||||||||||
Interest expense | (2,724 | ) | (19,511 | ) | 16,787 | (86 | %) | Interest expense | (2,701) | (2,701) | — | — | % | ||||||||||||||||||||||||||
Total other expense, net | (4,226 | ) | (21,306 | ) | 17,080 | (80 | %) | Total other expense, net | (183) | (10,597) | 10,414 | (98) | % | ||||||||||||||||||||||||||
Net loss | $ | (41,291 | ) | $ | (45,040 | ) | $ | 3,749 | (8 | %) | |||||||||||||||||||||||||||||
(Loss) income before income taxes | (Loss) income before income taxes | $ | (34,661) | $ | (34,299) | $ | (362) | 1 | % | ||||||||||||||||||||||||||||||
Income tax benefit | Income tax benefit | $ | — | $ | — | $ | — | * | |||||||||||||||||||||||||||||||
Net (loss) income | Net (loss) income | $ | (34,661) | $ | (34,299) | $ | (362) | 1 | % | ||||||||||||||||||||||||||||||
Other comprehensive income (loss) | Other comprehensive income (loss) | ||||||||||||||||||||||||||||||||||||||
Unrealized gain (loss) on marketable securities | (41 | ) | 7 | (48 | ) | NM | Unrealized gain (loss) on marketable securities | 4 | (39) | 43 | (110) | % | |||||||||||||||||||||||||||
Foreign currency translation adjustment | 69 | (12 | ) | 81 | NM | Foreign currency translation adjustment | (26) | (553) | 527 | (95) | % | ||||||||||||||||||||||||||||
Comprehensive loss | $ | (41,263 | ) | $ | (45,045 | ) | $ | 3,782 | (8 | %) | Comprehensive loss | $ | (34,683) | $ | (34,891) | $ | 208 | (1) | % | ||||||||||||||||||||
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Disposables | $ | 7,340 | $ | 6,545 | |||||||
Systems | 691 | 346 | |||||||||
Service/Other | 1,427 | 866 | |||||||||
Total revenue | $ | 9,458 | $ | 7,757 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Cost of products sold | $ | 166 | $ | 106 | ||||
Research and development | 378 | 292 | ||||||
Selling, general and administrative | 2,354 | 964 | ||||||
Total stock-based compensation | $ | 2,898 | $ | 1,362 | ||||
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
United States | $ | 5,373 | $ | 4,060 | |||||||
Outside the United States | 4,085 | 3,697 | |||||||||
Total revenue | $ | 9,458 | $ | 7,757 |
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Cost of products sold | $ | 228 | $ | 451 | |||||||
Research and development | 682 | 1,068 | |||||||||
Selling, general and administrative | 2,729 | 4,094 | |||||||||
Total stock-based compensation | $ | 3,639 | $ | 5,613 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Acutus Direct | ||||||||
Disposables | $ | 1,919 | $ | 1,487 | ||||
Systems | 520 | — | ||||||
Service/Other | 18 | 9 | ||||||
Total Acutus direct revenue | 2,457 | 1,496 | ||||||
Distribution agreements | 260 | 25 | ||||||
Total revenue | $ | 2,717 | $ | 1,521 | ||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Acutus Direct | ||||||||
United States | $ | 1,313 | $ | 456 | ||||
Europe | 1,144 | 1,040 | ||||||
Total Acutus direct revenue | 2,457 | 1,496 | ||||||
Distribution Agreements | ||||||||
United States | 15 | — | ||||||
Europe | 245 | 25 | ||||||
Total revenue through distribution | 260 | 25 | ||||||
Total revenue | $ | 2,717 | $ | 1,521 | ||||
Six Months Ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
(unaudited) | |||||||||||
Net cash used in operating activities | $ | (31,097) | $ | (50,706) | |||||||
Net cash provided by investing activities | 30,386 | 89,168 | |||||||||
Net cash used in financing activities | (234) | (11,643) | |||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (346) | (323) | |||||||||
Net change in cash, cash equivalents and restricted cash | $ | (1,291) | $ | 26,496 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Net cash used in operating activities | $ | (34,761 | ) | $ | (22,084 | ) | ||
Net cash provided by (used in) investing activities | 52,650 | (17,424 | ) | |||||
Net cash (used in) provided by financing activities | (3,115 | ) | 97,951 | |||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 69 | (12 | ) | |||||
Net change in cash, cash equivalents and restricted cash | $ | 14,843 | $ | 58,431 | ||||
Incorporated by Reference | ||||||||||||||||||||||||||||||||||||||
Exhibit No. | Exhibit Description | Form | File No. | Exhibit | Filing Date | Filed Herewith | ||||||||||||||||||||||||||||||||
3.1 | 8-K | 001-39430 | 3.1 | August 10, 2020 | ||||||||||||||||||||||||||||||||||
3.2 | 8-K | 001-39430 | 3.2 | August 10, 2020 | ||||||||||||||||||||||||||||||||||
3.3 | 8-K | 001-39430 | 3.1 | August 23, 2021 | ||||||||||||||||||||||||||||||||||
10.1 | X | |||||||||||||||||||||||||||||||||||||
31.1 | X | |||||||||||||||||||||||||||||||||||||
31.2 | X | |||||||||||||||||||||||||||||||||||||
32.1** | X | |||||||||||||||||||||||||||||||||||||
32.2** | X | |||||||||||||||||||||||||||||||||||||
101 | The following financial information from the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2023, formatted in Inline Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss), (iii) the Condensed Consolidated Statements of Stockholders’ Equity, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements (filed herewith). | |||||||||||||||||||||||||||||||||||||
104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
Acutus Medical, Inc. | |||||||||||||
(Registrant) | |||||||||||||
Date: | By: | /s/ | |||||||||||
David H. Roman President, | |||||||||||||
and Director (Principal Executive Officer) | |||||||||||||
Date: | By: | /s/ | |||||||||||
Takeo Mukai Senior Vice President and Chief Financial Officer | |||||||||||||
(Principal Financial and Accounting Officer) |