Recent Highlights:
- Reported revenue of
$5.0 million for the fourth quarter of 2022, a 14% increase compared to$4.4 million for the same quarter last year - Reported revenue of
$16.4 million for the full year of 2022, a 5% decrease compared to$17.3 million for the full year of 2021 - Global mapping procedure volumes increased 19% for the full year of 2022, compared to the full year of 2021
- Achieved key milestones under the asset purchase agreement with Medtronic of its left-heart access portfolio ahead of schedule, and received
$20 million in earn-out payments inDecember 2022 and an additional$17 million inJanuary 2023
“Our fourth quarter results demonstrated significant progress on our strategic and financial objectives, as we achieved our highest level of quarterly sales on record while also registering our lowest level of cash burn and operating expenses since IPO,” said
Fourth Quarter 2022 Financial Results
Revenue was
Operating expenses consisting of research & development and selling, general & administrative expenses on a GAAP basis were
Non-GAAP operating expenses were
Net income on a GAAP basis was
Excluding income tax expense, amortization of acquired intangibles, non-cash stock-based compensation expense, restructuring charges, change in fair value of warrant liability, change in the fair value of contingent consideration and gain on sale of business, the Company’s non-GAAP net loss for the fourth quarter of 2022 was
Full Year 2022 Financial Results
Revenue was
Gross margin on a GAAP basis was negative 95% for the full year of 2022, compared with negative 91% in the prior year, driven by unfavorable manufacturing variances carried into 2022 from the prior year, idle capacity, and the write-off of excess and obsolete inventory, offset by a partial reduction in manufacturing overhead from the restructuring actions taken in the first half of 2022.
Operating expenses consisting of research & development and selling, general & administrative expenses on a GAAP basis were
Net loss on a GAAP basis was
Excluding income tax expense, amortization of acquired intangibles, non-cash stock-based compensation expense, employee retention credit, goodwill impairment, restructuring charges, changes in the fair value of contingent consideration, gain on sale of business, loss on debt extinguishment and change in fair value of warrant liability, the Company’s non-GAAP net loss for the full year of 2022 was
Cash, cash equivalents, marketable securities and restricted cash were
2023 Outlook
The company expects full year 2023 revenue to be in a range from
Non-GAAP Financial Measures
This press release includes references to non-GAAP net loss and non-GAAP basic and diluted net loss per share, which are non-GAAP financial measures, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are primarily non-cash accounting line items unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as Acutus calculates them, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. Non-GAAP net loss is defined as net loss before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, employee retention credit, goodwill impairment, restructuring charges, changes in the fair value of contingent consideration, gain on sale of business, loss on debt extinguishment and change in fair value of warrant liability and other adjustments. To the extent such non-GAAP financial measures are used in the future, the Company expects to calculate them using a consistent method from period to period. A reconciliation of the most directly comparable GAAP financial measure to the non-GAAP financial measure has been provided under the heading “Reconciliation of GAAP Results to Non-GAAP Results” in the financial statement tables attached to this press release.
Webcast and Conference Call Information
Acutus will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on
About Acutus
Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in
Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of its products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase the Company’s systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in
Investor Contact: | Media Contact: |
Westwicke ICR | |
D: 415-202-5678 | M: 442-232-6094 |
caroline.corner@westwicke.com | media@acutusmedical.com |
Consolidated Balance Sheets
(in thousands, except per share amounts)
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 25,584 | $ | 24,071 | |||
Marketable securities, short-term | 44,863 | 76,702 | |||||
Restricted cash | 5,764 | 150 | |||||
Accounts receivable | 21,085 | 3,633 | |||||
Inventory | 13,327 | 16,408 | |||||
Employer retention credit receivable | 4,703 | — | |||||
Prepaid expenses and other current assets | 2,541 | 5,326 | |||||
Total current assets | 117,867 | 126,290 | |||||
Marketable securities, long-term | — | 7,120 | |||||
Property and equipment, net | 9,221 | 13,670 | |||||
Right-of-use asset, net | 3,872 | 4,521 | |||||
Intangible assets, net | 1,583 | 5,013 | |||||
— | 12,026 | ||||||
Other assets | 897 | 1,152 | |||||
Total assets | $ | 133,440 | $ | 169,792 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,721 | $ | 7,519 | |||
Accrued liabilities | 9,686 | 9,096 | |||||
Contingent consideration, short-term | 1,800 | 1,500 | |||||
Operating lease liabilities, short-term | 319 | 395 | |||||
Warrant liability | 3,346 | — | |||||
Total current liabilities | 19,872 | 18,510 | |||||
Operating lease liabilities, long-term | 4,103 | 4,591 | |||||
Long-term debt | 34,434 | 40,415 | |||||
Contingent consideration, long-term | — | 500 | |||||
Other long-term liabilities | 12 | 50 | |||||
Total liabilities | 58,421 | 64,066 | |||||
Commitments and contingencies | |||||||
Stockholders' equity | |||||||
Preferred stock: Series A Common Equivalent Preferred Stock, 0.001 par value; 5,000,000 shares authorized, and 6,666 shares issued and outstanding | — | — | |||||
Common stock: 0.001 par value; 260,000,000 shares authorized, 28,554,656 and 27,957,223 issued and outstanding at | 29 | 28 | |||||
Additional paid-in capital | 594,173 | 584,613 | |||||
Accumulated deficit | (518,314 | ) | (478,698 | ) | |||
Accumulated other comprehensive loss | (869 | ) | (217 | ) | |||
Total stockholders' equity | 75,019 | 105,726 | |||||
Total liabilities and stockholders' equity | $ | 133,440 | $ | 169,792 |
Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share amounts)
Three Months Ended | Twelve Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Revenue | $ | 4,962 | $ | 4,362 | $ | 16,363 | $ | 17,263 | |||||||
Costs and operating expenses (income): | |||||||||||||||
Cost of products sold | 8,321 | 9,939 | 31,910 | 32,925 | |||||||||||
Research and development | 6,269 | 8,840 | 28,153 | 36,683 | |||||||||||
Selling, general and administrative | 9,447 | 15,865 | 47,654 | 63,523 | |||||||||||
— | — | 12,026 | — | ||||||||||||
Restructuring | 91 | — | 2,371 | — | |||||||||||
Change in fair value of contingent consideration | (100 | ) | (382 | ) | 1,053 | (3,746 | ) | ||||||||
Gain on sale of business | (35,890 | ) | — | (79,465 | ) | — | |||||||||
Total costs and operating (income) expenses | (11,862 | ) | 34,262 | 43,702 | 129,385 | ||||||||||
Income (loss) from operations | 16,824 | (29,900 | ) | (27,339 | ) | (112,122 | ) | ||||||||
Other income (expense): | |||||||||||||||
Loss on debt extinguishment | — | — | (7,947 | ) | — | ||||||||||
Change in fair value of warrant liability | (871 | ) | — | 33 | — | ||||||||||
Interest income | 576 | 28 | 868 | 116 | |||||||||||
Interest expense | (1,339 | ) | (1,392 | ) | (5,149 | ) | (5,677 | ) | |||||||
Total other expense, net | (1,634 | ) | (1,364 | ) | (12,195 | ) | (5,561 | ) | |||||||
Income (loss) before income taxes | 15,190 | (31,264 | ) | (39,534 | ) | (117,683 | ) | ||||||||
Income tax expense | 82 | — | 82 | — | |||||||||||
Net income (loss) | $ | 15,108 | $ | (31,264 | ) | $ | (39,616 | ) | $ | (117,683 | ) | ||||
Other comprehensive income (loss): | |||||||||||||||
Unrealized gain (loss) on marketable securities | 39 | (34 | ) | 39 | (37 | ) | |||||||||
Foreign currency translation adjustment | 213 | (143 | ) | (691 | ) | (460 | ) | ||||||||
Comprehensive income (loss) | $ | 15,360 | $ | (31,441 | ) | $ | (40,268 | ) | $ | (118,180 | ) | ||||
Basic net income (loss) per common share | $ | 0.53 | $ | (1.12 | ) | $ | (1.40 | ) | $ | (4.11 | ) | ||||
Diluted net income (loss) per common share | $ | 0.41 | $ | (1.12 | ) | $ | (1.40 | ) | $ | (4.11 | ) | ||||
Basic weighted average shares outstanding | 28,471,389 | 27,953,803 | 28,322,753 | 28,654,313 | |||||||||||
Diluted weighted average shares outstanding | 37,236,064 | 27,953,803 | 28,322,753 | 28,654,313 |
Consolidated Statements of Cash Flows
(in thousands)
Year Ended | |||||||
2022 | 2021 | ||||||
(unaudited) | |||||||
Cash flows from operating activities | |||||||
Net loss | $ | (39,616 | ) | $ | (117,683 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation expense | 6,060 | 5,754 | |||||
AcQMap Systems converted to sales | 605 | 2,182 | |||||
Sales-type lease gain | (87 | ) | 28 | ||||
Amortization of intangible assets | 420 | 640 | |||||
Non-cash stock-based compensation expense | 9,391 | 13,754 | |||||
Amortization of premiums/(accretion of discounts) on marketable securities, net | (24 | ) | 1,277 | ||||
Amortization of debt issuance cost | 850 | 1,404 | |||||
Amortization of operating lease right-of-use assets | 649 | 496 | |||||
12,026 | — | ||||||
Loss on extinguishment of debt | 7,947 | — | |||||
Gain on sale of business, net | (79,465 | ) | — | ||||
Direct costs paid for sale of business | (4,027 | ) | — | ||||
Change in fair value of warrant liability | (33 | ) | — | ||||
Loss on disposal of fixed assets | 825 | — | |||||
Change in fair value of contingent consideration | 1,053 | (3,746 | ) | ||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (452 | ) | (1,473 | ) | |||
Inventory | 3,081 | (3,872 | ) | ||||
Employer retention credit receivable | (4,703 | ) | — | ||||
Prepaid expenses and other current assets | 2,804 | 1,133 | |||||
Other assets | 475 | 304 | |||||
Accounts payable | (2,852 | ) | (871 | ) | |||
Accrued liabilities | 605 | 1,549 | |||||
Operating lease liabilities | (526 | ) | (608 | ) | |||
Other long-term liabilities | (38 | ) | 50 | ||||
Net cash used in operating activities | (85,032 | ) | (99,682 | ) | |||
Cash flows from investing activities | |||||||
Proceeds from sale of business | 70,000 | — | |||||
Purchases of available-for-sale marketable securities | (54,508 | ) | (87,258 | ) | |||
Sales of available-for-sale marketable securities | 18,599 | 8,590 | |||||
Maturities of available-for-sale marketable securities | 74,642 | 107,707 | |||||
Purchases of fixed assets | (3,983 | ) | (9,973 | ) | |||
Net cash provided by investing activities | 104,750 | 19,066 | |||||
Cash flows from financing activities | |||||||
Proceeds from issuance of common stock, net of issuance costs | — | 82,657 | |||||
Proceeds from the exercise of stock options | 67 | 711 | |||||
Repurchase of common shares to pay employee withholding taxes | (111 | ) | — | ||||
Proceeds from employee stock purchase plan | 214 | 440 | |||||
Payment of contingent consideration | (872 | ) | (3,435 | ) | |||
Payment of deferred offering costs | — | (580 | ) | ||||
Payment of contingent consideration into escrow | — | (224 | ) | ||||
Repayment of old term loan | (44,550 | ) | — | ||||
Prepayment penalty fees | (1,063 | ) | — | ||||
Borrowing under new term loan | 34,825 | — | |||||
Payment of debt issuance costs for new loan | (626 | ) | — | ||||
Net cash (used in) provided by financing activities | (12,116 | ) | 79,569 | ||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (475 | ) | (116 | ) | |||
Net change in cash, cash equivalents and restricted cash | 7,127 | (1,163 | ) | ||||
Cash, cash equivalents and restricted cash, at the beginning of the period | 24,221 | 25,384 | |||||
Cash, cash equivalents and restricted cash, at the end of the period | $ | 31,348 | $ | 24,221 |
Reconciliation of GAAP Results to Non-GAAP Results
(in thousands)
(unaudited)
Three Months Ended | Cost of Products Sold | Research and Development | Selling, General and Administrative | Loss from Operations | Other Expense, Net | Net Income (loss) | Basic EPS | Diluted EPS | ||||||||||||||||||||||||
Reported | $ | 8,321 | $ | 6,269 | $ | 9,447 | $ | 16,824 | $ | (1,634 | ) | $ | 15,108 | |||||||||||||||||||
Amortization of acquired intangibles | (50 | ) | — | — | 50 | — | 50 | |||||||||||||||||||||||||
Stock-based compensation | (125 | ) | (319 | ) | (1,450 | ) | 1,894 | — | 1,894 | |||||||||||||||||||||||
Restructuring charges | — | — | — | 91 | — | 91 | ||||||||||||||||||||||||||
Change in fair value of warrant liability | — | — | — | — | 871 | 871 | ||||||||||||||||||||||||||
Change in fair value of contingent consideration | — | — | — | (100 | ) | — | (100 | ) | ||||||||||||||||||||||||
Gain on sale of business | — | — | — | (35,890 | ) | — | (35,890 | ) | $(1.26 | ) | $(0.96 | ) | ||||||||||||||||||||
Income tax expense | — | — | — | — | 82 | |||||||||||||||||||||||||||
Adjusted | $ | 8,146 | $ | 5,950 | $ | 7,997 | $ | (17,131 | ) | $ | (763 | ) | $ | (17,894 | ) | $(0.63 | ) | $(0.48 | ) | |||||||||||||
Three Months Ended | Cost of Products Sold | Research and Development | Selling, General and Administrative | Loss from Operations | Other Expense, Net | Net Loss | Basic and Diluted EPS | |||||||||||||||||||||||||
Reported | $ | 9,939 | $ | 8,840 | $ | 15,865 | $ | (29,900 | ) | $ | (1,364 | ) | $ | (31,264 | ) | $(1.12 | ) | |||||||||||||||
Amortization of acquired intangibles | (155 | ) | — | (5 | ) | 160 | — | 160 | ||||||||||||||||||||||||
Stock-based compensation | (241 | ) | (543 | ) | (2,710 | ) | 3,494 | — | 3,494 | |||||||||||||||||||||||
Change in fair value of contingent consideration | — | — | — | (382 | ) | — | (382 | ) | $(0.01 | ) | ||||||||||||||||||||||
Adjusted | $ | 9,543 | $ | 8,297 | $ | 13,150 | $ | (26,628 | ) | $ | (1,364 | ) | $ | (27,992 | ) | $(1.00 | ) |
Twelve Months Ended | Cost of Products Sold | Research and Development | Selling, General and Administrative | Loss from Operations | Other Expense, Net | Net Loss | Basic and Diluted EPS | |||||||||||||||||||||
Reported | $ | 31,910 | $ | 28,153 | $ | 47,654 | $ | (27,339 | ) | $ | (12,195 | ) | $ | (39,616 | ) | $(1.40 | ) | |||||||||||
Amortization of acquired intangibles | (410 | ) | — | (10 | ) | 420 | — | 420 | ||||||||||||||||||||
Stock-based compensation | (669 | ) | (1,736 | ) | (6,986 | ) | 9,391 | — | 9,391 | |||||||||||||||||||
— | — | — | 12,026 | — | 12,026 | |||||||||||||||||||||||
Restructuring charges | — | — | — | 2,371 | — | 2,371 | ||||||||||||||||||||||
Change in fair value of contingent consideration | — | — | — | 1,053 | — | 1,053 | ||||||||||||||||||||||
Gain on sale of business | — | — | — | (79,465 | ) | — | (79,465 | ) | $(2.79 | ) | ||||||||||||||||||
Loss on debt extinguishment | — | — | — | — | 7,947 | 7,947 | ||||||||||||||||||||||
Change in fair value of warrant liability | — | — | — | — | (33 | ) | (33 | ) | ||||||||||||||||||||
Employee retention credit | 2,316 | 1,808 | 2,661 | (6,785 | ) | — | (6,785 | ) | $(0.24 | ) | ||||||||||||||||||
Income tax expense | — | — | — | — | 82 | |||||||||||||||||||||||
Adjusted | $ | 33,147 | $ | 28,225 | $ | 43,319 | $ | (88,328 | ) | $ | (4,281 | ) | $ | (92,609 | ) | $(3.27 | ) | |||||||||||
Twelve Months Ended | Cost of Products Sold | Research and Development | Selling, General and Administrative | Loss from Operations | Other Expense, Net | Net Loss | Basic and Diluted EPS | |||||||||||||||||||||
Reported | $ | 32,925 | $ | 36,683 | $ | 63,523 | $ | (112,122 | ) | $ | (5,561 | ) | $ | (117,683 | ) | $(4.11 | ) | |||||||||||
Amortization of acquired intangibles | (310 | ) | — | (330 | ) | 640 | — | 640 | ||||||||||||||||||||
Stock-based compensation | (864 | ) | (2,181 | ) | (10,709 | ) | 13,754 | — | 13,754 | |||||||||||||||||||
Change in fair value of contingent consideration | — | — | — | (3,746 | ) | — | (3,746 | ) | $(0.13 | ) | ||||||||||||||||||
Adjusted | $ | 31,751 | $ | 34,502 | $ | 52,484 | $ | (101,474 | ) | $ | (5,561 | ) | $ | (107,035 | ) | $(3.74 | ) |
Key Business Metrics
(unaudited)
Installed Base & Procedure Volumes
Procedure volumes for the three months and twelve months ended
Three Months Ended | Twelve Months Ended | ||||||
2022 | 2021 | 2022 | 2021 | ||||
Procedure volumes | 472 | 425 | 1,861 | 1,570 |
The total installed base which includes AcQMap Systems as of
Revenue
The following table sets forth the Company’s revenue for disposables, systems and service/other for both the three months and the twelve months ended
Three Months Ended | Twelve Months Ended | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
Disposables | $ | 3,520 | $ | 3,249 | $ | 12,922 | $ | 11,938 | |||
Systems | 927 | 761 | 1,750 | 4,058 | |||||||
Service / other | 515 | 352 | 1,691 | 1,267 | |||||||
Total revenue | 4,962 | 4,362 | 16,363 | 17,263 |
The following table provides revenue by geographic location for both the three months and the twelve months ended
Three Months Ended | Twelve Months Ended | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
$ | 2,722 | $ | 2,069 | $ | 8,707 | $ | 8,325 | ||||
Outside | 2,240 | 2,293 | 7,656 | 8,938 | |||||||
Total revenue | $ | 4,962 | $ | 4,362 | $ | 16,363 | $ | 17,263 |
Source:
2023 GlobeNewswire, Inc., source