UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 14, 2024
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(Exact name of Registrant as Specified in Its Charter)
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(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (442 ) 232-6080
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | ||||||
| N/A | ||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
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Item 2.02. Results of Operations and Financial Condition.
On November 14, 2024, the Company issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of this press release is attached as Exhibit 99.1 to this current report on Form 8-K.
The information under Item 2.02 in this current report on Form 8-K and the related information in the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
Exhibit Number | Description | |||||||
| 99.1 | Press release dated November 14, 2024 | |||||||
| 104.0 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Acutus Medical, Inc. | ||||||||
| Date: November 14, 2024 | By: | /s/ Takeo Mukai | ||||||
| Takeo Mukai | ||||||||
| Chief Executive Officer | ||||||||
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| Press Release | Exhibit 99.1 | ||||
 | |||||
Acutus Medical Reports Third Quarter and Year-To-Date 2024 Financial Results
CARLSBAD, Calif., November 14, 2024 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus” or the “Company”) (OTC: AFIB) today reported results for the third quarter and year-to-date of 2024.
Recent Highlights:
•Third quarter revenue from Continuing Operations of $5.3 million grew 156% year-over-year, from $2.1 million in the same quarter last year.
•Operating income for continuing operations was $0.1 million, an improvement of 119% compared to the same period last year.
•Recorded $2.4 million in gain on sale of business, a decrease of 8% compared to the same period last year.
•Cash, cash equivalents, marketable securities and restricted cash were $12.6 million as of September 30, 2024.
Third Quarter 2024 Financial Results
Revenue from Continuing Operations was $5.3 million for the third quarter of 2024, an increase of 156% compared to $2.1 million for the third quarter of 2023.
Gross margin on a GAAP basis for continuing operations was 7% for the third quarter of 2024 compared to negative 53% for the same quarter last year. The improvement was driven by higher production volumes related to left-heart access manufacturing and reduced manufacturing overhead expenses.
Operating income for continuing operations on a GAAP basis was $0.1 million for the third quarter of 2024 compared to Operating expenses of $0.6 million for the same period last year. The decrease in operating expenses from reduced discretionary spend under this new business model.
Net loss on continuing operations on a GAAP basis was $0.8 million for the third quarter of 2024 and net loss per share was $0.03 on a weighted average basic and diluted outstanding share count of 29.8 million, compared to a net loss of $1.9 million and a net loss per share of $0.7 on a weighted average basic and diluted outstanding share count of 29.3 million for the same period last year.
Cash, cash equivalents, marketable securities and restricted cash were $12.6 million as of September 30, 2024.
Loss on Discontinued Operations
Loss on discontinued operations was $4.8 million for third quarter of 2024, compared to $13.2 million for the same period last year.
Loss on discontinued operations was $4.8 million for third quarter of 2024, compared to $13.2 million for the same period last year.
Outlook
Due to the announced plan to realign resources to support the left-heart access distribution business and exit from the electrophysiology mapping and ablation businesses, the Company will no longer provide financial guidance.
About Acutus
Acutus is focused on the production of left-heart access products under its distribution agreement with Medtronic, Inc. Founded in 2011, Acutus is based in Carlsbad, California.
Acutus is focused on the production of left-heart access products under its distribution agreement with Medtronic, Inc. Founded in 2011, Acutus is based in Carlsbad, California.
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
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
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risks and uncertainties that could cause actual results to differ materially from 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, successful completion of the Company’s restructuring plan, continued acceptance of the Company’s left-heart access products in the marketplace, the effect of global economic conditions on the ability and willingness of Medtronic to purchase the Company’s left-heart access products and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States and globally including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the Company’s ability to maintain its listing on Nasdaq, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, Acutus undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
| Investor Contact: | |||||
| Chad Hollister | |||||
| Acutus Medical, Inc. | |||||
| investors@acutus.com | |||||
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Acutus Medical, Inc.
Consolidated Balance Sheets
| September 30, 2024 | December 31, 2023 | ||||||||||
| (in thousands, except share and per share amounts) | (unaudited) | ||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 12,595 | $ | 19,170 | |||||||
| Marketable securities, short-term | — | 3,233 | |||||||||
| Restricted cash, short-term | — | 7,030 | |||||||||
| Accounts receivable | 9,970 | 11,353 | |||||||||
| Inventory | 4,191 | 4,278 | |||||||||
| Prepaid expenses and other current assets | 403 | 678 | |||||||||
| Current assets of discontinued operations (Note 3) | — | 510 | |||||||||
| Total current assets | 27,159 | 46,252 | |||||||||
| Property and equipment, net | 736 | 825 | |||||||||
| Right-of-use assets, net | 2,647 | 3,189 | |||||||||
| Other assets | 94 | 94 | |||||||||
| Non-current assets of discontinued operations (Note 3) | 1,531 | 3,600 | |||||||||
| Total assets | $ | 32,167 | $ | 53,960 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | 1,711 | 2,761 | |||||||||
| Accrued liabilities | 1,702 | 2,887 | |||||||||
| Operating lease liabilities, short-term | 897 | 718 | |||||||||
| Long-term debt, current portion | 7,084 | 1,864 | |||||||||
| Warrant liability | 302 | 409 | |||||||||
| Current liabilities of discontinued operations (Note 3) | 2,969 | 10,303 | |||||||||
| Total current liabilities | 14,665 | 18,942 | |||||||||
| Operating lease liabilities, long-term | 2,532 | 3,243 | |||||||||
| Long-term debt | 25,269 | 32,654 | |||||||||
| Total liabilities | 42,466 | 54,839 | |||||||||
| Commitments and contingencies (Note 11) | |||||||||||
| Stockholders' deficit | |||||||||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 6,666 shares of preferred stock, designated as Series A Common Equivalent Preferred Stock, are issued and outstanding as of September 30, 2024 and December 31, 2023 | — | — | |||||||||
Common stock, $0.001 par value; 260,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 29,912,305 and 29,313,667 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 30 | 29 | |||||||||
| Additional paid-in capital | 598,670 | 599,935 | |||||||||
| Accumulated deficit | (608,118) | (599,977) | |||||||||
| Accumulated other comprehensive loss | (881) | (866) | |||||||||
| Total stockholders' deficit | (10,299) | (879) | |||||||||
| Total liabilities and stockholders' deficit | $ | 32,167 | $ | 53,960 | |||||||
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Acutus Medical, Inc.
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
| (in thousands, except share and per share amounts) | (unaudited) | |||||||||||||||||||||||||
| Revenue | $ | 5,266 | $ | 2,060 | $ | 13,027 | $ | 4,816 | ||||||||||||||||||
| Cost of products sold | 4,894 | 3,150 | 13,019 | 7,835 | ||||||||||||||||||||||
| Gross profit (loss) | 372 | (1,090) | 8 | (3,019) | ||||||||||||||||||||||
| Operating expenses (income): | ||||||||||||||||||||||||||
| Research and development | — | 896 | — | 2,752 | ||||||||||||||||||||||
| Selling, general and administrative | 2,318 | 2,354 | 7,880 | 9,502 | ||||||||||||||||||||||
| Change in fair value of contingent consideration | — | — | — | 123 | ||||||||||||||||||||||
| Gain on sale of business | (2,435) | (2,648) | (8,096) | (5,927) | ||||||||||||||||||||||
| Total operating expenses (income) | (117) | 602 | (216) | 6,450 | ||||||||||||||||||||||
| Gain (loss) from operations | 489 | (1,692) | 224 | (9,469) | ||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||
| Change in fair value of warrant liability | (174) | 636 | 107 | 1,478 | ||||||||||||||||||||||
| Interest income | 153 | 547 | 641 | 2,223 | ||||||||||||||||||||||
| Interest expense | (1,395) | (1,409) | (4,384) | (4,110) | ||||||||||||||||||||||
| Other revenue | 111 | — | 187 | — | ||||||||||||||||||||||
| Total other expense, net | (1,305) | (226) | (3,449) | (409) | ||||||||||||||||||||||
| Loss from continuing operations before income taxes | (816) | (1,918) | (3,225) | (9,878) | ||||||||||||||||||||||
| Net loss from continuing operations | (816) | (1,918) | (3,225) | (9,878) | ||||||||||||||||||||||
| Discontinued operations: | ||||||||||||||||||||||||||
| Loss from discontinued operations before taxes | (4,791) | (11,244) | (4,906) | (37,945) | ||||||||||||||||||||||
| Income tax expense - discontinued operations | — | 75 | 10 | 75 | ||||||||||||||||||||||
| Net loss from discontinued operations | (4,791) | (11,319) | (4,916) | (38,020) | ||||||||||||||||||||||
| Net loss | $ | (5,607) | $ | (13,237) | $ | (8,141) | $ | (47,898) | ||||||||||||||||||
| Other comprehensive loss | ||||||||||||||||||||||||||
| Unrealized loss (gain) on marketable securities | — | 4 | — | 7 | ||||||||||||||||||||||
| Foreign currency translation adjustment | (15) | (66) | (15) | (91) | ||||||||||||||||||||||
| Comprehensive loss | $ | (5,622) | $ | (13,299) | $ | (8,156) | $ | (47,982) | ||||||||||||||||||
| Net loss per share, basic and diluted: | ||||||||||||||||||||||||||
| Loss from continuing operations | $(0.03) | $(0.07) | $(0.11) | $(0.34) | ||||||||||||||||||||||
| Loss from discontinued operations | $(0.16) | $(0.39) | $(0.17) | $(1.31) | ||||||||||||||||||||||
| Net loss per common share | $(0.19) | $(0.45) | $(0.27) | $(1.65) | ||||||||||||||||||||||
| Weighted average shares outstanding, basic and diluted | 29,799,241 | 29,262,768 | 29,768,208 | 29,024,353 | ||||||||||||||||||||||
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Acutus Medical, Inc.
Consolidated Statements of Cash Flows
| Nine Months Ended September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| (in thousands) | (unaudited) | ||||||||||
| Cash flows from operating activities | |||||||||||
| Net loss | $ | (8,141) | $ | (47,898) | |||||||
| Less: Loss from discontinued operations | 4,916 | 38,020 | |||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation expense | 235 | 384 | |||||||||
| Non-cash stock-based compensation expense | 459 | 1,272 | |||||||||
| Accretion of discounts on marketable securities, net | (28) | (1,318) | |||||||||
| Amortization of debt issuance costs | 460 | 325 | |||||||||
| Amortization of operating lease right-of-use assets | 542 | 513 | |||||||||
| Gain on sale of business, net | (8,096) | (5,927) | |||||||||
| Change in fair value of warrant liability | (107) | (1,478) | |||||||||
| Loss on disposal of property and equipment | — | — | |||||||||
| Change in fair value of contingent consideration | — | 123 | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | (3,499) | 3,247 | |||||||||
| Inventory | 87 | 11,567 | |||||||||
| Employer retention credit receivable | — | 4,703 | |||||||||
| Prepaid expenses and other current assets | 286 | 2,010 | |||||||||
| Accounts payable | (1,050) | (3,020) | |||||||||
| Accrued liabilities | (1,442) | (8,043) | |||||||||
| Operating lease liabilities | (532) | (253) | |||||||||
| Other long-term liabilities | — | 20 | |||||||||
| Net cash used in operating activities - continuing operations | (15,910) | (5,753) | |||||||||
| Net cash used in operating activities - discontinued operations | (11,692) | (39,352) | |||||||||
| Net cash used in operating activities | (27,602) | (45,105) | |||||||||
| Cash flows from investing activities | |||||||||||
| Proceeds from sale of business | 13,235 | 17,000 | |||||||||
| Purchases of available-for-sale marketable securities | — | (38,521) | |||||||||
| Sales of available-for-sale marketable securities | 500 | — | |||||||||
| Maturities of available-for-sale marketable securities | 2,750 | 70,250 | |||||||||
| Purchases of property and equipment | (148) | (1,187) | |||||||||
| Net cash provided by investing activities - continuing operations | 16,337 | 47,542 | |||||||||
| Net cash provided by (used in) investing activities - discontinued operations | 339 | (207) | |||||||||
| Net cash provided by investing activities | 16,676 | 47,335 | |||||||||
| Cash flows from financing activities | |||||||||||
| Repayment of debt | (2,625) | — | |||||||||
| Proceeds from the exercise of stock options | — | 4 | |||||||||
| Repurchase of common shares to pay employee withholding taxes | — | (35) | |||||||||
| Proceeds from employee stock purchase plan | — | 25 | |||||||||
| Net cash (used in) provided by financing activities - continuing operations | (2,625) | (1,929) | |||||||||
| Net cash used in financing activities - discontinued operations | (41) | (240) | |||||||||
| Net cash used in financing activities | (2,666) | (2,169) | |||||||||
| Effect of exchange rate changes on cash, cash equivalents and restricted cash | (13) | (294) | |||||||||
| Net change in cash, cash equivalents and restricted cash | (13,605) | (233) | |||||||||
| Cash, cash equivalents and restricted cash, at the beginning of the period | 26,200 | 31,348 | |||||||||
| Cash, cash equivalents and restricted cash, at the end of the period | $ | 12,595 | $ | 31,115 | |||||||
| Supplemental disclosure of cash flow information: | |||||||||||
| Cash paid for interest | 3,394 | 3,731 | |||||||||
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| Supplemental disclosure of noncash investing and financing activities: | |||||||||||
| Accounts receivable from sale of business | $ | 4,478 | $ | 6,111 | |||||||
| Change in unrealized (gain) on marketable securities | $ | — | $ | (7) | |||||||
| Change in unpaid purchases of property and equipment | $ | — | $ | 35 | |||||||