UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2020
OR
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 001-39430
ACUTUS MEDICAL, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
45-1306615 |
|
(State or other jurisdiction of |
(I.R.S. Employer |
|
|
|
|
2210 Faraday Ave., Suite 100, Carlsbad, CA |
92008 |
|
(Address of principal executive offices) |
(zip code) |
(Registrant’s telephone number, including area code) (442) 232-6080
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
|
Trading Symbol |
|
Name of each exchange on which registered |
|
Common Stock, par value $0.001 per share |
|
AFIB |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐
Indicate by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Large accelerated filer |
|
☐ |
Accelerated filer |
|
☐ |
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|
Non-accelerated filer |
|
☒ |
Smaller reporting company |
|
☒ |
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|
|
|
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. ☐
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.
|
Class of Common Stock |
|
Outstanding Shares as of November 9, 2020 |
|
Common Stock, $0.001 par value |
|
27,846,083 |
ACUTUS MEDICAL, INC. AND SUBSIDIARIES
Form 10-Q
For the Quarter Ended September 30, 2020
Table of Contents
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Page |
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PART I. FINANCIAL INFORMATION |
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Item 1. |
1 |
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Condensed Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019 |
1 |
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2 |
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3 |
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5 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
6 |
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Item 2. |
Management’s Discussion and Analysis of the Results of Operations |
31 |
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Item 3. |
47 |
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Item 4. |
47 |
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Item 1. |
48 |
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Item 1A. |
48 |
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Item 2. |
48 |
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Item 6. |
49 |
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50 |
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Acutus Medical, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
|
|
|
September 30, 2020 |
|
|
December 31, 2019 |
|
||
|
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|
(unaudited) |
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ASSETS: |
|
|
|
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|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
58,302 |
|
|
$ |
9,452 |
|
|
Marketable securities, short-term |
|
|
99,742 |
|
|
|
62,351 |
|
|
Restricted cash |
|
|
150 |
|
|
|
150 |
|
|
Accounts receivable |
|
|
1,893 |
|
|
|
263 |
|
|
Inventory |
|
|
10,932 |
|
|
|
8,424 |
|
|
Prepaid expenses and other current assets |
|
|
4,635 |
|
|
|
1,816 |
|
|
Total current assets |
|
|
175,654 |
|
|
|
82,456 |
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities, long-term |
|
|
8,789 |
|
|
|
— |
|
|
Property and equipment, net |
|
|
9,940 |
|
|
|
4,427 |
|
|
Right-of-use asset, net |
|
|
1,838 |
|
|
|
2,341 |
|
|
Intangible assets, net |
|
|
3,780 |
|
|
|
4,110 |
|
|
Goodwill |
|
|
12,026 |
|
|
|
12,026 |
|
|
Other assets |
|
|
482 |
|
|
|
95 |
|
|
Total assets |
|
$ |
212,509 |
|
|
$ |
105,455 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,723 |
|
|
$ |
3,882 |
|
|
Accrued liabilities |
|
|
6,500 |
|
|
|
10,076 |
|
|
Contingent consideration, short-term |
|
|
4,000 |
|
|
|
8,200 |
|
|
Operating lease liabilities, short-term |
|
|
907 |
|
|
|
833 |
|
|
Common and preferred stock warrant liability |
|
|
— |
|
|
|
8,919 |
|
|
Total current liabilities |
|
|
16,130 |
|
|
|
31,910 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities, long-term |
|
|
1,365 |
|
|
|
2,054 |
|
|
Long-term debt |
|
|
38,762 |
|
|
|
38,244 |
|
|
Contingent consideration, long-term |
|
|
3,600 |
|
|
|
5,700 |
|
|
Other long-term liabilities |
|
|
8 |
|
|
|
— |
|
|
Total liabilities |
|
|
59,865 |
|
|
|
77,908 |
|
|
|
|
|
|
|
|
|
|
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Commitments and contingencies (Note 12) |
|
|
|
|
|
|
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|
|
|
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|
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|
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Convertible preferred stock |
|
|
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|
|
Series A convertible preferred stock, $0.001 par value; no shares authorized, issued and outstanding as of September 30, 2020; 3,848,696 shares authorized and 391,210 shares issued and outstanding as of December 31, 2019; liquidation preference of $3,245 as of December 31, 2019 |
|
|
— |
|
|
|
3,059 |
|
|
Series B convertible preferred stock, $0.001 par value; no shares authorized, issued and outstanding as of September 30, 2020; 30,032,100 shares authorized and 3,088,444 shares issued and outstanding as of December 31, 2019; liquidation preference of $41,294 as of December 31, 2019 |
|
|
— |
|
|
|
40,685 |
|
|
Series C convertible preferred stock, $0.001 par value; no shares authorized, issued and outstanding as of September 30, 2020; 48,184,000 shares authorized and 4,499,921 shares issued and outstanding as of December 31, 2019; liquidation preference of $75,000 as of December 31, 2019 |
|
|
— |
|
|
|
74,575 |
|
|
Series D convertible preferred stock, $0.001 par value; no shares authorized, issued and outstanding as of September 30, 2020; 90,000,000 shares authorized and 8,200,297 issued and outstanding as of December 31, 2019; liquidation preference of $136,675 as of December 31, 2019 |
|
|
— |
|
|
|
135,039 |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity (deficit) |
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of September 30, 2020 and no shares authorized as of December 31, 2019; no shares issued and outstanding as of each of September 30, 2020 and December 31, 2019, respectively |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.001 par value; 260,000,000 shares authorized as of each of September 30, 2020 and December 31, 2019; 27,826,408 and 695,902 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively |
|
|
28 |
|
|
|
1 |
|
|
Additional paid-in capital |
|
|
484,162 |
|
|
|
33,252 |
|
|
Accumulated deficit |
|
|
(331,613 |
) |
|
|
(259,034 |
) |
|
Accumulated other comprehensive income (loss) |
|
|
67 |
|
|
|
(30 |
) |
|
Total stockholders' equity (deficit) |
|
|
152,644 |
|
|
|
(225,811 |
) |
|
Total liabilities, convertible preferred stock and stockholders' equity (deficit) |
|
$ |
212,509 |
|
|
$ |
105,455 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Acutus Medical, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
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2020 |
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2019 |
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2020 |
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2019 |
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||||
|
Revenue |
|
$ |
3,173 |
|
|
$ |
646 |
|
|
$ |
5,890 |
|
|
$ |
2,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
5,141 |
|
|
|
2,267 |
|
|
|
10,998 |
|
|
|
6,878 |
|
|
Research and development |
|
|
8,343 |
|
|
|
5,865 |
|
|
|
24,492 |
|
|
|
15,489 |
|
|
Research and development - license acquired |
|
|
— |
|
|
|
15,000 |
|
|
|
— |
|
|
|
15,000 |
|
|
Selling, general and administrative |
|
|
15,833 |
|
|
|
7,978 |
|
|
|
35,193 |
|
|
|
18,998 |
|
|
Change in fair value of contingent consideration |
|
|
118 |
|
|
|
700 |
|
|
|
(1,466 |
) |
|
|
700 |
|
|
Total costs and operating expenses |
|
|
29,435 |
|
|
|
31,810 |
|
|
|
69,217 |
|
|
|
57,065 |
|
|
Loss from operations |
|
|
(26,262 |
) |
|
|
(31,164 |
) |
|
|
(63,327 |
) |
|
|
(54,898 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrant liability and embedded derivative |
|
|
(3,683 |
) |
|
|
(3 |
) |
|
|
(5,555 |
) |
|
|
(608 |
) |
|
Loss on debt extinguishment |
|
|
— |
|
|
|
(49 |
) |
|
|
— |
|
|
|
(1,447 |
) |
|
Interest income |
|
|
23 |
|
|
|
525 |
|
|
|
393 |
|
|
|
733 |
|
|
Interest expense |
|
|
(1,366 |
) |
|
|
(1,394 |
) |
|
|
(4,090 |
) |
|
|
(20,905 |
) |
|
Total other expense, net |
|
|
(5,026 |
) |
|
|
(921 |
) |
|
|
(9,252 |
) |
|
|
(22,227 |
) |
|
Net loss |
|
$ |
(31,288 |
) |
|
$ |
(32,085 |
) |
|
$ |
(72,579 |
) |
|
$ |
(77,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
|
(9 |
) |
|
|
40 |
|
|
|
(50 |
) |
|
|
47 |
|
|
Foreign currency translation adjustment |
|
|
78 |
|
|
|
(45 |
) |
|
|
147 |
|
|
|
(57 |
) |
|
Comprehensive loss |
|
$ |
(31,219 |
) |
|
$ |
(32,090 |
) |
|
$ |
(72,482 |
) |
|
$ |
(77,135 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(1.95 |
) |
|
$ |
(47.21 |
) |
|
$ |
(12.36 |
) |
|
$ |
(115.66 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
|
16,080,467 |
|
|
|
679,591 |
|
|
|
5,870,861 |
|
|
|
666,823 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Acutus Medical, Inc. and Subsidiaries
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
(Unaudited)
For the Three Months Ended September 30, 2020
|
|
|
Series A |
|
|
Series B |
|
|
Series C |
|
|
Series D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Total |
|
||||||||||||||||||||||
|
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated |
|
|
Other Comprehensive |
|
|
Equity Stockholders' |
|
|||||||||||||||||||||||||||||
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income (Loss) |
|
|
(Deficit) |
|
||||||||||||||
|
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 |
) |
|
Unrealized loss on marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(9 |
) |
|
|
(9 |
) |
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
78 |
|
|
|
78 |
|
|
Conversion of convertible preferred stock into common stock upon IPO |
|
|
(391,210 |
) |
|
|
(3,059 |
) |
|
|
(3,088,444 |
) |
|
|
(40,685 |
) |
|
|
(4,499,921 |
) |
|
|
(74,575 |
) |
|
|
(8,593,360 |
) |
|
|
(142,236 |
) |
|
|
|
16,572,935 |
|
|
|
17 |
|
|
|
260,538 |
|
|
|
— |
|
|
|
— |
|
|
|
260,555 |
|
|
Issuance of common stock for cash, net of issuance costs of $16,361 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
10,147,058 |
|
|
|
10 |
|
|
|
166,276 |
|
|
|
— |
|
|
|
— |
|
|
|
166,286 |
|
|
Reclassification of warrant liability to stockholders' equity |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
14,474 |
|
|
|
— |
|
|
|
— |
|
|
|
14,474 |
|
|
Stock option exercises |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
27,661 |
|
|
|
— |
|
|
|
145 |
|
|
|
— |
|
|
|
— |
|
|
|
145 |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
303,351 |
|
|
|
— |
|
|
|
6,374 |
|
|
|
— |
|
|
|
— |
|
|
|
6,374 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(31,288 |
) |
|
|
— |
|
|
|
(31,288 |
) |
|
Balance as of September 30, 2020 (unaudited) |
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
— |
|
|
|
|
27,826,408 |
|
|
$ |
28 |
|
|
$ |
484,162 |
|
|
$ |
(331,613 |
) |
|
$ |
67 |
|
|
$ |
152,644 |
|
For the Three Months Ended September 30, 2019
|
|
|
Series A |
|
|
Series B |
|
|
Series C |
|
|
Series D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|||||||||||||||||||||
|
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated |
|
|
Other Comprehensive |
|
|
Total Stockholders' |
|
|||||||||||||||||||||||||||||
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income (Loss) |
|
|
Deficit |
|
||||||||||||||
|
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 |
) |
|
Unrealized gain on marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
40 |
|
|
|
40 |
|
|
Foreign currency translation adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(45 |
) |
|
|
(45 |
) |
|
Issuance of Series D convertible preferred stock for cash, net of issuance costs of $1,358 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,781,860 |
|
|
|
28,341 |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
4,612 |
|
|
|
— |
|
|
|
812 |
|
|
|
— |
|
|
|
— |
|
|
|
812 |
|
|
Stock option exercises |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
7,452 |
|
|
|
— |
|
|
|
19 |
|
|
|
— |
|
|
|
— |
|
|
|
19 |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(32,085 |
) |
|
|
— |
|
|
|
(32,085 |
) |
|
Balance as of September 30, 2019 (unaudited) |
|
|
391,210 |
|
|
$ |
3,059 |
|
|
|
3,088,444 |
|
|
$ |
40,685 |
|
|
|
4,499,921 |
|
|
$ |
74,575 |
|
|
|
8,200,297 |
|
|
$ |
135,043 |
|
|
|
|
684,024 |
|
|
$ |
1 |
|
|
$ |
32,400 |
|
|
$ |
(239,120 |
) |
|
$ |
10 |
|
|
$ |
(206,709 |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Acutus Medical, Inc. and Subsidiaries
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
(Unaudited)
For the Nine Months Ended September 30, 2020
|
|
|
Series A |
|
|
Series B |
|
|
Series C |
|
|
Series D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Total |
|
||||||||||||||||||||||
|
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
Convertible Preferred Stock |
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated |
|
|
Other Comprehensive |
|
|
Stockholders' Equity |
|
|||||||||||||||||||||||||||||
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income (Loss) |
|
|
(Deficit) |
|
||||||||||||||
|
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 |
|
|
$ |
||||||||||