afib-20221110
0001522860FALSE00015228602022-11-102022-11-10

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________________________________
FORM 8-K
_________________________________________
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 10, 2022
_________________________________________
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Acutus Medical, Inc.
(Exact name of Registrant as Specified in Its Charter)
_________________________________________
Delaware001-3943045-1306615
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
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
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
_________________________________________
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):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
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 ClassTrading Symbol(s)Name of Each Exchange on Which Registered
Common Stock, par value $0.001AFIBThe Nasdaq Stock Market LLC
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 
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 10, 2022, Acutus Medical, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its financial results for the quarter ended September 30, 2022. 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, 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
104.0Cover Page Interactive Data File (embedded within the Inline XBRL document)
2


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 10, 2022By:
/s/ Tom Sohn
Tom Sohn
Senior Vice President, General Counsel
3
Document
Exhibit 99.1
Press Release
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Acutus Medical Reports Third Quarter 2022 Financial Results

Carlsbad, Calif. – November 10, 2022 – Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the third quarter of 2022.
Recent Updates:
Reported revenue of $3.6 million in the third quarter of 2022, compared to $4.6 million in the same quarter last year
Global mapping procedures volumes increased 17% from the same quarter last year
Generated significant year-over-year reductions in operating expenses and cash burn for the third quarter of 2022
Submitted US premarket approval (PMA) application for the AcQBlate Force-Sensing Ablation Catheter and System
Announced achievement of Original Equipment Manufacturer milestone in sale of left-heart access portfolio to Medtronic, triggering a $20 million contingent consideration earnout payment from Medtronic

“Our teams continued to execute our strategy, as we achieved another quarter of strong year-over-year growth in procedure volumes while further improving our operating and financial performance,” said David Roman, President & CEO of Acutus. “We are pleased with the trends in our underlying results, including strong mapping procedure volume growth and increased revenue share capture within existing accounts, and we are taking the necessary steps to strengthen our foundation for future growth. These include the filing of the US PMA for AcQBlate and continued optimization of our expense profile, as well as furthering the transition of our left-heart access portfolio to Medtronic.”
Third Quarter 2022 Financial Results
Revenue was $3.6 million for the third quarter of 2022, compared to $4.6 million in the third quarter last year. This decrease of $1.0 million was entirely driven by a decrease of $1.1 million in capital revenue, offsetting a $0.1 million increase in Disposables and Service/Other revenue. Gross margin was negative 91% on a GAAP basis for the three months ended September 30, 2022 and negative 86% for the three months ended September 30, 2021. This decrease in gross margin was primarily attributable to lower sales and the recognition of unfavorable manufacturing variances.
Operating expenses on a GAAP basis were $17.2 million for the third quarter of 2022, compared with $23.2 million in the same quarter last year. The decrease of $6.0 million was primarily attributable to a $1.3 million benefit from the employee retention credit (ERC), lower selling, general and administrative expenses of $5.4 million from cost savings initiatives enacted earlier this year and a $2.8 million reduction in research and development expenses related to the program prioritization. These reductions were partially offset by $1.3 million in restructuring charges that were not incurred in the prior year and an increase of $2.2 million for the contingent consideration related to the acquisition of Rhythm Xience, Inc. prior to our IPO.

Net loss on a GAAP basis was $20.4 million for the third quarter of 2022 and net loss per share was $0.72 on a weighted average basic and diluted outstanding share count of 28.4 million, compared to a net loss of $28.5 million and a net loss per share of $0.94 on a weighted average basic and diluted outstanding share count of 30.5 million in the same period of the prior year.

Excluding amortization of acquired intangibles, non-cash stock-based compensation expense, goodwill impairment, gain on sale of business, debt refinancing charges, restructuring charges, the employee retention credit benefit and changes in the fair value of contingent consideration, the Company’s non-GAAP net loss for the third quarter of 2022 was $20.0 million, or $0.70 per share, compared to a net loss of $26.7 million, or $0.87 per share in the same period of the prior year.

Total cash, cash equivalents, marketable securities and restricted cash was $70.5 million as of September 30, 2022.

Outlook
The Company continues to experience year-over-year headwinds related to foreign exchange and capital equipment sales. In late September, the Company started to experience disruptions in the supply chain for certain raw materials that negatively impacted revenue in the third quarter of 2022 and is expected to have a further negative impact in the fourth quarter of 2022.


Press Release
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The Company now expects revenue to be in a range from $15.5-$16.0 million, which includes incremental headwinds related to both foreign exchange and supply chain pressures.
Non-GAAP Financial Measures
This press release includes references to non-GAAP net loss and non-GAAP 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 income (loss) before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, acquisition related costs, discontinued operations, asset/goodwill impairments, changes in the fair value of contingent consideration, restructuring charges, stock repurchases and other adjustments for non-operating items, such as gain on sale of business, debt financing charges, and employee retention credit benefits. 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 third quarter 2022 financial results after market close on Thursday, November 10, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link: https://register.vevent.com/register/BI3e071f2eac494dbcbf755038c36c29e9. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar of the call may be accessed by visiting the Events section of the Acutus investor relations website at ir.acutusmedical.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.
About Acutus Medical, Inc.
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 headquartered 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 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 the United States and globally, including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the impact of the coronavirus (COVID-19) pandemic and Acutus’ response to it, 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.


Press Release
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Investor Contact:
Media Contact:
Caroline Corner
Levitate
Westwicke ICR
M: 260-408-5383
D: 415-202-5678acutus@levitatenow.com
caroline.corner@westwicke.com


Press Release
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Acutus Medical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share amounts)September 30,
2022
December 31,
2021
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents$28,003 $24,071 
Marketable securities, short-term38,299 76,702 
Restricted cash, short-term150 150 
Accounts receivable3,213 3,633 
Inventory14,596 16,408 
Prepaid expenses and other current assets9,633 5,326 
Total current assets93,894 126,290 
Marketable securities, long-term— 7,120 
Restricted cash, long-term4,000 — 
Property and equipment, net10,087 13,670 
Right-of-use assets, net4,027 4,521 
Intangible assets, net1,633 5,013 
Goodwill— 12,026 
Other assets986 1,152 
Total assets$114,627 $169,792 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable$4,638 $7,519 
Accrued liabilities8,917 9,096 
Contingent consideration, short-term1,900 1,500 
Operating lease liabilities, short-term392 395 
Warrant liability2,475 — 
Total current liabilities18,322 18,510 
Operating lease liabilities, long-term4,204 4,591 
Long-term debt34,310 40,415 
Contingent consideration, long-term— 500 
Other long-term liabilities10 50 
Total liabilities56,846 64,066 
Stockholders' equity
Preferred stock, $0.001 par value— — 
Common stock, $0.001 par value28 28 
Additional paid-in capital592,296 584,613 
Accumulated deficit(533,422)(478,698)
Accumulated other comprehensive loss(1,121)(217)
Total stockholders' equity57,781 105,726 
Total liabilities and stockholders' equity$114,627 $169,792 


Press Release
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Acutus Medical, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in thousands, except share and per share amounts)2022202120222021
(unaudited)(unaudited)
Revenue$3,644 $4,601 $11,401 $12,901 
Costs and operating (income) expenses:
Cost of products sold6,951 8,539 23,589 22,986 
Research and development5,946 9,299 21,884 27,843 
Selling, general and administrative9,679 15,805 38,207 47,658 
Goodwill impairment— — 12,026 — 
Restructuring1,331 — 2,280 — 
Change in fair value of contingent consideration198 (1,953)1,153 (3,364)
Gain on sale of business— — (43,575)— 
Total costs and operating expenses24,105 31,690 55,564 95,123 
Loss from operations(20,461)(27,089)(44,163)(82,222)
Other income (expense):
Loss on debt extinguishment— — (7,947)— 
Change in fair value of warrant liability904 — 904 — 
Interest income241 19 292 88 
Interest expense(1,109)(1,441)(3,810)(4,285)
Total other income (expense), net36 (1,422)(10,561)(4,197)
Loss before income taxes(20,425)(28,511)(54,724)(86,419)
Income tax benefit— — — — 
Net loss$(20,425)$(28,511)$(54,724)$(86,419)
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities39 (13)— (3)
Foreign currency translation adjustment(351)(183)(904)(317)
Comprehensive loss$(20,737)$(28,707)$(55,628)$(86,739)
Net loss per common share, basic and diluted$(0.72)$(0.94)$(1.93)$(2.99)
Weighted average shares outstanding, basic and diluted28,359,516 30,460,466 28,273,207 28,890,382 


Press Release
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Acutus Medical, Inc.
Condensed Consolidated Statements of Cash Flows
Nine Months Ended
September 30,
(in thousands)20222021
(unaudited)
Cash flows from operating activities
Net loss$(54,724)$(86,419)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense4,653 4,227 
AcQMap Systems converted to sales266 — 
Sales-type lease gain(87)— 
Amortization of intangible assets370 480 
Stock-based compensation expense7,497 10,263 
Amortization of premiums and accretion of discounts on marketable securities, net237 1,011 
Amortization of debt issuance costs741 1,032 
Amortization of right-of-use assets480 496 
Goodwill impairment12,026 — 
Loss on debt extinguishment7,947 — 
Gain on sale of business(43,575)— 
Direct costs paid related to sale of business(2,917)— 
Change in fair value of warrant liability(904)— 
Change in fair value of contingent consideration1,153 (3,364)
Changes in operating assets and liabilities:
Accounts receivable420 (2,030)
Inventory1,812 (2,004)
Prepaid expenses and other current assets(4,296)(59)
Other assets386 (369)
Accounts payable(2,929)(1,813)
Accrued liabilities(179)1,862 
Operating lease liabilities(390)(432)
Other long-term liabilities(40)18 
Net cash used in operating activities(72,053)(77,101)
Cash flows from investing activities
Proceeds from sale of business50,000 — 
Purchases of available-for-sale marketable securities(33,235)(70,020)
Sales of available-for-sale marketable securities18,599 8,590 
Maturities of available-for-sale marketable securities59,642 98,507 
Purchases of property and equipment(2,473)(6,587)
Net cash provided by investing activities92,533 30,490 
Cash flows from financing activities
Repayment of debt(44,550)— 
Penalty fees paid for early prepayment of debt(1,063)— 
Borrowing under new debt34,825 — 
Payment of debt issuance costs(626)— 
Payment of deferred offering costs— (572)
Payment of contingent consideration(873)(3,152)
Repurchase of common shares to pay employee withholding taxes(62)— 
Proceeds from stock options exercises66 703 
Proceeds from issuance of common stock, net of issuance costs— 82,664 
Proceeds from employee stock purchase plan182 440 
Net cash (used in) provided by financing activities(12,101)80,083 
Effect of exchange rate changes on cash, cash equivalents and restricted cash(447)(214)
Net change in cash, cash equivalents and restricted cash7,932 33,258 
Cash, cash equivalents and restricted cash, at the beginning of the period24,221 25,384 
Cash, cash equivalents and restricted cash, at the end of the period$32,153 $58,642 


Press Release
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Acutus Medical, Inc.
Reconciliation of GAAP Results to Non-GAAP Results
(Unaudited)
Three Months Ended September 30, 2022Cost of products soldResearch and developmentSelling, general and administrativeIncome (loss) from operationsOther expenses, netNet income (loss)Basic and diluted EPS
Reported$6,951 $5,946 $9,679 $(20,461)$36 $(20,425)$(0.72)
Amortization of acquired intangibles(50)— — 50 — 50 — 
Stock-based compensation(93)(349)(1,442)1,884 — 1,884 0.07 
Employee retention credit813 414 919 (2,146)— (2,146)(0.08)
Restructuring— — — 1,331 — 1,331 0.05 
Change in fair value of contingent consideration— — — 198 — 198 0.01 
Change in fair value of warrant liability— — — — (904)— (0.03)
Adjusted$7,621 $6,011 $9,156 $(19,144)$(868)$(20,012)$(0.70)
Three Months Ended September 30, 2021Cost of products soldResearch and developmentSelling, general and administrativeLoss from operationsOther expenses, netNet lossBasic and diluted EPS
Reported$8,539 $9,299 $15,805 $(27,089)$(1,422)$(28,511)$(0.94)
Amortization of acquired intangibles(155)— (5)160 — 160 0.01 
Stock-based compensation(243)(567)(2,767)3,577 — 3,577 0.12 
Change in fair value of contingent consideration— — — (1,953)— (1,953)(0.06)
Adjusted$8,141 $8,732 $13,033 $(25,305)$(1,422)$(26,727)$(0.87)



Press Release
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Acutus Medical, Inc.
Key Business Metrics
Installed Base & Procedure Volumes

Our total installed base as of September 30, 2022 and 2021 are set forth in the table below:
September 30,
20222021
Key Business Metrics(unaudited)
Installed base (1)
74 71 
(1) Installed base includes AcQMap Systems.

Our total procedure volumes for the three and nine months ended September 30, 2022 and 2021 is set forth in the table below:


Three Months Ended September 30,
Nine Months Ended September 30,
2022202120222021
Key Business Metrics(unaudited)(unaudited)
Procedure volumes441 3771,389 1,145


Revenue
The following table sets forth the Company’s revenue for disposables, systems and service/other for the three and nine months ended September 30, 2022 and 2021 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022202120222021
(unaudited)(unaudited)
Disposables$2,857 $2,837 $9,402 $8,690 
Systems476 1,529 823 3,296 
Service/Other311 235 1,176 915 
Total revenue$3,644 $4,601 $11,401 $12,901 
The following table provides revenue by geographic location for the three and nine months ended September 30, 2022 and 2021 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2022202120222021
(unaudited)(unaudited)
United States$1,925 $2,189 $5,985 $6,256 
Outside the United States1,719 2,412 5,416 6,645 
Total revenue$3,644 $4,601 $11,401 $12,901