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Acutus Medical Reports Second Quarter 2023 Financial Results

CARLSBAD, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- 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 second quarter of 2023.

Recent Highlights:

  • Second quarter revenue of $5.3 million grew 30% year-over-year, reflecting strong procedure volume growth and improved capital sales
  • Quarterly AcQMap procedure volumes set a new record and increased 21% compared to the second quarter of 2022
  • Received FDA 510K clearance for AcQMap 9 next generation software platform featuring advanced algorithms and automation to improve diagnostic capabilities and procedure workflow
  • Significant improvements in non-GAAP gross margin and cash burn resulting from disciplined focus on operational excellence

“Our second quarter performance reflects significant progress on our key strategic initiatives to return our business to growth while driving further operational improvement. During the second quarter of 2023, we achieved record procedure volumes, as focused commercial execution, pull through from the AcQMap 8.5 software launch, and the positive results from the RECOVER AF study supported accelerated AcQMap adoption,” said David Roman, President & CEO of Acutus Medical. “The strategic actions we have successfully undertaken over the past year, along with our team’s crisp execution, are driving momentum in our business and enabling our mission to create a new paradigm for the diagnosis and treatment of complex cardiac arrhythmias.”

Second Quarter 2023 Financial Results

Revenue was $5.3 million for the second quarter of 2023, an increase of 30% compared to $4.1 million for the second quarter of 2022. The improvement over the same quarter last year was primarily driven by disposables sales, higher capital conversions, increases in service, rent and other revenue, and sales through the Company’s distribution agreement with Medtronic.

Non-GAAP gross margin was negative 49% for the second quarter of 2023 compared to negative 129% for the same quarter last year. The improvement was driven by higher production volumes, improved product and geographic mix, lower manufacturing variances, and a reduced manufacturing overhead structure.

Non-GAAP operating expenses were $14.5 million for the second quarter of 2023 compared with $19.7 million in the same quarter last year. The decrease in operating expenses resulted from the Company’s restructuring actions in the first half of 2022, reduced discretionary spend, and the reprioritization of certain research and development programs.

Non-GAAP net loss for the second quarter of 2023 was $17.6 million, or $0.60 per share on a weighted average basic and diluted outstanding share count of 29.0 million, compared to non-GAAP net loss of $26.2 million, or $0.93 per share on a weighted average basic and diluted outstanding share count of 28.3 million, for the second quarter of 2022.

Cash, cash equivalents, marketable securities and restricted cash were $61.5 million as of June 30, 2023.

2023 Outlook

The company now expects full year 2023 revenue to be in a range from $20.0-$22.0 million.

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 second quarter 2023 financial results after market close on Monday, August 7, 2023 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/BI93bb82b6296f43ae9eb227af3e9a6f7f. 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 at https://ir.acutusmedical.com.

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 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.

Investor Contact:Media Contact:
Caroline CornerRhiannon Pickus
Westwicke ICRAcutus Medical, Inc.
D: 415-202-5678M: 442-232-6094
caroline.corner@westwicke.comRhiannon.Pickus@acutus.com



ACUTUS MEDICAL, INC.
Condensed Consolidated Balance Sheets
(in thousands, except per share amounts)
 
 June 30, 2023 December 31, 2022
 (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 asset, 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   
    
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 



ACUTUS MEDICAL, INC.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except per share amounts)
 
 Three Months Ended June 30, Six Months Ended June 30,
  2023   2022   2023   2022 
 (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 



ACUTUS MEDICAL, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
 
 Six Months Ended June 30,
  2023   2022 
 (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 cost 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 
    
    
 Six Months Ended June 30,
  2023   2022 
 (unaudited)
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 



ACUTUS MEDICAL, INC.
Reconciliation of GAAP Results to Non-GAAP Results
(in thousands)
(unaudited)
 
Three Months Ended June 30, 2023 Cost of Products Sold Research and Development Selling,
General and Administrative
 Loss from Operations Other
Expense, Net
 Net Loss Basic and
Diluted EPS
  
Reported $8,063  $6,799  $9,284  $(17,171) $(1,175) $(18,346) $(0.63)  
Amortization of acquired intangibles  (50)        50      50   0.00   
Stock-based compensation  (153)  (336)  (1,245)  1,734      1,734   0.06   
Restructuring charges           463      463   0.02   
Change in fair value of warrant liability              604   604   0.02   
Change in fair value of contingent consideration           (77)     (77)  0.00   
Gain on sale of business           (2,072)     (2,072)  (0.07)  
Adjusted $7,860  $6,463  $8,039  $(17,073) $(571) $(17,644) $(0.60)  
                 
                 
Three Months Ended June 30, 2022 Cost of Products Sold Research and Development Selling,
General and Administrative
 Income (Loss) from
Operations
 Other
Expense, Net
 Net Income (Loss) Net income allocated to common stockholders Basic and Diluted EPS
Reported $9,697  $7,935  $14,143  $14,928  $(9,210) $5,718  $4,521  $0.16 
Amortization of acquired intangibles  (155)     (5)  160      160   160   0.01 
Stock-based compensation  (225)  (554)  (1,802)  2,581      2,581   2,581   0.09 
Change in fair value of contingent consideration           948      948   948   0.03 
Gain on sale of business           (43,575)     (43,575)  (43,575)  (1.54)
Loss on debt extinguishment              7,947   7,947   7,947   0.28 
Net income allocated to participating securities                    1,197   0.04 
Adjusted $9,317  $7,381  $12,336  $(24,958) $(1,263) $(26,221) $(26,221) $(0.93)



ACUTUS MEDICAL, INC.
Key Business Metrics
(unaudited)

Installed Base and Procedure Volumes

The total installed base which includes AcQMap Systems as of June 30, 2023 and 2022 are as follows:

 As of June 30,
  2023   2022 
Acutus       
U.S. 27   37 
Outside the U.S. 51   38 
Total Acutus net system placements 78   75 


Procedure volumes for the three and six months ended June 30, 2023 and 2022 are as follows:

 Three Months Ended Six Months Ended
 June 30, June 30,
  2023   2022   2023   2022 
Procedure volumes 584   481   1,035   948 


Revenue

The following table sets forth the Company’s revenue for disposables, systems and service/other for the three and six months ended June 30, 2023 and 2022 (in thousands):

 Three Months Ended Six Months Ended
 June 30, June 30,
  2023   2022   2023   2022 
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 


The following table presents revenue by geographic location for the three and six months ended June 30, 2023 and 2022 (in thousands):

 Three Months Ended Six Months Ended
 June 30, June 30,
  2023   2022   2023   2022 
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 


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