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 Corner Rhiannon Pickus
Westwicke ICR Acutus Medical, Inc.
D: 415-202-5678 M: 442-232-6094
caroline.corner@westwicke.com Rhiannon.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   OtherExpense, Net   Net Loss   Basic andDiluted 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) fromOperations   OtherExpense, 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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