Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB) today reported results for the third quarter of 2023.

Recent Highlights:

  • Third quarter revenue of $5.2 million grew 44% year-over-year, led by strong growth in distribution revenue from sales of left-heart access products to Medtronic
  • Registered significant year-over-year reductions in both GAAP and non-GAAP operating expenses and cash burn, resulting from disciplined focus on expense management
  • Announced strategic realignment of resources and corporate restructuring with the objective of optimizing financial position and maximizing free cash flow

Third Quarter 2023 Financial ResultsRevenue was $5.2 million for the third quarter of 2023, an increase of 44% compared to $3.6 million for the third quarter of 2022. The improvement over the same quarter last year was primarily driven by sales through the Company’s distribution agreement with Medtronic, higher capital sales, and increases in service, rent and other revenue.

Gross margin on a GAAP basis was negative 64% for the third quarter of 2023 compared to negative 91% for the same quarter last year. Non-GAAP gross margin was negative 60% for the third quarter of 2023 compared to negative 109% for the same quarter last year. The improvement on both a GAAP and non-GAAP basis was driven by higher production volumes primarily related to left-heart access manufacturing, lower manufacturing variances, and reduced manufacturing overhead expenses.

Operating expenses, consisting of research and development and selling, general and administrative expenses on a GAAP basis were $12.2 million for the third quarter of 2023 compared to $15.6 million for the same quarter last year. Non-GAAP operating expenses were $11.1 million for the third quarter of 2023 compared to $15.2 million for the same quarter last year. The decrease in operating expenses on both a GAAP and Non-GAAP basis resulted from reduced discretionary spend, and the reprioritization of certain research and development programs.

Net loss on a GAAP basis was $13.2 million for the third quarter of 2023 and net loss per share was $0.45 on a weighted average basic and diluted outstanding share count of 29.3 million, compared to a net loss of $20.4 million and a net loss per share of $0.72 on a weighted average basic and diluted outstanding share count of 28.4 million for the same quarter last year. Non-GAAP net loss for the third quarter of 2023 was $15.2 million, or $0.52 per share, compared to non-GAAP net loss of $20.0 million, or $0.70 per share, for the third quarter of 2022.

Cash, cash equivalents, marketable securities and restricted cash were $45.5 million as of September 30, 2023.

OutlookDue 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.

Non-GAAP Financial MeasuresThis press release includes references to non-GAAP gross margin, non-GAAP operating expenses, 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, and all non-GAAP figures provided herein adjust for stock-based compensation, amortization of acquisition-related intangibles, employee retention credit, restructuring charges, changes in the fair value of contingent consideration, gain on sale of business, and change in fair value of warrant liability (as applicable). 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.

About AcutusAcutus 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 StatementsThis 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, 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

ACUTUS MEDICAL, INC.
Condensed Consolidated Balance Sheets
(in thousands, except per share amounts)
 
  September 30, 2023   December 31, 2022
  (unaudited)    
ASSETS      
Current assets:      
Cash and cash equivalents $ 24,100     $ 25,584  
Marketable securities, short-term   14,375       44,863  
Restricted cash, short-term   7,015       5,764  
Accounts receivable   8,952       21,085  
Inventory   15,728       13,327  
Employer retention credit receivable         4,703  
Prepaid expenses and other current assets   2,467       2,541  
Total current assets   72,637       117,867  
       
Property and equipment, net   6,611       9,221  
Right-of-use asset, net   3,359       3,872  
Intangible assets, net   1,433       1,583  
Other assets   688       897  
Total assets $ 84,728     $ 133,440  
       
LIABILITIES AND STOCKHOLDERS' EQUITY      
Current liabilities:      
Accounts payable $ 4,754     $ 4,721  
Accrued liabilities   7,438       9,686  
Contingent consideration, short-term         1,800  
Operating lease liabilities, short-term   707       319  
Warrant liability   1,868       3,346  
Total current liabilities   14,767       19,872  
       
Operating lease liabilities, long-term   3,462       4,103  
Long-term debt   34,761       34,434  
Other long-term liabilities   32       12  
Total liabilities   53,022       58,421  
       
Commitments and contingencies      
       
Stockholders' equity      
Preferred stock, $0.001 par value; 5,000,000 shares authorized as of September 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 September 30, 2023 and December 31, 2022          
Common stock, $0.001 par value; 260,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 29,289,934 and 28,554,656 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively   29       29  
Additional paid-in capital   598,842       594,173  
Accumulated deficit   (566,212 )     (518,314 )
Accumulated other comprehensive loss   (953 )     (869 )
Total stockholders' equity   31,706       75,019  
Total liabilities and stockholders' equity $ 84,728     $ 133,440  

ACUTUS MEDICAL, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
 
  Three Months Ended September 30,   Nine Months Ended September 30,
    2023       2022       2023       2022  
  (unaudited)
Revenue $ 5,238     $ 3,644     $ 14,696     $ 11,401  
Cost of products sold   8,595       6,951       23,447       23,589  
Gross profit   (3,357 )     (3,307 )     (8,751 )     (12,188 )
               
Operating expenses (income):              
Research and development   4,795       5,946       17,712       21,884  
Selling, general and administrative   7,432       9,679       26,280       38,207  
Goodwill impairment                     12,026  
Restructuring         1,331       475       2,280  
Change in fair value of contingent consideration         198       123       1,153  
Gain on sale of business   (2,648 )           (5,927 )     (43,575 )
Total operating expenses   9,579       17,154       38,663       31,975  
Loss from operations   (12,936 )     (20,461 )     (47,414 )     (44,163 )
               
Other income (expense):              
Loss on debt extinguishment                     (7,947 )
Change in fair value of warrant liability   636       904       1,478       904  
Interest income   547       241       2,223       292  
Interest expense   (1,409 )     (1,109 )     (4,110 )     (3,810 )
Total other income (expense), net   (226 )     36       (409 )     (10,561 )
Loss before income taxes   (13,162 )     (20,425 )     (47,823 )     (54,724 )
Income tax expense   75             75        
Net loss $ (13,237 )   $ (20,425 )   $ (47,898 )   $ (54,724 )
               
Other comprehensive income (loss):              
Unrealized gain on marketable securities   4       39       7        
Foreign currency translation adjustment   (66 )     (351 )     (91 )     (904 )
Comprehensive loss $ (13,299 )   $ (20,737 )   $ (47,982 )   $ (55,628 )
               
Net loss per common share, basic and diluted $ (0.45 )   $ (0.72 )   $ (1.65 )   $ (1.93 )
Weighted average shares outstanding, basic and diluted   29,262,768       28,359,516       29,024,353       28,273,207  

ACUTUS MEDICAL, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
 
  Nine Months EndedSeptember 30,
    2023       2022  
  (unaudited)
Cash flows from operating activities      
Net loss $ (47,898 )   $ (54,724 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation expense   3,498       4,653  
AcQMap Systems converted to sales   238       266  
Sales-type lease gain   (310 )     (87 )
Amortization of intangible assets   150       370  
Non-cash stock-based compensation expense   4,915       7,497  
(Accretion of discounts) amortization of premiums on marketable securities, net   (1,318 )     237  
Amortization of debt issuance cost   325       741  
Amortization of operating lease right-of-use assets   513       480  
Loss on debt extinguishment         7,947  
Goodwill impairment         12,026  
Gain on sale of business, net   (5,927 )     (43,575 )
Direct costs paid related to sale of business         (2,917 )
Change in fair value of warrant liability   (1,478 )     (904 )
Loss on disposal of property and equipment   268        
Change in fair value of contingent consideration   123       1,153  
Changes in operating assets and liabilities:      
Accounts receivable   1,244       420  
Inventory   (2,401 )     1,812  
Employer retention credit receivable   4,703        
Prepaid expenses and other current assets   420       (4,296 )
Other assets   495       386  
Accounts payable   (2 )     (2,929 )
Accrued liabilities   (2,430 )     (179 )
Operating lease liabilities   (253 )     (390 )
Other long-term liabilities   20       (40 )
Net cash used in operating activities   (45,105 )     (72,053 )
       
Cash flows from investing activities      
Proceeds from sale of business   17,000       50,000  
Purchases of available-for-sale marketable securities   (38,521 )     (33,235 )
Sales of available-for-sale marketable securities         18,599  
Maturities of available-for-sale marketable securities   70,250       59,642  
Purchases of property and equipment   (1,394 )     (2,473 )
Net cash provided by investing activities   47,335       92,533  
       
Cash flows from financing activities      
Repayment of debt         (44,550 )
Penalty fees paid for early prepayment of debt         (1,063 )
Borrowing under new debt         34,825  
Payment of debt issuance costs         (626 )
Proceeds from the exercise of stock options   4       66  
Repurchase of common shares to pay employee withholding taxes   (275 )     (62 )
Proceeds from employee stock purchase plan   25       182  
Payment of contingent consideration   (1,923 )     (873 )
Net cash used in financing activities   (2,169 )     (12,101 )
       
Effect of exchange rate changes on cash, cash equivalents and restricted cash   (294 )     (447 )
       
Net change in cash, cash equivalents and restricted cash   (233 )     7,932  
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 $ 31,115     $ 32,153  
       
Supplemental disclosure of cash flow information:      
Cash paid for interest $ 3,731     $ 3,101  
       
       
  Nine Months EndedSeptember 30,
    2023       2022  
  (unaudited)
Supplemental disclosure of noncash investing and financing activities:      
Accounts receivable from sale of business $ 6,111     $  
Change in unrealized (gain) loss on marketable securities $ (7 )   $  
Change in unpaid purchases of property and equipment $ 35     $ 48  
Contingent consideration escrow release $     $ 380  
Net book value on AcQMap system sales-type leases $ 238     $ 244  
Amount of debt proceeds allocated to warrant liability $     $ 3,379  

ACUTUS MEDICAL, INC.
Reconciliation of GAAP Results to Non-GAAP Results
(in thousands)
(unaudited)
 
Three Months Ended September 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   $ 8,595     $ 4,795     $ 7,432     $ (12,936 )   $ (226 )   $ (13,237 )   $ (0.45 )
Amortization of acquired intangibles     (50 )                 50             50        
Stock-based compensation     (146 )     (317 )     (815 )     1,278             1,278       0.04  
Change in fair value of warrant liability                             (636 )     (636 )     (0.02 )
Change in fair value of contingent consideration                                         0.00  
Gain on sale of business                       (2,648 )           (2,648 )     (0.09 )
Adjusted   $ 8,399     $ 4,478     $ 6,617     $ (14,256 )   $ (862 )   $ (15,193 )   $ (0.52 )
                             
                             
Three Months Ended September 30, 2022   Cost of Products Sold   Research and Development   Selling, General and Administrative   Loss from Operations   Other Income (Expense), Net   Net 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  
Change in fair value of warrant liability                             (904 )     (904 )     (0.03 )
Change in fair value of contingent consideration                       198             198       0.01  
Restructuring                       1,331             1,331       0.05  
Employee retention credit     813       414       919       (2,146 )           (2,146 )     (0.08 )
Adjusted   $ 7,621     $ 6,011     $ 9,156     $ (19,144 )   $ (868 )   $ (20,012 )   $ (0.70 )
                             

ACUTUS MEDICAL, INC.Key Business Metrics(unaudited)

Installed Base and Procedure Volumes

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

  As of September 30,
  2023   2022
Acutus      
U.S. 26   32
Outside the U.S. 56   42
Total Acutus net system placements 82   74
       

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

  Three Months Ended   Nine Months Ended
  September 30,   September 30,
  2023   2022   2023   2022
Procedure volumes 531   441   1,566   1,389
               

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, 2023 and 2022 (in thousands):

  Three Months Ended   Nine Months Ended
  September 30,   September 30,
  2023   2022   2023   2022
Disposables $ 4,069   $ 2,857   $ 11,409   $ 9,402
Systems   563     476     1,254     823
Service / other   606     311     2,033     1,176
Total revenue $ 5,238   $ 3,644   $ 14,696   $ 11,401
                       

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

  Three Months Ended   Nine Months Ended
  September 30,   September 30,
  2023   2022   2023   2022
United States $ 3,347   $ 1,925   $ 8,720   $ 5,985
Outside the United States   1,891     1,719     5,976     5,416
Total revenue $ 5,238   $ 3,644   $ 14,696   $ 11,401
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