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Acutus Medical Reports First Quarter 2021 Financial Results

CARLSBAD, Calif., May 12, 2021 (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 first quarter of 2021.

Recent Highlights:

  • Reported revenue of $3.6 million in the first quarter of 2021, compared to $1.6 million in the same quarter last year.
  • Increased worldwide installed base of second generation AcQMap consoles to 57 as of March 31, 2021, up from 51 at the end of the prior quarter – bringing the total installed base of AcQMap consoles to 62 as of March 31, 2021.
  • Commenced US IDE trial for the AcQBlate Force-Sensing Ablation Catheter and System.
  • Advanced AcQBlate Force-Sensing Ablation Catheter and System from limited to full market release in CE Mark countries.
  • Received US 510K clearance for AcQCross, a full suite of universal transseptal crossing devices.

“We are pleased with the progress on several key strategic initiatives, including improved revenue performance and commercial execution, the initiation of our US ablation therapy IDE clinical trial, and new product introductions. In the face of regional COVID-19 headwinds, our commercial teams are driving accelerated uptake for our complete guided ablation solutions globally,” said Vince Burgess, President and CEO of Acutus. “Our Europe direct organization and Biotronik partnership led the Company’s first quarter performance, and we continue to see strong execution from these teams. In the US, we are encouraged to see this part of our business gaining momentum as end-markets improve.”

First Quarter 2021 Financial Results
Revenue was $3.6 million for the first quarter of 2021, compared to $1.6 million in the first quarter last year. The improvement over the same quarter last year was driven by increased direct sales of Acutus disposables, sales of the AcQMap consoles, and distributor sales through the Company’s partner, Biotronik.

Gross margin on a GAAP basis was negative 94% for the first quarter of 2021, compared with negative 102% in the same quarter last year. During the quarter, the Company incurred charges for the write-off of excess and obsolete inventory related to the transition to fully in-house manufacturing and product line transition for its transseptal access crossing device portfolio as well as for certain short shelf-life products currently in inventory. These charges had a significant impact on gross margin in the quarter, and this is not expected to recur in subsequent periods.

Operating expenses on a GAAP basis were $24.5 million for the first quarter of 2021, compared with $16.0 million in the same quarter last year. The increase was driven by the expansion of Acutus’ commercial team in conjunction with its full commercial launch, increased general and administrative costs incurred associated with being a public company, and change in fair value of the contingent consideration related to the acquisition of Rhythm Xience.

Net loss on a GAAP basis was $29.2 million for the first quarter of 2021 and net loss per share was $1.04 on a weighted average basic and diluted outstanding share count of 28.0 million, compared to $18.1 million and a net loss per share of $25.84 on a weighted average basic and diluted outstanding share count of 0.7 million in the same period of the prior year. Excluding amortization of acquired intangibles, non-cash stock-based compensation expense, remeasurement of the warrant liability, and changes in the fair value of contingent consideration, the Company’s non-GAAP net loss for the first quarter of 2021 was $27.3 million, or $0.97 per share, compared to $19.0 million, or $1.11 per share, after giving effect to the pro forma conversion of convertible preferred stock for the first quarter of 2020.

Cash, cash equivalents, marketable securities and restricted cash were $106.9 million as of March 31, 2021.

Outlook and COVID-19
COVID-19 continues to create significant uncertainty in several markets that the Company serves, most notably in Western Europe and the UK. Procedure volumes are stabilizing in the US, although some hospital access restrictions remain in effect. The impact of COVID-19 was more acutely negative earlier in 2021, and this dynamic is reflected in the Company’s first quarter financial results. Management anticipates continued regional headwinds in 2021, particularly in the first half of the year. For the full year 2021, management continues to expect revenue to range between $22.0 million and $30.0 million. With respect to the second quarter of 2021, management expects revenue to range between $3.8 million and $5.0 million.

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 loss before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, acquisition related costs, discontinued operations, asset impairments, non-operating items, restructuring charges, stock repurchases, 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 first quarter 2021 financial results after market close on Wednesday, May 12, 2021 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 570-1131 for U.S. callers or (914) 987-7078 for international callers, using conference ID: 9151567. The live webinar can be accessed at https://ir.acutusmedical.com.

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 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, 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 CornerHolly Windler
Westwicke ICRM: 619-929-1275
D: 415-314-1725media@acutusmedical.com
caroline.corner@westwicke.com 
  
  

Acutus Medical, Inc.
Consolidated Balance Sheets

  March 31,  December 31, 
(in thousands, except per share amounts) 2021  2020 
  (unaudited)    
ASSETS        
Current assets:        
Cash and cash equivalents $8,631  $25,234 
Marketable securities, short-term  86,888   105,839 
Restricted cash  150   150 
Accounts receivable  2,477   2,160 
Inventory  13,837   12,958 
Prepaid expenses and other current assets  4,124   5,047 
Total current assets  116,107   151,388 
         
Marketable securities, long-term  11,225   8,726 
Property and equipment, net  14,648   12,356 
Right-of-use assets, net  1,480   1,669 
Intangible assets, net  5,493   5,653 
Goodwill  12,026   12,026 
Other assets  967   717 
Total assets $161,946  $192,535 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $6,108  $8,266 
Accrued liabilities  8,808   7,308 
Contingent consideration, short-term  2,600   5,400 
Operating lease liabilities, short-term  955   933 
Total current liabilities  18,471   21,907 
         
Operating lease liabilities, long-term  875   1,134 
Long-term debt  39,339   39,011 
Contingent consideration, long-term  3,000   3,900 
Total liabilities  61,685   65,952 
         
Stockholders' equity        
Preferred stock, $0.001 par value      
Common stock, $0.001 par value  28   28 
Additional paid-in capital  490,369   487,290 
Accumulated deficit  (390,196)  (361,015)
Accumulated other comprehensive income  60   280 
Total stockholders' equity  100,261   126,583 
Total liabilities and stockholders' equity $161,946  $192,535 
 
 

Acutus Medical, Inc.
Consolidated Statements of Operations and Comprehensive Loss

 Three Months Ended March 31, 
(in thousands, except share and per share amounts)2021  2020 
 (unaudited) 
Revenue$3,591  $1,583 
        
Costs and operating expenses:       
Cost of products sold 6,955   3,194 
Research and development 9,370   7,973 
Selling, general and administrative 16,252   10,235 
Change in fair value of contingent consideration (1,153)  (2,219)
Total costs and operating expenses 31,424   19,183 
Loss from operations (27,833)  (17,600)
        
Other income (expense):       
Change in fair value of warrant liability    581 
Interest income 40   275 
Interest expense (1,388)  (1,354)
Total other expense, net (1,348)  (498)
Loss before income taxes (29,181)  (18,098)
Income tax benefit     
Net loss$(29,181) $(18,098)
        
Other comprehensive income (loss)       
Unrealized gain (loss) on marketable securities 6   (27)
Foreign currency translation adjustment (226)  (27)
Comprehensive loss$(29,401) $(18,152)
        
Net loss per common share, basic and diluted$(1.04) $(25.84)
Weighted average shares outstanding, basic and diluted 28,031,686   700,505 
 
 

Acutus Medical, Inc.
Consolidated Statements of Cash Flows

  Three Months Ended March 31, 
(in thousands) 2021  2020 
  (unaudited) 
Cash flows from operating activities        
Net loss $(29,181) $(18,098)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation expense  1,241   429 
Amortization of intangible assets  160   110 
Stock-based compensation expense  2,910   1,741 
Amortization of premiums/(accretion of discounts) on marketable securities, net  412   (5)
Amortization of debt issuance costs  328   154 
Amortization of right-of-use assets  180   169 
Change in fair value of warrant liability     (581)
Change in fair value of contingent consideration  (1,153)  (2,219)
Changes in operating assets and liabilities:        
Accounts receivable  (317)  (708)
Inventory  (879)  (1,809)
Prepaid expenses and other current assets  1,104   214 
Other assets  (250)  (267)
Accounts payable  (2,091)  3,602 
Accrued liabilities  1,500   (83)
Operating lease liabilities  (237)  (207)
Net cash used in operating activities  (26,273)  (17,558)
      GlobenewsWire
By: GlobenewsWire - 12 May 2021
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