Acutus Medical Reports Fourth Quarter and Full Year 2020 Financial Results
03/18/2021 - 06:00 AM
CARLSBAD, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the fourth quarter and full year ended December 31, 2020.
Recent Highlights:
Reported revenue of $2.6 million in the fourth quarter of 2020, compared to $0.7 million in the same quarter last year. Reported revenue of $8.5 million for the full year of 2020, compared to $2.8 million for the full year of 2019. Increased worldwide installed base of second generation AcQMap consoles to 51 as of December 31, 2020, up from 37 at the end of the prior quarter – bringing the total installed base of AcQMap consoles to 58 as of December 31, 2020. Appointed David Roman as Chief Financial Officer and Duane Wilder as Chief Commercial Officer. Expanded Board of Directors to include Daniella Cramp and John Sheridan. Vince Burgess, President and CEO of Acutus, said, “In the fourth quarter we made important progress on a number of fronts. Our US commercial team continued to expand our installed base of consoles, our EU direct organization grew their sales and clinical support teams in advance of the launch of our first therapy system, and our global partnership with Biotronik gained considerable momentum. Internally, our development and operations teams gained key approvals and made important progress on product improvements and line expansion, both critical elements of our plan to offer a complete suite of the most innovative products in the field of electrophysiology. Like most of our peers, we did face renewed COVID-19 related headwinds in the fourth quarter and into the first quarter of 2021, although we are starting to see hospital access improve and a pick-up in procedures.”
Mr. Burgess further highlighted, “I’m most excited about the results of our limited release of the AcQBlate Force Sensing Ablation System in Europe. In just the first nine weeks since introduction, we and our partner Biotronik have had successful ablation cases in ten centers across five countries with over 15 physicians in the UK and EU. These results have confirmed the quality and performance of our ablation system. It also reaffirms our view that adding ablation to our product bag streamlines procedures and facilitates a different level of engagement with our customers. We believe this will drive increased market share across multiple product lines and further reinforces our value proposition.”
Fourth Quarter 2020 Financial Results $2.6 million for the fourth quarter of 2020, compared to $0.7 million in the fourth quarter last year. The improvement over the same quarter last year was driven by increased direct sales of Acutus disposables, sales of our AcQMap consoles, and distributor sales through our partner, Biotronik.
Gross margin was negative 90% for the fourth quarter of 2020, compared with negative 254% in the same quarter last year. The improvement was driven by greater production volumes and efficiencies in labor and manufacturing overhead absorption when compared to the same period last year. We continue to make significant investments in our manufacturing infrastructure to support our aggressive launch expectations and to position us to scale in-house production as our business grows. As production volumes increase over time, and we recognize the benefits of console sales and conversions, we expect to see continued improvements to our gross margin profile.
Operating expenses were $25.7 million for the fourth quarter of 2020, compared with $16.0 million in the same quarter last year. The increase was driven by the expansion of our commercial team in conjunction with our full commercial launch, increased fair value of the contingent consideration related to our acquisition of Rhythm Xience, and increased general and administrative costs incurred associated with our initial public offering and becoming a public company.
Net loss on a GAAP basis was $29.4 million for the fourth quarter of 2020 and net loss per share was $1.05 on a weighted average basic and diluted outstanding share count of 27.9 million, compared to $19.9 million and a net loss per share of $28.98 on a weighted average basic and diluted outstanding share count of 0.7 million in the same period of the prior year. Excluding income tax expense, amortization of acquired intangibles, acquisition related costs, non-cash stock-based compensation expense, remeasurement of our warrant liability, and changes in the fair value of contingent consideration, our non-GAAP net loss for the fourth quarter of 2020 was $24.9 million , or $0.89 per share, compared to $17.9 million , or $1.06 per share, after giving effect to the pro forma conversion of our convertible preferred stock for the fourth quarter of 2019.
Cash, cash equivalents, marketable securities and restricted cash were $139.9 million as of December 31, 2020, which includes the $166.3 million in net proceeds from our IPO, which closed on August 10, 2020.
Full Year 2020 Financial Results $8.5 million for the full year of 2020, compared to $2.8 million in the prior year. The increase was driven by increased direct sales of Acutus disposables, sales of our AcQMap consoles, and distributor sales through our partner, Biotronik. Gross margin was negative 88% for the full year of 2020, compared with negative 226% in the prior year. This improvement was attributable to increased revenue and higher production volumes.
Operating expenses were $83.9 million for the full year of 2020, compared with $66.2 million in the prior year. The increase was driven primarily by general and administrative expenses related to growth in our commercial team in conjunction with our full commercial launch, costs related to being a public company, and various research and development projects offset by our prior year research and development license expense related to the Biotronik asset acquisition.
Net loss on a GAAP basis was $102.0 million for the full year of 2020 and net loss per share was $8.94 on a weighted average basic and diluted outstanding share count of 11.4 million, compared to $97.0 million and a net loss per share of $144.41 on a weighted average basic and diluted outstanding share count of 0.7 million in the prior year. Excluding income tax expense, amortization of acquired intangibles, acquisition related costs, non-cash stock-based compensation expense, remeasurement of our warrant liability, and changes in the fair value of contingent consideration, our non-GAAP net loss for the full year of 2020 was $83.7 million , or $3.91 per share, compared to $76.2 million , or $5.77 per share, after giving effect to the pro forma conversion of our convertible preferred stock for the fourth quarter of 2019.
Outlook and COVID-19 $22.0 million and $30.0 million . With respect to the first quarter of 2021, management expects revenue to range between $2.6 million and $3.0 million .
Non-GAAP Financial Measures
Webcast and Conference Call Information https://ir.acutusmedical.com .
About Acutus Medical, Inc.
Caution Regarding Forward-Looking Statements
Investor Contact:
Caroline CornerCaroline.corner@westwicke.com
Holly Windlermedia@acutusmedical.com
Acutus Medical, Inc. Consolidated Balance Sheets (Unaudited)
December 31, (in thousands, except per share amounts) 2020 2019 ASSETS Current assets: Cash and cash equivalents $ 25,234 $ 9,452 Marketable securities, short-term 105,839 62,351 Restricted cash 150 150 Accounts receivable 2,160 263 Inventory 12,958 8,424 Prepaid expenses and other current assets 5,047 1,816 Total current assets 151,388 82,456 Marketable securities, long-term 8,726 — Property and equipment, net 12,356 4,427 Right-of-use asset, net 1,669 2,341 Intangible assets, net 5,653 4,110 Goodwill 12,026 12,026 Other assets 717 95 Total assets $ 192,535 $ 105,455 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable $ 8,266 $ 3,882 Accrued liabilities 7,308 10,076 Contingent consideration, short-term 5,400 8,200 Operating lease liabilities, short-term 933 833 Common and preferred stock warrant liability — 8,919 Total current liabilities 21,907 31,910 Operating lease liabilities, long-term 1,134 2,054 Long-term debt 39,011 38,244 Contingent consideration, long-term 3,900 5,700 Total liabilities 65,952 77,908 Series A convertible preferred stock — 3,059 Series B convertible preferred stock — 40,685 Series C convertible preferred stock — 74,575 Series D convertible preferred stock — 135,039 Stockholders' equity (deficit) Preferred stock, $0.001 par value — — Common stock, $0.001 par value 28 1 Additional paid-in capital 487,290 33,252 Accumulated deficit (361,015 ) (259,034 ) Accumulated other comprehensive income (loss) 280 (30 ) Total stockholders' equity (deficit) 126,583 (225,811 ) Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 192,535 $ 105,455
Acutus Medical, Inc. Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
Three Months Ended December 31, Year Ended December 31, (in thousands, except share and per share amounts) 2020 2019 2020 2019 Revenue $ 2,574 $ 669 $ 8,464 $ 2,836 Costs and operating expenses: Cost of products sold 4,891 2,365 15,889 9,243 Research and development 8,962 7,540 33,454 23,029 Research and development - license acquired - - - 15,000 Selling, general and administrative 15,164 7,849 50,357 26,847 Impairment of property and equipment - 786 - 786 Change in fair value of contingent consideration 1,563 (200 ) 97 500 Total costs and operating expenses 30,580 18,340 99,797 75,405 Loss from operations (28,006 ) (17,671 ) (91,333 ) (72,569 ) Other income (expense): Change in fair value of warrant liability and embedded derivative - (1,311 ) (5,555 ) (1,919 ) Loss on debt extinguishment - - - (1,447 ) Interest income 43 431 436 1,164 Interest expense (1,416 ) (1,363 ) (5,506 ) (22,268 ) Total other expense, net (1,373 ) (2,243 ) (10,625 ) (24,470 ) Loss before income taxes (29,379 ) (19,914 ) (101,958 ) (97,039 ) Income tax expense 23 - 23 - Net loss (29,402 ) (19,914 ) (101,981 ) (97,039 ) Other comprehensive income (loss) Unrealized (loss) gain on marketable securities (3 ) (1 ) (53 ) 46 Foreign currency translation adjustment 216 (39 ) 363 (96 ) Comprehensive loss $ (29,189 ) $ (19,954 ) $ (101,671 ) $ (97,089 ) Net loss per common share, basic and diluted $ (1.05 ) $ (28.98 ) $ (8.94 ) $ (144.41 ) Weighted average shares outstanding, basic and diluted 27,897,224 687,176 11,407,542 671,953
Acutus Medical, Inc. Consolidated Statements of Cash Flows (Unaudited)
Year Ended December 31, (in thousands) 2020 2019 Cash flows from operating activities Net loss $ (101,981 ) $ (97,039 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 2,763 2,280 Amortization of intangible assets 457 250 Stock-based compensation expense 12,103 2,994 Amortization of premiums/(accretion of discounts) on marketable securities, net 484 (153 ) Amortization of debt issuance costs 767 17,579 Amortization of right-of-use assets 684 637 Research and development - license acquired — 15,000 Impairment of property and equipment — 786 Loss on debt extinguishment — 1,447 Change in fair value of warrant liability and embedded derivative 5,555 1,919 Change in fair value of contingent consideration 97 500 Changes in operating assets and liabilities, net of effect from business combination: Accounts receivable (1,897 ) (96 ) Inventory (3,891 ) (5,421 ) Prepaid expenses and other current assets (3,383 ) (928 ) Other assets (622 ) (8 ) Accounts payable 2,283 2,111 Accrued liabilities 2,232 2,901 Operating lease liabilities (820 ) (745 ) Net cash used in operating activities (85,169 ) (55,986 ) Cash flows from investing activities Purchases of available-for-sale marketable securities (114,694 ) (68,735 ) Sales of available-for-sale marketable securities 17,095 — Maturities of available-for-sale marketable securities 45,000 14,700 Purchases of property and equipment (11,225 ) (3,395 ) Purchase of research and development license — (10,000 ) Cash paid, net of cash acquired for the Rhythm Xience Acquisition — (3,000 ) Net cash used in investing activities (63,824 ) (70,430 ) Cash flows from financing activities Proceeds from issuance of debt and warrants — 77,000 Repayment of debt — (15,000 ) Payment of issuance and extinguishment costs related to debt — (2,332 ) Payment of contingent consideration (2,500 ) — Proceeds from issuance of convertible preferred stock, net of issuance costs — 66,563 Proceeds from warrants exercises 13 — Proceeds from issuance of common stock upon IPO, net of issuance costs 166,286 — Proceeds from stock options exercises 634 108 Net cash provided by financing activities 164,433 126,339 Effect of exchange rate changes on cash, cash equivalents and restricted cash 342 (96 ) Net change in cash, cash equivalents and restricted cash 15,782 (173 ) Cash, cash equivalents and restricted cash, at the beginning of the period 9,602 9,775 Cash, cash equivalents and restricted cash, at the end of the period $ 25,384 $ 9,602
Acutus Medical, Inc. Reconciliation of GAAP Results to Non-GAAP Results (Unaudited)
Three Months Ended December 31, Year Ended December 31, (in thousands, except share and per share amounts) 2020 2019 2020 2019 GAAP net loss $ (29,402 ) $ (19,914 ) $ (101,981 ) $ (97,039 ) Income tax expense 23 - 23 - Amortization of acquired intangibles 127 125 457 250 Acquisition related costs - (4 ) - 15,221 Stock-based compensation 2,831 820 12,103 2,994 Change in fair value of continent consideration 1,563 (200 ) 97 500 Change in fair value of warrant liability and embedded derivative - 1,311 5,555 1,919 Non-GAAP net loss $ (24,858 ) $ (17,862 ) $ (83,746 ) $ (76,155 ) Denominator Weighted average shares of common stock outstanding used in GAAP per share calculations 27,897,224 687,176 11,407,542 671,953 Adjustments to reflect the assumed conversion of convertible preferred stock (1) - 16,179,872 10,011,750 12,522,622 Shares used in non-GAAP per share calculations 27,897,224 16,867,048 21,419,293 13,194,575 GAAP net loss per share $ (1.05 ) $ (28.98 ) $ (8.94 ) $ (144.41 ) Non-GAAP net loss per share $ (0.89 ) $ (1.06 ) $ (3.91 ) $ (5.77 )
(1) Assumes the conversion of outstanding shares of convertible preferred stock into shares of common stock as if such conversion had occurred at the beginning of the period or their issuance dates, if later.
Acutus Medical, Inc. Key Business Metrics (Unaudited)
Installed Base
Our total installed base as of December 31, 2020 and 2019 is set forth in the table below:
As of December 31, 2020 2019 Acutus Direct US 37 10 Europe 14 17 Total Acutus Direct 51 27 Biotronik 7 — Total installed base 58 27
Our net increase in installed base for the years ended December 31, 2020 and 2019, exclusive of transfers between Acutus and Biotronik, is set forth in the table below:
Year Ended December 31, 2020 2019 Acutus Direct US 27 5 Europe 2 1 Total Acutus Direct 29 6 Net systems to Biotronik 2 — Total net system placements 31 6
Revenue
The following tables set forth our revenue for disposable, systems and service/other for the years ended December 31, 2020 and 2019:
Year Ended December 31, 2020 2019 Acutus Direct Disposables $ 5,221 $ 2,764 Systems 1,660 — Service/Other 91 19 Total Acutus direct revenue 6,972 2,783 Distribution agreements 1,492 53 Total revenue $ 8,464 $ 2,836
Year Ended December 31, 2020 2019 Acutus Direct United States $ 4,625 $ 738 Europe 2,347 2,045 Total Acutus direct revenue 6,972 2,783 Distribution Agreements United States 229 — Europe 1,263 53 Total revenue through distribution 1,492 53 Total revenue $ 8,464 $ 2,836
