Table of Contents



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 20212022

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                     to

 

Commission File Number 0-19437

ASENSUS SURGICAL, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

11-2962080

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

1 TW Alexander Drive, Suite 160, Durham, NC 27703

(Address of principal executive offices) (Zip Code)

 

Registrants telephone number, including area code: (919) 765-8400

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐.

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐.

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated Filer

Non-accelerated filer

 

Smaller reporting company

   

Emerging Growth Company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ☐

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)    Yes  ☐    No  ☒


 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading symbol

 

Name of each exchange on which registered

Common Stock
$0.001 par value per share

 

ASXC

 

NYSE American

 

The number of shares outstanding of the registrant’s common stock, as of July 30, 2021August 5, 2022 was 234,323,983.236,718,923.

 



 

 

 

ASENSUS SURGICAL, INC.

 

TABLE OF CONTENTS FOR FORM 10-Q

 

PART I.

FINANCIAL INFORMATION

2
   

Item 1.

Financial Statements

2
 

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

2

 

Condensed Consolidated Balance Sheets (unaudited)

3

 

Condensed Consolidated Statements of StockholdersStockholders’ Equity (unaudited)

4

 

Condensed Consolidated Statements of Cash Flows (unaudited)

5

 

Notes to Condensed Consolidated Financial Statements (unaudited)

6

Item 2.

ManagementsManagement’s Discussion and Analysis of Financial Condition and Results of Operations

2317

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3223

Item 4.

Controls and Procedures

3224

   

PART II.

OTHER INFORMATION

3224

   

Item 1.

Legal Proceedings

3224

Item 1A.

Risk Factors

3224

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3324

Item 3.

Defaults Upon Senior Securities

3324

Item 4.

Mine Safety Disclosures

3324

Item 5.

Other Information

3324

Item 6.

Exhibits

3425

   
 

SIGNATURES

3526

 

i

 

FORWARD-LOOKING STATEMENTS

In addition to historical financial information, this report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this report, including statements regarding future events, our future financial performance, our future business strategy and the plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “in the event that,” “may,” “plans,” “potential,” “predicts,” “should” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements, including the impact of the coronavirus (COVID-19) pandemic on our operating results. Readers are urged to carefully review and consider the various disclosures made by us, which attempt to advise interested parties of the risks, uncertainties, and other factors that affect our business, operating results, financial condition and stock price, including without limitation the disclosures made under the captions “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Financial Statements,” “Notes to Condensed Consolidated Financial Statements “and “Risk Factors” in this report, as well as the disclosures made in the Asensus Surgical, Inc. Annual Report on Form 10-K for the year ended December 31, 20202021 (the “Fiscal 20202021 Form 10-K”), and other filings we make with the SEC. Furthermore, such forward-looking statements speak only as of the date of this report. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations except as required by applicable law. To the extent that our business is negatively impacted due to a variety of factors, including the impact of COVID-19 and other geopolitical factors on our operating results, we may implement longer-term cost reduction efforts in order to mitigate such impact. References in this report to “we,” “our,” “us,” or the “Company” refer to Asensus Surgical, Inc., including its subsidiaries Asensus Surgical US, Inc., SafeStitch LLC, Asensus International, Inc., Asensus Surgical Italia S.r.l., Asensus Surgical Europe S.à.r.l., Asensus Surgical Taiwan Ltd., Asensus Surgical Japan K.K., Asensus Surgical Israel Ltd., Asensus Surgical Netherlands B.V., and Asensus Surgical Canada, Inc.

 

Any disclosure in this report regarding the receipt of CE Mark or Section 510(k) clearance for any of the Company’s products does not mean or infer any endorsement of the Company’s products by any government agency including, without limitation, the U.S. Food and Drug Administration, or FDA.

 

1

 

 

PART 1. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

Asensus Surgical, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands except per share amounts)

(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

  

Three Months Ended

 

Six Months Ended

 
 

June 30,

  

June 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 

Revenue:

  

Product

 $696  $315  $2,400  $557  $254  $363  $601  $1,726 

Service

  406   340   785   698  424  406  732  785 

Lease

  316   333   727   674 

Total revenue

 1,102  655  3,185  1,255  994  1,102  2,060  3,185 
  

Cost of revenue:

  

Product

 1,478  720  3,858  1,633  883  1,003  1,259  2,678 

Service

  869   693   1,601   1,518  646  636  1,141  1,002 

Lease

  818   708   1,770   1,779 

Total cost of revenue

 2,347  1,413  5,459  3,151  2,347  2,347  4,170  5,459 
                  

Gross loss

 (1,245) (758) (2,274) (1,896) (1,353) (1,245) (2,110) (2,274)

Operating Expenses:

  

Research and development

 4,089  4,257  8,304  8,191  7,253  4,089  13,681  8,304 

Sales and marketing

 3,562  2,901  6,615  7,154  3,602  3,562  7,321  6,615 

General and administrative

 3,848  3,619  7,840  6,968  4,992  3,848  10,525  7,840 

Amortization of intangible assets

 2,862  2,619  5,729  5,183  2,533  2,862  5,203  5,729 

Change in fair value of contingent consideration

 478  212  735  1,268  (598) 478  (752) 735 

Restructuring and other charges

  0   0   0   858 

Property and equipment impairment

  432   0   432   0 

Total Operating Expenses

 14,839  13,608  29,223  29,622  18,214  14,839  36,410  29,223 
                  

Operating Loss

 (16,084) (14,366) (31,497) (31,518) (19,567) (16,084) (38,520) (31,497)

Other Income (Expense)

 

Other Income (Expense), net

 �� 

Gain on extinguishment of debt

 2,847  0  2,847  0  0  2,847  0  2,847 

Change in fair value of warrant liabilities

 0  (114) (1,981) (269) 0  0  0  (1,981)

Interest income

 79  4  131  31  260  79  515  131 

Interest expense

 (5) 0  (12) 0  (141) (5) (341) (12)

Other expense, net

  (7)  (55)  (36)  (70)  (86)  (7)  (232)  (36)

Total Other Income (Expense), net

 2,914  (165) 949  (308) 33  2,914  (58) 949 
  

Loss before income taxes

 (13,170) (14,531) (30,548) (31,826) (19,534) (13,170) (38,578) (30,548)

Income tax (expense) benefit

 (2) 691  36  1,388   (85)  (2)  (169)  36 
         

Net loss

 (13,172) (13,840) (30,512) (30,438) (19,619) (13,172) (38,747) (30,512)

Deemed dividend related to beneficial conversion feature of preferred stock

 0  0  0  (412)

Deemed dividend related to conversion of preferred stock into common stock

  (299) 0  (299)

Net loss attributable to common stockholders

 (13,172) (14,139) (30,512) (31,149)
  

Comprehensive loss:

  

Net loss

 (13,172) (13,840) (30,512) (30,438) (19,619) (13,172) (38,747) (30,512)

Foreign currency translation gain (loss)

 472  962  (1,466) 90 
         

Foreign currency translation (loss) gain

 (1,713) 472  (2,363) (1,466)

Unrealized loss on available-for-sale investments

  (144)  0   (696)  0 

Comprehensive loss

 $(12,700) $(12,878) $(31,978) $(30,348) $(21,476) $(12,700) $(41,806) $(31,978)
          

Net loss per common share attributable to common stockholders - basic and diluted

 $(0.06) $(0.27) $(0.14) $(0.77) $(0.08) $(0.06) $(0.16) $(0.14)

Weighted average number of shares used in computing net loss per common share - basic and diluted

  233,250   52,351   219,199   40,628   236,505   233,250   236,201   219,199 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

2

 

 

Asensus Surgical, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share amounts)

(Unaudited)

 

 

June 30, 2021

  

December 31, 2020

  

June 30, 2022

  

December 31, 2021

 

Assets

  

Current Assets:

  

Cash and cash equivalents

 $157,078  $16,363  $10,844  $18,129 

Short-term investments, available-for-sale

 83,360  80,262 

Accounts receivable, net

 960  1,115  699  749 

Inventories

 12,523  10,034  8,451  8,634 

Prepaid expenses

 2,927  3,255 

Employee retention tax credit receivable

 1,147  1,311 

Other current assets

  3,446   6,501   1,134   957 

Total Current Assets

 174,007  34,013  108,562  113,297 
  

Restricted cash

 1,045  1,166  1,290  1,154 

Long-term investments, available-for-sale

 9,581  37,435 

Inventories, net of current portion

 6,590  8,813  7,258  7,074 

Property and equipment, net

 9,876  10,342  9,389  10,971 

Intellectual property, net

 15,943  22,267  4,122  9,892 

Net deferred tax assets

 288  307  244  288 

Operating lease right-of-use assets, net

 4,099  1,164  4,747  5,348 

Other long term assets

  156   186 

Other long-term assets

  2,157   1,014 

Total Assets

 $212,004  $78,258  $147,350  $186,473 
  

Liabilities and Stockholders' Equity

  

Current Liabilities:

  

Accounts payable

 $2,653  $1,965  $3,849  $3,448 

Accrued expenses

 4,007  5,615 

Accrued employee compensation and benefits

 3,127  3,559 

Accrued expenses and other current liabilities

 1,617  1,617 

Operating lease liabilities - current portion

 861  686  579  683 

Deferred revenue

 786  789   510   543 

Notes payable - current portion, net of debt discount

  0   1,228 

Total Current Liabilities

 8,307  10,283  9,682  9,850 
  

Long Term Liabilities:

 

Long-Term Liabilities:

 

Contingent consideration

 4,671  3,936  1,619  2,371 

Noncurrent operating lease liabilities

 3,465  628   4,610   5,006 

Notes payable, less current portion

 0  1,587 

Warrant liabilities

  0   255 

Total Liabilities

 16,443  16,689  15,911  17,227 
  

Commitments and Contingencies (Note 10)

       

Commitments and Contingencies (Note 14)

       
  

Stockholders' Equity:

  

Common stock $0.001 par value, 750,000,000 shares authorized at June 30, 2021 and December 31, 2020; 234,231,132 and 116,231,072 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

 234  116 

Preferred stock, $0.01 par value, 25,000,000 shares authorized, no shares issued and outstanding at June 30, 2021 and December 31, 2020

 0  0 

Common stock $0.001 par value, 750,000,000 shares authorized at June 30, 2022 and December 31, 2021; 236,620,415 and 235,218,552 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

 237  235 

Preferred stock, $0.01 par value, 25,000,000 shares authorized, no shares issued and outstanding at June 30, 2022 and December 31, 2021

 0  0 

Additional paid-in capital

 947,249  781,397  958,646  954,649 

Accumulated deficit

 (753,424) (722,912) (824,121) (785,374)

Accumulated other comprehensive income

 1,502  2,968 

Accumulated other comprehensive loss

  (3,323)  (264)

Total Stockholders' Equity

 195,561  61,569   131,439   169,246 

Total Liabilities and Stockholders' Equity

 $212,004  $78,258  $147,350  $186,473 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3

 

 

Asensus Surgical, Inc.

Condensed Consolidated Statements of Changes in Stockholders Equity

(in thousands)

(Unaudited)

 

 

Common Stock

  

Preferred Stock

  

Treasury Stock

                  

Common Stock

 

Treasury Stock

                
 

Shares

  

Amount

  

Shares

  

Amount

  

Additional Paid

-in Capital

  

Accumulated

Deficit

  

Accumulated

Other

Comprehensive

Income (Loss)

  

Total

Stockholders'

Equity

 

Balance, December 31, 2021

  235,219  $235  0  $0  $954,649  $(785,374) $(264) $169,246 

Stock-based compensation

 -  0  -  -  2,245  0  0  2,245 

Exercise of stock options

 30  0  0  0  12  0  0  12 

Award of restricted stock units

 1,166  1  0  0  0  0  0  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  436  0  (349) 0  0  (349)

Cancellation of treasury stock

 0  0  (436) 0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  0  0  (1,202) (1,202)

Net loss

  -   0   -   0   -   (19,128)  0   (19,128)

Balance, March 31, 2022

  236,415  $236   0  $0  $956,557  $(804,502) $(1,466) $150,825 

Stock-based compensation

 -  0  -  -  2,083  0  0  2,083 

Exercise of stock options

 13  0  0  0  6  0  0  6 

Award of restricted stock units

 192  1  0  0  0  0  0  1 

Other comprehensive loss

 -  0  -  -  -  0  (1,857) (1,857)

Net loss

  -   0   -   -   -   (19,619)  0   (19,619)

Balance, June 30, 2022

  236,620  $237   0  $0  $958,646  $(824,121) $(3,323) $131,439 
 

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Additional Paid-in

Capital

  

Accumulated

Deficit

  

Accumulated

Other

Comprehensive

Income (Loss)

  

Total

Stockholders'

Equity

                  

Balance, December 31, 2020

  116,231  $116  0  $0  0  $0  $781,397  $(722,912) $2,968  $61,569   116,231  $116  0  $0  $781,397  $(722,912) $2,968  $61,569 

Stock-based compensation

 -  0  -  0  -  0  1,786  0  0  1,786  -  0  -  0  1,786  0  0  1,786 

Issuance of common stock, net of issuance costs

 70,666  71  0  0  0  0  129,251  0  0  129,322  70,666  71  0  0  129,251  0  0  129,322 

Exercise of stock options and warrants

 45,114  45  0  0  0  0  32,687  0  0  32,732  45,114  45  0  0  32,687  0  0  32,732 

Award of restricted stock units

 706  1  0  0  0  0  0  0  0  1  706  1  0  0  0  0  0  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  0  0  67  0  (214) 0  0  (214) 0  0  67  0  (214) 0  0  (214)

Cancellation of treasury stock

 0  0  0  0  (67) 0  0  0  0  0  0  0  (67) 0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  -  0  0  0  (1,938) (1,938) -  0  -  0  0  0  (1,938) (1,938)

Net loss

  -  0   -  0   -  0   0   (17,340)  0   (17,340)  -   0   -   0   0   (17,340)  0   (17,340)

Balance, March 31, 2021

  232,717   233   0   0   0   0   944,907   (740,252)  1,030  $205,918   232,717  $233   0  $0  $944,907  $(740,252) $1,030  $205,918 

Stock-based compensation

 -  0  -  0  -  0  1,842  0  0  1,842  -  0  -  0  1,842  0  0  1,842 

Issuance of common stock, net of issuance costs

 332  0  0  0  0  0  992  0  0  992  332  0  0  0  992  0  0  992 

Exercise of stock options and warrants

 508  0  0  0  0  0  337  0  0  337  508  0  0  0  337  0  0  337 

Award of restricted stock units

 674  1  0  0  0  0  0  0  0  1  674  1  0  0  0  0  0  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  0  0  246  0  (829) 0  0  (829) 0  0  246  0  (829) 0  0  (829)

Cancellation of treasury stock

 0  0  0  0  (246) 0  0  0  0  0  0  0  (246) 0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  -  0  0  0  472  472 

Other comprehensive gain

 -  0  -  0  0  0  472  472 

Net loss

  -  0   -  0   -  0   0   (13,172)  0   (13,172)  -   0   -   0   0   (13,172)  0   (13,172)

Balance, June 30, 2021

  234,231  $234   0  $0   0  $0  $947,249  $(753,424) $1,502  $195,561   234,231  $234   0  $0  $947,249  $(753,424) $1,502  $195,561 
                     
                     

Balance, December 31, 2019

  20,691  $21  0  $0  0  0  $720,484  $(663,600) $(1,370) $55,535 

Stock-based compensation

 -  0  -  ��0  -  0  1,923  0  0  1,923 

Issuance of common stock, preferred stock and warrants under 2020 financing, net of issuance costs

 14,122  14  7,937  79  0  0  13,432  0  0  13,525 

Issuance of common stock, net of issuance costs

 7,030  7  0  0  0  0  11,205  0  0  11,212 

Conversion of preferred stock to common stock

 3,053  3  (3,053) (30) 0  0  27  0  0  0 

Exchange of shares for Series B Warrants

 2,041  2  0  0  0  0  2,468  0  0  2,470 

Award of restricted stock units

 141  0  0  0  0  0  0  0  0  0 

Return of common stock to pay withholding taxes on restricted stock

 0  0  0  0  28  0  (33) 0  0  (33)

Cancellation of treasury stock

 0  0  0  0  (28) 0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  -  0  0  0  (872) (872)

Net loss

  -  0   -  0   -  0   0   (16,598)  0   (16,598)

Balance, March 31, 2020

  47,078   47   4,884   49   0   0   749,506   (680,198)  (2,242) $67,162 

Stock-based compensation

 -  0  -  0  -  0  1,933  0  0  1,933 

Exercise of warrants

 4,913  5  0  0  0  0  3,335  0  0  3,340 

Conversion of preferred stock to common stock

 4,884  5  (4,884) (49) 0  0  44  0  0  0 

Award of restricted stock units

 28  0  0  0  0  0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  -  0  0  0  962  962 

Net loss

  -  0   -  0   -  0   0   (13,840)  0   (13,840)

Balance, June 30, 2020

  56,903  $57   0  $0   0  $0  $754,818  $(694,038) $(1,280) $59,557 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

4

 

 

Asensus Surgical, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

Six Months Ended June 30,

  

Six Months Ended June 30,

 
 

2021

  

2020

  

2022

  

2021

 

Operating Activities:

  

Net loss

 $(30,512) $(30,438) $(38,747) $(30,512)

Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:

  

Depreciation

 1,585  1,162  1,720  1,585 

Amortization of intangible assets

 5,729  5,183  5,203  5,729 

Amortization of discounts and premiums on investments, net

 444  0 

Stock-based compensation

 3,628  3,856  4,328  3,628 

Gain on extinguishment of debt

 (2,847) 0  0  (2,847)

Deferred tax benefit

 (36) (1,388)

Write down of inventory

 288  0 

Deferred tax expense (benefit)

 169  (36)

Bad debt expense

 9  0 

Change in inventory reserves

 (567) 288 

Property and equipment impairment

 432  0 

Loss on disposal of property and equipment

 97  0 

Change in fair value of warrant liabilities

 1,981  269  0  1,981 

Change in fair value of contingent consideration

 735  1,268  (752) 735 
  

Changes in operating assets and liabilities:

  

Accounts receivable

 127  (350) (8) 127 

Inventories

 (1,687) (2,332) (1,933) (1,687)

Operating lease right-of-use assets

 (2,970) 546  409  (2,970)

Other current and long term assets

 3,177  281 

Prepaid expenses

 189  517 

Other current and long-term assets

 (1,169) 2,660 

Accounts payable

 679  (1,221) 524  679 

Accrued expenses

 (1,428) (1,451) (284) (1,428)

Deferred revenue

 14  22  (4) 14 

Operating lease liabilities

 3,052  (608)  (290)  3,052 

Other long term liabilities

  0   65 

Net cash and cash equivalents used in operating activities

 (18,485) (25,136) (30,230) (18,485)
  

Investing Activities:

  

Purchase of available-for-sale investments

 (17,792) 0 

Proceeds from maturities of available-for-sale investments

 41,408  0 

Purchase of property and equipment

  (700)  (3)  (443)  (700)

Net cash and cash equivalents used in investing activities

 (700) (3)

Net cash and cash equivalents provided by (used in) investing activities

 23,173  (700)
  

Financing Activities:

  

Proceeds from issuance of common stock, preferred stock and warrants under 2020 financing, net of issuance costs

 0  13,525 

Proceeds from issuance of common stock, net of issuance costs

 130,314  11,212  0  130,314 

Proceeds from notes payable, net of issuance costs

 0  2,815 

Taxes paid related to net share settlement of vesting of restricted stock units

 (1,041) (33) (349) (1,041)

Payment of contingent consideration

 0  (74)

Proceeds from exercise of stock options and warrants

  30,835   3,340   18   30,835 

Net cash and cash equivalents provided by financing activities

 160,108  30,785 

Net cash and cash equivalents (used in) provided by financing activities

 (331) 160,108 
  

Effect of exchange rate changes on cash and cash equivalents

  (329)  17   239   (329)

Net increase in cash, cash equivalents and restricted cash

 140,594  5,663 

Net (decrease) increase in cash, cash equivalents and restricted cash

 (7,149) 140,594 

Cash, cash equivalents and restricted cash, beginning of period

  17,529   10,567   19,283   17,529 

Cash, cash equivalents and restricted cash, end of period

 $158,123  $16,230  $12,134  $158,123 
 

Supplemental Disclosure for Cash Flow Information

 

Cash paid for leases

 $549  $539 

Cash paid for taxes

 $65  $50 
  

Supplemental Schedule of Non-cash Investing and Financing Activities:

  

Transfer of inventories to property and equipment

 $1,243  $3,403  $724  $1,243 

Acquisition of property and equipment in accounts payable

 $67  $0  $0  $67 

Reclass of warrant liability to common stock and additional paid-in-capital

 $2,236  $0  $0  $2,236 

Lease liabilities arising from obtaining right-of-use assets

 $3,461  $0  $0  $3,461 

Exchange of common stock for Series B Warrants

 $0  $2,470 

Transfer of in-process research and development to intellectual property

 $0  $2,425 

Conversion of preferred stock to common stock

 $0  $79 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

5

 

Asensus Surgical, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

 

1.

Organization and CapitalizationDescription of the Business

 

Asensus Surgical, Inc. (formerly known as TransEnterix, Inc.) (the "Company") is a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. The Company is focused on the market development for and commercialization of the Senhance® Surgical System, which digitizes laparoscopic minimally invasive surgery, or MIS. The Senhance System is the first and only digital, multi-port laparoscopic platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including 33mm mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control and fully-reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy.

The Senhance System is available for sale in Europe, the United States, Japan, Taiwan, Russia and select other countries.

The Senhance System has a CE Mark in Europe for adult and pediatric laparoscopic abdominal and pelvic surgery, as well as limited thoracic surgeries excluding cardiac and vascular surgery.

In the United States, the Company has received 510(k) clearance from the FDA for use of the Senhance System in general laparoscopic surgical procedures and laparoscopic gynecologic surgery in a total of 31 indicated procedures, including benign and oncologic procedures, laparoscopic inguinal, hiatal and paraesophageal hernia, sleeve gastrectomy and laparoscopic cholecystectomy (gallbladder removal) surgery.

In Japan, the Company has received regulatory approval and reimbursement for 98 laparoscopic procedures.

The Senhance System has received its registration certificate by the Russian medical device regulatory agency, Roszdravnadzor, allowing for its sale and utilization throughout the Russian Federation.

In 2020, the Company obtained regulatory clearance for the Senhance ultrasonic system in Taiwan and Japan. On February 12, 2020, the Company expanded its claims in the EU for the Senhance System to include pediatric patients, allowing accessibility to more surgeons and patients, as well as expanding its potential market to include pediatric hospitals in Europe. The Company anticipates the robotic precision provided by the Senhance System, coupled with the already available 3 mm diameter instruments, will prove to be an effective tool in surgery with smaller patients. On March 13, 2020 the Company announced that it received FDA clearance for the Intelligent Surgical Unit™ (ISU™) for use with the Senhance System. The Company believes it is the first such FDA submission seeking clearance for machine vision technology in abdominal robotic surgery. On September 23, 2020, the Company announced the first surgical procedures successfully completed using the ISU.

On January 19, 2021, the Company announced that it received CE Mark for the ISU. Finally, on July 28, 2021, the Company announced that it received FDA clearance for 5 mm diameter articulating instruments, offering better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the EU.

On October 31, 2018, the Company acquired the assets, intellectual property and highly experienced multidisciplinary personnel of MST Medical Surgical Technologies, Inc., or MST, an Israeli-based medical technology company.  Through this acquisition the Company acquired MST’s AutoLap™ assets and technology, one of the only image-guided robotic scope positioning systems with FDA clearance and CE Mark.  The Company believes MST’s image analytics technology will accelerate and drive meaningful Senhance System developments and allow the Company to expand the Senhance System to add augmented, intelligent vision capability. The Company sold the AutoLap assets in October 2019, while retaining the core technology.

6

At-the-Market Offering

On May 19, 2021, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the “Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), Robert W. Baird & Co. Incorporated (“Baird”) and Oppenheimer & Co. Inc. (“Oppenheimer”). Each of Cantor, Baird and Oppenheimer are individually an “Agent” and collectively are the “Agents” under the Agreement. Also on May 19, 2021, the Company filed a prospectus supplement relating to an at-the-market offering (the “2021 ATM Offering”) by the Company of up to an aggregate of $100,000,000 of shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), which shares of Common Stock are registered under the Registration Statement on Form S-3 ASR (File No.333-256284) and automatically effective on May 19, 2021.

 

 

2.

Summary of Significant Accounting Policies

 

Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and include the accounts of the Company and its direct and indirect wholly owned subsidiaries. The Company has prepared the accompanying unaudited interim condensed consolidated financial statementsAll inter-company accounts and transactions have been eliminated in accordance with the instructions to Form 10-Q and the standards of accounting measurement set forth in the Interim Reporting Topic of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”). Consequently, the Company has not necessarily included in this Form 10-Q all information and footnotes required for audited financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements in this Form 10-Q contain all adjustments, consisting only of normal recurring adjustments, except as otherwise indicated, necessary for a fair statement of its financial position, results of operations, and cash flows of the Company for all periods presented.consolidation. The results reported in these unaudited interim condensed consolidated financial statements should not be regarded as necessarily indicative of results that may be expected for any subsequent period or for the entire year. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in the Fiscal 20202021 Form 10-K. Certain information and footnote disclosures normally included in the annual consolidated financial statements prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”)GAAP have been condensed or omitted in the accompanying interim condensed consolidated financial statements. The year-endIn the opinion of the Company’s management, the accompanying unaudited condensed consolidated balance sheet data was derived from audited financial statements but does not includecontain all disclosures required by U.S. GAAP.adjustments, consisting only of normal recurring adjustments, except as otherwise indicated, necessary for a fair statement of its financial position, results of operations, and cash flows of the Company for all periods presented.

 

LiquidityPrinciples of Consolidation

The Company had an accumulated deficitaccompanying condensed consolidated financial statements include the accounts of $753.4 million and working capital of $165.7 million as of June 30, 2021. The Company has not established sufficient sales revenues to cover its operating costs and believes it may require additional capital in the future to proceed with its operating plan.

The Company believes the COVID-19 pandemic will continue to negatively impact its operations and ability to implement its market development efforts, which will have a negative effect on its financial condition.

In the first quarter of 2021, the Company raised additional capital through equity offerings, including raising net proceeds of $73.4 millionand its direct and indirect wholly owned subsidiaries, Asensus Surgical US, Inc., Asensus International, Inc., Asensus Surgical Italia S.r.l., Asensus Surgical Europe S.à.r.l., Asensus Surgical Taiwan Ltd., Asensus Surgical Japan K.K., Asensus Surgical Israel Ltd., Asensus Surgical Netherlands B.V., and Asensus Surgical Canada, Inc. All inter-company accounts and transactions have been eliminated in a January 2021 public offering, $28.6 million in a January 2021 registered direct offering, and $27.3 million in an at-the-market offering launched in 2020 (the “2020 ATM Offering”). Also, outstanding Series B, C and D warrants were exercised in the six months ended June 30, 2021 for aggregate proceeds to the Company of $30.6 million.consolidation.

In the second quarter of 2021, the Company launched the 2021 ATM Offering and raised proceeds, net of legal costs and commissions, of $1.0 million under this offering in the three months ended June 30, 2021.

As of June 30, 2021, the Company had cash and cash equivalents, excluding restricted cash, of approximately $157.1 million.

While the Company believes that its existing cash and cash equivalents as of June 30, 2021 will be sufficient to sustain operations for at least the next 12 months from the issuance of these financial statements, the Company believes it may need to obtain additional financing in the future to proceed with its business plan. Management's plan to obtain additional resources for the Company may include additional sales of equity under the 2021 ATM Offering or otherwise, traditional financing, such as loans, entry into a strategic collaboration, entry into an out-licensing arrangement or provision of additional distribution rights in some or all of our markets. However, management cannot provide any assurance that the Company will be successful in accomplishing any or all of its plans.

 

7

Risk and Uncertainties

The Company is subject to risks similar to other similarly sized companies in the medical device industry. These risks include, without limitation: potential negative impacts on the Company's operations caused by the COVID-19 pandemic;pandemic and other geopolitical factors; the historical lack of profitability; the Company’s ability to raise additional capital; the success of its market development efforts, the liquidity and capital resources of its partners;efforts; its ability to successfully develop, clinically test and commercialize its products; the timing and outcome of the regulatory review process for its products; changes in the health care and regulatory environments of the United States, the United Kingdom, the European Union, Japan, Taiwan, and other countries in which the Company operates or intends to operate; its ability to attract and retain key management, marketing and scientific personnel; its ability to successfully prepare, file, prosecute, maintain, defend and enforce patent claims and other intellectual property rights; its ability to successfully transition from a research and development company to a marketing, sales and distribution concern;company; competition in the market for robotic surgical devices; and its ability to identify and pursue development of additional products.

 

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include impairment considerations for long- term intangiblelong-lived assets, fair value estimates related to contingent consideration, warrant liabilities, stock compensation expense, revenue recognition, accounts receivable reserves, short-term and long-term investments, excess and obsolete inventory reserves, inventory classification between current and non-current, measurement of lease liabilities and corresponding ROUright-of-use (“ROU”) assets, and deferred tax asset valuation allowances.

The COVID-

196 pandemic has caused significant social and economic restrictions that

Significant Accounting Policies

There have been imposedno new or material changes to the significant accounting policies discussed in the United States and abroad, which has resulted in significant volatility in the global economy and led to reduced economic activity. In the preparation of theseCompany’s audited financial statements and related disclosures, the Company has assessed the impact that COVID-19 has had on its estimates, assumptions, forecasts, and accounting policies. The Company continues to monitor closely the COVID-19 pandemic impact on its estimates, assumptions and forecasts usednotes thereto included in the preparation of its financial statements. AsAnnual Report on Form 10-K for the COVID-fiscal year ended 19December 31, 2021. situation is unprecedented and ever evolving, future events and effects related to COVID-

19 cannot be determined with precision, and actual results could significantly differ from estimates or forecasts.

 

Reclassifications

Principles of Consolidation and Foreign Currency Considerations

The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its direct and indirect wholly owned subsidiaries, Asensus Surgical US, Inc., SafeStitch LLC, Asensus International, Inc., Asensus Surgical Italia S.r.l., Asensus Surgical Europe S.à.r.l., Asensus Surgical Taiwan Ltd., Asensus Surgical Japan K.K., Asensus Surgical Israel Ltd., Asensus Surgical Netherlands B.V., and Asensus Surgical Canada, Inc. All inter-company accounts and transactionsCertain amounts reported previously have been eliminated in consolidation.

The functional currencyreclassified to conform to current year presentation, with no effect on stockholders’ equity or net loss as previously reported. These reclassifications relate to revenue and cost of the Company’s operational foreign subsidiaries is predominantly the Euro. The assets and liabilities of the Company’s foreign subsidiaries are translated into U.S. dollars at exchange rates in effect at the balance sheet date. Income and expense items are translated at the average exchange rates prevailing during the period. The cumulative translation effectrevenue for a subsidiary using a functional currency other than the U.S. dollar isleases which historically were included in accumulated other comprehensive income or loss as a separate componentproduct and service revenue and corresponding cost of stockholders’ equity.

The Company’s intercompany accounts are denominated in the functional currency of the foreign subsidiary. Gains and losses resulting from the remeasurement of intercompany receivables that the Company considers to be of a long-term investment nature are recorded as a cumulative translation adjustment in accumulated other comprehensive income or loss as a separate component of stockholders’ equity, while gains and losses resulting from the remeasurement of intercompany receivables from a foreign subsidiary for which the Company anticipates settlement in the foreseeable future are recorded in the condensed consolidated statements of operations and comprehensive loss. The net gains and losses included in net loss inrevenue on the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2021 2021.and 2020 were not significant.

Cash and Cash Equivalents and Restricted Cash

The Company considers all highly liquid investments with original maturities of 90 days or less at the time of purchase to be cash equivalents.

Restricted cash as of June 30, 2021 and December 31,2020 includes $1.0 million and $1.2 million, respectively, in cash accounts held as collateral primarily under the terms of an office operating lease, credit cards, and automobile leases.

8

Concentrations and Credit Risk

The Company’s principal financial instruments subject to potential concentration of credit risk are cash and cash equivalents, including amounts held in money market accounts. The Company places cash deposits with a federally insured financial institution. The Company maintains its cash at banks and financial institutions it considers to be of high credit quality; however, the Company’s domestic cash deposits may at times exceed the Federal Deposit Insurance Corporation’s insured limit. Balances in excess of federally insured limitations may not be insured. The Company has not experienced losses on these accounts, and management believes that the Company is not exposed to significant risks on such accounts.

The Company’s accounts receivable are derived from sales and leases to customers located throughout the world. The Company evaluates its customers’ financial condition and, generally, requires no collateral from its customers. The Company provided reserves for potential credit losses and recorded no bad debt charges during the three and six months ended June 30, 2021 and 2020. The Company had 4 customers who constituted 59% of the Company’s net accounts receivable as of June 30, 2021. The Company had seven customers who constituted 68% of the Company’s net accounts receivable at December 31,2020. The Company had 5 customers who accounted for 39% of revenue in the three months ended June 30, 2021 and 7 customers who accounted for 60% of revenue in the three months ended June 30, 2020. The Company had 4 customers who accounted for 54% of revenue in the six months ended June 30, 2021 and 9 customers who accounted for 65% of revenue in the six months ended June 30, 2020.

 

Impact of Recently Issued Accounting Standards

Accounts Receivable

Accounts receivable are recordedIn June 2016, the Financial Accounting Standards Board (“FASB”), issued ASU 2016-13,Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which is designed to provide financial statement users with more information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at net realizable value, which includes an allowance for estimated uncollectible accounts.each reporting date. The allowance for uncollectible accounts was determined on a customer specific basis based on deemed collectability. The allowance for doubtful accounts was $1.7 million and $1.8 millionCompany adopted ASU 2016-13 as of June 30, 2021January 1, 2022, andon a modified retrospective basis. The cumulative-effect adjustment related to the adoption was December 31, 2020, notrespectively. material.

 

Inventories

Inventories are stated at In August 2020, the lower of cost (determinedFASB issued ASU 2020-06,Debt Debt with Conversion and Other Options(Subtopic 470-20) and Derivatives and Hedging Contracts in Entitys Own Equity (Subtopic 815-40) guidance on the accounting for convertible debt instruments and contracts in an entity’s own equity. The guidance simplifies the accounting for convertible instruments by reducing the various accounting models that can require the instrument to be separated into a first-in, first-out basis)debt component and equity component or net realizable value. Inventory costs include direct materials, direct labor, and normal manufacturing overhead.derivative component. The Company records reserves, when necessary, to reduce the carrying valueadopted ASU 2020-06 as of inventory to its net realizable value. Management considers forecast demand in relationJanuary 1, 2022. The adoption did not have a material impact to the inventory on hand, competitiveness of product offerings, market conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. At the point of loss recognition, a new, lower-cost basis for that inventory is established, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.

Any inventory on hand at the measurement date in excess of the Company's current requirements based on anticipated levels of sales is classified as long-term on the Company's condensed consolidated balance sheets. The Company's classification of long-term inventory requires it to estimate the portion of on hand inventory that can be realized over the upcoming twelve months.

Intellectual Property

Intellectual property consists of purchased patent rights and developed technology acquired as part of previous business acquisitions. Amortization of the patent rights is recorded using the straight-line method over the estimated useful life of the patents of 10 years. Amortization of the developed technology is recorded using the straight-line method over the estimated useful life of 5 to 7 years.financial statements.

 

The Company periodically evaluates intellectual property for impairment whenever events or changes in circumstances indicate that the carrying amount may has evaluated all other issued and ASUs not be recoverable. To determineyet adopted and believes the recoverability, the Company evaluates the probability that future estimated undiscounted net cash flowsadoption of these standards will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the assets, then such assets are written down to their fair value. NaN impairment of intellectual property was identified during the three and six months ended June 30, 2021 and 2020.

Property and Equipment

Property and equipment consists primarily of operating lease Senhance System assets, machinery, manufacturing equipment, demonstration equipment, computer equipment, furniture, and leasehold improvements, which are recorded at cost less accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets as follows:

Operating lease assets – Senhance System leasing (in years)

5

Machinery, manufacturing and demonstration equipment (in years)

3-5

Computer equipment (in years)

3

Furniture (in years)

5

Leasehold improvements

Lesser of lease term or 3 to 10 years

9

Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.

The Company reviews its property and equipment assets for possible impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine the recoverability, the Company evaluates the probability that future estimated undiscounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the assets, then such assets are written down to their fair value. The Company did not identify any impairment during the three and six months ended June 30, 2021 and 2020.

Notes Payable Payroll Protection Program

The Company’s policy is to account for forgivable loans received through the U.S. Small Business Administration (the “SBA”) under the CARES Act Payroll Protection Program (“PPP”), as debt in accordance with ASC 470, Debt, and other related accounting pronouncements. The forgiveness of debt, in whole or part, is recognized once the debt is extinguished, which occurs when the Company is legally released from the liability by the SBA. Any portion of debt forgiven, adjusted for accrued interest forgiven and unamortized debt issuance costs, is recorded ashave a gainmaterial impact on extinguishment of debt, and presented in theits condensed consolidated statements of operations and comprehensive loss. On June 10, 2021, the Company received notification from the SBA that the principal amount of its PPP loan of $2.8 million and related interest had been forgiven.

Contingent Consideration

Contingent consideration is recorded as a liability and is the estimate of the fair value of potential milestone payments related to business acquisitions. Contingent consideration is measured at fair value using a discounted cash flow model utilizing significant unobservable inputs including the probability of achieving each of the potential milestones, future Euro-to-USD exchange rates, and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones. Significant increasesloss, balance sheets, or decreases in any of the probabilities of success or changes in expected achievement of any of these milestones would result in a significantly higher or lower fair value of these milestones, respectively, and commensurate changes to the associated liability. The contingent consideration is revalued at each reporting period and changes in fair value are recognized in the condensed consolidated statements of operations and comprehensive loss.cash flows.

On September 21,2015, the Company completed the strategic acquisition, through its wholly owned subsidiary TransEnterix International, from Sofar, of all of the assets, employees and contracts related to the advanced robotic system for minimally invasive laparoscopic surgery now known as the Senhance System. Under the terms of the Purchase Agreement, as amended in 2016, as of June 30, 2021 the Company has accrued $4.7 million of estimated fair value of remaining contingent consideration which shall be payable upon achievement of trailing revenues from sales or services contracts of the Senhance System of at least 25.0 million over a calendar quarter.

Warrant Liabilities

The Company’s Series B Warrants (see Note 8) were measured at fair value using a simulation model which took into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock, its expected volatility, holding cost and the risk-free interest rate for the term of the warrant (see Note 3). The warrant liability was revalued at each reporting period and changes in fair value were recognized in the condensed consolidated statements of operations and comprehensive loss. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. All remaining outstanding Series B Warrants were exercised in the first quarter 2021.

Revenue Recognition

The Company’s revenue consists of product revenue resulting from the sale and lease of Systems, System components, instruments and accessories, and service revenue. The Company accounts for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. The Company's revenues are measured based on consideration specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities. The Company’s System sale arrangements generally include a five-year service period; the first year of service is generally free and included in the System sale arrangement and the remaining four years are generally included at a stated service price.

 

10

The Company’s System sale arrangements generally contain multiple products and services. For these consolidated sale arrangements, the Company accounts for individual products and services as separate performance obligations if they are distinct, which is if a product or service is separately identifiable from other items in the consolidated package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company’s System sale arrangements may include a combination of the following performance obligations: system(s), system components, instruments, accessories, and system services.

For arrangements that contain multiple performance obligations, revenue is allocated to each performance obligation based on its relative estimated standalone selling price. When available, standalone selling prices are based on observable prices at which the Company separately sells the products or services; however due to limited sales to date, standalone selling prices generally are not directly observable. The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer, and market conditions. The Company regularly reviews estimated standalone selling prices and updates these estimates if necessary.

The Company recognizes revenues as the performance obligations are satisfied by transferring control of the product or service to a customer. The Company generally recognizes revenue for the performance obligations as follows:

3.

System sales. For Systems and System components sold directly to end customers (including those arising from System purchases under lease rights to purchase), revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. For Systems sold through distributors, for which distributors are responsible for installation, revenue is recognized generally at the time of shipment. The Company’s System arrangements generally do not provide a right of return. The Systems are generally covered by a one-year warranty. Warranty costs were not material for the periods presented.

Instruments and accessories. Revenue from sales of instruments and accessories is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but also occurs at the time of delivery depending on the customer arrangement.

Service. Service revenue is recognized ratably over the term of the service period as the customers benefit from the service throughout the service period. Revenue related to services performed on a time-and-materials basis is recognized when performed. Recognition

 

The following table presents revenue disaggregated by type and geography:

 

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2021

  

2020

  

2021

  

2020

 
  

(in thousands)

  

(in thousands)

 

U.S.

                

Systems

 $91  $45  $184  $75 

Instruments and accessories

  79   7   141   67 

Services

  104   103   202   171 

Total U.S. revenue

  274   155   527   313 
                 

Outside of U.S. ("OUS")

                

Systems

  258   117   1,430   127 

Instruments and accessories

  268   146   645   288 

Services

  302   237   583   527 

Total OUS revenue

  828   500   2,658   942 
                 

Total

                

Systems

  349   162   1,614   202 

Instruments and accessories

  347   153   786   355 

Services

  406   340   785   698 

Total revenue

 $1,102  $655  $3,185  $1,255 

The Company recognizes sales by geographic area based on the country in which the customer is based. Operating lease revenue from Senhance System Leasing is included as Systems in the above table and was approximately $0.3 million and $0.1 million in the three months ended June 30, 2021 and 2020, respectively, and $0.7 million and $0.2 million in the six months ended June 30, 2021 and 2020, respectively.

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands)

  

(in thousands)

 

U.S.

                

Systems

 $0  $0  $0  $3 

Instruments and accessories

  18   79   82   141 

Services

  75   104   149   202 

Leases

  51   91   164   181 

Total U.S. revenue

  144   274   395   527 
                 

Outside of U.S. ("OUS")

                

Systems

  0   0   0   921 

Instruments and accessories

  236   284   519   661 

Services

  349   302   583   583 

Leases

  265   242   563   493 

Total OUS revenue

  850   828   1,665   2,658 
                 

Total

                

Systems

  0   0   0   924 

Instruments and accessories

  254   363   601   802 

Services

  424   406   732   785 

Leases

  316   333   727   674 

Total revenue

 $994  $1,102  $2,060  $3,185 

 

117

 

Remaining Performance Obligations

Transaction price allocated to remaining performance obligations relates to amounts allocated to products and services for which the revenue has not yet been recognized. A significant portion of this amount relates to service obligations performed under the Company's system sales contracts that will be invoiced and recognized as revenue in future periods. Transaction price allocated to remaining performance obligations was approximately $3.2 million and $3.1 million as of June 30, 20212022 and December 31,2020, respectively.was $2.1 million, which is expected to be recognized over one to four years. 

 

Contract Assets and Liabilities

The Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets for the periods presented primarily represent the difference between the revenue that was recognized based on the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Contract assets are included in accounts receivable and totaled $0.1 million and $0.1 million as of June 30, 2021 and December 31,2020, respectively. Deferred revenue for the periods presented was primarily related to service obligations, for which the service fees are billed up-front, generally annually. The associated deferred revenue is generally recognized ratably over the service period. The Company did not have any significant impairment losses on its contract assets for the periods presented. Revenue recognized for the three months ended June 30, 20212022 and 20202021 that was included in the deferred revenue balance at the beginning of each reporting period was $0.2$0.3 million and $0.4$0.2 million, respectively. Revenue recognized for the six months ended June 30, 20212022 and 20202021 that was included in the deferred revenue balance at the beginning of each reporting period was $0.5 million and $0.4 million, and $0.6 million, respectively. The aggregate amount of transaction price allocated to performance obligations that remain unsatisfied as of June 30, 2021 was $3.2 million, which is expected to be recognized as revenue over one to three years.

 

In connection withThe following information summarizes the Company’s contract assets recognized from the costs to obtain a contract with a customer, the Company determined that the sales incentive programs for its sales team do not meet the requirements to be capitalized as the Company does not expect to generate future economic benefits from the related revenue from the initial sales transaction and such costs are expensed as incurred.liabilities:

 

  

As of

 
  

June 30, 2022

  

December 31, 2021

 
  

(in thousands)

 

Contract Assets

 $57  $91 

Deferred Revenue

 $510  $543 

Senhance System Leasing

The Company enters into operating lease arrangements with certain qualified customers. Revenue related to arrangements including lease elements are allocated to lease and non-lease elements based on their relative standalone selling prices. Lease elements generally include a Senhance System, while non-lease elements generally include instruments, accessories, and services. For some lease arrangements, the customers are provided with the rightoption to purchase the leased System at some point during and/or at the end of the lease term. In some arrangements lease payments are based on the usage of the System. For the three and six months ended June 30, 2022, and 2021, variable lease revenue related to usage-based arrangements was not material.  

 

In determining whetherTrade Accounts Receivable

The allowance for doubtful accounts is based on the Company’s assessment of collectability of customer accounts. The Company regularly reviews the allowance by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect a transaction should be classifiedcustomer’s ability to pay. The allowance for doubtful accounts was $1.5 million and $1.7 million as of June 30, 2022, and December 31, 2021, respectively. For the three and six months ended June 30, 2022, and 2021, bad debt expense was not material.

8

4.

Fair Value

The following are categories of assets and liabilities measured at fair value on a sales-type, operating,recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3):

  

June 30, 2022

 
  

(in thousands)

 
                 

Description

 

Quoted Prices in

Active Markets for

Identical Assets

(Level 1)

  

Significant Other

Observable Inputs

(Level 2)

  

Significant

Unobservable

Inputs (Level 3)

  

Total

 

Assets measured at fair value

                

Cash and cash equivalents (1)

 $10,844  $0  $0  $10,844 

Restricted cash

  1,290   0   0   1,290 

Short-term investments

  0   83,360   0   83,360 

Long-term investments

  0   9,581   0   9,581 

Total assets measured at fair value

 $12,134  $92,941  $0  $105,075 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $1,619  $1,619 

Total liabilities measured at fair value

 $0  $0  $1,619  $1,619 

(1) Includes investments that are readily convertible to cash with original maturities of 90 days or less.

  

December 31, 2021

 
  

(in thousands)

 
                 

Description

 

Quoted Prices in

Active Markets for

Identical Assets

(Level 1)

  

Significant Other

Observable Inputs

(Level 2)

  

Significant

Unobservable

Inputs (Level 3)

  

Total

 

Assets measured at fair value

                

Cash and cash equivalents (1)

 $18,129  $0  $0  $18,129 

Restricted cash

  1,154   0   0   1,154 

Short-term investments

  0   80,262   0   80,262 

Long-term investments

  0   37,435   0   37,435 

Total assets measured at fair value

 $19,283  $117,697  $0  $136,980 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $2,371  $2,371 

Total liabilities measured at fair value

 $0  $0  $2,371  $2,371 

(1) Includes investments that are readily convertible to cash with original maturities of 90 days or less.

The carrying values of accounts receivable, other current assets, accounts payable, and accrued expenses and other current liabilities as of June 30, 2022, and December 31, 2021, approximate their fair values due to the short-term nature of these items.

The Company’s financial liabilities consisted of contingent consideration payable to an assignee of Sofar, S.p.A., the seller, related to the Company’s 2015 acquisition of the Senhance Surgical System (the “Senhance Acquisition”). Adjustments associated with the change in fair value of contingent consideration are included in the Company’s condensed consolidated statements of operations and comprehensive loss.

The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements for contingent consideration utilizing a Monte-Carlo simulation as of June 30, 2022 and December 31, 2021:

 

Valuation

Methodology

 

Significant Unobservable

Input

 

June 30, 2022

  

December 31, 2021

 
            

Contingent consideration

Probability weighted income approach

 

Milestone dates

  2031   2031 
   

Discount rate

  14.5%  9.5%
   

Revenue volatility

  40.0%  39.0%
   

EUR-to-USD exchange rate

  1.05   1.14 

9

The following table summarizes the change in fair value, as determined by Level 3 inputs for the contingent consideration for the six months ended June 30, 2022 and 2021:

  

Fair Value Measurement at

Reporting Date (Level 3)

 
  

(in thousands)

 
  

Series B

Warrants

  

Contingent

consideration

 

Balance at December 31, 2021

 $0  $2,371 

Change in fair value

  0   (752)

Balance at June 30, 2022

 $0  $1,619 
         

Balance at December 31, 2020

 $255  $3,936 

Exercise of warrants

  (2,236)  0 

Change in fair value

  1,981   257 

Balance at June 30, 2021

 $0  $4,193 
         

Current portion

 $0  $0 

Long-term portion

  0   1,619 

Balance at June 30, 2022

 $0  $1,619 

5.

Investments, available-for-sale

The aggregate fair values of investment securities along with unrealized gains and losses determined on an individual investment security basis and included in other comprehensive loss are as follows:

  

June 30, 2022

 
  

(in thousands)

 
                         
  

Amortized

Cost

  

Unrealized

Gain

  

Unrealized

Loss

  

Fair Value

  

Short-term

investments

  

Long-term

investments

 

Commercial Paper

 $35,643  $0  $(191) $35,452  $35,452  $0 

Corporate Bonds

  58,242   0   (753)  57,489   47,908   9,581 

Total Investments

 $93,885  $0  $(944) $92,941  $83,360  $9,581 

  

December 31, 2021

 
  

(in thousands)

 
                         
  

Amortized

Cost

  

Unrealized

Gain

  

Unrealized

Loss

  

Fair Value

  

Short-term

investments

  

Long-term

investments

 

Commercial Paper

 $50,705  $0  $(46) $50,659  $50,660  $0 

Corporate Bonds

  67,239   1   (202)  67,038   29,602   37,435 

Total Investments

 $117,944  $1  $(248) $117,697  $80,262  $37,435 

The following table summarizes the contractual maturities of the Company’s available-for-sale investments:

  

June 30, 2022

 
  

(in thousands)

 
  

Amortized

Cost

  

Fair Value

 

Mature in less than one year

 $84,173  $83,360 

Mature in one to two years

  9,712   9,581 

Total

 $93,885  $92,941 

Actual maturities may differ from contractual maturities because certain borrowers have the right to call or direct financingprepay certain obligations. There were no sales of investments or gross realized gains or losses for the six months ended June 30, 2022, and 2021, respectively.

10

6.

Inventories

The components of inventories are as follows:

  

June 30, 2022

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $14,687  $(2,931) $11,756 

Raw materials

  6,137   (2,184)  3,953 

Total inventories

 $20,824  $(5,115) $15,709 
             

Current Portion

 $10,113  $(1,662) $8,451 

Long-term portion

  10,711   (3,453)  7,258 

Total inventories

 $20,824  $(5,115) $15,709 

  

December 31, 2021

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $13,066  $(2,987) $10,079 

Raw materials

  8,324   (2,695)  5,629 

Total inventories

 $21,390  $(5,682) $15,708 
             

Current Portion

 $9,931  $(1,297) $8,634 

Long-term portion

  11,459   (4,385)  7,074 

Total inventories

 $21,390  $(5,682) $15,708 

The Company has determined that its December 31, 2021 and March 31, 2022 inventory footnote presentation overstated raw materials and understated finished goods by approximately $2.5 million. For comparative purposes, the Company’s prior year inventory footnote has been revised to reflect the adjustment to raw materials and finished goods. The revision had no effect on the previously reported total gross and net carrying value of inventory. The revision also had no effect on the previously reported balance sheets, statements of operations and comprehensive loss, cash flows and stockholders’ equity. 

7.

Intellectual Property

The components of gross intellectual property, accumulated amortization, and net intellectual property are as follows:

  

June 30, 2022

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

 

Developed technology

 $68,838  $(64,094) $(812) $3,932 

Technology and patents purchased

  400   (220)  10   190 

Total intellectual property

 $69,238  $(64,314) $(802) $4,122 

  

December 31, 2021

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

 

Developed technology

 $68,838  $(58,912) $(262) $9,664 

Technology and patents purchased

  400   (199)  27   228 

Total intellectual property

 $69,238  $(59,111) $(235) $9,892 

The weighted average remaining useful life of the developed technology and technology and patents purchased was 2.0 years and 4.8 years, respectively, as of June 30, 2022.  

11

8.

Leases

Lessee Information

The Company determines if an arrangement contains a lease or service contract at inception. Where an arrangement contains a lease, the Company considersdetermines if it is an operating lease or a finance lease. Subsequently, if the following terms at lease commencement: (1) whether title ofarrangement is modified, the Senhance System transfers automatically orCompany reevaluates the classification. The Company has entered into operating leases for a nominal fee by the endcorporate office buildings, vehicles, and machinery and equipment. Some of the lease term, (2) whetheragreements have renewal options, tenant improvement allowances, rent escalation clauses, and assignment and subletting clauses. While the presentoperating leases range from one year to ten years, some include options to extend the lease generally between one year and six years, and some include options to terminate the leases within one year.

Components of operating lease expense are primarily recorded in general and administrative on the condensed consolidated statements of operations and comprehensive loss were as follows:

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands)

  

(in thousands)

 

Long-term Operating

 $386  $485  $785  $923 

Short-term Operating

  0   0   0   0 

Total Operating lease expense

 $386  $485  $785  $923 

Supplemental balance sheet information related to operating leases was as follows:

  

June 30, 2022

  

December 31, 2021

 

Weighted-average remaining lease term (in years)

  7.4    7.8  

Weighted-average discount rate

  7.4%    7.8%  

Incremental borrowing rate

 6.1%-8.5%  6.1%-8.5 

Maturities of operating lease obligations as of June 30, 2022 were as follows (in thousands):

Fiscal Year

    

2022

 $430 

2023

  972 

2024

  886 

2025

  881 

2026

  822 

Thereafter

  2,958 

Total minimum lease payments

 $6,949 

Less: Amount of lease payments representing interest

  (1,760)

Present value of future minimum lease payments

 $5,189 

9.

Property and Equipment Impairment

During the three and six months ended June 30, 2022, the Company recorded a non-cash asset impairment charge of $0.4 million to reduce the carrying value of the minimum lease payments equals or exceeds substantially all of theproperty and equipment to its estimated fair value. The property and equipment is associated with returned Senhance Systems under operating leases that are not expected to generate future cash flows sufficient to recover their net book value. The fair value was estimated based on the discounted cash flows expected to be produced by the property and equipment. The impairment was recorded in property and equipment impairment on the condensed consolidated statements of operations and comprehensive loss.

10.

Income Taxes

Income taxes have been accounted for using the leased System, (asset and liability method in accordance with ASC 3740) whether “Income Taxes”. The Company computes its interim provision for income taxes by applying the lease term isestimated annual effective tax rate method. The Company estimates an annual effective tax rate of (0.4)% for the major partyear ending December 31, 2022. This rate does not include the impact of the remaining economic life of the leased System, (4) whether the lease grants the lessee an option to purchase the leased System that the lessee is reasonably certain to exercise, and (5) whether the underlying System is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term. All such arrangements through June 30, 2021 are classified as operating leases.

Revenue related to lease elements from operating lease arrangements is generally recognized on a straight-line basis over the lease term or based upon System usage and is presented as product revenue. Revenue related to lease elements from operating lease arrangements was approximately $0.3 million and $0.1 millionany discrete items. The Company’s effective tax rate for the three months ended June 30, 20212022 and 2020,2021 respectively,was (0.4)% and $0.7 million and $0.2 million0.0%, respectively. The Company’s effective tax rate for the six months ended June 30, 20212022 and 2020,2021 was (0.4)% and 0.1%, respectively.

 

Cost of Revenue

Cost of revenue consists of contract manufacturing, materials, labor, and manufacturing overhead incurred internally to produce the products. Shipping and handling costs incurred by the Company are included in cost of revenue. During the three months ended June 30, 2021 and 2020, the Company recorded $0.2 million and $0 million, respectively, of expenses for inventory obsolescence related to certain System components. During the six months ended June 30, 2021 and 2020, the Company recorded $0.3 million and $0 million, respectively, of expenses for inventory obsolescence related to certain System components.

Research and Development Costs

Research and development expenses primarily consist of engineering, product development and regulatory expenses, incurred in the design, development, testing and enhancement of our products. Research and development costs are expensed as incurred.

12

 

The Company incurred losses for the three and six months ended June 30, 2022, and is forecasting additional losses through the year, resulting in an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2022. Due to the Company’s history of losses, there is not sufficient evidence to record a net deferred tax asset associated with the U.S., Luxembourg, Swiss, Italian, Taiwanese, and Canadian operations. Accordingly, a full valuation allowance has been recorded related to the net deferred tax assets in those jurisdictions.

The total tax (expense) benefit during the three months ended June 30, 2022 and 2021, was approximately ($0.1) million and ($0.002) million, respectively. The total tax (expense) benefit during the six months ended June 30, 2022 and 2021, was approximately ($0.2) million and $0.036 million, respectively.

At June 30, 2022 the Company had 0 unrecognized tax benefits that would affect the Company’s effective tax rate.

The FASB Staff Q&A, Topic 740,No.5, Accounting for Global Intangible Low-Taxed Income (“GILTI”), states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. The Company does not expect a GILTI inclusion for 2022;no GILTI tax has been recorded for the six months ended June 30, 2022 or 2021.

11.

Stock-Based Compensation

The Company recognizes expenses for share-based awards exchanged for services rendered equal to the estimated fair value of these awards over the requisite service period. The Company recognizes as expense, the grant-date fair value of stock options and other stock-based compensation issued to employees and non-employee directors over the requisite service periods, which are typically the vesting periods. The Company uses the Black-Scholes-Merton model to estimate the fair value of our stock options. The volatility assumption used in the Black-Scholes-Merton model is based on the Company’s historical volatility. The expected term of options granted has been determined based upon the simplified method, because the Company does not have sufficient historical information regarding its options to derive the expected term. Under this approach, the expected term is the mid-point between the weighted average of vesting period and the contractual term. The risk-free interest rate is based on U.S. Treasury rates whose term is consistent with the expected life of the stock options. The Company has not paid and does not anticipate paying cash dividends on its shares of common stock; therefore, the expected dividend yield is assumed to be zero. The Company estimates forfeitures based on its historical experience and adjust the estimated forfeiture rate based upon actual experience. For awards with performance conditions, we begin recognizing compensation expense when it becomes probable that the performance condition will be attained.

 

The fair value of restricted stock units is determined by the market price of the Company’s common stock on the date of grant.

The Company records as expense the fair value of stock-based compensation awards, including stock options and restricted stock units. Compensation expense for stock-based compensation was approximately $1.8 million and $1.9 million for the three months ended June 30, 2021 and 2020, respectively, and was approximately $3.6 million and $3.9 million for the six months ended June 30, 2021 and 2020, respectively.

Stock Options

The following table summarizes the Company’s stock option activity, including grants to non-employees, for the six months ended June 30, 2022:

  

Number of

Shares

  

Weighted-

Average Exercise

Price

  

Weighted-Average

Remaining

Contractual Term

(Years)

 

Balance at December 31, 2021

  4,640,660  $6.64   5.66 

Granted

  2,555,396   0.77     

Forfeited

  (23,047)  3.22     

Cancelled

  (16,983)  33.27     

Exercised

  (43,453)  0.41     

Balance at June 30, 2022

  7,112,573  $4.52   5.71 

The following table summarizes information about stock options outstanding at June 30, 2022:

  

Number of

Shares

  

Weighted-

Average Exercise

Price

  

Weighted-Average

Remaining

Contractual Term

(Years)

  

Aggregate

Intrinsic Value

(Millions)

 

Exercisable at June 30, 2022

  3,119,355  $8.02   5.08  $0 

Vested or expected to vest at June 30, 2022

  6,777,170  $4.67   5.67  $0 

13

Restricted Stock Units

The following is a summary of the restricted stock units activity, including performance restricted stock units, for the six months ended June 30, 2022:

  

Number of

Restricted Stock

Units

Outstanding

  

Weighted-

Average Grant

Date Fair Value

 

Unvested December 31, 2021

  3,839,030  $2.36 

Granted

  6,040,915   0.75 

Vested

  (1,794,623)  2.47 

Forfeited

  (100,047)  1.36 

Unvested Jun 30, 2022

  7,985,275  $1.13 

Performance Restricted Stock Units

In 2022 and 2021, the Company granted performance-based restricted stock units with vesting terms based on our attainment of certain operational targets by October 1, 2023 and October 1, 2022, respectively. The number of shares earnable under the 2022 and 2021 awards are based on achieving designated corporate goals.

Stock-based Compensation Expense

The following table summarizes non-cash stock-based compensation expense by award type for the three and six months ended June 30, 2022, and 2021:

  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands)

  

(in thousands)

 

Stock options

 $924  $1,087  $1,901  $2,207 

Restricted stock units

  822   690   1,707   1,293 

Performance restricted stock units

  337   33   720   70 
  $2,083  $1,810  $4,328  $3,570 

As of June 30, 2022, the Company had future employee stock-based compensation expense of approximately $3.6 million related to unvested stock options, which is expected to be recognized over an estimated weighted-average period of 2.0 years. As of June 30, 2022, the unrecognized stock-based compensation expense related to unvested restricted stock units was approximately $6.0 million, which is expected to be recognized over a weighted average period of approximately 1.8 years.

The fair value of options granted were estimated using the Black-Scholes-Merton option pricing model based on the assumptions in the table below:

  

Six Months Ended June 30,

 
  

2022

  

2021

 

Expected dividend yield

   0%    0%  

Expected volatility

  128%-133%  118%-136% 

Risk-free interest rate

  1.25%-2.98%  0.33%-0.58% 

Expected life (in years)

  4.3-4.5  3.8-4.5 

Income Taxes12.

The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets or liabilities for the temporary differences between financial reporting and tax basis of the Company’s assets and liabilities, and for tax carryforwards at enacted statutory rates in effect for the years in which the asset or liability is expected to be realized. The effect on deferred taxes of a change in tax rates is recognized in income during the period that includes the enactment date. In addition, valuation allowances are established when necessary to reduce deferred tax assets and liabilities to the amounts expected to be realized. The Company has elected to account for global intangible low-taxed income (“GILTI”) as a period expense in the year the tax is incurred.

The Company recognizes the financial statement benefit of an income tax position only after determining that the relevant taxing authority would more likely than not sustain the position following audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require application of significant judgment. The Company is subject to U.S. federal and various state, local and foreign jurisdictions. Due to the Company’s net operating loss carryforwards, the Company may be subject to examination by authorities for all previously filed income tax returns.

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources.

Segments

The Company operates in 1 business segment—the research, development and sale of medical device robotics to improve minimally invasive surgery. The Company’s chief operating decision maker (determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results.

Approximately 77% and 27% of the Company’s total consolidated assets are located within the U.S. as of June 30, 2021 and December 31, 2020, respectively. The remaining assets are mostly located in Europe and are primarily related to the Company’s facility in Italy, and include intellectual property, other current assets, property and equipment, cash, accounts receivable, other long-term assets and inventory of $47.6 million and $56.8 million as of June 30, 2021 and December 31, 2020, respectively. Total assets outside of the United States amounted to 23% and 73% of total consolidated assets as of June 30, 2021 and December 31, 2020, respectively.  Long-lived assets in the U.S. were 21% and 11%, Italy were 37% and 48%, and Switzerland were 40% and 41%, as of June 30, 2021 and December 31, 2020, respectively. The Company recognizes sales by geographic area based on the country in which the customer is based. For the three months ended June 30, 2021 and 2020, 25% and 24%, respectively, of net revenue were generated in the United States; while 53% and 56%, respectively, were generated in Europe; and 22% and 20% were generated in Asia. For the six months ended June 30, 2021 and 2020, 17% and 25%, respectively, of net revenue were generated in the United States; while 32% and 52%, respectively, were generated in Europe; and 51% and 23% were generated in Asia.

13

Impact of Recently Issued Accounting Standards

In December 2019, the FASB issued ASU 2019-12,Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in ASC 740,Income Tax and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-12 effective January 1, 2021; the adoption did not result in a material impact on the Company's financial statements and related disclosures.

In June 2016, the FASB issued ASU 2016-13,Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which is designed to provide financial statement users with more information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. When determining such expected credit losses, the guidance requires companies to apply a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This guidance is effective on a modified retrospective basis for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The guidance is not expected to have a material impact on the Company's financial statements and related disclosures.

In August 2020, the FASB issued ASU 2020-06Debt Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entitys Own Equity (subtopic 815-40) guidance on the accounting for convertible debt instruments and contracts in an entity’s own equity. The guidance simplifies the accounting for convertible instruments by reducing the various accounting models that can require the instrument to be separated into a debt component and equity component or derivative component. Additionally, the guidance eliminated certain settlement conditions previously required to be able to classify a derivative in equity. The new guidance is effective on a modified or full retrospective basis for fiscal years beginning after December 15, 2023, including interim periods with those fiscal years. The Company is currently evaluating the impact on the condensed consolidated financial statements upon adoption.Offerings

The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not

Equity financing transactions for the six months ended June 30, 2021, include:

2020 ATM Offering. On October 9, 2020, the Company filed a prospectus supplement relating to an at-the-market offering with Cantor pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $40.0 million of shares of the Company’s common stock (the “2020 ATM Offering”). The Company terminated this agreement in January 2021. 

January 2021 Public Offering. On January 29, 2021, the Company completed an underwritten public offering of 26,545,832 shares of its common stock, including the underwriter’s full exercise of an over-allotment option on February 1, 2021, at the public offering price of $3.00 per share, generating net proceeds of approximately $73.4 million.

January 2021 Registered Direct Purchase Agreement. On January 12, 2021, the Company sold in a registered direct offering 25,000,000 shares of common stock at a purchase price per share of $1.25 for aggregate net proceeds of $28.6 million.

14 have a material impact on its condensed consolidated statements of operations and comprehensive loss, balance sheets, or statements of cash flows.

3.

Fair Value

The Company held certain assets and liabilities that are required to be measured at fair value on a recurring basis. These assets and liabilities include cash and cash equivalents, restricted cash, contingent consideration and warrant liabilities. ASC 820-10 (“Fair Value Measurement Disclosure”) requires the valuation using a three-tiered approach, which requires that fair value measurements be classified and disclosed in one of three tiers. These tiers are: Level 1, defined as quoted prices in active markets for identical assets or liabilities; Level 2, defined as valuations based on observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable input data; and Level 3, defined as valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. The Company did not have any transfers of assets and liabilities between Level 1, Level 2, and Level 3 of the fair value hierarchy during the three and six months ended June 30, 2021 and 2020.

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data and therefore, are based primarily upon estimates, are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, the results cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique, and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the results of current or future values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

As prescribed by U.S. GAAP, the Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy.

14

The determination of where an asset or liability falls in the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures and based on various factors, it is possible that an asset or liability may be classified differently from period to period. However, the Company expects changes in classifications between levels will be rare.

The carrying values of accounts receivable, other current assets, accounts payable, and certain accrued expenses as of June 30, 2021 and December 31,2020 approximate their fair values due to the short-term nature of these items. The Company’s notes payable balance also approximates fair value as of December 31,2020, as the interest rate on the notes payable approximates the rates available to the Company as of this date.

The following are the major categories of assets and liabilities measured at fair value on a recurring basis as of June 30, 2021 and December 31,2020, using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3):

  

June 30, 2021

 
  

(in thousands)

 
                 

Description

 

Quoted Prices in Active Markets for Identical Assets (Level 1)

  

Significant Other Observable Inputs (Level 2)

  

Significant Unobservable Inputs (Level 3)

  

Total

 

Assets measured at fair value

                

Cash and cash equivalents

 $157,078  $0  $0  $157,078 

Restricted cash

  1,045   0   0   1,045 

Total assets measured at fair value

 $158,123  $0  $0  $158,123 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $4,671  $4,671 

Total liabilities measured at fair value

 $0  $0  $4,671  $4,671 

  

December 31, 2020

 
  

(in thousands)

 
                 

Description

 

Quoted Prices in Active Markets for Identical Assets (Level 1)

  

Significant Other Observable Inputs (Level 2)

  

Significant Unobservable Inputs (Level 3)

  

Total

 

Assets measured at fair value

                

Cash and cash equivalents

 $16,363  $0  $0  $16,363 

Restricted cash

  1,166   0   0   1,166 

Total assets measured at fair value

 $17,529  $0  $0  $17,529 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $3,936  $3,936 

Warrant liabilities

  0   0   255   255 

Total liabilities measured at fair value

 $0  $0  $4,191  $4,191 

The Company’s financial liabilities consisted of contingent consideration payable to Sofar related to the Senhance Acquisition in September 2015. This liability is reported as Level 3 as estimated fair value of the contingent consideration related to the acquisition requires significant management judgment or estimation and is calculated using the income approach, using various revenue and cost assumptions, and applying a probability to each outcome. The increase in fair value of the contingent consideration of $0.5 million and $0.7 million for the three and six months ended June 30, 2021, respectively was primarily due to a lower discount rate, increased volatility, and the passage of time. The increase in fair value of the contingent consideration of $0.2 million and $1.3 million for the three and six months ended June 30, 2020, respectively was primarily due to the passage of time. Adjustments associated with the change in fair value of contingent consideration are included in the Company’s condensed consolidated statements of operations and comprehensive loss. The Company uses a probability-weighted income approach for estimating the fair value of the contingent consideration. The significant unobservable inputs used in this approach include estimates of amounts and timing of stated milestones, volatility, and the discount rate.

On April 28, 2017, the Company sold 24.9 million units (the “Units”), each consisting of approximately 0.077 shares of the Company's Common Stock, a Series A warrant to purchase approximately 0.077 shares of Common Stock with an exercise price of $13.00 per share (the “Series A Warrants”), and a Series B warrant to purchase approximately 0.058 shares of Common Stock with an exercise price of $13.00 per share (the “Series B Warrants,” together with the Series A Warrants, the “Warrants”), at an offering price of $1.00 per Unit. All of the Series A Warrants were exercised prior to the expiration date of October 31, 2017. As of December 31, 2020, 567,660 Series B Warrants were outstanding with an exercise price of $0.35 per share. All outstanding Series B Warrants were exercised in the first quarter 2021.

15

The final remeasurement upon exercise of the Series B warrants was on February 8, 2021 and all Series B warrants have been exercised as of June 30, 2021. The change in fair value of the Series B warrants for the six months ended June 30, 2021 and 2020 was an increase of $2.0 million and an increase of $0.3 million, respectively and was included in the Company’s condensed consolidated statements of operations and comprehensive loss. The increase in fair value of the Series B warrants of $2.0 million for the six months ended June 30, 2021 was primarily due to an increase in share price, a lower discount rate, increased volatility, and the passage of time. NaN change in fair value was recorded for the three months ended June 30, 2021. The change in fair value of the Series B warrants for the three months ended June 30, 2020 was an increase of $0.1 million and was primarily due to a lower discount rate, decreased volatility, and the passage of time. The following table presents the inputs and valuation methodologies used for the Company’s fair value of the Series B warrants:

  

December 31,

 

Series B Warrants

 

2020

 
     

Valuation methodology

 

Black-Scholes-Merton

 

Term (years)

  1.32 

Risk free rate

  0.10%

Dividends

  0 

Volatility

  150.97%

Share price

 $0.63 

The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements for contingent consideration as of June 30, 2021 and December 31,2020:

  

Methodology

 

Unobservable Input

 

2021

  

2020

 
               

Contingent consideration

 

Probability weighted income approach

 

Milestone dates

 2025to2029  2024to2029 
    

Discount rate

  9.0%    9.50%  
    

Volatility

  74.0%    71.0%  

The following table summarizes the change in fair value, as determined by Level 3 inputs for the warrants and the contingent consideration for the six months ended June 30, 2021:

  

Fair Value Measurement at Reporting Date (Level 3)

 
  

(in thousands)

     
  

Common stock warrants

  

Contingent consideration

 

Balance at December 31, 2020

 $255  $3,936 

Exercise of warrants

  (2,236)  0 

Change in fair value

  1,981   735 

Balance at June 30, 2021

 $0  $4,671 
         

Current portion

 $0  $0 

Long-term portion

  0   4,671 

Balance at June 30, 2021

 $0  $4,671 

4.

Inventories

The components of inventories are as follows:

  

June 30, 2021

  

December 31, 2020

 
  

(in thousands)

 

Finished goods

 $13,238  $10,749 

Raw materials

  5,875   8,098 

Total inventories

 $19,113  $18,847 
         

Current portion

 $12,523  $10,034 

Long-term portion

  6,590   8,813 

Total inventories

 $19,113  $18,847 

During the three and six months ended June 30, 2021, the Company recorded a $0.2 million and a $0.3 million charge for inventory obsolescence related to certain system components, respectively. There were 0 such write-downs or charges for the three and six months ended June 30, 2020.

5.

Intellectual Property

The components of gross intellectual property, accumulated amortization, and net intellectual property as of June 30, 2021 and December 31,2020 are as follows:

  

June 30, 2021

 
  

(in thousands)

 
  

Gross Carrying Amount

  

Accumulated Amortization

  

Foreign Currency Translation Impact

  

Net Carrying Amount

 

Developed technology

 $68,838  $(55,755) $2,601  $15,684 

Technology and patents purchased

  400   (185)  44   259 

Total intellectual property

 $69,238  $(55,940) $2,645  $15,943 

  

December 31, 2020

 
  

(in thousands)

 
  

Gross Carrying Amount

  

Accumulated Amortization

  

Foreign Currency Translation Impact

  

Net Carrying Amount

 

Developed technology

 $68,838  $(51,734) $4,872  $21,976 

Technology and patents purchased

  400   (168)  59   291 

Total intellectual property

 $69,238  $(51,902) $4,931  $22,267 

The weighted average remaining useful life of the developed technology and technology and patents purchased was 1.8 years and 5.8 years, respectively as of June 30, 2021.  


6.

Income Taxes

Income taxes have been accounted for using the asset and liability method in accordance with ASC 740 “Income Taxes”. The Company computes its interim provision for income taxes by applying the estimated annual effective tax rate method. The Company estimates an annual effective tax rate of (0.1)% for the year ending December 31, 2021. This rate does not include the impact of any discrete items. The Company’s effective tax rate for the three months ended June 30, 2021 and 2020 was 0.0% and 4.8%, respectively. The Company’s effective tax rate for the six months ended June 30, 2021 and 2020 was 0.1% and 4.4%, respectively

17

The Company incurred losses for the three- and six- month periods ended June 30, 2021 and is forecasting additional losses through the year, resulting in an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2021. Due to the Company’s history of losses, there is not sufficient evidence to record a net deferred tax asset associated with the U.S., Luxembourg, Swiss, Italian, Taiwanese, and Canadian operations. Accordingly, a full valuation allowance has been recorded related to the net deferred tax assets in those jurisdictions.

Income tax benefit on the condensed consolidated statement of operations and comprehensive loss is comprised of deferred tax benefit and current tax expense (benefit). The deferred tax benefit during the three months ended June 30, 2021 and 2020, was approximately $0.0 million and $0.7 million, respectively. The deferred tax benefit during the six months ended June 30, 2021 and 2020, was approximately $0.0 million and $1.4 million, respectively. The current tax expense (benefit) during the three months ended June 30, 2021 and 2020, was approximately $0.0 million and $0.01 million, respectively. The current tax expense (benefit) during the six months ended June 30, 2021 and 2020, was approximately $(0.04) million and $0.03 million, respectively.

At June 30, 2021, the Company had 0 unrecognized tax benefits that would affect the Company’s effective tax rate.

The FASB Staff Q&A, Topic 740,No.5, Accounting for Global Intangible Low-Taxed Income (“GILTI”), states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. The Company does not expect a GILTI inclusion for 2021;no GILTI tax has been recorded for the three or six months ended June 30, 2021 or 2020.

7.

Notes Payable  Payroll Protection Program

The CARES Act was passed in the United States and signed into law on March 7, 2020 and was amended on June 5, 2020 through the enactment of the Paycheck Protection Program Flexibility Act. On April 27, 2020, Asensus Surgical US, Inc., a wholly owned subsidiary of the Company, received funding under a promissory note dated April 18, 2020 (the “Promissory Note”), evidencing an unsecured non-recourse loan in the principal amount of $2,815,200 under the PPP provisions of the CARES Act. The PPP is administered by the U.S. Small Business Administration (the “SBA”). The Promissory Note was made through City National Bank of Florida, a national banking association (the “Lender”). The Company accounted for the PPP loan as debt and included the principal amount within notes payable on the condensed consolidated balance sheet.

The Promissory Note has a two-year term, maturing on April 27, 2022, and bears interest at 1.00% per annum. The Promissory Note may be forgiven partially or fully if the proceeds are used for covered payroll, rent and utility costs incurred during the Covered Period and if at least 60% of the proceeds are used for covered payroll costs. All or a portion of the Promissory Note may be forgiven by the SBA upon application by the Company and documentation of expenditures in accordance with the SBA requirements. If the Promissory Note is not forgiven, payments can be deferred until 10 months after the end of the Company’s covered period, which is the 24-week period beginning on the date the Company received the PPP loan proceeds from the Lenders (the “Covered Period”). The Promissory Note contains customary events of default relating to, among other things, payment defaults, and breach of representations and warranties, or other provisions of the Promissory Note. The Promissory Note was classified as long term except for the portion to be paid within twelve months of the year end, which was classified as current.

The Company submitted its application for forgiveness of the Promissory Note in full to the Lender on February 10, 2021. On June 10, 2021, the Company received notification from the SBA that the principal amount of $2.8 million and related interest had been forgiven. Gain on extinguishment of debt of $2.8 million was recognized for the three and six months ended June 30, 2021 on the condensed consolidated statement of operations and comprehensive loss.

8.

Equity Offerings

On August 12, 2019, the Company entered into a Controlled Equity Offering Sales Agreement (the “2019 Sales Agreement”), with Cantor Fitzgerald & Co., (“Cantor”), and commenced an at-the-market offering (the “2019 ATM Offering”) pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $25.0 million shares of the Company’s common stock, through Cantor, as sales agent. Sales of the common stock under the 2019 ATM Offering were made under the Company’s previously filed and currently effective shelf registration statement on Form S-3. The aggregate compensation payable to Cantor was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock. Under the 2019 ATM Offering, the Company raised gross proceeds of $7.2 million and net proceeds of $7.0 million during the year ended December 31, 2019, and an additional $11.6 million of gross proceeds and $11.2 million of net proceeds during the year ended December 31, 2020.

18

On October 9, 2020, the Company filed a prospectus supplement relating to an at-the-market offering with Cantor pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $40.0 million of shares of the Company’s common stock, through Cantor as sales agent, pursuant to the 2019 Sales Agreement (the “2020 ATM Offering”). Sales of the common stock were made on the Company’s shelf registration statement on Form S-3, which was declared effective by the SEC on February 10, 2020. The aggregate compensation payable to Cantor was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock.

The following table summarizes the total sales under the 2020 ATM Offering for the six months ended June 30, 2021 (in thousands except for share and per share amounts):

  

For the Six Months

Ended June 30,

2021

 

Total shares of common stock sold

  19,120,037 
     

Average price per share

 $1.47 
     

Gross proceeds

 $28,100 

Commissions earned by Cantor

 $843 

Net proceeds

 $27,257 

On May 19, 2021, the Company entered into a Controlled Equity OfferingSales Agreement (the “2021 Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), Robert W. Baird & Co. Incorporated (“Baird”) and Oppenheimer & Co. Inc. (“Oppenheimer”). Each of Cantor, Baird and Oppenheimer are individually an “Agent” and collectively are the “Agents” under the Agreement. Also on May 19, 2021, the Company commenced an at-the-market offering (the “2021 ATM Offering”) pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $100.0 million shares of the Company’s common stock. The aggregate compensation payable to the Agents was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock.

The following table summarizes the total sales under the 2021 ATM Offering for the six months ended June 30, 2021 (in

2021 ATM Offering. On May 19, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “2021 Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), Robert W. Baird & Co. Incorporated (“Baird”) and Oppenheimer & Co. Inc. (“Oppenheimer”). Each of Cantor, Baird and Oppenheimer are individually an “Agent” and collectively are the “Agents” under the Agreement. Also On May 19, 2021, the Company commenced an at-the-market offering (the “2021 ATM Offering”) pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $100.0 million shares of the Company’s common stock. The aggregate compensation payable to the Agents was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock.

Sales during the six months ended June 30, 2021, under the 2021 and 2020 ATM Offering are as follows (in thousands, except for share and per share amounts):

 

  

Six Months Ended
June 30, 2021

 
  

2021 ATM

  

2020 ATM

  

Total

 

Total shares of common stock sold

  331,811   19,120,037   19,451,848 

Average price per share

 $3.47  $1.47  $1.50 

Gross proceeds

 $1,152  $28,100  $29,252 

Commission earned by Sales Agents

 $34  $843  $877 

Net proceeds

 $1,118  $27,257  $28,375 

2021 Exercise of Warrants. During the six months ended June 30, 2021, certain holders of our Series B, C and D warrants to purchase shares of our common stock exercised such warrants for aggregate proceeds to the Company of $30.6 million.

2022 ATM Offering. On March 18, 2022, the Company entered a Controlled Equity Offering Sales Agreement (the “2022 Sales Agreement”), with Cantor Fitzgerald & Co., and Oppenheimer & Co. Inc. The Company commenced an at-the-market offering (the “2022 ATM Offering”) pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $100.0 million shares of the Company’s common stock. NaN sales of common stock were made under the 2022 ATM Offering during the six months ended June 30, 2022.

For the Six Months

Ended June 30,

2021

Total shares of common stock sold

331,811

Average price per share

$3.47

Gross proceeds

$1,152

Commissions earned by Agents

$34

Net proceeds

$1,118

13.

On March 10, 2020, the Company closed the March 2020 Public OfferingBasic and sold an aggregate of 14,121,766 Class A Units at a public offering price of $0.68Diluted Net Loss per Class A UnitShare

Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed giving effect to all potential dilutive common shares that were outstanding during the period when the effect is dilutive. Potential dilutive common shares consist of incremental shares issuable upon exercise of stock options, restricted stock units, and warrants. No adjustments have been made to the weighted average outstanding common shares figures for the three and six months ended June 30, 2022 or 2021 as the assumed exercise of outstanding options, warrants and restricted stock units would be anti-dilutive.

Potential common shares not included in calculating diluted net loss per share are as follows:

  

June 30,

 
  

2022

  

2021

 

Stock options

  7,112,573   4,279,335 

Stock warrants

  1,120,300   1,016,383 

Nonvested restricted stock units

  7,985,275   1,768,861 

Total

  16,218,148   7,064,579 

14.

Commitments and 7,937,057 Class B Units at a public offering price of $0.68 per Class B Unit. Each Class A Unit consistsContingencies

License and Supply Agreements

As part of the Company’s acquisition of the Senhance System in 2015, the Company assumed certain license and supply agreements. Additionally, the Company has purchase orders with various suppliers for certain tooling, supplies, contract engineering and research services. Commitments related to these agreements and purchase orders are as follows (in thousands):

Fiscal Year

    

2022

 $8,465 

2023

  852 

2024

  550 

2025

  339 

2026

  0 

Thereafter

  0 

Total commitments

 $10,206 

15

one15. share of the Company’s common stock, one warrant to purchase one share of common stock that expires on the first anniversary of the date of issuance (collectively, the “Series C Warrants”),

Segments and one warrant to purchase one share of common stock that expires on the fifth anniversary of the date of issuance (collectively, the “Series D Warrants”). Each Class B Unit consists of one share of Series A Convertible Preferred Stock, par value $0.01 per share (the “Series A Preferred Stock”), convertible into one share of common stock, a Series C Warrant to purchase one share of common stock and a Series D Warrant to purchase one share of common stock. The Class A Units and Class B Units have no stand-alone rights and were not certificated or issued as stand-alone securities. The shares of common stock, Series A Preferred Stock, Series C Warrants and Series D Warrants are immediately separable. In addition, the underwriter for the public offering exercised an overallotment option and purchased 3,308,823 Series C Warrants and 3,308,823 Series D Warrants.Geographic Areas

19

The shares of Series A Preferred Stock rank on par with the shares of the common stock, in each case, as to dividend rights and distributions of assets upon liquidation, dissolution or winding up of the Company. With certain statutory exceptions, as described in the Series A Preferred Stock Certificate of Designation, the shares of Series A Preferred Stock have no voting rights. Each share of Series A Preferred Stock was convertible at any time at the holder’s option into one share of common stock, which conversion ratio was subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series A Preferred Stock Certificate of Designation. The Company recorded a beneficial conversion feature of $0.4 million as a deemed dividend included in additional paid-in capital and an immediate charge to earnings available to common stockholders for the year ended December 31, 2020. All of the shares of Series A Preferred Stock were converted to common stock by the holders by June 30, 2020. Upon conversion, the Company recorded $0.3 million as a deemed dividend as an immediate charge to earnings available to common stockholders for the year ended December 31, 2020. In accordance with the Series A Preferred Stock Certificate of Designation, the shares of Series A Preferred Stock regained the status of authorized and unissued shares of preferred stock.

The net proceeds to the Company from the March 2020 Public Offering were approximately $13.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. All shares of Series A Preferred Stock were converted into 7.9 million shares of common stock prior to June 30, 2020. Approximately 4.9 million Series C Warrants were exercised during the year ended December 31, 2020, generating net proceeds of $3.3 million. The Class A Units, the Class B Units, the Series A Preferred Stock, the Series C Warrants and the Series D Warrants (together with the shares of common stock underlying the shares of Series A Preferred Stock and such warrants) were offered under the Company’s previously filed Registration Statement on Form S-3, which registration statement expired in May 2020. The Company filed a new registration statement on Form S-1 covering the exercise of the outstanding Series C Warrants and Series D Warrants, which was declared effective by the SEC on May 27, 2020.

On July 6, 2020, the Company completed an underwritten public offering of 42,857,142 shares of its common stock, including the underwriter’s full exercise of an over-allotment option, at the public offering price per share of $0.35 per share, generating net proceeds of approximately $13.6 million. Following the offering, the exercise price of the outstanding Series B Warrants was adjusted to $0.35 per share and the number of shares of common stock underlying such warrants increased to 567,660 shares.

On January 12, 2021, the Company sold in a registered direct offering, 25,000,000 shares of common stock at a purchase price per share of $1.25 for aggregate gross proceeds of $31.25 million, and net proceeds of $28.6 million.

On January 29, 2021, the Company completed an underwritten public offering of 26,545,832 shares of its common stock, including the underwriter’s full exercise of an over-allotment option on February 1, 2021, at the public offering price of $3.00 per share, for aggregate gross proceeds of $79.6 million and net proceeds of approximately $73.4 million.

During the six months ended June 30, 2021, the Company issued 45,314,101 shares of common stock upon the exercise of Series B, C, and D warrants for aggregate proceeds of $30.6 million.

The Company operates in 1 business segment—the research, development, and sale of medical device robotics to improve minimally invasive surgery. The Company’s chief operating decision maker (determined to be the Chief Executive Officer), does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results.

The following table presents consolidated assets and long-lived assets by geographic area, which includes property and equipment, intellectual property, and operating lease assets:

 

 

  

June 30, 2022

 
  

Long-Lived Assets

  

Total Assets

 

U.S.

  33%  77%
         

EMEA

        

Switzerland

  40%  18%

Italy

  20%  3%

Other

  7%  1%

Total EMEA

  67%  22%
         

Asia

  0%  1%

Total

  100%  100%

  

December 31, 2021

 
  

Long-Lived Assets

  

Total Assets

 

U.S.

  26%  77%
         

EMEA

        

Switzerland

  34%  16%

Italy

  36%  5%

Other

  4%  1%

Total EMEA

  74%  22%
         

Asia

  0%  1%

Total

  100%  100%

The Company recognizes sales by geographic area based on the country in which the customer is based. For the three months ended June 30, 2022 and 2021, 15% and 25%, respectively, of net revenue were generated in the United States; while 63% and 53%, respectively, were generated in Europe; and 22% and 22% were generated in Asia. For the six months ended June 30, 2022 and 2021, 19% and 17%, respectively, of net revenue were generated in the United States; while 56% and 32%, respectively, were generated in Europe; and 25% and 51% were generated in Asia.

16.

Related Person Transactions

In March 2018, Asensus Surgical Europe S.à.r.l entered into a Service Supply Agreement with 1 Med S.A. for certain regulatory consulting services. Andrea Biffi, a current member of the Company’s Board of Directors, owns a non-controlling interest in 1 Med S.A. Expenses under the Service Supply Agreement were approximately $68,000 and $0 for the three months ended June 30, 2022 and 2021, respectively and $141,000 and $93,000 for the six months ended June 30, 2022 and 2021, respectively.

16
 

9.

Basic and Diluted Net Loss per Share

Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed giving effect to all potential dilutive common shares that were outstanding during the period when the effect is dilutive. Potential dilutive common shares consist of incremental shares issuable upon exercise of stock options, restricted stock units, warrants and preferred stock. For the six months ended June 30, 2020, the effects of the Series A Preferred Stock beneficial conversion charge and conversion are included in the calculation of net loss attributable to common stockholders. No adjustments have been made to the weighted average outstanding common shares figures for the six months ended June 30, 2021 or 2020 as the assumed exercise of outstanding options, warrants and restricted stock units would be anti-dilutive.

20

Potential common shares not included in calculating diluted net loss per share are as follows:

  

June 30, 

 
  

2021

  

2020

 

Stock options

  4,279,335   4,278,967 

Stock warrants

  1,016,383   46,461,630 

Nonvested restricted stock units

  1,768,861   3,036,176 

Total

  7,064,579   53,776,773 

10.

Commitments and Contingencies

Contingent Consideration

On September 21,2015, the Company completed the strategic acquisition, through its wholly owned subsidiary TransEnterix International, from Sofar, of all of the assets, employees and contracts related to the advanced robotic system for minimally invasive laparoscopic surgery now known as the Senhance System. Under the terms of the Purchase Agreement, as amended in 2016, as of June 30, 2021 the Company has accrued $4.7 million of estimated fair value of remaining contingent consideration which shall be payable upon achievement of trailing revenues from sales or services contracts of the Senhance System of at least €25.0 million over a calendar quarter.

Legal Proceedings

No liability or related charge was recorded to earnings in the Company’s condensed consolidated financial statements for legal contingencies for the three or six months ended June 30, 2021 and 2020.

Operating Leases

Many of the Company’s leases include base rental periods coupled with options to renew or terminate the lease, generally at the Company’s discretion.  In evaluating the lease term, the Company considers whether renewal is reasonably certain.  To the extent a significant economic incentive exists to renew the lease, the option is included within the lease term.  Based on the Company’s leases, renewal options generally do not provide a significant economic incentive and are therefore excluded from the lease term. The ROU asset is included in operating lease right-of-use assets, net on the condensed consolidated balance sheets.  The current portion of operating lease liabilities are presented within operating lease liabilities – current portion on the condensed consolidated balance sheets and the non-current portion of operating lease liabilities are presented within noncurrent operating lease liabilities on the condensed consolidated balance sheets and represents the present value of the remaining lease payments, discounted using the Company’s incremental borrowing rate, which ranges between 6.1% and 8.5% based on the terms of the lease.  The weighted average discount rate was 7.9% and 8.2% as of June 30, 2021 and December 31, 2020, respectively. 

As of June 30, 2021, the right-of-use asset totaled $4.1 million and the lease liability totaled $4.3 million, of which $0.9 million is classified as current and $3.5 million is classified as non-current.  Operating lease costs for the three months ended June 30, 2021 and 2020 totaled $0.4 million and $0.5 million and are included within operating expenses in the condensed consolidated statement of operations and comprehensive loss. Operating lease costs for the six months ended June 30, 2021 and 2020 totaled $0.9 million and $1.0 million and are included within operating expenses in the condensed consolidated statement of operations and comprehensive loss. The weighted average remaining lease term for operating leases as of June 30, 2021 was 8.9 years. Total cash paid for operating leases, which is included within cash flows from operating activities within the condensed consolidated statement of cash flows, was $0.1 million and $0.3 million during the three months ended June 30, 2021 and 2020, respectively, and was $0.5 million and $0.7 million during the six months ended June 30, 2021 and 2020, respectively.

21

The following table presents the minimum lease payments as of June 30, 2021 (in thousands):

Fiscal Year

    

Remainder of 2021

 $515 

2022

  851 

2023

  585 

2024

  484 

2025

  487 

Thereafter

  2,932 

Total minimum lease payments

 $5,854 

Less: Amount of lease payments representing interest

  (1,528)

Present value of future minimum lease payments

 $4,326 

License and Supply Agreements

As part of the Company’s acquisition of the Senhance System in 2015, the Company assumed certain license and supply agreements. Payments under these arrangements generally become due and payable only upon the achievement of certain milestones. For instances in which the achievement of these milestones is neither probable nor reasonably estimable, such contingencies are not included in the estimated amount. The Company has also placed orders with various suppliers for the purchase of certain tooling, supplies and contract engineering and research services. Each of these orders has a duration or expected completion within the next twelve months. Commitments under these agreements amount to approximately $3.6 million in 2021, $0.1 million in 2022, $0.3 million in 2023, $0.2 million in 2024, and $0.2 million thereafter until termination in 2027.

 

 

Item 2.   Managements Discussion and Analysis of Financial Conditions and Results of Operation

 

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes to our condensed consolidated financial statements included in this report. The following discussion contains forward-looking statements. See cautionary note regarding Forward-Looking Statements at the beginning of this report.

 

Overview

Asensus Surgical is a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided SurgerySurgery™ by unlocking the clinical intelligence to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance® Surgical System powered by the Intelligent Surgical UnitUnit™, or ISU™, to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. The Company is focused on the market development for and commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery, or MIS. The Senhance System is the first and only digital, multi-port laparoscopic platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including 3 mm3mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control and fully-reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy.

 

The Senhance System is available for sale in Europe, the United States, Japan, Taiwan, Russia (to the extent lawful), and select other countries.

 

 

The Senhance System has a CE Mark in Europe for adult and pediatric laparoscopic abdominal and pelvic surgery, as well as limited thoracic surgeries excluding cardiac and vascular surgery.

 

 

In the United States, the Company has received 510(k) clearance from the FDA for use of the Senhance System in general laparoscopic surgical procedures and laparoscopic gynecologic surgery in a total of 31 indicated procedures, including benign and oncologic procedures, laparoscopic inguinal, hiatal and paraesophageal hernia, sleeve gastrectomy and laparoscopic cholecystectomy (gallbladder removal) surgery.

 

 

In Japan, the Company has received regulatory approval and reimbursement for 98 laparoscopic procedures.

 

 

The Senhance System has received its registration certificate by the Russian medical device regulatory agency, Roszdravnadzor, in December 2020, allowing for its sale and utilization throughout the Russian Federation.

 

We also enter into lease arrangements with certain qualified customers. For some lease arrangements, the customers are provided with the right to purchase the leased Senhance System during or at the end of the lease term ("Lease Buyout").  In the first quarter of 2021, we completed a Lease Buyout of a Senhance System.

 

InOn February 23, 2021, we changed our name from TransEnterix, Inc. to Asensus Surgical, Inc. as part of our strategy to utilize the Senhance System and ISU capabilities, along with our other augmented intelligence related offerings and instrumentation to unlock clinical intelligence to enable consistently superior outcomes and a new standard of surgery we are calling Performance-Guided Surgery. We believe our product offerings, and our digitization of the interface between the surgeon and the patient allows us to assist the surgeon in all aspects of laparoscopic surgery including:

 

 

Pre-operative - in what we call “intelligent preparation,” our machine learning models will take data from all of the procedures done utilizing our current Senhance System with the ISU, such as tracking surgical motion and team interaction, to create a large and constantly improving database of surgeries and their outcomes to enable surgeons to best inform their approach and surgical setup.

 

 

Intra-operative – we believe the Senhance System provides perceptive real-time guidance for intra-operative tasks, allowing any surgeon performing a procedure with the Senhance System to perform multiple tasks and benefit from the collective knowledge and rules-based performance of thousands of other successful Senhance-based procedures. Not only will this provide the surgeon with a pathway to better outcomes, but we also believe it will ultimately help reduce the cognitive load of the surgeons.

 

 

Future use post-operativePost-operative finally, by tapping into the vast amount of data captured during procedures, surgeons and operating room staff will be able to get actionable assessments of their performance giving them the information needed to improve performance over time. We intend on buildingto establish a new standard of analytics to improve not only the skills of all surgeons but movingmove towards best-practice-sharing that bridges the global surgeon community.

 

We received FDA clearance in March 2020 for our ISU. We believe it is the only FDA cleared device for machine vision technology in abdominal robotic surgery. On September 23,


2020, we announced the first surgical procedures successfully completed using the ISU. In January 2021, we received CE Mark for the ISU.

In February 2020, we received CE Mark for the Senhance System and related instruments for pediatric use indications in CE Mark territories.

 

In 2020, the Companywe obtained regulatory clearance for the Senhance ultrasonic system in both Taiwan and Japan. On February 12, 2020,We also received clearance for the Company expanded its claimsISU in both the U.S. and Japan. Finally, in the EU, we expanded our claims for the Senhance System to include pediatric patients, allowing accessibility to more surgeons and patients, as well as expanding itsour potential market to include pediatric hospitals in Europe. The Company anticipatesWe anticipate the robotic precision provided by the Senhance System, coupled with the already available 3 mm diameter3mm instruments will prove to be an effective tool in surgery with smaller patients. On March 13, 2020 the Company announced that it received FDA clearance for the Intelligent Surgical Unit™ (ISU™) for use with the Senhance System. The Company believes it is the first such FDA submission seeking clearance for machine vision technology in abdominal robotic surgery. On September 23, 2020, the Company announced the first surgical procedures successfully completed using the ISU.

 

On January 19, 2021, the Company announced that it received CE Mark for the ISU. Finally, on July 28, 2021, the Company announced that it received FDA clearance for 5 mm5mm diameter articulating instruments, offering better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the EU.

 

The Company believes that future outcomes of minimally invasive laparoscopic surgery will be enhanced through its combination of more advanced tools and robotic functionality, which are designed to: (i) empower surgeons with improved precision, dexterity and visualization; (ii) improve patient satisfaction and enable a desirable post-operative recovery; and (iii) provide a cost-effective robotic system, compared to existing alternatives today, for a wide range of clinical indications.

 

From our inception, we devoted a substantial percentage of our resources to research and development and start-up activities, consisting primarily of product design and development, clinical studies, manufacturing, recruiting qualified personnel and raising capital.  We expect to continue to invest in research and development and market development as we implement our strategy.

 

Since inception, we have been unprofitable. As of June 30, 2021,2022, we had an accumulated deficit of $753.4$824.1 million.

We operate in one business segment.

 

Recent Financing Transactions

 

January 2021 Public OfferingAt-the -Market Offerings

On January 29, 2021, the Company completed an underwritten public offering of 26,545,832 shares of its common stock, including the underwriter’s full exercise of an over-allotment option on February 1, 2021, at the public offering price of $3.00 per share, generating net proceeds of approximately $73.4 million.  

 

January 2021 Registered Direct Purchase Agreement

On January 12, 2021,March 18, 2022, the Company sold in a registered direct offering 25,000,000 shares of common stock at a purchase price per share of $1.25 for aggregate gross proceeds of $31.25 million, and net proceeds of $28.6 million.

At-the-Market Offering

On May 19, 2021, the Company entered into a Controlled Equity OfferingSMSales Agreement (the “Agreement”“2022 Sales Agreement”), with Cantor Fitzgerald & Co. (“Cantor”), Robert W. Baird & Co. Incorporated (“Baird”) and Oppenheimer & Co. Inc. (“Oppenheimer”).  Each of Cantor, Baird and Oppenheimer are individually an “Agent” and collectively are the “Agents” under the Agreement.  Also on May 19, 2021, theThe Company filed a prospectus supplement relating tocommenced an at-the-market offering (the “2021“2022 ATM Offering”) bypursuant to which the Company ofcould sell from time to time, at its option, up to an aggregate of $100,000,000 of$100.0 million shares of the Company’s common stock. No sales of common stock par value $0.001 per share (the “Common Stock”), which shares of Common Stock are registeredwere made under the Registration Statement on Form S-3 ASR (File No. 333-256284) and automatically effective on May 19, 2021.

In June 2021, the Company launched the 2021 ATM Offering.  Sales to date under the 20212022 ATM Offering are as follows (in thousands except for share and per share amounts):

  

For the Quarter

Ended June 30,

2021

 
     

Total shares of common stock sold

  331,811 

Average price per share

 $3.47 

Gross proceeds

 $1,152 

Commisssion earned by Sales Agents

 $34 

Net proceeds

 $1,118 

2021 Exercise of Warrants

Duringduring the six months ended June 30, 2021, Series B, C and D warrants have been exercised for aggregate proceeds to the Company of $30.6 million.2022.

 

Results of Operations

- Comparison of Three Months Ended June 30, 20212022 and 20202021

 

Revenue

In the second quarter of 2021,2022, our revenue consisted of ongoing System leasing payments, and sales of instruments and accessories, and services revenue for Systems sold or placed in Europe, Asia, and the U.S. in prior periods.

 

Product revenue for the three months ended June 30, 2021 increased2022 decreased to $0.7$0.3 million compared to $0.4 million for the three months ended June 30, 2021. Service revenue remained consistent at $0.4 million for the three months ended June 30, 2022 and 2021. Lease revenue remained consistent at $0.3 million for the three months ended June 30, 2020.2022 and 2021. The $0.4 million increase was primarily the result of revenues from a higher number of lease arrangements and increased instruments and accessories sales for previously installed Senhance Systems during the three months ended June 30, 2021 as compared to the three months ended June 30, 2020. We expect revenue from customer exercises of the buyout optionsfluctuations in their leases to fluctuate period to period based on the timing of when, and if customers choose to exercise the buyout options.

Service revenue for the three months ended June 30, 2022 and 2021, increased to $0.4 million compared to $0.3 million forwere primarily the three months ended June 30, 2020. The $0.1 million increase is primarily due to a higher numberresult of systems with maintenance agreementscustomer mix and fluctuations in the current period.exchange rates.

 

Cost of Revenue

Cost of revenue consists of contract manufacturing, materials, labor, and manufacturing overhead incurred internally to produce the products. Shipping and handling costs incurred by the Company are included in cost of revenue. We expense all inventory obsolescence provisions as cost of revenue. The manufacturing overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment depreciation and operations supervision and management. We expect overhead costs as a percentage of revenues to become less significantdecline as our production volume increases. We expect cost of revenue to increase in absolute dollars to the extent our revenues grow and as we continue to invest in our operational infrastructure to support anticipated growth.

 

Product cost for the three months ended June 30, 20212022 decreased to $0.9 million as compared to $1.0 million for the three months ended June 30, 2021. The $0.1 million decrease primarily relates to a decrease in personnel-related costs.

Service cost remained consistent at $0.6 million for the three months ended June 30, 2022 and 2021.

Lease cost for the three months ended June 30, 2022 increased to $1.5$0.8 million as compared to $0.7 million for the three months ended June 30, 2020. The $0.8 million increase primarily relates to $0.5 million increase in product costs driven by higher system leasing revenue, $0.2 million increase due to a write down of inventory and $0.1 million increase in personnel costs.2021.

 

Service cost for the three months ended June 30, 2021 increased to $0.9 million as compared to $0.7 million for the three months ended June 30, 2020. This $0.2 million increase primarily relates to an increase in supplies costs. Cost of revenue exceeds revenue primarily due to part replacements under maintenance plans, which are expensed when incurred, along with salaries for the field service teams.

Research and Development

Research and development, or R&D, expenses primarily consist of engineering, product development and regulatory expenses incurred in the design, development, testing and enhancement of our products and legal services associated with our efforts to obtain and maintain broad protection for the intellectual property related to our products. In future periods, we expect R&D expenses to continue to increase moderately as we continue to invest in additional regulatory approvals as well as new products, instruments, and accessories to be offered with the Senhance System. R&D expenses are expensed as incurred.

 

R&D expenses for the three months ended June 30, 2021 decreased 5%2022 increased 78% to $4.1$7.3 million as compared to $4.3$4.1 million for the three months ended June 30, 2020.2021 as we continue to invest in basic research, clinical studies, and product development in the areas of robotics and digital technologies supporting the growth of the Senhance System and ISU digital and cloud capabilities. All activities are in the effort of building the future for Performance-Guided Surgery. The $0.2$3.2 million decreaseincrease primarily relates to decreasedincreased personnel costs of $1.5 million driven by additional headcount as well as the transfer of employees within functional areas due to the evolving nature and commercialization of our business. The change was also driven by an increase in contract engineering services, consulting, and other outside services of $1.0 million, increased supplies costs of $0.3 million, decreased technology fees of $0.1 million and decreased supplies costs of $0.1 million partially offset by increased personnel-related costs of $0.1 million, increased miscellaneous costs of $0.1 million, and increased facilities costs of $0.1$0.4 million.

 

Sales and Marketing

Sales and marketing expenses include costs for sales and marketing personnel, travel, demonstration product, market development, physician training, tradeshows, marketing clinical studies and consulting expenses. We expect sales and marketing expenses to remain lower compared to prior years as we refocus our resources and efforts on market development activities pursuant to our restructuring plan.

 

Sales and marketing expenses for the three months ended June 30, 2022 and 2021 increased 24% toremained consistent at $3.6 million compared to $2.9 million for the three months ended June 30, 2020. The $0.7 million increase was primarily related to increased personnel costs of $0.3 million, increased consulting costs of $0.2 million, increased travel costs of $0.1 million, increased supplies costs of $0.1 million and increased miscellaneous costs of $0.1 million, partially offset by decreased depreciation expense of $0.1 millionmillion.

 

General and Administrative

General and administrative expenses consist of personnel costs related to the executive, finance, legal and human resource functions, as well as professional service fees, legal fees, accounting fees, insurance costs, and general corporate expenses. We expect general and administrative costs to remain flat in future periods.

 

General and administrative expenses for the three months ended June 30, 20212022 increased 6%32% to $3.8$5.0 million compared to $3.6$3.8 million for the three months ended June 30, 2020.2021. The $0.2$1.2 million increase was primarily related to increased stockholder meetingpersonnel costs of $0.2$1.0 million driven by additional headcount as well as the transfer of employees within functional areas due to the evolving nature and increased suppliescommercialization of our business. The change was also driven by an increase in miscellaneous costs of $0.1$0.5 million, partially offset by a decrease in bad debt expense of facilities$0.2 million, and a decrease in supplies costs of $0.1 million.

 

Amortization of Intangible Assets

Amortization of intangible assets for the three months ended June 30, 2021 increased 8%2022 decreased to $2.8$2.5 million compared to $2.6$2.9 million for the three months ended June 30, 2020.2021. The $0.2$0.4 million increase wasdecrease is primarily driven by changes in the result of foreign currency exchange rates.rate.

 

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration in connection with the Senhance Acquisition was a $0.6 million decrease for the three months ended June 30, 2022 compared to a $0.5 million increase for the three months ended June 30, 2021 compared2021. The decrease was primarily due to a $0.2changes in market assumptions utilized in the valuation of fair value of the contingent consideration.

Property and Equipment Impairment

During the three months ended June 30, 2022, the Company recorded an impairment charge of $0.4 million increaseto reduce the carrying value of property and equipment to its estimated fair value. The property and equipment is associated with operating leases that did not elect to renew their agreements. No impairment charge was recognized for the three months ended June 30, 2020. The $0.32021.

Other Income (Expense)

Other income for the three months ended June 30, 2022 decreased to $0.0 million increasecompared to $2.9 million for the three months ended June 30, 2021. Other income for the three months ended June 30, 2021 primarily related to the gain on extinguishment of debt of $2.8 million. No related income was due to changesrecorded in the Company's fair value measurement of a discounted cash flow model using significant unobservable inputs including the probability of achieving the potential milestone, future Euro-to-USD exchange rates, and an estimated discount rate associated with the risks of the expected cash flows attributable to the milestone.three months ended June 30, 2022.

 

Income Tax (Expense) Benefit

The Company recognized $0.1 million income tax expense for the three months ended June 30, 2022, compared to $0.0 million income tax expense for the three months ended June 30, 2021, compared to $0.7 million income tax benefit for the three months ended June 30, 2020. Income tax benefit for the three months ended June 30, 2020 consists primarily of taxes related to the amortization of purchase accounting intangibles in connection with the Italian taxing jurisdiction for Asensus Surgical Italia as a result of the acquisition of the Senhance System.2021.

 

Results of Operations - Comparison of Six Months Ended June 30, 20212022 and 20202021

 

Revenue

In the six months ended June 30, 2021,2022, our revenue consisted of one Lease Buyout, ongoing System leasing payments, and sales of instruments and accessories, and services revenue for Systems sold or placed in Europe, Asia, and the U.S. in prior periods.

 

Product revenue for the six months ended June 30, 2021 increased2022 decreased to $2.4$0.6 million compared to $0.6$1.7 million for the six months ended June 30, 2020.2021. The $1.8$1.1 million increasedecrease was primarily the result of a Lease Buyout and revenues from multiple lease arrangements duringin the six months ended June 30, 2021 as compared to only revenues from leasing arrangements as well as instrument and accessory sales for previously installed Senhance System during the six months ended June 30, 2020. We expect revenue from customer exercises of the buyout options in their leases to fluctuate period to period based on the timing of when, and if customers choose to exercise the buyout options.prior period.

 

Service revenue for the six months ended June 30, 2021 increased30,2022 decreased to $0.8$0.7 million compared to $0.7$0.8 million for the six months ended June 30, 2020.2021. The $0.1 million increase is primarily due to a higher numberdecrease was the result of systems with maintenance agreementscustomer mix and fluctuations in the current period.exchange rates.

 

Lease revenue for the six months ended June 30, 2022 and 2021 remained consistent at $0.7 million.

Cost of Revenue

Cost of revenue consists of contract manufacturing, materials, labor, and manufacturing overhead incurred internally to produce the products. Shipping and handling costs incurred by the Company are included in cost of revenue. We expense all inventory obsolescence provisions as cost of revenue. The manufacturing overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment depreciation and operations supervision and management. We expect overhead costs as a percentage of revenues to become less significantdecline as our production volume increases. We expect cost of revenue to increase in absolute dollars to the extent our revenues grow and as we continue to invest in our operational infrastructure to support anticipated growth.

 

Product cost for the six months ended June 30, 2021 increased2022 decreased to $3.9$1.3 million as compared to $1.6$2.7 million for the six months ended June 30, 2020.2021. The increase$1.4 million decrease primarily relates to a Lease Buyout and higher$0.7 million decrease in product costs driven by higher system leasing revenue.a Lease Buyout in the prior period and a $0.9 million decrease in personnel-related costs, partially offset by a $0.1 million increase in supplies costs and $0.1 million increase in freight expenses.

 

Service cost for the six months ended June 30, 20212022 increased to $1.6$1.1 million as compared to $1.5$1.0 million for the six months ended June 30, 2020. This2021. The $0.1 million increase primarily relates to increased suppliesan increase in personnel-related costs. Cost of revenue exceeds revenue primarily due to part replacements under maintenance plans, which are expensed when incurred, along with salaries for the field service teams.

 

Lease cost for the six months ended June 30, 2022 and 2021 remained consistent at $1.8 million.

Research and Development

Research and development, or R&D, expenses primarily consist of engineering, product development and regulatory expenses incurred in the design, development, testing and enhancement of our products and legal services associated with our efforts to obtain and maintain broad protection for the intellectual property related to our products. In future periods, we expect R&D expenses to continue to increase moderately as we continue to invest in additional regulatory approvals as well as new products, instruments and accessories to be offered with the Senhance System. R&D expenses are expensed as incurred.

 

R&D expenses for the six months ended June 30, 20212022 increased 1%65% to $8.3$13.7 million as compared to $8.2$8.3 million for the six months ended June 30, 2020.2021 as we continue to invest in basic research, clinical studies, and product development in the areas of robotics and digital technologies supporting the growth of the Senhance System and ISU digital and cloud capabilities. All activities are in the effort of building the future for Performance-Guided Surgery. The $0.1$5.4 million increase primarily relates to increased technology fees of $0.3 million, facilitiespersonnel costs of $0.1$2.5 million driven by additional headcount as well as the transfer of employees within functional areas due to the evolving nature and commercialization of our business. The change was also driven by an increase in contract engineering services, consulting, and other outside services costs of $0.1$1.9 million, increased supplies costs of $0.1$0.4 million, testing costs of $0.1 million, partially offset by decreased personneland increased miscellaneous costs of $0.6 million.

 

Sales and Marketing

Sales and marketing expenses include costs for sales and marketing personnel, travel, demonstration product, market development, physician training, tradeshows, marketing clinical studies and consulting expenses. We expect sales and marketing expenses to remain lower compared to prior years as we refocus our resources and efforts on market development activities pursuant to our restructuring plan.

 

Sales and marketing expenses for the six months ended June 30, 2021 decreased 8%2022 increased 11% to $6.6$7.3 million compared to $7.2$6.6 million for the six months ended June 30, 2020.2021. The $0.6$0.7 million decreaseincrease was primarily related to decreased personnelincreased consulting costs of $0.4$0.5 million, decreasedincreased travel related costs of $0.2 million, and decreased depreciation expense of $0.2$0.5 million, partially offset by increased consulting costs of $0.1 million and increaseddecreased supplies costs of $0.1$0.3 million.

 

General and Administrative

General and administrative expenses consist of personnel costs related to the executive, finance, legal and human resource functions, as well as professional service fees, legal fees, accounting fees, insurance costs, and general corporate expenses. We expect general and administrative costs to remain flat in future periods.

 

General and administrative expenses for the six months ended June 30, 20212022 increased 11%35% to $7.8$10.5 million compared to $7.0$7.8 million for the six months ended June 30, 2020. The $0.82021. The$2.7 million increase was primarily related to increased personnel costs of $0.7$1.9 million stockholder meetingdriven by additional headcount as well as the transfer of employees within functional areas due to the evolving nature and commercialization of our business. The change was also driven by an increase in software costs of $0.4 million, increased consulting costs of $0.2 million, and supplies costs of $0.1 million, offset by decreased facilitiesincreased miscellaneous costs of $0.2 million.

 

Amortization of Intangible Assets

Amortization of intangible assets for the six months ended June 30, 2021 increased 10%2022 decreased to $5.7$5.2 million compared to $5.2$5.7 million for the six months ended June 30, 2020.2021. The $0.5 million increasedecrease is primarily the result of the transfer of IPR&D to definite-lived intangible assetsdriven by changes in the first quarter of 2020 and fluctuations in foreign currency exchange rates.rate.

 

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration in connection with the Senhance Acquisition was a $0.8 million decrease for the six months ended June 30, 2022 compared to a $0.7 million increase for the six months ended June 30, 2021 compared2021. The decrease was primarily due to a $1.3changes in market assumptions utilized in the valuation of fair value of the contingent consideration.

Property and Equipment Impairment

During the six months ended June 30, 2022, the Company recorded an impairment charge of $0.4 million increaseto reduce the carrying value of property and equipment to its estimated fair value. The property and equipment is associated with operating leases that did not elect to renew their agreements. No impairment charge was recognized for the six months ended June 30, 2020. The $0.6 million decrease was due to changes in the Company's fair value measurement of a discounted cash flow model using significant unobservable inputs including the probability of achieving the potential milestone, future Euro-to-USD exchange rates, and an estimated discount rate associated with the risks of the expected cash flows attributable to the milestone.2021.

 

Change in Fair Value of Warrant LiabilitiesOther Income (Expense)

The change in fair value of Series B Warrants issued in April 2017 was $2.0Company recognized $0.1 other expense for the six months ended June 30, 2022, compared to $0.9 million other income for the six months ended June 30, 2021. Other income for the six months ended June 30, 2021 comparedprimarily related to $0.3the gain on extinguishment of debt of $2.8 million, partially offset by the change in the fair value of Series B Warrants of $2.0 million.  No related income or expense was recorded in the six months ended June 30, 2022.

Income Tax (Expense) Benefit

The Company recognized $0.2 million income tax expense for the six months ended June 30, 2020. The net $1.7 million increase was the result of an increase in the stock price.

Income Tax (Expense) Benefit

The Company recognized2022, compared to $0.0 million income tax benefit for the six months ended June 30, 2021, compared to $1.4 million for the six months ended June 30, 2020. Income tax benefit for the six months ended June 30, 2020 consists primarily of taxes related to the amortization of purchase accounting intangibles in connection with the Italian taxing jurisdiction for Asensus Surgical Italia as a result of the acquisition of the Senhance System.2021.

 

Liquidity and Capital Resources

The Company had an accumulated deficit of $753.4$824.1 million and working capital of $165.7$98.9 million as of June 30, 2021.2022. The Company has not established sufficient sales revenues to cover its operating costs and believes it maywill require additional capital in the future to proceed with its operating plan. As of June 30, 2021,2022, the Company had cash, and cash equivalents, short-term investments and long-term investments, excluding restricted cash, of approximately $157.1$103.8 million.

 

The Company believes the COVID-19 pandemic and other geopolitical factors will continue to negatively impact its operations and ability to implement its market development efforts, which will have a negative effect on its financial condition.

 

While the Company believes that its existing cash, and cash equivalents, short-term and long-term investments, as of June 30, 20212022 and as of the date of filing, will be sufficient to sustain operations for at least the next 12 months from the issuance of these financial statements, the Company believes it maywill need to obtain additional financing in the future to proceed with its business plan. Management's plan to obtain additional resources for the Company may include additional sales of equity, traditional financing, such as loans, entry into a strategic collaboration, entry into an out-licensing arrangement or provision of additional distribution rights in some or all of our markets. However, management cannot provide any assurance that the Company will be successful in accomplishing any or all of its plans.

 

The Company is subject to risks similar to other similarly sized companies in the medical device industry. These risks include, without limitation: potential negative impacts on the Company's operations caused by the COVID-19 pandemic;pandemic and other geopolitical factors; the historical lack of profitability; the Company’s ability to increase utilization of the Senhance System and grow its placements, the Company’s ability to raise additional capital; the success of its market development efforts, the liquidity and capital resources of its partners;efforts; its ability to successfully develop, clinically test and commercialize its products; the timing and outcome of the regulatory review process for its products; changes in the health care and regulatory environments of the United States, the United Kingdom, the European Union, Japan, Taiwan and other countries in which the Company operates or intends to operate; its ability to attract and retain key management, marketing and scientific personnel; its ability to successfully prepare, file, prosecute, maintain, defend and enforce patent claims and other intellectual property rights; its ability to successfully transition from a research and development company to a marketing, sales and distribution concern; competition in the market for robotic surgical devices; and its ability to identify and pursue development of additional products.

 

Sources of Liquidity

Our principal sources of cash to date have been proceeds from public offerings of common stock, incurrence of debt, the sale of equity securities held as investments and asset sales. We have financed our operations from these financing transactions, as discussed in detail in “Overview – Recent Financing Transactions” above.

 

Consolidated Cash Flow Data

 

 

Six Months Ended June 30,

  

Six Months Ended June 30,

 

(in millions)

 

2021

  

2020

 

(Unaudited, in millions)

 

2022

  

2021

 

Net cash (used in) provided by

  

Operating activities

 $(18.5) $(25.1) $(30.2) $(18.5)

Investing activities

 (0.7) (0.0) 23.2  (0.7)

Financing activities

 160.1  30.8  (0.3) 160.1 

Effect of exchange rate changes on cash and cash equivalents

  (0.3)  (0.0)  0.2   (0.3)

Net increase in cash, cash equivalents and restricted cash

 $140.6  $5.7 

Net (decrease) increase in cash, cash equivalents and restricted cash

 $(7.1) $140.6 

 

Operating Activities

For the six months ended June 30, 2022, cash used in operating activities of $30.2 million consisted of a net loss of $38.7 million, changes in operating assets and liabilities of $2.6 million, offset by non-cash items of $11.1 million. The non-cash items primarily consisted of $5.2 million of amortization of intangible assets, $4.3 million of stock-based compensation expense, $1.7 million of depreciation, $0.4 million of net amortization of discounts and premiums on investments, $0.4 million in impairment of property and equipment, $0.2 million deferred tax expense, offset by $0.6 million change in inventory reserves and $0.8 million of change in fair value of contingent consideration. The decrease in cash from changes in operating assets and liabilities primarily relates to a $1.9 million increase in inventory net of transfers to property and equipment, $1.2 million increase in other current and long-term assets, $0.3 million decrease in accrued expenses, $0.3 million decrease in operating lease liabilities, offset by a $0.5 million increase in accounts payable, $0.4 million decrease in operating lease right-of-use assets, and a $0.2 million decrease in prepaid expenses.

For the six months ended June 30, 2021, cash used in operating activities of $18.5 million consisted of a net loss of $30.5 million offset by cash generated from workingwork capital of $1$1.0 million and non-cash items of $11.1 million. The non-cash items primarily consisted of $3.6 million of stock-based compensation expense, $5.7 million of amortization of intangible assets, $2.0 million change in fair value of warrant liabilities, $1.6 million of depreciation, $0.7 million change in fair value of contingent consideration, and $0.3 million write down ofchange in inventory reserves, offset by $2.8 million gain on extinguishment of debt. The increase in cash from changes in working capital primarily relates to a $3.2$3.1 million increase in operating lease liabilities, a $2.7 million decrease in other current and long-term assets, a $3.1 million increase in operating lease liabilities, a $0.7 million increase in accounts payable, a $0.5 million decrease in prepaid expenses, and a $0.1 million decrease in accounts receivable, offset by a $3.0 million increase in operating lease right-of-use assets,asset, a $1.7 million increase in inventory net of transfers toof property and equipment, and a $1.4 million decrease in accrued expenses.

 

Investing Activities

For the six months ended June 30, 2022, net cash provided by investing activities was $23.2 million. This amount consists of $41.4 million of proceeds from maturities of available-for-sale investments, offset by $17.8 million of purchases of available-for-sale investments and $0.4 million purchases of property and equipment.

For the six months ended June 30, 2021, net cash used in investing activities was $0.7 million. This amount consists of $0.7 million, related to purchases of property and equipment.

 

Financing Activities

For the six months ended June 30, 2022, net cash used in financing activities was $0.3 million, related to taxes paid for the net share settlement of vesting of restricted stock units.

For the six months ended June 30, 2021, net cash provided by financing activities was $160.1 million. The net change primarily related to $130.3 million in net proceeds from the issuance of common stock of $73.4 million in the January 2021 public offering, $28.6 million in the January 2021 registered direct offering, $27.3 million in the 2020 ATM Offering, $1.0 million in the 2021 ATM Offering, $30.6and $30.8 million aggregate proceeds from the exercise of Series B, C and D warrants, and $0.2 million proceeds from stock option exercises,partially offset by $1.0 million of taxes paid related to net share settlement of vesting of restricted stock units.

 

Operating Capital and Capital Expenditure Requirements

 

We intend to spend substantial amounts on research and development activities, including product development, regulatory and compliance, and clinical studies in support of our future product offerings, commercial activities and the enhancement and protection of our intellectual property. We obtained financing for these activities over the past six months but cannot assure you that additional financing will not be required in the future to support our operations.studies. We intend to use financing opportunities strategically to continue to strengthen our financial position.

 

Cash and cash equivalents held by our foreign subsidiaries totaled $2.9$2.4 million as of June 30, 2021,2022, including restricted cash. We do not intend or currently foresee a need to repatriate cash and cash equivalents held by our foreign subsidiaries. If these funds are needed in the United States, we believe that the potential U.S. tax impact to repatriate these funds would be immaterial.

 

Off-Balance Sheet Arrangements

As of June 30, 2021, we did not have any material off-balance sheet arrangements.

Critical Accounting Policies and Estimates

 

The discussion and analysis of our financial condition and results of operations set forth above under the headings “Results of Operations” and “Liquidity and Capital Resources” have been prepared in accordance with U.S. GAAP and should be read in conjunction with our financial statements and notes thereto appearing in this Form 10-Q and in the Fiscal 20202021 Form 10-K. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our critical accounting policies and estimates, including identifiable intangible assets, contingent consideration, warrant liabilities, stock-based compensation, inventory, revenue recognition and income taxes. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. A more detailed discussion on the application of these and other accounting policies can be found in Note 2 in the Notes to the Financial Statements in this Form 10-Q. Actual results may differ from these estimates under different assumptions and conditions. There have been no new or material changes to the critical accounting estimates discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, that are of significance, or potential significance, to us.

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

We are exposed to changes in foreign currency exchange rates. Operations outside of the United States accounted for 81% and 83% of revenue for six months ended June 30, 2022 and 2021, respectively, and are concentrated principally in Europe. We translate the revenue and expenses of our foreign operations using average exchange rates prevailing during the period. The effect of a 10% change in the average foreign currency exchange rates among the U.S. dollar versus the Euro for the six months ended June 30, 2022, would result in revenue changing by $0.2 million. This change would be not material to our cash flows and our results of operations.

 

 

While all accounting policies impact the financial statements, certain policies may be viewed as critical. Critical accounting policies are those that are both most important to the portrayal of financial condition and results of operations and that require management’s most subjective or complex judgments and estimates.

Intellectual Property

Intellectual property consists of purchased patent rights and developed technology acquired as part of a business acquisition. Developed technology includes reclassified IPR&D assets related to (i) the Senhance System acquired in 2015 and reclassified in 2017 and (ii) MST acquired in 2018 and reclassified in 2020. We amortize patent rights using the straight-line method over the estimated useful life of the patents of 10 years. Amortization of the developed technology is recorded using the straight-line method over the estimated useful life of 5 to 7 years.

We periodically evaluate intellectual property for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. To determine the recoverability, we evaluate the probability that future estimated undiscounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the assets, then such assets are written down to their fair value. No impairment of intellectual property was identified during the six months ended June 30, 2021 and 2020.

Contingent Consideration

Contingent cash consideration arising from business combinations is recorded as a liability and is the estimate of the fair value of potential milestone payments related to those acquisitions. Contingent consideration is measured at fair value using a discounted cash flow model using significant unobservable inputs including the probability of achieving each of the potential milestones, future Euro-to-USD exchange rates, and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones. Significant increases or decreases in any of the probabilities of success or changes in expected achievement of any of these milestones would result in a significantly higher or lower fair value of these milestones, respectively, and commensurate changes to the associated liability. The contingent consideration is revalued at each reporting period and changes in fair value are recognized in the condensed consolidated statements of operations and comprehensive loss.

Inventory

Inventory, which includes material, labor, and overhead costs, is stated at the lower of cost, determined on a first-in, first-out basis, or net realizable value. We record reserves, when necessary, to reduce the carrying value of inventory to its net realizable value. At the point of loss recognition, a new, lower-cost basis for that inventory is established, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.

Any inventory on hand at the measurement date in excess of the Company's current requirements based on anticipated levels of sales is classified as long-term on the Company's condensed consolidated balance sheets. The Company's classification of long-term inventory requires us to estimate the portion of on hand inventory that can be realized over the upcoming twelve months.

Revenue Recognition

Our revenue consists of product revenue resulting from the sale and lease of Systems, System components, instruments and accessories, and service revenue. We account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. Our revenues are measured based on consideration specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities. Our System sale arrangements generally include a five-year service period; the first year of service is generally free and included in the System sale arrangement and the remaining four years are generally included at a stated service price.

Our System sale arrangements generally contain multiple products and services. For these condensed consolidated sale arrangements, we account for individual products and services as separate performance obligations if they are distinct, which is if a product or service is separately identifiable from other items in the condensed consolidated package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. Our System sale arrangements may include a combination of the following performance obligations: system(s), system components, instruments, accessories, and system services.

For arrangements that contain multiple performance obligations, revenue is allocated to each performance obligation based on its relative estimated standalone selling price. When available, standalone selling prices are based on observable prices at which the Company separately sells the products or services; however, due to limited sales to date, standalone selling prices are not directly observable. We estimate the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer, and market conditions. We regularly review estimated standalone selling prices and updates these estimates if necessary.

We recognize revenues as the performance obligations are satisfied by transferring control of the product or service to a customer. We generally recognize revenue for the performance obligations as follows:

System sales. For Systems and System components sold directly to end customers (including those arising from Lease Buyouts), revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. For Systems sold through distributors, for which distributors are responsible for installation, revenue is recognized generally at the time of shipment. The Company’s System arrangements generally do not provide a right of return. The Systems are generally covered by a one-year warranty. Warranty costs were not material for the periods presented.

Instruments and accessories. Revenue from sales of instruments and accessories is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but also occurs at the time of delivery depending on the customer arrangement.

Service. Service revenue is recognized ratably over the term of the service period as the customers benefit from the service throughout the service period. Revenue related to services performed on a time-and-materials basis is recognized when performed.

We invoice our customers based on the billing schedules in our sales arrangements. Contract assets for the periods presented primarily represent the difference between the revenue that was recognized based on the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Deferred revenue for the periods presented was primarily related to service obligations, for which the service fees are billed up-front, generally annually. The associated deferred revenue is generally recognized ratably over the service period.

In connection with assets recognized from the costs to obtain a contract with a customer, we have determined that sales incentive programs for our sales team do not meet the requirements to be capitalized as we do not expect to generate future economic benefits from the related revenue from the initial sales transaction.

We enter into lease arrangements with certain qualified customers. Revenue related to arrangements including lease elements are allocated to lease and non-lease elements based on their relative standalone selling prices. Lease elements generally include a System, while non-lease elements generally include instruments, accessories, and services. For some lease arrangements, the customers are provided with the right to purchase the leased System at some point during or at the end of the lease term. In some arrangements lease payments are based on the usage of the System.

In determining whether a transaction should be classified as a sales-type or operating lease, we consider the following terms at lease commencement: (1) whether title of the System transfers automatically or for a nominal fee by the end of the lease term, (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased System, (3) whether the lease term is for the major part of the remaining economic life of the leased System, (4) whether the lease grants the lessee an option to purchase the leased System that the lessee is reasonably certain to exercise, and (5) whether the underlying System is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term. As of June 30, 2021, all such arrangements have been classified as operating leases.

Income Taxes

We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets or liabilities for the temporary differences between financial reporting and tax basis of our assets and liabilities, and for tax carryforwards at enacted statutory rates in effect for the years in which the asset or liability is expected to be realized. The effect on deferred taxes of a change in tax rates is recognized in income during the period that includes the enactment date. In addition, valuation allowances are established when necessary to reduce deferred tax assets and liabilities to the amounts expected to be realized.

We recognize the financial statement benefit of an income tax position only after determining that the relevant taxing authority would more-likely-than-not sustain the position following audit. For tax positions meeting the more likely than not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant taxing authority. We recognize interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require application of significant judgment. We are subject to U.S. federal and various state and local jurisdictions. Due to our net operating loss carryforwards, we may be subject to examination by authorities for all previously filed income tax returns.

Recent Accounting Pronouncements

See “Note 2. Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements in the Company’s Fiscal 2020 Form 10-K, as well as the notes to the condensed consolidated financial statements above in this Form 10-Q, for a full description of recent accounting pronouncements including the respective expected dates of adoption and effects on our Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations and Comprehensive Loss.

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

Item 4.

Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2021.2022. We maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Executive Vice President and Chief Financial Officer concluded that, as of June 30, 2021,2022, our disclosure controls and procedures were effective at a reasonable assurance level.

 

Changes in Internal Controls Over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2021,2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We have not experienced any material impact to our internal controls over financial reporting despite the fact that mostsome of our employees are working remotely due to the COVID-19 pandemic. We are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.

 

PART II. OTHER INFORMATION

 

Item 1

Legal ProceedingsProceedings.

 

None.

 

Item 1A

Risk Factors.

 

Reference is made to the Risk Factors included in our Fiscal 20202021 Form 10-K. There have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our Fiscal 2021 Form 10-K, aswhich are supplemented by the following.following:

 

The coronavirus (COVID-19) pandemic continues to negatively impact our operations.

We have facilities and/or customers located in the United States, Israel, Japan, and Italy and a few other locations. All of our facilities are in locations that are subject to, or have been subject to, stay-at-home or shelter-in-place orders that have been re‑instated from time to time as pandemic surges occur. A variety of travel restrictions continue to cause delays in our product installation and training activities and are expected to continue. In the first quarter of 2021, elective surgeries were significantly reduced in Europe, Japan, and to some extent in different locations in the United States. These pandemic-related events have negatively impacted our implementation of new leasing arrangements, performance of surgical procedures using the Senhance System in some locations, and our product installation and training activities. In the second quarter of 2021, elective surgeries continued to be cancelled, particularly in Europe. Although we believe such disruptions may be temporary, we cannot assure you thatsee the impact of the COVID-19 pandemic and other geopolitical factors on our business, and cannot assure you that we will be able to grow our business as forecast.

We continue to see delays in implementing robotic systems, training physicians on the use of the Senhance System and working with hospitals and surgeons to increase procedure volumes because of the impact of the COVID-19 pandemic, related world-wide supply shortages and the ongoing war in the Ukraine, as well as other geopolitical factors. We cannot assure you that we can implement our growth plans on the timeline desired, and continued delays could have a material negative impact on our business, results of operations and financial condition.

We may experience difficulties implementing our new global enterprise resource planning system.

We are engaged in a multi-year implementation of a new global enterprise resource planning system (“ERP”), which is entering a critical phase in 2022. The ERP is designed to efficiently maintain our books and records and provide information important to the operation of our business to our management team.  The ERP will continue to require significant investment of human and financial resources.  In implementing the ERP, we may experience significant delays, increased costs and other difficulties. Any significant disruption or deficiency in the design and implementation of the ERP could adversely affect our ability to process orders, ship product, send invoices and track payments, fulfill contractual obligations or otherwise operate our business. In addition, our efforts to centralize various business processes and functions within our organization in connection with our ERP implementation may continue to disrupt our operations and negatively impact our business, results of operations and financial condition.

Many of our Senhance Systems are placed under leasing arrangements with a buy-out option.If the customer does not extend the leasing arrangement or elect to purchase the Senhance System, it reduces future revenue.

Many of our Senhance Systems are placed under leasing arrangements with a buy-out option.  If the customer does not elect to extend the lease arrangement or purchase the Senhance System it is returned to us, which reduces future revenue as we will not receive revenues from the capital purchases.  In the quarter ended June 30, 2022, four customers chose not to extend their lease arrangements.  As our leasing arrangements expire, we may see a termination of more leasing arrangements, which could have a material impact on our business and financial results.future revenues.

 

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds.

 

The following table summarizes the Company’s purchases of its common stock for the quarter ended June 30, 2021:None.

  

Issuer Purchases of Equity Securities

     
          

Total

  

Maximum

 
          

Number of

  

Number of

 
          

Shares

  

Shares

 
          

Purchased

  

that May

 
          

as Part of

  

Yet be

 
  

Total

      

Publicly

  

Purchased

 
  

Number

  

Average

  

Announced

  

Under the

 
  

of Shares

  

Price Paid

  

Plans or

  

Plan or

 

Period

 

Purchased (1)

  

per Share

  

Programs

  

Programs

 

April 1 - 31, 2021

  -  $-   -   - 

May 1 - 31, 2021

  -   -   -   - 

June 1 - 30, 2021

  245,850   3.37   -   - 

Total

  245,850  $3.37   -   - 

(1)

These amounts consist of 245,850 shares we acquired from employees associated with the withholding of shares to pay certain withholding taxes upon the vesting of stock-based compensation in accordance with the terms of our equity compensation plan that were previously approved by our stockholders and disclosed in our proxy statements. We purchased these shares at their fair market value, as determined by reference to the closing price of our common stock on the vesting date.  

 

Item 3

Defaults Upon Senior Securities.

 

None.

 

Item 4

Mine Safety Disclosures.

 

Not applicable.

 

Item 5

Other Information.

 

None.

 

 

Item 6.

EXHIBITS

 

Exhibit

No.

 

Description

3.1

Amended and Restated Bylaws of Asensus Surgical, Inc., effective July 15, 2021 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 15, 2021).

10.1 +

Asensus Surgical, Inc. Amended and Restated Incentive Compensation Plan effective as of July 22, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 23, 2021).

31.1 *

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a).

   

31.2 *

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a).

   

32.1 *

 

Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

   

32.2 *

 

Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

   

101.INS *

 

Inline XBRL Instance Document.

   

101.SCH* *

 

Inline XBRL Taxonomy Extension Schema Document.

   

101.CAL* *

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

   

101.DEF* *

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

   

101.LAB* *

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

   

  101.PRE *

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

   

104

 

The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021,2022, formatted in Inline XBRL (included in Exhibit 101).

 


+         A management contract, compensatory plan or arrangement required to be separately identified.

*         Filed herewith.

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

   

Asensus Surgical, Inc.

    

Date: August 5, 20218, 2022

 

By:

/s/ Anthony Fernando

  

Anthony Fernando

  

President and Chief Executive Officer

    

Date: August 5, 20218, 2022

 

By:

/s/ Shameze Rampertab

  

Shameze Rampertab

  

Executive Vice President and Chief Financial Officer

 

3526