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, 2022March 31, 2023

 

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 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 August 5, 2022May 8, 2023 was 236,718,923.239,465,556.

 



 

 

 

 

ASENSUS SURGICAL, INC.

 

TABLE OF CONTENTS FOR FORM 10-Q

 

PART I.

FINANCIAL INFORMATION

 
   

Item 1.

Financial Statements

 
 

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

2

 

Condensed Consolidated Balance Sheets (unaudited)

3

 

Condensed Consolidated Statements of Stockholders’ Equity (unaudited)

4

 

Condensed Consolidated Statements of Cash Flows (unaudited)

5

 

Notes to Condensed Consolidated Financial Statements (unaudited)

6

Item 2.

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

1716

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

2321

Item 4.

Controls and Procedures

2421

   

PART II.

OTHER INFORMATION

2422

   

Item 1.

Legal Proceedings

2422

Item 1A.

Risk Factors

2422

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

2422

Item 3.

Defaults Upon Senior Securities

2423

Item 4.

Mine Safety Disclosures

2423

Item 5.

Other Information

2423

Item 6.

Exhibits

2524

   
 

SIGNATURES

2625

 

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 impactour ability to grow utilization of the coronavirus (COVID-19) pandemic on our operating results.Senhance Systems and our ability to advance development of our next-generation products and our collaborations with third parties. 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, 20212022 (the “Fiscal 20212022 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, but not limited to, the impact of COVID-19 and other geopolitical factors on our operating results, and the demand for our products, 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., Asensus International, Inc., Asensus Surgical Italia S.r.l., Asensus Surgical Europe S.à.r.l.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

 
 

June 30,

  

June 30,

  

March 31,

 
 

2022

  

2021

  

2022

  

2021

  

2023

  

2022

 

Revenue:

  

Product

 $254  $363  $601  $1,726  $293  $347 

Service

 424  406  732  785  195  308 

Lease

  316   333   727   674   488   411 

Total revenue

 994  1,102  2,060  3,185  976  1,066 
  

Cost of revenue:

  

Product

 883  1,003  1,259  2,678  1,225  375 

Service

 646  636  1,141  1,002  749  496 

Lease

  818   708   1,770   1,779   973   952 

Total cost of revenue

 2,347  2,347  4,170  5,459  2,947  1,823 
              

Gross loss

 (1,353) (1,245) (2,110) (2,274) (1,971) (757)

Operating Expenses:

  

Research and development

 7,253  4,089  13,681  8,304  10,139  6,428 

Sales and marketing

 3,602  3,562  7,321  6,615  4,553  3,719 

General and administrative

 4,992  3,848  10,525  7,840  5,468  5,533 

Amortization of intangible assets

 2,533  2,862  5,203  5,729  112  2,670 

Change in fair value of contingent consideration

 (598) 478  (752) 735   105   (154)

Property and equipment impairment

  432   0   432   0 

Total Operating Expenses

 18,214  14,839  36,410  29,223  20,377  18,196 
              

Operating Loss

 (19,567) (16,084) (38,520) (31,497) (22,348) (18,953)

Other Income (Expense), net

 ��  

Gain on extinguishment of debt

 0  2,847  0  2,847 

Change in fair value of warrant liabilities

 0  0  0  (1,981)

Interest income

 260  79  515  131  439  255 

Interest expense

 (141) (5) (341) (12) -  (200)

Other expense, net

  (86)  (7)  (232)  (36)  (218)  (146)

Total Other Income (Expense), net

 33  2,914  (58) 949  221  (91)
  

Loss before income taxes

 (19,534) (13,170) (38,578) (30,548) (22,127) (19,044)

Income tax (expense) benefit

  (85)  (2)  (169)  36 

Income tax expense

  (91)  (84)

Net loss

 (19,619) (13,172) (38,747) (30,512) (22,218) (19,128)
  

Comprehensive loss:

  

Net loss

 (19,619) (13,172) (38,747) (30,512) (22,218) (19,128)

Foreign currency translation (loss) gain

 (1,713) 472  (2,363) (1,466)

Unrealized loss on available-for-sale investments

  (144)  0   (696)  0 

Foreign currency translation gain (loss)

 550  (650)

Unrealized gain (loss) on available-for-sale investments

  307   (552)

Comprehensive loss

 $(21,476) $(12,700) $(41,806) $(31,978) $(21,361) $(20,330)
          

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

 $(0.08) $(0.06) $(0.16) $(0.14) $(0.09) $(0.08)

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

  236,505   233,250   236,201   219,199  238,280  235,892 

 

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, 2022

  

December 31, 2021

  

March 31, 2023

  

December 31, 2022

 

Assets

  

Current Assets:

  

Cash and cash equivalents

 $10,844  $18,129  $18,737  $6,329 

Short-term investments, available-for-sale

 83,360  80,262  37,697  64,195 

Accounts receivable, net

 699  749  658  2,256 

Inventories

 8,451  8,634  8,844  8,284 

Prepaid expenses

 2,927  3,255  3,326  3,584 

Employee retention tax credit receivable

 1,147  1,311  554  554 

Other current assets

  1,134   957   1,740   1,671 

Total Current Assets

 108,562  113,297  71,556  86,873 
  

Restricted cash

 1,290  1,154  1,142  1,141 

Long-term investments, available-for-sale

 9,581  37,435  958  3,865 

Inventories, net of current portion

 7,258  7,074  5,198  5,469 

Property and equipment, net

 9,389  10,971  8,972  9,542 

Intellectual property, net

 4,122  9,892  1,506  1,576 

Net deferred tax assets

 244  288  171  174 

Operating lease right-of-use assets, net

 4,747  5,348  4,769  4,950 

Other long-term assets

  2,157   1,014   2,251   2,463 

Total Assets

 $147,350  $186,473  $96,523  $116,053 
  

Liabilities and Stockholders' Equity

  

Current Liabilities:

  

Accounts payable

 $3,849  $3,448  $4,972  $3,348 

Accrued employee compensation and benefits

 3,127  3,559  3,391  4,508 

Accrued expenses and other current liabilities

 1,617  1,617  1,283  1,293 

Operating lease liabilities - current portion

 579  683  775  800 

Deferred revenue

  510   543   456   465 

Total Current Liabilities

 9,682  9,850  10,877  10,414 
  

Long-Term Liabilities:

  

Contingent consideration

 1,619  2,371  1,361  1,256 

Noncurrent operating lease liabilities

  4,610   5,006   4,568   4,738 

Total Liabilities

 15,911  17,227  16,806  16,408 
  

Commitments and Contingencies (Note 14)

       

Commitments and Contingencies (Note 13)

       
  

Stockholders' Equity:

  

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 

Common stock $0.001 par value, 750,000,000 shares authorized at March 31, 2023 and December 31, 2022; 239,341,570 and 236,895,440 issued and outstanding at March 31, 2023 and December 31, 2022, respectively

 239  237 

Preferred stock, $0.01 par value, 25,000,000 shares authorized, no shares issued and outstanding at March 31, 2023 and December 31, 2022

 -  - 

Additional paid-in capital

 958,646  954,649  964,162  962,731 

Accumulated deficit

 (824,121) (785,374) (883,153) (860,935)

Accumulated other comprehensive loss

  (3,323)  (264)  (1,531)  (2,388)

Total Stockholders' Equity

  131,439   169,246   79,717   99,645 

Total Liabilities and Stockholders' Equity

 $147,350  $186,473  $96,523  $116,053 

 

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

 

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, 2022

  236,895  $237  -  $-  $962,731  $(860,935) $(2,388) $99,645 

Stock-based compensation

 -  -  -  -  1,916  -  -  1,916 

Exercise of stock options

 13  -  -  -  5  -  -  5 

Award of restricted stock units

 2,434  2  -  -  -  -  -  2 

Return of common stock to pay withholding taxes on restricted stock

 -  -  649  1  (490) -  -  (489)

Cancellation of treasury stock

 -  -  (649) (1) -  -  -  (1)

Other comprehensive loss

 -  -  -  -  -  -  857  857 

Net loss

  -  -   -  -   -   (22,218)  -   (22,218)

Balance, March 31, 2023

  239,342  $239   -  $-  $964,162  $(883,153) $(1,531) $79,717 
 

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

Stock-based compensation

 -  0  -  -  2,245  0  0  2,245  -  -  -  -  2,245  -  -  2,245 

Exercise of stock options

 30  0  0  0  12  0  0  12  30  -  -  -  12  -  -  12 

Award of restricted stock units

 1,166  1  0  0  0  0  0  1  1,166  1  -  -  -  -  -  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  436  0  (349) 0  0  (349) -  -  436  -  (349) -  -  (349)

Cancellation of treasury stock

 0  0  (436) 0  0  0  0  0  -  -  (436) -  -  -  -  - 

Other comprehensive loss

 -  0  -  0  0  0  (1,202) (1,202) -  -  -  -  -  -  (1,202) (1,202)

Net loss

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

Balance, March 31, 2022

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

Balance, December 31, 2020

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

Stock-based compensation

 -  0  -  0  1,786  0  0  1,786 

Issuance of common stock, net of issuance costs

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

Exercise of stock options and warrants

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

Award of restricted stock units

 706  1  0  0  0  0  0  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  67  0  (214) 0  0  (214)

Cancellation of treasury stock

 0  0  (67) 0  0  0  0  0 

Other comprehensive loss

 -  0  -  0  0  0  (1,938) (1,938)

Net loss

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

Balance, March 31, 2021

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

Stock-based compensation

 -  0  -  0  1,842  0  0  1,842 

Issuance of common stock, net of issuance costs

 332  0  0  0  992  0  0  992 

Exercise of stock options and warrants

 508  0  0  0  337  0  0  337 

Award of restricted stock units

 674  1  0  0  0  0  0  1 

Return of common stock to pay withholding taxes on restricted stock

 0  0  246  0  (829) 0  0  (829)

Cancellation of treasury stock

 0  0  (246) 0  0  0  0  0 

Other comprehensive gain

 -  0  -  0  0  0  472  472 

Net loss

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

Balance, June 30, 2021

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

 

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,

  

Three Months Ended March 31,

 
 

2022

  

2021

  

2023

  

2022

 

Operating Activities:

  

Net loss

 $(38,747) $(30,512) $(22,218) $(19,128)

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

  

Depreciation

 1,720  1,585  813  869 

Amortization of intangible assets

 5,203  5,729  112  2,670 

Amortization of discounts and premiums on investments, net

 444  0  (89) 215 

Stock-based compensation

 4,328  3,628  1,916  2,245 

Gain on extinguishment of debt

 0  (2,847)

Deferred tax expense (benefit)

 169  (36)

Deferred tax expense

 91  84 

Bad debt expense

 9  0  -  177 

Change in inventory reserves

 (567) 288  (374) (180)

Property and equipment impairment

 432  0 

Loss on disposal of property and equipment

 97  0 

Change in fair value of warrant liabilities

 0  1,981 

Change in fair value of contingent consideration

 (752) 735  105  (154)
  

Changes in operating assets and liabilities:

  

Accounts receivable

 (8) 127  1,607  25 

Inventories

 (1,933) (1,687) 203  (1,440)

Operating lease right-of-use assets

 409  (2,970) 187  197 

Prepaid expenses

 189  517  250  201 

Other current and long-term assets

 (1,169) 2,660  (27) (487)

Accounts payable

 524  679  1,608  74 

Accrued expenses

 (284) (1,428)

Accrued employee compensation and benefits

 (1,120) (1,043)

Accrued expenses and other current liabilities

 (93) (107)

Deferred revenue

 (4) 14  (13) (1)

Operating lease liabilities

  (290)  3,052   (206)  (160)

Net cash and cash equivalents used in operating activities

 (30,230) (18,485) (17,248) (15,943)
  

Investing Activities:

  

Purchase of available-for-sale investments

 (17,792) 0  (2,949) (5,967)

Proceeds from maturities of available-for-sale investments

 41,408  0  32,750  29,258 

Purchase of property and equipment

  (443)  (700)  (64)  (246)

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

 23,173  (700)

Net cash and cash equivalents provided by investing activities

 29,737  23,045 
  

Financing Activities:

  

Proceeds from issuance of common stock, net of issuance costs

 0  130,314 

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

 (349) (1,041) (488) (348)

Proceeds from exercise of stock options and warrants

  18   30,835   5   12 

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

 (331) 160,108 

Net cash and cash equivalents used in financing activities

 (483) (336)
  

Effect of exchange rate changes on cash and cash equivalents

  239   (329)  403   (45)

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

 (7,149) 140,594 

Net increase in cash, cash equivalents and restricted cash

 12,409  6,721 

Cash, cash equivalents and restricted cash, beginning of period

  19,283   17,529   7,470   19,283 

Cash, cash equivalents and restricted cash, end of period

 $12,134  $158,123  $19,879  $26,004 
  

Supplemental Disclosure for Cash Flow Information

  

Cash paid for leases

 $549  $539  $330  $300 

Cash paid for taxes

 $65  $50  $190  $29 
  

Supplemental Schedule of Non-cash Investing and Financing Activities:

  

Transfer of inventories to property and equipment

 $724  $1,243  $112  $160 

Acquisition of property and equipment in accounts payable

 $0  $67 

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

 $0  $2,236 

Lease liabilities arising from obtaining right-of-use assets

 $0  $3,461  $45  $- 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

5

 

Asensus Surgical, Inc.

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

 

1.

Description 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-Guidedwhat we are calling “Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. Based upon the foundations of digital laparoscopy and the Senhance® Surgical System, the Company is developing the LUNA™ Surgical System, a next generation robotic and instrument system as a foundation of its digital surgery solution. These systems will be powered by the Intelligent Surgical Unit™(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 thecontinues market development for and commercialization of the Senhance® SurgicalSenhance 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 3mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control and fully-reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy.

 

 

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. All inter-company accounts and transactions have been eliminated in 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 20212022 Form 10-K. Certain information and footnote disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted in the accompanying interim condensed consolidated financial statements. In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements 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.

 

Going Concern

The Company's condensed consolidated financial statements are prepared using U.S. GAAP applicable to a going concern, which contemplate the realization of assets and liquidation of liabilities in the normal course of business. The Company had an accumulated deficit of $883.2 million and working capital of $60.7 million as of March 31, 2023. The Company has not established sufficient sales revenues to cover its operating costs and requires additional capital to proceed with its operating plan. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable.

The Company will need to obtain additional financing 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 strategic collaborations, 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 ability to successfully resolve these factors raise substantial doubt about the Company’s ability to meet its existing obligations, and to continue as a going concern within one year from the date that these financial statements are issued. The consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and 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.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 consolidation.

 

6

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: the historical lack of profitability; the Company’s ability to raise additional capital; its ability to successfully develop, clinically test and commercialize its products and products in development; negative impacts on the Company's operations caused by the COVID-19 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; 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 andhealthcare regulatory environments of the United States, 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 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-lived assets, fair value estimates related to contingent consideration, 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 right-of-use (“ROU”) assets, and deferred tax asset valuation allowances.

 

6

Significant Accounting Policies

There have been no new or material changes to the significant accounting policies discussed in the Company’s audited financial statements and the notes thereto included in the Annual Report onFiscal 2022 Form 10-K for the fiscal year ended December 31, 2021.-K.

Reclassifications

Certain amounts reported previously have been reclassified 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 revenue for leases which historically were included in product and service revenue and corresponding cost of revenue on the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2021.

 

Impact of Recently Issued Accounting Standards

In 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 each reporting date. The Company adopted ASU 2016-13 as of January 1, 2022, on a modified retrospective basis. The cumulative-effect adjustment related to the adoption was not material.

In August 2020, the FASB 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 debt component and equity component or derivative component. The Company adopted ASU 2020-06 as of January 1, 2022. The adoption did not have a material impact to the consolidated financial statements.

The Company has evaluated all other issued and ASUs not yet adopted and believes the adoption of these standards will not have a material impact on its condensed consolidated statements of operations and comprehensive loss, balance sheets, or statements of cash flows.financial statements.

 

 

3.

Revenue Recognition

 

The following table presents revenue disaggregated by type and geography:

 

 

Three Months Ended June 30,

  

Six Months Ended June 30,

  

Three Months Ended March 31,

 
 

2022

  

2021

  

2022

  

2021

  

2023

  

2022

 
 

(in thousands)

 

(in thousands)

  

(in thousands)

 

U.S.

                    

Systems

 $0  $0  $0  $3  $-  $- 

Instruments and accessories

 18  79  82  141  60  64 

Services

 75  104  149  202  75  74 

Leases

  51   91   164   181   71   113 

Total U.S. revenue

 144  274  395  527  206  251 
          

Outside of U.S. ("OUS")

                    

Systems

 0  0  0  921  -  - 

Instruments and accessories

 236  284  519  661  233  283 

Services

 349  302  583  583  120  234 

Leases

  265   242   563   493   417   298 

Total OUS revenue

 850  828  1,665  2,658  770  815 
          

Total

                    

Systems

 0  0  0  924  -  - 

Instruments and accessories

 254  363  601  802  293  347 

Services

 424  406  732  785  195  308 

Leases

  316   333   727   674   488   411 

Total revenue

 $994  $1,102  $2,060  $3,185  $976  $1,066 

 

7

Remaining Performance Obligations

TransactionThe 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. TransactionThe transaction price allocated to remaining performance obligations as of June 30, 2022March 31, 2023 was $2.1$0.9 million, which is expected to be recognized over one to four years. 

 

7

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. 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, 2022March 31, 2023 and 20212022 that was included in the deferred revenue balance at the beginning of each reporting period was $0.3$0.2 million and $0.2 million, respectively. Revenue recognized for the six months ended June 30, 2022 and 2021 that was included in the deferred revenue balance at the beginning of each reporting period was $0.5 million and $0.4 million, respectively.

 

The following information summarizes the Company’s contract assets and liabilities:

 

 

As of

  

As of

 
 

June 30, 2022

  

December 31, 2021

  

March 31, 2023

  

December 31, 2022

 
 

(in thousands)

  

(in thousands)

 

Contract Assets

 $57  $91  $81  $116 

Deferred Revenue

 $510  $543  $456  $465 

 

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 optionright to purchase the leased Senhance 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 Senhance System. For the three and sixmonths ended June 30, 2022,March 31, 2023, and 2021,2022, variable lease revenue related to usage-based arrangements was not material.  

 

Trade Accounts Receivable

Accounts receivable are recorded at net realizable value, which includes an allowance for expected credit losses. The allowance for doubtful accountsexpected credit losses is based on the Company’s assessment of the 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 customer’s ability to pay. The allowance for doubtful accountsexpected credit losses was $1.5$1.6 million and $1.7$1.6 million as of June 30, 2022,March 31, 2023 and December 31, 2021,2022, respectively. ForThe Company recorded immaterial amounts for expected credit losses during the three and sixmonths ended June 30, 2022,March 31, 2023 and 2021,2022, bad debt expense was not material.respectively.          

 

8

 

4.

Fair Value

 

The following are categories of assets and liabilities measured at fair value on a 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

  

March 31, 2023

 
 

(in thousands)

  

(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

  

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  $18,737  $-  $-  $18,737 

Restricted cash

 1,290  0  0  1,290  1,142  -  -  1,142 

Short-term investments

 0  83,360  0  83,360  -  37,697  -  37,697 

Long-term investments

  0   9,581   0   9,581   -   958   -   958 

Total assets measured at fair value

 $12,134  $92,941  $0  $105,075  $19,879  $38,655  $-  $58,534 

Liabilities measured at fair value

  

Contingent consideration

 $0  $0  $1,619  $1,619  $-  $-  $1,361  $1,361 

Total liabilities measured at fair value

 $0  $0  $1,619  $1,619  $-  $-  $1,361  $1,361 

 

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

 

 

December 31, 2021

  

December 31, 2022

 
 

(in thousands)

  

(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

  

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  $6,329  $-  $-  $6,329 

Restricted cash

 1,154  0  0  1,154  1,141  -  -  1,141 

Short-term investments

 0  80,262  0  80,262  -  64,195  -  64,195 

Long-term investments

  0   37,435   0   37,435   -   3,865   -   3,865 

Total assets measured at fair value

 $19,283  $117,697  $0  $136,980  $7,470  $68,060  $-  $75,530 

Liabilities measured at fair value

  

Contingent consideration

 $0  $0  $2,371  $2,371  $-  $-  $1,256  $1,256 

Total liabilities measured at fair value

 $0  $0  $2,371  $2,371  $-  $-  $1,256  $1,256 

 

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

 

The carrying values of accounts receivable, prepaid expenses, employee retention tax credit receivables, other current assets, accounts payable, accrued employee compensation and benefits, accrued expenses and other current liabilities, and deferred revenue as of June 30, 2022,March 31, 2023, and December 31, 2021,2022, 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.Three Heads Investment S.r.l., the seller, related to the Company’s 2015 acquisition of the Senhance Surgical System from an assignor to Three Heads Investment S.r.l. (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, 2022March 31, 2023 and December 31, 2021:2022:

 

 

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 
 

Valuation

Methodology

 

Significant Unobservable

Input

 

March 31, 2023

  

December 31, 2022

 
            

Contingent consideration

Probability weighted income approach

 

Milestone dates

 

2032

  

2032

 
   

Discount rate

  16.0%   16.5% 
   

Revenue volatility

  40.0%   45.0% 
   

EUR-to-USD exchange rate

  1.09   1.07 

 

9

 

The following table presents the current and long-term portion of the contingent consideration for the three months ended March 31, 2023 and summarizes the change in fair value, as determined by Level 3 inputs for the contingent consideration for the sixthree months ended June 30, 2022March 31, 2023 and 2021:2022:

 

  

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 

  

Fair Value

Measurement at

Reporting Date

(Level 3)

 
  

(in thousands)

 
  

Contingent

consideration

 

Balance at December 31, 2021

 $2,371 

Change in fair value

  (154)

Balance at March 31, 2022

 $2,217 
     

Balance at December 31, 2022

 $1,256 

Change in fair value

  105 

Balance at March 31, 2023

 $1,361 
     

Current portion

 $- 

Long-term portion

  1,361 

Balance at March 31, 2023

 $1,361 

 

 

5.

Investments, available-for-sale

 

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

 

 

June 30, 2022

  

March 31, 2023

 
 

(in thousands)

  

(in thousands)

 
      
 

Amortized

Cost

  

Unrealized

Gain

  

Unrealized

Loss

  

Fair Value

  

Short-term

investments

  

Long-term

investments

  

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  $5,442  $-  $(16) $5,426  $5,426  $- 

Corporate Bonds

  58,242   0   (753)  57,489   47,908   9,581  29,459  2  (178) 29,283  28,325  958 

U.S. Treasuries

 2,953  -  (1) 2,952  2,952  - 

U.S. Government Agencies

  999   -   (5)  994   994   - 

Total Investments

 $93,885  $0  $(944) $92,941  $83,360  $9,581  $38,853  $2  $(200) $38,655  $37,697  $958 

 

 

  

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 

  

December 31, 2022

 
  

(in thousands)

 
                         
  

Amortized

Cost

  

Unrealized

Gain

  

Unrealized

Loss

  

Fair Value

  

Short-term

investments

  

Long-term

investments

 

Commercial Paper

 $12,364  $-  $(49) $12,315  $12,315  $- 

Corporate Bonds

  55,201   -   (447)  54,754   50,889   3,865 

U.S. Government Agencies

  999   -   (8)  991   991   - 

Total Investments

 $68,564  $-  $(504) $68,060  $64,195  $3,865 

 

 

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

 

 

June 30, 2022

  

March 31, 2023

 
 

(in thousands)

  

(in thousands)

 
 

Amortized

Cost

  

Fair Value

  

Amortized

Cost

  

Fair Value

 

Mature in less than one year

 $84,173  $83,360  $37,897  $37,697 

Mature in one to two years

  9,712   9,581   956   958 

Total

 $93,885  $92,941  $38,853  $38,655 

 

Actual maturities may differ from contractual maturities because certain borrowers have the right to call or prepay certain obligations. There were no sales of investments or gross realized gains or losses for the sixthree months ended June 30, 2022,March 31, 2023 andor 2021,2022. respectively.

 

10

 

 

6.

Inventories

 

The components of inventories are as follows:

 

 

March 31, 2023

 
 

June 30, 2022

  

(in thousands)

 
 

(in thousands)

    
 

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $14,687  $(2,931) $11,756  $16,101  $(4,175) $11,926 

Raw materials

  6,137   (2,184)  3,953   4,617   (2,501)  2,116 

Total inventories

 $20,824  $(5,115) $15,709  $20,718  $(6,676) $14,042 
  

Current Portion

 $10,113  $(1,662) $8,451  $10,013  $(1,169) $8,844 

Long-term portion

  10,711   (3,453)  7,258   10,705   (5,507)  5,198 

Total inventories

 $20,824  $(5,115) $15,709  $20,718  $(6,676) $14,042 

 

  

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. 

  

December 31, 2022

 
  

(in thousands)

 
    
  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $15,337  $(4,129) $11,208 

Raw materials

  4,718   (2,173)  2,545 

Total inventories

 $20,055  $(6,302) $13,753 
             

Current Portion

 $9,399  $(1,115) $8,284 

Long-term portion

  10,656   (5,187)  5,469 

Total inventories

 $20,055  $(6,302) $13,753 

 

 

7.

Intellectual Property

 

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

 

 

June 30, 2022

  

March 31, 2023

 
 

(in thousands)

  

(in thousands)

 
 

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

 

Developed technology

 $68,838  $(64,094) $(812) $3,932  $68,838  $(66,646) $(853) $1,339 

Technology and patents purchased

  400   (220)  10   190   400   (248)  15   167 

Total intellectual property

 $69,238  $(64,314) $(802) $4,122  $69,238  $(66,894) $(838) $1,506 

 

 

December 31, 2021

  

December 31, 2022

 
 

(in thousands)

  

(in thousands)

 
 

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

  

Gross

Carrying

Amount

  

Accumulated

Amortization

  

Foreign

Currency

Translation

Impact

  

Net

Carrying

Amount

 

Developed technology

 $68,838  $(58,912) $(262) $9,664  $68,838  $(66,562) $(874) $1,402 

Technology and patents purchased

  400   (199)  27   228   400   (239)  13   174 

Total intellectual property

 $69,238  $(59,111) $(235) $9,892  $69,238  $(66,801) $(861) $1,576 

 

The weighted average remaining useful life of the developed technology and technology and patents purchased was 2.03.9 years and 4.84.1 years, respectively, as of June 30,March 31, 2023. The weighted average remaining useful life of the developed technology and technology and patents purchased was 4.2 years and 4.3 years, respectively as of December 31, 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 determines if it is an operating lease or a finance lease. Subsequently, if the arrangement is modified, the Company reevaluates the classification. The Company has entered into operating leases for corporate office buildings, vehicles, and machinery and equipment. Some of the lease agreements have renewal options, tenant improvement allowances, rent escalation clauses, and assignment and subletting clauses. While the operating 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 

  

Three Months Ended March 31,

 
  

2023

  

2022

 
  

(in thousands)

 

Long-term Operating

 $451  $398 

Short-term Operating

  -   - 

Total Operating lease expense

 $451  $398 

 

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 

  

March 31, 2023

  

December 31, 2022

 

Weighted-average remaining lease term (in years)

  6.7    6.8  

Weighted-average discount rate

  8.4%    8.4%  

Incremental borrowing rate

 7.07%-14.5%  6.1%-14.5% 

 

Maturities of operating lease obligations as of June 30, 2022March 31, 2023 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 

Fiscal Year

    

2023

 $897 

2024

  1,142 

2025

  1,061 

2026

  847 

2027

  780 

Thereafter

  2,199 

Total minimum lease payments

 $6,926 

Less: Amount of lease payments representing interest

  (1,583)

Present value of future minimum lease payments

 $5,343 

 

 

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 property 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 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 (0.4)% for the year ending December 31, 2022.2023. This rate does not include the impact of any discrete items. The Company’s effective tax rate for the three months ended June 30, 2022March 31, 2023 and 20212022 was (0.4)% and 0.0%, respectively. The Company’s effective tax rate for the six months ended June 30, 2022 and 2021 was (0.4)% and 0.1%, respectively.

 

12

The Company incurred losses for the three and sixmonths ended June 30, 2022,March 31, 2023, 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, 2022.2023. 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) benefitexpense during the three months ended June 30, 2022March 31, 2023 and 2021,2022, was approximately ($0.1)$0.09 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$0.08 million, respectively.

 

At June 30, 2022March 31, 2023 the Company had 0no 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;2023; no GILTI tax has been recorded for the sixthree months ended June 30, 2022March 31, 2023 or 2021.2022, respectively.

12

 

 

11.10.

Stock-Based Compensation

 

Stock Options

The following table summarizes the Company’s stock option activity, including grants to non-employees, for the sixthree months ended June 30, 2022:March 31, 2023:

 

 

Number of

Shares

  

Weighted-

Average Exercise

Price

  

Weighted-Average

Remaining

Contractual Term

(Years)

  

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 

Balance at December 31, 2022

 7,584,967  $4.22  5.31 

Granted

 2,555,396  0.77     2,748,415  0.73    

Forfeited

 (23,047) 3.22     -  -    

Cancelled

 (16,983) 33.27     (913) 4.21    

Exercised

  (43,453)  0.41       (13,300)  0.38     

Balance at June 30, 2022

  7,112,573  $4.52   5.71 

Balance at March 31, 2023

  10,319,169  $3.30   5.54 

 

The following table summarizes information about stock options outstanding at June 30, 2022:March 31, 2023:

 

  

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.

  

Number of

Shares

  

Weighted-

Average Exercise

Price

  

Weighted-Average

Remaining

Contractual Term

(Years)

  

Aggregate

Intrinsic Value

(Millions)

 

Exercisable at March 31, 2023

  4,843,264  $5.96   4.80  $0.4 

Vested or expected to vest at March 31, 2023

  9,645,630  $3.47   5.47  $0.6 

 

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 

12.

Equity Offerings

  

Three Months Ended March 31,

 
  

2023

  

2022

 

Expected dividend yield

  0%    0%  

Expected volatility

 124%-126%  131%-133% 

Risk-free interest rate

 3.73%-4.14%  1.25%-1.94% 

Expected life (in years)

 4.3-4.5  4.3-4.5 

 

Equity financing transactionsRestricted Stock Units

The following is a summary of the restricted stock units activity, including performance restricted stock units, for the sixthree months ended June 30, 2021, March 31, 2023:include:

  

Number of

Restricted Stock

Units

Outstanding

  

Weighted-

Average Grant

Date Fair Value

 

Unvested December 31, 2022

  8,483,491  $1.04 

Granted

  7,340,630   0.73 

Vested

  (3,082,354)  1.18 

Forfeited

  (84,673)  1.13 

Unvested March 31, 2023

  12,657,094  $0.83 

 

Performance Restricted Stock Units

In 20202023 ATM Offering. Onand 2022, the Company granted performance-based restricted stock units with vesting terms based on our attainment of certain operational targets by December 31, 2023 and October 9, 2020,1, 2023, 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 millionrespectively. The number of shares ofearnable under the Company’s common2023 and 2022 awards are based on achieving designated corporate goals. These operational targets have been achieved for the awards granted in 2022, therefore the 2022 performance-based restricted stock (theunits are fully earned and remain subject to “2020three ATM Offering”).-year time-based vesting requirements. The Company terminated this agreementhas not yet achieved the operational targets required for the awards granted in January 2021. 2023.

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.

 

1413

 

2021 ATM OfferingStock-based Compensation Expense. 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 aggregatefollowing table summarizes non-cash stock-based compensation payable to the Agents was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock.

Sales duringexpense by award type for the sixthree months ended June 30, 2021,March 31, 2023 under the 2021and 20202022: 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 
  

Three Months Ended March 31,

 
  

2023

  

2022

 
  

(in thousands)

 

Stock options

 $665  $978 

Restricted stock units

  859   883 

Performance restricted stock units

  392   384 
  $1,916  $2,245 

 

2021 ExerciseAs of Warrants. During the sixMarch 31, 2023, 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 had future employee stock-based compensation expense of $30.6 million.approximately $2.9 million related to unvested stock options, which is expected to be recognized over an estimated weighted-average period of approximately 2.0 years. As of March 31, 2023, the unrecognized stock-based compensation expense related to unvested restricted stock units and performance restricted stock units was approximately $7.4 million, which is expected to be recognized over a weighted average period of approximately 1.9 years.

11.

Equity Offerings

 

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. NaNNo sales of common stock were made under the 2022 ATM Offering during the sixthree months ended June 30, 2022.March 31, 2023 and 2022, respectively.

 

 

13.12.

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, and warrants. No adjustments have been made to the weighted average outstanding common shares figures for the three and sixmonths ended June 30, 2022March 31, 2023 or 20212022 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 

  

March 31,

 
  

2023

  

2022

 

Stock options

  10,319,169   6,766,520 

Stock warrants

  1,021,076   1,120,300 

Nonvested restricted stock units

  12,657,094   7,299,111 

Total

  23,997,339   15,185,931 

 

 

14.13.

Commitments and Contingencies

 

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, theThe 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  $8,058 

2024

 550  439 

2025

 339  315 

2026

 0   303 

Thereafter

  0 

Total commitments

 $10,206  $9,115 

 

15
14

 

 

15.14.

Segments and Geographic Areas

 

The Company operates in 1one business segment—the research, development and sale of medical device roboticsdevices 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

  

March 31, 2023

 
 

Long-Lived Assets

  

Total Assets

  

Long-Lived Assets

  

Total Assets

 

U.S.

 33% 77% 36% 71%
  

EMEA

        

Switzerland

 40% 18% 45% 24%

Italy

 20% 3% 8% 2%

Other

  7%  1%  8%  2%

Total EMEA

 67% 22% 61% 28%
  

Asia

  0%  1%  3%  1%

Total

  100%  100%  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%

  

December 31, 2022

 
  

Long-Lived Assets

  

Total Assets

 

U.S.

  35%  72%
         

EMEA

        

Switzerland

  46%  24%

Italy

  8%  2%

Other

  8%  1%

Total EMEA

  62%  27%
         

Asia

  3%  1%

Total

  100%  100%

 

The Company recognizesfollowing table presents 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.

 

  

Three Months Ended March 31,

 
  

2023

  

2022

 
         

US

  21%  24%

EMEA

  58%  48%

Asia

  21%  28%

Total

  100%  100%

 

 

16.15.

Related PersonParty Transactions

 

In March 2018, Asensus Surgical Europe S.à.r.lr.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$19,000 and $0$73,000 for the three months ended June 30, 2022March 31, 2023 and 2021, respectively and $141,000 and $93,000 for the six months ended June 30, 2022,and 2021, respectively.

 

16

 

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 isWe are a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guidedwhat we call “Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. This buildsBased upon the foundationfoundations of Digital Laparoscopy withdigital laparoscopy and the Senhance® Surgical System, the Company is developing the LUNA™ Surgical System, a next generation robotic and instrument system as a foundation of its digital surgery solution. These systems will be powered by the Intelligent Surgical Unit™, or ISU™, (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

Our strategy is focusedto focus on the realization of Performance-Guided Surgery through the continued collection of surgical data via the ISU and Asensus Cloud leveraging the Senhance System and by other means of non-robotic laparoscopic surgery, while completing the design and development of the LUNA System and its capabilities.

We continue 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 3mm 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 surgery.

 

 

In Japan, the Company has received regulatory approval and reimbursement for 98124 laparoscopic procedures.

 

 

The Senhance System 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").

 

On 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 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 improvingexpanding database of surgeries and their outcomes to enable surgeons to best inform their surgical approach and surgical setup.

 

 

Intra-operative – we believe the Senhance System provides perceptive“perceptive real-time guidanceguidance” for intra-operative tasks, allowing any surgeonsurgeons performing a procedure with the Senhance System and ISU to performexecute multiple tasks and benefitwhile benefitting from the collective knowledge and rules-based performance of thousands of other successful Senhance-based procedures.procedures delivered through augmented intelligence in real time. 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.surgeons, enabling more sustained peak performance over time and reducing risk of burn-out.

 

Post-operative – finally, by tapping into the vast amount of data captured during procedures, surgeons and operating room staff will be ablehave access to get“performance analytics” with actionable assessments of their performance giving them the information needed to improve performance over time.constantly and consistently improve. We intend to establish a new standard of descriptive, diagnostic, predictive and prescriptive analytics to improve not only the skills of all surgeons but move 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 2022 we received FDA clearance for advanced features of the ISU, and received CE Mark for such enhancements in January 2023.

 

In February 2020, we received CE Mark for the Senhance System and related instruments for pediatric use indications in CE Mark territories. We received FDA clearance in March 2023 for the pediatric indication for the Senhance System. The expanded indication allows accessibility to more surgeons and patients, as well as expanding our potential market to include pediatric hospitals. We anticipate the robotic precision provided by the Senhance System, coupled with the already available 3mm instruments and haptic feedback will prove to be an effective tool in surgery with smaller patients.

 

In 2020, we obtained regulatory clearance for the Senhance ultrasonic system in both Taiwan and Japan. We also received clearance for the ISU 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 our potential market to include pediatric hospitals in Europe. We anticipate the robotic precision provided by the Senhance System, coupled with the already available 3mm instruments will prove to be an effective tool in surgery with smaller patients.

 

On July 28, 2021, the Company announced that it received FDA clearance for 5mm 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 February 21, 2023, we held an investor day to describe our focus on developing a next generation robotic system we call the LUNA Surgical System and the ongoing developments in our Performance-Guided Surgery platform. Performance-Guided Surgery is comprised of three strategic pillars:

enhanced robotic precision and manipulation capabilities, via the Senhance System today and, when developed and approved, the LUNA System;

expanded intra-operative augmented intelligence clinical decision support guidance for the surgeon via the ISU; and

integration of cloud and big data to harness best practices across pre-, intra- and post-operative settings, and make it available to surgeons around the world via the Asensus Cloud.

 

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 are a data driven company that expects to continue to invest in research and development, market development, and generation and analysis of clinical evidence as we implement our strategy. As a result, we will need to generate significant revenue in order to achieve profitability. 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, 2022,March 31, 2023, we had an accumulated deficit of $824.1 million.$883.2 million, and there is substantial doubt about our ability to continue as a going concern. We operate in one business segment.

 

Recent Financing Transactions

 

At-the -Market OfferingsOffering

 

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. No sales of common stock were made under the 2022 ATM Offering during the sixthree months ended June 30, 2022.March 31, 2023.

 

Results of Operations - Comparison of Three Months Ended June 30,March 31, 2023 and 2022 and 2021

 

Revenue

InBoth in the secondfirst quarter of 2023 and 2022, our revenue consisted of ongoing System leasing payments, sales of instruments and accessories, and services revenue for Senhance Systems sold or placed in Europe, Asia, and the U.S. in prior periods.

 

Product revenue for the three months ended June 30,March 31, 2023 and 2022 remained constant at approximately $0.3 million, respectively.

Service revenue for the three months ended March 31, 2023 decreased to $0.2 million compared to $0.3 million for the three months ended March 31, 2022.

Lease revenue for the three months ended March 31, 2023 increased to $0.5 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, 2022 and 2021. The fluctuations in revenue for the three months ended June 30, 2022 and 2021, were primarily the result of customer mix and fluctuations in exchange rates.March 31, 2022.

 

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 excess and 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 decline 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, 2022 decreasedMarch 31, 2023 increased to $0.9$1.2 million as compared to $1.0$0.4 million for the three months ended June 30, 2021.March 31, 2022. The $0.1$0.8 million decreaseincrease primarily relates to a decrease$0.4 million increase in personnel-related costs.product costs, $0.2 million increase in personnel costs, and $0.2 million increase in the change in inventory reserves.

 

Service cost remained consistent at $0.6for the three months ended March 31, 2023 increased to $0.7 million as compared to $0.5 million for the three months ended June 30, 2022March 31, 2022. The $0.2 million increase primarily relates to an increase in personnel-related costs of $0.1 million and 2021.an increase in materials costs of $0.1 million. 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 three months ended June 30,March 31, 2023 and 2022 increased to $0.8remained constant at $1.0 million, as compared to $0.7 million for the three months ended June 30, 2021.respectively.

 

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 substantially increase as we continue to invest in additional regulatory approvals as well as new products, instruments,the LUNA System and accessories to be offered with the Senhance System.our digital laparoscopy platform. R&D expenses are expensed as incurred.

 

R&D expenses for the three months ended June 30, 2022March 31, 2023 increased 78%58% to $7.3$10.1 million as compared to $4.1$6.4 million for the three months ended June 30, 2021March 31, 2022 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 SenhanceLUNA System and ISUour digital and cloud capabilities.laparoscopy platform. All activities are in the effort of building the future for Performance-Guided Surgery. The $3.2$3.7 million increase primarily relates to increased 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$2.4 million. The change was also driven by increased personnel costs of $0.7 million, driven by additional headcount, and increased supplies costs of $0.3 million, and increased miscellaneous costs of $0.4$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.

 

Sales and marketing expenses for the three months ended June 30, 2022March 31, 2023 increased 24% to $4.6 million compared to $3.7 million for the three months ended March 31, 2022. The $0.9 million increase was primarily related to increased employee-related costs of $0.7 million due to an increase in headcount, increased travel costs of $0.1 million, and 2021 remained consistent at $3.6increased consulting expenses of $0.1 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.

 

General and administrative expenses for the three months ended June 30,March 31, 2023 and 2022 increased 32% to $5.0remained constant at approximately $5.5 million, compared to $3.8 million for the three months ended June 30, 2021. The $1.2 million increase was primarily related to increased personnel costs of $1.0 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 miscellaneous costs of $0.5 million, partially offset by a decrease in bad debt expense of $0.2 million, and a decrease in supplies costs of $0.1 million.respectively.

 

Amortization of Intangible Assets

Amortization of intangible assets for the three months ended June 30, 2022March 31, 2023 decreased to $2.5$0.1 million compared to $2.9$2.7 million for the three months ended June 30, 2021.March 31, 2022. The $0.4$2.6 million decrease is primarily driven by changes inrelated to two developed technologies intangibles that fully amortized during the foreign currency exchange rate.year ended December 31, 2022.

 

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$0.1 million increase for the three months ended March 31, 2023 compared to a $0.2 million decrease for the three months ended June 30, 2022 compared to a $0.5 millionMarch 31, 2022. The increase for the three months ended June 30, 2021. The decrease was primarily due to changes in the Company’s forecast of future revenue, including changes 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 to 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, 2021.discount rate utilized.

 

Other Income (Expense), net

Other income for the three months ended June 30, 2022 decreasedMarch 31, 2023 increased $0.3 million to $0.0$0.2 million income compared to $2.9$0.1 million loss for the three months ended June 30, 2021. Other income for the three months ended June 30, 2021March 31, 2022. The change primarily related to the gainchanges in interest amortization and accretion on extinguishment of debt of $2.8 million. No related income was recorded in the three months ended June 30, 2022.investments.

 

Income Tax (Expense) BenefitExpense

The Company recognized $0.1$0.09 million income tax expense for the three months ended June 30, 2022,March 31, 2023, compared to $0.0$0.08 million income tax expense for the three months ended June 30, 2021.

ResultsMarch 31, 2022. Income tax expense consisted primarily of Operations - Comparison of Six Months Ended June 30, 2022 and 2021

Revenue

In the six months ended June 30, 2022, our revenue consisted of ongoing System leasing payments, sales of instruments and accessories, and services revenue for Systems sold or placedcurrent income taxes related to profitable foreign jurisdictions in Europe, Asia,Japan, Israel, and the U.S. in prior periods.

Product revenue for the six months ended June 30, 2022 decreased to $0.6 million compared to $1.7 million for the six months ended June 30, 2021. The $1.1 million decrease was primarily the result of a Lease Buyout in the prior period.

Service revenue for the six months ended June 30,2022 decreased to $0.7 million compared to $0.8 million for the six months ended June 30, 2021. The $0.1 million decrease was the result of customer mix and fluctuations in 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 decline 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, 2022 decreased to $1.3 million as compared to $2.7 million for the six months ended June 30, 2021. The $1.4 million decrease primarily relates to a $0.7 million decrease in product costs driven by 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, 2022 increased to $1.1 million as compared to $1.0 million for the six months ended June 30, 2021. The $0.1 million increase primarily relates to an 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, 2022 increased 65% to $13.7 million as compared to $8.3 million for the six months ended June 30, 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 $5.4 million increase primarily relates to increased personnel costs of $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 $1.9 million, increased supplies costs of $0.4 million, and 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.

Sales and marketing expenses for the six months ended June 30, 2022 increased 11% to $7.3 million compared to $6.6 million for the six months ended June 30, 2021. The $0.7 million increase was primarily related to increased consulting costs of $0.5 million, increased travel costs of $0.5 million, partially offset by decreased supplies costs of $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.

General and administrative expenses for the six months ended June 30, 2022 increased 35% to $10.5 million compared to $7.8 million for the six months ended June 30, 2021. The$2.7 million increase was primarily related to increased personnel costs of $1.9 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 software costs of $0.4 million, increased consulting costs of $0.2 million, and increased miscellaneous costs of $0.2 million.

Amortization of Intangible Assets

Amortization of intangible assets for the six months ended June 30, 2022 decreased to $5.2 million compared to $5.7 million for the six months ended June 30, 2021. The $0.5 million decrease is primarily driven by changes in the foreign currency exchange 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. The decrease was primarily due to changes 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 to 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, 2021.

Other Income (Expense)

The Company 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 primarily related to the 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, 2022, compared to $0.0 million income tax benefit for the six months ended June 30, 2021.

Netherlands.

 

Liquidity and Capital Resources

Going Concern

The Company’s consolidated financial statements are prepared using U.S. GAAP applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company had an accumulated deficit of $824.1$883.2 million and working capital of $98.9$60.7 million as of June 30, 2022.March 31, 2023. The Company has not established sufficient revenues to cover its operating costs and believes it will require additional capital in the future to proceed with its operating plan.continue as a going concern. As of June 30, 2022,March 31, 2023, the Company had cash, cash equivalents, short-term investments and long-term investments, excluding restricted cash, of approximately $103.8$57.4 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 We believe that itsour existing cash, cash equivalents, short-term investments and long-term investments, as of June 30, 2022together with cash received from product, service, and as of the date of filing,lease sales will be sufficient to sustain operations for at leastmeet our anticipated cash needs into the next 12 months from the issuancefirst quarter of these financial statements, the2024.

The Company believes it will 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. If sufficient funds are not received on a timely basis, the Company would then need to purse a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. The ability to successfully resolve these factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date that these financial statements are issued. The consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties.

 

The Company is subject to risks similar to other similarly sized companies in the medical device industry. These risks include, without limitation: the historical lack of profitability; the Company’s ability to grow its placements and increase utilization of the Senhance System by customers, the Company’s ability to raise additional capital; its ability to successfully develop, clinically test and commercialize its products and products in development; negative impacts on the Company's operations caused by the COVID-19 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; 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 andhealthcare regulatory environments of the United States, 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 and digital 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.

 

Consolidated Cash Flow Data

 

  

Six Months Ended June 30,

 

(Unaudited, in millions)

 

2022

  

2021

 

Net cash (used in) provided by

        

Operating activities

 $(30.2) $(18.5)

Investing activities

  23.2   (0.7)

Financing activities

  (0.3)  160.1 

Effect of exchange rate changes on cash and cash equivalents

  0.2   (0.3)

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

 $(7.1) $140.6 

  

Three Months Ended March 31,

 

(Unaudited, in millions)

 

2023

  

2022

 

Net cash (used in) provided by

        

Operating activities

 $(17.2) $(15.9)

Investing activities

  29.7   23.0 

Financing activities

  (0.5)  (0.3)

Effect of exchange rate changes on cash and cash equivalents

  0.4   (0.1)

Net increase in cash, cash equivalents and restricted cash

 $12.4  $6.7 

 

Operating Activities

For the sixthree months ended June 30, 2022,March 31, 2023, cash used in operating activities of $30.2$17.2 million consisted of a net loss of $38.7$22.2 million, changes in operating assets and liabilities of $2.6$2.4 million, offset byand changes in non-cash items of $11.1$2.6 million. The non-cash items primarily consisted of $5.2$1.9 million of stock-based compensation expense, $0.8 million of depreciation, $0.1 million of amortization of intangible assets, $4.3$0.1 million of change in fair value of contingent consideration, offset by $0.4 million change in inventory reserves, and $0.1 million of net amortization of discounts and premiums on investments. The increase in cash from changes in operating assets and liabilities primarily relates to a $1.6 million increase in accounts payable, a $1.6 million decrease in accounts receivable, a $0.3 million decrease in prepaid expenses, offset by a $1.1 million decrease in accrued employee compensation and benefits.

For the three months ended March 31, 2022, cash used in operating activities of $15.9 million consisted of a net loss of $19.1 million, changes in operating assets and liabilities of $2.7 million, offset by non-cash items of $5.9 million. The non-cash items primarily consisted of $2.7 million of amortization of intangible assets, $2.2 million of stock-based compensation expense, $1.7$0.9 million of depreciation, $0.4$0.2 million of net amortization of discounts and premiums on investments, $0.4$0.2 million in impairment of property and equipment, $0.2bad debt expense, $0.1 million deferred tax expense, offset by $0.6$0.2 million change in inventory reserves and $0.8$0.2 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$1.4 million increase in inventory net of transfers to property and equipment, $1.2$1.1 million decrease in accrued expenses, $0.5 million increase in other current and long-term assets, $0.3 million decrease in accrued expenses, $0.3$0.2 million decrease in operating lease liabilities, offset by a $0.5$0.2 million increasedecrease in accounts payable, $0.4prepaid expenses, $0.2 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 work capital of $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 change 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 $3.1 million increase in operating lease liabilities, a $2.7 million decrease in other current and long-term assets, a $0.7$0.1 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 asset, a $1.7 million increase in inventory net of transfers of property and equipment, and a $1.4 million decrease in accrued expenses.payable.

 

Investing Activities

For the sixthree months ended June 30, 2022,March 31, 2023, net cash provided by investing activities was $23.2$29.7 million. This amount consists of $41.4$32.8 million of proceeds from maturities of available-for-sale investments, offset by $17.8$2.9 million of purchases of available-for-sale investments and $0.4$0.1 million purchases of property and equipment.

 

For the sixthree months ended June 30, 2021,March 31, 2022, net cash used inprovided by investing activities was $0.7$23.0 million. This amount consists of $29.2 million related toof proceeds from maturities of available-for-sale investments, offset by $6.0 million of purchases of available-for-sale investments and $0.2 million purchases of property and equipment.

 

Financing Activities

For the sixthree months ended June 30, 2022,March 31, 2023, net cash used in financing activities was $0.3$0.5 million, primarily related to taxes paid for the net share settlement of vesting of restricted stock units.

 

For the sixthree months ended June 30, 2021,March 31, 2022, net cash provided byused in financing activities was $160.1 million. The net change primarily$0.3 million, related to $130.3 million in net proceeds from the issuance of common stock and $30.8 million aggregate proceeds from the exercise of Series B, C and D warrants, partially offset by $1.0 million of taxes paid related tofor the 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.studies in support of the development of the LUNA System and our digital solutions platform. We intend to use financing opportunities strategically to continue to strengthen our financial position.

 

Cash and cash equivalents held by our foreign subsidiaries totaled $2.4$1.0 million as of June 30, 2022,March 31, 2023, 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.

 

Critical Accounting 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 20212022 Form 10-K. The preparation of these consolidated 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, 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 onFiscal 2022 Form 10-K, for the fiscal year ended December 31, 2021, that are of significance, or potential significance, to us.

 

While all accounting policies impact the consolidated financial statements, certain policies may be viewed as critical. Critical accounting estimates 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. Our management believes the policies that fall within this category are the estimates on accounting for identifiable intangible assets, contingent consideration, stock-based compensation, inventory, revenue recognition and income taxes.

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%79% and 83%76% of revenue for sixthe three months ended June 30,March 31, 2023 and 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 monthsquarter ended June 30,March 31, 2022, would result in revenue changing by $0.2$0.1 million. This change would not be not material to our cash flows and our results of operations.

 

Item 4.

Controls and Procedures

 

Evaluation of 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, 2022.March 31, 2023. 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, 2022,March 31, 2023, our disclosure controls and procedures were not effective at a reasonable assurance level.due to the material weakness in internal control over financial reporting, described below.

 

Changes in Internal Controls Over Financial Reporting

 

ThereOther than the remediation efforts described below, there were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2022,March 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Material Weakness in Internal Control over Financial Reporting

During the year ended December 31, 2022, management identified a deficiency constituting a material weakness related to the design and implementation of information technology general controls (“ITGCs”) related to the implementation of our new global enterprise resource planning system (“ERP”) utilized in the preparation of our consolidated financial statements. Specifically, we did not design and maintain user access controls to adequately restrict user and privileged access to the financial application and data to appropriate Company personnel.

The material weakness identified above did not result in any identified misstatements to our consolidated interim financial statements, and our management has concluded that the consolidated financial statements present fairly, in all material respects, our financial position, results of operations, and cash flows in conformity with U.S. GAAP.

Remediation Efforts

We have not experienced anycommenced measures to remediate the identified material weakness. Management has been and will continue designing and implementing an improved process for requesting, authorizing, and reviewing user access to key systems which impact to our internal controls over financial reporting, despiteincluding identifying access to roles where manual business process controls may be required. This implementation will include the factaddition of detection controls which will include the review of user access and activity logs related to systems that somewere accessed. We will also enhance the training of our employeespersonnel regarding their roles and responsibilities within the information technology general controls objectives and activities. The material weakness will not be considered remediated until management designs and implements effective controls that operate for a sufficient period of time for management to conclude, through testing, that the controls are working remotely due to the COVID-19 pandemic. Weoperating effectively. The material weakness is not considered remediated as of March 31, 2023 as remediation efforts are continually monitoring and assessing the COVID-19 situation on our internal controls to minimize the impact on their design and operating effectiveness.ongoing.

 

PART II. OTHER INFORMATION

 

Item 1

Legal Proceedings.

 

None.

 

Item 1A

Risk Factors.

 

Reference is made to the Risk Factors included in our Fiscal 20212022 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 20212022 Form 10-K, which are supplemented by the following:

We continue to see 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 future revenues.

10-K.

 

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.The following table summarizes the Company’s purchases of its common stock for the quarter ended March 31, 2023:

  

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

 

January 1 - 31, 2023

  -   -   -   - 

February 1 - 28, 2023

  649,524  $0.75   -   - 

March 1 - 31, 2023

  -   -   -   - 

Total

  649,524  $0.75   -   - 

These amounts consist of 649,524 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

Item6.EXHIBITS6.

EXHIBITS

 

Exhibit

No.

 

Description

10.1 * +

Form of 2023 Performance-Based Restricted Stock Unit Award Notice

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, 2022,March 31, 2023, formatted in Inline XBRL (included in Exhibit 101).

 


*         Filed herewith.

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

 

 

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 8, 2022May 11, 2023

 

By:

/s/ Anthony Fernando

  

Anthony Fernando

  

President and Chief Executive Officer

    

Date: August 8, 2022May 11, 2023

 

By:

/s/ Shameze Rampertab

  

Shameze Rampertab

  

Executive Vice President and Chief Financial Officer

 

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