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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, 2022
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)
Registrant’s 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, 2022 was 236,718,923.
ASENSUS SURGICAL, INC.
TABLE OF CONTENTS FOR FORM 10-Q
FORWARD-LOOKING STATEMENTS
In addition to historical financial information, this report
contains “forward-looking statements” within the meaning of Section
27A of the Securities Act of 1933, as amended, or the Securities
Act, and Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act, that concern matters that involve
risks and uncertainties that could cause actual results to differ
materially from those projected in the forward-looking statements.
These forward-looking statements are intended to qualify for the
safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. All statements other than statements
of historical fact contained in this report, including statements
regarding future events, our future financial performance, our
future business strategy and the plans and objectives of management
for future operations, are forward-looking statements. We have
attempted to identify forward-looking statements by terminology
including “anticipates,” “believes,” “can,” “continue,” “could,”
“estimates,” “expects,” “intends,” “in the event that,” “may,”
“plans,” “potential,” “predicts,” “should” or “will” or the
negative of these terms or other comparable terminology. Although
we do not make forward-looking statements unless we believe we have
a reasonable basis for doing so, we cannot guarantee their
accuracy. Such forward-looking statements are subject to risks,
uncertainties and other factors that could cause actual results and
the timing of certain events to differ materially from future
results expressed or implied by such forward-looking statements,
including the impact of the coronavirus (COVID-19) pandemic on our
operating results. Readers are urged to carefully review and
consider the various disclosures made by us, which attempt to
advise interested parties of the risks, uncertainties, and other
factors that affect our business, operating results, financial
condition and stock price, including without limitation the
disclosures made under the captions “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,”
“Financial Statements,” “Notes to Condensed Consolidated Financial
Statements “and “Risk Factors” in this report, as well as the
disclosures made in the Asensus Surgical, Inc. Annual Report on
Form 10-K for the year ended December 31, 2021 (the “Fiscal 2021
Form 10-K”), and other filings we make with the SEC. Furthermore,
such forward-looking statements speak only as of the date of this
report. We expressly disclaim any intent or obligation to update
any forward-looking statements after the date hereof to conform
such statements to actual results or to changes in our opinions or
expectations except as required by applicable law. To the extent
that our business is negatively impacted due to a variety of
factors, including the impact of COVID-19 and other geopolitical
factors on our operating results, we may implement longer-term cost
reduction efforts in order to mitigate such impact. References in
this report to “we,” “our,” “us,” or the “Company” refer to Asensus
Surgical, Inc., including its subsidiaries Asensus Surgical US,
Inc., Asensus International, Inc., Asensus Surgical Italia S.r.l.,
Asensus Surgical Europe S.à.r.l., Asensus Surgical Taiwan Ltd.,
Asensus Surgical Japan K.K., Asensus Surgical Israel Ltd., Asensus
Surgical Netherlands B.V., and Asensus Surgical Canada, Inc.
Any disclosure in this report regarding the receipt of CE Mark or
Section 510(k) clearance for any of the Company’s products does not
mean or infer any endorsement of the Company’s products by any
government agency including, without limitation, the U.S. Food and
Drug Administration, or FDA.
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
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
$ |
254 |
|
|
$ |
363 |
|
|
$ |
601 |
|
|
$ |
1,726 |
|
Service
|
|
|
424 |
|
|
|
406 |
|
|
|
732 |
|
|
|
785 |
|
Lease
|
|
|
316 |
|
|
|
333 |
|
|
|
727 |
|
|
|
674 |
|
Total revenue
|
|
|
994 |
|
|
|
1,102 |
|
|
|
2,060 |
|
|
|
3,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
|
883 |
|
|
|
1,003 |
|
|
|
1,259 |
|
|
|
2,678 |
|
Service
|
|
|
646 |
|
|
|
636 |
|
|
|
1,141 |
|
|
|
1,002 |
|
Lease
|
|
|
818 |
|
|
|
708 |
|
|
|
1,770 |
|
|
|
1,779 |
|
Total cost of revenue
|
|
|
2,347 |
|
|
|
2,347 |
|
|
|
4,170 |
|
|
|
5,459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross loss
|
|
|
(1,353 |
) |
|
|
(1,245 |
) |
|
|
(2,110 |
) |
|
|
(2,274 |
) |
Operating Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
7,253 |
|
|
|
4,089 |
|
|
|
13,681 |
|
|
|
8,304 |
|
Sales and marketing
|
|
|
3,602 |
|
|
|
3,562 |
|
|
|
7,321 |
|
|
|
6,615 |
|
General and administrative
|
|
|
4,992 |
|
|
|
3,848 |
|
|
|
10,525 |
|
|
|
7,840 |
|
Amortization of intangible assets
|
|
|
2,533 |
|
|
|
2,862 |
|
|
|
5,203 |
|
|
|
5,729 |
|
Change in fair value of contingent consideration
|
|
|
(598 |
) |
|
|
478 |
|
|
|
(752 |
) |
|
|
735 |
|
Property and equipment impairment
|
|
|
432 |
|
|
|
- |
|
|
|
432 |
|
|
|
- |
|
Total Operating Expenses
|
|
|
18,214 |
|
|
|
14,839 |
|
|
|
36,410 |
|
|
|
29,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Loss
|
|
|
(19,567 |
) |
|
|
(16,084 |
) |
|
|
(38,520 |
) |
|
|
(31,497 |
) |
Other Income (Expense), net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment of debt
|
|
|
- |
|
|
|
2,847 |
|
|
|
- |
|
|
|
2,847 |
|
Change in fair value of warrant liabilities
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,981 |
) |
Interest income
|
|
|
260 |
|
|
|
79 |
|
|
|
515 |
|
|
|
131 |
|
Interest expense
|
|
|
(141 |
) |
|
|
(5 |
) |
|
|
(341 |
) |
|
|
(12 |
) |
Other expense, net
|
|
|
(86 |
) |
|
|
(7 |
) |
|
|
(232 |
) |
|
|
(36 |
) |
Total Other Income (Expense), net
|
|
|
33 |
|
|
|
2,914 |
|
|
|
(58 |
) |
|
|
949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(19,534 |
) |
|
|
(13,170 |
) |
|
|
(38,578 |
) |
|
|
(30,548 |
) |
Income tax (expense) benefit
|
|
|
(85 |
) |
|
|
(2 |
) |
|
|
(169 |
) |
|
|
36 |
|
Net loss
|
|
|
(19,619 |
) |
|
|
(13,172 |
) |
|
|
(38,747 |
) |
|
|
(30,512 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(19,619 |
) |
|
|
(13,172 |
) |
|
|
(38,747 |
) |
|
|
(30,512 |
) |
Foreign currency translation (loss) gain
|
|
|
(1,713 |
) |
|
|
472 |
|
|
|
(2,363 |
) |
|
|
(1,466 |
) |
Unrealized loss on available-for-sale investments
|
|
|
(144 |
) |
|
|
- |
|
|
|
(696 |
) |
|
|
- |
|
Comprehensive loss
|
|
$ |
(21,476 |
) |
|
$ |
(12,700 |
) |
|
$ |
(41,806 |
) |
|
$ |
(31,978 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share attributable to common stockholders -
basic and diluted
|
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.14 |
) |
Weighted average number of shares used in computing net loss per
common share - basic and diluted
|
|
|
236,505 |
|
|
|
233,250 |
|
|
|
236,201 |
|
|
|
219,199 |
|
See accompanying notes to unaudited condensed consolidated
financial statements.
Asensus
Surgical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts)
(Unaudited)
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
Assets
|
|
|
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
10,844 |
|
|
$ |
18,129 |
|
Short-term investments, available-for-sale
|
|
|
83,360 |
|
|
|
80,262 |
|
Accounts receivable, net
|
|
|
699 |
|
|
|
749 |
|
Inventories
|
|
|
8,451 |
|
|
|
8,634 |
|
Prepaid expenses
|
|
|
2,927 |
|
|
|
3,255 |
|
Employee retention tax credit receivable
|
|
|
1,147 |
|
|
|
1,311 |
|
Other current assets
|
|
|
1,134 |
|
|
|
957 |
|
Total Current Assets
|
|
|
108,562 |
|
|
|
113,297 |
|
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
1,290 |
|
|
|
1,154 |
|
Long-term investments, available-for-sale
|
|
|
9,581 |
|
|
|
37,435 |
|
Inventories, net of current portion
|
|
|
7,258 |
|
|
|
7,074 |
|
Property and equipment, net
|
|
|
9,389 |
|
|
|
10,971 |
|
Intellectual property, net
|
|
|
4,122 |
|
|
|
9,892 |
|
Net deferred tax assets
|
|
|
244 |
|
|
|
288 |
|
Operating lease right-of-use assets, net
|
|
|
4,747 |
|
|
|
5,348 |
|
Other long-term assets
|
|
|
2,157 |
|
|
|
1,014 |
|
Total Assets
|
|
$ |
147,350 |
|
|
$ |
186,473 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
3,849 |
|
|
$ |
3,448 |
|
Accrued employee compensation and benefits
|
|
|
3,127 |
|
|
|
3,559 |
|
Accrued expenses and other current liabilities
|
|
|
1,617 |
|
|
|
1,617 |
|
Operating lease liabilities - current portion
|
|
|
579 |
|
|
|
683 |
|
Deferred revenue
|
|
|
510 |
|
|
|
543 |
|
Total Current Liabilities
|
|
|
9,682 |
|
|
|
9,850 |
|
|
|
|
|
|
|
|
|
|
Long-Term Liabilities:
|
|
|
|
|
|
|
|
|
Contingent consideration
|
|
|
1,619 |
|
|
|
2,371 |
|
Noncurrent operating lease liabilities
|
|
|
4,610 |
|
|
|
5,006 |
|
Total Liabilities
|
|
|
15,911 |
|
|
|
17,227 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 14)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
- |
|
|
|
- |
|
Additional paid-in capital
|
|
|
958,646 |
|
|
|
954,649 |
|
Accumulated deficit
|
|
|
(824,121 |
) |
|
|
(785,374 |
) |
Accumulated other comprehensive loss
|
|
|
(3,323 |
) |
|
|
(264 |
) |
Total Stockholders' Equity
|
|
|
131,439 |
|
|
|
169,246 |
|
Total Liabilities and Stockholders' Equity
|
|
$ |
147,350 |
|
|
$ |
186,473 |
|
See accompanying notes to unaudited condensed consolidated
financial statements.
Asensus
Surgical, Inc.
Condensed Consolidated Statements of Changes in
Stockholders’ Equity
(in thousands)
(Unaudited)
|
|
Common Stock
|
|
|
Treasury Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional Paid
-in Capital
|
|
|
Accumulated
Deficit
|
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
|
Total
Stockholders'
Equity
|
|
Balance, December 31, 2021
|
|
|
235,219 |
|
|
$ |
235 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
954,649 |
|
|
$ |
(785,374 |
) |
|
$ |
(264 |
) |
|
$ |
169,246 |
|
Stock-based compensation
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,245 |
|
|
|
- |
|
|
|
- |
|
|
|
2,245 |
|
Exercise of stock options
|
|
|
30 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
12 |
|
|
|
- |
|
|
|
- |
|
|
|
12 |
|
Award of restricted stock units
|
|
|
1,166 |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
Return of common stock to pay withholding taxes on restricted
stock
|
|
|
- |
|
|
|
- |
|
|
|
436 |
|
|
|
- |
|
|
|
(349 |
) |
|
|
- |
|
|
|
- |
|
|
|
(349 |
) |
Cancellation of treasury stock
|
|
|
- |
|
|
|
- |
|
|
|
(436 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,202 |
) |
|
|
(1,202 |
) |
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(19,128 |
) |
|
|
- |
|
|
|
(19,128 |
) |
Balance, March 31, 2022
|
|
|
236,415 |
|
|
$ |
236 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
956,557 |
|
|
$ |
(804,502 |
) |
|
$ |
(1,466 |
) |
|
$ |
150,825 |
|
Stock-based compensation
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,083 |
|
|
|
- |
|
|
|
- |
|
|
|
2,083 |
|
Exercise of stock options
|
|
|
13 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
6 |
|
|
|
- |
|
|
|
- |
|
|
|
6 |
|
Award of restricted stock units
|
|
|
192 |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
Other comprehensive loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,857 |
) |
|
|
(1,857 |
) |
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(19,619 |
) |
|
|
- |
|
|
|
(19,619 |
) |
Balance, June 30, 2022
|
|
|
236,620 |
|
|
$ |
237 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
958,646 |
|
|
$ |
(824,121 |
) |
|
$ |
(3,323 |
) |
|
$ |
131,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2020
|
|
|
116,231 |
|
|
$ |
116 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
781,397 |
|
|
$ |
(722,912 |
) |
|
$ |
2,968 |
|
|
$ |
61,569 |
|
Stock-based compensation
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,786 |
|
|
|
- |
|
|
|
- |
|
|
|
1,786 |
|
Issuance of common stock, net of issuance costs
|
|
|
70,666 |
|
|
|
71 |
|
|
|
- |
|
|
|
- |
|
|
|
129,251 |
|
|
|
- |
|
|
|
- |
|
|
|
129,322 |
|
Exercise of stock options and warrants
|
|
|
45,114 |
|
|
|
45 |
|
|
|
- |
|
|
|
- |
|
|
|
32,687 |
|
|
|
- |
|
|
|
- |
|
|
|
32,732 |
|
Award of restricted stock units
|
|
|
706 |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
Return of common stock to pay withholding taxes on restricted
stock
|
|
|
- |
|
|
|
- |
|
|
|
67 |
|
|
|
- |
|
|
|
(214 |
) |
|
|
- |
|
|
|
- |
|
|
|
(214 |
) |
Cancellation of treasury stock
|
|
|
- |
|
|
|
- |
|
|
|
(67 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,938 |
) |
|
|
(1,938 |
) |
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(17,340 |
) |
|
|
- |
|
|
|
(17,340 |
) |
Balance, March 31, 2021
|
|
|
232,717 |
|
|
$ |
233 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
944,907 |
|
|
$ |
(740,252 |
) |
|
$ |
1,030 |
|
|
$ |
205,918 |
|
Stock-based compensation
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,842 |
|
|
|
- |
|
|
|
- |
|
|
|
1,842 |
|
Issuance of common stock, net of issuance costs
|
|
|
332 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
992 |
|
|
|
- |
|
|
|
- |
|
|
|
992 |
|
Exercise of stock options and warrants
|
|
|
508 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
337 |
|
|
|
- |
|
|
|
- |
|
|
|
337 |
|
Award of restricted stock units
|
|
|
674 |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
Return of common stock to pay withholding taxes on restricted
stock
|
|
|
- |
|
|
|
- |
|
|
|
246 |
|
|
|
- |
|
|
|
(829 |
) |
|
|
- |
|
|
|
- |
|
|
|
(829 |
) |
Cancellation of treasury stock
|
|
|
- |
|
|
|
- |
|
|
|
(246 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Other comprehensive gain
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
472 |
|
|
|
472 |
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(13,172 |
) |
|
|
- |
|
|
|
(13,172 |
) |
Balance, June 30, 2021
|
|
|
234,231 |
|
|
$ |
234 |
|
|
|
- |
|
|
$ |
- |
|
|
$ |
947,249 |
|
|
$ |
(753,424 |
) |
|
$ |
1,502 |
|
|
$ |
195,561 |
|
See accompanying notes to unaudited condensed consolidated
financial statements.
Asensus
Surgical, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
|
|
Six Months Ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
Operating Activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(38,747 |
) |
|
$ |
(30,512 |
) |
Adjustments to reconcile net loss to net cash and cash equivalents
used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,720 |
|
|
|
1,585 |
|
Amortization of intangible assets
|
|
|
5,203 |
|
|
|
5,729 |
|
Amortization of discounts and premiums on investments, net
|
|
|
444 |
|
|
|
- |
|
Stock-based compensation
|
|
|
4,328 |
|
|
|
3,628 |
|
Gain on extinguishment of debt
|
|
|
- |
|
|
|
(2,847 |
) |
Deferred tax expense (benefit)
|
|
|
169 |
|
|
|
(36 |
) |
Bad debt expense
|
|
|
9 |
|
|
|
- |
|
Change in inventory reserves
|
|
|
(567 |
) |
|
|
288 |
|
Property and equipment impairment
|
|
|
432 |
|
|
|
- |
|
Loss on disposal of property and equipment
|
|
|
97 |
|
|
|
- |
|
Change in fair value of warrant liabilities
|
|
|
- |
|
|
|
1,981 |
|
Change in fair value of contingent consideration
|
|
|
(752 |
) |
|
|
735 |
|
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(8 |
) |
|
|
127 |
|
Inventories
|
|
|
(1,933 |
) |
|
|
(1,687 |
) |
Operating lease right-of-use assets
|
|
|
409 |
|
|
|
(2,970 |
) |
Prepaid expenses
|
|
|
189 |
|
|
|
517 |
|
Other current and long-term assets
|
|
|
(1,169 |
) |
|
|
2,660 |
|
Accounts payable
|
|
|
524 |
|
|
|
679 |
|
Accrued expenses
|
|
|
(284 |
) |
|
|
(1,428 |
) |
Deferred revenue
|
|
|
(4 |
) |
|
|
14 |
|
Operating lease liabilities
|
|
|
(290 |
) |
|
|
3,052 |
|
Net cash and cash equivalents used in operating activities
|
|
|
(30,230 |
) |
|
|
(18,485 |
) |
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
Purchase of available-for-sale investments
|
|
|
(17,792 |
) |
|
|
- |
|
Proceeds from maturities of available-for-sale investments
|
|
|
41,408 |
|
|
|
- |
|
Purchase of property and equipment
|
|
|
(443 |
) |
|
|
(700 |
) |
Net cash and cash equivalents provided by (used in) investing
activities
|
|
|
23,173 |
|
|
|
(700 |
) |
|
|
|
|
|
|
|
|
|
Financing Activities:
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
- |
|
|
|
130,314 |
|
Taxes paid related to net share settlement of vesting of restricted
stock units
|
|
|
(349 |
) |
|
|
(1,041 |
) |
Proceeds from exercise of stock options and warrants
|
|
|
18 |
|
|
|
30,835 |
|
Net cash and cash equivalents (used in) provided by financing
activities
|
|
|
(331 |
) |
|
|
160,108 |
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
239 |
|
|
|
(329 |
) |
Net (decrease) increase in cash, cash equivalents and restricted
cash
|
|
|
(7,149 |
) |
|
|
140,594 |
|
Cash, cash equivalents and restricted cash, beginning of period
|
|
|
19,283 |
|
|
|
17,529 |
|
Cash, cash equivalents and restricted cash, end of period
|
|
$ |
12,134 |
|
|
$ |
158,123 |
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure for Cash Flow Information
|
|
|
|
|
|
|
|
|
Cash paid for leases
|
|
$ |
549 |
|
|
$ |
539 |
|
Cash paid for taxes
|
|
$ |
65 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
Supplemental Schedule of Non-cash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
|
Transfer of inventories to property and equipment
|
|
$ |
724 |
|
|
$ |
1,243 |
|
Acquisition of property and equipment in accounts payable
|
|
$ |
- |
|
|
$ |
67 |
|
Reclass of warrant liability to common stock and additional
paid-in-capital
|
|
$ |
- |
|
|
$ |
2,236 |
|
Lease liabilities arising from obtaining right-of-use assets
|
|
$ |
- |
|
|
$ |
3,461 |
|
See accompanying notes to unaudited condensed consolidated
financial statements.
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-Guided Surgery™ by unlocking clinical intelligence
for surgeons to enable consistently superior outcomes and a new
standard of surgery. The Company is focused on the market
development for and commercialization of the Senhance® Surgical
System, which digitizes laparoscopic minimally invasive surgery, or
MIS. The Senhance System is the first and only digital, multi-port
laparoscopic platform designed to maintain laparoscopic MIS
standards while providing digital benefits such as haptic feedback,
robotic precision, comfortable ergonomics, advanced instrumentation
including 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 2021 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.
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., 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.
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: 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 and 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.
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 on Form 10-K for the fiscal year ended December 31, 2021.
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 Entity’s 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.
The following table presents revenue disaggregated by type and
geography:
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
(in thousands)
|
|
|
(in thousands)
|
|
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Systems
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3 |
|
Instruments and accessories
|
|
|
18 |
|
|
|
79 |
|
|
|
82 |
|
|
|
141 |
|
Services
|
|
|
75 |
|
|
|
104 |
|
|
|
149 |
|
|
|
202 |
|
Leases
|
|
|
51 |
|
|
|
91 |
|
|
|
164 |
|
|
|
181 |
|
Total U.S. revenue
|
|
|
144 |
|
|
|
274 |
|
|
|
395 |
|
|
|
527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outside of U.S. ("OUS")
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Systems
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
921 |
|
Instruments and accessories
|
|
|
236 |
|
|
|
284 |
|
|
|
519 |
|
|
|
661 |
|
Services
|
|
|
349 |
|
|
|
302 |
|
|
|
583 |
|
|
|
583 |
|
Leases
|
|
|
265 |
|
|
|
242 |
|
|
|
563 |
|
|
|
493 |
|
Total OUS revenue
|
|
|
850 |
|
|
|
828 |
|
|
|
1,665 |
|
|
|
2,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Systems
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
924 |
|
Instruments and accessories
|
|
|
254 |
|
|
|
363 |
|
|
|
601 |
|
|
|
802 |
|
Services
|
|
|
424 |
|
|
|
406 |
|
|
|
732 |
|
|
|
785 |
|
Leases
|
|
|
316 |
|
|
|
333 |
|
|
|
727 |
|
|
|
674 |
|
Total revenue
|
|
$ |
994 |
|
|
$ |
1,102 |
|
|
$ |
2,060 |
|
|
$ |
3,185 |
|
7
Remaining Performance Obligations
Transaction price allocated to remaining performance obligations
relates to amounts allocated to products and services for which the
revenue has not yet been
recognized. A significant portion of this amount relates to service
obligations performed under the Company's system sales contracts
that will be invoiced and recognized as revenue in future periods.
Transaction price allocated to remaining performance obligations as
of June 30, 2022 was $2.1
million, which is expected to be recognized over one to four years.
Contract Assets and Liabilities
The Company invoices its customers based on the billing schedules
in its sales arrangements. Contract assets for the periods
presented primarily represent the difference between the revenue
that was recognized based on the relative selling price of the
related performance obligations and the contractual billing terms
in the arrangements. 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, 2022 and 2021 that was included in the deferred
revenue balance at the beginning of each reporting period was $0.3
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
|
|
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
|
|
(in thousands)
|
|
Contract Assets
|
|
$ |
57 |
|
|
$ |
91 |
|
Deferred Revenue
|
|
$ |
510 |
|
|
$ |
543 |
|
Senhance System Leasing
The Company enters into operating lease arrangements with certain
qualified customers. Revenue related to arrangements including
lease elements are allocated to lease and non-lease elements based
on their relative standalone selling prices. Lease elements
generally include a Senhance System, while non-lease elements
generally include instruments, accessories, and services. For some
lease arrangements, the customers are provided with the option to
purchase the leased System at some point during and/or at the end
of the lease term. In some arrangements lease payments are based on
the usage of the System. For the three and six
months ended June 30, 2022, and
2021, variable lease revenue
related to usage-based arrangements was not material.
Trade Accounts Receivable
The allowance for doubtful accounts is based on the Company’s
assessment of collectability of customer accounts. The Company
regularly reviews the allowance by considering factors such as
historical experience, credit quality, the age of the accounts
receivable balances, and current economic conditions that
may affect a customer’s ability to
pay. The allowance for doubtful accounts was $1.5 million and $1.7
million as of June 30, 2022, and
December 31, 2021, respectively.
For the three and six months ended June 30, 2022, and 2021, bad debt expense was not material.
8
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
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
|
Quoted Prices in
Active Markets for
Identical Assets
(Level 1)
|
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
|
Total
|
|
Assets measured at fair value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents (1)
|
|
$ |
10,844 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
10,844 |
|
Restricted cash
|
|
|
1,290 |
|
|
|
- |
|
|
|
- |
|
|
|
1,290 |
|
Short-term investments
|
|
|
- |
|
|
|
83,360 |
|
|
|
- |
|
|
|
83,360 |
|
Long-term investments
|
|
|
- |
|
|
|
9,581 |
|
|
|
- |
|
|
|
9,581 |
|
Total assets measured at fair value
|
|
$ |
12,134 |
|
|
$ |
92,941 |
|
|
$ |
- |
|
|
$ |
105,075 |
|
Liabilities measured at fair value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,619 |
|
|
$ |
1,619 |
|
Total liabilities measured at fair value
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,619 |
|
|
$ |
1,619 |
|
(1) Includes investments that are
readily convertible to cash with original maturities of 90 days or less.
|
|
|
December 31, 2021
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
|
Quoted Prices in
Active Markets for
Identical Assets
(Level 1)
|
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
|
Significant
Unobservable
Inputs (Level 3)
|
|
|
Total
|
|
Assets measured at fair value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents (1)
|
|
$ |
18,129 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
18,129 |
|
Restricted cash
|
|
|
1,154 |
|
|
|
- |
|
|
|
- |
|
|
|
1,154 |
|
Short-term investments
|
|
|
- |
|
|
|
80,262 |
|
|
|
- |
|
|
|
80,262 |
|
Long-term investments
|
|
|
- |
|
|
|
37,435 |
|
|
|
- |
|
|
|
37,435 |
|
Total assets measured at fair value
|
|
$ |
19,283 |
|
|
$ |
117,697 |
|
|
$ |
- |
|
|
$ |
136,980 |
|
Liabilities measured at fair value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
2,371 |
|
|
$ |
2,371 |
|
Total liabilities measured at fair value
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
2,371 |
|
|
$ |
2,371 |
|
(1) Includes investments that are
readily convertible to cash with original maturities of 90 days or less.
|
The carrying values of accounts receivable, other current assets,
accounts payable, and accrued expenses and other current
liabilities as of June 30, 2022,
and December 31, 2021, approximate
their fair values due to the short-term nature of these items.
The Company’s financial liabilities consisted of contingent
consideration payable to an assignee of Sofar, S.p.A., the seller,
related to the Company’s 2015
acquisition of the Senhance Surgical System (the “Senhance
Acquisition”). Adjustments associated with the change in fair value
of contingent consideration are included in the Company’s condensed
consolidated statements of operations and comprehensive loss.
The following table presents quantitative information about the
inputs and valuation methodologies used for the Company’s fair
value measurements for contingent consideration utilizing a
Monte-Carlo simulation as of June 30,
2022 and December 31,
2021:
|
Valuation
Methodology
|
|
Significant Unobservable
Input
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
|
Probability weighted income
approach
|
|
Milestone dates
|
|
|
2031 |
|
|
|
2031 |
|
|
|
|
Discount rate
|
|
|
14.5 |
% |
|
|
9.5 |
% |
|
|
|
Revenue volatility
|
|
|
40.0 |
% |
|
|
39.0 |
% |
|
|
|
EUR-to-USD exchange rate
|
|
|
1.05 |
|
|
|
1.14 |
|
The following table summarizes the change in fair value, as
determined by Level 3 inputs for
the contingent consideration for the six months ended June 30, 2022 and 2021:
|
|
Fair Value Measurement at
Reporting Date (Level 3)
|
|
|
|
(in thousands)
|
|
|
|
Series B
Warrants
|
|
|
Contingent
consideration
|
|
Balance at December 31, 2021
|
|
$ |
- |
|
|
$ |
2,371 |
|
Change in fair value
|
|
|
- |
|
|
|
(752 |
) |
Balance at June 30, 2022
|
|
$ |
- |
|
|
$ |
1,619 |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2020
|
|
$ |
255 |
|
|
$ |
3,936 |
|
Exercise of warrants
|
|
|
(2,236 |
) |
|
|
- |
|
Change in fair value
|
|
|
1,981 |
|
|
|
257 |
|
Balance at June 30, 2021
|
|
$ |
- |
|
|
$ |
4,193 |
|
|
|
|
|
|
|
|
|
|
Current portion
|
|
$ |
- |
|
|
$ |
- |
|
Long-term portion
|
|
|
- |
|
|
|
1,619 |
|
Balance at June 30, 2022
|
|
$ |
- |
|
|
$ |
1,619 |
|
5.
|
Investments, available-for-sale
|
The aggregate fair values of investment securities along with
unrealized gains and losses determined on an individual investment
security basis and included in other comprehensive loss are as
follows:
|
|
June 30, 2022
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair Value
|
|
|
Short-term
investments
|
|
|
Long-term
investments
|
|
Commercial Paper
|
|
$ |
35,643 |
|
|
$ |
- |
|
|
$ |
(191 |
) |
|
$ |
35,452 |
|
|
$ |
35,452 |
|
|
$ |
- |
|
Corporate Bonds
|
|
|
58,242 |
|
|
|
- |
|
|
|
(753 |
) |
|
|
57,489 |
|
|
|
47,908 |
|
|
|
9,581 |
|
Total Investments
|
|
$ |
93,885 |
|
|
$ |
- |
|
|
$ |
(944 |
) |
|
$ |
92,941 |
|
|
$ |
83,360 |
|
|
$ |
9,581 |
|
|
|
December 31, 2021
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gain
|
|
|
Unrealized
Loss
|
|
|
Fair Value
|
|
|
Short-term
investments
|
|
|
Long-term
investments
|
|
Commercial Paper
|
|
$ |
50,705 |
|
|
$ |
- |
|
|
$ |
(46 |
) |
|
$ |
50,659 |
|
|
$ |
50,660 |
|
|
$ |
- |
|
Corporate Bonds
|
|
|
67,239 |
|
|
|
1 |
|
|
|
(202 |
) |
|
|
67,038 |
|
|
|
29,602 |
|
|
|
37,435 |
|
Total Investments
|
|
$ |
117,944 |
|
|
$ |
1 |
|
|
$ |
(248 |
) |
|
$ |
117,697 |
|
|
$ |
80,262 |
|
|
$ |
37,435 |
|
The following table summarizes the contractual maturities of the
Company’s available-for-sale investments:
|
|
June 30, 2022
|
|
|
|
(in thousands)
|
|
|
|
Amortized
Cost
|
|
|
Fair Value
|
|
Mature in less than one year
|
|
$ |
84,173 |
|
|
$ |
83,360 |
|
Mature in one to two years
|
|
|
9,712 |
|
|
|
9,581 |
|
Total
|
|
$ |
93,885 |
|
|
$ |
92,941 |
|
Actual maturities may differ from
contractual maturities because certain borrowers have the right to
call or prepay certain obligations. There were no sales of investments or
gross realized gains or losses for the six months ended June 30, 2022, and 2021, respectively.
The components of inventories are as follows:
|
|
June 30, 2022
|
|
|
|
(in thousands)
|
|
|
|
Gross
Carrying
Amount
|
|
|
Reserve Balance
|
|
|
Net
Carrying
Amount
|
|
Finished goods
|
|
$ |
14,687 |
|
|
$ |
(2,931 |
) |
|
$ |
11,756 |
|
Raw materials
|
|
|
6,137 |
|
|
|
(2,184 |
) |
|
|
3,953 |
|
Total inventories
|
|
$ |
20,824 |
|
|
$ |
(5,115 |
) |
|
$ |
15,709 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Portion
|
|
$ |
10,113 |
|
|
$ |
(1,662 |
) |
|
$ |
8,451 |
|
Long-term portion
|
|
|
10,711 |
|
|
|
(3,453 |
) |
|
|
7,258 |
|
Total inventories
|
|
$ |
20,824 |
|
|
$ |
(5,115 |
) |
|
$ |
15,709 |
|
|
|
December 31, 2021
|
|
|
|
(in thousands)
|
|
|
|
Gross
Carrying
Amount
|
|
|
Reserve Balance
|
|
|
Net
Carrying
Amount
|
|
Finished goods
|
|
$ |
13,066 |
|
|
$ |
(2,987 |
) |
|
$ |
10,079 |
|
Raw materials
|
|
|
8,324 |
|
|
|
(2,695 |
) |
|
|
5,629 |
|
Total inventories
|
|
$ |
21,390 |
|
|
$ |
(5,682 |
) |
|
$ |
15,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Portion
|
|
$ |
9,931 |
|
|
$ |
(1,297 |
) |
|
$ |
8,634 |
|
Long-term portion
|
|
|
11,459 |
|
|
|
(4,385 |
) |
|
|
7,074 |
|
Total inventories
|
|
$ |
21,390 |
|
|
$ |
(5,682 |
) |
|
$ |
15,708 |
|
The Company has determined that its December 31, 2021 and March 31, 2022 inventory footnote
presentation overstated raw materials and understated finished
goods by approximately $2.5 million. For comparative purposes, the
Company’s prior year inventory footnote has been revised to reflect
the adjustment to raw materials and finished goods. The revision
had no effect on the previously
reported total gross and net carrying value of inventory. The
revision also had no effect on the
previously reported balance sheets, statements of operations and
comprehensive loss, cash flows and stockholders’ equity.
The components of gross intellectual property, accumulated
amortization, and net intellectual property are as follows:
|
|
June 30, 2022
|
|
|
|
(in thousands)
|
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Foreign
Currency
Translation
Impact
|
|
|
Net
Carrying
Amount
|
|
Developed technology
|
|
$ |
68,838 |
|
|
$ |
(64,094 |
) |
|
$ |
(812 |
) |
|
$ |
3,932 |
|
Technology and patents purchased
|
|
|
400 |
|
|
|
(220 |
) |
|
|
10 |
|
|
|
190 |
|
Total intellectual property
|
|
$ |
69,238 |
|
|
$ |
(64,314 |
) |
|
$ |
(802 |
) |
|
$ |
4,122 |
|
|
|
December 31, 2021
|
|
|
|
(in thousands)
|
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Foreign
Currency
Translation
Impact
|
|
|
Net
Carrying
Amount
|
|
Developed technology
|
|
$ |
68,838 |
|
|
$ |
(58,912 |
) |
|
$ |
(262 |
) |
|
$ |
9,664 |
|
Technology and patents purchased
|
|
|
400 |
|
|
|
(199 |
) |
|
|
27 |
|
|
|
228 |
|
Total intellectual property
|
|
$ |
69,238 |
|
|
$ |
(59,111 |
) |
|
$ |
(235 |
) |
|
$ |
9,892 |
|
The weighted average remaining useful life of the developed
technology and technology and patents purchased was 2.0 years and
4.8 years, respectively, as of June 30,
2022.
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
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Total Operating lease expense
|
|
$ |
386 |
|
|
$ |
485 |
|
|
$ |
785 |
|
|
$ |
923 |
|
Supplemental balance sheet information related to operating leases
was as follows:
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
Weighted-average remaining lease term (in years)
|
|
|
7.4 |
|
|
|
|
7.8 |
|
|
Weighted-average discount rate
|
|
|
7.4% |
|
|
|
|
7.8% |
|
|
Incremental borrowing rate
|
|
6.1% |
- |
8.5% |
|
|
6.1% |
- |
8.5 |
|
Maturities of operating lease obligations as of June 30, 2022 were as follows (in
thousands):
Fiscal Year
|
|
|
|
|
2022
|
|
$ |
430 |
|
2023
|
|
|
972 |
|
2024
|
|
|
886 |
|
2025
|
|
|
881 |
|
2026
|
|
|
822 |
|
Thereafter
|
|
|
2,958 |
|
Total minimum lease payments
|
|
$ |
6,949 |
|
Less: Amount of lease payments representing interest
|
|
|
(1,760 |
) |
Present value of future minimum lease payments
|
|
$ |
5,189 |
|
9.
|
Property and Equipment Impairment
|
During the three and six months ended June 30, 2022, the Company recorded a
non-cash asset impairment charge of $0.4 million to reduce the
carrying value of 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.
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. This rate does not
include the impact of any discrete items. The Company’s effective
tax rate for the three months ended
June 30, 2022 and 2021 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.
The Company incurred losses for the three and six
months ended June 30, 2022, and is
forecasting additional losses through the year, resulting in an
estimated net loss for both financial statement and tax purposes
for the year ending December 31,
2022. Due to the Company’s history of losses, there is
not sufficient evidence to record a
net deferred tax asset associated with the U.S., Luxembourg, Swiss,
Italian, Taiwanese, and Canadian operations. Accordingly, a full
valuation allowance has been recorded related to the net deferred
tax assets in those jurisdictions.
The total tax (expense) benefit during the three months ended June 30, 2022 and 2021, was approximately ($0.1) million and
($0.002) million, respectively. The total tax (expense) benefit
during the six months ended
June 30, 2022 and 2021, was approximately ($0.2) million and
$0.036 million, respectively.
At June 30, 2022 the Company had no
unrecognized tax benefits that would affect the Company’s effective
tax rate.
The FASB Staff Q&A, Topic 740,
No. 5, Accounting for Global Intangible Low-Taxed
Income (“GILTI”), states that an entity can make an accounting
policy election to either recognize deferred taxes for temporary
basis differences expected to reverse as GILTI in future years or
to provide for the tax expense related to GILTI in the year the tax
is incurred as a period expense only. The Company has elected to
account for GILTI as a period expense in the year the tax is
incurred. The Company does not
expect a GILTI inclusion for 2022;
no GILTI tax has been recorded for
the six months ended June 30, 2022 or 2021.
11.
|
Stock-Based Compensation
|
Stock Options
The following table summarizes the Company’s stock option activity,
including grants to non-employees, for the six months ended June 30, 2022:
|
|
Number of
Shares
|
|
|
Weighted-
Average Exercise
Price
|
|
|
Weighted-Average
Remaining
Contractual Term
(Years)
|
|
Balance at December 31, 2021
|
|
|
4,640,660 |
|
|
$ |
6.64 |
|
|
|
5.66 |
|
Granted
|
|
|
2,555,396 |
|
|
|
0.77 |
|
|
|
|
|
Forfeited
|
|
|
(23,047 |
) |
|
|
3.22 |
|
|
|
|
|
Cancelled
|
|
|
(16,983 |
) |
|
|
33.27 |
|
|
|
|
|
Exercised
|
|
|
(43,453 |
) |
|
|
0.41 |
|
|
|
|
|
Balance at June 30, 2022
|
|
|
7,112,573 |
|
|
$ |
4.52 |
|
|
|
5.71 |
|
The following table summarizes information about stock options
outstanding at June 30, 2022:
|
|
Number of
Shares
|
|
|
Weighted-
Average Exercise
Price
|
|
|
Weighted-Average
Remaining
Contractual Term
(Years)
|
|
|
Aggregate
Intrinsic Value
(Millions)
|
|
Exercisable at June 30, 2022
|
|
|
3,119,355 |
|
|
$ |
8.02 |
|
|
|
5.08 |
|
|
$ |
- |
|
Vested or expected to vest at June 30, 2022
|
|
|
6,777,170 |
|
|
$ |
4.67 |
|
|
|
5.67 |
|
|
$ |
- |
|
Restricted Stock Units
The following is a summary of the restricted stock units activity,
including performance restricted stock units, for the six months ended June 30, 2022:
|
|
Number of
Restricted Stock
Units
Outstanding
|
|
|
Weighted-
Average Grant
Date Fair Value
|
|
Unvested December 31, 2021
|
|
|
3,839,030 |
|
|
$ |
2.36 |
|
Granted
|
|
|
6,040,915 |
|
|
|
0.75 |
|
Vested
|
|
|
(1,794,623 |
) |
|
|
2.47 |
|
Forfeited
|
|
|
(100,047 |
) |
|
|
1.36 |
|
Unvested Jun 30, 2022
|
|
|
7,985,275 |
|
|
$ |
1.13 |
|
Performance Restricted Stock Units
In 2022 and 2021, the Company granted performance-based
restricted stock units with vesting terms based on our attainment
of certain operational targets by October 1, 2023 and October 1, 2022, respectively. The number of
shares earnable under the 2022 and
2021 awards are based on achieving
designated corporate goals.
Stock-based Compensation Expense
The following table summarizes non-cash stock-based compensation
expense by award type for the three
and six months ended June 30, 2022, and 2021:
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
(in thousands)
|
|
|
(in thousands)
|
|
Stock options
|
|
$ |
924 |
|
|
$ |
1,087 |
|
|
$ |
1,901 |
|
|
$ |
2,207 |
|
Restricted stock units
|
|
|
822 |
|
|
|
690 |
|
|
|
1,707 |
|
|
|
1,293 |
|
Performance restricted stock units
|
|
|
337 |
|
|
|
33 |
|
|
|
720 |
|
|
|
70 |
|
|
|
$ |
2,083 |
|
|
$ |
1,810 |
|
|
$ |
4,328 |
|
|
$ |
3,570 |
|
As of June 30, 2022, the Company
had future employee stock-based compensation expense of
approximately $3.6 million related to unvested stock options, which
is expected to be recognized over an estimated weighted-average
period of 2.0 years. As of June 30,
2022, the unrecognized stock-based compensation expense
related to unvested restricted stock units was approximately
$6.0 million, which is expected to be recognized over a
weighted average period of approximately 1.8 years.
The fair value of options granted were estimated using the
Black-Scholes-Merton option pricing model based on the assumptions
in the table below:
|
|
Six Months Ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
Expected dividend yield
|
|
|
|
0% |
|
|
|
|
0% |
|
|
Expected volatility
|
|
|
128% |
- |
133% |
|
|
118% |
- |
136% |
|
Risk-free interest rate
|
|
|
1.25% |
- |
2.98% |
|
|
0.33% |
- |
0.58% |
|
Expected life (in years)
|
|
|
4.3 |
- |
4.5 |
|
|
3.8 |
- |
4.5 |
|
Equity financing transactions for the six months ended June 30, 2021, include:
2020 ATM Offering. On
October 9, 2020, the Company filed
a prospectus supplement relating to an at-the-market offering with
Cantor pursuant to which the Company could sell from time to time,
at its option, up to an aggregate of $40.0 million of shares of the
Company’s common stock (the “2020
ATM Offering”). The Company terminated this agreement in January 2021.
January 2021 Public
Offering. On January 29, 2021,
the Company completed an underwritten public offering of 26,545,832
shares of its common stock, including the underwriter’s full
exercise of an over-allotment option on February 1, 2021, at the public offering
price of $3.00 per share, generating net proceeds of approximately
$73.4 million.
January 2021 Registered Direct
Purchase Agreement. On January 12,
2021, the Company sold in a registered direct offering
25,000,000 shares of common stock at a purchase price per share of
$1.25 for aggregate net proceeds of $28.6 million.
2021 ATM Offering. On
May 19, 2021, the Company entered
into a Controlled Equity Offering Sales Agreement (the “2021 Sales Agreement”) with Cantor
Fitzgerald & Co. (“Cantor”), Robert W. Baird & Co.
Incorporated (“Baird”) and Oppenheimer & Co. Inc.
(“Oppenheimer”). Each of Cantor, Baird and Oppenheimer are
individually an “Agent” and collectively are the “Agents” under the
Agreement. Also On May 19, 2021,
the Company commenced an at-the-market offering (the “2021 ATM Offering”) pursuant to which the
Company could sell from time to time, at its option, up to an
aggregate of $100.0 million shares of the Company’s common stock.
The aggregate compensation payable to the Agents was 3.0% of the aggregate gross proceeds from
each sale of the Company’s common stock.
Sales during the six months ended
June 30, 2021, under the 2021 and 2020
ATM Offering are as follows (in thousands, except for share and per
share amounts):
|
|
Six Months Ended
June 30, 2021
|
|
|
|
2021 ATM
|
|
|
2020 ATM
|
|
|
Total
|
|
Total shares of common stock sold
|
|
|
331,811 |
|
|
|
19,120,037 |
|
|
|
19,451,848 |
|
Average price per share
|
|
$ |
3.47 |
|
|
$ |
1.47 |
|
|
$ |
1.50 |
|
Gross proceeds
|
|
$ |
1,152 |
|
|
$ |
28,100 |
|
|
$ |
29,252 |
|
Commission earned by Sales Agents
|
|
$ |
34 |
|
|
$ |
843 |
|
|
$ |
877 |
|
Net proceeds
|
|
$ |
1,118 |
|
|
$ |
27,257 |
|
|
$ |
28,375 |
|
2021 Exercise of Warrants.
During the six months ended
June 30, 2021, certain holders of
our Series B, C and D warrants to purchase shares of our common
stock exercised such warrants for aggregate proceeds to the Company
of $30.6 million.
2022 ATM Offering. On
March 18, 2022, the Company entered
a Controlled Equity Offering Sales Agreement (the “2022 Sales Agreement”), with Cantor
Fitzgerald & Co., and Oppenheimer & Co. Inc. The Company
commenced an at-the-market offering (the “2022 ATM Offering”) pursuant to which the
Company could sell from time to time, at its option, up to an
aggregate of $100.0 million shares of the Company’s common stock.
No sales of common stock were made under the 2022 ATM Offering during the six months ended June 30, 2022.
13.
|
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 six
months ended June 30, 2022 or
2021 as the assumed exercise of
outstanding options, warrants and restricted stock units would be
anti-dilutive.
Potential common shares not
included in calculating diluted net loss per share are as
follows:
|
|
June 30,
|
|
|
|
2022
|
|
|
2021
|
|
Stock options
|
|
|
7,112,573 |
|
|
|
4,279,335 |
|
Stock warrants
|
|
|
1,120,300 |
|
|
|
1,016,383 |
|
Nonvested restricted stock units
|
|
|
7,985,275 |
|
|
|
1,768,861 |
|
Total
|
|
|
16,218,148 |
|
|
|
7,064,579 |
|
14.
|
Commitments and 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, the Company has
purchase orders with various suppliers for certain tooling,
supplies, contract engineering and research services. Commitments
related to these agreements and purchase orders are as follows (in
thousands):
Fiscal Year
|
|
|
|
|
2022
|
|
$ |
8,465 |
|
2023
|
|
|
852 |
|
2024
|
|
|
550 |
|
2025
|
|
|
339 |
|
2026
|
|
|
- |
|
Thereafter
|
|
|
- |
|
Total commitments
|
|
$ |
10,206 |
|
15.
|
Segments and Geographic Areas
|
The Company operates in one business segment—the research,
development, and sale of medical device robotics to improve
minimally invasive surgery. The Company’s chief operating decision
maker (determined to be the Chief Executive Officer), does
not manage any part of the Company
separately, and the allocation of resources and assessment of
performance are based on the Company’s consolidated operating
results.
The following table presents consolidated assets and long-lived
assets by geographic area, which includes property and equipment,
intellectual property, and operating lease assets:
|
|
June 30, 2022
|
|
|
|
Long-Lived Assets
|
|
|
Total Assets
|
|
U.S.
|
|
|
33 |
% |
|
|
77 |
% |
|
|
|
|
|
|
|
|
|
EMEA
|
|
|
|
|
|
|
|
|
Switzerland
|
|
|
40 |
% |
|
|
18 |
% |
Italy
|
|
|
20 |
% |
|
|
3 |
% |
Other
|
|
|
7 |
% |
|
|
1 |
% |
Total EMEA
|
|
|
67 |
% |
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
Asia
|
|
|
0 |
% |
|
|
1 |
% |
Total
|
|
|
100 |
% |
|
|
100 |
% |
|
|
December 31, 2021
|
|
|
|
Long-Lived Assets
|
|
|
Total Assets
|
|
U.S.
|
|
|
26 |
% |
|
|
77 |
% |
|
|
|
|
|
|
|
|
|
EMEA
|
|
|
|
|
|
|
|
|
Switzerland
|
|
|
34 |
% |
|
|
16 |
% |
Italy
|
|
|
36 |
% |
|
|
5 |
% |
Other
|
|
|
4 |
% |
|
|
1 |
% |
Total EMEA
|
|
|
74 |
% |
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
Asia
|
|
|
0 |
% |
|
|
1 |
% |
Total
|
|
|
100 |
% |
|
|
100 |
% |
The Company recognizes sales by geographic area based on the
country in which the customer is based. For the three months ended June 30, 2022 and 2021, 15% and 25%, respectively, of net
revenue were generated in the United States; while 63% and 53%,
respectively, were generated in Europe; and 22% and 22% were
generated in Asia. For the six
months ended June 30, 2022 and
2021, 19% and 17%, respectively, of
net revenue were generated in the United States; while 56% and 32%,
respectively, were generated in Europe; and 25% and 51% were
generated in Asia.
16.
|
Related Person Transactions
|
In March 2018, Asensus Surgical
Europe S.à.r.l entered into a Service Supply Agreement with
1 Med S.A. for certain regulatory
consulting services. Andrea Biffi, a current member of the
Company’s Board of Directors, owns a non-controlling interest in
1 Med S.A. Expenses under the
Service Supply Agreement were approximately $68,000 and $0 for the
three months ended June 30, 2022 and 2021, respectively and $141,000 and $93,000
for the six months ended June 30, 2022 and 2021, respectively.
Item 2.
Management’s Discussion and Analysis of Financial
Conditions and Results of Operation
The following discussion of our financial condition and results
of operations should be read in conjunction with our condensed
consolidated financial statements and the related notes to our
condensed consolidated financial statements included in this
report. The following discussion contains forward-looking
statements. See cautionary note regarding “Forward-Looking
Statements” at the beginning of this report.
Overview
Asensus Surgical is a medical device company that is digitizing the
interface between the surgeon and the patient to pioneer a new era
of Performance-Guided Surgery™ by unlocking clinical intelligence
to enable consistently superior outcomes and a new standard of
surgery. This builds upon the foundation of Digital Laparoscopy
with the Senhance® Surgical System powered by the Intelligent
Surgical Unit™, or ISU™, to increase surgeon control and reduce
surgical variability. With the addition of machine vision,
augmented intelligence, and deep learning capabilities throughout
the surgical experience, we intend to holistically address the
current clinical, cognitive and economic shortcomings that drive
surgical outcomes and value-based healthcare. The Company is
focused on the market development for and commercialization of the
Senhance Surgical System, which digitizes laparoscopic minimally
invasive surgery, or MIS. The Senhance System is the first and only
digital, multi-port laparoscopic platform designed to maintain
laparoscopic MIS standards while providing digital benefits such as
haptic feedback, robotic precision, comfortable ergonomics,
advanced instrumentation including 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 98 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 improving database of surgeries and their outcomes
to enable surgeons to best inform their approach and surgical
setup.
|
|
●
|
Intra-operative – we believe the Senhance System provides
perceptive real-time guidance for intra-operative tasks, allowing
any surgeon performing a procedure with the Senhance System to
perform multiple tasks and benefit from the collective knowledge
and rules-based performance of thousands of other successful
Senhance-based procedures. Not only will this provide the surgeon
with a pathway to better outcomes, but we also believe it will
ultimately help reduce the cognitive load of the surgeons.
|
|
●
|
Post-operative – by tapping into the vast amount of data
captured during procedures, surgeons and operating room staff will
be able to get actionable assessments of their performance giving
them the information needed to improve performance over time. We
intend to establish a new standard of 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 February 2020, we received CE Mark for the Senhance System and
related instruments for pediatric use indications in CE Mark
territories.
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.
The Company believes that future outcomes of minimally invasive
laparoscopic surgery will be enhanced through its combination of
more advanced tools and robotic functionality, which are designed
to: (i) empower surgeons with improved precision, dexterity and
visualization; (ii) improve patient satisfaction and enable a
desirable post-operative recovery; and (iii) provide a
cost-effective robotic system, compared to existing alternatives
today, for a wide range of clinical indications.
From our inception, we devoted a substantial percentage of our
resources to research and development and start-up activities,
consisting primarily of product design and development, clinical
studies, manufacturing, recruiting qualified personnel and raising
capital. We expect to continue to invest in research and
development and market development as we implement our
strategy.
Since inception, we have been unprofitable. As of June 30, 2022, we
had an accumulated deficit of $824.1 million. We operate in one
business segment.
Recent Financing Transactions
At-the -Market Offerings
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 six months ended June 30,
2022.
Results of Operations - Comparison of Three Months Ended June
30, 2022 and 2021
Revenue
In the second quarter of 2022, our revenue consisted of ongoing
System leasing payments, sales of instruments and accessories, and
services revenue for Systems sold or placed in Europe, Asia, and
the U.S. in prior periods.
Product revenue for the three months ended June 30, 2022 decreased
to $0.3 million compared to $0.4 million for the three months ended
June 30, 2021. Service revenue remained consistent at $0.4 million
for the three months ended June 30, 2022 and 2021. Lease revenue
remained consistent at $0.3 million for the three months ended June
30, 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.
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 three months ended June 30, 2022 decreased to
$0.9 million as compared to $1.0 million for the three months ended
June 30, 2021. The $0.1 million decrease primarily relates to a
decrease in personnel-related costs.
Service cost remained consistent at $0.6 million for the three
months ended June 30, 2022 and 2021.
Lease cost for the three months ended June 30, 2022 increased to
$0.8 million as compared to $0.7 million for the three months ended
June 30, 2021.
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 as we continue to invest in additional
regulatory approvals as well as new products, instruments, and
accessories to be offered with the Senhance System. R&D
expenses are expensed as incurred.
R&D expenses for the three months ended June 30, 2022 increased
78% to $7.3 million as compared to $4.1 million for the three
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 $3.2 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 million, increased supplies costs of $0.3
million, and increased miscellaneous costs of $0.4 million.
Sales and Marketing
Sales and marketing expenses include costs for sales and marketing
personnel, travel, demonstration product, market development,
physician training, tradeshows, marketing clinical studies and
consulting expenses.
Sales and marketing expenses for the three months ended June 30,
2022 and 2021 remained consistent at $3.6 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, 2022 increased 32% to $5.0 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.
Amortization of Intangible Assets
Amortization of intangible assets for the three months ended June
30, 2022 decreased to $2.5 million compared to $2.9 million for the
three months ended June 30, 2021. The $0.4 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 $0.6 million decrease for the
three months ended June 30, 2022 compared to a $0.5 million
increase for the three months ended June 30, 2021. 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 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.
Other Income (Expense)
Other income for the three months ended June 30, 2022 decreased to
$0.0 million compared to $2.9 million for the three months ended
June 30, 2021. Other income for the three months ended June 30,
2021 primarily related to the gain on extinguishment of debt of
$2.8 million. No related income was recorded in the three months
ended June 30, 2022.
Income Tax (Expense) Benefit
The Company recognized $0.1 million income tax expense for the
three months ended June 30, 2022, compared to $0.0 million income
tax expense for the three months ended June 30, 2021.
Results 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 placed in
Europe, Asia, 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.
Liquidity and Capital Resources
The Company had an accumulated deficit of $824.1 million and
working capital of $98.9 million as of June 30, 2022. 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. As of June 30, 2022, the
Company had cash, cash equivalents, short-term investments and
long-term investments, excluding restricted cash, of approximately
$103.8 million.
The Company believes the COVID-19 pandemic and other geopolitical
factors will continue to negatively impact its operations and
ability to implement its market development efforts, which will
have a negative effect on its financial condition.
While the Company believes that its existing cash, cash
equivalents, short-term and long-term investments, as of June 30,
2022 and as of the date of filing, will be sufficient to sustain
operations for at least the next 12 months from the issuance of
these financial statements, the Company believes it 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.
The Company is subject to risks similar to other similarly sized
companies in the medical device industry. These risks include,
without limitation: 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 and 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
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 |
|
Operating
Activities
For the six months ended June 30, 2022, cash used in operating
activities of $30.2 million consisted of a net loss of $38.7
million, changes in operating assets and liabilities of $2.6
million, offset by non-cash items of $11.1 million. The non-cash
items primarily consisted of $5.2 million of amortization of
intangible assets, $4.3 million of stock-based compensation
expense, $1.7 million of depreciation, $0.4 million of net
amortization of discounts and premiums on investments, $0.4 million
in impairment of property and equipment, $0.2 million deferred tax
expense, offset by $0.6 million change in inventory reserves and
$0.8 million of change in fair value of contingent consideration.
The decrease in cash from changes in operating assets and
liabilities primarily relates to a $1.9 million increase in
inventory net of transfers to property and equipment, $1.2 million
increase in other current and long-term assets, $0.3 million
decrease in accrued expenses, $0.3 million decrease in operating
lease liabilities, offset by a $0.5 million increase in accounts
payable, $0.4 million decrease in operating lease right-of-use
assets, and a $0.2 million decrease in prepaid expenses.
For the six months ended June 30, 2021, cash used in operating
activities of $18.5 million consisted of a net loss of $30.5
million offset by cash generated from 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 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.
Investing
Activities
For the six months ended June 30, 2022, net cash provided by
investing activities was $23.2 million. This amount consists of
$41.4 million of proceeds from maturities of available-for-sale
investments, offset by $17.8 million of purchases of
available-for-sale investments and $0.4 million purchases of
property and equipment.
For the six months ended June 30, 2021, net cash used in investing
activities was $0.7 million, related to purchases of property and
equipment.
Financing
Activities
For the six months ended June 30, 2022, net cash used in financing
activities was $0.3 million, related to taxes paid for the net
share settlement of vesting of restricted stock units.
For the six months ended June 30, 2021, net cash provided by
financing activities was $160.1 million. The net change primarily
related to $130.3 million in net proceeds from the issuance of
common stock 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 to net share settlement of vesting of restricted
stock units.
Operating Capital and Capital Expenditure Requirements
We intend to spend substantial amounts on research and development
activities, including product development, regulatory and
compliance, and clinical studies. 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 million as of June 30, 2022, including restricted cash. We do
not intend or currently foresee a need to repatriate cash and cash
equivalents held by our foreign subsidiaries. If these funds are
needed in the United States, we believe that the potential U.S. tax
impact to repatriate these funds would be immaterial.
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 2021 Form 10-K. The
preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. On an on-going basis, we
evaluate our critical accounting policies and estimates, including
identifiable intangible assets, contingent consideration,
stock-based compensation, inventory, revenue recognition and income
taxes. We base our estimates on historical experience and on
various other assumptions that are believed to be reasonable under
the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that
are not readily apparent from other sources. A more detailed
discussion on the application of these and other accounting
policies can be found in Note 2 in the Notes to the Financial
Statements in this Form 10-Q. Actual results may differ from these
estimates under different assumptions and conditions. There have
been no new or material changes to the critical accounting
estimates discussed in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021, that are of significance, or
potential significance, to us.
Item 3.
|
Quantitative and Qualitative
Disclosures about Market Risk
|
We are exposed to changes in foreign currency exchange rates.
Operations outside of the United States accounted for 81% and 83%
of revenue for six months ended June 30, 2022 and 2021,
respectively, and are concentrated principally in Europe. We
translate the revenue and expenses of our foreign operations using
average exchange rates prevailing during the period. The effect of
a 10% change in the average foreign currency exchange rates among
the U.S. dollar versus the Euro for the six months ended June 30,
2022, would result in revenue changing by $0.2 million. This change
would be not material to our cash flows and our results of
operations.
Item 4.
|
Controls and Procedures
|
Disclosure Controls and Procedures
Our management, with the participation of our principal executive
officer and principal financial officer, evaluated the
effectiveness of our disclosure controls and procedures (as such
term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange
Act) as of June 30, 2022. We maintain disclosure controls and
procedures that are designed to provide reasonable assurance that
information required to be disclosed in our reports filed or
submitted under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in the SEC’s rules
and forms and that such information is accumulated and communicated
to our management, including our principal executive officer and
principal financial officer, as appropriate, to allow for timely
decisions regarding required disclosure. Our management recognizes
that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in
evaluating the cost-benefit relationship of possible controls and
procedures. Based on such evaluation, our Chief Executive Officer
and Executive Vice President and Chief Financial Officer concluded
that, as of June 30, 2022, our disclosure controls and procedures
were effective at a reasonable assurance level.
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial
reporting that occurred during the quarter ended June 30, 2022,
that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
We have not experienced any material impact to our internal
controls over financial reporting despite the fact that some of our
employees are working remotely due to the COVID-19 pandemic. We are
continually monitoring and assessing the COVID-19 situation on our
internal controls to minimize the impact on their design and
operating effectiveness.
PART
II. OTHER INFORMATION
Item
1
|
Legal Proceedings.
|
None.
Reference is made to the Risk Factors included in our Fiscal 2021
Form 10-K. There have been no material changes to our risk factors
from those disclosed under “Risk Factors” in Part I, Item 1A of our
Fiscal 2021 Form 10-K, 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.
Item
2
|
Unregistered Sales of Equity Securities and Use of
Proceeds.
|
None.
Item
3
|
Defaults Upon Senior Securities.
|
None.
Item
4
|
Mine Safety Disclosures.
|
Not applicable.
Item
5
|
Other Information.
|
None.
* Filed
herewith.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
|
|
Asensus Surgical, Inc.
|
|
|
|
|
Date: August 8, 2022
|
|
By:
|
/s/ Anthony Fernando
|
|
|
Anthony Fernando
|
|
|
President and Chief Executive Officer
|
|
|
|
|
Date: August 8, 2022
|
|
By:
|
/s/ Shameze Rampertab
|
|
|
Shameze Rampertab
|
|
|
Executive Vice President and Chief Financial Officer
|
Asensus Surgical (AMEX:ASXC)
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