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.
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? 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.
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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.
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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.
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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.
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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.
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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.
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