Asensus Surgical, Inc. (NYSE American: ASXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to pioneer a new era of Performance-Guided Surgery™,
today announced its operating and financial results for the fourth
quarter and full year 2021.
Fourth Quarter Highlights
- Over 500 procedures were performed globally during the quarter,
representing growth of 30% over the fourth quarter 2020
- Six Senhance Surgical Programs were initiated during the
quarter
- Fourth quarter revenue of $2.5 million
Year-End Highlights
- Over 2,100 procedures performed globally, representing 44%
growth compared to 2020
- 10 Senhance Surgical Programs were initiated
- Received four regulatory clearances:
- FDA 510(k) clearance for expansion of machine vision
capabilities for the Intelligent Surgical Unit™ (ISU™)
- FDA 510(k) clearance for articulating instruments
- Expanded FDA 510(k) clearance for general surgery
indication
- CE Mark approval for the ISU
- Full year 2021 revenue of $8.2 million, representing growth of
159% over the prior year
- The Company had cash, cash equivalents, short-term and
long-term investments, excluding restricted cash, of approximately
$135.8 million at December 31, 2021
"Despite the macro headwinds that persisted throughout the year,
we were able to significantly grow our active installed base, drive
the highest procedure volumes in Senhance’s commercial history, and
make great strides with the development and expansion of our
portfolio. We continue to believe that there is a critical need to
elevate the way surgery is performed globally by bringing clinical
intelligence to the OR, and the growth we achieved in 2021
validates the clinical utility Senhance delivers to surgeons and
hospitals,” said Anthony Fernando, Asensus Surgical President and
CEO. “As we look towards 2022, we expect to continue to drive the
global adoption of Senhance through our market development and
portfolio expansion efforts while at the same time focusing on the
ongoing development of the platform’s innovative digital
capabilities to deliver on the promise of Performance-Guided
Surgery."
Upcoming 2022 Milestones
For the full year 2022, the Company expects to initiate 10 - 12
new Senhance Surgical Systems.
During the second half of 2022, the Company expects to achieve
the following commercial and regulatory milestones:
- Full scale commercialization of articulating instruments
globally
- File a 510(k) for FDA clearance of Senhance for pediatric
indication
- Receive CE Mark for expanded machine vision capabilities for
the ISU
Market Development
2021 Senhance Program Initiations
Throughout 2021, the Company completed 10 Senhance Surgical
Program initiations: one in the US, six in EMEA, and three in
Asia.
During the fourth quarter of 2021, the Company initiated six
programs, one in the US, three in EMEA, and two in Asia.
Procedure Volumes
In 2021, surgeons performed over 2,100 procedures utilizing the
Senhance System, representing a 44% increase over the previous
year. Compared to 2020, US-based procedure volumes increased 95%,
EMEA increased 42%, and Asia increased 18%. These procedures
included general surgery, gynecology, urology, bariatric, and
colorectal surgical cases.
Clinical Validation
During 2021, there were 21 peer-reviewed clinical papers
published providing further support for the clinical utility of the
Senhance System across a variety of surgical specialties.
Portfolio Expansion
Performance-Guided Surgery (PGS)
As an organization, the Company’s goal is to revolutionize the
way surgery is performed. The fact that there are complications
with one in five surgeries is unacceptable, and, more importantly,
avoidable. The Company is helping to unlock clinical intelligence
and capabilities to reduce surgical variability and the
complications associated with it. PGS builds upon the foundation of
Digital Laparoscopy by adding machine vision, augmented
intelligence, and deep learning capabilities. These capabilities
shift the promise of consistently superior surgery into practice
regardless of a surgeon’s experience or skill level by guiding
improved decision making, enriching collaboration, and enhancing
predictability.
Expanded Global ISU Machine Vision Capabilities
In September 2021, the Company announced that it had received
510(k) clearance from the FDA for an expansion of machine vision
capabilities on the previously cleared ISU. The ISU is utilized
with the Senhance System which enables Digital Laparoscopy. The
initial features of the ISU enable machine vision-driven control of
the camera for a surgeon by responding to commands and recognizing
certain objects and locations in the surgical field, and allow a
surgeon to change the visualized field of view using the movement
of their instruments. The newest ISU features expanded upon these
capabilities and introduced more advanced features including:
real-time 3D measurement, digital tagging, image enhancement, and
enhanced camera control based on real-time data from anatomical
structures while performing surgery. This is the first time any of
these features will be clinically available in soft-tissue
abdominal surgery.
Articulating Instrument Clearance
In July 2021, the Company announced that it had received 510(k)
clearance for 5mm articulating instruments, which offer better
access to difficult-to-reach areas of the anatomy.
General Surgery Indication Expansion
In March 2021, the Company announced that it had received an
additional FDA clearance for the Senhance Surgical System which
allows for indication expansion in general surgery in the US.
CE Mark for Intelligent Surgical Unit
In January 2021, the Company announced that it had received CE
Mark approval for the ISU that enables machine vision capabilities
on the Senhance System. This approval will provide Senhance Digital
Laparoscopy programs in Europe access to this technology.
Fourth Quarter Financial Results
For the three months ended December 31, 2021, the Company
reported revenue of $2.5 million as compared to revenue of $1.1
million in the three months ended December 31, 2020. Revenue in the
fourth quarter of 2021 included $1.7 million in system revenue,
$0.5 million in instruments and accessories, and $0.3 million in
services.
For the three months ended December 31, 2021, total operating
expenses were $15.9 million, as compared to $14.2 million, in the
three months ended December 31, 2020.
For the three months ended December 31, 2021, net loss was $15.9
million, or $0.07 per share, as compared to a net loss of $13.8
million, or $0.13 per share, in the three months ended December 31,
2020.
Adjusted net loss is a non-GAAP financial measure. See the
reconciliation of GAAP to Non-GAAP Measures below. For the three
months ended December 31, 2021, the adjusted net loss was $15.7
million, or $0.07 per share, as compared to an adjusted net loss of
$9.7 million, or $0.9 per share in the three months ended December
31, 2020, after adjusting for the following charges: amortization
of intangible assets, change in fair value of contingent
consideration, change in fair value of warrant liabilities, and
restructuring and other charges, all of which are non-cash
charges.
Balance Sheet Updates
The Company had cash, cash equivalents, short-term and long-term
investments, excluding restricted cash of approximately $135.8
million as of December 31, 2021.
Conference Call
Asensus Surgical, Inc. will host a conference call on Monday,
February 28, 2022, at 4:30 PM ET to discuss its fourth quarter and
fiscal year 2021 operating and financial results. To listen to the
conference call on your telephone, please dial 1-855-327-6837 for
domestic callers and 1-631-891-4304 for international callers, and
reference conference ID 10017809 approximately ten minutes prior to
the start time. To access the live audio webcast or archived
recording, use the following link
https://ir.asensus.com/events-and-presentations. The replay will be
available on the Company’s website.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the
surgeon and 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. This
builds upon the foundation of Digital Laparoscopy with the Senhance
Surgical System powered by the Intelligent Surgical Unit (ISU) to
increase surgeon control and reduce surgical variability. With the
addition of machine vision, augmented intelligence, and deep
learning capabilities throughout the surgical experience, we intend
to holistically address the current clinical, cognitive and
economic shortcomings that drive surgical outcomes and value-based
healthcare. Learn more about Performance-Guided Surgery and Digital
Laparoscopy with the Senhance Surgical System here:
www.senhance.com. Now available for sale in the US, EU, Japan,
Russia, and select other countries. For a complete list of
indications for use, visit: www.senhance.com/indications. For more
information, visit www.asensus.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and our 2021 results. These statements and other statements
regarding our future plans and goals constitute "forward looking
statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934, and
are intended to qualify for the safe harbor from liability
established by the Private Securities Litigation Reform Act of
1995. Such statements are subject to risks and uncertainties that
are often difficult to predict, are beyond our control and which
may cause results to differ materially from expectations and
include whether we will be able to continue to progress our
strategic plan in 2022, including achieving our commercial and
regulatory milestones; whether the growth we achieved in 2021
validates the clinical utility the Senhance System delivers to
surgeons and hospitals; whether we can continue to drive the global
adoption of Senhance through our market development and portfolio
expansion efforts while at the same time focusing on the ongoing
development of the platform’s innovative digital capabilities to
deliver on the promise of Performance-Guided Surgery; whether we
will initiate 10-12 new Senhance Surgical Systems placements in
2022; whether we can continue to increase Senhance System
placements and sales; and whether we can continue to add
foundational sites and receive regulatory clearances and approvals
that we seek. For a discussion of the risks and uncertainties
associated with the Company’s business, please review our filings
with the Securities and Exchange Commission (SEC). You are
cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the origination date of
this press release. We undertake no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Asensus Surgical, Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(in thousands except per share
amounts)
(Unaudited)
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Revenue:
Product
$
2,136
$
620
$
6,712
$
1,612
Service
340
488
1,520
1,563
Total revenue
2,476
1,108
8,232
3,175
Cost of revenue:
Product
1,457
(99)
7,974
2,254
Service
830
691
3,122
2,912
Total cost of revenue
2,287
592
11,096
5,166
Gross profit (loss)
189
516
(2,864
)
(1,991
)
Operating Expenses:
Research and development
6,575
3,752
19,348
16,621
Sales and marketing
3,229
2,774
13,395
13,064
General and administrative
5,926
3,712
19,323
14,137
Amortization of intangible assets
2,721
2,837
11,254
10,801
Change in fair value of contingent
consideration
(2,578)
1,154
(1,565)
2,924
Restructuring and other charges
—
(8)
—
851
Total Operating Expenses
15,873
14,221
61,755
58,398
Operating Loss
(15,684
)
(13,705
)
(64,619
)
(60,389
)
Other Income (Expense):
Gain on extinguishment of debt
—
—
2,847
—
Change in fair value of warrant
liabilities
—
(130)
(1,981
)
(336
)
Interest income
337
2
590
35
Interest expense
(293
)
(19)
(370
)
(19
)
Employee retention tax credit
—
—
1,311
—
Other expense, net
(12)
(67)
(15
)
(119
)
Total Other Income (Expense), net
32
(214)
2,382
(439
)
Loss before income taxes
(15,652
)
(13,919
)
(62,237
)
(60,828
)
Income tax (expense) benefit
(229
)
130
(225
)
1,516
Net loss
(15,881
)
(13,789
)
(62,462
)
(59,312
)
Deemed dividend related to beneficial
conversion feature of preferred stock
—
—
—
(412
)
Deemed dividend related to conversion of
preferred stock into common stock
—
—
—
(299
)
Net loss attributable to common
stockholders
(15,881
)
(13,789
)
(62,462
)
(60,023
)
Comprehensive loss:
Net loss
(15,881
)
(13,789
)
(62,462
)
(59,312
)
Foreign currency translation (loss)
gain
(588)
2,147
(2,985
)
4,338
Unrealized loss on available-for-sale
investments
(194)
—
(247
)
—
Comprehensive loss
$
(16,663
)
$
(11,642
)
$
(65,694
)
$
(54,974
)
Net loss per common share attributable to
common stockholders – basic and diluted
$
(0.07
)
$
(0.13
)
$
(0.28
)
$
(0.85
)
Weighted average number of shares used in
computing net loss per common share – basic and diluted
234,851
103,783
226,960
70,809
Asensus Surgical, Inc.
Consolidated Balance
Sheets
(in thousands, except share
amounts)
(Unaudited)
December 31,
December 31,
2021
2020
Assets
Current Assets:
Cash and cash equivalents
$
18,129
$
16,363
Short-term investments,
available-for-sale
80,262
—
Accounts receivable, net
749
1,115
Inventories
8,634
10,034
Prepaid expenses
3,255
3,535
Employee retention tax credit
receivable
1,311
—
Other current assets
957
2,966
Total Current Assets
113,297
34,013
Restricted cash
1,154
1,166
Long-term investments,
available-for-sale
37,435
—
Inventories, net of current portion
7,074
8,813
Property and equipment, net
10,971
10,342
Intellectual property, net
9,892
22,267
Net deferred tax assets
288
307
Operating lease right-of-use assets,
net
5,348
1,164
Other long-term assets
1,014
186
Total Assets
$
186,473
$
78,258
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
3,448
$
1,965
Accrued expenses
5,176
5,615
Operating lease liabilities – current
portion
683
686
Deferred revenue
543
789
Notes payable – current portion, net of
debt discount
—
1,228
Total Current Liabilities
9,850
10,283
Long Term Liabilities:
Contingent consideration
2,371
3,936
Noncurrent operating lease liabilities
5,006
628
Notes payable, less current portion
—
1,587
Warrant liabilities
—
255
Total Liabilities
17,227
16,689
Commitments and Contingencies
Stockholders’ Equity
Common stock $0.001 par value, 750,000,000
shares authorized at December 31, 2021 and 2020; 235,218,552 and
116,231,072 shares issued and outstanding at December 31, 2021 and
2020, respectively
235
116
Preferred stock, $0.01 par value,
25,000,000 shares authorized, no shares issued and outstanding at
December 31, 2021 and 2020, respectively
—
—
Additional paid-in capital
954,649
781,397
Accumulated deficit
(785,374
)
(722,912
)
Accumulated other comprehensive income
(264
)
2,968
Total Stockholders’ Equity
169,246
61,569
Total Liabilities and Stockholders’
Equity
$
186,473
$
78,258
Asensus Surgical, Inc.
Consolidated Statements of
Cash Flows
(in thousands)
(Unaudited)
Years Ended
December 31,
2021
2020
Operating Activities:
Net loss
$
(62,462)
$
(59,312)
Adjustments to reconcile net loss to net
cash and cash equivalents used in
operating activities:
Depreciation
2,857
2,898
Amortization of intangible assets
11,254
10,801
Amortization of discounts and premiums on
investments, net
409
—
Stock-based compensation
9,429
7,911
Gain on extinguishment of debt
(2,847)
—
Deferred tax expense (benefit)
225
(1,516)
Bad debt expense
144
—
Change in inventory reserves
(492)
(3,034)
Change in fair value of warrant
liabilities
1,981
336
Change in fair value of contingent
consideration
(1,565)
2,924
Changes in operating assets and
liabilities:
Accounts receivable
174
(447)
Inventories
(611)
(4,164)
Operating lease right-of-use assets
(4,254)
1,106
Prepaid expenses
146
824
Employee retention tax credit
receivable
(1,311)
—
Other current and long-term assets
902
366
Accounts payable
1,614
(1,758)
Accrued expenses
(475)
(2,219)
Deferred revenue
(229)
(105)
Operating lease liabilities
4,452
(1,203)
Other long-term liabilities
—
(83)
Net cash and cash equivalents used in
operating activities
(40,659)
(46,675)
Investing Activities:
Purchase of available-for-sale
investments
(122,330)
—
Proceeds from maturities of
available-for-sale investments
4,030
—
Purchase of property and equipment
(1,368)
(3)
Net cash and cash equivalents used in
investing activities
(119,668)
(3)
Financing Activities:
Proceeds from issuance of common stock,
preferred stock and warrants under 2020 financing, net of issuance
costs
—
13,478
Proceeds from issuance of common stock,
net of issuance costs
131,929
33,847
Proceeds from notes payable, net of
issuance costs
—
2,815
Taxes paid related to net share settlement
of vesting of restricted stock units
(1,063)
(36)
Payment of contingent consideration
—
(74)
Proceeds from exercise of stock options
and warrants
30,839
3,340
Net cash and cash equivalents provided by
financing activities
161,705
53,370
Effect of exchange rate changes on cash
and cash equivalents
376
270
Net increase in cash, cash equivalents and
restricted cash
1,754
6,962
Cash, cash equivalents and restricted
cash, beginning of period
17,529
10,567
Cash, cash equivalents and restricted
cash, end of period
$
19,283
$
17,529
Years Ended
December 31,
2021
2020
Supplemental Disclosure for Cash Flow
Information:
Cash paid for taxes
$
170
$
82
Supplemental Schedule of Non-cash
Investing and Financing Activities:
Transfer of inventories to property and
equipment
$
3,244
$
8,113
Right-of-use assets recognized related to
new lease obligations
$
5,119
$
—
Reclass of warrant liability to common
stock and additional paid-in-capital
$
2,236
$
—
Exchange of common stock for Series B
Warrants
$
—
$
2,470
Transfer of in-process research and
development to intellectual property
$
—
$
2,425
Deemed dividend related to beneficial
conversion feature of preferred stock
$
—
$
412
Deemed dividend related to conversion of
preferred stock into common stock
$
—
$
299
Conversion of preferred stock to common
stock
$
—
$
79
Asensus Surgical, Inc.
Reconciliation of Non-GAAP
Measures
Adjusted Net Loss and Adjusted
Net Loss per Share
(in thousands except per share
amounts)
(Unaudited)
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Net loss attributable to common
stockholders (GAAP)
$
(15,881
)
$
(13,789
)
$
(62,462
)
$
(60,023
)
Adjustments
Amortization of intangible assets
2,721
2,837
11,254
10,801
Change in fair value of contingent
consideration
(2,578
)
1,154
(1,565
)
2,924
Change in fair value of warrant
liabilities
—
130
1,981
336
Restructuring and other charges
—
(8
)
—
851
Gain on extinguishment of debt
—
—
(2,847
)
—
Employee retention tax credit
—
—
(1,311
)
—
Deemed dividend related to beneficial
conversion feature of preferred stock
—
—
—
412
Deemed dividend related to conversion of
preferred stock into common stock
—
—
—
299
Adjusted net loss attributable to
common stockholders (Non-GAAP)
$
(15,738
)
$
(9,676
)
$
(54,950
)
$
(44,400
)
Three Months Ended
Years Ended
December 31,
December 31,
2021
2020
2021
2020
Net loss per share attributable to
common stockholders (GAAP)
$
(0.07
)
$
(0.13
)
$
(0.28
)
$
(0.85
)
Adjustments
Amortization of intangible assets
0.01
0.03
0.05
0.15
Change in fair value of contingent
consideration
(0.01
)
0.01
(0.01
)
0.04
Change in fair value of warrant
liabilities
—
—
0.01
—
Restructuring and other charges
—
—
—
0.01
Gain on extinguishment of debt
—
—
(0.01
)
—
Employee retention tax credit
—
—
—
—
Deemed dividend related to beneficial
conversion feature of preferred stock
—
—
—
0.01
Deemed dividend related to conversion of
preferred stock into common stock
—
—
—
0.01
Adjusted net loss per share
attributable to common stockholders (Non-GAAP)
$
(0.07
)
$
(0.09
)
$
(0.24
)
$
(0.63
)
The non-GAAP financial measures for the three months and year
ended December 31, 2021 and 2020, provide management with
additional insight into the Company’s results of operations from
period to period without non-recurring and non-cash charges, and
are calculated using the following adjustments:
a) Intangible assets that are amortized consist of developed
technology and purchased patent rights recorded at cost and
amortized over 5 to 10 years.
b) Contingent consideration in connection with the acquisition
of the Senhance System in 2015 is recorded as a liability and is
the estimate of the fair value of potential milestone payments
related to business acquisitions. Contingent consideration is
measured at fair value using a Monte-Carlo simulation utilizing
significant unobservable inputs including the probability of
achieving each of the potential milestones, revenue volatility, and
an estimated discount rate associated with the risks of the
expected cash flows attributable to the various milestones.
Significant increases or decreases in any of the probabilities of
success or changes in expected timelines for achievement of any of
these milestones would result in a significantly higher or lower
fair value of these milestones, respectively, and commensurate
changes to the associated liability. The contingent consideration
is revalued at each reporting period and changes in fair value are
recognized in the consolidated statements of operations and
comprehensive loss.
c) The Company’s Series B Warrants are measured at fair value
using a simulation model which takes into account, as of the
valuation date, factors including the current exercise price, the
expected life of the warrant, the current price of the underlying
stock, its expected volatility, holding cost and the risk-free
interest rate for the term of the warrant. The warrant liability is
revalued at each reporting period or upon exercise and changes in
fair value are recognized in the consolidated statements of
operations and comprehensive loss.
d) Beginning in the fourth quarter of 2019 and continuing into
the first quarter of 2020, we implemented a restructuring plan to
reduce operating expenses as we continue the global market
development of the Senhance platform. During the first quarter of
2020, the Company continued the restructuring efforts with
additional headcount reductions, which resulted in $0.9 million in
severance costs in the year ended December 31, 2020.
e) During the second quarter of 2021, the Company received
notification from the U.S. Small Business Administration (the
“SBA”) that the principal amount of its Paycheck Protection Program
loan (“PPP loan”) of $2.8 million and related interest had been
forgiven. Gain on extinguishment of debt of $2.8 million was
recognized for the year ended December 31, 2021, in the
consolidated statement of operations and comprehensive loss.
f) During the third quarter of 2021, the Company submitted a
refund for incurred employee payroll taxes of $1.3 million under
the Employee Retention Tax Credit provision as part of the
Coronavirus Aid, Relief, and Economic Security Act (the “CARES
Act”). A corresponding tax credit receivable of $1.3 million was
recorded on the consolidated balance sheet at December 31,
2021.
g) During the first quarter of 2020, the Company closed an
underwritten public offering under which it issued, as part of
units and the exercise of an over-allotment option, 25,367,646
Series C Warrants, each to acquire one share of Common Stock at an
exercise price of $0.68 per share, and 25,367,646 Series D
Warrants, each to acquire one share of Common Stock at an exercise
price of $0.68 per share. The Company concluded that the Series C
Warrants and Series D Warrants are considered equity instruments.
The fair value of the Series C and Series D Warrants on the
issuance date was determined using a Black-Scholes Merton model.
The unit proceeds were then allocated to the Series A preferred
stock, Series C Warrants, and Series D Warrants, respectively,
based on their relative fair values. As a result, the Company
determined that a beneficial conversion feature was created by the
difference between the effective conversion price of the Series A
preferred stock of $0.37 and the fair value of the Company's common
stock as of the issuance date of $0.42. The Company therefore
recorded a beneficial conversion charge of $0.4 million as an
immediate charge to loss available to common stockholders for the
year ended December 31, 2020. Upon conversion of the Series A
preferred stock to common stock, an additional deemed dividend of
$0.3 million was recorded as an immediate charge to loss available
to common stockholders for the year ended December 31, 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220228005917/en/
INVESTOR CONTACT: Mark Klausner or Mike Vallie,
443-213-0499 invest@asensus.com
MEDIA CONTACT: Kristin Schaeffer, 858-354-8850 CG Life
kschaeffer@cglife.com
Asensus Surgical, Inc. (NYSE:ASXC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Asensus Surgical, Inc. (NYSE:ASXC)
Historical Stock Chart
From Sep 2023 to Sep 2024