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 third
quarter 2022.
Recent Highlights
- Over 1,900 procedures were performed globally during the nine
months ended September 30, 2022, representing growth of 27% over
the prior year
- Five new Senhance program initiations year to date, 3 in
Germany, 1 in Japan, 1 in CIS region
- Submitted FDA 510(k) application for pediatric indication in
the U.S.
- Received the Society of Laparoscopic & Robotic Surgeons
2022 Innovation of the Year award for the Intelligent Surgical
Unit™(ISU™)
- The Company had cash, cash equivalents, short-term and
long-term investments, excluding restricted cash, of approximately
$88.3 million at September 30, 2022
“We are very pleased with what we have accomplished this
quarter, with impressive utilization metrics, a growing base of
clinical evidence highlighting the benefits of the Senhance system
and the ISU, and the growth of our installed base,” said Anthony
Fernando, Asensus Surgical President and CEO. “As we have made
great progress towards the ongoing development of
Performance-Guided Surgery and its suite of digital capabilities,
we look forward to continuing to progress the platform to enable
safer, more consistent surgery - resulting in better outcomes for
hospitals and patients alike.”
Digital Surgery Portfolio Expansion
Expanded Global ISU Machine Vision CapabilitiesThe Company
continues to expand the utilization and applicability of the ISU
globally. The Company is seeking CE Mark approval for expanded
machine vision capabilities in Europe, which the Company continues
to expect to receive in late 2022. The newest ISU features include:
real-time 3D measurement, digital tagging, image enhancement, and
enhanced camera control based on real-time data while performing
surgery. The expanded machine vision capabilities have both U.S.
FDA 510(k) clearance and Japanese PMDA approval.
This filing included a review of the entire Senhance System
platform, and if successful, would represent one of the first
robotic surgical systems to be approved through the new, more
rigorous MDR process.
Articulating Instrument LaunchThese instruments are currently in
a pilot launch in the U.S. and Europe, and the Company continues to
expect a full scale commercial launch by the end of 2022.
Articulating Instruments offer better access to difficult-to-reach
areas of the anatomy by providing two additional degrees of
freedom.
U.S. Pediatric Regulatory SubmissionThe Company submitted its
510(k) application for pediatric clearance in the U.S. during the
third quarter of 2022. The Senhance System’s unique combination of
the 3mm instrumentation with 5mm camera scope combined with haptic
feedback make it a unique robotic assisted laparoscopic solution
for pediatric surgeries.
Market Development
Procedure VolumesDuring the first nine months of 2022, over
1,900 procedures have been completed utilizing the Senhance System,
a 27% increase over the same period in 2021. In the third quarter,
surgeons performed over 600 procedures, representing an 18%
increase over the third quarter of 2021. This growth was primarily
driven by strong utilization trends as a result of an expanded
installed base and a growth in new surgeon users at existing
installations as well as a broader market recovery.
When a procedure is performed with a Senhance System, the
Company is able to collect robust data, including surgical video.
Over time, the accumulation of this digital surgical data library
will enable the Company to generate powerful clinical insights that
will fuel the development of Performance-Guided Surgery
capabilities to help surgeons reduce surgical variability and drive
consistently superior surgical outcomes.
Clinical Registry (TRUST)The Company is leveraging its growing
body of real-world clinical data through the utilization of its
TRUSTTM clinical registry. The Company believes TRUST is the
largest multi-specialty robotic-assisted laparoscopic registry in
the industry. The Company continues to grow this body of clinical
data to support its commercial strategy as well as help to
facilitate an increasing number of high-quality clinical
publications demonstrating the value of the Senhance System and
Performance-Guided Surgery, with over 2,000 patients enrolled to
date. The registered procedures consist of approximately 67%
general surgery, including abdominal and thoracic, 15% GYN, and 18%
urology.
Clinical ValidationDuring the quarter, there were three
peer-reviewed clinical papers published providing further support
for the clinical utility of the Senhance System across a variety of
surgical specialties.
These papers can be found at the Company’s website,
www.senhance.com/us/resources.
During the quarter, the Company received the Society of
Laparoscopic & Robotic Surgeons 2022 Innovation of the Year
award for the ISU. Each year, The Society of Laparoscopic &
Robotic Surgeons recognizes the most innovative products that have
a multidisciplinary application in minimally invasive surgery.
New Program InitiationsDuring the third quarter, the Company
announced four Senhance System initiations:
- Evangelical Hospital Goettingen-Weende in Göttingen,
Germany
- Saiseikai Shiga Hospital in Ritto, Japan
- The Clinic for General and Visceral Surgery at the St. Bernhard
Hospital in Kamp-Lintfort, Germany
- A hospital in the Commonwealth of Independent States (CIS)
region
Subsequent to the end of the third quarter, the Company
announced one additional Senhance System initiation, bringing the
year to date total to five:
- The Dr. von Hauner Children's Hospital at the Ludwig
Maximilians University of Munich, located in Munich, Germany.
For the full year 2022, the Company continues to expect to
initiate 8 - 10 new Senhance Surgical Systems.
Third Quarter Financial Results
For the three months ended September 30, 2022, the Company
reported revenue of $2.6 million as compared to revenue of $2.6
million in the three months ended September 30, 2021. Revenue in
the third quarter of 2022 included $1.2 million in system revenue,
$0.3 million in lease revenue, $0.8 million in instruments and
accessories, and $0.3 million in services.
For the three months ended September 30, 2022, total operating
expenses were $17.2 million, as compared to $16.7 million, in the
three months ended September 30, 2021.
For the three months ended September 30, 2022, net loss was
$18.9 million, or $0.08 per share, as compared to a net loss of
$16.1 million, or $0.07 per share, in the three months ended
September 30, 2021.
Adjusted net loss is a non-GAAP financial measure. See the
reconciliation of GAAP to Non-GAAP Measures below. For the three
months ended September 30, 2022, the adjusted net loss was $16.9
million, or $0.07 per share, as compared to an adjusted net loss of
$14.3 million, or $0.06 per share in the three months ended
September 30, 2021, after adjusting for the following charges:
amortization of intangible assets, change in fair value of
contingent consideration, and employee retention tax credit, 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 $88.3
million as of September 30, 2022.
Conference Call
Asensus Surgical, Inc. will host a conference call on Thursday,
November 10, 2022, at 4:30 PM ET to discuss its third quarter 2022
operating and financial results. To listen to the conference call
on your telephone, please dial 1-866-652-5200 for domestic callers
and 1-412-317-6060 for international callers, and reference
conference ID 10171489 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 at
https://ir.asensus.com/events-and-presentations.
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.
Follow Asensus
- Email Alerts: https://ir.asensus.com/email-alerts
- LinkedIn:
https://www.linkedin.com/company/asensus-surgical-inc
- Twitter: https://twitter.com/AsensusSurgical
- YouTube: https://www.youtube.com/c/transenterix
- Vimeo: https://vimeo.com/asxc
- TikTok: https://www.tiktok.com/@asensus_surgical
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and our 2022 third quarter 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 the Company’s platform to enable safer, more consistent
surgery resulting in better outcomes for hospitals and patients
alike; whether the Company will receive CE Mark approval for
expanded machine vision capabilities in Europe in late 2022;
whether the Company’s articulating instruments will undergo a full
scale commercial launch by the end of 2022; whether the Company
will receive a pediatric clearance for the Senhance Surgical System
from the FDA; whether the Company’s TRUST clinical registry is the
largest multi-specialty robotic-assisted laparoscopic registry in
the industry and whether the Company will continue to grow the
Trust registry data to support its commercial strategy; and whether
we will initiate 8-10 new Senhance Surgical Systems placements in
2022. 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.Condensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands,
except per share amounts)(Unaudited)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
1,964 |
|
|
$ |
1,922 |
|
|
$ |
2,565 |
|
|
$ |
3,651 |
|
Service |
|
|
335 |
|
|
|
395 |
|
|
|
1,067 |
|
|
|
1,180 |
|
Lease |
|
|
264 |
|
|
|
254 |
|
|
|
991 |
|
|
|
925 |
|
Total revenue |
|
|
2,563 |
|
|
|
2,571 |
|
|
|
4,623 |
|
|
|
5,756 |
|
Cost of revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
3,057 |
|
|
|
1,993 |
|
|
|
4,316 |
|
|
|
4,671 |
|
Service |
|
|
365 |
|
|
|
342 |
|
|
|
1,506 |
|
|
|
1,344 |
|
Lease |
|
|
982 |
|
|
|
1,015 |
|
|
|
2,752 |
|
|
|
2,794 |
|
Total cost of revenue |
|
|
4,404 |
|
|
|
3,350 |
|
|
|
8,574 |
|
|
|
8,809 |
|
Gross loss |
|
|
(1,841 |
) |
|
|
(779 |
) |
|
|
(3,951 |
) |
|
|
(3,053 |
) |
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,741 |
|
|
|
4,469 |
|
|
|
20,422 |
|
|
|
12,773 |
|
Sales and marketing |
|
|
3,615 |
|
|
|
3,551 |
|
|
|
10,936 |
|
|
|
10,166 |
|
General and administrative |
|
|
4,853 |
|
|
|
5,557 |
|
|
|
15,378 |
|
|
|
13,397 |
|
Amortization of intangible assets |
|
|
2,398 |
|
|
|
2,804 |
|
|
|
7,601 |
|
|
|
8,533 |
|
Change in fair value of contingent consideration |
|
|
(416 |
) |
|
|
278 |
|
|
|
(1,168 |
) |
|
|
1,013 |
|
Property and equipment impairment |
|
|
— |
|
|
|
— |
|
|
|
432 |
|
|
|
— |
|
Total Operating Expenses |
|
|
17,191 |
|
|
|
16,659 |
|
|
|
53,601 |
|
|
|
45,882 |
|
Operating Loss |
|
|
(19,032 |
) |
|
|
(17,438 |
) |
|
|
(57,552 |
) |
|
|
(48,935 |
) |
Other Income (Expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,847 |
|
Change in fair value of warrant liabilities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,981 |
) |
Interest income |
|
|
291 |
|
|
|
122 |
|
|
|
806 |
|
|
|
253 |
|
Interest expense |
|
|
(99 |
) |
|
|
(65 |
) |
|
|
(440 |
) |
|
|
(77 |
) |
Employee retention tax credit |
|
|
— |
|
|
|
1,311 |
|
|
|
— |
|
|
|
1,311 |
|
Other (expense) income, net |
|
|
(29 |
) |
|
|
33 |
|
|
|
(261 |
) |
|
|
(3 |
) |
Total Other Income (Expense),
net |
|
|
163 |
|
|
|
1,401 |
|
|
|
105 |
|
|
|
2,350 |
|
Loss before income taxes |
|
|
(18,869 |
) |
|
|
(16,037 |
) |
|
|
(57,447 |
) |
|
|
(46,585 |
) |
Income tax (expense) benefit |
|
|
(55 |
) |
|
|
(32 |
) |
|
|
(224 |
) |
|
|
4 |
|
Net loss |
|
|
(18,924 |
) |
|
|
(16,069 |
) |
|
|
(57,671 |
) |
|
|
(46,581 |
) |
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(18,924 |
) |
|
|
(16,069 |
) |
|
|
(57,671 |
) |
|
|
(46,581 |
) |
Foreign currency translation
loss |
|
|
(1,655 |
) |
|
|
(931 |
) |
|
|
(4,018 |
) |
|
|
(2,397 |
) |
Unrealized gain (loss) on
available-for-sale investments |
|
|
86 |
|
|
|
(53 |
) |
|
|
(610 |
) |
|
|
(53 |
) |
Comprehensive loss |
|
$ |
(20,493 |
) |
|
$ |
(17,053 |
) |
|
$ |
(62,299 |
) |
|
$ |
(49,031 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share
attributable to common stockholders – basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
used in computing net loss per common share – basic and
diluted |
|
|
236,713 |
|
|
|
234,337 |
|
|
|
236,373 |
|
|
|
224,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Asensus Surgical,
Inc.Condensed Consolidated Balance
Sheets(in thousands, except share
amounts)(Unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,870 |
|
|
$ |
18,129 |
|
Short-term investments, available-for-sale |
|
|
72,481 |
|
|
|
80,262 |
|
Accounts receivable, net |
|
|
2,250 |
|
|
|
749 |
|
Inventories |
|
|
9,035 |
|
|
|
8,634 |
|
Prepaid expenses |
|
|
3,713 |
|
|
|
3,255 |
|
Employee retention tax credit receivable |
|
|
1,147 |
|
|
|
1,311 |
|
Other current assets |
|
|
1,034 |
|
|
|
957 |
|
Total Current Assets |
|
|
103,530 |
|
|
|
113,297 |
|
Restricted cash |
|
|
1,107 |
|
|
|
1,154 |
|
Long-term investments, available-for-sale |
|
|
1,937 |
|
|
|
37,435 |
|
Inventories, net of current portion |
|
|
3,441 |
|
|
|
7,074 |
|
Property and equipment, net |
|
|
9,145 |
|
|
|
10,971 |
|
Intellectual property, net |
|
|
1,529 |
|
|
|
9,892 |
|
Net deferred tax assets |
|
|
227 |
|
|
|
288 |
|
Operating lease right-of-use assets, net |
|
|
4,799 |
|
|
|
5,348 |
|
Other long-term assets |
|
|
2,938 |
|
|
|
1,014 |
|
Total Assets |
|
$ |
128,653 |
|
|
$ |
186,473 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,637 |
|
|
$ |
3,448 |
|
Accrued employee compensation and benefits |
|
|
3,868 |
|
|
|
3,559 |
|
Accrued expenses and other current liabilities |
|
|
1,320 |
|
|
|
1,617 |
|
Operating lease liabilities – current portion |
|
|
662 |
|
|
|
683 |
|
Deferred revenue |
|
|
357 |
|
|
|
543 |
|
Total Current Liabilities |
|
|
9,844 |
|
|
|
9,850 |
|
Long Term Liabilities: |
|
|
|
|
|
|
|
|
Contingent consideration |
|
|
1,203 |
|
|
|
2,371 |
|
Noncurrent operating lease liabilities |
|
|
4,630 |
|
|
|
5,006 |
|
Total Liabilities |
|
|
15,677 |
|
|
|
17,227 |
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Common stock $0.001 par value, 750,000,000 shares authorized at
September 30, 2022 and December 31, 2021; 236,783,315
and235,218,552 shares issued and outstanding at September 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 September 30, 2022 and December
31, 2021, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
960,676 |
|
|
|
954,649 |
|
Accumulated deficit |
|
|
(843,045 |
) |
|
|
(785,374 |
) |
Accumulated other comprehensive loss |
|
|
(4,892 |
) |
|
|
(264 |
) |
Total Stockholders’
Equity |
|
|
112,976 |
|
|
|
169,246 |
|
Total Liabilities and
Stockholders’ Equity |
|
$ |
128,653 |
|
|
$ |
186,473 |
|
|
|
Asensus Surgical,
Inc.Condensed Consolidated Statements of Cash
Flows(in
thousands)(Unaudited)
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
2022 |
|
|
2021 |
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(57,671 |
) |
|
$ |
(46,581 |
) |
Adjustments to reconcile net loss to net cash and cash equivalents
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
2,481 |
|
|
|
2,416 |
|
Amortization of intangible assets |
|
|
7,601 |
|
|
|
8,533 |
|
Amortization of discounts and premiums on investments, net |
|
|
556 |
|
|
|
65 |
|
Stock-based compensation |
|
|
6,361 |
|
|
|
6,589 |
|
Gain on extinguishment of debt |
|
|
— |
|
|
|
(2,847 |
) |
Deferred tax expense (benefit) |
|
|
224 |
|
|
|
(4 |
) |
Change in inventory reserves |
|
|
386 |
|
|
|
377 |
|
Bad debt expense |
|
|
9 |
|
|
|
— |
|
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 |
|
|
(1,168 |
) |
|
|
1,013 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(1,735 |
) |
|
|
113 |
|
Inventories |
|
|
(535 |
) |
|
|
(1,941 |
) |
Operating lease right-of-use assets |
|
|
237 |
|
|
|
(3,174 |
) |
Prepaid expenses |
|
|
(693 |
) |
|
|
1,220 |
|
Employee retention tax credit receivable |
|
|
164 |
|
|
|
(1,311 |
) |
Other current and long-term assets |
|
|
(2,123 |
) |
|
|
2,098 |
|
Accounts payable |
|
|
449 |
|
|
|
1,376 |
|
Accrued expenses |
|
|
236 |
|
|
|
(588 |
) |
Deferred revenue |
|
|
(139 |
) |
|
|
(81 |
) |
Operating lease liabilities |
|
|
(53 |
) |
|
|
3,259 |
|
Net cash and cash equivalents
used in operating activities |
|
|
(44,884 |
) |
|
|
(27,487 |
) |
Investing Activities: |
|
|
|
|
|
|
|
|
Purchase of available-for-sale investments |
|
|
(25,588 |
) |
|
|
(88,232 |
) |
Proceeds from maturities of available-for-sale investments |
|
|
67,702 |
|
|
|
— |
|
Purchase of property and equipment |
|
|
(904 |
) |
|
|
(838 |
) |
Net cash and cash equivalents
provided by (used in) investing activities |
|
|
41,210 |
|
|
|
(89,070 |
) |
Financing Activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
— |
|
|
|
130,361 |
|
Taxes paid related to net share settlement of vesting of restricted
stock units |
|
|
(350 |
) |
|
|
(1,058 |
) |
Proceeds from exercise of stock options and warrants |
|
|
18 |
|
|
|
30,838 |
|
Net cash and cash equivalents
(used in) provided by financing activities |
|
|
(332 |
) |
|
|
160,141 |
|
Effect of exchange rate changes
on cash and cash equivalents |
|
|
(300 |
) |
|
|
(181 |
) |
Net (decrease) increase in cash,
cash equivalents and restricted cash |
|
|
(4,306 |
) |
|
|
43,403 |
|
Cash, cash equivalents and
restricted cash, beginning of period |
|
|
19,283 |
|
|
|
17,529 |
|
Cash, cash equivalents and
restricted cash, end of period |
|
$ |
14,977 |
|
|
$ |
60,932 |
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure for Cash
Flow Information: |
|
|
|
|
|
|
|
|
Cash paid for leases |
|
$ |
729 |
|
|
$ |
781 |
|
Cash paid for taxes |
|
$ |
79 |
|
|
$ |
63 |
|
|
|
|
|
|
|
|
|
|
Supplemental Schedule of Non-cash
Investing and Financing Activities: |
|
|
|
|
|
|
|
|
Transfer of inventories to property and equipment |
|
$ |
1,293 |
|
|
$ |
2,156 |
|
Reclass of warrant liability to common stock and additional
paid-in-capital |
|
$ |
— |
|
|
$ |
2,236 |
|
Lease liabilities arising from obtaining right-of-use assets |
|
$ |
316 |
|
|
$ |
3,857 |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders (GAAP) |
$ |
(18,924 |
) |
|
$ |
(16,069 |
) |
|
$ |
(57,671 |
) |
|
$ |
(46,581 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
|
2,398 |
|
|
|
2,804 |
|
|
|
7,601 |
|
|
|
8,533 |
|
|
Change in fair
value of contingent consideration |
|
(416 |
) |
|
|
278 |
|
|
|
(1,168 |
) |
|
|
1,013 |
|
|
Property and
equipment impairment |
|
— |
|
|
|
— |
|
|
|
432 |
|
|
|
— |
|
|
Gain on
extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,847 |
) |
|
Change in fair
value of warrant liabilities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,981 |
|
|
Employee retention
tax credit |
|
— |
|
|
|
(1,311 |
) |
|
|
— |
|
|
|
(1,311 |
) |
Adjusted
net loss attributable to common stockholders
(Non-GAAP) |
$ |
(16,942 |
) |
|
$ |
(14,298 |
) |
|
$ |
(50,806 |
) |
|
$ |
(39,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
Net loss
per share attributable to common stockholders (GAAP) |
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
intangible assets |
|
0.01 |
|
|
|
0.01 |
|
|
|
0.03 |
|
|
|
0.04 |
|
|
Change in fair
value of contingent consideration |
|
0.00 |
|
|
|
0.01 |
|
|
|
0.00 |
|
|
|
0.01 |
|
|
Property and
equipment impairment |
|
— |
|
|
|
— |
|
|
|
0.00 |
|
|
|
— |
|
|
Gain on
extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(0.01 |
) |
|
Change in fair
value of warrant liabilities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0.01 |
|
|
Employee retention
tax credit |
|
— |
|
|
|
(0.01 |
) |
|
|
— |
|
|
|
(0.01 |
) |
Adjusted
net loss per share attributable to common stockholders
(Non-GAAP) |
$ |
(0.07 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The non-GAAP financial measures for the three and nine months
ended September 30, 2022 and 2021, which provide management with
additional insight into the Company’s results of operations from
period to period without 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 7 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, EURO to USD exchange rate, 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) Property and equipment impairment
associated with returned Senhance Systems under operating leases
that are not expected to generate future cash flows sufficient to
recover their net book value.
d) During the second quarter of 2021, the
Company received notification from the U.S. Small Business
Administration that the principal amount of its Paycheck Protection
Program loan of $2.8 million and related interest had been
forgiven. Gain on extinguishment of debt of $2.8 million was
recognized for the nine months ended September 30, 2021, in the
consolidated statement of operations and comprehensive loss.
e) The Company’s Series B Warrants were
measured at fair value using a simulation model which took into
account, as of the valuation date, factors including the current
exercise price, the expected life of the warrant, the current price
of the underlying stock, its expected volatility, holding cost and
the risk-free interest rate for the term of the warrant. The
warrant liability was revalued upon exercise and the final change
in fair value was recognized in the first quarter of
2021.
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 condensed consolidated balance sheet at
September 30, 2021.
INVESTOR CONTACT:Mark Klausner or Mike Vallie,
443-213-0499invest@asensus.com
OR
MEDIA CONTACT:Isabella Rodriguez,
708-833-1572CG Lifeirodriguez@cglife.com
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