UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-K


ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2019

2021

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

TRANSENTERIX,

ASENSUS SURGICAL, INC.

(Exact name of registrant as specified in its charter)

Delaware

11-2962080

Delaware11-2962080

(State or other jurisdiction of


incorporation or organization)

(I.R.S. Employer


Identification No.)

635 Davis

1 TW Alexander Drive,, Suite 300, Morrisville, 160, Durham, NC27560

27703

(Address of principal executive offices) (Zip Code)

Registrant’s

Registrants telephone number, including area code: (919) (919) 765-8400

Securities registered pursuant to Section12(b) of the Act:

Title of each class

 

Trading Symbol(s)

 

Name of each exchange where registered

Common Stock
$0.001 par value per share

 TRXC

ASXC

 

NYSE American

Securities registered pursuant to Section12(g) of the Act:

None

(Title of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☐    ☒    Nox.

  ☐.

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ☐    Nox.

  ☒.

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.    Yesx  ☒    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).    Yesx  ☒    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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)    Yes      No  x.


☒.

On June 30, 2019,2021, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value (based on the average bid and asked price of its common stock on that date) of the voting stock held by non-affiliates of the registrant was $244.9$732.0 million.

The number of shares outstanding of the registrant’s common stock as of March 12, 2020February 25, 2022 was 46,089,766.

236,408,339.

Documents Incorporated By Reference:  Part III of this Annual Report on Form 10-K is incorporated by reference to our Definitive Proxy Statement on Schedule 14A to be filed in respect of our 20202022 Annual Meeting of Stockholders.



1



TRANSENTERIX,

ASENSUS SURGICAL, INC.

ANNUAL REPORT ON FORM 10-K

DECEMBER 31, 2019

2021

Table of Contents

  

Page

  

   

  

ITEM 9.C.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

81
   

  

   

  

2


FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K, or Annual Report, contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 21E of the Securities Exchange Act of 1934, as amended or the Exchange Act. Such forward-looking statements contain information about our expectations, beliefs or intentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or prospects. You can identify forward-looking statements by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements.

Many factors could cause our actual operations or results to differ materially from the operations and results anticipated in forward-looking statements. These factors include, but are not limited to:

our history of operating losses:
our need to obtain additional funding to continue our operations;
our ability to successfully transition from a research and development company to a company focused on market development activities and sales and distribution of our products;
our ability to successfully develop, clinically test and commercialize our products;
our ability to identify and pursue development of additional products;
the timing and outcome of the regulatory review process for our products;
competition from existing and new market entrants;
the impact of foreign currency fluctuations on our financial results;
our ability to attract and retain key management, marketing and scientific personnel;
our ability to successfully prepare, file, prosecute, maintain, defend and enforce patent claims and other intellectual property rights;
changes in the health care and regulatory environments of the United States, Europe and other jurisdictions in which the Company operates; and
other factors contained in the section entitled “Risk Factors” contained in this Annual Report.

our history of operating losses:

our ability to successfully grow the sales and distribution of our products;

our ability to successfully implement our Performance-Guided Surgery™  strategy and grow our business as a result;

our ability to increase use of our products by existing and new customers;

competition from existing and new market entrants;

our ability to successfully develop, clinically test and commercialize our new products;

our ability to identify and pursue development of additional products;

the timing and outcome of the regulatory review process for our products;

the impact of foreign currency fluctuations on our financial results;

our ability to attract and retain key management, marketing and scientific personnel;

our ability to successfully prepare, file, prosecute, maintain, defend and enforce patent claims and other intellectual property rights;

changes in the health care and regulatory environments of the United States, Europe and other jurisdictions in which the Company operates; and

other factors contained in the section entitled “Risk Factors” contained in this Annual Report.

We do not undertake any obligation to update our forward-looking statements, except as required by applicable law.

In February 2021, we changed our name from TransEnterix, Inc. to Asensus Surgical, Inc. In this Annual Report we refer to TransEnterix,Asensus Surgical, Inc. and its subsidiaries collectively as the “Company,” “it,” “we,” “our” or “us.”  The Company’s subsidiaries are: TransEnterixAsensus Surgical US, Inc., SafeStitch LLC, TransEnterixAsensus International, Inc.; TransEnterixAsensus Surgical Italia S.r.l.; TransEnterixAsensus Surgical Europe S.à.R.L; TransEnterix Asia Pte. Ltd.; TransEnterix.r.l; Asensus Surgical Taiwan Ltd; TransEnterixAsensus Surgical Japan KK, TransEnterixK.K.; Asensus Surgical Israel Ltd.; Asensus Surgical Netherlands B.V.; and TransEnterix Netherlands B.V.Asensus Surgical Canada, Inc.

3

PART I

ITEM 1.

BUSINESS

ITEM 1.BUSINESS

Overview

In February 2021, we changed our name from TransEnterix, isInc. to Asensus Surgical, Inc. We are a medical device company that is digitizing the interface between the surgeon and the patient in laparoscopyto pioneer a new era of Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of laparoscopic surgery. This builds upon the foundation of Digital Laparoscopy with our 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.

Our mission is focused on leveraging robotic technologies, augmented intelligence, and machine learning capabilities to: reduce variability in today’s value-basedsurgery, drive more predictable outcomes, optimize resources and costs, and work with hospital systems that strive to employ innovative healthcare environment.strategies. By leveraging advanced digital technologies, we aim to enable surgeons to take the best surgical practices and techniques from everywhere and utilize them to help improve outcomes, reduce variability, control the unexpected, reduce costs, reduce cognitive and physical fatigue of surgeons, and provide patients with the best care possible. We believe that by digitizing the interface between the surgeon and patient, we can unlock clinical intelligence to pioneer a new era of surgery, which we are calling Performance-Guided Surgery.

Historical advances in surgery have largely focused on bringing tools and techniques into the operating room to reduce the invasiveness of procedures. When we introduced Digital Laparoscopy, our intention was to help surgeons minimize surgical variability in a cost-effective manner. The next logical step in the progression is looking for ways to deliver clinical intelligence and analytics which we believe can be enabled by what we refer to as Performance-Guided Surgery.

Performance-Guided Surgery builds upon our foundation of Digital Laparoscopy by adding machine vision, augmented intelligence, and deep learning capabilities through all surgical phases to help guide improved decision making, enriched collaboration, and enhanced predictability for all surgeons (independent of skill level and experience). Our Performance-Guided Surgery strategy is composed of the following framework:

Pre-operative - in what we call “intelligent preparation,” our machine learning models will take data from all 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 – finally, by tapping into the vast amount of data captured during procedures, surgeons and operating room staff will be able to get “performance analytics” with 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 continue the market development for and commercialization of the Senhance® SurgicalSystem, which digitizes laparoscopic minimally invasive surgery, or MIS. The Senhance Surgical System is the first and only multi-port, digital multi-port laparoscopiclaparoscopy platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including 3 millimeter3mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control and fully-reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy.

We believe that future outcomes of minimally invasive surgery will be enhanced through our combination of more advanced tools and robotic functionality which are designed to:

empower surgeons with improved precision, ergonomics, dexterity and visualization;
offer high patient satisfaction and enable a desirable post-operative recovery; and
provide a cost-effective robotic system, compared to existing alternatives today, for a wide range of clinical applications and operative sites within the healthcare system.

empower surgeons with improved precision, ergonomics, dexterity and visualization;

offer high patient satisfaction and enable a desirable post-operative recovery; and

provide a cost-effective robotic system, compared to existing alternatives today, for a wide range of clinical applications and operative sites within the healthcare system.

Our strategy is to focus on the market development, commercialization, and further development of the Senhance System.

We further believe that:
laparoscopic and robotic surgery will need to continue to evolve given the pressures of value-based healthcare and existing operating room inefficiencies, surgical variability and workforce challenges;
with the Senhance System, surgeons can benefit from the haptic feedback, enhanced three-dimensional, high definition, or 3D HD, vision and open architecture consistent with current laparoscopic surgery procedures; and
patients will continue to seek a minimally invasive option, offering minimal scarring and fewer incisions, for many common general abdominal and gynecologic surgeries, which desires are addressed by the Senhance System.

laparoscopic robotic surgery will need to continue to evolve given the pressures of value-based healthcare and existing operating room inefficiencies, surgical variability, and workforce challenges;

with the Senhance System, surgeons can benefit from the haptic feedback, enhanced three-dimensional, high definition, or 3DHD, vision, and open architecture consistent with current laparoscopic surgery procedures; and

patients will continue to seek a minimally invasive option, offering minimal scarring and fewer incisions, for many common general abdominal and gynecologic surgeries, which desires are addressed by the Senhance System.

The Senhance System addresses these key challenges for laparoscopic surgeons and hospitals by delivering the benefits of robotics with improved control of the surgical field, enhanced visualization and camera control and improved ergonomics, coupled with the familiarity of laparoscopic motion and consistent per-procedure costs.

The Senhance System is available for sale in Europe, the United States, Japan, Taiwan, Russia 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.

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, we have 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 (gallbladder removal) surgery.

In Japan, we have received regulatory approval and reimbursement for 98 laparoscopic procedures.

The Senhance System received its registration certificate by the Russian medical device regulatory agency, Roszdravnadzor, 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 (which we refer to as a Lease Buyout). In the first quarter of 2021, we completed one Lease Buyout of a Senhance System.

Our focus over the last few years has been on seeking regulatory approvals and clearances for the Senhance System and related product offerings and instruments and pursuing commercialization of our products. The following chart describes our success in achieving regulatory clearances and approvals to date.

Product/Indications

FDA Clearance

CE Mark

Other Approvals

Senhance System

October 2017

January 2012

Taiwan – April 2018

Japan – May 2019

Russian Federation – December 2020

Indications for Use of Senhance System

●     Initial general surgery indications for laparoscopic colorectal and gynecologic surgery procedures

October 2017

N/A

N/A

●     Extended to cholecystectomy and inguinal hernia repair

May 2018

N/A

N/A

●     Extended to hiatal and paraesophageal hernia, sleeve gastrectomy, and sacrocolpopexy

March 2021

N/A

N/A

●     General surgery indications

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

For adult and pediatric laparoscopic abdominal and pelvic surgery, as well as limited thoracic surgeries excluding cardiac and vascular surgery

Japan – regulatory approval and reimbursement for 98 laparoscopic procedures – July 2019

●     Pediatric indications

N/A

February 2020

N/A

Instruments and Other Products

●     Intelligent Surgical Unit, or ISU

Initial - March 2020

Expansion of augmented intelligence in August 2021

January 2021

Japan - December 2020

●     5mm articulating instruments

July 2021

September 2018

N/A

●     3mm diameter instruments

October 2018

April 2019

Taiwan - November 2018

Japan - October 2019

●     Senhance ultrasonic system

January 2019

September 2018

Japan - October 2020

●     3 and 5mm hooks

5mm July 2019

3mm November 2019

December 2019

Japan - December 2020

On January 19, 2021, we announced that we received CE Mark for the ISU, allowing us to expand our augmented intelligence capabilities to all global areas accepting CE Marks. In addition, in August 2021, we received FDA clearance for expanded augmented intelligence features on the ISU. The ISU enables machine vision-driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical fields and allows a surgeon to change the visualized field of view using the movement of their instruments. The newest ISU features expand upon these capabilities and introduce more advanced features including 3D measurement, digital tagging, image enhancement, and enhanced camera control based on real-time data from anatomical structures while performing surgery. We acquired the assets used in the development of the ISU as part of our October 2018 acquisition of the assets, intellectual property and highly experienced multidisciplinary personnel of Medical Surgical Technologies, Inc., or MST, an Israeli-based medical technology company.

On July 28, 2021, we announced that we 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 previously received CE Mark for use in the EU.

We also focused on expanding the indications for use of the Senhance System. As of March 2021, the Senhance System is FDA cleared for use in general laparoscopic colorectalsurgical procedures and laparoscopic gynecologic surgery in a total of 2831 indicated procedures, including benign and oncologic procedures, laparoscopic inguinal, hiatal and paraesophageal hernia, sleeve gastrectomy and laparoscopic cholecystectomy (gallbladder removal) surgery.

In Japan, we have received regulatorycholecystectomy. We continue to make additional submissions for clearance or approval and reimbursement for 98 laparoscopic procedures.
During 2018 and 2019, we successfully obtained FDA clearance and CE Mark for our 3 millimeter diameter instruments, our Senhance ultrasonic system, our 3 millimeter and 5 millimeter hooks, and the Senhance articulating system. The 3 millimeter instruments enableenhancements to the Senhance System to be used for microlaparoscopic surgeries, allowing for tiny incisions. The ultrasonic system is an advanced energy device used to deliver controlled energy to ligate and divide tissue, while minimizing thermal injury to surrounding structures. The Senhance articulating system was launchedrelated instruments and accessories, including additional filings and approvals sought in Europe in November 2019 and we are evaluating our pathway forward to launch such a system in the United States with a planned submission for US clearance at the end of 2020.
In January 2020, we submitted an application to the FDA seeking clearance of the first machine vision system for our robotic surgery unit named Intelligent Surgical Unit (ISU™). Such Intelligent Surgical Unit was developed using the image analytics technology acquired from MST. The Company believes it is the first such FDA submission seeking clearance for machine vision technology in abdominal robotic surgery. On March 13, 2020, the Company announced that it has received FDA clearance for the Intelligent Surgical Unit.

We believe that future outcomes of minimally invasive laparoscopic surgery will be enhanced through our combination of more advanced tools and robotic functionality, which are designed to: (i) empower surgeons with improved precision, dexterity, visualization, and tools that help reduce the cognitive load on surgeons during surgery thus reducing surgeon fatigue; (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.
Japan.

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. As a result, we will need to generate significant revenue in order to achieve profitability. The Company operates in one business segment.

2021 Market Development Activities

In 2021 we filed an amendmentcontinued to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our common stock at a ratio of one-for-thirteen, or the Reverse Stock Split. Our common stock began trading on a split-adjusted basis on NYSE American on the morning of December 12, 2019. No fractional shares were issued in connection with the Reverse Stock Split. Instead, we rounded up each fractional share resulting from the reverse stock split to the nearest whole share. As a result of the Reverse Stock Split, our outstanding common stock decreased from approximately 261.9 million shares to approximately 20.2 million shares (without giving effect to the rounding up for each fractional share).


Unless otherwise noted, all share and per share data referenced in this Annual Report have been retroactively adjusted to reflect the Reverse Stock Split. Certain amounts in the financial statements, the notes thereto, and elsewhere in this Annual Report, may be slightly different than previously reported due to rounding of fractional shares as a result of the Reverse Stock Split.
Restructuring
Despite the number of advances and regulatory clearances received in 2018 and 2019, our Senhance System sales in 2019 were disappointing. Adoption of new technologies, particularly for capital intensive devices such as the Senhance System can be slow and uneven as market development and commercial development is time-consuming and expensive. We have determined to refocusfocus our resources and efforts in 2020 on market development activities to increase awareness of:
the benefits of the use of the Senhance System in laparoscopic surgery;
the digitization of high volume procedures using the Senhance System;
the indications for use, including pediatric indications of use in CE Mark territories; and
the overall cost efficiency of the Senhance System

the benefits of the use of the Senhance System in laparoscopic surgery;

the digitization of high volume procedures using the Senhance System;

the technical advancement of digital surgical tools to lead to the realization of Performance-Guided Surgery;

the indications for use, including pediatric indications of use in CE Mark territories; and

the overall cost efficiency of the Senhance System.

We intend to focusare focusing on markets with high utilization of laparoscopic techniques, including Japan, Western Europe and the United States. Our focus will beis on (1) increasing the number of placements of the Senhance System, not necessarily through sales, but through leasing arrangements, (2) increasing the number of procedures conducted using the Senhance System quarter over quarter, and (3) solidifying key opinion leader support and publications related to the use of the Senhance System in laparoscopic procedures. During this period we willWe are not focuscurrently focusing on revenue targets.

Duringtargets, especially in the United States.

2021 Senhance Surgical System Programs

We define the initiation of a Senhance Surgical program as entering into an agreement to purchase or lease, and subsequently utilize a Senhance Surgical System. Throughout 2021, we initiated ten Senhance System programs, one in the U.S., six in EMEA, and three in Asia. We initiated six Senhance System programs in the fourth quarter of 2019,2021 alone.

Training Sites

In February 2021, we announced an agreement with the implementationAmsterdam Skills Centre establishing the second European surgical training site for Senhance System Digital Laparoscopy. This site will serve surgeons and staff throughout Europe with basic and advanced training on the Senhance System. The Amsterdam Skills Centre will also provide Asensus with a world-class facility to engage European surgeons in technology and clinical development studies.

We now have six global training sites, including three in the United States at the Advent Health Nicholson Center in Celebration, Florida, at LSU Health’s University Medical Center New Orleans, and our office in Research Triangle Park North Carolina; two in Europe at Amsterdam Skills Center, and our office in Milan, Italy; and, one in Japan at Saitama Medical University International Medical Center in Tokyo.

Procedure Volumes

In 2021, surgeons performed over 2,100 procedures utilizing the Senhance System, representing a 45% increase over the previous year, despite the continued impact of a restructuring planthe COVID-19 pandemic on elective surgeries and hospital operations. These procedures included general surgery, gynecology, urology, colorectal and bariatric surgical cases.

Foundational Sites

Foundational sites are hospitals that are performing clinical procedures with the Senhance System at an annualized rate of greater than 100 procedures per year. The COVID-19 pandemic’s impact on establishing sites, and training physicians, coupled with periodic suspension of elective surgeries by hospitals have impacted case volumes resulting in volatility in specific hospitals and regions. As we continue to emphasize the training and onboarding of new surgeon users and focus on increased utilization, we expect to see growth in foundational sites.

Performance-Guided Surgery (PGS)

PGS builds upon the foundation of Digital Laparoscopy by adding machine vision, augmented intelligence, and deep learning capabilities to help guide improved decision making, enrich collaboration, and enhance predictability for all surgeons, independent of training or experience, to shift the promise of consistently superior surgery into practice.  Historical advances in surgery have largely focused on bringing tools and techniques into the OR to reduce the invasiveness of procedures and improve the execution of discrete tasks. Unlike many other industries, very little focus has been on improving the decision-making aspects of the surgical process, which is crucial in the high-pressure, highly variable situations which happen repeatedly during any surgery.  PGS focuses on a holistic solution for the entire surgeon workflow to drive consistently superior outcomes. We believe PGS can deliver real-time clinical decision support to boost surgeon capabilities to perceive complex environments, make decisions, and perform the desired tasks with increased precision, safety, and efficiency to mitigate surgical errors and complications.

Senhance Connect

Senhance Connect is a mobile tool that allows surgeons in an operating expenses as we continueroom to connect with and communicate with other Senhance surgeons in other locations. The process allows for streaming of multiple camera views and an endoscopic view simultaneously, and allows for two-way screen sharing and annotation. This feature is part of our PGS ability to provide real-time digital collaboration capabilities to surgeons.

7

Clinical Validation

During 2021, there were 21 peer-reviewed clinical papers published providing further support of the global market developmentclinical utility of the Senhance platform. UnderSurgical System across gynecology, general surgery, urology, and colorectal procedures demonstrating the restructuring plan, we reduced headcountutility breadth and the complexity of procedures being performed. In particular, there were four milestone papers published in 2021:

In April, a study was published comparing health economic outcomes of the Senhance System versus another robotic system, as well as traditional laparoscopy. According to the study, the Senhance System was less than half the median instrument cost compared to procedures performed on another robotic platform and was comparable to traditional laparoscopic-assisted vaginal hysterectomy costs for certain gynecologic procedures.

In May, a study was published which analyzed the outcomes of over 800 Senhance System procedures across multiple specialties including hernia repairs, cholecystectomies, and prostatectomies based on data from the Company’s real-world clinical data registry, TRUST. According to the study, Senhance System procedures are safe and reproducible and deliver promising clinical outcomes.

In August, a study was published which analyzed the outcomes and experience of utilizing the Senhance System to perform a high volume of urologic procedures. According to the study, the Senhance System is a safe and feasible platform to perform multiple common urologic procedures, namely upper urinary tract and extraperitoneal radical prostatectomies.

In September, a study was published which analyzed the outcomes of inguinal hernia repair procedures based on data from the Company’s TRUST registry. According to the study, the Senhance System is a safe and doable platform to perform inguinal hernia repair procedures, and it can deliver high quality clinical outcomes related to patient recovery time, length of hospital stay, and postoperative pain.

Impact of COVID-19

The COVID-19 pandemic had a significant impact on us in 2021 and continues to have a significant impact on our operations, primarily in the sales and marketing functions and determined that the carrying value of our inventory exceeded the net realizable value due to a decreasethe continued repeated temporary cessation of elective surgical procedures in expected sales. The restructuring charges amountedmany markets, and the challenges and restrictions caused by stay-at-home orders, social distancing requirements and travel restrictions. Our business and customers were negatively impacted by the COVID-19 pandemic, which suspended many elective surgical procedures globally, curtailed travel and necessarily diverted the attention of hospital customers. A variety of travel restrictions have caused delays in product installation and training activities. This has significantly impacted our ability to $8.8 million,implement our market development activities to place our Senhance Systems, provide training, and increase the use of which $7.4 million was an inventory write down and was includedthe Senhance Systems in costplace. Given the dynamic nature of product revenue and $1.4 million related to employee severance costs and was included as restructuring and other charges inthis health emergency, the consolidated statementsfull impact of the COVID-19 pandemic on ongoing business, results of operations and comprehensive loss, during the fourth quarter of 2019. Future payments under the restructuring plan are expected to conclude in 2020.

During March 2020, we continued our restructuring with additional headcount reductions which resulted in $0.8 million related to severance costs which are expected tooverall financial performance cannot be paid in 2020 and 2021.
reasonably estimated at this time.

Recent Financing Transactions

The Company has

In 2021, we engaged in a number of equity financing transactions to fund our operations and extend our cash reach to provide capital raising transactions in 2019 and 2020 to date. progress our strategy. These financings included:

January 2021 Public Offering. On January 29, 2021, we completed an underwritten public offering of 26,545,832 shares of our 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, we sold in a registered direct offering 25,000,000 shares of common stock at a purchase price per share of $1.25 for aggregate gross proceeds of $31.25 million, and net proceeds of $28.6 million.

At-the-Market Offerings. On October 9, 2020, we filed a prospectus supplement relating to an at-the-market offering, referred to as the “2020 ATM Offering”, with Cantor Fitzgerald & Co, or Cantor, pursuant to which we could sell from time to time, at our option, up to an aggregate of $40.0 million of shares of our common stock, through Cantor as sales agent, pursuant to a Controlled Equity Offering Sales Agreement dated August 12, 2019, referred to as the 2019 Sales Agreement. We terminated this agreement in January 2021.

On August 12, 2019, the CompanyMay 19, 2021, we entered into a Controlled Equity Offering Sales Agreement, or the 2019SM Sales Agreement with Cantor, FitzgeraldRobert W. Baird & Co. Incorporated and Oppenheimer & Co. Inc., or Cantor, pursuantas our sales agents, relating to which the Company may sell from time to time, at its option,an at-the-market offering of up to an aggregate of $25.0 million$100,000,000 of shares of the Company’s


our common stock, through Cantor,referred to as sales agent, or the 2019“2021 ATM Offering. The aggregate compensation payable to Cantor was 3.0%Offering”.

8

Sales during the year ended December 31, 2019,2021, under the 2020 and an additional $11.22021 ATM Offerings are as follows (in thousands except for share and per share amounts):

  

Year Ended

December 31, 2021

 
     

Total shares of common stock sold

  20,237,045 

Average price per share

 $1.53 

Gross proceeds

 $30,943 

Commisssion earned by Sales Agents

 $928 

Net proceeds

 $30,015 

2021 Exercise of Warrants. During 2021, certain holders of 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.

Following such financing transactions, we had cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of $135.8 million as of net proceeds to date in 2020.

On September 4, 2019, the Company entered into an Underwriting Agreement, or the Underwriting Agreement, with Cantor. Subject to the termsDecember 31, 2021, and conditions of the 2019 Underwriting Agreement, the Company sold to Cantor, in a firm commitment underwritten offering, 2,153,846 shares of the Company’s common stock. In addition, the Company granted Cantor a 30-day option to purchase 323,077 of additional shares of common stock. The Company raised $18.8 million in gross proceeds and $18.7 million in net proceeds under this offering. The option to purchase additional shares of common stock was not exercised.
On February 10, 2020, we entered into a purchase agreement, or the LPC 2020 Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, pursuant to whichbelieve we have the rightsufficient capital to sell to Lincoln Park up to an aggregate of $25,000,000 in shares offund our common stock, subject to certain limitations and conditions set forth in the LPC 2020 Purchase Agreement, including a limitation on the number of shares of common stock we can put to LPC and the pricing parametersoperations for the sales.   In consideration for entering into the LPC 2020 Purchase Agreement, we issued to Lincoln Park 343,171 shares of Common Stock as commitment shares. We also committed to issue up to an additional 171,585 shares of Common Stock to Lincoln Park on a pro rata basis based on the number of shares Common Stock purchased by Lincoln Park pursuant to the LPC 2020 Purchase Agreement.
On March 10, 2020, the Company closed a firm commitment underwritten public offering, or the 2020 Public Offering, pursuant to which it sold an aggregate of 14,121,766 Class A Units at a public offering price of $0.68 per Class A Unit and 7,937,057 Class B Units at a public offering price of $0.68 per Class B Units. Each Class A Unit consists of one share of the Company’s common stock, one warrant to purchase one share of common stock that expires on the first anniversary of the date of issuance, or collectively, the Series C Warrants, and one warrant to purchase one share of common stock that expires on the fifth anniversary of the date of issuance, or collectively, the Series D Warrants. Each Class B Unit consists of one share of Series A Convertible Preferred Stock, par value $0.01 per share, or the Series A Preferred Stock, convertible into one share of common stock, a Series C Warrant to purchase one share of Common Stock and a Series D Warrant to purchase one share of Common Stock. The Class A Units and Class B Units have no stand-alone rights and were not certificated or issued as stand-alone securities. The shares of common stock, Series A Preferred Stock, Series C Warrants and Series D Warrants are immediately separable. In addition, the underwriter for the 2020 Public Offering exercised its overallotment option to purchase 3,308,823 Series C Warrants and 3,308,823 Series D Warrants for an aggregate purchase price of $60 thousand. The net proceeds to the Company were $13.4 million.
more than 12 months.

Market Overview

Over the past three decades, laparoscopic surgery has emerged as a minimally invasive alternative to open surgery. In laparoscopic surgery, multiple incisions are necessary to provide surgical access ports. Carbon dioxide gas insufflation is then used to create room in the body cavity, and long rigid instruments are introduced through ports placed in the incisions to perform surgical tasks. Millions of laparoscopic surgical procedures across a broad range of clinical applications are now performed each year worldwide, though many surgeries are still performed in an open fashion.

While laparoscopy has improved the invasive nature of many previously open procedures, it still has many limitations. Traditional, or rigid, laparoscopy still requires multiple incisions to achieve the visualization and instrument triangulation required to perform successful surgery. Rigid laparoscopy also creates physical challenges by forcing the surgeon’s hands and arms into awkward angles, requiring the surgeon to hold instruments in fixed positions for long periods of time and requiring an assistant to stabilize and move a laparoscopic camera. Another challenge associated with rigid laparoscopic surgery is the creation of a cumbersome and potentially tissue-damaging fulcrum at the patient’s abdominal wall where instruments are manipulated. Nearly all laparoscopic instruments are rigid instruments that lack internal articulation to enhance dexterity in complex tasks. Most laparoscopic surgeries are performed with two-dimensional, or 2-D, visualization of the operative field, making depth perception difficult.

Despite such limitations, traditional laparoscopy remains the prevalent technique in minimally invasive surgery. We believe that robotic devices that replicate laparoscopic motion are more comfortable for surgeons to adopt. Our Senhance System mimics laparoscopic surgery.

We are uniquely focused on the laparoscopic surgical market as we believe it separates us from our competitors and allows surgeons to perform minimally invasive surgery in a method more comfortable for the patient than open surgery utilizing fully reusable tools, smaller instruments to broaden applicability of the laparoscopic method, including in pediatric cases, and to utilize the additional Senhance System technology such as the ISU.

Robotic and computer-controlled assistance have developed as technologies that offer the potential to improve upon many aspects of the laparoscopic surgical experience. Hundreds of thousands of robotic-assisted surgicalAccording to DRG Global Market’s Laparoscopic Surgical Robotic Devices (October 2020), the existing laparoscopic market for soft tissue abdominal surgery is 16 million procedures are now performed each year worldwide, but they still represent a small fraction (less than 10%) of the total abdominal laparoscopic procedures performed. While initialannually. Initial widespread adoption of robotic-assisted surgery was focused on urologic and gynecologic procedures that were primarily performed in an open fashion prior to robotics, but more recently developed robotic approaches like the Senhance System have been applied to many other


clinical applications, particularly in general surgery.

Despite recent advances and new entrants into the market, we believe there remain many limitations associated with current robotic-assisted surgery systems used in connection with laparoscopic surgeries.

systems.

We digitize the surgical interface between the surgeon and the patient.patient by providing a computer controller interface for the surgeon to manipulate surgical instruments and move the visualization system.  We believe image analytics technology will help accelerate and drive meaningful adoption of the Senhance System and allow us to expand the Senhance System capabilities to add augmented intelligence and reality vision capabilities.

The historical advances in surgery have largely focused on bringing tools and techniques into the operating room to reduce the invasiveness of procedures. When we introduced Digital Laparoscopy, our intention was to help surgeons minimize surgical variability in a cost-effective manner. The next step in the progress is looking for ways to deliver superior outcomes which we believe can be enabled by what we refer to as Performance-Guided Surgery.

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Factors plaguing the healthcare industry that amplify the urgency for Performance-Guided Surgery include:

Value-based care is shifting a greater responsibility for poor quality and inefficiency to hospitals and physicians;

COVID-19 exposed the financial frailty of the hospital system as well as capacity and resource constraints, which must be bolstered and requires an acceleration of innovation; and

Patients are presenting with more complex conditions and treating them becomes more complicated. The absolute number of patients seeking care is increasing, and many more patients have multiple chronic conditions than they did a generation, or even a decade ago.

These factors make it the ideal time to integrate advanced technology in the operating room.

Product Overview

We are addressing the challenges in laparoscopy and robotic-assisted surgery with technologically advanced products and product candidates that leverage the best features of both approaches to minimally invasive surgery, or MIS.

The Senhance Surgical System

On September 18, 2015, the Company entered into a Membership Interest Purchase Agreement, or the Purchase Agreement, with Sofar S.p.A., or Sofar, as seller, pursuant to which the Company acquired the Senhance System and related assets and personnel, or the Senhance Acquisition. The closing occurred on September 21, 2015. For a description of the Senhance Acquisition and related transactions, see the disclosure titled “Senhance Acquisition and Related Transactions” under Item 7, “Management’s Discussion and Analysisin Note 3 of the Notes to the Consolidated Financial Condition and Results of Operations”Statements in this Annual Report.

The Senhance System is a multi-port robotic surgery system that allows up to four arms to control robotic instruments and a camera. The system builds on the success of laparoscopy by enhancing the traditional features that surgeons have come to expect from existing products and by addressing some of the limitations associated with robotic surgery systems for laparoscopic procedures. The Senhance System also offers responsible economics to hospitals through its robotic technology coupled with reusable standard instruments that yield minimal additional costs per surgery when compared to laparoscopy. The Senhance System has a CE Mark in Europe for laparoscopic abdominal and pelvic surgery, as well as limited thoracic operations excluding cardiac and vascular surgery. In April 2017, the Company submitted a 510(k) submission to the FDA for the Senhance System. On October 13, 2017, the Company received 510(k) clearance for the Senhance System for use in laparoscopic colorectal and gynecologic surgery.  In May 2018, the indications for use expanded when we received 510(k) clearance from the FDA for use of the Senhance System in laparoscopic inguinal hernia and laparoscopic cholecystectomy surgery for a total of 28 indicated procedures.  During 2018 and early 2019, we successfully obtained FDA clearance and CE Mark for a number of instruments used with the Senhance System, as described further below. In February 2020, we received CE Mark for the Senhance System and related instruments for pediatric use indications in CE Mark territories.

In March 2021, we received 510(k) clearance from the FDA for indication expansion in general surgery allowing for sleeve gastrectomy, and hiatal and paraesophageal hernia repair.

The Senhance System is commercially available for sale in the United States, Europe, Japan, Taiwan, Russia and select other countries.

Key features of the Senhance System are:

Fully Reusable, Autoclavable Instrumentation: the

Fully Reusable, Autoclavable Instrumentation: The Senhance System offers standard instrumentation that is cleaned and sterilized using current autoclave technology that does not require additional, less standard instrumentation that is cleaned and sterilized using current autoclave technology that does not require additional, non-standard sterilization methods, and that has no pre-set limitation on number of uses that require them to be disposed.

Enhanced Vision, Eye-Tracking Camera Control: The Senhance System is compatible with three-dimensional high definition, or 3DHD, vision technology, which provides the surgeon with additional depth and spatial relation of organs; and a tremor free view of the surgical field and is centered in the surgeon’s field of vision. Eye-tracking camera control, allows hands free, surgeon-controlled visualization.

Intelligent Surgical Unit or ISU: The ISU enables machine vision capabilities providing the ability to recognize certain objects and locations in the surgical field. This capability enhances visualization and camera control over currently available surgical technologies, and provides the foundation for additional augmented intelligence capabilities, with a number of enhancements added and FDA-cleared in 2021. Additionally, the ISU improves surgical team collaboration by seamlessly sharing the surgeon’s console view in real-time across the entire operating room. The most recently cleared augmented intelligence features available in the U.S. and Japan include 3D point-to-point measurement, advanced endoscopic control modalities, image enhancement, and intra-operative surgeon digital tagging. Further features may include anatomical structure identification, further enhancing the digital laparoscopic experience with the Senhance System.

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Enhanced Vision, Eye Tracking Camera Control: the Senhance System is compatible with three-dimensional high definition, or 3D HD, vision technology providing the surgeon with additional depth and spatial relation of organs; tremor free view of the surgical field and is centered in the surgeon’s field of vision. Eye-tracking camera control, allows hands’ free, surgeon-controlled visualization;
Haptic Feedback: the Senhance System’s haptic feedback feature heightening the surgeon’s sensing of pressure/tension throughout the surgical procedure, haptics provide the surgeon with the ability to feel the tissue response of the body during a procedure;
Laparoscopic Motion: digital laparoscopy, maintaining familiar motions, tools and techniques that is similar to the motion used during traditional laparoscopic surgeries;
Comfortable Ergonomics: ergonomic seating for the surgeon throughout the procedure to help reduce fatigue and risk of musculoskeletal injuries;
E-Fulcrum: a digital fulcrum, setting a dynamic virtual pivot point that helps to potentially minimize incision trauma;
Open-Platform Architecture: allows the use and integration of existing operating room technologies to maximize benefit from capital investments and support surgeon preference (e.g., trocars, electrosurgical units, insufflators, select vision systems, etc.); and

View of the Sterile Field: the Senhance System offers the user an open view of the operating room and sterile field from the ergonomically-designed console.

Haptic Feedback: The Senhance System’s haptic feedback feature heightens the surgeon’s sensing of pressure/tension throughout the surgical procedure; haptics provides the surgeon with the ability to feel the tissue response of the body during a procedure.

Laparoscopic Motion: Digital laparoscopy maintains familiar motions, tools, and techniques that are similar to the motion used during traditional laparoscopic surgeries.

Comfortable Ergonomics: Ergonomic seating for the surgeon throughout the procedure helps to reduce fatigue and risk of musculoskeletal injuries.

E-Fulcrum: A digital fulcrum, setting a dynamic virtual pivot point, helps to potentially minimize incision trauma.

Open-Platform Architecture: The Senhance System allows the use and integration of existing operating room technologies to maximize benefit from capital investments and support surgeon preference (e.g., trocars, electrosurgical units, insufflators, select vision systems, etc.).

View of the Sterile Field: The Senhance System offers the user an open view of the operating room and sterile field from the ergonomically-designed console.

The Senhance System is manufactured for us by third partythird-party contract manufacturers. We or our manufacturers acquire raw materials and components of the Senhance System from vendors, some of which are sole suppliers. We believe our relationships with our vendors and manufacturing contractors are good. We further believe that we have the manufacturing capacity and inventory reserves to meet our anticipated Senhance System sales for the foreseeable future. We are currently taking steps to develop redundant manufacturing and supply alternatives that will expand our manufacturing capacity to help meet future demand.  

Instruments and Other Products

Instruments

During 2018 and 2019, we

We successfully obtained FDA clearance and CE Mark for a number of instruments, including, our 3 millimeter3mm diameter instruments, our Senhance ultrasonic system, our 3 millimeter3mm and 5 millimeter5mm hooks and the Senhance articulating system.instruments. The 3 millimeter3mm instruments enable the Senhance System to be used for microlaparoscopic surgeries, allowing for tiny incisions. We currently offer approximately 80 instruments and accessories in our portfolio.  We also have designed the Senhance System so that third-party manufactured instruments can be easily adapted for use.

Other Products

The Senhance ultrasonic system is an advanced energy device used to deliver controlled energy to ligate and divide tissue, while minimizing thermal injury to surrounding structures. The Senhance articulating system was launched in Europe in November 2019 and we are evaluating a pathway to bring the instruments to the United States with a planned regulatory filing by the end of 2020. We currently offer approximately 40 instruments and accessories in our portfolio.  We also have designed the Senhance System so that third-party manufactured instruments can be easily adapted for use.

SurgiBot System
The Company has also developed the SurgiBot System. The SurgiBot System is a single-port system designed to utilize flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, while the surgeon remains patient-side within the sterile field.   In December 2017, we entered into an agreement with Great Belief International Limited, or GBIL, to advance the SurgiBot System towards global commercialization. The agreement transferred ownership of the SurgiBot System assets, while the Company retained the option to distribute or co-distribute the SurgiBot System outside of China. GBIL intends to have the SurgiBot System manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company, or CSIMC, for the Chinese market. The agreement provided the Company with proceeds of at least $29 million, of which $15 million has been received to date. The remaining $14.0 million, representing minimum royalties, will be paid beginning at the earlier of receipt of Chinese regulatory approval or March 2023.     
Products in Development
Instruments
We continue to work on the development and regulatory clearance for articulating instruments for the Senhance System.  In December 2018, we submitted a 510(k) submission to the FDA related to wristed instruments for the Senhance System. That 510(k) submission was withdrawn in 2019 to provide us additional time to pursue development efforts and clinical trials. We intend to submit a new 510(k) submission by the end of 2020.
MST Assets
On October 31, 2018, we acquired the assets, intellectual property and highly experienced multidisciplinary personnel of Israel-based MST Medical Surgical Technologies, Inc., or MST. Through this acquisition we acquired MST’s AutoLap™ technology, one of the only image-guided robotic scope positioning systems with FDA clearance and CE Mark. The AutoLap technology is a fully vetted technology used in over 1,500 surgeries in multiple specialties and accompanied by post-marketing publication and studies, a broad intellectual property portfolio and personnel with clinical, scientific and engineering experience. We believe MST’s image analytics technology will accelerate and drive meaningful Senhance System developments and allow us to expand the Senhance System to add augmented, intelligent vision capability.
On July 3, 2019, we entered into a System Sale Agreement with GBIL to sell certain assets related to the AutoLap technology. On October 15, 2019, we entered into an Amended and Restated System Sale Agreement (the “Amended AutoLap Agreement”) with GBIL to restructure the previously announced sale of certain AutoLap assets. Pursuant to the Amended AutoLap Agreement, the Company sold the AutoLap laparoscopic vision system, or AutoLap, and related assets to GBIL for $17 million, all of which was received in 2019 in the form of $16 million in cash and a payment by GBIL of $1.0 million to settle certain Company obligations in China. The assets include inventory, spare parts, production equipment, testing equipment and certain intellectual property

specifically related to the AutoLap. In addition, the Company entered into a cross‑license agreement with GBIL to retain rights to use any AutoLap-related intellectual property sold to GBIL, and to non-exclusively license additional intellectual property to the Buyer.

In January 2020, we submitted a 510(k) submission to the FDA for our Intelligent Surgical Unit thatISU, which is designed to enable machine vision capabilities on the Senhance System. Such Intelligent Surgical UnitThe ISU was developed using the MST image analytics technology that we retained. The Company believes it is the first such FDA submission seeking clearance for machine vision technology in abdominal robotic surgery. On March 13, 2020, the Companywe announced that it haswe had received FDA clearance for the Intelligent Surgical Unit.ISU. On September 23, 2020, we announced the first surgical procedures successfully completed using the ISU. In January 2021, we received the CE Mark for the ISU and in September 2021 we received FDA clearance for additional augmented intelligence features of the ISU.

Indications for Use

We continue to work on expanding the indications for use of the Senhance System and our instruments and other products. The most notable recent advances are:

We received CE Mark approval for an expanded indication to treat pediatric patients.

In 2020, we submitted an application to the FDA for 510(k) clearance for expanded General Surgery indications for use for the Senhance System. In March 2021, we received such clearance for hiatal and paraesophageal hernia, and sleeve gastrectomy procedures. These additional indications helped to increase procedure volume to over 2,100 cases in 2021.

Products in Development

Instruments

In July 2021, we received FDA clearance for 5mm articulating instruments, which offer better access to difficult-to-reach areas of the anatomy. We are working on introducing other advanced instrumentation and functionality to the Senhance System.

Augmented Intelligence Assets with Global Use

In September 2021, we announced that we had received 510(k) clearance from the FDA for an expansion of machine vision capabilities on the previously cleared ISU. 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 allows 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. In addition, we received a CE mark for the ISU in 2021, expanding its global use potential. We are currently working on additional enhancements to assist in Performance-Guided Surgery.

Business Strategy

Our current strategy is to focus our resources on the market development of the Senhance System and related instruments.

instruments as we work to accelerate adoption of Performance-Guided Surgery techniques to maximize the benefits of our technology and products.

We believe that:

the Senhance System is easier to use in MIS laparoscopic surgery, particularly for surgeons well versed in laparoscopic technique;
markets outside of the United States, particularly where laparoscopic surgery is more heavily utilized, such as Japan, may more readily adopt the use of the Senhance System;
because of the capital-intensive nature of the purchase of a robotic system, we are exploring contracts with new hospitals that provide for the lease of the Senhance System;
there are a number of hospitals and an increasing number of ambulatory surgery centers internationally and in the United States that can benefit from the addition of robotic-assisted MIS and, through the Senhance System, lower operational costs as contrasted with other robotic systems;
with the Senhance System, surgeons can benefit from the security of haptic feedback, enhanced 3D HD vision and open-platform architecture consistent with current laparoscopic surgery procedures;
patients continue to seek a minimally invasive option for many common general abdominal and gynecologic surgeries that are addressed by the Senhance System;
the addition of advanced energy and 3 millimeter instruments for the Senhance System help to increase adoption of our products in the laparoscopic surgery market;
leveraging haptic feedback, 3 millimeter instruments, independent arms and lower operating cost, the Senhance system is well suited for pediatric surgeries; and
the enablement of image analytics technology, augmented intelligence and reality vision capabilities, such as the Intelligent Surgical Unit, will help accelerate and drive meaningful adoption of the Senhance System into the future and help clearly differentiate our offering in surgical robotics.
We intend to continue our development activities and seek 510(k) clearance and CE Mark for additional instruments, including the Senhance articulating system, in 2020 as we pursue our strategy.

our Performance-Guided Surgery framework, which focuses on leveraging robotic technologies, augmented intelligence and machine learning capabilities will assist in reducing variability in surgery, drive more predictable outcomes, optimize resources and costs, and resonate with hospital systems that seek to employ innovative healthcare strategies;

the Senhance System is easier to use in MIS laparoscopic surgery, particularly for surgeons well versed in laparoscopic technique;

markets outside of the United States, particularly where laparoscopic surgery is more heavily utilized, such as Japan, may more readily adopt the use of the Senhance System;

because of the capital-intensive nature of the purchase of a robotic system, our strategy to lease the Senhance System to additional hospitals will increase our placements and use of our systems;

there are a number of hospitals and an increasing number of ambulatory surgery centers internationally and in the United States that can benefit from the addition of robotic-assisted MIS and, through the Senhance System, lower operational costs as contrasted with other robotic systems;

with the Senhance System, surgeons can benefit from the security of haptic feedback, enhanced 3DHD vision and open-platform architecture consistent with current laparoscopic surgery procedures;

patients continue to seek a minimally invasive option for many common general abdominal and gynecologic surgeries that are addressed by the Senhance System;

the addition of advanced energy and 3mm instruments and 5mm articulating instruments for the Senhance System help to increase adoption of our products in the laparoscopic surgery market;

leveraging haptic feedback, 3mm instruments, independent arms and lower operating cost, the Senhance system is well suited for pediatric surgeries; and

the enablement of image analytics technology, augmented intelligence and reality vision capabilities, such as the Intelligent Surgical Unit, will help accelerate and drive meaningful adoption of the Senhance System into the future and help clearly differentiate our offering in surgical robotics.

Sales and Marketing

At the end of 2019 we reduced our sales and marketing team as we shifted our focus to market development and promoting utilization of our current Senhance Systems.

We utilize distributors in a number of jurisdictions where we do not sell directly.  Our distribution agreements typically provide exclusivity in a specific territory or jurisdiction.

As of December 31, 2019, we have two training centers, one in Milan, Italy and the other at the Institute for Surgical Advancement at Florida Hospital Orlando and three research and development centers, one in Research Triangle Park, North Carolina, one in Milan, Italy and the other in Yokne'am Illit, Israel.

We do not intend to increaseare dependent on growing the number of such centershospital customers and increasing the number of customers with installed Senhance Systems. Throughout 2021, we initiated ten Senhance surgical programs, one in 2020.

the U.S., six in EMEA, and three in Asia. We relydefine the initiation of a Senhance Surgical program as entering into an agreement to purchase or lease, and subsequently utilizing a Senhance Surgical System. We also focused on customersgrowing the number of our sold and placed Senhance Systems to usefoundational sites using the Senhance System on a consistent basis. We had six customers who accounted for 82%System.


We believe that our intellectual property and expertise is an important competitive resource. Our experienced research and development team has created a substantial portfolio of intellectual property, including patents, patent applications, trade secrets and proprietary know-how. We maintain an active program of intellectual property protection, both to assure that the proprietary technology developed by us is appropriately protected and, where necessary, to assure that there is no infringement of our proprietary technology by competitive technologies.

The following summarizes our current patent and patent application portfolio.

As of December 31, 2019,2021, the Company’s patent portfolio includes 40approximately 66 United States patents, and approximately 92over 100 patents issued outside the United States, and more than 140150 patent applications filed in the United States and internationally.  We own all right, title and interest in all but the 42approximately 38 of our patents and patent applications that are exclusively licensed to us. We also hold non-exclusive licensesus and the approximately 25 patents and patent applications that are non-exclusively licensed to an additional 6 U.S. and 4 non-U.S. patents.

us.

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Several of our issued patents resulted from filings related to the Senhance System.  These include 78 United States patents, and approximately 40 patents outside the United States. The earliest to expire U.S. and non-U.S. patents within this part of our portfolio will remain in force until 2027.  The patent applications include over 90120 that relate to the Senhance System or other features, instruments, or components for robotic-assisted surgery. Our patents and applications that we acquired from MST relate to image analytics and robotic surgery, among other things. We intend to continue to seek further patent and other intellectual property protection in the United States and internationally, where available and when appropriate, as we continue our product development efforts.

Some of our issued patents and pending applications for the Senhance System, as well as associated technology and know-how, are exclusively licensed to TransEnterixAsensus Surgical Italia from the European Union. The license agreement with the European Union has a term which runs until the final licensed patent expires unless the agreement is terminated earlier by mutual consent of the parties, for the Company’s convenience, or for breach. The Company is currently in compliance with the terms of this license agreement.

Competition

Our industry is highly competitive, subject to change and significantly affected by new product introductions and other activities of industry participants. Many of our competitors have significantly greater financial and human resources than we do and have established reputations with our target customers, as well as worldwide distribution channels that are more established and developed than ours.

There were new entrants in the market for robotic surgery in 2021, and some forward steps by a number of existing entrants, such as the CE Mark attained by Medtronic for its Hugo™ robot. We believe that our focus on the laparoscopic market and our Performance-Guided Surgery initiative help us to remain competitive in this growing field.

There are many competitive offerings in the field of minimally invasive surgery. Several companies have launched devices that enable reduced incision or single incision laparoscopic surgery with or without robotic assistance.  Our surgical competitors include, but are not limited to: Johnson & Johnson/Verb Surgical Inc., Medtronic plc, Intuitive Surgical Inc., Titan Medical, Vicarious Surgical, Memic Innovative Surgery Ltd., Distalmotion SA, and CMR Surgical Ltd. We are aware that more entrants anticipate introducing additional robotic-based instruments in the next few years.

In addition to surgical device manufacturer competitors, there are many products and therapies designed to reduce the need for or attractiveness of surgical intervention. These products and therapies may impact the overall volume of surgical procedures and negatively impact our business.

Our ability to compete may be affected by the failure to fully educate physicians in the use of our products and products in development, or by the level of physician expertise. This may have the effect of making our products less attractive. Among currently available surgical robotic systems, we expectWe believe the Senhance System to differentiatecan be distinguished from other currently available robotic systems on the basis of (1) overall attractiveness to laparoscopic surgeons due to its ability to provide robotic benefits while leveraging their laparoscopic training and experience, (2) the additions we have made, including the ISU, (3) lower per procedure costs when compared to other robotic systems on the market today; and we(4) increasing indications for use, including pediatric indications. We further expect the Senhance System to differentiate in most cases, its ability to provide the surgeon with valuable tactile feedback for increased security.and clinical intelligence to help guide better outcomes. Several medical device companies are actively engaged in research and development of robotic systems or other medical devices and tools used in minimally invasive surgery procedures. We cannot predict the basis upon which we will compete with new products marketed by others.

Government Regulation of our Product Development Activities

The U.S. government and foreign governments regulate the medical device industry through various agencies, including but not limited to, the U.S. FDA, which administers the Federal Food, Drug and Cosmetic Act, or the FDCA. The design, testing, manufacturing, storage, labeling, distribution, advertising, and marketing of medical devices are subject to extensive regulation by federal, state and local governmental authorities in the United States, including the FDA, and by similar agencies in other


countries, including the European Union. Any device product that we develop must receive all requisite regulatory approvals or clearances, as the case may be, before it may be marketed in a particular country.

Device Development, Marketing Clearance and Approval

Medical devices are subject to varying levels of pre-market regulatory requirements. The FDA classifies medical devices into one of three classes: (i) Class I devices are relatively simple and can be manufactured and distributed with general controls; (ii) Class II devices are somewhat more complex and receive greater scrutiny from the FDA and have heightened regulatory requirements; and (iii) Class III devices are new, high riskhigh-risk devices, and frequently are permanently implantable or help sustain life and generally require a Pre-Market Approval, or PMA, by the FDA.

In the United States, a company generally can obtain permission to distribute a new medical device in one of two ways. The first applies to any device that is substantially equivalent to a device first marketed prior to May 1976, or to another device legally marketed after that date, but which is not subject to premarket approval (PMA) (described below). These devices are generally either Class I or Class II devices. To obtain FDA clearance to distribute the medical device, a company generally must submit a 510(k) notification and receive an FDA order finding substantial equivalence to a predicate device (pre-May 1976 device or post-May 1976 device is legally marketed and not subject to PMA) and permitting commercial distribution of that medical device for its intended use. A 510(k) notification must provide information supporting a claim of substantial equivalence to a single medical device, the predicate device, or multiple predicates in certain circumstances. If clinical data from human experience are required to support the 510(k) notification, these data must be gathered in compliance with the investigational device exemption, or IDE, regulations for investigations performed in the United States. The 510(k) process is normally used for products of the type that we are developing and propose to market and sell. The FDA review process for premarket notifications submitted pursuant to Section 510(k) of the FDCA takes, pursuant to statutory requirements, 90 days, but it can take substantially longer if the FDA has questions regarding the regulatory submission. It is possible for 510(k) clearance procedures to take from six to twelve months, depending on the concerns raised by the FDA and the complexity of the device. There is no guarantee that the FDA will “clear” a medical device for marketing, in which case the device cannot be distributed in the United States. There is also no guarantee that the FDA will deem the applicable device subject to the 510(k) process, as opposed to the more time-consuming and resource-intensive PMA process described below.

The second, more comprehensive, approval process applies to a new device that is not substantially equivalent to a predicate product or that is to be used in supporting or sustaining life or preventing impairment. These devices are normally Class III devices. For example, many implantable devices are subject to the approval process as a Class III device. Two steps of FDA approval are generally required before a company can market a product in the United States that is subject to PMA approval, as opposed to clearance, as a Class III device. First, a company must comply with IDE regulations in connection with any human clinical investigation of the device conducted in the United States. While the IDE regulations permit a company to undertake a clinical study of a “non-significant risk” device without formal FDA approval prior express FDA approval is required if the device is a significant risk device. Second, the FDA must approve the company’s PMA application, which typically contains, among other things, clinical information acquired under the IDE. Additionally, devices subject to PMA approval may be subject to an Advisory Panel review to obtain marketing approval and are required to pass a factory inspection in accordance with the current “good manufacturing practices” standards in order to obtain approval. The FDA will approve the PMA application if it finds there is reasonable assurance that the device is safe and effective for its intended use. The PMA process takes substantially longer than the 510(k) process, approximately one to two years or more.

However, in some instances the FDA may find that a device is new and not substantially equivalent to a predicate device but is also not a high riskhigh-risk device as is generally the case with Class III PMA devices. In these instances, the FDA may allow a device to be down classified from Class III to Class I or II. The de novo classification option is an alternate pathway to classify novel devices of low to moderate risk. A sponsor may submit a de novo classification request to the FDA for novel low to moderate risk devices without first being required to submit a 510(k) submission. These types of applications are referred to as “Evaluation of Automatic Class III Designation” or “de novo request.” In instances where a low to moderate risk device is deemed not substantially equivalent to a predicate device, the candidate device may be filed under a de novo request. FDA review of a de novo request may lead the FDA to identify the device as either a Class I or II device subject to the 510(k) regulatory pathway. Review times for de novo requests vary widely, and may take in excess of one year.

The Company believes the Senhance System and many related products are Class II devices as evidenced by the Company’s cleared 510(k) premarket notifications. The Company intends to further develop the product line by adding additional instrumentation to and expanding the capabilities of the Senhance System.  At this time, the Company believes that the items under development are Class II devices subject to 510(k) premarket notification. The FDA might find that the 510(k) submission does not provide the evidence required to prove that the additional instruments or accessories for use with the Senhance System are substantially equivalent to marketed Class II devices. If that were to occur, the Company would be required to undertake the more complex and


costly PMA process or perhaps be considered for a de novo reclassification. For either the 510(k), de novo, or the PMA process, the FDA could require the Company to conduct clinical trials, which would take more time, cost more money and pose other risks and uncertainties. The Company does not believe it has any need to, and is not currently planning to conduct, any clinical trials.

If needed in the future, clinical studies conducted in the United States or used in any U.S. application on an unapproved medical device that presents a significant risk require approval from the FDA prior to initiation. Even when a clinical study has been approved by the FDA or deemed approved, the study is subject to factors beyond a sponsor's control, including, but not limited to, the fact that the institutional review board, or IRB, at a specified clinical site might not approve the study, might decline to renew approval, or might suspend or terminate the study before its completion. There is no assurance that a clinical study at any given site will progress as anticipated. In addition, there can be no assurance that the clinical study will provide sufficient evidence to assure the FDA that the product is safe and effective, a prerequisite for FDA approval of a PMA, or substantially equivalent in terms of safety and effectiveness to a predicate device, a prerequisite for clearance under Section 510(k). Even if the FDA approves or clears a device, it may limit its intended uses in such a way that manufacturing and distribution of the device may not be commercially feasible.

After clearance or approval to market is given, the FDA and foreign regulatory agencies, upon the occurrence of certain serious adverse events, are authorized under various circumstances to withdraw the clearance or approval of the device, or require changes to a device, its manufacturing process or its labeling or require additional proof that regulatory requirements have been met.

A manufacturer of a device approved through the PMA process is not permitted to make changes to the device which affect its safety or effectiveness without first submitting a supplement application to its PMA and obtaining FDA approval for that supplement, prior to marketing the modified device. In some instances, the FDA may require clinical trials to support a supplement application. A manufacturer of a device cleared through the 510(k) process must submit an additional premarket notification if it intends to make a change or modification in the device that could significantly affect the safety or effectiveness of the device, such as a significant change or modification in design, material, chemical composition, energy source, labeling or manufacturing process. A change in the intended uses of a PMA device or a 510(k) device generally requires an approval supplement or newly cleared premarket notification or de novo request. Exported devices are subject to the regulatory requirements of each country to which the device is exported, as well as certain FDA export requirements.

Continuing FDA Regulation

After a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These include:

establishment registration and device listing with the FDA;
quality system regulations that require manufacturers to follow stringent design, testing, process control, documentation and other quality assurance procedures;
labeling regulations that prohibit the promotion of products for unapproved, i.e. “off label,” uses and impose other restrictions on labeling;
Medical Device Reporting, or MDR, regulations that require manufacturers to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;
corrections and removal reporting regulations that require manufacturers to report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and
requirements to conduct postmarket surveillance studies to establish continued safety data.

establishment registration and device listing with the FDA;

quality system regulations that require manufacturers to follow stringent design, testing, process control, documentation and other quality assurance procedures;

labeling regulations that prohibit the promotion of products for unapproved, i.e. “off label,” uses and impose other restrictions on labeling;

Medical Device Reporting, or MDR, regulations that require manufacturers to report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur;

corrections and removal reporting regulations that require manufacturers to report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; and

requirements to conduct post-market surveillance studies to establish continued safety data.

We are required to, and have, registered with the FDA as a medical device manufacturer. We must obtain all necessary permits and licenses to operate our business in all regions in which we do business. As manufacturers, we and our suppliers are subject to announced and unannounced inspections by the FDA to determine our compliance with the Quality System Regulation, or QSR, and other regulations.

In Europe, we comply with the requirements of the 93/42/EEC Medical Devices Directive, or MDD, and appropriately affix the CE Mark on our products to attest to such compliance. TransEnterixAsensus Surgical Italia S.R.L.S.r.l. is the legal manufacturer in the European Union. Our products marketed in the EU meet the “Essential Requirements” of the MDD relating to safety and performance. We have undergone verification of our regulatory compliance, or conformity assessment, by a Notified Body duly authorized by an EU country and must continue to do so as new products and changes to the products arise. The level of scrutiny of such assessment depends on the regulatory class of the product. We are subject to continued surveillance by our Notified Body and are required to


report any serious adverse incidents to the appropriate authorities. We also must comply with additional requirements of individual countries in which our products are marketed. In the European Union, we are required to maintain certain quality system certifications in order to sell products. These regulations require us or our manufacturers to manufacture products and maintain documents in a prescribed manner with respect to design, manufacturing, testing, labeling and control activities.  As legal manufacturers, we and our suppliers are subject to announced and unannounced inspections by the European Notified Bodies and Competent Authorities.

In May 2020,2021, the Medical Device Directive will bewas replaced by the updated European Medical Device Regulation, or 2017/745 (MDR), after a three yearfour-year transition period.   AnyHowever, any of our products that are currentlywere certified to comply with the MDD have been or will have to be re-evaluated by a designated Notified Body according to the new regulations after their certificates expire or in case of a substantial change.  The new regulations will place new requirements regarding labeling, post-market surveillance, and technical documentation on all medical device manufacturers.  In addition, Notified Bodies are undergoingunderwent the transition as well, leading to reduced capacity to take on new clients or review new medical devices for CE markMark approvals or existing medical devices for substantial changes.  Transition to the new regulations will take time and resources from our internal personnel and external consultants to gain compliance, which may reduce the resources available for market expansion and new product introductions.

Impact of Regulation

Failure to comply with the applicable regulatory requirements can result in enforcement action by the FDA and other international regulatory bodies, which may include, among other things, any of the following sanctions:

warning letters, fines, injunctions, consent decrees and civil penalties;
repair, replacement, refund or seizure of our products;
operating restrictions, partial suspension or total shutdown of production;
refusing our request for market access approvals of new products or modifications to existing products;
withdrawing or suspending clearances or approvals that are already granted;
criminal prosecution; and
disgorgement of profits.

warning letters, fines, injunctions, consent decrees and civil penalties;

repair, replacement, refund or seizure of our products;

operating restrictions, partial suspension or total shutdown of production;

refusing our request for market access approvals of new products or modifications to existing products;

withdrawing or suspending clearances or approvals that are already granted;

criminal prosecution; and

disgorgement of profits.

Further, the levels of revenues and profitability of medical device companies like us may be affected by the continuing efforts of government and third partythird-party payors to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing or profitability of products is subject to governmental control. In the United States, there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental controls.

Therefore, we cannot assure you that any of our products will be considered cost effective, or that, following any commercialization of our products, coverage and reimbursement will be available or sufficient to allow us to manufacture and sell them competitively and profitably.

Health Care Regulation

Our business activities are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security and physician payment transparency laws. If our operations are found to be in violation of any of such laws that apply to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

In the United States, there have been, and we expect there to continue to be, a number of legislative and regulatory initiatives, at both the federal and state government levels, to change the healthcare system in ways that, if approved, could affect our ability to sell our products profitably. At the current time, our products are not defined as durable medical equipment. Non-DME devices used in surgical procedures are normally paid directly by the hospital or health care provider and not reimbursed separately by third-party payors. Instead, the hospital or health care provider is reimbursed based on the procedure performed and the inpatient or outpatient stay. As a result, these types of devices are subject to intense price competition that can place a small manufacturer at a competitive disadvantage as hospitals, ambulatory surgery centers and health care providers attempt to negotiate lower prices for products such as the ones we develop and sell.

16

In 2010, the Patient Protection and Affordable Care Act, or the Affordable Care Act, and the reconciliation law known as Health Care and Education Reconciliation Act, or the Reconciliation Act, and, with the Affordable Care Act, the 2010 Health Care Reform Legislation, were enacted into law. Due to ongoing legal challenges and changes toWith the 2010 Health Care Reform Legislation since its enactment,recent change in federal administration, the Company cannot predict with certainty the long-term impact of federal health care legislation on its business.

The 2010 Health Care Reform Legislation includes the Open Payments Act (formerly referred to as the Physician Payments Sunshine Act), which, in conjunction with its implementing regulations, requires certain manufacturers of certain drugs, biologics, and devices that are reimbursed by Medicare, Medicaid and the Children’s Health Insurance Program to report annually certain payments or “transfers of value” provided to physicians and teaching hospitals and to report annually ownership and investment interests held by physicians and their immediate family members during the preceding calendar year. We have provided reports under the Open Payments Act to the Centers for Medicare & Medicaid Services since 2014. Amendments to the Open Payments Act expanded the categories of health care providers for which reporting is required.  The failure to report appropriate data accurately, timely, and completely could subject us to significant financial penalties. Other countries and several states currently have similar laws and more may enact similar legislation.

International Regulation and Potential Impact

The Company has market development and commercial activities in a number of international markets and intends to focus on such markets in the near term. Some of these markets maintain unique regulatory requirements outside of or in addition to those of the FDA and the European Union. The Senhance System is CE marked,Marked, which is the basis to allow us to offer the product for sale in a number of jurisdictions, including select countries in Europe, the Middle East and Asia.  Due to the variations in regulatory requirements within territories, the Company may be required to perform additional safety or clinical testing or fulfill additional agency requirements for specific territories. The Company may also be required to apply for registration using third parties within those territories and may be dependent upon the third parties’ successful regulatory processes to file, register and list the product applications and associated labeling, which could lead to significant investments and resource use. These additional requirements may result in delays in international registrations and commercialization of our products in certain countries.

In addition, we are utilizing distributors and sales agents in various territories throughout Europe, the Middle East, Africa, and Africa,the Commonwealth of Independent States, and need to ensure that our activities, and the activities of our distributors and sales agents, are compliant with local law and U.S. laws governing the sales of medical devices.  We have also established subsidiaries and contracted with third parties in Asia, including Japan and Taiwan, to seek regulatory approvals to offer our products in Asia.  The laws governing the registration, approval, clearance, and sales of medical devices, such as the Senhance System, in multiple jurisdictions are complex, and the failure to comply with such laws in any given jurisdiction could subject us to financial penalties or suspension or termination of our ability to sell our products in the applicable jurisdiction.

Employees

Environmental, Social and Governance

Environmental

As a company, we are committed to encouraging and fostering sustainable practices to support the global environment. We comply with environmental regulations in each of our locations. We have a corporate goal of limiting the use of plastic with paper cups and recyclable materials and, prior to COVID, adopted a no plastic policy in our Milan office, which was interrupted due to the need for single-use packaging for health concerns during COVID. Our employees located in our European facilities are encouraged to travel by train rather than aircraft, and some employees benefit from local government incentives to use electric cars. We also put safety first in our locations. Our employees at our manufacturing facility in Italy follow mandatory safety training and take mandatory vision tests and a check-up by the occupational doctor every five years; we also have safety procedures which are drafted with assistance from a third-party safety consultant and updated twice a year. 

Social

Company Culture

Our employees are passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The Company fosters a significant amount of collaboration and synergy among employees. Team members at any level are encouraged to provide suggestions and input to enable the Company’s success.

Employee Demographics

As of December 31, 2019,2021, we had 163167 employees, including 160 full time153 full-time employees, of whom 55 were in the R&D department, 15 were in Quality and Regulatory Affairs, 34 were in marketing and sales, 29 were in Corporate Administration, and 20 were in Customer Care. As of December 31, 2021, approximately 33% of the Company’s workforce were female, and minorities represented approximately 24% of the Company’s workforce. As of December 31, 2021, approximately 58% of the Company’s employees were  in the United States and 42% were outside of the United States. In 2021, our turnover rate was approximately 18% and we hired 48 full-time employees. The

Diversity, Equity & Inclusion (DEI)

We believe in contributing to a society that welcomes diverse voices and values differences in lived experiences, culture, religion, age, gender identity, sexual orientation, race, ethnicity, and neurodiversity. We are committed to ensuring this same environment for our employees – a culture where individuals feel safe, heard, and respected. We celebrate the uniqueness of our global workforce, especially in a company of our size, and appreciate that only through inclusion, ongoing learning, and partnership can we succeed.

In 2020, we created an internal webpage dedicated to diversity, equity and inclusion (or DEI) resources for our employees, kicked off a DEI committee and partnered with a DEI alliance to further evolve our DEI efforts. In 2021, we launched e-learning modules hosted by a third-party to provide our employees with education and training on DEI topics. We are also focused on incorporating DEI principles into our governance structure and believe having mix of backgrounds and experience in our Board composition is essential to understanding and reflecting the needs of our diverse stakeholders. Currently, two of eight board members self-identify as women, and three of our eight Board members self-identify as individuals from underrepresented communities (defined as an individual who self-identifies as Black, African American, Hispanic, Latino, Asian, Pacific Islander, Native American, Native Hawaiian, or Alaska Native, or who self-identifies as gay, lesbian, bisexual, or transgender).

COVID-19 Pandemic

Throughout the COVID-19 pandemic, employee safety is of top priority. Until August 2021, most of our employees globally worked from home since the beginning of the pandemic, except for those with a business need to engage in work onsite. Beginning in August 2021, we encouraged a return to the office on a hybrid basis, while monitoring the ongoing impact of the pandemic on our office locations. Ongoing safety measures remain in place at each of our locations including implementing pre-screening and social distancing requirements in addition to providing PPE. Our Global Prevention Team continues to monitor the impact of the pandemic on our global workforce and to carry out our ongoing planning and response efforts. We increased our employee communications to ensure frequent connections while working remotely across the company including regular all-hands meetings and employee newsletters.

Health & Wellness

Throughout 2021, health and wellness was a key focus of the Company, considersespecially in light of the ongoing pandemic and new variants. Many of our employee communications focused on the physical and mental health of our employees. We remain committed to providing our workforce with flexible remote working schedules to suit their personal needs through this challenging time. We also continue to benchmark all of our health insurance offerings to ensure plan competitiveness.

People Strategy

Our People Strategy is to create and maintain a culture of high performance and accountability through the attraction, retention and development of expert talent. To enhance our employees’ satisfaction and retention, we offer ongoing training opportunities that support professional growth. We have an annual performance review process for all employees worldwide to review performance and inform compensation recommendations. We compete for top talent with effective recruitment strategies, well defined roles and attractive total compensation packages. We keep talent engaged through appreciation, communication and creation of a great work environment. We support employee growth professionally and personally through formal and informal opportunities and leadership support.

Employee Engagement

We partner with Gallup, Inc, a global analytics and advice firm, to monitor and improve the engagement of our workforce. Gallup’s Q12 survey measures employee engagement based on twelve key needs of employees. We utilize survey results to identify strengths and weaknesses and create action plans to improve engagement and ultimately team performance. In 2021, we saw an increase in our engagement score over the prior year. We continue to incorporate Gallup’s programs into our overall People Strategy.  

Compensation

In addition to competitive base salaries, we offer incentive-based compensation programs tied to the performance of key objectives. We also provide compensation in the form of retention grants of restricted stock units and/or stock options, which we believe help align longer term employee incentives with our company performance. Ensuring fair and equitable pay is also an important commitment we make to our employees.

Governance

Our Board of Directors, through its relationshipsNominating and Corporate Governance Committee, evaluates the governance and management practices of the Company. We believe our corporate governance guidelines and structure provide our stockholders with its employeesa dedicated, qualified and skilled board of directors and management team. Our governance structure includes:

annual elections of all board members;

an independent Board chair and separation of the CEO/Chair role;

diversity in skills, gender and ethnicity in our board and management team;

the addition of two new board members in 2021 and transition of our Board chair; and

the ability of stockholder to propose candidates for potential nomination to the board and proposals for consideration by stockholders at annual meetings.

Corporate Information

On February 23, 2021, we changed our corporate name to be good.

Corporate Information
The Company’sAsensus Surgical, Inc. Effective March 10, 2021, our principal executive offices are located at 635 Davis1 TW Alexander Drive, Suite 300, Morrisville,160, Durham, NC 27560.27703. The Company was originally incorporated on August 19, 1988 as a Delaware corporation.
As of December 31, 2019, the

The active subsidiaries of the Company are TransEnterixAsensus Surgical US, Inc., SafeStitch LLC, TransEnterixAsensus International, Inc.; TransEnterix, Asensus Surgical Italia S.r.l.; TransEnterix, Asensus Surgical Europe S.à.R.L; TransEnterix Asia Pte..r.l., Asensus Surgical Taiwan Ltd.; TransEnterix Taiwan Ltd; TransEnterix, Asensus Surgical Japan KK; TransEnterixK.K., Asensus Surgical Israel Ltd., Asensus Surgical Netherlands B.V., and TransEnterix Netherlands B.V.

Asensus Surgical Canada, Inc.

Available Information

The Company maintains a website at www.transenterix.com.www.asensus.com. We are not incorporating our website by reference into this Annual Report. Our Code of Business Conduct and Ethics, as reviewed and updated on October 24, 2019,28, 2021, is available on our website. Our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to those reports, filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, are available free of charge on our website as soon as practicable after electronic filing of such material with, or furnishing it to, the U.S. Securities and Exchange Commission, or the SEC.

ITEM 1.A.

ITEM 1.A.

RISK FACTORS


Our risk factors are grouped into the following categories: (1) Risks Related to the Operation of our Business; (2) Risks Related to Our Status as a Public Company; (3) Risks Related to Protection of our Intellectual Property; (4) Risks Related to the Regulation of our Business; and (5) General Risk Factors.

Risks Related to the Operation of our Business

We have a history of operating losses, and we may not be able to achieve or sustain profitability. In addition, we may be unable to continue as a going concern.

We have a limited operating history. We are not profitable and have incurred losses since our inception. Management concluded that substantial doubt exists about our ability to continue as a going concern as a result of anticipated capital needs as well as past recurring losses and anOur accumulated deficit. Our independent registered public accounting firm also included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended December 31, 2019 with respect to this uncertainty. Our net loss for the year ended December 31, 2019deficit was $154.2$785.4 million and our accumulated deficitworking capital was $103.4 million as of December 31, 2019 was $663.6 million.2021. We believe that our existing cash and cash equivalents, together with cash receivedshort-term investments, and long-term investments, including proceeds from productour capital raising transactions in 2021 and instrument sales and leases will bethe warrant exercises are sufficient to meetfund our anticipated cash needs into the fourth quarter of 2020.

operations for more than 12 months.

We expect to continue to incur losses for the foreseeable future, and these losses will likely increase as we continue to develop and commercialize our products. We will continue to incur research and development and general and administrative expenses related to our operations, and sales and marketing expenses to support our commercial activities, as restructured. Even if we are successful in reducing our expenses or achieving profitability in the future, we may not be able to sustain profitability in subsequent periods.

The coronavirus (COVID-19) pandemic has negatively impacted our operations.

We will require substantial additional fundinghave facilities located in the United States, Israel, Japan, and Italy. All of our facilities are in locations that are subject to, or have been subject to, travel restrictions, stay-at-home or shelter-in-place orders, or return-to-work on a hybrid basis. Our Senhance Systems are manufactured at a contract manufacturing facility in Milan. A variety of travel restrictions, caused delays in our product installation and training activities in 2021, particularly in the second quarter. Elective surgeries have also been curtailed a number of times during variant surges in 2021 in various parts of the globe. Although such procedures have recommenced in large part, the limits on elective procedures significantly impacted our ability to place our Senhance Systems, provide training, and increase the use of the Senhance Systems in place. It is uncertain whether elective surgeries will continue to be negatively impacted or halted again in the future by a resurgence of COVID-19 cases in any of these jurisdictions.

The global spread of COVID-19 and the various attempts to contain it continue to create significant volatility, uncertainty and economic disruption. The full extent to which the COVID-19 pandemic and the various responses to it impacts our business, operations and financial results continues to depend on numerous factors that we may not be able to accurately predict, including: the duration and scope of the pandemic, including new variants; governmental, business and individuals’ actions that have been and continue to be taken in response to the pandemic; the availability and cost to access the capital markets; the decline in elective surgery procedures; the effect on our customers and customer demand for Senhance Systems and the ability to provide training services; disruptions or restrictions on our employees’ ability to work and travel; and shortages of certain supplies and materials. In addition, any preventative or protective actions that governments implement or that we take in respect of COVID-19, such as travel restrictions or stay-at-home orders, may interfere with the ability of our employees, vendors and contract manufacturers to perform their respective responsibilities and obligations relative to the conduct of our business. Such results could have a material adverse effect on our operations, business, financial condition, results of operations, or cash flows.

We believe the COVID-19 pandemic, including emerging variant strains of the virus, will continue to negatively impact our operations and our ability to implement our market development efforts, which will have a negative effect on our financial condition. There is a risk that government actions will not be effective at containing further COVID-19 outbreaks, including from variants, and that government actions, including the orders and restrictions described above, that are intended to contain the spread of COVID-19 will have a devastating negative impact on the world economy at large, in which case the risks to our sales, operating results and financial condition described herein would be elevated significantly.

Our strategic focus, on delivering tools and assistance to provide Performance-Guided Surgery opportunities, may not result in the growth of our business in the timeline we envision or at all.

On February 23, 2021, we announced a strategic focus on providing clinical intelligence to surgeons to provide Performance-Guided Surgery opportunities. We believe that the Senhance System, which digitizes the interface between the surgeon and the patient in laparoscopic surgery can also be used, with our augmented intelligence offerings, to provide real-time clinical data throughout the entire surgical experience, assist in removing elements and factors that contribute to surgical variability and reduce complications. Our efforts to communicate and implement this strategy with hospitals, surgery centers and surgeons may take longer than we anticipate, may not be as successful as we contemplate and may not result in a meaningful increase in our business or financial condition.

We are currently highly dependent on a single product, the Senhance System.We cannot give any assurance that the Senhance System can be successfully commercialized.

We are currently highly dependent on the Senhance System, which is FDA cleared for sale in the United States, CE Marked for sale in the European Union and other countries, registered for sale in the Russian Federation, and approved for sale and reimbursement in Japan. We began our selling efforts for the Senhance System in the fourth quarter of 2015 in Europe, in the fourth quarter of 2017 in the United States, in the second quarter of 2018 in Asia and, through distributors in the Russian Federation in 2021.  We have had limited commercial success to date, particularly in 2019 and 2020. We have determined to focus our energies on market development and increased usage of the Senhance Systems that have been purchased and placed, as well as on our Performance-Guided Surgery strategy. We cannot assure you that we will be able to successfully improve the commercialization of the Senhance System, for a number of reasons, including, without limitation, failure in our market development and sales efforts, the long sales cycle associated with the purchase of capital equipment, and the potential introduction by our competitors of more clinically effective or cost-effective alternatives.  Failure to successfully commercialize the Senhance System would have a material and adverse effect on our business.

The sales cycle for the Senhance System has been lengthy and unpredictable, leading us to refocus our energies on entering into placement and leasing arrangements with hospitals, which has had an impact on our revenue.

Purchase of a surgical robotic system such as the Senhance System represents a capital purchase by hospitals and other potential customers, which is a time-intensive process involving adoption by surgeons and approval of the capital purchase by administration. We are also expanding the potential market for robotic surgical systems with our focus on laparoscopic surgery.  Such expansion requires a different sales and marketing approach than a focus on open procedures.  We have found that sales are extremely difficult and take substantial effort. In late 2019, we began leasing Senhance Systems to hospitals with lease terms ranging from twelve to twenty-four months or more. In 2021 we initiated ten Senhance Systems programs. We cannot assure you that these lease arrangements will lead to longer term placements or result in sales of our Senhance System.

We currently have limited marketing, sales and distribution capabilities. We are focusing on market development efforts and have curtailed our sales force in the United States, and are focusing on select countries in Europe, the Russian Federation and in Japan. Sales efforts in certain of these countries are conducted through the use of independent contractor and distribution agreements with companies possessing established sales and marketing operations in the medical device industry.  There can be no assurance that we will be successful in building our sales capabilities after this period of market development. With respect to future sales in the Russian Federation, we are monitoring geo-political events and assessing whether the implementation of sanctions may result in our inability to conduct future sales in the Russian Federation through our distributors or at all.  Any such disruption in our sales efforts could have an adverse impact on our financial results. To the extent that we enter into additional distribution, co-promotion or other arrangements, our product revenue is likely to be lower than if we directly market or sell our products. In addition, any revenue we receive will depend in whole or in part upon the efforts of such third parties, which may not be availablesuccessful and are generally not within our control. If we are unable to usenter into such arrangements on acceptable terms or at all.

all, we may not be able to successfully commercialize our products. If we are not successful in commercializing our existing and future products, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.

We dohave procedures in place to require our distributors and sales agents to comply with applicable laws and regulations governing the sales of medical devices in the jurisdictions where they operate.  Failure to meet such requirements could subject us to financial penalties or the suspension or termination of the ability to sell our products in such jurisdiction.  

The surgical robotics industry is increasingly competitive, which can negatively impact our commercial opportunities.

The medical device industry is highly competitive, and we face significant competition from many companies that are researching and marketing products designed to address minimally invasive and robotic-assisted surgery, including new entrants in the competitive market. We are currently commercializing the Senhance System in the United States with FDA 510(k) clearance, in Europe which accepts a CE Mark, the Middle East, the Commonwealth of Independent States, and selected countries in Asia. We face significant competition in such markets. Many of our competitors, including Intuitive Surgical, have significantly greater financial, manufacturing, marketing and product development resources than we do. Some of the medical device companies we compete with or expect to compete with include Johnson & Johnson/Verb Surgical Inc., Medtronic plc, Intuitive Surgical Inc., Titan Medical, Vicarious Surgical, Memic Innovative Surgery Ltd., Distalmoton SA, and CMR Surgical Ltd. and a number of minimally invasive surgical device and robotic surgical device manufacturers and providers of products and therapies that are designed to reduce the need for or attractiveness of surgical intervention. In addition, many other universities and private and public research institutions are or may become active in research involving surgical devices for minimally invasive and robotic-assisted surgery.

We are also expanding the potential market for robotic surgical systems with our focus on laparoscopic surgery. Such expansion may lead to additional competition with companies with sufficiently higher resources than ours. We believe that our ability to successfully compete will depend on, among other things:

the efficacy, safety and reliability of our products;

our ability to commercialize and market our cleared or approved products;

the completion of our development efforts and receipt of regulatory clearance or approval for instruments and accessories to support the use of the Senhance System;

the cost of ownership and use of our products in relation to alternative devices;

the timing and scope of regulatory clearances or approvals, including any expansion of the indications of use for our products;

whether our competitors substantially reduce the cost of ownership and use of an alternative device;

our ability to protect and defend intellectual property rights related to our products;

our ability to have our partners manufacture and sell commercial quantities of any cleared or approved products to the market;

the availability of adequate coverage and reimbursement by third-party payors for the procedures in which our products are used;

our ability to adapt to changes in the regulatory environment;

the effectiveness of our sales and marketing efforts; and

acceptance of future products by physicians and other health care providers.

If our competitors market products that are more effective, safer, easier to use or less expensive than our products or future products, or that reach the market sooner than our products, we may not achieve commercial success. In addition, the medical device industry is characterized by rapid technological change. It may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or products obsolete or less competitive.

We anticipate that the net proceedshighly competitive surgical robotics environment can lead our competitors to attempt to slow or derail our commercial progress. We are using our best efforts to enter the commercial markets effectively and efficiently while maintaining compliance with all regulatory and legal requirements. Responding to the actions of prior equity financingsour competitors will be sufficientrequire the attention of our management and may distract the management team from its focus on our commercial operations and lead to support developmentincreased costs of commercialization, which could have a negative impact on our financial position.

We also anticipate that the competitive surgical robotics environment will become more intense because of increased consolidation by companies in the health care industry looking to achieve cost reductions. Such consolidation may have an adverse effect on our business operations.

Negative publicity, whether true or not, concerning us or our products could reduce market acceptance of our products and product candidatescould result in decreased demand for the Senhance System.

There have been social media and provideother publications regarding us and the Senhance System published from time to time since we started selling the Senhance System. Negative media and social media coverage, whether true or not, concerning our products or us could reduce market acceptance of the Senhance System and increase volatility in our stock price.

In order to compete successfully within the surgical robotics industry, we need to continue to evolve the Senhance System, including the innovations associated with assets we acquired.Failure to develop, seek regulatory approval for and commercialize such developments could have a material adverse effect on our business and financial position.

In order to compete successfully within the highly competitive surgical robotics industry, we need to continue to advance and innovate the Senhance System, including the innovations associated with the necessary resourcesassets we acquired from Medical Surgery Technologies, Ltd., or MST, in 2018.  Our focus currently is on harnessing the image technology acquired in the MST acquisition to advance the intelligence of the Senhance System through the ISU to provide meaningful real-time data to surgeons.  We have developed and received CE Mark for articulating instruments in Europe and FDA clearance in the U.S. These assets are also vital to our Performance-Guided Surgery strategy. If we fail to continue to develop such innovations, or fail to obtain regulatory approval or clearance for or successfully commercialize such innovations, such failure could have a material adverse effect on our business and financial position.

Fluctuations in foreign currency exchange rates may adversely affect our financial results.

We conduct operations in several different countries, including the United States and throughout Europe, and portions of our revenues, expenses, assets and liabilities are denominated in U.S. dollars, Euros, and other currencies. Since our consolidated financial statements are presented in U.S. dollars, we must translate revenues, income and expenses, as well as assets and liabilities, into U.S. dollars at exchange rates in effect during or at the end of each reporting period. We have not historically hedged our exposure to foreign currency fluctuations.  Accordingly, increases or decreases in the value of the U.S. dollar against the Euro and other currencies could materially affect our net operating revenues, operating income and the value of balance sheet items denominated in foreign currencies.

Our global operations expose us to additional risks and challenges associated with conducting business internationally.

The international nature of our business, particularly in Europe, Israel, Asia and the Russian Federation, may expose us to risks inherent in conducting foreign operations. These risks include:

challenges associated with managing geographically diverse operations, which require an effective organizational structure and appropriate business processes, procedures and controls;

the high cost of doing business in foreign jurisdictions, including compliance with international and U.S. laws and regulations that apply to our international operations;

currency exchange and interest rate fluctuations and the resulting effect on our revenue and expenses, and the cost and risk of entering into hedging transactions, if we chose to do so in the future;

changes in a specific country’s or region’s political or economic environment;

trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments;

potentially adverse tax consequences;

complexities and difficulties in obtaining protection and enforcing our intellectual property;

compliance with additional regulations and government authorities in a highly regulated business;

difficulties associated with staffing and managing foreign operations, including differing labor relations; and

general economic and political conditions outside of the U.S.

The risks that we face in our international operations may continue to intensify as we further develop and expand our international operations.

We may require substantial additional funding to advance our current plans.

We are focused on our market development efforts and commercialization of the Senhance System and other products, throughas well as research and development activities for advancements for the lengthy sales cycle.Senhance System and our other products. We intend to advance multiple additional products through clinical and pre-clinical development in the future. We believe we will need to raise substantial additional capital in the future in order to continue our operationsfund these priorities and achieve our business objectives.

We have two effective shelf registration statements. As of March 10, 2020, we had approximately $5.5 million available for future financings under a shelf registration statement due to expire in May 2020. We have an additional shelf registration statement that was declared effective on February 10, 2020 registering up to $150 million of our securities. As of the date of this Annual Report, we had approximately $124 million available for future financings under such shelf registration statement. We cannot assure you that we will be successful in obtaining such additional financing in the future on terms acceptable to the Company or at all.

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Our future funding requirements will depend on many factors, including, but not limited to:
the costs
the costs and timing of seeking and obtaining FDA and other non-U.S. regulatory clearances and approvals for our products in development;
the costs associated with our manufacturing capabilities;
our need to expand our research and development activities;
the costs of acquiring, licensing or investing in businesses, products and technologies;
the economic and other terms and timing of our existing licensing arrangement and any collaboration, licensing or other arrangements into which we may enter in the future;
the effect of competing technological and market developments;
our need to implement additional internal systems and infrastructure, including financial and reporting systems, quality systems and information technology systems; and
our ability to maintain, expand and defend the scope of our intellectual property portfolio.

Until we generate a sufficient amount of revenue to finance our cash requirements, which may never occur, we expect to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our research and development programs. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution; and debt financing, if available, may involve restrictive covenants that limit our operations. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our products or grant licenses on terms that may not be favorable to us.


We announced that we are seeking strategic and financing alternatives. We may not be successful in achieving a suitable transaction.
On October 17, 2019, we announced that we had engaged J.P. Morgan Securities LLC to assist the Board of Directors in considering strategic alternatives for the Company to enhance stockholder value, including, but not limited to a sale of the Company, a financing of the Company, a strategic partnership or collaboration or some other form of commercial relationship. In addition, we announced the implementation of a restructuring plan to reduce operating expenses as we continue the global market development of the Senhance platform. We may not be able to identify, successfully negotiate with and consummate a suitable transaction with a buyer or other commercial partner. We may not be able to raise the funds needed to operate the business for any specific period of time. If we are not successful in consummating a transaction or financing, our financial condition will be materially adversely affected.
We have announced a restructuring plan to reduce our operating expenses. We may not achieve some or all of the expected benefits of our restructuring plan and the restructuring may adversely affect our business.
Following the disappointing 2019 commercial results, we have determined to restructure our organization to focus on market development and increasing use of the Senhance System, rather than focusing on building our sales team. Our restructuring is designed to re-align our commercial organization through re-prioritization of certain geographical markets and to implement operational excellence through strategic reallocation of resources. We need to fully implement the restructuring plan while evaluating strategic alternatives. We may encounter unexpected costs while implementing the restructuring plan and may not be successful in reducing our operating expenses as much as needed. We may undertake additional restructurings in the future. Implementation of a restructuring plan is costly and disruptive to our business, and we may not be able to obtain the estimated cost savings and benefits that were initially anticipated in connection with our restructuring in a timely manner or at all. Additionally, as a result of any restructuring, we may experience a loss of continuity, loss of accumulated knowledge and/or inefficiency during transitional periods and may lose momentum in the sales of Senhance Systems. Reorganization and restructuring can require a significant amount of management and other employees’ time and focus, which may divert attention from operating and growing our business. Any failure to properly execute the restructuring plans could result in total costs that are greater than expected and cause us not to achieve the expected long-term operational benefits and adversely affect our financial condition, operating results and future operations.
Under the restructuring plan, we determined that the carrying value of our inventory exceeded the net realizable value due to a decrease in expected sales. The restructuring charges amounted to $8.8 million, of which $7.4 million was an inventory write down based on management’s 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 significantly from those estimates. Significant items subject to such estimates and assumptions include identifiable intangible assets, contingent consideration, warrant liabilities, stock compensation expense, revenue recognition, accounts receivable reserves, excess and obsolete inventory reserves, inventory classification between current and non-current, and deferred tax asset valuation allowances. We cannot assure you that additional write downs or other charges related to any management estimates will not be needed.
We are currently highly dependent on a single product, the Senhance System.  We cannot give any assurance that the Senhance System can be successfully commercialized.
We are currently highly dependent on the Senhance System, which is FDA cleared for sale in the United States, CE marked for sale in the European Union and other countries, and approved for sale and reimbursement in Japan. We began our selling efforts for the Senhance System in the fourth quarter of 2015 in Europe, in the fourth quarter of 2017 in the United States and in the second quarter of 2018 in Asia.  We have had limited commercial success to date, particularly in 2019. We have determined to focus our energies on market development and increased usage of the Senhance Systems that have been purchased and placed. We cannot assure you that we will be able to successfully improve the commercialization of the Senhance System, for a number of reasons, including, without limitation, failure in our market development and sales efforts, the long sales cycle associated with the purchase of capital equipment, and the potential introduction by our competitors of more clinically effective or cost-effective alternatives.  Failure to successfully commercialize the Senhance System would have a material and adverse effect on our business.
The sales cycle for the Senhance System has been lengthy and unpredictable, which has made it difficult for us to forecast revenue and increased the magnitude of quarterly fluctuations in our operating results.
Purchase of a surgical robotic system such as the Senhance System represents a capital purchase by hospitals and other potential customers.  The capital purchase nature of the transaction, the complexity of our product, the relative newness of surgical robotics

and the competitive landscape requires us to spend substantial time and effort to assist potential customers in evaluating our robotic systems. We must communicate with multiple surgeons, administrative staff and executives within each potential customer in order to receive all approvals on behalf of such organizations. We face difficulty identifying and establishing contact with such decision makers. Even after initial acceptance, the negotiation and documentation processes can be lengthy. Additionally, our customers may have strict limitations on spending depending on the current economic climate or trends in healthcare management. We are also expanding the potential market for robotic surgical systems with our focus on laparoscopic surgery.  Such expansion requires a different sales and marketing approach than a focus on open procedures.  We have found that sales are extremely difficult and take substantial effort. In late 2019 we began leasing Senhance Systems to hospitals with lease terms ranging from twelve to twenty-four months or more. We began delivering these units during the first quarter of fiscal year 2020. We cannot assure you that these lease arrangements will lead to more sales of our Senhance System.
We currently have limited marketing, sales and distribution capabilities. We are focusing on market development efforts and have curtailed our sales force in the United States, and are focusing on select countries in Europe and in Japan. Sales efforts elsewhere are conducted through the use of independent contractor and distribution agreements with companies possessing established sales and marketing operations in the medical device industry.  There can be no assurance that we will be successful in building our sales capabilities after this period of market development. To the extent that we enter into additional distribution, co-promotion or other arrangements, our product revenue is likely to be lower than if we directly market or sell our products. In addition, any revenue we receive will depend in whole or in part upon the efforts of such third parties, which may not be successful and are generally not within our control. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our products. If we are not successful in commercializing our existing and future products, either on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.
We have procedures in place to require our distributors and sales agents to comply with applicable laws and regulations governing the sales of medical devices in the jurisdictions where they operate.  Failure to meet such requirements could subject us to financial penalties or the suspension or termination of the ability to sell our products in such jurisdiction.  

We expect our gross margins to vary over time, and changes in our gross margins could adversely affect our financial condition or results of operations.

We began selling the Senhance System in 2015.  Our gross margins have fluctuated from period to period, and we expect that they will continue to fluctuate in the future. Our gross margins have been and may continue to be adversely affected by numerous factors, including:

service costs;
costs, changes in customer, geographic or product mix;
introduction the number of new products, which may have lower margins than our existing products;
Senhance Systems sold vs. placed, our ability to maintain or reduce production costs;
changes to our pricing strategy;
changes in competition;
costs, changes in production volume driven by demand for our products;
products, changes in material, labor or other manufacturing-related costs, including increases in costs relating to global supply shortages and inflation, and the impact of foreign exchange rate fluctuations for foreign-currency denominated costs;
costs, fluctuations in foreign currency exchange rates and changes to U.S. and foreign trade policies, including the enactment of tariffs on goods imported into the U.S.;
, inventory obsolescence and product recall charges;charges and
market conditions.

If we are unable to offset the unfavorable impact of the factors noted above by increasing the volume of products shipped, reducing product manufacturing costs or otherwise, our business, financial condition, results of operations or cash flows may be materially adversely affected.


Negative publicity, whether true or not, concerning

We face risks arising from sole suppliers of components and our ability to meet delivery schedules for sales of our products.

The Senhance System is manufactured for us under contract by a third-party manufacturer. We or our manufacturer acquire raw materials and components of the Senhance System from vendors, some of which are sole suppliers. Although we believe that we have the manufacturing capacity and inventory reserves to meet our anticipated Senhance System sales for the foreseeable future, we are currently taking steps to develop redundant manufacturing and supply alternatives. We cannot assure you that we will be successful in developing these redundant supply and manufacturing capabilities. If we are not successful, our business operations could suffer.

Our products require precise, high-quality manufacturing. We and our contract manufacturers will be subject to ongoing periodic unannounced inspection by the FDA and non-U.S. regulatory authorities to ensure strict compliance with the quality systems regulations, current “good manufacturing practices” and other applicable government regulations and corresponding standards. If we or our contract manufacturers fail to achieve and maintain high manufacturing standards in compliance with QSR, we may experience manufacturing errors resulting in patient injury or death, product recalls or withdrawals, delays or interruptions of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for our products, cost overruns or other problems that could reduce market acceptanceseriously harm our business.

Global supply shortages may prevent or restrict our ability to purchase adequate supplies of materials, parts and components at acceptable prices, which could result in delivery delays for our products or increases in our manufacturing costs.

A disruption or termination in the supply of components could result in our inability to meet demand for our products, which could harm our ability to generate revenues, lead to customer dissatisfaction, and damage our reputation and our brand. Furthermore, if we are required to change the manufacturer of a key component of our products, we may be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The time and processes associated with the verification of a new manufacturer could delay our ability to manufacture our products on schedule or within budget, which may have a material adverse impact on our business, financial condition, results of operations, or cash flows. In addition, our ability to meet customers’ demands depends, in part, on our ability to timely obtain an adequate delivery of quality materials, parts, and components from our suppliers. Any such supply shortage could adversely impact our business, financial condition, results of operations, or cash flows.

Labor shortages may disrupt our operations and result in delays in the manufacture and delivery of our products.

Increased labor shortages globally, including staff burnout and attrition, could also impact our ability to hire and retain personnel critical to our manufacturing, logistics, and commercial operations. We are also highly dependent on the principal members of our management and scientific staff. Attracting and retaining qualified personnel is critical to our success, and competition for them has become more intense. The loss of critical members of our team, or our inability to attract and retain qualified personnel, could significantly harm our operations, business, and ability to compete. In addition, hospitals are also experiencing staffing shortages and supply chain issues that could impact their ability to provide patient care.

The inflationary environment could materially adversely impact our business and results of operations.

Changes in economic conditions and supply chain constraints and steps taken by governments and central banks, particularly in response to the COVID-19 pandemic as well as other stimulus and spending programs, could lead to higher inflation than previously experienced or expected, which could, in turn, lead to an increase in costs. An inflationary environment could have a negative impact on our expenses, increase our labor costs and reduce our available cash flow.

Because our design, development and manufacturing capabilities are limited, we rely on third parties to design, develop, manufacture or supply some of our products. An inability to find additional or alternate sources for these services and products could materially and adversely affect our financial condition and results of operations.

We have used third-party design and development sources to assist in the design and development of our medical device products. In the future, we may choose to use additional third-party sources for the design and development of our products. If these design and development partners are unable to provide their services in the timeframe or to the performance level that we require, we may not be able to establish a contract and obtain a sufficient alternative supply from another supplier on a timely basis and in the manner that we require.

Natural disasters and the effects of climate change could disrupt our business and harm our financial condition.

The effects of climate change, weather or other events could adversely impact our supply chain, including our ability to manufacture our products, source materials or components or services from suppliers (including sole-source suppliers) that are needed for such manufacturing (including sterilization), or provide products to our customers, including events that impact key distributors. Natural disasters, including the impacts of climate change, hurricanes, tornadoes, windstorms, fires, earthquakes and floods and other extreme weather events, global health pandemics, war, terrorism, labor disruptions and international conflicts that could cause significant economic disruption and political and social instability, could result in decreased demand for the Senhance System.

There have been social media and other publications regarding us and the Senhance System published from time to time since we started selling the Senhance System. Negative media and social media coverage, whether true or not, concerning our products, or usadversely affect our manufacturing and distribution capabilities or cause interruptions in our supply chain.

Our operations, and the activities of our customers, vendors or distributors, could reduce market acceptancebe disrupted by climate change. The physical changes caused by climate change may prompt changes in regulations or consumer preferences which in turn could have negative consequences for our and our customers’ businesses. Potential physical risks from climate change may include altered distribution and intensity of the Senhance System.

The spreadrainfall, prolonged droughts or flooding, increased frequency of the coronavirus (COVID-19) has negatively impacted our operations.
We have facilities located in the United States, Israel and Italy. The engineerswildfires and other employees working in those facilitiesnatural disasters, rising sea levels, and a rising heat index, any of which could cause negative impacts to our and our customers’ businesses. If such events affect our customers’ businesses, they may purchase fewer of our products, and our revenues may be at greater risk for exposure to and for contracting the coronavirus, COVID-19. A portion of our operations are in Milan, Italy and our Senhance Systems are manufactured at a contract manufacturing facility in Milan. With the quarantine in Northern Italy, the assembly of new unitsnegatively impacted.

There has been disrupted. In addition, on March 13, 2020, President Trump declared a broad range of proposed and promulgated state, national emergencyand international regulations aimed at reducing the effects of climate change. Such regulations could result in the United States,additional costs to maintain compliance and additional income or other countries in which we operate have restrictions in place. A variety of travel restrictions, actual and pending, have caused a delay in our product installation and training activities in recent weeks, and are expected to continue. The COVID-19 pandemic could continue to harm our operations and negatively impact our financial condition.

In order to compete successfully within the surgical robotics industry, we need totaxes. Climate change regulations continue to evolve, the Senhance System, including the innovations associated with the MST assets we acquired.  Failure to develop, seek regulatory approval for and commercialize such developments could have a material adverse effect on our business and financial position.
In order to compete successfully within the highly competitive surgical robotics industry, we need to continue to advance and innovate the Senhance System, including the innovations associated with the MST assets we acquired.  Our focus currently is on harnessing the image technology acquired in the MST acquisition to advance the intelligence of the Senhance System to provide meaningful real-time data to surgeons.  If we fail to develop such innovations, or fail to obtain regulatory approval or clearance for or successfully commercialize such innovations, such failure could have a material adverse effect on our business and financial position.
Fluctuations in foreign currency exchange rates may adversely affect our financial results.
We conduct operations in several different countries, including the United States and throughout Europe, and portions of our revenues, expenses, assets and liabilities are denominated in U.S. dollars, Euros, and other currencies. Since our consolidated financial statements are presented in U.S. dollars, we must translate revenues, income and expenses, as well as assets and liabilities, into U.S. dollars at exchange rates in effect during or at the end of each reporting period. We have not historically hedged our exposure to foreign currency fluctuations.  Accordingly, increases or decreases in the value of the U.S. dollar against the Euro and other currencies could materially affect our net operating revenues, operating income and the value of balance sheet items denominated in foreign currencies.
Our global operations expose us to additional risks and challenges associated with conducting business internationally.
The international nature of our business, particularly in Europe, Israel and Asia, may expose us to risks inherent in conducting foreign operations. These risks include:
challenges associated with managing geographically diverse operations, which require an effective organizational structure and appropriate business processes, procedures and controls;
the high cost of doing business in foreign jurisdictions, including compliance with international and U.S. laws and regulations that apply to our international operations;
currency exchange and interest rate fluctuations and the resulting effect on our revenue and expenses, and the cost and risk of entering into hedging transactions, if we chose to do so in the future;
changes in a specific country’s or region’s political or economic environment;
trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments;
potentially adverse tax consequences;
complexities and difficulties in obtaining protection and enforcing our intellectual property;
compliance with additional regulations and government authorities in a highly regulated business;

difficulties associated with staffing and managing foreign operations, including differing labor relations; and
general economic and political conditions outside of the U.S.
The risks that we face in our international operations may continue to intensify as we further develop and expand our international operations.
We effected a reverse stock split of our common stock on December 11, 2019, which may not achieve one or more of our objectives.
On December 11, 2019, following receipt of approval from stockholders at a special meeting of stockholders held on the same day, we filed an amendment to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our common stock at a ratio of one-for-thirteen, or the Reverse Stock Split. We cannot predict with certainty the effect of the Reverse Stock Split upon the market price of our common stock. As such, it is not possible that the market price of our shares may fluctuate and decline.
One objective of the Reverse Stock Split was to strengthen our strategic alternative considerations. However, there is no assurance that the per-share market price of our common stock after the Reverse Stock Split will attract institutional investors or investment funds, or meet investing guidelines of institutional investors or investment funds. It is possible that the reduced number of outstanding shares of our common stock following the Reverse Stock Split may adversely impact the liquidity of the shares of our common stock. Moreover, an increased number of stockholders may own odd lots (less than 100 shares) of our common stock following the Reverse Stock Split. These stockholders may face greater trading commissions for the sale of such shares and may have greater difficulty effecting such sales.
accurately estimate potential future compliance costs.

Risks Related to Our Status as a Public Company

Our stock price has been volatile and may experience additional volatility and fluctuation in the future.

The market price of our common stock has been, and may continue to be, highly volatile, and such volatility could cause the market price of our common stock tocould decrease and could cause you to lose some or all of your investment in our common stock.  During the two yeartwo-year period ended December 31, 2019,2021, the market price of our common stock fluctuated from a high of $90.74$6.32 per share to a low of $1.35$0.29 per share, after giving effect to the one-for-thirteen Reverse Stock Split effected on December 11, 2019.share. The market price of our common stock may continue to fluctuate significantly in response to numerous factors, some of which are beyond our control, such as:

as

the announcement of favorable or unfavorable news regarding us, including our product development efforts and regulatory clearance activities;

the achievement of lease placements or commercial sales of our products;

the announcement of new products or product enhancements or collaborations by us or our competitors;

the success of our Performance-Guided Surgery initiative;

variations in our and our competitors’ results of operations;

developments in surgical robotics;

future issuances of common stock or other securities;

the addition or departure of key personnel;

announcements by us or our competitors of acquisitions, investments or strategic alliances; and

general market conditions and other factors, including factors unrelated to our operating performance.

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the achievement of commercial sales of our products;
the announcement of new products or product enhancements by us or our competitors;
developments concerning intellectual property rights and regulatory approvals;
variations in our and our competitors’ results of operations;
changes in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts;
developments in surgical robotics;
the results of product liability or intellectual property lawsuits;
future issuances of common stock or other securities;
the addition or departure of key personnel;
the reduced volume of stock trades that may result as a consequence of the Reverse Stock Split;
announcements by us or our competitors of acquisitions, investments or strategic alliances; and
general market conditions and other factors, including factors unrelated to our operating performance.

Our stockholders have experienced dilution of their percentage ownership of our stock and may experience additional dilution in the future.


We have raised significant capital through the issuance of our common stock and warrants and anticipate that we willmay need to raise substantial additional capital in order to continue our operations and achieve our business objectives. We have two effective shelf registration statements under which we have the current ability to raise up to approximately $129.5 million in future financings, as well as our existing at-the-market, or ATM, offering and the recently announced equity line financing under which we may raise up to $25 million through the issuance of common stock over 36 months.  Any additional issuances under the ATM offering or equity line financing cannot commence until June 30, 2020. We cannot assure you that we will be able to sell shares or other securities in any offering at a price per share that is equal to or greater than the price per share paid by investors in previous offerings, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our common stock or other securities convertible into or exchangeable for our common stock in future transactions may be higher or lower than the price per share in previous offerings. The future issuance of the Company’s equity securities will further dilute the ownership of our outstanding common stock.  The market price of our common stock has been, and may continue to be, highly volatile, and such volatility could cause the market price of our common stock to decrease and could cause you to lose some or all of your investment in our common stock.

The exercise of our outstanding warrants will dilute stockholders and could decrease our stock price.
The existence of our outstanding warrants, including the outstanding remaining Series B Warrants and the recently issued Series C Warrants and Series D Warrants, may adversely affect our stock price due

We do not currently intend to issuances of a large number of shares or the perception that such sales could occur. These factors also could make it more difficult to raise funds through future offerings of common stock or warrants, and could adversely impact the terms under which we could obtain additional equity capital. Exercise of outstanding warrants, or any future issuance of additional shares of common stock or other equity securities, including but not limited to options, warrants or other derivative securities convertible intopay dividends on our common stock, may result in significant dilutionand any return to our stockholders and may decrease our stock price.

We issued 24,900,000 Series B Warrants in May 2017; the outstanding warrants must be revalued each reporting period.  In addition, we owe contingent considerationinvestors is expected to Sofar under the Purchase Agreement that is also revalued each reporting period.  Such assessments involve the use of estimates that could later be found to differ materiallycome, if at all, only from actual results.
On April 28, 2017, we sold 24.9 million units, each consisting of approximately 0.077 shares of common stock, a Series A warrant to purchase approximately 0.077 shares of common stock, and a Series B warrant to purchase approximately 0.058 shares of common stock, at a public offering price of $1.00 per unit for aggregate gross proceeds of $24.9 million in an underwritten firm commitment public offering.  As of December 31, 2017, all Series A warrants were exercised. The outstanding Series B Warrants contain provisions, often referred to as “down-round protection” that has led to adjustments of the exercise price and number of underlying warrant shares with respect to future issuances by the Company of its securities, including its common stock or convertible securities or debt securities.  The “down-round protection” has led to and may continue to lead to additional adjustments of the exercise price and number of underlying warrant shares in the future. As of March 10, 2020, Series B Warrants to acquire 292,178 shares of common stock at an exercise price of $0.68 per share were outstanding. In addition, the third tranche of the contingent consideration to be paid to Sofar under the Purchase Agreement remains outstanding, to be paid if the designated milestone is met.
The Series B Warrants and the contingent consideration are each recorded as a liability on our financial statements, and we are required to revalue each of the outstanding Series B Warrants and the contingent consideration at each reporting period.  Such revaluations necessarily involve the use of estimates, assumptions, probabilities and application of complex accounting principles.  Actual value at the time the Series B Warrants are exercised or the contingent consideration paid could vary significantly from the value assigned to such liabilities on a quarterly basis. We cannot assure you that the revaluation of the Series B Warrants and contingent consideration will equal the value in the future, and know that the actual value could be significantly different, which could have a material adverse effect on us.
The surgical robotics industry is increasingly competitive, which can negatively impact our commercial opportunities.
The life sciences industry is highly competitive, and we face significant competition from many medical device companies that are researching and marketing products designed to address minimally invasive and robotic-assisted surgery, including new entrants in the competitive market. We are currently commercializing the Senhance System in the United States with FDA 510(k) clearance, in Europe which accepts a CE Mark, the Middle East and selected countries in Asia. We face significant competition in such markets. Many of our competitors, including Intuitive Surgical, have significantly greater financial, manufacturing, marketing and product development resources than we do. Some of the medical device companies we compete with or expect to compete with include Johnson & Johnson/Verb Surgical Inc., Medtronic plc, Intuitive Surgical Inc., and CMR Surgical Ltd. and a number of minimally invasive surgical device and robotic surgical device manufacturers and providers of products and therapies that are designed to reduce the need for or attractiveness of surgical intervention. In addition, many other universities and private and

public research institutions are or may become active in research involving surgical devices for minimally invasive and robotic-assisted surgery.
We are also expanding the potential market for robotic surgical systems with our focus on laparoscopic surgery. Such expansion may lead to additional competition with companies with sufficiently higher resources than ours.
We believe that our ability to successfully compete will depend on, among other things:
the efficacy, safety and reliability of our products;
our ability to commercialize and market our cleared or approved products;
the completion of our development efforts and receipt of regulatory clearance or approval for instruments and accessories to support the use of the Senhance System;
the cost of ownership and use of our products in relation to alternative devices;
the timing and scope of regulatory clearances or approvals, including any expansion of the indications of use for our products;
whether our competitors substantially reduce the cost of ownership and use of an alternative device;
our ability to protect and defend intellectual property rights related to our products;
our ability to have our partners manufacture and sell commercial quantities of any cleared or approved products to the market;
the availability of adequate coverage and reimbursement by third-party payors for the procedures in which our products are used;
our ability to adapt to changes in the regulatory environment;
the effectiveness of our sales and marketing efforts; and
acceptance of future products by physicians and other health care providers.

If our competitors market products that are more effective, safer, easier to use or less expensive than our products or future products, or that reach the market sooner than our products, we may not achieve commercial success. In addition, the medical device industry is characterized by rapid technological change. It may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or products obsolete or less competitive.
We anticipate that the highly competitive surgical robotics environment can lead our competitors to attempt to slow or derail our commercial progress. We are using our best efforts to enter the commercial markets effectively and efficiently while maintaining compliance with all regulatory and legal requirements. Responding to the actions of our competitors will require the attention of our management and may distract the management team from its focus on our commercial operations and lead to increased costs of commercialization, which could have a negative impact on our financial position.
We also anticipate that the competitive surgical robotics environment will become more intense because of increased consolidation by companies in the health care industry looking to achieve cost reductions. Such consolidation may have an adverse effect on our business operations.
We utilize distributors for a portion of our sales, which subjects us to a number of risks that could harm our business.
We use distributors for sales and service of our products in certain foreign countries. If these relationships are terminated and not replaced, our revenues and/or ability to sell or service our products in the markets serviced by these distributors could be adversely affected. The actions of our distributors may affect our ability to effectively market our products in certain foreign countries or regulatory jurisdictions if the distributor holds the regulatory authorization in such countries or within such regions and causes, by action or inaction, the suspension of such marketing authorization or sanctions for non-compliance. It may be difficult, expensive and time consuming for us to re-establish market access or regulatory compliance in such case.
We face risks arising from sole suppliers of components and our ability to meet delivery schedules for sales of our products.
The Senhance System is manufactured for us under contract by a third party manufacturer. We or our manufacturer acquire raw materials and components of the Senhance System from vendors, some of which are sole suppliers. Although we believe that we have the manufacturing capacity and inventory reserves to meet our anticipated Senhance System sales for the foreseeable future, we are currently taking steps to develop redundant manufacturing and supply alternatives. We cannot assure you that we will be successful in developing these redundant supply and manufacturing capabilities. If we are not successful, our business operations could suffer.

Because our design, development and manufacturing capabilities are limited, we rely on third parties to design, develop, manufacture or supply some of our products. An inability to find additional or alternate sources for these services and products could materially and adversely affect our financial condition and results of operations.
We have used third-party design and development sources to assist in the design and development of our medical device products. In the future, we may choose to use additional third-party sources for the design and development of our products. If these design and development partners are unable to provide their services in the timeframe or to the performance level that we require, we may not be able to establish a contract and obtain a sufficient alternative supply from another supplier on a timely basis and in the manner that we require.
Our ability to replace any then-existing manufacturer may be difficult because the number of potential manufacturers is limited and, in the case of Class III devices, the FDA must approve any replacement manufacturer before manufacturing can begin. The process of identifying and engaging new manufacturers may be time-consuming and costly. It may be difficult or impossible for us to identify and engage a replacement manufacturer on acceptable terms in a timely manner, or at all. This may adversely affect our product availability and, as a result, our business.
Reliance on third parties to manufacture or supply some of our products may harm our business if such third parties do not meet regulatory and performance standards.
Our products require precise, high quality manufacturing. We and our contract manufacturers will be subject to ongoing periodic unannounced inspection by the FDA and non-U.S. regulatory authorities to ensure strict compliance with the quality systems regulations, current “good manufacturing practices” and other applicable government regulations and corresponding standards. If we or our contract manufacturers fail to achieve and maintain high manufacturing standards in compliance with QSR, we may experience manufacturing errors resulting in patient injury or death, product recalls or withdrawals, delays or interruptions of production or failures in product testing or delivery, delay or prevention of filing or approval of marketing applications for our products, cost overruns or other problems that could seriously harm our business.
Any performance failure by us or on the part of our design and development partners or contract manufacturers could delay product development or regulatory clearance or approval of our products, or commercialization of our products and future products, depriving us of potential product revenue and resulting in additional losses. In addition, our dependence on any third party for design, development or manufacturing could adversely affect our future profit margins.
We sold our SurgiBot System assets in 2017, and we may not obtain the royalty income we anticipate from such sale.
In December 2017, we transferred ownership of the SurgiBot System assets to GBIL. The agreements provide rights to the purchaser to manufacture, or have manufactured, the SurgiBot System in China, and provides exclusive distribution rights to the Chinese market.  The agreement provides us with minimum royalties of $14.0 million over a future five-year period.  If the buyer is not successful in gaining Chinese regulatory approval or marketing the SurgiBot System, we will only receive such minimum royalties, decreasing the return on the funds expended in the development of the SurgiBot System.
We had significant management changes in the fourth quarter of 2019. Such changes could divert attention from the operation of the business and create uncertainty.
Joseph P. Slattery, our former chief financial officer, retired on December 31, 2019. In January 2020 we hired Brett Farabaugh as our interim Chief Financial Officer. A search is in process for a new chief financial officer but we may have difficulty recruiting a new chief financial officer with the current issues facing the Company.
On November 8, 2019, we announced the departure of Todd M. Pope as our president and chief executive officer, and as a member of our Board of Directors, and announced the appointment of Anthony Fernando as president and chief executive officer and his election to the Board of Directors. Any such significant management changes can divert focus away from the operation of the business and could create uncertainty in our personnel. We cannot assure you that the change in senior leadership will not have an adverse impact on the Company and its financial condition.
We identified a material weakness in our internal control over financial reporting related to our preparation, documentation and review of the income tax provision in accordance with GAAP. We may identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, which may result in material misstatements of our financial statements or cause us to fail to meet our reporting obligations.

In connection with the preparation of our consolidated financial statements for the year ended December 31, 2019, we identified a material weakness in our internal control over financial reporting related to our income tax provision and related accounting and disclosures. A material weakness is defined as a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. As of December 31, 2019, we did not maintain effective controls relating to the income tax accounting and disclosures for the significant components of deferred tax assets and liabilities related to a foreign non-recurring transaction.
Based on this finding, management is implementing a remediation plan to address the control deficiency that led to the material weakness. The remediation plan includes implementing specific review procedures, including strengthening our income tax control with improved documentation standards, technical oversight and training.
Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. If we are unable to successfully remediate our existing or any future material weakness in our internal control over financial reporting, or identify any additional material weaknesses that may exist, the accuracy and timing of our financial reporting may be adversely affected. Additionally, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports as well as applicable stock exchange listing requirements. We may be unable to prevent fraud, investors may lose confidence in our financial reporting, and our stock price may also decline. Our reporting obligations as a public company could place a significant strain on our management, operational and financial resources and systems for the foreseeable future and may cause us to fail to timely achieve and maintain the adequacy of our internal control over financial reporting.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies and procedures may deteriorate. Because of its inherent limitations, internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. As a result, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. We cannot assure you that the measures we are currently undertaking or may take in the future will be sufficient to maintain effective internal controls or to avoid potential future deficiencies in internal control, including material weaknesses. In addition, failing to maintain effective disclosure controls and internal controls over financial reporting could have a material and adverse effect on our business and operating results and could cause a declineincreases in the price of our securities.
common stock.

At the present time, we intend to use available funds to finance our operations. Accordingly, while payments of dividends is within the discretion of our board of directors, no cash dividends on our common stock have been declared or paid by us, and we have no intention of paying any such dividends in the foreseeable future. Any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.  

Risks Related to Protection of our Intellectual Property

Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.

Other entities may have or obtain patents or proprietary rights that could limit our ability to manufacture, use, sell, offer for sale or import products or impair our competitive position. In addition, to the extent that a third partythird-party develops new technology that covers our products, we may be required to obtain licenses to that technology, which licenses may not be available or may not be available on commercially reasonable terms, if at all. If licenses are not available to us on acceptable terms, we will not be able to market the affected products or conduct the desired activities, unless we challenge the validity, enforceability or infringement of the third-party patent or circumvent the third-party patent, which would be costly and would require significant time and attention of our management. Third parties may have or obtain valid and enforceable patents or proprietary rights that could block us from developing products using our technology. Our failure to obtain a license to any technology that we require may materially harm our business, financial condition and results of operations.

If we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our product development and commercialization efforts, any of which could materially adversely affect our liquidity, business prospects and results of operations.

Third parties may sue us for infringing their patent rights. Likewise, we may need to resort to litigation to enforce a patent issued or licensed to us or to determine the scope and validity of proprietary rights of others. In addition, a third partythird-party may claim that we have improperly obtained or used its confidential or proprietary information. Furthermore, in connection with our third-party license agreements, we generally have agreed to indemnify the licensor for costs incurred in connection with litigation relating to intellectual property rights. The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than us because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.


If any parties successfully claim that our creation or use of proprietary technologies infringes upon their intellectual property rights, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might have to pay, a court could require us to stop the infringing activity or obtain a license. Any license required under any patent may not be made available on commercially acceptable terms, if at all. In addition, such licenses are likely to be non-exclusive and, therefore, our competitors may have access to the same technology licensed to us. If we fail to obtain a required license and are unable to design around a patent, we may be unable to effectively market some of our technology and products, which could limit our ability to generate revenues or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.

For our Senhance System, we rely on our license from the European Union, and any loss of our rights under such license agreement, or failure to properly prosecute, maintain or enforce the patent applications underlying such license agreement, could materially adversely affect our business prospects for the Senhance System.

Some of the patents and patent applications in our patent portfolio related to the Senhance System are licensed to TransEnterixAsensus Surgical Italia S.r.l. under a license agreement with the European Union. Presently, we rely on such licensed technology for our Senhance System products and may license additional technology from the European Union or other third parties in the future. The EU license agreement gives us rights for the commercial exploitation of the licensed patents, patent applications and know-how, subject to certain provisions of the license agreement. Failure to comply with these provisions could result in the loss of our rights under the EU license agreement. Our inability to rely on these patents and patent applications which are the basis of certain aspects of our Senhance System technology would have an adverse effect on our business.

Further, our success will depend in part on the ability of us, the European Union and other third-party licensors to obtain, maintain and enforce patent protection for our licensed intellectual property and, in particular, those patents to which we have secured exclusive rights. We, the European Union or other third-party licensors may not successfully prosecute the patent applications which are licensed to us, may fail to maintain these patents, and may determine not to pursue litigation against other companies that are infringing these patents, or may pursue such litigation less aggressively than necessary to obtain an acceptable outcome from any such litigation. Without protection for the intellectual property we have licensed, other companies might be able to offer substantially identical products for sale, which could materially adversely affect our competitive business position, business prospects and results of operations.

If we or our licensors are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.

In addition to patent protection, we also rely on other proprietary rights, including protection of trade secrets, know-how and confidential and proprietary information. To maintain the confidentiality of trade secrets and proprietary information, we will seek to enter into confidentiality agreements with our employees, consultants and collaborators upon the commencement of their relationships with us. These agreements generally require that all confidential information developed by the individual or made known to the individual by us during the course of the individual’s relationship with us be kept confidential and not disclosed to third parties. Our agreements with employees also generally provide and will generally provide that any inventions conceived by the individual in the course of rendering services to us shall be our exclusive property. However, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information. To the extent that our employees, consultants or contractors use technology or know-how owned by third parties in their work for us, disputes may arise between us and those third parties as to the rights in related inventions. Adequate remedies may not exist in the event of unauthorized use or disclosure of our confidential information. The disclosure of our trade secrets would impair our competitive position and may materially harm our business, financial condition and results of operations.

If we are unable to obtain and enforce patent protection for our products, our business could be materially harmed.

Our success depends, in part, on our ability to protect proprietary methods and technologies that we develop or license under the patent and other intellectual property laws of the United States and other countries, so that we can prevent others from unlawfully using our inventions and proprietary information. However, we may not hold proprietary rights to some patents required for us to commercialize our proposed products. Because certain U.S. patent applications are confidential until patents issue, such as applications filed prior to November 29, 2000, or applications filed after such date which will not be filed in foreign countries, third parties may have filed patent applications for technology covered by our pending patent applications without our being aware of those applications, and our patent applications may not have priority over those applications. For this and other reasons, we or our third-party collaborators may be unable to secure desired patent rights, thereby losing desired exclusivity. If licenses are not


available to us on acceptable terms, we will not be able to market the affected products or conduct the desired activities, unless we challenge the validity, enforceability or infringement of the third-party patent or otherwise circumvent the third-party patent.

Our strategy depends on our ability to promptly identify and seek patent protection for our discoveries. In addition, we may rely on third-party collaborators to file patent applications relating to proprietary technology that we develop jointly during certain collaborations. The process of obtaining patent protection is expensive and time-consuming. If our present or future collaborators fail to file and prosecute all necessary and desirable patent applications at a reasonable cost and in a timely manner, our business will be adversely affected. Despite our efforts and the efforts of our collaborators to protect our proprietary rights, unauthorized parties may be able to develop and use information that we regard as proprietary.

The issuance of a patent provides a presumption, but does not guarantee that it is valid. Any patents we have obtained, or obtain in the future, may be challenged or potentially circumvented. Moreover, the United States Patent and Trademark Office, or the USPTO, may commence interference proceedings involving our patents or patent applications. Any such challenge to our patents or patent applications would be costly, would require significant time and attention of our management and could have a material adverse effect on our business. In addition, future court decisions may introduce uncertainty in the enforceability or scope of any patent, including those owned by medical device companies.

Our pending patent applications may not result in issued patents. The patent position of medical device companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards that the USPTO and its foreign counterparts use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in medical device patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. The legal systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Therefore, the enforceability or scope of our owned or licensed patents in the United States or in foreign countries cannot be predicted with certainty, and, as a result, any patents that we own or license may not provide sufficient protection against competitors. We may not be able to obtain or maintain patent protection for our pending patent applications, those we may file in the future, or those we may license from third parties.

We cannot assure you that any patents that will issue, that may issue or that may be licensed to us will be enforceable or valid or will not expire prior to the commercialization of our products, thus allowing others to more effectively compete with us. Therefore, any patents that we own or license may not adequately protect our future products.

Risks Related to Regulation of our Business

Even if we obtain regulatory clearances or approvals for our products, the terms thereof and ongoing regulation of our products may limit how we manufacture and market our products, which could materially impair our ability to generate anticipated revenues.

Once regulatory clearance or approval has been granted, the cleared or approved product and its manufacturer are subject to continual review. Any cleared or approved product may be promoted only for its indicated uses. In addition, if the FDA or other non-U.S. regulatory authorities clear or approve any of our products, the labeling, packaging, adverse event reporting, storage, advertising and promotion for the product will be subject to extensive regulatory requirements. We and any outsourced manufacturers of our products are also required to comply with the FDA’s QSR, or similar requirements of non-U.S. regulatory authorities which includes requirements relating to quality control and quality assurance, as well as the corresponding maintenance of records and documentation as well as other quality system requirements and regulations from non-U.S. regulatory authorities. Further, regulatory agencies must approve our manufacturing facilities for Class III devices before they can be used to manufacture our products, and all manufacturing facilities are subject to ongoing regulatory inspection. If we fail to comply with the regulatory requirements of the FDA, either before or after clearance or approval, or other non-U.S. regulatory authorities, or if previously unknown problems with our products, manufacturers or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions, including:

restrictions on the products, manufacturers or manufacturing process;
adverse inspectional observations (Form 483), warning letters, non-warning letters incorporating inspectional observations, or consent decrees;
civil or criminal penalties or fines;
injunctions;
product seizures, detentions or import bans;
voluntary or mandatory product recalls and publicity requirements;

suspension or withdrawal of regulatory clearances or approvals;
total or partial suspension of production;
imposition of restrictions on operations, including costly new manufacturing requirements;
refusal to clear or approve pending applications or premarket notifications; and
import and export restrictions.

restrictions on the products, manufacturers or manufacturing process;

adverse inspectional observations (Form 483), warning letters, non-warning letters incorporating inspectional observations, or consent decrees;

civil or criminal penalties or fines;

injunctions;

product seizures, detentions or import bans;

voluntary or mandatory product recalls and publicity requirements;

suspension or withdrawal of regulatory clearances or approvals;

total or partial suspension of production;

imposition of restrictions on operations, including costly new manufacturing requirements;

refusal to clear or approve pending applications or premarket notifications; and

import and export restrictions.

Any of these sanctions could have a material adverse effect on our reputation, business, results of operations and financial condition. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements, which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

In addition, the FDA and other non-U.S. regulatory authorities may change their policies and additional regulations may be enacted that could prevent or delay regulatory clearance or approval of our products. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we would likely not be permitted to market our future products and we may not achieve or sustain profitability.

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We may be liable if the FDA or another regulatory agency concludes that we have engaged in the off-label promotion
Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of the off-label use of the Senhance System and our other products. Healthcare providers may use our products off-label, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine. However, if the FDA determines that our promotional materials, sales practices or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine and criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties. Although we train our marketing and direct sales force to not promote our products for uses outside of their cleared uses and our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, the off-label use of our products may increase the risk of product liability claims. Product liability claims are expensive to defend and could result in substantial damage awards against us and harm our reputation.
The regulatory approval and clearance processes are expensive, time-consuming and uncertain and may prevent us from obtaining approvals or clearances, as the case may be, for the commercialization of some or all of our products.
Regulatory approval of a PMA or PMA, or supplement or clearance pursuant to a 510(k) premarket notification, or granting of a de novo request is not guaranteed, and the approval or clearance process, as the case may be, is expensive, uncertain and may, especially in the case of the PMA application, take several years. The FDA also has substantial discretion in the medical device clearance process or approval process. Despite the time and expense exerted, failure can occur at any stage, and we could encounter problems that cause us to repeat or perform additional development, standardized testing, pre-clinical studies and clinical trials. The number of pre-clinical studies and clinical trials that will be required for FDA clearance or approval varies depending on the medical device candidate, the disease or condition that the medical device candidate is designed to address, and the regulations applicable to any particular medical device candidate. The FDA or other non-U.S. regulatory authorities can delay, limit or deny clearance or approval of a medical device candidate for many reasons, including:
a medical device candidate may not be deemed to provide a reasonable assurance of safety or effectiveness, in the case of a PMA application;
a medical device candidate may not be deemed to be substantially equivalent to a lawfully marketed predicate device through the 510(k) premarket notification process;
a medical device candidate may not be deemed to be in conformance with applicable standards and regulations;
FDA or other regulatory officials may not find the data from pre-clinical studies and clinical trials sufficient;
FDA may not approve our processes or facilities or those of any of our third-party manufacturers for a Class III PMA device;

���other non-U.S. regulatory authorities may not approve our processes or facilities or those of any of our third-party manufacturers, thereby restricting export; or
FDA or other non-U.S. regulatory authorities may change clearance or approval policies or adopt new regulations.
The laws governing the regulatory approval or clearance pathways in jurisdictions outside of the United States are complex.  We need to ensure that our activities, and the activities of our distributors and agents, comply with such laws.  If we do not comply with such laws, we may not be able to sell our products, including the Senhance System, in all jurisdictions we have targeted, which could have an adverse effect on our business operations and financial condition.  

Once our products are cleared or approved, modifications to our products may require new 510(k) clearances, de novo clearance, premarket approvals or new or amended CE Certificates of Conformity, and may require us to cease marketing or recall the modified products until clearances, approvals or the relevant CE Certificates of Conformity are obtained.

Any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use requires a new 510(k) clearance or, possibly, a PMA or de novo clearance. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review such determinations. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary. If the FDA disagrees with our determinations for any future changes, or prior changes to previously marketed products, as the case may be, we may be required to cease marketing or to recall the modified products until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.

Furthermore, the FDA’s ongoing review of the 510(k) program may make it more difficult for us to make modifications to our products, either by imposing more strict requirements on when a new 510(k) for a modification to a previously cleared product must be submitted, or applying more onerous review criteria to such submissions. In October 2017, the FDA issued guidance documents addressing when to submit a new 510(k) due to modifications to 510(k) cleared products and the criteria for evaluating substantial equivalence. The interpretation of the guidance documents by the FDA staff could lead to instances where the FDA disagrees with the Company’s decision regarding a change, and could result in warning letters and other enforcement actions.

Our products are subject to international regulatory processes and approval or certification requirements. If we do not obtain and maintain the necessary international regulatory approvals or certifications, we will not be able to sell our products in other countries.

To be able to sell our products in other countries, we must obtain regulatory approvals or certifications and comply with the regulations of those countries, which may differ substantially from those of the U.S. These regulations, including the requirements for approvals or certifications and the time required for regulatory review, and vary from country to country. Obtaining and maintaining foreign regulatory approvals or certifications is complex, and timing to obtain clearances or certifications in those countries varies; therefore, we cannot be certain that we will receive regulatory approvals or certifications in any other country in which we plan to market our products or obtain such approvals or certifications on a favorable schedule. The time required to obtain marketing authorization in other countries might differ from that required to obtain FDA authorization. If we fail to obtain or maintain regulatory approval or certification in any other country in which we plan to market our products, our ability to generate revenue will be harmed. Regulatory authorization of a product in one country does not ensure regulatory authorization in another, but a failure or delay in obtaining marketing authorization in one country may negatively impact the regulatory process in others.

One of the most significant moving targets related to the regulatory landscape is in the EU; more specifically, the medical devices regulation has recently evolved. Regulation (EU) 2017/745 on medical devices became applicable in the European Union on May 26, 2021. The Medical Device Regulation (MDR) changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for the European Medicines Agency (EMA) and for national competent authorities in the assessment of certain categories of products. Our products in EU countries must now comply with extensive safety and quality regulations detailed in the MDR.

The MDR, which replaced the MDD in May 2021 after a four-year transition period, imposes significant additional premarket and post-market certification requirements on medical devices marketed in the EU. European Economic Area (EEA) Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national codes of conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare providers harming our business, operating results and financial condition.  If we are unable to obtain timely, updated post-market certifications for our products under the MDR, or experience difficulty scheduling with a Notified Body, our business prospects in the EU could be materially adversely affected, which could have a material adverse effect on our financial results.

Even after clearance or approval for our products is obtained, we are subject to extensive post-market regulation by the FDA and other regulators. Our failure to meet strict regulatory requirements could require us to pay fines, incur other costs or even close our facilities.

Even after we have obtained the proper regulatory clearance or approval to market a product, the FDA has the power to require us to conduct post-market studies. These studies can be very expensive and time-consuming to conduct. Failure to complete such studies in a timely manner could result in the revocation of clearance or approval and the recall or withdrawal of the product, which could prevent us from generating sales from that product in the United States. The FDA has broad enforcement powers, and any regulatory enforcement actions or inquiries, or other increased scrutiny on us, could dissuade some surgeons from using our products and adversely affect our reputation and the perceived safety and efficacy of our products.

We are also required to comply with the FDA’s QSR, which covers the methods used in, and the facilities and controls used for, the design, manufacture, quality assurance, labeling, packaging, sterilization, storage, shipping, installation and servicing of our marketed products. The FDA enforces the QSR through periodic announced and unannounced inspections of manufacturing facilities. In addition, in the future, regulatory authorities and/or customers may require specific packaging of sterile products, which could increase our costs and the price of our products. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

In Europe, the advertising and promotion of our products is subject to the MDD, as well as other European Economic Area, or EEA, Member State legislation governing the advertising and promotion of medical devices. The MDR, which will replace the MDD in May 2020 after a three-year transition period, will impose significant additional premarket and post-market certification requirements on medical devices marketed in the EU. EEA Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national codes of conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare providers harming our business, operating results and financial condition.  If we are unable to obtain

timely, updated post-market certifications for our products under the MDR, or experience difficulty scheduling with a Notified Body, our business prospects in the EU could be materially adversely affected, which could have a material adverse effect on our financial results.

If one of our products, or a malfunction of one of our products, causes or contributes to a death or a serious injury, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

Under the FDA’s MDR regulations, we are required to report to the FDA any incident in which our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Repeated product malfunctions may result in a voluntary or involuntary product recall, which could divert managerial and financial resources, impair our ability to manufacture our products in a cost-effective and timely manner, and have an adverse effect on our reputation, results of operations and financial condition. We are also required to follow detailed recordkeeping requirements for all firm-initiated medical device corrections and removals, and to report such corrective and removal actions to the FDA if they are carried out in response to a risk to health and have not otherwise been reported under the MDR regulations.

All manufacturers bringing medical devices to market in the EEA are legally bound to report any incident that led or might have led to the death or serious deterioration in the state of health of a patient, user or other person, and which the manufacturer’s device is suspected to be a contributory cause, to the competent authority in whose jurisdiction the incident occurred. In such case, the manufacturer must file an initial report with the relevant competent authority, which would be followed by further evaluation or investigation of the incident and a final report indicating whether further action is required.  Any adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Adverse events involving our products have been reported to us in the past, and we cannot guarantee that they will not occur in the future. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results.

A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

The FDA and similar foreign governmental authorities such as the competent authorities of the EEA countries have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture or in the event that a product poses an unacceptable risk to health. Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues.

Any future recalls of any of our products would divert managerial and financial resources and could have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be required to bear other costs or take other actions that may have a negative impact on our future sales and our ability to generate profits.

U.S. legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.

Legislative changes could significantly alter the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products. In addition, FDA regulations and guidance could be revised or reinterpreted by the FDA in ways that could significantly affect our business and our products. Any new regulations or revisions, or reinterpretations of existing regulations, may impose additional costs or lengthen review times of future products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations will be changed, and what the impact of such changes, if any, may be.

Even if we receive regulatory clearance

Disruptions at the FDA and other government agencies or approvalnotified bodies caused by funding shortages or global health concerns could hinder their ability to markethire, retain, or deploy key leadership and other personnel, or otherwise prevent products from being developed, cleared, certified, approved, or commercialized in a timely manner or at all, which may adversely affect our products, the market may not be receptive to our products, which could undermine our financial viability.

Even if our products obtain regulatory clearance or approval, resulting products may not gain market acceptance amongbusiness.

The delivery of healthcare by hospitals, health systems, and physicians patients, health care payors and/or the medical community. We have experienced minimal sales of our Senhance System, to date. We believe that the degree of market acceptance will dependdepends on a number of factors, including:

timing of market introduction of competitive products;

safetygovernment agencies and efficacy of our products;
physician training in the use of our products;
prevalenceservices. Further prolonged government shutdowns or restrictions could impact inspections, regulatory review and severity of any side effects;
potential advantagescertifications, grants, or disadvantages over alternative treatments;
strength of marketing and distribution support; and
price of our future products, both in absolute terms and relativeapprovals or could cause other situations that could impede their ability to alternative treatments.
If applicable, availability of coverage and reimbursement from governmenteffectively deliver healthcare, including attempts to reduce payments and other third-party payorsreimbursements to hospitals by federal healthcare programs. These situations could adversely affect our customers’ ability to perform procedures with our devices and/or their decisions to purchase additional products from us.

In addition, the review and clearance, approval, or certification of new products can also impact the acceptancebe affected by a variety of our product offerings.

If we failfactors globally, including government budget and funding levels, ability to attracthire and retain key managementpersonnel and professional personnel, we may be unable to successfully commercialize or develop our products.
We will need to effectively manage our operational, salesaccept the payment of user fees, and marketing, developmentstatutory, regulatory, and policy changes. In addition, government funding of other resources in order to successfully pursue our commercialization andgovernment agencies that fund research and development activities is subject to unpredictable and ever-changing political processes. Disruptions at the FDA and other agencies or notified bodies for any of these or other reasons may cause significant regulatory delays and, therefore, delay our efforts for our existingto seek clearances, approvals, or certifications from the FDA, foreign authorities, and future products. Our success dependsnotified bodies and adversely affect business travel and import and export of products, all of which could have a material adverse effect on our continuedbusiness, financial condition, results of operations, or cash flows. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately, in response to the global COVID-19 pandemic, in early 2020, the FDA announced its intention to postpone most foreign inspections of manufacturing facilities and products through April 2020 and temporarily postponed routine surveillance inspections of domestic manufacturing facilities. In mid-2020, the FDA resumed certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. In 2021, the FDA resumed standard inspectional operations of domestic facilities and announced its intention to resume certain prioritized inspections of foreign manufacturing facilities, including surveillance and application-related inspections, starting in February 2022. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA, other regulatory authorities, or notified bodies from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact their ability to attract, retaintimely review and motivate highly qualified personnel.   If we are not successful in retaining and recruiting highly qualified personnel,process our business may be harmed asregulatory submissions, which could have a result.

material adverse effect on our business.

We may be subject, directly or indirectly, to federal and state anti-kickback, fraud and abuse, false claims, privacy and security and physician payment transparency laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Our business activities are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security and physician payment transparency laws. If our operations are found to be in violation of any of such laws that apply to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

Current legislation

We are subject to an evolving set of complex laws and future legislativeregulations relating to privacy, data protection and information collection matters.

There are numerous state, federal, and foreign laws, regulations, decisions, and directives regarding privacy and the collection, storage, transmission, use, processing, disclosure, and protection of different types of personal data and personal information and other customer or regulatory reformother data, the scope of which is continually evolving and subject to differing interpretations. We also must comply with the health care systempolicies, procedures and business requirements of our customers relating to data privacy and security, which can vary based upon the customer, the customer’s industry or location, and the product the customer selects, and which may affectbe more restrictive than the privacy and security measures required by law or regulation. In particular, the European Union and many countries in Europe have stringent privacy laws and regulations, which may impact our ability to sellprofitably operate in certain European countries or to offer products that meet the needs of customers subject to European Union privacy laws and regulations.

For example, the General Data Protection Regulation (the “GDPR”) in effect across the EEA, imposes several stringent requirements for controllers and processors of personal data, including imposing strict standards when obtaining consent from individuals to process their personal data, requiring detailed disclosures to individuals, providing individual data rights, imposing short time lines for data breach notifications, limiting retention periods and secondary use of information, imposing certain requirements pertaining to health data, as well as additional obligations when we contract third-party processors to process personal data. The GDPR provides that EEA Member States may make their own further laws and regulations limiting the processing of genetic, biometric, or health data, which could limit our products profitably.

Inability to use and share personal data or could cause our costs to increase and harm our business and financial condition. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the EEA member states may result in fines of up to 4% of the total worldwide annual turnover of the preceding financial year and other administrative penalties. Compliance with the new data protection rules imposed by GDPR may be onerous and adversely affect our business, financial condition, and results of operations.

Likewise, the California Consumer Privacy Act, or the CCPA, is a state law that gives California residents expanded rights to access and delete their personal information, opt out of certain personal information sharing, and receive detailed information and how their personal information is used and imposes compliance obligations on many organizations doing business in California that collect information about California residents. The definition of personal information is very broad and may impact our ability to profitably operate across the United States there have been,given that our customers’ employees may be resident in California or to offer products that meet the needs of customers subject to California privacy laws and we expect thereregulations. The CCPA also allows for significant fines by the state attorney general as well as a private right of action for individuals in connection with certain security breaches. The enactment of the CCPA is prompting a wave of similar legislative developments in other US states and creating the potential for a patchwork of overlapping but different state laws. These developments are increasing our compliance burden and our risk, including risks of regulatory fines, litigation and associated reputational harm.

The costs of compliance with, and other burdens imposed by, our customers’ own requirements and the privacy and security laws and regulations that are applicable to continueour customers’ businesses may limit the use and adoption of our products and reduce overall demand. Non-compliance with our customers’ specific requirements may lead to be,termination of contracts with these customers or liabilities to the customers; non-compliance with applicable laws and regulations may lead to significant fines, penalties or liabilities.

Furthermore, privacy concerns may cause our customers’ workers to resist providing the personal data necessary to allow our customers to use our products effectively. If a numbercustomer experiences a significant data security breach involving our products, our customers could lose confidence in our ability to protect the personal information of their employees, customers and suppliers, which could cause our customers to discontinue use of our products. The loss of confidence from a significant data security breach involving our software products could hurt our reputation, cause sales and marketing challenges to existing and new customers, cause loss of market share or exacerbate competitive pressures, result in an increase in our development costs to address any potential vulnerabilities in our software products, and may result in reduced demand and revenue. Even the perception of privacy concerns, whether or not valid, may inhibit market adoption of our products in certain industries.

Domestic and international legislative and regulatory initiatives at bothand our customers’ privacy policies and practices may adversely affect our and our customers’ ability to process, handle, store, use and transmit demographic and personal information from their employees, customers and suppliers, which could reduce demand for our products.

In addition to government activity, privacy advocacy groups and the federaltechnology and state government levels,other industries are considering various new, additional or different self-regulatory standards that may place additional burdens on our software products. Complying with these varying requirements could cause us to incur substantial costs or require it to change the healthcare systemour business practices in ways that, if approved, could affect our abilitya manner adverse to sell our products profitably. While many of the proposed policy changes require congressional approval to implement, we cannot assure you that reimbursement payments under governmental and private third-party payor programs to health care providers will remain at levels comparable to present levels or will be sufficient to cover the costs allocable to patients eligible for reimbursement under these programs. Any changes that lower reimbursement rates under Medicare, Medicaid or private payor programs could negatively affect our business.

To the extent that any of our products are deemed to be durable medical equipment, or DME, they may be subject to distribution under Medicare’s Competitive Acquisition regulations, which could adversely affect the amount that we can seek from payors. Non‑DME devices used in surgical procedures are normally paid directly by the hospital or health care provider and not reimbursed separately by third-party payors. As a result, these types of devices are subject to intense price competition that can place a small manufacturer at a competitive disadvantage as hospitals and health care providers attempt to negotiate lower prices for products such as the ones we develop and sell.
With the continued uncertainty regarding the status of the 2010 Health Care Reform Legislation, at this time, the Company is not certain as to the impact of federal health care legislation on its business.
Further, the 2010 Health Care Reform Legislation includes the Open Payments Act (formerly referred to as the Physician Payments Sunshine Act), which, in conjunction with its implementing regulations, requires certain manufacturers of certain drugs, biologics, and devices that are reimbursed by Medicare, Medicaid and the Children’s Health Insurance Program to report annually certain payments or “transfers of value” provided to physicians and teaching hospitals and to report annually ownership and investment interests held by physicians and their immediate family members during the preceding calendar year. We provided reports under

the Open Payments Act to the Centers for Medicare & Medicaid Services, or CMS. The failure to report appropriate data accurately, timely, and completely could subject us to significant financial penalties. Other countries and several states currently have similar laws and more may enact similar legislation.
We are unable to predict what additional legislation or regulation relating to the health care industry or third-party coverage and reimbursement may be enacted in the future or what effect such legislation or regulation would have on our business. Any cost containment measuresfailure, or other health care system reforms that are adopted could have a material and adverse effectperceived failure, on our abilitypart to comply with any regulatory requirements or international privacy or consumer protection-related laws and regulations could result in proceedings or actions against it by governmental entities or others, subject it to significant penalties or fines and negative publicity and adversely affect us.

General Risk Factors

If we fail to attract and retain key management and professional personnel, we may be unable to successfully commercialize or develop our products.

We will need to effectively manage our operational, sales and marketing, development and other resources in order to successfully pursue our commercialization and research and development efforts for our existing and future products successfully.

products. Our success depends on our continued ability to attract, retain and motivate highly qualified personnel.  If we are not successful in retaining and recruiting highly qualified personnel, our business may be harmed as a result.

We may become subject to potential product liability claims, and we may be required to pay damages that exceed our insurance coverage.

Our business exposes us to potential product liability claims that are inherent in the design, testing, manufacture, sale and distribution of our products and each of our product candidates that we are seeking to introduce to the market. Surgical medical devices involve significant risks of serious complications, including bleeding, nerve injury, paralysis, infection, and even death. Any product liability claim brought against us, with or without merit, could result in the increase of our product liability insurance rates or in our inability to secure coverage in the future on commercially reasonable terms, if at all. In addition, if our product liability insurance proves to be inadequate to pay a damages award, we may have to pay the excess of this award out of our cash reserves, which could significantly harm our financial condition. If longer-term patient results and experience indicate that our products or any component of a product causes tissue damage, motor impairment or other adverse effects, we could be subject to significant liability. A product liability claim, even one without merit, could harm our reputation in the industry, lead to significant legal fees, and result in the diversion of management’s attention from managing our business.

If we experience an intrusion of or disruption to our information technology systems, we may be harmed.

We rely on sophisticated information technology systems to operate our business. Our systems are subject to cyber-attacks, viruses, worms, malicious software programs, outages, equipment malfunction or constraints, software deficiencies, human error and other malicious intrusions, which may materially disrupt our business and compromise our data. We may not be able to anticipate and prevent such disruptions or intrusions, and we may not be able to mitigate them when and if they occur. OurAny failure, breach or unauthorized access to our or third-party systems could result in the loss of confidential, sensitive or proprietary information, interruptions in service or production or otherwise our ability to effectively operate ourconduct business operations and comply with applicable lawscould result in potential reductions in revenue and regulations may be materially impaired by any such disruptionprofits, damage to its reputation or intrusion.liability. Furthermore, we may incur significant costs in responding to any such disruption or intrusion and remedying our systems. In such event we may also be subject to litigation and other potential liability, which could materially impact our business and financial condition. Moreover, a breach or disruption of our information technology systems could damage our reputation. Further, as regulatory focus on privacy and data security issues continues to increase and worldwide laws and regulations concerning the protection of information become more complex, the potential risks and costs of compliance to the company’s business will intensify.

ITEM 1.B.

ITEM 1.B.

UNRESOLVED STAFF COMMENTS

None.

ITEM 2.

PROPERTIES

ITEM 2.PROPERTIES
Our

Effective March 10, 2021, our principal corporate office is located at 635 Davis1 TW Alexander Drive, Suite 300, Morrisville,160, Durham, North Carolina. We lease this facility, which consists of 37,32827,807 square feet. In June 2019, the Company entered into a lease amendment extending the term of the leasefeet, for a period of twelve months commencing on January 1, 2020ten year and expiring on December 31, 2020, with no remaining renew rights or options to extend thefive month term of the lease.

ending in August 2031.

Our Italian research and development and demonstration facilities are located at Viale dell'Innovazione 3, 20126 Milan, Italy. We lease these facilities, which consist of 11,27311,733 square feet, for a six-yearseven-year and three month term ending on JulyDecember 31, 2022,2028, under a lease that commenced on May 12, 2016.

October 1, 2021.

Our Israeli research and development facilities are located at Ha-Tsmikha Street 1,Ha Kadima 9, Fibernet Building, 4th Floor, Yokne'am Illit, Israel. We lease these facilities, which consist of 5,5978,471 square feet, for a five-year term ending on April 14, 2024,June 30, 2026, under a lease that commenced on April 15, 2019.

July 1, 2021.

Our Japanese office is located at 1-3-5 Kojimachi Chiyoda-ku, Mikuni Building, 5th Floor, Tokyo, Japan. We lease this facility, which consists of 737 square feet, for a five-year term ending on April 24, 2023, under a lease that commenced on April 25, 2018.

Our Swiss administrative office is located at Via Serafino Balestra 12, Lugano, Switzerland. We lease this facility, which consists of 3,208 square feet, for a five-year term ending on June 30, 2023, under a lease that commenced on July 1, 2018.


ITEM 3.

ITEM 3.

LEGAL PROCEEDINGS

None.

ITEM 4.

ITEM 4.

MINE SAFETY DISCLOSURES

Not applicable.


PART II

ITEM 5.

ITEM 5.

MARKET FOR REGISTRANT’SREGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Since April 2, 2014, our common stock has been listed on the NYSE American. Our trading symbol is “TRXC.“ASXC,

which changed from “TRXC” on March 5, 2021 when we changed our name from TransEnterix Surgical, Inc. to Asensus Surgical, Inc. In June 2021, we were added to the Russell 2000 and the Russell Microcap Indexes.

Holders

As of March 12, 2020,February 25, 2022, there were approximately 6459 record holders of our common stock (counting all shares held in single nominee registration as one stockholder).

Dividends

We have never declared or paid any cash dividends on our common stock. We intend to retain earnings for use in the operation and 1 record holderexpansion of our preferred stock.

business.

Recent Sales of EquityUnregistered Securities and Use of Proceeds.

None.

Issuer Purchases of Equity Securities

The Company did not re-purchase anyfollowing table summarizes the Company’s purchases of its common stock duringfor the quarter ended December 31, 2019.

ITEM 6.SELECTED FINANCIAL DATA
2021:

  

Issuer Purchases of Equity Securities

     
          

Total

  

Maximum

 
          

Number of

  

Number of

 
          

Shares

  

Shares

 
          

Purchased

  

that May

 
          

as Part of

  

Yet be

 
  

Total

      

Publicly

  

Purchased

 
  

Number

  

Average

  

Announced

  

Under the

 
  

of Shares

  

Price Paid

  

Plans or

  

Plan or

 

Period

 

Purchased

  

per Share

  

Programs

  

Programs

 

October 1 - 31, 2021

  -   -   -   - 

November 1 - 30, 2021

  1,365  $1.74   -   - 

December 1 - 31, 2021

  -   -   -   - 

Total

  1,365  $1.74   -   - 

These amounts consist of 1,365 shares we acquired from employees associated with the withholding of shares to pay certain withholding taxes upon the vesting of stock-based compensation in accordance with the terms of our equity compensation plan that were previously approved by our stockholders and disclosed in our proxy statements filed with the Securities and Exchange Commission. We are a smaller reporting companypurchased these shares at their fair market value, as defineddetermined by Rule 12b-2reference to the closing price of our common stock on the vesting date.  

Stock Performance Graph

This graph is not soliciting material or deemed filed with the SEC for purposes of Section 18 of the Exchange Act of 1934., or otherwise subject to liabilities under the Section, and shall not be deemed incorporated by reference into any filings of Asensus Surgical, Inc. under the Securities Act of 1933, as amended, whether made before or after the date hereof and irrespective of any general incorporate language in any such filing.

The graph set forth below compares the cumulative total stockholder return on our common stock between December 31, 2016, and December 31, 2021, with the cumulative total return of (i) the NYSE American Composite Index, (ii) the Russell 2000 Index, and (iii) the Russell Microcap Index over the same period. This graph assumes an investment of $100.00 on December 31, 2016 in our common stock, the NYSE American Composite Index, the Russell 2000 Index, and the Russell Microcap Index and assumes the re-investment of dividends, if any.

The comparisons shown in the graph below are based upon historical data. We caution that the stock price performance shown in the graph below is not requirednecessarily indicative of, nor is it intended to provideforecast, the information under this item.potential future performance of our common stock.

COMPARISON OF CUMULATIVE TOTAL RETURN AMONG ASENSUS SURGICAL, INC., NYSE AMERICAN COMPOSITE, RUSSELL 2000 INDEX, AND RUSSELL MICROCAP INDEX

a1.jpg

  

COMPARISON OF CUMULATIVE TOTAL RETURN

 

Company/Market

 

2016

  

2017

  

2018

  

2019

  

2020

  

2021

 
                         

Asensus Surgical, Inc.

 $100.00  $148.46  $173.85  $8.70  $3.70  $6.57 

NYSE American Composite Index

 $100.00  $115.32  $99.32  $110.60  $102.29  $148.49 

Russell 2000 Index

 $100.00  $114.65  $102.02  $128.06  $153.62  $176.39 

Russell Microcap Index

 $100.00  $113.17  $98.36  $120.43  $145.67  $173.84 

ITEM 6.

RESERVED

ITEM 7.

MANAGEMENT’S

MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our “Risk Factors”Risk Factors and our consolidated financial statements and the related notes to our consolidated financial statements included in this Annual Report. The following discussion contains forward-looking statements. See cautionary note regarding “Forward-Looking Statements”Forward-Looking Statements at the beginning of this Annual Report.

Overview

TransEnterix

Asensus Surgical is a medical device company that is digitizing the interface between the surgeon and the patient in laparoscopyto 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 in today’svariability. 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 environment.healthcare. The Company is focused on the market development for and commercialization of the Senhance®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 3 millimeter3mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control and reusablefully-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 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.

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 colorectal surgical procedures and laparoscopic gynecologic surgery in a total of 2831 indicated procedures, including benign and oncologic procedures, laparoscopic inguinal, hiatal and paraesophageal hernia, sleeve gastrectomy and laparoscopic cholecystectomy (gallbladder removal) 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 Company has received regulatory approval and reimbursement for 98 laparoscopic procedures.


During 2018 and 2019, we successfully obtained FDA clearance and CE Mark for our 3 millimeter diameter instruments, our Senhance ultrasonic system, our 3 millimeter and 5 millimeter hooks, andcustomers are provided with the Senhance articulating system. The 3 millimeter instruments enableright to purchase the leased Senhance System to be used for microlaparoscopic surgeries, allowing for tiny incisions. The ultrasonic system is an advanced energy device used to deliver controlled energy to ligate and divide tissue, while minimizing thermal injury to surrounding structures. The Senhance articulating system was launched in Europe in November 2019 and we are evaluating our pathway forward to launch such a system in the United States with a planned submission for US clearanceduring or at the end of 2020.the lease term ("Lease Buyout"). In the first quarter of 2021, we completed one Lease Buyout of a Senhance System.

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.

34

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 January 2020 we submitted an application to the FDA seeking clearance of the first machine vision system for robotic surgery (Intelligentour Intelligent Surgical Unit). The Company believesUnit, or ISU. We believe it is the first suchonly FDA submission seeking clearancecleared device for machine vision technology in abdominal robotic surgery. On March 13,September 23, 2020, we announced the Company announced that it hasfirst surgical procedures successfully completed using the ISU. In January 2021, we received FDA clearanceCE Mark for the Intelligent Surgical Unit.


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 October 17, 2019,July 28, 2021, the Company announced that it has engaged J.P. Morgan Securities LLCreceived FDA clearance for 5mm diameter articulating instruments, offering better access to assist the Board of Directors in considering strategic alternatives for the Company to enhance stockholder value, including, but not limited to a saledifficult-to-reach areas of the Company, a financinganatomy by providing two additional degrees of the Company, a strategic partnership or collaboration or some other form of commercial relationship. In addition, the Company announced the implementation of a restructuring plan to reduce operating expenses as it continues the global market development of the Senhance platform.

On October 31, 2018, the Company acquired the assets, intellectual property and highly experienced multidisciplinary personnel of MST Medical Surgical Technologies, Inc., or MST, an Israeli-based medical device company.  Through this acquisition, the Company acquired MST’s AutoLap™ technology, one of the only image-guided robotic scope positioning systems with FDA clearance andfreedom. These instruments have previously received CE Mark. The Company believes MST’s image analytics technology will accelerate and drive meaningful Senhance System developments, and allow it to expand the Senhance System to add augmented, intelligent vision capability. On October 15, 2019, the Company announced the sale of certain AutoLap assets, as discussedMark for use in the "Sale of AutoLap Assets" section below.
The Company has also developed the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform. In December 2017, the Company entered into an agreement with Great Belief International Limited, or GBIL, to advance the SurgiBot System towards global commercialization. The agreement transferred ownership of the SurgiBot System assets, while the Company retained the option to distribute or co-distribute the SurgiBot System outside of China. GBIL intends to have the SurgiBot System

manufactured in China and obtain Chinese regulatory clearance from the China Food and Drug Administration while entering into a nationwide distribution agreement with China National Scientific and Instruments and Materials Company for the Chinese market. The agreement provides the Company with proceeds of at least $29 million, of which $15 million has been received to date.  The remaining $14.0 million, representing minimum royalties, will be paid beginning at the earlier of receipt of Chinese regulatory approval or March 2023.
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 December 31, 2019,2021, we had an accumulated deficit of $663.6$785.4 million.

Due to a decline in market conditions and changes in our forecast, the Company tested its goodwill and in-process research & development, or IPR&D, for potential impairment as of September 30, 2019. During the third quarter of 2019, the Company determined that the carrying value of both its goodwill and IPR&D were impaired, and recorded impairment charges of $79.0 million and $7.9 million, respectively.

We operate in one business segment.

On December 11, 2019, following receipt of approval from stockholders at a special meeting of stockholders held on the same day,

Financing Transactions

During late 2020 and 2021, the Company filed an amendment to our Amended and Restated Certificate of Incorporation to effectengaged in a reverse stock split of the Company’s common stock at a ratio of one-for-thirteen, or the Reverse Stock Split. The Company’s common stock began trading on a split-adjusted basis on NYSE American on the morning of December 12, 2019. No fractional shares were issued in connection with the Reverse Stock Split. Instead, the Company rounded up each fractional share resulting from the reverse stock split to the nearest whole share. As a result of the Reverse Stock Split, the Company’s outstanding common stock decreased from approximately 261.9 million shares to approximately 20.2 million shares (without giving effect to the rounding up for each fractional share).

Unless otherwise noted, all share and per share data referenced in this Annual Report have been retroactively adjusted to reflect the Reverse Stock Split. Certain amounts in the financial statements, the notes thereto, and elsewhere in this Annual Report, may be slightly different than previously reported due to rounding of fractional shares as a result of the Reverse Stock Split.
Restructuring
Despite the number of advances and regulatory clearances received in 2018 and 2019, the Company’s Senhance System sales in 2019 were disappointing. Adoption of new technologies, particularly for capital intensive devices such as the Senhance System can be slow and uneven as market development and commercial development is time-consuming and expensive. The Company has determinedequity financing transactions to refocusfund its resources and efforts in 2020 on market development activities to increase awareness of:
the benefits of the use of the Senhance System in laparoscopic surgery;
the digitization of high volume procedures using the Senhance System;
the indications for use, including pediatric indications of use in CE Mark territories;
the overall cost efficiency of the Senhance System
We intend to focus on markets with high utilization of laparoscopic technique, including Japan, Western Europe and the United States. Our focus will be on (1) increasing the number of placements of the Senhance System, not necessarily through sales, but through leasing arrangements, (2) increasing the number of procedures conducted using the Senhance System quarter over quarter, and (3) solidifying key opinion leader support and publications related to the use of the Senhance System in laparoscopic procedures. During this period we will not focus on revenue targets, especially in the United States.
During the fourth quarter of 2019, we announced the implementation of a restructuring plan to reduce operating expenses as we continue the global market development of the Senhance platform. Under the restructuring plan, we reduced headcount primarily in the sales and marketing functions and determined that the carrying value of our inventory exceeded the net realizable value due

to a decrease in expected sales. The restructuring charges amounted to $8.8 million, of which $7.4 million was an inventory write down and was included in cost of product revenue and $1.4 million related to employee severance costs and was included as restructuring and other charges in the consolidated statements of operations and comprehensive loss, during the fourth quarterextend its cash reach to provide capital to progress its strategy. These financings included:

October 2020 At-the-Market Offering. On October 9, 2020, the Company filed a prospectus supplement relating to an at-the-market offering with Cantor Fitzgerald & Co., or 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 through Cantor as sales agent, pursuant to the 2019 Sales Agreement, referred to as 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 gross proceeds of $31.25 million, and net proceeds of $28.6 million.

2021 At-the-Market Offering. On May 19, 2021, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor, Robert W. Baird & Co. Incorporated and Oppenheimer & Co. Inc., as our sales agents, relating to an at-the-market offering of up to an aggregate of $100,000,000 of shares of our common stock, referred to as the “2021 ATM Offering”.

35

Debt Transactions
On May 23, 2018, the Company and its domestic subsidiaries, as co-borrowers, entered into a Loan and Security Agreement, or the Hercules Loan Agreement, with several banks and other financial institutions or entities from time to time party to the Loan Agreement, or collectively, the Lender, and Hercules Capital, Inc., as administrative agent and collateral agent, or the Agent. Under the Hercules Loan Agreement, the Lender agreed to make certain term loans to the Company in the aggregate principal amount of up to $40.0 million. Funding of the first $20.0 million tranche occurred on May 23, 2018, or the Initial Funding Date. On October 23, 2018, the Lender funded the second tranche of $10.0 million under the Hercules Loan Agreement.  The Company was entitled to make interest-only payments until December 1, 2020, and at the end of the interest-only period, the Company would have been required to repay the term loans over an eighteen-month period based on an eighteen-month amortization schedule, with a final maturity date of June 1, 2022. The term loans were required to be repaid if the term loans are accelerated following an event of default.

On May 7, 2019, the parties executed an amendment to the Hercules Loan Agreement, or the Hercules Amendment, effective April 30, 2019, under which the Hercules Loan Agreement was amended to eliminate the availability of the Tranche III loan facility, add a new Tranche IV loan facility of up to $20.0 million, revise certain financial covenants and make other changes.  The availability of advances under the Tranche IV Loan was not milestone-based, rather the Company could request advances in minimum $5.0 million increments at any time during the period from July 1, 2019 through December 31, 2020, subject to the funding discretion of the Lender. The monthly trailing six month net revenue financial covenant was amended to be tested quarterly and to change the projected net revenue percentage to be met for the six months ending on the last day of each fiscal quarter.  If such quarterly financial covenant was not achieved as of the last day of any fiscal quarter, as tested on the thirtieth day after quarter end, the Company must have complied with the waiver conditions in the Hercules Amendment from such test date until the next quarterly test date. The Amendment was treated as a debt modification for accounting purposes.

In connection with the entry into an agreement to sell certain AutoLap assets, the Company commenced discussions with the Agent in order to obtain the required consent of the Agent and the Lender with respect to such AutoLap assets sale. In connection with obtaining such consent, the Company entered into the Consent and Second Amendment to the Loan and Security Agreement on July 10, 2019, or the Hercules Second Amendment. Under the Hercules Second Amendment, in consideration for the consent to the sale of, and the release of the Lender’s security interest on, the AutoLap assets, the Company reduced its indebtedness under the Hercules Loan Agreement by repaying $15.0 million of the $30.0 million of outstanding indebtedness thereunder, without any prepayment penalties, amendment fee or acceleration of the end of term charges, and received adjustments to the quarterly financial covenants and related waiver conditions to reflect the decreased outstanding indebtedness. The Amendment was treated as a debt modification for accounting purposes.
Under the Hercules Second Amendment, the applicable waiver condition for fiscal year 2019 was changed to maintenance of unrestricted cash equal to $7.0 million.
The term loans bore interest at a rate equal to the greater of (i) 9.55% per annum, or the Fixed Rate, and (ii) the Fixed Rate plus the prime rate (as reported in The Wall Street Journal) minus 5.00%. On the Initial Funding Date, the Company was obligated to pay a facility fee of $0.4 million, recorded as a debt discount. The Company also incurred other debt issuance costs totaling $1.1 million in conjunction with its entry into the Hercules Loan Agreement. In addition, the Company was permitted to prepay the term loans in full at any time, with a prepayment fee of 3.0% of the outstanding principal amount of the loan in the first year after the Initial Funding Date, 2.0% if the prepayment occurred in the second year after the Initial Funding Date and 1.0% thereafter. Upon prepayment of the term loans in full or repayment of the term loans at the maturity date or upon acceleration, the Company was required to pay a final fee of 6.95% of the aggregate principal amount of term loans funded. The final payment fee was accreted to interest expense over the life of the term loan and included within notes payable on the consolidated balance sheet.
The Company’s obligations under the Hercules Loan Agreement were guaranteed by all current and future material foreign subsidiaries of the Company and were secured by a security interest in all of the assets of the Company and their current and future domestic subsidiaries and all of the assets of their current and future material foreign subsidiaries, including a security interest in the intellectual property. The Hercules Loan Agreement contained customary representations and covenants that, subject to

exceptions, restricted the Company’s and its subsidiaries’ ability to do the following, among other things: declare dividends or redeem or repurchase equity interests; incur additional indebtedness and liens; make loans and investments; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that were not related to its existing business. Under the terms of the Hercules Loan Agreement, the Company was required to maintain cash and/or investment property in accounts which perfected the Agent’s first priority security interest in such accounts in an amount equal to the lesser of (i) (x) 120% of the then-outstanding principal balance of the term loans, including accrued interest and any other fees payable under the agreement to the extent accrued and payable plus (y) an amount equal to the then-outstanding accounts payable of the Company on a consolidated basis that were more than 90 days past due and (ii) 80% of the aggregate cash of the Company and its consolidated subsidiaries. The Agent was granted the option to invest up to $2.0 million in any future equity offering broadly marketed by the Company to investors on the same terms as the offering to other investors.
On November 4, 2019, the Company entered into a payoff letter with the Agent pursuant to which the Company terminated the Hercules Loan Agreement, as amended. The Company determined it was in the best interests of the Company to pay down the debt and terminate the Hercules Agreement to simplify the Company’s balance sheet and provide additional flexibility as the Board of Directors continued to evaluate strategic and financial alternatives for the Company. Under the payoff letter, the Company repaid all amounts owed under the Hercules Loan Agreement totaling approximately $16.4 million, which included end of term fees of $1.4 million, and Hercules released all security interests held on the assets of the Company and its subsidiaries, including, without limitation, on the intellectual property assets of the Company. The Company recognized a loss of $1.0 million on the extinguishment of notes payable, which is included in interest expense on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2019.
In connection with its entrance into the Hercules Loan Agreement in 2018, the Company repaid its existing loan and security agreement, or the Innovatus Loan Agreement, with Innovatus Life Sciences Lending Fund I, LP, or Innovatus. The Company recognized a loss of $1.4 million on the extinguishment of notes payable which was included in interest expense on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2018. The Company paid $0.7 million in final payment obligations and $0.3 million in prepayment fees under the Innovatus Loan Agreement upon repayment. For a description of the Innovatus Loan Agreement, see “Notes to Consolidated Financial Statements – Note 13. Notes Payable.”
Financing Transactions
May 2017 Public Offering
On April 28, 2017, we entered into an underwriting agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, relating to an underwritten public offering of an aggregate of 24.9 million Units, each consisting of approximately 0.077 shares of the Company’s Common Stock, a Series A Warrant to purchase approximately 0.077 shares of Common Stock and a Series B Warrant to purchase approximately 0.058 shares of Common Stock at an offering price to the public of $1.00 per Unit. Certain of the Company’s officers, directors and existing stockholders purchased approximately $2.5 million of Units in the public offering. The closing of the public offering occurred on May 3, 2017. The net proceeds to the Company from the offering were approximately $23.2 million, prior to any exercise of the Series A Warrants or Series B Warrants, after deducting underwriting discounts and commissions and estimated offering expenses paid by the Company. The net proceeds to the Company from the exercise of all of the Series A Warrants and the Series B Warrants exercised prior to December 31, 2019 were approximately $37.6 million.
Each Series A Warrant had an initial exercise price of $13.00 per share and was able to be exercised at any time beginning on the date of issuance, and from time to time thereafter, through and including the first anniversary of the issuance date, unless terminated earlier as provided in the Series A Warrant. Receipt of 510(k) clearance for the Senhance System on October 13, 2017, triggered the acceleration of the expiration date of the Series A Warrants to October 31, 2017. As of December 31, 2017, all of the Series A Warrants had been exercised.
Each Series B Warrant had an initial exercise price of $13.00 per share and may be exercised at any time beginning on the date of issuance and from time to time thereafter through and including the fifth anniversary of the issuance date, or by May 3, 2022. As of December 31, 2019, Series B Warrants representing approximately 1.2 million shares had been exercised.
The exercise prices and the number of shares issuable upon exercise of the outstanding Series B Warrants are subject to adjustment upon the occurrence of certain events, including, but not limited to, stock splits or dividends, business combinations, sale of assets, similar recapitalization transactions, or other similar transactions. The Series B Warrants are subject to adjustment in the event that the Company issues or is deemed to issue shares of common stock for less than the then applicable exercise price of the Series B Warrants. Such adjustments occurred in August, September, November, and December 2019 due to sales under the 2019

Sales Agreement and the Underwriting Agreement at prices less than the then applicable exercise price of the Series B Warrants. See "Notes to Consolidated Financial Statements - Note 16 Warrants." The exercisability of the Series B Warrants may be limited if,


upon exercise, the holder or any of its affiliates would beneficially own more than 4.99% of our common stock. If, at any time Series B Warrants are outstanding, any fundamental transaction occurs, as described in the Series B Warrants and generally including any consolidation or merger into another corporation, the consummation of a transaction whereby another entity acquires more than 50% of the Company’s outstanding voting stock, or the sale of all or substantially all of its assets, the successor entity must assume in writing all of the obligations to the Series B Warrant holders. Additionally, in the event of a fundamental transaction, each Series B Warrant holder will have the right to require the Company, or its successor, to repurchase the Series B Warrants for an amount of cash equal to the Black-Scholes value of the remaining unexercised portion of such Series B Warrants.
On December 15, 2017, we filed a registration statement on Form S-3 (File No. 333-222103) to register shares of common stock underlying outstanding Series B Warrants previously issued as part of the Company’s May 3, 2017 public offering.  The new registration statement replaced the registration statement on Form S-3 that expired on December 19, 2017 with respect to these securities.  On January 26, 2018, we filed an Amendment No. 1 to such registration statement on Form S-3 to update the information in the registration statement.  The registration statement covers up to 736,914 shares of common stock underlying the then-outstanding Series B Warrants.  This registration statement on Form S-3 was declared effective on January 29, 2018. On February 7, 2020, we filed a new registration statement (File No. 333-236337) to register 2,500,000 additional shares of common stock to cover the “down-round protection” adjustments made to the Series B Warrant Shares pursuant to sale prices below the then-current exercise price. This registration statement on Form S-3 was declared effective on February 13, 2020.
On February 24, 2020, the Company entered into a Series B Warrants Exchange Agreement, or the Exchange Agreement, with holders of Series B Warrants. Under the terms of the Exchange Agreement, each Series B Warrant was canceled in exchange for 0.61 of a share of common stock. The Warrant holders participating in the exchange held 3,373,900 of the 3,638,780 Series B Warrants then outstanding, and received an aggregate of 2,040,757 shares of common stock, leaving 264,880 Series B Warrants outstanding to acquire 160,226 shares of common stock.
Lincoln Park Purchase Agreement
On February 10, 2020, we entered into a purchase agreement, or the LPC 2020 Purchase Agreement, with Lincoln Park, pursuant to which we have the right to sell to Lincoln Park up to an aggregate of $25,000,000 in shares of our common stock, subject to certain limitations and conditions set forth in the LPC 2020 Purchase Agreement, including a limitation on the
number of shares of common stock we can put to LPC and the pricing parameters for the sales.   In consideration for entering into the LPC 2020 Purchase Agreement, we issued to Lincoln Park 343,171 shares of Common Stock as commitment shares. We also committed to issue up to an additional 171,585 shares of Common Stock to Lincoln Park on a pro rata basis based on the number of shares Common Stock purchased by Lincoln Park pursuant to the LPC 2020 Purchase Agreement.
At-the-Market Offerings
On December 28, 2018, we entered into an At-the-Market Equity Offering Sales Agreement, or the 2018 Sales Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, under which we could offer and sell, through Stifel, up to approximately $75.0 million in shares of common stock in an at-the-market offering, or the 2018 ATM Offering. All sales of shares were to be made pursuant to an effective shelf registration statement on Form S-3 filed with the SEC. Stifel would have received a commission of approximately 3% of the aggregate gross proceeds received from all sales of common stock under the 2018 Sales Agreement. Effective August 12, 2019, the Company terminated the 2018 Sales Agreement. The Company sold no shares of its common stock under the 2018 Sales Agreement.

On August 12, 2019, the Company entered into a Controlled Equity Offering Sales Agreement, or the 2019 Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $25.0 million shares of the Company’s common stock, through Cantor, as sales agent, or the 2019 ATM Offering. Pursuant to the 2019 Sales Agreement, sales of the common stock were made under the Company’s previously filed and currently effective Registration Statement on Form S-3. The aggregate compensation payable to Cantor was 3.0% of the aggregate gross proceeds from each sale of the Company’s common stock. The Company raised gross proceeds of $7.2 million under the 2019 ATM Offering and net proceeds of $7.0 million during the year ended December 31, 2019, and an additional $11.6 million of gross proceeds and $11.2 million of net proceeds to date in 2020.
On September 4, 2019, the Company entered into an Underwriting Agreement, or the Underwriting Agreement, with Cantor. Subject to the terms and conditions of the 2019 Underwriting Agreement, the Company sold to Cantor, in a firm commitment underwritten offering, 2,153,846 shares of the Company’s common stock, or the Firm Commitment Offering. In addition, the Company granted Cantor a 30-day option to purchase 323,077 of additional shares of common stock. The Company raised $18.8 million in gross proceeds under this offering. The option to purchase additional shares of common stock was not exercised.

The following table summarizes the total sales2021, under the 20192020 and 2021 ATM Offering and Firm Commitment Offering for the period indicatedOfferings are as follows (in thousands except for share and per share amounts):
 2019 Firm Commitment  
 ATM Offering Offering  
 For the year ended For the year ended Total
 December 31, 2019
 December 31, 2019 December 31, 2019
Total shares of common stock sold1,374,686 2,153,846 3,528,532
Average price per share$5.23
 $8.73
 $7.37
Gross proceeds$7,193
 $18,796
 $25,989
Commissions earned by Cantor$212
 $
 $212
Net Proceeds$6,981
 $18,796
 $25,777

Since January 1,

  

Year Ended

December 31, 2021

 
     

Total shares of common stock sold

  20,237,045 

Average price per share

 $1.53 

Gross proceeds

 $30,943 

Commisssion earned by Sales Agents

 $928 

Net proceeds

 $30,015 

2021 Exercise of Warrants. During 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.

Paycheck Protection Program

During 2020, the Company has raised,received an unsecured non-recourse loan of $2.8 million under the 2019 ATM Offering, net proceeds of $11.2 million through the sale of 6,687,846 shares of common stock.

2020 Public Offering
On March 10, 2020, the Company closed an underwritten public offering (the "2020 Public Offering") with Ladenburg Thalmann & Co. Inc. as underwriter and sold an aggregate of 14,121,766 Class A Units at a public offering price of $0.68 per Class A Unit and 7,937,057 Class B Units at a public offering price of $0.68 per Class B Unit. Each Class A Unit consists of one share of the Company’s common stock, one warrant to purchase one share of common stock that expires on the first anniversary of the date of issuance (the "Series C Warrants"), and one warrant to purchase one share of common stock that expires on the fifth anniversary of the date of issuance (the "Series D Warrants"). Each Class B Unit consists of one share of Series A Convertible Preferred Stock, par value $0.01 per share (the "Series A Preferred Stock"), convertible into one share of common stock, a Series C Warrant to purchase one share of common stock and a Series D Warrant to purchase one share of common stock. The Class A Units and Class B Units have no stand-alone rights and were not certificated or issued as stand-alone securities. The shares of common stock, Series A Preferred Stock, Series C Warrants and Series D Warrants are immediately separable. In addition, the underwriter for the public offering exercised an overallotment option allowing it to purchase 3,308,823 additional Series C Warrants and 3,308,823 additional Series D Warrants at the closing.
Each Series C Warrant included in the Units has an exercise price of $0.68 per share, and each Series D Warrant included in the Units has an exercise price of $0.68 per share. The Series C Warrants and the Series D Warrants are exercisable at any time on or after the date of issuance until their respective expiration dates.
The exercise prices and the number of shares issuable upon exercise of each of the Series C Warrants and Series D Warrants are subject to adjustment upon the occurrence of stock splits or dividends, business combinations, similar recapitalization transactions, or other similar transactions. The exercisability of the Series C Warrants and Series D Warrants may be limited if, upon exercise, the holder or any of its affiliates would beneficially own more than 4.99% of the Common Stock. If, at any time Series C Warrants or Series D Warrants are outstanding, any fundamental transaction occurs, as described in the Warrants and generally including any consolidation or merger into another corporation, the consummation of a transaction whereby another entity acquires more than 50% of the Company’s outstanding voting stock, or the sale of all or substantially all of its assets, the successor entity must assume in writing all of the obligations to the holders of the Series C Warrants and Series D Warrants. Additionally, in the event of a fundamental transaction, each holder of the Series C Warrants and Series D Warrants will have the right to require the Company, or its successor, to repurchase the Series C Warrants and Series D Warrants it holds for an amount of cash equal to the Black-Scholes value of the remaining unexercised portion of such Series C Warrants or Series D Warrants, as applicable.
The shares of Series A Preferred Stock rank on par with the shares of the common stock with regard to dividend rights and distributions of assets upon liquidation, dissolution or winding up of the Company. With certain exceptions, as described in the Series A Certificate of Designation, the shares of Series A Preferred Stock have no voting rights. However, as long as any shares of Series A Preferred Stock remain outstanding, the Series A Certificate of Designation provides that the Company shall not, without the affirmative vote of holders of a majority of the then outstanding shares of Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Series A Certificate of Designation, (b) amend the Company’s certificate of incorporation or other charter documents in any manner that adversely affects

any rights of the holders of Series A Preferred Stock, (c) increase the number of authorized shares of Series A Preferred Stock, or (d) enter into any agreement with respect to any of the foregoing.
Each share of Series A Preferred Stock is convertible at any time at the holder’s option into one share of common stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series A Certificate of Designation. Notwithstanding the foregoing, the Series A Certificate of Designation further provides that the Company shall not effect any conversion of the shares of Series A Preferred Stock, with certain exceptions, to the extent that, after giving effect to an attempted conversion, the holder of shares of Series A Preferred Stock (together with such holder’s affiliates and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of Common Stock in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance) of the shares of Common Stock then outstanding. At the holder’s option, upon notice to the Company, the holder may increase or decrease this beneficial ownership limitation not to exceed 9.99% of the shares of Common Stock then outstanding, with any such increase becoming effective upon 61 days’ prior notice to the Company.
The net proceeds to the Company from the 2020 Public Offering were approximately $13.4 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

MST Acquisition and Related Transactions
Purchase Agreement
On September 23, 2018, the Company entered into an Asset Purchase Agreement, or the MST Purchase Agreement, with MST Medical Surgery Technologies Ltd., an Israeli private company, or MST, and two of the Company’s wholly owned subsidiaries, as purchasers of the assets of the Seller, including the intellectual property assets, or collectively, the Buyers. The closing of the transactions contemplated by the MST Purchase Agreement occurred on October 31, 2018, pursuant to which the Company acquired MST's assets consisting of intellectual property and tangible assets related to surgical analytics with its core image analytics technology designed to empower and automate the surgical environment, with a focus on medical robotics and computer-assisted surgery. The core technology acquired under the MST Purchase Agreement is a software-based image analytics information platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.
Under the terms of the MST Purchase Agreement, at the closing the Buyers purchased substantially all of the assets of MST. The acquisition price consisted of two tranches. At or prior to the closing of the transaction the Buyers paid $5.8 million in cash and approximately 242,310 shares of the Company’s common stock, or the Initial Shares. A second tranche of $6.6 million in additional consideration was payable in cash, stock or cash and stock, at the discretion of the Company, within one year after the closing date.
On August 7, 2019, the Company notified MST that the Company would satisfy the payment of additional consideration of $6.6 million due to MST under the MST Purchase Agreement by issuing shares of the Company's common stock, as permitted by the MST Purchase Agreement. The number of shares issued to MST as the additional consideration was 370,423 shares of common stock, or the Additional Consideration Shares. In accordance with thePaycheck Protection Program (PPP) provisions of the MST Purchase Agreement,Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). The Company accounted for the number of Additional Consideration Shares was calculated basedPPP promissory note as debt within notes payable on the volume-weighted averageconsolidated balance sheet. As of December 31, 2020, $1.6 million of the closing prices of the Company's common stockpromissory note was classified as quoted on the NYSE American for the ninety (90) day period ended August 6, 2019.
Sale of AutoLap Assets
long-term and $1.2 million was classified as current. On July 3, 2019,June 10, 2021, the Company entered into a System Sale Agreement with GBIL to sell certain assets related toreceived notification from the AutoLap technology. On October 15, 2019,Small Business Administration that the Company amended the prior AutoLap Sale Agreement with GBIL. Pursuant to the amended agreement the Company sold the AutoLap laparoscopic vision system, or AutoLap,principal amount of $2.8 million and related assets to GBIL. The assets include inventory, spare parts, production equipment, testing equipment and certain intellectual property specifically related to the AutoLap. The purchase priceinterest had been forgiven. Gain on extinguishment of debt of $2.8 million was $17.0 million, all of which was received in 2019 in the form of $16 million in cash and a payment by GBIL of $1.0 million to settle certain Company obligations in China. Under the amended AutoLap Agreement, the Company entered into a cross‑license agreement with GBIL to retain rights to use any AutoLap-related intellectual property sold to GBIL, and to non-exclusively license additional intellectual property to GBIL. The Company recorded a $16 million gain on the sale of the AutoLap assets duringrecognized for the year ended December 31, 2019, which represented2021 on the proceeds received in excessconsolidated statement of the carrying valueoperations and comprehensive loss.  

Results of the assets, less contract costs.

Registration Rights and Lock-Up Agreements

In connection with the closing under the MST Purchase Agreement, or the MST Acquisition, the Company and MST entered into a lock-up agreement dated October 31, 2018, or the Lock-Up Agreement, pursuant to which MST agreed, subject to certain exceptions, not to sell, transfer or otherwise convey any of the Initial Shares for six months following the closing date of the MST Purchase Agreement.  As of the date of this Annual Report, 75% of the Initial Shares are free from the lock-up restrictions. For the remaining 25% of the Initial Shares, the Lock-Up Agreement provides that all of the Initial Shares will be released from the lock-up restrictions on May 1, 2020, or earlier upon certain other conditions.   The Additional Consideration Shares were released from the lock-up restrictions on February 7, 2020.
In connection with the MST Acquisition, the Company also entered into a Registration Rights Agreement, dated as of October 31, 2018, with MST, pursuant to which the Company agreed to register the Initial Shares and Additional Consideration Shares, or collectively, the Securities Consideration, such that such Securities Consideration is eligible for resale following the end of the lock-up periods described above. All of the Securities Consideration is eligible to be sold by the holders without restriction
under Rule 144, therefore the Registration Rights Agreement has expired.
Senhance Acquisition and Related Transactions
Membership Interest Purchase Agreement and Amendment
On September 21, 2015, the Company announced that it had entered into a Membership Interest Purchase Agreement, dated September 18, 2015, or the Purchase Agreement, with Sofar S.p.A., or Sofar, as the seller, Vulcanos S.r.l., as the acquired company, and TransEnterix International, Inc., a wholly owned subsidiary of the Company as the Buyer. The closing of the transactions contemplated by the Purchase Agreement occurred on September 21, 2015. The Buyer acquired all of the membership interests of the acquired company from Sofar, and changed the name of the acquired company to TransEnterix Italia S.r.l. On the closing date, pursuant to the Purchase Agreement, the Company completed the strategic acquisition from Sofar of all of the assets, employees and contracts related to the advanced robotic system for minimally invasive laparoscopic surgery now known as the Senhance System, or the Senhance Acquisition.
Under the terms of the Purchase Agreement, the consideration consisted of the issuance of 1,195,647 shares of the Company’s common stock, or the Sofar Consideration, and approximately $25.0 million U.S. Dollars and €27.5 million Euro in cash consideration, or the Cash Consideration. The Sofar Consideration was issued in full at closing of the acquisition; the Cash Consideration was or will be paid in four tranches, with U.S. $25.0 million paid at closing and the remaining Cash Consideration of €27.5 million to be paid in three additional tranches based on achievement of negotiated milestones. On December 30, 2016, the Company and Sofar entered into an Amendment to the Purchase Agreement to restructure the terms of the second tranche of the Cash Consideration. Under the Amendment, the second tranche was restructured to reduce the contingent cash consideration by €5.0 million in exchangeOperations for the issuance of 286,360 shares of the Company’s common stock with an aggregate fair market value of €5.0 million, which were issued on January 4, 2017. The price per share was $18.252 and was calculated based on the average of the closing prices of the Company’s common stock on ten consecutive trading days ending one day before the execution of the Amendment. 
As ofYears Ended December 31, 2019, the Company has paid all Cash Consideration due under the second tranche2021 and approximately €2.4 million of the €2.5 million due under the fourth tranche. The third tranche, consisting of €15.0 million, has not yet been paid
and is subject to certain sales revenue milestones. The fourth tranche of the Cash Consideration is payable in installments by December 31 of each year as reimbursement for certain debt payments made by Sofar under an existing Sofar loan agreement in such year.
The Purchase Agreement contains customary representations and warranties of the parties and the parties have customary indemnification obligations, which are subject to certain limitations described further in the Purchase Agreement.
Registration Rights
2020

Revenue

In connection with the Senhance Acquisition, we also entered into a Registration Rights Agreement, dated as of September 21, 2015, with Sofar, pursuant to which we agreed to register the Securities Consideration shares for resale following the end of the lock-up periods. The resale Registration Statement has been filed and is effective.

Results of Operations
Revenue
In 2019,2021, our revenue consisted of product and service revenue primarily resulting from the sale of a total of fourtwo Senhance Systems, one Lease Buyout, ongoing Senhance System leasing payments, sales of instruments and accessories, and services for Senhance Systems sold or placed in Europe, (one)Asia and Asia (three),the U.S. In 2020, our revenue consisted of Senhance System leasing payments, and relatedsales of instruments, accessories, and services for current and prior year system sales. The

Company also recognized $1.3 million during the year ended December 31, 2019 related to a 2017 system sale for which revenue was deferred until the first clinical use of the system, which occurred in the second quarter of 2019. In 2018, our revenue consisted of product and service revenue primarily resulting from the sale of a total of fifteen Senhance Systems sold in Europe, (eleven), Asia (one) and the United States (three), and related instruments, accessories and services.
U.S. in prior periods.

Product, instrument, and accessory revenue for the year ended December 31, 2019 decreased2021 increased to $7.1$6.7 million compared to $23.3$1.6 million for the year ended December 31, 2018.2020. The $16.2$5.1 million decreaseincrease was the result of the revenue recognized onderived primarily from the sale of fourtwo Senhance Systems and a Lease Buyout in 2021, versus fifteen in the prior year,2020 revenue driven by system leasing arrangements, as well as instruments and accessories.accessories sales. Services revenue for the year ended December 31, 2019 increased2021 decreased to $1.4$1.5 million from $0.8$1.6 million for the year ended December 31, 20182020 due to the increase intiming of the service contracts and number of Senhance Systems under service contracts.

We expect to experience some variability in the number and trend, and average selling price or leasing price of units soldour products given the early stage of commercialization of our products.

Cost of Revenue

Cost of revenue consists primarily of costs related to contract manufacturing, materials, and manufacturing overhead.overhead incurred internally to produce the products. Depreciation expense related to leased systems is included in the cost of revenue. Shipping and handling costs incurred by the Company are included in the cost of revenue.  We expense all inventory obsolescence provisions related to normal manufacturing changes 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 become less significantdecline 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 year ended December 31, 20192021 increased to $16.4$8.0 million as compared to $14.2$2.3 million for the year ended December 31, 2018.2020. This $2.2$5.7 million increase over the prior year period was primarily the result of increased materials cost of $6.2 million, which is driven by increased system placements in the $7.4current year. The change also includes a decrease in the inventory reserve of $0.5 million. The decrease in the inventory reserve was driven by the sale of previously reserved inventory. Also contributing to the increase were increased facility costs of $0.1 million inventory write-down under our restructuring plan,and increased freight costs of $0.1 million offset by decreased personnel costs totaling $1.7 million,of $0.6 million in increased standardand decreased supplies cost variances, $0.3 million in increased travel, freight, and supplies costs, and a $1.5 million reserve for obsolete inventory offset by $9.1 million in lower product costs caused by decreased sales.of $0.1 million.

Service cost for the year ended December 31, 20192021 increased to $4.3$3.1 million as compared to $2.0$2.9 million for the year ended December 31, 2018.2020. This $2.3$0.2 million increase over the prior year period was the resultprimarily related to $0.3 million in increased supplies and $0.1 million in increased consulting costs offset by $0.1 million in reduced personnel costs, and $0.1 million in reduced facilities costs. Cost of increasedrevenue exceeds revenue primarily due to part replacements under maintenance plans, which are expensed when incurred, along with salaries for the field service costs of $1.7 million for repairs and maintenance on a greater cumulative number of installed Senhance Systems, and a $0.6 million increase in personnel costs due to increased headcount.

teams.

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 increase moderately but at a reduced rate due to the restructuring, 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 year ended December 31, 20192021 increased 3%16% to $22.5$19.3 million as compared to $21.8$16.6 million for the year ended December 31, 2018.2020. The $0.7$2.7 million increase primarily relates to higherincreased personnel costs totalingof $2.0 million, increased supplies costs of $0.3 million, increased consulting costs of $0.3 million and increased facility costs of $0.1 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. We expect sales and marketing expenses to increase moderately as we refocus our resources and efforts on market development activities.

Sales and marketing expenses for the year ended December 31, 2021 increased 2% to $13.4 million compared to $13.1 million for the year ended December 31, 2020. The $0.3 million increase was primarily related to increased consulting costs of $0.2 million, increased software costs of $0.2 million, increased travel costs of $0.1 million, increased supplies expense of $0.1 million, and increased other costs of $0.2 million offset by decreased depreciation expense of $0.4 million and decreased personnel costs of $0.1 million.

General and Administrative

General and administrative expenses consist of personnel costs related to the executive, finance and human resource functions, as well as professional service fees, legal fees, accounting fees, insurance costs, and general corporate expenses. We expect general and administrative costs to remain flat in future periods.

General and administrative expenses for the year ended December 31, 2021 increased 37% to $19.3 million compared to $14.1 million for the year ended December 31, 2020. The $5.2 million increase was primarily due to increased personnel costs of $4.0 million, which is primarily driven by an increase in employee headcount and a $1.6 million increase in stock compensation expense. The change is also driven by increased shareholder meeting costs of $0.6 million, increased supplies expense of $0.2 million, increased product costs of $0.1 million, increased depreciation expense of $0.1 million, and increased other costs of $0.3 million, offset by decreased facilities costs of $0.1 million.

Amortization of Intangible Assets

Amortization of intangible assets for the year ended December 31, 2021 increased to $11.3 million compared to $10.8 million for the year ended December 31, 2020. The $0.5 million increase was primarily the result of a higher headcountEuro to Dollar exchange rate.

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration in connection with the Senhance Acquisition described in the Product Overview section above was a $1.6 million decrease for the year ended December 31, 2021 compared to an increase of $2.9 million for the year ended December 31, 2020. The $4.5 million decrease was primarily due to changes in the Company's forecast of future product revenue.  

Other Income (Expense)

Other income (expense) for the year ended December 31, 2021 primarily related to the $2.8 million gain on extinguishment of debt from the PPP loan forgiveness and $1.3 million refund for the Employee Retention Tax Credit (ERTC), offset by a $2.0 million increase in the fair value of warrant liabilities recorded during the year.

Income Tax (Expense) Benefit

Income tax expense of $0.2 million in the year ended December 31, 2021 consisted primarily of current income taxes related to profitable foreign jurisdictions in Japan, Israel, and the Netherlands.

Income tax benefit of $1.5 million in the year ended December 31, 2020, consisted primarily of taxes related to the amortization of purchase accounting intangibles in connection with the Italian taxing jurisdiction for Asensus Surgical Italia as a result of the MST acquisitionSenhance Acquisition.

Results of Operations for the Years Ended December 31, 2020 and 2019

Revenue

In 2020, our revenue consisted of Senhance System leasing payments, and sales of instruments, accessories, and services for Senhance Systems sold in Europe, Asia and the U.S. in prior periods. In 2019, our revenue consisted of product and service revenue primarily resulting from the sale of a total of four Senhance Systems in Europe (one) and Asia (three), and related instruments, accessories and services for current and prior year system sales. The Company also recognized $1.3 million during the year ended December 31, 2019 related to a 2017 system sale for which revenue was deferred until the first clinical use of the system, which occurred in the second quarter of 2019.

Product, instrument, and accessory revenue for the year ended December 31, 2020 decreased to $1.6 million compared to $7.1 million for the year ended December 31, 2019. The $5.5 million decrease was due to the 2020 revenue being derived primarily from system leasing arrangements, versus 2019 revenue driven by the sale of four Senhance Systems, as well as instruments and accessories. Services revenue for the year ended December 31, 2020 increased to $1.6 million from $1.4 million for the year ended December 31, 2019 due to the increase in the number of Senhance Systems under service contracts.

We expect to experience variability in the number and trend, and average selling price or leasing price of our products given the early stage of commercialization of our products.

Cost of Revenue

Product cost for the year ended December 31, 2020 decreased to $2.3 million as compared to $16.4 million for the year ended December 31, 2019. This $14.1 million decrease over the prior year period was primarily the result of decreased materials cost of $11.6 million, which is driven by fewer system placements compared to the prior period. This change includes an inventory write-down in the amount of $7.4 million under our restructuring plan during the year ended December 31, 2019. Also contributing to the decrease were lower personnel costs totaling $1.6 million, decreased facility costs totaling $0.3 million, decreased freight costs of $0.2 million, decreased travel costs of $0.2 million, and decreased supplies cost of $0.2 million.

Service cost for the year ended December 31, 2020 decreased to $2.9 million as compared to $4.3 million for the year ended December 31, 2019. This $1.4 million decrease over the prior year period was primarily related to $1 million in reduced supplies costs, $0.3 million in reduced travel expenses for field service engineers driven by the COVID-19 pandemic, and $0.1 million in reduced other 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.

Research and Development

R&D expenses for the year ended December 31, 2020 decreased 26% to $16.6 million as compared to $22.5 million for the year ended December 31, 2019. The $5.9 million decrease primarily relates to decreased personnel costs of $3.7 million driven by a reduced headcount under our restructuring plan, decreased technology fees of $0.6 million, decreased supplies costs of $0.6 million, decreased travel costs of $0.5 million, decreased consulting costs of $0.4 million, decreased facility costs of $0.1 million, and decreased other costs of $0.2 million offset by $0.5 million in lower technology fees, $0.2 million in lower consulting costs, and $0.2 million in lowerincreased testing and validation costs. R&D expenses for the year ended December 31, 2019 also include an impairment of IPR&D in the amount of $7.9 million that is presented separately in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2019.

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. We expect sales and marketing expenses to decrease significantly as we refocus our resources and efforts on market development activities pursuant to our restructuring plan.

Sales and marketing expenses for the year ended December 31, 2019 increased 9%2020 decreased 53% to $28.0$13.1 million compared to $25.7$28.0 million for the year ended December 31, 2018.2019. The $2.3$14.9 million increasedecrease was primarily related to increaseddecreased personnel related costs of $0.8$7.6 million, increaseddecreased travel of $0.8$3.7 million, decreased consulting costs of $2.1 million, decreased supplies expense of $0.9 million, decreased facilities costs of $0.3 million, decreased depreciation expense of $0.2 million, and increased product demonstration and trade showdecreased other costs of $0.7 million as we increased our U.S, sales and marketing efforts as we focused on$0.1 million. These decreases were primarily the commercializationresult of the Senhance System.restructuring plan implemented in the fourth quarter of 2019 together with reductions in travel and cancellation of tradeshows beginning in the first quarter of 2020 in response to the COVID-19 pandemic.

38

General and Administrative

General and administrative expenses consist of personnel costs related to the executive, finance and human resource functions, as well as professional service fees, legal fees, accounting fees, insurance costs, and general corporate expenses. In future periods, we expect general and administrative expenses to decrease due to the restructuring.

General and administrative expenses for the year ended December 31, 2019 increased 35%2020 decreased 25% to $18.8$14.1 million compared to $13.9$18.8 million for the year ended December 31, 2018.2019. The $4.9$4.7 million increasedecrease was primarily due to increaseddecreased personnel costs of $1.5$2.3 million, increaseddecreased bad debt expense of $1.6 million, decreased consulting and outside services costs of $1.3$0.3 million, increased taxes, licenses, and fees of $0.4 million, increased facilities costsdecreased supplies expense of $0.2 million, decreased travel costs of $0.1$0.2 million, and a bad debt chargedecreased other costs of $1.6$0.5 million offset by increased facilities costs of $0.4 million. TheIn 2019, the Company recorded the bad debt charge due to uncertainty regarding collectability on a 2018 system sale in North Africa.

Restructuring Charge

During the fourth quarter of 2019, we announced the implementation of a restructuring plan to reduce operating expenses as we continue the global market development of the Senhance platform. Under the restructuring plan, we reduced headcount primarily in the sales and marketing functions and determined that the carrying value of our inventory exceeded the net realizable value due to a decrease in expected sales. The restructuring charges amounted to $8.8 million, of which $7.4 million was an inventory write down and was included in cost of product revenue and $1.4 million related to employee severance costs and was included as restructuring and other charges in the consolidated statements of operations and comprehensive loss, during the fourth quarter of 2019.

Payments under the restructuring plan concluded in 2020.

During March 2020, we continued our restructuring with additional headcount reductions which resulted in $0.8$0.9 million related to severance costs which are expected to bewere paid in 2020 and 2021.

2020.

Gainfrom Sale of AutoLap Assets, Net

The net gain from the sale of AutoLap assets net to GBIL was $16.0 million for the year ended December 31, 2019, as further explained in the "Overview" section.2019. The gain represented the difference between the purchase price of $17 million and a $1 million liability incurred as a result of entering into the sale.

Gain from Sale of SurgiBot Assets, Net
The gain from the sale of SurgiBot assets, net to GBIL was $11.8 million for the year ended December 31, 2018, as further explained in the “Overview” section.

Amortization of Intangible Assets

Amortization of intangible assets for the year ended December 31, 2019 decreased2020 increased to $10.3$10.8 million compared to $10.9$10.3 million for the year ended December 31, 2018.2019. The $0.6$0.5 million decreaseincrease was primarily the result of a lowerhigher Euro to Dollar exchange rate.

Impairment of Goodwill and IPR&D Assets

The Company typically testshistorically tested goodwill for impairment annually as of year-end, however, due to market conditions as well as reduced forecasts, we tested our goodwill and IPR&D carrying values as of September 30, 2019.


Pursuant to ASU 2017-04, a company must record a goodwill impairment charge if a reporting unit’s carrying value exceeds its fair value. The Company generally determines the fair value of its reporting unit using two valuation methods: the “Income Approach — Discounted Cash Flow Analysis” method, and the “Market Approach — Guideline Public Company Method.”


Under the “Income Approach — Discounted Cash Flow Analysis” method, the key assumptions consider projected sales, cost of sales, and operating expenses. These assumptions were determined by management utilizing the Company's internal operating plan, growth rates for revenues and operating expenses, and margin assumptions. An additional key assumption under this approach is the discount rate, which is determined by looking at current risk-free rates of capital, current market interest rates, and the evaluation of risk premium relevant to the business segment. If our assumptions relative to growth rates were to change or were incorrect, our fair value calculation may change.


Under the “Market Approach — Guideline Public Company Method,” the Company identified several publicly traded companies, which it believed had sufficiently relevant similarities. Similar to the income approach discussed above, sales, cost of sales,


operating expenses, and their respective growth rates are key assumptions utilized. The market prices of the Company’s common stock and other guideline companies are additional key assumptions. If these market prices increase, the estimated market value would increase. If the market prices decrease, the estimated market value would decrease.

The results of these two methods were weighted based upon management’s evaluation of the relevance of the two approaches. In the 2019 evaluation, management determined that the income and market value approach should be weighted 50%-50%. In addition, management considered the decline in both our stock price and market capitalization after the September 30, 2019 measurement date as relevant factors in the analysis.

As of September 30, 2019, the Company determined that the goodwill associated with the business was impaired, and recorded impairment charges of $79.0 million. The impairment charge resulted from decreased sales and estimated cash flows and a significant decline in the Company's stock price. The Company does not have any goodwill on its consolidated balance sheets as of December 31, 2021 and 2020. The Company also recognized a $7.9 million impairment charge to its IPR&D as it concluded that under the market value approach, the fair value of the IPR&D was lower than the carrying value.

value during the year ended December 31, 2019.  No charge for goodwill and intangible assetsuch impairment was requiredrecognized for the year ended December 31, 2018.
2020.

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration in connection with the Senhance Acquisition was a $2.9 million increase for the year ended December 31, 2020 compared to a decrease of $9.6 million decreasefor the year ended December 31, 2019. The $12.5 million increase was primarily due to changes in the Company's fair value measurement of a discounted cash flow model using significant unobservable inputs including the probability of achieving the potential milestone, future Euro-to-USD exchange rates, revenue volatility, and an estimated discount rate associated with the risks of the expected cash flows attributable to the milestone.

Other Income (Expense)

Other income (expense) for the year ended December 31, 2020 primarily related to a $0.3 million increase in the fair value of warrant liabilities recorded for the year. Other income (expense) for the year ended December 31, 2019 comparedprimarily related to a decrease of $1.0$3.6 million forin interest expense related to notes payable obligations outstanding during the year, ended December 31, 2018. The net $8.6 million decrease was primarily due to a significant reduction in the Company's five-year revenue forecast.

Change in Fair Value of Warrant Liabilities
The change in fair value of Series B Warrants issued in April 2017 was a decrease of $2.2 million for the year ended December 31, 2019 compared to an increase of $14.3 million for the year ended December 31, 2018. The net $16.5 million decrease in the change in the fair value of warrant liabilities recorded for the year, ended December 31, 2019 over the year ended December 31, 2018 includes re-measurement associated with the warrants exercised during the year ended December 31, 2019 and 2018, and the outstanding warrants at December 31, 2019. The decrease in value at December 31, 2019 was primarily the result of the decrease in the stock price at December 31, 2019 versus December 31, 2018.
Acquisition Related Costs
Acquisition related costs of $0.6 million for the year ended December 31, 2018 were incurred in connection with the MST Acquisition.
Reversal of Transfer Fee Accrual
In connection with the Senhance Acquisition, the Company recorded an accrual of $3.0 million in the third quarter of 2015 for the potential assessment of additional transfer fees that could be assessed during a three year period. In September 2018, the Company determined that the accrual was no longer required and reversed the accrual.
Interest Income
Interest income for the year ended December 31, 2019 was $0.6 million compared to $1.4 million for the year ended December 31, 2018. The decrease of $0.8 million was due to less cash and short-term investments on hand during the year ended December 31, 2019 earning less interest.
Interest Expense
Interest expense for the year ended December 31, 2019 was $4.6 million compared to $4.2 million for the year ended December 31, 2018. The Company incurred a $1.4 million loss on extinguishment of debt, classified as interest expense, during the second quarter of 2018 as compared to a $1.0 million loss on extinguishment of debt for the year ended December 31, 2019. This decrease in loss on extinguishment of debt was offset by greater interest incurred on the higher average principal balance of notes payable during 2019 as compared to 2018.
debt.

Income Tax Benefit

Income tax benefit consists primarily of taxes related to the amortization of purchase accounting intangibles in connection with the Italian taxing jurisdiction for TransEnterixAsensus Surgical Italia as a result of the acquisition of the Senhance System.Acquisition. We recognized $3.1$1.5 million and $3.4$3.1 million of income tax benefit for the years ended December 31, 2020 and 2019, and 2018, respectively.


Liquidity and Capital Resources

Going Concern

The Company's consolidated financial statements are prepared using U.S. generally accepted accounting principles (“GAAP”)GAAP applicable to a going concern, which contemplate the realization of assets and liquidation of liabilities in the normal course of business. The Company had an accumulated deficit of $663.6 million as of December 31, 2019 and has working capital of $14.9 million as of December 31, 2019. The Company has not established sufficient sales revenues to cover its operating costs and requiresmay require additional capital to proceed with its operating plan. In October 2019, the Company announced the implementation of a restructuring plan to reduce operating expenses. During March 2020, the Company continued the restructuring efforts with additional headcount reductions. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. In order to continue as a going concern, the Company will need, among other things, additional capital resources. The Company believes that its existing cashhad an accumulated deficit of $785.4 million as of December 31, 2021 and cash equivalents from recent financings, together with cash received from product and instrument sales and leases will be sufficient to meet its anticipated cash needs into the fourth quarterworking capital of 2020.

Traditionally, the$103.4 million as of December 31, 2021.

The Company has raised additional capital through equity offerings.offerings, including raising net proceeds of $73.4 million in the January 2021 public offering, $28.6 million in the January 2021 registered direct offering, $57.2 million in the 2019, 2020, and 2021 ATM Offerings, $13.5 million in the March 2020 public offering, an additional $13.6 million in net proceeds in the July 2020 public offering (see Note 17 to the Company’s consolidated financial statements included in this Annual Report), aggregate proceeds to the Company of $33.7 million for exercises of Series B, C and D warrants in 2020 and 2021, and $2.8 million related to a non-recourse loan under the PPP provisions of the CARES Act that was forgiven as of December 31, 2021. Management's plan to obtain suchadditional 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. In addition, as discussed below, the Company has engaged J.P. Morgan Securities LLC to assist it in considering strategic alternatives, including a fundamental business combination transaction. If the Company is unable to obtain adequate capital through one of these methods, it would need to reduce its sales and marketing and administrative expenses, delay research and development projects, including the purchase of equipment and supplies, and take other steps to reduce its expenses until it is able to obtain sufficient funds. If such sufficient funds are not received on a timely basis, the Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. ManagementHowever, management cannot provide any assurance that the Company will be successful in accomplishing any or all of its plans. The Company believes the COVID-19 pandemic will continue to negatively impact its operations and ability to successfully resolve these factors raise substantial doubt aboutimplement its market development efforts, which will have a negative effect on its financial condition.

As of December 31, 2021, the Company’s abilityCompany had cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of $135.8 million. While the Company believes that its existing cash, cash equivalents, short-term investments and long-term investments as of December 31, 2021 will be sufficient to continue as a going concern within one yearsustain operations for at least the next 12 months from the date thatissuance of these financial statements are issued. The consolidated financial statements, of the Company do notbelieves 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 any adjustments that may result from the outcome of these aforementioned uncertainties.

Sources of Liquidity
Our principal sources of cash to date have been proceeds from public offerings of common stock, private placements of common and preferred stock, incurrence of debt, the saleadditional sales of equity securities heldunder the 2021 ATM Offering or otherwise, traditional financing, such as investments and asset sales.
We currently have two effective shelf registration statements on file with the SEC.  The first shelf registration statement was declared effective by the SEC on May 19, 2017 and registered up to $150.0 millionloans, entry into a strategic collaboration, entry into an out-licensing arrangement or provision of debt securities, common stock, preferred stock,additional distribution rights in some or warrants, orall of our markets. However, management cannot provide any combination thereof for future financing transactions. The second shelf registration statement was declared effective by the SEC on February 10, 2020, and also registers up to $150.0 million of debt securities, common stock, preferred stock, or warrants, or any combination thereof for future financing transactions. We have raised or have reserved for issuance under such registration statements approximately $170.5 million since 2017. As of March 10, 2020,assurance that the Company had approximately $5.5 million available under the first effective shelf registration statement, which is duewill be successful in accomplishing any or all of its plans or be able to expire in May 2020. As of the date of this Annual Report,secure additional funding when needed on terms acceptable to the Company, has approximately $124 million available for future financings under the second shelf registration statement.
or at all. For a discussion of our recent equity financings, see “Financing Transactions” above in this Management’s Discussion and Analysis and Results of Operations,Operations.

Trends and Uncertainties

Our industry is highly competitive, subject to change and significantly affected by new product introductions and other activities by competitors. Many of these competitors have significantly greater financial and human resources than we do, have established reputations with our target customers, and more established worldwide distribution channels. There were new entrants in the market for robotic surgery in 2021, and some forward steps by existing competitors, such as the CE Mark attained by Medtronic for its Hugo robot. Several competitors have launched devices that enable reduced incision or single incision laparoscopic surgery with or without robotic assistance. We believe that our focus on the laparoscopic market and our Performance-Guided Surgery initiative will help us to remain competitive in this growing field.

Our strategy is to pioneer a discussionnew era of Performance-Guided Surgery by unlocking the clinical intelligence to enable consistently superior outcomes and a new standard of surgery. We are currently focused on increasing utilization of the 2019 saleexisting Senhance Systems by increasing the number of procedures conducted using the AutoLap Assets, see “MST Acquisition and Related Transactions - SaleSenhance System quarter over quarter. We are also focused on increasing the number of AutoLap Assets” above in this Management’s Discussion and Analysis of Financial Condition and Results of Operations.


At December 31, 2019, we had cash and cash equivalents, excluding restricted cash, of approximately $9.6 million.

On October 17, 2019, the Company announced that it has engaged J.P. Morgan Securities LLC to assist the Board of Directors in considering strategic alternatives for the Company to enhance stockholder value, including, but not limited to a sale of the Company, a financing of the Company, a strategic partnership or collaboration or some other form of commercial relationship. In addition, the Company announced the implementation of a restructuring plan to reduce operating expenses as it continues the global market developmentplacements of the Senhance platform. System, not necessarily though sales, but through leasing arrangements. Our efforts to communicate and implement this strategy with hospitals, surgery centers and surgeons may take longer than we anticipate, may not be as successful as we contemplate and may not result in a near-term meaningful increase in our business or financial condition.

We will need additional new products and product enhancements to deliver the opportunities of Performance-Guided Surgery. Such new products and product enhancements are subject to regulatory clearances or approvals, and our ability to provide training and implement the use of such new products.

The Companyglobal spread of COVID-19 and the various attempts to contain it continue to create significant volatility, uncertainty, and economic disruption. Elective surgeries have also been curtailed a number of times during variant surges in 2021 in various parts of the globe. Although such elective surgeries have recommenced in large part, the limits on elective procedures significantly impacted our ability to place our Senhance Systems, provide training, and increase the use of the Senhance Systems in place. It is continuinguncertain whether elective surgeries will continue to evaluate all potential alternatives, including pursuitbe negatively impacted or halted again in the future by a resurgence of financing opportunities.

COVID-19 cases in any of the jurisdictions we operate in.

Changes in economic conditions and supply chain constraints and steps taken by governments and central banks, particularly in response to the COVID-19 pandemic as well as other stimulus and spending programs, could lead to higher inflation than previously experienced or expected, increased labor shortages, our ability to hire and retain personnel, which could, in turn, lead to an increase in costs. An inflationary environment could have a negative impact on our expenses, increase our labor costs and reduce our available cash flow.

Consolidated Cash Flow Data


 Years Ended December 31,
 2019 2018
(in millions)   
Net cash (used in) provided by   
Operating activities$(73.5) $(48.5)
Investing activities67.6
 (53.5)
Financing activities(5.6) 26.5
Effect of exchange rate changes on cash and cash equivalents0.4
 (0.5)
Net decrease in cash, cash equivalents and restricted cash$(11.1) $(76.0)

  

Year Ended December 31,

 
  

2021

  

2020

  

2019

 
  

in millions

 

Net cash (used in) provided by

            

Operating activities

 $(40.7) $(46.7) $(73.5)

Investing activities

  (119.7)  (0.0)  67.6 

Financing activities

  161.7   53.4   (5.6)

Effect of exchange rate changes on cash and cash equivalents

  0.4   0.3   0.4 

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

 $1.7  $7.0  $(11.1)

Operating Activities

For the year ended December 31, 2021, net cash used in operating activities of $40.7 million consisted of a net loss of $62.5 million and cash provided by working capital of $0.4 million, offset by non-cash items of $21.4 million. The non-cash items primarily consisted of $11.3 million of net amortization of intangible assets, $9.4 million of stock-based compensation expense, $2.9 million of depreciation, $2.8 million gain on extinguishment of debt, $2.0 million change in fair value of warrant liabilities, $1.6 million change in fair value of contingent consideration, $0.5 million change in inventory reserves, $0.4 million of accretion of discounts and amortization of premiums on investments, net, $0.2 million deferred tax expense and $0.1 million bad debt expense. The decrease in cash from changes in working capital included a $4.5 million increase in operating lease liabilities, a $4.3 million increase in operating lease right-of-use assets, a $0.6 million increase in inventories net of transfers to property and equipment, a $1.6 million increase in accounts payable, a $1.3 million increase in tax credit receivable, a $0.9 million increase in other current and long-term assets, a $0.5 million decrease in accrued expenses, a $0.2 million decrease in accounts receivable, a $0.2 million decrease in deferred revenue, and a $0.1 million decrease in prepaid expenses

For the year ended December 31, 2020, net cash used in operating activities of $46.7 million consisted of a net loss of $59.3 million and cash used for working capital of $7.7 million, offset by non-cash items of $20.3 million. The non-cash items primarily consisted of $10.8 million of net amortization of intangible assets, $7.9 million of stock-based compensation expense, $3.0 million change in inventory reserves, $2.9 million change in fair value of contingent consideration, $2.9 million of depreciation, $1.5 million deferred tax benefit, and $0.3 million change in fair value of warrant liabilities. The decrease in cash from changes in working capital included $4.2 million increase in inventories, $2.2 million decrease in accrued expenses, $1.8 million decrease in accounts payable, $1.2 million decrease in operating lease liabilities, $1.1 million decrease in operating lease right-of-use assets, $0.8 million decrease in prepaid expenses, $0.4 million increase in accounts receivable, $0.4 million decrease in other current and long term assets, $0.1 million decrease in other long term liabilities, and $0.1 million decrease in deferred revenue.

For the year ended December 31, 2019, net cash used in operating activities of $73.5 million consisted of a net loss of $154.2 million and cash used for working capital of $12.8 million, offset by non-cash items of $93.5 million. The non-cash items primarily consisted of $86.9 million in goodwill and IPR&D impairment, $11.5 million of stock-based compensation expense, $11.5$10.3 million of net amortization of intangible assets, $1.5 million amortization of debt discount and debt issuance costs, $0.3 million net amortization of discounts and short-termpremiums on investments, discount, $2.2 million of depreciation, $1.6 million of bad debt expense, $1.0 million loss on debt extinguishment, $8.9 million related to the write-down of obsolete inventory, and $0.8 million in interest expense on deferred consideration related to the MST Acquisition, offset by $16.0 million gain from sale of AutoLap assets, $9.6 million change in fair value of contingent consideration, $3.2 million deferred income tax benefit, and $2.2 million change in fair value of warrant liabilities. The decrease in cash from changes in working capital included $16.4 million increase in inventories, $1.2$6.1 million decrease in accruedaccounts receivable, $5.4 million other current and long-term assets, $2.5 million decrease in operating lease liabilities, $2.5 million decrease in prepaid expenses, $2.4 million other long-term liabilities, $2.3 million decrease in operating lease right-of-use assets, $1.0 million decrease in deferred revenue, $0.7 million decrease in accounts payable, and $0.7 million increase in other current and long term assets, offset by $6.1 million decrease in accounts receivable and $1.0 million increase in other long term liabilities.payable. The decrease in cash from changes in working capital was primarily driven by an increase in manufacturing activities combined with decreased Senhance System sales infor the current year.

year ended December 31, 2019.

Investing Activities

For the year ended December 31, 2018,2021, net cash used in operatinginvesting activities was $119.7 million. This amount primarily consists of $48.5$122.3 million consistedin purchases of aavailable-for-sale investments, $1.4 million in purchases of property and equipment, offset by $4.0 million proceeds from maturities of available-for-sale securities.

For the year ended December 31, 2020, net loss of $61.8 million and cash used for working capital of $5.9 million, offset by non-cash items of $19.2 million. The non-cash items primarily consisted of $14.3 million change in fair value of warrant liabilities, $11.2 million of net amortization of intangible assets, debt discount and debt issuance costs and short-term investment discount, $9.0 million of stock-based compensation expense, $2.4 million of depreciation, and $1.4 million loss on debt extinguishment, offset by $11.8 million gain from sale of SurgiBot assets, $3.0 million reversal of transfer fee, $3.4 million deferred income tax benefit, and $1.0 million change in fair value of contingent consideration. The decrease in cash from changes in working capital included $2.1 million increase in inventories, $7.2 million increase in accounts receivable, and $0.3 million increase in other current and long term assets, offset by $0.8 million increase in accounts payable, $2.1 million increase in accrued expenses and $0.8 million increase in deferred revenue.

Investing Activities
investing activities was not significant.

For the year ended December 31, 2019, net cash provided by investing activities was $67.6 million. This amount primarily consists of $65.0 million proceeds from maturities of short-termavailable-for-sale investments and $16.0 million in proceeds related to the sale of the AutoLap assets, offset by $12.9 million purchase of short-termavailable-for-sale investments and $0.4 million purchases of property and equipment.

Financing Activities

For the year ended December 31, 2018,2021, net cash used in investingprovided by financing activities was $53.5$161.7 million. This amountThe net change primarily consistsrelated to $131.9 million in proceeds from the issuance of $55.4shares of our common stock in equity financings, net of issuance costs, $30.9 million purchasein proceeds from the exercise of short-term investments, $5.8 million payment for acquisition of MSTstock options and $0.8 million purchases of property and equipment,warrants, partially offset by $4.5$1.1 million proceedsin taxes paid related to the salenet share settlement of vesting of restricted stock units.

For the year ended December 31, 2020, net cash provided by financing activities was $53.4 million. The net change primarily related to $13.5 million in net proceeds from the issuance of common stock, preferred stock, and warrants under the March 2020 Public Offering, $33.8 million in net proceeds from the issuance of common stock, $3.3 million from the exercise of warrants, and $2.8 million from the receipt of funding under a Promissory Note under the PPP provisions of the SurgiBot assets and proceeds from maturities of short-term investments of $4.0 million.

Financing Activities
CARES Act.

For the year ended December 31, 2019, net cash used in financing activities was $5.6 million. This amount was primarily related to $31.4 million payment of notes payable and $0.5 million related to the taxes withheld on restricted stock unit, or RSU, awards, offset by $25.8 million in proceeds from the issuance of common stock and warrants and $0.5 million in proceeds from the exercise of stock options and warrants.

For the year ended December 31, 2018, net cash provided by financing activities was $26.5 million. This amount was primarily related to $28.5 million in proceeds from the issuance of debt, which was partially offset by $15.3 million in payment of debt, $12.4 million in proceeds from the exercise of stock options and warrants and $3.0 million received for shares issued related to the sale of the SurgiBot assets, offset by $1.7 million related to the taxes withheld on RSU awards and $0.8 million payment of contingent consideration.

Operating Capital and Capital Expenditure Requirements

We intend to spend substantial amounts on commercial activities, on research and development activities, including product development, regulatory and compliance, clinical studies in support of our future product offerings, commercial activities and the enhancement and protection of our intellectual property. We will need to obtaincannot assure you that additional financing will not be required in the future to pursuesupport our business strategy,operations. We intend to responduse financing opportunities strategically to new competitive pressures orcontinue to take advantage of opportunities that may arise. To meetstrengthen our capital needs, we are considering multiple alternatives, including, but not limited to, additional equity financings, debt financings, strategic collaborations, other funding transactions or a fundamental business combination transaction. There can be no assurance that we will be able to complete any such transaction on acceptable terms or otherwise. If we are unable to obtain the necessary capital, we will need to pursue a plan to license or sell our assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection.

financial position.

Cash and cash equivalents held by our foreign subsidiaries totaled $1.5$4.8 million at December 31, 2019,2021, 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.

42

Hercules Loan Agreement
On May 23, 2018, the Company and its domestic subsidiaries, as co-borrowers, entered into the Hercules Loan Agreement with several banks and other financial institutions or entities from time to time party to the Hercules Loan Agreement and Hercules Capital, Inc., or Hercules, as administrative agent and collateral agent. Effective April 30, 2019, the Hercules Loan Agreement was amended to eliminate the availability
Contractual Obligations and Commercial Commitments
The following table summarizes our contractual obligations as of December 31, 2019 (in millions):
 Payments due by period  
 Total 
Less than
1 year
 1 to 3 years 3 to 5 years Thereafter
Operating leases$2.8
 $1.4
 $1.2
 $0.2
 $
License, supply and vendor agreements$9.1
 $5.6
 $1.3
 $1.1
 $1.1
Total contractual obligations$11.9
 $7.0
 $2.5
 $1.3
 $1.1
During 2019, the Company fully repaid its outstanding indebtedness to Hercules Capital, and all related liens and encumbrances

have been terminated.

Off-Balance Sheet Arrangements

As of December 31, 2019, the third tranche contingent consideration that may be paid under the Purchase Agreement with Sofar upon the achievement of milestones is €15.0 million. Due to uncertainty regarding the timing and amount of future payments related to this liability, the amount is excluded from the contractual obligations table above.

Operating lease amounts include future minimum lease payments under all our non-cancelable operating leases with an initial term in excess of one year. We rent office space in North Carolina under an operating lease which expires in 2020. In Italy, we rent space for research and development and demonstration facilities under an operating lease which expires in 2022. In Israel, we rent space for research and development under an operating lease which expires in 2024. In Japan, we rent office space under an operating lease which expires in 2023. In Switzerland, we rent office space under an operating lease which expires in 2023. This table does not include obligations for any lease extensions.
License, supply and third party vendor agreements include agreements assumed as part of the Senhance Acquisition and other third party vendor agreements.
Off-Balance Sheet Arrangements
As of December 31, 2019,2021, we did not have any off-balance sheet arrangements.

Critical Accounting Policies and 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 consolidated financial statements and notes thereto appearing in Item 8 of this Annual Report. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our critical accounting policies and estimates, including identifiable intangible assets and goodwill, business acquisitions, in-process research and development, contingent consideration, warrant liabilities, 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 Consolidated Financial Statements which are included in Item 8 of this Annual Report. Actual results may differ from these estimates under different assumptions and conditions.

While all accounting policies impact the consolidated financial statements, certain policies may be viewed as critical. Critical accounting policies are those that are both most important to the portrayal of financial condition and results of operations and that require management’s most subjective or complex judgments and estimates. Our management believes the policies that fall within this category are the policies on accounting for identifiable intangible assets, and goodwill, business acquisitions, in-process research and development, contingent consideration, warrant liabilities, stock-based compensation, inventory, revenue recognition and income taxes.

Identifiable Intangible Assets and Goodwill

Identifiable intangible assets consist of purchased patent rights recorded at cost and developed technology acquired as part of a business acquisitionacquisitions recorded at estimated fair value. Intangible assets are amortized over 5 to 10 years. We periodically evaluate identifiable intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.  

Indefinite-lived intangible assets, such as goodwill, are not amortized. We test the carrying amounts of goodwill for recoverability on an annual basis or when events or changes in circumstances indicate evidence of potential impairment exists by performing either a qualitative evaluation or a quantitative assessment. The qualitative evaluation is an assessment of factors, including industry, market and general economic conditions, market value, and future projections to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount, including goodwill.
As of December 31, 2018, we elected to bypass the qualitative assessment and calculated the fair value of our sole reporting unit based on our market capitalization, which exceeded the carrying amount. Accordingly, no charge for goodwill impairment was required as of December 31, 2018. During the third quarter of 2019, the Company's stock price declined significantly as a result of decreased sales and estimated cash flows. As of September 30, 2019, goodwill was deemed to be fully impaired, and the Company recorded an impairment charge of $79.0 million.
A significant amount of judgment is involved in determining if an indicator of goodwill impairment has occurred. Such indicators may include, among others: a significant decline in expected future cash flows; a sustained, significant decline in the Company's

stock price and market capitalization; a significant adverse change in legal factors or in the business climate; adverse assessment or action by a regulator; and unanticipated competition. Key assumptions used in the annual goodwill impairment test are highly judgmental and include selection of comparable companies and amount of control premium. Any change in these indicators or key assumptions could have a significant negative impact on the Company's financial condition, impact the goodwill impairment analysis or cause the Company to perform a goodwill impairment analysis more frequently than once per year.
Business Acquisitions
Business acquisitions are accounted for using the acquisition method of accounting in accordance with Accounting Standards Codification (“ASC”) 805, “Business Combinations.” ASC 805 requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values, as determined in accordance with ASC 820, “Fair Value Measurements,” as of the acquisition date. For certain assets and liabilities, book value approximates fair value. In addition, ASC 805 establishes that consideration transferred be measured at the closing date of the acquisition at the then-current market price. Under ASC 805, acquisition-related costs (i.e., advisory, legal, valuation and other professional fees) and certain acquisition-related restructuring charges impacting the target company are expensed in the period in which the costs are incurred. The application of the acquisition method of accounting requires the Company to make estimates and assumptions related to the estimated fair values of net assets acquired.
Significant judgments are used during this process, particularly with respect to intangible assets. Generally, intangible assets are amortized over their estimated useful lives. Goodwill and other indefinite-lived intangibles are not amortized, but are annually assessed for impairment. Therefore, the purchase price allocation to intangible assets and goodwill has a significant impact on future operating results.
In-Process Research and Development
In-process research and development (“IPR&D”) assets represent the fair value assigned to technologies that were acquired, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. During the period that the IPR&D assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval, and the Company is able to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value. During the year ended December 31, 2019, the Company also did an impairment analysis related to its IPR&D, and concluded that under the market value approach, the fair value of its IPR&D was lower than the carrying value and recorded an impairment charge of $7.9 million.
The IPR&D from MST was acquired on October 31, 2018.

Contingent Consideration

Contingent consideration is recorded as a liability and measured at fair value using a discounted cash flow modelMonte-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 achievement of 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 fair value of the contingent consideration at each reporting date will be updated by reflecting the changes in fair value in our consolidated statements of operations and comprehensive loss.

Warrant Liabilities

For the Series B Warrants, the warrants are recorded as liabilities and are revalued at each reporting period. The change in fair value is recognized in the consolidated statements of operations and comprehensive loss. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. As the warrant liability is required to be measured at fair value at each reporting date, it is reasonably possible that these estimates and assumptions could change in the near term.


All remaining outstanding Series B Warrants were exercised in the first quarter 2021.

Stock-Based Compensation

We recognize as expense, the grant-date fair value of stock options and other stock basedstock-based compensation issued to employees and non-employee directors over the requisite service periods, which are typically the vesting periods. We use the Black-Scholes-Merton model to estimate the fair value of our stock-based payments. The volatility assumption used in the Black-Scholes-Merton model is based on the calculated historical volatility based on an analysis of reported data for a peer group of companies as well as the Company’s historical volatility. The expected term of options granted by us has been determined based upon the simplified method, because we do not have sufficient historical information regarding our options to derive the expected term. Under this approach, the expected term is the mid-point between the weighted average of vesting period and the contractual term. The risk-free interest rate is based on U.S. Treasury rates whose term is consistent with the expected life of the stock options. We have not paid and do not anticipate paying cash dividends on our shares of common stock; therefore, the expected dividend yield is assumed to be zero. We estimate forfeitures based on our historical experience and adjust the estimated forfeiture rate based upon actual experience.

43

Inventories

Inventory, which includes material, labor and overhead costs, is stated at the lower of cost, determined on a first-in, first-out basis, or net realizable value. We record reserves, when necessary, to reduce the carrying value of inventory to its net realizable value. At the point of loss recognition, a new, lower-cost basis for that inventory is established, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.

Any inventory on hand at the measurement date in excess of the Company's current requirements based on anticipated levels of sales is classified as long-term on the Company's consolidated balance sheets. The Company's classification of long-term inventory requires us to estimate the portion of on hand inventory that can be realized over the upcoming twelve months.

Revenue Recognition

Our

The Company’s revenue consists of product revenue resulting from the sale and lease of systems, systemSenhance Systems, Senhance System components, instruments and accessories, and service revenue. We accountThe Company accounts for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. OurThe Company's revenues are measured based on consideration specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities.

Our system The Company’s Senhance System sale arrangements generally include a five-year service period; the first year of service is generally free and included in the Senhance System sale arrangement and the remaining four years are generally included at a stated service price.

The Company’s Senhance System sale arrangements generally contain multiple products and services. For these bundledconsolidated sale arrangements, we accountthe Company accounts for individual products and services as separate performance obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundledconsolidated package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. Our systemThe Company’s Senhance System sale arrangements may include a combination of the following performance obligations: system(s), system components, instruments, accessories, and system service. Our system sale arrangements generally include a five-year period of service. The first year of service is generally free and included in the system sale arrangement and the remaining four years are generally included at a stated service price. We consider the service terms in theservices.

For arrangements that contain multiple performance obligations, revenue is allocated to each performance obligation based on its relative estimated standalone selling price. When available, standalone selling prices are legally enforceablebased on observable prices at which the Company separately sells the products or services; however due to limited sales to date, standalone selling prices may not be performance obligations. Other than service, we generally satisfy alldirectly observable. The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the performance obligations up-front. System components, system accessories, instruments, accessories,products and service are also sold on aservices, geographies, type of customer, and market conditions. The Company regularly reviews estimated standalone basis.

We recognizeselling prices and updates these estimates if necessary.

The Company recognizes revenues when or as the performance obligations are satisfied by transferring control of the product or service to a customer. WeThe Company generally recognizerecognizes revenue for the performance obligations at the following points in time:

as follows: 

System sales. For systemsSenhance Systems and systemSenhance System components sold directly to end customers (including those arising from System purchases under lease rights to purchase), revenue is recognized when we transferthe Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. For systemslease buyouts, where the customer has already acknowledged installation of the system, transfer of control occurs when we receive an executed contract for the lease buyout of the Senhance System. For Senhance Systems sold through distributors, with thefor which distributors are responsible for installation, revenue is recognized generally at the time of shipment. Our systemThe Company’s Senhance System arrangements generally do not provide a right of return. The systemsSenhance Systems are generally covered by a one-year warranty. Warranty costs were not material for the periods presented.

Instruments and accessories.Revenue from sales of instruments and accessories is recognized when control is transferred to the customers, which generally occuroccurs at the time of shipment, but also occuroccurs at the time of delivery depending on the customer arrangement. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products such as replacement endoscopes, camera heads, light guides, and other items that facilitate use of the Senhance Surgical System.


Service. Service revenue is recognized ratably over the term of the service period as the customers benefit from the service throughout the service period. Revenue related to services performed on a time-and-materials basis is recognized when performed.

For multiple-element
44

We enter into lease arrangements revenue isfor our Senhance Systems with certain qualified customers. Revenue related to arrangements including lease elements are allocated to each performance obligationlease and non-lease elements based on itstheir relative standalone selling price. Standalone selling pricesprices. 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 right to purchase the leased Senhance at some point during and/or at the end of the lease term. In some arrangements lease payments are based on observable prices at which we separately sell the products or services. Due to limited sales to date, standalone selling prices are not yet directly observable. We estimate the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionalityusage of the productsSenhance System. In determining whether a transaction should be classified as a sales-type, operating, or direct financing lease, we consider the following terms at lease commencement: (1) whether title of the Senhance System transfers automatically or for a nominal fee by the end of the lease term, (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased Senhance System, (3) whether the lease term is for the major part of the remaining economic life of the leased Senhance System, (4) whether the lease grants the lessee an option to purchase the leased Senhance System that the lessee is reasonably certain to exercise, and services, geographies, type(5) whether the underlying Senhance System is of customer,such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term. All such arrangements through December 31, 2021 are classified as operating leases. Revenue related to lease elements from operating lease arrangements is generally recognized on a straight-line basis over the lease term or based upon Senhance System usage and market conditions. We regularly review standalone selling prices and update these estimates if necessary. 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 our system sales contracts that will be invoiced and recognizedis presented as revenue in future periods.

product revenue. 

We invoice our customers based on the billing schedules in ourits 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.

In connection with assets recognized from the costs to obtain a contract with a customer, we have determined that sales incentive programs for our sales team do not meet the requirements to be capitalized as we do not expect to generate future economic benefits from the related revenue from the initial sales transaction.

Income Taxes

We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets or liabilities for the temporary differences between financial reporting and tax basis of our assets and liabilities, and for tax carryforwards at enacted statutory rates in effect for the years in which the asset or liability is expected to be realized. The effect on deferred taxes of a change in tax rates is recognized in income during the period that includes the enactment date. In addition, valuation allowances are established when necessary to reduce deferred tax assets and liabilities to the amounts expected to be realized.

On December 22, 2017, the Tax Cuts and Jobs Act (“Tax Legislation”) was enacted into law, which reduced the U.S. federal corporate income tax rate to 21% for tax years beginning after December 31, 2017. As a result of the newly enacted tax rate, we adjusted our U.S. deferred tax assets as of December 31, 2017, by applying the new 21% rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $36.1 million.

The Tax Legislation also implements a territorial tax system. Under the territorial tax system, in general, our foreign earnings will no longer be subject to tax in the U.S. As part of transition to the territorial tax system the Tax Legislation includes a mandatory deemed repatriation of all undistributed foreign earnings that are subject to a U.S. income tax. We estimate that the deemed repatriation will not result in any additional U.S. income tax liability as we estimate we currently have no undistributed foreign earnings.

U.S. shareholders are subject to tax on global intangible low-taxed income (GILTI) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, 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 in the year the tax is incurred. As of December 31, 2019,2020 and 2021, no GILTI tax has been recorded.

In a referendum held on May 19, 2019, Swiss voters adopted the Federal Act on Tax Reform and AVS Financing (TRAF). TRAF introduces major changes in the Swiss tax system by abolishing certain current preferential tax regimes and replacing them with new measures that are in line with international standards. The referendum did not have a material impact on the Company’s 2019 tax provision. The Company will continue to evaluate the impact of these provisions in future periods as the enactment process in completed.

Recent Accounting Pronouncements

See “Note 2. Summary of Significant Accounting Policies” of the Notes to Consolidated Financial Statements in “Item 8. Financial Statements and Supplementary Data” of this Annual Report for a full description of recent accounting pronouncements including


the respective expected dates of adoption and effects on our Consolidated Balance Sheets and Consolidated Statements of Operations and Comprehensive Loss.

ITEM 7.A.

ITEM 7.A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company as defined by Rule 12b-2exposed to changes in foreign currency exchange rates. Operations outside of the Exchange ActUnited States accounted for 87% and 73% of revenue for 2021 and 2020, respectively, and are not requiredconcentrated 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 year ended December 31, 2021, would result in revenue changing by $0.8 million. This change would be material to provide the information under this item.our cash flows and our results of operations.

ITEM 8.

ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

Page

(BDO USA, LLP; Raleigh, NC; PCAOB ID #243)
  

Consolidated Financial Statements:

 

46

Report of Independent Registered Public Accounting Firm

Stockholders

Shareholders and Board of Directors

TransEnterix,

Asensus Surgical, Inc.

Morrisville,

Durham, North Carolina

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of TransEnterix,Asensus Surgical, Inc. (the “Company”) as of December 31, 20192021 and 2018,2020, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the three years thenin the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 20192021 and 2018,2020, and the results of its operations and its cash flows for each of the three years thenin the period ended, December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company's internal control over financial reporting as of December 31, 2019,2021, based on criteria established in Internal Control - Integrated Framework(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and our report dated March 16, 2020February 28, 2022 expressed an adverseunqualified opinion thereon.

Change in Accounting Principle
As discussed in Note 2 to the consolidated financial statements, the Company changed its method of accounting for leases in the year ended December 31, 2019 upon adoption of Accounting Standards Codification Topic 842, Leases, using the modified retrospective method.
Going Concern Uncertainty
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note 2 to the consolidated financial statements, the Company has suffered recurring losses from operations and has not generated significant revenue or positive cash flows from operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Inventories Valuation

Inventories totaled approximately $15.7 million at December 31, 2021, including approximately $7.1 million classified as long-term. As described in Note 2 to the Company’s consolidated financial statements, inventories are stated at the lower of cost or net realizable value. Management considers forecasted demand in relation to inventories on hand, competitiveness of product offerings, and product life cycles when estimating net realizable value.

We identified management’s estimation of the net realizable value of inventories as a critical audit matter. The Company’s limited sales history requires management to make significant judgments and assumptions with respect to future demand for the Company’s products and product life cycles that affect the estimation of the net realizable value of inventories. Auditing such assumptions required a high degree of auditor judgment and an increased auditor effort.

The primary procedures we performed to address this critical audit matter included:

Assessing the reasonableness of management’s forecasted demand for instruments and accessories, included in finished goods inventories, by (i) comparing forecasts to historical sales of the Company’s identical products, (ii) evaluating the reasonableness of the period over which forecasted sales are expected to occur, and (iii) performing a lookback analysis to compare the Company’s historical estimates of future demand to actual sales results for the same period.

Assessing the reasonableness of management’s forecasted consumption of raw materials inventories by (i) comparing to production plans obtained from the Company’s supply chain personnel, and (ii) evaluating forecasted demand and expectations with respect to changes in product life cycles of the Company’s finished products.

Testing management’s estimation of the net realizable value of Senhance Systems, included in finished goods inventories, by evaluating the Company’s assumptions with respect to future sales quantities and selling prices as well as the Company’s assumptions with respect to expected sale and lease terms of future arrangements related to the Senhance Systems.

Contingent Consideration Valuation

As described in Notes 2 and 6 to the Company’s consolidated financial statements, the Company has recorded a contingent consideration liability of approximately $2.4 million related to the Senhance acquisition. Contingent consideration is recorded as the estimated fair value of potential milestone payments to be made related to the acquisition. Contingent consideration is measured using a Monte-Carlo simulation utilizing significant unobservable inputs including the probability of achieving each of the potential milestones, future Euro-to-USD exchange rates,  revenue volatility and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones.

We have identified management’s estimation of the contingent consideration liability as a critical audit matter. Due to the Company’s limited sales history, the inherent uncertainty involved in estimating long-range forecasts, and the complexity of the Monte-Carlo simluation utilized by management, auditing the contingent consideration liability required increased auditor effort including the use of valuation specialists.

The primary procedures we performed to address this critical audit matter included:

Evaluating the reasonableness of management’s forecast of future revenues by comparing against historical operating results, relevant market data, analyst expectations for the Company and discussions with the Company’s research and development personnel knowledgeable about changes in the Company’s product life cycles.

Utilizing professionals with specialized knowledge and skills in valuation to assist in evaluating the valuation methodology selected by management as well as assessing the reasonableness of key inputs including the discount rate and revenue volatility.

/s/ BDO USA, LLP

We have served as the Company's auditor since 2013.

Raleigh, North Carolina

February 28, 2022

48

March 16, 2020


Report of Independent Registered Public Accounting Firm

Stockholders

Shareholders and Board of Directors

TransEnterix,

Asensus Surgical, Inc.

Morrisville,

Durham, North Carolina

Opinion on Internal Control over Financial Reporting

We have audited TransEnterix,Asensus Surgical Inc.’s (the “Company’s”) internal control over financial reporting as of December 31, 2019,2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “COSO criteria”). In our opinion, the Company did not maintain,maintained, in all material respects, effective internal control over financial reporting as of December 31, 2019,2021, based on the COSO criteria.

We do not express an opinion or any other form of assurance on management’s statements referring to any corrective actions taken by the Company after the date of management’s assessment.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated balance sheets of the Company as of December 31, 20192021 and 2018,2020, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the three years thenin the period ended December 31, 2021, and the related notes and our report dated March 16, 2020February 28, 2022 expressed an unqualified opinion thereon.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Item 9.A., “Management’s9A, Management’s Report on Internal Control over Financial Reporting”.Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit of internal control over financial reporting in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. A material weakness regarding management’s failure to design and maintain controls over the Company’s income tax accounting and disclosures for the significant components of deferred tax assets and liabilities related to a foreign non-recurring transaction has been identified and described in management’s assessment. This material weakness was considered in determining the nature, timing, and extent of audit tests applied in our audit of the 2019 financial statements, and this report does not affect our report dated March 16, 2020 on those financial statements.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.



Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ BDO USA, LLP

Raleigh, North Carolina

February 28, 2022

49

March 16, 2020




TransEnterix,

Asensus Surgical, Inc.

Consolidated Balance Sheets

(in thousands, except share amounts)

  

December 31, 2021

  

December 31, 2020

 

Assets

        

Current Assets:

        

Cash and cash equivalents

 $18,129  $16,363 

Short-term investments, available-for-sale

  80,262   0 

Accounts receivable, net

  749   1,115 

Inventories

  8,634   10,034 

Prepaid expenses

  3,255   3,535 

Employee retention tax credit receivable

  1,311   0 

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   0 

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

  0   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

  0   1,587 

Warrant liabilities

  0   255 

Total Liabilities

  17,227   16,689 
         

Commitments and Contingencies (Note 20)

          
         

Stockholders' Equity:

        

Common stock $0.001 par value, 750,000,000 shares authorized at December 31, 2021 and December 31, 2020; 235,218,552 and 116,231,072 shares issued and outstanding at December 31, 2021 and December 31, 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 December 31, 2020

  0   0 

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 
 December 31,
2019
 December 31,
2018
Assets   
Current Assets   
Cash and cash equivalents$9,598
 $21,061
Short-term investments
 51,790
Accounts receivable, net620
 8,560
Inventories10,653
 10,941
Interest receivable
 26
Other current assets7,084
 9,205
Total Current Assets27,955
 101,583
Restricted cash969
 590
Inventories, net of current portion7,594
 
Property and equipment, net4,706
 6,337
Intellectual property, net28,596
 39,716
In-process research and development2,470
 10,747
Goodwill
 80,131
Other long term assets2,489
 203
Total Assets$74,779
 $239,307
Liabilities and Stockholders’ Equity   
Current Liabilities   
Accounts payable$3,579
 $4,433
Accrued expenses8,553
 9,619
Deferred revenue – current portion818
 1,733
Contingent consideration – current portion73
 72
Deferred consideration - MST Acquisition
 5,962
Total Current Liabilities13,023
 21,819
Long Term Liabilities   
Deferred revenue – less current portion27
 109
Contingent consideration – less current portion1,011
 10,565
Notes payable, net of debt discount
 28,937
Warrant liabilities2,388
 4,636
Net deferred tax liabilities1,392
 4,720
Other long term liabilities1,403
 
Total Liabilities19,244
 70,786
Commitments and Contingencies (Note 21)


 


Stockholders’ Equity   
Common stock $0.001 par value, 750,000,000 shares authorized at December 31, 2019 and December 31, 2018; 20,691,301 and 16,641,999 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively21
 17
Additional paid-in capital720,484
 676,572
Accumulated deficit(663,600) (509,406)
Accumulated other comprehensive (loss) income(1,370) 1,338
Total Stockholders’ Equity55,535
 168,521
Total Liabilities and Stockholders’ Equity$74,779
 $239,307

See accompanying notes to consolidated financial statements.

TransEnterix,

Asensus Surgical, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands except per share amounts)

  

Year ended

 
  

December 31,

 
  

2021

  

2020

  

2019

 

Revenue:

            

Product

 $6,712  $1,612  $7,104 

Service

  1,520   1,563   1,427 

Total revenue

  8,232   3,175   8,531 
             

Cost of revenue:

            

Product

  7,974   2,254   16,439 

Service

  3,122   2,912   4,292 

Total cost of revenue

  11,096   5,166   20,731 
             

Gross loss

  (2,864)  (1,991)  (12,200)

Operating Expenses:

            

Research and development

  19,348   16,621   22,468 

Sales and marketing

  13,395   13,064   28,014 

General and administrative

  19,323   14,137   18,758 

Amortization of intangible assets

  11,254   10,801   10,301 

Change in fair value of contingent consideration

  (1,565)  2,924   (9,553)

Restructuring and other charges

  0   851   1,374 

Goodwill impairment

  0   0   78,969 

Intangible assets impairment

  0   0   7,912 

Loss from sale of SurgiBot assets, net

  0   0   97 

Gain from sale of AutoLap assets, net

  0   0   (15,965)

Total Operating Expenses

  61,755   58,398   142,375 
             

Operating Loss

  (64,619)  (60,389)  (154,575)

Other Income (Expense)

            

Gain (loss) on extinguishment of debt

  2,847   0   (1,006)

Change in fair value of warrant liabilities

  (1,981)  (336)  2,248 

Interest income

  590   35   582 

Interest expense

  (370)  (19)  (3,607)

Employee retention tax credit

  1,311   0   0 

Other expense, net

  (15)  (119)  (967)

Total Other Income (Expense), net

  2,382   (439)  (2,750)
             

Loss before income taxes

  (62,237)  (60,828)  (157,325)

Income tax (expense) benefit

  (225)  1,516   3,124 

Net loss

  (62,462)  (59,312)  (154,201)

Deemed dividend related to beneficial conversion feature of preferred stock

  0   (412)  0 

Deemed dividend related to conversion of preferred stock into common stock

  0   (299)  0 

Net loss attributable to common stockholders

  (62,462)  (60,023)  (154,201)
             

Comprehensive loss:

            

Net loss

  (62,462)  (59,312)  (154,201)

Foreign currency translation (loss) gain

  (2,985)  4,338   (2,708)

Unrealized loss on available-for-sale investments

  (247)  0   0 

Comprehensive loss

 $(65,694) $(54,974) $(156,909)
             

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

 $(0.28) $(0.85) $(8.69)

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

  226,960   70,809   17,737 
 Year ended December 31,
2019 2018
Revenue:   
Product7,104
 23,268
Service1,427
 834
Total revenue8,531
 24,102
Cost of revenue:   
Product16,439
 14,162
Service4,292
 2,009
Total cost of revenue20,731
 16,171
Gross (loss) profit(12,200) 7,931
Operating Expenses (Income)   
Research and development22,468
 21,823
Sales and marketing28,014
 25,736
General and administrative18,758
 13,854
Amortization of intangible assets10,301
 10,868
Change in fair value of contingent consideration(9,553) (1,011)
Restructuring and other charges1,374
 
Goodwill impairment78,969
 
In-process research and development impairment7,912
 
Acquisition related costs
 647
Loss (gain) from sale of SurgiBot assets, net97
 (11,840)
Gain from sale of AutoLap assets, net(15,965) 
Reversal of transfer fee accrual
 (2,994)
Total Operating Expenses142,375
 57,083
Operating Loss(154,575) (49,152)
Other Income (Expense)   
Change in fair value of warrant liabilities2,248
 (14,320)
Interest income582
 1,400
Interest expense(4,613) (4,208)
Other (expense) income(967) 1,126
Total Other Expense, net(2,750) (16,002)
Loss before income taxes$(157,325) $(65,154)
Income tax benefit3,124
 3,377
Net loss$(154,201) $(61,777)
Comprehensive loss   
Foreign currency translation loss(2,708) (3,690)
Comprehensive loss$(156,909) $(65,467)
Net loss per common share - basic and diluted$(8.69) $(3.88)
Weighted average number of shares used in computing net loss per common share - basic and diluted17,737
 15,938

See accompanying notes to consolidated financial statements.

TransEnterix,

Asensus Surgical, Inc.

Consolidated Statements of Stockholders’Stockholders Equity

(in thousands)

  

Common Stock

  

Preferred Stock

  

Treasury Stock

                 
  

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Additional

Paid-in Capital

  

Accumulated

Deficit

  

Accumulated Other Comprehensive

Income (Loss)

  

Total Stockholders' Equity

 

Balance, December 31, 2018

  16,642  $17   0  $0   0  $0  $676,572  $(509,406) $1,338  $168,521 

Stock-based compensation

  -   0   -   0   -   0   11,508   0   0   11,508 

Issuance of common stock, net of issuance costs

  3,571   4   0   0   0   0   25,773   0   0   25,777 

Issuance of common stock consideration of MST

  370   0   0   0   0   0   6,599   0   0   6,599 

Exercise of stock options and warrants

  38   0   0   0   0   0   538   0   0   538 

Award of restricted stock units

  70   0   0   0   0   0   0   0   0   0 

Return of common stock to pay withholding taxes on restricted stock

  0   0   0   0   15   0   (499)  0   0   (499)

Cancellation of treasury stock

  0   0   0   0   (15)  0   0   0   0   0 

Cumulative effect of change in accounting principle

  -   0   -   0   -   0   (7)  7   0   0 

Other comprehensive loss

  -   0   -   0   -   0   0   0   (2,708)  (2,708)

Net loss

  -   0   -   0   -   0   0   (154,201)  0   (154,201)

Balance, December 31, 2019

  20,691  $21   0  $0   0  $0  $720,484  $(663,600) $(1,370) $55,535 

Stock-based compensation

      0       0       0   7,911   0   0   7,911 

Issuance of common stock, preferred stock and warrants under 2020 financing, net of issuance costs

  14,122   14   7,937   79   0   0   13,384   0   0   13,477 

Issuance of common stock, net of issuance costs

  66,241   66   0   0   0   0   33,780   0   0   33,846 

Conversion of preferred stock to common stock

  7,937   8   (7,937)  (79)  0   0   71   0   0   0 

Exchange of shares for Series B Warrants

  2,041   2   0   0   0   0   2,468   0   0   2,470 

Exercise of stock options and warrants

  4,913   5   0   0   0   0   3,335   0   0   3,340 

Award of restricted stock units

  286   0   0   0   0   0   0   0   0   0 

Return of common stock to pay withholding taxes on restricted stock

  0   0   0   0   28   0   (36)  0   0   (36)

Cancellation of treasury stock

  0   0   0   0   (28)  0   0   0   0   0 

Other comprehensive income

  -   0   -   0   -   0   0   0   4,338   4,338 

Net loss

  -   0   -   0   -   0   0   (59,312)  0   (59,312)

Balance, December 31, 2020

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

Stock-based compensation

  -   0   -   0   -   0   9,429   0   0   9,429 

Issuance of common stock, net of issuance costs

  71,787   72   0   0   0   0   131,857   0   0   131,929 

Exercise of stock options and warrants

  45,630   46   0   0   0   0   33,029   0   0   33,075 

Award of restricted stock units

  1,571   1   0   0   0   0   0   0   0   1 

Return of common stock to pay withholding taxes on restricted stock

  0   0   0   0   320   0   (1,063)  0   0   (1,063)

Cancellation of treasury stock

  0   0   0   0   (320)  0   0   0   0   0 

Other comprehensive loss

  -   0   -   0   -   0   0   0   (3,232)  (3,232)

Net loss

  -   0   -   0   -   0   0   (62,462)  0   (62,462)

Balance, December 31, 2021

  235,219  $235   0  $0   0  $0  $954,649  $(785,374) $(264) $169,246 
 Common Stock Treasury Stock Additional Paid-in Capital 
Accumulated
Deficit
 
Accumulated Other
Comprehensive
(Loss) Income
 
Total
Stockholders’
Equity
 Shares Amount Shares Amount    
Balance, December 31, 201715,329
 $16
 
 $
 $621,446
 $(447,640) $5,028
 $178,850
Stock-based compensation
 
 
 
 9,039
 
 
 9,039
Issuance of common stock and warrants, net of issuance costs
 
 
 
 279
 
 
 279
Issuance of common stock for MST Acquisition242
 0
 
 
 8,300
 
 
 8,300
Exercise of stock options and warrants889
 1
 
 
 36,171
 
 
 36,172
Award of restricted stock units82
 0
 
 
 
 
 
 
Return of common stock to pay withholding taxes on restricted stock
 
 41
 1
 (1,663) 
 
 (1,662)
Cancellation of treasury stock
 
 (41) (1) 
 
 
 (1)
Issuance of common stock related to sale of SurgiBot assets100
 0
 
   3,000
 
 
 3,000
Cumulative effect of change in accounting principle (Note 2)
 
 
 
 
 11
 
 11
Other comprehensive loss
 
 
 
 
 
 (3,690) (3,690)
Net loss
 
 
 
 
 (61,777) 
 (61,777)
Balance, December 31, 201816,642
 $17
 
 $
 $676,572
 $(509,406) $1,338
 $168,521
Stock-based compensation
 
 
 
 11,508
 
 
 11,508
Issuance of common stock, net of issuance costs3,571
 4
 
 
 25,773
 
 
 25,777
Issuance of common stock consideration to MST370
 0
 
 
 6,599
 
 
 6,599
Exercise of stock options and warrants38
 0
 
 
 538
 
 
 538
Award of restricted stock units70
 0
 
 
 
 
 
 
Return of common stock to pay withholding taxes on restricted stock
 
 15
 0
 (499) 
 
 (499)
Cancellation of treasury stock
 
 (15) 0
 
 
 
 
Cumulative effect of change in accounting principle (Note 2)
 
 
 
 (7) 7
 
 
Other comprehensive loss
 
 
 
 
 
 (2,708) (2,708)
Net loss
 
 
 
 
 (154,201) 
 (154,201)
Balance, December 31, 201920,691
 $21
 
 $
 $720,484
 $(663,600) $(1,370) $55,535

See accompanying notes to consolidated financial statements.

TransEnterix,

Asensus Surgical, Inc.

Consolidated Statements of Cash Flows

(in thousands)

  

Year Ended December 31,

 
  

2021

  

2020

  

2019

 

Operating Activities:

            

Net loss

 $(62,462) $(59,312) $(154,201)

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

            

Gain from sale of AutoLap assets, net

  0   0   (15,965)

Loss from sale of SurgiBot assets, net

  0   0   97 

Goodwill and intangible assets impairment

  0   0   86,881 

Depreciation

  2,857   2,898   2,166 

Amortization of intangible assets

  11,254   10,801   10,301 

Amortization of debt discount and debt issuance costs

  0   0   1,513 

Amortization of discounts and premiums on investments, net

  409   0   (327)

Stock-based compensation

  9,429   7,911   11,508 

Interest expense on deferred consideration - MST acquisition

  0   0   756 

(Gain) loss on extinguishment of debt

  (2,847)  0   1,006 

Deferred tax expense (benefit)

  225   (1,516)  (3,124)

Bad debt expense

  144   0   1,634 

Change in inventory reserves

  (492)  (3,034)  8,931 

Change in fair value of warrant liabilities

  1,981   336   (2,248)

Change in fair value of contingent consideration

  (1,565)  2,924   (9,553)
             

Changes in operating assets and liabilities:

            

Accounts receivable

  174   (447)  6,083 

Inventories

  (611)  (4,164)  (16,404)

Operating lease right-of-use assets

  (4,254)  1,106   2,271 

Prepaid expenses

  146   824   2,541 

Employee retention tax credit receivable

  (1,311)  0   0 

Other current and long-term assets

  902   366   (5,441)

Accounts payable

  1,614   (1,758)  (668)

Accrued expenses

  (475)  (2,219)  (168)

Deferred revenue

  (229)  (105)  (959)

Operating lease liabilities

  4,452   (1,203)  (2,515)

Other long-term liabilities

  0   (83)  2,401 

Net cash and cash equivalents used in operating activities

  (40,659)  (46,675)  (73,484)
             

Investing Activities:

            

Proceeds from sale of AutoLap assets

  0   0   15,965 

Purchase of available-for-sale investments

  (122,330)  0   (12,883)

Proceeds from maturities of available-for-sale investments

  4,030   0   65,000 

Purchase of property and equipment

  (1,368)  (3)  (437)

Net cash and cash equivalents used in investing activities

  (119,668)  (3)  67,645 
             

Financing Activities:

            

Proceeds from issuance of common stock, preferred stock and warrants under 2020 financing, net of issuance costs

  0   13,478   0 

Proceeds from issuance of common stock, net of issuance costs

  131,929   33,847   25,777 

Proceeds from notes payable, net of issuance costs

  0   2,815   0 

Payment of note payable

  0   0   (31,425)

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

  (1,063)  (36)  (499)

Payment of contingent consideration

  0   (74)  0 

Proceeds from exercise of stock options and warrants

  30,839   3,340   538 

Net cash and cash equivalents provided by financing activities

  161,705   53,370   (5,609)
             

Effect of exchange rate changes on cash and cash equivalents

  376   270   364 

Net increase in cash, cash equivalents and restricted cash

  1,754   6,962   (11,084)

Cash, cash equivalents and restricted cash, beginning of period

  17,529   10,567   21,651 

Cash, cash equivalents and restricted cash, end of period

 $19,283  $17,529  $10,567 
 Twelve Months Ended
December 31,
 2019 2018
Operating Activities   
Net loss$(154,201) $(61,777)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:   
Gain from sale of AutoLap assets, net(15,965) 
Loss (gain) from sale of SurgiBot assets, net97
 (11,840)
Goodwill and in-process research and development impairment86,881
 
Depreciation2,166
 2,420
Amortization of intangible assets10,301
 10,868
Amortization of debt discount and debt issuance costs1,513
 725
Amortization of short-term investment discount(327) (351)
Stock-based compensation11,508
 9,039
Inventory write-down related to restructuring7,408
 
Inventory write-down1,523
 
Bad debt expense1,634
 
Interest expense on deferred consideration - MST acquisition756
 
Deferred tax benefit(3,224) (3,377)
Loss on extinguishment of debt1,006
 1,400
Change in fair value of warrant liabilities(2,248) 14,320
Change in fair value of contingent consideration(9,553) (1,011)
Reversal of transfer fee accrual
 (2,994)
Changes in operating assets and liabilities, net of effect of acquisition:   
Accounts receivable6,083
 (7,225)
Interest receivable26
 54
Inventories(16,404) (2,145)
Other current and long term assets(655) (325)
Accounts payable(668) 767
Accrued expenses(1,180) 2,134
Deferred revenue(959) 825
Other long term liabilities998
 
Net cash and cash equivalents used in operating activities(73,484) (48,493)
Investing Activities   
Proceeds from sale of AutoLap assets15,965
 
Purchase of short-term investments(12,883) (55,439)
Proceeds from maturities of short-term investments65,000
 4,000
Payment for acquisition of a business
 (5,800)
Proceeds related to sale of SurgiBot assets, net
 4,496
Purchase of property and equipment(437) (770)
Proceeds from sale of property and equipment
 32
Net cash and cash equivalents provided by (used in) investing activities67,645
 (53,481)
Financing Activities   
Payment of notes payable(31,425) (15,305)
Proceeds from issuance of debt and warrants, net of issuance costs
 28,507
Payment of contingent consideration
 (770)
Proceeds from issuance of common stock and warrants, net of issuance costs25,777
 279
Taxes paid related to net share settlement of vesting of restricted stock units(499) (1,662)
Proceeds from issuance of common stock related to sale of SurgiBot assets
 3,000
Proceeds from exercise of stock options and warrants538
 12,403
Net cash and cash equivalents (used in) provided by financing activities(5,609) 26,452
Effect of exchange rate changes on cash and cash equivalents364
 (433)
Net (decrease) increase in cash, cash equivalents and restricted cash(11,084) (75,955)
Cash, cash equivalents and restricted cash, beginning of period21,651
 97,606
Cash, cash equivalents and restricted cash, end of period$10,567

$21,651


TransEnterix, Inc.
Consolidated Statements of Cash Flows
(in thousands)

Supplemental Disclosure for Cash Flow Information   
Interest paid$2,187
 $1,730
Supplemental Schedule of Non-cash Investing and Financing Activities   
Transfer of inventories to property and equipment$486
 $2,160
Transfer of property and equipment to inventories$323
 $637
Reclass of warrant liability to common stock and additional paid-in capital$
 $23,774
Cashless exercise of warrants$
 $4,272
Issuance of common stock related to MST acquisition$6,600
 $8,300
Proceeds from sale of AutoLap assets exchanged for settlement of Company obligations$1,000
 $
Deferred consideration - MST acquisition$
 $5,962

See accompanying notes to consolidated financial statements.

TransEnterix,
  

Year Ended December 31,

 
  

2021

  

2020

  

2019

 

Supplemental Disclosure for Cash Flow Information:

            

Interest paid

 $0  $0  $2,187 

Cash paid for taxes

 $170  $82  $75 
             

Supplemental Schedule of Non-cash Investing and Financing Activities:

            

Transfer of inventories to property and equipment

 $3,244  $8,113  $486 

Right-of-use assets recognized related to new lease obligations

 $5,119  $0  $0 

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

 $2,236  $0  $0 

Exchange of common stock for Series B Warrants

 $0  $2,470  $0 

Transfer of in-process research and development to intellectual property

 $0  $2,425  $0 

Deemed dividend related to beneficial conversion feature of preferred stock

 $0  $412  $0 

Deemed dividend related to conversion of preferred stock into common stock

 $0  $299  $0 

Issuance of common stock - MST acquisition

 $0  $0  $6,600 

Proceeds from sale of AutoLap assets exchanged for settlement of Company obligations

 $0  $0  $1,000 

Transfer of property and equipment to inventories

 $0  $0  $323 

Conversion of preferred stock to common stock

 $0  $79  $0 

See accompanying notes to consolidated financial statements.

Asensus Surgical, Inc.

Notes to Consolidated Financial Statements

1.Organization and Capitalization

1.Organization and Capitalization

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 in laparoscopy to increase controlpioneer a new era of Performance-Guided Surgery™ by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and reduce surgical variability in today’s value-based healthcare environment.a new standard of surgery. The Company is focused on the market development for and commercialization of the Senhance™Senhance® Surgical System, which digitizes laparoscopic minimally invasive surgery.surgery, or MIS. The Senhance System allows foris 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, haptic feedback, surgeoncomfortable ergonomics, advanced instrumentation including 3mm microlaparoscopic instruments, 5mm articulating instruments, eye-sensing camera control via eye sensing and improved ergonomics while offering responsible economics.

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 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 laparoscopic colorectal and gynecologic surgery in a total of 28 indicated procedures, including benign and oncologic procedures, laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) 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 (gallbladder removal) surgery.

•   In Japan, the Company has received regulatory approval and reimbursement for 98 laparoscopic procedures.

During 2018

•   The Senhance System has received its registration certificate by the Russian medical device regulatory agency, Roszdravnadzor, allowing for its sale and 2019,utilization throughout the Russian Federation.

In 2020, the Company successfully obtained FDAregulatory clearance and CE Mark for the Company's 3 millimeter diameter instruments, Senhance ultrasonic system 3 millimeterin Taiwan and 5 millimeter hooks, and Japan. On February 12, 2020, the Senhance articulating system. The 3 millimeter instruments enableCompany expanded its claims in the EU for the Senhance System to be used for microlaparoscopic surgeries,include pediatric patients, allowing for tiny incisions. The ultrasonic system is an advanced energy device usedaccessibility to deliver controlled energymore surgeons and patients, as well as expanding its potential market to ligate and divide tissue, while minimizing thermal injury to surrounding structures. The Senhance articulating system was launchedinclude pediatric hospitals in Europe in November 2019 and the Company is evaluating its pathway forward to launch such a system in the United States with a planned submission for U.S. clearance at the end of 2020.

The Senhance System is a multi-port robotic surgery system that allows multiple robotic arms to control instruments and a camera. The system features advanced technology to enable surgeons with haptic feedback and the ability to move the camera via eye movement.
On October 31, 2018, the Company acquired the assets, intellectual property and highly experienced multidisciplinary personnel of MST Medical Surgical Technologies, Inc., or MST, an Israeli-based medical technology company.  Through this acquisition the Company acquired MST’s AutoLap™ assets and technology, one of the only image-guided robotic scope positioning systems with FDA clearance and CE Mark.Europe. The Company believes MST’s image analytics technology will accelerate and drive meaningful Senhance System developments, and allowanticipates the Company to expandrobotic precision provided by the Senhance System, coupled with the already available 3mm diameter instruments, will prove to add augmented, intelligent vision capability. See Note 3 for a description of the acquisition transaction. The Company sold the AutoLap assets, while retaining the core technology,be an effective tool in October 2019. See Note 3 for a description of the asset sale. surgery with smaller patients.

On January 14,March 13, 2020, the Company announced that it had filed a 510(k) submission withreceived FDA clearance for the U.S. Food and Drug Administration for its Intelligent Surgical UnitUnit™ (ISU™) for use with the Senhance System. The Company believes it is the first such FDA submission seeking clearance for machine vision technology in abdominal robotic surgery. On March 13,September 23, 2020, the Company announced the first surgical procedures successfully completed using the ISU. On September 1, 2021, the Company announced that it has received FDA clearance for an expansion of machine vision capabilities. On January 19, 2021, the Intelligent Surgical Unit.

Company announced that it received CE Mark for the ISU. Lastly, 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 has also developed the SurgiBot System, a single-port, robotically enhanced laparoscopic surgical platform. In December 2017, the Company entered into an agreement with Great Belief International Limited, or GBIL, to advance the SurgiBot System towards global commercialization. The agreement transferred ownership of the SurgiBot System assets to GBIL, while the Company retained the option to distribute or co-distribute the SurgiBot System outside of China. GBIL intends to manufacture the SurgiBot System in China, obtain Chinese regulatory clearance from the National Medical Products Administration ("NMPA"), and commercialize in the Chinese market. The agreement provides the Company with proceeds of at least $29.0 million, of which $15.0 million has been received to date. The remaining $14.0 million represents future minimum royalties and will be paidpayable beginning at the earlier of receipt of Chinese regulatory approval or March 2023. In estimating the consideration in this transaction, the Company applied the guidance on constraining estimates of variable consideration. The Company recorded a gain duringreassesses the year ended December 31, 2018 based onestimate every reporting period and the cash proceeds (excluding future royalties) in excessvariable consideration will be adjusted when it is deemed no longer constrained.

2.Summary of the carrying value of the assets sold.

On September 18, 2015, the Company entered into a Membership Interest Purchase Agreement, (the “Purchase Agreement”) with Sofar S.p.A., (“Sofar”) as seller, Vulcanos S.r.l. (“Vulcanos”), as the acquired company, and TransEnterix International, Inc.

(“TransEnterix International”), a direct, wholly owned subsidiary of the Company that was incorporated in September 2015, as buyer. The closing of the transactions occurred on September 21, 2015 (the “Closing Date”) pursuant to which the Company acquired all of the membership interests of Vulcanos from Sofar (now known as the “Senhance Acquisition”), and changed the name of Vulcanos to TransEnterix Italia S.r.l (“TransEnterix Italia”). The Senhance Acquisition included all of the assets, employees and contracts related to the Senhance System. See Note 3 for a description of the related transactions.
On September 3, 2013, TransEnterix Surgical, Inc. a Delaware corporation (“TransEnterix Surgical”), and SafeStitch Medical, Inc., a Delaware corporation (“SafeStitch”) consummated a merger transaction whereby TransEnterix Surgical merged with a merger subsidiary of SafeStitch, with TransEnterix Surgical as the surviving entity in the merger (the “Merger”). As a result of the Merger, TransEnterix Surgical became a wholly owned subsidiary of SafeStitch. On December 6, 2013, SafeStitch changed its name to TransEnterix, Inc. and increased the authorized shares of common stock from 225,000,000 to 750,000,000, and authorized 25,000,000 shares of preferred stock, par value $0.01 per share.
As used herein, the term “Company” refers to the combination of SafeStitch and TransEnterix Surgical after giving effect to the Merger, and includes TransEnterix Surgical, Inc., SafeStitch LLC, TransEnterix International, Inc.; TransEnterix Italia S.r.l.; TransEnterix Europe S.à.R.L; TransEnterix Asia Pte. Ltd.; TransEnterix Taiwan Ltd.; TransEnterix Japan KK; TransEnterix Israel Ltd. and TransEnterix Netherlands B.V.
2.Summary of Significant Accounting Policies
Significant Accounting Policies

Basis of Presentation

The accompanying 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, SafeStitch LLC, TransEnterix Surgical, Inc., TransEnterix International, Inc., TransEnterix Italia S.r.l., TransEnterix Europe S.à.R.L; TransEnterix Asia Pte. Ltd.; TransEnterix Taiwan Ltd.; TransEnterix Japan KK; TransEnterix Israel Ltd. and TransEnterix Netherlands B.V.subsidiaries. All material inter-company accounts and transactions have been eliminated in consolidation.

On December 11, 2019, following receipt

Reclassifications

Certain amounts reported previously have been reclassified to conform to the current year presentation, with no effect on stockholders’ equity or net loss as previously reported. These reclassifications relate to the (gain) loss on extinguishment of approval from stockholders at a special meeting of stockholders helddebt which was historically included in interest expense on the same day,consolidated statements of operations for the Company filed an amendment to our Amended and Restated Certificateyear ended December 31, 2019.

55

Unless otherwise noted, all share and per share data referenced in the consolidated financial statements and the notes thereto have been retroactively adjusted to reflect the Reverse Stock Split. As a result of the Reverse Stock Split, certain amounts in the consolidated financial statements and the notes thereto may be slightly different than previously reported due to rounding of fractional shares, and certain amounts within the consolidated balance sheets were reclassified between common stock and additional paid-in capital.
Going Concern
The Company's consolidated financial statements are prepared using U.S. GAAP applicable to a going concern, which contemplate the realization of assets and liquidation of liabilities in the normal course of business.

Liquidity

The Company had an accumulated deficit of $663.6$785.4 million and working capital of $103.4 million as of December 31, 2019, and has working capital of $14.9 million as of December 31, 2019. 2021. The Company has not established sufficient sales revenues to cover its operating costs and requiresbelieves it may require additional capital in the future to proceed with its operating plan.

The Company believes the COVID-19 pandemic will continue to negatively impact its operations and ability ofto implement its market development efforts, which will have a negative effect on its financial condition.

In 2021, the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. In order to continue as a going concern, the Company will need, among other things, additional capital resources.


Traditionally, the Company has raised additional capital through equity offerings.offerings, including raising net proceeds of $73.4 million in a January 2021 public offering, $28.6 million in a January 2021 registered direct offering, and $27.3 million in an at-the-market offering launched in 2020 (the “2020 ATM Offering”). Additionally, in 2021, the Company launched the 2021 ATM Offering and raised proceeds, net of legal costs and commissions, of $2.8 million under this offering during the year ended December 31, 2021. Also, certain holders of our Series B, Series C, and D warrants to purchase shares of our common stock exercised such warrants in 2021 for aggregate proceeds to the Company of $30.6 million.

As of December 31, 2021, the Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of $135.8 million.

While the Company believes that its existing cash, cash equivalents, and short-term investments as of December 31, 2021 will be sufficient to sustain operations for at least the next 12 months from the issuance of these consolidated financial statements, the Company believes it may need to obtain additional financing in the future to proceed with its business plan. Management's plan to obtain suchadditional resources for the Company may include additional sales of equity under the 2021 ATM Offering or otherwise, 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. In addition, the Company may consider fundamental business combination transactions. If the Company is unable to obtain adequate capital through one of these methods, or if expected capital from existing agreements is not received when due, or at all, it would need to reduce its sales and marketing and administrative expenses and delay research and development projects, including the purchase of equipment and supplies, until it is able to obtain sufficient funds. If such sufficient funds are not received on a timely basis, the


Company would then need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek bankruptcy protection. However, management cannot provide any assurance that the Company will be successful in accomplishing any or all of its plans. plans and be able to secure additional funding when needed on terms acceptable to the Company, or at all. 

Risk and Uncertainties

The abilityCompany is subject to successfully resolve these factors raise substantial doubt aboutrisks similar to other similarly sized companies in the medical device industry. These risks include, without limitation: potential negative impacts on the Company's operations caused by the COVID-19 pandemic, including new variants of the virus; the historical lack of profitability; the Company’s ability to meetraise additional capital; the success of its existing obligations,market development efforts, the liquidity and capital resources of its partners; its ability to continue as a going concern within one year fromsuccessfully develop, clinically test and commercialize its products; the date that these financial statements are issued. The consolidated financial statementstiming 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 do not include any adjustments that may resultoperates 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 outcomemarket for robotic surgical devices; and its ability to identify and pursue development of these aforementioned uncertainties.

additional products.

The COVID-19 pandemic had a significant impact on the Company in 2021 and continues to have a significant impact on its operations, primarily due to the continued repeated temporary cessation of elective surgical procedures in many markets, and the challenges and restrictions caused by stay-at-home orders, social distancing requirements and travel restrictions. The Company’s business and customers were negatively impacted by the COVID-19 pandemic, which suspended many elective surgical procedures globally, curtailed travel and necessarily diverted the attention of hospital customers. A variety of travel restrictions have caused delays in product installation and training activities. This has significantly impacted the Company’s ability to implement its market development activities to place Senhance Systems, provide training, and increase the use of the Senhance Systems in place. Given the dynamic nature of this health emergency, the full impact of the COVID-19 pandemic on ongoing business, results of operations and overall financial performance cannot be reasonably estimated at this time.

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 consolidated 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 identifiable intangibleimpairment considerations for long- term assets, and goodwill,fair value estimates related to contingent consideration, warrant liabilities, 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.

Cash

Principles of Consolidation and Cash Equivalents and Restricted Cash

Foreign Currency Considerations

The Company considers all highly liquid investments with original maturities of 90 days or less ataccompanying consolidated financial statements include the time of purchase to be cash equivalents.

Restricted cash at December 31, 2019 and 2018 includes $1.0 million and $0.6 million, respectively, in cash accounts held as collateral primarily under the terms of an office operating lease, credit cards, automobile leases, and a performance guarantee required by the government of a country in which a Senhance System was sold in 2018.
Short-term Investments
Short-term investments are considered to be “held-to-maturity” and are carried at amortized cost using the effective interest method. As of December 31, 2018, short-term investments consisted of $51.8 million in U.S. government securities, all of which matured in less than a year. There were 0 short-term investments as of December 31, 2019.
The Company reassesses the appropriateness of the classification ofCompany and its investments at the end of each reporting period. The Company determined that its debt securities should be classified as held-to-maturity as of December 31, 2018. The Company had no debt securities as of December 31, 2019. This classification as of December 31, 2018 was based upon management’s determination that it has the positive intentdirect and ability to hold the securities until their maturity dates, as the investments mature within six monthsindirect 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 the underlying cash invested in these securities is not required prior to the investments maturity. Due to the short-term maturities of these instruments, the amortized cost approximated the related fair values, which was based on level 1 inputs as defined in Note 5. As of December 31, 2018, the gross holding gains and losses were immaterial.
The Company reviews its short-term investments for other-than-temporary impairment if the cost exceeds the fair value. NaN such impairment was recorded during the years ended December 31, 2019 or 2018.
Concentrations and Credit Risk
The Company’s principal financial instruments subject to potential concentration of credit risk are cash and cash equivalents, including amounts held in money market accounts. The Company places cash deposits with a federally insured financial institution. The Company maintains its cash at banks and financial institutions it considers to be of high credit quality; however, the Company’s domestic cash deposits may at times exceed the Federal Deposit Insurance Corporation’s insured limit. Balances in excess of federally insured limitations may not be insured. The Company has not experienced losses on theseAsensus Surgical Canada, Inc. All inter-company accounts and management believes that the Company is not exposed to significant risks on such accounts.
The Company’s accounts receivable are derived from sales to customers located throughout the world. The Company evaluates its customers’ financial condition and, generally, requires no collateral from its customers. The Company provides reserves for potential credit losses and recorded a bad debt charge totaling $1.6 million during the year ended December 31, 2019. The Company had eight customers who constituted 85% of the Company’s net accounts receivable at December 31, 2019. The Company had five customers who constituted 89% of the Company’s net accounts receivable at December 31, 2018. The Company had six customers who accounted for 82% of salestransactions have been eliminated in 2019 and twelve customers who accounted for 89% of sales in 2018.
Accounts Receivable

Accounts receivable are recorded at net realizable value, which includes an allowance for estimated uncollectible accounts. The allowance for uncollectible accounts was determined on a customer specific basis based on deemed collectability.
Inventories
Inventories are stated at the lower of cost (determined on a first-in, first-out basis) or net realizable value. Inventory costs include direct materials, direct labor, and normal manufacturing overhead. The Company records reserves, when necessary, to reduce the carrying value of inventory to its net realizable value. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. At the point of loss recognition, a new, lower-cost basis for that inventory is established, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.
Any inventory on hand at the measurement date in excess of the Company's current requirements based on anticipated levels of sales is classified as long-term on the Company's consolidated balance sheets. The Company's classification of long-term inventory requires it to estimate the portion of on hand inventory that can be realized over the upcoming twelve months.
Identifiable Intangible Assets and Goodwill
Identifiable intangible assets are recorded at cost, or when acquired as part of a business acquisition, at estimated fair value. Certain intangible assets are amortized over 5 to 10 years. Similar to tangible personal property and equipment, the Company periodically evaluates identifiable intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
Intellectual property consists of purchased patent rights and developed technology acquired as part of a business acquisition. Amortization of the patent rights is recorded using the straight-line method over the estimated useful life of the patents of 10 years. Amortization of the developed technology is recorded using the straight-line method over the estimated useful life of 5 to 7 years.
The Company continues to operate in 1 segment, which is considered to be the sole reporting unit and therefore, goodwill is tested for impairment at the enterprise level. Indefinite-lived intangible assets, such as goodwill, are not amortized.

The Company typically tests goodwill for impairment annually, however, market conditions as well as reduced forecasts required that the Company test its goodwill carrying value as of September 30, 2019.

Subsequent to the adoption of Accounting Standards Update ("ASU") 2017-04 Intangibles - Goodwill and Other (Topic 350):Simplifying the Test for Goodwill Impairment , a company must record a goodwill impairment charge if a reporting unit’s carrying value exceeds its fair value. The Company generally determines the fair value of its reporting unit using two valuation methods: the “Income Approach — Discounted Cash Flow Analysis” method, and the “Market Approach — Guideline Public Company Method.”

Under the “Income Approach — Discounted Cash Flow Analysis” method the key assumptions consider projected sales, cost of sales, and operating expenses. These assumptions were determined by management utilizing the Company's internal operating plan, growth rates for revenues and operating expenses, and margin assumptions. An additional key assumption under this approach is the discount rate, which is determined by looking at current risk-free rates of capital, current market interest rates, and the evaluation of risk premium relevant to the business segment. If the Company's assumptions relative to growth rates were to change or were incorrect, the fair value calculation may change.

Under the “Market Approach — Guideline Public Company Method” the Company identified several publicly traded companies, which it believed had sufficiently relevant similarities. Similar to the income approach discussed above, sales, cost of sales, operating expenses, and their respective growth rates are key assumptions utilized. The market prices of the Company’s common stock and other guideline companies are additional key assumptions. If these market prices increase, the estimated market value would increase. If the market prices decrease, the estimated market value would decrease.

The results of these two methods were weighted based upon management’s evaluation of the relevance of the two approaches. In the 2019 evaluation, management determined that the income and market value approach should be weighted 50%-50%. In addition, management considered the decline in both the Company's stock price and market capitalization after the September 30, 2019 measurement date as relevant factors in the analysis.

The Company also performed a recoverability test on the intellectual property and concluded that there was 0 impairment as of September 30, 2019 or December 31, 2019.

During the third quarter of 2019, the Company determined that the goodwill associated with the business was impaired, and recorded impairment charges of $79.0 million. The impairment charge resulted from decreased sales and estimated cash flows and a significant decline in the Company's stock price. The Company also recognized a $7.9 million impairment charge to its IPR&D as it concluded that under the market value approach, the fair value of the IPR&D was lower than the carrying value.
No impairment existed at December 31, 2018.
In-Process Research and Development
In-process research and development (“IPR&D”) assets represent the fair value assigned to technologies that were acquired, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. During the period that the IPR&D assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval, and the Company is able to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.
The IPR&D for the Senhance System was acquired on September 21, 2015. On October 13, 2017, upon receiving FDA clearance and the ability to commercialize the products associated with the IPR&D assets, the assets were deemed definite-lived, reclassified to intellectual property and are now amortized based on their estimated useful lives.
The IPR&D from MST was acquired on October 31, 2018.
The Company performed an impairment test of its IPR&D at the end of the third quarter 2019 as recent events and changes in market conditions indicated that the asset might be impaired.
The impairment test consisted of a comparison of the fair value of the IPR&D with its carrying amount. If the carrying amount of the IPR&D exceeds its fair value, an impairment loss is recognized in an amount equal to that excess.
Significant judgment is applied when testing for impairment. This judgment includes developing cash flow projections, selecting appropriate discount rates, identifying relevant market comparables, and incorporating general economic and market conditions.
During the third quarter of 2019, the Company concluded that the fair value determined by the market value approach, was lower than the carrying value. As a result, the Company recognized a $7.9 million impairment charge to its IPR&D. The company performed its annual impairment assessment at December 31, 2019 and no additional impairment was required.
Property and Equipment
Property and equipment consists primarily of machinery, manufacturing equipment, demonstration equipment, computer equipment, furniture, and leasehold improvements, which are recorded at cost.
Depreciation is recorded using the straight-line method over the estimated useful lives of the assets as follows:
Machinery, manufacturing and demonstration equipment3-5 years
Computer equipment3 years
Furniture5 years
Leasehold improvementsLesser of lease term or 3 to 10 years
Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.
Impairment of Long-Lived Assets
The Company reviews its long-lived assets for possible impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine the recoverability of its long-lived assets, the Company

evaluates the probability that future estimated undiscounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the long-lived assets, then such assets are written down to their fair value. The Company’s estimates of anticipated cash flows and the remaining estimated useful lives of long-lived assets could be reduced in the future, resulting in a reduction to the carrying amount of long-lived assets.
Contingent Consideration
Contingent consideration 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 discounted cash flow model utilizing significant unobservable inputs including the probability of achieving each of the potential milestones, future Euro-to-USD exchange rates, 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 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.
Warrant Liabilities
The Company’s Series B Warrants (see Note 16) 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 (see Note 5). The warrant liability is revalued at each reporting period and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss. The selection of the appropriate valuation model and the inputs and assumptions that are required to determine the valuation requires significant judgment and requires management to make estimates and assumptions that affect the reported amount of the related liability and reported amounts of the change in fair value. Actual results could differ from those estimates, and changes in these estimates are recorded when known. As the warrant liability is required to be measured at fair value at each reporting date, it is reasonably possible that these estimates and assumptions could change in the near term.
Translation of Foreign Currencies
consolidation.

The functional currency of the Company’s operational foreign subsidiaries is predominantly the Euro. The assets and liabilities of the Company’s foreign subsidiaries are translated into U.S. dollars at exchange rates in effect at the balance sheet date. Income and expense items are translated at the average exchange rates prevailing during the period. The cumulative translation effect for a subsidiary using a functional currency other than the U.S. dollar is included in accumulated other comprehensive income or loss as a separate component of stockholders’ equity.

56

The Company’s intercompany accounts are denominated in the functional currency of the foreign subsidiary. Gains and losses resulting from the remeasurement of intercompany receivables that the Company considers to be of a long-term investment nature are recorded as a cumulative translation adjustment in accumulated other comprehensive income or loss as a separate component of stockholders’ equity, while gains and losses resulting from the remeasurement of intercompany receivables from a foreign subsidiary for which the Company anticipates settlement in the foreseeable future are recorded in the consolidated statements of operations and comprehensive loss. The net gains and losses included in net loss in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2021, 2020, and 2019 were not significant.

Cash and Cash Equivalents, Restricted Cash, and Investments

The Company considers all highly liquid investments with original maturities of 90 days or less at the time of purchase to be cash equivalents.

Restricted cash as of December 31, 2021 and 2020 includes $1.2 million and $1.2 million, respectively, in cash accounts held as collateral primarily under the terms of an office operating lease, credit cards, and automobile leases.

The Company’s investments as of December 31, 2021 consisted of commercial paper and corporate bonds and were classified as available-for-sale. Investments classified as available-for-sale are measured at fair value, and net unrealized gains and losses are recorded as a component of accumulated other comprehensive income (loss) on the consolidated balance sheets until realized. Realized gains and losses on sales of investment securities are determined based on the specific-identification method and are recorded in interest income, net. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity computed under the effective interest method. Such amortization and accretion is included in interest expense, net. The Company held 0 investments as of December 31, 2020. The Company recognized an immaterial amount of gross realized losses for the year ending December 31, 2021. There were no gross realized gains for the year ended December 31, 2021. There were no gross realized gain or losses recorded for the years ended December 31, 2020 and 2019. The Company reclassified an immaterial amount of unrealized losses from accumulated other comprehensive income (loss) for the year ended December 31, 2021 with 0 related reclassification for the years ended December 31, 2020 and 2019. Investments with remaining maturities at date of purchase greater than 90 days and remaining maturities as of the reporting period less than one year are classified as short-term investments. Investments with remaining maturities greater than one year are classified as long-term investments. 

Concentrations and Credit Risk

The Company’s principal financial instruments subject to potential concentration of credit risk are cash and cash equivalents, and investments, including amounts held in money market funds, commercial paper, and corporate bonds. The Company places cash deposits with a federally insured financial institution. The Company maintains its cash at banks and financial institutions it considers to be of high credit quality; however, the Company’s domestic cash deposits may at times exceed the Federal Deposit Insurance Corporation’s insured limit. Balances in excess of federally insured limitations may not be insured. The Company has not experienced losses on these accounts, and management believes that the Company is not exposed to significant risks on such accounts. Investments are stated at their estimated fair values, based on quoted market prices for the same or similar instruments. The counterparties to the agreements relating to the Company’s investments consist of various major corporations, financial institutions, and government agencies of high credit standing.

The Company’s accounts receivable are derived from sales and leases to customers located throughout the world. The Company evaluates its customers’ financial condition and, generally, requires no collateral from its customers. The Company provided reserves for potential credit losses and recorded $0.1 million, $0 million, and $1.6 million in bad debt charges during the years ended December 31, 2021, 2020 and 2019, respectively. The Company had three customers who constituted 61% of the Company’s net accounts receivable as of December 31, 2021. The Company had seven customers who constituted 68% of the Company’s net accounts receivable at December 31, 2020. The Company had two customers who accounted for 52% of revenue in 2021,nine customers who accounted for 55% of revenue in 2020, and six customers who accounted for 82% of revenue in 2019.

Accounts Receivable

Accounts receivable are recorded at net realizable value, which includes an allowance for estimated uncollectible accounts. The allowance for uncollectible accounts was determined on a customer specific basis based on deemed collectability. The allowance for doubtful accounts was $1.7 million and $1.8 million as of December 31, 2021 and December 31, 2020, respectively.

57

Inventories

Inventories are stated at the lower of cost (determined on a first-in, first-out basis) or net realizable value. Inventory costs include direct materials, direct labor, and normal manufacturing overhead. The Company records reserves, when necessary, to reduce the carrying value of inventory to its net realizable value. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. At the point of loss recognition, a new, lower-cost basis for that inventory is established, and any subsequent improvements in facts and circumstances do not result in the restoration or increase in that newly established cost basis.

Any inventory on hand at the measurement date in excess of the Company's current requirements based on anticipated levels of sales is classified as long-term on the Company's consolidated balance sheets. The Company's classification of long-term inventory requires it to estimate the portion of on hand inventory that can be realized over the upcoming twelve months.

Identifiable Intangible Assets

Definite-Lived Intangible Assets - Intellectual Property

Intellectual property consists of purchased patent rights and developed technology acquired as part of a business acquisition. Developed technology includes reclassified in-process research and development (“IPR&D”) assets related to (i) the Senhance System acquired in 2015 and reclassified in 2017 and (ii) the MST acquisition in 2018 and reclassified in 2020. Amortization of the patent rights is recorded using the straight-line method over the estimated useful life of the patents of 10 years. Amortization of the developed technology is recorded using the straight-line method over the estimated useful life of 5 to 7 years.

The Company periodically evaluates intellectual property for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. To determine the recoverability, the Company evaluates the probability that future estimated undiscounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the assets, then such assets are written down to their fair value. NaN impairment of intellectual property was identified during the year ended December 31, 2021, 2020 and 2019.

Indefinite-Lived Intangible Assets

IPR&D assets represent the fair value assigned to technologies that were acquired, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. During the period that the IPR&D assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. To determine the recoverability, the Company evaluates the probability that future estimated discounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the assets, then such assets are written down to their fair value.

The Company reclassifies IPR&D assets to intellectual property when development is complete, which generally occurs upon regulatory approval when the Company is able to commercialize products. The completed IPR&D assets are then classified as definite-lived intangible assets and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.

The Company performed an impairment test of its IPR&D at the end of the third quarter 2019 as events and changes in market conditions indicated that the asset might be impaired. During the third quarter of 2019, the Company concluded that the fair value determined by the market value approach was lower than the carrying value and recognized a $7.9 million impairment charge to its IPR&D. The Company performed its annual impairment assessment at December 31, 2019 and 2018 were not significant.

Business Acquisitions
Business acquisitionsno additional impairment was required. As of December 31, 2020, all IPR&D asset development was completed and reclassified to intellectual property.

Property and Equipment

Property and equipment consists primarily of operating lease Senhance System assets, machinery, manufacturing equipment, demonstration equipment, computer equipment, furniture, and leasehold improvements, and purchased software which are accounted forrecorded at cost less accumulated depreciation. Depreciation is recorded using the acquisitionstraight-line method over the estimated useful lives of accountingthe assets as follows:

 

Years

Operating lease assets – Senhance System leasing

  

5

 

Machinery, manufacturing, and demonstration equipment

 

3

-

5

Computer equipment

  

3

 

Furniture

  

5

 

Leasehold improvements

Lesser of lease term or 3 to 10

Purchased Software  5 

58

The Company reviews its property and equipment assets for possible impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable. To determine the recoverability of its long-lived assets, the Company evaluates the probability that future estimated undiscounted net cash flows will be less than the carrying amount of the assets. If such estimated cash flows are less than the carrying amount of the long-lived assets, then such assets are written down to their fair value. The Company did not identify any impairment during the years ended December 31, 2021, 2020, and 2019.

Operating Leases

We have operating leases for our corporate office buildings, vehicles, and machinery and equipment. At inception, we determine whether an agreement represents a lease and, at commencement, we evaluate each lease agreement to determine whether the lease constitutes an operating or financing lease.

On January 1, 2019, the Company adopted ASU No.2016-02, applying the package of practical expedients to leases that commenced before the effective date whereby the Company elected to not reassess the following: (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The Company also elected, for all classes of underlying assets, to not separate non-lease components from lease components and instead to account for them as a single component. Non-lease components consist of common area maintenance payments for most real estate leases, which are determined based on costs incurred by the lessor. Many of the Company’s leases include base rental periods coupled with options to renew or terminate the lease, generally at the Company’s discretion.  In evaluating the lease term, the Company considers whether renewal is reasonably certain.  To the extent a significant economic incentive exists to renew the lease, the option is included within the lease term.  Based on the Company’s leases, renewal options generally do not provide a significant economic incentive and are therefore excluded from the lease term.

Adoption of ASU No.2016-02 did not have a material impact on the Company’s cash flows from operations or the Company’s operating results. The most significant impact was the recognition of operating lease right-of-use assets and operating lease liabilities on our balance sheet. Lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, we utilize the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Operating lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms.

Employee Retention Tax Credit Receivable

The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) included an Employee Retention Tax Credit (“ERTC”) provision designed to encourage employers to keep employees on their payroll.  The ERTC is a refundable tax credit against certain payroll taxes paid by employers for eligible wages.  We assessed the government assistance in accordance with Topic 958-605,Not for Profit Entities-Revenue Recognition, and concluded it represents a conditional non-exchange transaction that is recognized when the conditions have been substantially met. During the year ended December 31, 2021, we submitted an ERTC refund for $1.3 million and recorded the amount into Other Income (Expense) on the consolidated statements of operations and comprehensive loss. The Company believes the relevant conditions of the employee retention credit provision of the CARES Act have been substantially met and that it will receive the credit.

Notes Payable Payroll Protection Program

The Company’s policy is to account for forgivable loans received through the U.S. Small Business Administration (the “SBA”) under the CARES Act Payroll Protection Program (“PPP”), as debt in accordance with ASC 805, “Business Combinations.” ASC 805 requires, among470, Debt, and other things,related accounting pronouncements. The forgiveness of debt, in whole or part, is recognized once the debt is extinguished, which occurs when the Company is legally released from the liability by the SBA. Any portion of debt forgiven, adjusted for accrued interest forgiven and unamortized debt issuance costs, is recorded as a gain on extinguishment of debt, and presented in the consolidated statements of operations and comprehensive loss. On June 10, 2021, the Company received notification from the SBA that the principal amount of its PPP loan of $2.8 million and related interest had been forgiven.

Contingent Consideration

Contingent consideration 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, future Euro-to-USD exchange rates, 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 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.

59

On September 21, 2015, the Company completed the strategic acquisition, through its wholly owned subsidiary TransEnterix International, from Sofar S.p.A., an Italian company (“Sofar”), of all of the assets, employees and contracts related to the advanced robotic system for minimally invasive laparoscopic surgery now known as the Senhance System. Under the terms of the Purchase Agreement, as amended in 2016, as of December 31, 2021, the Company has accrued $2.4 million of estimated fair value of remaining contingent consideration related to a milestone of €15.0 million which shall be payable upon achievement of trailing revenues from sales or services contracts of the Senhance System of at least €25.0 million over a calendar quarter or in the event that (i) the Company or Asensus International is acquired, and liabilities assumed be recognized(ii) the Company significantly reduces or suspends selling efforts of the Senhance System, or (iii) the Company acquires a business that offers alternative products that are directly competitive with the Senhance System.

Warrant Liabilities

The Company’s Series B Warrants (see Note 16) were measured at their fair values, as determined in accordance with ASC 820, “Fair Value Measurements,”value using a simulation model which took into account, as of the acquisition date. For certain assets and liabilities, book value approximates fair value. In addition, ASC 805 establishes that consideration transferred be measured atvaluation date, factors including the closing datecurrent exercise price, the expected life of the acquisitionwarrant, 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 at the then-current market price. Under ASC 805, acquisition-related costs (i.e., advisory, legal, valuationeach reporting period and other professional fees) and certain acquisition-related restructuring charges impacting the target company are expensedchanges in fair value were recognized in the period in which the costs are incurred.consolidated statements of operations and comprehensive loss. The applicationselection of the acquisition method of accountingappropriate valuation model and the inputs and assumptions that are required to determine the valuation requires the Companysignificant judgment and requires management to make estimates and assumptions that affect the reported amount of the related toliability and reported amounts of the estimatedchange in fair values of net assets acquired.

Significant judgmentsvalue. Actual results could differ from those estimates, and changes in these estimates are used during this process, particularly with respect to intangible assets. Therefore, the purchase price allocation to intangible assets and goodwill has a significant impact on future operating results.
Risk and Uncertainties

The Company is subject to a number of risks similar to other similarly-sized companiesrecorded when known. All remaining outstanding Series B Warrants were exercised in the medical device industry. These risks include, without limitation, the Company's ability to continue as a going concern, the historical lack of profitability; the Company’s ability to raise additional capital; the liquidity and capital resources of its partners; 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.
first quarter 2021.

Revenue Recognition

The Company adopted ASC Topic 606, Revenue from Contracts with Customers (the “New Revenue Standard”), on January 1, 2018.

The Company’s revenue consists of product revenue resulting from the sale and lease of systems, systemSenhance Systems, Senhance System components, instruments and accessories, and service revenue. The Company accounts for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. The Company's revenues are measured based on consideration specified in the contract with each customer, net of any sales incentives and taxes collected from customers that are remitted to government authorities.

The Company's systemCompany’s Senhance System sale arrangements generally include a five-year service period; the first year of service is generally free and included in the Senhance System sale arrangement and the remaining four years are generally included at a stated service price.

The Company’s Senhance System sale arrangements generally contain multiple products and services. For these bundledconsolidated sale arrangements, the Company accounts for individual products and services as separate performance obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundledconsolidated package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company’s systemSenhance System sale arrangements may include a combination of the following performance obligations: system(s), system components, instruments, accessories, and system service. The Company’s system saleservices.

For arrangements that contain multiple performance obligations, revenue is allocated to each performance obligation based on its relative estimated standalone selling price. When available, standalone selling prices are based on observable prices at which the Company separately sells the products or services; however due to limited sales to date, standalone selling prices generally include a five years period of service. The first year of service is generally free and included in the system sale arrangement and the remaining four years are generally included at a stated service price.not directly observable. The Company considersestimates the service terms instandalone selling price using the arrangements that are legally enforceablemarket assessment approach considering market conditions and entity-specific factors including, but not limited to, be performance obligations. Other than service, the Company generally satisfies allfeatures and functionality of the performance obligations up-front. System components, system accessories, instruments, accessories,products and service are also sold on aservices, geographies, type of customer, and market conditions. The Company regularly reviews estimated standalone basis.

selling prices and updates these estimates if necessary.

The Company recognizes revenues when or as the performance obligations are satisfied by transferring control of the product or service to a customer. The Company generally recognizes revenue for the performance obligations as follows:

•   System sales. For systemsSenhance Systems and systemSenhance System components sold directly to end customers (including those arising from Senhance System purchases under lease rights to purchase), revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. For systemslease buyouts, where the customer has already acknowledged installation of the system, transfer of control occurs when the Company receives an executed contract for the lease buyout of the Senhance System. For Senhance Systems sold through distributors, for which distributors are responsible for installation, revenue is recognized generally at the time of shipment. The Company’s systemSenhance System arrangements generally do not provide a right of return. The systemsSenhance Systems are generally covered by a one-yearone-year warranty. Warranty costs were not material for the periods presented.

60

•   Instruments and accessories. Revenue from sales of instruments and accessories is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but also occurs at the time of delivery depending on the customer arrangement. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products such as replacement endoscopes, camera heads, light guides, and other items that facilitate use of the Senhance System.

•   Service. Service revenue is recognized ratably over the term of the service period as the customers benefit from the service throughout the service period. Revenue related to services performed on a time-and-materials basis is recognized when performed.

For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services. Due to limited sales to date, standalone selling prices are not directly observable. The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer, and market conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.

The following table presents revenue disaggregated by type and geography:


 Year Ended
December 31,
 2019 2018
 (in thousands)
U.S.   
Systems$90
 $2,556
Instruments and accessories108
 967
Services338
 255
Total U.S. revenue536
 3,778
    
Outside of U.S. ("OUS")   
Systems5,459
 16,193
Instruments and accessories1,447
 3,552
Services1,089
 579
Total OUS revenue7,995
 20,324
    
Total   
Systems5,549
 18,749
Instruments and accessories1,555
 4,519
Services1,427
 834
Total revenue$8,531
 $24,102

  

Years Ended December 31,

 
  

2021

  

2020

  

2019

 
  

(in thousands)

 

U.S.

            

Systems

 $380  $282  $90 

Instruments and accessories

  270   187   108 

Services

  383   380   338 

Total U.S. revenue

  1,033   849   536 
             

Outside of U.S. ("OUS")

            

Systems

  4,363   490   5,459 

Instruments and accessories

  1,699   653   1,447 

Services

  1,137   1,183   1,089 

Total OUS revenue

  7,199   2,326   7,995 
             

Total

            

Systems

  4,743   772   5,549 

Instruments and accessories

  1,969   840   1,555 

Services

  1,520   1,563   1,427 

Total revenue

 $8,232  $3,175  $8,531 

The Company recognizes sales by geographic area based on the country in which the customer is based.

Operating lease revenue from Senhance System leasing is included as Systems revenues in the above table and was approximately $1.3 million, $0.7 million, and $0 million in the years ended December 31, 2021, 2020 and 2019, respectively.

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 was approximately $3.0 million, $3.1 million, and $3.7 million as of December 31, 2019.

2021, 2020, and 2019, respectively. The amounts as of December 31, 2021 are expected to be recognized as revenue over one to five years.

The Company invoices its customers based on the billing schedules in its sales arrangements. Payments are generally due 30 to 60 days from the date of invoice. 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. Contract assets are included in accounts receivable and totaled $0.2$0.1 million and $0.2$0.1 million as of December 31, 2019 2021 and 2018,2020, respectively. 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 fromfor the years ended December 31, 2021, 2020 and 2019 that was included in the deferred revenue attributable to warrantybalance at the beginning of each reporting period was $0.6 million, $0.6 million and maintenance agreements totaled $1.0 million, for the year ended December 31, 2019. The Company also recognized $1.3 million during the year ended December 31, 2019, half of which was deferred at December 31, 2018, related to a 2017 system sale where revenue was deferred until its first clinical use, which occurred in the second quarter of 2019. Revenue recognized from deferred revenue for the year ended December 31, 2018 totaled $0.4 million.

respectively.

In connection with assets recognized from the costs to obtain a contract with a customer, the Company determined that the sales incentive programs for its sales team do not meet the requirements to be capitalized as the Company does not expect to generate future economic benefits from the related revenue from the initial sales transaction. transaction and such costs are expensed as incurred.

Senhance System Leasing

The Company enters into 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 right to purchase the leased Senhance System at some point during and/or at the end of the lease term. In some arrangements lease payments are based on the usage of the Senhance System.

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In determining whether a transaction should be classified as a sales-type, operating, or direct financing lease, the Company considers the following terms at lease commencement: (1) whether title of the Senhance System transfers automatically or for a nominal fee by the end of the lease term, (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased Senhance System, (3) whether the lease term is for the major part of the remaining economic life of the leased System, (4) whether the lease grants the lessee an option to purchase the leased Senhance System that the lessee is reasonably certain to exercise, and (5) whether the underlying Senhance System is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term. All such arrangements through December 31, 2021 are classified as operating leases.

Revenue related to lease elements from operating lease arrangements is generally recognized on a straight-line basis over the lease term or based upon Senhance System usage and is presented as product revenue. Revenue related to lease elements from operating lease arrangements was approximately $1.3 million, $0.7 million, $0 million for the years ended December 31, 2021, 2020 and 2019, respectively.

Cost of Revenue

Cost of revenue consists of contract manufacturing, materials, labor and manufacturing overhead incurred internally to produce the products. Depreciation expense related to leased systems is included in the cost of revenue. Shipping and handling costs incurred by the Company are included in the cost of revenue.  During the year ended December 31, 2019, the Company recorded a $7.4 million inventory write-down as part of a restructuring plan and a $1.5 million charge forWe expense all inventory obsolescence related to certain system components.

provisions as cost of revenue.

Research and Development Costs

Research and development expenses primarily consist of engineering, product development and regulatory expenses, incurred in the design, development, testing and enhancement of our products. Research and development costs are expensed as incurred.

Reversal of Transfer Fee Accrual

In connection with the Senhance acquisition, the Company recorded an accrual of $3.0 million in the 2015 third quarter for the potential assessment of additional transfer fees that could be assessed during a three year period. In September 2018, the Company determined that the accrual was no longer required and reversed the accrual.

Stock-Based Compensation

The Company follows ASC 718 “Stock Compensation”, which provides guidance in accountingrecognizes expenses for share-based awards exchanged for services rendered and requires companiesequal to expense the estimated fair value of these awards over the requisite service period.

The Company recognizes as expense, the grant-date fair value of stock options and other stock-based compensation expense for stock-based awards based on estimated fair values onissued to employees and non-employee directors over the date of grant for awards.requisite service periods, which are typically the vesting periods. The Company uses the Black-Scholes-Merton option pricing model to determineestimate the fair value of stock options. The volatility assumption used in the Black-Scholes-Merton model is based on the Company’s historical volatility. The expected term of options granted has been determined based upon the simplified method, because the Company does not have sufficient historical information regarding its options to derive the expected term. Under this approach, the expected term is the mid-point between the weighted average of vesting period and the contractual term. The risk-free interest rate is based on U.S. Treasury rates whose term is consistent with the expected life of the stock options. The Company has not paid and does not anticipate paying cash dividends on its shares of common stock; therefore, the expected dividend yield is assumed to be zero. The Company estimates forfeitures based on its historical experience and adjust the estimated forfeiture rate based upon actual experience. For awards with performance conditions, we begin recognizing compensation expense when it becomes probable that the performance condition will be attained.

The fair value of restricted stock units is determined by the market price of the Company’s common stock on the date of grant. The expense associated with stock-based compensation is recognized on a straight-line basis over the requisite service period of each award.

The Company records as expense the fair value of stock-based compensation awards, including stock options and restricted stock units. Compensation expense for stock-based compensation was approximately $11,508,000$9.4 million, $7.9 million, and $9,039,000$11.5 million for the years ended December 31, 20192021,2020, and 2018,2019 respectively.

Income Taxes

The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets or liabilities for the temporary differences between financial reporting and tax basis of the Company’s assets and liabilities, and for tax carryforwards at enacted statutory rates in effect for the years in which the asset or liability is expected to be realized. The effect on deferred taxes of a change in tax rates is recognized in income during the period that includes the enactment date. In addition, valuation allowances are established when necessary to reduce deferred tax assets and liabilities to the amounts expected to be realized.

On December 22, 2017, the Tax Cuts and Jobs Act (“Tax Legislation”) was enacted into law, which reduced the U.S. federal corporate income tax rate to 21% for tax years beginning after December 31, 2018. As a result of the newly enacted tax rate, the Company adjusted its U.S. deferred tax assets as of December 31, 2018, by applying the new 21% rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $36.1 million, resulting in no impact to the consolidated statement of operations and comprehensive loss.
The Tax Legislation also implements a territorial tax system. Under the territorial tax system, in general, the Company's foreign earnings will no longer be subject to tax in the U.S. As part of transition to the territorial tax system the Tax Legislation includes a mandatory deemed repatriation of all undistributed foreign earnings that are subject to a U.S. income tax. The Company has determined that the deemed repatriation applicable to the year ended December 31, 2018 did not result in an additional U.S. income tax liability as it has no undistributed foreign earnings.
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 GILTIglobal intangible low-taxed income (“GILTI”) as a period expense in the year the tax is incurred.
In a referendum held on May, 19 2019, Swiss voters adopted

The Company recognizes the Federal Act on Tax Reform and AVS Financing (TRAF). TRAF introduces major changesfinancial statement benefit of an income tax position only after determining that the relevant taxing authority would more likely than not sustain the position following audit. For tax positions meeting the more likely than not threshold, the amount recognized in the Swissfinancial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant taxing authority. The Company recognizes interest accrued related to unrecognized tax system by abolishing certain current preferentialbenefits and penalties in the provision for income taxes.

Tax regulations within each jurisdiction are subject to the interpretation of the related tax regimeslaws and replacing them with new measures that are in line with international standards.regulations and require application of significant judgment. The referendum did not have a material impact onCompany is subject to U.S. federal and various state, local and foreign jurisdictions. Due to the Company’s 2019net operating loss carryforwards, the Company may be subject to examination by authorities for all previously filed income tax provision. Thereturns.

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Revision of Previously Disclosed Amounts

During the course of preparing the Company’s consolidated financial statements as of and for the year ended December 31 2021, the Company will continuecompleted an Internal Revenue Code Section 382 and 383 analysis of its historical net operating loss and tax credit carryforward amounts. As a result, a portion of the prior year net operating loss and tax credit carryforwards were determined to evaluate the impact of these provisions in future periods as the enactment process in completed.

be limited. See Note 11—Income Taxes, for further details. 

Comprehensive Loss

Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources.

Segments

The Company operates in 1one 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.

Approximately 19%77% and 54%27% of the Company’s total consolidated assets are located within the U.S. as of December 31, 20192021 and 2018,2020, respectively. The remaining assets are mostly located in Europe and are primarily related to the Company’s facility in Italy, and include goodwill (as of December 2018 only), intellectual property, in-process research and development, other current assets, property and equipment, cash, accounts receivable, other long-term assets and inventory of $60.5$43.2 million and $111.0$56.8 million at as of December 31, 2019 2021 and 2018.2020, respectively. Total assets outside of the U.S. excluding goodwillUnited States amounted to 81%23% and 34%73% of total consolidated assets at December 31, 2019 2021 and 2018,2020, respectively. Long-lived assets in the U.S. were 63% and 11%, Switzerland were 22% and 41%, and Italy were 13% and 48%, as of December 31, 2021 and 2020, respectively.

The Company recognizes sales by geographic area based on the country in which the customer is based. For the years ended December 31, 20192021, 2020 and 2018,2019, 13%, 27% and 6% and 16%, respectively, of net revenue werewas generated in the United States; 39%while 62%, 53% and 78% were39%, respectively, was generated in Europe; and 55%25%, 20%, and 6% were55%, respectively, was generated in Asia.

For the year ended December 31, 2021, 47% of net revenue was generated in Germany, 22% was generated in Japan, and 13% was generated in the United States. For the year ended December 31, 2020, 28% of net revenue was generated in Germany, 27% was generated in the Untied States, 10% was generated in Japan, and 10% was generated in Taiwan. For the year ended December 31, 2019, 53% of net revenue was generated in Taiwan, and 23% was generated in Germany.

Impact of Recently Issued Accounting Standards

In August 2018, December 2019, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes2019-12, Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the Disclosure Requirements for Fair Value Measurement.general principles in ASC 740, Income Tax and also clarifies and amends existing guidance to improve consistent application. The Company adopted ASU 2019-12 effective January 1, 2021; the adoption did not result in a material impact on the Company's financial statements and related disclosures.

In June 2016, the 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. When determining such expected credit losses, the guidance requires companies to apply a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. This ASU eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. The standardguidance is effective for all entities for financial statements issuedon a modified retrospective basis for fiscal years beginning after December 15, 2019, and2022, including interim periods within those fiscal years. Early adoptionThe guidance is permitted. The adoption of this ASU should not expected to have a material impact on the consolidatedCompany's financial statements.

statements and related disclosures.

In June 2018, August 2020, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-based Payments. This ASU expands the scope of Topic 718 to include share-based payment transactions for acquiring goods2020-06 Debt – Debt with Conversion and services from non-employees. The Company adopted ASU 2018-07Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (subtopic 815-40) guidance on January 1, 2019, whereby the accounting for share-based paymentsconvertible debt instruments and contracts in an entity’s own equity. The guidance simplifies the accounting for non-employeesconvertible instruments by reducing the various accounting models that can require the instrument to be separated into a debt component and employees willequity component or derivative component. Additionally, the guidance eliminated certain settlement conditions previously required to be substantiallyable to classify a derivative in equity. The new guidance is effective on a modified or full retrospective basis for fiscal years beginning after December 15, 2021, including interim periods with those fiscal years. The Company is currently evaluating the same. Withimpact on the consolidated financial statements upon adoption.

The Company has evaluated all other issued and unadopted ASUs and believes the adoption of ASU 2018-07, the Company recorded a charge to accumulated deficit of $7 thousand.

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. The amendments in this update are intended to simplify the accounting for certain equity-linked financial instruments and embedded features with down round features that result in the strike price being reduced on the basis of the pricing of future equity offerings. Under the new guidance, a down round featurethese standards will no longer need to be considered when determining whether certain financial instruments or embedded features should be classified as liabilities or equity instruments. That is, a down round feature will no longer preclude equity classification when assessing whether an instrument or embedded feature is indexed to an entity's own stock. In addition, the amendments clarify existing disclosure requirements for equity-classified instruments. These amendments are effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The adoption of this ASU did not have a material impact on the consolidated financial statements.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic (842), which establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for most leases. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842), Targeted Improvements, which amends the guidance to add a method of adoption whereby the issuer may elect to recognize a cumulative effect adjustment at the beginning of the period of adoption. ASU 2018-11 Leases (Topic 842), Targeted Improvements, does not require comparative period financial information to be adjusted. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement.
ASU 2016-02 defines a lease as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period of time in exchange for consideration. To determine whether a contract conveys the right to control the use of the identified asset for a period of time, the customer has to have both (i)the right to obtain substantially all of the economic benefits from the use of the identified asset and (ii)the right to direct the use of the identified asset. A contract does not contain an identified asset if the supplier has a substantive right to substitute such asset ("the leasing criteria"). As part of the adoption of ASC 842, the Company performed an assessment of the impact that the new lease recognition standard will have on its consolidated financial statements. The Company’s leases relate to office equipment, company owned vehicles and corporate offices, all of which are classified as operating leases and include fixed payments. The Company does not have any material leases, individually or in the aggregate, classified as a finance leasing arrangement under the new lease recognition standard.
On January 1, 2019, the Company adopted ASU No. 2016-02, applying the package of practical expedients to leases that commenced before the effective date whereby the Company elected to not reassess the following: (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The Company also elected, for all classes of underlying assets, to not separate non-lease components from lease components and instead to account for them as a single component.  The Company elected to apply the transition provisions as of January 1, 2019, the date of adoption, using the effective date approach, and recorded lease ROU assets and related liabilities on its balance sheet

without restating prior periods.  Many of the Company’s leases include base rental periods coupled with options to renew or terminate the lease, generally at the Company’s discretion.  In evaluating the lease term, the Company considers whether renewal is reasonably certain.  To the extent a significant economic incentive exists to renew the lease, the option is included within the lease term.  Based on the Company’s leases, renewal options generally do not provide a significant economic incentive and are therefore excluded from the lease term. The ROU asset is included in other long-term assets on the consolidated balance sheets.  The current portion of operating lease liabilities are presented within accrued liabilities while the non-current portion of operating lease liabilities are presented within other long term liabilities on the consolidated balance sheets and represents the present value of the remaining lease payments, discounted using the Company’s incremental borrowing rate, which ranges between 6.1% and 8.5% based on the terms of the lease.  The weighted average discount rate as of December 31, 2019 was 7.8%. As a result of the adoption of ASU 2016-02, other long-term assets increased by $1.8 million, accrued expenses increased by $0.5 million, and other long-term liabilities increased by $1.2 million. There was no change to the Company’s consolidated statements of operations and comprehensive loss, balance sheets, or cash flows as a result of the adoption of ASU 2016-02.
As of December 31, 2019, the right-of-use asset totaled $2.3 million and is included within other long term assets on the consolidated balance sheet and the lease liability totaled $2.5 million, of which $1.1 million is classified as current within accrued expenses and $1.4 million is classified as non-current and makes up the full balance of other long term liabilities on the consolidated balance sheet.  Operating lease costs for the year ended December 31, 2019 totaled $1.4 million and are included within operating expenses in the consolidated statement of operations and comprehensive loss. Rent expense for the year ended December 31, 2018 was approximately $1.2 million. The weighted average remaining lease term for operating leases as of December 31, 2019 was 2.6 years. Total cash paid for operating leases during the year ended December 31, 2019 was $1.7 million and is included within cash flows from operating activities within the consolidated statementstatements of cash flows.

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3.Acquisitions

MST Medical Surgery Technologies Ltd. Acquisition

On September 23,2018, the Company entered into an Asset Purchase Agreement (the “MST Purchase Agreement”) with MST Medical Surgery Technologies Ltd., an Israeli private company (the “Seller”), and two of the Company’s wholly owned subsidiaries, as purchasers of the assets of the Seller, (collectively, the “Buyers”). The closing of the transactions occurred on October 31, 2018, pursuant to which the Company acquired the Seller’s assets consisting of intellectual property and tangible assets related to surgical analytics with its core image analytics technology designed to empower and automate the surgical environment, with a focus on medical robotics and computer-assisted surgery. The core technology acquired under the MST Purchase Agreement is a software-


basedsoftware-based image analytics information platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

Under the terms of the MST Purchase Agreement, at the closing the Buyers purchased substantially all of the assets of the Seller.MST. The acquisition price consisted of two tranches. At or prior to the closing of the transaction the Buyers paid $5.8 million in cash and the Company issued approximately 242,310 shares of the Company’s common stock (the "Initial Shares"). A second tranche of $6.6$6.6 million in additional consideration was payable in cash, stock or cash and stock, at the discretion of the Company, within one year after the closing date. On August 7, 2019, the Company notified MST that the Company would satisfy the additional consideration payment of $6.6 million by issuing shares of TransEnterixthe Company’s common stock. The number of shares issued to MST was 370,423 (the “Additional Consideration Shares” and, together with the Initial Shares, the “Securities Consideration”).

The MST Purchase Agreement contains customary representations and warranties of the parties and the parties have customary indemnification obligations, which are subject to certain limitations described further in the MST Purchase Agreement.
In connection with the closing under the MST Purchase Agreement (the “MST Acquisition”), the Company and the Seller entered into a Lock-Up Agreement, dated October 31, 2018, pursuant to which the Seller agreed, subject to certain exceptions, not to sell, transfer or otherwise convey any of the Initial Shares for six months following the Closing Date.  As of the date of this report, 75% of the Initial Shares are free from the lock-up restrictions. For the remaining 25% of the Initial Shares, the Lock-Up Agreement provides that all of the Initial Shares will be released from the lock-up restrictions on May 1, 2020, or earlier upon certain other conditions.  The Additional Consideration Shares were released from the lock-up restrictions on February 7, 2020.  
In connection with the MST Acquisition, the Company also entered into a Registration Rights Agreement, dated as of October 31, 2018, with MST, pursuant to which the Company agreed to register the Securities Consideration such that such Securities Consideration is eligible for resale following the end of the lock-up periods described above. All of the Securities Consideration is eligible to be sold by the holders without restriction under Rule 144, therefore the Registration Rights Agreement has expired. The MST Purchase Agreement was accounted for as a business combination utilizing the methodology prescribed in ASC 805. The purchase price for the acquisition was allocated to the assets acquired and liabilities assumed based on their estimated fair values.
The following table summarizes the acquisition date fair value of the consideration (in thousands).
Stock consideration$8,300
Cash consideration5,800
Present value of deferred consideration5,900
Other consideration314
Total consideration$20,314

The value of the stock consideration was determined based on the fair value of the stock on the closing date, adjusted for a lack of marketability discount related to the Lock-Up Agreement.  The value of the deferred consideration was determined based on the present value of the future payment using a market interest rate.
The following table summarizes the estimated fair values of the assets acquired and liabilities assumed on October 31, 2018, the date of acquisition (in thousands):
Property and equipment$43
In-process research and development10,633
Goodwill9,638
Net assets acquired$20,314

The Company allocated $10.6 million of the purchase price to identifiable intangible assets of in-process research and development that met the separability and contractual legal criterion of ASC 805. IPR&D is principally the estimated fair value of the MST technology which had not reached commercial technological feasibility nor had alternative future use at the time of the acquisition and therefore the Company considered IPR&D, with assigned values to be allocated to the IPR&D assets acquired.
Goodwill is calculated as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired and liabilities assumed. The goodwill resulting from this acquisition arises largely from synergies expected

from combining the intellectual property acquired from MST with the Company’s existing intellectual property as well as acquired employees. The goodwill is deductible for income tax purposes.
The following unaudited pro forma information presents the combined results of operations for the year ended December 31, 2018, as if the Company had completed the MST Acquisition at the beginning of fiscal 2018. The pro forma financial information is provided for comparative purposes only and is not necessarily indicative of what actual results would have been had the acquisition occurred on the date indicated, nor does it give effect to synergies, cost savings, fair market value adjustments, and other changes expected to result from the acquisition. Accordingly, the pro forma financial results do not purport to be indicative of consolidated results of operations as of the date hereof, for any period ended on the date hereof, or for any other future date or period. The pro forma consolidated financial information has been calculated after applying the Company’s accounting policies and includes adjustments for transaction-related costs.
 Year Ended December 31,
 2018
 
(In thousands except
per share amounts)
(unaudited)
Revenue$24,170
Net loss(64,365)
Net loss per share$(0.31)

During the year ended December 31, 2018 0 revenue and a net loss of $0.4 million associated with MST’s operations are included in the consolidated financial statements.

On July 3, 2019, the Company entered into a System Sale Agreement with GBIL to sell certain assets related to the AutoLap technology. On October 15, 2019, the Company amended the prior AutoLap Sale Agreement with GBIL. Pursuant to the amended agreement the Company sold the AutoLap laparoscopic vision system, or AutoLap, and related assets to GBIL. The assets include inventory, spare parts, production equipment, testing equipment and certain intellectual property specifically related to the AutoLap. The purchase price was $17.0 million, all of which was received in 2019 in the form of $16 million in cash and a commitment by GBIL to pay $1.0 million to settle certain Company obligations in China. GBIL subsequently paid the obligation. Under the amended AutoLap Agreement, the Company entered into a cross‑license agreement with GBIL to retain rights to use any AutoLap-related intellectual property sold to GBIL, and to non-exclusively license additional intellectual property to GBIL. The Company recorded a $16.0 million gain on the sale of the AutoLap assets during the year ended December 31, 2019, which represented the proceeds received in excess of the carrying value of the assets, less contract costs.

Senhance Surgical Robotic System

On September 21,2015, the Company completed the strategic acquisition, through its wholly owned subsidiary TransEnterix International, from Sofar, of all of the assets, employees and contracts related to the advanced robotic system for minimally invasive laparoscopic surgery now known as the Senhance System.

Under the terms of the Purchase Agreement, the consideration consisted of the issuance of (i) 1,195,647 shares of the Company’s common stock (the “Securities Consideration”) and (ii) approximately $25.0 million U.S. Dollars and €27.5 million Euro in cash consideration (the “Cash Consideration”).
On February 25, 2021, TransEnterix International changed its name to Asensus International.

On December 30,2016, the Company and Sofar entered into an Amendment to the Purchase Agreement (the “Amendment”) to restructure the terms of the second tranche of the Cash Consideration (the “Second Tranche”). The initial Securities Consideration was issued in full at the closing of the Senhance Acquisition; under the Amendment, the Second Tranche of the Cash Consideration was restructured, and an additional issuance of 286,360 shares of the Company’s common stock with an aggregate fair market value of €5.0 million occurred in January 2017.terms. Following the Amendment, the total Cash Consideration was $25.0 million U.S. Dollars and approximately €22.5 million Euro, of which all but €15.1 million Euro has been paid as of December 31, 2019.  The majority of the remaining Cash Consideration to be paid is the third tranche of the Cash Consideration (the “Third Tranche”) of €15.0€15.0 million which shall be payable upon achievement of trailing revenues from sales or services contracts of the Senhance System of at least €25.0€25.0 million over a calendar quarter.

The fourth tranche of the Cash Consideration of €2.5 million was payable in installments by December 31 of each year as reimbursement for certain debt payments made by Sofar under an existing Sofar loan agreement in such year, with payments beginning as of December 31, 2017. As of December 31, 2019, the Company had paid €2.4 million of the fourth tranche.

The Third Tranche payments will be accelerated in the event that (i) the Company or TransEnterixAsensus International is acquired, (ii) the Company significantly reduces or suspends selling efforts of the Senhance System, or (iii) the Company acquires a business that offers alternative products that are directly competitive with the Senhance System. The remaining amounts due to Sofar are included in contingent consideration as of December 31, 20192021 and 2018.2020 at their estimated fair value.

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The Purchase Agreement contains customary representations

4.Cash, Cash Equivalents, and warranties of the parties and the parties have customary indemnification obligations, which are subject to certain limitations described further in the Purchase Agreement.

4.Cash, Cash Equivalents, and Restricted Cash
Restricted Cash

Cash, cash equivalents and restricted cash consist of the following:

 December 31,
2019
 December 31,
2018
 (In thousands)
Cash$9,596
 $1,485
Money market2
 19,576
Total cash and cash equivalents$9,598
 $21,061
Restricted cash969
 590
Total$10,567
 $21,651

  

December 31,

  

December 31,

 
  

2021

  

2020

 
  

(in thousands)

 

Cash

 $8,343  $6,679 

Money Market

  5,287   9,684 

Commerical Paper

  4,499   0 

Total cash and cash equivalents

 $18,129  $16,363 

Restricted Cash

  1,154   1,166 

Total

 $19,283  $17,529 

Restricted cash at December 31, 20192021 and 20182020 includes $1.0$1.2 million and $0.6$1.2 million, respectively, in cash accounts held as collateral primarily under the terms of an office operating lease, credit cards, automobile leases, and a performance guarantee required by the government of a country in which a Senhance System was sold in 2018.

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 income are as follows:

  

December 31, 2021

 
  

(in thousands)

 
                         
  

Amortized

Cost

  

Unrealized

Gain

  

Unrealized

Loss

  

Fair Value

  

Short-term

investments

  

Long-term

investments

 

Commerical Paper

 $50,705  $0  $(46) $50,659  $50,660  $0 

Corporate Bonds

  67,239   1   (202)  67,038   29,602   37,435 

Total Investments

 $117,944  $1  $(248) $117,697  $80,262  $37,435 

The following table summarizes the contractual maturities of the Company’s available-for-sale investments, as of December 31, 2021:

  

Amortized

Cost

  

Fair Value

 

Mature in less than one year

 $80,336  $80,262 

Mature in one to two years

  37,608   37,435 

Total

 $117,944  $117,697 

Actual maturities may differ from contractual maturities because certain borrowers have the right to call or prepay certain obligations. There were 0 sales of investments or gross realized gains for the years ended December 31, 2021, 2020 and 2019, respectively. The Company recorded an immaterial amount of gross realized losses for the year ended December 31, 2021 related to the maturity of investments.

5.Fair Value

6.Fair Value

The Company held certain assets and liabilities that are required to be measured at fair value on a recurring basis. These assets and liabilities include cash and cash equivalents, restricted cash, contingent consideration and warrant liabilities. ASC 820-10820-10 (“Fair Value Measurement Disclosure”) requires the valuation using a three-tieredthree-tiered approach, which requires that fair value measurements be classified and disclosed in one of three tiers. These tiers are: Level 1, defined as quoted prices in active markets for identical assets or liabilities; Level 2, defined as valuations based on observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable input data; and Level 3, defined as valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. The Company did not have any transfers of assets and liabilities between Level 1, Level 2, and Level 3 of the fair value hierarchy during the years ended December 31, 20192021 and 2018.2020.

65

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data and therefore, are based primarily upon estimates, are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, the results cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique, and changes in the underlying assumptions used, including revenue volatility, discount rates and estimates of future cash flows, could significantly affect the results of current or future values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

As prescribed by U.S. GAAP, the Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy.

The determination of where an asset or liability falls in the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures and based on various factors, it is possible that an asset or liability may be classified differently from period to period. However, the Company expects changes in classifications between levels will be rare.


The carrying values of accounts receivable, short-term investments, interest receivable,other current assets, accounts payable, and certain accrued expenses at as of December 31, 2019 2021 and 2018,2020 approximate their fair values due to the short-term nature of these items. The Company’s notes payable balance also approximates fair value as of December 31, 2018, 2020, as the interest rate on the notes payable approximates the rates available to the Company as of this date.

The following are the major categories of assets and liabilities measured at fair value on a recurring basis as of December 31, 20192021 and 2018,2020, using quoted prices in active markets for identical assets (Level 1)1); significant other observable inputs (Level 2)2); and significant unobservable inputs (Level 3)3):

  

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  $0  $0  $18,129 

Restricted cash

  1,154   0   0  $1,154 

Short-term investments

  0   80,262   0  $80,262 

Long-term investments

  0   37,435   0  $37,435 

Total assets measured at fair value

 $19,283  $117,697  $0  $136,980 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $2,371  $2,371 

Total liabilities measured at fair value

 $0  $0  $2,371  $2,371 

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

  

December 31, 2020

 
  

(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

 $16,363  $0  $0  $16,363 

Restricted cash

  1,166   0   0   1,166 

Total assets measured at fair value

 $17,529  $0  $0  $17,529 

Liabilities measured at fair value

                

Contingent consideration

 $0  $0  $3,936  $3,936 

Warrant liabilities

  0   0   255   255 

Total liabilities measured at fair value

 $0  $0  $4,191  $4,191 

66
 December 31, 2019
 
(In thousands)
(unaudited)
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$9,598
 $
 $
 $9,598
Restricted cash969
 
 
 969
Total Assets measured at fair value$10,567
 $
 $
 $10,567
Liabilities measured at fair value       
Contingent consideration$
 $
 $1,084
 $1,084
Warrant liabilities
 
 2,388
 2,388
Total liabilities measured at fair value$
 $
 $3,472
 $3,472

 December 31, 2018
 (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$21,061
 $
 $
 $21,061
Restricted cash590
 
 
 590
Total Assets measured at fair value$21,651
 $
 $
 $21,651
Liabilities measured at fair value       
Contingent consideration$
 $
 $10,637
 $10,637
Warrant liabilities
 
 4,636
 4,636
Total liabilities measured at fair value$
 $
 $15,273
 $15,273

The Company’s financial liabilities consisted of contingent consideration potentially payable to Sofar related to the Senhance Acquisition in September 2015 (Note 3)3). This liability is reported as Level 3 as estimated fair value of the contingent consideration related to the acquisition requires significant management judgment or estimation and is calculated using a Monte-Carlo simulation utilizing significant unobservable inputs including the income approach, usingprobability of achieving each of the potential milestones, future Euro-to-USD exchange rates, revenue volatility and an estimated discount rate associated with the risks of the expected cash flows attributable to the various revenue and cost assumptions and applying a probability to each outcome.milestones. The decrease in fair value of the contingent consideration of $1.6 million for the year ended December 31,2021 was primarily due to changes in the Company's forecast of future revenue. The increase in fair value of the contingent consideration of $2.9 million for the year ended December 31, 2020 was primarily due to lower discount rate, stronger Euro versus the U.S. dollar, and the passage of time. The decrease in the fair value of the contingent consideration of $9.6 million for the year ended December 31, 2019 was primarily due to a change in the Company's long-term forecast.  The decrease in fair value of the contingent consideration of $1.0 million for the year ended December 31, 2018 was primarily due to the impact of foreign currency exchange rates and changeschange in the Company's long-range forecast.Company’s forecast of future revenue. Adjustments associated with the change in fair value of contingent consideration are included in the Company’s 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 as of December 31,2021 and 2020:

     

December 31,

 
 

Valuation
Methodology

 

Significant
Unobservable
Input

 

2021

  

2020

 
            

Contingent consideration

Probability
weighted income
approach

 

Milestone dates

 

 

2031  

 

2025 
   

Discount rate

  9.5%   9.5% 
   

Revenue volatility

  39.0%   71.0% 

On April 28, 2017, the Company sold 24.9 million units (the “Units”), each consisting of approximately 0.077 shares of the Company's Common Stock, a Series A warrant to purchase approximately 0.077 shares of Common Stock with an exercise price of $13.00 per share (the “Series A Warrants”), and a Series B warrant to purchase approximately 0.058 shares of Common Stock with an exercise price of $13.00 per share (the “Series B Warrants,” together with the Series A Warrants, the “Warrants”), at an offering price of $1.00 per Unit. Each Series A Warrant was exercisable at any time beginning on the date of issuance, and from time to time thereafter, through and including the first anniversary of the issuance date, unless terminated earlier as provided in the Series A Warrant. Receipt of 510(k) clearance for the Senhance System on October 13, 2017 triggered the acceleration of the expiration date of the Series A Warrants to October 31, 2017 (see Note 16). As such, allAll of the Series A Warrants were exercised


prior to the expiration date. Eachdate of October 31, 2017. On February 24, 2020, the Company entered into a Series B Warrants Exchange Agreement (the “Exchange Agreement”) with certain holders of its unexercised Series B Warrants. Under the terms of the Exchange Agreement, each Series B Warrant may be exercised at any time beginning onwas canceled in exchange for 0.61 shares of common stock. The Warrant holders participating in the date of issuance and from time to time thereafter through and including the fifth anniversaryexchange held 3,373,900 of the issuance date.
The fair value of the Series A Warrants of $2.5 million at the date of issuance was estimated using the Black-Scholes Merton model which used the following inputs: term of 1 year, risk free rate of 1.07%, 0 dividends, volatility of 73.14%, and share price of $8.45 per share based on the trading price of the Company’s Common Stock. All Series A Warrants were exercised as of October 31, 2017.
The exercise prices and the number of shares issuable upon exercise of each of the3,638,780 Series B Warrants are subject to adjustment uponthen outstanding and received an aggregate of 2,040,757 shares of common stock. As a result, the occurrence of certain events, including, but not limited to, stock splits or dividends, business combinations, sale of assets, similar recapitalization transactions, or other similar transactions. The Series B warrants contain provisions, often referred to as “down-round protection,” that leads to adjustment ofwarrant liability decreased by $2.5 million and the exercise price and number of underlying warrant shares ifadditional paid in capital increased by the Company issues securities, including its common stock or convertible securities or debt securities, in the future at sale prices below the then-current exercise price.same amount. As a result of thisthe March 2020 Public Offering and adjustment feature, and after giving effect to the Company’s reverse stock split at a ratio of one-for-thirteen shares effective December 11, 2019, or the Reverse Stock Split, the exercise price of all outstanding Series B Warrants has been adjusted to $1.39$0.35 per share and the number of shares of common stock reserved for and issuable upon the exercise of outstanding Series B Warrants has been adjusted to 1,963,451567,660 underlying warrant shares as of December 31, 2019.
2020. The final remeasurement upon exercise of the Series B warrants was recorded during the first quarter of 2021 and all outstanding Series B Warrants were exercised.

The change in fair value of all outstanding Series B warrants for the years ended December 31, 20192021 and 2018 of a decrease of $2.2 million and2020 was an increase of $14.3$2.0 million and $0.3 million, respectively, was included in the Company’s consolidated statements of operations and comprehensive loss. loss and was primarily due to an increase in share price, a lower risk free rate, increased volatility, and the passage of time. The change in the fair value of all outstanding Series B warrants for the year ended December 31, 2019, was a decrease of $2.2 million.

The following table presents the inputs and valuation methodologies used for the Company’s fair value of the Series B warrants:

  

December 31,

  

December 31,

  

December 31,

 

Series B Warrants

 

2021

  

2020

  

2019

 
             

Valuation methodology

 

Black-Scholes-Merton

  

Black-Scholes-Merton

  

Monte Carlo

 

Term (years)

  1.22   1.32   2.32 

Risk free rate

  0.07%  0.10%  1.59%

Dividends

  0   0   0 

Volatility

  174.00%  150.97%  109.80%

Share price

 $4.21  $0.63  $1.47 

67

Series B December 31, 2019 December 31, 2018
Fair value $2.4 million $4.6 million
Valuation methodology Monte Carlo Monte Carlo
Term 2.32 years 3.32 years
Risk free rate 1.59% 2.47%
Dividends  
Volatility 109.80% 87.60%
Share price $1.47 $29.38
Probability of additional financing 100% in 2020 100% in 2019
The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements for contingent consideration as
Valuation
Methodology
Significant
Unobservable Input
Weighted Average
(range, if
applicable)
December 31, 2019December 31, 2018
Contingent  consideration
Probability  weighted
income approach
Milestone dates2020 to 20242019 to 2022
Discount rate10% to 11%11.5% to 12%

The following table summarizes the change in fair value, as determined by Level 3 inputs for the warrants and the contingent consideration for the years ended December 31, 20192021,2020 and 2018:2019:

  

Fair Value Measurement at Reporting Date (Level 3)

 
  

(in thousands)

 
  

Series B Warrants

  

Contingent consideration

 

Balance at December 31, 2018

 $4,636  $10,637 

Change in fair value

  (2,248)  (9,553)

Balance at December 31, 2019

 $2,388  $1,084 

Exchange of warrants for common stock

  (2,469)  - 

Payment for contingent consideration

  -   (74)

Change in fair value

  336   2,924 

Balance at December 31, 2020

 $255  $3,936 

Exercise of warrants

 $(2,236) $0 

Change in fair value

  1,981  $(1,565)

Balanceat December 31, 2021

 $0  $2,371 
         

Current portion

 $0  $0 

Long-term portion

  0   2,371 

Balance at December 31, 2021

 $0  $2,371 


  
Fair Value
Measurement at
Reporting Date
(Level 3)
  (In thousands)
  
Common stock
warrants
 
Contingent
consideration
Balance at December 31, 2017 $14,090
 $12,418
Payment for contingent consideration 
 (770)
Exercise of warrants (23,774) 
Change in fair value 14,320
 (1,011)
Balance at December 31, 2018 4,636
 10,637
Change in fair value (2,248) (9,553)
Balance at December 31, 2019 2,388
 1,084
Current portion 
 73
Long-term portion 2,388
 1,011
Balance at December 31, 2019 $2,388
 $1,084

6.    

7.Accounts Receivable, Net

The following table presents the components of accounts receivable:

 December 31,
2019
 December 31,
2018
 (In thousands)
Gross accounts receivable$2,274
 $8,640
Allowance for uncollectible accounts(1,654) (80)
Total accounts receivable, net$620
 $8,560


  

December 31,
2021

  

December 31,
2020

 
  

(In thousands)

 

Gross accounts receivable

 $2,426  $2,917 

Allowance for uncollectible accounts

  (1,677

)

  (1,802

)

Total accounts receivable, net

 $749  $1,115 

The Company recorded $0.1 million, $0 million, and $1.6 million in bad debt expense during the yearyears ended December 31, 2019.2021, 2020 and 2019, respectively.

68


7.Inventories

8.Inventories

The components of inventories are as follows:

 December 31,
2019
 December 31,
2018
 (In thousands)
Finished goods$9,737
 $5,439
Raw materials8,510
 5,502
Total inventories$18,247
 $10,941
    
Current Portion$10,653
 $10,941
Long-term portion7,594
 
Total inventories$18,247
 $10,941

  

December 31, 2021

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $10,566  $(2,987) $7,579 

Raw materials

  10,824   (2,695)  8,129 

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 

  

December 31, 2020

 
  

(in thousands)

 
  

Gross

Carrying

Amount

  

Reserve Balance

  

Net

Carrying

Amount

 

Finished goods

 $13,858  $(3,109) $10,749 

Raw materials

  11,163   (3,065)  8,098 

Total inventories

 $25,021  $(6,174) $18,847 
             

Current Portion

 $11,444  $(1,410) $10,034 

Long-term portion

  13,577   (4,764)  8,813 

Total inventories

 $25,021  $(6,174) $18,847 

The Company records an inventory reserve for estimated excess and obsolete inventory based upon historical consumption and assumptions about future demand for its products. The Company recorded a write-down of obsolete inventory for the year-ended December 31, 2019 totaling $7.4 million as part of a restructuring plan and a $1.5 million charge for inventory obsolescence related to certain system components. There were 0 such write-downs or chargesThe decrease in the inventory reserve balance was $0.5 million and $3.0 million for the yeartwelve months ended December 31, 2018.2021 and 2020, respectively.

8.    Other Current Assets
The following table presents the components of other current assets:

 December 31,
2019
 December 31,
2018
 (In thousands)
Advances to vendors$2,534
 $5,427
Prepaid expenses1,834
 1,443
VAT receivable2,716
 2,335
Total$7,084
 $9,205

9.Property and Equipment

9.Property and Equipment

Property and equipment consisted of the following:

 December 31,
2019
 December 31,
2018
 (In thousands)
Machinery, manufacturing and demonstration equipment$10,421
 $12,320
Computer equipment2,321
 2,260
Furniture637
 639
Leasehold improvements2,295
 2,280
Total property and equipment15,674
 17,499
Accumulated depreciation and amortization(10,968) (11,162)
Property and equipment, net$4,706
 $6,337

  

December 31,
2021

  

December 31,
2020

 
  

(In thousands)

 

Machinery, manufacturing, and demonstration equipment

 $8,289  $9,909 

Operating lease assets - Senhance System leasing

  10,143   8,906 

Computer equipment

  325   2,297 

Furniture

  644   640 

Leasehold improvements

  1,259   2,309 

Total property and equipment

  20,660   24,061 

Accumulated depreciation and amortization

  (9,689

)

  (13,719

)

Property and equipment, net

 $10,971  $10,342 

Depreciation expense was approximately $2.2$2.9 million, $2.9 million and $2.4$2.2 million for the years ended December 31, 2021, 2020,2019, respectively. 

69

10.Goodwill, In-Process Research and 2018, respectively.

10.Goodwill, In-Process Research and Development and Intellectual Property
Development and Intellectual Property

Goodwill

Goodwill consisted of $93.8 million that was recorded in connection with the 2013 merger transaction with SafeStitch Medical, Inc., or the Merger, as described in Note 1, goodwill of $38.3 million that was recorded in connection with the Senhance Acquisition, as described in Note 3, and goodwill of $9.6 million that was recorded in connection with the MST Acquisition, as described in Note 3.3, before impairment of $61.7 million that was recorded in 2016. The carrying value of goodwill and the change in the balance for the yearsyear ended December 31,2019 and 2018 is as follows:

 Goodwill
 (In thousands)
Balance at December 31, 201771,368
Additions9,638
Foreign currency translation impact(875)
Balance at December 31, 2018$80,131
Foreign currency translation impact(1,162)
Impairment(78,969)
Balance at December 31, 2019$

Accumulated impairment of goodwill as of December 31, 2019 and 2018 was $140.8 million and $61.8 million, respectively.

  

Goodwill

 
  

(In thousands)

 

Balance at December 31, 2018

 $80,131 

Foreign currency translation impact

  (1,162

)

Impairment

  (78,969

)

Balance at December 31, 2019

 $0 

The Company performsperformed an annual impairment test of goodwill at December 31 of each year, or more frequently if events or changes in circumstances indicateindicated that the carrying value of the Company’s one reporting unit may not be recoverable. As of December 31, 2018, the Company calculated the fair value of the Company’s sole reporting unit, based on the Company’s market capitalization, which exceeded the carrying amount. Accordingly, 0 charge for goodwill impairment was required as of December 31, 2018. During the third quarter of 2019, the Company's stock price declined significantly as a result of decreased sales.significantly. As of September 30, 2019, goodwill was deemed to be fully impaired, and the Company recorded an impairment charge of $79.0 million.


In-Process Research and Development

As described in Note 3, on October 31, 2018, the Company acquired the MST assets, technology and business from MST and recorded $10.6 million of IPR&D. The estimated fair value of the IPR&D was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flows were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the acquisition date and the time and resources needed to complete development. The Company used a discount rate of 15% and cash flows that have been probability adjusted to reflect the risks of product integration, which the Company believes are appropriate and representative of market participant assumptions.

The Company performed an impairment test of its IPR&D at the end of the third quarter 2019 as recent events and changes in market conditions indicated that the asset might be impaired. The impairment test consisted of a comparison of the fair value of the IPR&D with its carrying amount. If the carrying amount of the IPR&D exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. Significant judgment is applied when testing for impairment. This judgment includes developing cash flow projections, selecting appropriate discount rates, identifying relevant market comparables, and incorporating general economic and market conditions. During the third quarter of 2019, the Company concluded that the fair value determined by the market value approach was lower than the carrying value. As a result, the Company recognized a $7.9 million impairment charge to its IPR&D. The companyCompany performed its annual impairment assessment at December 31, 2019 and no additional impairment was required.

As of December 31, 2020, all IPR&D asset development was completed and reclassified to intellectual property.

The carrying value of the Company’s IPR&D assets and the change in the balance for the years ended December 31, 20182020 and 2019 is as follows:

 
In-Process
Research and
Development
 (In thousands)
Balance at December 31, 2017$
Additions10,633
Foreign currency translation impact114
Balance at December 31, 201810,747
Impairment(7,912)
Foreign currency translation impact(365)
Balance at December 31, 2019$2,470

  

In-Process
Research and
Development

 
  

(In thousands)

 

Balance at December 31, 2018

 $10,747 

Impairment

  (7,912

)

Foreign currency translation impact

  (365

)

Balance at December 31, 2019

  2,470 

Impairment

  0 

Foreign currency translation impact

  (45

)

Transfer of in-process research and development to intellectual property

  (2,425

)

Balance at December 31, 2020

 $0 

Intellectual Property

As described in Note 3, on

On September 21,2015, the Company acquired all of the assets related to the Senhance System and recorded $17.1 million of IPR&D. The estimated fair value of the IPR&D was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flows were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the acquisition date and the time and resources needed to complete development. The Company used a discount rate of 45% and cash flows that have been probability adjusted to reflect the risks of product commercialization, which the Company believes are appropriate and representative of market participant assumptions. On October 13, 2017, upon regulatory approval and the ability to commercialize the products associated with the IPR&D assets, the assets were deemed definite-lived, reclassified to intellectual property and are now being amortized based on their estimated useful lives.

70


On March 13, 2020, upon regulatory approval and the ability to commercialize the products associated with the IPR&D assets in the United States, the remaining MST assets were deemed definite-lived, reclassified to intellectual property and are now being amortized based on their estimated useful lives.

The components of gross intellectual property, accumulated amortization, and net intellectual property as of December 31, 20192021 and 20182020 are as follows:

 December 31, 2019  December 31, 2018
 (In thousands)  (In thousands)
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Foreign
currency
translation
impact
 
Net
Carrying
Amount
  
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Foreign
currency
translation
impact
 
Net
Carrying
Amount
Developed technology$66,413
 $(36,918) $(1,208) $28,287
  $66,413
 $(27,174) $119
 $39,358
Technology and patents purchased400
 (112) 21
 309
  400
 (72) 30
 358
Total intellectual property$66,813
 $(37,030) $(1,187) $28,596
  $66,813
 $(27,246) $149
 $39,716

  

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 

  

December 31, 2020

 
  

(in thousands)

 
  

Gross Carrying Amount

  

Accumulated Amortization

  

Foreign Currency Translation Impact

  

Net Carrying Amount

 

Developed technology

 $68,838  $(51,734) $4,872  $21,976 

Technology and patents purchased

  400   (168)  59   291 

Total intellectual property

 $69,238  $(51,902) $4,931  $22,267 

The weighted average remaining useful life of the developed technology and technology and patents purchased was 2.81.6 years and 7.35.3 years, respectively as of December 31, 2019.  

2021.

The estimated future amortization expense of intangible assets as of December 31, 20192021 is as follows:

  

Year ending

December 31, 2021

 
  

(In thousands)

 

2022

  8,218 

2023

  400 

2024

  400 

2025

  400 

2026

  400 

Thereafter

  74 

Total

 $9,892 

71
 Year ending December 31, 2019
 (In thousands)
2020$10,328
202110,328
20227,757
202342
202442
Thereafter99
Total$28,596


11.Income Taxes

11.Income Taxes

The components for the income tax expense (benefit) are as follows for the years ended December 31 (in thousands):

 2019 2018
Current income taxes   
Federal$
 $
State
 
Foreign100
 
Deferred income taxes   
Federal
 
State
 
Foreign(3,224) (3,377)
Total income tax benefit$(3,124) $(3,377)

  

2021

  

2020

  

2019

 

Current income taxes

            

Federal

 $0  $0  $0 

State

  0   0   0 

Foreign

  232   169   100 

Deferred income taxes

            

Federal

  0   0   0 

State

  0   0   0 

Foreign

  (7)  (1,685)  (3,224)

Total income tax expense (benefit)

 $225  $(1,516) $(3,124)

The United States and foreign components of loss from operations before taxes are as follows for the years ended December 31 (in thousands):

 2019 2018
United States$(91,935) $(44,744)
Foreign(65,390) (20,410)
Total loss from operations before taxes$(157,325) $(65,154)


  

2021

  

2020

  

2019

 
             

United States

 $(32,094) $(34,398) $(91,935)

Foreign

  (30,143)  (26,430)  (65,390)

Total loss from operations before taxes

 $(62,237) $(60,828) $(157,325)

Significant components of the Company’s deferred tax assets consist of the following at December 31 (in thousands):

  

2021

  

2020

 
         

Deferred Tax assets:

        

Stock-based compensation

 $2,440  $4,253 

Accrued expenses and other

  2,423   906 

Research credit carryforward

  564   0 

Fixed Assets

  101   385 

Capitalized start-up costs and other intangibles

  1,109   2,686 

Net operating loss carryforwards

  75,237   63,786 
   81,874   72,016 

Valuation Allowance

  (78,294)  (67,312)

Net deferred tax asset

  3,580   4,704 

Deferred tax liabilities

        

Fixed assets and other

  (1,176)  (1,590)

Purchase accounting intangibles

  (2,116)  (2,807)

Net deferred tax liability

  (3,292)  (4,397)

Net deferred tax asset (liability)

 $288  $307 

During the current year, the Company completed an assessment of the available net operating loss and tax credit carryforwards under Section 382 and Section 383 of the Internal Revenue Code, respectively. The Company determined that it underwent multiple ownership changes throughout its history as defined under Section 382, including most recently in 2020. As a result of the identified ownership changes, the portion of net operating loss and tax credits carryforwards attributable to the pre-ownership change periods are subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code. The Company has adjusted its net operating loss and tax credit carryforwards to address the impact of the 382 ownership changes. This resulted in a reduction of available Federal and State NOLs of $253 million and $204 million, respectively. The write down of the NOLs reduced the net operating loss carryforward line as previously disclosed for the year ended December 31, (in thousands):

 2019 2018
Noncurrent deferred tax assets:   
Stock-based compensation$3,665
 $2,281
Accrued expenses and other1,007 795
Research credit carryforward6,776
 6,182
Fixed assets345
 392
Capitalized start-up costs and other intangibles3,618
 1,859
Net operating loss carryforwards113,410
 74,566
 128,821
 86,075
Valuation allowance(123,108) (81,337)
Net noncurrent deferred tax asset5,713
 4,738
Noncurrent deferred tax liabilities   
Fixed assets and other(1,445) (686)
Purchase accounting intangibles(5,660) (8,772)
Net noncurrent deferred tax liability(7,105) (9,458)
Net deferred tax liability$(1,392) $(4,720)

At 2020 by $58.4 million, with a corresponding decrease in the valuation allowance. The Company also reduced its research credit carryforwards for the year ended December 31, 20192020 by $7.2 million with a corresponding decrease in the valuation allowance. The $7.2 million reduction was net of the related unrecognized tax benefit in the amount of $1.6 million.

Since the limitation affected the prior period, the Company has determined that its December 31, 2020 tax footnote presentation overstated the gross deferred tax asset and 2018,corresponding valuation allowance by $65.6 million. However, there was no net impact to the net deferred tax asset and tax expense as the decrease in the net operating loss carryforward was offset completely by a corresponding adjustment to the Company’s overall valuation allowance. For comparative purposes, the Company’s prior year tax footnote has been revised to reflect the adjustment to the net operating losses and valuation allowance. The change had no effect on the previously reported balance sheets, statements of operations and comprehensive loss, cash flows and stockholders’ equity.

72

At December 31, 2021 and 2020, the Company has provided a full valuation allowance against its net deferred tax assets in the U.S., Canada, Italy, Luxembourg, Swiss,Switzerland, and AsianTaiwan tax jurisdictions, since realization of these benefits is not more likely than not. The valuation allowance increased approximately $41.8$11.0 million from the prior year. At December 31, 2019, 2021, the Company had U.S. federal net operating loss carryforwards of $337.6 million.$397.2 million, of which $253 million are expected to expire unused under the limitations imposed by Internal Revenue Code Section 382 (as discussed above). Of thisthe total amount of Federal NOLs (notwithstanding the 382 limitation), $254.5 million begin to expire in 2027, while the remaining $83.1$142.7 million carry forward indefinitely. At December 31, 2019, 2021, the Company had U.S. state net operating loss carryforwards of $287.5 million.$309.2 million, of which $204 million are expected to expire unused under the state tax law equivalents of Internal Revenue Code Section 382. Of this amount $282.8(notwithstanding the 382 limitations), $299.9 million of state NOLs begin to expire in 2022, while the remaining $4.7$9.3 million carry forward indefinitely. At December 31, 2019, 2021, the Company had federal research credit carryforwards in the amount of $6.8$9.4 million. These carryforwards begin to expire in 2027.  However, under the limitations of Internal Revenue Code Section 383, it is expected that $8.8 million of this carryforward will expire unused. The utilization of the federal net operating loss carryforwards and credit carryforwards will depend on the Company’s ability to generate sufficient taxable income prior to the expiration of the carryforwards. In addition, the maximum annual use of net operating loss and research credit carryforwards is limited in certain situations where changes occur in stock ownership.

At December 31, 2019, 2021, the Company had foreign operating loss carryforwards in Italy of approximately $23.1$25.2 million, which can be carried forward indefinitely; foreign operating loss carryforwards in Luxembourg of approximately $95.1$96.6 million, which will begin to expire in 2035;2034; foreign operating loss carryforwards in Switzerland of approximately $42.3$90.6 million, which begin to expire in 2023;2023, and foreign operating loss carryforwards in JapanCanada of approximately $2.0$0.5 million, which begin to expire in 2028.

2040.

The Company has evaluated its tax positions to consider whether it has any unrecognized tax benefits. As of December 31, 2019, 2021, the Company had gross unrecognized tax benefits of approximately $1.5$0.1 million. Of the total, none would reduce the Company’s effective tax rate if recognized. The Company does not anticipate a significant change in total unrecognized tax benefits or the Company’s effective tax rate due to the settlement of audits or the expiration of statutes of limitations within the next twelve months. Furthermore, the Company does not expect any cash settlement with the taxing authorities as a result of these unrecognized tax benefits as the Company has sufficient unutilized carryforward attributes to offset the tax impact of these adjustments.

Note that the Company removed $1.6 million of the unrecognized tax benefits associated with R&D credit carryforwards that it expects to expire unused due to Section 383 limitations. This  adjustment is reflected in the table below as of December 31, 2020.

The following is a tabular reconciliation of the Company’s change in gross unrecognized tax positions at December 31 (in thousands):

 2019 2018
Beginning balance$1,363
 $1,202
Gross increases for tax positions related to current periods149
 161
Gross increases for tax positions related to prior periods
 
Ending balance$1,512
 $1,363

  

2021

  

2020

  

2019

 
             

Beginning balance

 $0  $1,512  $1,363 

Gross increases for tax positions related to current periods

  141   108   149 

Gross decreases related to 382 limitations

  0   (1,620)  0 

Ending balance

 $141  $0  $1,512 

The Company recognizes interest and penalties related to uncertain tax positions in the provision for income taxes. As of December 31, 20192021 and 2018,2020, the Company had 0 accrued interest or penalties related to uncertain tax positions.


The Company has analyzed its filing positions in all significant federal, state, and foreign jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. With few exceptions, the Company is no longer subject to United States Federal, state, and local tax examinations by tax authorities for years before 2016,2018, although carryforward attributes that were generated prior to 2016 2018may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities.

Taxes computed at the then-current statutory federal income tax rate of 21% are reconciled to the provision for income taxes as follows for the years ended December 31:

  

2021

  

2020

  

2019

 
  

Amount

  

Percent of

Pretax

Earnings

  

Amount

  

Percent of

Pretax

Earnings

  

Amount

  

Percent of

Pretax

Earnings

 

United States federal tax at statutory rate

 $(13,070)  21.0% $(12,774)  21.0% $(33,038)  21.0%

State taxes (net of deferred benefit)

  (2,205)  3.5%  (1,768)  2.9%  (4,778)  3.0%

Nondeductible expenses

  (440)  0.7%  719   (1.2%)  709   (0.5%)

Change in fair market value of contingent consideration

  (397)  0.6%  717   (1.2%)  (2,342)  1.5%

Warrant remeasurment and financing costs

  502   (0.8%)  82   (0.1%)  (551)  0.4%

Research & Development

  (705)  1.1%  (542)  0.9%  (743)  0.5%

Change in unrecognized tax benefits

  141   (0.2%)  (1,512)  2.5%  149   (0.1%)

Foreign tax rate differential

  1,911   (3.1%)  1,589   -2.6%  2,590   (1.6%)

Goodwill and investment impairments

  0   0   0   0   (6,638)  4.2%

Adjustment for 382 Limitations

  0   0   67,255   (110.6%)  0   0.0%

True-up to Stock Compensation - Cancellations

  2,832   (4.6%)  0   0   0   0.0%

Change in enacted tax rates and other, net

  731   (1.0%)  533   (0.9%)  (253)  0.2%

Change in valuation allowance

  10,925   (17.6%)  (55,815)  91.8%  41,771   26.6%

Income tax expense (benefit)

 $225   (0.4%) $(1,516)  2.5% $(3,124)  2.0%

73
 2019 2018
 Amount 
% of Pretax
Earnings
 Amount 
% of Pretax
Earnings
United States federal tax at statutory rate$(33,038) 21.0 % $(13,682) 21.0 %
State taxes (net of deferred benefit)(4,778) 3.0 % (1,080) 1.7 %
Nondeductible expenses709
 (0.5)% (1,320) 2.0 %
Change in fair market value of contingent consideration(2,342) 1.5 % (256) 0.4 %
Warrant remeasurement and financing costs(551) 0.4 % 3,630
 (5.6)%
Research & Development credits(743) 0.5 % (803) 1.2 %
Change in unrecognized tax benefits149
 (0.1)% 161
 (0.2)%
Foreign tax rate differential2,590
 (1.6)% (96) 0.1 %
Goodwill impairment(6,638) 4.2 % 
 
Change in enacted tax rates and other, net(253) 0.2 % 252
 (0.3)%
Change in valuation allowance41,771
 (26.6)% 9,817
 (15.1)%
Income tax benefit$(3,124) 2.0 % $(3,377) 5.2 %

12.OperatingLeases

We determine if an arrangement is a lease or service contract at inception. Where an arrangement is a lease, we determine if it is an operating lease or a finance lease.  Subsequently, if the arrangement is modified, we reevaluate our classification.  We have entered into operating leases for corporate office buildings, vehicles, and machinery and equipment.  Some of our lease agreements have renewal options, tenant improvement allowances, rent escalation clauses, and assignment and subletting clauses.  While our operating leases range from
one


U.S. shareholders are subject year to taxten years, some may include options to extend the lease generally between one year and six years, and some may include options to terminate the leases within one year. 

Operating lease liabilities presented on global intangible low-taxed income (GILTI) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, 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 providethe consolidated balance sheets represents the present value of the remaining lease payments, discounted using the Company’s incremental borrowing rate, which ranges between 6.1% and 8.5% based on the terms of the lease. 

Operating lease costs for the tax expenseyear ended December 31, 2021, 2020 and 2019 were $1.8 million, $2.0 million and $2.1 million, respectively. Total cash paid for operating leases during the year ended December 31, 2021, 2020 and 2019 was $1.5 million, $1.5 million and $1.7 million, respectively, and is included in with cash flows from operating activities with the consolidated statement of cash flows.

Supplemental balance sheet information, as of December 31, 2021 and 2020, related to GILTIoperating leases was as follows:

  

December 31,

 
  

2021

  

2020

 

Weighted-average remaining lease term (in years)

 

7.8

  

1.8

 

Weighted-average discount rate

  7.8%  8.2%

Maturities of operating lease obligations were as follows (in thousands):

Fiscal Year

    

2022

 $994 

2023

  1,008 

2024

  918 

2025

  920 

2026

  854 

Thereafter

  3,004 

Total minimum lease payments

 $7,698 

Less: Amount of lease payments representing interest

  (2,009)

Present value of future minimum lease payments

 $5,689 

During 2021 we entered into three building leases; the first with a 125-month term beginning in the yearfirst quarter of 2021; the tax is incurred assecond with a period expense only. The Company has elected to account for GILTI60-month term beginning in the yearsecond month of the tax is incurred. As of December 31, 2019, 0 GILTI tax has been recorded.

In a referendum held on May, 19 2019, Swiss voters adoptedquarter; and the Federal Act on Tax Reform and AVS Financing (TRAF). TRAF introduces major changesthird with an 87-month term beginning in the Swiss tax system by abolishing certain current preferential tax regimes and replacing them with new measures that are in line with international standards.fourth quarter of 2021. The referendum did not have a material impact on the Company’s 2019 tax provision. The Company will continue to evaluate the impact oftotal lease commitment for these provisions in future periods as the enactment process in completed.three operating leases is approximately $7.1 million.

12.Accrued Expenses

13.Accrued Expenses

The following table presents the components of accrued expenses:

  

December 31,
2021

  

December 31,
2020

 
  

(In thousands)

 

Compensation and benefits

 $3,682  $4,541 

Consulting and other vendors

  128   66 

Other

  124   177 

Royalties

  247   147 

Legal and professional fees

  503   314 

Taxes and other assessments

  492   351 

Interest

  0   19 

Total

 $5,176  $5,615 

74

 December 31,
2019
 December 31,
2018
 (In thousands)
Compensation and benefits$5,061
 $6,243
Restructuring costs882
 
Consulting and other vendors308
 895
Other242
 539
Lease Liability1,112
 
Royalties148
 498
Legal and professional fees474
 432
Deferred rent
 391
Taxes and other assessments326
 365
Interest
 256
Total$8,553
 $9,619


13.Notes Payable

14.Notes Payable

Paycheck Protection Program

On April 27, 2020, the Company received an unsecured non-recourse loan of $2.8 million under the Paycheck Protection Program (“PPP”) provisions of the CARES Act. The Company accounted for the PPP promissory note as debt within notes payable on the consolidated balance sheet. As of December 31, 2020, $1.6 million of the promissory note was classified as long-term and $1.2 million was classified as current.

On June 10, 2021, the Company received notification from the SBA that the principal amount 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 on the consolidated statement of operations and comprehensive loss. There were 0 related amounts recorded for the year ended December, 31, 2020 and 2019, respectively.  

Hercules Loan Agreement

On May 23,2018, the Company and its domestic subsidiaries, as co-borrowers, entered into a Loan and Security Agreement (the “Hercules Loan Agreement”) with several banks and other financial institutions or entities from time to time party to the Loan Agreement (collectively, the “Lender”) and Hercules Capital, Inc., as administrative agent and collateral agent (the “Agent”). Under the Hercules Loan Agreement, the Lender agreed to make certain term loans to the Company in the aggregate principal amount of up to $40.0 million. Funding of the first $20.0 million tranche occurred on May 23, 2018 (the “Initial Funding Date”). On October 23, 2018, the Lender funded the second tranche of $10.0 million under the Hercules Loan Agreement. The Company was entitled to make interest-only payments until December 1, 2020, and at the end of the interest-only period, the Company would have been required to repay the term loans over an eighteen-month period based on an eighteen-month amortization schedule, with a final maturity date of June 1, 2022. The term loans were required to be repaid if the term loans were accelerated following an event of default.

Effective April 30, 2019, the Hercules Loan Agreement was amended (the “Hercules Amendment”) to eliminate the availability of the Tranche III Loan facility, add a new Tranche IV Loan facility of up to $20.0 million, revise certain financial covenants and make other changes.modified on two separate occasions in 2019. The availability of advances under the Tranche IV Loan was not milestone-based, rather the Company could request advances in minimum $5.0 million increments at any time during the period from July 1, 2019 through December 31, 2020, subject to the funding discretion of the Lender. The monthly trailing six month net revenue financial covenant was amended to be tested quarterly and to change the projected net revenue percentage to be met for the six months ending on the last day of each fiscal quarter.  If such quarterly financial covenant was not achieved as of the last day of any fiscal quarter, as tested on the thirtieth day after quarter end, the Company must have complied with the waiver conditions in the Hercules Amendment from such test date until the next quarterly test date.  The Hercules Amendment was executed by the parties on May 7, 2019. The Amendment wasAmendments were treated as a debt modification for accounting purposes.

In connection with the entry into the AutoLap Sale Agreement with respect to the AutoLap assets, the Company commenced discussions with the Agent in order to obtain the required consent of the Agent and the Lender with respect to the sale of the AutoLap assets. In connection with obtaining such consent, the Company entered into the Consent and Second Amendment to the Loan and Security Agreement on July 10, 2019 (the(the “Hercules Second Amendment”). Under the Hercules Second Amendment, in consideration for the consent to the sale of, and the release of the Lender’s security interest on, the AutoLap assets, the Company reduced its indebtedness under the Hercules Loan Agreement by repaying $15.0 million of the $30.0 million of outstanding indebtedness thereunder, without any prepayment penalties, amendment fee or acceleration of the end of term charges, and received adjustments to the quarterly financial covenants and related waiver conditions to reflect the decreased outstanding indebtedness. The Amendment was treated as a debt modification for accounting purposes. Under the Hercules Second Amendment, the applicable waiver condition for fiscal year 2019 was changed to maintenance of unrestricted cash equal to $7.0 million.

The term loans bore interest at a rate equal to the greater of (i) 9.55% per annum (the “Fixed Rate”) and (ii) the Fixed Rate plus the prime rate (as reported in The Wall Street Journal) minus 5.00%.

On the Initial Funding Date, the Company was obligated to pay a facility fee of $0.4 million, recorded as a debt discount. The Company also incurred other debt issuance costs totaling $1.1 million in conjunction with its entry into the Hercules Loan Agreement. In addition, the Company was permitted to prepay the term loans in full at any time, with a prepayment fee of 3.0% of the outstanding principal amount of the loan in the first year after the Initial Funding Date, 2.0% if the prepayment occurred in the second year after the Initial Funding Date and 1.0% thereafter. Upon prepayment of the term loans in full or repayment of the terms loans at the maturity date or upon acceleration, the Company


was required to pay a final fee of 6.95% of the aggregate principal amount of term loans funded. The final payment fee was accreted to interest expense over the life of the term loan and included within notes payable on the consolidated balance sheet.
The Company’s obligations under the Hercules Loan Agreement were guaranteed by all current and future material foreign subsidiaries of the Company and were secured by a security interest in all of the assets of the Company and their current and future domestic subsidiaries and all of the assets of their current and future material foreign subsidiaries, including a security interest in the intellectual property. The Hercules Loan Agreement contained customary representations and covenants that, subject to exceptions, restricted the Company’s and its subsidiaries’ ability to do the following, among other things: declare dividends or redeem or repurchase equity interests; incur additional indebtedness and liens; make loans and investments; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that were not related to its existing business. Under the terms of the Hercules Loan Agreement, the Company was required to maintain cash and/or investment property in accounts which perfected the Agent’s first priority security interest in such accounts in an amount equal to the lesser of (i) (x) 120% of the then-outstanding principal balance of the term loans, including accrued interest and any other fees payable under the agreement to the extent accrued and payable plus (y) an amount equal to the then-outstanding accounts payable of the Company on a consolidated basis that were more than 90 days past due and (ii) 80% of the aggregate cash of the Company and its consolidated subsidiaries. The Agent was granted the option to invest up to $2.0 million in any future equity offering broadly marketed by the Company to investors on the same terms as the offering to other investors.
On November 4, 2019, the Company entered into a payoff letter with the Agent pursuant to which the Company terminated the Hercules Loan Agreement, as amended. The Company determined it was in the best interests of the Company to pay down the debt and terminate the Hercules Agreement to simplify the Company's balance sheet and provide additional flexibility as the Board of Directors continues to explore strategic and financial alternatives for the Company. Under the payoff letter, the Company repaid all amounts owed under the Hercules Loan Agreement totaling approximately $16.4 million, which included end of term fees of $1.4 million, and Hercules released all security interests held on the assets of the Company and its subsidiaries, including, without limitation, on the intellectual property assets of the Company. The Company recognized a loss of $1.0 million on the extinguishment of notes payable which is included in interest expense on the consolidated statement of operations and comprehensive loss for the year ended December 31,2019.

In connection with its entrance into

15.Stock-Based Compensation

Overview

On July 22, 2021, at the Hercules Loan Agreement, the Company repaid its existing loan and security agreement (the “Innovatus Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”). The Company recognized a loss2021 Annual Meeting of $1.4 million on the extinguishment of notes payable which was included in interest expense on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2018. The Company paid $0.7 million in final payment obligations and $0.3 million in prepayment fees under the Innovatus Loan Agreement upon repayment.

Under the Innovatus Loan Agreement, entered into on May 10, 2017, Innovatus agreedStockholders, stockholders voted to make certain term loans in the aggregate principal amount of up to $17.0 million. Funding of the first $14.0 million tranche occurred on May 10, 2017.
The Innovatus Loan Agreement allowed for interest-only payments for up to twenty-four months at a fixed rate equal to 11% per annum, of which 2.5% could be paid in-kind and added to the outstanding principal amount of the term loans until the earlier of (i) the first anniversary following the funding date and (ii)approve the Company’s failure to achieve an Interest-Only Milestone. At the end of the interest-only period, the Company would be required to repay the term loans over a two-year period, based on a twenty-four (24) month amortization schedule, with a final maturity date of May 10, 2021.
In connection with the Innovatus funding, the Company paid a facility fee of $0.2 million on the date of funding of the first tranche and incurred additional debt issuance costs of approximately $1.2 million, recorded as a debt discount.  In addition, the Company issued warrants to Innovatus to purchase shares of the Company’s common stock that will expire five years from such issue date. The warrants issued in connection with funding of the first tranche entitle Innovatus to purchase up to 95,750 shares of the Company’s common stock at an exercise price of $13.00 per share. The Company estimated the fair value of the warrants to be $0.3 million. The value of the warrants was classified as equity and recorded as a discount to the loan.  The debt discount was amortized as interest expense using the effective interest method over the life of the loan. As of December 31, 2018, the unamortized debt discount was $0.
14.Stock-Based Compensation
The Company’s stock-based compensation plans include the TransEnterix, Inc. Amended and Restated Incentive Compensation Plan previously named the TransEnterix, Inc. 2007 Incentive Compensation Plan, or the Plan, as well as options outstanding under the TransEnterix, Inc. Stock Option Plan, or the 2006 Plan. As part of the Merger, options outstanding, whether vested or unvested, under the 2006 Plan were adjusted by the Exchange Ratio of approximately 0.0887, and assumed by the Company concurrent with the closing of the Merger.

The Plan was initially approved by the majority of the stockholders on November 13, 2007. The Plan was amended on June 19, 2012(the “Plan”) to increase the number of shares of common stock available for issuance to 76,923 and was amended on October 29, 2013 to (a) increase the number of shares of common stock authorized for issuance under the Plan from 76,923 shares of common stock to 380,000 shares of common stock, (b) increase the per-person award limitations for options or stock appreciation rights from 15,385 to 76,923 shares and for restricted stock, deferred stock, performance shares and/or other stock-based awards from 7,692 to 38,462 shares, and (c) change the name of the Plan to reflect the Merger-related change. The Plan was again amended on May 7, 2015 to (i) increase the number of shares reserved for issuance under the Plan to 918,462 shares; (ii) extend the termby 22,000,000 shares. As of the Plan until May 7, 2025;December 31, 2021, there were 32,072,308 shares authorized for issuance, and (iii) make other changes and updates to the Plan and was further amended in October 2015 to add French Sub-Plan amendments applicable to awards made to France-based employees. The Plan was further amended on June 8, 2016 to (a) approve an increase in the number of20,755,273 shares reservedavailable for future issuance under the Plan to 1,456,923 shares and (b) establish maximumPlan. To date all equity award limits for initial awards and annual awards to non-employee directors. The Plan was subsequently amended as of May 25, 2017, increasing the number of shares of Common Stock authorized under the Plan to 1,995,385. The Plan was again amended on May 24, 2018, increasing the numberhave consisted of shares of Common Stock authorized under the Plan to 3,149,231. The Plan was again amended in October 2018 to add an Israeli Sub-Plan applicable to awards made to Israel-based employees. The Plan was again amended on April 24, 2019, to increase the number of shares of Common Stock authorized under the Plan to 4,072,308nonqualified stock options, incentive stock options, and to make other changes.
The October 2013, May 2015, June 2016, May 2017, May 2018, and April 2019 amendments were approved by the Board of Directors and stockholders; the French Sub-Plan and Israeli Sub-Plan were approved by the Board of Directors. restricted stock units.

Under the Plan, which is administered by the Compensation Committee, the Company may grant stock options, stock appreciation rights, restricted stock and/or deferred stock to employees, officers, directors, consultants and vendors. The exercise price of stock options or stock appreciation rights may not be less than the fair market value of the Company’s shares at the date of grant. Additionally, no stock options or stock appreciation rights granted under the Plan may have a term exceeding ten years.

The 2006 Plan was adopted and approved by stockholders in September 2006 and provided for the granting of up to 6,154 stock options to employees, directors, and consultants. Under the 2006 Plan, both employees and non-employees were eligible for such stock options. In 2009, the 2006 Plan was amended to increase the total options pool to 85,389. In 2011, the 2006 Plan was amended to increase the total options pool to 259,861. The amendments were approved by the Board of Directors and stockholders. The Board of Directors had the authority to administer the plan and determine, among other things, the exercise price, term and dates of the exercise of all options at their grant date. Under the 2006 Plan, options become vested generally over four years, and expire not more than 10 years after the date of grant. As part of the Merger, options outstanding under the 2006 Plan were adjusted by the Conversion Ratio, and remain in existence as options of TransEnterix.

During the years ended December 31, 20192021,2020 and 2018,2019, the Company recognized approximately $11.5$9.4 million, $7.9 million, and $9.0$11.5 million, respectively, of stock-based compensation expense, including stock options and restricted stock units.

Stock Options

The Company recognizes as expense, the grant-date fair value of stock options and other stock basedstock-based compensation issued to employees and non-employee directors over the requisite service periods, which are typically the vesting periods. The Company uses the Black-Scholes-Merton model to estimate the fair value of its stock-based payments. The volatility assumption used in the Black-Scholes-Merton model is based on the calculated historical volatility based on an analysis of reported data for a peer group of companies as well as the Company’s historical volatility. The expected term of options granted by the Company has been determined based upon the simplified method, because the Company does not have sufficient historical information regarding its options to derive the expected term. Under this approach, the expected term is the mid-point between the weighted average of vesting period and the contractual term. The risk-free interest rate is based on U.S. Treasury rates whose term is consistent with the expected life of the stock options. The Company has not paid and does not anticipate paying cash dividends on its shares of common stock; therefore, the expected dividend yield is assumed to be 0.zero. The Company estimates forfeitures based on the historical experience of the Company and adjusts the estimated forfeiture rate based upon actual experience.

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The fair value of options granted were estimated using the Black-Scholes-Merton option pricing model based on the assumptions in the table below:

 Year ended December 31,
 2019 2018
Expected dividend yield0% 0%
Expected volatility81% - 92% 73% - 75%
Risk-free interest rate1.39% - 2.66% 2.35% - 3.02%
Expected life (in years)5.5 - 6.1 5.5 - 6.1


  

Year Ended December 31,

   
  

2021

  

2020

  

2019

 

Expected dividend yield

   0%     0%     0%  

Expected volatility

  118%-139%   82%-126%   81%-92% 

Risk-free interest rate

  0.33%-1.11%   0.2%-1.69%   1.39%-2.66% 

Expected life (in years)

  3.8-4.5   3.8-6.1   5.5-6.1 

The following table summarizes the Company’s stock option activity, including grants to non-employees, for the year ended December 31, 2019:

 
Number of
Shares
 
Weighted-
Average
Exercise Price
 
Weighted-
Average
Remaining
Contractual
Term (Years)
Options outstanding at December 31, 20181,529,964
 $31.45
 7.82
Granted623,272
 29.79
  
Forfeited(248,834) 33.13
  
Cancelled(43,525) 38.67
  
Exercised(29,919) 18.00
  
Options Outstanding December 31, 20191,830,958
 $30.71
 7.36

2021:

  

Number of
Shares

  

Weighted-
Average Exercise
Price

  

Weighted-Average
Remaining
Contractual Term
(Years)

 

Options outstanding at December 31, 2020

  4,361,872  $10.49   6.05 

Granted

  1,490,266   4.06     

Forfeited

  (285,391)  8.10     

Cancelled

  (610,287)  30.32     

Exercised

  (315,800)  0.67     

Options outstanding at December 31, 2021

  4,640,660  $6.64   5.66 

The following table summarizes information about stock options outstanding at December 31, 2019:

 
Number of
Shares
 
Weighted
Average
Exercise Price
 
Weighted
Average
Remaining
Contractual
Term (Years)
Exercisable at December 31, 2019926,498
 $32.48
 6.14
Vested or expected to vest at December 31, 20191,763,300
 $30.75
 7.28

Stock options outstanding, exercisable, and vested or expected to vest at December 31, 2019 had no intrinsic value based on the closing market price of the Company’s common stock at December 31, 2019.
The total intrinsic value of options exercised during 2019 and 2018 was approximately $0.2 million and $9.3 million, respectively. Proceeds from options exercised during 2019 and 2018 were approximately $0.5 million and $7.1 million, respectively.
2021:

  

Number of Shares

  

Weighted-
Average Exercise
Price

  

Weighted-Average
Remaining
Contractual Term
(Years)

  

Aggregate
Intrinsic Value
(Millions)

 

Exercisable at December 31, 2021

  1,887,155  $11.50   5.40  $0.7 

Vested or expected to vest at December 31, 2021

  4,498,953  $6.75   5.65  $1.4 

The Company granted 623,2721,490,266, 3,005,964, and 669,662623,272 options to employees and non-employees during the years ended December 31, 20192021,2020, and 2018,2019, respectively, with a weighted-average grant date fair value of $2.40, $0.53, and $21.23, and $20.67, respectively.

As of December 31, 2019,2021, the Company had future employee stock-based compensation expense of approximately $19.6$4.0 million related to unvested share awards,stock options, which is expected to be recognized over an estimated weighted-average period of 2.51.5 years.

15.Restricted Stock Units
In 2018

Restricted Stock Units

During 2021,2020, and 2019, the Company issued Restricted Stock Units (“RSUs”) to certain employees which vest over two years and three years. The RSUs vest on defined vesting dates and in certain circumstances subject to certain performance criteria, subject to the continuous service with the Company at the applicable vesting event. Vesting can be accelerated upon a change in control under the Plan if the RSUs are not assumed by the successor company, and will be accelerated for certain executive officers under existing employment agreements if any such executive officer has a termination of employment in connection with a change in control event.  When vested, the RSUs represent the right to be issued the number of shares of the Company’s common stock that is equal to the number of RSUs granted. The fair value of each RSU is estimated based upon the closing price of the Company’s common stock on the grant date. Share-based compensation expense related to RSUs is recognized over the requisite service period as adjusted for estimated forfeitures.

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The following is a summary of the RSU activity, including performance restricted stock units, for the years ended December 31,2021,2020, and 2019:

  

Number of
Restricted Stock
Units Oustanding

  

Weighted-
Average Grant
Date Fair Value

 

Unvested December 31, 2018

  382,098  $20.24 

Granted

  192,987   31.42 

Vested

  (85,153)  25.98 

Forfeited

  (46,005)  21.38 

Unvested December 31, 2019

  443,927  $23.88 

Granted

  3,112,382   0.67 

Vested

  (313,508)  19.38 

Forfeited

  (245,402)  6.54 

Unvested December 31, 2020

  2,997,399  $1.41 

Granted

  3,133,753   2.77 

Vested

  (1,891,869)  1.63 

Forfeited

  (400,253)  1.86 

Unvested December 31, 2021

  3,839,030  $2.36 

As of December 31, 20192021, 2020, and 2018:


 
Number of
Restricted
Stock Units
Outstanding
 
Weighted
Average
Grant
Date Fair
Value
Unvested December 31, 2017338,055
 $14.95
Granted170,403
 28.66
Vested(123,539) 17.44
Forfeited(2,821) 17.71
Unvested December 31, 2018382,098
 $20.24
Granted192,987
 31.42
Vested(85,153) 25.98
Forfeited(46,005) 21.38
Unvested December 31, 2019443,927
 $23.88

As of December 31, 2019, and 2018, the Company recorded approximately $3.2$4.8 million, $1.7 million, and $2.9$3.2 million, respectively, in compensation expense for the RSUs. As of December 31, 2019,2021, the unrecognized stock-based compensation expense related to unvested RSUs was approximately $5.5$4.3 million, which is expected to be recognized over a weighted average period of approximately 1.41.3 years.
16.Warrants
On March 22, 2013, SafeStitch entered into a

Performance Restricted Stock Units

In 2021 and 2020, the Company granted performance-based restricted stock purchase agreementunits with approximately 17 investors (the “2013 PIPE Investors”) pursuant to whichvesting 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 2013 PIPE Investors purchased an aggregate2021 and 2020 awards were based on achieving designated corporate goals. As of approximately 186,092 shares of common stock at a price of $16.25 per share for aggregate consideration of approximately $3.0 million. Included in this private placement was the issuance of warrants to purchase approximately 93,046 common shares, representing one warrant for every two common shares purchased, with an exercise price of $21.45 per share and five years expiration. Among the 2013 PIPE Investors purchasing shares were related parties who purchased 98,462 shares and received 49,231 warrants. There were approximately 92,277 warrants outstanding that were assumed as of the Merger. During the years ended December 31, 2018 2021 and 2017, 61,538 and 18,462, respectively of these warrants were exercised. During the year ended December 31, 2018, the remaining 7,354 warrants expired.

On January 17, 2012, TransEnterix Surgical entered into an original Loan Agreement with Silicon Valley Bank ("SVB") and Oxford Financial LLC (the "Prior Lenders"). Pursuant to such agreement, TransEnterix Surgical issued preferred stock warrants to the Prior Lenders on January 17, 2012 and December 21, 2012, respectively, to purchase shares of TransEnterix Surgical preferred stock. The preferred stock warrants expire ten years from the issue date. The preferred stock warrants were remeasured immediately prior to the Merger. As of the Merger, the preferred stock warrants converted to common stock warrants, adjusted based on a Merger exchange ratio of approximately 0.0887, and the preferred stock warrant liability was reclassified to additional paid-in capital. These warrants are exercisable for an aggregate of approximately 21,506 shares of common stock, with an exercise price of $18.85 per share. During the year ended December 31, 2013, 10,753 of these warrants were exercised in a cashless transaction for 8,674 shares of common stock. During the year ended December 31, 2018, the remaining 10,753 of these warrants were exercised in a cashless transaction for 8,065 shares of common stock.
On September 26, 2014,2020, the Company entered into an amendment to the SVB Loan Agreement with the Prior Lenders. In connection with the first tranche borrowings under such amendment, the Company issued 2,948 commonrecorded approximately $0.9 million and $0.1 million, respectively, in compensation expense for these performance-based restricted stock warrants to the Prior Lenders to purchase shares of the Company’s common stock, with an exercise price of $52.20 per share. The warrants expire seven years from their respective issue date. The Company concluded that the warrants are considered equity instruments. The warrants were recognized at the relative fair value on the issuance date as a debt discount and were amortized using the effective interest method from issuance to the maturity of the term loans. NaN of these warrants were exercised during the years ended December 31, 2019. During the year ended December 31, 2018, 2,145 of these warrants were exercised in a cashless transaction for 660 shares of common stock.units.  

16.Warrants

On August 14,2015, in connection with an amendment to the SVB Loan Agreementa then-existing loan agreement with Silicon Valley Bank and first tranche borrowings thereunder, the Company issued 8,684 common stock warrants to the Prior Lenders to purchase shares of the Company’s common stock, with an exercise price of $40.30 per share. The warrants expire seven years from their respective issue date. The Company concluded that the warrants are considered equity instruments. The warrants were recognized at the relative fair value on the issuance date as a debt discount and were amortized using the effective interest method from issuance to the maturity of the note. NaNNone of these warrants were exercised during the years ended December 31,2021,2020, or 2019. During the year ended December 31, 2018, 5,211 of these warrants were exercised in a cashless transaction for 2,426 shares of common stock.


On April 28, 2017, the Company sold 24.9 million Units, each consisting of approximately 0.077 shares of the Company's Common Stock, a Series A Warrant to purchase approximately 0.077 shares of Common Stock with an exercise price of $13.00 per share, and a Series B Warrant to purchase approximately 0.058 shares of Common Stock with an exercise price of $13.00 per share at an offering price of $1.00 per Unit. Receipt of 510(k) clearance for the Senhance System on October 13, 2017, triggered the acceleration of the expiration date of the Series A Warrants to October 31, 2017. As such, all of the Series A Warrants were exercised prior to the expiration date. Each Series AB Warrant waswere exercisable at any time beginning on the date of issuance and from time to time thereafter through and including the firstfifth anniversary of the issuance date, unless terminated earlierand were liability classified. All Series B Warrants have been exercised as provided inof December 31, 2021.

On February 24, 2020, the Company entered into a Series A Warrant. ReceiptB Warrants Exchange Agreement (the “Exchange Agreement”) with certain holders of 510(k) clearance forits unexercised Series B Warrants. Under the Senhance System on October 13, 2017, triggered the accelerationterms of the expiration date of the Series A Warrants to October 31, 2017. As such, all of the Series A Warrants were exercised prior to the expiration date. EachExchange Agreement, each Series B Warrant may be exercised at any time beginning onwas canceled in exchange for 0.61 shares of common stock. The Warrant holders participating in the date of issuance and from time to time thereafter through and including the fifth anniversaryexchange held 3,373,900 of the issuance date.

The exercise prices and the number of shares issuable upon exercise of each of the3,638,780 Series B Warrants are subject to adjustment uponthen outstanding and received an aggregate of 2,040,757 shares of common stock. As a result, the occurrence of certain events, including, but not limited to, stock splits or dividends, business combinations, sale of assets, similar recapitalization transactions, or other similar transactions. The Series B warrants contain provisions, often referred to as “down-round protection,” that leads to adjustment ofwarrant liability decreased by $2.5 million and the exercise price and number of underlying warrant shares ifadditional paid in capital increased by the Company issues securities, including its common stock or convertible securities or debt securities, in the future at sale prices below the then-current exercise price.same amount.  As a result of thisthe March 2020 Public Offering and adjustment feature, and after giving effect to the Company’s reverse stock split at a ratio of one-for-thirteen shares effective December 11, 2019, or the Reverse Stock Split, the exercise price of all outstanding Series B Warrants has been adjusted to $1.39$0.35 per share and the number of shares of common stock reserved for and issuable upon the exercise of outstanding Series B Warrants has been adjusted to 1,963,451567,660 underlying warrant shares as of December 31, 2019.
2020.The exercisability of the Series B Warrants may be limited if, upon exercise, the holder or any of its affiliates would beneficially own more than 4.99% of the Common Stock. If, at any time Series B Warrants are outstanding, any fundamental transaction occurs, as described in the Series B Warrants and generally including any consolidation or merger into another corporation, the consummation of a transaction whereby another entity acquires more than 50% of the Company’s outstanding voting stock, or the sale of all or substantially all of its assets, the successor entity must assume in writing all of the obligations to the Series B Warrant holders. Additionally, in the event of a fundamental transaction, each Series B Warrant holder will have the right to require the Company, or its successor, to repurchase the Series B Warrants for an amount of cash equal to the Black-Scholes value of the remaining unexercised portion of such Series B Warrants. During the years ended December 31, 2018 and 2017, 542,478 and 684,131, respectively, Series B Warrants were exercised in full in February 2021.

On March 10, 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. As of December 31, 2021, 25,306,942 Series C Warrants and 24,354,263 Series D Warrants have been exercised. ThereThe remaining Series C warrants expired on March 10, 2021.

77

The Series C Warrants and Series D Warrants are equity classified. The fair value of the Series C Warrants and Series D Warrants on the issuance date was determined using a Black-Scholes Merton model. The unit proceeds were 0then allocated to the Common Stock, Series BA Preferred Stock, Series C Warrants, exercised duringand 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 preferred stock and the fair value of the Company's Common Stock as of the issuance date. The Company therefore recorded a beneficial conversion feature of $0.4 million as a deemed dividend included in additional paid-in capital and an immediate charge to earnings available to common stockholders for the year ended December 31, 2019.

2020.

On May 10, 2017, in connection with the entry into the Innovatus Loan Agreement, the Company issued warrants to Innovatus to purchase shares of the Company’s common stock.  The warrants are issued on the funding date of each tranche and will expire five (5) years from such issue date. The warrants issued in connection with funding of the first tranche will entitle Innovatus to purchase up to 95,750 shares of the Company’s common stock at an exercise price of $13.00 per share. NaNNone of these warrants were exercised as of December 31,2021,2020 or 2019.

On September 12,2017, the Company entered into a service agreement with a third party-party vendor. In connection with the service agreement, the Company issued 73,076 common stock warrants (“Service Warrants”) to purchase shares of the Company’s common stock, with an exercise price of $13.00 per share. The Service Warrants vest as follow: (a) twenty-five percent (25%) on the date of execution of the services agreement; (b) fifty percent (50%) upon completion of hiring the sales team; and (c) the remaining twenty-five percent (25%) upon achieving cumulative product revenue of $15.0 million. The Service Warrants expire ten years from their issue date. The Company concluded that the Service Warrants are considered equity instruments. The fair value of the Service Warrants on the issuance date was determined using a Black-Scholes Merton model. The fair value of the remaining Service Warrants was updated each reporting period and the expense was recorded over the service period. The initial expense of $0.6 million and additional expense of $0.3 million was recognized during the year ended December 31, 2017.  In February 2018, the Company terminated its relationship with the vendor and accelerated the full vesting of the Service Warrants in accordance with the service agreement. The remaining expense of $0.3 million was recognized during the year ended December 31, 2018. During the year ended December 31, 2019 and 2018, 15,385 and 50,000None of these warrants were exercised respectively.


 
Number of
Warrant Shares
 
Weighted
Average
Exercise
Price
 
Weighted
Average
Remaining
Contractual
Life (in years)
 
Weighted
Average
Fair Value
Outstanding at Outstanding at December 31, 20171,012,513
 $14.04
 4.5 $5.07
Exercised(672,125) 14.17
 0 
Expired(7,354) 21.45
 0 
Outstanding at Outstanding at December 31, 2018333,034
 $13.39
 3.7 $3.38
Exercised(15,385) 13.00
 0 
Reserved for future issuance1,753,523
 1.39
 2.2 1.22
Outstanding at Outstanding at December 31, 20192,071,172
 $2.05
 2.4 $1.34

during the years ended December 31,2021,2020 or 2019.

  

Number of
Warrant Shares

  

Weighted-
Average Exercise
Price

  

Weighted-
Average
Remaining
Contractual Life
(in years)

  

Weighted-
Average Fair
Value

 

Outstanding at December 31, 2018

  333,034   13.39   3.70   3.38 

Exercised

  (15,385)  13.00   -   - 

Reserve for future issuance

  1,753,523   1.39   2.20   1.22 

Outstanding at December 31, 2019

  2,071,172  $2.05   2.40  $1.34 

Granted

  50,735,292   0.68   2.40   0.19 

Exercised

  (4,911,764)  0.68   -   - 

Exchanged

  (2,040,757)  1.24   -   - 

Reserve for future issuance

  644,966   0.35   1.30   0.45 

Unvested December 31, 2020

  46,498,909  $0.71   2.40  $0.20 

Exercised

  (45,317,101)  0.68   -   - 

Expired

  (61,508)  1.35   -   - 

Outstanding at December 31, 2021

  1,120,300  $1.94   3.00  $0.55 

The aggregate intrinsic value of the common stock warrants in the above table was $0.4 million, $0.2 million, and $5.3$0.2 million at December 31, 20192021,2020, and 2018,2019, respectively. The aggregate intrinsic value is before applicable income taxes and is calculated based on the difference between the exercise price of the warrants and the estimated fair market value of the applicable stock as of the respective dates.

17.Purchase Agreement and Offerings

17.Equity Offerings

At-the-Market Offerings

On August 12, 2019, the Company entered into a Controlled Equity Offering Sales Agreement (the “2019“2019 Sales Agreement”), with Cantor Fitzgerald & Co., (“Cantor”), and commenced an at-the-market offering (the “2019 ATM Offering”) pursuant to which the Company maycould sell from time to time, at its option, up to an aggregate of $25.0 million shares of the Company’s common stock, through Cantor, as sales agent (the “2019agent. The 2019 ATM Offering”). PursuantOffering was completed in February 2020.

On October 9, 2020, the Company filed a prospectus supplement relating to an at-the-market offering with Cantor pursuant to which the Sales Agreement, salesCompany could sell from time to time, at its option, up to an aggregate of the Common Stock were made under the Company’s previously filed and currently effective Registration Statement on Form S-3. The aggregate compensation payable to Cantor was 3.0%$40.0 million of the aggregate gross proceeds from each saleshares of the Company’s common stock.stock, through Cantor as sales agent, pursuant to the 2019 Sales Agreement (the “2020 ATM Offering”). The Company terminated this agreement in January 2021. 

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On May 19, 2021, the Company entered into a Controlled Equity OfferingSales Agreement (the “2021 Sales Agreement”) with Cantor, Robert W. Baird & Co. Incorporated (“Baird”) and Oppenheimer & Co. Inc. (“Oppenheimer”). 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 following table summarizes the total sales under the 2019,2020, and 2021 ATM Offerings during the years ended December 31, 2021, 2020 and 2019, respectively (in thousands except for share and per share amounts):

  

December 31,

 
  

2021

  

2020

  

2019

 

Total shares of common stock sold

  20,237,045   23,008,639   1,374,685 
             

Average price per share

 $1.53  $0.90  $5.23 
             

Gross proceeds

 $30,943  $20,822  $7,193 

Commissions

 $928  $625  $212 

Net proceeds

 $30,015  $20,197  $6,981 

Public Offerings of Securities

On March 10, 2020, the Company closed the March 2020 Public Offering and sold an aggregate of 14,121,766 Class A Units at a public offering price of $0.68 per Class A Unit and 7,937,057 Class B Units at a public offering price of $0.68 per Class B Unit. The underwriter for the public offering exercised an overallotment option and purchased 3,308,823 Series C Warrants and 3,308,823 Series D Warrants.

All of the shares of Series A Preferred Stock were converted to 7.9 million shares of common stock by the holders by June 30, 2020. Upon conversion, the Company recorded $0.3 million as a deemed dividend as an immediate charge to earnings available to common stockholders for the year ended December 31, 2020. In accordance with the Series A Preferred Stock Certificate of Designation, the shares of Series A Preferred Stock regained the status of authorized and unissued shares of preferred stock.

The net proceeds to the Company from the March 2020 Public Offering were approximately $13.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. Approximately 4.9 million Series C Warrants were exercised during the year ended December 31, 2020, generating net proceeds of $3.3 million.

On July 6, 2020, the Company completed an underwritten public offering of 42,857,142 shares of its common stock, including the underwriter’s full exercise of an over-allotment option, at the public offering price per share of $0.35 per share, generating net proceeds of approximately $13.6 million. Following the offering, the exercise price of the outstanding Series B Warrants was adjusted to $0.35 per share and the number of shares of common stock underlying such warrants increased to 567,660 shares.

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 gross proceeds of $31.25 million, and net proceeds of $28.6 million.

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, for aggregate gross proceeds of $79.6 million and net proceeds of approximately $73.4 million.

During the year ended December 31, 2021, the Company issued 45,317,101 shares of common stock upon the exercise of Series B, C, and D warrants for aggregate proceeds of $30.6 million. 

Firm Commitment Offering

On September 4, 2019, the Company entered into an Underwriting Agreement, (the “Underwriting Agreement”)or the Underwriting Agreement, with Cantor (the “Underwriter”).Cantor. Subject to the terms and conditions of the 2019Underwriting Agreement, the Company agreedsold to sell to the Underwriter,Cantor, in a firm commitment underwritten offering, 2,153,846 shares of the Company’s common stock (the “Firm Commitment Offering”).stock. In addition, the Company granted the UnderwriterCantor a 30-day30-day option to purchase 323,077 of additional shares of common stock. The 30-dayCompany raised $18.8 million in gross proceeds under this offering during the year ended December 31, 2019. The option was not exercised.


The following table summarizes the total sales under the ATM Offering and Firm Commitment Offering for the period indicated (in thousands except for share and per share amounts):
   Firm Commitment  
 ATM Offering Offering  
 For the year ended For the year ended Total
 December 31, 2019
 December 31, 2019
 December 31, 2019
Total shares of common stock sold1,374,686 2,153,846 3,528,532
Average price per share$5.23
 $8.73
 $7.37
Gross proceeds$7,193
 $18,796
 $25,989
Commissions earned by Cantor212
 
 212
Net Proceeds$6,981
 $18,796
 $25,777


On December 28, 2018, the Company entered into an At-the-Market Equity Offering Sales Agreement (the “2018 Sales Agreement”) with Stifel, Nicolaus & Company, Incorporated ("Stifel") as sales agent, pursuant to which the Company could sell through Stifel, from time to time, up to $75.0 million inpurchase additional shares of common stock in an at-the-market offering. The Company was not exercised.

18.Basic and Diluted Net Loss per Share

Basic net loss per common share is computed by dividing net loss attributable to pay Stifel a commissioncommon stockholders by the weighted average number of approximately 3%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, warrants and preferred stock. For the year ended December 31, 2020, the effects of the aggregate gross proceeds received from all sales of common stock under the 2018 Sales Agreement. Effective August 12, 2019, the Company terminated the 2018 Sales Agreement. The Company sold 0 shares of its common stock under the Stifel Sales Agreement.

On April 28, 2017, the Company sold 24.9 million units, each consisting of approximately 0.077 shares of the Company’s common stock, a Series A warrantPreferred Stock beneficial conversion charge and conversion are included in the calculation of net loss attributable to purchase approximately 0.077common stockholders. In computing diluted net loss per share for the years ended December 31, 2021, 2020, and 2019,no adjustments have been made to the weighted average outstanding common shares of Common Stock with an exercise price of $13.00 per share,

and a Series B warrant to purchase approximately 0.058 shares of common stock with an exercise price of $13.00 per Unit for aggregate gross proceeds of $24.9 million in an underwritten firm commitment public offering. Net proceeds after issuance costs were $23.2 million, assuming noas the assumed exercise of the warrants. The closingoutstanding options, warrants and restricted stock units would be anti-dilutive.

79

Potential common shares not included in calculating diluted net loss per share are as follows:

  

December 31,

  

December 31,

  

December 31,

 
  

2021

  

2020

  

2019

 

Stock options

  4,640,660   4,361,872   1,830,958 

Stock warrants

  1,120,300   46,498,909   2,071,172 

Nonvested restricted stock units

  3,839,030   2,959,099   443,927 

Total

  9,599,990   53,819,880   4,346,057 

18.    

19.Restructuring

During the fourth quarter of 2019, the Company announced the implementation of a restructuring plan to reduce operating expenses as the Company continues the global market development of the Senhance platform. Under the restructuring plan, the Company reduced headcount primarily in the sales and marketing functions and determined that the carrying value of its inventory exceeded the net realizable value due to a decrease in expected sales. The restructuring charges amounted to $8.8 million, of which $7.4 million was an inventory write down and was included in cost of product revenue and $1.4 million related to employee severance costs and was included as restructuring and other charges in the consolidated statements of operations and comprehensive loss, for the year ended December 31, 2019. Future paymentsDuring the year ended December 31, 2020, the Company continued the restructuring efforts with additional headcount reductions which resulted in $0.9 million related to severance costs. Payments under the restructuring plan are expected to concludeconcluded in 2020 and total $0.9 million.2020. During the year ended December 31, 2019, 2020, the activity related to the Company's restructuring liability, which is included in accrued expenses in the consolidated balance sheet, was as follows:

  

Restructuring Liability

 
  

(In thousands)

 

Balance at December 31, 2019

 $882 

Amount charged to operating expenses

  851 

Cash payments

  (1,733

)

Balance at December 31, 2020

 $0 

  Restructuring Liability
  (In thousands)
Balance at December 31, 2018 $
Amount charged to operating expenses 1,374
Cash payments (492)
Balance at December 31, 2019 $882

19.    Basic

20.Commitments and Diluted Net Loss per Share

Basic net loss per common share is computed by dividing net loss attributableContingencies

Legal Proceedings

No liability or related charge was recorded to common stockholders byearnings in the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed giving effect to all dilutive potential common shares that were outstanding during the period. Diluted potential common shares consist of incremental shares issuable upon exercise of stock options, warrants and restricted stock units. No adjustments have been made to the weighted average outstanding common shares figuresCompany’s consolidated financial statements for legal contingencies for the years ended December 31, 2019 or 2018 as the assumed exercise of outstanding options, warrants2021, 2020 and restricted stock units would be anti-dilutive.

Potential common shares not included2019.

License and Supply Agreements

As discussed in calculating diluted net loss per share are as follows:

 December 31
 2019 2018
Stock options1,830,958
 1,529,964
Stock warrants2,071,172
 333,034
Nonvested restricted stock units443,927
 382,098
Total4,346,057
 2,245,096

20.Related Person Transactions
A member of the Company’s Board of Directors is an executive officer of Synecor, LLC. Various research and development services were purchased by Note 3, in September 2015, the Company from Synecor, LLCcompleted the Senhance Acquisition. As part of this transaction, the Company assumed certain license and its wholly owned subsidiary Synchrony Labs LLC. These purchases were approved by the Audit Committee and totaled approximately $0 and $24,000supply agreements. The Company has placed orders with various suppliers for the years ended December 31, 2019purchase of certain tooling, supplies and 2018, respectively.
A member ofcontract engineering and research services. Commitments under these agreements amount to approximately $2.3 million in 2022, $0.1 million in 2023, and $0.2 million in 2024 when the Company's Board of Directors is an executive officer of Sofar S.p.A. Various equipment was purchased by the Company from Sofar S.p.A. and totaled approximately $26,000 and $0 for the years ended December 31, 2019 and 2018, respectively.agreements terminate.

21.Related Person Transactions

In March 2018, TransEnterixAsensus 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 $12,000$186,000, $110,000, and $71,000$12,000 for the years ended December 31, 20192021, 2020 and 2018,2019, respectively.


ITEM 9.

21.Commitments and Contingencies
Contingent Consideration
As discussed in Note 3, in September 2015, the Company completed the Senhance Acquisition using a combination of cash, stock and potential post-acquisition milestone payments. These milestone payments may be payable in the future, depending on the achievement of certain commercial milestones. On December 30, 2016, the Company entered into an Amendment to restructure the terms of the Second Tranche of the Cash Consideration. Under the Amendment, the Second Tranche was restructured to reduce the contingent cash consideration by €5.0 million in exchange for the issuance of 286,360 shares of the Company’s common stock with an aggregate fair market value of €5.0 million.  As of December 31, 2019, the fair value of the contingent consideration was $1.1 million.
Legal Proceedings 
When determining the estimated probable loss or range of losses, significant judgment is required to be exercised in order to estimate the amount and timing of the loss to be recorded.  Estimating an amount or range of possible losses resulting from litigation proceedings is inherently difficult and requires an extensive degree of judgment, particularly where the matters involve indeterminate claims for monetary damages, are in the early stages of the proceedings, and are subject to appeal.  In addition, because most legal proceedings are resolved over extended periods of time, potential losses are subject to change due to, among other things, new developments, changes in legal strategy, the outcome of intermediate procedural and substantive rulings and other parties’ settlement posture and their evaluation of the strength or weakness of their case against the Company.  For these reasons, the Company is currently unable to predict the ultimate timing or outcome of, or reasonably estimate the possible losses or a range of possible losses resulting from, the matters described above. Based on information currently available, the Company does not believe that any reasonably possible losses arising from currently pending legal matters will be material to the Company’s results of operations or financial condition. However, in light of the inherent uncertainties involved in such matters, an adverse outcome in one or more of these matters could materially and adversely affect the Company’s financial condition, results of operations or cash flows in any particular reporting period.
NaN liability or related charge was recorded to earnings in the Company’s consolidated financial statements for legal contingencies for the years ended December 31, 2019 and 2018.
Operating Leases
On November 2, 2009, TransEnterix Surgical entered into an operating lease for its corporate offices for a period of five years commencing in April 2010. On June 12, 2014, the Company entered into a lease amendment extending the term of the lease for a period of 3 years and 2 months commencing on May 1, 2015 and expiring on June 30, 2018, with an option to renew for an additional three years. On January 8, 2018, the Company entered into a lease amendment extending the term of the lease for a period of eighteen months commencing on July 1, 2018 and expiring on December 31, 2019, with an option to renew for an additional five years. On June 10, 2019, the Company entered into a lease amendment extending the term of the lease for an additional twelve months commencing on January 1, 2020 and expiring on December 31, 2020, with no option to renew. On October 25, 2013, the Company entered into an operating lease for its warehouse for a period of four years and four months commencing in January 2014, with an option to renew for an additional six years. On December 27, 2017, the Company entered into an agreement to terminate this lease effective January 31, 2018. On May 12, 2016, TransEnterix Italia entered into an operating lease for research and development and demonstration facilities for a period of six years commencing in July 2016. On April 15, 2019, TransEnterix Israel entered into an operating lease for research and development facilities for a period of five years commencing in April 2019. On April 25, 2018, TransEnterix Japan entered into an operating lease for office space for a period of five years commencing in April 2018. On July 1, 2018, TransEnterix Europe S.à.R.L entered into an operating lease for office space for a period of five years commencing in July 2018. Rent expense was approximately $1.4 million and $1.2 million for the years ended December 31, 2019 and 2018, respectively.
License and Supply Agreements
As discussed in Note 3, in September 2015, the Company completed the Senhance Acquisition. As part of this transaction, the Company assumed certain license and supply agreements. Commitments under these agreements amount to approximately  $5.5 million in 2020, $0.6 million in 2021, $0.6 million in 2022, $0.6 million in 2023, $0.6 million in 2024, and $1.1 million thereafter until termination in 2027.
The Company has placed orders with various suppliers for the purchase of certain tooling, supplies and contract engineering and research services. Each of these orders has a duration or expected completion within the next twelve months.

22.     Subsequent Events
Series B Warrant Exchange
On February 24, 2020, the Company entered into a Series B Warrants Exchange Agreement (the “Exchange Agreement”) with holders of its Series B Warrants. Under the terms of the Exchange Agreement, each Series B Warrant was canceled in exchange for 0.61 shares of common stock. The Warrant holders participating in the exchange held 3,373,900 of the 3,638,780 Series B Warrants then outstanding, and received an aggregate of 2,040,757 shares of common stock, leaving 264,880 Series B Warrants outstanding to acquire 160,226 shares of common stock. The number of shares of common stock subject to the outstanding Series B Warrants increased to 292,178 shares as a result of the adjustment made following the 2020 Public Offering.
Lincoln Park Capital Purchase Agreement
On February 10, 2020, the Company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC, an Illinois limited liability company, pursuant to which the Company has the right to sell to Lincoln Park up to an aggregate of $25,000,000 in shares of common stock over the 36-month term of the Purchase Agreement, subject to certain limitations and conditions set forth in the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to Lincoln Park 343,171 shares of common stock as commitment shares on February 10, 2020. No shares have been sold to Lincoln Park under the Purchase Agreement to date.
Public Offering of Securities
On March 10, 2020, the Company closed an underwritten public offering (the "2020 Public Offering") with Ladenburg Thalmann & Co. Inc. as underwriter and sold an aggregate of 14,121,766 Class A Units at a public offering price of $0.68 per Class A Unit and 7,937,057 Class B Units at a public offering price of $0.68 per Class B Unit. Each Class A Unit consists of one share of the Company’s common stock, one warrant to purchase one share of common stock that expires on the first anniversary of the date of issuance (collectively, the “Series C Warrants”), and one warrant to purchase one share of common stock that expires on the fifth anniversary of the date of issuance (collectively, the “Series D Warrants”). Each Class B Unit consists of one share of Series A Convertible Preferred Stock, par value $0.01 per share (the “Series A Preferred Stock”), convertible into one share of common stock, a Series C Warrant to purchase one share of Common Stock and a Series D Warrant to purchase one share of Common Stock. The Class A Units and Class B Units have no stand-alone rights and were not certificated or issued as stand-alone securities. The shares of common stock, Series A Preferred Stock, Series C Warrants and Series D Warrants are immediately separable. In addition, the underwriter for the public offering exercised an overallotment option allowing them to purchase 3,308,823 Series C Warrants and 3,308,823 Series D Warrants.
The net proceeds to the Company from the 2020 Public Offering were approximately $13.4 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.
At-The-Market Offering
The following table summarizes the total sales under the 2019 Sales Agreement for the period commencing January 1, 2020 through the date of this filing (in thousands except for per share amounts):
Total shares of common stock sold6,688
Average price per share$1.73
Gross proceeds$11,558
Commissions earned by Cantor$347
Net Proceeds$11,211

Restructuring
During March 2020, the Company continued the restructuring efforts with additional headcount reductions which resulted in $0.8 million related to severance costs. These 2020 severance costs are primarily expected to be paid in 2020 and 2021.
ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.


ITEM 9.A.

ITEM 9.A.

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 December 31, 2019.2021. 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 Chief Financial Officer concluded that, as of December 31, 2019, due to the material weakness in our internal control over financial reporting described below,2021, our disclosure controls and procedures were ineffective.effective at a reasonable assurance level.

80

Management’s

Managements Report on Internal Control Over Financial Reporting

We are responsible for establishing and maintaining adequate internal control over financial reporting. As defined in the securities laws, internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officer and effected by our Board of Directors, management, and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the acquisitions and dispositions of our assets; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

For the year ended December 31, 2019,2021, pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, management (with the participation of our principal executive officer and principal financial officer) conducted an evaluation of the effectiveness of our internal control over financial reporting, based on the original framework established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on that assessment,this evaluation, management concluded that, as of December 31, 2019,2021, our internal control over financial reporting was not effective because a material weakness existed in our internal controls related to the Company’s income tax process. Specifically, we did not maintain effective controls over the documentation and review relating to the income tax accounting and disclosures for the significant components of deferred tax assets and liabilities related to a foreign non-recurring transaction. The Company’s management has concluded that this control deficiency constitutes a material weakness as of December 31, 2019.

Based on this finding, management is implementing a remediation plan to address the control deficiency that led to the material weakness. The remediation plan includes enhancing specific review procedures over the income tax provision and related disclosures, including strengthening the Company’s documentation standards, technical oversight and training.

effective.

The Company’s independent registered public accounting firm, BDO USA, LLP, audited the effectiveness of the Company’s internal control over financial reporting as of December 31, 2019.2021. BDO USA, LLP’s report on the effectiveness of the Company’s internal control over financial reporting as of December 31, 20192021 is set forth herein and contains an adverse opinion.

herein.

Changes in Internal Controls Over Financial Reporting

Except for the material weakness identified above, there

There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, 20192021 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.


ITEM 9.B.

ITEM 9.B.

OTHER INFORMATION

None.

ITEM 9.C.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

As part of the Company’s restructuring program initiated in November 2019 and continued into the first quarter of 2020, the Company determined that it would eliminate the role of Chief Commercial Officer effective March 31, 2020. Eric Smith, the current Chief Commercial Officer is party to an Employment Agreement, dated August 15, 2018 with the Company (the “Employment Agreement”). The elimination by the Company of the Chief Commercial Officer role is a termination without cause by the Company under the Employment Agreement, entitling Mr. Smith to receive, for nine months following the date of termination a monthly amount equal to one-twelfth of his annual base salary in effect as of March 13, 2020, plus the target bonus for 2020, and continued provision of health care benefits for nine months. In addition, the short-term retention bonus awarded to Mr. Smith in November 2019 vested and was earned as of March 6, 2020 and will be paid to Mr. Smith by April 30, 2020. Mr. Smith is providing the Company a release of claims and will continue to be subject to the non-competition, non‑solicitation and confidentiality and inventions disclosure provisions of the Employment Agreement. The Company and Mr. Smith are entering into a Separation and Release Agreement to memorialize these understandings.

None.

PART III

ITEM 10.

ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.

The information required by this item is incorporated by reference from the information contained in our Proxy Statement for the Annual Meeting of Shareholders expected to be filed with the SEC on or prior to April 29, 2020.

May 2, 2022.

ITEM 11.

ITEM 11.

EXECUTIVE COMPENSATION.

The information required by this item is incorporated by reference from the information contained in our Proxy Statement for the Annual Meeting of Shareholders expected to be filed with the SEC on or prior to April 29, 2020.

May 2, 2022.

ITEM 12.

ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

The information required by this item is incorporated by reference from the information contained in our Proxy Statement for the Annual Meeting of Shareholders expected to be filed with the SEC on or prior to April 29, 2020.May 2, 2022.

Securities Authorized for Issuance Under Equity Compensation Plans.

The Company currently has one equity compensation plan under which it makes awards, the TransEnterix,Asensus Surgical, Inc. Amended and Restated Incentive Compensation Plan (the “Plan”). The Plan was originally approved by the Board of Directors of the Company, or the Board, and adopted by the majority of our stockholders on November 13, 2007. The Plan was subsequently amended, approved by the Board, and approved by stockholders as follows:

No.

No.

Amendment Purpose

Date of Stockholders’ approval

1

increase the number of shares of common stock authorized under the Plan to 918,462 shares, and to make other changes

May 7, 2015

2

increase the number of shares reserved for issuance under the Plan to 1,456,923 shares, and to make other changes

June 8, 2016

3

increase the number of shares reserved for issuance under the Plan to 1,995,385 shares

May 25, 2017

4

increase the number of shares reserved for issuance under the Plan to 3,149,231 shares

May 24, 2018

5

increase the number of shares reserved for issuance under the Plan to 4,072,308 shares, and to make other changes

April 24, 2019

6

increase the number of shares reserved for issuance under the Plan to 10,072,307 shares, and to make other changes

June 8, 2020

7

Increase the number of shares reserved for issuance under the Plan to 32,072,307 shares.

July 22, 2021

The Plan is used for plan-based awards for officers, other employees, consultants, advisors and non-employee directors. In connection with the 2013 merger transaction with SafeStitch Medical, Inc., or the Merger, we assumed all of the options that were issued and outstanding immediately prior to the Merger as issued by TransEnterixAsensus Surgical US, Inc., and adjusted based on the Merger at the exchange ratio, which are now exercisable for approximately 32,590 shares of common stock. Such options were granted under the TransEnterix, Inc. 2006 Stock Plan (the “2006 Plan”) which was assumed by the Company in the Merger. The 2006 Plan is maintained solely for the purpose of the stock options granted under such 2006 Plan that remain outstanding; no future awards are authorized to be made under the 2006 Plan.

The following table gives information about the Company’s common stock that may be issued upon the exercise of options and other equity awards as of December 31, 2019:

Plan Category
Number of
securities to be
issued upon
exercise of
outstanding
options (1)
 
Weighted
average exercise
price of
outstanding
options
 
Number of
securities
remaining
available
for future
issuance (2)
Equity compensation plans approved by security holders2,242,295  30.84  1,340,527 
Equity compensation plans not approved by security holders (3)32,590  23.71  0 
Total2,274,885    1,340,527 
2021:

Plan Category

 

Number of
securities to be
issued upon
exercise of
outstanding
options and other

equity awards (1)

  

Weighted
average exercise
price of
outstanding
options

  

Number of
securities
remaining
available
for future
issuance (2)

 

Equity compensation plans approved by security holders

  8,298,442   6.85   20,755,273 

Equity compensation plans not approved by security holders (3)

  186,058   0.49   0 

Total

  8,484,500       20,755,273 

_____________________________


(1)

(1)

Includes 1,798,3684,488,795 shares underlying outstanding stock options awarded under the Plan and 443,9273,809,647 restricted stock units awarded under the Plan.

(2)

(2)

These shares are all available for future awards under the Plan.

(3)

(3)

Represents 32,5903,000 shares underlying outstanding stock options awarded prior to the Merger under the 2006 Plan and assumed in the Merger.Merger and 183,000 shares underlying outstanding stock options, restricted stock units, and performance-based restricted stock units issued as an employment inducement grant as an exception to the NYSE American stockholder approval rules.

ITEM 13.

ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

The information required by this item is incorporated by reference from the information contained in our Proxy Statement for the Annual Meeting of Shareholders expected to be filed with the SEC on or prior to April 29, 2020.

May 2, 2022.

ITEM 14.

ITEM 14.

PRINCIPAL ACCOUNTING FEES AND SERVICES.

The information required by this item is incorporated by reference from the information contained in our Proxy Statement for the Annual Meeting of Shareholders expected to be filed with the SEC on or prior to April 29, 2020.


May 2, 2022.

PART IV

ITEM 15.

ITEM 15.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a).

(a).

(1)

(1)

The following consolidated financial statements are filed as a part of this Annual Report:

(2)

Consolidated Financial Statement Schedules: The information required by this item has been omitted in this report because they are not applicable, not required under these instructions, or included in the consolidated financial statements or related notes thereto contained in Item 8 of this Annual Report.

(3)

Exhibits: The following exhibits are filed as part of, or incorporated by reference into, this Annual Report.

Exhibit


No.

 

Description

2.1

 

2.1(a)

 

3.1

3.1.1

 

3.1.1

3.1.2

 
3.1.2
3.1.3

3.2

 

4.1

 

4.2

 

4.3

 

4.4

 

4.5

 

4.6

 

Exhibit
No.

4.7

 Description
4.7

4.8*

4.8

 

10.1 +

 

10.2 +

10.2+

 
10.3.1 +

10.3.2 +

10.2.1+

 
10.4.1 +

10.4.2+

10.3 +

 
10.5 +

10.6

10.4 +

 

10.7

10.4.1 + *

 

10.4.2 + *

Form of Employee Restricted Stock Unit/Performance Restricted Stock Unit Award Notice

10.4.3 +

Form of EmployeeNon-Employee Director Stock Option Agreement pursuant to the Plan (filed as Exhibit 10.1510.4.5 to our Annual Report on Form 10-K, for the year ended December 31, 2013, filed with the SEC on March 5, 201411, 2021 and incorporated herein by reference herein)reference).

10.8

10.4.4 +

 
10.9 +
10.10 +

10.11 ++

10.4.5 +

 

10.4.6 +

Form of Non-Employee Director Stock Option Grant in Lieu of Cash Retainer (filed as Exhibit 10.4.7 to our Annual Report on Form 10-K, filed with the SEC on March 11, 2021 and incorporated herein by reference).

10.5+ *

Non-Qualified Deferred Compensation Plan, adopted December 8, 2021

10.6 ++

License Contract between the European Union and Vulcanos S.r.l. (now known as TransEnterixAsensus Surgical Italia S.r.l.), dated September 18, 2015 (filed as Exhibit 10.5 to our Quarterly Report on Form 10-Q, filed with the SEC on November 9, 2015 and incorporated by reference herein).

10.12

10.6.1 +++*

 

10.6

Amended and Restated AutoLap System Sale Agreement, dated October 15, 2019, by and between the Registrant and Great Belief International Limited (filed as Exhibit 10.1 to our Current Report on Form 8-K, filed with the SEC on October 17, 2019)2019 and incorporated by reference herein).

10.13

10.7+++

 

10.13.1

10.7.1+++

 

Exhibit
No.

10.7.2

 Description
10.13.2

10.14

10.8 +

 

10.15

10.9

 
10.16
10.17

10.18

10.10

 

10.11

Form of Securities Purchase Agreement dated January 12, 2021, by and among the Registrant and the Purchasers (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on January 3, 202014, 2021 and incorporated by reference herein)reference).

21.1 *

 

23.1 *

 

31.1 *

 

31.2 *

 

32.1 *

 

32.2 *

 

101.INS *

 

Inline XBRL Instance Document.

101.SCH *

 

Inline XBRL Taxonomy Extension Schema Document.

101.CAL *

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF *

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB *

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE *

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104

The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, formatted in Inline XBRL (included in Exhibit 101).

+

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

++

Confidential treatment has been granted for certain portions of the agreement pursuant to a confidential treatment request filed with the Commission on November 9, 2015. Such provisions have been filed separately with the Commission.

*

+++

Filed herewith.

Portions of this exhibit have been omitted because the information is not material and would likely cause competitive harm if publicly disclosed.

*

Filed herewith.

ITEM 16.

FORM 10-K SUMMARY.

Registrants may voluntarily include a summary of information required by Form 10-K under this Item 16. The Company has elected not to include such summary information.

85

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.

February 28, 2022

March 16, 2020TransEnterix,

Asensus Surgical, Inc.

   
 

By:

/s/ Anthony Fernando

  

Anthony Fernando

  

President, Chief Executive Officer

  

and a Director

  

(principal executive officer)

POWER OF ATTORNEY

We, the undersigned officers and directors of TransEnterix,Asensus Surgical, Inc., hereby severally constitute and appoint Anthony Fernando and Brett Farabaugh,Shameze Rampertab, our true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution in him for him and in his name, place and stead, and in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the Registrant in the capacities and on the dates indicated.

Signature

 

Title(s)

 

Date

   

/s/ Anthony Fernando

 

President, Chief Executive Officer and a Director

February 28, 2022

Anthony Fernando

(principal executive officer)

March 16, 2020
Anthony Fernando

  
   

/s/ Brett FarabaughShameze Rampertab

 
Interim

Executive Vice President and Chief Financial Officer

February 28, 2022

Shameze Rampertab

(principal financial officer and principal accounting officer)

March 16, 2020
Brett Farabaugh

  
     

/s/ Paul A. LaVioletteDavid B. Milne

 

Chairman of the Board and a Director

 March 16, 2020

February 28, 2022

Paul A. LaViolette

David B. Milne

    
   

/s/ Andrea Biffi

 

Director

 March 16, 2020

February 28, 2022

Andrea Biffi

    
   

/s/ Jane H. Hsaio

 

Director

 March 16, 2020

February 28, 2022

Jane H. Hsaio, Ph.D.

    
   

/s/ William N. KelleyKevin Hobert

 

Director

 March 16, 2020

February 28, 2022

William N. Kelley, M.D.

Kevin Hobert

    
   

/s/ David B. MilneElizabeth Kwo, M.D.

Director March 16, 2020February 28, 2022
David B. Milne

Elizabeth Kwo, M.D.

/s/ Richard C. Pfenniger, Jr.

Director

February 28, 2022

Richard C. Pfenniger, Jr.

    
   

/s/ Richard C. Pfenniger,William N. Starling, Jr.

 

Director

 March 16, 2020

February 28, 2022

Richard C. Pfenniger,

William N. Starling, Jr.

    
/s/ William N. Starling, Jr.DirectorMarch 16, 2020
William N. Starling, Jr.

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