Asensus Surgical, Inc. Reports Operating and Financial Results for the Fourth Quarter and Full Year 2020
RESEARCH TRIANGLE PARK, N.C --
- Senhance Surgical System received expanded 510(k) clearance for general surgery indication
- Asensus Surgical received CE Mark for Intelligent Surgical Unit™(ISU™), enabling machine vision capabilities in Europe
- Performed first pediatric cases utilizing Senhance® Surgical System, representing the first time that 3 mm instruments were used in robotic pediatric surgery
- Senhance received its registration certificate by the Russian medical device regulatory agency, Roszdravnadzor, allowing for its sale and utilization throughout the Russian Federation
- Announced partnering arrangement with Amsterdam Skills Centre to launch Senhance surgical training center in the Netherlands
- Closed two equity financings, totaling approximately $111 million in gross proceeds in aggregate, extending cash runway into 2024
“We are very pleased with the momentum we generated during 2020 and particularly during the fourth quarter,” said Anthony Fernando, President and CEO of Asensus Surgical. “This momentum continued into the early part of 2021 where we have already accomplished a number of significant milestones, including the bolstering of our balance sheet, the rebranding of the organization, and the introduction of our vision for Performance-Guided Surgery. As we look to the balance of 2021, we look to continue to drive the adoption of Senhance, bringing transformative technology to surgeons, hospitals and patients across the globe. Concurrently, we will work to expand the capabilities of Senhance and deliver on our surgical assurance framework.”
On February 23, 2021, the Company announced that it changed its corporate name to Asensus Surgical, Inc. The name change reflects the company's broader vision of shaping the future of surgery by integrating computer vision and machine learning with surgical robotics.
Upcoming 2021 Milestones
For the full year 2021, the Company expects to install 10 - 12 new Senhance Surgical Systems.
During the first half of 2021, the Company expects to achieve the following regulatory milestones:
- File for FDA 510(k) clearance for articulating instruments
- File for FDA 510(k) clearance for the next generation ISU features
During the first half of 2021, the Company expects to publish clinical papers in peer reviewed journals on the following subjects:
- Health economic studies comparing Senhance Digital Laparoscopy, laparoscopy, and robotic surgery
- Clinical performance when utilizing the Senhance Surgical System
Commercial and Clinical Update
Throughout 2020, the Company initiated ten new clinical programs: three in the US, four in Europe, and three in Asia.
On October 13, 2020, the Company announced that surgeons at Maastricht University Medical Center+ (MUMC+) in the Netherlands, had successfully operated on multiple pediatric patients, becoming the first pediatric surgical program in the world to utilize the Senhance Surgical System and integrate digital laparoscopy with instruments as small as 3 mm into their standard of surgical care.
On December 16, 2020, the Company announced that the Senhance Surgical System received its registration certificate by Roszdravnadzor, the Russian medical device regulatory agency allowing for its sale and utilization throughout the Russian Federation.
On January 19, 2021, the Company announced it received CE Mark approval for the ISU that enables machine vision capabilities on the Senhance Surgical System. This approval will provide Senhance digital laparoscopic programs in Europe access to this new technology, ushering them to the forefront of surgical innovation utilizing augmented intelligence.
On February 18, 2021, the Company agreed to team with the Amsterdam Skills Centre (ASC) in the Netherlands for surgical training. This site will serve surgeons and staff throughout Europe with basic and advanced training on the Senhance Surgical System. The ASC will also provide Asensus Surgical with a world-class facility to engage European surgeons in technology and clinical development studies.
On March 3, 2021, the Company announced it received an additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery in the United States.
Fourth Quarter Financial Results
For the three months ended December 31, 2020, the Company reported revenue of $1.1 million as compared to revenue of $0.7 million in the three months ended December 31, 2019. Revenue in the fourth quarter of 2020 included $0.3 million in system leasing, $0.3 million in instruments and accessories, and $0.5 million in services.
For the three months ended December 31, 2020, total net operating expenses were $14.2 million, as compared to $18.1 million, excluding the gain from the sale of the AutoLap assets, in the three months ended December 31, 2019.
For the three months ended December 31, 2020, net loss was $13.8 million, or $0.13 per share, as compared to a net loss of $13.7 million, or $0.69 per share, in the three months ended December 31, 2019.
For the three months ended December 31, 2020, the adjusted net loss was $9.7 million, or $0.09 per share, as compared to an adjusted net loss of $16.4 million, or $0.83 per share in the three months ended December 31, 2019, after adjusting for the following charges: net gain on the sale of the AutoLap assets, amortization of intangible assets, change in fair value of contingent consideration, change in fair value of warrant liabilities, restructuring and other charges, inventory write-down related to the restructuring plan, and loss on extinguishment of debt. Adjusted net loss is a non-GAAP financial measure. See the reconciliation from GAAP to Non-GAAP Measures below.
Balance Sheet Updates
The Company had cash and cash equivalents and restricted cash of approximately $17.5 million as of December 31, 2020.
On January 14, 2021, the Company announced the closing of its registered direct offering of 25,000,000 shares of its common stock. The offering was priced at a purchase price per share of $1.25, for gross proceeds of approximately $31.25 million.
On February 1, 2021, the Company announced the closing of a bought deal offering of common stock and full exercise of the underwriter’s option to purchase additional shares. The Company issued 26,545,832 shares at a public offering price of $3.00 per share, for gross proceeds of approximately $79.64 million.
Following such financing transactions as well as proceeds from the ATM Offering and exercises of our Series C and D Warrants, the Company has cash and cash equivalents, including restricted cash, of $169.5 million as of February 1, 2021.
Asensus Surgical, Inc. will host a conference call on Thursday, March 11, 2021, at 4:30 PM ET to discuss its fourth quarter and fiscal year 2020 operating and financial results. To listen to the conference call on your telephone, please dial 1-855-327-6837 for domestic callers and 1-631-891-4304 for international callers, and reference conference ID 10013234 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.asensus.com/events.cfm. The replay will be available on the Company’s website.