ASXC: 2Q2023 Results

Recent Highlights

"During the second quarter, we continued to make progress on all fronts, highlighted by strong 27% year-over-year growth in procedure volumes. This continued growth plays a vital role in our ability to expand and optimize our digital surgery capabilities, enabling our machine learning engine to better provide valuable clinical intelligence to surgeons through the ISU,” said Anthony Fernando, Asensus Surgical President and CEO. “Our focus for the remainder of the year will be on expanding the utilization of Senhance and advancing our clinical body of evidence. Additionally, we have some exciting milestones on the horizon, including the initiation of a preclinical evaluation of the LUNA™ Surgical System.”

Upcoming 2023 Milestones

For the full year 2023, the Company continues to expect to initiate 10 - 12 new Senhance programs.

During the second half of 2023, the Company continues to expect to achieve the following developmental milestones:

Complete integrated system testing for LUNA Surgical System
Finalize manufacturing strategy for LUNA Surgical System
Initiate preclinical evaluation for LUNA Surgical System
Finalize strategic relationship with a graphics hardware provider
LUNA

LUNA System development has made notable progress in R&D, now transitioning to testing and evaluation before regulatory filings. Integrated system testing is set to begin in the upcoming quarter, alongside finalization of the manufacturing strategy. The pre-clinical evaluation is on track to conclude by the fourth quarter. Future milestones include freezing the system's design in Q1 2024, followed by verification, validation testing, and pilot manufacturing. By the close of 2024, submissions to the FDA and other regulatory bodies are targeted, with the anticipation of FDA clearance in mid-2025, followed by a commercial pilot launch in the second half of 2025.

The Company believes that there is a clear regulatory pathway for the LUNA System. Based on ongoing communications with the FDA, significant in-house regulatory expertise and the successful regulatory submissions for Senhance, the Company expects to utilize a traditional 510(k) pathway in the U.S., rather than the more extensive de novo pathway. The Company believes this streamlined regulatory strategy will apply not only to the United States but also to the European Union, Japan, and other parts of the world. This de-risked regulatory process should allow for a quicker time-to-market compared to new entrants in this space.

Market Development

Procedure Volumes

During the second quarter of 2023, there was a 27% increase in total surgical procedures completed utilizing the Senhance System over the same period in 2022. The main drivers of this expansion were consistent utilization patterns brought on by an increased installed base, an increase of new surgeon users at existing installations, and a broader market recovery.

2023 Senhance Program Initiations

Year to date, the Company initiated two new Senhance Surgical System placements, which consisted of one in Japan and one in the United States.

Second Quarter Financial Results

For the three months ended June 30, 2023, the Company reported revenue of $1.1 million, as compared to revenue of $1.0 million in the three months ended June 30, 2022. Revenue in the second quarter of 2023 included $0.5 million in lease revenue, $0.3 million in instruments and accessories, and $0.3 million in services.

For the three months ended June 30, 2023, total operating expenses were $18.9 million, as compared to $18.2 million, in the three months ended June 30, 2022.

For the three months ended June 30, 2023, net loss was $20.7 million, or $0.09 per share, as compared to a net loss of $19.6 million, or $0.08 per share, in the three months ended June 30, 2022.

Adjusted net loss is a non-GAAP financial measure. See the reconciliation of GAAP to Non-GAAP Measures below. For the three months ended June 30, 2023, the adjusted net loss was $20.3 million, or $0.09 per share, as compared to the adjusted net loss of $17.3 million, or $0.07 per share in the three months ended June 30, 2022, after adjusting for the following non-cash charges: amortization of intangible assets, change in fair value of contingent consideration, and impairment of property and equipment.

Balance Sheet Updates

The Company had cash and cash equivalents and short-term investments, excluding restricted cash, of approximately $40.0 million as of June 30, 2023.

In July, subsequent to the conclusion of the second quarter, a registered direct offering was successfully completed, yielding approximately $10 million in gross proceeds. The infusion of these funds is strategically earmarked to fortify working capital and contribute to ongoing research and development endeavors.

Based on the recent financing and our current operating plan, the Company anticipates that available cash will now sustain operations until late second quarter of 2024.

Conference Call

To listen to the conference call on your telephone, please dial 1-844-826-3033 for domestic callers and 1-412-317-5185 for international callers, approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link ir.asensus.com/events-and-presentations . The replay will be available on the Company’s website.

About Asensus Surgical, Inc.

Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. Based upon the foundations of digital laparoscopy and the Senhance Surgical System, the Company is developing the LUNA Surgical System, a next generation robotic and instrument system as a foundation of its digital surgery solution. These systems will be powered by the Intelligent Surgical Unit to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. The Senhance Surgical System is now available for sale in the US, EU, Japan, Russia, and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. To learn more about Performance-Guided Surgery, and digital laparoscopy with the Senhance Surgical System visit www.asensus.com.