EX-99.1 2 ex_446130.htm EXHIBIT 99.1 ex_446130.htm

Exhibit 99.1

 

Asensus Surgical, Inc. Reports Operating and Financial Results for the Third Quarter 2022

 

RESEARCH TRIANGLE PARK, N.C.--(GLOBE NEWSWIRE)--November 10, 2022-- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced its operating and financial results for the third quarter 2022.

 

Recent Highlights

 

 

Over 1,900 procedures were performed globally during the nine months ended September 30, 2022, representing growth of 27% over the prior year

 

Five new Senhance program initiations year to date, 3 in Germany, 1 in Japan, 1 in CIS region

 

Submitted FDA 510(k) application for pediatric indication in the U.S.

 

Received the Society of Laparoscopic & Robotic Surgeons 2022 Innovation of the Year award for the Intelligent Surgical Unit™(ISU™)

 

The Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash, of approximately $88.3 million at September 30, 2022

 

“We are very pleased with what we have accomplished this quarter, with impressive utilization metrics, a growing base of clinical evidence highlighting the benefits of the Senhance system and the ISU, and the growth of our installed base,” said Anthony Fernando, Asensus Surgical President and CEO. “As we have made great progress towards the ongoing development of Performance-Guided Surgery and its suite of digital capabilities, we look forward to continuing to progress the platform to enable safer, more consistent surgery - resulting in better outcomes for hospitals and patients alike.”

 

Digital Surgery Portfolio Expansion

 

Expanded Global ISU Machine Vision Capabilities

The Company continues to expand the utilization and applicability of the ISU globally. The Company is seeking CE Mark approval for expanded machine vision capabilities in Europe, which the Company continues to expect to receive in late 2022. The newest ISU features include: real-time 3D measurement, digital tagging, image enhancement, and enhanced camera control based on real-time data while performing surgery. The expanded machine vision capabilities have both U.S. FDA 510(k) clearance and Japanese PMDA approval.

 

This filing included a review of the entire Senhance System platform, and if successful, would represent one of the first robotic surgical systems to be approved through the new, more rigorous MDR process.

 

Articulating Instrument Launch

These instruments are currently in a pilot launch in the U.S. and Europe, and the Company continues to expect a full scale commercial launch by the end of 2022. Articulating Instruments offer better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom.

 

U.S. Pediatric Regulatory Submission

The Company submitted its 510(k) application for pediatric clearance in the U.S. during the third quarter of 2022. The Senhance System’s unique combination of the 3mm instrumentation with 5mm camera scope combined with haptic feedback make it a unique robotic assisted laparoscopic solution for pediatric surgeries.

 

 

 

Market Development

 

Procedure Volumes

During the first nine months of 2022, over 1,900 procedures have been completed utilizing the Senhance System, a 27% increase over the same period in 2021. In the third quarter, surgeons performed over 600 procedures, representing an 18% increase over the third quarter of 2021. This growth was primarily driven by strong utilization trends as a result of an expanded installed base and a growth in new surgeon users at existing installations as well as a broader market recovery.

 

When a procedure is performed with a Senhance System, the Company is able to collect robust data, including surgical video. Over time, the accumulation of this digital surgical data library will enable the Company to generate powerful clinical insights that will fuel the development of Performance-Guided Surgery capabilities to help surgeons reduce surgical variability and drive consistently superior surgical outcomes.

 

Clinical Registry (TRUST)

The Company is leveraging its growing body of real-world clinical data through the utilization of its TRUSTTM clinical registry. The Company believes TRUST is the largest multi-specialty robotic-assisted laparoscopic registry in the industry. The Company continues to grow this body of clinical data to support its commercial strategy as well as help to facilitate an increasing number of high-quality clinical publications demonstrating the value of the Senhance System and Performance-Guided Surgery, with over 2,000 patients enrolled to date. The registered procedures consist of approximately 67% general surgery, including abdominal and thoracic, 15% GYN, and 18% urology.

 

Clinical Validation

During the quarter, there were three peer-reviewed clinical papers published providing further support for the clinical utility of the Senhance System across a variety of surgical specialties.

 

These papers can be found at the Company’s website, www.senhance.com/us/resources.

 

During the quarter, the Company received the Society of Laparoscopic & Robotic Surgeons 2022 Innovation of the Year award for the ISU. Each year, The Society of Laparoscopic & Robotic Surgeons recognizes the most innovative products that have a multidisciplinary application in minimally invasive surgery.

 

New Program Initiations

During the third quarter, the Company announced four Senhance System initiations:

 

Evangelical Hospital Goettingen-Weende in Göttingen, Germany

 

Saiseikai Shiga Hospital in Ritto, Japan

 

The Clinic for General and Visceral Surgery at the St. Bernhard Hospital in Kamp-Lintfort, Germany

 

A hospital in the Commonwealth of Independent States (CIS) region

 

Subsequent to the end of the third quarter, the Company announced one additional Senhance System initiation, bringing the year to date total to five:

 

The Dr. von Hauner Children's Hospital at the Ludwig Maximilians University of Munich, located in Munich, Germany.

 

For the full year 2022, the Company continues to expect to initiate 8 - 10 new Senhance Surgical Systems.

 

Third Quarter Financial Results

 

For the three months ended September 30, 2022, the Company reported revenue of $2.6 million as compared to revenue of $2.6 million in the three months ended September 30, 2021. Revenue in the third quarter of 2022 included $1.2 million in system revenue, $0.3 million in lease revenue, $0.8 million in instruments and accessories, and $0.3 million in services.

 

 

 

For the three months ended September 30, 2022, total operating expenses were $17.2 million, as compared to $16.7 million, in the three months ended September 30, 2021.

 

For the three months ended September 30, 2022, net loss was $18.9 million, or $0.08 per share, as compared to a net loss of $16.1 million, or $0.07 per share, in the three months ended September 30, 2021.

 

Adjusted net loss is a non-GAAP financial measure. See the reconciliation of GAAP to Non-GAAP Measures below. For the three months ended September 30, 2022, the adjusted net loss was $16.9 million, or $0.07 per share, as compared to an adjusted net loss of $14.3 million, or $0.06 per share in the three months ended September 30, 2021, after adjusting for the following charges: amortization of intangible assets, change in fair value of contingent consideration, and employee retention tax credit, all of which are non-cash charges.

 

Balance Sheet Updates

 

The Company had cash, cash equivalents, short-term and long-term investments, excluding restricted cash of approximately $88.3 million as of September 30, 2022.

 

Conference Call

 

Asensus Surgical, Inc. will host a conference call on Thursday, November 10, 2022, at 4:30 PM ET to discuss its third quarter 2022 operating and financial results. To listen to the conference call on your telephone, please dial 1-866-652-5200 for domestic callers and 1-412-317-6060 for international callers, and reference conference ID 10171489 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link https://ir.asensus.com/events-and-presentations. The replay will be available on the Company’s website at https://ir.asensus.com/events-and-presentations.

 

About Asensus Surgical, Inc.

 

Asensus Surgical, Inc. is digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking clinical intelligence for surgeons to enable consistently superior outcomes and a new standard of surgery. This builds upon the foundation of Digital Laparoscopy with the Senhance Surgical System powered by the Intelligent Surgical Unit (ISU) to increase surgeon control and reduce surgical variability. With the addition of machine vision, augmented intelligence, and deep learning capabilities throughout the surgical experience, we intend to holistically address the current clinical, cognitive and economic shortcomings that drive surgical outcomes and value-based healthcare. Learn more about Performance-Guided Surgery and Digital Laparoscopy with the Senhance Surgical System here: www.senhance.com. Now available for sale in the US, EU, Japan, Russia, and select other countries. For a complete list of indications for use, visit: www.senhance.com/indications. For more information, visit www.asensus.com.

 

Follow Asensus

 

 

Email Alerts: https://ir.asensus.com/email-alerts

 

LinkedIn: https://www.linkedin.com/company/asensus-surgical-inc

 

Twitter: https://twitter.com/AsensusSurgical

 

YouTube: https://www.youtube.com/c/transenterix

 

Vimeo: https://vimeo.com/asxc

 

TikTok: https://www.tiktok.com/@asensus_surgical

 

 

 

Forward-Looking Statements

 

This press release includes statements relating to the Senhance System and our 2022 third quarter results. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether we will be able to continue to progress the Company’s platform to enable safer, more consistent surgery resulting in better outcomes for hospitals and patients alike; whether the Company will receive CE Mark approval for expanded machine vision capabilities in Europe in late 2022; whether the Company’s articulating instruments will undergo a full scale commercial launch by the end of 2022; whether the Company will receive a pediatric clearance for the Senhance Surgical System from the FDA; whether the Company’s TRUST clinical registry is the largest multi-specialty robotic-assisted laparoscopic registry in the industry and whether the Company will continue to grow the Trust registry data to support its commercial strategy; and whether we will initiate 8-10 new Senhance Surgical Systems placements in 2022. For a discussion of the risks and uncertainties associated with the Company’s business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

 

 

Asensus Surgical, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except per share amounts)

(Unaudited)

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

June 30,

 
   

2022

   

2021

   

2022

   

2021

 

Revenue:

                               

Product

  $ 1,964     $ 1,922     $ 2,565     $ 3,651  

Service

    335       395       1,067       1,180  

Lease

    264       254       991       925  

Total revenue

    2,563       2,571       4,623       5,756  

Cost of revenue:

                               

Product

    3,057       1,993       4,316       4,671  

Service

    365       342       1,506       1,344  

Lease

    982       1,015       2,752       2,794  

Total cost of revenue

    4,404       3,350       8,574       8,809  

Gross loss

    (1,841

)

    (779

)

    (3,951

)

    (3,053

)

Operating Expenses:

                               

Research and development

    6,741       4,469       20,422       12,773  

Sales and marketing

    3,615       3,551       10,936       10,166  

General and administrative

    4,853       5,557       15,378       13,397  

Amortization of intangible assets

    2,398       2,804       7,601       8,533  

Change in fair value of contingent consideration

    (416

)

    278       (1,168

)

    1,013  

Property and equipment impairment

                432        

Total Operating Expenses

    17,191       16,659       53,601       45,882  

Operating Loss

    (19,032

)

    (17,438

)

    (57,552

)

    (48,935

)

Other Income (Expense), net:

                               

Gain on extinguishment of debt

                      2,847  

Change in fair value of warrant liabilities

                      (1,981

)

Interest income

    291       122       806       253  

Interest expense

    (99

)

    (65

)

    (440

)

    (77

)

Employee retention tax credit

          1,311             1,311  

Other (expense) income, net

    (29

)

    33       (261

)

    (3

)

Total Other Income (Expense), net

    163       1,401       105       2,350  

Loss before income taxes

    (18,869

)

    (16,037

)

    (57,447

)

    (46,585

)

Income tax (expense) benefit

    (55

)

    (32

)

    (224

)

    4  

Net loss

    (18,924

)

    (16,069

)

    (57,671

)

    (46,581

)

Comprehensive loss:

                               

Net loss

    (18,924

)

    (16,069

)

    (57,671

)

    (46,581

)

Foreign currency translation loss

    (1,655

)

    (931

)

    (4,018

)

    (2,397

)

Unrealized gain (loss) on available-for-sale investments

    86       (53

)

    (610

)

    (53

)

Comprehensive loss

  $ (20,493

)

  $ (17,053

)

  $ (62,299

)

  $ (49,031

)

                                 

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

  $ (0.08

)

  $ (0.07

)

  $ (0.24

)

  $ (0.21

)

                                 

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

    236,713       234,337       236,373       224,300  

 

 

 

Asensus Surgical, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share amounts)

(Unaudited)

 

   

September 30,

   

December 31,

 
   

2022

   

2021

 
                 

Assets

               

Current Assets:

               

Cash and cash equivalents

  $ 13,870     $ 18,129  

Short-term investments, available-for-sale

    72,481       80,262  

Accounts receivable, net

    2,250       749  

Inventories

    9,035       8,634  

Prepaid expenses

    3,713       3,255  

Employee retention tax credit receivable

    1,147       1,311  

Other current assets

    1,034       957  

Total Current Assets

    103,530       113,297  

Restricted cash

    1,107       1,154  

Long-term investments, available-for-sale

    1,937       37,435  

Inventories, net of current portion

    3,441       7,074  

Property and equipment, net

    9,145       10,971  

Intellectual property, net

    1,529       9,892  

Net deferred tax assets

    227       288  

Operating lease right-of-use assets, net

    4,799       5,348  

Other long-term assets

    2,938       1,014  

Total Assets

  $ 128,653     $ 186,473  

Liabilities and Stockholders’ Equity

               

Current Liabilities:

               

Accounts payable

  $ 3,637     $ 3,448  

Accrued employee compensation and benefits

    3,868       3,559  

Accrued expenses and other current liabilities

    1,320       1,617  

Operating lease liabilities – current portion

    662       683  

Deferred revenue

    357       543  

Total Current Liabilities

    9,844       9,850  

Long Term Liabilities:

               

Contingent consideration

    1,203       2,371  

Noncurrent operating lease liabilities

    4,630       5,006  

Total Liabilities

    15,677       17,227  

Commitments and Contingencies

               

Stockholders’ Equity

               

Common stock $0.001 par value, 750,000,000 shares authorized at September 30, 2022 and December 31, 2021; 236,783,315 and 235,218,552 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

    237       235  

Preferred stock, $0.01 par value, 25,000,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

           

Additional paid-in capital

    960,676       954,649  

Accumulated deficit

    (843,045

)

    (785,374

)

Accumulated other comprehensive loss

    (4,892

)

    (264

)

Total Stockholders’ Equity

    112,976       169,246  

Total Liabilities and Stockholders’ Equity

  $ 128,653     $ 186,473  

 

 

 

Asensus Surgical, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

   

Nine Months Ended

 
   

September 30,

 
   

2022

   

2021

 

Operating Activities:

               

Net loss

  $ (57,671

)

  $ (46,581

)

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

               

Depreciation

    2,481       2,416  

Amortization of intangible assets

    7,601       8,533  

Amortization of discounts and premiums on investments, net

    556       65  

Stock-based compensation

    6,361       6,589  

Gain on extinguishment of debt

          (2,847

)

Deferred tax expense (benefit)

    224       (4

)

Change in inventory reserves

    386       377  

Bad debt expense

    9        

Property and equipment impairment

    432        

Loss on disposal of property and equipment

    97        

Change in fair value of warrant liabilities

          1,981  

Change in fair value of contingent consideration

    (1,168

)

    1,013  

Changes in operating assets and liabilities:

               

Accounts receivable

    (1,735

)

    113  

Inventories

    (535

)

    (1,941

)

Operating lease right-of-use assets

    237       (3,174

)

Prepaid expenses

    (693

)

    1,220  

Employee retention tax credit receivable

    164       (1,311

)

Other current and long-term assets

    (2,123

)

    2,098  

Accounts payable

    449       1,376  

Accrued expenses

    236       (588

)

Deferred revenue

    (139

)

    (81

)

Operating lease liabilities

    (53

)

    3,259  

Net cash and cash equivalents used in operating activities

    (44,884

)

    (27,487

)

Investing Activities:

               

Purchase of available-for-sale investments

    (25,588

)

    (88,232

)

Proceeds from maturities of available-for-sale investments

    67,702        

Purchase of property and equipment

    (904

)

    (838

)

Net cash and cash equivalents provided by (used in) investing activities

    41,210       (89,070

)

Financing Activities:

               

Proceeds from issuance of common stock, net of issuance costs

          130,361  

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

    (350

)

    (1,058

)

Proceeds from exercise of stock options and warrants

    18       30,838  

Net cash and cash equivalents (used in) provided by financing activities

    (332

)

    160,141  

Effect of exchange rate changes on cash and cash equivalents

    (300

)

    (181

)

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

    (4,306

)

    43,403  

Cash, cash equivalents and restricted cash, beginning of period

    19,283       17,529  

Cash, cash equivalents and restricted cash, end of period

  $ 14,977     $ 60,932  
                 

Supplemental Disclosure for Cash Flow Information:

               

Cash paid for leases

  $ 729     $ 781  

Cash paid for taxes

  $ 79     $ 63  
                 

Supplemental Schedule of Non-cash Investing and Financing Activities:

               

Transfer of inventories to property and equipment

  $ 1,293     $ 2,156  

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

  $     $ 2,236  

Lease liabilities arising from obtaining right-of-use assets

  $ 316     $ 3,857  

 

 

 

 

Asensus Surgical, Inc.

Reconciliation of Non-GAAP Measures

Adjusted Net Loss and Adjusted Net Loss per Share

(in thousands except per share amounts)

(Unaudited)

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2022

   

2021

   

2022

   

2021

 
                                 

Net loss attributable to common stockholders (GAAP)

  $ (18,924 )   $ (16,069 )   $ (57,671 )   $ (46,581 )
                                 

Adjustments

                               
Amortization of intangible assets     2,398       2,804       7,601       8,533  
Change in fair value of contingent consideration     (416 )     278       (1,168 )     1,013  
Property and equipment impairment                 432        
Gain on extinguishment of debt                       (2,847 )
Change in fair value of warrant liabilities                       1,981  
Employee retention tax credit           (1,311 )           (1,311 )

Adjusted net loss attributable to common stockholders (Non-GAAP)

  $ (16,942 )   $ (14,298 )   $ (50,806 )   $ (39,212 )

 

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
    2022    

2021

   

2022

   

2021

 

Net loss per share attributable to common stockholders (GAAP)

  $ (0.08 )   $ (0.07 )   $ (0.24 )   $ (0.21 )
                                 

Adjustments

                               
Amortization of intangible assets     0.01       0.01       0.03       0.04  
Change in fair value of contingent consideration     0.00       0.01       0.00       0.01  
Property and equipment impairment                 0.00        
Gain on extinguishment of debt                       (0.01 )
Change in fair value of warrant liabilities                       0.01  
Employee retention tax credit           (0.01 )           (0.01 )

Adjusted net loss per share attributable to common stockholders (Non-GAAP)

  $ (0.07 )   $ (0.06 )   $ (0.21 )   $ (0.17 )

 

 

 

 

The non-GAAP financial measures for the three and nine months ended September 30, 2022 and 2021, which provide management with additional insight into the Company’s results of operations from period to period without non-cash charges and are calculated using the following adjustments:

 

a)   Intangible assets that are amortized consist of developed technology and purchased patent rights recorded at cost and amortized over 7 to 10 years.

 

b)   Contingent consideration in connection with the acquisition of the Senhance System in 2015 is recorded as a liability and is the estimate of the fair value of potential milestone payments related to business acquisitions. Contingent consideration is measured at fair value using a Monte-Carlo simulation utilizing significant unobservable inputs including the probability of achieving each of the potential milestones, revenue volatility, EURO to USD exchange rate, and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones. Significant increases or decreases in any of the probabilities of success or changes in expected timelines for achievement of any of these milestones would result in a significantly higher or lower fair value of these milestones, respectively, and commensurate changes to the associated liability. The contingent consideration is revalued at each reporting period and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss.

 

c)   Property and equipment impairment associated with returned Senhance Systems under operating leases that are not expected to generate future cash flows sufficient to recover their net book value.  

 

d)  During the second quarter of 2021, the Company received notification from the U.S. Small Business Administration that the principal amount of its Paycheck Protection Program loan of $2.8 million and related interest had been forgiven.  Gain on extinguishment of debt of $2.8 million was recognized for the nine months ended September 30, 2021, in the consolidated statement of operations and comprehensive loss.

 

e)  The Company’s Series B Warrants were measured at fair value using a simulation model which took into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock, its expected volatility, holding cost and the risk-free interest rate for the term of the warrant. The warrant liability was revalued upon exercise and the final change in fair value was recognized in the first quarter of 2021. 

 

f)  During the third quarter of 2021, the Company submitted a refund for incurred employee payroll taxes of $1.3 million under the Employee Retention Tax Credit provision as part of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).  A corresponding tax credit receivable of $1.3 million was recorded on the condensed consolidated balance sheet at September 30, 2021. 

 

INVESTOR CONTACT:

Mark Klausner or Mike Vallie, 443-213-0499

invest@asensus.com

 

OR

 

MEDIA CONTACT:

Isabella Rodriguez, 708-833-1572

CG Life

irodriguez@cglife.com