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Asensus Surgical, Inc. Reports Operating and Financial Results for the First Quarter 2024

May 14, 2024 at 4:05 PM EDT

RESEARCH TRIANGLE PARK, N.C., May 14, 2024 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a global leader of innovative digital solutions for the operating room, announced its operating and financial results for the first quarter 2024.

Recent Highlights

  • Announced non-binding acquisition proposal and exclusivity arrangement with KARL STORZ SE & Co. KG (KARL STORZ)
  • KARL STORZ to provide up to $20 million in financing
  • Nearly 900 procedures performed globally during the quarter
  • One Senhance® Surgical Program initiation year-to-date
  • First quarter revenue of $1.1 million
  • The Company had cash and cash equivalents and short-term investments, excluding restricted cash, of approximately $8.0 million at March 31, 2024

“In the first quarter, we made steady progress in the continued adoption and utilization of Senhance and the ISU, as well as the development of the LUNA™ Surgical System,” said Anthony Fernando, Asensus Surgical President and CEO. “We also recently announced a potential acquisition by KARL STORZ, which we believe could accelerate our mission to transform the way surgery is performed on a global scale. Looking to the balance of 2024, our team remains focused on goals and milestones for LUNA and the negotiation of a definitive merger agreement with KARL STORZ, which we hope will lead to a completed transaction.”

Upcoming 2024 Milestones

For the full year 2024, the Company expects:

  • To initiate 8 - 10 new Senhance programs
  • Procedure volume growth of 15% to 20% over 2023
  • Achieve design freeze for the LUNA Surgical System
  • Verification and validation testing, and pilot manufacturing for the LUNA Surgical System

Non-Binding Acquisition Proposal and Exclusivity Arrangement with KARL STORZ

In April, the Company announced a non-binding letter of intent with KARL STORZ, a global medical technology company, regarding a potential acquisition. KARL STORZ proposed to acquire 100% of Asensus' outstanding shares for $0.35 per share in cash. During an exclusivity period of up to ten weeks, KARL STORZ will conduct due diligence, and the parties will negotiate a definitive merger agreement. Asensus entered into a secured loan of up to $20 million from KARL STORZ to support operations during the exclusivity period and potential transaction process. This loan will provide up to $10 million of liquidity during the exclusivity period. As of today the Company has drawn the first $7 million of the initial $10 million tranche of the loan which has provided liquidity for operations. If a definitive merger agreement is successfully negotiated and executed, additional funding in an aggregate amount of up to $10 million will be available under the loan to fund operations while the Company pursues stockholder approval. If a definitive merger agreement is reached and approved by Asensus' stockholders, and all other closing conditions are met, the Company will be acquired by KARL STORZ and cease to be publicly traded.

Market Development

Procedure Volumes

In the first quarter of 2024, surgeons performed nearly 900 procedures utilizing the Senhance System. These procedures included general surgery, gynecology, urology, colorectal, pediatric, and bariatric surgical cases.

2024 Senhance Program Initiations

Year to date, the Company initiated one new Senhance Surgical System placement at Sendai Tokushukai Hospital in Japan.

Clinical Registry (TRUST)

The Company continues to leverage its growing body of real-world clinical data through the utilization of its TRUST™ clinical registry. The Company believes TRUST is the largest multi-specialty robotic-assisted laparoscopic registry in the industry, with approximately 3,500 patients enrolled to date, a 45% increase from first quarter 2023.

Clinical Validation

Year to date, there were 6 peer-reviewed clinical papers published providing further support for the clinical utility of the Senhance System across a variety of surgical specialties. These papers, along with a library of similar papers, can be found on the Company’s website:
https://www.asensus.com/resources/clinical-publications

First Quarter Financial Results

For the three months ended March 31, 2024, the Company reported revenue of $1.1 million as compared to revenue of $1.0 million in the three months ended March 31, 2023. Revenue in the first quarter of 2024 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 March 31, 2024, total operating expenses were $22.7 million, as compared to $20.4 million, in the three months ended March 31, 2023.

For the three months ended March 31, 2024, net loss was $22.5 million, or $0.08 per share, as compared to a net loss of $22.2 million, or $0.09 per share, in the three months ended March 31, 2023.

Adjusted net loss is a non-GAAP financial measure. See the reconciliation of GAAP to Non-GAAP Measures below. For the three months ended March 31, 2024, the adjusted net loss was $18.0 million, or $0.07 per share, as compared to an adjusted net loss of $22.0 million, or $0.09 per share in the three months ended March 31, 2023, after adjusting for the following charges: amortization of intangible assets, change in fair value of contingent consideration, and change in fair value of warrant liabilities, all of which are non-cash charges.

Balance Sheet Updates

The Company had cash, cash equivalents and short-term investments, excluding restricted cash of approximately $8.0 million as of March 31, 2024.

Conference Call

To listen to the conference call on your telephone, please dial 1-888-886-7786 for domestic callers and 416-764-8658 for international callers, 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.

About Asensus Surgical, Inc.

Asensus Surgical is revolutionizing surgery with the first intra-operative Augmented Intelligence technology approved for use in operating rooms around the world. Recognized as an award-winning leader in digital technology, Asensus is committed to making surgery more accessible and predictable while delivering consistently superior outcomes. The Company’s novel approach to digitizing laparoscopy has led to system placements globally. Led by engineers, medical professionals, and industry luminaries, Asensus is powered by human ingenuity and driven by collaboration. To learn more about the Senhance® Surgical System and the new LUNA™ System in development, visit www.asensus.com.

Follow Asensus

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

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

X: https://twitter.com/AsensusSurgical

YouTube: https://www.youtube.com/@AsensusSurgical

Forward-Looking Statements

This press release includes statements relating to Asensus Surgical, and our 2024 first quarter results, and of the potential acquisition transaction with KARL STORZ (the “Potential Acquisition”). 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 meet our milestones for the year, including the initiation of 8-10 new Senhance programs, 15% to 20% procedure volume growth over the full year 2023, active design freeze for the LUNA Surgical System, and verification and validation testing and pilot manufacturing for the LUNA Surgical System; whether the Potential Acquisition by KARL STORZ will occur, the results of the due diligence investigation by KARL STORZ, the possibility that KARL STORZ will terminate the exclusivity period, whether the parties will successfully negotiate and enter into a definitive merger agreement and, if so, whether it will be approved, the risk that the terms of the definitive agreement may not be as favorable to the Company’s stockholders as proposed in the letter of intent, including the purchase price, the timing of execution of such agreement, the availability and sufficiency for funding the Company’s near-term operations of up to $20 million available under the secured promissory note (the “Note”), if received, and whether the Company will be able to repay the Note if the Potential Acquisition is not consummated. 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
March 31,
  
  2024
   2023
  
Revenue:                
Product $ 313     $ 293    
Service   285       195    
Lease   525       488    
Total revenue   1,123       976    
Cost of revenue:                
Product   1,681       1,225    
Service   452       749    
Lease   923       973    
Total cost of revenue   3,056       2,947    
Gross loss   (1,933 )     (1,971 )  
Operating expenses:                
Research and development   8,091       10,139    
Sales and marketing   3,642       4,553    
General and administrative   4,374       5,468    
Amortization of intangible assets   114       112    
Change in fair value of contingent consideration   6,480       105    
Total operating expenses   22,701       20,377    
Operating loss   (24,634 )     (22,348 )  
Other income (expense), net:                
Change in fair value of warrant liabilities   2,116       —    
Interest income   126       439    
Other expense, net   (59 )     (218 )  
Total other income (expense), net   2,183       221    
Loss before income taxes   (22,451 )     (22,127 )  
Income tax expense   (46 )     (91 )  
Net loss   (22,497 )     (22,218 )  
                 
Comprehensive loss:                
Net loss   (22,497 )     (22,218 )  
Foreign currency translation (loss) gain   (494 )     550    
Unrealized gain on available-for-sale investments   8       307    
Comprehensive loss $ (22,983 )   $ (21,361 )  
                 
Net loss per common share attributable to common
stockholders – basic and diluted		 $ (0.08 )   $ (0.09 )  
                 
Weighted average number of shares used in computing
net loss per common share – basic and diluted		   269,265       238,280    
   


Asensus Surgical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts)
(Unaudited)
  
   
  March 31,
2024
   December 31,
2023
  
                 
Assets                
Current Assets:                
Cash and cash equivalents $ 6,995     $ 17,096    
Short-term investments, available-for-sale   994       3,971    
Accounts receivable, net   675       3,508    
Inventories   5,958       7,172    
Prepaid expenses   3,314       3,143    
Other current assets   1,312       1,496    
Total Current Assets   19,248       36,386    
                 
Restricted cash   1,483       1,642    
Inventories, net of current portion   3,954       4,043    
Property and equipment, net   8,630       8,959    
Intellectual property, net   1,114       1,237    
Net deferred tax assets   37       44    
Operating lease right-of-use assets, net   4,926       5,165    
Other long-term assets   1,422       1,610    
Total Assets $ 40,814     $ 59,086    
Liabilities and Stockholders’ Equity                
Current Liabilities:                
Accounts payable $ 4,036     $ 4,145    
Accrued employee compensation and benefits   3,814       5,390    
Accrued expenses and other current liabilities   1,243       1,636    
Contingent consideration, current   8,700       —    
Operating lease liabilities, current   1,056       1,036    
Deferred revenue   439       421    
Total Current Liabilities   19,288       12,628    
Long-Term Liabilities:                
Deferred revenue – less current portion   330       290    
Contingent consideration   —       2,220    
Warrant liabilities   3,772       5,888    
Noncurrent operating lease liabilities   4,400       4,646    
Total Liabilities   27,790       25,672    
Commitments and Contingencies                
Stockholders’ Equity                
Common stock $0.001 par value, 750,000,000 shares authorized at
March 31, 2024 and December 31, 2023; 271,986,369 and
264,921,526 shares issued and outstanding at March 31, 2024 and
December 31, 2023, respectively		   272       265    
Preferred stock, $0.01 par value, 25,000,000 shares authorized, no shares
issued and outstanding at March 31, 2024 and December 31, 2023,
respectively		   —       —    
Additional paid-in capital   975,715       973,129    
Accumulated deficit   (961,865 )     (939,368 )  
Accumulated other comprehensive income   (1,098 )     (612 )  
Total Stockholders’ Equity   13,024       33,414    
Total Liabilities and Stockholders’ Equity $ 40,814     $ 59,086    
   


Asensus Surgical, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
  
   
  Three Months Ended
March 31,
  
  2024
   2023
  
Operating Activities:                
Net loss $ (22,497 )   $ (22,218 )  
     Adjustments to reconcile net loss to net cash and cash equivalents used in
       operating activities:		                
          Depreciation   841       813    
          Amortization of intangible assets   114       112    
          Accretion of discounts and premiums on investments, net   (15 )     (89 )  
          Stock-based compensation   1,745       1,916    
          Deferred tax expense   —       91    
          Bad debt expense   (2 )     —    
          Change in inventory reserves   959       (374 )  
          Change in fair value of warrant liabilities   (2,116 )     —    
          Change in fair value of contingent consideration   6,480       105    
          Changes in operating assets and liabilities:                
                 Accounts receivable   2,776       1,607    
                 Inventories   (559 )     203    
                 Operating lease right-of-use assets   177       187    
                 Prepaid expenses   (183 )     250    
                 Other current and long-term assets   313       (27 )  
                 Accounts payable   (74 )     1,608    
                 Accrued employee compensation and benefits   (1,523 )     (1,120 )  
                 Accrued expenses and other current liabilities   (359 )     (93 )  
                 Deferred revenue   73       (13 )  
                 Operating lease liabilities   (158 )     (206 )  
Net cash and cash equivalents used in operating activities   (14,008 )     (17,248 )  
Investing Activities:                
Purchase of available-for-sale investments   —       (2,949 )  
Proceeds from maturities of available-for-sale investments   3,000       32,750    
Purchase of property and equipment   —       (64 )  
Net cash and cash equivalents provided by investing activities   3,000       29,737    
Financing Activities:                
Proceeds from issuance of common stock, net of issuance costs   982       —    
Taxes paid related to net share settlement of vesting of restricted stock units   (171 )     (488 )  
Proceeds from exercise of stock options   —       5    
Net cash and cash equivalents provided by (used in) financing activities   811       (483 )  
Effect of exchange rate changes on cash and cash equivalents   (63 )     403    
Net (decrease) increase in cash, cash equivalents and restricted cash   (10,260 )     12,409    
Cash, cash equivalents and restricted cash, beginning of period   18,738       7,470    
Cash, cash equivalents and restricted cash, end of period $ 8,478     $ 19,879    
                 
Supplemental Disclosure for Cash Flow Information:                
Cash paid for leases $ 351     $ 330    
Cash paid for taxes $ 87     $ 190    
                 
Supplemental Schedule of Non-cash Investing and Financing Activities:                
Transfer of inventories to property and equipment $ 630     $ 112    
Lease liabilities arising from obtaining right-of-use assets $ 72     $ 45    
   


Asensus Surgical, Inc.
Reconciliation of Non-GAAP Measures
Adjusted Net Loss and Net Loss per Share
(in thousands except per share amounts)
(Unaudited)
  
   
  Three Months Ended
March 31,
  
  2024   2023  
                 
Net loss attributable to common stockholders
(GAAP)		 $ (22,497 )   $ (22,218 )  
                 
Adjustments                
Amortization of intangible assets (a)   114       112    
Change in fair value of contingent consideration (b)   6,480       105    
Change in fair value of warrant liabilities (c)   (2,116 )     —    
Adjusted net loss attributable to common
stockholders (Non-GAAP)		 $ (18,019 )   $ (22,001 )  
   
   
  Three Months Ended
March 31,
  
  2024   2023  
Net loss per share attributable to common
stockholders (GAAP)		 $ (0.08 )   $ (0.09 )  
                 
Adjustments                
Amortization of intangible assets (a)   —       —    
Change in fair value of contingent consideration (b)   0.02       —    
Change in fair value of warrant liabilities (c)   (0.01 )     —    
Adjusted net loss per share attributable to common
stockholders (Non-GAAP)		 $ (0.07 )   $ (0.09 )  
   

The non-GAAP financial measures for the three months ended March 31, 2024 and 2023, 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 probability of occurrence related to a non-binding letter of intent with KARL STORZ SE & Co. KG for a potential acquisition of the Company and 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)    The Company recorded warrant liabilities related to common stock warrants issued in the registered direct offering in July 2023.

Warrant liabilities were recorded at their initial estimated fair value. Adjustments associated with changes in fair value of the warrant liabilities are included in the Company’s consolidated statements of operations and comprehensive loss.

INVESTOR CONTACT:

Mark Klausner or Mike Vallie
ICR Westwicke
invest@asensus.com
443-213-0499

MEDIA CONTACT:

Dan Ventresca
Matter Communications
AsensusPR@matternow.com
617-874-5488


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Source: Asensus Surgical, Inc.