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Table of Contents
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM
10-Q
 
 
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 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
001-09341
 
 
iCAD, Inc.
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
 
02-0377419
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification No.)
   
98 Spit Brook Road, Suite 100, Nashua, NH
 
03062
(Address of principal executive offices)
 
(Zip Code)
(603)
882-5200
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
 
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading
symbol(s)
 
Name of each exchange
on which registered
Common Stock, $0.01 par value
 
ICAD
 
The Nasdaq Stock Market LLC
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 requirement for the past 90 days.    YES  ☒    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
during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    YES  ☒    NO  ☐.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, an emerging growth company or a smaller reporting 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 is a shell company (as defined in Rule
12b-2
of the Exchange Act)    YES  ☐    NO  .
As of the close of business on
April 30, 2021
, there were
 
24,983,491 shares outstanding of the registrant’s Common Stock, $0.01 par value.
 
 
 

Table of Contents
iCAD, Inc.
INDEX
 
         Page  
PART I
          
     
Item 1
          
     
         3  
     
         4  
     
         5  
     
         6  
     
         7  
     
Item 2
       30  
     
Item 3
       40  
     
Item 4
       40  
     
PART II
       41  
     
Item 1
       41  
     
Item 1A
       42  
     
Item 6
       43  
     
         44  
 
2

Table of Contents
iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands except for share data)
 
    
March 31,
   
December 31,
 
    
2021
   
2020
 
Assets
                
Current assets:
                
Cash and cash equivalents
   $ 46,907     $ 27,186  
Trade accounts receivable, net of allowance for doubtful accounts of $111 in 2021 and $111 in 2020
     10,649       10,027  
Inventory, net
     2,498       3,144  
Prepaid expenses and other current assets
     2,188       1,945  
    
 
 
   
 
 
 
Total current assets
     62,242       42,302  
    
 
 
   
 
 
 
Property and equipment, net of accumulated depreciation of $6,854 in 2021 and $6,778 in 2020
     930       744  
Operating lease assets
     1,565       1,758  
Other assets
     1,564       1,527  
Intangible assets, net of accumulated amortization of $8,552 in 2021 and $8,494 in 2020
     831       889  
Goodwill
     8,362       8,362  
    
 
 
   
 
 
 
Total assets
   $ 75,494     $ 55,582  
    
 
 
   
 
 
 
Liabilities and Stockholders’ Equity
                
Current liabilities:
                
Accounts payable
   $ 1,251     $ 2,869  
Accrued and other expenses
     5,819       7,039  
Notes payable - current portion
     269           
Lease payable - current portion
     847       726  
Deferred revenue
     5,957       6,117  
    
 
 
   
 
 
 
Total current liabilities
     14,143       16,751  
    
 
 
   
 
 
 
Lease payable, long-term portion
     860       1,075  
Notes payable, long-term portion
     6,703       6,960  
Deferred revenue, long-term portion
     420       267  
Deferred tax
     4       4  
    
 
 
   
 
 
 
Total liabilities
     22,130       25,057  
    
 
 
   
 
 
 
Commitments and Contingencies (Note 7)
            
     
Stockholders’ equity:
                
Preferred stock, $0.01 par value: authorized 1,000,000 shares; none
 
issued
.
     —         —    
Common stock, $0.01 par value: authorized 30,000,000 shares; issued 25,143,432
 a
s of March 31, 2021 and 23,693,735 as of December 31, 2020
.
                
Outstanding 24,957,601 as of March 31, 2021 and 23,508,575 as of December 31, 2020
.
     251       236  
Additional
paid-in
capital
     298,106       273,639  
Accumulated deficit
     (243,578     (241,935
Treasury stock at cost, 185,831 shares in 2021 and 2020
     (1,415     (1,415
    
 
 
   
 
 
 
Total stockholders’ equity
     53,364       30,525  
    
 
 
   
 
 
 
Total liabilities and stockholders’ equity
   $ 75,494     $ 55,582  
    
 
 
   
 
 
 
See accompanying notes to condensed consolidated financial statements.
 
3

Table of Contents
iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands except for per share data)
 
    
Three Months Ended March 31,
 
    
2021
   
2020
 
Revenue:
                
Products
   $ 5,557     $ 3,795  
Service and supplies
     3,087       2,756  
    
 
 
   
 
 
 
Total revenue
     8,644       6,551  
     
Cost of revenue:
                
Products
     1,409       1,017  
Service and supplies
     867       927  
Amortization and depreciation
     79       97  
    
 
 
   
 
 
 
Total cost of revenue
     2,355       2,041  
    
 
 
   
 
 
 
Gross profit
     6,289       4,510  
    
 
 
   
 
 
 
Operating expenses:
                
Engineering and product development
     2,192       2,211  
Marketing and sales
     3,424       3,608  
General and administrative
     2,151       2,532  
Amortization and depreciation
     55       52  
    
 
 
   
 
 
 
Total operating expenses
     7,822       8,403  
    
 
 
   
 
 
 
Loss from operations
     (1,533     (3,893
     
Interest expense
     (112     (130
Other income
     2       42  
Loss on extinguishment of debt
           (341
Loss on fair value of convertible debentures
           (7,464
    
 
 
   
 
 
 
Other expense, net
     (110     (7,893
Loss before income tax expense
     (1,643     (11,786
    
 
 
   
 
 
 
Tax expense
           (26
    
 
 
   
 
 
 
Net loss and comprehensive loss
   $ (1,643   $ (11,812
    
 
 
   
 
 
 
Net loss per share:
                
Basic
   $ (0.07   $ (0.59
    
 
 
   
 
 
 
Diluted
   $ (0.07   $ (0.59
    
 
 
   
 
 
 
Weighted average number of shares used in computing loss per share:
                
Basic
     23,929       20,175  
    
 
 
   
 
 
 
Diluted
     23,929       20,175  
    
 
 
   
 
 
 
See accompanying notes to condensed consolidated financial statements.
 
4

Table of Contents
iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
 
    
For the three months ended
March 31,
 
    
2021
   
2020
 
     (in thousands)  
Cash flow from operating activities:
                
Net loss
   $ (1,643   $ (11,812
Adjustments to reconcile net loss to net cash used for operating activities:
                
Amortization 
     58       78  
Depreciation
     76       71  
Bad debt provision
     —         119  
Stock-based compensation
     935       464  
Amortization of debt discount and debt costs
     12       40  
Loss on extinguishment of debt
     —         341  
Deferred tax expense
     —         1  
Change in fair value of convertible debentures
     —         7,464  
Changes in operating assets and liabilities:
                
Accounts receivable
     (622     2,610  
Inventory
     647       149  
Prepaid and other assets
     (89     (72
Accounts payable
     (1,617     (317
Accrued expenses
     (1,313     (439
Deferred revenue
     (7     (113
    
 
 
   
 
 
 
Total adjustments
     (1,920     10,396  
    
 
 
   
 
 
 
Net cash used for operating activities
     (3,563     (1,416
    
 
 
   
 
 
 
Cash flow from investing activities:
                
Additions to patents, technology and other
     —         (1
Additions to property and equipment
     (262     (155
    
 
 
   
 
 
 
Net cash used for investing activities
     (262     (156
    
 
 
   
 
 
 
Cash flow from financing activities:
                
Issuance of common stock pursuant to stock option plans
     270       196  
Issuance of common stock pursuant to Employee Stock Purchase Plan
     47       —    
Proceeds from issuance of common stock, net
     23,229       —    
Principal repayment of debt financing
     —         (4,638
Repayment on line of credit
     —         (2,000
Proceeds from notes payable
     —         7,000  
Debt issuance costs
     —         (43
    
 
 
   
 
 
 
Net cash provided by financing activities
     23,546       515  
    
 
 
   
 
 
 
Increase
(decrease
)
in cash and equivalents
     19,721       (1,057
Cash and cash equivalents, beginning of period
     27,186       15,313  
    
 
 
   
 
 
 
Cash and cash equivalents, end of period
   $ 46,907     $ 14,256  
    
 
 
   
 
 
 
Supplemental disclosure of cash flow information:
                
Interest paid
   $ 92     $ 122  
    
 
 
   
 
 
 
Taxes paid
   $ —       $ 26  
    
 
 
   
 
 
 
Issuance of common stock upon conversion of debentures
     —         21,164  
    
 
 
   
 
 
 
Right-of-use
assets obtained in exchange for new operating lease liabilities
   $ —       $ 69  
    
 
 
   
 
 
 
See accompanying notes to condensed consolidated financial statements.
 
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Table of Contents
Consolidated Statements of Stockholders’ Equity Year to Date
(In thousands except shares)
 
    
Common Stock
    
Additional
              
 
     
    
Number of
           
Paid-in
    
Accumulated
   
Treasury
 
 
Stockholders’
 
    
Shares Issued
    
Par Value
    
Capital
    
Deficit
   
Stock
 
 
Equity
 
Balance at December 31, 2020
     23,694,406      $ 236      $ 273,639      $ (241,935   (1,415
 
$ 30,525  
Issuance of common stock relative to vesting of restricted stock
     20,000        —          —          —         —    
 
  —    
Issuance of common stock, net
     1,393,738        14        23,215        —         —    
 
  23,229  
Issuance of common stock pursuant to stock option plans
     28,934        1        270        —         —    
 
  271  
Issuance of common stock pursuant Employee Stock Purchase Plan
     6,354        —          47        —         —    
 
  47  
Stock-based compensation
     —          —          935        —         —    
 
  935  
Net loss
     —          —          —          (1,643     —    
 
   (1,643
Balance at March 31, 2021
     25,143,432      $ 251      $ 298,106      $ (243,578   $ (1,415
 
$
53,364  
Consolidated Statements of Stockholders’ Equity Quarter to Date
(In thousands except shares)
 
    
Common Stock
    
Additional
        
 
           
    
Number of
           
Paid-in
    
Accumulated
 
 
Treasury
   
Stockholders’
 
    
Shares Issued
    
Par Value
    
Capital
    
Deficit
 
 
Stock
   
Equity
 
Balance at December 31, 2019
     19,546,151      $ 196      $ 230,615      $ (224,325
 
$
(1,415
)
 
$
 
5,071  
Issuance of common stock relative to vesting of restricted stock
     23,500        —          —          —    
 
  —      
 
—    
Issuance of common stock pursuant to stock option plans
     36,799        1        195        —    
 
  —      
 
196  
Issuance of stock upon conversion of Debentures
     1,819,466        18        21,146        —    
 
  —      
 
21,164  
Stock-based compensation
                       464           
 
        
 
464  
Net loss
     —          —          —          (11,812
 
  —      
 
(11,812
    
 
 
    
 
 
    
 
 
    
 
 
 
 
 
 
   
 
 
 
Balance at March 31, 2020
     21,425,916      $ 215      $ 252,420      $ (236,137
 
$
(1,415  
$
15,083  
 
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Table of Contents
Notes to Condensed Consolidated Financial Statements:
Note 1 – Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements of iCAD, Inc. and its subsidiaries (together “iCAD” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). In the opinion of the Company’s management, these unaudited interim condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the financial position of the Company at March 31, 2021, the results of operations of the Company for the three -month periods ended March 31, 2021 and 2020, cash flows of the Company for the three-month periods ended March 31, 2021 and 2020, and stockholders’ equity for the Company for the three-month periods ended March 31, 2021 and 2020.
Although the Company believes that the disclosures made in these interim financial statements are adequate to make the information presented not misleading, certain information normally included in the footnotes prepared in accordance with US GAAP has been omitted as permitted by the rules and regulations of the Securities and Exchange Commission (the “SEC”). The accompanying interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form
10-K
for the fiscal year ended December 31, 2020 filed with the SEC on March 15, 2020, as amended on April 30, 2021. The results for the three -month period ended March 31, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021, or any future period.
Segments
The Company reports the results of two segments: Cancer Detection (“Detection”) and Cancer Therapy (“Therapy”). The Detection segment consists of advanced image analysis and workflow products. The Therapy segment consists of radiation therapy (“Axxent”) products.
Risk and Uncertainty
On March 12, 2020, the World Health Organization declared
COVID-19
to be a pandemic. In an effort to contain and mitigate the spread of the
COVID-19
pandemic, the United States, many countries in Europe, as well as Canada and China, imposed unprecedented restrictions on travel, and there have been business closures and reductions in economic activity in countries that have had significant outbreaks of
COVID-19.
As a provider of devices and services to the health care industry, the Company’s operations have been materially affected in part due to
stay-at-home
and social distancing orders as well as uncertainty in the market. Significant uncertainty remains as to the continuing impact of the
COVID-19
pandemic on the Company’s operations and on the global economy as a whole. 
 
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It is currently not possible to predict the duration of the pandemic or the time needed for economic activity to return to prior levels. The
COVID-19
pandemic has resulted in significant financial market volatility and uncertainty. Although the United States and other countries have made significant progress related to vaccinating significant portions of their populations, the efficacy of each individual vaccine against the multiple strains of the
COVID-19
virus is unknown. Moreover, a new “wave” of
COVID-19
cases may exacerbate the increased levels of market disruption and volatility seen in the recent past will have an adverse effect on the Company’s ability to access capital, on its business, results of operations and financial condition, and on the market price of its common stock.
The Company’s results for the quarter ending March 31, 2021 reflect a negative impact from the
COVID-19
pandemic due to some healthcare facilities’ additional focus on
COVID-19.
Although the Company does not provide guidance to investors relating to its future results of operations, its results for the quarter ending June 30, 2021, and possibly future quarters, could reflect a continued negative impact from the
COVID-19
pandemic for similar reasons. The duration and severity of the pandemic is unknown, and so the continued effect on the Company’s results over the long term is uncertain.
Although the Company did not experience any material impact to trade accounts receivable losses in the quarter ended March 31, 2021, the Company’s exposure may increase if its customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current
COVID-19
pandemic, or other customer-specific factors. The Company has not historically experienced significant trade account receivable losses, but it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade account receivables as hospitals’ cash flows are impacted by their response to the
COVID-19
pandemic.
Recently Adopted Accounting Pronouncements
There are no significant recently adopted accounting pronouncements. For a full list of the Company’s response to all relevant recent accounting pronouncements, please refer to Note 13 below.
 
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Revenue Recognition
Revenue is recognized wh
e
n a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration which the Company expects to be entitled to receive in exchange for these goods or services and excludes any sales incentives or taxes collected from customers which are subsequently remitted to government authorities.
Disaggregation of Revenue
The following tables presents the Company’s revenues disaggregated by major good or service line, timing of revenue recognition, and sales channel, reconciled to its reportable segments (in thousands).
 
 
  
Three months ended March 31, 2021
 
 
  
Reportable Segments
 
 
  
Detection
 
  
Therapy
 
  
Total
 
Major Goods/Service Lines
                          
Products
   $ 4,161      $ 2,103      $ 6,264  
Service contracts
     1,558        340        1,898  
Supply and source usage agreements
     —          481        481  
Professional services
     —          1        1  
    
 
 
    
 
 
    
 
 
 
     $ 5,719      $ 2,925      $ 8,644  
Timing of Revenue Recognition
                          
Goods transferred at a point in time
   $ 4,161      $ 2,104      $ 6,265  
Services transferred over time
     1,558        821        2,379  
    
 
 
    
 
 
    
 
 
 
     $ 5,719      $ 2,925      $ 8,644  
Sales Channels
                          
Direct sales force
   $ 3,875      $ 674      $ 4,549  
OEM partners  
     1,844        —          1,844  
Channel partners
     —          2,251        2,251  
    
 
 
    
 
 
    
 
 
 
     $ 5,719      $ 2,925      $ 8,644  
 
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Table of Contents
    
Three months ended March 31, 2020
 
    
Reportable Segments
 
    
Detection
    
Therapy
    
Total
 
Major Goods/Service Lines
                          
Products
   $ 3,100      $ 1,346      $ 4,446  
Service contracts
     1,347        347        1,694  
Supply and source usage agreements
     —          371        371  
Professional services
     —          11        11  
Other
     29                  29  
    
 
 
    
 
 
    
 
 
 
     $ 4,476      $ 2,075      $ 6,551  
Timing of Revenue Recognition
                          
Goods transferred at a point in time
   $ 3,129      $ 1,383      $ 4,512  
Services transferred over time
     1,347        692        2,039  
    
 
 
    
 
 
    
 
 
 
     $ 4,476      $ 2,075      $ 6,551  
Sales Channels
                          
Direct sales force
   $ 2,172      $ 1,469      $ 3,641  
OEM partners
     2,304        —          2,304  
Channel partners
     —          606        606  
    
 
 
    
 
 
    
 
 
 
     $ 4,476      $ 2,075      $ 6,551  
 
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Products.
Product revenue consists of sales of cancer detection products, cancer therapy systems, cancer therapy applicators (including disposable applicators) and other accessories that are typically shipped with a cancer therapy system. The Company transfers control and recognizes a sale when the product is shipped from the manufacturing or warehousing facility to the customer.
Service Contracts.
The Company sells service contracts in which it provides professional services, including product installations, maintenance, training, and service repairs, and in certain cases leases equipment, to hospitals, imaging centers, radiology practices, radiation oncologists and treatment centers. These contracts represent separate performance obligations to the Company. The Company allocates revenue to each performance obligation based on the Standalone Selling Price (“SSP”). Revenue for lease and
non-lease
components, or the entire arrangement when accounted for under ASC 606, “Revenue from Contracts with Customers” (“ASC 606”), is recognized on a straight-line basis over the term of the agreement. The service contracts range from 12 months to 48 months. The Company typically receives payment at the inception of the contract and recognizes revenue on a straight-line basis over the term of the agreement.
Supply and Source Usage Agreements.
Revenue from supply and source usage agreements is recognized on a straight-line basis over the term of the supply or source usage agreement.
 
These agreements represent a separate performance obligation to the Company. The Company allocates revenue to each performance obligation based on the SSP.
Professional Services.
Revenue from fixed fee service contracts is recognized on a straight-line basis over the term of the agreement. Revenue from professional service contracts entered into with customers on a time and materials basis is recognized over the term of the agreement in proportion to the costs incurred in satisfying the obligations under the contract.
Other.
Other revenue consists primarily of miscellaneous products and services. The Company transfers control and recognizes a sale when the product is shipped from the manufacturing or warehousing facility to the customer or the installation services are performed.
Contract Balances
Contract liabilities are a component of deferred revenue, current contract assets are a component of prepaid and other assets and
non-current
contract assets are a component of other assets. The following table provides information about receivables, current and
non-current
contract assets, and contract liabilities from contracts with customers (in thousands)
.
Contract balances
 
   
Balance at

March 31, 2021
   
Balance at

December 31, 2020
 
Receivables, which are included in ‘Trade accounts receivable’
  $ 10,649     $ 10,027  
Current contract assets, which are included in “Prepaid and other assets”
    701       481  
Non-current
contract assets, which are included in “other assets”
    1,478       1,434  
Contract liabilities, which are included in “Deferred revenue”
    6,377       6,384  
Timing of revenue recognition may differ from timing of invoicing of customers. The Company records a receivable when revenue is recognized prior to receipt of cash payment and the Company has the unconditional right to such consideration, or unearned revenue when cash payments are received or due in advance of performance. For multi-year agreements, the Company generally invoices customers annually at the beginning of each annual service period.
The Company’s accounts receivable from contracts with customers, net of allowance for doubtful accounts, was $10.6 million and $10.0 million as of March 31, 2021 and December 31, 2020, respectively.
The Company records net contract assets or contract liabilities on a
contract-by-contract
basis. The Company records a contract asset for unbilled revenue when the Company’s performance is in excess of amounts billed or billable. The Company classifies the net contract asset as either a current or
non-current
based on the expected timing of the Company’s right to bill under the terms of the contract. The current contract asset balance primarily relates to the net unbilled revenue balances with two significant customers, which the Company expects to be able to bill for within one year. The
non-current
contract asset balance consists of net unbilled revenue balances with one customer which the Company expects to be able to bill for in more than one year.
 
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Contract liabilities, or deferred revenue from contracts with customers, is primarily composed of fees related to long-term service arrangements, which are generally billed in advance. Deferred revenue also includes payments for installation and training that has not yet been completed and other offerings for which the Company has been paid in advance and earn the revenue when it transfers control of the product or service. The balance of deferred revenue at March 31, 2021 and December 31, 2020 is as follows (in thousands):
 
Contract liabilities
  
March 31, 2021
    
December 31, 2020
 
Short term
   $ 5,957      $ 6,117  
Long term
     420        267  
    
 
 
    
 
 
 
Total
   $ 6,377      $ 6,384  
    
 
 
    
 
 
 
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Changes in deferred revenue from contracts with customers were as follows (in thousands):
 
    
Three Months

Ended March 31,

2021
 
Balance at beginning of period
   $ 6,384  
Deferral of revenue
     3,259  
Recognition of deferred revenue
     (3,266
    
 
 
 
Balance at end of period
   $ 6,377  
    
 
 
 
Note 2 – Net Loss per Common Share
The Company’s basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period.
A summary of the Company’s calculation of net loss per share is as follows (in thousands except per share amounts):
 
    
Three Months Ended
 
    
March 31,
 
    
2021
    
2020
 
Net loss
  
$
(1,643
  
$
(11,812
    
 
 
    
 
 
 
Shares used in the calculation of basic and diluted net loss per share
     23,929        20,175  
    
 
 
    
 
 
 
Diluted shares used in the calculation of net loss per share
     23,929        20,175  
    
 
 
    
 
 
 
Net loss per share - basic and diluted
   $ (0.07    $ (0.59
    
 
 
    
 
 
 
The shares of the Company’s common stock issuable upon the exercise of convertible securities, stock options and vesting of restricted stock that were excluded from the calculation of diluted net loss per share because their effect would have been antidilutive are as follows:
 
 
  
As of
 
 
  
March 31,
 
 
  
2021
 
  
2020
 
Stock options
     2,246,776        1,747,363  
Restricted stock
     31,654        74,492  
    
 
 
    
 
 
 
Total
     2,278,430        1,821,855  
    
 
 
    
 
 
 
Note 3 – Inventory
Inventory is valued at the lower of cost or net realizable value, with cost determined by the
first-in,
first-out
method. The Company regularly reviews inventory quantities on hand and records a reserve for excess and/or obsolete inventory primarily based upon the estimated usage of its inventory as well as other factors. Inventory consisted of the following (in thousands) and includes an inventory reserve of approximately $0.2 million for both periods ended March 31, 2021 and December 31, 2020.
 
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March 31, 2021
    
December 31, 2020
 
Raw materials
   $ 1,305      $ 1,538  
Work in process
     194        76  
Finished Goods
     1,238        1,774  
    
 
 
    
 
 
 
Inventory Gross
     2,737        3,388  
Inventory Reserve
     (239      (244
    
 
 
    
 
 
 
Inventory Net
   $ 2,498      $ 3,144  
    
 
 
    
 
 
 
 
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Table of Contents
Note 4 – Financing Arrangements
(a) Loan and Security Agreement – Western Alliance Bank
On March 30, 2020, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Western Alliance Bank (the “Bank”) that provided an initial term loan (“Term Loan”) facility of $7.0 million and a $5.0 million revolving line of credit.
The Loan Agreement was amended effective June 16, 2020. The Loan Agreement, as amended, requires the Company to either (i) meet a minimum revenue covenant based on certain testing periods (to be agreed upon and set in good faith by the Company and the Bank) or (ii) maintain a ratio of unrestricted cash at the Bank to aggregate indebtedness owed to the Bank of at least 1.25 to 1.00 (the “Unrestricted Cash Covenant”). In accordance with the amendment, the Company and the Bank agreed that if there is not
a
minimum
revenue covenant in place, the Company shall, at all times, be required to comply with the Unrestricted Cash Covenant. As of March 31, 2021, the Company was in compliance with the Unrestricted Cash Covenant
.
If at any point the Company is not in compliance with certain covenants under the Loan Agreement and is unable to obtain an amendment or waiver, such noncompliance may result in an event of default under the Loan Agreement, which could permit acceleration of the outstanding indebtedness and require the Company to repay such indebtedness before the scheduled due date. The Company was required, periodically in the past, to seek modifications from its prior lender to avoid
non-compliance
with its earlier covenants.
Interest in arrears on the Term Loan began to be repaid on April 1, 2020 and will continue to be paid on the first of each successive month thereafter until the principal repayment starts. Commencing on the principal repayment date March 1, 2022 and continuing on the first day of each month thereafter, the Company will make equal monthly payments of principal, together with applicable interest in arrears, to the Bank. The interest rate is set at 1% above the Prime Rate, which is defined in the Loan Agreement as the greater of 4.25% or the Prime Rate published in the Money Rates section of the Western Edition of the Wall Street Journal. The Prime Rate as of March 31, 2020 was 3.25%.
The Company has the option to prepay all, but not less than all, of the Term Loan advanced by the Bank under the Loan Agreement. The Company prepayment is subject to payment of (1) all outstanding principal of the Term Loan plus accrued and unpaid interest thereon through the prepayment date, (2) the final payment ($122,500 or 1.75% of the original loan amount), (3) a 2% of principal if prepaid after March 30, 2021 but before June 30, 2022, or 1% of principal if prepaid after March 30, 2022) plus (4) all other obligations that are due and payable, including the Bank’s expenses and interest at the default rate with respect to any past due amounts.
Obligations to the Bank under the Loan Agreement are secured by a first priority security interest in the Company’s assets, except for certain permitted liens that have priority to the Bank’s security interest by operation of law.
In connection with the Loan Agreement, the Company incurred approximately $141,000 of closing costs. The closing costs have been deduced from the carrying value of the debt and will be amortized through March 30, 2022, the maturity date of the Term Loan.
The maturity date of the revolving loan is March 30, 2022 and there was no outstanding amount as of March 31, 2021.
On April 27, 2021, the Company repaid its obligations in the aggregate amount of $7,354,283 under and terminated the Loan Agreement with the Bank, and its collateral securing the facility was released.
(b) Loan and Security Agreement – Silicon Valley Bank
On August 7, 2017, the Company entered into a Loan and Security Agreement, which has since been modified several times through November 1, 2019 (as amended, the “SVB Loan Agreement”), with Silicon Valley Bank that provided an initial term loan facility of $6.0 million and a $4.0 million revolving line of credit.
On March 30, 2020, the Company elected to repay all outstanding obligations (including accrued interest) and retire the SVB Loan Agreement. The Company accounted for this repayment and retirement as an extinguishment of the SVB Loan Agreement. In addition to the outstanding principal and accrued interest, the Company was required to pay the $510,000 final payment, a termination fee of $114,000 and other costs totaling $10,000. The Company also wrote off unamortized original closing costs as of the extinguishment date.
In
M
arch
2020 the
Company recorded a loss on extinguishment of approximately $341,000 related to the repayment and retirement of the SVB Loan Agreement. The loss on extinguishment was composed of approximately $185,000 for the unaccrued final payment, $114,000 termination fee, and $42,000 of unamortized and other closing costs.
 
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Table of Contents
(c) Convertible Debentures
On December 20, 2018, the Company entered into a Securities Purchase Agreement (the “SPA”) with certain institutional and accredited investors (the “Investors”), including, but not limited to, all directors and executive officers of the Company at the time, pursuant to which the Investors purchased unsecured subordinated convertible debentures (the “Convertible Debentures”) with an aggregate principal amount of approximately $7.0 million in a private placement.
 
On February 21, 2020 (the “Conversion Date”), the conditions permitting a forced conversion were met, and the Company elected to exercise its forced conversion right under the terms of the Convertible Debentures.
As a result of this election, all of the outstanding Convertible Debentures were converted, at a conversion price of $4.00 per share, into 1,742,500 shares of the Company’s common stock. In accordance with the make-whole provisions in the Convertible Debentures, the Company also issued an additional 76,966 shares of its common stock. The make-whole amount represented the total interest which would have accrued through the maturity date of the Convertible Debentures, less the amounts previously paid, totaling $697,000. The conversion prices related to the make-whole amount were dependent on whether the Investors were related parties or unrelated third parties.
Accounting Considerations and Fair Value Measurements Related to the Convertible Debentures
The Company had previously elected to make
a one-time, irrevocable
election to utilize the fair value option to account for the Convertible Debentures as a single hybrid instrument at its fair value, with changes in fair value from period to period being recorded either in current earnings, or as an element of other comprehensive income (loss), for the portion of the change in fair value determined to relate to the Company’s own credit risk. The Company believed that the election of the fair value option allowed for a more meaningful representation of the total fair value of its obligation under the Convertible Debentures and allowed for a better understanding of how changes in the external market environment and valuation assumptions impact such fair value.
As of the December 31, 2019 valuation and the prior measurement dates, the Company utilized a Monte Carlo simulation model to estimate the fair value of the Convertible Debentures. The simulation model was designed to capture the potential settlement features of the Convertible Debentures, in conjunction with simulated changes in the Company’s stock price and the probability of certain events occurring. The simulation utilized 100,000 trials or simulations to determine the estimated fair value.
The simulation utilized the assumptions that if the Company was able to exercise its forced conversion right (if the requirements to do so were met), that it would do so in 100% of such scenarios. Additionally, if an event of default occurred during the simulated trial (based on the Company’s probability of default), the Investors would opt to redeem the Convertible Debentures in 100% of such scenarios. If neither event occurred during a simulated trial, the simulation assumed that the Investor would hold the Convertible Debentures until the maturity date. The value of the cash flows associated with each potential settlement were discounted to present value in each trial based on either the risk-free rate (for an equity settlement) or the effective discount rate (for a redemption or cash settlement).
The Company also recorded a final adjustment to the Convertible Debentures based on their fair value on the Conversion Date, just prior to the forced conversion being completed. Given that the Company’s prior simulation model included the assumption that the Company would elect to force conversion in 100% of scenarios when the requirements were met, the final valuation was based on the actual results of the forced conversion. As such, the Company based the final fair value adjustment to the Convertible Debentures just prior to conversion on the number of shares of common stock that were issued to the Investors upon conversion and the fair value of the Company’s common stock as of the Conversion Date.
 
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The Company notes that the key inputs to the valuation models that were utilized to estimate the fair value of the Convertible Debentures included:
 
Input
  
December 31, 2019
   
February 21, 2020
 
Company’s stock price
   $ 7.77     $ 11.64  
Conversion price
     4.00       4.00  
Remaining term (years)
     1.97       0.00  
Equity volatility
     49.00     N/A  
Risk free rate
     1.57     N/A  
1
Probability of default event
     0.45     N/A  
1
Utilization of Forced Conversion (if available)
     100.00     100.00
1
Exercise of Default Redemption (if available)
     100.00     N/A  
1
Effective discount rate
     18.52     N/A  
 
1
Represents a Level 3 unobservable input, as defined in Note 8 - Fair Value Measurements, below.
The Company’s stock price was based on the closing stock price on the valuation date. The conversion price was based on the contractual conversion price included in the SPA.
The remaining term was determined based on the remaining time period to maturity of the Convertible Debentures, or remaining term under the expectation of the Company’s election of its forced conversion right.
The Company’s equity volatility estimate was based on the Company’s historical equity volatility, the Company’s implied and observed volatility of option pricing, and the historical equity and observed volatility of option pricing for a selection of public companies.
The risk-free rate was determined based on U.S. Treasury securities with similar terms.
The probability of the occurrence of a default event was based on Bloomberg’s
1-year
estimate of default risk for the Company (extrapolated over the remaining term).
The utilization of the forced conversion right and the default redemption right was based on management’s best estimate of both features being exercised upon the occurrence of the related contingent events.
The effective discount rate utilized at the December 31, 2019 valuation date was based on yields on
CCC-rated
debt instruments with terms equivalent to the remaining term of the Convertible Debentures. The credit rating estimate was based on the implied credit rating determined at issuance and no changes were identified by the Company that would impact this assessment.
 
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The fair value and principal value of the Convertible Debentures as of December 31, 2019 and the Conversion Date was as follows (in thousands):
 
Convertible Debentures
  
December 31, 2019
    
February 21, 2020
 
Fair value, in accordance with fair value option
   $ 13,642      $ 21,164  
    
 
 
    
 
 
 
Principal value outstanding
   $ 6,970      $ 6,970  
    
 
 
    
 
 
 
In February 2020
 
t
he Company recorded a loss from the change in fair value of the Convertible Debentures of approximately $
7.5
 million for period through the Conversion Date which is described in the additional fair value disclosures related to the Convertible Debentures in Note
8
.
Upon the consummation of the forced conversion, the Company issued 1,816,466 shares of common stock with a fair value of approximately $21.2 million, which was reclassified to stockholders’ equity.
(d) Principal and Interest Payments Related to Financing Arrangements
Future principal, interest payments, and final payment related to the Loan Agreement are as follows (in thousands) as of March 31, 2021:
 
Fiscal Year
  
Amount Due
 
2021
     281  
2022
     3,224  
2023
     3,636  
2024
     712  
    
 
 
 
Total
   $ 7,853  
The following amounts are included in interest expense in the Company’s consolidated statement of operations for the three months ended March 31, 2021 and 2020 (in thousands): 
 
    
Three Months Ended March 31,
 
    
2021
    
2020
 
Cash interest expense
   $ 92      $ 43  
Interest on convertible debentures
    
—  
       49  
Accrual of notes payable final payment
     7        31  
Amortization of debt costs
     13        7  
    
 
 
    
 
 
 
Total interest expense
   $ 112      $ 130  
    
 
 
    
 
 
 
 
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Note 5 – Lease Commitments
Under ASC 842, “Leases” (“ASC 842”), the Company determines if an arrangement contains a lease at inception. A lease is a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment (i.e., an identified asset) for a period of time in exchange for consideration. Leases are classified as either operating leases or financing leases. At lease inception, the Company recognizes a lease liability equal to the present value of the remaining lease payments, and a right of use asset equal to the lease liability, subject to certain adjustments, such as for lease incentives. The Company uses its incremental borrowing rate to determine the present value of the lease payments. The Company determines the incremental borrowing rates for its leases by applying its applicable, fully collateralized borrowing rate, with adjustment as appropriate for the lease term. The lease term at the lease commencement date is determined based on the
non-cancellable
period for which the Company has the right to use the underlying asset, together with any periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option. The Company considers a number of factors when evaluating whether the options in its lease contracts are reasonably certain of exercise, such as length of time before option exercise, expected value of the leased asset at the end of the initial lease term, importance of the lease to overall operations, costs to negotiate a new lease, and any contractual or economic penalties.
Right-of-use
assets and obligations for short-term leases (leases with an initial term of 12 months or less) are not recognized in the consolidated balance sheet. Lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company does not sublease any of its leased assets to third parties. The Company’s lease agreements do not contain any residual value guarantees or restrictive covenants. The Company has lessor agreements that contain lease and
non-lease
components. As the Company has determined that the
non-lease
component of these agreements is the predominant component, the Company accounted for the complete agreement under ASC 606 upon adoption of ASC 842.
ASC 842 includes a number of reassessment and
re-measurement
requirements for lessees based on certain triggering events or conditions, including whether a contract is or contains a lease, assessment of lease term and purchase options, measurement of lease payments, assessment of lease classification and assessment of the discount rate. The Company reviewed the reassessment and
re-measurement
requirements and identified two lease modifications which are reflected in the table below showing the maturity of the Company’s lease liabilities as of March 31, 2021. This includes an extension of an operating lease for the facility leased by the Company in San Jose, California as well as some equipment. In addition, there were no impairment indicators identified during the quarter ended March 31, 2021 that required an impairment test for the Company’s
right-of-use
assets or other long-lived assets in accordance with ASC 360 10 “Property Plant and Equipment” (“ASC 360”).
Certain of the Company’s leases include variable lease costs to reimburse the lessor for real estate tax and insurance expenses, and certain
non-lease
components that transfer a distinct service to the Company, such as common area maintenance services. The Company has elected to not separate its accounting of lease components and
non-lease
components for real estate and equipment leases
.
 
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Components of Leases:
The Company has leases for office space and office equipment. The leases have remaining lease terms ranging from less than one year to three years and three months as of March 31, 2021
.
The components of lease expense for the period are as follows (in thousands):
 
Lease Cost
  
Classification
  
Three Months

Ended March 31,

2021
 
Operating lease cost - Right of Use Asset
  
Operating expenses
   $ 217  
Operating lease cost - Variable
  
Operating expenses
      
57
 
Finance lease costs
 
 
 
 
 
 
Amortization of leased assets
  
Amortization and depreciation
         
Interest on lease liabilities
  
Interest expense
         
         
 
 
 
Total
        $ 274  
Other information related to leases was as follows (in thousands):
 
 
  
Three Months

Ended March 31,

2021
 
Cash paid from operating cash flows for operating leases
   $ 118  
 
 
 
 
    
As of March 31,

2021
 
Weighted-average remaining lease term of operating leases (in years)
     1.96  
Weighted-average discount rate for operating leases
     5.5
 
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Maturity of the Company’s lease liabilities as of March 31, 2021 was as follows (in thousands):
 
Three Months Ended March 31, 2021:
  
Operating

Leases
 
2021
     692  
2022
     899  
2023
     211  
2024
     5  
    
 
 
 
Total lease payments
     1,807  
Less: imputed interest
     (100
    
 
 
 
Total lease liabilities
     1,707  
Less: current portion of lease liabilities
     (847
    
 
 
 
Long-term lease liabilities
   $ 860  
    
 
 
 
Note 6 – Stockholders Equity
(a) Financing Activity
On March 2, 2021, the Company entered into an underwriting agreement with Guggenheim Securities, LLC, as representative of the several underwriters thereto, in connection with an underwritten public offering of 1,393,738 shares of the Company’s common stock at an offering price of $18.00 per share. The Offering closed on March 5, 2021 for gross proceeds of approximately $25.1 million and net proceeds of approximately $23.2 million to the Company.
(b) Stock-Based Compensation
The Company granted options to purchase 428,938 shares of the Company’s stock during the three months ended March 31, 2021. Options granted under the Company’s stock incentive plans were valued utilizing the Black-Scholes model using the following assumptions and had the following fair values:
 
    
March 31,
    
2021
 
2020
Average risk-free interest rate
   0.20%   1.24%
Expected dividend yield
   None   None
Expected life
   3.5 years   3.5 years
Expected volatility
   66.0% to 66.0%   50.2% to 64.0%
Weighted average exercise price
   $18.00   $8.26
Weighted average fair value
   $8.37   $3.19
 
    
Three Months Ended
 
    
March 31,
 
    
2021
    
2020
 
Cost of revenue
   $ 14      $ 1  
Engineering and product development
     149        54  
Marketing and sales
     353        58  
General and administrative
     419        351  
    
 
 
    
 
 
 
     $ 935      $ 464  
    
 
 
    
 
 
 
 
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As of March 31, 2021, unrecognized compensation cost (in thousands) related to unvested options and unvested restricted stock and the weighted average term of such equity instruments is as follows:
 
Remaining expense
   $ 3,823  
Weighted average term
     1.26  
The Company’s restricted stock awards typically vest in either one year or three equal annual installments with the first installment vesting one year from the grant date.
The Company granted 22,488 and 0 shares of restricted stock during the three-month period ended March 31, 2021 and 2020, respectively. 
The Company’s aggregate intrinsic value for stock options and restricted stock outstanding is as follows (in thousands):
 
    
As of
 
    
March 31,
 
Aggregate intrinsic value
  
2021
    
2020
 
Stock options
   $ 29,305      $ 2,273  
Restricted stock
     672        1,396  
The Company issued 48,934 shares of common stock upon the exercise of outstanding stock options in the three-month periods ended March 31, 2021. The Company received cash proceeds of approximately $271,000 in the three -month period ended March 31, 2021. The intrinsic value of restricted shares that vested in the three months ended March 31, 2021 was $0.3 million.
 There were
20,000 restricted shares
that
vested in the three months ended March 31, 2021.
Employee Stock Purchase Plan
In December 2019, the 2019 Employee Stock Purchase Plan (“ESPP”) was adopted by the Company’s Board of Directors (the “Board”) and approved by stockholders, effective January 1, 2020.
The ESPP provides for the issuance of up to 950,000 shares of common stock, subject to adjustment in the event of a stock split, stock dividend or other change in the Company’s capitalization. The ESPP may be terminated or amended by the Board at any time. Certain amendments to the ESPP require stockholder approval.
Substantially all of the Company’s employees whose customary employment is for more than 20 hours a week are eligible to participate in the ESPP. Any employee who owns 5% or more of the voting power or value of the Company’s shares of common stock is not eligible to participate in the ESPP.
 
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Any eligible employee can enroll in the ESPP as of the beginning of a respective quarterly accumulation period. Employees who participate in the ESPP may purchase shares by authorizing payroll deductions of up to
15
% of their base compensation during an accumulation period. Unless the participating employee withdraws from participation, accumulated payroll deductions are used to purchase shares of common stock on the last business day of the accumulation period (the “Purchase Date”) at a price equal to
85
% of the lower of the fair market value on (i) the Purchase Date or (ii) the first day of such accumulation period. Under applicable tax rules, no employee may purchase more than $
25,000
worth of common stock, valued at the start of the purchase period, under the ESPP in any calendar year.
The Company issued 6,354 shares under the ESPP in the three -month period ended March 31, 2021. The Company recorded approximately $
27,000
 
of stock-based compensation expense pursuant to ESPP for the three-month period ended March 31, 2021. The next accumulation period under the ESPP commenced on January 31, 2021 and ended on March 31, 2021, and the related shares purchased by the participants were issued in April 2021. As of March 31, 2021, the Company recorded a liability of $
82,000
related to employee withholdings in connection with the ESPP accumulation period ended March 31, 2021, which was included as a component of accrued expenses and other current liabilities.
Note 7 – Commitments and Contingencies
Other Commitments
The Company is obligated to pay approximately $4.1 million for firm purchase obligations to suppliers for future product and service deliverables
 
and $0.5 million for minimum royalty obligations.
Litigation
In December 2016, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Invivo Corporation (“Invivo”). In accordance with the Asset Purchase Agreement, the Company sold to Invivo all right, title and interest to certain intellectual property relating to the Company’s VersaVue Software and DynaCAD product and related assets
for $3.2 million. The Company closed the transaction on January 30, 2017 less a holdback reserve of $350,000
(the “Escrowed Amount”) for net proceeds of approximately
 $2.9 million.
On September 5, 2018, third-party Yeda Research and Development Company Ltd. (“Yeda”), filed a complaint (the “Complaint”) against the Company and Invivo in the United States District Court for the Southern District of New York, captioned Yeda Research and Development Company Ltd. v. iCAD, Inc. and Invivo Corporation, Case No. 1:18-cv-08083-GBD, related to the Company’s sale of the VersaVue software and DynaCAD product under the Asset Purchase Agreement. Yeda alleged, among other things, that the Company infringed upon Yeda’s source code, which was originally licensed to the Company, by using it in the products that the Company sold to Invivo and that it is entitled to damages that could include, among other things, profits relating to the sales of these products On April 13, 2021, the Company and Yeda entered into a Settlement and Release Agreement (the “Settlement Agreement”) whereby the Company furnished to Yeda a one-time cash payment of 
$85,000
and received a full, non-conditional release from Yeda of any and all claims related to the Complaint and the subject of the Complaint. Neither the Company nor Invivo acknowledged any wrongdoing at any point in connection with the Complaint or the subject matter thereof. The Escrowed Amount was reserved, in part, to cover any legal expenses related to the Asset Purchase Agreement and the transactions contemplated therein. The remaining balance of the Escrowed Amount following such expenses is due and payable to the Company in accordance with the terms of the Asset Purchase Agreement. However, the Company is unaware of the amount Invivo may claim it is entitled to of the Escrowed Amount, if any, under the Asset Purchase Agreement.
The Company may be a party to various legal proceedings and claims arising out of the ordinary course of its business. Although the final results of all such matters and claims cannot be predicted with certainty, the Company currently believes that there are no current proceedings or claims pending against it the ultimate resolution of which would have a material adverse effect on its financial condition or results of operations. However, should the Company fail to prevail in any legal matter or should several legal matters be resolved against the Company in the same reporting period, such matters could have a material adverse effect on the Company’s operating results and cash flows for that particular period. The Company may be a party to certain actions that have been filed against the Company which are being vigorously defended. The Company has determined that potential losses in these matters are neither probable or reasonably possible at this time. In all cases, at each reporting period, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under ASC 450, “Contingencies.” Legal costs are expensed as incurred.
 
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Note 8 - Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset
or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following:
 
   
Level 1 - Quoted prices in active markets for identical assets or liabilities.
 
   
Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
 
   
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The Company’s financial instruments consist of cash and cash equivalents, accounts receivable, accounts payable, and notes payable and convertible debentures. Due to their short-term nature and market rates of interest, the carrying amounts of the financial instruments (except the Convertible Debentures, which were measured at fair value in accordance with the fair value option election) approximated fair value as of February 21, 2020 and December 31, 2019.
The Company’s assets and liabilities that are measured at fair value on a recurring basis include the Company’s money market accounts and Convertible Debentures.
The money market accounts are included in cash and cash equivalents in the accompanying consolidated balance sheet and are considered a Level 1 measurement as they are valued at quoted market prices in active markets.
The Convertible Debentures were recorded as a separate component of the Company’s consolidated balance sheet and are considered a Level 3 measurement due to the utilization of significant unobservable inputs in their valuation. See Note 4(b) for a discussion of these fair value measurements.
The following table sets forth the Company’s assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands).
 
Fair Value Measurements as of December 31, 2020
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
Assets
                                   
Money market accounts
   $ 27,186        —          —        $ 27,186  
    
 
 
    
 
 
    
 
 
    
 
 
 
Total Assets
   $ 27,186        —          —        $ 27,186  
    
 
 
    
 
 
    
 
 
    
 
 
 
 
Fair Value Measurements (in thousands) as of March 31, 2021
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
Assets
                                   
Money market accounts
   $ 46,907     
—       
—        $ 46,907  
    
 
 
    
 
    
 
    
 
 
 
Total Assets
   $ 46,907     
—       
—        $ 46,907  
    
 
 
    
 
 
    
 
 
    
 
 
 
 
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Note 9 - Income Taxes
The Coronavirus Aid, Relief, and Economic Security Act was enacted on March 27, 2020 and did not have a material impact on the Company’s provision for income taxes for the three months ended March 31, 2021.
The Company recorded an income tax provision of $0 for the three months ended March 31, 2021,
and $26,000 for the three months ended March 31, 2020.
 
The Company adopted ASU
2019-12
as of January 1, 2021, in accordance with this provision
non-income
and state franchise taxes are now classified as a component of operating expenses in General and Administrative expense. Income based tax expense will continue to be recognized as tax expense in the Consolidated Financial Statements. Tax expense for three months ended March 31, 2020 represent
non-income
and state franchise tax, however the expense was not reclassified to operating expenses in accordance with ASU
2019-12.
The Company had no material unrecognized tax benefits and a deferred tax liability of approximately $4,000 related to tax amortizable goodwill. No other adjustments were required under ASC 740, “Income Taxes.” The Company does not expect that its unrecognized tax benefits will materially increase within the next 12 months. The Company did not recognize any interest or penalties related to uncertain tax positions at March 31, 2021.
The Company files United States federal income tax returns and income tax returns in various states and local jurisdictions. The Company’s three preceding tax years remain subject to examination by federal and state tax authorities. In addition, because the Company has net operating loss carry-forwards, the Internal Revenue Service and state jurisdictions are permitted to audit earlier years and propose adjustments up to the amount of net operating loss generated in those years. The Company is not currently under examination by any federal or state jurisdiction for any tax years.
Note 10 - Goodwill
The Company tests goodwill for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of the reporting unit is less than its carrying value. There were no impairment indicators present as of March 31, 2021.
Factors the Company considers important, which could trigger an impairment of such asset, include the following:
 
   
significant underperformance relative to historical or projected future operating results;
 
   
significant changes in the manner or use of the assets or the strategy for the Company’s overall business;
 
   
significant negative industry or economic trends;
 
   
significant decline in the Company’s stock price for a sustained period; and
 
   
a decline in the Company’s market capitalization below net book value.
The Company would record an impairment charge when such assessment indicates that the fair value of a reporting unit is less than the carrying value. In evaluating potential impairments outside of the annual measurement date, judgment is required in determining whether an event has occurred that may impair the value of goodwill or intangible assets.
The Company utilizes either discounted cash flow models or other valuation models, such as comparative transactions and market multiples, to determine the fair value of reporting units. The Company makes assumptions about future cash flows, future operating plans, discount rates, comparable companies, market multiples, purchase price premiums and other factors in those models. Different assumptions and judgment determinations could yield different conclusions that would result in an impairment charge to income in the period that such change or determination was made.
 
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The Company determines the fair values for each reporting unit using a weighting of the income approach and the market approach. For purposes of the income approach, fair value is determined based on the present value of estimated future cash flows, discounted at an appropriate risk adjusted rate. The Company uses internal forecasts to estimate future cash flows and includes estimates of long-term future growth rates based on its most recent views of the long-term forecast for each segment. Accordingly, actual results can differ from those assumed in the Company’s forecasts. Discount rates are derived from a capital asset pricing model and by analyzing published rates for industries relevant to the Company’s reporting units to estimate the cost of equity financing. The Company uses discount rates that are commensurate with the risks and uncertainty inherent in the respective businesses of its reporting units and in the Company’s internally developed forecasts.
In the market approach, the Company uses a valuation technique in which values are derived based on market prices of publicly traded companies with similar operating characteristics and in similar industries. A market approach allows for comparison to actual market transactions and multiples. It can be somewhat limited in its application because the population of potential comparable publicly-traded companies can be limited due to differing characteristics of the comparative business and the Company, as well as the fact that market data may not be available for divisions within larger conglomerates or
non-public
subsidiaries that could otherwise qualify as comparable, and the specific circumstances surrounding a market transaction (e.g., synergies between the parties, terms and conditions of the transaction, etc.) may be different or irrelevant with respect to the business.
The Company corroborates the total fair values of the reporting units using a market capitalization approach; however, this approach cannot be used to determine the fair value of each reporting unit. The blend of the income approach and market approach is more closely aligned to the business profile of the Company, including markets served and products available. In addition, required rates of return, along with uncertainties inherent in the forecast of future cash flows, are reflected in the selection of the discount rate. In addition, under the blended approach, reasonably likely scenarios and associated sensitivities can be developed for alternative future states that may not be reflected in an observable market price. The Company will assess each valuation methodology based upon the relevance and availability of the data at the time the valuation is performed and weights the methodologies appropriately.
The Company has two operating segments, Detection and Therapy, as further discussed in Note 12 below.
 
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A rollforward of goodwill activity by reportable segment is as follows (in thousands):
 
 
  
Consolidated
reporting unit
 
  
Detection
 
  
Therapy
 
  
Total
 
Accumulated Goodwill
   $ 47,937      $ —        $ —        $ 47,937  
Accumulated impairment
     (26,828      —          —          (26,828
Fair value allocation
     (21,109      7,663        13,446        —    
Acquisition of DermEbx and Radion
     —          —          6,154        6,154  
Acquisition measurement period adjustments
     —          —          116        116  
Acquisition of VuComp
     —          1,093        —          1,093  
Sale of MRI assets
     —          (394               (394
Impairment
     —          —          (19,716      (19,716
    
 
 
    
 
 
    
 
 
    
 
 
 
Balance at December 31, 2020 and March 31, 2021
     —          8,362        —          8,362  
    
 
 
    
 
 
    
 
 
    
 
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
Note 11 – Long-lived assets
The Company assesses long-lived assets for impairment if events and circumstances indicate it is more likely than not that the fair value of the asset group is less than its carrying value.
There is no set interval or frequency for recoverability evaluation. Rather, the determination of when, if at all, an asset (or asset group) is evaluated for recoverability is based on “events and circumstances.” The following factors are examples of events or changes in circumstances that indicate the carrying amount of an asset (or asset group) may not be recoverable and thus is to be evaluated for recoverability.
 
   
A significant decrease in the market price of a long-lived asset (or asset group);
 
   
A significant adverse change in the extent or manner in which a long-lived asset (or asset group) is being used or in its physical condition;
 
   
A significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (or asset group), including an adverse action or assessment by a regulator;
 
   
An accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (or asset group); and
 
   
A current operating period, or cash flow loss combined with a history of operating or cash flow losses or a projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (or asset group).
The Company determined there were no such triggering events in the quarter ended March 31, 2021.
If the carrying amount of an asset or asset group (in use or under development) is evaluated and found not to be fully recoverable (e.g., the carrying amount exceeds the estimated gross, undiscounted cash flows from use and disposition), then an impairment loss must be recognized. The impairment loss is measured as the excess of the carrying amount over the fair value of the asset (or asset group). The Company determined the “Asset Group” of the Company to be the assets of the Therapy segment and the Detection segment, which the Company considers to be the lowest level for which the identifiable cash flows were largely independent of the cash flows of other assets and liabilities.
A considerable amount of judgment and assumptions are required in performing the impairment tests, principally in determining the fair value of the asset group and the reporting unit. While the Company believes that its judgments and assumptions are reasonable, different assumptions could change the estimated fair values and, therefore additional impairment charges could be required. Significant negative industry or economic trends, disruptions to the Company’s business, loss of significant customers, inability to effectively integrate acquired businesses, unexpected significant changes or planned changes in use of the assets may adversely impact the assumptions used in the fair value estimates and ultimately result in future impairment charges.
 
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Note 12 – Segment Reporting
Operating segments are defined as components of an enterprise that engage in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance.
The Company’s CODM is the Chief Executive Officer. Each reportable segment generates revenue from the sale of medical equipment and related services and/or sale of supplies. The Company has determined there are two segments, Detection and Therapy.
The Detection segment consists of the Company’s advanced image analysis and workflow products, and the Therapy segment consists of the Company’s radiation therapy products, “Axxent,” and related services. The primary factors used by the Company’s CODM to allocate resources are based on revenues, gross profit, operating income, and earnings or loss before interest, taxes, depreciation, amortization, and other specific and
non-recurring
items of each segment. Included in segment operating income are stock compensation, amortization of technology and depreciation expense. There are no intersegment revenues.
The Company does not track assets by operating segment and the Company’s CODM does not use asset information by segment to allocate resources or make operating decisions.
Segment revenues, gross profit, segment operating income or loss, and a reconciliation of segment operating income or loss to US GAAP loss before income tax is as follows (in thousands):
 
     Three Months Ended  
     March 31,  
     2021      2020  
Segment revenues:
                 
     
Detection
   $ 5,719      $ 4,476  
Therapy
     2,925        2,075  
    
 
 
    
 
 
 
Total Revenue
   $ 8,644      $ 6,551  
    
 
 
    
 
 
 
Segment gross profit:
                 
     
Detection
   $ 4,725      $ 3,467  
Therapy
     1,564        1,043  
    
 
 
    
 
 
 
Segment gross profit
   $ 6,289      $ 4,510  
    
 
 
    
 
 
 
Segment operating income (loss):
                 
     
Detection
   $ 941      $ (346
Therapy
     (312      (1,006
    
 
 
    
 
 
 
Segment operating income (loss)
   $ 629      $ (1,352
    
 
 
    
 
 
 
General, administrative, depreciation and amortization expense
   $ (2,162    $ (2,541
Interest expense
     (112      (130
Other income
     2        42  
Loss on extinguishment of debt
     —          (341
Fair value of convertible debentures
     —          (7,464
    
 
 
    
 
 
 
Loss before income tax
   $ (1,643    $ (11,786
    
 
 
    
 
 
 
 
 
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Table of Contents
Note 13 - Recent Accounting Pronouncements
Recently Adopted Accounting Standards
In December 2019, the Financial Accounting Standard Board (the “FASB”) issued ASU
2019-12,
“Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes” (“ASU
2019-12”).
ASU
2019-12
is intended to simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments also improve consistent application of and simplify
US-GAAP
for other areas of Topic 740 by clarifying and amending existing guidance. ASU
2019-12
is effective for the Company for the fiscal year and interim periods therein beginning January 1, 2021. The Company notes that the adoption of ASU
2019-12
resulted in the reclassification of an immaterial amount from income tax expense to
non-income
tax included in operating expenses related to the accounting for state and Franchise taxes, with no impact to the Company’s consolidated income, equity or cash flows.
Recently Issued Accounting Standards Not Yet Adopted
In June 2016, the FASB issued
ASU 2016-13, “Financial
Instruments - Credit Losses (Topic 326)”
(“ASU 2016-13”),
which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost.
ASU 2016-13
replaces the existing incurred loss impairment model with an expected loss model which requires the use of forward-looking information to calculate credit loss estimates. These changes will result in earlier recognition of credit losses. In November 2019, the FASB elected to defer the adoption date of ASU
2016-13
for public business entities that meet the definition of a smaller reporting company to fiscal years beginning after December 15, 2022. Early adoption of the guidance in ASU
2016-13
is permitted. The Company is currently evaluating the impact that the adoption of ASU
2016-13
will have on its consolidated financial statements.
In March 2020, the FASB issued ASU
2020-04,
“Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting” (“ASU
2020-04”). ASU
2020-04
was issued because the London Interbank Offered Rate (“LIBOR”) is a benchmark interest rate referenced in a variety of agreements that are used by all types of entities, and at the end of 2021, banks will no longer be required to report information that is used to determine LIBOR. As a result, LIBOR is expected to be discontinued as a benchmark interest rate. Other interest rates used globally could also be discontinued for similar reasons. ASU
2020-04
provides companies with optional guidance to ease the potential accounting burden associated with transitioning away from reference rates that are expected to be discontinued. Companies can apply the ASU immediately. However, the guidance will only be available for a limited time (generally through December 31, 2022). The Company is currently evaluating the impact that the adoption of ASU
2020-04
will have on its consolidated financial statements.
In August 2020, the FASB issued ASU
2020-06,
“Debt – Debt with Conversion and Other Options (Subtopic
470-20)
and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic
815-40):
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU
2020-06”).
ASU
2020-06
was issued to simplify the accounting for convertible instruments by removing major separation models required under current U.S. GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrument and more convertible preferred stock as a single equity instrument with no separate accounting for embedded conversion features. ASU
2020-06
removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for it. ASU
2020-06
also simplifies the diluted earnings per share calculation in certain areas. ASU
2020-06
is effective for the Company for the fiscal year and interim periods therein beginning January 1, 2022. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU
2020-06
will have on its consolidated financial statements.
Note 14 – Subsequent Events
Settlement with Yeda Research and Development Company Ltd.
On April 13, 2021, as described in Part II, Item 1 and Note 7 of the Notes to the Condensed Consolidated Financial Statements herein, the Company and Yeda entered into the Settlement Agreement, whereby the Company furnished to Yeda a
one-time
cash payment of $85,000 and received a full,
non-conditional
release from Yeda of any and all claims related to the Complaint and the subject matter of the Complaint. Neither the Company nor Invivo acknowledged any wrongdoing at any point in connection with the Complaint or the subject matter thereof. As described elsewhere in this report, the Escrowed Amount, being $350,000,
was held back in reserve from the gross proceeds furnished in connection with the Asset Purchase Agreement, in part, to cover any legal expenses related to the Asset Purchase Agreement and the transactions contemplated therein. The remaining balance of the Escrowed Amount following such expenses is due and payable to the Company in accord with the terms of the Asset Purchase Agreement. However, the Company is unaware of the amount Invivo may claim it is entitled to of the Escrowed Amount, if any, under the Asset Purchase Agreement.
 
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Termination of Western Alliance Bank Loan and Security Agreement
On April 27, 2021, as described in Note 4 of the Notes to the Condensed Consolidated Financial Statements herein, the Company repaid its obligations in the aggregate amount of $7,354,283 under and terminated the Loan Agreement with the Bank, and its collateral securing the facility was released.
 
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Certain information included in this Item 2 and elsewhere in this Form
10-Q
that are not historical facts contain statements that may be deemed “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve or may involve a number of known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to following: the impact of the
COVID-19
pandemic on the Company’s business and the global economy; uncertainty of future sales and expense levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, regulatory changes and requirements applicable to our products, product market acceptance, possible technological obsolescence of products, increased competition, integration of acquired businesses, the impact of litigation and/or government regulation, changes in Medicare reimbursement policies,
 
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competitive factors, the effects of a decline in the economy in markets served by the Company and other risks detailed in the Company’s other filings with the Securities and Exchange Commission. The words “believe”, “plan”, “intend”, “expect”, “estimate”, “anticipate”, “likely”, “seek”, “should”, “would”, “could” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date the statement was made. Except as required by law, we undertake no obligation to update any such forward-looking statements to reflect events or circumstances after the date of such statements.
Results of Operations
Overview
iCAD, Inc. is a global medical technology company providing innovative cancer detection and therapy solutions. The Company reports in two segments: Detection and Therapy.
In the Detection segment, the Company’s solutions include (i) advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier, and (ii) a comprehensive range of high-performance, Artificial Intelligence and Computer-Aided Detection (CAD) systems and workflow solutions for 2D and 3D mammography, Magnetic Resonance Imaging (MRI) and Computed Tomography (CT).
In the Therapy segment, the Company offers the Xoft System, an isotope-free cancer treatment platform technology. The Xoft System can be used for the treatment of early-stage breast cancer, endometrial cancer, cervical cancer and nonmelanoma skin cancer.
On January 30, 2017, the Company completed the sale of certain intellectual property relating to the VersaVue Software and the DynaCAD product and related assets to Invivo for $3,200,000 in cash with a holdback amount of $350,000. The Company recently settled litigation with a third-party relating to this transaction, as further described in “Item 1—Legal Proceedings” and Note 7 hereto. The three months ended March 31, 2020 included a $7.8 million charge related to the losses on the extinguishment of debentures and debt, and in April 2021, the Company used approximately $7.4 million of cash to repay its credit facility in full.
The Company’s headquarters are located in Nashua, New Hampshire, with a manufacturing facility in New Hampshire and an operations, research, development, manufacturing and warehousing facility in San Jose, California.
COVID-19
Impact
On March 12, 2020, the World Health Organization declared
COVID-19
to be a pandemic. In an effort to contain and mitigate the spread of the
COVID-19
pandemic, the United States, many countries in Europe, as well as Canada and China, have imposed unprecedented restrictions on travel, and there have been business closures and a substantial reduction in economic activity in countries that have had significant outbreaks of
COVID-19.
As a provider of devices and services to the health care industry, our operations have been materially affected. Significant uncertainty remains as to the continuing impact of the
COVID-19
pandemic on our operations and on the global economy as a whole. It is currently not possible to predict how long the pandemic will last or the time that it will take for economic activity to return to prior levels. The
COVID-19
pandemic has resulted in significant financial market volatility and uncertainty. A worsening level of market disruption and volatility seen in the recent past will have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on the market price of our common stock. Our results for the quarter ending March 31, 2021 reflect a negative impact from the
COVID-19
pandemic, due to some healthcare facilities’ additional focus on
COVID-19.
Although we do not provide guidance to investors relating to our results of operations, our results for the quarter ending June 30, 2021, and possibly future quarters, could reflect a continued negative impact from the
COVID-19
pandemic for similar reasons.
During the first quarter of fiscal 2020, the Company entered into an equity distribution agreement with JMP Securities to provide for an
at-
the-market
offering program to provide additional potential liquidity through the sale of common stock having a value of up to $25.0 million (the “ATM Facility”). On December 17, 2020 the company sold 470,704 shares of common stock under the ATM Facility for gross proceeds of approximately $6.6 million and net proceeds of approximately $6.1 million. On March 2, 2021, the Company terminated the ATM Facility. Also on March 2, 2021, the Company entered into an underwriting agreement with Guggenheim Securities, LLC, as representative of the several underwriters thereto, in connection with an underwritten public offering of 1,393,738 shares of the Company’s common stock at an offering price of $18.00 per share. The Offering closed on March 5, 2021 for gross proceeds of approximately $25.1 million and net proceeds of approximately $23.2 million to the Company. The Company believes that its current liquidity and capital resources are sufficient to sustain operations through at least the next 12 months, primarily due to cash on hand of $46.9 million at March 31, 2021 and anticipated revenue and cash collections. However, the resurgence of the
COVID-19
pandemic could affect our liquidity.
 
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Critical Accounting Estimates
The Company’s discussion and analysis of its financial condition, results of operations, and cash flows are based on the Company’s consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.
The preparation of these 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 ongoing basis, the Company evaluates these estimates, including those related to revenue recognition, allowance for doubtful accounts, inventory valuation and obsolescence, intangible assets, goodwill, income taxes, contingencies, and litigation. Additionally, the Company uses assumptions and estimates in calculations to determine stock-based compensation, the fair value of convertible debentures, and evaluation of litigation. The Company bases its estimates on historical experience and on various other assumptions that it believes 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. Actual results may differ from these estimates under different assumptions or conditions.
Due to the
COVID-19
pandemic, there has been uncertainty and disruption in the global economy and financial markets. The Company is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the date of issuance of this Quarterly Report on Form
10-Q.
These estimates may change, as new events occur, and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions.
Other than as described herein, there have been no additional material changes to our critical accounting policies as discussed in our 2020 Annual Report on Form
10-K
(the “2020
10-K”).
For a comprehensive list of the Company’s critical accounting policies, reference should be made to the 2020
10-K.
 
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Three months ended March 31, 2021 compared to three months ended March 31, 2020.
Revenue: (in thousands)
Three months ended March 31, 2021 and 2020:
 
    
Three months ended March 31,
 
    
2021
    
2020
    
Change
    
% Change
 
Detection revenue
           
Product revenue
   $ 4,161      $ 3,100      $ 1,061        34.2
Service and supplies revenue
     1,558        1,376        182        13.2
  
 
 
    
 
 
    
 
 
    
 
 
 
Subtotal
     5,719        4,476        1,243        27.8
  
 
 
    
 
 
    
 
 
    
 
 
 
Therapy revenue
           
Product revenue
     1,396        695        701        100.9
Service and supplies revenue
     1,529        1,380        149        10.8
  
 
 
    
 
 
    
 
 
    
 
 
 
Subtotal
     2,925        2,075        850        41.0
  
 
 
    
 
 
    
 
 
    
 
 
 
Total revenue
   $ 8,644      $ 6,551      $ 2,093        31.9
  
 
 
    
 
 
    
 
 
    
 
 
 
Total revenue increased by approximately $2.1 million, or 31.9%, from $6.6 million for the three months ended March 31, 2020 to $8.6 million for the three months ended March 31, 2021. The increase is due to an increase in Detection revenue of approximately $1.2 million and an increase in Therapy revenue of $0.9 million.
Detection product revenue increased by approximately $1.1 million, or 34.2%, from $3.1 million for the three months ended March 31, 2020 to $4.2 million for the three months ended March 31, 2021. The overall increase is due primarily to an increase in direct customer revenue of $1.7 million offset by a decrease in original equipment manufacturer customer revenue of $0.5 million, in each case relating primarily to revenue from 3D imaging and density assessment products.
Detection service and supplies revenue, which is primarily sold to direct customers, increased by $0.2 million, or 13.2%, from $1.4 million in the three months ended March 31, 2020 to $1.6 million in the three months ended March 31, 2021.
Therapy product revenue increased by approximately $0.7 million, or 100.9%, from $0.7 million for the three months ended March 31, 2020 to $1.4 million for the three months ended March 31, 2021. Therapy product revenue is related to the sale of our Axxent systems and can vary significantly from quarter to quarter due to changes in the number of units sold, and the average selling price.
Therapy service and supplies revenue increased by approximately $0.1 million, or 10.8%, from $1.4 million for the three months ended March 31, 2020 to $1.5 million for the three months ended March 31, 2021. The Company believes that Therapy service and supplies revenue, specifically the use of balloons for procedures, was adversely affected by the
COVID-19
pandemic during the three months ended March 31, 2020, due to
stay-at-home
and social distancing orders as well as the uncertainty in the market. The Company saw higher service and supplies revenues due to higher balloon sales in the three months ended March 31, 2021 as compared to the three months ended March 31, 2020. The Company is not able to predict how the
COVID-19
pandemic will affect future Therapy service and supplies revenue.
 
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Cost of Revenue and Gross Profit: (in thousands)
Three months ended March 31, 2021 and 2020:
 
    
Three months ended March 31,
 
    
2021
   
2020
   
Change
    
% Change
 
Products
   $ 1,409     $ 1,017     $ 392        38.5
Service and supplies
     867       927       (60      (6.5 )% 
Amortization and depreciation
     79       97       (18      (18.6 )% 
  
 
 
   
 
 
   
 
 
    
 
 
 
Total cost of revenue
   $ 2,355     $ 2,041     $ 314        15.4
  
 
 
   
 
 
   
 
 
    
 
 
 
Gross profit
   $ 6,289     $ 4,510     $ 1,779        39.4
    
Three months ended March 31,
 
    
2021
   
2020
   
Change
    
% Change
 
Detection gross profit
   $ 4,725     $ 3,467     $ 1,258        36.3
Therapy gross profit
     1,564       1,043       521        50.0
  
 
 
   
 
 
   
 
 
    
 
 
 
Gross profit
   $ 6,289     $ 4,510     $ 1,779        39.4
  
 
 
   
 
 
   
 
 
    
 
 
 
Gross profit %
     72.8     68.8     
 
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Gross profit for the three months ended March 31, 2021 was approximately $6.3 million, or 72.8% of revenue, as compared to $4.5 million, or 68.8% of revenue, for the three months ended March 31, 2020. The
COVID-19
pandemic adversely affected revenues from Detection products and the Therapy segment in the three months ended March 31, 2020, and as a result, lower gross profit in both segments in 2020. The Company also underwent cost cutting efforts throughout 2020 and has been able to maintain a lower cost structure, specifically personnel costs, as compared to 2020, through March 31, 2021.
Cost of products increased by approximately $0.4 million, or 38.5%, from $1.0 million for the three months ended March 31, 2020 to $1.4 million for the three months ended March 31, 2021. Cost of product revenue as a percentage of product revenue was approximately 26.8% for the three months ended March 31, 2020 as compared to 37.1% for the three months ended March 31, 2021. The increase in cost of products is primarily due to the increased sales in the both Therapy and Detection resulting in increases in cost of products of $0.3 and $0.1 million respectively.
Cost of service and supplies was relatively flat at approximately $0.9 million for both the three months ended March 31, 2021 and 2020. Cost of service and supplies revenue as a percentage of service and supplies revenue was approximately 33.6% for the three months ended March 31, 2020 as compared to 31.5% for the three months ended March 31, 2021. Although the service and supplies revenue increased, there was still a 6.5% decrease in service and supplies costs due primarily to a decrease in personnel costs.
Amortization and depreciation, which relates primarily to acquired intangible assets and depreciation of machinery and equipment, was approximately $0.1 million for each of the three months ended March 31, 2021 and 2020.
 
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Operating Expenses: (in thousands)
Three months ended March 31, 2021 and 2020:
 
    
Three months ended March 31,
 
     2021      2020      Change $     Change %  
Operating expenses:
                                  
Engineering and product development
   $ 2,192      $ 2,211      $ (19     (0.9 )% 
Marketing and sales
     3,424        3,608        (184     (5.1 )% 
General and administrative
     2,151        2,532        (381     (15.0 )% 
Amortization and depreciation
     55        52        3       5.8
    
 
 
    
 
 
    
 
 
   
 
 
 
Total operating expenses
   $ 7,822      $ 8,403      $ (581     (6.9 )% 
    
 
 
    
 
 
    
 
 
   
 
 
 
Operating expenses decreased by approximately $0.6 million, or 6.9%, from $8.4 million in the three months ended March 31, 2020 to $7.8 million in the three months ended March 31, 2021. The Company took steps throughout 2020 to reduce operating expenses during the
COVID-19
pandemic and continues to take a disciplined approach with expenses. Although the Company reinstated furloughed employees, many expenses like travel and in person trade shows have yet to go back to the pre
COVID-19
levels as evident by the reduction year over year.
Engineering and Product Development
. Engineering and product development costs remained relatively flat at $2.2 million for the three months ended March 31, 2020 and 2021.
Marketing and Sales
. Marketing and sales expenses decreased by approximately $0.2 million, or 5.1%, from $3.6 million in the three months ended March 31, 2020 to $3.4 million in the three months ended March 31, 2021. Detection marketing and sales expenses remained relatively flat at $2.4 million in the three months ended March 31, 2020 and 2021. Therapy marketing and sales expenses decreased by approximately $0.2 million, from $1.2 million in the three months ended March 31, 2020 to $1.0 million in the three months ended March 31, 2021. The decrease in Therapy marketing and sales expenses is due primarily to decreased personnel costs, travel, and reduced trade show costs during the first quarter of 2021 as compared to the first quarter of 2020.
General and Administrative
. General and administrative expenses decreased by approximately $0.4 million, or 15.0%, from $2.5 million in the three months ended March 31, 2020 to $2.1 million for the three months ended March 31, 2021. The decrease includes lower personnel, legal, and travel costs.
Amortization and Depreciation.
Amortization and depreciation, which relates primarily to acquired intangible assets and depreciation of machinery and equipment, increased by approximately $3,000, or 5.8% from $52,000 for the three months ended March 31, 2020 to $55,000 for the three months ended March 31, 2021.
 
36