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

☒         QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

☐         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

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’sRegistrants telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)


Securities registered pursuant to Section12(b) of the Act:

Title of each class

Trading

symbol(s)

Trading
symbol(s)

Name of each exchange

on which registered

Common Stock, $0.01 par value

ICAD

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.    YESYes  ☒    NONo  ☐.

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).    YESYes  ☒    NONo  ☐.

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

    

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)    YESYes  ☐    NONo  ☒.

As of the close of business on

May 10, 2022
,2023, there were 25,181,85725,446,407 shares outstanding of the registrant’s Common Stock, $0.01 par value.



 


iCAD, Inc.

INDEX

Page

PART I

FINANCIAL INFORMATION

   

Item 1

Page

Financial Statements

 
PART I
 
 
Item 1

1

  1
 

2

  
2

Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three months ended March 31, 2023 and 2022

3

 

4

  3
 4

5

  5

Item 2

17

  18

Item 3

22

  
25

Item 4

Controls and Procedures

23

 

PART II

OTHER INFORMATION

24

Item 4
  
25

Item 1A

Risk Factors

24

 

Item 6

Exhibits

25

PART II
  26
Item 1A
 26
Item 6
27

26

28

 


iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands, except for share data)

(Unaudited)

  

March 31,

  

December 31,

 
  

2023

  

2022

 

Assets

        

Current assets:

        

Cash and cash equivalents

 $19,663  $21,313 

Trade accounts receivable, net of allowance for credit losses of $922 as of both March 31, 2023 and December 31, 2022

  7,381   8,898 

Inventory, net

  4,866   5,389 

Prepaid expenses and other current assets

  2,292   2,641 

Total current assets

  34,202   38,241 

Property and equipment, net of accumulated depreciation of $2,151 and $2,135 as of March 31, 2023 and December 31, 2022, respectively

  1,153   1,074 

Operating lease assets

  3,200   3,361 

Other assets

  55   69 

Intangible assets, net of accumulated amortization of $8,980 and $8,932 as of March 31, 2023 and December 31, 2022, respectively

  436   482 

Goodwill

  8,362   8,362 

Deferred tax assets

  111   116 

Total assets

 $47,519  $51,705 

Liabilities and Stockholders’ Equity

        

Current liabilities:

        

Accounts payable

 $1,888  $1,973 

Accrued and other expenses

  4,213   4,681 

Lease payable—current portion

  569   582 

Deferred revenue—current portion

  6,211   6,216 

Total current liabilities

  12,881   13,452 

Lease payable, net of current

  2,639   2,803 

Deferred revenue, net of current

  283   542 

Deferred tax

  6   6 

Total liabilities

  15,809   16,803 
         

Commitments and Contingencies (Note 12)

          

Stockholders’ equity:

        

Preferred stock, $0.01 par value: authorized 1,000,000 shares; none issued.

      

Common stock, $0.01 par value: authorized 60,000,000 shares; issued 25,446,407 as of both March 31, 2023 and December 31, 2022.

        

Outstanding 25,260,576 as of both March 31, 2023 and December 31, 2022.

  254   254 

Additional paid-in capital

  303,485   302,899 

Accumulated deficit

  (270,614)  (266,836)

Treasury stock at cost, 185,831 shares as of both March 31, 2023 and December 31, 2022

  (1,415)  (1,415)

Total stockholders’ equity

  31,710   34,902 

Total liabilities and stockholders’ equity

 $47,519  $51,705 
         
   
March 31,
  
December 31,
 
   
2022
  
2021
 
   
(Unaudited)
    
Assets         
Current assets:         
Cash and cash equivalents  $29,798  $34,282 
Trade accounts receivable, net of allowance for doubtful accounts of $573 in 2022 and $268 in 2021   10,309   8,891 
Inventory, net   4,736   4,171 
Prepaid expenses and other current assets   3,090   2,962 
          
Total current assets   47,933   50,306 
          
Property and equipment, net of accumulated depreciation of $7,192 in 2022 and $7,106 in 2021   947   882 
Operating lease assets   859   1,059 
Other assets   104   899 
Intangible assets, net of accumulated amortization of $8,776 in 2022 and $8,724 in 2021   640   683 
Goodwill   8,362   8,362 
          
Total assets  $58,845  $62,191 
          
Liabilities and Stockholders’ Equity
         
Current liabilities:         
Accounts payable  $2,681  $2,779 
Accrued and other expenses   5,128   5,642 
Lease payable—current portion   887   889 
Deferred revenue   5,765   5,652 
          
Total current liabilities   14,461   14,962 
          
Lease payable, long-term portion   54   266 
Deferred revenue, long-term portion   571   441 
Deferred tax   6   5 
          
Total liabilities   15,092   15,674 
          
Commitments and Contingencies (Note 13)       
Stockholders’ equity:         
Preferred stock, $0.01 par value: authorized 1,000,000 shares; NaN issued.   0—     0—   
Common stock, $0.01 par value: authorized 60,000,000 shares; issued 25,359,175 as of March 31, 2022 and 25,326,086 as of December 31, 2021.         
Outstanding 25,173,344 as of March 31, 2022 and 25,140,255   253   253 
as of December 31, 2021.         
Additional
paid-in
capital
   301,640   300,859 
Accumulated deficit   (256,725  (253,180
Treasury stock at cost, 185,831 shares in 2022 and 2021   (1,415  (1,415
          
Total stockholders’ equity   43,753   46,517 
          
Total liabilities and stockholders’ equity  $58,845  $62,191 
          

See accompanying notes to condensed consolidated financial statements.

1


iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except for per share data)

(Unaudited)

  

Three Months Ended

 
  

March 31,

 
  

2023

  

2022

 

Revenue:

        

Products

 $2,744  $4,560 

Service and supplies

  3,034   2,963 

Total revenue

  5,778   7,523 

Cost of revenue:

        

Products

  586   1,087 

Service and supplies

  993   1,049 

Amortization and depreciation

  69   75 

Total cost of revenue

  1,648   2,211 

Gross profit

  4,130   5,312 

Operating expenses:

        

Engineering and product development

  2,281   2,275 

Marketing and sales

  2,857   3,565 

General and administrative

  2,862   2,931 

Amortization and depreciation

  55   63 

Total operating expenses

  8,055   8,834 

Loss from operations

  (3,925)  (3,522)

Other income/ (expense):

        

Interest expense

     (9)

Interest income

  150    

Other income (expense), net

  2   (13)

Other income (expense), net

  152   (22)

Loss before provision for income taxes

  (3,773)  (3,544)

Provision for tax expense

  (5)  (1)

Net loss and comprehensive loss

 $(3,778) $(3,545)

Net loss per share:

        

Basic and diluted

 $(0.15) $(0.14)

Weighted average number of shares used in computing loss per share:

        

Basic and diluted

  25,261   25,160 
         
   
Three Months Ended March 31,
 
   
2022
  
2021
 
Revenue:         
Products  $4,560  $5,557 
Service and supplies   2,963   3,087 
          
Total revenue   7,523   8,644 
Cost of revenue:         
Products   1,087   1,409 
Service and supplies   1,049   867 
Amortization and depreciation   75   79 
          
Total cost of revenue   2,211   2,355 
          
Gross profit   5,312   6,289 
          
Operating expenses:         
Engineering and product development   2,275   2,192 
Marketing and sales   3,565   3,424 
General and administrative   2,931   2,151 
Amortization and depreciation   63   55 
          
Total operating expenses   8,834   7,822 
          
Loss from operations   (3,522  (1,533
Interest expense   (9  (112
Other income (expense)   (13  2 
          
Other expense, net   (22  (110
Loss before income tax expense   (3,544  (1,643
          
Tax expense   (1  0   
          
Net loss and comprehensive loss  $ (3,545)  $ (1,643) 
          
Net loss per share:         
Basic  $(0.14 $(0.07
          
Diluted  $(0.14 $(0.07
          
Weighted average number of shares used in computing loss per share:         
Basic   25,160   23,929 
          
Diluted   25,160   23,929 
          

See accompanying notes to condensed consolidated financial statements.

2


iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash FlowsStockholders Equity

(In thousands, except shares)

(Unaudited)

  

For the three months ended March 31, 2023

 
  

Common Stock

  

Additional

             
  

Number of

  

Paid-in

  

Accumulated

  

Treasury

  

Stockholders’

 
  

Shares Issued

  

Par Value

  

Capital

  

Deficit

  

Stock

  

Equity

 

Balance at December 31, 2022

  25,446,407  $254  $302,899  $(266,836) $(1,415) $34,902 

Stock-based compensation

        586         586 

Net loss

           (3,778)     (3,778)

Balance at March 31, 2023

  25,446,407  $254  $303,485  $(270,614) $(1,415) $31,710 

  

For the three months ended March 31, 2022

 
  

Common Stock

  

Additional

             
  

Number of

  

Paid-in

  

Accumulated

  

Treasury

  

Stockholders’

 
  

Shares Issued

  

Par Value

  

Capital

  

Deficit

  

Stock

  

Equity

 

Balance at December 31, 2021

  25,326,086  $253  $300,859  $(253,180) $(1,415) $46,517 

Issuance of common stock related to vesting of restricted stock

  875   1             

Issuance of common stock pursuant to stock option plans

  22,833   1   66         66 

Issuance of common stock pursuant Employee Stock Purchase Plans

  9,381      60         60 

Stock-based compensation

        655         655 

Net loss

           (3,545)     (3,545)

Balance at March 31, 2022

  25,359,175  $253  $301,640  $(256,725) $(1,415) $43,753 
(Unaudited)
         
   
For the three months
ended March 31,
 
   
2022
  
2021
 
   (in thousands) 
Cash flow from operating activities:         
Net loss  $ (3,545)  $ (1,643) 
Adjustments to reconcile net loss to net cash used for operating activities:         
Amortization   53   58 
Depreciation   86   76 
Bad debt provision   305   0   
Stock-based compensation   655   935 
Deferred tax   1   0   
Amortization of debt discount and debt costs   0     12 
Changes in operating assets and liabilities:         
Accounts receivable   (1,723  (622
Inventory   (565  647 
Prepaid and other assets   653   (89
Accounts payable   (98  (1,617
Accrued expenses   (514  (1,313
Deferred revenue   243   (7
          
Total adjustments   (904  (1,920
          
Net cash used for operating activities   (4,449  (3,563
          
Cash flow from investing activities:         
Additions to patents, technology and other   (10  0   
Additions to property and equipment   (151  (262
          
Net cash used for investing activities   (161  (262
          
Cash flow from financing activities:         
Proceeds from option exercises pursuant to stock option plans   66   270 
Proceeds from issuance of common stock pursuant to Employee Stock Purchase Plans   60   47 
Proceeds from issuance of common stock, net   0     23,229 
          
Net cash provided by financing activities   126   23,546 
          
(Decrease) increase in cash and cash equivalents   (4,484  19,721 
Cash and cash equivalents, beginning of period   34,282   27,186 
          
Cash and cash equivalents, end of period  $ 29,798  $ 46,907 
          
Supplemental disclosure of cash flow information:         
Interest paid  $9  $92 
          
Taxes paid  $0    $0   
          

See accompanying notes to condensed consolidated financial statements.

3

iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity Year to Date 2022

(Unaudited)
Cash Flows

(In thousands except shares)thousands)

(Unaudited)

  

For the Three Months ended

 
  

March 31,

 
  

2023

  

2022

 

Cash flow from operating activities:

        

Net loss

 $(3,778) $(3,545)

Adjustments to reconcile net loss to net cash used for operating activities:

        

Amortization

  46   53 

Depreciation

  78   86 

Non-cash lease expense

  161   200 

Bad debt provision

     305 

Stock-based compensation

  586   655 

Deferred tax

  5   1 

Changes in operating assets and liabilities:

        

Accounts receivable

  1,517   (1,723)

Inventory

  523   (565)

Prepaid and other assets

  363   653 

Accounts payable

  (120)  (84)

Accrued and other expenses

  (468)  (514)

Lease liabilities

  (177)  (214)

Deferred revenue

  (264)  243 

Total adjustments

  2,250   (904)

Net cash used for operating activities

  (1,528)  (4,449)

Cash flow from investing activities:

        

Additions to patents, technology and other

     (10)

Additions to property and equipment

  (122)  (151)

Net cash used for investing activities

  (122)  (161)

Cash flow from financing activities:

        

Proceeds from option exercises pursuant to stock option plans

     66 

Proceeds from issuance of common stock pursuant to Employee Stock Purchase Plans

     60 

Net cash provided by financing activities

     126 

(Decrease) increase in cash and cash equivalents

  (1,650)  (4,484)

Cash and cash equivalents, beginning of period

  21,313   34,282 

Cash and cash equivalents, end of period

 $19,663  $29,798 

Supplemental disclosure of cash flow information:

        

Interest paid

 $  $9 

                         
   
Common Stock
   
Additional
           
   
Number of
Shares Issued
   
Par Value
   
Paid-in

Capital
   
Accumulated
Deficit
  
Treasury
Stock
  
Stockholders’
Equity
 
Balance at December 31, 2021   25,326,086   $253   $300,859   $(253,180 $(1,415 $46,517 
Issuance of common stock relative to vesting of restricted stock   875    0      0      —     —     0   
Issuance of common stock pursuant to stock option plans   22,833    0      66    —     —     66 
Issuance of common stock pursuant Employee Stock Purchase Plans   9,381    0      60    —     —     60 
Stock-based compensation   —      —      655    —     —     655 
Net loss   —      —      —      (3,545  —     (3,545
                             
Balance at March 31, 2022   25,359,175   $253   $301,640   $(256,725 $(1,415 $43,753 
                             
Consolidated Statements of Stockholders’ Equity Year to Date 2021
(Unaudited)
(In thousands except shares)

                         
   
Common Stock
   
Additional
           
   
Number of
Shares Issued
   
Par Value
   
Paid-in

Capital
   
Accumulated
Deficit
  
Treasury
Stock
  
Stockholders’
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    0      0      —     —     0   
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 
                             

See accompanying notes to condensed consolidated financial statements.

4


iCAD, INC. AND SUBSIDIARIES

(In thousands, except for share and per share data or as noted)

Notes to Condensed Consolidated Financial Statements:

Note 1 Organization and Business

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”), which requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses during the reporting period and disclosure of contingent assets and liabilities at the date of the financial statements. Actual results could differ from those estimates. It is reasonably possible that changes may occur in the near term that would affect management’s estimates with respect to assets and liabilities. 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, 2022,2023, the results of operations of the Company for the three-month periodsthree months ended March 31, 2022 2023 and 2021,2022, cash flows of the Company for the three-month periodsthree months ended March 31, 2022 2023 and 2021,2022, and stockholders’ equity for the Company for the three-month periodsthree months ended March 31, 2022 2023 and 2021.

2022.

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
10-K for the fiscal year ended December 31, 2021,2022, filed with the SEC on March 29, 2022. 31, 2023. The results for the three-month periodthree months ended March 31, 2022,2023, are not necessarily indicative of the results that may be expected for the three-month period ended June 30, 2022,fiscal year ending December 31,2023, or any interim or any future period.

Principles of Consolidation and Business Segments

The condensed consolidated financial statements include the accounts of iCAD, Inc. and its wholly owned subsidiaries: Xoft, Inc., Xoft Solutions, LLC, iCAD France, LLC and iCAD France,Italy, LLC. All material inter-company transactions and balances have been eliminated in consolidation.

The Company reports the results of

two
two segments: Cancer Detection (“Detection”) and Cancer Therapy (“Therapy”). The Detection segment consists of advanced image analysis and workflow products for the detection of cancer. The Therapy segment consists of radiation therapy (“Xoft”, “Axxent”) products for the treatment of certain cancers.

Risk and Uncertainty

On March 12,2020, the World Health Organization declared

COVID-19
COVID-19to be a pandemic. In an effort to contain and mitigate the spread of the
COVID-19
pandemic,COVID-19, the United States and most countries of the world have imposed some level of unprecedented restrictions onsuch as travel bans and there have been business closures and awhich caused substantial reductionreductions in economic activity in countries that have had significant outbreaks of
COVID-19.
activity. As a provider of devices and services to the health care industry, the Company’sCompany believes its operations have been materially affected in all periods presented. Significant uncertainty remains as toWhile the continuing impact of the
COVID-19
pandemic on the Company’s operations and on the global economy. 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 continuing or worsening level of market disruption and volatility seen since the startworst of the pandemic willdisruptions appear to have an adverse effect on subsided as of March 31, 2023, the Company’s abilityCompany continues to access capital, onbe impacted by slowness in the Company’s business, results of the Company’s operations and financial condition, and on the market price of the Company’s common stock.overall economic recovery. The Company’s expected results for the years ended December 31, 2021 and 2020, as well as all quarterly results beginning with the first quarter of 2020 through the first quarter of 2022, reflect a negative impact from the
COVID-19
pandemic, including but not limited to healthcare customers and potential customers providing additional focus on
COVID-19;
pandemic-related public health impacts,
5

including significant shifts in workforce availability and priorities, on customer, supplier, and iCAD’s business processes; and effects on healthcare customers and potential customers of pandemic related supply chain issues. The Company’s quarterly results for the quarter ending June 30, 2022, and possibly future quarters,periods could reflect a continuing negative impact from the
COVID-19
COVID-19pandemic for similar or additional reasons.
Although the Company did not see any material impact to trade accounts receivable losses

In late February 2022, Russian military forces launched significant military action against Ukraine. Sustained conflict and disruption in the three-month period ended region has continued through March 31, 2022, the Company’s exposure may increase if its customers are adversely affected by changes in healthcare laws, coverage, 2023 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 historically not 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 clinical customers’ cash flows are impacted by their response to the
COVID-19
pandemic as well as public health considerations impacting their underlying businesses.
beyond. Economic, civil, military and political uncertainty may arise or increase in regions where the Company operates or derives revenue. Further, countries from which the Company derives revenue may experience military action and/or civil and political unrest; may be subject to government export controls, economic sanctions, embargoes, or trade restrictions; and experience currency, inflation, and interest rate uncertainties. While the impact to the Company has been limited to date, it is not possible to predict the potential outcome should the conflict expand and/or additional sanctions be imposed.  For the fiscal yearthree months ended 2021, March 31, 2023, approximately 8.6%15% of the Company’s total revenue and approximately 39.0% of the Company’s exportCompany's revenue was derived from customers located in Europe. In late February 2022, Russian military forces launched significant military action against Ukraine. Sustained conflict and disruption in the region is likely. The aggregate impact to Eastern Europe and Europe as a whole, as well as actions taken by other countries, including new and stricter sanctions byoutside the United States, Canada, the United Kingdom, the European Union, and other countries and organizations against officials, individuals, regions, and industries in Russia, Belarus and Ukraine, and each country’s potential response to such sanctions, tensions and military actions, is not knowable at this time, and could have a material adverse effect on the Company, its business and operations. Any such material adverse effect from the conflict and enhanced sanctions activity may disrupt the Company’s sales to customers in the region. Prolonged unfavorable economic conditions or uncertainty may have an adverse effect on the Company’s sales and profitability.
States.  

Recently Adopted Accounting Pronouncements

On January 1, 2022, the Company adopted ASU No.
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”).”
The impact of adopting ASU
2020-06
had no impact on the Company’s consolidated financial statements.
Recently Issued Accounting Standards

In June 2016, the Financial Accounting Standards Board (the “FASB”) issued ASU

2016-13,
“Financial2016-13, “Financial Instruments—Credit Losses (Topic 326)326)” (“ASU
2016-13”2016-13),
which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU
2016-13
2016-13replaces the existing incurred loss impairment model with an expected loss model which requires the use of forward- lookingforward-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
2016-13for 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
2016-13is permitted.  The Company is currently evaluatingadopted ASU 2016-13 effective January 1, 2023.  Adoption caused the impactCompany to modify its approach to estimating its allowance for potentially uncollectable accounts receivable. Specifically, the Company began applying an expected credit loss model that uses historical loss rates of its accounts receivable for the adoptionprevious twelve months as well as expectations about the future where the Company has been able to develop forecasts to support its estimates.  Adoption of ASU
2016-13
will2016-13 did not have a material impact on itsthe Company's consolidated financial statements.

6
5


Recently Issued Accounting Standards (Not Yet Adopted)

There are no recently issued accounting pronouncements that have not yet been adopted as of March 31, 2023 that are expected to have a material impact on the Company's financial statements.

Note 2 - Fair Value Measurements

The Company follows the provisions of FASB ASC Topic 820,

Fair “Fair Value Measurement and Disclosures
Disclosures” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about 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 Company applies the fair value hierarchy based on three levels of inputs, of which the firsttwo are considered observable and the last unobservable, which are the following:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs other than

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

The assigned level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Money market funds included in cash and cash equivalents in the accompanying consolidated balance sheet are considered a Level 1 measurement as they are valued at quoted market prices in active markets.

The following table sets forth the Company’s assets which are measured at fair value on a recurring basis by level within the fair value hierarchy:

Fair Value Measurements 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
The assigned level within the fair value hierarchy is based on the lowest levelMarch 31, 2023

  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets

                

Money market accounts

 $14,949  $  $  $14,949 

Total Assets

 $14,949  $  $  $14,949 

Fair Value Measurements as of any input that is significant to the fair value measurement.

Money market funds included in cash and cash equivalents in the accompanying consolidated balance sheet are considered a Level 1 measurement as they are valued at quoted market prices in active markets.
The following table sets forth the Company’s assets which are measured at fair value on a recurring basis by level within the fair value hierarchy (in thousand):
                 
Fair Value Measurements (in thousands) as of March 31, 2022
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Assets                    
Money market accounts  $ 24,235    —      —     $ 24,235 
                     
Total Assets  $24,235    —      —     $24,235 
                     
                 
Fair Value Measurements (in thousands) as of December 31, 2021
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Assets                    
Money market accounts  $ 30,573    —      —     $ 30,573 
                     
Total Assets  $30,573    —      —     $30,573 
                     
7

December 31, 2022

  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets

                

Money market accounts

 $15,067  $  $  $15,067 

Total Assets

 $15,067  $  $  $15,067 

There were no Level 2 or 3 instruments measured at fair value as of March 31, 20222023 or December 31, 2021.

2022.

6

Note 3 - Revenue

Revenue Recognition

Revenue is recognized when 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).segments.

  

Three months ended March 31, 2023

 
  

Reportable Segments

     
  

Detection

  

Therapy

  

Total

 

Major Goods/Service Lines

            

Products

 $2,460  $284  $2,744 

Service contracts

  1,874   372   2,246 

Supply and source usage agreements

     493   493 

Disposable applicators

     225   225 

Other

     70   70 
  $4,334  $1,444  $5,778 

Timing of Revenue Recognition

            

Goods transferred at a point in time

 $2,028  $608  $2,636 

Services transferred over time

  2,306   836   3,142 
  $4,334  $1,444  $5,778 

Sales Channels

            

Direct sales force

 $2,778  $1,056  $3,834 

OEM partners

  1,556      1,556 

Channel partners

     388   388 
  $4,334  $1,444  $5,778 

7

8

 
  

Three months ended March 31, 2022

 
  

Reportable Segments

     
  

Detection

  

Therapy

  

Total

 

Major Goods/Service Lines

            

Products

 $3,864  $696  $4,560 

Service contracts

  1,657   386   2,043 

Supply and source usage agreements

     413   413 

Disposable applicators

     415   415 

Other

     92   92 
  $5,521  $2,002  $7,523 

Timing of Revenue Recognition

            

Goods transferred at a point in time

 $3,881  $1,264  $5,145 

Services transferred over time

  1,640   738   2,378 
  $5,521  $2,002  $7,523 

Sales Channels

            

Direct sales force

 $2,895  $815  $3,710 

OEM partners

  2,626      2,626 

Channel partners

     1,187   1,187 
  $5,521  $2,002  $7,523 

   
Three months ended March 31, 2022
 
   
Reportable Segments
 
   
Detection
   
Therapy
   
Total
 
Major Goods/Service Lines
               
Products  $ 3,864   $696   $ 4,560 
Service   1,657    386    2,043 
Sources and source usage agreements   —      413    413 
Disposable applicators   —      415    415 
Other   —      92    92 
                
   $5,521   $ 2,002   $7,523 
                
Timing of Revenue Recognition
               
Goods transferred at a point in time  $3,881   $ 1,264   $5,145 
Services transferred over time   1,640    738    2,378 
                
   $5,521   $2,002   $7,523 
                
Sales Channels
               
Direct sales force  $2,895   $815   $3,710 
OEM partners   2,626    —      2,626 
Channel partners   —      1,187    1,187 
                
   $5,521   $2,002   $7,523 
                
             
   
Three months ended March 31, 2021
 
   
Reportable Segments
 
   
Detection
   
Therapy
   
Total
 
Major Goods/Service Lines
               
Products  $ 4,161   $ 1,396   $ 5,557 
Service   1,558    350    1,908 
Sources and source usage agreements   —      629    629 
Disposable applicators   —      495    495 
Other   —      55    55 
                
   $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 
                
8

Products. Product revenue consists of sales of cancer detection systems and perpetual licenses and cancer therapy systems and cancer therapy applicators. The Company transfers control and recognizes a sale when the product is shipped from the manufacturing or warehousing facility to the customer.

9

Service

. The Company sells service contracts in which the Company provides professional services including product installations, maintenance, training and service repairs, and in certain cases leases equipment to hospitals, imaging centers, radiological practices and radiation oncologists and treatment centers. 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.

Sources and Source Usage Agreements

. Revenue from sources is recognized upon transfer of control to the customer. Revenue from source usage agreements is recognized on a straight-line basis over the term of the source agreement.

Disposable applicators

. Revenue for the sale of disposable applicators is recognized upon the transfer of control to the customer.
Other
.

Other. Other revenue consists primarily of miscellaneous products and services. The Company transfers control and recognizes a sale when the installation services are performed or when the Company ships the product from the Company’s manufacturing or warehouse facility to the customer.

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).
customers.

Contract balances

  

Balance at

  

Balance at

 
  

March 31, 2023

  

December 31, 2022

 

Receivables, which are included in ‘Trade accounts receivable’

 $7,381  $8,898 

Current contract assets, which are included in “Prepaid and other assets”

 $638  $759 

Non-current contract assets, which are included in “other assets”

 $  $15 

Contract liabilities, which are included in “Deferred revenue”

 $6,494  $6,758 

9
   
Balance at
March 31, 2022
   
Balance at
December 31, 2021
 
Receivables, which are included in ‘Trade accounts receivable’  $ 10,309   $ 8,891 
Current contract assets, which are included in “Prepaid and other assets”  $1,174   $1,895 
Non-current
contract assets, which are included in “other assets”
  $49   $844 
Contract liabilities, which are included in “Deferred revenue”  $6,336   $6,093 

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 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.

Changes in deferred revenue from contracts with customers were as follows (in thousands):

   
Three Months
Ended March 31,
2022
 
Balance at beginning of period  $6,093 
Deferral of revenue   2,940 
Recognition of deferred revenue   (2,697
      
Balance at end of period  $6,336 
      
follows:

  

Three Months

 
  

Ended March 31,

 
  

2023

 

Balance at beginning of period

 $6,758 

Deferral of revenue

  5,514 

Recognition of deferred revenue

  (5,778)

Balance at end of period

 $6,494 

The Company expects to recognize estimated revenues related to performance obligation that are unsatisfied (or partially satisfied) in the amounts of approximately $5.9$3.4 million in 2022, $2.2 million in 2023, $1.3 million in 2024, and $1.1 $1.0 million in 2025.

2025 and $0.8 million in 2026.

 
10

Note 4 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 thousands000s, except for Net loss per share amounts)share):

   
Three Months Ended

March 31,
 
   
2022
   
2021
 
Net loss
  
$
 (3,545)
 
  
$
 (1,643)
 
           
Shares used in the calculation of basic and diluted net loss per share   25,160    23,929 
           
Diluted shares used in the calculation of net loss per share   25,160    23,929 
           
Net loss per share—basic and diluted  $(0.14  $(0.07
           

  

Three Months Ended

 
  

March 31,

 
  

2023

  

2022

 

Net loss

 $(3,778) $(3,545)

Shares used in the calculation of basic and diluted net loss per share

  25,261   25,160 

Net loss per share - basic and diluted

 $(0.15) $(0.14)

The shares of the Company’s common stock issuable upon the exercise of 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,
 
   
2022
   
2021
 
Stock options   2,894,449    2,246,776 
Restricted stock   0      31,654 
           
Total   2,894,449    2,278,430 
           

  

March 31,

 
  

2023

  

2022

 

Stock options

  2,946,470   2,894,449 

Total

  2,946,470   2,894,449 

10

Note 5 Inventories

The Company values its inventory at the lower of cost or net realizable value. Cost includes materials, labor, and manufacturing overhead and is determined using the

first-in,
first-out
first-in, first-out (FIFO) method. On a quarterly basis, management reviews inventory quantities on hand and analyzes the provision for excess and obsolete inventory based primarily on product expiration dating and estimated sales forecast, which is based on sales history and anticipated future demand. Inventory consisted of the following (in thousands) and includes an inventory reserve of approximately $0.3 million at both March 31, 2022 2023 and $0.2 million at December 31, 2021.
         
   
March 31, 2022
   
December 31, 2021
 
Raw materials  $ 3,333   $ 2,962 
Work in process   504    173 
Finished Goods   1,174    1,279 
           
Inventory Gross   5,011    4,414 
Inventory Reserve   (275   (243
           
Inventory Net  $4,736   $4,171 
           
2022.

  

March 31, 2023

  

December 31, 2022

 

Raw materials

 $3,113  $2,658 

Work in process

  213   101 

Finished Goods

  1,802   2,892 

Inventory Gross

  5,128   5,651 

Inventory Reserve

  (262)  (262)

Inventory Net

 $4,866  $5,389 

 
11

Note 6 - 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 0 impairment indicators present as of March 31, 2022.

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 considered indicators of impairment, and there were no triggering events identified, no indication of impairment of the Company’s goodwill and no impairment charges recorded during the three months ended March 31, 2023 or 2022.

Note 7 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 quarterperiod ended March 31, 2022.

2023.

11

Note 8 Lease Commitments

Per

In accordance with ASC Topic 842, "Leases" ("ASC 842"), the Company determines if an arrangement contains a lease at inception. A lease is an operating or financing contract, or part of a contract, that conveys the right to control the use of an identified tangible asset for a period of time in exchange for consideration.

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. In determining the present value of the lease payments, the Company uses itscalculates an incremental borrowing rate, which is determined by estimating the Company’s applicable, fully collateralized borrowing rate, with adjustment as appropriate for 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 extension option if the Company is reasonably certain to exercise that option.

Assumptions made by the Company at the commencement date of each lease are re-evaluated upon occurrence of certain events, including a lease modification. A lease modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification results in a separate contract, it is accounted for in the same manner as a new lease.

Right-of-use

assets and obligations for leases with an initial term of 12 months or less are considered short term and are a) not recognized in the consolidated balance sheet and b) recognized as an expense on a straight-line basis over the lease term. The Company does not sublease any of its leased assets to third parties and 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, but the Company is accounting for the complete agreement under ASC 606 after determining that the
non-lease
component is the predominant component of these agreements.
12

ASC 842 includes a number of reassessment and

re-measurement
remeasurement requirements for lessees based on certain triggering events or conditions. There were no impairment indicators identified during the three-month periodthree months ended March 31, 20222023 that would require impairment testing of the Company’s
right-of-use
assets.

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 separate the accounting for lease components and
non-lease
components for real estate and equipment leases.

Components of Leases:

The Company has leases for office space and office equipment. The leases expire at various dates through 2024.
2028.

   

Three Months Ended

 

Lease Cost

Classification

 

March 31, 2023

 

Operating lease cost - Right of Use Asset

Operating expenses

 $216 

12
       
Lease Cost
  
Classification
  
Three Months
Ended March 31,
2022
 
Operating lease cost—Right of Use Asset  Operating expenses  $215 
Operating lease cost—Variable  Operating expenses   61 
         
Total     $276 
         

Other information related to leases was as follows (in thousands):

     
   
Three Months
Ended March 31,
2022
 
Cash paid from operating cash flows for operating leases  $229 
  
   
As of March 31,
2022
 
Weighted-average remaining lease term of operating leases (in year)   1.02 
Weighted-average discount rate for operating leases   5.5
follows:

  

Three Months

 
  

Ended March 31, 2023

 

Cash paid from operating cash flows for operating leases

 $232 

As of March 31,

2023

Weighted-average remaining lease term of operating leases (years)

3.6

Weighted-average discount rate for operating leases

7.0%

Maturity of the Company’s lease liabilities as of March 31, 20222023 was as follows (in thousands):

     
2022   701 
2023   253 
2024   16 
      
Total lease payments   970 
Less: imputed interest   (29
      
Total lease liabilities   941 
Less: current portion of lease liabilities   (887
      
Long-term lease liabilities  $54 
      
Note 9 – Notes Payable
(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. Obligations to the Bank under the Loan Agreement were 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.
follows:

2023

 $549 

2024

  846 

2025

  848 

2026

  749 

2027

  685 

2028

  172 

Total lease payments

  3,849 

Less: effects of discounting

  (641)

Total lease liabilities

  3,208 

Less: current portion of lease liabilities

  569 

Long-term lease liabilities

 $2,639 

 

13


On April 27, 2021, the Company repaid its obligations in the aggregate amount of $7,354,283 and terminated the Loan Agreement with the Bank, and the Company’s collateral securing the facility was released. The Company accounted for this repayment and retirement as an extinguishment of the Loan Agreement. The Company recorded a loss on extinguishment of approximately $386,000 at that time related to the repayment and retirement of the Loan Agreement. The loss on extinguishment was composed of approximately $140,000 for a prepayment fee, $122,000 for the unaccrued final payment, $65,000 termination and other fees, and $58,000 for the unamortized discount and other closing costs from origination of the loan.

The following amounts are included in interest expense related to the Loan Agreement in the Company’s consolidated statement of operations for the three months ended March 31, 2022 and 2021 (in thousands):
         
   
Three Months Ended March 31,
 
   
2022
   
2021
 
Cash interest expense  $0     $92 
Accrual of notes payable final payment   0      7 
Amortization of debt costs   0      13 
           
Total interest expense  $0     $112 
           

Note 10 9 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 up to an aggregate of 675,000541,142 shares of the Company’s stock during the three months ended March 31, 2022. 2023. The full amount of options were granted in the firstthree months of 2023.

The Company’s stock-based compensation expense, including options and restricted stock by category is as follows:

  

Three Months Ended

 
  

March 31,

 
  

2023

  

2022

 

Cost of revenue

 $1  $ 

Engineering and product development

  73   68 

Marketing and sales

  131   199 

General and administrative

  381   388 
  $586  $655 

During the three months ended March 31, 2023, the Company recorded incremental stock-based compensation of approximately $0.23 million as a result of modifications of certain stock option awards.  The modifications related to extending the contractual life of certain stock options by five years for four grantees whose awards were scheduled to expire during 2023.  In addition, the amount of time to exercise vested stock options upon termination for one grantee was extended from 60 days to 24 months.   

As of March 31, 2023, there was approximately $1.6 million of total unrecognized compensation cost related to unvested options. That cost is expected to be recognized over a weighted average period of 2.09 years.  

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:

     
   
Three Months Ended
March 31,
   
2022
 
2021
Average risk-free interest rate  1.46% 0.20%
Expected dividend yield  NaN NaN
Expected life  3.5 years 3.5 years
Expected volatility  66.3% to 69.5% 66.0% to 66.0%
Weighted average exercise price  $5.22 $18.00
Weighted average fair value  $2.56 $8.37
14

  

Three Months Ended

 
  

March 31,

 
  

2023

  

2022

 

Average risk-free interest rate

  4.19%  1.46%

Expected dividend yield

 

None

  

None

 

Expected life (in years)

  3.0   3.5 

Expected volatility

  72.69% - 77.53%   66.3% - 69.5% 

Weighted average exercise price

 $2.16  $5.22 

Weighted average fair value

 $1.14  $2.56 

The Company’s stock-based compensation expense, including options2023 and restricted stock by category2022 average expected volatility and average expected life is as follows (amounts in thousands):

         
   
Three Months Ended
March 31,
 
   
2022
   
2021
 
Cost of revenue  $0     $14 
Engineering and product development   68    149 
Marketing and sales   199    353 
General and administrative   388    419 
           
   $655   $935 
           
15

Asthe Company’s historical information. The risk-free rate is based on the rate of March 31, 2022, there was approximately $3.9 millionU.S. Treasury zero-coupon issues with a remaining term equal to the expected life of total unrecognized compensation cost related to unvested options and restricted stock. That cost is expected to be recognized over a weighted average period of 1.82 years.
option grants. The Company granted 0has paid no dividends on its common stock in the past and 22,488does not anticipate paying any dividends in the future.

The Company did not grant any shares of restricted stock during the three-month periodsthree-months ended March 31, 2023 or 2022 and 2021, respectively.

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. All of the Company’s restricted stock grants in 2021 had time-based vesting requirements The grant date fair value for restricted stock awards is based on the quoted market value of Company stock on the grant date.

14

The Company’s aggregate intrinsic value

A summary of stock option activity for all stock options and restricted stock outstandingoption plans for the period ended March 31, 2023 is as follows (in thousands):

        
   
As of

March 31,
 
Aggregate intrinsic value  
2022
   
2021
 
Stock options  $1,311   $29,305 
Restricted stock   0      672 
follows:

  

Number of

  

Weighted Average

  

Intrinsic

 
  

Options

  

Exercise Price

  

Value

 

Outstanding as of December 31, 2022

  2,610,992  $7.54  $ 

Granted

  541,142  $2.16  $ 

Exercised

    $  $ 

Cancelled

  (204,331) $9.27  $ 

Outstanding as of March 31, 2023

  2,947,803  $9.44  $ 

Options Exercisable as of December 31, 2022

  1,619,855  $6.47  $ 

Options Exercisable as of March 31, 2023

  1,985,026  $7.44  $ 

The Company issued 0 and 22,833 shares of common stock upon the exercise of outstanding stock options in the three-month periodthree months ended March 31, 2022.2023 and 2022, respectively. The Company received cash proceeds from stock option exercises of approximately $66,000 induring the three -month period months ended March 31, 2022. The intrinsic value of 20,000 restricted shares that vested in the three months ended March 31, 2021 was $0.3 million.

Employee Stock Purchase Plan

In December 2019, the Company’s Board of Directors adopted, and the stockholders approved 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 of Directors at any time. Certain amendments to the ESPP require stockholder approval.

  In October 2022, the Company suspended the ESPP such that the accumulation period from October 1,2022 through December 31,2022 and beyond will not occur.

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 inpurchase shares under the ESPP.

Any

Prior to the Company's suspension of the Plan, any eligible employee cancould enroll in the ESPP as of the beginning of a respective quarterly accumulation period. Employees who participateparticipated in the ESPP maywere able to purchase shares by authorizing payroll deductions of up to 15% of their base compensation during an accumulation period. Unless the participating employee withdrawswithdrew from participation, accumulated payroll deductions arewere 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 maywas able to 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 9,381 shares under the ESPP in the three-monththree-month period ended March 31,2022. The Company recorded approximately $10,000 of stock-based compensation expense pursuant to ESPP for the three-monththree-month period ended March 31,2022.

Note 10 Income Taxes

The determination of the annual effective tax rate is based upon a number of significant estimates and judgments, including the estimated annual pretax income in each tax jurisdiction in which the Company operates and the development of tax planning strategies during the year. As such, there can be significant volatility in interim tax provisions.

Income tax expense was approximately $5,000 and $1,000 for the three months ended March 31, 2022.2023 and 2022, respectively. The next accumulation period undereffective tax rates for the ESPP commenced on January 31, 2022 andthree months ended on March 31, 2022, 2023 and 2022 were less than 1% in each period. The difference between the related shares purchased byCompany’s effective tax rates in 2023 and 2022 compared to the participants were issuedU.S. statutory tax rate of 21% is primarily due changes in April 2022. As of March 31, 2022, the Company recorded a liability of approximately $33,000 related to employee withholdings in connectionvaluation allowances associated with the ESPP accumulation period ended March 31, 2022, which was included as a componentCompany’s assessment of accrued expenses and other current liabilities.

Note 11 - Income Taxes
the likelihood of the recoverability of deferred tax assets. The Company had 0 material unrecognizedhas valuation allowances against substantially all of its net operating loss carryforwards and tax benefits and a deferred tax liability of approximately $6,000 related to tax amortizable goodwill at March 31, 2022. 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, 2022.
credit carryforwards.

16
15


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 12 11 Segment Reporting

Operating segments are the components of the Company’s business for which separate financial information is available that is evaluated regularly by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is the chief executive officer. The Company’s operating segments are generally organized by the type of product or service offered and by geography.

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 2segments: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, and related services. The primary factors used by the Company’s CODM to allocate resources are based on revenues, gross profit, operating income or loss, 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 its assets by operating segment and the 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 GAAP loss before income tax is as follows (in thousands):
         
   Three Months Ended
March 31,
 
   2022   2021 
Segment revenues:
          
Detection  $5,521   $5,719 
Therapy   2,002    2,925 
           
Total Revenue  $7,523   $8,644 
           
Segment gross profit:
          
Detection  $4,661   $4,725 
Therapy   651    1,564 
           
Segment gross profit  $5,312   $6,289 
           
Segment operating income (loss):
          
Detection  $622   $941 
Therapy   (1,209   (312
           
Segment operating income (loss)  $(587  $629 
           
General, administrative, depreciation and amortization expense  $(2,935  $(2,162
Interest expense   (9   (112
Other (expense) income   (13   2 
           
Loss before income tax  $(3,544  $(1,643
           
follows:

  

Three Months Ended

 
  

March 31,

 
  

2023

  

2022

 

Segment revenues:

        

Detection

 $4,334  $5,521 

Therapy

  1,444   2,002 

Total revenue

 $5,778  $7,523 

Segment gross profit:

        

Detection

 $3,544  $4,661 

Therapy

  586   651 

Segment gross profit

 $4,130  $5,312 

Segment operating income (loss):

        

Detection

 $(124) $622 

Therapy

  (883)  (1,209)

Segment operating income (loss):

 $(1,007) $(587)

General, administrative, depreciation and amortization expense

 $(2,918) $(2,935)

Interest expense

     (9)

Interest income

  150    

Other expense

  2   (13)

Loss before income tax

 $(3,773) $(3,544)

 
17

Note 13 12 Commitments and Contingencies

Other Commitments

The Company is obligated to pay approximately $5.8$4.2 million for firm purchase obligations to suppliers for future product and service deliverables and $0.2 million for minimum royalty obligations.

Litigation

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, other than as set forth above.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. 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.

Note 13 Restructuring

On March 20,2023, the Company committed to a restructuring plan intended to support its long term strategic goals and reduce operating expenses by further aligning its cost structure to focus on areas the Company believes are more likely to generate the best long-term results, in light of current industry and macroeconomic environments (the “RIF”). The Company reduced its workforce by approximately 28%, decreasing its headcount by approximately 23 employees, predominantly from the Company’s detection business unit. Xoft, Inc., a wholly-owned subsidiary of the Company, furloughed 12 of its employees, or approximately 50% of its workforce.    

During the three months ended March 31, 2023, the Company incurred pre-tax charges to its statements of operations of $0.08 million related to cash severance and benefits.  The Company expects to incur additional charges of $0.1 million during the remainder of the 2023 and no additional charges beyond that time.  All of the incurred and estimated future charges are one-time, cash expenses.  Estimated amounts are subject to change until finalized and the Company may incur additional costs during the remainder of 2023.

The Company's accrual for restructuring charges for the three months ended March 31, 2023 was follows (in thousands):

Balance of as January 31, 2023$

 — 

Charges

 

76

Cash payments

 

— 

Balance as of March 31, 2023

$

76

16

Note 14 – Subsequent Events

The Company has evaluated events and transactions subsequent to the balance sheet date to the date of the filing and is not aware of any events or transactions that occurred subsequent to the balance sheet date that would require recognition or disclosure in the consolidated financial statements.


 
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item2.Managements Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the accompanying notes included in Part I, Item 1 of this Form 10-Q, as well as our Annual Report on Form 10-K for the year ended December31, 2022. Some of the information contained in this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. As a result of many factors, including those factors set forth in the section titled Risk Factors, our actual results could differ materially from those discussed in or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled Risk Factors. Please also refer to the section titled Special Note Regarding Forward Looking Statements.

Special Note Regarding Forward Looking Statements

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 1995.1995, Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). 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 the following: the continuing impact of the
COVID-19
pandemic, the continuing impact of military and political conflict in Eastern Europe, the ability to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare reimbursement policies, risks relating to our existing andpotential future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company, and other risks detailed in this report and in the Company’s other filings with the United States Securities and Exchange Commission (the “SEC”). 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.

Unless the context otherwise requires, the terms “iCAD”, the “Company”, “we”, “our”, “registrant”, and “us” mean iCAD, Inc. and its consolidated subsidiaries.

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 solutions suite 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) that focus on cancer detection, breast density assessment, and short-term cancer risk estimation.

18

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 and is in clinical studies for treatment of brain cancers.

The Company’s headquarters are located in Nashua, New Hampshire, with a manufacturing facility in New Hampshire, an operations, research, development, manufacturing and warehousing facility in San Jose, California, and an office in Lyon, France.

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 and most countries of the world have imposed some level of unprecedented restrictions onsuch as travel bans and there have been business closures and awhich caused substantial reductionreductions in economic activity in countries that have had significant outbreaks of
COVID-19.
activity. As a provider of devices and services to the health care industry, the Company’swe believe our operations have been materially affected in all periods presented. Significant uncertainty remainsWhile the worst of the disruptions seem to have subsided as of March 31, 2023, and the pandemic emergency has been deemed to be over, we continue dealing with the continuing impact of the
COVID-19
pandemic onslowness in the Company’s operations and on the global economy. It is currently not possible to predict how long the pandemic will last or the time that it will take foroverall economic activity to return to prior levels. The
COVID-19
pandemic has resulted in significant financial market volatility and uncertainty. A continuing or worsening level of market disruption and volatility seen since the start of the pandemic will have an adverse effect on the Company’s ability to access capital, on the Company’s business, results of the Company’s operations and financial condition, and on the market price of the Company’s common stock. The Company’srecovery. Our expected results for the yearsyear ended December 31, 2021 and 2020, as well as all quarterly results beginning with the first quarter of 2020 through the first quarter of 2022, reflect a negative impact from the
COVID-19
pandemic,2023, including but not limited to healthcare customers and potential customers providing additional focus on
COVID-19;
pandemic-related public health impacts, including significant shifts in workforce availability and priorities, on customer, supplier, and iCAD’s business processes; and effects on healthcare customers and potential customers of pandemic related supply chain issues. The Company’s quarterly results for the quarter ending June 30, 2022, and possiblyany interim or future quarters,periods, could reflect a continuing negative impact from thecontinuing negative economic conditions. 

COVID-19
17
pandemic for similar or additional reasons.

The Company believes

We believe that itsour current liquidity and capital resources are sufficient to sustain operations through at least the next 12 months, primarily due to cash on hand of $29.7$19.7 million at March 31, 20222023 and anticipated revenue and cash collections. However, the resurgence of the

COVID-19
pandemic could affect the Company’s liquidity and capital resources.
collections as well as cost savings actions taken.

Eastern European Conflict Impact

In late February 2022, Russian military forces launched significant military action against Ukraine. Sustained conflict and disruption in the region is likely. The aggregatehas continued through March 31, 2023 and beyond. Economic, civil, military and political uncertainty may arise or increase in regions where the Company operates or derives revenue. Further, countries from which we derive revenue may experience military action and/or civil and political unrest; may be subject to government export controls, economic sanctions, embargoes, or trade restrictions; and experience currency, inflation, and interest rate uncertainties. While the impact to Eastern Europe and Europe as a whole, as well as actions taken by other countries, including new and stricter sanctions by the United States, Canada, the United Kingdom, the European Union, and other countries and organizations against officials, individuals, regions, and industries in Russia, Belarus and Ukraine, and each country’s potential responseus has been limited to such sanctions, tensions and military actions,date, it is not knowable at this time, and could have a material adverse effect onpossible to predict the Company, its business and operations. Any such material adverse effect frompotential outcome should the conflict and enhancedexpand and/or additional sanctions activity may disrupt the Company’s sales to customers in the region. Prolonged unfavorable economic conditions or uncertainty may have an adverse effect on the Company’s sales and profitability.be imposed.  For the fiscal yearthree months ended 2021,March 31, 2023, approximately 8.6%15% of the Company’s total revenue and approximately 39.0% of the Company’s exportCompany's revenue was derived from customers located in Europe.

outside the United States. 

Critical Accounting Estimates

The Company’s

Our discussion and analysis of its financial condition, results of operations, and cash flows are based on the Company’sour 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 evaluateswe evaluate these estimates, including those related to revenue recognition, allowanceallowances for doubtfulcredit losses on accounts receivable, inventory valuation and obsolescence, intangible assets, goodwill, income taxes, contingencies, and litigation. Additionally, the Company useswe use assumptions and estimates in calculations to determine stock-based compensation, and evaluation of litigation. The Company bases itsWe base 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 and its lingering impact, global armed conflicts and related political uncertainty, as well as dramatic inflation, there has been uncertainty and disruption in the global economy and financial markets. The Company isWe are 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 20212022 Annual Report on Form

10-K
(the “2021
(the “2022 10-K”).
For a comprehensive list of the Company’sour critical accounting policies, reference should be made to the 2021
2022 10-K.
19

Three months ended March 31, 20222023 compared to three months ended March 31, 2021.

Revenue:2022 (in thousands)
thousands, except share data or as noted)

Revenue

Three months ended March 31, 20222023 and 2021:

   
Three months ended March 31,
 
   
2022
   
2021
   
Change
   
% Change
 
Detection revenue
        
Product revenue
  $3,864   $4,161   $(297   (7.1)% 
Service and supplies revenue
   1,657    1,558    99    6.4
  
 
 
   
 
 
   
 
 
   
 
 
 
Subtotal
   5,521    5,719    (198   (3.5)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Therapy revenue
        
Product revenue
   696    1,396    (700   (50.1)% 
Service and supplies revenue
   1,306    1,529    (223   (14.6)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Subtotal
   2,002    2,925    (923   (31.6)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total revenue
  $7,523   $8,644   $(1,121   (13.0)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

  

Three months ended March 31

 
  

2023

  

2022

  

$ Change

  

% Change

 

Detection revenue

                

Product revenue

 $2,460  $3,864  $(1,404)  (36.3)%

Service and supplies revenue

  1,874   1,657   217   13.1%

Subtotal

  4,334   5,521   (1,187)  (21.5)%

Therapy revenue

                

Product revenue

  284   696   (412)  (59.2)%

Service and supplies revenue

  1,160   1,306   (146)  (11.2)%

Subtotal

  1,444   2,002   (558)  (27.9)%

Total revenue

 $5,778  $7,523  $(1,745)  (23.2)%

Total revenue decreased by approximately $1.1$1.7 million or 13.0%(23.2%), from $8.6 million for the three months ended March 31, 2021 to $7.5 million for the three months ended March 31, 2022. The change is due2022 to decreases in Detection revenue of $0.2 million and Therapy revenue of $0.9 million, respectively.

Detection product revenue decreased by approximately $0.3 million, or 7.1%, from $4.2$5.8 million for the three months ended March 31, 20212023. The decrease is due primarily to our shift to a subscription model as well as continued weakness in recovery to pre-pandemic levels prior to Covid-19.  During the first three months of 2023, we have seen an increased customer demand for subscription licenses, which currently remains a small portion of the Company’s total license revenue. We believe this trend could accelerate, and have begun to shift our marketing efforts to a subscription model. An increase in subscription revenue would negatively impact revenue in the short term, because revenue from subscription licenses are recognized over time, as opposed to being recognized upon delivery for perpetual licenses. 

Detection product revenue decreased by approximately $1.4 million, or (36.3%), from $3.9 million for the three months ended March 31, 2022.2022 to $2.5 million for the three months ended March 31, 2023. The changeoverall decrease is due primarily to the impact of our transition to a decrease of $1.1 million in direct customer revenue related tosubscription model and ongoing COVID related restrictions earlychallenges faced in the quarter combined with impact fromeconomic recovery due to the reorganization and refocusing of the U.S. commercial organization offset by a $0.8 million increase in original equipment manufacturer customer revenue.

COVID 19 pandemic.

Detection service and supplies revenue, which is primarily sold to direct customers, increased by $0.1approximately $0.2 million, or 6.4%13.1%, from $1.6$1.7 million for the three months ended March 31, 2022 to $1.9 million in the three months ended March 31, 20212023.  The increase is due primarily to $1.7 million in the three months ended March 31, 2022.

timing of delivery on service and supply agreements.

Therapy product revenue decreased by $0.7approximately $0.4 million, or 50.1%(59.2)%, from $1.4$0.7 million for the three months ended March 31, 20212022 to $.7$0.3 million for the three months ended March 31, 2022. The decline in2023. Therapy product sales was largelyrevenue is related to the sale of our Axxent systems and can vary significantly from quarter to quarter due to changes in the timingnumber of a significant additional capital raise by one of our skin distributors.

units sold and the average selling price.

Therapy service and supplies revenue decreased by approximately $0.2$0.1 million, or 14.6%(11.2)%, from $1.5 million for the three months ended March 31, 2021 to $1.3 million for the three months ended March 31, 2022. The decline was largely2022 to $1.2 million for the three months ended March 31, 2023.  We saw lower service and supplies revenues due to reducedlower balloon sales of sources forin the Axxent system and a temporary reduction in average selling price for certain suppliesthree months ended March 31, 2023 as compared to certain customers, including clinical trial participants.

the three months ended March 31, 2022. 

2019


Cost of Revenue and Gross Profit: (in thousands)

Three months ended March 31, 20222023 and 2021:

   
Three months ended March 31,
 
   
2022
   
2021
   
Change
   
% Change
 
Products
  $1,087   $1,409   $(322   (22.9)% 
Service and supplies
   1,049    867    182    21.0
Amortization and depreciation
   75    79    (4   (5.1)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total cost of revenue
  $2,211   $2,355   $(144   (6.1)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
   
Three months ended March 31,
 
   
2022
   
2021
   
Change
   
% Change
 
Detection gross profit
  $4,661   $4,725   $(64   (1.4%) 
Therapy gross profit
   651    1,564    (913   (58.4%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Gross profit
  $5,312   $6,289   $(977   (15.5%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

Cost of Revenue and Gross Profit:

 

Three months ended March 31

 
  

2023

  

2022

  

$ Change

  

% Change

 

Products

 $586  $1,087  $(501)  (46.1)%

Service and supplies

  993   1,049   (56)  (5.3)%

Amortization and depreciation

  69   75   (6)  (8.0)%

Total cost of revenue

 $1,648  $2,211  $(563)  (25.5)%

  

Three months ended March 31

 
  

2023

  

2022

  

$ Change

  

% Change

 

Detection gross profit

 $3,544  $4,661  $(1,117)  (24.0)%

Therapy gross profit

  586   651   (65)  (10.0)%

Gross profit

 $4,130  $5,312  $(1,182)  (22.3)%

Gross profit for the three months ended March 31, 20222023 was approximately $5.3$4.1 million, or 70.6%71.4% of revenue, as compared to $6.3$5.3 million, or 72.8%70.1% of revenue, for the three months ended March 31, 2021. Detection gross profit percentage increased from 82.6% for the three months ended March 31, 2021 to 84.4% for the three months ended March 31, 2022. Therapy gross profit percentage decreased from 53.5% for the three months ended March 31, 2021 to 32.5% for the three months ended March 31, 2022. Detection gross profit percentage increased from 84.2% for the three months ended March 31, 2022 to 85.0% for the three months ended March 31, 2023. Therapy gross profit percentage decreased from 49.3% for the three months ended March 31, 2022 to 33.5% for the three months ended March 31, 2023. Detection gross profit represented 75.1%86.0% of total Company gross profit for the three months ended March 31, 20212022 compared to 87.7% for the three months ended March 31, 2022.

2023.

Cost of products decreased by approximately $0.3$0.5 million, or 22.9%(46.1%), from $1.4 million for the three months ended March 31, 2021 to $1.1 million for the three months ended March 31, 2022.2022 to $0.6 million for the three months ended March 31, 2023. Cost of product revenue as a percentage of product revenue was approximately 25.4%21.4% for the three months ended March 31, 20212022 as compared to 23.8%30.1% for the three months ended March 31, 2022.2023. The product mix in the three-month period ended March 31, 20222023 compared to the same period in 20212022 included more Detection products which havewith a lowerhigher relative cost of sales.

Cost of service and supplies increaseddecreased by approximately $0.1$0.06 million, or (5.3%) from $0.9$1.1 million for the three months ended March 31, 20212022 to $1.0 million for the three months ended March 31, 2022.2023. Cost of service and supplies revenue as a percentage of service and supplies revenue was approximately 28.1%32.7% for the three months ended March 31, 20212022 as compared to 35.4%22.6% for the three months ended March 31, 2022.2023. The cost of service and supplies as a percentage of revenue increaseddecreased primarily as a result of a temporary reductionthe relative mix of service and supplies in average selling price for certain supplies to certain customers, including clinical trial participants.

the comparable periods.

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, 20222023 and 2021.

2022.

2120


Operating Expenses: (in thousands)

Three months ended March 31, 20222023 and 2021:

   
Three months ended March 31,
 
   2022   2021   Change $   Change % 
Operating expenses:
        
Engineering and product development
  $2,275   $2,192   $83    3.8
Marketing and sales
   3,565    3,424    141    4.1
General and administrative
   2,931    2,151    780    36.3
Amortization and depreciation
   63    55    8    14.5
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating expenses
  $8,834   $7,822   $1,012    12.9
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

  

Three Months Ended March 31,

 
  

2023

  

2022

  

$ Change

  

% Change

 

Operating expenses:

                

Engineering and product development

 $2,281  $2,275  $6   0.3%

Marketing and sales

  2,857   3,565   (708)  (19.9)%

General and administrative

  2,862   2,931   (69)  (2.4)%

Amortization and depreciation

  55   63   (8)  (12.7)%

Total operating expenses

 $8,055  $8,834  $(779)  (8.8)%

Operating expenses increaseddecreased by approximately $1.0$0.1 million, or 12.9%(8.8%), from $7.8 million in the three months ended March 31, 2021 to $8.8 million in the three months ended March 31, 2022. The increase is largely due2022 to limited employee-related expenses$8.1 million in the three-month periodthree months ended March 31, 2021 due to

COVID-19
pandemic response and the subsequent restoration of the organization and resumption of activity in later 2021 resulting in higher employee related expenses, including travel, in the three-month period ended March 31, 2022.
2023.

Engineering and Product Development

. Engineering and product development costs increased slightly from $2.2 million for the three months ended March 31, 2021 towere consistent at approximately $2.3 million for the three months ended March 31, 2022. The increase was primarily related to higher employee costs in 2022  offset by a reduction in external service and  clinical study expenses.
March 31, 2023.  

Marketing and Sales

. Marketing and sales expenses increaseddecreased by approximately $0.2$0.7 million, or 4.1%(19.9%), from $3.4 million in the three months ended March 31, 2021 to $3.6 million in the three months ended March 31, 2022. Detection marketing and sales expenses increased by approximately $0.2 million from $2.42022 to $2.9 million in the three months ended March 31, 2021 to $2.6 million in the three months ended March 31, 2022.2023. The increasedecrease was primarily duerelated to increased employee-related costs associated withlower headcount and commission expense during the U.S. commercial group reorganization and refocusing and increased travel costs resulting from the reduction of pandemic travel restrictions. Therapy marketing and sales expenses remained flat at $1.0 million for each of the three months ended March 31, 2022 and 2021, respectively.
comparable periods.  

General and Administrative

. General and administrative expenses increased bywere consistent at approximately $0.8 million, or 36.3%, from $2.1 million in the three months ended March 31, 2021 to $2.9 million for the three months ended March 31, 2022. The increase is due to higher personnel costs partially offset by reduced external services as multiple functions were brought
in-house,
recruiting costs associated with2022  and the U.S. commercial group reorganization and refocusing, increased travel costs, and an increase of $0.3 million to the allowance for doubtful accounts.
three months ended March 31, 2023.   

Amortization and Depreciation.

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, 2022 and 2021.
22

Table of Contents
Other Income and Expense: (in thousands)
Three months ended March 31, 2022 and 2021:
   
Three months ended March 31,
 
   2022   2021   Change $  Change % 
Interest expense
  $(9  $(112  $103   (92.0)% 
Other income (expense)
   (13   2    (15  (750.0)% 
  
 
 
   
 
 
   
 
 
  
 
 
 
  $(22  $(110  $88   (80.0)% 
  
 
 
   
 
 
   
 
 
  
 
 
 
Tax expense
  $(1  $—     $ (1)   0.0
Interest expense
. Interest expense decreased by approximately $0.1 million, or 92.0%, from $0.1 millionwere flat for the three months ended March 31, 2021 to2023 and 2022.

Other Income and Expense:

Three months ended March 31, 2023 and 2022:

Other Income and Expense:

                
  

Three months ended March 31

 
  

2023

  

2022

  

$ Change

  

% Change

 

Interest expense

 $  $(9) $9   (100)%

Interest income

 $150  $  $150   100%

Other income (expense)

  2   (13)  15   (115.4)%
  $152  $(22) $174   (790.9)%

Tax (expense)

 $(5) $(1) $(4)  400.0%

Interest expense. Interest expense was approximately $9,000$(9,000) for the three months ended March 31, 2022.  The decreaseThere was due tono interest expense during the Company retiring the Loan agreement with Western Alliance Bank on April 27, 2021.

Otherthree months ended March 31, 2023.

Interest income

. Other expenseInterest income increased by approximately $15,000,$150,000, or 750.0%100%, from other income of $2,000zero for the three months ended March 31, 20212022 to other expense of $13,000$150,000 for the three months ended March 31, 2023. The increase results from higher interest rates in 2023 compared to 2022.

Tax expense
. Tax expense increased by approximately $1,000 due to an increase in the deferred tax liability related to goodwill.
2321


Other income (expense). Other income (expense) was a loss of $(13,000) during the three months ended March 31, 2022 compared to income of $2,000 during the three months ended March 31, 2023. The change is driven lower foreign exchange losses recorded in 2023 compared to 2022.

Tax (expense). Income tax expense was $5,000 and $1,000 for the three months ended March 31, 2023 and 2022, respectively. The effective tax rates for the three months ended March 31, 2023 and 2022 were less than 1% in each period. The difference between the Company’s effective tax rates in 2023 and 2022 compared to the U.S. statutory tax rate of 21% is primarily due changes in valuation allowances associated with the Company’s assessment of the likelihood of the recoverability of deferred tax assets. The Company has valuation allowances against substantially all of its net operating loss carryforwards and tax credit carryforwards. 

Liquidity and Capital Resources

(in thousands, except as noted)

The Company believes that its cash and cash equivalents balance of $29.7$19.7 million as of March 31, 2022,2023, and projected cash balances are sufficient to sustain operations through at least the next 12 months. The Company’s ability to generate cash adequate to meet its future capital requirements will depend primarily on operating cash flow. If sales or cash collections are reduced from current expectations, or if expenses and cash requirements are increased, the Company may require additional financing, although there are no guarantees that the Company will be able to obtain the financing if necessary. In addition, the resurgence of the

COVID-19
pandemic could affect our liquidity. The CompanyWe will continue to closely monitor its liquidity and the capital and credit markets.

The Company had net working Capitalcapital of $33.5$21.3 million at March 31, 2022.2023. The ratio of current assets to current liabilities at March 31, 20222023 and December 31, 20212022 was 3.322.66 and 3.36,2.84, respectively.

   
For the three months ended March 31,
 
   
2022
   
2021
 
   (in thousands) 
Net cash used for operating activities
  $ (4,449  $ (3,563
Net cash used for investing activities
   (161   (262
Net cash provided by financing activities
   126    23,546 
  
 
 
   
 
 
 
(Decrease) increase in cash and cash equivalents
  $ (4,484  $ 19,721 
  
 
 
   
 
 
 

  

Three Months Ended March 31,

 
  

2023

  

2022

 

Net cash used for operating activities

 $(1,528) $(4,449)

Net cash used for investing activities

  (122)  (161)

Net cash provided by financing activities

     126 

Decrease in cash and equivalents

 $(1,650) $(4,484)

Net cash used for operating activities for the three months ended March 31, 20222023 was $4.4$1.5 million, compared to $3.6$4.4 million for the three months ended March 31, 2021.2022. The improvement in net cash used for operating activities for the three months ended March 31, 20222023 resulted primarily from the Company’s net loss and working capital changes resulting from increases infocus on collections of accounts receivable and inventory, which increased in order to

de-risk
supply chain elongation, offset by a decrease in prepaid and other assets and decreases in accounts payable and accrued expenses.ongoing cost saving initiatives.  We expect that net cash used for or provided by operating activities to fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, the timing of when we recognize revenue, collections of accounts receivable, inventory expansion due to supply chain risk, and the timing of other payments.

Net cash used for investing activities for the three months ended March 31, 20222023 was $161,000,$122,000, compared to $262,000$161,000 for the three months ended March 31, 2021.2022. The net cash used for investing activities for the three months ended March 31, 20222023 and 20212022 is primarily for purchases of property and equipment.

Net cash provided by financing activities for the three months ended March 31, 2021 was $0.1 million, compared to $23.6 million for the three months ended March 31, 2021. Net cash provided by financing activities for the three months ended March 31, 2022 is duewas $126,000 related to cash of $126,000 from the issuance of common stock pursuant to the Company’s stock option and employee stock purchase plans. Net cash provided by financing activities

The Company is obligated to pay approximately $4.2 million for the three months ended March 31, 2021 is from the underwritten public offering of 1,393,738 shares of the Company’s common stock at an offering price of $18.00 per share resulting in net proceeds of approximately $23.2firm purchase obligations to suppliers for future product and service deliverables and $0.2 million and $0.3 million from the issuance of common stock pursuant the Company’s stock option and employee stock purchase plans.

24

Table of Contents
for minimum royalty obligations.

Recent Accounting Pronouncements

See Note 1 to the Condensed Consolidated Financial Statements.

Item
3
.
Quantitative and Qualitative Disclosures about Market Risk

Item3.Quantitative and Qualitative Disclosures about Market Risk

The Company believes that it is not subject to material foreign currency exchange rate fluctuations, as substantially all of its sales and expenses are denominated in the U.S. dollar. The Company does not hold derivative securities and has not entered into contracts embedded with derivative instruments, such as foreign currency and interest rate swaps, options, forwards, futures, collars or warrants, either to hedge existing risks or for speculative purposes.

22

Item
4.
Controls and Procedures

Item4.Controls and Procedures

The Company’s management, with the participation of its principal executive officer and principal financial officer, evaluated the effectiveness of the design and operation of its disclosure controls and procedures as of the end of the period covered by this report. Based on this evaluation, as of March 31, 2022,2023, the principal executive officer and principal financial officer concluded that the Company’s disclosure controls and procedures (as defined in Rule

13a-15(e)
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”))1934) were effective at a reasonable level of assurance.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. The Company conducts periodic evaluations to enhance, where necessary, its controls and procedures.

The Company’s principal executive officer and principal financial officer conducted an evaluation of the Company’s internal control over financial reporting (as defined in Rule

13a-15(f)
of the Exchange Act) and have determined there are no changes in its internal controls over financial reporting during the quarter ended March 31, 20222023 that have materially affected or which are reasonably likely to materially affect internal control over financial reporting.

2523


PART II OTHER

INFORMATION

Item
1A.
Risk Factors:
We operate in a changing environment that involves numerous known and unknown

Item1A.Risk Factors:

Our business is subject to various risks, and uncertainties that could materially adversely affect our operations. In addition to the risk factors below, factors that have affected our Company areincluding those described in Part I, Item 1A of our Annual Report on Form

10-K
for the fiscal year ended December 31, 2022, which we strongly encourage you to review. There have been no material changes to the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2021 as2022 filed with the SEC on March 29, 2022 and are incorporated by reference herein.
31, 2023.  

The Company expects the novel coronavirus (COVID-19) pandemic, including the emergence of new variants, to have a significant effect on the Company’s results of operations. In addition, the pandemic has resulted in significant financial market volatility, and its impact on the global economy appears to be significant. A continuation or worsening of the pandemic will have a material adverse impact on the Company’s business, results of operations and financial condition and on the market price of the Company’s common stock.24

As a provider of devices and services to the health care industry, the Company’s operations have been materially affected, and may continue to be impacted, by the COVID-19 pandemic. Beginning with the first quarter of 2020 through the first quarter of 2022, the COVID-19 pandemic has presented a number of challenges and risks for the Company’s business, including, but not limited to the following: decreased product demand due to reduced numbers of in-person meetings with potential clients; potential clients’ singular focus on surging COVID-19 infection rates following the emergence of the Omicron variant, causing attention to be diverted from purchasing decisions; pandemic-related public health impacts, including significant shifts in workforce availability and priorities, on customer, supplier, and iCAD’s business process; supply chain interruptions; disruptions to the Company’s clinical trials; challenges operating in a virtual work environment; impacts resulting from travel limitations and mobility restrictions; and other challenges presented by disruptions to the Company’s normal operations in response to the pandemic, as well as uncertainties regarding the duration and severity of the pandemic on the global economy and the Company’s operations, and the unpredictable and periodic emergence of new variants of the COVID-19 virus.
The COVID-19 pandemic has resulted in significant financial market volatility and uncertainty. A continuing or worsening level of market disruption and volatility observed since the start of the pandemic 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 the Company’s common stock. Although the Company does not provide guidance to investors relating to the Company’s results of operations, the Company’s quarterly results for the quarter ending June 30, 2022, and possibly future quarters, could reflect a continuing negative impact from the COVID-19 pandemic for similar or additional reasons.
The Company’s exposure to trade accounts receivable losses 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 historically not 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.
Instability in geographies where the Company has operations and personnel or where the Company derives revenue could have a material adverse effect on the Company’s business, customers, operations and financial results.
Economic, civil, military and political uncertainty may arise or increase in regions where the Company operates or derives revenue. Further, countries from which the Company derives revenue may experience military action and/or civil and political unrest; may be subject to government export controls, economic sanctions, embargoes, or trade restrictions; and experience currency, inflation, and interest rate uncertainties. For the fiscal year ended 2021, approximately 8.6% of the Company’s revenue was derived from customers located in Europe, and approximately 39.0% of the Company’s export revenue was derived from customers located in Europe. In late February 2022, Russian military forces launched significant military action against Ukraine. Sustained conflict and disruption in the region is likely. The aggregate impact to Eastern Europe and Europe as a whole, as well as actions taken by other countries, including new and stricter sanctions by the United States, Canada, the United Kingdom, the European Union, and other countries and organizations against officials, individuals, regions, and industries in Russia, Belarus and Ukraine, and each country’s potential response to such sanctions, tensions and military actions, is not knowable at this time, and could have a material adverse effect on the Company, its business and operations. Any such material adverse effect from the conflict and enhanced sanctions activity may disrupt the Company’s sales to customers in the region. Prolonged unfavorable economic conditions or uncertainty may have an adverse effect on the Company’s sales and profitability.
26

Item6.Exhibits

Item
6.
Exhibits

Exhibit

No.

 

Description

10.1 Employment Agreement, entered intoagreement dated March 22, 2022 and effective March 1, 202210, 2023, by and between iCAD, Inc. and Dana Brown (filed as Exhibit 10(p) to the CompanyAnnual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 30, 2023.
10.2Separation agreement dated March 10, 2023, by and between iCAD, Inc. and Stacey Stevens (incorporated by reference to(filed as Exhibit 10.110(q) to the CurrentAnnual Report on Form 8-K10-K for the year ended December 31, 2022 filed with the SEC on March 28, 2022)31, 2023.
31.1* 

31.1*

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2* 

31.2*

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1** 

32.1**

Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2** 

32.2**

Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101* 

101*

The following materials formatted in Inline XBRL (eXtensible Business Reporting Language); (i) Condensed Consolidated Balance Sheets as of March 31, 20222023 and December 31, 2021,2022, (ii) Condensed Consolidated Statements of Operations for the three months ended March 31, 20222023 and 2021,2022, (iii) Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022, and 2021, (iv) Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 20222023 and March 31, 20212022 and (v) Notes to Condensed Consolidated Financial Statements.

104* 

104*

Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101).

*         Filed herewith

**       Furnished herewith

*
Filed herewith
**
Furnished herewith
2725


Signatures

Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

iCAD, Inc.

 (Registrant)                
Date: May 11, 2022 By:

(Registrant)

 /s/ Stacey Stevens

Date: May 15, 2023

 Name:

By:

/s/ Dana Brown

 Stacey Stevens

Name:

Title:

Title:

Dana Brown

Chief Executive Officer

(Principal Executive Officer)

Date: May 11, 2022 By:

Date: May 15, 2023

 

By:

/s/ Charles R. CarterEric Lonnqvist

 

Name:

Title:

Charles R. Carter
Title:

Eric Lonnqvist

Chief Financial Officer

(Principal Financial Officer)

2826