ICAD INC - Quarter Report: 2022 June (Form 10-Q)

Large Accelerated filer

Accelerated filer

Non-accelerated
filer

Smaller reporting company

Emerging growth company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM

10-Q

(Mark One)

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

For the quarterly period ended June 30, 2022

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

For the transition period from

Commission file number

001-09341

iCAD, Inc.

(Exact name of registrant as specified in its charter)


Delaware		02-0377419
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

98 Spit Brook Road, Suite 100, Nashua, NH		03062
(Address of principal executive offices)		(Zip Code)

(603)

882-5200

(Registrant’s telephone number, including area code)

Not Applicable

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

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value	ICAD	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirement for the past 90 days. YES ☒ NO ☐.

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation

S-T

during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a

non-accelerated

filer, an emerging growth company or a

smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule

12b-2

of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐.

Indicate by check mark whether the registrant is a shell company (as defined in Rule

12b-2

of the Exchange Act) YES ☐ NO ☒.

As of the close of business on August

, 2022, there were 25,333,935 shares outstanding of the registrant’s Common Stock, $0.01 par value.

Table of Contents

iCAD, Inc.

INDEX


		Page

PART I	FINANCIAL INFORMATION

Item 1	Financial Statements

	Condensed Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021		1

	Condensed Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2022 and 2021		2

	Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three and six months ended June 30, 2022 and 2021		3

	Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2022 and 2021		4

	Notes to Condensed Consolidated Financial Statements (unaudited)		5

Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations		16

Item 3	Quantitative and Qualitative Disclosures about Market Risk		24

Item 4	Controls and Procedures		24

PART II	OTHER INFORMATION		25

Item 1A	Risk Factors		25

Item 6	Exhibits		26

	Signatures		27

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iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands, except for share data)

(Unaudited)


	June 30,			December 31,
	2022			2021
Assets
Current assets:
Cash and cash equivalents	$	27,180		$	34,282
Trade accounts receivable, net of allowance for doubtful accounts of $778 in 2022 and $268 in 2021		10,171			8,891
Inventory, net		5,001			4,171
Prepaid expenses and other current assets		2,953			2,962

Total current assets		45,305			50,306

Property and equipment, net of accumulated depreciation of $7,275 in 2022 and $7,106 in 2021		968			882
Operating lease assets		3,102			1,059
Other assets		55			899
Intangible assets, net of accumulated amortization of $8,820 in 2022 and $8,724 in 2021		587			683
Goodwill		8,362			8,362

Total assets	$	58,379		$	62,191

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,198		$	2,779
Accrued and other expenses		5,271			5,642
Lease payable—current portion		566			889
Deferred revenue—current portion		6,171			5,652

Total current liabilities		14,206			14,962

Lease payable, net of current		2,598			266
Deferred revenue, net of current		581			441
Deferred tax		4			5

Total liabilities		17,389			15,674

Commitments and Contingencies (Note 13)
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 25,373,858 as of June 30, 2022 and 25,326,086 as of December 31, 2021.
Outstanding 25,188,027 as of June 30, 2022 and 25,140,255 as of December 31, 2021.		254			253
Additional paid-in capital		301,994			300,859
Accumulated deficit		(259,843	)		(253,180	)
Treasury stock at cost, 185,831 shares in 2022 and 2021		(1,415	)		(1,415	)

Total stockholders’ equity		40,990			46,517

Total liabilities and stockholders’ equity	$	58,379		$	62,191

See accompanying notes to condensed consolidated financial statements.

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iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(In thousands, except for per share data)

(Unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2022			2021			2022			2021
Revenue:
Products	$	4,475		$	4,552		$	9,035		$	10,109
Service and supplies		3,100			3,274			6,063			6,361

Total revenue		7,575			7,826			15,098			16,470
Cost of revenue:
Products		1,008			1,377			2,095			2,786
Service and supplies		1,001			832			2,050			1,699
Amortization and depreciation		75			79			150			158

Total cost of revenue		2,084			2,288			4,295			4,643

Gross profit		5,491			5,538			10,803			11,827

Operating expenses:
Engineering and product development		2,367			2,268			4,642			4,460
Marketing and sales		3,435			3,429			7,000			6,853
General and administrative		2,742			2,652			5,673			4,803
Amortization and depreciation		61			60			124			115

Total operating expenses		8,605			8,409			17,439			16,231

Loss from operations		(3,114	)		(2,871	)		(6,636	)		(4,404	)
Other income/ (expense):
Interest expense		—			(29	)		(1	)		(129	)
Interest income		14			19			16			33
Other loss, net		(18	)		(13	)		(41	)		(37	)
Loss on extinguishment of debt		—			(386	)		—			(386	)

Other expense, net		(4	)		(409	)		(26	)		(519	)
Loss before provision for income taxes		(3,118	)		(3,280	)		(6,662	)		(4,923	)

Provision for tax expense		—			—			(1	)		—

Net loss and comprehensive loss	$	(3,118	)	$	(3,280	)	$	(6,663	)	$	(4,923	)

Net loss per share:
Basic and diluted	$	(0.12	)	$	(0.13	)	$	(0.26	)	$	(0.20	)

Weighted average number of shares used in computing loss per share:
Basic and diluted		25,185			24,989			25,172			24,462

See accompanying notes to condensed consolidated financial statements.

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iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except shares)

(Unaudited)


	For the three months ended June 30, 2022
	Common Stock				Additional
	Number of				Paid-in		Accumulated			Treasury			Stockholders’
	Shares Issued		Par Value		Capital		Deficit			Stock			Equity
Balance at March 31, 2022		25,359,175	$	253	$	301,640	$	(256,725	)	$	(1,415	)	$	43,753
Issuance of common stock related to vesting of restricted stock		—		—		—		—			—			—
Issuance of common stock pursuant to stock option plans		6,000		1		12		—			—			13
Issuance of common stock pursuant Employee Stock Purchase Plans		8,683		—		33		—			—			33
Stock-based compensation		—		—		309		—			—			309
Net loss		—		—		—		(3,118	)		—			(3,118	)

Balance at June 30, 2022		25,373,858	$	254	$	301,994	$	(259,843	)	$	(1,415	)	$	40,990


	For the six months ended June 30, 2022
	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		—		—		—			—			—
Issuance of common stock pursuant to stock option plans		28,833		1		78		—			—			79
Issuance of common stock pursuant Employee Stock Purchase Plans		18,064		—		93		—			—			93
Stock-based compensation		—		—		964		—			—			964
Net loss		—		—		—		(6,663	)		—			(6,663	)

Balance at June 30, 2022		25,373,858	$	254	$	301,994	$	(259,843	)	$	(1,415	)	$	40,990


	For the three months ended June 30, 2021
	Common Stock				Additional
	Number of				Paid-in		Accumulated			Treasury			Stockholders’
	Shares Issued		Par Value		Capital		Deficit			Stock			Equity
Balance at March 31, 2021		25,143,432	$	251	$	298,106	$	(243,578	)	$	(1,415	)	$	53,364
Issuance of common stock related to vesting of restricted stock		9,166		—		—		—			—			—
Issuance of common stock, net		54,814		—		365		—			—			365
Issuance of common stock pursuant to stock option plans		—		—		—		—			—			—
Issuance of common stock pursuant Employee Stock Purchase Plans		5,890		—		67		—			—			67
Stock-based compensation		—		—		511		—			—			511
Net loss		—		—		—		(3,280	)		—			(3,280	)

Balance at June 30, 2021		25,213,302	$	251	$	299,049	$	(246,858	)	$	(1,415	)	$	51,027


	For the six months ended June 30, 2021
	Common Stock				Additional
	Number of				Paid-in		Accumulated			Treasury			Stockholders’
	Shares Issued		Par Value		Capital		Deficit			Stock			Equity
Balance at December 31, 2020		23,694,406	$	236	$	273,639	$	(241,935	)	$	(1,415	)	$	30,525
Issuance of common stock related to vesting of restricted stock		29,166		—		—		—			—			—
Issuance of common stock, net		1,393,738		14		23,215		—			—			23,229
Issuance of common stock pursuant to stock option plans		83,748		1		635		—			—			636
Issuance of common stock pursuant Employee Stock Purchase Plans		12,244		—		114		—			—			114
Stock-based compensation		—		—		1,446		—			—			1,446
Net loss		—		—		—		(4,923	)		—			(4,923	)

Balance at June 30, 2021		25,213,302	$	251	$	299,049	$	(246,858	)	$	(1,415	)	$	51,027

See accompanying notes to condensed consolidated financial statements.

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iCAD, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)


	For the Six Months ended June 30,
	2022			2021
Cash flow from operating activities:
Net loss	$	(6,663	)	$	(4,923	)
Adjustments to reconcile net loss to net cash used for operating activities:
Amortization		105			115
Depreciation		169			157
Non-cash lease expense		391			388
Bad debt provision		510			(3	)
Stock-based compensation		964			1,446
Amortization of debt discount and debt costs		—			17
Loss on extinguishment of debt		—			386
Changes in operating assets and liabilities:
Accounts receivable		(1,790	)		(924	)
Inventory		(830	)		284
Prepaid and other assets		853			122
Accounts payable		(581	)		(1,829	)
Accrued and other expenses		(371	)		(432	)
Lease liabilities		(425	)		(304	)
Deferred revenue		659			(77	)

Total adjustments		(346	)		(654	)

Net cash used for operating activities		(7,009	)		(5,577	)

Cash flow from investing activities:
Additions to patents, technology and other		(10	)		—
Additions to property and equipment		(255	)		(336	)

Net cash used for investing activities		(265	)		(336	)

Cash flow from financing activities:
Proceeds from option exercises pursuant to stock option plans		79			636
Proceeds from issuance of common stock pursuant to Employee Stock Purchase Plans		93			114
Proceeds from issuance of common stock, net		—			23,229
Issuance of stock upon conversion of debentures		—			(7,363	)

Net cash provided by financing activities		172			16,616

(Decrease) increase in cash and cash equivalents		(7,102	)		10,703
Cash and cash equivalents, beginning of period		34,282			27,186

Cash and cash equivalents, end of period	$	27,180		$	37,889

Supplemental disclosure of cash flow information:
Interest paid	$	9		$	92

Amendment to right-of-use assets obtained in exchange for operating lease liabilities	$	2,434		$	—

See accompanying notes to condensed consolidated financial statements.

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iCAD, INC. AND SUBSIDIARIES

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

Notes to Condensed Consolidated Financial Statements:

Note 1 – Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements of iCAD, Inc. and its subsidiaries (together “iCAD” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), 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 June 30, 2022, the results of operations of the Company for the three and six months ended June 30, 2022 and 2021, cash flows of the Company for the six months ended June 30, 2022 and 2021, and stockholders’ equity for the Company for the three and six months ended June 30, 2022 and 2021.

Although the Company believes that the disclosures made in these interim financial statements are adequate to make the information presented not misleading, certain information normally included in the footnotes prepared in accordance with US GAAP has been omitted as permitted by the rules and regulations of the Securities and Exchange Commission (the “SEC”). The accompanying interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form

10-K

for the fiscal year ended December 31, 2021, filed with the SEC on March 29, 2022. The results for the three and six months ended June 30, 2022, are not necessarily indicative of the results that may be expected for fiscal year ending December 31, 2022, 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 Italy, LLC,. All material inter-company transactions and balances have been eliminated in consolidation.

The Company reports the results of two segments: Cancer Detection (“Detection”) and Cancer Therapy (“Therapy”). The Detection segment consists of advanced image analysis and workflow products 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

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 on travel, and there have been business closures and a substantial reduction in economic activity in countries that have had significant outbreaks of

COVID-19.

As a provider of devices and services to the health care industry, the Company’s operations have been materially affected in all periods presented. Significant uncertainty remains as to 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 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’s 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 second 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, 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 expected results for the nine months ending September 30, 2022, or any interim or any future period could reflect a continuing negative impact from the

COVID-19

pandemic for similar or additional reasons.

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Although the Company has seen some impact to trade accounts receivable losses in the three and six months ended June 30, 2022 due to disruptions associated with the current

COVID-19

pandemic, the Company’s exposure may increase if its customers are adversely affected by changes in healthcare laws, coverage, and reimbursement, economic pressures or uncertainty associated with local or global economic recessions, disruption associated with the current

COVID-19

pandemic, or other customer-specific factors. The Company has 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.

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 total revenue 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.

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,

“Financial Instruments—Credit Losses (Topic 326)” (“ASU

2016-13”),

which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU

2016-13

replaces the existing incurred loss impairment model with an expected loss model which requires the use of forward- looking information to calculate credit loss estimates. These changes will result in earlier recognition of credit losses. In November 2019, the FASB elected to defer the adoption date of ASU

2016-13

for public business entities that meet the definition of a smaller reporting company to fiscal years beginning after December 15, 2022. Early adoption of the guidance in ASU

2016-13

is permitted. The Company is currently evaluating the impact that the adoption of ASU

2016-13

will have on its consolidated financial statements.

Note 2 – Fair Value Measurements

The Company follows the provisions of FASB ASC Topic 820, “Fair Value Measurement and 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 first two 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 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.

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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 of June 30, 2022


	Level 1		Level 2		Level 3		Total

Assets
Money market accounts	$	22,047	$	—	$	—	$	22,047

Total Assets	$	22,047	$	—	$	—	$	22,047

Fair Value Measurements 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

There were no Level 3 instruments measured at fair value as of June 30, 2022 or December 31, 2021.

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.


	Three months ended June 30, 2022
	Reportable Segments
	Detection		Therapy		Total
Major Goods/Service Lines
Products	$	3,467	$	1,008	$	4,475
Service contracts		1,822		361		2,183
Supply and source usage agreements		—		367		367
Disposable applicators		—		463		463
Other		—		87		87

	$	5,289	$	2,286	$	7,575

Timing of Revenue Recognition
Goods transferred at a point in time	$	3,455	$	1,547	$	5,002
Services transferred over time		1,834		739		2,573

	$	5,289	$	2,286	$	7,575

Sales Channels
Direct sales force	$	3,505	$	703	$	4,208
OEM partners		1,784		—		1,784
Channel partners		—		1,583		1,583

	$	5,289	$	2,286	$	7,575

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	Six months ended June 30, 2022
	Reportable Segments
	Detection		Therapy		Total
Major Goods/Service Lines
Products	$	7,330	$	1,705	$	9,035
Service contracts		3,479		747		4,226
Supply and source usage agreements		—		780		780
Disposable applicators		—		878		878
Other		—		179		179

	$	10,809	$	4,289	$	15,098

Timing of Revenue Recognition
Goods transferred at a point in time	$	7,335	$	2,812	$	10,147
Services transferred over time		3,474		1,477		4,951

	$10,809		$4,289		$15,098

Sales Channels
Direct sales force	$	6,399	$	1,519	$	7,918
OEM partners		4,410		—		4,410
Channel partners		—		2,770		2,770

	$	10,809	$	4,289	$	15,098


	Three months ended June 30, 2021
	Reportable Segments
	Detection		Therapy		Total
Major Goods/Service Lines
Products	$	3,164	$	2,119	$	5,283
Service contracts		1,625		371		1,996
Supply and source usage agreements		—		529		529
Other		—		18		18

	$	4,789	$	3,037	$	7,826

Timing of Revenue Recognition
Goods transferred at a point in time	$	3,164	$	2,136	$	5,300
Services transferred over time		1,625		901		2,526

	$	4,789	$	3,037	$	7,826

Sales Channels
Direct sales force	$	3,188	$	1,252	$	4,440
OEM partners		1,601		—		1,601
Channel partners		—		1,785		1,785

	$	4,789	$	3,037	$	7,826

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	Six months ended June 30, 2021
	Reportable Segments
	Detection		Therapy		Total
Major Goods/Service Lines
Products	$	7,325	$	4,222	$	11,547
Service contracts		3,183		711		3,894
Supply and source usage agreements		—		1,010		1,010
Other		—		19		19

	$	10,508	$	5,962	$	16,470

Timing of Revenue Recognition
Goods transferred at a point in time	$	7,325	$	4,240	$	11,565
Services transferred over time		3,183		1,722		4,905

	$	10,508	$	5,962	$	16,470

Sales Channels
Direct sales force	$	7,063	$	1,926	$	8,989
OEM partners		3,445		—		3,445
Channel partners		—		4,036		4,036

	$	10,508	$	5,962	$	16,470

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.

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 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.

Contract balances


	Balance at		Balance at
	June 30, 2022		December 31, 2021
Receivables, which are included in ‘Trade accounts receivable’	$	10,171	$	8,891
Current contract assets, which are included in “Prepaid and other assets”	$	1,399	$	1,895
Non-current contract assets, which are included in “other assets”	$	—	$	844
Contract liabilities, which are included in “Deferred revenue”	$	6,752	$	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.

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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:


	Six Months Ended June 30, 2022
Balance at beginning of period	$	6,093
Deferral of revenue		6,333
Recognition of deferred revenue		(5,674	)

Balance at end of period	$	6,752

The Company expects to recognize estimated revenues related to performance obligation that are unsatisfied (or partially satisfied) in the amounts of approximately $4.6 million in 2022, $3.5 million in 2023, $1.3 million in 2024, $1.1 million in 2025 and $0.1 million thereafter.

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:


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2022			2021			2022			202 1
Net loss	$	(3,118	)	$	(3,280	)	$	(6,663	)	$	(4,923	)

Shares used in the calculation of basic and diluted net loss per share		25,185			24,989			25,172			24,462

Net loss per share - basic and diluted	$	(0.12	)	$	(0.13	)	$	(0.26	)	$	(0.20	)

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:


	June 30,
	2022		2021
Stock options		1,819,897		2,176,607
Restricted stock		—		21,613

Total		1,819,897		2,198,220

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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

(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 and includes an inventory reserve of $0.3 million at June 30, 2022 and $0.2 million at December 31, 2021.


	June 30, 2022			December 31, 2021
Raw materials	$	2,549		$	2,962
Work in process		218			173
Finished Goods		2,503			1,279

Inventory Gross		5,270			4,414
Inventory Reserve		(269	)		(243	)

Inventory Net	$	5,001		$	4,171

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 no impairment indicators present as of June 30, 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.

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 period ended June 30, 2022.

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Note 8 – Lease Commitments

Per 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 its incremental borrowing rate, 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 that we made 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.

In May of 2022, the Company entered into an agreement to amend its Irvine operating lease (the “Irvine Amendment”). The Irvine Amendment extended the lease term of the premises by 5 years, or until March of 2028. Fixed monthly rent for the space will be incurred at a rate of $2.10 per square foot per year beginning in April 2023, subject to annual increases of $.06 per square foot in 2025 and 2026 as well as annual increases of $.07 per square foot in 2027 and 2028.

The Irvine Amendment includes a five-year option to extend the term. Upon the execution of the Irvine Amendment, which was deemed to be a lease modification, the Company

re-evaluated

the assumptions made at the original lease commencement date. The Company determined the Irvine Amendment consists of one separate contract under ASC 842, which is related to the modification of term for the original lease. The

ompany recorded an additional

right-of-use

asset and lease liability upon lease commencement of the expanded duration of the lease. The Irvine Amendment, resulted an increase of the

right-of-use

asset lease asset and lease liability of $2.4

million as of June 30, 2022.

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.

ASC

842 includes a number of reassessment and

re-measurement

requirements for lessees based on certain triggering events or conditions. There were no impairment indicators identified during the three and six months ended June 30, 2022 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 2028.


		Three Months		Six Months
		Ended June 30,		Ended June 30,
Lease Cost	Classification	2022		2022
Operating lease cost - Right of Use Asset	Operating expenses	$	215	$	430

Other information related to leases was as follows:


	Three Months		Six Months
	Ended June 30,		Ended June 30,
	2022		202 2
Cash paid from operating cash flows for operating leases	$	236	$	465

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	As of June 30, 2022
Weighted-average remaining lease term of operating leases (year s )		5.7
Weighted-average discount rate for operating leases		7.4	%

Maturity of the Company’s lease liabilities as of June 30, 2022 was as follows:


2022	$	467
2023		611
2024		642
2025		644
2026		664
2027		684
2028		172

Total lease payments		3,884
Less: imputed interest		(720	)

Total lease liabilities		3,164
Less: current portion of lease liabilities		(566	)

Long-term lease liabilities	$	2,598

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.

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 and six months ended June 30, 2022 and 2021:


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Cash interest expense	$	—	$	27	$	—	$	107
Accrual of notes payable final payment		—		2		—		9
Amortization of debt costs		—		—		—		13

Total interest expense	$	—	$	29	$	—	$	129

Note 10 – 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 85,000 and 760,000 shares of the Company’s stock during the three and six months ended June 30, 2022 respectively. The full amount of options were granted in the first six months of 2022.

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


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2022		2021		2022		2021
Cost of revenue	$	1	$	2	$	1	$	16
Engineering and product development		70		58		138		208
Marketing and sales		109		128		308		481
General and administrative		129		323		517		741

	$	309	$	511	$	964	$	1446

As of June 30, 2022, there was approximately $2.8 million 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 1.92 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		Six Months Ended
	June 30,		June 30,
	2022	2021	2022	2021
Average risk-free interest rate	2.56%	N/A	1.90%	0.20%
Expected dividend yield	None	None	None	None
Expected life	3.5 years	3.5 years	3.5 years	3.5 years
Expected volatility	69.7% to 70.5%	N/A	66.3% to 70.5%	66.0% to 66.0%
Weighted average exercise price	$5.19	N/A	$5.22	$18.00
Weighted average fair value	$1.72	N/A	$2.46	$8.37

The Company’s 2022 and 2021 average expected volatility and average expected life is based on the average of the Company’s historical information. The risk-free rate is based on the rate of U.S.

Treasury zero-coupon

issues with a remaining term equal to the expected life of option grants. The Company has paid no dividends on its common stock in the past and does not anticipate paying any dividends in the future.

The Company did not grant any shares of restricted stock during the three-months ended June 30, 2022 or 2021. The Company granted 0 and 22,488 shares of restricted stock during the six months ended June 30, 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.

A summary of stock option activity for all stock option plans for the period ended June 30, 2022 is as follows:


	Number of Options			Weighted Average Exercise Price		Intrinsic Value
Outstanding as of December 31, 2021		2,486,511		$	9.27	$	3,820
Granted		760,000		$	5.22	$	3
Exercised		(28,833	)	$	2.74	$	75
Cancelled		(479,797	)	$	12.33	$	—

Outstanding as of June 30, 2022		2,737,881		$	7.68	$	833

Options Exercisable as of December 31, 2021		1,619,855		$	6.47	$	3,730

Options Exercisable as of June 30, 2022		1,819,897		$	7.44	$	830

The Company issued 6,000 and 28,833 shares of common stock upon the exercise of outstanding stock options in the three and six months ended June

, 2022, respectively. The Company received cash proceeds of approximately $13,000 and $79,000 in the three and six months ended June

, 2022, respectively. The intrinsic value of restricted shares that vested in the three and six months ended June 30, 2022 was $0.0 million and $0.0 million, respectively.

There were no restricted shares that vested in the three and six months ended June 30, 2022.

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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”), effective January 1, 2020. The ESPP provides for the issuance of up 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.

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 purchase shares under the ESPP.

Any eligible employee can enroll in the Plan as of the beginning of a respective quarterly accumulation period. Employees who participate in the ESPP may purchase shares by authorizing payroll deductions of up to 15% of their base compensation during an accumulation period. Unless the participating employee withdraws from participation, accumulated payroll deductions are used to purchase shares of common stock on the last business day of the accumulation period (the “Purchase Date”) at a price equal to 85% of the lower of the fair market value on (i) the Purchase Date or (ii) the first day of such accumulation period. Under applicable tax rules, no employee may purchase more than $25,000 worth of common stock, valued at the start of the purchase period, under the ESPP in any calendar year.

The Company issued 8,683 and 18,064 shares under the ESPP in the three and six months ended June 30, 2022 respectively. The Company recorded approximately $12,000 and $22,000 of stock-based compensation expense pursuant to ESPP for the three and six months ended June 30, 2022, respectively. The next accumulation period under the ESPP commenced on March 31, 2022 and ended on June 30, 2022, and the related shares purchased by the participants were issued in July 2022. As of June 30, 2022, the Company recorded a liability of approximately $34,000 related to employee withholdings in connection with the ESPP accumulation period ended June 30, 2022, which was included as a component of accrued expenses and other current liabilities.

Note 11 - Income Taxes

The Company had no material unrecognized tax benefits and a deferred tax liability of approximately $5,100 related to tax amortizable goodwill at June 30, 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 June 30, 2022.

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 – 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 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.

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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:


	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2022			2021			2022			2021

Segment revenues:
Detection	$	5,289		$	4,789		$	10,809		$	10,508
Therapy		2,286			3,037			4,289			5,962

Total Revenue	$	7,575		$	7,826		$	15,098		$	16,470
Segment gross profit:
Detection	$	4,554		$	4,005		$	9,215		$	8,730
Therapy		937			1,533			1,588			3,097

Segment gross profit	$	5,491		$	5,538		$	10,803		$	11,827
Segment operating income (loss):
Detection	$	446		$	52		$	1,068		$	993
Therapy		(797	)		(250	)		(2,006	)		(562	)

Segment operating income (loss):	$	(351	)	$	(198	)	$	(938	)	$	431
General, administrative, depreciation and amortization expense	$	(2,763	)	$	(2,673	)	$	(5,698	)	$	(4,835	)
Interest expens e		—			(29	)		(1	)		(129	)
Interest income		14			19			16			33
Other expense		(18	)		(13	)		(41	)		(37	)
Loss on extinguishment of debt		—			(386	)		—			(386	)

Loss before income tax	$	(3,118	)	$	(3,280	)	$	(6,662	)	$	(4,923	)

Note 13 – Commitments and Contingencies

Other Commitments

The Company is obligated to pay approximately $5.1 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. 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 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

Certain information included in this Item 2 and elsewhere in this Form

10-Q

that are not historical facts contain statements that may be deemed “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve or may involve a number of known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to the following: the continuing impact of the

COVID-19

pandemic, the continuing impact of military and political conflict in

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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 and 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.

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

COVID-19.

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, 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 expected results for the nine months ending September 30, 2022, or any interim or any future period, could reflect a continuing negative impact from the

COVID-19

pandemic for similar or additional reasons.

The Company believes that its current liquidity and capital resources are sufficient to sustain operations through at least the next 12 months, primarily due to cash on hand of $27.2 million at June 30, 2022 and anticipated revenue and cash collections. However, the resurgence of the

COVID-19

pandemic could affect the Company’s liquidity and capital resources.

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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 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. For the fiscal year ended 2021, approximately 8.6% of the Company’s total revenue and approximately 39.0% of the Company’s export revenue was derived from customers located in Europe.

Critical Accounting Estimates

The Company’s discussion and analysis of its financial condition, results of operations, and cash flows are based on the Company’s consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates these estimates, including those related to revenue recognition, allowance for doubtful accounts, inventory valuation and obsolescence, intangible assets, goodwill, income taxes, contingencies, and litigation. Additionally, the Company uses assumptions and estimates in calculations to determine stock-based compensation, and evaluation of litigation. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Due to the

COVID-19

pandemic 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 is not aware of any specific event or circumstance that would require an update to its estimates or judgments or a revision of the carrying value of its assets or liabilities as of the date of issuance of this Quarterly Report on Form

10-Q.

These estimates may change, as new events occur, and additional information is obtained. Actual results could differ materially from these estimates under different assumptions or conditions.

Other than as described herein, there have been no additional material changes to our critical accounting policies as discussed in our 2021 Annual Report on Form

10-K

(the “2021

10-K”).

For a comprehensive list of the Company’s critical accounting policies, reference should be made to the 2021

10-K.

Three and six months ended June 30, 2022 compared to three and six months ended June 30, 2021 (in thousands, except share data or as noted)

Revenue

Three months ended June 30, 2022 and 2021:


	Three months ended June 30
	2022		2021		$ Change			% Change
Detection revenue
Product revenue	$	3,467	$	3,164	$	303			9.6	%
Service and supplies revenue		1,822		1,625		197			12.1	%

Subtotal		5,289		4,789		500			10.4	%
Therapy revenue
Product revenue		1,008		1,388		(380	)		-27.4	%
Service and supplies revenue		1,278		1,649		(371	)		-22.5	%

Subtotal		2,286		3,037		(751	)		-24.7	%

Total revenue	$	7,575	$	7,826	$	(251	)		-3.2	%

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Total revenue decreased by approximately $0.2 million or (3.2%), from $7.8 million for the three months ended June 30, 2021 to $7.6 million for the three months ended June 30, 2022. The decrease is due to an increase in Detection revenue of approximately $0.5 million offset by a decrease in Therapy revenue of $0.7 million. During the first half of 2022, the Company has seen increased customer demand for subscription licenses, which currently remains a small portion of the Company’s total license revenue. The Company believes this trend could accelerate. 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 on delivery for perpetual licenses.

Detection product revenue increased by approximately $0.3 million, or 9.6%, from $3.2 million for the three months ended June 30, 2021 to $3.5 million for the three months ended June 30, 2022. The overall increase is due primarily to an increase in direct customer revenue of $0.3 million relating primarily to revenue from 3D imaging and density assessment products. The Company also believes that the

COVID-19

pandemic adversely affected revenues during the three months ended June 30, 2022 and 2021.

Detection service and supplies revenue, which is primarily sold to direct customers, increased by $0.2 million, or 12.1%, from $1.6 million in the three months ended June 30, 2021 to $1.8 million in the three months ended June 30, 2022.

Therapy product revenue decreased by approximately $0.4 million, or (27.4)%, from $1.4 million for the three months ended June 30, 2021 to $1.0 million for the three months ended June 30, 2022. Therapy product revenue is related to the sale of our Axxent systems and can vary significantly from quarter to quarter due to changes in the number of units sold, and the average selling price.

Therapy service and supplies revenue decreased by approximately $0.4 million, or (22.5)%, from $1.7 million for the three months ended June 30, 2021 to $1.3 million for the three months ended June 30, 2022. The Company believes that Therapy product revenue was adversely affected by the

COVID-19

pandemic during the three months ended June 30, 2022 and 2021. The Company saw lower service and supplies revenues due to lower balloon sales in the three months ended June 30, 2022 as compared to the three months ended June 30, 2021. The Company is not able to predict how the

COVID-19

pandemic will affect future Therapy service and supplies revenue.

Six months ended June 30, 2022 and 2021:


	Six months ended June 30
	2022		2021		$ Change			% Change
Detection revenue
Product revenue	$	7,331	$	7,325	$	6			0.1	%
Service and supplies revenue		3,478		3,183		295			9.3	%

Subtotal		10,809		10,508		301			2.9	%
Therapy revenue
Product revenue		1,704		2,784		(1,080	)		-38.8	%
Service and supplies revenue		2,585		3,178		(593	)		-18.7	%

Subtotal		4,289		5,962		(1,673	)		-28.1	%

Total revenue	$	15,098	$	16,470	$	(1,372	)		-8.3	%

Total revenue decreased by approximately $1.4 million, or (8.3%), from $16.5 million for the six months ended June 30, 2021 to $15.1 million for the six months ended June 30, 2022. The decrease is due to a decrease in Therapy revenue of approximately $1.7 million offset by an increase in Detection revenue of $0.3 million. During the first half of 2022, the Company has seen increased customer demand for subscription licenses, which currently remains a small portion of the Company’s total license revenue. The Company believes this trend could accelerate. 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 on delivery for perpetual licenses.

Detection product revenue was relatively flat at $7.3 million for both the six months ended June 30, 2022 and 2021.

Detection service and supplies revenue, which is primarily sold to direct customers, increased by $0.3 million, or 9.3%, from $3.2 million in the six months ended June 30, 2021 to $3.5 million in the six months ended June 30, 2022.

Therapy product revenue decreased by approximately $1.1 million, or (38.8%), from $2.8 million for the six months ended June 30, 2021 to $1.7 million for the six months ended June 30, 2022. Therapy product revenue is related to the sale of our Axxent systems and can vary significantly from quarter to quarter due to changes in the number of units sold, and the average selling price. The Company believes that Therapy product revenue was adversely affected by the COVID-19 pandemic during the six months ended June 30, 2022 and 2021.

Therapy service and supplies revenue decreased by approximately $0.6 million, or (18.7)%, from $3.2 million for the six months ended June 30, 2021 to $2.6 million for the six months ended June 30, 2022. The Company believes that Therapy service and supplies revenue was adversely affected by the

COVID-19

pandemic during the six months ended June 30, 2022 and 2021. The Company saw lower service and supplies revenues due to lower balloon sales in the six months ended June 30, 2022 as compared to the six months ended June 30, 2021. The Company is not able to predict how the

COVID-19

pandemic will affect future Therapy service and supplies revenue.

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Cost of Revenue and Gross Profit:

Three months ended June 30, 2022 and 2021:


Cost of Revenue and Gross Profit:	Three months ended June 30
	2022		2021		$ Change			% Change
Products	$	1,008	$	1,377	$	(369	)		-26.8	%
Service and supplies		1,001		832		169			20.3	%
Amortization and depreciation		75		79		(4	)		-5.1	%

Total cost of revenue	$	2,084	$	2,288	$	(204	)		-8.9	%


	Three months ended June 30
	2022		2021		$ Change			% Change
Detection gross profit	$	4,554	$	4,005	$	549			13.7	%
Therapy gross profit		937		1,533		(596	)		-38.9	%

Gross profit	$	5,491	$	5,538	$	(47	)		-0.8	%

Gross profit for the three months ended June 30, 2022 was approximately $5.5 million, or 72.5% of revenue, as compared to $5.5 million, or 70.8% of revenue, for the three months ended June 30, 2021. Detection gross profit percentage increased from 83.6% for the three months ended June 30, 2021 to 86.1% for the three months ended June 30, 2022. Therapy gross profit percentage increased from 70.8% for the three months ended June 30, 2021 to 72.5% for the three months ended June 30, 2022. Detection gross profit represented 72.3% of total Company gross profit for the three months ended June 30, 2021 compared to 82.9% for the three months ended June 30, 2022.

Cost of products decreased by approximately $0.4 million, or (26.8%), from $1.4 million for the three months ended June 30, 2021 to $1.0 million for the three months ended June 30, 2022. Cost of product revenue as a percentage of product revenue was approximately 30.3% for the three months ended June 30, 2021 as compared to 22.5% for the three months ended June 30, 2022. The product mix in the three-month period ended June 30, 2022 compared to the same period in 2021 included more Detection products, which have a lower relative cost of sales.

Cost of service and supplies increased by approximately $0.2 million from $0.8 million for the three months ended June 30, 2021 to $1.0 million for the three months ended June 30, 2022. Cost of service and supplies revenue as a percentage of service and supplies revenue was approximately 25.4% for the three months ended June 30, 2021 as compared to 32.3% for the three months ended June 30, 2022. The cost of service and supplies as a percentage of revenue increased primarily as a result of a temporary reduction in average selling price for certain supplies to certain customers, including clinical trial participants.

Amortization and depreciation, which relates primarily to acquired intangible assets and depreciation of machinery and equipment, was approximately $0.1 million for the three months ended June 30, 2022 and 2021.

Six months ended June 30, 2022 and 2021:


Cost of Revenue and Gross Profit:
	Six months ended June 30
	2022		2021		$ Change			% Change
Products	$	2,095	$	2,786	$	(691	)		-24.8	%
Service and supplies		2,050		1,699		351			20.7	%
Amortization and depreciation		150		158		(8	)		-5.1	%

Total cost of revenue	$	4,295	$	4,643	$	(348	)		-7.5	%


	Six months ended June 30
	2022		2021		$ Change			% Change
Detection gross profit	$	9,215	$	8,730	$	485			5.6	%
Therapy gross profit		1,588		3,097		(1,509	)		-48.7	%

Gross profit	$	10,803	$	11,827	$	(1,024	)		-8.7	%

Gross profit for the six months ended June 30, 2022 was approximately $10.8 million, or 71.6% of revenue, as compared to $11.8 million, or 71.8% of revenue, for the six months ended June 30, 2021. Detection gross profit percentage increased from 83.1% for the six months ended June 30, 2021 to 85.3% for the six months ended June 30, 2022. Therapy gross profit percentage decreased from 51.9% for the six months ended June 30, 2021 to 37.0% for the six months ended June 30, 2022. Detection gross profit represented 73.8% of total Company gross profit for the six months ended June 30, 2021 compared to 85.3% for the six months ended June 30, 2022.

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Cost of products decreased by approximately $0.7 million, or (24.8)%, from $2.8 million for the six months ended June 30, 2021 to $2.1 million for the six months ended June 30, 2022. Cost of product revenue as a percentage of product revenue was approximately 27.6% for the six months ended June 30, 2021 as compared to 23.2% for the six months ended June 30, 2022. The product mix in the

six-month

period ended June 30, 2022 compared to the same period in 2022 included more Detection products, which have a lower relative cost of sales.

Cost of service and supplies increased by approximately $0.4 million, or 20.7%, from $1.7 million for the six months ended June 30, 2021 to $2.1 million for the six months ended June 30, 2022. Cost of service and supplies revenue as a percentage of service and supplies revenue was approximately 26.7% for the six months ended June 30, 2021 as compared to 33.8% for the six months ended June 30, 2022. The cost of service and supplies as a percentage of revenue increased primarily as a result of a temporary reduction in average selling price for certain supplies to certain customers, including clinical trial participants.

Amortization and depreciation, which relates primarily to acquired intangible assets and depreciation of machinery and equipment, was approximately $0.2 million for both the six months ended June 30, 2022 and 2021.

Operating Expenses:

Three months ended June 30, 2022 and 2021:


	Three months ended June 30,
	2022		2021		$ Change		% Change
Operating expenses:
Engineering and product development	$	2,367	$	2,268	$	99		4.4	%
Marketing and sales		3,435		3,429		6		0.2	%
General and administrative		2,742		2,652		90		3.4	%
Amortization and depreciation		61		60		1		1.7	%

Total operating expenses	$	8,605	$	8,409	$	196		2.3	%

Operating expenses increased by approximately $0.2 million, or 2.3%, from $8.4 million in the three months ended June 30, 2021 to $8.6 million in the three months ended June 30, 2022.

Engineering and Product Development

. Engineering and product development costs increased by approximately $0.1 million, or 4.4%, from $2.3 million for the three months ended June 30, 2021 to $2.4 million for the three months ended June 30, 2022. The increase was primarily related to higher employee costs in 2022 offset by a reduction in external service and clinical study expenses.

Marketing and Sales

. Marketing and sales expenses were flat at $3.4 million in the three months ended June 30, 2022 and 2021.

General and Administrative

. General and administrative expenses increased by approximately $0.1 million, or 3.4%, from $2.6 million in the three months ended June 30, 2021 to $2.7 million for the three months ended June 30, 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 with the U.S. commercial group reorganization and refocusing, increased travel costs, and an increase of $0.2 million to the allowance for doubtful accounts.

Amortization and Depreciation.

Amortization and depreciation, which relates primarily to acquired intangible assets and depreciation of machinery and equipment, were flat for the three months ended June 30, 2022 and 2021.

Other Income and Expense:

Three months ended June 30, 2022 and 2021:


Other Income and Expense:
	Three months ended June 30
	2022			2021			$ Change			% Change
Interest expense	$	—		$	(29	)	$	29			-100.0	%
Interest income		14			19			(5	)		-26.3	%
Other loss		(18	)		(13	)		(5	)		38.5	%
Loss on extinguishment of debt		—			(386	)		386			-100.0	%

	$	(4	)	$	(409	)	$	405			-99.0	%

Tax benefit (expense)	$	—		$	—		$	—			0.0	%

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Interest expense

. Interest expense decreased $29,000, or 100.0%, from $(29,000) in the three months ended June 30, 2021 to $0 for the three months ended June 30, 2022. The decrease is due to the timing of termination of the Loan Agreement in 2021.

Interest income

. Interest income decreased by approximately $5,000, or 26.3%, from $19,000 for the three months ended June 30, 2021 to $14,000 for the three months ended June 30, 2022.

Other income (loss)

. Other income (loss) increased by approximately $5,000, or 38.5%, from other loss of $5,000 for the three months ended June 30, 2021 to other loss of $18,000 for the three months ended June 30, 2022.

Loss on extinguishment of debt:

The Company recorded a loss on extinguishment of approximately $386,000 related to the repayment and retirement of the Loan Agreement as of the three months ended June 30, 2021. 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 and other closing costs from opening the loan.

Tax expense

. Tax expense was approximately flat for the three months ending June 30, 2022 and 2021.

Operating Expenses:

Six months ended June 30, 2022 and 2021:


	Six months ended June 30
	2022		2021		$ Change		% Change
Operating expenses:
Engineering and product development	$	4,642	$	4,460	$	182		4.1	%
Marketing and sales		7,000		6,853		147		2.1	%
General and administrative		5,673		4,803		870		18.1	%
Amortization and depreciation		124		115		9		7.8	%

Total operating expenses	$	17,439	$	16,231	$	1,208		7.4	%

Operating expenses increased by approximately $1.2 million, or 7.4%, from $16.2 million in the six months ended June 30, 2021 to $17.4 million in the six months ended June 30, 2022.

Engineering and Product Development

. Engineering and product development costs increased by approximately $0.2 million, or 4.1%, from $4.5 million for the six months ended June 30, 2021, to $4.7 million for the six months ended June 30, 2022. The increase was primarily related to higher employee costs in 2022 offset by a reduction in external service and clinical study expenses.

Marketing and Sales

. Marketing and sales expenses increased by approximately $0.1 million, or 2.1%, from $6.9 million in the six months ended June 30, 2021, to $7.0 million in the six months ended June 30, 2022. The increase was primarily due to increased employee-related costs associated with the U.S. commercial group reorganization and refocusing and increased travel costs resulting from the reduction of pandemic travel restrictions.

General and Administrative

. General and administrative expenses increased by approximately $0.9 million, or 18.1%, from $4.8 million in the six months ended June 30, 2021 to $5.7 million for the six months ended June 30, 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 with the U.S. commercial group reorganization and refocusing, increased travel costs, and an increase of $0.5 million to the allowance for doubtful accounts.

Amortization and Depreciation.

Amortization and depreciation which relates primarily to acquired intangible assets and depreciation of machinery and equipment, increased by approximately $9,000, or 7.8%, from $115,000 for the six months ended June 30, 2022, to $124,000 for the six months ended June 30, 2022.

Other Income and Expense:

Six months ended June 30, 2022 and 2021:


Other Income and Expense:
	Six months ended June 30
	2022			2021			$ Change			% Change
Interest expense	$	(1	)	$	(129	)	$	128			-99.2	%
Interest income		16			33			(17	)		-51.5	%
Other loss		(41	)		(37	)		(4	)		10.8	%
Loss on extinguishment of debt		—			(386	)		386			-100.0	%

	$	(26	)	$	(519	)	$	493			-95.0	%

Tax benefit (expense)	$	(1	)	$	—		$	(1	)		0.0	%

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Interest expense

. Interest expense decreased $128,000, or 99.2%, from $129,000 in the six months ended June 30, 2021 to $1,000 for the six months ended June 30, 2022. The decrease is due to the timing of termination of the Loan Agreement in 2021.

Interest income.

Interest income decreased by approximately $17,000, or 51.5%, from $33,000 for the six months ended June 30, 2021 to $16,000 for the six months ended June 30, 2022.

Other income (loss)

. Other loss increased by approximately $4,000, or 10.8%, from other loss of $37,000 for the six months ended June 30, 2021 to other loss of $41,000 for the six months ended June 30, 2022.

Loss on extinguishment of debt:

The Company recorded a loss on extinguishment of approximately $386,000 related to the repayment and retirement of the Loan Agreement as of the six months ended June 30, 2021. 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 and other closing costs from opening the loan

Tax expense

. Tax expense was approximately flat, from $0 for the six months ended June 30, 2021 to $(1,000) for the six months ended June 30, 2022.

Liquidity and Capital Resources (in thousands, except as noted)

The Company believes that its cash and cash equivalents balance of $27.2 million as of June 30, 2022, 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 Company will continue to closely monitor its liquidity and the capital and credit markets.

The Company had net working capital of $31.2 million at June 30, 2022. The ratio of current assets to current liabilities at June 30, 2022 and December 31, 2021 was 3.19 and 3.36, respectively.


	For the six months ended June 30,
	2022			2021
Net cash used for operating activities	$	(7,009	)	$	(5,577	)
Net cash used for investing activities		(265	)		(336	)
Net cash provided by financing activities		172			16,616

(Decrease) increase in cash and equivalents	$	(7,102	)	$	10,703

Net cash used for operating activities for the six months ended June 30, 2022 was $7.0 million, compared to $5.6 million for the six months ended June 30, 2021. The increase in net cash used for operating activities for the six months ended June 30, 2022 resulted primarily from the Company’s net loss and working capital changes resulting from increases in 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. 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 six months ended June 30, 2022 was $265,000, compared to $336,000 for the six months ended June 30, 2021. The net cash used for investing activities for the six months ended June 30, 2022 and 2021 is primarily for purchases of property and equipment.

Net cash provided by financing activities for the six months ended June 30, 2022 was $172,000, compared to $16.6 million for the six months ended June 30, 2021. Net cash provided by financing activities for the six months ended June 30, 2022 is primarily due to cash of $172,000 from the issuance of common stock pursuant the Company’s stock option and employee stock purchase plans. Net cash provided by financing activities for the six months ended June 30, 2021 is primarily from the March 2, 2021 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 $23.2 million.

Recent Accounting Pronouncements

See Note 1 to the Condensed Consolidated Financial Statements.

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Item 3.

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.

Item 4.

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 June 30, 2022, 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”)) 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 June 30, 2022 that have materially affected or which are reasonably likely to materially affect internal control over financial reporting.

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PART II OTHER

INFORMATION

Item 1A.

Risk Factors:

We operate in a changing environment that involves numerous known and unknown risks and uncertainties that could materially adversely affect our operations. In addition to the risk factors below, factors that have affected our Company are described in Part I, Item 1A of our Annual Report on Form

10-K

for the year ended December 31, 2021 as filed with the SEC on March 29, 2022 and are incorporated by reference herein.

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.

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 second 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 expected quarterly results for the nine months ending September 30, 2022, or any interim or any future period, 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.

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Item 6.

Exhibits


Exhibit No.		Description

10.1*		Lease between The Irvine Company LLC and iCAD, Inc. dated June 29, 2012, together with First Amendment to Lease dated September 19, 2016, Second Amendment to Lease dated August 12, 2019, and Third Amendment to Lease dated May 19, 2022.

10.2		Consulting Agreement, dated May 24, 2022 by and between iCAD, Inc. and Daley and Associates, LLC (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on May 31, 2022).

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

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

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

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

101*		The following materials formatted in XBRL (eXtensible Business Reporting Language); (i) Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021, (ii) Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2022 and 2021, (iii) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021, (iv) Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021 and (v) Notes to Condensed Consolidated Financial Statements.

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

*	Filed herewith

**	Furnished herewith

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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)