iCAD Reports Financial Results for Fourth Quarter and Year Ended December 31, 2021

Rhea-AI Summary

iCAD, a leader in cancer detection and therapy solutions, reported Q4 2021 revenues of $7.8 million, down 25% from $10.5 million in Q4 2020. Annual revenues rose 13.3% to $33.6 million. The company faced challenges from the Omicron variant, which impacted order processing. A net loss of $4.1 million for Q4 was reported, compared to $1.6 million loss in the same quarter last year. The company maintains a cash reserve of $34.3 million. New initiatives include launching the ProFound AI Risk tool and securing a global distribution agreement with Arterys.

Positive

• Annual revenue increased by 13.3% to $33.6 million.
• Therapy revenue for 2021 surged 50.9% compared to 2020.
• Gross profit margin improved to 72.1% for the year.

Negative

• Q4 2021 revenue declined by 25% year-over-year.
• Net loss widened to $4.1 million in Q4 from $1.6 million in Q4 2020.
• Product revenue decreased by 38% in Q4 2021.

Launched ProFound AI® Risk, the world’s first clinical decision support tool for short term breast cancer risk estimation

Demonstrated compelling survival data for the use of Xoft^® Brain IORT in recurrent glioblastoma (GBM) as published in Surgical Neurology International

Company to Host Conference Call & Webcast Today at 4:30 PM ET

NASHUA, N.H., Feb. 28, 2022 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today reported its financial and operating results for the three and 12 months ended December 31, 2021.

Revenues for the three-month and 12-month periods ended December 31, 2021 were $7.8 million and $33.6 million, respectively, compared to $10.5 million and $29.7 million in the three- and 12-month periods ended December 31, 2020, respectively. Net loss for the three-month and 12-month periods ended December 31, 2021, were $4.1 million and $11.2 million, respectively, compared to $1.6 million and $17.6 million in the three- and 12-month periods ended December 31, 2020, respectively.

Recent Highlights:

• Accelerated the adaptation of commercial operations to evolving market trends in order to maximize access to iCAD’s large addressable markets
• Reorganized the sales functions to address marketplace changes
• Appointed Dana Brown and Timothy Norris, who each offer significant insight and decades of relevant experience in corporate leadership, brand stewardship, and health technologies, as well as proven track records of leading innovation and strategic change, to the Board of Directors
• Signed a global distribution agreement with Arterys, the world's leading vendor-neutral AI platform, to launch Arterys’ AI SaaS solution
• Granted an Authorization to Operate from the U.S. Department of Defense for its breast AI platform 
  

“As it affected many segments of the global economy, the surge in the Omicron variant in December had a negative impact on our customers in the fourth quarter,” said Stacey Stevens, incoming CEO. “Customer focus on surging COVID-19 infection rates, severe staffing shortages and resource limitations made the processing of new purchase orders challenging, resulting in the postponement of several, larger enterprise deals in the quarter. The effects of this recent variant were also felt within our own team, as approximately 1/3 of our global sales staff was afflicted with COVID-19 in December.”

“Two months into 2022, we are encouraged to see some gradual improvements in the market,” continued Stevens. “As the Omicron surge is subsiding, we are seeing customers beginning to focus more on non-COVID related business decisions.”

“We are currently at an important and exciting inflection point in the Company from both a product and operational perspective,” said Stevens. “We have a robust portfolio of superior technologies for the detection, risk assessment, and treatment of breast and other cancers and we are operating in large, under-penetrated markets with superior clinical and economic value propositions that are making a major contribution towards better patient care.”

“A key theme for us this year is the focus on driving increased revenue and growth from our existing portfolio of leading solutions. To this end, we are enhancing our commercial sales infrastructure, sharpening our focus to maximize our access to the entirety of our large addressable market, and helping customers to adopt our technologies more flexibly,” concluded Stevens.

Fourth Quarter 2021 Financial Results

Total Detection and Therapy revenue for the fourth quarter of 2021 was $7.8 million, a decrease of $2.6 million, or 25%, as compared to the fourth quarter of 2020, reflecting a 38% decline in product revenue, offset by 10% growth in service and supplies revenue.

In $000's
		Three months ended December 31,
		2021			2020			$ Change				% Change
	Product revenue	$	4,762		$	7,683		$	(2,921	)		(38	)%
	Service and supplies revenue	3,046			2,768			278				10	%
Total Revenue		$	7,808		$	10,451		$	(2,643	)		(25	)%

Revenue: Cancer Detection revenue for the fourth quarter of 2021, which includes the Company’s mammography and breast density products, and the associated service and supplies revenue, decreased by approximately $2.6 million, or 32%, as compared to the fourth quarter of 2020. Therapy revenue for the fourth quarter of 2021, which includes Xoft^® Axxent® eBx^® System^® sales, as well as the associated service and supplies revenue, decreased by $0.04 million, or 1%, as compared to the fourth quarter of 2020.  

 

In $000's
		Three months ended December 31,
		2021			2020			$ Change				% Change
Detection revenue
	Product revenue	$	3,882		$	6,600		$	(2,718	)		(41	)%
	Service and supplies revenue	1,622			1,512			110				7	%
Detection Revenue		$	5,504		$	8,112		$	(2,608	)		(32	)%
Therapy revenue
	Product revenue	$	880		$	1,083		$	(203	)		(19	)%
	Service and supplies revenue	1,424			1,256			168				13	%
Therapy Revenue		$	2,304		$	2,339		$	(35	)		(1	)%
Total Revenue		$	7,808		$	10,451		$	(2,643	)		(25	)%

Gross Profit: Gross profit for the fourth quarter of 2021 was $5.7 million, or 73% of revenue, as compared to $7.5 million, or 71% of revenue, in the fourth quarter of 2020.

Operating Expenses: Total operating expenses for the fourth quarter of 2021 were $9.9 million, a $0.9 million, or 10%, increase from $9.0 million in the fourth quarter of 2020.  

GAAP Net Loss: Net loss for the fourth quarter of 2021 was ($4.1) million, or ($0.17) per diluted share, as compared to a net loss of ($1.6) million, or ($0.07) per diluted share, for the fourth quarter of 2020.

Non-GAAP Adjusted Net Loss: Non-GAAP adjusted net loss, a non-GAAP financial measure as defined below, for the fourth quarter of 2021 was ($4.1) million, or ($0.17) per diluted share, as compared to a non-GAAP adjusted net loss of ($1.4) million, or ($0.06) per diluted share, for the fourth quarter of 2020. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the three-month periods ended December 31, 2021 and 2020, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, for the fourth quarter of 2021 was a loss of ($3.3) million, a $ 2.4 million increase as compared to the fourth quarter 2020 non-GAAP adjusted EBITDA loss of ($0.9) million. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the three-month periods ended December 31, 2021 and 2020, respectively.

Twelve months ended December 31, 2021 Financial Results

Total Detection and Therapy revenue for the year ended December 31, 2021, was $33.6 million, an increase of $3.9 million, or 13.3%, as compared to the same period of 2020, reflecting a 12.1% increase in product revenue, and a 15.3% increase in service and supplies revenue.

In $000's
		Twelve months ended December 31,
			2021			2020		$ Change			% Change
	Product revenue	$	21,191		$	18,903		$	2,288		12.1	%
	Service revenue		12,447			10,795			1,652		15.3	%
Total Revenue		$	33,638		$	29,698		$	3,940		13.3	%

Cancer Detection revenue for the year ended December 31, 2021, which includes the Company’s mammography and breast density products, and the associated service and supplies revenue, remained relatively consistent at $22 million, as compared to the same period of 2020.

Therapy revenue for the year ended December 31, 2021, which includes Xoft^® Axxent® eBx^® System^® sales, as well as the associated service and supplies revenue, increased by $3.9 million, or 50.9%, as compared to the same period of 2020.

In $000's
		Twelve months ended December 31,
			2021			2020		$ Change				% Change
Detection revenue
	Product revenue	$	15,661		$	16,291		$	(630	)		(3.9	)%
	Service revenue		6,358			5,706			652			11.4	%
Detection Revenue		$	22,019		$	21,997		$	22			0.1	%
Therapy revenue
	Product revenue	$	5,530		$	2,612		$	2,918			111.7	%
	Service revenue		6,089			5,089			1,000			19.7	%
Therapy Revenue		$	11,619		$	7,701		$	3,918			50.9	%
Total Revenue		$	33,638		$	29,698		$	3,940			13.3	%

Gross Profit: Gross profit for the year ended December 31, 2021 was $24.2 million, or 72.1% of revenue, as compared to $21.4 million, or 71.9% of revenue, in the same period of 2020.

Operating Expenses: Total operating expenses for the year ended December 31, 2021 were $35.0 million, an increase of $4.3 million or 13.8%, compared to $30.7 million in the same period of 2020.

GAAP Net Loss: Net loss for the year ended December 31, 2021, was ($11.2) million, or ($0.45) per diluted share, as compared to a net loss of ($17.6) million, or ($0.80) per diluted share, for the same period of 2020.

Non-GAAP Adjusted Net Loss: Non-GAAP adjusted net loss, a non-GAAP financial measure as defined below, for the year ended December 31, 2021, was ($10.7) million, or ($0.43) per diluted share, as compared to a Non-GAAP adjusted net loss of ($9.5) million, or ($0.43) per diluted share, for the same period of 2020. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the years ended December 31, 2021 and 2020, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP adjusted EBITDA, a non-GAAP financial measure as defined below, for the year ended December 31, 2021, was a loss of ($7.3) million, a $1.5 million increase compared to the year ended December 31, 2020, non-GAAP adjusted EBITDA loss of ($5.7) million. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the years ended December 31, 2021 and 2020, respectively.

Cash and Cash Equivalents: As of December 31, 2021, the Company had cash and cash equivalents of $34.3 million, compared to cash and cash equivalents of $27.2 million at December 31, 2020.

Conference Call
Monday, February 28th @ 4:30pmET
Domestic:	877-407-0784
International:	201-689-8560
Conference ID:	13726987
Webcast:	https://themediaframe.com/mediaframe/webcast.html?webcastid=ELUrpENc

Financial Information included in this Press Release

Financial information included herein is not audited. The Company’s audited financial statements will be included in its Annual Report on Form 10K for the year ended December 31, 2021 that will be filed shortly with the Securities and Exchange Commission. As the Company and its accountants complete the preparation and the audit of its financial statements to be included in the Annual Report on Form 10-K, there may be adjustments or revisions to the information provided in this press release.

Use of Non-GAAP Financial Measures
In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements. When analyzing the Company's operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP. The Company's quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company's website at www.icadmed.com.

About iCAD, Inc.
Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the expected benefits of ProFound AI®, the benefits of the Company’s products, external factors affecting the market for our products, behavior of clients and prospective clients and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening in light of risks of potential exposure to Covid-19, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians, the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare or other 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 the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:
Media Inquiries:
Jessica Burns, iCAD 
+1-201-423-4492
jburns@icadmed.com

Investor Inquiries:
iCAD Investor Relations
ir@icadmed.com

iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
			December 31,				December 31,
Assets			2021				2020
Current assets:
Cash and cash equivalents		$	34,282			$	27,186
Trade accounts receivable, net of allowance for doubtful
accounts of $268 in 2021 and $111 in 2020			8,891				10,027
Inventory, net			4,171				3,144
Prepaid expenses and other current assets			2,962				1,945
Total current assets			50,306				42,302
Property and equipment, net of accumulated depreciation
and amortization of $7,106 in 2021 and $6,778 in 2020			882				744
Operating lease assets			1,059				1,758
Other assets			899				1,527
Intangible assets, net of accumulated amortization
of $8,724 in 2021 and $8,494 in 2020			683				889
Goodwill			8,362				8,362
Total assets		$	62,191			$	55,582
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	2,779			$	2,869
Accrued and other expenses			5,642				7,039
Lease payable - current portion			889				726
Deferred revenue			5,652				6,117
Total current liabilities			14,962				16,751
Notes payable, long-term portion			-				6,960
Lease payable - long-term portion			266				1,075
Deferred revenue, long-term portion			441				267
Deferred tax			5				4
Total Liabilities			15,674				25,057
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 25,326,086 in 2021 and 23,694,406 in 2020;
Outstanding 25,140,255 in 2021 and 23,508,575 in 2020			253				236
Additional paid-in capital			300,859				273,639
Accumulated deficit			(253,180	)			(241,935	)
Treasury stock at cost, 185,831 shares in 2021 and 2020			(1,415	)			(1,415	)
Total Stockholders' Equity			46,517				30,525
Total Liabilities and Stockholders' Equity		$	62,191			$	55,582

iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands except for per share data)
	Three Months Ended December 31,								Twelve Months Ended December 31,
		2021				2020				2021				2020
Revenue:
Products	$	4,762			$	7,683			$	21,191			$	18,903
Service and supplies		3,046				2,768				12,447				10,795
Total revenue		7,808				10,451				33,638				29,698
Cost of revenue:
Products		1,061				2,101				5,653				5,000
Service and supplies		963				796				3,425				2,965
Amortization and depreciation		80				92				317				379
Total cost of revenue		2,104				2,989				9,395				8,344
Gross profit		5,704				7,462				24,243				21,354
Operating expenses:
Engineering and product development		2,449				2,176				9,194				8,114
Marketing and sales		4,396				4,094				15,135				13,312
General and administrative		2,945				2,641				10,406				9,117
Amortization and depreciation		62				46				240				199
Total operating expenses		9,852				8,957				34,975				30,742
Loss from operations		(4,148	)			(1,495	)			(10,732	)			(9,388	)
Interest expense		-				(116	)			(141	)			(476	)
Loss on fair value of convertible debentures		-				-				-				(7,464	)
Loss on extinguishment of debt		-				-				(386	)			(341	)
Other income		3				12				15				97
Other expense, net		3				(104	)			(512	)			(8,184	)
Loss before income tax expense		(4,145	)			(1,599	)			(11,244	)			(17,572	)
Tax expense		(1	)			(4	)			(1	)			(38	)
Net loss and comprehensive loss	$	(4,146	)		$	(1,603	)		$	(11,245	)		$	(17,610	)
Net loss per share:
Basic	$	(0.17	)		$	(0.07	)		$	(0.45	)		$	(0.80	)
Diluted	$	(0.17	)		$	(0.07	)		$	(0.45	)		$	(0.80	)
Weighted average number of shares
used in computing loss per share:
Basic		25,125				23,072				24,778				22,140
Diluted		25,125				23,072				24,778				22,140

iCAD, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
	For the twelve months ended December 31,
		2021				2020
Cash flow from operating activities:
Net loss	$	(11,245	)		$	(17,610	)
Adjustments to reconcile net loss to net cash
used for operating activities:
Amortization		230				309
Depreciation		327				268
Bad debt provision		167				94
Stock-based compensation expense		2,783				2,844
Amortization of debt discount and debt costs		17				78
Change in fair value of convertible debentures		-				7,464
Deferred tax		1				1
Loss on disposal of assets		97				-
Loss on extinguishment of debt		386				341
Changes in operating assets and liabilities
Accounts receivable		969				(302	)
Inventory		(1,027	)			(533	)
Prepaid and other current assets		391				(1,390	)
Accounts payable		(90	)			878
Accrued expenses		(2,123	)			(207	)
Deferred revenue		(291	)			780
Total adjustments		1,837				10,625
Net cash used for operating activities		(9,408	)			(6,985	)
Cash flow from investing activities:
Additions to patents, technology and other		(24	)			(13	)
Additions to property and equipment		(563	)			(461	)
Net cash used for investing activities		(587	)			(474	)
Cash flow from financing activities:
Issuance of common stock pursuant to stock option plans		1,027				729
Issuance of common stock pursuant to Employee Stock Purchase Plan		257				266
Taxes paid related to restricted stock issuance		(59	)			(225	)
Principal repayment of notes payable		(7,363	)			(4,638	)
Proceeds from Line of Credit		-				775
Repayment to Line of Credit		-				(2,775	)
Proceeds from debt financing		-				6,957
Debt issuance costs		-				(42	)
Proceeds from issuance of common stock, net		23,229				18,285
Net cash provided by financing activities		17,091				19,332
Increase in cash and equivalents		7,096				11,873
Cash and equivalents, beginning of period		27186				15,313
Cash and equivalents, end of period	$	34,282			$	27,186

Non-GAAP Adjusted EBITDA
Set forth below is a reconciliation of the Company's "Non-GAAP Adjusted EBITDA"
(Unaudited)
(In thousands except for per share data)
	Three Months Ended December 31,								Twelve Months Ended December 31,
		2021				2020				2021				2020
GAAP Net Loss	$	(4,146	)		$	(1,603	)		$	(11,245	)		$	(17,610	)
Interest Expense		-				116				141				476
Other income		(3	)			(12	)			(15	)			(97	)
Stock Compensation		681				286				2,783				2,828
Depreciation		85				62				327				269
Amortization		54				76				230				310
Tax expense		1				4				1				38
Severance and Furlough		25				35				25				224
Cares Credit		-				-				-				(283	)
Loss on extinguishment of debt		-				-				386				341
Loss of fair value of convertible debentures		-				-				-				7,464
Litigation related		-				104				117				322
Non-GAAP Adjusted EBITDA	$	(3,303	)		$	(932	)		$	(7,250	)		$	(5,718	)
	Three Months Ended December 31,								Twelve Months Ended December 31,
		2021				2020				2021				2020
GAAP Net Loss	$	(4,146	)		$	(1,603	)	-	$	(11,245	)	-	$	(17,610	)
Adjustments to Net Loss:
Severance and Furlough		25				67				25				256
Cares Credit		-				-				-				(283	)
Loss from extinguishment of debt		-				-				386				341
Litigation related		-				104				117				322
Loss of fair value of convertible debentures		-				-				-				7,464
Non-GAAP Adjusted Net Loss	$	(4,121	)		$	(1,432	)		$	(10,717	)		$	(9,510	)
Net Loss per share
GAAP Net Loss per share	$	(0.17	)		$	(0.07	)		$	(0.45	)		$	(0.80	)
Adjustments to Net Loss (as detailed above)		-				0.01				0.02				0.37
Non-GAAP Adjusted Net Loss per share	$	(0.17	)		$	(0.06	)		$	(0.43	)		$	(0.43	)

FAQ

What were iCAD's revenue figures for Q4 2021?

iCAD reported Q4 2021 revenues of $7.8 million, down 25% from $10.5 million in Q4 2020.

What is the net loss reported by iCAD for Q4 2021?

iCAD reported a net loss of $4.1 million in Q4 2021, compared to a $1.6 million loss in Q4 2020.

How much cash did iCAD have at the end of 2021?

As of December 31, 2021, iCAD had cash and cash equivalents of $34.3 million.

What new products did iCAD launch recently?

iCAD launched ProFound AI Risk, a clinical decision support tool for breast cancer risk estimation.

What was the impact of the Omicron variant on iCAD's business?

The Omicron variant negatively impacted order processing and resulted in postponed enterprise deals in Q4 2021.