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iCAD Reports Financial Results for Fourth Quarter and Year Ended December 31, 2021
المصدر: Nasdaq GlobeNewswire / 28 فبراير 2022 16:05:01 America/New_York
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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.comInvestor Inquiries:
iCAD Investor Relations
ir@icadmed.comiCAD, 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 ) 
