- Third Quarter Revenues of
- Third Quarter 2021 Revenues Represented 31% Growth Compared to the Third Quarter 2020 -
- Improving Enterprise Sales in the Third Quarter of 2021 Resulted in a 41% Sequential Quarter Increase in Detection Product Revenues -
- Xoft® Product Revenue Reflected a 34% Sequential Quarter Increase in the Third Quarter of 2021 with Continued Surge in Dermatology Controller Installations -
- Company to Host Conference Call & Webcast today at
Revenues for the three-month and nine-month periods ended
Recent Highlights:
- Experienced continued market demand for ProFound AI® Risk, the first and only commercially available clinical decision support tool providing two-year breast cancer risk estimation personalized for each woman, in the
U.S. andEurope , with improving enterprise sales in the third quarter resulting in a 41% increase in sequential quarter Detection product revenues, withU.S. product sales increasing 56% compared to last quarter - Launched ProFound AI® Risk (3D mammography), alongside an enhanced version of PowerLook® Density Assessment. These technologies provide critical, risk-adaptive solutions for clinicians facing complex screening challenges when personalizing wellness assessments regardless of a patient’s ethnicity
- Continued commercial focus in the Therapy business drove
$3.4 million in revenues, which represents a 10% increase in sequential quarter revenues, supported by the ongoing demand for dermatology controller installations, which continues to benefit from favorable market conditions from both a regulatory and reimbursement standpoint - Increased portfolio of clinical evidence around iCAD’s Xoft® brain intraoperative radiation therapy (IORT) with new data presented at
American Association of Neurological Surgeons demonstrating significant improvement in overall survival in recurrent glioblastoma patients after treatment
“Our third quarter total revenue of
“Moreover, we continued to experience significant growth in our Therapy business in the third quarter of 2021, as we generated sequential quarter and year-over-year third quarter increases in Xoft® product revenues of 34% and 188%, respectively. This momentum is being driven by an ongoing surge in dermatology controller installations, propelled by the emergence of positive shifts in reimbursement, payor coverage and regulatory changes. Our Xoft® brain IORT application represents a key catalyst for our Therapy segment, and we continue to generate compelling data supporting its efficacy and expect to treat the first patients in our GLIOX clinical trial later this month,”
Third Quarter 2021 Financial Results
Total Detection and Therapy revenue for the third quarter of 2021 was
Revenue: Cancer Detection revenue for the third quarter of 2021, which includes the Company’s mammography and breast density products, and the associated service and supplies revenue, increased by approximately
Three months ended | ||||||||||
2021 | 2020 | Change | % Change | |||||||
Detection revenue | ||||||||||
Product revenue | $ | 4,454 | $ | 3,889 | $ | 565 | 14.5 | % | ||
Service and supplies revenue | 1,554 | 1,402 | 152 | 10.8 | % | |||||
Subtotal | 6,008 | 5,291 | 717 | 13.6 | % | |||||
Therapy revenue | ||||||||||
Product revenue | 1,866 | 649 | 1,217 | 187.5 | % | |||||
Service and supplies revenue | 1,487 | 1,189 | 298 | 25.1 | % | |||||
Subtotal | 3,353 | 1,838 | 1,515 | 82.4 | % | |||||
Total revenue | $ | 9,361 | $ | 7,129 | $ | 2,232 | 31.3 | % | ||
Gross Profit: Gross profit for the third quarter of 2021 was
Operating Expenses: Total operating expenses for the third quarter of 2021 were
GAAP Net Loss: Net loss for the third quarter of 2021 was
Non-GAAP Adjusted Net Loss: Non-GAAP Adjusted Net Loss, a non-GAAP financial measure as defined below, for the third quarter of 2021 was
Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the third quarter of 2021 was
Nine Months Ended
Total Detection and Therapy revenue for the nine months ended
Revenue: Cancer Detection revenue for the nine months ended
Nine months ended | ||||||||||
2021 | 2020 | Change | % Change | |||||||
Detection revenue | ||||||||||
Product revenue | $ | 11,779 | $ | 9,691 | $ | 2,088 | 21.5 | % | ||
Service revenue | $ | 4,736 | 4,194 | 542 | 12.9 | % | ||||
Subtotal | 16,515 | 13,885 | 2,630 | 18.9 | % | |||||
Therapy revenue | ||||||||||
Product revenue | $ | 4,650 | 1,529 | 3,121 | 204.1 | % | ||||
Service revenue | $ | 4,665 | 3,833 | 832 | 21.7 | % | ||||
Subtotal | 9,315 | 5,362 | 3,953 | 73.7 | % | |||||
Total revenue | $ | 25,830 | $ | 19,247 | $ | 6,583 | 34.2 | % | ||
Gross Profit: Gross profit for the nine months ended
Operating Expenses: Total operating expenses for the nine months ended
GAAP Net Loss: Net loss for the nine months ended
Non-GAAP Adjusted Net Loss: Non-GAAP Adjusted Net Loss, a non-GAAP financial measure as defined below, for the first nine months of 2021 was
Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the first nine months of 2021 was
Conference Call | ||
Domestic: | 855-327-6837 | |
International: | 631-891-4304 | |
Conference ID: | 10016811 | |
Webcast Link: | https://themediaframe.com/mediaframe/webcast.html?webcastid=cp8sjumj |
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
Headquartered in
"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. For example, when the Company discusses the potential of ProFound AI® Risk, the benefits of the Company’s products, the Enterprise sales cycle, trends driving positive shifts, and clinical plans and updates, it is using forward-looking statements. 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, increase sales and acceptance of products, adoption by CMS of a new payment model, and that such model will prove beneficial to the Company, which is not assured, implement expansion plans, 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, ability to successfully defend itself in litigation matters, 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; the effects of a global pandemic, and other risks detailed in the Company’s filings with the
Contact:
Media Inquiries:
+1-201-423-4492
jburns@icadmed.com
Investor Relations:
+ 1-212-915-2578
britchie@lifesciadvisors.com
Condensed Consolidated Balance Sheets | |||||||
(In thousands except for share data) | |||||||
(Unaudited) | |||||||
Assets | 2021 | 2020 | |||||
Current assets: | |||||||
Cash and cash equivalents | $ | 35,805 | $ | 27,186 | |||
Trade accounts receivable, net of allowance for doubtful accounts of | 11,792 | 10,027 | |||||
Inventory, net | 3,290 | 3,144 | |||||
Prepaid expenses and other current assets | 1,989 | 1,945 | |||||
Total current assets | 52,876 | 42,302 | |||||
Property and equipment, net of accumulated depreciation of | 925 | 744 | |||||
Operating lease assets | 1,176 | 1,758 | |||||
Other assets | 1,657 | 1,527 | |||||
Intangible assets, net of accumulated amortization of | 741 | 889 | |||||
8,362 | 8,362 | ||||||
Total assets | $ | 65,737 | $ | 55,582 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,651 | $ | 2,869 | |||
Accrued and other expenses | 5,523 | 7,039 | |||||
Lease payable - current portion | 856 | 726 | |||||
Deferred revenue | 5,930 | 6,117 | |||||
Total current liabilities | 14,960 | 16,751 | |||||
Lease payable, long-term portion | 431 | 1,075 | |||||
Notes payable, long-term portion | - | 6,960 | |||||
Deferred revenue, long-term portion | 520 | 267 | |||||
Deferred tax | 5 | 4 | |||||
Total liabilities | 15,916 | 25,057 | |||||
Commitments and Contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock, | |||||||
none issued. | - | - | |||||
Common stock, | |||||||
shares; issued 25,287,837 as of | |||||||
23,693,735 as of | |||||||
Outstanding 25,102,006 as of | 253 | 236 | |||||
as of | |||||||
Additional paid-in capital | 300,017 | 273,639 | |||||
Accumulated deficit | (249,034 | ) | (241,935 | ) | |||
(1,415 | ) | (1,415 | ) | ||||
Total stockholders' equity | 49,821 | 30,525 | |||||
Total liabilities and stockholders' equity | $ | 65,737 | $ | 55,582 | |||
Condensed Consolidated Statements of Operations | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands except for per share data) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenue: | |||||||||||||||
Products | $ | 6,320 | $ | 4,538 | $ | 16,429 | $ | 11,220 | |||||||
Service and supplies | 3,041 | 2,591 | 9,401 | 8,027 | |||||||||||
Total revenue | 9,361 | 7,129 | 25,830 | 19,247 | |||||||||||
Cost of revenue: | |||||||||||||||
Products | 1,807 | 1,345 | 4,592 | 2,899 | |||||||||||
Service and supplies | 763 | 667 | 2,462 | 2,169 | |||||||||||
Amortization and depreciation | 79 | 92 | 237 | 287 | |||||||||||
Total cost of revenue | 2,649 | 2,104 | 7,291 | 5,355 | |||||||||||
Gross profit | 6,712 | 5,025 | 18,539 | 13,892 | |||||||||||
Operating expenses: | |||||||||||||||
Engineering and product development | 2,285 | 1,849 | 6,745 | 5,938 | |||||||||||
Marketing and sales | 3,886 | 2,979 | 10,739 | 9,218 | |||||||||||
General and administrative | 2,658 | 1,834 | 7,461 | 6,476 | |||||||||||
Amortization and depreciation | 64 | 52 | 178 | 153 | |||||||||||
Total operating expenses | 8,893 | 6,714 | 25,123 | 21,785 | |||||||||||
Loss from operations | (2,181 | ) | (1,689 | ) | (6,584 | ) | (7,893 | ) | |||||||
Interest expense | - | (115 | ) | (141 | ) | (360 | ) | ||||||||
Other income | 5 | 10 | 12 | 85 | |||||||||||
Loss on extinguishment of debt | - | - | (386 | ) | (341 | ) | |||||||||
Loss on fair value of convertible debentures | - | - | - | (7,464 | ) | ||||||||||
Other income (expense), net | 5 | (105 | ) | (515 | ) | (8,080 | ) | ||||||||
Loss before income tax expense | (2,176 | ) | (1,794 | ) | (7,099 | ) | (15,973 | ) | |||||||
Tax expense | - | (3 | ) | - | (34 | ) | |||||||||
Net loss and comprehensive loss | $ | (2,176 | ) | $ | (1,797 | ) | $ | (7,099 | ) | $ | (16,007 | ) | |||
Net loss per share: | |||||||||||||||
Basic | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.29 | ) | $ | (0.73 | ) | |||
Diluted | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.29 | ) | $ | (0.73 | ) | |||
Weighted average number of shares used in computing loss per share: | |||||||||||||||
Basic | 25,053 | 23,173 | 24,662 | 21,827 | |||||||||||
Diluted | 25,053 | 23,173 | 24,662 | 21,827 | |||||||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
For the Nine Months ended | |||||||
2021 | 2020 | ||||||
(in thousands) | |||||||
Cash flow from operating activities: | |||||||
Net loss | $ | (7,099 | ) | $ | (16,007 | ) | |
Adjustments to reconcile net loss to net cash used for operating activities: | |||||||
Amortization | 176 | 234 | |||||
Depreciation | 242 | 206 | |||||
Bad debt provision | (25 | ) | 80 | ||||
Stock-based compensation | 2,102 | 2,542 | |||||
Amortization of debt discount and debt costs | 17 | 65 | |||||
Loss on extinguishment of debt | 386 | 341 | |||||
Deferred tax expense | - | 1 | |||||
Change in fair value of convertible debentures | - | 7,464 | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (1,827 | ) | 1,151 | ||||
Inventory | (146 | ) | (535 | ) | |||
Prepaid and other assets | 493 | 69 | |||||
Accounts payable | (217 | ) | 96 | ||||
Accrued expenses | (2,028 | ) | (2,322 | ) | |||
Deferred revenue | 65 | 532 | |||||
Total adjustments | (762 | ) | 9,924 | ||||
Net cash used for operating activities | (7,861 | ) | (6,083 | ) | |||
Cash flow from investing activities: | |||||||
Additions to patents, technology and other | (24 | ) | (11 | ) | |||
Additions to property and equipment | (426 | ) | (275 | ) | |||
Net cash used for investing activities | (450 | ) | (286 | ) | |||
Cash flow from financing activities: | |||||||
Issuance of common stock pursuant to stock option plans | 933 | 415 | |||||
Issuance of common stock pursuant to Employee Stock Purchase Plan | 190 | 209 | |||||
Proceeds from issuance of common stock, net | 23,229 | 12,174 | |||||
Taxes paid related to restricted stock issuance | (59 | ) | (225 | ) | |||
Principal payments of capital lease obligations | - | (4,638 | ) | ||||
Repayment of debt financing | (7,363 | ) | 775 | ||||
Repayment on line of credit | - | (2,000 | ) | ||||
Proceeds from notes payable | - | 6,957 | |||||
Debt issuance costs | - | 22 | |||||
Net cash provided by financing activities | 16,930 | - | 13,689 | ||||
Increase in cash and equivalents | 8,619 | 7,320 | |||||
Cash and cash equivalents, beginning of period | 27,186 | 15,313 | |||||
Cash and cash equivalents, end of period | $ | 35,805 | $ | 22,633 | |||
Supplemental disclosure of cash flow information: | |||||||
Interest paid | $ | 92 | $ | 127 | |||
Taxes paid | $ | - | $ | 34 | |||
Issuance of common stock upon conversion of debentures | - | 21,164 | |||||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ | - | $ | 69 | |||
Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures
The Company reports its financial results in accordance with
Management defines "Non-GAAP Adjusted EBITDA" as the sum of GAAP Net Loss before provisions for interest expense, other income, stock-based compensation expense, depreciation and amortization, tax expense, severance, gain on sale of assets, loss on disposal of assets, acquisition and litigation related expenses. Management considers this non-GAAP financial measure to be an indicator of the Company's operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company's overall financial performance.
The non-GAAP financial measures do not replace the presentation of the Company's GAAP financial results and should only be used as a supplement to, not as a substitute for, the Company’s financial results presented in accordance with GAAP. The Company has provided a reconciliation of each non-GAAP financial measure used in its financial reporting and investor presentations to the most directly comparable GAAP financial measure.
Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item:
- Interest expense: The Company excludes interest expense which includes interest from the facility agreement, interest on capital leases and interest on the convertible debentures from its non-GAAP Adjusted EBITDA calculation.
- Stock-based compensation expense: excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company's business, and also because the total amount of expense is partially outside of the Company's control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the expense is incurred.
- Tax Expense: The Company excludes this non-cash item from the 2020 periods as it was not considered by management in making operating decisions, and management believes that such item does not have a direct correlation to future business operations. In
January 2021 , the Company adopted ASU 2019-12 requiring these taxes be moved to operating expenses and are no longer excluded. - CARES Act Credit: The Company excludes this item as it is related to COVID-19 legislation that does not have a direct correlation to future business operations, as this item was in direct response to the initial wave of the COVID-19 pandemic.
- Severance and Furlough: The Company excludes this item as it is related to COVID-19 business impact that does not have a direct correlation to future business operations, as this item was in direct response to the initial wave of the COVID-19 pandemic.
- Amortization and Depreciation: Purchased assets and intangibles are amortized over a period of several years and generally cannot be changed or influenced by management after they are acquired. Accordingly, these non-cash items are not considered by management in making operating decisions, and management believes that such expenses do not have a direct correlation to future business operations. Thus, including such charges does not accurately reflect the performance of the Company's ongoing operations for the period in which such charges are incurred.
- Loss on fair value of convertible debentures. The Company excludes this non-cash item as it is not considered by management in making operating decisions, and management believes that such item does not have a direct correlation to future business operations.
- Litigation related: These expenses consist primarily of settlement, legal and other professional fees related to litigation. The Company excludes these costs from its non-GAAP measures primarily because the Company believes that these costs have no direct correlation to the core operations of the Company.
- Loss on extinguishment of debt: The Company excludes this non-cash item as it is not considered by management in making operating decisions, and management believes that such item does not have a direct correlation to future business operations.
On occasion in the future, there may be other items, such as significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.
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 | Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
GAAP Net Loss | $ | (2,176 | ) | $ | (1,797 | ) | $ | (7,099 | ) | $ | (16,007 | ) | |||
Interest Expense | - | 115 | 141 | 360 | |||||||||||
Other income | (5 | ) | (10 | ) | (12 | ) | (85 | ) | |||||||
Stock Compensation | 656 | 465 | 2,102 | 2,542 | |||||||||||
Depreciation | 85 | 64 | 242 | 207 | |||||||||||
Amortization | 61 | 80 | 176 | 234 | |||||||||||
Tax expense | - | 3 | - | 34 | |||||||||||
Severance and Furlough | - | 76 | - | 189 | |||||||||||
Cares Credit | - | - | - | (283 | ) | ||||||||||
Loss on extinguishment of debt | - | - | 386 | 341 | |||||||||||
Loss of fair value of convertible debentures | - | - | - | 7,464 | |||||||||||
Litigation related | 1 | 18 | 117 | 218 | |||||||||||
Non GAAP Adjusted EBITDA | $ | (1,378 | ) | $ | (986 | ) | $ | (3,947 | ) | $ | (4,786 | ) | |||
Three Months Ended | Nine Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
GAAP Net Loss | $ | (2,176 | ) | $ | (1,797 | ) | $ | (7,099 | ) | $ | (16,007 | ) | |||
Adjustments to net loss | |||||||||||||||
Severance and Furlough | - | 76 | - | 189 | |||||||||||
Cares Credit | - | - | - | (283 | ) | ||||||||||
Loss from extinguishment of debt | - | - | 386 | 341 | |||||||||||
Litigation | 1 | 18 | 117 | 218 | |||||||||||
Loss of fair value of convertible debentures | - | - | - | 7,464 | |||||||||||
Non GAAP Adjusted Net Loss | $ | (2,175 | ) | $ | (1,703 | ) | $ | (6,596 | ) | $ | (8,078 | ) | |||
Net loss income per share | |||||||||||||||
GAAP Net loss per share | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.29 | ) | $ | (0.73 | ) | |||
Adjustments to net loss (as detailed above) | - | - | 0.02 | 0.36 | |||||||||||
Non GAAP Adjusted Net loss per share | $ | (0.09 | ) | $ | (0.08 | ) | $ | (0.27 | ) | $ | (0.37 | ) |
Source:
2021 GlobeNewswire, Inc., source