ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
(Address of principal executive offices) |
(Zip Code) |
Title of Class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Large Accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Smaller reporting company | |||||
Emerging growth company |
Item 1 . |
Business . |
• | anti-kickback, false claims, and physician self-referral statutes; |
• | U.S. state laws and regulations regarding fee splitting and other relationships between healthcare providers and non-professional entities, such as companies that provide management and reimbursement support services; |
• | anti-bribery laws, such as the U.S. Foreign Corrupt Practices Act, the UK Anti-Bribery Act, the Canadian Corruption of Foreign Public Officials Act, and guidance promulgated by certain multi-national groups, such as the United Nations Convention Against Corruption and the Organization for Economic Cooperation and Development Convention on Combatting Bribery of Foreign Public Officials in International Business Transactions; |
• | laws regulating the privacy and security of health data, protected health information and personally identifiable information. These include the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act, the General Data Protection Regulation (“GDPR”) in the EU, and the Personal Information Protection and Electronic Documents Act in Canada; and |
• | healthcare reform laws in the United States, such as the Affordable Care Act (“ACA”) and the 21st Century Cures Act, which include new regulatory mandates and other measures designed to reduce the rate of medical inflation. These include, among other things, stringent new reporting requirements of financial relationships between device manufacturers and physicians and teaching hospitals. |
• | the referral of an individual for a service or product for which payment may be made by Medicare, Medicaid or other government-sponsored healthcare program; or |
• | purchasing, ordering, arranging for, or recommending the ordering of, any service or product for which payment may be made by a government-sponsored healthcare program. |
• | whether the product or service is a covered benefit under its health plan; |
• | whether the product or service is appropriate and medically necessary for the specific indication; |
• | cost effectiveness of the product or service; |
• | whether the product is being used in a manner consistent with its FDA-approved or cleared label (i.e., “on-label”); and |
• | a determination that the product or service is neither experimental nor investigational (e.g., that its use is supported by relevant evidence in the peer reviewed literature, its use is supported by medical professional society treatment guidelines). |
Item 1A. |
Risk Factors. |
• | We have incurred significant losses from inception through 2020 and there can be no assurance that we will be able to achieve and sustain future profitability. |
• | Our quarterly and annual operating and financial results and our gross margins are likely to fluctuate significantly in future periods. |
• | We expect the novel coronavirus (COVID-19) pandemic to have a significant effect on our results of operations. In addition, it 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 our business, results of operations and financial condition and on the market price of our common stock. |
• | The markets for our products and treatments and newly introduced enhancements to our existing products and treatments may not develop as expected, we continue to face barriers to broad market acceptance. |
• | An unfavorable resolution of the Yeda litigation could have a material adverse effect on our business, financial condition, results of operations and cash flows. |
• | Sales and market acceptance of our products is dependent upon the coverage and reimbursement decisions made by third-party payers, including carve-out radiology benefits managers. The failure of third-party payers to provide appropriate levels of coverage and reimbursement, and/or meeting prior authorization and other requirements for approval to use our products and treatments facilitated by our products could harm our business and prospects. |
• | A limited number of customers account for a significant portion of our total revenue. The loss of a principal customer could seriously hurt our business. |
• | The markets for many of our products are subject to changing technology. |
• | We distribute our products in highly competitive markets and our sales may suffer as a result. |
• | We rely on intellectual property and proprietary rights to maintain our competitive position and may not be able to protect these rights. |
• | Our future prospects depend on our ability to retain current key employees and attract additional qualified personnel. |
• | The market price of our common stock has been, and may continue to be volatile, which could reduce the market price of our common stock. |
• | Future issuances of shares of our common stock may cause significant dilution of equity interests of existing holders of common stock and decrease the market price of shares of our common stock. |
• | market acceptance of our products; |
• | uncertainty of the development of a market for such product or treatment; |
• | trends relating to, or the introduction or existence of, competing products, technologies or alternative treatments or therapies that may be more effective, safer or easier to use than our products, technologies, treatments or therapies; |
• | the perceptions of our products or treatments as compared to other products and treatments; |
• | recommendation and support for the use of our products or treatments by influential customers, such as hospitals, radiological practices, breast surgeons and radiation oncologists and treatment centers and U.S. and international medical professional societies; |
• | the availability and extent of data demonstrating the clinical efficacy of our products or treatments; |
• | competition, including the presence of competing products sold by companies with longer operating histories, more recognizable names and more established distribution networks; and |
• | other technological developments. |
• | harm to our reputation; |
• | lost sales; |
• | delays in commercial releases; |
• | product liability claims; |
• | delays in or loss of market acceptance of our solutions; |
• | license terminations or renegotiations; |
• | unexpected expenses and diversion of resources to remedy errors; and |
• | privacy and security vulnerabilities. |
• | non-approval of an investigational device exemption (IDE), which is required by the FDA for the study in humans of a significant risk device that is not approved for the indication being studied; |
• | failure to reach an agreement with contract research organizations or clinical trial sites; |
• | failure of third-party contract research organizations to properly implement or monitor the clinical trial protocols; |
• | failure of IRBs to approve our clinical trial protocols or suspension or termination of our clinical trial by the IRB, DSMB, or the FDA; |
• | slower than expected rates of patient recruitment and enrollment, which may be further negatively impacted by the COVID-19 global pandemic; |
• | inability to retain patients in clinical trials, which may be further negatively impacted by the COVID-19 global pandemic; |
• | lack of effectiveness during clinical trials; |
• | unforeseen safety issues; |
• | inability or unwillingness of medical clinical investigators and institutional review boards to follow our clinical trial protocols; |
• | failure of clinical investigators or sites to maintain necessary licenses or permits or comply with good clinical practices, or GCP, or other regulatory requirements; and |
• | lack of sufficient funding to finance the clinical trials. |
• | requires us to dedicate a portion of our cash flow to payments on our debt obligations, which reduces the availability of our cash flow to fund working capital, capital expenditures and other corporate requirements; |
• | imposes restrictions on our ability to incur indebtedness, other than permitted indebtedness, and could impede us from obtaining additional financing in the future for working capital, capital expenditures, mergers, acquisitions and general corporate purposes; |
• | imposes restrictions on us with respect to the use of our available cash, including in connection with future acquisitions; |
• | requires us to agree by a certain date with the Bank regarding minimum revenue levels for the 2021 calendar year. Failure to agree will result in acceleration of the indebtedness under the Loan Agreement; and |
• | requires us to provide certain financial information on a monthly and annual basis. Failure to do so will result in acceleration of the indebtedness under the Loan Agreement. |
• | could impair our liquidity; |
• | could make it more difficult for us to satisfy our other obligations; |
• | make us more vulnerable in the event of a downturn in our business prospects and could limit our flexibility to plan for, or react to, changes in our licensing markets; |
• | could result in a prepayment or make-whole premium if we elected to prepay the indebtedness under the Loan Agreement prior to its maturity date; and |
• | could place us at a competitive disadvantage when compared to our competitors who have less debt. |
Item 1B. |
Unresolved Staff Comments. |
Item 2. |
Properties. |
Item 3. |
Legal Proceedings. |
Item 4. |
Mine Safety Disclosures. |
Item 5. |
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. |
Item 6 . |
Selected Financial Data . |
Item 7 . |
Management’s Discussion and Analysis of Financial Condition and Results of Operations . |
• | Revenue recognition; |
• | Valuation of long-lived and intangible assets; |
• | Goodwill; |
• | Stock based compensation; and |
• | Income taxes; |
1) | Identify the contract(s) with a customer |
2) | Identify the performance obligations in the contract |
3) | Determine the transaction price |
4) | Allocate the transaction price to the performance obligations in the contract |
5) | Recognize revenue when (or as) the Company satisfies a performance obligation |
• | 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. |
• | A significant decrease in the market price of a long-lived asset (asset group); |
• | A significant adverse change in the extent or manner in which a long-lived asset (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 (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 (asset group); |
• | A current period operating 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 (asset group). |
Twelve months ended December 31, |
||||||||||||||||
2020 |
2019 |
$ Change |
% Change |
|||||||||||||
Detection revenue |
||||||||||||||||
Product revenue |
$ | 16,291 | $ | 16,788 | $ | (497 | ) | (3.0 | )% | |||||||
Service revenue |
5,706 | 5,531 | 175 | 3.2 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
21,997 | 22,319 | (322 | ) | (1.4 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Therapy revenue |
||||||||||||||||
Product revenue |
2,612 | 2,979 | (367 | ) | (12.3 | )% | ||||||||||
Service revenue |
5,089 | 6,042 | (953 | ) | (15.8 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
7,701 | 9,021 | (1,320 | ) | (14.6 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenue |
$ | 29,698 | $ | 31,340 | $ | (1,642 | ) | (5.2 | )% | |||||||
|
|
|
|
|
|
|
|
Twelve months ended December 31, |
||||||||||||||||
2020 |
2019 |
Change |
% Change |
|||||||||||||
Products |
$ | 5,000 | $ | 3,278 | $ | 1,722 | 52.5 | % | ||||||||
Service and supplies |
2,965 | 3,438 | (473 | ) | (13.8 | )% | ||||||||||
Amortization and depreciation |
379 | 397 | (18 | ) | 100.0 | % | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenue |
$ | 8,344 | $ | 7,113 | $ | 1,231 | 17.3 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 21,354 | $ | 24,227 | $ | (2,873 | ) | (11.9 | )% | |||||||
profit % |
71.9 | % | 77.3 | % | ||||||||||||
For the year ended December 31, |
||||||||||||||||
2020 |
2019 |
Change |
% Change |
|||||||||||||
Detection gross profit |
$ | 17,856 | $ | 18,627 | $ | (771 | ) | (4.1 | )% | |||||||
Therapy gross profit |
3,498 | 5,600 | (2,102 | ) | (37.5 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 21,354 | $ | 24,227 | $ | (2,873 | ) | (11.9 | )% | |||||||
|
|
|
|
|
|
|
|
Year ended December 31, |
||||||||||||||||
2020 | 2019 | Change | Change % | |||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
$ | 8,114 | $ | 9,271 | $ | (1,157 | ) | (12.5 | )% | |||||||
Marketing and sales |
13,312 | 13,634 | (322 | ) | (2.4 | )% | ||||||||||
General and administrative |
9,117 | 7,443 | 1,674 | 22.5 | % | |||||||||||
Amortization and depreciation |
199 | 276 | (77 | ) | (27.9 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 30,742 | $ | 30,624 | $ | 118 | 0.4 | % | ||||||||
|
|
|
|
|
|
|
|
Year ended December 31, |
||||||||||||||||
2020 | 2019 | Change | Change% | |||||||||||||
Interest expense |
$ | (476 | ) | $ | (784 | ) | $ | 308 | (39.3 | )% | ||||||
Interest income |
97 | 344 | (247 | ) | (71.8 | )% | ||||||||||
Loss on extinguishment of debt |
(341 | ) | — | (341 | ) | 0.0 | % | |||||||||
Loss on fair value of debentures |
(7,464 | ) | (6,671 | ) | (793 | ) | 11.9 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | (8,184 | ) | $ | (7,111 | ) | $ | (1,073 | ) | 15.1 | % | ||||||
|
|
|
|
|
|
|
|
|||||||||
Tax expense |
$ | 38 | $ | 43 | $ | (5 | ) | (11.6 | )% |
Twelve months ended December 31, |
||||||||||||||||
2019 |
2018 |
Change |
% Change |
|||||||||||||
Detection revenue |
||||||||||||||||
Product revenue |
$ | 16,788 | $ | 10,783 | $ | 6,005 | 55.7 | % | ||||||||
Service revenue |
5,531 | 6,081 | (550 | ) | (9.0 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
22,319 | 16,864 | 5,455 | 32.3 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Therapy revenue |
||||||||||||||||
Product revenue |
2,979 | 2,328 | 651 | 28.0 | % | |||||||||||
Service revenue |
6,042 | 6,429 | (387 | ) | (6.0 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
9,021 | 8,757 | 264 | 3.0 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenue |
$ | 31,340 | $ | 25,621 | $ | 5,719 | 22.3 | % | ||||||||
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|
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|
|
|
Twelve months ended December 31, |
||||||||||||||||
2019 |
2018 |
Change |
% Change |
|||||||||||||
Products |
$ | 3,278 | $ | 2,161 | $ | 1,117 | 51.7 | % | ||||||||
Service and supplies |
3,438 | 3,627 | (189 | ) | (5.2 | )% | ||||||||||
Amortization and depreciation |
397 | 403 | (6 | ) | 100.0 | % | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenue |
$ | 7,113 | $ | 6,191 | $ | 922 | 14.9 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 24,227 | $ | 19,430 | $ | 4,797 | 24.7 | % | ||||||||
profit % |
77.3 | % | 75.8 | % |
For the year ended December 31, |
||||||||||||||||
2019 |
2018 |
Change |
% Change |
|||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
$ | 9,271 | $ | 9,445 | $ | (174 | ) | (1.8 | )% | |||||||
Marketing and sales |
13,634 | 8,693 | 4,941 | 56.8 | % | |||||||||||
General and administrative |
7,443 | 9,117 | (1,674 | ) | (18.4 | )% | ||||||||||
Amortization and depreciation |
276 | 305 | (29 | ) | (9.5 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 30,624 | $ | 27,560 | $ | 3,064 | 11.1 | % | ||||||||
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|
For the year ended December 31, |
||||||||||||||||
2019 |
2018 |
Change |
Change % |
|||||||||||||
Interest expense |
$ | (784 | ) | $ | (504 | ) | (280 | ) | 55.6 | % | ||||||
Interest income |
344 | 110 | 234 | 212.7 | % | |||||||||||
Financing costs |
— | (451 | ) | 451 | (100.0 | )% | ||||||||||
Loss on fair value of debentures |
(6,671 | ) | — | (6,671 | ) | — | ||||||||||
|
|
|
|
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|
|
|||||||||
$ | (7,111 | ) | $ | (845 | ) | $ | (6,266 | ) | 741.5 | % | ||||||
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|
|||||||||
Income tax (benefit) expense |
$ | 43 | $ | 42 | 1 | 2.4 | % |
Year Ended December 31, | ||||||||||||
2020 | 2019 | 2018 | ||||||||||
Segment revenues: |
||||||||||||
Detection |
$ | 21,997 | $ | 22,319 | $ | 16,864 | ||||||
Therapy |
7,701 | 9,021 | 8,757 | |||||||||
|
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|||||||
Total Revenue |
$ | 29,698 | $ | 31,340 | $ | 25,621 | ||||||
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|||||||
Segment gross profit: |
||||||||||||
Detection |
$ | 17,856 | $ | 18,627 | $ | 14,709 | ||||||
Therapy |
3,498 | 5,600 | 4,721 | |||||||||
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Segment gross profit |
$ | 21,354 | $ | 24,227 | $ | 19,430 | ||||||
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Segment operating income (loss): |
||||||||||||
Detection |
$ | 2,719 | $ | 2,564 | $ | 3,412 | ||||||
Therapy |
(3,028 | ) | (1,476 | ) | (2,373 | ) | ||||||
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|
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Segment operating income (loss) |
$ | (309 | ) | $ | 1,088 | $ | 1,039 | |||||
|
|
|
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|
|||||||
General administrative |
$ | (9,079 | ) | $ | (7,486 | ) | $ | (9,169 | ) | |||
Interest expense |
(476 | ) | (784 | ) | (504 | ) | ||||||
Financing costs |
— | — | (451 | ) | ||||||||
Loss on extinguishment of debt |
(341 | ) | ||||||||||
Other income |
97 | 345 | 110 | |||||||||
Fair value of convertible debentures |
(7,464 | ) | (6,671 | ) | ||||||||
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|
|
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|||||||
Loss before income tax |
$ | (17,572 | ) | $ | (13,508 | ) | $ | (8,975 | ) | |||
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Item 7A. |
Quantitative and Qualitative Disclosures about Market Risk. |
Item 8. |
Financial Statements and Supplementary Data. |
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. |
Item 9A. |
Controls and Procedures. |
Item 9B. |
Other Information. |
Item 10 . |
Directors, Executive Officers and Corporate Governance . |
Item 11 . |
Executive Compensation . |
Item 12 . |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters . |
Item 13 . |
Certain Relationships and Related Transactions, and Director Independence . |
Item 14 . |
Principal Accounting Fees and Services . |
Item 15 . |
Exhibits, Financial Statement Schedules. |
21.1 |
| |
23.1 |
Consent of BDO USA, LLP, Independent Registered Public Accounting Firm. | |
31.1 |
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 |
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 |
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2 |
Certification of Chief 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) Consolidated Balance Sheets as of December 31, 2020 and December 31, 2019, (ii) Consolidated Statements of Operations for the years ended December 31, 2020, 2019 and 2018, (iii) Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2020, 2019 and 2018, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2020, 2019 and 2018, and (v) Notes to Consolidated Financial Statements. | |
104 |
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
* | Denotes a management compensation plan or arrangement. |
** | The Registrant has omitted certain schedules and exhibits pursuant to Item 601(b)(2) of Regulation S-K and shall furnish supplementally to the SEC copies any of the omitted schedules and exhibits upon request by the SEC. |
Item 16. |
Form 10-K Summary. |
By: | /s/ Michael Klein | |
Michael Klein | ||
Chief Executive Officer, Executive Chairman |
Signature |
Title |
Date | ||
/s/ Michael Klein |
Executive Chairman, Director, Chief Executive Officer (Principal Executive Officer) |
March 15, 2021 | ||
Michael Klein | ||||
/s/ R. Scott Areglado |
Chief Financial Officer (Principal Financial and Accounting Officer) |
March 15, 2021 | ||
R. Scott Areglado | ||||
/s/ Nathaniel Dalton |
Director | March 15, 2021 | ||
Nathaniel Dalton | ||||
/s/ Rakesh Patel |
Director | March 15, 2021 | ||
Rakesh Patel, MD | ||||
/s/ Andy Sassine |
Director | March 15, 2021 | ||
Andy Sassine | ||||
/s/ Susan Wood |
Director | March 15, 2021 | ||
Susan Wood, Ph.D |
Page |
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F-2 |
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F-4 |
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F-5 |
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F-6 |
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F-7 |
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F-8–F-50 |
• | Evaluating management’s accounting policies and practices, including the reasonableness of management’s judgments and assumptions related to the identification of each distinct performance obligation and its pattern of delivery. |
• | Testing these agreements together with their underlying documents and company assessments to evaluate the appropriate identification of each distinct performance obligation and its respective pattern of revenue recognition. |
December 31, |
December 31, |
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Assets |
2020 |
2019 |
||||||
(in thousands except shares and per share data) | ||||||||
Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Trade accounts receivable, net of allowance for doubtful |
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accounts of $ |
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Inventory, net |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment: |
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Equipment |
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Leasehold improvements |
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Furniture and fixtures |
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Marketing assets |
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Less accumulated depreciation and amortization |
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Property and equipment, net |
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Other assets: |
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Operating lease assets |
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Other assets |
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Intangible assets, net of accumulated amortization of $ |
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Goodwill |
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Total other assets |
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Total assets |
$ | $ | ||||||
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
||||||||
Accounts payable |
$ | $ | ||||||
Accrued and other expenses |
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Notes payable, current |
— | |||||||
Lease payable, current |
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Deferred revenue, current |
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Total current liabilities |
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Lease payable, long-term |
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Deferred revenue, long-term |
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Notes payable, long-term |
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Convertible debentures payable to non-related parties, at fair value |
— | |||||||
Convertible debentures payable to related parties, at fair value |
— | |||||||
Deferred tax |
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Total liabilities |
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Commitments and contingencies (Note 9) |
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Stockholders’ equity: |
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Preferred stock, $ par value: authorized |
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Common stock, $ par value: authorized |
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Additional paid-in capital |
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Accumulated deficit |
( |
) | ( |
) | ||||
Treasury stock at cost, |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total stockholders’ equity |
||||||||
|
|
|
|
|||||
Total liabilities and stockholders’ equity |
$ | $ | ||||||
|
|
|
|
|||||
See accompanying notes to consolidated financial statements. |
For the Years Ended December 31, |
||||||||||||
2020 |
2019 |
2018 |
||||||||||
(in thousands except per share data) | ||||||||||||
Revenue: |
||||||||||||
Products |
$ | $ | $ | |||||||||
Service and supplies |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenue |
||||||||||||
Cost of Revenue: |
||||||||||||
Products |
||||||||||||
Service and supplies |
||||||||||||
Amortization and depreciation |
||||||||||||
|
|
|
|
|
|
|||||||
Total cost of revenue |
||||||||||||
|
|
|
|
|
|
|||||||
Gross profit |
||||||||||||
|
|
|
|
|
|
|||||||
Operating expenses: |
||||||||||||
Engineering and product development |
||||||||||||
Marketing and sales |
||||||||||||
General and administrative |
||||||||||||
Amortization and depreciation |
||||||||||||
|
|
|
|
|
|
|||||||
Total operating expenses |
||||||||||||
|
|
|
|
|
|
|||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Other expense |
||||||||||||
Interest expense |
( |
) | ( |
) | ( |
) | ||||||
Interest income |
||||||||||||
Financing costs |
— | — | ( |
) | ||||||||
Loss on extinguishment of debt |
( |
) | — | — | ||||||||
Loss on fair value of convertible debentures |
( |
) | ( |
) | — | |||||||
|
|
|
|
|
|
|||||||
Other expense, net |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Loss before income tax expense |
( |
) | ( |
) | ( |
) | ||||||
Income tax expense |
||||||||||||
|
|
|
|
|
|
|||||||
Net loss and comprehensive loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
|
|
|
|
|
|
|||||||
Net loss per share: |
||||||||||||
Basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Weighted average number of shares used in computing net loss per share: |
||||||||||||
Basic |
||||||||||||
Diluted |
||||||||||||
See accompanying notes to consolidated financial statements. |
Common Stock |
Additional |
|||||||||||||||||||||||
Number of |
Paid-in |
Accumulated |
Treasury |
Stockholders’ |
||||||||||||||||||||
Shares Issued |
Par Value |
Capital |
Deficit |
Stock |
Equity |
|||||||||||||||||||
Balance at December 31, 2017 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
Cumulative impact from the adoption of ASC 606 (see Note 1) |
— |
— |
— |
— |
||||||||||||||||||||
Issuance of common stock relative to vesting of restricted stock, net of |
( |
) |
— |
— |
( |
) | ||||||||||||||||||
Issuance of common stock pursuant to stock option plans |
1 |
— |
— |
|||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) |
— |
( |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2018 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Issuance of common stock relative to vesting of restricted stock, net of |
( |
) |
— |
— |
( |
) | ||||||||||||||||||
Issuance of common stock pursuant to stock option plans |
— |
— |
||||||||||||||||||||||
Issuance of common stock, net |
— |
— |
||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net Loss |
— |
— |
— |
( |
) |
— |
( |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2019 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Issuance of common stock relative to vesting of restricted stock, net of |
— |
( |
) |
— |
— |
( |
) | |||||||||||||||||
Issuance of common stock pursuant to stock option plans |
— |
— |
||||||||||||||||||||||
Issuance of common stock, net |
— |
— |
||||||||||||||||||||||
Issuance of common stock pursuant employee stock purchase plan |
— |
— |
||||||||||||||||||||||
Issuance of common stock upon conversion of debentures |
— |
— |
||||||||||||||||||||||
Stock-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) |
— |
( |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at December 31, 2020 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31, |
||||||||||||
2020 |
2019 |
2018 |
||||||||||
(in thousands) |
||||||||||||
Cash flow from operating activities: |
||||||||||||
Net loss |
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | |||
Adjustments to reconcile net loss to net cash used for operating activities: |
||||||||||||
Amortization |
||||||||||||
Depreciation |
||||||||||||
Bad debt provision |
||||||||||||
Stock-based compensation expense |
||||||||||||
Amortization of debt discount and debt costs |
||||||||||||
Loss on extinguishment of debt |
— |
— |
||||||||||
Deferred tax |
( |
) | ||||||||||
Loss on disposal of assets |
— |
— |
||||||||||
Change in fair value of convertible debentures |
— |
|||||||||||
Changes in operating assets and liabilities, net of acquisition: |
||||||||||||
Accounts receivable |
( |
) |
( |
) |
||||||||
Inventory |
( |
) |
( |
) |
||||||||
Prepaid and other assets |
( |
) |
||||||||||
Accounts payable |
( |
) | ||||||||||
Accrued and other expenses |
( |
) |
||||||||||
Deferred revenue |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||
Total adjustments |
||||||||||||
|
|
|
|
|
|
|||||||
Net cash used for operating activities |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Cash flow used for investing activities: |
||||||||||||
Additions to patents, technology and other |
( |
) |
( |
) |
( |
) | ||||||
Additions to property and equipment |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Net cash provided by (used for) investing activities |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Cash flow from financing activities: |
||||||||||||
Issuance of common stock for cash, net |
— |
|||||||||||
Issuance of common stock pursuant to Employee Stock Purchase Plan |
— |
— |
||||||||||
Issuance of common stock pursuant to stock option plans |
||||||||||||
Taxes paid related to restricted stock issuance |
( |
) |
( |
) |
( |
) | ||||||
Proceeds from convertible debentures |
— |
— |
||||||||||
Principal payments of capital lease obligations |
— |
( |
) |
( |
) | |||||||
Proceeds from notes payable |
— |
— |
||||||||||
Principal repayment of notes payable |
( |
) |
( |
) |
— |
|||||||
Debt issuance costs |
( |
) |
— |
— |
||||||||
Proceeds from line of credit |
— |
|||||||||||
Repayment line of credit |
( |
) |
( |
) |
— |
|||||||
|
|
|
|
|
|
|||||||
Net cash provided by financing activities |
||||||||||||
|
|
|
|
|
|
|||||||
Increase in cash and equivalents |
||||||||||||
Cash and equivalents, beginning of year |
||||||||||||
|
|
|
|
|
|
|||||||
Cash and equivalents, end of year |
$ |
$ |
$ |
|||||||||
|
|
|
|
|
|
|||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Interest paid |
$ |
$ |
$ |
|||||||||
|
|
|
|
|
|
|||||||
Taxes paid |
$ |
$ |
$ |
|||||||||
|
|
|
|
|
|
|||||||
Right-of-use |
— |
|||||||||||
|
|
|
|
|
|
|||||||
Issuance of common stock upon conversion of debentures |
$ |
— |
— |
|||||||||
|
|
|
|
|
|
(1) |
Summary of Significant Accounting Policies |
2020 |
2019 |
2018 |
||||||||||
Balance at beginning of period |
$ |
$ |
$ |
|||||||||
Additions charged to costs and expenses |
||||||||||||
Reductions |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Balance at end of period |
$ |
$ |
$ |
|||||||||
|
|
|
|
|
|
Inventory balances, net of reserves, were as follows: |
| |||||||
December 31, |
December 31, |
|||||||
2020 |
2019 |
|||||||
Raw materials |
$ |
$ |
||||||
Work in process |
||||||||
Finished Goods |
||||||||
|
|
|
|
|||||
Inventory Net |
$ |
$ |
||||||
|
|
|
|
Estimated life | ||
Equipment |
||
Leasehold improvements |
||
Furniture and fixtures |
||
Marketing assets |
• | 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. |
Consolidated |
||||||||||||||||
reporting unit |
Detection |
Therapy |
Total |
|||||||||||||
Accumulated Goodwill |
$ |
$ |
— |
$ |
— |
$ |
||||||||||
Accumulated impairment |
( |
) |
— |
— |
( |
) | ||||||||||
Fair value allocation |
( |
) |
— |
|||||||||||||
Acquisition of DermEbx and Radion |
— |
— |
||||||||||||||
Acquisition measurement period adjustments |
— |
— |
||||||||||||||
Acquisition of VuComp |
— |
— |
||||||||||||||
Sale of MRI assets |
— |
( |
) |
( |
) | |||||||||||
Impairment |
— |
— |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Prior to December 31, 2019 |
— |
— |
||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance at December 31, 2020 |
$ |
— |
$ |
$ |
— |
$ |
||||||||||
|
|
|
|
|
|
|
|
• | A significant decrease in the market price of a long-lived asset (asset group); |
• | A significant adverse change in the extent or manner in which a long-lived asset (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 (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 (asset group); |
• | A current period operating 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 (asset group). |
Weighted |
||||||||||||
average |
||||||||||||
2020 |
2019 |
useful life |
||||||||||
Gross Carrying Amount |
||||||||||||
Patents and licenses |
$ |
$ |
||||||||||
Technology |
||||||||||||
Customer relationships |
||||||||||||
Tradename |
||||||||||||
|
|
|
|
|||||||||
Total amortizable intangible assets |
||||||||||||
|
|
|
|
|||||||||
Accumulated Amortization |
||||||||||||
Patents and licenses |
$ |
$ |
||||||||||
Technology |
||||||||||||
Customer relationships |
||||||||||||
Tradename |
||||||||||||
|
|
|
|
|||||||||
Total accumulated amortization |
||||||||||||
|
|
|
|
|||||||||
Total amortizable intangible assets, net |
$ |
$ |
||||||||||
|
|
|
|
Estimated |
||||
For the years ended |
amortization |
|||
December 31: |
expense |
|||
2021 |
||||
2022 |
||||
2023 |
||||
2024 |
||||
2025 |
||||
|
|
|||
$ | ||||
|
|
1) |
Identify the contract(s) with a customer |
2) |
Identify the performance obligations in the contract |
both capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other resources that are readily available from third parties or from the Company, and are distinct in the context of the contract, whereby the transfer of the goods or services is separately identifiable from other promises in the contract. To the extent a contract includes multiple promised goods or services, the Company must apply judgment to determine whether promised goods or services are capable of being distinct and distinct in the context of the contract. If these criteria are not met the promised goods or services are accounted for as a combined performance obligation. The Company’s contracts typically do not include options that would result in a material right. If options to purchase additional goods or services are included in customer contracts, the Company evaluates the option in order to determine if the Company’s arrangement include promises that may represent a material right and needs to be accounted for as a performance obligation in the contract with the customer. The Company did not note any significant provisions within its typical contracts that would create a material right. |
3) |
Determine the transaction price |
4) |
Allocate the transaction price to the performance obligations in the contract |
5) |
Recognize revenue when (or as) the Company satisfies a performance obligation |
Year ended December 31, 2020 |
||||||||||||
Reportable Segments |
||||||||||||
Detection |
Therapy |
Total |
||||||||||
Major Goods/Service Lines |
||||||||||||
Products |
$ | |
$ | |
$ | |
||||||
Service contracts |
||||||||||||
Supply and source usage agreements |
— | |||||||||||
Professional services |
— | |||||||||||
Other |
— | |||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Timing of Revenue Recognition |
||||||||||||
Goods transferred at a point in time |
$ | $ | $ | |||||||||
Services transferred over time |
||||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Sales Channels |
||||||||||||
Direct sales force |
$ | $ | $ | |||||||||
OEM partners |
— | |||||||||||
Channel partners |
— | |||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
Year ended December 31, 2019 |
||||||||||||
Reportable Segments |
||||||||||||
Detection |
Therapy |
Total |
||||||||||
Major Goods/Service Lines |
||||||||||||
Products |
$ | |
$ | |
$ | |
||||||
Service contracts |
||||||||||||
Supply and source usage agreements |
— | |||||||||||
Professional services |
— | |||||||||||
Other |
||||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Timing of Revenue Recognition |
||||||||||||
Goods transferred at a point in time |
$ | $ | $ | |||||||||
Services transferred over time |
||||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Sales Channels |
||||||||||||
Direct sales |
$ | $ | $ | |||||||||
OEM partners |
— | |||||||||||
Channel partners |
— | |||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
Year ended December 31, 2018 |
||||||||||||
Reportable Segments |
||||||||||||
Detection |
Therapy |
Total |
||||||||||
Major Goods/Service Lines |
||||||||||||
Products |
$ | |
$ | |
$ | |
||||||
Service contracts |
||||||||||||
Supply and source usage agreements |
— | |||||||||||
Professional services |
— | |||||||||||
Other |
||||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Timing of Revenue Recognition |
||||||||||||
Goods transferred at a point in time |
$ | $ | $ | |||||||||
Services transferred over time |
||||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Sales Channels |
||||||||||||
Direct sales force |
$ | $ | $ | |||||||||
OEM partners |
— | |||||||||||
Channel partners |
— | |||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
|||||||
Total Revenue |
||||||||||||
Revenue from contracts with customers |
$ | $ | $ | |||||||||
Revenue from lease components |
— | |||||||||||
|
|
|
|
|
|
|||||||
$ | $ | $ | ||||||||||
|
|
|
|
|
|
Balance at December 31, 2020 |
Balance at December 31, 2019 |
|||||||
Receivables, which are included in “Trade accounts receivable” |
$ | |
$ | |
||||
Current contract assets, which are included in “Prepaid and other assets” |
||||||||
Non-current contract assets, which are included in “other assets” |
||||||||
Contract liabilities, which are included in “Deferred revenue” |
Contract liabilities |
December 31, 2020 |
December 31, 2019 |
||||||
Short term |
$ | |
$ | |
||||
Long term |
||||||||
Total |
$ | $ | ||||||
Year Ended December 31, 2020 |
Year Ended December 31, 2019 |
|||||||
Balance at beginning of period |
$ | |
$ | |
||||
Deferral of revenue |
||||||||
Recognition of deferred revenue |
( |
) | ( |
) | ||||
Balance at end of period |
$ | $ | ||||||
Years Ended December 31, |
||||||||
2020 |
2019 |
|||||||
Balance at beginning of period |
$ | |
$ | |
||||
Deferral of costs to obtain a contract |
||||||||
Recognition of costs to obtain a contract |
( |
) | ( |
) | ||||
Balance at end of period |
$ | $ | ||||||
2020 |
2019 |
2018 |
||||||||||
Beginning accrual balance |
$ | |
$ | |
$ | |
||||||
Warranty provision |
||||||||||||
Usage |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Ending accrual balance |
$ | $ | $ | |||||||||
|
|
|
|
|
|
2020 |
2019 |
2018 |
||||||||||
Net loss available to common shareholders |
$ |
( |
) | $ |
( |
) | $ |
( |
) | |||
|
|
|
|
|
|
|||||||
Basic shares used in the calculation of earnings per share |
||||||||||||
Effect of dilutive securities: |
||||||||||||
Stock options |
— | — | — | |||||||||
Restricted stock |
— | — | — | |||||||||
|
|
|
|
|
|
|||||||
Diluted shares used in the calculation of earnings per share |
||||||||||||
|
|
|
|
|
|
|||||||
Net loss per share : |
||||||||||||
Basic |
$ ( |
) | $ ( |
) | $ ( |
) | ||||||
Diluted |
$ ( |
) | $ ( |
) | $ ( |
) |
Year Ended December 31, |
||||||||||||
2020 |
2019 |
2018 |
||||||||||
Common stock options |
||||||||||||
Restricted Stock |
||||||||||||
Convertible Debentures |
— | |||||||||||
|
|
|
|
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• | 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 |
Fair Value Measurements as of December 31, 2020 |
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Level 1 |
Level 2 |
Level 3 |
Total |
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Assets |
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Money market accounts |
$ | |
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$ | |
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Total Assets |
$ | |
$ | |||||||||||||
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Liabilities |
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Convertible debentures |
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Total Liabilities |
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Fair Value Measurements as of December 31, 2019 |
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Level 1 |
Level 2 |
Level 3 |
Total |
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Assets |
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Money market accounts |
$ | — | — | $ | ||||||||||||
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Total Assets |
$ | — | — | $ | ||||||||||||
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Liabilities |
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Convertible debentures |
— | — | $ | $ | ||||||||||||
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Total Liabilities |
— | — | $ | $ | ||||||||||||
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Convertible Debentures | ||||
Balance, December 20, 2019 |
$ | |||
Issuances |
||||
Fair value adjustments |
||||
Conversion |
( |
) | ||
|
|
|||
Balance, December 31, 2020 |
$ | |||
|
|
(2) |
Sale of MRI Assets |
(3) |
Financing Arrangements |
December 31, 2020 (Western Alliance Bank) * |
||||
Principal Amount of Term Loan |
$ | |||
Unamortized closing costs |
( |
) | ||
Accrued Final Payment |
||||
Amount Drawn on Line of Credit |
— | |||
|
|
|||
Carrying amount of Term Loan |
||||
|
|
|||
Less current portion of Term Loan |
||||
|
|
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Notes payable long-term portion |
$ | |||
|
|
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* No December 31, 2019 balance. Debt opened in 2020 |
December 31, 2019 (Silicon Valley Bank) * |
||||
Principal Amount of Term Loan |
$ | |||
Unamortized closing costs |
( |
) | ||
Accrued Final Payment |
||||
Amount Drawn on Line of Credit |
||||
|
|
|||
Carrying amount of Term Loan |
||||
|
|
|||
Less current portion of Term Loan |
( |
) | ||
|
|
|||
Notes payable long-term portion |
$ | |||
|
|
|||
* No December 31, 2020 balance. Debt closed in 2020 |
Input |
December 31, 2019 |
February 21, 2020 |
||||||
Company’s stock price |
$ | $ | ||||||
Conversion price |
||||||||
Remaining term (years) |
||||||||
Equity volatility |
% | N/A | ||||||
Risk free rate |
% | N/A | ||||||
1 Probabilty of default event |
% | N/A | ||||||
1 Utilization of Forced Conversion (if available) |
% | % | ||||||
1 Exercise of Default Redemption (if available) |
% | N/A | ||||||
1 Effective discount rate |
% | N/A | ||||||
1 Represents a Level 3 unobservable input, as defined in Note 8 - Fair Value Measurements, below. |
|
Convertible Debentures |
December 31, 2019 |
February 21, 2020 |
||||||
Fair value, in accordance with fair value option |
$ | $ | ||||||
|
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|
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Principal value outstanding |
$ | $ | ||||||
|
|
|
|
Fiscal Year |
Amount Due |
|||
2021 |
||||
2022 |
||||
2023 |
||||
2024 |
||||
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|
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Total |
$ | |||
|
|
Year Ended December 31, |
||||||||||||
2020 | 2019 | 2018 | ||||||||||
Cash interest expense, notes payable |
$ | $ | $ | |||||||||
Cash interest expense, convertible debentures |
||||||||||||
Amortization of debt costs |
||||||||||||
Accrual of notes payable final payment |
||||||||||||
Interest expense capital lease |
— | |||||||||||
|
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|
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Total interest expense |
$ | $ | $ | |||||||||
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(4) |
Accrued and Other Expenses |
2020 | 2019 | |||||||
Accrued salary and related expenses |
$ | $ | ||||||
Accrued accounts payable |
||||||||
Accrued professional fees |
||||||||
Other accrued expenses |
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$ | |
$ | |
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(5) |
Leases |
Year Ended December 31, |
||||||||||
Lease Cost |
Classification |
2020 |
2019 |
|||||||
Operating lease cost - Right of Use |
Operating expenses | $ | $ | |||||||
Operating lease cost - Variable Costs |
Operating expenses | $ | ||||||||
Finance lease costs |
||||||||||
Amortization of leased assets |
Amortization and depreciation | |||||||||
Interest on lease liabilities |
Interest expense | |||||||||
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Total |
$ | $ | ||||||||
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Other information related to leases was as follows (in thousands): |
| |||||||||
2020 |
2019 |
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Cash paid for operating cash flows from operating leases |
$ | $ | ||||||||
Cash paid for operating cash flows from finance leases |
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Cash paid for financing cash flows from finance leases |
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2020 |
2019 |
|||||||||
Weighted-average remaining lease term of operating leases (in years) |
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Weighted-average remaining lease term of finance leases (in years) |
.00 | |||||||||
Weighted-average discount rate for operating leases |
% | % | ||||||||
Weighted-average discount rate for finance leases |
% |
Year Ended December 31, 2020: |
Operating Leases |
|||
2021 |
$ |
|||
2022 |
||||
2023 |
||||
2024 |
||||
|
|
|||
Total lease payments |
||||
Less: imputed interest |
( |
) | ||
|
|
|||
Total |
||||
Less: current portion of lease liabilities |
( |
) | ||
|
|
|||
Long-term lease liabilities |
$ | |||
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(6) |
Stockholders’ Equity |
Number of Shares |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term |
||||||||||
Outstanding, December 31, 2018 |
$ | |||||||||||
Granted |
$ | |||||||||||
Exercised |
( |
) | $ | |||||||||
Forfeited |
( |
) | $ | |||||||||
Outstanding, December 31, 2019 |
$ | |||||||||||
Granted |
$ | |||||||||||
Exercised |
( |
) | $ | |||||||||
Forfeited |
( |
) | $ | |||||||||
Outstanding, December 31, 2020 |
$ | |||||||||||
Exercisable at December 31, 2018 |
$ | |||||||||||
Exercisable at December 31, 2019 |
$ | |||||||||||
Exercisable at December 31, 2020 |
$ | |||||||||||
Year Ended December 31, |
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2020 |
2019 |
2018 |
||||||||||
Cost of revenue |
$ | $ | $ | |||||||||
Engineering and product development |
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Marketing and sales |
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General and administrative expense |
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$ |
$ |
$ |
||||||||||
Year Ended December 31, | ||||||
2020 |
2019 |
2018 | ||||
Average risk-free interest rate |
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Expected dividend yield |
||||||
Expected life |
||||||
Expected volatility |
||||||
Weighted average exercise price |
$ |
$ |
$ | |||
Weighted average fair value |
$ |
$ |
$ |
Years Ended December 31, |
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2020 |
2019 |
2018 |
||||||||||
Outstanding |
$ | $ | $ | |||||||||
Exercisable |
||||||||||||
Exercised |
||||||||||||
Company’s stock price at December 31 |
$ | $ | $ |
Years Ended December 31, |
||||||||||||
2020 |
2019 |
2018 |
||||||||||
Beginning outstanding balance |
||||||||||||
Granted |
— | |||||||||||
Vested |
( |
) | ( |
) | ( |
) | ||||||
Forfeited |
( |
) | ( |
) | ( |
) | ||||||
Ending outstanding balance |
||||||||||||
Years Ended December 31, |
||||||||||||
2020 |
2019 |
2018 |
||||||||||
Outstanding |
$ | $ | $ | |||||||||
Vested |
||||||||||||
Company’s stock price at December 31 |
$ | $ | $ |
(7) |
Income Taxes |
2020 | 2019 | 2018 | ||||||||||
Current provision (benefit): |
||||||||||||
Federal |
$ | $ | — | $ | — | |||||||
State |
||||||||||||
$ | $ | $ | ||||||||||
Deferred provision: |
||||||||||||
Federal |
$ | $ | $ | ( |
) | |||||||
State |
— | — | ( |
) | ||||||||
$ | $ | $ | ( |
) | ||||||||
Total |
$ | $ | $ | |||||||||
2020 | 2019 | 2018 | ||||||||||
Federal statutory rate |
% |
% |
% | |||||||||
State income taxes, net of federal benefit |
% |
% |
% | |||||||||
Net state impact of deferred rate change |
( |
%) |
( |
%) |
% | |||||||
Stock compensation expense |
% |
( |
%) |
( |
%) | |||||||
Tax amortization on goodwill |
% |
% |
% | |||||||||
Goodwill impairment |
% |
% |
% | |||||||||
Other permanent differences |
( |
%) |
% |
( |
%) | |||||||
Change in valuation allowance |
( |
%) |
( |
%) |
( |
%) | ||||||
Tax credits |
% |
% |
% | |||||||||
Federal Rate Change |
% |
% |
% | |||||||||
Accrual to tax return |
% |
% |
% | |||||||||
Increase Xoft NOLs under 382 Study |
% |
% |
% | |||||||||
Change in FV of convertible debt |
( |
%) |
( |
%) |
% | |||||||
Foreign Rate Differential |
% |
% |
% | |||||||||
True Ups - NOL Expiration/162(m) limits |
( |
%) |
% |
% | ||||||||
Effective income tax |
( |
%) |
( |
% ) |
( |
% ) | ||||||
2020 | 2019 | |||||||
Inventory (Section 263A) |
$ | $ | ||||||
Inventory reserves |
||||||||
Receivable reserves |
||||||||
Other accruals |
||||||||
Deferred revenue |
||||||||
Accumulated depreciation/amortization |
||||||||
Stock options |
||||||||
Developed technology |
||||||||
Tax credits |
||||||||
NOL carryforward |
||||||||
Lease liability |
||||||||
Net deferred tax assets |
||||||||
Valuation allowance |
( |
) | ( |
) | ||||
Right of Use Asset |
( |
) | ( |
) | ||||
Goodwill tax amortization |
( |
) | ( |
) | ||||
Deferred tax liability |
$ | ( |
) | $ | ( |
) | ||
(8) |
Segment Reporting, Geographical Information and Major Customers |
Year Ended December 31, | ||||||||||||
2020 | 2019 | 2018 | ||||||||||
Segment revenues: |
||||||||||||
Detection |
$ | $ | $ | |||||||||
Therapy |
||||||||||||
Total Revenue |
$ | $ | $ | |||||||||
Segment gross profit: |
||||||||||||
Detection |
$ | $ | $ | |||||||||
Therapy |
||||||||||||
Segment gross profit |
$ | $ | $ | |||||||||
Segment operating income (loss): |
||||||||||||
Detection |
$ | $ | $ | |||||||||
Therapy |
( |
) | ( |
) | ( |
) | ||||||
Segment operating income (loss) |
$ | ( |
) | $ | $ | |||||||
General administrative |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Interest expense |
( |
) | ( |
) | ( |
) | ||||||
Financing costs |
— | — | ( |
) | ||||||||
Loss on extinguishment of debt |
( |
) | ||||||||||
Other income |
||||||||||||
Fair value of convertible debentures |
( |
) | ( |
) | ||||||||
Loss before income tax |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Year Ended December 31, | ||||||||||||
2020 | 2019 | 2018 | ||||||||||
Detection depreciation and amortization |
||||||||||||
Depreciation |
$ | $ | $ | |||||||||
Amortization |
||||||||||||
Therapy depreciation and amortization |
||||||||||||
Depreciation |
$ | $ | $ | |||||||||
Amortization |
Percent of Export sales |
||||||||||||
Region |
2020 | 2019 | 2018 | |||||||||
Europe |
% | % | % | |||||||||
Taiwan |
% | % | % | |||||||||
Canada |
% | % | % | |||||||||
China |
% | % | % | |||||||||
Other |
% | % | % | |||||||||
|
|
|
|
|
|
|||||||
Total |
% | % | % | |||||||||
|
|
|
|
|
|
|||||||
Total Export sales |
$ | $ | $ |
Percent of Export sales |
||||||||||||
Region |
2020 | 2019 | 2018 | |||||||||
France |
% | % | % | |||||||||
Spain |
% | % | % | |||||||||
Germany |
% | % | % | |||||||||
Italy |
% | % | % | |||||||||
United Kingdon |
|
% | |
% | |
% |
(9) |
Commitments and Contingencies |