UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2013
OR
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-9341
iCAD, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 02-0377419 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
98 Spit Brook Road, Suite 100, Nashua, NH | 03062 | |
(Address of principal executive offices) | (Zip Code) |
(603) 882-5200
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirement for the past 90 days. YES x NO ¨.
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES x NO ¨.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large Accelerated filer | ¨ | Accelerated filer | ¨ | |||
Non-accelerated filer | ¨ (do not check if a smaller reporting company) | Smaller reporting company | x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) YES ¨ NO x.
As of the close of business on November 6, 2013 there were 10,850,244 shares outstanding of the registrants Common Stock, $.01 par value.
INDEX
Page | ||||||
PART I |
FINANCIAL INFORMATION |
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Item 1 |
Financial Statements (unaudited) |
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Condensed Consolidated Balance Sheets as of September 30, 2013 and December 31, 2012 |
3 | |||||
4 | ||||||
5 | ||||||
6-22 | ||||||
Item 2 |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
23-32 | ||||
Item 3 |
33 | |||||
Item 4 |
33 | |||||
PART II |
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Item 1 |
34 | |||||
Item 1A |
34 | |||||
Item 2 |
34 | |||||
Item 6 |
34 | |||||
35 |
2
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands except for share data)
September 30, | December 31, | |||||||
2013 | 2012 | |||||||
Assets | ||||||||
Current assets: |
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Cash and cash equivalents |
$ | 10,209 | $ | 13,948 | ||||
Trade accounts receivable, net of allowance for doubtful accounts of $73 in 2013 and $48 in 2012 |
8,419 | 4,980 | ||||||
Inventory, net |
2,003 | 2,119 | ||||||
Prepaid expenses and other current assets |
658 | 486 | ||||||
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Total current assets |
21,289 | 21,533 | ||||||
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Property and equipment, net of accumulated depreciation and amortization of $4,106 in 2013 and $3,627 in 2012 |
1,825 | 1,483 | ||||||
Other assets |
475 | 638 | ||||||
Intangible assets, net of accumulated amortization of $12,034 in 2013 and $10,744 in 2012 |
13,963 | 15,230 | ||||||
Goodwill |
21,109 | 21,109 | ||||||
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Total assets |
$ | 58,661 | $ | 59,993 | ||||
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Liabilities and Stockholders Equity | ||||||||
Current liabilities: |
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Accounts payable |
$ | 2,018 | $ | 1,940 | ||||
Accrued and other expenses |
3,515 | 4,142 | ||||||
Interest payable |
569 | 499 | ||||||
Capital lease - current portion |
130 | | ||||||
Warrant liability |
1,054 | 1,538 | ||||||
Deferred revenue |
7,498 | 6,520 | ||||||
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Total current liabilities |
14,784 | 14,639 | ||||||
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Deferred revenue, long-term portion |
1,633 | 1,502 | ||||||
Other long-term liabilities |
1,313 | 1,341 | ||||||
Capital lease - long-term portion |
279 | | ||||||
Notes payable |
15,299 | 14,846 | ||||||
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Total liabilities |
33,308 | 32,328 | ||||||
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Commitments and Contingencies (see Note 6) |
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Stockholders equity: |
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Preferred stock, $ .01 par value: authorized 1,000,000 shares; none issued. |
| | ||||||
Common stock, $ .01 par value: authorized 85,000,000 shares; issued 11,036,075 in 2013 and 10,993,933 in 2012; outstanding 10,850,244 in 2013 and 10,808,102 in 2012 |
110 | 110 | ||||||
Additional paid-in capital |
166,302 | 165,416 | ||||||
Accumulated deficit |
(139,644 | ) | (136,446 | ) | ||||
Treasury stock at cost, 185,831 shares in 2013 and 2012 |
(1,415 | ) | (1,415 | ) | ||||
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Total stockholders equity |
25,353 | 27,665 | ||||||
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Total liabilities and stockholders equity |
$ | 58,661 | $ | 59,993 | ||||
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See accompanying notes to condensed consolidated financial statements.
3
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands except for per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Revenue: |
||||||||||||||||
Products |
$ | 4,765 | $ | 5,661 | $ | 14,329 | $ | 13,248 | ||||||||
Service and supplies |
3,525 | 2,522 | 9,603 | 7,209 | ||||||||||||
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Total revenue |
8,290 | 8,183 | 23,932 | 20,457 | ||||||||||||
Cost of revenue: |
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Products |
1,383 | 1,527 | 4,184 | 3,603 | ||||||||||||
Service and supplies |
747 | 541 | 2,251 | 1,678 | ||||||||||||
Amortization of acquired intangibles |
234 | 233 | 701 | 698 | ||||||||||||
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Total cost of revenue |
2,364 | 2,301 | 7,136 | 5,979 | ||||||||||||
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Gross profit |
5,926 | 5,882 | 16,796 | 14,478 | ||||||||||||
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Operating expenses: |
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Engineering and product development |
2,112 | 1,971 | 5,734 | 6,158 | ||||||||||||
Marketing and sales |
2,617 | 2,842 | 7,392 | 7,976 | ||||||||||||
General and administrative |
1,551 | 1,773 | 4,825 | 4,971 | ||||||||||||
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Total operating expenses |
6,280 | 6,586 | 17,951 | 19,105 | ||||||||||||
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Loss from operations |
(354 | ) | (704 | ) | (1,155 | ) | (4,627 | ) | ||||||||
Gain from change in fair value of warrant |
624 | 126 | 484 | 512 | ||||||||||||
Interest expense |
(807 | ) | (883 | ) | (2,467 | ) | (2,549 | ) | ||||||||
Other income |
4 | 9 | 16 | 27 | ||||||||||||
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Other expense, net |
(179 | ) | (748 | ) | (1,967 | ) | (2,010 | ) | ||||||||
Loss before income tax expense |
(533 | ) | (1,452 | ) | (3,122 | ) | (6,637 | ) | ||||||||
Income tax expense |
(56 | ) | (13 | ) | (76 | ) | (35 | ) | ||||||||
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Net loss and comprehensive loss |
$ | (589 | ) | $ | (1,465 | ) | $ | (3,198 | ) | $ | (6,672 | ) | ||||
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Net loss per share: |
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Basic and diluted |
$ | (0.05 | ) | $ | (0.14 | ) | $ | (0.30 | ) | $ | (0.62 | ) | ||||
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Weighted average number of shares used in computing loss per share: |
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Basic and diluted |
10,849 | 10,805 | 10,835 | 10,792 | ||||||||||||
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See accompanying notes to consolidated financial statements.
4
Condensed Consolidated Statements of Cash Flows
(unaudited)
For the nine months ended September 30, |
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2013 | 2012 | |||||||
(in thousands) | ||||||||
Cash flow from operating activities: |
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Net loss |
$ | (3,198 | ) | $ | (6,672 | ) | ||
Adjustments to reconcile net loss to net cash used for operating activities: |
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Depreciation |
528 | 701 | ||||||
Amortization |
1,291 | 1,472 | ||||||
Bad debt provision |
35 | | ||||||
Gain from change in fair value of warrant |
(484 | ) | (512 | ) | ||||
Loss on disposal of assets |
49 | 143 | ||||||
Stock-based compensation expense |
908 | 731 | ||||||
Amortization of debt discount and debt costs |
588 | 761 | ||||||
Interest on settlement obligations |
214 | 313 | ||||||
Changes in operating assets and liabilities: |
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Accounts receivable |
(3,474 | ) | (1,712 | ) | ||||
Inventory |
116 | 178 | ||||||
Prepaid and other current assets |
(145 | ) | 215 | |||||
Accounts payable |
78 | 1,106 | ||||||
Accrued expenses |
(799 | ) | (2,172 | ) | ||||
Deferred revenue |
1,110 | 818 | ||||||
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Total adjustments |
15 | 2,042 | ||||||
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Net cash used for operating activities |
(3,183 | ) | (4,630 | ) | ||||
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Cash flow from investing activities: |
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Additions to patents, technology and other |
(24 | ) | (3 | ) | ||||
Additions to property and equipment |
(510 | ) | (465 | ) | ||||
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Net cash used for investing activities |
(534 | ) | (468 | ) | ||||
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Cash flow from financing activities: |
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Issuance of common stock for cash |
3 | | ||||||
Taxes paid related to restricted stock issuance |
(25 | ) | (13 | ) | ||||
Proceeds from debt financing, net |
| 14,325 | ||||||
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Net cash (used for) provided by financing activities |
(22 | ) | 14,312 | |||||
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Increase (decrease) in cash and equivalents |
(3,739 | ) | 9,214 | |||||
Cash and equivalents, beginning of period |
13,948 | 4,576 | ||||||
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Cash and equivalents, end of period |
$ | 10,209 | $ | 13,790 | ||||
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Supplemental disclosure of cash flow information: |
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Interest paid |
$ | 1,664 | $ | 1,516 | ||||
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Taxes paid |
$ | 117 | 43 | |||||
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Equipment purchased under capital lease |
$ | 409 | | |||||
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See accompanying notes to consolidated financial statements.
5
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Note 1 - Basis of Presentation and Significant Accounting Policies
The accompanying condensed consolidated financial statements of iCAD, Inc. and subsidiary (iCAD or the Company) have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP). In the opinion of management, these unaudited interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the financial position at September 30, 2013, the results of operations for the three and nine month period ended September 30, 2013 and 2012, respectively, and cash flows for the three and nine month period ended September 30, 2013 and 2012, respectively. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information normally included in the footnotes prepared in accordance with US GAAP has been omitted as permitted by the rules and regulations of the Securities and Exchange Commission (SEC). The accompanying financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2012 filed with the SEC on February 27, 2013. The results for the three and nine month periods ended September 30, 2013 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2013, or any future period.
Revenue Recognition
The Company recognizes revenue primarily from the sale of products and from the sale of services and supplies. Revenue is recognized when delivery has occurred, persuasive evidence of an arrangement exists, fees are fixed or determinable and collectability of the related receivable is probable. For product revenue, delivery has occurred upon shipment provided title and risk of loss has passed to the customer. Services and supplies revenue are considered to be delivered as the services are performed or over the estimated life of the supply agreement.
The Company recognizes revenue from the sale of its digital, film-based CAD and electronic brachytherapy (eBx) products and services in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Update No. 2009-13, Multiple-Deliverable Revenue Arrangements (Accounting Standards Update ASU 2009-13) and ASC Update No. 2009-14, Certain Arrangements That Contain Software Elements (Update No. 2009-14). (ASU 2009-14). Revenue for the sale of certain CAD products is recognized in accordance with ASC 840 (Leases) (ASC 840). For multiple element arrangements, revenue is allocated to all deliverables based on their relative selling prices. In such circumstances, a hierarchy is used to determine the selling price to be used for allocating revenue to deliverables as follows: (i) vendor-specific objective evidence of fair value (VSOE), (ii) third-party evidence of selling price (TPE), and (iii) best estimate of the selling price (BESP). VSOE generally exists only when the deliverable is sold separately and is the price actually charged for that deliverable. The process for determining BESP for deliverables without
6
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
VSOE or TPE considers multiple factors including relative selling prices; competitive prices in the marketplace, and management judgment, however, these may vary depending upon the unique facts and circumstances related to each deliverable.
The Company primarily uses customer purchase orders that are subject to the Companys terms and conditions or, in the case of an Original Equipment Manufacturer (OEM) are governed by distribution agreements. In accordance with our distribution agreements, the OEM does not have a right of return, and title and risk of loss passes to the OEM upon shipment. The Company generally ships Free On Board shipping point and uses shipping documents and third-party proof of delivery to verify delivery and transfer of title. In addition, the Company assesses whether collection is probable by considering a number of factors, including past transaction history with the customer and the creditworthiness of the customer, as obtained from third party credit references.
If the terms of the sale include customer acceptance provisions and compliance with those provisions cannot be demonstrated, all revenue is deferred and not recognized until such acceptance occurs. The Company considers all relevant facts and circumstances in determining when to recognize revenue, including contractual obligations to the customer, the customers post-delivery acceptance provisions, if any, and the installation process.
The Company has determined that iCADs Digital, MRI and film based sales generally follow the guidance of FASB ASC Topic 605 Revenue Recognition (ASC 605) as the software has been considered essential to the functionality of the product per the guidance of ASU 2009-14. Typically, the responsibility for the installation process lies with the OEM partner. When iCAD is responsible for product installation, the installation element is considered a separate unit of accounting because the delivered product has stand-alone value to the customer. In these instances, the Company allocates the deliverables based on the framework established within ASU 2009-13. Therefore, the installation and training revenue is recognized as the services are performed according to the VSOE of the element. Revenue from the Digital, MRI and film based equipment when there is installation is recognized based on the relative selling price allocation of the BESP.
Sales of the Companys eBx product typically include a controller, accessories, and service and source agreements. The Company allocates revenue to the deliverables in the arrangement based on the BESP in accordance with ASU 2009-13. Product revenue is generally recognized when the product has been delivered and service and source revenue is typically recognized over the life of the service and source agreement.
The Company defers revenue from the sale of service contracts related to future periods and recognizes revenue on a straight-line basis in accordance with ASC Topic 605-20, Services. The Company provides for estimated warranty costs on original product warranties at the time of sale.
7
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Cost of Revenue
Cost of revenue consists of the costs of products purchased for resale, cost relating to service including costs of service contracts to maintain equipment after the warranty period, product installation, training, customer support, certain warranty repair costs, inbound freight and duty, manufacturing, warehousing, material movement, inspection, scrap, rework, depreciation and in-house product warranty repairs. For the three and nine months ended September 30, 2013, included in cost of revenue is, approximately $119,000 and $389,000, respectively of expense related to the newly enacted Medical Device Excise tax.
Segments
The Company now reports the results of two segments, Cancer Detection (Detection) and Cancer Therapy (Therapy). The Detection segment consists of our advanced image analysis and workflow products, and the Therapy segment consists of our radiation therapy (Axxent) products.
Note 2 - Net Loss per Common Share
The Companys basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period and, if there are dilutive securities, diluted loss per share is computed by including common stock equivalents which includes shares issuable upon the exercise of stock options, net of shares assumed to have been purchased with the proceeds, using the treasury stock method.
A summary of the Companys calculation of net loss per share is as follows (in thousands except per share amounts):
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
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Net loss |
$ | (589 | ) | $ | (1,465 | ) | $ | (3,198 | ) | $ | (6,672 | ) | ||||
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Basic shares used in the calculation of net loss per share |
10,849 | 10,805 | 10,835 | 10,792 | ||||||||||||
Effect of dilutive securities: |
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Stock options |
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Restricted stock |
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Diluted shares used in the calculation of net loss per share |
10,849 | 10,805 | 10,835 | 10,792 | ||||||||||||
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Net loss per share - basic |
$ | (0.05 | ) | $ | (0.14 | ) | $ | (0.30 | ) | $ | (0.62 | ) | ||||
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Net loss per share - diluted |
$ | (0.05 | ) | $ | (0.14 | ) | $ | (0.30 | ) | $ | (0.62 | ) | ||||
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8
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
The shares of the Companys common stock, issuable upon the exercise of stock options and warrants and vesting of restricted stock that were excluded from the calculation of diluted net loss per share because their effect would have been antidilutive is as follows:
Period Ended | ||||||||
September 30, | ||||||||
2013 | 2012 | |||||||
Stock Options |
1,389,897 | 1,351,117 | ||||||
Warrants |
550,000 | 550,000 | ||||||
Restricted Stock |
216,917 | 67,741 | ||||||
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Stock options, warrants and restricted stock |
2,156,814 | 1,968,858 | ||||||
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Note 3 - Long Term Debt
On December 29, 2011, the Company entered into several agreements with entities affiliated with Deerfield Management, a healthcare investment fund (Deerfield), pursuant to which Deerfield agreed to provide $15 million in funding to the Company. Pursuant to the terms of a Facility Agreement, dated as of December 29, 2011 (the Facility Agreement), on January 6, 2012 (the Funding Date), the Company issued to Deerfield promissory notes in the aggregate principal amount of $15 million (the Note). Under a Revenue Purchase Agreement, dated as of December 29, 2011 (the Revenue Purchase Agreement), the Company agreed to pay Deerfield a portion of the Companys revenues until the maturity date of the Note, whether or not the Note is outstanding through that date. On the Funding Date, the Company issued to Deerfield (i) six-year warrants to purchase up to 450,000 shares of common stock at an exercise price of $3.50 per share (the Warrants) and (ii) a second Warrant (the B Warrant) to purchase an additional 100,000 shares of common stock at an exercise price of $3.50 per share, which may become exercisable if certain conditions are met, as described in the Warrants. Collectively, these transactions are referred to as the Transactions. On the Funding Date, the Company received net proceeds of $14,325,000 from the Transactions, representing $15,000,000 of gross proceeds, less a $225,000 facility fee and a $450,000 finders fee before deducting other expenses of the Transactions.
The Facility Agreement has been accounted for as debt pursuant to ASC 470, Debt (ASC 470). The Facility Agreement had an original issue discount of approximately $4.1 million and an additional value allocated to the warrants of approximately $1.0 million. The discount is being accreted to the $15.0 million face value of the Note using the effective interest method with an effective interest rate of 17.35% based on the discount of approximately $5.1 million.
The original issue discount of approximately $4.1 million was assigned to the Revenue Purchase Agreement. Under this agreement, the Company is obligated to pay (1) 4.25% of annual revenues up to $25 million, (2) 2.75% of annual revenues from $25 million to $50 million during 2013 and 2014, and 2.25% of annual revenues in that range during 2015, 2016 and if the Facility Agreement is extended, in 2017, and (3) 1.0% of annual revenues in excess of $50 million. The $4.1 million discount assigned to the Revenue Purchase Agreement was capitalized as debt in accordance with ASC 470-10-25, Sales of Future
9
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Revenues or Various Other Measures of Income. The Company has estimated the cash flows associated with the Revenue Purchase Agreement and is amortizing the discount to interest expense over the expected term of the arrangement at an effective amortization rate of approximately 23.6%.
The overall effective interest rate of the financing arrangement, excluding changes in the fair value of the warrants, is currently estimated to be approximately 19%.
The Warrants have been classified as debt in accordance with ASC 480, Distinguishing Liabilities from Equity, as the Warrants contain a feature whereby the Company could be required to redeem the Warrants for cash upon the occurrence of a major transaction, as defined in the Warrants. The value of the Warrants was determined using a binomial lattice model. The Warrant is being valued at fair value at each reporting period with changes in fair value recorded in the consolidated statement of operations (see Note 7).
The Company determined that the B Warrant did not have any value as of the Funding Date, as the B Warrant is exercisable upon the Companys election to extend the Facility Agreement. The Company does not plan to extend the Facility Agreement at this time. If the Company determines it will extend the Facility Agreement, the value of the B Warrant will be determined using the binomial lattice model at such time.
The following amounts are included in the consolidated balance sheet as of September 30, 2013 related to the Facility Agreement and Revenue Purchase Agreement:
Principal Amount of Facility Agreement |
$ | 15,000 | ||
Unamortized discount |
(3,403 | ) | ||
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Carrying amount of Facility Agreement |
11,597 | |||
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Revenue Purchase Agreement |
3,702 | |||
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Notes payable total |
$ | 15,299 | ||
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10
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
The following amounts comprise interest included in our consolidated statement of operations for the three and nine months ended September 30, 2013 and 2012:
Three months ended September 30 | ||||||||
2013 | 2012 | |||||||
Cash interest expense |
$ | 568 | $ | 564 | ||||
Non-cash amortization of debt discount |
130 | 180 | ||||||
Amortization of debt costs |
46 | 42 | ||||||
Amortization of settlement obligations |
62 | 97 | ||||||
Interest expense capital lease |
1 | | ||||||
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Total interest expense |
$ | 807 | $ | 883 | ||||
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Nine months ended September 30 | ||||||||
2013 | 2012 | |||||||
Cash interest expense |
$ | 1,664 | $ | 1,516 | ||||
Non-cash amortization of debt discount |
453 | 596 | ||||||
Amortization of debt costs |
135 | 124 | ||||||
Amortization of settlement obligations |
214 | 313 | ||||||
Interest expense capital lease |
1 | | ||||||
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Total interest expense |
$ | 2,467 | $ | 2,549 | ||||
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Cash interest expense represents the amount of interest expected to be paid in cash under the Facility Agreement and the Revenue Purchase Agreement, which represents the interest of 5.75% on the Facility Agreement and the expected cash payments on the Revenue Purchase Agreement for the period. Non-cash amortization is the amortization of the discount on the Facility Agreement. The amortization of debt costs represents the costs incurred with the financing, which is primarily the facility fee and the finders fee which has been capitalized and, is expensed using the effective interest method. The amortization of the settlement obligations represent the interest associated with the settlement agreements for both Carl Zeiss Meditec AG and Hologic, Inc. Interest expense capital lease represents interest related to the capital lease as noted in Note 4.
Note 4 - Lease Commitments
Operating leases
Facilities are leased under operating leases expiring at various dates through September, 2020. Certain of these leases contain renewal options. For the nine month period ended September 30, 2013 and 2012, rent expense under operating leases was $522,000 and $610,000, respectively.
11
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
As of September 30, 2013, future minimum lease payments under non-cancelable operating leases were as follows:
Fiscal Year | Operating Leases |
|||
2013 |
$ | 131 | ||
2014 |
476 | |||
2015 |
473 | |||
2016 |
490 | |||
2017 |
255 | |||
|
|
|||
$ | 1,825 | |||
|
|
Capital leases
The Company entered into a capital lease agreement for the purchase of certain equipment in August 2013 for approximately $409,000. Under the guidance of ASC Topic 840, Leases the Company determined that the lease was a capital lease as it contained a bargain purchase option wherein the Company has the option to buy the equipment for $1 at the end of the lease term. Accordingly, the equipment has been capitalized and a liability has been recorded. The equipment cost of $409,000 is reflected as property and equipment in the balance sheet and will be depreciated over its useful life.
Future minimum lease payments under this lease are as follows:
Fiscal Year |
Capital Leases |
|||
2013 |
$ | 42 | ||
2014 |
145 | |||
2015 |
145 | |||
2016 |
109 | |||
|
|
|||
subtotal minimum lease obligation |
441 | |||
less interest |
(32 | ) | ||
|
|
|||
Total, net |
409 | |||
less current portion |
(130 | ) | ||
|
|
|||
long term portion |
$ | 279 | ||
|
|
12
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Note 5 - Stock-Based Compensation
The Company follows the guidance in ASC Topic 718, Compensation - Stock Compensation, (ASC 718).
Options granted under the Companys stock incentive plans were valued utilizing the Black-Scholes model using the following assumptions and had the following fair values:
Three Months Ended | Nine Months Ended | |||||||
September 30, | September 30, | |||||||
2013 | 2012 | 2013 | 2012 | |||||
Average risk-free interest rate |
0.64% | 0.66% | 0.53% | 1.06% | ||||
Expected dividend yield |
None | None | None | None | ||||
Expected life |
3.5 years | 3.5 years | 3.5 years | 3.5 years | ||||
Expected volatility |
57.6% to 57.7% | 66.5% to 67.1% | 57.6% to 68.9% | 66.5% to 68.8% | ||||
Weighted average exercise price |
$6.08 | $2.25 | $5.25 | $2.46 | ||||
Weighted average fair value |
$2.53 | $1.07 | $2.28 | $1.18 |
As of September 30, 2013 unrecognized compensation cost related to unexercisable options and unvested restricted stock and the weighted average remaining period is as follows:
Remaining expense |
$ | 1,581,046 | ||
Weighted average term |
1.0 years |
The Companys aggregate intrinsic value for stock options and restricted stock outstanding is as follows:
Period Ended | ||||||||
September 30, | ||||||||
Aggregate intrinsic value |
2013 | 2012 | ||||||
Stock options |
$ | 2,194,000 | $ | 8,300 | ||||
Restricted stock |
1,143,000 | 146,000 |
Note 6 - Commitments and Contingencies
Foreign Tax Claim
In July 2007, a dissolved former Canadian subsidiary of the Company, CADx Medical Systems Inc. (CADx Medical), received a tax re-assessment of approximately $6,800,000 from the Canada Revenue Agency (CRA) resulting from CRAs audit of CADx Medicals Canadian federal tax return for the year ended December 31, 2002. In February 2010 the CRA reviewed the matter and reduced the tax re-assessment to approximately $703,000, excluding interest and penalties. The Company believes that it is not liable for the re-assessment against CADx Medical and no accrual has been recorded for this matter as of September 30, 2013.
13
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Settlement Obligations
In connection with the acquisition of Xoft, the Company recorded a royalty obligation pursuant to a settlement agreement entered into between Xoft and Hologic in August 2007. Xoft received a nonexclusive, irrevocable, perpetual, worldwide license, including the right to sublicense certain Hologic patents, and a non-compete covenant as well as an agreement not to seek further damages with respect to the alleged patent violations. In return, the Company has a remaining obligation to pay a minimum annual royalty payment to Hologic, of $250,000 payable through 2016. In addition to the minimum annual royalty payments, the litigation settlement agreement with Hologic also provided for payment of royalties based upon a specified percentage of future net sales on any products that practice the licensed rights. The estimated fair value of the patent license and non-compete covenant is $100,000 and is being amortized over the estimated remaining useful life of approximately six years. In addition, a liability has been recorded within accrued expenses and long-term settlement cost for future payment and for future minimum royalty obligations totaling $770,000. The Company recorded interest expense of approximately $33,000 and $94,000 in the three and nine months ended September 30, 2013, and $38,000 and $110,000 in the three and nine months ended September 30, 2012, respectively, related to this obligation.
On December 22, 2011, the Company agreed to a settlement related to the litigation with Carl Zeiss Meditec AG. The Company determined that this settlement should be recorded as a measurement period adjustment and accordingly recorded the present value of the litigation to the opening balance sheet of Xoft. The present value of the liability was estimated at approximately $1.8 million as of December 31, 2011. The Company is obligated to pay $0.5 million in June 2015 and $0.5 million in June 2017, for a total of $1.0 million. As of September 30, 2013, the remaining liability recorded within accrued expenses and long-term settlement cost for future payment and for future minimum royalty obligations is $0.7 million. The Company recorded interest expense of approximately $28,000 and $119,000 in the three and nine months ended September 30, 2013, and $59,000 and $203,000 in the three and nine months ended September 30, 2012, respectively related to this obligation.
Other Commitments
The Company is obligated to pay approximately $1.9 million for firm purchase obligations to suppliers for future product deliverables.
Litigation
On February 18, 2011, in the Orange County Superior Court (Docket No. 30-2011-00451816-CU-PL-CXC), named plaintiffs Jane Doe and John Doe filed a complaint against Xoft, the Company, and Hoag Memorial Hospital Presbyterian asserting causes of action for general negligence, breach of warranty, and strict liability and seeking unlimited damages in excess of $25,000. On March 2, 2011, the Company received a Statement of
14
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Damages - specifying that the damages being sought aggregated an amount of at least approximately $14.5 million. On April 6, 2011, plaintiffs Jane Doe and John Doe amended their complaint alleging only medical malpractice against Hoag Memorial Hospital Presbyterian. On April 8, 2011, another complaint was filed in the Orange County Superior Court (Docket No. 30-2011-00465448-CU-MM-CXC) on behalf of four additional Jane Doe plaintiffs and two John Doe spouses with identical allegations against the same defendants. One John Doe spouse from this group of plaintiffs was later dismissed on August 18, 2011. On April 19, 2011, a sixth Jane Doe plaintiff filed an identical complaint in the Orange County Superior Court (Docket No. 30-2011-00468687-CU-MM-CXC), and on May 4, 2011, a seventh Jane Doe plaintiff and John Doe spouse filed another complaint in the Orange County Superior Court (Docket No. 30-2011-00473120-CU-PO-CXC), again with identical allegations against the same defendants. On July 12, 2011, an eighth Jane Doe plaintiff and John Doe spouse filed a complaint in the Orange County Superior Court (Docket No. 30-2011-00491068-CU-PL-CXC), and on July 14, 2011, a ninth Jane Doe plaintiff and John Doe spouse filed another complaint in the Orange County Superior Court (Docket No. 30-2011-00491497-CU-PL-CXC), each with identical allegations as the previously filed complaints. On August 18, 2011, these two groups of Jane Doe plaintiffs and John Doe spouses amended their complaints to correct certain deficiencies. Additionally on August 18, 2011, a tenth Jane Doe plaintiff and two additional John Doe spouses filed a complaint in the Orange County Superior Court (Docket No. 30-2011-501448-CU-PL-CXC), again with identical allegations against the same defendants. On January 18, 2012, three additional Jane Doe plaintiffs and one additional John Doe spouse filed a complaint in the Orange County Superior Court (Docket No. 30-2012-00538423-CU-PL-CXC) with identical allegations against the same defendants. On April 11, 2012, the above-referenced cases were consolidated for all purposes, excluding trial. On May 2, 2012, plaintiffs filed a master consolidated complaint, with the same case number as the original filed complaint. On August 2, 2012, plaintiffs filed fictitious name amendments adding defendants, Mel Silverstein, M.D., Peter Chen, M.D., Lisa Guerrera, M.D., Ralph Mackintosh, Ph.D., Robert Dillman, M.D., and Jack Cox. On September 14, 2012, an additional Jane Doe plaintiff and John Doe spouse filed a complaint in the Orange County Superior Court (Docket No. 30-2012-00598740-CU-PL-CXC) with identical allegations as plaintiffs above against the same original defendants. On October 17, 2012, plaintiff John Doe No. 11 dismissed his complaint, with prejudice, as to all defendants. On November 26, 2012, plaintiffs filed an additional fictitious name amendment adding defendant, American Ceramic Technology, Inc. On January 15, 2013, plaintiffs filed a dismissal, with prejudice, as to defendant, Mel Silverstein, M.D., only. On May 28, 2013, plaintiffs filed an additional fictitious name amendment adding defendant, American Ceramic Technology. On July 11, 2013, American Ceramic Technology filed a cross-complaint for express and implied indemnity, apportionment, contribution and declaratory relief against all defendants. On October 24, 2013, plaintiffs filed an amended master consolidated complaint. It is alleged that each Jane Doe plaintiff was a patient who was treated with the Axxent Electronic Brachytherapy System that incorporated the Axxent Flexishield Mini. The Company believes that all of the Jane Doe plaintiffs were part of the group of 29 patients treated using the Axxent Flexishield Mini as part of a clinical trial. The Axxent Flexishield Mini was the subject of
15
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
a voluntary recall. These claims are still in the early stages. Based upon our preliminary analysis, the Company plans to vigorously defend the lawsuits however a loss is reasonably possible. Since the amount of the potential damages in the event of an adverse result is not reasonably estimable, we are unable to estimate a range of loss and no expense has been recorded with respect to the contingent liability associated with this matter.
Note 7 - Fair Value Measurements
The Company follows the provisions of ASC Topic 820, Fair Value Measurement and Disclosures, (ASC 820). This topic defines fair value, establishes a framework for measuring fair value under US GAAP and enhances disclosures about fair value measurements. Fair value is defined under ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following:
| Level 1 - Quoted prices in active markets for identical assets or liabilities. |
| Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
| Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value. |
A financial instruments level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Our financial instruments include cash and cash equivalents, accounts receivable, accounts payable and certain accrued liabilities and our notes payable. The carrying amounts of our cash and cash equivalents (which are comprised primarily of deposit and overnight sweep accounts), accounts receivable, accounts payable and certain accrued liabilities approximate fair value due to the short maturity of these instruments. The carrying value of our notes payable approximates fair value.
The Companys assets that are measured at fair value on a recurring basis relate to the Companys money market accounts. The Companys liabilities that are measured at fair value on a recurring basis relate to contingent consideration resulting from the acquisition of Xoft and the Warrants issued in connection with the Deerfield Facility Agreement.
The Companys money market funds are included in cash and cash equivalents in the accompanying balance sheet, and are considered a Level 1 investment as they are valued at quoted market prices in active markets.
16
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
The following table sets forth Companys assets and liabilities which are measured at fair value on a recurring basis by level within the fair value hierarchy.
Fair value measurements using: (000s) as of December 31, 2012 |
||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets |
||||||||||||||||
Money market accounts |
$ | 12,336 | $ | | $ | | $ | 12,336 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Assets |
$ | 12,336 | $ | | $ | | $ | 12,336 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities |
||||||||||||||||
Contingent Consideration |
$ | | $ | | $ | | $ | | ||||||||
Warrant Liability |
| | 1,538 | 1,538 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Liabilities |
$ | | $ | | $ | 1,538 | $ | 1,538 | ||||||||
|
|
|
|
|
|
|
|
Fair value measurements using: (000s) as of September 30, 2013 |
||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets |
||||||||||||||||
Money market accounts |
$ | 8,824 | $ | | $ | | $ | 8,824 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Assets |
$ | 8,824 | $ | | $ | | $ | 8,824 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Liabilities |
||||||||||||||||
Contingent Consideration |
$ | | $ | | $ | | $ | | ||||||||
Warrant Liability |
| | 1,054 | 1,054 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Liabilities |
$ | | $ | | $ | 1,054 | $ | 1,054 | ||||||||
|
|
|
|
|
|
|
|
The fair value of contingent consideration is a Level 3 liability and was determined to be $0 at December 31, 2012 and September 30, 2013, as the Company does not expect to meet the revenue thresholds for the Xoft transaction.
As discussed in Note 3, the Company issued 450,000 warrants which were immediately exercisable and therefore were valued as of the Funding Date. The warrant liability for the warrants associated with the debt was valued using the binomial lattice-based valuation methodology because that model embodies all of the relevant assumptions that address the features underlying these instruments. Significant assumptions in valuing the warrant liability were as follows as of December 31, 2012 and September 30, 2013.
17
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
September 30, 2013 |
December 31, 2012 |
|||||||
Warrants |
||||||||
Exercise price |
$ | 3.50 | $ | 3.50 | ||||
Volatility |
31.4 | % | 82.4 | % | ||||
Equivalent term (years) |
4.27 | 5.00 | ||||||
Risk-free interest rate |
1.2 | % | 0.8 | % |
The volatility was determined based on the definition in the Warrants, and the risk-free interest rate was determined using the six year LIBOR rate as of the measurement date.
In addition the other significant assumptions include the probability of voluntary exercise versus a major transaction (as defined in the Warrants); and assuming a major transaction, the probability of cashless major exercise; and assuming a cashless major exercise, the annual probabilities for a major transaction. The Company has estimated a low probability of these items as of September 30, 2013.
The following sets forth a reconciliation of the changes in the fair value of warrants payable during the period:
Nine months ended September 30, 2013 |
||||
Balance as of December 31, 2012 |
$ | 1,538 | ||
Fair value adjustment |
(484 | ) | ||
|
|
|||
Balance as of September 30, 2013 |
$ | 1,054 | ||
|
|
Items Measured at Fair Value on a Nonrecurring Basis
Certain assets, including our goodwill, are measured at fair value on a nonrecurring basis. These assets are recognized at fair value when they are deemed to be impaired. We did not consider any assets to be impaired during the three months ended September 30, 2013.
Note 8 - Income Taxes
At September 30, 2013, the Company had no material unrecognized tax benefits and no adjustments to liabilities or operations were required under ASC 740, Income Taxes. The Company does not expect that the unrecognized tax benefits will materially increase within the next twelve months. The Company did not recognize any interest or penalties related to uncertain tax positions at September 30, 2013. The Company files United States federal income tax returns and income tax returns in various states and local jurisdictions. The Companys three preceding tax years remain subject to examination by federal and state taxing authorities. In addition, because the Company has net operating loss carry-forwards, the Internal Revenue Service and state jurisdictions are permitted to audit earlier years and propose adjustments up to the amount of net operating loss generated in those years. The Company is not under examination by any other federal or state jurisdiction for any tax years.
18
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Note 9 - Goodwill
In accordance with FASB ASC Topic 350-20, Intangibles - Goodwill and Other, (ASC 350-20), the Company tests goodwill for impairment on an annual basis and between annual tests if events and circumstances indicate it is more likely than not that the fair value of the Company is less than the carrying value of the Company.
The Companys goodwill arose in connection with its acquisitions in June 2002, December 2003 and December 2010.
The Company assesses the potential impairment of goodwill on an annual basis or whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors management considers important, which could trigger an impairment of such asset, include the following:
| significant underperformance relative to historical or projected future operating results; |
| significant changes in the manner or use of the assets or the strategy for our overall business; |
| significant negative industry or economic trends; |
| significant decline in our stock price for a sustained period; and |
| a sustained decline in our market capitalization below net book value. |
During the second quarter of 2013, the Company determined that it operated in two segments and, accordingly, determined that there are two reporting units. The Company is in the process of allocating the goodwill by reporting unit and will complete the analysis in conjunction with the annual impairment assessment. We do not expect the allocation of goodwill by reporting unit to have a material impact on the financial statements. In addition, the Company concluded there were no triggering events as of September 30, 2013.
The carrying amount of goodwill (in thousands) for the quarter ended September 30, 2013 was approximately $21,109.
Note 10 - Segment Reporting
In accordance with FASB Topic ASC 280, Segments, operating segments, are defined as components of an enterprise that engage in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance.
19
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
The Company now reports the results of two segments, Cancer Detection (Detection) and Cancer Therapy (Therapy). The Detection segment consists of our advanced image analysis and workflow products, and the Therapy segment consists of our radiation therapy (Axxent) products. The primary factors used by our CODM to allocate resources are based on revenues, operating income, and earnings before interest, taxes, depreciation, amortization, and other specific and non-recurring items (Adjusted EBITDA) of each segment. Included in segment operating income are stock compensation, amortization of technology and depreciation expense.
We do not track our assets by operating segment and our CODM does not use asset information by segment to allocate resources or make operating decisions.
20
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
Segment revenues, segment operating income, segment adjusted EBITDA and a reconciliation of segment operating income to loss before income tax is as follows:
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Segment revenues: |
||||||||||||||||
Detection |
$ | 4,310 | $ | 3,780 | $ | 12,755 | $ | 12,552 | ||||||||
Therapy |
3,980 | 4,403 | 11,177 | 7,905 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total Revenue |
$ | 8,290 | $ | 8,183 | $ | 23,932 | $ | 20,457 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment operating income (loss): |
||||||||||||||||
Detection |
$ | 1,485 | $ | 611 | $ | 4,111 | $ | 2,804 | ||||||||
Therapy |
(288 | ) | 458 | (441 | ) | (2,460 | ) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment operating income (loss) |
$ | 1,197 | $ | 1,069 | $ | 3,670 | $ | 344 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
General and administrative expenses |
$ | (1,551 | ) | $ | (1,773 | ) | $ | (4,825 | ) | $ | (4,971 | ) | ||||
Interest expense |
(807 | ) | (883 | ) | (2,467 | ) | (2,549 | ) | ||||||||
Gain on fair value of warrant |
624 | 126 | 484 | 512 | ||||||||||||
Other income |
4 | 9 | 16 | 27 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Loss before income tax |
$ | (533 | ) | $ | (1,452 | ) | $ | (3,122 | ) | $ | (6,637 | ) | ||||
|
|
|
|
|
|
|
|
|||||||||
Segment adjusted EBITDA: |
||||||||||||||||
Detection segment operating income |
$ | 1,485 | $ | 611 | $ | 4,111 | $ | 2,804 | ||||||||
Stock compensation |
98 | 84 | 292 | 245 | ||||||||||||
Depreciation |
45 | 34 | 131 | 107 | ||||||||||||
Amortization |
129 | 130 | 388 | 390 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Detection adjusted EBITDA |
$ | 1,757 | $ | 859 | $ | 4,923 | $ | 3,546 | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Therapy segment operating income (loss) |
$ | (288 | ) | $ | 458 | $ | (441 | ) | $ | (2,460 | ) | |||||
Stock compensation |
34 | 24 | 101 | 71 | ||||||||||||
Depreciation |
95 | 166 | 321 | 473 | ||||||||||||
Amortization |
234 | 233 | 702 | 698 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Therapy adjusted EBITDA |
$ | 75 | $ | 881 | $ | 683 | $ | (1,218 | ) | |||||||
|
|
|
|
|
|
|
|
Note 11 - Recent Accounting Pronouncements
In July 2013, the FASB issued Accounting Standards Update No. 2013-11, Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (ASU 2013-11). ASU 2013-11 requires the
21
iCAD, INC. AND SUBSIDIARY.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2013
netting of unrecognized tax benefits (UTBs) against a deferred tax asset for a loss or other carryforward that would apply in settlement of the uncertain tax positions. UTBs are required to be netted against all available same-jurisdiction loss or other tax carryforwards that would be utilized, rather than only against carryforwards that are created by the UTBs. ASU 2013-11 is effective for interim and annual periods beginning after December 15, 2013. The adoption of ASU 2013-11 is not expected to have a material impact on the Companys consolidated financial statements
22
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain information included in this Item 2 and elsewhere in this Form 10-Q that are not historical facts contain forward looking statements that involve a number of known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievement expressed or implied by such forward looking statements. These risks and uncertainties include, but are not limited to, uncertainty of future sales and expense levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, regulatory changes and requirements applicable to our products, product market acceptance, possible technological obsolescence of products, increased competition, integration of the acquired businesses, the impact of litigation and/or government regulation, changes in Medicare reimbursement policies, competitive factors, the effects of a decline in the economy in markets served by the Company and other risks detailed in the Companys other filings with the Securities and Exchange Commission. The words believe, plan, intend, expect, estimate, anticipate, likely, seek, should, would, could and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made.
Results of Operations
Overview
iCAD is an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy solutions for the early identification and treatment of cancer. The Company now reports in two segments - Detection and Therapy.
The Company has grown primarily through acquisitions including CADx, Qualia Computing, CAD Sciences and Xoft to become a broad player in the oncology market.
In the Detection segment, its industry-leading solutions include advanced image analysis and workflow solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing the most prevalent cancers earlier, a comprehensive range of high-performance, upgradeable Computer-Aided Detection (CAD) systems and workflow solutions for mammography, Magnetic Resonance Imaging (MRI) and Computed Tomography CT.
The Company intends to continue the extension of its superior image analysis and clinical decision support solutions for mammography, MRI and CT imaging. iCAD believes that advances in digital imaging techniques should bolster its efforts to develop additional commercially viable CAD/advanced image analysis and workflow products.
In the Therapy segment the Company offers an isotope-free cancer treatment platform technology. The Xoft Electronic Brachytherapy System (Xoft eBx) can be used for the treatment of early-stage breast cancer, endometrial cancer, cervical cancer and skin cancer. We believe the Xoft eBx
23
system platform indications represent strategic opportunities in the United States and International markets to offer differentiated treatment alternatives. In addition, the Xoft eBx system generates additional recurring revenue for the sale of consumables and related accessories which will continue to drive growth in this segment.
The Companys headquarters are located in Nashua, New Hampshire, with manufacturing and contract manufacturing facilities in New Hampshire and Massachusetts and an operations, research, development, manufacturing and warehousing facility in San Jose, California.
Critical Accounting Policies
The Companys discussion and analysis of its financial condition, results of operations, and cash flows are based on the Companys consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates these estimates, including those related to accounts receivable allowance, inventory valuation and obsolescence, intangible assets, income taxes, warranty obligations, contingencies and litigation. Additionally, the Company uses assumptions and estimates in calculations to determine stock-based compensation. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. For a comprehensive list of the Companys critical accounting policies, reference should be made to the Annual Report on Form 10-K for the year ended December 31, 2012 filed on February 27, 2013.
24
Three months ended September 30, 2013 compared to the three months ended September 30, 2012
Revenue:
Three months ended September 30, | ||||||||||||||||
2013 | 2012 | Change | % Change | |||||||||||||
Detection revenue |
||||||||||||||||
Product revenue |
$ | 2,246 | $ | 2,023 | $ | 223 | 11.0 | % | ||||||||
Service revenue |
2,064 | 1,757 | 307 | 17.5 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
4,310 | 3,780 | 530 | 14.0 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Therapy revenue |
||||||||||||||||
Product revenue |
2,519 | 3,638 | (1,119 | ) | (30.8 | )% | ||||||||||
Service revenue |
1,461 | 765 | 696 | 91.0 | % | |||||||||||
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|
|
|
|
|||||||||
Subtotal |
3,980 | 4,403 | (423 | ) | (9.6 | )% | ||||||||||
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|
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|
|
|||||||||
Total revenue |
$ | 8,290 | $ | 8,183 | $ | 107 | 1.3 | % | ||||||||
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|
|
|
|
|
|
Three months ended September 30, 2013:
Total revenue for the three month period ended September 30, 2013 was $8.3 million compared with revenue of $8.2 million for the three month period ended September 30, 2012, an increase of approximately $107,000, or 1.3%. The increase in revenue was due to a $423,000 decrease in revenue from Therapy products offset by an increase in Detection revenues of approximately $530,000.
Detection product revenue increased by approximately $0.2 million from $2.0 million to $2.2 million or 11% in the three months ended September 30 2013 as compared to September 30, 2012. The increase is due primarily to an increase in our Digital, CAD revenue of approximately $0.5 million and a decrease in film based revenues of $0.3 million. The increase in Digital CAD revenue is due primarily to an increase in direct customer sales. Film based revenues continue to decrease as a result of the transition to digital technologies.
Detection service revenue increased approximately $0.3 million from $1.8 million in the three months ended September 30, 2012 to $2.1 million in the three months ended September 30, 2013. The increase in service revenue reflects the sale of service contracts as the result of our initiatives to sell into our installed base of customers as well as additional billable MRI engineering revenue.
Therapy product revenue decreased by $1.1 million from $3.6 million in the three months ended September 30, 2012 to $2.5 million in the three months ended September 30, 2013. Product sales for our Axxent eBx systems decreased due primarily to a decrease in system sales of approximately $0.8 million and a decrease in sales of accessories of $0.3 million. Revenue from the sale of our Axxent eBx systems can vary due to an increase or decrease in the number of units sold which can cause a significant fluctuation in revenue in the period. However, we continue to see interest in the Xoft solution for both its use in the treatment of non-melanoma skin cancers as well as the intra-operative radiation therapy (IORT) market. Revenue growth for electronic brachytherapy products is also enhanced by sales of our balloon and surface applicators, which we believe is based on market adoption of the systems resulting in increased procedure volumes.
25
Therapy service and supply revenue increased approximately $0.7 million from $0.8 million in the three months ended September 30, 2012 to $1.5 million for the three months ended September 30, 2013. The increase in Therapy service and supply revenue is due primarily to increases in service revenue due to the growing installed base and source agreement revenues which is driven by increased procedure volumes. We expect service and supply revenue for our electronic brachytherapy products to increase as patient treatment volume and our installed base of electronic brachytherapy products increases.
Gross Profit:
Three months ended Sept 30, | ||||||||||||||||
2013 | 2012 | Change | % Change | |||||||||||||
Products |
$ | 1,383 | $ | 1,527 | $ | (144 | ) | (9.4 | )% | |||||||
Service & supply |
747 | 541 | 206 | 38.1 | % | |||||||||||
Amortization of acquired technology |
234 | 233 | 1 | 0.4 | % | |||||||||||
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|
|
|
|
|||||||||
Total cost of revenue |
$ | 2,364 | $ | 2,301 | $ | 63 | 2.7 | % | ||||||||
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|
|
|
|
|
|||||||||
Gross profit |
$ | 5,926 | $ | 5,882 | $ | 44 | 0.7 | % | ||||||||
profit % |
71.5 | % | 71.9 | % |
Gross profit for the three month period ended September 30, 2013 was $5.9 million, or 71.5% of revenue as compared to $5.9 million or 71.9% of revenue in the three month period ended September 30, 2012. Gross profit percent changes primarily due to changes in the mix of business, consulting costs related to non-recurring engineering revenue, and additional manufacturing investments. Gross profit percent is also impacted by amortization of acquired technology, and the impact of the medical device excise tax implemented as of January 1, 2013 which represented an additional $119,000 of expense as compared to the quarter ended September 30, 2012.
Operating Expenses:
Three months ended Sept 30, | ||||||||||||||||
2013 | 2012 | Change | Changer % | |||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
$ | 2,112 | $ | 1,971 | $ | 141 | 7.2 | % | ||||||||
Marketing and sales |
2,617 | 2,842 | (225 | ) | (7.9 | )% | ||||||||||
General and administrative |
1,551 | 1,773 | (222 | ) | (12.5 | )% | ||||||||||
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|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 6,280 | $ | 6,586 | $ | (306 | ) | (4.6 | )% | |||||||
|
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|
|
|
|
|
|
Engineering and Product Development. Engineering and product development costs for the three month period ended September 30, 2013 increased by $0.1 million or 7.2%, from $2.0 million in 2012 to $2.1 million in 2013. The increase in engineering and product development costs was primarily due to an increase in expenses related to an IORT clinical trial, consulting and subcontracting costs.
26
Marketing and Sales. Marketing and sales expenses decreased by $0.2 million or 7.9%, from $2.8 million in the three month period ended September 30, 2012 to $2.6 million in the three month period ended September 30, 2013. The decrease in marketing and sales expenses primarily resulted from reductions in salary and related expenses as compared to the three months ended September 30, 2012.
General and Administrative. General and administrative expenses decreased by $0.2 million or 12.5%, from $1.8 million in the three month period ended September 30, 2012 to $1.6 million in the three month period ended September 30, 2013. Decreases in amortization expense, consulting and legal, were offset by increases in stock compensation costs, bonus expense and travel costs.
Other Income and Expense:
Three months ended September 30, | ||||||||||||||||
2013 | 2012 | Change | Change % | |||||||||||||
Gain from change in fair value of warrants |
$ | 624 | $ | 126 | 498 | 395.2 | % | |||||||||
Interest expense |
(807 | ) | (883 | ) | 76 | (8.6 | )% | |||||||||
Other income |
4 | 9 | (5 | ) | (55.6 | )% | ||||||||||
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|
|
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|
|
|||||||||
$ | (179 | ) | $ | (748 | ) | $ | 569 | (76.1 | )% | |||||||
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|
|
|||||||||
Tax expense |
(56 | ) | (13 | ) | (43 | ) | 330.8 | % |
Gain from change in fair value of warrants. The $624,000 and $126,000 gain from the change in fair value of the warrants for the periods ended September 30, 2013 and 2012, respectively, resulted from a decrease in the fair value of the warrants under the binomial lattice based valuation methodology, due primarily to a decrease in the Companys stock price, and volatility which are the key assumptions in determining the value of the warrants. We expect the value of the warrants to continue to fluctuate as changes in the Company stock price and volatility, which is driven by changes in our stock price, can have a significant impact on the value of the Warrants.
Interest expense. Interest expense of $807,000 decreased by $76,000 or 8.6% for the three month period ended September 30, 2013 as compared to interest expense of $883,000 in the three month period ended September 30, 2012. Interest expense is due primarily to interest expense related to the credit facility entered into with certain entities affiliated with Deerfield Management. Interest related to the Hologic and Zeiss settlement obligations was $61,000 in the three months ended September 30, 2013 as compared to $97,000 in the same period in 2012.
Interest income. Interest income of $4,000 and $9,000 for the quarters ended September 30, 2013, and 2012, respectively reflects income earned from our money market accounts.
Tax expense. Tax expense of $56,000 and $13,000 for the quarters ended September 30, 2013, and 2012, respectively is due primarily to state non-income and franchise based taxes.
27
Nine months ended September 30, 2013 compared to the nine months ended September 30, 2012
Revenue:
Nine months ended September 30, | ||||||||||||||||
2013 | 2012 | Change | % Change | |||||||||||||
Detection revenue |
||||||||||||||||
Product revenue |
$ | 6,566 | $ | 7,327 | $ | (761 | ) | (10.4 | )% | |||||||
Service revenue |
6,189 | 5,225 | 964 | 18.4 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
12,755 | 12,552 | 203 | 1.6 | % | |||||||||||
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|
|
|
|
|
|
|
|||||||||
Therapy revenue |
||||||||||||||||
Product revenue |
7,763 | 5,921 | 1,842 | 31.1 | % | |||||||||||
Service revenue |
3,414 | 1,984 | 1,430 | 72.1 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Subtotal |
11,177 | 7,905 | 3,272 | 41.4 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenue |
$ | 23,932 | $ | 20,457 | $ | 3,475 | 17.0 | % | ||||||||
|
|
|
|
|
|
|
|
Nine months ended September 30, 2013:
Total revenue for the nine month period ended September 30, 2013 was $23.9 million compared with revenue of $20.5 million for the nine month period ended September 30, 2012, an increase of approximately $3.5 million, or 17.0%. The increase in revenue was primarily due to an increase in Therapy revenue of $3.3 million and an increase in Detection revenue of $0.2 million.
Detection product revenue decreased by approximately $0.7 million from $7.3 million to $6.6 million or 10.4% in the nine months ended September 30 2013 as compared to the nine months ended September 30, 2012. The decrease is due primarily to a decrease in film based revenues of $0.8 million as a result of the slowing of the transition from analog to digital technology.
Detection service revenue increased approximately $1.0 million from $5.2 million in the nine months ended September 30, 2012 to $6.2 million in the nine months ended September 30, 2013. The increase in service revenue reflects the sale of service contracts as the result of our initiatives to sell into our installed base of customers as well as additional billable MRI engineering revenue.
Therapy product revenue increased $1.9 million or 31.1% from $5.9 million in the nine months ended September 30, 2012 to $7.8 million in the nine months ended September 30, 2013. The increase in product revenue is due to sales of our Axxent Electronic Brachytherapy System and accessories which has continued to increase both for its use in in the treatment of non-melanoma skin cancers as well as the IORT market. Revenue from the sale of our Axxent eBx systems can vary due to an increase or decrease in the number of units sold which can cause a significant fluctuation in revenue in the period. Revenue growth for electronic brachytherapy products was also enhanced by continued sales increases for balloon and surface applicators, which we believe is based on market adoption of the systems resulting in increased procedure volumes.
Therapy service and supply revenue increased approximately $1.4 million from $2.0 million in the nine months ended September 30, 2012 to $3.4 million for the nine months ended September 30, 2013. The increase in service and supply revenue is due primarily to increases in service and source agreements related to sales of the electronic brachytherapy system which is driven by
28
increased procedure volumes. We expect service and supply revenue for our electronic brachytherapy products to increase as our installed base of electronic brachytherapy products increases.
Gross Profit:
Nine months ended Sept 30, | ||||||||||||||||
2013 | 2012 | Change | % Change | |||||||||||||
Products |
$ | 4,184 | $ | 3,603 | $ | 581 | 16.1 | % | ||||||||
Service & supply |
2,251 | 1,678 | 573 | 34.1 | % | |||||||||||
Amortization of acquired technology |
701 | 698 | 3 | 0.4 | % | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total cost of revenue |
$ | 7,136 | $ | 5,979 | $ | 1,157 | 19.4 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit |
$ | 16,796 | $ | 14,478 | $ | 2,318 | 16.0 | % | ||||||||
profit % |
70.2 | % | 70.8 | % |
Gross profit for the nine month period ended September 30, 2013 was $16.8 million, or 70.2% of revenue as compared to $14.5 million or 70.8% of revenue in the nine month period ended September 30, 2012. Gross profit percent decreased slightly due to the impact of the medical device excise tax implemented as of January 1, 2013 which represented an additional $389,000 of expense as compared to the quarter ended September 30, 2012. This decrease was offset by an increase in gross profit percent due to the impact of higher revenue which absorbed the fixed manufacturing expenses and the amortization of acquired technology.
Operating Expenses:
Nine months ended Sept 30, | ||||||||||||||||
2013 | 2012 | Change | Change % | |||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
$ | 5,734 | $ | 6,158 | $ | (424 | ) | (6.9 | )% | |||||||
Marketing and sales |
7,392 | 7,976 | (584 | ) | (7.3 | )% | ||||||||||
General and administrative |
4,825 | 4,971 | (146 | ) | (2.9 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total operating expenses |
$ | 17,951 | $ | 19,105 | $ | (1,154 | ) | (6.0 | )% | |||||||
|
|
|
|
|
|
|
|
Engineering and Product Development. Engineering and product development costs for the nine month period ended September 30, 2013 decreased by $0.4 million or 6.9%, from $6.2 million for the nine month period ended September 30, 2012 to $5.7 million for the same period in 2013. The decrease in engineering and product development costs was primarily due to a decrease in consulting, subcontracting, licensing and personnel costs of approximately $560,000 offset by an increase in clinical research expenses.
Marketing and Sales. Marketing and sales expenses decreased by $0.6 million or 7.3%, from $8.0 million in the nine month period ended September 30, 2012 to $7.4 million in nine month period ended September 30, 2013. The decrease in marketing and sales expenses primarily resulted from reductions in salary and salary related expenses during the nine months ended September 30, 2013 as compared to the nine months ended September 30, 2012.
29
General and Administrative. General and administrative expenses decreased by $146,000 or 2.9%, from $5.0 million in the nine month period ended September 30, 2012 to $4.8 million in the nine month period ended September 30, 2013. The decrease in general and administrative expense for the period ended September 30, 2013 is primarily due to a decrease in amortization and legal expense offset by an increase in personnel costs, stock compensation and bad debt expense as compared to the nine months ended September 30, 2012.
Other Income and Expense:
Nine months ended September 30, | ||||||||||||||||
2013 | 2012 | Change | Change % | |||||||||||||
Gain from change in fair value of warrants |
$ | 484 | $ | 512 | (28 | ) | (5.5 | )% | ||||||||
Interest expense |
(2,467 | ) | (2,549 | ) | 82 | (3.2 | )% | |||||||||
Other income |
16 | 27 | (11 | ) | (40.7 | )% | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | (1,967 | ) | $ | (2,010 | ) | $ | 43 | (2.1 | )% | |||||||
|
|
|
|
|
|
|
|
|||||||||
Tax expense |
(76 | ) | (35 | ) | (41 | ) | 117.1 | % |
Gain from change in fair value of warrants. The $484,000 and $512,000 gain from the change in fair value of the warrants for the period ended September 30, 2013 and 2012, respectively, resulted from a changes in the fair value of the warrants under the binomial lattice based valuation methodology, due primarily to changes in volatility, the expected life of the warrant and the stock price of the Company at the valuation date, which are key drivers in determining the value of the warrants. We expect the value of the warrants to continue to fluctuate as changes in volatility which is driven by changes in our stock price, and changes in the Company stock price can have a significant impact on the value of the warrants.
Interest Expense. Interest expense is approximately $2.5 million for each of the nine month periods ended September 30, 2013 and 2012. Interest expense is due primarily to interest expense of approximately $2.3 million related to the credit facility entered into with certain entities affiliated with Deerfield Management. Interest related to the Hologic and Zeiss settlement obligations was $214,000 in the nine months ended September 30, 2013 as compared to $313,000 in the same period in 2012.
Interest Income. Interest income of $16,000 and $27,000 for the nine months ended September 30, 2013, and 2012, respectively reflects income earned from our money market accounts.
Tax expense. Tax expense of $76,000 and $35,000 for the nine months ended September 30, 2013, and 2012, respectively is due primarily to state non-income and franchise based taxes.
Liquidity and Capital Resources
We believe that our current liquidity and capital resources are sufficient to sustain operations through at least the next twelve months, primarily due to cash on hand and projected cash generation from operations. Our ability to generate cash that is adequate to meet our future capital requirements will depend primarily on operating cash flow. If sales or cash collections are reduced
30
from current expectations, or if expenses and cash requirements are increased, we may require additional financing, although there are no guarantees that we will be able to obtain the financing if necessary, on acceptable terms or at all.
As of September 30, 2013, the Company had cash and cash equivalents of $10.2 million, current assets of $21.3 million, current liabilities of $14.8 million and working capital of $6.5 million. The ratio of current assets to current liabilities was 1.44:1.
Pursuant to the agreements with Deerfield Management, a healthcare investment fund (Deerfield) in December 2011, the Company is obligated under the terms these agreements, to repay an aggregate principal amount of $15 million. In addition, we agreed to pay Deerfield a portion of our revenues until the maturity date of the note payable, whether or not the note is outstanding through that date. We also issued warrants at an exercise price of $3.50 per share and a second B warrant (to purchase an additional 100,000 shares of common stock at an exercise price of $3.50 per share, which may become exercisable if certain conditions are met. As a result, we are obligated to pay interest at 5.75% on the outstanding balance of the note which is approximately $216,000 per quarter until the fourth quarter of 2014. In 2015, interest is approximately $162,000 per quarter and in 2016, interest is approximately $108,000 per quarter, with the final payment of $7.5 million on the note payable due in January 2017 (unless we elect to extend). We are also required to pay a minimum commitment of $125,000 per quarter based on our revenue; however this minimum is met at approximately $2.9 million of revenue per quarter. We expect to exceed the minimum revenue thresholds on a quarterly basis as we did in the quarter ended September 30, 2013.
Net cash used for operating activities for the nine month period ended September 30, 2013 was $3.2 million, compared to net cash used for operating activities of $4.6 million for the nine month period ended September 30, 2012. The cash used for operating activities for the nine months ended September 30, 2013 resulted primarily from uses of cash due to an increase in accounts receivable of $3.5 million, a $0.7 million decrease in accounts payable and accrued expenses, offset by sources of cash due to an increase of $1.1 million in deferred revenue. We expect that cash used or provided by operating activities may fluctuate in future periods as a result of a number of factors, including fluctuations in our operating results, specifically the timing of when we recognize revenue, our accounts receivable collections and the timing of other payments.
The net cash used for investing activities for the nine month period ended September 30, 2013 was $534,000 as compared to $468,000 for the nine month period ended September 30, 2012. Cash used for investing activities consisted primarily of additions to property and equipment.
Net cash used for financing activities for the nine month period ended September 30, 2013 was $22,000 as compared to net cash provided by financing activities for the nine month period ended September 30, 2012 of $14.3 million, which consisted of cash received in connection with the credit facility entered into with Deerfield in December 2011, described in Note 3 of the accompanying Condensed Consolidated Financial Statements.
31
Contractual Obligations
The following table summarizes, for the periods presented, our future estimated cash payments under existing contractual obligations (in thousands).
Contractual Obligations |
Payments due by period | |||||||||||||||||||
Total | Less than 1 year |
1-3 years | 3-5 years | 5+ years | ||||||||||||||||
Operating Lease Obligations |
$ | 1,825 | $ | 491 | $ | 954 | $ | 380 | $ | | ||||||||||
Capital Lease Obligations |
409 | $ | 133 | 276 | | |||||||||||||||
Settlement Obligations |
2,475 | 275 | 800 | 1,050 | 350 | |||||||||||||||
Notes Payable |
19,122 | 1,363 | 9,794 | 7,965 | | |||||||||||||||
Other Commitments |
1,869 | 1,869 | | | | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total Contractual Obligations |
$ | 25,700 | $ | 4,131 | $ | 11,824 | $ | 9,395 | $ | 350 | ||||||||||
|
|
|
|
|
|
|
|
|
|
Settlement obligations represent the minimum payments attributable to the obligations related primarily to Zeiss and Hologic.
Other commitments represent firm purchase obligations to suppliers for future product deliverables.
In addition to the contractual obligations related to the interest payments from the note payable, the Company is obligated under the revenue agreement discussed in Note 3 of the accompanying financial statements, to pay Deerfield 4.25% of revenues up to $25 million, either 2.75% (for 2013 and 2014) or 2.25% (for 2015, 2016 and if applicable 2017) of annual revenues from $25 million to $50 million and 1.0% of annual revenues in excess of $50 million. Included in the above amounts are the minimum annual payments under the revenue agreement of $125,000 per quarter payable in arrears. The Company has included only the minimum annual payments in Notes Payable.
Recent Accounting Pronouncements
See Note 11 to the Condensed Consolidated Financial Statements.
32
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
We believe we are not subject to material foreign currency exchange rate fluctuations, as substantially all of our sales and expenses are denominated in the U.S. dollar. We do not hold derivative securities and have not entered into contracts embedded with derivative instruments, such as foreign currency and interest rate swaps, options, forwards, futures, collars or warrants, either to hedge existing risks or for speculative purposes.
Item 4. | Controls and Procedures |
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on this evaluation, as of September 30, 2013, the principal executive officer and principal financial officer concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934 (Exchange Act) were effective at the reasonable level of assurance.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. We conduct periodic evaluations to enhance, where necessary our procedures and controls.
Our principal executive officer and principal financial officer conducted an evaluation of our internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) to determine whether any changes in internal control over financial reporting occurred during the quarter ended September 30, 2013, that have materially affected or which are reasonably likely to materially affect internal control over financial reporting. Based on that evaluation, there has been no such change during such period.
33
PART II | OTHER INFORMATION |
Please refer to the detailed discussion regarding litigation set forth in Note 6 of the Notes to Condensed Consolidated Financial Statements in this Form 10-Q.
The Company is involved in various legal matters that are in the process of litigation or settled in the ordinary course of business. Although the final results of all such matters and claims cannot be predicted with certainty, we believe that the ultimate resolution of all such matters and claims will not have a material adverse effect on our financial condition. However, such matters could have a material adverse effect on our operating results and cash flows for a particular period.
Our risk factors are described in Part I, Item 1A of our Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2012 as filed with the SEC on February 27, 2013. There have been no material changes in the risks affecting iCAD since the filing of our Form 10-K.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
There were no unregistered sales of equity securities in the quarter ended September 30, 2013.
Item 6. | Exhibits |
Exhibit |
Description | |
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 September 30, 2013 and December 31, 2012, (ii) Consolidated Statements of Operations for the three and nine months ended September 30, 2013 and 2012, (iii) Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2013 and 2012, and (iv) Notes to Consolidated Financial Statements. |
34
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
iCAD, Inc. | ||||||||
(Registrant) | ||||||||
Date: | November 13, 2013 |
By: | /s/ Kenneth M. Ferry | |||||
Kenneth M. Ferry | ||||||||
President, Chief Executive Officer, Director | ||||||||
Date: | November 13, 2013 |
By: | /s/ Kevin C. Burns | |||||
Kevin C. Burns | ||||||||
Executive Vice President of Finance and Chief Financial Officer, Treasurer |
35