þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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) |
Large Accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(do not check if a smaller reporting company) |
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EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 | ||||||||
EX-32.2 | ||||||||
EX-101 INSTANCE DOCUMENT | ||||||||
EX-101 SCHEMA DOCUMENT | ||||||||
EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||
EX-101 LABELS LINKBASE DOCUMENT | ||||||||
EX-101 PRESENTATION LINKBASE DOCUMENT |
2
September 30, | December 31, | |||||||
2011 | 2010 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 5,288 | $ | 16,269 | ||||
Trade accounts receivable, net of allowance for doubtful
accounts of $50 in 2011 and 2010 |
5,656 | 3,389 | ||||||
Inventory, net |
2,132 | 3,489 | ||||||
Prepaid expenses and other current assets |
576 | 581 | ||||||
Total current assets |
13,652 | 23,728 | ||||||
Property and equipment, net of accumulated depreciation
and amortization of $2,600 in 2011 and $2,852 in 2010 |
2,118 | 2,774 | ||||||
Other assets |
604 | 675 | ||||||
Intangible assets, net of accumulated amortization
of $8,317 in 2011 and $6,746 in 2010 |
17,584 | 21,165 | ||||||
Goodwill |
20,907 | 45,689 | ||||||
Total assets |
$ | 54,865 | $ | 94,031 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,407 | $ | 2,500 | ||||
Accrued and other expenses |
4,518 | 5,902 | ||||||
Deferred revenue |
5,702 | 4,906 | ||||||
Total current liabilities |
12,627 | 13,308 | ||||||
Contingent consideration |
| 5,000 | ||||||
Deferred revenue, long-term portion |
1,628 | 961 | ||||||
Other long-term liabilities |
1,000 | 1,552 | ||||||
Total liabilities |
15,255 | 20,821 | ||||||
Commitments and Contingencies (see Note 5) |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par
value: authorized 1,000,000 shares;
none issued |
| | ||||||
Common stock, $.01 par
value: authorized 85,000,000
shares; issued 54,751,176 in 2011 and 54,383,747 in 2010;
outstanding 54,683,300 in 2011 and 54,315,871 in 2010 |
547 | 544 | ||||||
Additional paid-in capital |
163,775 | 163,101 | ||||||
Accumulated deficit |
(123,762 | ) | (89,485 | ) | ||||
Treasury stock at cost (67,876 shares) |
(950 | ) | (950 | ) | ||||
Total stockholders equity |
39,610 | 73,210 | ||||||
Total liabilities and stockholders equity |
$ | 54,865 | $ | 94,031 | ||||
3
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue: |
||||||||||||||||
Products |
$ | 5,754 | $ | 4,059 | $ | 15,463 | $ | 13,987 | ||||||||
Service and supplies |
2,298 | 1,527 | 6,579 | 4,217 | ||||||||||||
Total revenue |
8,052 | 5,586 | 22,042 | 18,204 | ||||||||||||
Cost of revenue: |
||||||||||||||||
Products |
1,280 | 544 | 3,627 | 1,769 | ||||||||||||
Service and supplies |
650 | 587 | 2,191 | 1,792 | ||||||||||||
Amortization of acquired intangibles |
233 | | 700 | | ||||||||||||
Total cost of revenue |
2,163 | 1,131 | 6,518 | 3,561 | ||||||||||||
Gross profit |
5,889 | 4,455 | 15,524 | 14,643 | ||||||||||||
Operating expenses: |
||||||||||||||||
Engineering and product development |
2,630 | 1,715 | 8,709 | 4,796 | ||||||||||||
Marketing and sales |
3,108 | 2,347 | 10,780 | 7,363 | ||||||||||||
General and administrative |
2,147 | 1,805 | 8,363 | 6,131 | ||||||||||||
Contingent consideration |
(3,800 | ) | | (4,900 | ) | | ||||||||||
Goodwill impairment |
26,750 | | 26,750 | | ||||||||||||
Total operating expenses |
30,835 | 5,867 | 49,702 | 18,290 | ||||||||||||
Loss from operations |
(24,946 | ) | (1,412 | ) | (34,178 | ) | (3,647 | ) | ||||||||
Gain on sale of patent |
| | | 275 | ||||||||||||
Interest (expense) income net |
(37 | ) | 19 | (99 | ) | 58 | ||||||||||
Net loss |
$ | (24,983 | ) | $ | (1,393 | ) | $ | (34,277 | ) | $ | (3,314 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic and diluted |
$ | (0.46 | ) | $ | (0.03 | ) | $ | (0.63 | ) | $ | (0.07 | ) | ||||
Weighted average number of shares
used in
computing loss per share: |
||||||||||||||||
Basic and diluted |
54,681 | 45,922 | 54,533 | 45,782 | ||||||||||||
4
Nine Months Ended | Nine Months Ended | |||||||
September 30, 2011 | September 30, 2010 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (34,277 | ) | $ | (3,314 | ) | ||
Adjustments to reconcile net loss
to net cash (used for) provided by operating
activities: |
||||||||
Depreciation |
813 | 367 | ||||||
Amortization |
1,570 | 875 | ||||||
Loss on disposal of assets |
21 | | ||||||
Goodwill impairment |
26,750 | | ||||||
Stock based compensation |
684 | 1,261 | ||||||
Gain on sale of patent |
| (275 | ) | |||||
Interest on royalty obligation |
122 | | ||||||
Fair value of contingent consideration |
(4,900 | ) | | |||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(2,267 | ) | 1,574 | |||||
Inventory |
1,357 | 393 | ||||||
Prepaid expenses, other current assets and deposits |
75 | (79 | ) | |||||
Accounts payable |
(93 | ) | (255 | ) | ||||
Accrued salaries, warranty and other expenses |
(703 | ) | 499 | |||||
Deferred revenue |
1,384 | 877 | ||||||
Net cash (used for) provided by operating activities |
(9,464 | ) | 1,923 | |||||
Cash flows from investing activities: |
||||||||
Additions to patents, technology and other |
(9 | ) | (28 | ) | ||||
Additions to property and equipment |
(233 | ) | (232 | ) | ||||
Proceeds from sale of patent |
| 275 | ||||||
Cash paid for acquisition of Xoft |
(1,268 | ) | | |||||
Net cash (used for) provided by investing activities |
(1,510 | ) | 15 | |||||
Cash flows from financing activities: |
||||||||
Taxes paid related to restricted stock issuance |
(7 | ) | (70 | ) | ||||
Net cash used for financing activities |
(7 | ) | (70 | ) | ||||
Increase (decrease) in cash and equivalents |
(10,981 | ) | 1,868 | |||||
Cash and equivalents, beginning of period |
16,269 | 16,248 | ||||||
Cash and equivalents, end of period |
$ | 5,288 | $ | 18,116 | ||||
5
The accompanying 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, 2011, the results of operations for the three and nine month periods ended
September 30, 2011 and 2010, and cash flows for the nine month periods ended September 30,
2011 and 2010. 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, 2010 filed with the SEC on March 30, 2011.
The results for the three and nine month periods ended September 30, 2011 are not
necessarily indicative of the results that may be expected for the fiscal year ending
December 31, 2011, or any future period. Interim period amounts are not necessarily
indicative of the results of operations for the full fiscal year. |
Subsequent Events |
We evaluated all subsequent events that occurred after the balance sheet date through
the date and time our financial statements were issued. |
The Company recognizes revenue when the product ships provided title and risk of loss has
passed to the customer, persuasive evidence of an arrangement exists, fees are fixed or
determinable, collectability is probable and there are no uncertainties regarding customer
acceptance. |
The Company recognizes revenue from the sale of certain of its MRI CAD products and services
in accordance with Financial Accounting Standards Board (FASB) Accounting Standards
Codification (ASC) 985-605, (Software, Revenue Recognition) (ASC 985-605). |
6
The Company recognizes revenue from the sale of the digital, film-based CAD and electronic
brachytherapy products and services in accordance with ASU No. 2009-13, Multiple-Deliverable
Revenue Arrangements (ASU 2009-13). In accordance with the guidance of ASU 2009-13, fair
value as the measurement criteria is replaced with the term selling price and establishes a
hierarchy for determining the selling price of a deliverable. ASU 2009-13 also eliminates
the use of the residual value method for determining the allocation of arrangement
consideration. For multi-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 an BESP
for deliverables without VSOE or TPE considers multiple factors including relative selling
prices; however, these may vary depending upon the unique facts and circumstances related to
each deliverable. Sales of the electronic brachytherapy product typically include several
devices, accessories, service and supply. The Company generally allocates revenue to the
deliverables in the arrangement based on the BESP. Revenue is recognized when the product
has been delivered, and service and supply revenue is recognized over the life of the
service and supply agreement. |
For most of iCADs Digital, MRI and film based sales, the responsibility for the
installation process lies with its Original Equipment Manufacturer (OEM) partners, GE
Healthcare, Siemens Medical and others. On occasion, 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. The adoption of ASU 2009-13 did not have a material effect on the financial
condition or results of operations of the Company. |
The Company uses customer purchase orders that include all terms of the arrangement and in
the case of OEM customers are also supported by distribution agreements. 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 reasonably assured 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 revenues are 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 defers revenue from the sale of extended service contracts related to future
periods and recognizes revenue on a straight-line basis in accordance with FASB ASC Topic
605-20, Services. The Company provides for estimated warranty costs on original product
warranties at the time of sale. |
7
The Company also adopted ASC Update No. 2009-14, Certain Arrangements That Contain Software
Elements (Update No. 2009-14). This Update amended the scope of ASC
Subtopic No. 985-605, Revenue Recognition, to exclude tangible products that include
software and non-software components that function together to deliver the products
essential functionality. The adoption of this standard did not have a material effect on
its financial condition or results of operations. |
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. The Company has reclassified on
the statement of operations for the three and nine months ended September 30, 2010, the cost
of product installation, training, customer support and certain warranty repair costs of
approximately $420,000 and $1.3 million, respectively that were previously included in sales
and marketing expenses to cost of revenue to conform to current period classifications. |
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 loss per share is as follows: |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
$ | (24,983 | ) | $ | (1,393 | ) | $ | (34,277 | ) | $ | (3,314 | ) | ||||
Basic shares used in the calculation of net loss per share |
54,681 | 45,922 | 54,533 | 45,782 | ||||||||||||
Effect of dilutive securities: |
||||||||||||||||
Stock options |
| | | | ||||||||||||
Restricted stock |
| | | | ||||||||||||
Diluted shares used in the calculation of net loss per
share |
54,681 | 45,922 | 54,533 | 45,782 | ||||||||||||
Net loss per share basic |
$ | (0.46 | ) | $ | (0.03 | ) | $ | (0.63 | ) | $ | (0.07 | ) | ||||
Net loss per share diluted |
$ | (0.46 | ) | $ | (0.03 | ) | $ | (0.63 | ) | $ | (0.07 | ) | ||||
As of September 30, 2011 and 2010, there were 5.7 million and 6.0 million shares of the
Companys common stock, respectively 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. |
8
On December 30, 2010, the Company completed its acquisition of Xoft, Inc. (Xoft), a
privately held company based in California. Xoft designs, develops, manufactures, markets
and sells electronic brachytherapy (eBx) products for the treatment of breast and other
cancers, used in a broad range of clinical settings. The acquisition was made pursuant to an
Agreement and Plan of Merger dated December 15, 2010, by and between the Company, XAC, Inc.,
a wholly-owned subsidiary of the Company (the Merger Sub), Xoft and Jeffrey Bird as the
representative of the stockholders of Xoft (the Merger Agreement). Upon the terms of the
Merger Agreement, Xoft was merged with and into the Merger Sub with the Merger Sub surviving
the merger (the Merger). |
The Company acquired 100% of the outstanding stock of Xoft in exchange for 8,348,501 shares
of the Companys common stock and approximately $1.2 million in cash, of which approximately
$972,000 was accrued at December 31, 2010 and paid in January 2011, for a total
consideration at closing of approximately $12.9 million based on a per share value of $1.40,
the closing price of the Companys common stock on the closing date. The Company also paid
certain transaction expenses of Xoft totaling approximately $1.0 million which were accrued
as of December 31, 2010 and paid in January 2011. Following completion of the Merger, Xoft
stockholders owned approximately 15.4% of the Companys outstanding common stock. |
Under the Merger Agreement, there is an additional earn-out potential for the sellers that
is tied to cumulative net revenue of Xoft products over the three years following the date
of the Merger, and payable at the end of that period. The threshold for earn-out
consideration begins at $50 million of cumulative revenue of Xoft Products (as defined in
the Merger Agreement) from January 1, 2011 through December 31, 2013. The targeted
earn-out cash consideration of $20.0 million will occur at $76.0 million of cumulative
revenue of Xoft Products and the maximum earn-out consideration of $40.0 million would be
achieved at $104.0 million of cumulative revenue of Xoft Products over the three year
period. |
At closing, 10% of the cash amount and 10% of the amount of the Companys common stock
comprising the merger consideration was placed in escrow. It will remain in escrow for a
period of 15 months following the closing of the Merger to secure post-closing
indemnification obligations of Xoft stockholders. |
The purchase price of $17.8 million, which includes $12.9 million of merger consideration
and $4.9 million of contingent consideration, has been allocated to net assets acquired
based upon the estimated fair value of those assets. As discussed in Note 6, at September
30, 2011 the Company has determined that the fair value of the contingent consideration is
$0.0. The change in fair value of approximately $3.8 million and $4.9 million has been
included in the statement of operations for the three and nine months ended September 30,
2011, respectively. |
9
The following is a summary of the preliminary allocation of the total purchase price based
on the estimated fair values of the assets acquired and liabilities assumed as of the date
of the acquisition and the amortizable lives of the intangible assets: |
Estimated | ||||||||
Amount | Amortizable | |||||||
(000s) | Life | |||||||
Current assets |
$ | 4,030 | ||||||
Property and equipment |
1,951 | 3 7 Years | ||||||
Identifiable intangible assets |
13,700 | 15 Years | ||||||
Patent license |
100 | 6 Years | ||||||
Other assets |
643 | |||||||
Goodwill |
4,142 | |||||||
Current liabilities |
(5,196 | ) | ||||||
Long-term liabilities |
(1,591 | ) | ||||||
Purchase price |
$ | 17,779 | ||||||
The goodwill of $4.1 million is not deductible for income tax purposes. |
The unaudited proforma operating results for the Company for the three and nine months ended
September 30, 2010, assuming the acquisition of Xoft occurred as of January 1, 2010 are as
follows: |
Three months | Nine months | |||||||
ended September | ended September | |||||||
30, 2010 | 30, 2010 | |||||||
(In thousands, except for per share data) | ||||||||
Revenue |
$ | 6,943 | $ | 22,447 | ||||
Loss from operations |
(4,212 | ) | (12,805 | ) | ||||
Net loss |
(4,217 | ) | (12,869 | ) | ||||
Net loss per share: |
||||||||
Basic and Diluted |
$ | (0.08 | ) | $ | (0.24 | ) |
10
The Company follows the guidance in FASB ASC Topic 718, Compensation Stock
Compensation, (ASC 718). The Company issued 864,616 and 2,795,533 stock options in the
three months and nine months ended September 30, 2011, respectively. The Company issued
200,000 and 310,000 shares of restricted stock in the three and nine months ended September
30, 2011, respectively. In the three and nine months ended September 30, 2010, the Company
issued 57,700 and 186,018 stock options, respectively. The Company issued 530,500 shares of
restricted stock in the nine months ended September 30, 2010. The Company did not issue any
shares of restricted stock in the three months ended September 30, 2010. |
In accordance with ASC 718, the Company recorded $100,000 and $684,000 of stock-based
compensation expense for the three months and nine months ended September 30, 2011,
respectively, and $280,000 and $1,261,000 of stock based compensation expense in the three
and nine months ended September 30, 2010, respectively. |
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, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Average risk-free interest rate |
2.21 | % | 1.58 | % | 2.78 | % | 2.14 | % | ||||||||
Expected dividend yield |
None | None | None | None | ||||||||||||
Expected life |
3.5 years | 3.5 years | 3.5 years | 3.5 years | ||||||||||||
Expected volatility |
67.0% to 67.6% | 70.5% to 71.2% | 67.0% to 69.2% | 65.6% to 71.6% | ||||||||||||
Weighted average exercise price |
$ | 0.95 | $ | 1.82 | $ | 1.12 | $ | 1.65 | ||||||||
Weighted average fair value |
$ | 0.47 | $ | 0.79 | $ | 0.56 | $ | 0.69 |
As of September 30, 2011, there was approximately $1,699,000 of total unrecognized
compensation cost related to unvested options and restricted stock. That cost is expected
to be recognized over a weighted average period of 1.35 years. |
The Companys aggregate intrinsic value of options outstanding at September 30, 2011 was
approximately $0. The aggregate intrinsic value of restricted stock outstanding at
September 30, 2011, was approximately $294,000. The Companys aggregate intrinsic value of
options outstanding at September 30, 2010 was approximately $489,000. The aggregate
intrinsic value of restricted stock outstanding at September 30, 2010, was approximately
$1.4 million. |
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, 2011. |
11
Royalty Obligation |
As a result of the acquisition of Xoft, the Company recorded a royalty obligation pursuant
to a settlement agreement entered into between Xoft and Hologic, Inc.(Hologic) in August
2007. Pursuant to the settlement agreement, 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
certain alleged patent violations. In return the Company has a remaining obligation to pay
a minimum annual royalty payment to Hologic of $250,000 annually 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 fair value of the royalty payment
was estimated at $900,000. The additional amount will be recorded as interest expense over
the life of the agreement. During the three and nine months ended September 30, 2011, the
Company recorded approximately $42,000 and
$122,000, respectively, of interest expense related to the liability. The obligation in
excess of one year of approximately $772,000 has been recorded in long term liabilities. In
addition, the Company recorded a purchase price adjustment of $100,000 in the quarter ended
March 31, 2011 to reflect the estimated fair value of the patent license and non-compete
covenant. This asset is being amortized over the estimated useful life of approximately six
years. |
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 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 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. |
12
It is alleged that each plaintiff Jane Doe 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
is the subject of a voluntary recall. Because of the preliminary nature of the complaints,
the Company is unable to evaluate the merits of the claims; however, based upon its
preliminary analysis, it plans to vigorously defend the lawsuits. Accordingly, since the
amount of the potential damages in the event of an adverse result is not
reasonably estimable, no expense or purchase price adjustment has been recorded with respect
to the contingent liability associated with this matter. |
On April 16, 2010, Carl Zeiss Meditec Inc. and Carl Zeiss Surgical GmbH filed suit against
Xoft in the Federal District Court of Delaware asserting infringement of 4 U.S. Patent Nos.
The complaint requests the court to (1) make a declaration, (2) preliminarily and
permanently adjoin Xoft from infringing the named patents, and (3) order the payment of
unspecified damages and attorneys fees in connection with such patent infringement
allegations. The Company intends to vigorously defend the lawsuit and is currently unable
to estimate the potential financial impact this action may have on the Company. Since the
amount of potential damages in the event of an adverse result is not reasonably estimable,
no expense or purchase price adjustment has been recorded with respect to the contingent
liability associated with this matter. In addition, the merger agreement provides for
indemnity for certain losses relating to the Zeiss litigation, subject to limitations
specified in the merger agreement. |
In addition to the matters discussed above, the Company is, from time to time, party to
legal proceedings, lawsuits and other claims incident to the Companys business activities.
Such matters may include, among other things, assertions of contract breach or intellectual
property infringement and claims for indemnity arising in the course of business. Such
matters are subject to many uncertainties and outcomes are not predictable. The Company is
unable to estimate the ultimate aggregate amount of monetary liability, amounts which may be
covered by insurance or recoverable from third parties, or the financial impact with respect
to these matters as of the date of this report. |
13
The Company has adopted FASB 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. 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 Companys liabilities that are measured at fair value on a recurring basis relate to its
contingent consideration resulting from the acquisition of Xoft
completed on December 30, 2010. The fair value measurements for
this liability are
valued using Level 3 inputs. The Company recorded a contingent consideration liability of
$5.0 million based upon the estimated fair value of the additional earn-out potential for
the sellers that is tied to cumulative net revenue of Xoft products from January 1, 2011
through December 31, 2013, payable January, 2014. During the quarter ended March 31, 2011,
the Company recorded a measurement period adjustment of $100,000 and reduced the value of
the contingent consideration to $4.9 million. The Company determines the fair value of the
contingent consideration liability based on a probability-weighted approach derived from
earn-out criteria estimates and a probability assessment with respect to the likelihood of
achieving the various earnout criteria. Accordingly, the value of contingent consideration
is evaluated each quarter. During the quarter ended June 30, 2011, the Company reduced the
value of contingent consideration to $3.8 million as a result of lower expectations of Xoft
product revenue. In the quarter ended September 30, 2011, the Company evaluated the revenue
expectations of Xoft products and determined that the thresholds were unlikely to be met,
and therefore reduced the value of contingent consideration to $0.0. The measurement is
based upon significant inputs not observable in the market. Subsequent changes in the value
of this liability will be recorded in the statement of operations. |
14
The following table sets forth Companys liabilities which are measured at fair value on a
recurring basis by level within the fair value hierarchy. |
Liabilities | ||||||||||||||||
at Fair | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Value | |||||||||||||
Contingent
consideration |
| | $ | 5,000 | $ | 5,000 | ||||||||||
Total |
| | $ | 5,000 | $ | 5,000 | ||||||||||
Liabilities | ||||||||||||||||
at Fair | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Value | |||||||||||||
Contingent consideration |
| | $ | | $ | | ||||||||||
Total |
| | $ | | $ | | ||||||||||
The changes in the fair value of contingent consideration during the period are as
follows: |
Nine months ended September 30, | ||||
Balance as of December 31, 2010 |
$ | 5,000 | ||
Measurement period adjustment |
(100 | ) | ||
Mark to market |
(4,900 | ) | ||
Balance as of September 30, 2011 |
$ | 0 | ||
As noted above the Company recorded an additional $3.8 million reduction in the fair
value of the contingent consideration as a gain in the statement of operations during the
quarter ended September 30, 2011. |
15
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. As noted in
Note 8 we recorded an estimated impairment charge for goodwill of $26.8 million during the
three months ended September 30, 2011. We did not consider any other assets to be impaired
during the three and nine months ended September 30, 2011. |
At September 30, 2011, 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, 2011. The Company files United States federal
income tax returns and income tax returns in various states and local jurisdictions.
Generally, the Companys three preceding tax years remain subject to examination by federal
and state taxing authorities. The Company completed an examination by the Internal Revenue
Service with respect to the 2008 tax year in January 2011, which resulted in no changes to
the tax return originally filed. The Company is not under examination by any other federal
or state jurisdiction for any tax years. |
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 its carrying value. Events that would indicate impairment and
trigger an interim impairment assessment include, but are not limited to, current economic
and market conditions, changes in its results of operations and changes in its forecasts or
market expectation relating to future results. |
The Companys goodwill arose in connection with its acquisitions in June 2002, December 2003
and December 2010. The Company operates in one segment and one reporting unit since
operations are supported by one central staff and the results of operations are evaluated as
one business unit. In general the Companys medical device products are similar in nature
based on production, distribution, services provided and regulatory requirements. The
Company uses market capitalization as the best evidence of fair value (market capitalization
is calculated using the quoted closing share price of the Companys common stock at its
annual impairment testing date of October 1, multiplied by the number of common shares
outstanding) of the Company. The Company tests goodwill for impairment by comparing its
market capitalization (fair value) to its carrying value. The fair value of the Company is
compared to the carrying amount at the same date as the basis to determine if a potential
impairment exists. |
16
We assess the potential impairment of goodwill whenever events or changes in circumstances
indicate that the carrying value may not be recoverable and at least annually. Factors we
consider 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 decline in our market capitalization below net book value. |
During the quarter ended September 30, 2011, as a result of the sustained decline in the
market capitalization of the Company, an interim Step 1 analysis was completed. The interim
Step 1 test resulted in the determination that the carrying value of equity exceeded the
fair value of equity, thus requiring the Company to measure the amount of any goodwill
impairment by performing the second step of the impairment test. The Company corroborated
the Step 1 analysis using an income approach. |
The second step (defined as Step 2) of the goodwill impairment test, used to measure the
amount of impairment loss, compares the implied fair value of reporting unit goodwill with
the carrying amount of that goodwill. The guidance in FASB ASC 350 Intangibles
Goodwill and Other (which includes what was originally issued as SFAS 142, Goodwill and
Other Intangible Assets) was used to estimate the implied fair value of goodwill. The
guidance provides that If the carrying amount of the Companys goodwill exceeds the implied
fair value of that goodwill, an impairment loss shall be recognized in an amount equal to
that excess. The loss recognized cannot exceed the carrying amount of goodwill. After a
goodwill impairment loss is recognized, the adjusted carrying amount of goodwill shall be
its new accounting basis. |
The implied fair value of goodwill was determined in the same manner as the amount of
goodwill recognized in a business combination is determined. The excess of the fair value of
the single reporting unit over the amounts assigned to its assets and liabilities is the
implied amount of goodwill. The Company identified several intangible assets that were
valued during this process, including technology, customer relationships, trade names,
non-compete agreements, and the Companys workforce. The allocation process was performed
only for purposes of goodwill impairment. |
17
The Company determined the value of the select assets utilizing the income approach. This
approach was selected as it measures the income producing assets, primarily technology and
customer relationships. This method estimates the fair value based upon the ability to
generate future cash flows, which is particularly applicable when future profit margins and
growth are expected to vary significantly from historical operating results. |
Other significant assumptions include terminal value margin rates, future capital
expenditures, and changes in future working capital requirements. The Company also compared
and reconciled the overall fair value to the Companys market capitalization. While there
are inherent uncertainties related to the assumptions used and to the application of these
assumptions to this analysis, the income approach provides a reasonable estimate of the fair
value of the Companys single reporting unit. |
The Step 2 test resulted in determining the fair value of goodwill of $20,907 which resulted
in an impairment loss of $26,750. |
The changes in the carrying amount of goodwill for the nine months ended September 30, 2011,
are as follows: |
Nine months ended September 30, 2011 | ||||
Balance as of December 31, 2010 |
$ | 45,689 | ||
Purchase accounting adjustments |
1,968 | |||
Impairment |
(26,750 | ) | ||
Balance as of September 30, 2011 |
$ | 20,907 | ||
Purchase accounting adjustments, considered to be measurement period adjustments, were
recorded in the six months ended June 30, 2011 and consisted primarily of a $1.5 million
decrease of the acquired patent asset, a decrease of $500,000 in the acquired technology
asset, a decrease in the fair value estimate of the royalty obligation of $200,000 and a
decrease of $100,000 related to contingent consideration and an increase of approximately
$300,000 related to unrecorded liabilities. We did not record any measurement period
adjustments during the quarter ended September 30, 2011. The measurement period adjustments
had no effect on the Companys operations and results and had an immaterial effect on the
December 31, 2010 balance sheet. Accordingly, the adjustments were recorded during
the six months ended June 30, 2011. |
In May 2011, the FASB issued Accounting Standards Update No. 2011-04, Amendments to Achieve
Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International
Financial Reporting Standards (Topic 820)Fair Value Measurement (ASU 2011-04), to provide
a consistent definition of fair value and ensure that the fair value measurement and
disclosure requirements are similar between U.S. GAAP and International Financial Reporting
Standards. ASU 2011-04 changes certain fair value measurement principles and enhances the
disclosure requirements particularly for level 3 fair value measurements. ASU 2011-04 is
effective for fiscal years and interim periods within those years, beginning after December
15, 2011. The Company does not expect the adoption to have a material impact on its
financial statements. |
18
In June 2011, the FASB issued ASU 2011-05, Comprehensive Income (Topic 220): Presentation of
Comprehensive Income (ASU 2011-05). ASU 2011-05 increases the prominence of other
comprehensive income in financial statements. Under ASU 2011-05, companies will have the
option to present the components of net income and comprehensive income in either one or two
consecutive financial statements. ASU 2011-05 eliminates the option to present other
comprehensive income in the statement of changes in equity and is applied retrospectively.
For public companies, ASU 2011-05 is effective for fiscal years, and interim periods within
those years, beginning after December 15, 2011. The Company does not expect the adoption to
have a material impact on its financial statements. |
In September 2011, the FASB issued Accounting Standards Update No. 2011-08,
IntangiblesGoodwill and Other (Topic 350)Testing Goodwill for Impairment (ASU 2011-08),
to allow entities to use a qualitative approach to test goodwill for impairment. ASU 2011-08
permits an entity to first perform a qualitative assessment to determine whether it is more
likely than not that the fair value of a reporting unit is less than its carrying value. If
it is concluded that this is the case, it is necessary to perform the currently prescribed
two-step goodwill impairment test. Otherwise, the two-step goodwill impairment test is not
required. ASU 2011-08 is effective for fiscal years beginning after December 15, 2011,
however early adoption is permitted. The Company does not expect this to have a material
impact on its financial statements. |
19
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
20
21
22
Three months ended September 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Digital & MRI revenue |
$ | 3,791 | $ | 3,311 | $ | 480 | 14.5 | % | ||||||||
Film based revenue |
616 | 748 | (132 | ) | (17.7 | )% | ||||||||||
Electronic brachytherapy |
1,347 | | 1,347 | | ||||||||||||
Service & supply revenue |
2,298 | 1,527 | 771 | 50.5 | % | |||||||||||
Total revenue |
$ | 8,052 | $ | 5,586 | $ | 2,466 | 44.1 | % | ||||||||
23
Nine months ended September 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Digital & MRI revenue |
$ | 10,751 | $ | 11,468 | $ | (717 | ) | (6.2 | )% | |||||||
Film based revenue |
1,670 | 2,519 | (849 | ) | (33.7 | )% | ||||||||||
Electronic brachytherapy |
3,042 | | 3,042 | | ||||||||||||
Service & supply revenue |
6,579 | 4,217 | 2,362 | 56.0 | % | |||||||||||
Total revenue |
$ | 22,042 | $ | 18,204 | $ | 3,838 | 21.1 | % | ||||||||
24
Three months ended Sept 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Products |
$ | 1,280 | $ | 545 | $ | 735 | 134.9 | % | ||||||||
Service & supply |
650 | 586 | 64 | 10.9 | % | |||||||||||
Amortization of acquired technology |
233 | | 233 | 100.0 | % | |||||||||||
Total cost of revenue |
$ | 2,163 | $ | 1,131 | $ | 1,032 | 91.2 | % | ||||||||
Gross Margin |
$ | 5,889 | $ | 4,455 | $ | 1,434 | 32.2 | % |
Nine months ended Sept 30, | ||||||||||||||||
2011 | 2010 | Change | % Change | |||||||||||||
Products |
$ | 3,627 | $ | 1,770 | $ | 1,857 | 104.9 | % | ||||||||
Service & supply |
2,191 | 1,791 | 400 | 22.3 | % | |||||||||||
Amortization of acquired technology |
700 | | 700 | 100.0 | % | |||||||||||
Total cost of revenue |
$ | 6,518 | $ | 3,561 | $ | 2,957 | 83.0 | % | ||||||||
Gross Margin |
$ | 15,524 | $ | 14,643 | $ | 881 | 6.0 | % |
25
Three months ended Sept 30, | Nine months ended Sept 30, | |||||||||||||||||||||||||||||||
Operating expenses: | 2011 | 2010 | Change | Change % | 2011 | 2010 | Change | Change % | ||||||||||||||||||||||||
Engineering and product development |
$ | 2,630 | $ | 1,715 | $ | 915 | 53 | % | $ | 8,709 | $ | 4,796 | $ | 3,913 | 82 | % | ||||||||||||||||
Marketing and sales |
3,108 | 2,347 | 761 | 32 | % | 10,780 | 7,363 | 3,417 | 46 | % | ||||||||||||||||||||||
General and administrative |
2,147 | 1,805 | 342 | 19 | % | 8,363 | 6,131 | 2,232 | 36 | % | ||||||||||||||||||||||
Contingent Consideration |
(3,800 | ) | | (3,800 | ) | 100 | % | (4,900 | ) | | (4,900 | ) | 100 | % | ||||||||||||||||||
Impairment |
26,750 | | 26,750 | 100 | % | 26,750 | | 26,750 | 100 | % | ||||||||||||||||||||||
Total operating expenses |
$ | 30,835 | $ | 5,867 | $ | 24,968 | 426 | % | $ | 49,702 | $ | 18,290 | $ | 31,412 | 172 | % | ||||||||||||||||
26
27
Payments due by period | ||||||||||||||||||||
Less than 1 | ||||||||||||||||||||
Contractual Obligations | Total | year | 1-3 years | 3-5 years | 5+ years | |||||||||||||||
Lease Obligations |
$ | 1,247 | $ | 782 | $ | 465 | $ | | $ | | ||||||||||
Royalty Obligation |
$ | 1,491 | $ | 241 | $ | 750 | $ | 500 | $ | | ||||||||||
Other
Commitments |
$ | 400 | $ | 400 | $ | | $ | | $ | | ||||||||||
Total Contractual Obligations |
$ | 3,138 | $ | 1,423 | $ | 1,215 | $ | 500 | $ | | ||||||||||
28
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Item 4. | Controls and Procedures |
29
Item 1. | Legal Proceedings |
30
Item 1A. | Risk Factors |
31
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
Total number of | Maximum dollar | |||||||||||||||
shares purchased | value of shares | |||||||||||||||
as part of | that may yet be | |||||||||||||||
Total number | Average | publicly | purchaed under | |||||||||||||
of shares | price paid per | announced plans | the plans or | |||||||||||||
Month of purchase | purchased (1) | share | or programs | programs | ||||||||||||
July 1 July 31, 2011 |
| $ | | $ | | $ | | |||||||||
August 1 August 31, 2011 |
1,312 | $ | 0.76 | $ | | $ | | |||||||||
September 1 September 30, 2011 |
441 | $ | 0.65 | $ | | $ | | |||||||||
Total |
1,753 | $ | 0.73 | $ | | $ | | |||||||||
(1) | Represents shares of common stock surrendered by employees to the Company
to pay employee withholding taxes due upon the vesting of restricted stock. |
Item 6. | Exhibits |
Exhibit No. | 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, 2011 and December 31, 2010, (ii) Consolidated
Statements of Operations for the three and nine months ended September 30, 2011 and 2010,
(iii) Consolidated Statements of Cash Flows for the three and nine months ended September 30,
2011 and 2010, and (iv) Notes to Consolidated Financial Statements**. |
** | Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are
deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or
12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under
those sections. |
32
iCAD, Inc. | ||||
(Registrant) |
||||
Date: November 10, 2011 | By: | /s/ Kenneth M. Ferry | ||
Kenneth M. Ferry | ||||
President, Chief Executive Officer, Director | ||||
Date: November 10, 2011 | By: | /s/ Kevin C. Burns | ||
Kevin C. Burns | ||||
Executive Vice President of Finance and Chief Financial Officer, Treasurer |
33