Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended March 31, 2010
or
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Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transitional period from to
Commission file number: 0-29100
eResearchTechnology, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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22-3264604 |
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(State or other jurisdiction of incorporation
or organization)
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(I.R.S. Employer Identification No.) |
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1818 Market Street
Philadelphia, PA
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19103 |
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(Address of principal executive offices)
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(Zip code) |
215-972-0420
(Registrants telephone number, including area code)
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 requirements for the past 90 days. Yes þ No o
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 o No o
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.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date.
The number of shares of Common Stock, $.01 par value, outstanding as of April 23, 2010, was
48,801,401.
eResearchTechnology, Inc. and Subsidiaries
INDEX
2
Part 1. Financial Information
Item 1. Financial Statements
eResearchTechnology, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(unaudited)
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December 31, 2009 |
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March 31, 2010 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
68,979 |
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$ |
72,175 |
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Short-term investments |
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9,782 |
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7,065 |
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Investment in marketable securities |
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1,026 |
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1,317 |
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Accounts receivable, less allowance for doubtful accounts of
$548 and $510, respectively |
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16,579 |
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15,309 |
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Prepaid income taxes |
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2,698 |
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2,563 |
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Prepaid expenses and other |
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3,308 |
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4,569 |
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Deferred income taxes |
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1,649 |
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1,547 |
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Total current assets |
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104,021 |
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104,545 |
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Property and equipment, net |
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24,205 |
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25,096 |
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Goodwill |
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34,676 |
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34,711 |
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Intangible assets |
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1,607 |
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1,493 |
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Other assets |
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352 |
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353 |
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Total assets |
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$ |
164,861 |
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$ |
166,198 |
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Liabilities and Stockholders Equity |
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Current Liabilities: |
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Accounts payable |
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$ |
3,007 |
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$ |
3,085 |
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Accrued expenses |
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5,990 |
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6,803 |
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Income taxes payable |
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346 |
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Deferred revenues |
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11,728 |
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11,167 |
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Total current liabilities |
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21,071 |
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21,055 |
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Deferred rent |
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2,357 |
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2,299 |
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Deferred income taxes |
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2,502 |
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2,387 |
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Other liabilities |
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1,259 |
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1,138 |
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Total liabilities |
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27,189 |
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26,879 |
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Commitments and contingencies |
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Stockholders Equity: |
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Preferred stock $10.00 par value, 500,000 shares authorized,
none issued and outstanding |
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Common stock $.01 par value, 175,000,000 shares authorized,
60,189,235 and 60,380,142 shares issued, respectively |
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602 |
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604 |
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Additional paid-in capital |
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97,367 |
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98,048 |
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Accumulated other comprehensive loss |
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(1,580 |
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(2,368 |
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Retained earnings |
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121,166 |
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122,918 |
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Treasury stock, 11,589,603 shares at cost |
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(79,883 |
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(79,883 |
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Total stockholders equity |
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137,672 |
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139,319 |
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Total liabilities and stockholders equity |
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$ |
164,861 |
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$ |
166,198 |
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The accompanying notes are an integral part of these statements.
3
eResearchTechnology, Inc. and Subsidiaries
Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
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Three Months Ended March 31, |
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2009 |
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2010 |
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Net revenues: |
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Services |
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$ |
16,108 |
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$ |
14,835 |
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Site support |
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6,260 |
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7,033 |
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EDC licenses and services |
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1,418 |
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Total net revenues |
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23,786 |
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21,868 |
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Costs of revenues: |
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Cost of services |
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7,693 |
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7,311 |
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Cost of site support |
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3,635 |
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2,799 |
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Cost of EDC licenses and services |
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466 |
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Total costs of revenues |
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11,794 |
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10,110 |
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Gross margin |
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11,992 |
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11,758 |
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Operating expenses: |
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Selling and marketing |
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3,426 |
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3,408 |
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General and administrative |
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4,077 |
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4,745 |
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Research and development |
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1,149 |
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858 |
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Total operating expenses |
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8,652 |
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9,011 |
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Operating income |
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3,340 |
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2,747 |
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Other income, net |
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116 |
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100 |
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Income before income taxes |
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3,456 |
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2,847 |
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Income tax provision |
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1,386 |
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1,095 |
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Net income |
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$ |
2,070 |
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$ |
1,752 |
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Net income per share: |
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Basic |
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$ |
0.04 |
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$ |
0.04 |
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Diluted |
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$ |
0.04 |
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$ |
0.04 |
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Shares used in computing net income per share: |
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Basic |
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50,879 |
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48,675 |
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Diluted |
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51,164 |
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48,845 |
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The accompanying notes are an integral part of these statements.
4
eResearchTechnology, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(In thousands)
(unaudited)
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Three Months Ended March 31, |
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2009 |
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2010 |
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Operating activities: |
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Net income |
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$ |
2,070 |
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$ |
1,752 |
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Adjustments
to reconcile net income to net cash provided by operating activities: |
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Depreciation and amortization |
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3,404 |
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2,624 |
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Cost of sales of equipment |
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7 |
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1 |
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Provision for uncollectible accounts |
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105 |
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Share-based compensation |
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901 |
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605 |
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Deferred income taxes |
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111 |
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(160 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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7,331 |
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1,033 |
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Prepaid expenses and other |
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(459 |
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(1,341 |
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Accounts payable |
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143 |
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539 |
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Accrued expenses |
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(2,194 |
) |
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920 |
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Income taxes |
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(1,601 |
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(193 |
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Deferred revenues |
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(858 |
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(368 |
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Deferred rent |
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107 |
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(145 |
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Net cash provided by operating activities |
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9,067 |
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5,267 |
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Investing activities: |
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Purchases of property and equipment |
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(1,613 |
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(3,852 |
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Purchases of investments |
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(999 |
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Proceeds from sales of investments |
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3,716 |
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Payments for acquisition |
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(203 |
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Net cash used in investing activities |
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(1,613 |
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(1,338 |
) |
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Financing activities: |
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Repayment of capital lease obligations |
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(43 |
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Proceeds from exercise of stock options |
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59 |
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51 |
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Stock option income tax benefit |
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38 |
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6 |
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Repurchase of common stock for treasury |
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(8,190 |
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Net cash (used in) provided by financing
activities |
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(8,136 |
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57 |
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Effect of exchange rate changes on cash |
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(176 |
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(790 |
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Net (decrease) increase in cash and cash equivalents |
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(858 |
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3,196 |
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Cash and cash equivalents, beginning of period |
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66,376 |
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68,979 |
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Cash and cash equivalents, end of period |
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$ |
65,518 |
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$ |
72,175 |
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The accompanying notes are an integral part of these statements.
5
eResearchTechnology, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
(unaudited)
Note 1. Basis of Presentation
The accompanying unaudited consolidated financial statements, which include the accounts of
eResearchTechnology, Inc. (the Company, ERT or we) and its wholly-owned subsidiaries, have
been prepared in accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring adjustments) considered necessary for a fair presentation have been
included. Operating results for the three-month period ended March 31, 2010 are not necessarily
indicative of the results that may be expected for the year ending December 31, 2010. Further
information on potential factors that could affect our financial results can be found in our Report
on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission
(SEC) and in this Form 10-Q. Subsequent events have been evaluated for disclosure and recognition.
Recent Developments
On April 29, 2010, we announced an acquisition see Note 14.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of ERT and its
wholly-owned subsidiaries. All significant intercompany accounts and transactions have been
eliminated. We consider our business to consist of one segment as this represents managements
view of our operations.
Reclassifications
The consolidated financial statements for prior periods have been reclassified to conform to
the current periods presentation. In particular, the revenue and cost of revenue of our former
EDC operations, which we sold on June 23, 2009 (see Note 6), have been reclassified from the
licenses and services categories to the EDC category on the consolidated statements of operations
for all periods presented. Additionally, the remaining revenues and costs of sales in licenses,
related to cardiac safety reporting and electronic patient reported outcomes (ePRO), were
reclassified to the services category on the consolidated statements of operations for all periods
presented.
Use of Estimates
The preparation of financial statements in accordance with accounting principles generally
accepted in the United States requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported revenues and expenses during the reporting
period. Actual results could differ from those estimates.
Revenue Recognition
Our services revenues consist primarily of our services offered under our Cardiac Safety and,
to a lesser extent, ePRO solutions. Our site support revenue consists of cardiac safety equipment
rentals and sales along with related supplies and logistics management.
Services revenues consist of Cardiac Safety and ePRO services that we provide on a fee for
services basis and are recognized as the services are performed. We also provide Cardiac Safety
consulting services on a time and materials basis and recognize revenues as we perform the
services. Site support revenues are recognized at the time of sale or over the rental period.
At the time of each transaction, management assesses whether the fee associated with the
transaction is fixed or determinable and whether or not collection is reasonably assured. The
assessment of whether the fee is fixed or determinable is based upon the payment terms of the
transaction. If a significant portion of a fee is due after our normal payment terms or upon
implementation or client acceptance, the fee is accounted for as not being fixed or determinable
and revenue is recognized as the fees become due or after implementation or client acceptance has
occurred.
Collectability is assessed based on a number of factors, including past transaction history
with the client and the creditworthiness of the client. If it is determined that collection of a
fee is not reasonably assured, the fee is deferred and revenue is recognized at the time collection
becomes reasonably assured, which is generally upon receipt of cash. Under a typical contract for
Cardiac Safety services,
clients pay us a portion of our fee for these services upon contract execution as an upfront
deposit, some of which is typically nonrefundable upon contract termination. Revenues are then
recognized under Cardiac Safety service contracts as the services are performed.
6
For arrangements with multiple deliverables where the fair value of each element is known, the
revenue is allocated to each component based on the relative fair value of each element. For
arrangements with multiple deliverables where the fair value of one or more delivered elements is
not known, revenue is allocated to each component of the arrangement using the residual method
provided that the fair value of all undelivered elements is known. Fair values for undelivered
elements are based primarily upon stated renewal rates for future products or services.
We have recorded reimbursements received for out-of-pocket expenses incurred as revenue in the
accompanying consolidated statements of operations.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer
pursuant to contractual terms. In general, such amounts become billable in accordance with
predetermined payment schedules, but recognized as revenue as services are performed. Amounts
included in unbilled revenue are expected to be collected within one year and are included within
current assets.
Our former electronic data capture (EDC) operations are included in EDC licenses and services
revenue and include license revenue, technology consulting and training services and software
maintenance services. We recognized up-front license fee revenues under the residual method when a
formal agreement existed, delivery of the software and related documentation occurred,
collectability was probable and the license fee was fixed or determinable. We recognized monthly
and annual term license fee revenues over the term of the arrangement. Hosting service fees were
recognized evenly over the term of the service. We recognized revenues from software maintenance
contracts on a straight-line basis over the term of the maintenance contract, which was typically
twelve months. We provided consulting and training services on a time and materials basis and
recognized revenues as we performed the services.
Concentration of Credit Risk and Significant Clients
Our business depends entirely on the clinical trials that pharmaceutical, biotechnology and
medical device companies conduct. Our revenues and profitability will decline if there is less
competition in the pharmaceutical, biotechnology or medical device industries, which could result
in fewer products under development and decreased pressure to accelerate a product approval. Our
revenues and profitability will also decline if the FDA or similar agencies in foreign countries
modify their requirements in a manner that decreases the need for our solutions.
Financial instruments that potentially subject us to concentration of credit risk consist
primarily of trade accounts receivable from companies operating in the pharmaceutical,
biotechnology and medical device industries. For the three months ended March 31, 2009 and 2010,
one client accounted for approximately 16% and 19% of net revenues, respectively. The loss of this
client could have a material adverse effect on our operations. We maintain reserves for potential
credit losses. Such losses, in the aggregate, have not historically exceeded managements
estimates.
Cash and Cash Equivalents
We consider cash on deposit and in overnight investments and investments in money market funds
with financial institutions to be cash equivalents. At the balance sheet dates, cash equivalents
consisted primarily of investments in money market funds. At December 31, 2009 and March 31, 2010,
approximately $13.9 million and $14.7 million, respectively, was held by our UK subsidiary.
Short-term Investments and Investments in Marketable Securities
At March 31, 2010, short-term investments consisted of investments in municipal securities,
bonds of government sponsored agencies, certificates of deposit with fixed rates and maturities of
less than one year, A1P1 rated commercial bonds and paper and an auction rate security issued by a
government-sponsored agency while marketable securities consisted of common stock received from the
buyer of certain assets of our EDC operations. Available-for-sale securities are carried at fair
value, based on quoted market prices, with unrealized gains and losses reported as a separate
component of stockholders equity. We classified our short-term investments and investment in
marketable securities at December 31, 2009 and March 31, 2010 as available-for-sale. At December
31, 2009 and March 31, 2010, unrealized gains and losses were immaterial. Realized gains and losses
during the three months ended March 31, 2009 and 2010 were immaterial. For purposes of determining
realized gains and losses, the cost of the securities sold is based upon specific identification.
7
The following summarizes the short-term investments at December 31, 2009 and March 31, 2010
(in thousands):
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December 31, 2009 |
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Gross |
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Gross |
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Unrealized |
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Unrealized |
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Amortized cost |
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Gains |
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Losses |
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Fair Value |
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Municipal securities |
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$ |
6,764 |
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$ |
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$ |
(2 |
) |
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$ |
6,762 |
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Corporate debt securities |
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1,769 |
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1 |
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1,770 |
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Bonds of government sponsored agencies |
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1,250 |
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1,250 |
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Total short-term investments as of
December 31, 2009 |
|
$ |
9,783 |
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|
$ |
1 |
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|
$ |
(2 |
) |
|
$ |
9,782 |
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|
|
March 31, 2010 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
Amortized cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Municipal securities |
|
$ |
6,062 |
|
|
$ |
|
|
|
$ |
(4 |
) |
|
$ |
6,058 |
|
Corporate debt securities |
|
|
1,009 |
|
|
|
|
|
|
|
(2 |
) |
|
|
1,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments as of March 31, 2010 |
|
$ |
7,071 |
|
|
$ |
|
|
|
$ |
(6 |
) |
|
$ |
7,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment are stated at cost. Depreciation is provided using the straight-line
method over the estimated useful lives of three years for computer and other equipment, two to four
years for cardiac safety rental equipment, five years for furniture and fixtures and three to five
years for system development costs. Leasehold improvements are amortized using the straight-line
method over the shorter of the estimated useful life of the asset or the remaining lease term.
Repair and maintenance costs are expensed as incurred. Improvements and betterments are
capitalized. Depreciation expense was $2.4 million and $1.6 million for the three months ended
March 31, 2009 and 2010, respectively.
We capitalize costs associated with internally developed and/or purchased software systems for
new products and enhancements to existing products that have reached the application development
stage and meet recoverability tests. These costs are included in property and equipment.
Capitalized costs include external direct costs of materials and services utilized in developing or
obtaining internal-use software, and payroll and payroll-related expenses for employees who are
directly associated with and devote time to the internal-use software project.
Amortization of capitalized software development costs is charged to costs of revenues.
Amortization of capitalized software development costs was $0.9 million for each of the three-month
periods ended March 31, 2009 and 2010. For the three-month periods ended March 31, 2009 and 2010,
we capitalized $0.5 million and $1.2 million, respectively, of software development costs primarily
related to EXPERT, ePRO and other internal-use software development. As of March 31, 2010, $3.6
million of capitalized costs have not yet been placed in service and are therefore not being
amortized.
The largest component of property and equipment is cardiac safety equipment. Our clients use
the cardiac safety equipment to perform the ECG and Holter recordings, and it also provides the
means to send such recordings to ERT. We provide this equipment to clients primarily through
rentals via cancellable agreements and, in some cases, through non-recourse equipment sales. The
equipment rentals and sales are included in, or associated with, our Cardiac Safety services
agreements with our clients and the decision to rent or buy equipment is made by our clients prior
to the start of the cardiac safety study. The decision to buy rather than rent is usually
predicated upon the economics to the client based upon the length of the study and the number of
ECGs to be performed each month. The longer the study and the fewer the number of ECGs performed,
the more likely it is that the client may request to purchase cardiac safety equipment rather than
rent. Regardless of whether the client rents or buys the cardiac safety equipment, we consider the
resulting cash flow to be part of our operations and reflect it as such in our consolidated
statements of cash flows.
Our Cardiac Safety services agreements contain multiple elements. As a result, significant
contract interpretation is sometimes required to determine the appropriate accounting. In doing
so, we consider factors such as whether the deliverables specified in a multiple element
arrangement should be treated as separate units of accounting for revenue recognition purposes and,
if so, how the contract value should be allocated among the deliverable elements and when to
recognize revenue for each element. We recognize revenue for delivered elements only when the fair
values of undelivered elements are known, uncertainties regarding client acceptance are resolved
and there
are no client-negotiated refund or return rights affecting the revenue recognized for
delivered elements.
The gross cost for cardiac safety equipment was $37.3 million and $38.0 million at December
31, 2009 and March 31, 2010, respectively. The accumulated depreciation for cardiac safety
equipment was $30.9 million at December 31, 2009 and March 31, 2010.
8
Goodwill
The carrying value of goodwill was $34.7 million as of December 31, 2009 and March 31, 2010.
During the first three months of 2010, goodwill increased less than $0.1 million due to contingent
payments related to the CCSS acquisition. Contingent payments of less than $0.1 million are
included in accrued expenses at March 31, 2010. See Note 4 for additional disclosure regarding the
CCSS acquisition. Goodwill is not amortized but is subject to an impairment test at least
annually. We perform the impairment test annually as of December 31 or more frequently if events
or circumstances indicate that the value of goodwill might be impaired. No provisions for goodwill
impairment were recorded during 2009 or during the three months ended March 31, 2010.
When it is determined that the carrying value of goodwill may not be recoverable, measurement
of any impairment will be based on a projected discounted cash flow method using a discount rate
commensurate with the risk inherent in the current business model.
Long-lived Assets
When events or circumstances so indicate, we assess the potential impairment of our long-lived
assets based on anticipated undiscounted cash flows from the assets. Such events and circumstances
include a sale of all or a significant part of the operations associated with the long-lived asset,
or a significant decline in the operating performance of the asset. If an impairment is indicated,
the amount of the impairment charge would be calculated by comparing the anticipated discounted
future cash flows to the carrying value of the long-lived asset. No impairment was indicated
during either of the three-month periods ended March 31, 2009 or March 31, 2010.
Software Development Costs
Research and development expenditures related to software development are charged to
operations as incurred. We capitalize certain software development costs subsequent to the
establishment of technological feasibility. Because software development costs have not been
significant after the establishment of technological feasibility, all such costs have been charged
to expense as incurred.
Stock-Based Compensation
Accounting for Stock-Based Compensation
Share-based compensation expense is measured at the grant date based on the fair value of the
award and is recognized as expense over the vesting period. The aggregate share-based compensation
expense recorded in the Consolidated Statements of Operations for the three months ended March 31,
2009 and March 31, 2010 was $0.9 million and $0.6 million, respectively.
Valuation Assumptions for Options Granted
The fair value of each stock option granted during the three months ended March 31, 2009 and
2010 was estimated at the date of grant using Black-Scholes, assuming no dividends and using the
weighted-average valuation assumptions noted in the following table.
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2010 |
|
Risk-free interest rate |
|
|
1.33 |
% |
|
|
2.42 |
% |
Expected life |
|
3.5 years |
|
|
3.8 years |
|
Expected volatility |
|
|
63.97 |
% |
|
|
61.85 |
% |
The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The expected life (estimated period of time outstanding) of the stock options granted was estimated
using the historical exercise behavior of employees. Expected volatility was based on historical
volatility for a period equal to the stock options expected life, calculated on a daily basis.
Fluctuations in the market that affect these estimates could have an impact on the resulting
compensation cost. The above assumptions were used to determine the weighted-average per share
fair value of $2.13 and $2.89 for stock options granted during the first three months of 2009 and
2010, respectively.
Equity Incentive Plans
In 1996, we adopted a stock option plan (the 1996 Plan) that authorized the grant of both
incentive and non-qualified options to acquire up to 9,450,000 shares of the Companys common
stock, as subsequently amended. Our Board of Directors determined the exercise price of the
options under the 1996 Plan. The exercise price of incentive stock options was not below the
market value of the common stock on the grant date. Incentive stock options under the 1996 Plan
expire ten years from the grant date and are exercisable in accordance with vesting provisions set
by the Board, which generally are over three to five years. No additional options have been
granted under this plan, as amended, since December 31, 2003 and no additional options may be
granted thereunder in accordance with the terms of the 1996 Plan.
9
In May 2003, the stockholders approved a new stock option plan (the 2003 Plan) that
authorized the grant of both incentive and non-qualified options to acquire shares of our common
stock and provided for an annual option grant of 10,000 shares to each outside director. The
Compensation Committee of our Board of Directors determines or makes recommendations to our Board
of Directors regarding the recipients of option grants, the exercise price and other terms of the
options under the 2003 Plan. The exercise price of incentive stock options may not be set below
the market value of the common stock on the grant date. Incentive stock options under the 2003
Plan expire ten years from the grant date, or at the end of such shorter period as may be
designated by the Compensation Committee, and are exercisable in accordance with vesting provisions
set by the Compensation Committee, which generally are over four years. In accordance with the
terms of the 2003 Plan, there are a total of 7,318,625 shares reserved for issuance under the 2003
Plan and there were 1,462,853 shares available for grant as of March 31, 2010.
On April 26, 2007, the stockholders approved the adoption of the Companys Amended and
Restated 2003 Equity Incentive Plan (the 2003 Equity Plan) which included prohibition on
repricing of any stock options granted under the Plan unless the stockholders approve such
repricing and permitted awards of stock appreciation rights, restricted stock, long term
performance awards and performance shares in addition to grants of stock options. On April 29,
2009 the Board of Directors approved a revised amendment to the Plan that provides for the
inclusion of restricted stock units in addition to the other equity-based awards authorized
thereunder and eliminated the fixed option grants to outside directors. Restricted stock was
granted for the first time in the first quarter of 2010 which is being recorded as compensation
expense over the four-year vesting period.
Information regarding the stock option and equity incentive plans for the three months ended
March 31, 2010 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
|
|
|
|
Average |
|
|
Term |
|
|
Value |
|
Share Options |
|
Shares |
|
|
Exercise Price |
|
|
(in years) |
|
|
(in thousands) |
|
Outstanding as of January 1, 2010 |
|
|
4,406,606 |
|
|
$ |
9.62 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
672,658 |
|
|
|
6.05 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(13,588 |
) |
|
|
3.80 |
|
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
(36,887 |
) |
|
|
8.78 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2010 |
|
|
5,028,789 |
|
|
$ |
9.17 |
|
|
|
4.9 |
|
|
$ |
4,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable or expected to vest at March 31, 2010 |
|
|
4,147,586 |
|
|
$ |
9.78 |
|
|
|
4.5 |
|
|
$ |
3,693 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2010 |
|
|
3,036,121 |
|
|
$ |
10.75 |
|
|
|
4.1 |
|
|
$ |
2,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
Restricted Stock |
|
Shares |
|
|
Fair Value |
|
Outstanding as of January 1, 2010 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
177,319 |
|
|
|
6.05 |
|
Exercised |
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2010 |
|
|
177,319 |
|
|
$ |
6.05 |
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value in the share options table above represents the total pre-tax
intrinsic value (the difference between the closing price of our common stock on the last trading
day of the first quarter of 2010 and the exercise price, multiplied by the number of in-the-money
options) that would have been received by the option holders had all option holders exercised their
options on March 31, 2010. This amount changes based on the fair market value of the Companys
common stock. The total intrinsic value of options exercised for the three months ended March 31,
2009 and 2010 was $0.1 million and less than $0.1 million, respectively.
As of March 31, 2010, 3,036,121 options with a weighted average exercise price of $10.75 per
share were exercisable under the 1996 Plan and the 2003 Plan.
As of March 31, 2010, there was $6.0 million of total unrecognized compensation cost related
to non-vested share-based compensation arrangements (including stock options and restricted stock
awards) granted under the plans. That cost is expected to be recognized over a weighted-average
period of 2.6 years.
10
Tax Effect Related to Stock-based Compensation Expense
Income tax effects of share-based payments are recognized in the financial statements for
those awards that will normally result in tax deductions under existing tax law. Under current
U.S. federal tax law, we receive a compensation expense deduction related to non-qualified stock
options only when those options are exercised. Accordingly, the consolidated financial statement
recognition of compensation cost for non-qualified stock options creates a deductible temporary
difference which results in a deferred tax asset and a corresponding deferred tax benefit in the
consolidated statement of operations. We do not recognize a tax benefit for compensation expense
related to incentive stock options (ISOs) unless the underlying shares are disposed of in a
disqualifying disposition. Accordingly, compensation expense related to ISOs is treated as a
permanent difference for income tax purposes. The tax benefit recognized in our Consolidated
Statement of Operations for each of the three-month periods ended March 31, 2009 and 2010 related
to stock-based compensation expense was approximately $0.1 million.
Note 3. Fair Value of Financial Instruments
A fair value measurement assumes that the transaction to sell an asset or transfer a liability
occurs in the principal market for the asset or liability or, in the absence of a principal market,
the most advantageous market for the asset or liability. Fair value is based upon an exit price
model.
We measure certain financial assets and liabilities at fair value on a recurring basis,
including available-for-sale securities. Available-for-sale securities as of March 31, 2010
consisted of an auction rate security, or ARS, issued by a municipality, short-term investments in
municipal securities, bonds of government sponsored agencies, A1P1 rated commercial bonds and
paper, and marketable securities received from the buyer of certain assets of our EDC operations.
Available-for-sale securities are included in short-term investments in our consolidated balance
sheets with the exception of the marketable securities. The marketable securities, which are
priced at a discount due to a restriction on trading that remains in effect until June 23, 2010,
are included in investments in marketable securities in our consolidated balance sheets. The
discount on the marketable securities is valued using an option pricing model and takes into
consideration multiple inputs including quoted prices of the securities, volatility factors and
discount rates. The three levels of the fair value hierarchy are described below:
Level 1 |
|
Unadjusted quoted prices in active markets for identical assets or liabilities |
|
Level 2 |
|
Unadjusted quoted prices in active markets for similar assets or liabilities, or
Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or
Inputs other than quoted prices that are observable for the asset or liability |
|
Level 3 |
|
Unobservable inputs for the asset or liability |
11
The following tables represent our fair value hierarchy for financial assets (cash equivalents
and investments) measured at fair value on a recurring basis as of December 31, 2009 and March 31,
2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at December 31, 2009 |
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
in Active Markets |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
|
|
|
|
for Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Money market funds |
|
$ |
68,979 |
|
|
$ |
68,979 |
|
|
$ |
|
|
|
$ |
|
|
Municipal securities |
|
|
6,762 |
|
|
|
6,712 |
|
|
|
|
|
|
|
50 |
|
Corporate debt securities |
|
|
1,770 |
|
|
|
1,770 |
|
|
|
|
|
|
|
|
|
Bonds of government
sponsored agencies |
|
|
1,250 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
Marketable securities |
|
|
1,026 |
|
|
|
|
|
|
|
1,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
79,787 |
|
|
$ |
78,711 |
|
|
$ |
1,026 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at March 31, 2010 |
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
in Active Markets |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
|
|
|
|
for Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Money market funds |
|
$ |
72,175 |
|
|
$ |
72,175 |
|
|
$ |
|
|
|
$ |
|
|
Municipal securities |
|
|
6,058 |
|
|
|
6,008 |
|
|
|
|
|
|
|
50 |
|
Corporate debt securities |
|
|
1,007 |
|
|
|
1,007 |
|
|
|
|
|
|
|
|
|
Marketable securities |
|
|
1,317 |
|
|
|
|
|
|
|
1,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
80,557 |
|
|
$ |
79,190 |
|
|
$ |
1,317 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 4. Business Combination
On November 28, 2007, we completed the acquisition of Covance Cardiac Safety Services, Inc.
(CCSS) from Covance Inc. (Covance). Under the terms of the Purchase Agreement, we purchased all of
the outstanding shares of capital stock of CCSS in consideration of an upfront cash payment of
$35.2 million plus additional cash payments of up to approximately $14.0 million. We fully
integrated the operations of CCSS into our existing operations in the quarter ended September 30,
2008. We did so by merging CCSSs Reno, Nevada based operations into our existing operations and
closing the operations in Reno. The following table sets forth the activity and balance of our
accrued liability relating to lease costs associated with the closing of CCSS operations, which is
included in Accrued expenses and Other liabilities on our Consolidated Balance Sheets (in
thousands):
|
|
|
|
|
|
|
Lease |
|
|
|
Liability |
|
Balance at December 31, 2009 |
|
|
1,758 |
|
Cash payments |
|
|
(121 |
) |
|
|
|
|
Balance at March 31, 2010 |
|
$ |
1,637 |
|
|
|
|
|
Backlog is being amortized over three years on an accelerated basis. Customer relationships
are being amortized over ten years using the straight-line method and technology was amortized over
one year using the straight-line method.
12
Note 5. Intangible Assets
Amortization of intangible assets represents the amortization of the intangible assets from
the CCSS acquisition. The gross and net carrying amounts of the acquired intangible assets as of
December 31, 2009 and March 31, 2010 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
Net Book |
|
|
Useful Life |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Value |
|
|
(in years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,643 |
|
|
$ |
257 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
350 |
|
|
$ |
1,350 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
$ |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
2,393 |
|
|
$ |
1,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
Net Book |
|
|
Useful Life |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Value |
|
|
(in years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,715 |
|
|
$ |
185 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
392 |
|
|
$ |
1,308 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
$ |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
2,507 |
|
|
$ |
1,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The backlog is being amortized over three years on an accelerated basis. |
The related amortization expense reflected in our consolidated statements of operations for
the three months ended March 31, 2009 and 2010 was $137 and $114, respectively.
Estimated amortization expense for the remaining estimated useful life of the acquired
intangible assets is as follows for the years ending December 31 (the 2010 amount represents the
amortization expense to be recognized over the last nine months of the year (in thousands)):
|
|
|
|
|
|
|
Amortization of |
|
|
|
Intangible |
|
Years ending December 31, |
|
Assets |
|
2010 |
|
$ |
317 |
|
2011 |
|
|
170 |
|
2012 |
|
|
170 |
|
2013 |
|
|
170 |
|
2014 |
|
|
170 |
|
Thereafter |
|
|
496 |
|
|
|
|
|
Total |
|
$ |
1,493 |
|
|
|
|
|
Note 6. Net Income per Common Share
Basic net income per share is computed by dividing net income by the weighted average number
of shares of common stock outstanding during the period. Diluted net income per share is computed
by dividing net income by the weighted average number of shares of common stock outstanding during
the period, adjusted for the dilutive effect of common stock equivalents, which consist of stock
options. The dilutive effect of stock options is calculated using the treasury stock method.
13
The tables below set forth the reconciliation of the numerators and denominators of the basic
and diluted net income per share computations (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net |
|
|
|
|
|
|
Per Share |
|
Three Months Ended March 31, |
|
Income |
|
|
Shares |
|
|
Amount |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
2,070 |
|
|
|
50,879 |
|
|
$ |
0.04 |
|
Effect of dilutive shares |
|
|
|
|
|
|
285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
2,070 |
|
|
|
51,164 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
1,752 |
|
|
|
48,675 |
|
|
$ |
0.04 |
|
Effect of dilutive shares |
|
|
|
|
|
|
170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
1,752 |
|
|
|
48,845 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
In computing diluted net income per share, options to purchase 3,083,000 and 2,969,000 shares
of common stock were excluded from the computations for the three months ended March 31, 2009 and
2010, respectively. These options were excluded from the computations because the exercise prices
of such options were greater than the average market price of our common stock during the
respective period.
Note 7. Comprehensive Income
Companies are required to classify items of other comprehensive income by their nature in the
financial statements and display the accumulated balance of other comprehensive income separately
from retained earnings and additional paid-in-capital in the stockholders equity section of the
balance sheet. Our comprehensive income includes net income and unrealized gains and losses from
marketable securities and foreign currency translation as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2009 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,070 |
|
|
$ |
1,752 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
Change in unrealized losses on
marketable securities |
|
|
|
|
|
|
189 |
|
Currency translation adjustment |
|
|
(232 |
) |
|
|
(977 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income, net of tax |
|
$ |
1,838 |
|
|
$ |
964 |
|
|
|
|
|
|
|
|
Note 8. Recent Accounting Pronouncements
In September 2009, the FASB issued a new accounting standard regarding revenue arrangements
with multiple deliverables. As codified in ASC 605-25 (formerly Emerging Issues Task Force Issue
No. 08-1, Revenue Arrangements with Multiple Deliverables), this accounting standard sets forth
requirements that must be met for an entity to recognize revenue from the sale of a delivered item
that is part of a multiple-element arrangement when other items have not yet been delivered. One
of those current requirements is that there be objective and reliable evidence of the standalone
selling price of the undelivered items, which must be supported by either vendor-specific
objective evidence (VSOE) or third-party evidence (TPE).
This consensus eliminates the requirement that all undelivered elements have VSOE or TPE
before an entity can recognize the portion of an overall arrangement fee that is attributable to
items that already have been delivered. In the absence of VSOE or TPE of the standalone selling
price for one or more delivered or undelivered elements in a multiple-element arrangement, entities
will be required to estimate the selling prices of those elements. The overall arrangement fee
will be allocated to each element (both delivered and undelivered items) based on their relative
selling prices, regardless of whether those selling prices are evidenced by VSOE or TPE or are
based on the entitys estimated selling price. Application of the residual method of
allocating an overall arrangement fee between delivered and undelivered elements will no longer be
permitted. The accounting standard is effective prospectively for revenue arrangements entered
into or materially modified in fiscal years beginning on or after June 15, 2010. We are evaluating
the potential impact of these requirements on our consolidated financial statements.
14
In January 2010, the FASB issued Accounting Standard Update 2010-06 which will require
reporting entities to make new disclosures about recurring or nonrecurring fair-value measurements
including significant transfers into and out of Level 1 and Level 2 fair-value measurements and
information on purchases, sales, issuances, and settlements on a gross basis in the reconciliation
of Level 3 fair-value measurements. The FASB also clarified existing fair-value measurement
disclosure guidance about the level of disaggregation, inputs, and valuation techniques. Except
for the detailed Level 3 roll forward disclosures, we adopted this standard effective January 1,
2010. The adoption of this aspect of the accounting standard did not have any impact on our
consolidated financial statements. The new disclosures about purchases, sales, issuances, and
settlements in the roll forward activity for Level 3 fair-value measurements are effective for
interim and annual reporting periods beginning after December 15, 2010. We are evaluating the
potential impact of these requirements on our consolidated financial statements.
Note 9. Income Taxes
At December 31, 2009, we had $0.2 million of unrecognized tax benefits, all of which would
affect our effective tax rate if recognized. At March 31, 2010, we had $0.2 million of unrecognized
tax benefits. We recognize interest and penalties related to unrecognized tax benefits in income
tax expense. The tax years 2006 through 2009 remain open to examination by the major taxing
jurisdictions to which we are subject.
The Company or one of its subsidiaries files income tax returns in the U.S. federal
jurisdiction, and various states and foreign jurisdictions. With few exceptions, we are no longer
subject to U.S. federal, state and local, or non-U.S. income tax examinations by tax authorities
for years before 2006. We recognized a $0.1 million tax benefit related to the reversal of a tax
accrual for a previously uncertain tax position in the three months ended March 31, 2009 as a
result of a lapse of the applicable statute of limitations.
Our effective income tax rate was 40.1% and 38.5% for the three months ended March 31, 2009
and 2010, respectively.
Note 10. Related Party Transactions
Our Chairman, Dr. Morganroth, is a cardiologist who, through his wholly-owned professional
corporation, provides medical professional services to the Company and receives consulting fees as
an independent contractor. Additionally, beginning in January 2007, we entered into an arrangement
with Dr. Morganroths professional corporation, relating to Dr. Morganroths initiation of an ERT
consulting practice through the transition of his historic consulting services to us. Our
Executive Vice President and Chief Medical Officer is responsible for assigning the consulting work
to internal and external resources based upon the requirements of the engagement. In return, Dr.
Morganroths professional corporation receives a percentage fee of 80% of the net amounts we bill
for Dr. Morganroths services to our customers. Beginning in March 2010, we entered into a new
arrangement with Dr. Morganroths professional corporation which eliminated the consulting fees
other than the percentage fees. We recorded revenues in connection with services billed to
customers under this consulting arrangement of approximately $0.4 million and $0.3 million in the
three months ended March 31, 2009 and 2010, respectively. We incurred percentage fees under this
consulting arrangement of approximately $0.3 million in each of the three month periods ended March
31, 2009 and 2010. Total amounts payable incurred under this consulting arrangement, including
consulting fees and the percentage fees, approximated $0.4 million and $0.3 million in the three
months ended March 31, 2009 and 2010, respectively. At
December 31, 2009 and March 31, 2010, we owed $0.1
million to the professional corporation in connection with this consulting agreement, which is
included in accounts payable.
Note 11. Commitments and Contingencies
We have a long-term strategic relationship with Healthcare Technology Systems, Inc. (HTS), a
leading authority in the research, development and validation of computer administered clinical
rating instruments. The strategic relationship includes the exclusive licensing (subject to one
pre-existing license agreement) of 57 Interactive Voice Response (IVR) clinical assessments offered
by HTS along with HTSs IVR system. We placed the system into production in December 2007. As of
March 31, 2010, we paid HTS $1.5 million for the license and $1.0 million in advanced payments
against future royalties. As of March 31, 2010, HTS earned royalties of $0.2 million, which were
offset against these advanced payments. Royalty payments will be made to HTS based on the level of
revenues received from the assessments and the IVR system. Any royalties earned by HTS will be
applied against these payments. All future
payments to HTS will be solely based on royalty payments based on revenues received from ePRO
sales.
On November 28, 2007, we completed the acquisition of CCSS. Under the terms of the purchase
agreement, we purchased all of the outstanding shares of capital stock of CCSS in consideration of
an upfront cash payment of $35.2 million plus additional cash payments of up to approximately $14.0
million, based upon our potential realization of revenue from the backlog transferred and from new
contracts secured through Covances marketing activities. Through March 31, 2010, Covance earned
$5.3 million of this contingent amount with $0.1 million earned during the three months ended March
31, 2010. At March 31, 2010, less than $0.1 million of the contingent amount
earned remained to be paid to Covance, which we recorded in accounts payable. These
contingent payments increased goodwill by $5.3 million. The acquisition included a marketing
agreement under which Covance is obligated to use us as its provider of centralized cardiac safety
solutions, and to offer these solutions to Covances clients, on an exclusive basis, for a 10-year
period, subject to certain exceptions. We expense payments to Covance based upon a portion of the
revenues we receive during each calendar year of the 10-year term that are based primarily on
referrals made by Covance under the agreement. The agreement does not restrict our continuing
collaboration with our other key CRO, Phase I units, Academic Research Centers and other strategic
partners.
15
Note 12. Operating Segments / Geographic Information
We consider our business to consist of one segment as this represents managements view of our
operations. We operate on a worldwide basis with two locations in the United States and one
location in the United Kingdom, which are categorized below as North America and Europe,
respectively. The majority of our revenues are allocated among our geographic segments based upon
the profit split transfer pricing methodology, and revenues are generally allocated to the
geographic segment where the work is performed.
Geographic information is as follows (in thousands of dollars):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2009 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
America |
|
|
Europe |
|
|
Total |
|
Service revenues |
|
$ |
13,886 |
|
|
$ |
2,222 |
|
|
$ |
16,108 |
|
Site support revenues |
|
|
4,443 |
|
|
|
1,817 |
|
|
|
6,260 |
|
EDC licenses and services revenues |
|
|
1,418 |
|
|
|
|
|
|
|
1,418 |
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
$ |
19,747 |
|
|
$ |
4,039 |
|
|
$ |
23,786 |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
2,985 |
|
|
$ |
355 |
|
|
$ |
3,340 |
|
Long-lived assets |
|
$ |
23,881 |
|
|
$ |
3,224 |
|
|
$ |
27,105 |
|
Total assets |
|
$ |
141,334 |
|
|
$ |
16,933 |
|
|
$ |
158,267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2010 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
America |
|
|
Europe |
|
|
Total |
|
Service revenues |
|
$ |
9,944 |
|
|
$ |
4,891 |
|
|
$ |
14,835 |
|
Site support revenues |
|
|
4,773 |
|
|
|
2,260 |
|
|
|
7,033 |
|
EDC licenses and services revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
$ |
14,717 |
|
|
$ |
7,151 |
|
|
$ |
21,868 |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
750 |
|
|
$ |
1,997 |
|
|
$ |
2,747 |
|
Long-lived assets |
|
$ |
21,348 |
|
|
$ |
3,748 |
|
|
$ |
25,096 |
|
Total assets |
|
$ |
144,208 |
|
|
$ |
21,990 |
|
|
$ |
166,198 |
|
Note 13. Stock Repurchase
Our board of directors has authorized the repurchase of up to an aggregate of 12.5 million
shares, of which 5.0 million shares remain to be purchased as of March 31, 2010. The stock
buy-back authorization allows us, but does not require us, to purchase the authorized shares.
During the three months ended March 31, 2009, we purchased 1,965,452 shares of our common stock at
a cost of $10.0 million. We did not purchase any shares during the three months ended March 31,
2010.
Note 14. Subsequent Event
On April 29, 2010, we announced that we agreed to acquire the research services division of
CareFusion Corporation (CRS). CRS is a leading provider of respiratory diagnostics services and
manufacturer of diagnostic devices and also offers cardiac safety and ePRO
services. We expect the transaction to close in June 2010 pending satisfaction of customary
closing conditions. No stockholder approvals are required.
We will pay $81 million in cash for CRS, subject to closing balance sheet adjustments. We
will finance the transaction through a combination of existing cash and debt. As of March 31,
2010, we had $79 million in cash and we have obtained a commitment for a new $40 million revolving
credit facility through Citizens Bank of Pennsylvania. We anticipate drawing down approximately
$20 million of this facility to fund this purchase.
16
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Statement for Forward-Looking Information
Except for historical matters, the matters discussed in this Form 10-Q are forward-looking
statements that involve risks and uncertainties. Forward-looking statements include, but are not
limited to, statements within the meaning of the Private Securities Litigation Reform Act of 1995
that reflect our current views as to future events and financial performance with respect to our
operations. These statements can be identified by the fact that they do not relate strictly to
historical or current facts. They use words such as aim, anticipate, are confident,
estimate, expect, will be, will continue, will likely result, project, intend,
plan, believe, look to and other words and terms of similar meaning in conjunction with a
discussion of future operating or financial performance.
These statements are subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in the forward-looking statements. Factors that
might cause such a difference include: unfavorable economic conditions; our ability to obtain new
contracts and accurately estimate net revenues due to variability in size, scope and duration of
projects and internal issues at the sponsoring client; our ability to successfully integrate
acquisitions; competitive factors in the market for centralized cardiac safety services; changes in
the pharmaceutical, biotechnology and medical device industries to which we sell our solutions;
technological development; and market demand. There is no guarantee that the amounts in our backlog
will ever convert to revenue. Should the current economic conditions continue or deteriorate
further, the cancellation rates that we have historically experienced could increase. Further
information on potential factors that could affect the Companys financial results can be found in
the reports we file with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date made. We undertake no obligation to
update any forward-looking statements, including prior forward-looking statements, to reflect the
events or circumstances arising after the date as of which they were made. As a result of these
risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking
statements included in this discussion or that may be made in our filings with the Securities and
Exchange Commission or elsewhere from time to time by, or on behalf of, us.
Overview
eResearchTechnology, Inc. (ERT), a Delaware corporation, was founded in 1977 to provide
Cardiac Safety solutions to evaluate the safety of new drugs. ERT and its consolidated
subsidiaries collectively are referred to as the Company or we. We provide technology and
service solutions that enable the pharmaceutical, biotechnology and medical device industries to
collect, interpret and distribute cardiac safety and clinical data more efficiently. We are a
market leader in providing centralized electrocardiographic solutions (Cardiac Safety solutions)
and a provider of technology solutions that streamline the clinical trials process by enabling our
clients to evolve from traditional, paper-based methods to electronic processing using our
electronic patient reported outcomes (ERT ePRO) solutions.
Our solutions improve the accuracy, timeliness and efficiency of trial set-up, data collection
from sites worldwide, data interpretation, and new drug, biologic and device application
submissions. We offer Cardiac Safety solutions, which are utilized by pharmaceutical,
biotechnology and medical device companies, clinical trial sponsors and clinical research
organizations (CROs) during the conduct of clinical trials. Our Cardiac Safety solutions include
the collection, interpretation and distribution of electrocardiographic (ECG) data and images and
are performed during clinical trials in all phases of the clinical research process. The ECG
provides an electronic map of the hearts rhythm and structure, and is performed in most clinical
trials. Our Cardiac Safety solutions permit assessments of the safety of therapies by documenting
the occurrence of cardiac electrical change. Specific trials, such as a Thorough QTc study, focus
on the cardiac safety profile of a compound. Thorough QTc studies are comprehensive studies that
typically are of large volume and short duration and are recommended by the United States Food and
Drug Administration (FDA) under guidance issued in 2005 by the International Committee on
Harmonization (ICH E14). We also offer site support, which includes the rental and sale of cardiac
safety equipment along with related supplies and logistics management. We also offer ePRO
solutions along with proprietary clinical assessments.
On June 23, 2009, we completed the sale of certain assets relating to our electronic data
capture (EDC) operations. Under the terms of the transaction, OmniComm Systems, Inc. issued to us
8.1 million shares of common stock and assumed certain liabilities including deferred revenue
relating to our EDC operations in exchange for our EDC assets which primarily included our EDC
software, applications and fixed assets and $1.15 million in cash we paid. During the year ended
December 31, 2009, we recorded a gain on the sale of these assets of $0.5 million within general
and administrative expenses in the consolidated statement of operations. The revenue and cost of
revenue of our former EDC operations have been reclassified from the licenses and services
categories to the EDC category on the consolidated statements of operations for all periods
presented. Additionally, the remaining revenues and costs of sales in licenses, related to cardiac
safety reporting and ePRO, were reclassified to the services category on the consolidated
statements of operations for all periods presented.
17
We
offer the following products and services on a global basis:
Cardiac Safety. Cardiac Safety solutions, including our EXPERT® technology platform, provide
for workflow-enabled cardiac safety data collection, interpretation and distribution of
electrocardiographic (ECG) data and images as well as for analysis and cardiologist
interpretation of ECGs performed on research subjects in connection with our clients clinical
trials. EXPERT® is designed specifically to address global regulatory guidance and technical
standards for digital ECG processing to include digital collection, waveform measurements and
annotations, review and output to the regulatory standard file format. Also included in
Cardiac Safety solutions is FDA XML delivery, which provides for the delivery of ECGs in a
format compliant with the United States Food and Drug Administrations XML standard for digital
ECGs. We also provide ECG equipment through rental and sales to clients to perform the ECG
recordings and give them means to send such recordings to us. Our portal product, MyStudy
Portal, provides sponsors and investigator sites with the ability to order supplies, gain real
time reports and respond to queries via a secure web portal in lieu of less efficient means
such as faxing and telephone calls.
Cardiac Safety Consulting. The centralization of electrocardiograms in clinical research has
become increasingly important to organizations involved in the development of new drugs.
Global regulators each apply their own slightly different interpretation of the International
Conference on Harmonization E14 guidelines and, as a result, sponsors look to their vendors to
provide key scientific input into the overall process. Our cardiac safety consulting service
aids sponsors in the development of protocol synopses, the creation and analysis of statistical
plans as well as the provision of an expert medical report with regard to the cardiac findings.
We are involved in all phases of clinical development from a consultancy point of view. We
offer this service both as a stand-alone service and integrated with our full suite of Cardiac
Safety solutions.
ePRO. Our ePRO solution is an Interactive Voice Response (IVR) system that allows subjects to
easily and quickly report data for a clinical trial. Because it can be accessed from a
standard phone, our ePRO system is cost effective while being extremely scalable and suitable
from Phase I through Phase IV. Diaries, screening, recruitment and all clinical assessments
can be completed directly by the subject without requiring clinician involvement.
Project Assurance. We provide a full spectrum of consulting services for all of our products
that augment the study management and implementation efforts of clients in support of their
clinical research requirements.
Our services revenues consist primarily of our services offered under our Cardiac Safety and,
to a lesser extent, ePRO solutions that we provide on a fee for services basis and are recognized
as the services are performed. We also provide Cardiac Safety consulting services on a time and
materials basis and recognize revenues as we perform the services. Site support revenues,
consisting of cardiac safety equipment rentals and sales along with related supplies and logistics
management, are recognized at the time of sale or over the rental period.
For arrangements with multiple deliverables where the fair value of each element is known, the
revenue is allocated to each component based on the relative fair values of each element. For
arrangements with multiple deliverables where the fair value of one or more delivered elements is
not known, revenue is allocated to each component of the arrangement using the residual method
provided that the fair value of all undelivered elements is known. Fair values for undelivered
elements are based primarily upon stated renewal rates for future products or services.
We have recorded reimbursements received for out-of-pocket expenses incurred as revenue in the
accompanying consolidated financial statements.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer
pursuant to contractual terms. In general, such amounts become billable in accordance with
predetermined payment schedules, but recognized as revenue as services are performed. Amounts
included in unbilled revenue are expected to be collected within one year and are included within
current assets.
Our former electronic data capture (EDC) operations were included in EDC licenses and services
revenue and include license revenue, technology consulting and training services and software
maintenance services. We recognized up-front license fee revenues under the residual method when a
formal agreement existed, delivery of the software and related documentation occurred,
collectability was probable and the license fee was fixed or determinable. We recognized monthly
and annual term license fee revenues over the term of the arrangement. Hosting service fees were
recognized evenly over the term of the service. We recognized revenues from software maintenance
contracts on a straight-line basis over the term of the maintenance contract, which was typically
twelve months. We provided consulting and training services on a time and materials basis and
recognized revenues as we performed the services.
18
Cost of services includes the cost of Cardiac Safety and ePRO services. Cost of services
consists primarily of direct costs related to our centralized Cardiac Safety services and includes
wages, depreciation, amortization, fees paid to consultants and other direct operating costs. Cost
of site support consists primarily of wages, cardiac safety equipment rent and depreciation,
related supplies, cost of equipment sold, shipping expenses and other direct operating costs.
Selling and marketing expenses consist primarily of wages and incentive compensation paid to sales
personnel, travel expenses and advertising and promotional expenditures. General and
administrative expenses consist primarily of wages and direct costs for our finance,
administrative, corporate information technology and executive
management functions, in addition to professional service fees and corporate insurance.
Research and development expenses consist primarily of wages paid to our product development staff,
costs paid to outside consultants and other direct costs associated with the development of our
technology.
Costs of our former EDC operations included primarily wages, fees paid to outside consultants
and other direct operating costs related to our software licensing, consulting and client support
functions.
We conduct our operations through offices in the United States (U.S.) and the United Kingdom
(UK). Our international net revenues represented approximately 17% and 33% of total net revenues
for the three months ended March 31, 2009 and 2010, respectively. The majority of our revenues are
allocated among our geographic segments based upon the profit split transfer pricing methodology
which equalizes gross margins for each legal entity based upon its respective direct revenue or
direct costs, as determined by the relevant revenue source. Through September 30, 2009, we
calculated our transfer pricing for Cardiac Safety services using a profit split methodology based
on cost. After reviewing the transfer pricing methodology, management decided to modify its
application of the profit split methodology for Cardiac Safety services to allocate costs based on
revenue beginning in 2009. This has resulted in an increase in revenue attributed to the UK
beginning in the fourth quarter of 2009.
On April 29, 2010, we announced that we agreed to acquire the research services division of
CareFusion Corporation (CRS). CRS is a leading provider of respiratory diagnostics services and
manufacturer of diagnostic devices and also offers cardiac safety and ePRO services. We expect the
transaction to close in June 2010 pending satisfaction of customary closing conditions. No
stockholder approvals are required.
We will pay $81 million in cash for CRS, subject to closing balance sheet adjustments. We
will finance the transaction through a combination of existing cash and debt. As of March 31,
2010, we had $79 million in cash and we have obtained a commitment for a new $40 million revolving
credit facility through Citizens Bank of Pennsylvania. We anticipate drawing down approximately
$20 million of this facility to fund this purchase. The line has a 3-year term and annual interest
rates based upon LIBOR plus a margin of 1.00% to 1.75% based upon a total leverage ratio and unused
commitment fees of 0.10% to 0.20% based upon the same total leverage ratio. Financial covenants
include maximum total senior funded debt to earnings before interest, income taxes, depreciation
and amortization (EBITDA) of 2.0 and minimum debt service coverage ratio of 1.5.
We believe this is a transformative acquisition for us, combining two common product lines
between the companies with two new product lines from CRS. CRS offers two services, cardiac safety
and ePRO, that are complementary to those offered by ERT currently. CRS is also a leading provider
of respiratory diagnostic services and a leading manufacturer of respiratory diagnostic devices.
This transaction delivers on our stated strategy to leverage our leadership position in cardiac
safety and our expertise as a service and technology provider to more broadly support the remote
collection, interpretation and delivery of clinical efficacy and safety information critical for
all phases of clinical research. It will also provide support to leverage our core expertise into
the larger healthcare market. It is a natural and complementary strategic fit for us.
Reclassifications
The consolidated financial statements for prior periods have been reclassified to conform to
the current periods presentation. In particular, the revenue and cost of revenue of our former
EDC operations, which we sold on June 23, 2009, have been reclassified from the licenses and
services categories to the EDC category on the consolidated statements of operations for all
periods presented. Additionally, the remaining revenues and costs of sales in licenses, related to
cardiac safety reporting and ePRO, were reclassified to the services category on the consolidated
statements of operations for all periods presented.
19
Results of Operations
Executive Overview
Net revenues were $21.9 million for the first quarter of 2010, a decrease of $1.9 million or
8.1% from $23.8 million in the first quarter of 2009, with $1.4 million of that decline consisting
of EDC revenue in the first quarter of 2009 for which we had no corresponding revenue in 2010. In
addition, Thorough QT revenue declined significantly in this period. Offsetting these revenue
decreases were increases in routine revenues, site support, and ePRO revenue, which we believe are
positive trends going into the second quarter.
Gross margin percentage was 53.8% in the first quarter of 2010 compared to 50.4% in the first
quarter of 2009. The increase in gross margin percentage was driven primarily by increased margins
for site support. Our gross margin on site support was 60.2% for the first quarter, up both
sequentially and year over year due to lower depreciation as a portion of our older, more expensive
ECG equipment has become fully depreciated. In addition, we have more equipment out in the field
which is contributing a higher level of revenue. The gross margin percentage for services
decreased to 50.7% in the first quarter of 2010 from 52.2% in the first quarter of 2009 due to a
decrease in volume and the impact of single digit percentage price decreases. The increase in
total gross margin percentage is also a testament to some of the operational changes and
efficiencies that we have implemented over the past year.
Operating income for the first quarter of 2010 was $2.7 million or 12.6% of total net revenues
compared to $3.3 million or 14.0% of total net revenues in the first quarter of 2009. Operating
income for the first quarter of 2010 was negatively impacted by a $687,000 increase in legal and
accounting costs resulting from activities associated with the recently announced pending
acquisition of CRS, which reduced our operating margin by approximately 3.1%. Our effective income
tax rate for the first quarter of 2010 was 38.5% compared to 40.1% in the first quarter of 2009.
Net income for the first quarter of 2010 was $1.8 million, or $0.04 per diluted share,
compared to $2.1 million, or $0.04 per diluted share, in the first quarter of 2009.
In the quarter we announced our new Centralized Cardiac Safety 2.0. This is a continued step
in our focus on increasing centralization that we have discussed several times on these calls. As
part of this new service, we announced the introduction of ELI PC under exclusive license from
Mortara Instrument. This small hand-held ECG collection device will make it easier for companies
to adopt centralization, especially in long-term Phase II and Phase III trials. It will also help
accelerate trial timelines by reducing queries and speeding up time to database lock. Clients are
reacting very well to the concepts of Centralization 2.0 as they see the opportunities to get
better science for lower costs.
20
The following table presents certain financial data as a percentage of total net revenues:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2009 |
|
|
2010 |
|
Net revenues: |
|
|
|
|
|
|
|
|
Services |
|
|
67.7 |
% |
|
|
67.8 |
% |
Site support |
|
|
26.3 |
|
|
|
32.2 |
|
EDC licenses and services |
|
|
6.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
|
|
|
100.0 |
|
|
|
|
|
|
|
|
Costs of revenues: |
|
|
|
|
|
|
|
|
Cost of services |
|
|
32.3 |
|
|
|
33.4 |
|
Cost of site support |
|
|
15.3 |
|
|
|
12.8 |
|
Cost of EDC licenses and services |
|
|
2.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Total costs of revenues |
|
|
49.6 |
|
|
|
46.2 |
|
|
|
|
|
|
|
|
Gross margin |
|
|
50.4 |
|
|
|
53.8 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
14.4 |
|
|
|
15.6 |
|
General and administrative |
|
|
17.2 |
|
|
|
21.7 |
|
Research and development |
|
|
4.8 |
|
|
|
3.9 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
36.4 |
|
|
|
41.2 |
|
|
|
|
|
|
|
|
Operating income |
|
|
14.0 |
|
|
|
12.6 |
|
Other income (expense), net |
|
|
0.5 |
|
|
|
0.4 |
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
14.5 |
|
|
|
13.0 |
|
Income tax provision |
|
|
5.8 |
|
|
|
5.0 |
|
|
|
|
|
|
|
|
Net income |
|
|
8.7 |
% |
|
|
8.0 |
% |
|
|
|
|
|
|
|
21
Three Months Ended March 31, 2009 Compared to Three Months Ended March 31, 2010.
The following table presents our consolidated statements of operations with product line
detail (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
2009 |
|
|
2010 |
|
|
Increase (Decrease) |
|
Services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
16,108 |
|
|
$ |
14,835 |
|
|
$ |
(1,273 |
) |
|
|
(7.9 |
%) |
Costs of revenues |
|
|
7,693 |
|
|
|
7,311 |
|
|
|
(382 |
) |
|
|
(5.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
8,415 |
|
|
$ |
7,524 |
|
|
$ |
(891 |
) |
|
|
(10.6 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Site support: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
6,260 |
|
|
$ |
7,033 |
|
|
$ |
773 |
|
|
|
12.3 |
% |
Costs of revenues |
|
|
3,635 |
|
|
|
2,799 |
|
|
|
(836 |
) |
|
|
(23.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
2,625 |
|
|
$ |
4,234 |
|
|
$ |
1,609 |
|
|
|
61.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EDC licenses and services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
1,418 |
|
|
$ |
|
|
|
$ |
(1,418 |
) |
|
|
(100.0 |
%) |
Costs of revenues |
|
|
466 |
|
|
|
|
|
|
|
(466 |
) |
|
|
(100.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
952 |
|
|
$ |
|
|
|
$ |
(952 |
) |
|
|
(100.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
23,786 |
|
|
$ |
21,868 |
|
|
$ |
(1,918 |
) |
|
|
(8.1 |
%) |
Costs of revenues |
|
|
11,794 |
|
|
|
10,110 |
|
|
|
(1,684 |
) |
|
|
(14.3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
11,992 |
|
|
|
11,758 |
|
|
|
(234 |
) |
|
|
(2.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
3,426 |
|
|
|
3,408 |
|
|
|
(18 |
) |
|
|
(0.5 |
%) |
General and administrative |
|
|
4,077 |
|
|
|
4,745 |
|
|
|
668 |
|
|
|
16.4 |
% |
Research and development |
|
|
1,149 |
|
|
|
858 |
|
|
|
(291 |
) |
|
|
(25.3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
8,652 |
|
|
|
9,011 |
|
|
|
359 |
|
|
|
4.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
3,340 |
|
|
|
2,747 |
|
|
|
(593 |
) |
|
|
(17.8 |
%) |
Other income (expense), net |
|
|
116 |
|
|
|
100 |
|
|
|
(16 |
) |
|
|
(13.8 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
3,456 |
|
|
|
2,847 |
|
|
|
(609 |
) |
|
|
(17.6 |
%) |
Income tax provision |
|
|
1,386 |
|
|
|
1,095 |
|
|
|
(291 |
) |
|
|
(21.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,070 |
|
|
$ |
1,752 |
|
|
$ |
(318 |
) |
|
|
(15.4 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents costs of revenues as a percentage of related net revenues and
operating expenses as a percentage of total net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
2009 |
|
|
2010 |
|
|
Increase (Decrease) |
|
Cost of services |
|
|
47.8 |
% |
|
|
49.3 |
% |
|
|
1.5 |
% |
Cost of site support |
|
|
58.1 |
% |
|
|
39.8 |
% |
|
|
(18.3 |
%) |
Cost of EDC licenses and services |
|
|
32.9 |
% |
|
|
N/A |
|
|
|
N/A |
|
Total costs of revenues |
|
|
49.6 |
% |
|
|
46.2 |
% |
|
|
(3.4 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
14.4 |
% |
|
|
15.6 |
% |
|
|
1.2 |
% |
General and administrative |
|
|
17.2 |
% |
|
|
21.7 |
% |
|
|
4.5 |
% |
Research and development |
|
|
4.8 |
% |
|
|
3.9 |
% |
|
|
(0.9 |
%) |
22
EDC
On June 23, 2009, we completed the sale of certain assets relating to our EDC operations.
Revenues
The decrease in services revenues was primarily due to a $0.9 million reduction in transaction
revenue related to lower volume of transactions performed in the three months ended March 31, 2010
as compared to the three months ended March 31, 2009. There was also a decrease in average revenue
per transaction that was largely due to certain lower transaction prices which resulted in a
decrease in revenue of approximately $0.7 million. Project management fees decreased $0.3 million,
consistent with the decreased Cardiac Safety activity. These decreases were partially offset by a
number of revenue increases totaling $0.6 million, primarily from our ePRO operations.
Site support revenues increased primarily due to $0.4 million associated with an increase in
the number of units rented in the three months ended March 31, 2010 as compared to the three months
ended March 31, 2009 and $0.3 million attributable to increases in average rental per unit.
Costs of Revenues
The decrease in the cost of services was primarily due to a $0.4 million reduction in labor
costs as a result of efficiency initiatives realized in the latter part of 2009. Additionally,
depreciation expense decreased by $0.2 million as computer equipment purchased for the development
and implementation of the EXPERT® 2 technology platform has become fully depreciated. Partially
offsetting these decreases are increases in telephone, connectivity and variable incentive
compensation expenses. The increase in the cost of services as a percentage of service revenues
reflects the fact that some of the costs do not necessarily change in direct relation with changes
in revenue.
The decrease in the cost of site support, both in absolute terms and as a percentage of site
support revenues, was primarily due to a $0.6 million decrease in depreciation expense as older,
more expensive ECG equipment has become fully depreciated and a $0.1 million decrease in freight.
Additional smaller decreases totaling $0.1 million occurred in labor, costs of equipment sold and
other expenses.
Operating Expenses
The increase in general and administrative expenses, both in absolute terms and as a
percentage of total net revenues, was due primarily to $0.7 million of legal and accounting fees
incurred related to transaction costs associated with our proposed acquisition of CRS.
Additionally, consulting and software costs have each increased $0.1 million as a result of an
information technology modernization and virtualization project started in late 2009 and continuing
in 2010. Partially offsetting these increases are $0.2 million in lower share-based compensation
expense resulting from the timing of grants to our directors. Director grants were made in the
three months ended March 31, 2009, but the 2010 grants have been made in the three months ended
June 30, 2010.
The decrease in research and development expenses, both in absolute terms and as a percentage
of total net revenues, was primarily due to a $0.2 million reduction in labor costs as a result of
the sale of our former EDC operations in June 2009. The balance of the decrease is due to an
increase in the capitalization of salaries and consultant fees associated with internal-use
software development projects.
Our effective tax rate for the three months ended March 31, 2010 was 38.5% compared to 40.1%
for the three months ended March 31, 2009. Through September 30, 2009, we calculated our transfer
pricing for Cardiac Safety services using a profit split methodology based on cost. The profit
split transfer pricing methodology was modified for Cardiac Safety services to allocate costs based
on revenue instead of allocating revenue based on costs.
Liquidity and Capital Resources
At March 31, 2010, we had $79.2 million of cash, cash equivalents and short-term investments.
We generally place our investments in highly-rated securities such as municipal securities, bonds
of government sponsored agencies, certificates of deposit with fixed rates and maturities of less
than one year, and A1P1 rated commercial bonds and paper. Of the $79.2 million, $14.7 million is
held by our UK subsidiary. Although a portion of our UK subsidiarys current undistributed net
earnings, as well as the future net earnings, will be permanently reinvested, we believe that this
does not have a material impact on our overall liquidity.
For the three months ended March 31, 2010, our operations provided cash of $5.3 million, a
decrease of $3.8 million compared to $9.1 million during the three months ended March 31, 2009. The
decrease was primarily the result of a decrease in accounts receivable in the three months ended
March 31, 2010 of $1.0 million as compared to $7.3 million in the three months ended March 31,
2009. The accounts receivable were reduced significantly during the three months ended March 31,
2009 as a result of focused collection efforts and a reduction in revenue which also contributed to
a smaller decrease in accounts receivable in the three months ended March 31, 2010. Partially
offsetting this negative impact on cash flow was a $0.9 million increase in accrued expenses in the
three months ended March 31, 2010 as compared to a $2.2 million decrease in the three months ended March 31, 2009. The
decrease in 2009 was largely the result of the payment of a greater amount in 2009 for variable
incentive compensation related to the prior years results.
23
For the three months ended March 31, 2010, our investing activities used cash of $1.3 million
as compared to $1.6 million during the three months ended March 31, 2009. Proceeds from sales of
investments net of purchases were $2.7 million during the three months ended March 31, 2010 with no
activity during the three months ended March 31, 2009.
During the three months ended March 31, 2010 and 2009, we capitalized $3.9 million and $1.6
million, respectively, of property and equipment. Included in property and equipment acquisitions
is $1.2 million and $0.5 million for the three months ended March 31, 2010 and 2009, respectively,
of internal use software. The balance of the change was primarily due to an increase in purchases
of ECG equipment commensurate with the additional units rented in the three months ended March 31,
2010 as compared to the three month ended March 31, 2009.
For the three months ended March 31, 2010, our financing activities provided cash of $0.1
million as compared to an $8.1 million use of cash for the three months ended March 31, 2009. In
the three months ended March 31, 2009, we repurchased $10.0 million of our common stock under our
stock buy-back program, of which $1.8 million was recorded in accounts payable at March 31, 2009,
with no corresponding expenditure in the three months ended March 31, 2010.
We have a line of credit arrangement with Wachovia Bank, National Association, a Wells Fargo
Company, totaling $3.0 million which expires on June 1, 2010. To date, we have not borrowed any
amounts under our line of credit. As of March 31, 2010, we had outstanding letters of credit of
$0.5 million, which reduced our available borrowings under the line of credit to $2.5 million. We
do not anticipate renewing this line of credit upon expiration.
We have commitments to purchase approximately $2.8 million of private label cardiac safety
equipment from a manufacturer over a twelve-month period beginning upon completion of our user
acceptance testing, which was completed in the first quarter of 2010. We expect to purchase this
cardiac safety equipment in the normal course of business and thus this commitment does not
represent a significant commitment above our expected purchases of ECG equipment during this
period. As of March 31, 2010, approximately $0.2 million of equipment was purchased under the
commitments; accordingly the balance of such commitments as of March 31, 2010 was $2.6 million.
In March 2010, the Patient Protection and Affordable Care Act and the Health Care and
Education Act of 2010 became law. We are currently evaluating the impact, if any, on our future
operating results.
We expect that existing cash and cash equivalents, cash flows from operations and amounts to
be made available under the $40 million credit facility as discussed above will be sufficient to
meet our foreseeable cash needs for at least the next year, including the cost to complete the
acquisition of CRS. We expect to close on the credit facility on or before the closing date of the
acquisition. Should delays in closing on the credit facility occur or should the bank revoke its
commitment, we would have to find alternative sources to fund any cash shortfall as of closing.
The closing of the acquisition is not conditioned upon our having adequate funding sources. In the
event we could not find alternative funding to make up any shortfall and could not close, we could
be in breach of the purchase agreement with the seller. In addition, there may be acquisition and
other growth opportunities that require additional external financing and we may from time to time
seek to obtain additional funds from the public or private issuances of equity or debt securities.
There can be no assurance that any such acquisitions will occur or that such financing will be
available or available on terms acceptable to us, particularly in view of current capital market
uncertainty.
Our board of directors has authorized the repurchase of up to an aggregate of 12.5 million
shares, of which 5.0 million shares remain to be purchased as of March 31, 2010. The stock
buy-back authorization allows us, but does not require us, to purchase the authorized shares. The
purchase of the remaining shares authorized could require us to use a significant portion of our
cash, cash equivalents and investments and could also require us to seek additional external
financing. During the three months ended March 31, 2009, we purchased 1,965,452 shares of our
common stock at a cost of $10.0 million. No shares were purchased during the three months ended
March 31, 2010.
On November 28, 2007, we completed the acquisition of CCSS from Covance Inc. Under the terms
of our agreement to purchase CCSS, the total initial purchase consideration was $35.2 million. We
may also pay contingent consideration of up to approximately $14.0 million based upon our potential
realization of revenue from the backlog transferred and from new contracts secured through
Covances marketing activities. The period for contingent payments runs through December 31, 2010.
Through March 31, 2010, Covance earned $5.3 million of this contingent amount with $0.1 million
earned during the three months ended March 31, 2010. At March 31, 2010, approximately $0.1 million
of the contingent amount earned remained to be paid to Covance, which we recorded in accounts
payable. These contingent payments increased goodwill by $5.3 million. Under the terms of the
marketing agreement, Covance agreed to exclusively use us as its provider of centralized cardiac
safety solutions for a ten-year period, subject to certain exceptions, and we agreed to pay
referral fees on certain revenues.
Inflation
We believe the effects of inflation and changing prices generally do not have a material
effect on our consolidated results of operations or financial condition.
24
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our primary financial market risks include fluctuations in interest rates and currency
exchange rates.
Interest Rate Risk
We generally place our investments in highly-rated securities such as money market funds,
municipal securities, bonds of government sponsored agencies, certificates of deposit with fixed
rates with maturities of less than one year and A1P1 rated commercial bonds and paper. We actively
manage our portfolio of cash equivalents and short-term investments, but in order to ensure
liquidity, will only invest in instruments with high credit quality where a secondary market
exists. We have not held and do not hold any derivatives related to our interest rate exposure.
Due to the average maturity and conservative nature of our investment portfolio, a sudden change in
interest rates would not have a material effect on the value of the portfolio. The impact on
interest income of future changes in investment yields will depend largely on the gross amount of
our cash, cash equivalents, short-term investments and log-term investments. See Liquidity and
Capital Resources as part of Managements Discussion and Analysis of Financial Condition and
Results of Operations.
Foreign Currency Risk
We operate on a global basis from locations in the United States (U.S.) and the United Kingdom
(UK). All international net revenues and expenses are billed or incurred in either U.S. dollars or
pounds sterling. As such, we face exposure to adverse movements in the exchange rate of the pound
sterling. As the currency rate changes, translation of the statement of operations of our UK
subsidiary from the local currency to U.S. dollars affects year-to-year comparability of operating
results. We do not hedge translation risks because any cash flows from UK operations are
reinvested in the UK.
Management estimates that a 10% change in the exchange rate of the pound sterling would have
impacted the reported operating income for the three months ended March 31, 2010 by approximately
$0.2 million.
Item 4. Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness
of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act
of 1934, as amended, as of the end of the period covered by this report. Based upon that
evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures as of the end of the period covered by this report were designed and
functioning effectively to provide reasonable assurance that information required to be disclosed
by the Company (including our consolidated subsidiaries) in the reports we file with or submit to
the Securities and Exchange Commission is (i) recorded, processed, summarized and reported within
the time periods specified in the Commissions rules and forms and (ii) accumulated and
communicated to our management, including our Chief Executive Officer and our Chief Financial
Officer, as appropriate to allow timely decisions regarding required disclosure. There were no
changes in our internal control over financial reporting during the quarter ended March 31, 2010
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
25
Part II. Other Information
Item 6. Exhibits
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|
|
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10.9 |
|
|
Definitive Purchase Agreement between Blitz F10-acht-drei-fünf GmbH & Co. KG, an
indirect wholly-owned subsidiary of eResearchTechnology, Inc., and CareFusion Germany 234
GmbH, an indirect wholly-owned subsidiary of CareFusion Corporation, dated April 29, 2010. |
|
|
|
|
|
|
10.10 |
|
|
Reciprocal Guaranty between CareFusion Corporation, in favor of Blitz
F10-acht-drei-fünf GmbH & Co. KG, and eResearchTechnology, Inc., in favor of CareFusion
Germany 234 GmbH, dated April 29, 2010. |
|
|
|
|
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10.13 |
|
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2010 Bonus Plan.* |
|
|
|
|
|
|
10.42 |
|
|
Management Employment Agreement effective March 1, 2010 between Dr. Joel Morganroth and
the Company.* |
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|
|
|
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10.46 |
|
|
Consultant Agreement effective March 1, 2010 between Joel Morganroth, M.D., P.C. and the
Company.* |
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|
|
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10.49 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Michael
McKelvey and the Company.* |
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|
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10.50 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Jeffrey
S. Litwin and the Company.* |
|
|
|
|
|
|
10.51 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Amy
Furlong and the Company.* |
|
|
|
|
|
|
10.56 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Keith D.
Schneck and the Company.* |
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|
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|
|
31.1 |
|
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Certification of Chief Executive Officer. |
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31.2 |
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Certification of Chief Financial Officer. |
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32.1 |
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Statement of Chief Executive Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
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32.2 |
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Statement of Chief Financial Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
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* |
|
Management contract or compensatory plan or arrangement. |
26
Signatures
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.
|
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eResearchTechnology, Inc.
(Registrant)
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Date: May 7, 2010 |
By: |
/s/ Michael J. McKelvey
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Michael J. McKelvey |
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President and Chief Executive Officer,
(Principal executive officer) |
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Date: May 7, 2010 |
By: |
/s/ Keith D. Schneck
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Keith D. Schneck |
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|
Executive Vice President, Chief Financial
Officer and Secretary
(Principal financial and accounting officer) |
|
27
EXHIBIT INDEX
|
|
|
|
|
Exhibit No. |
|
Exhibit |
|
|
|
|
|
|
10.9 |
|
|
Definitive Purchase Agreement between Blitz F10-acht-drei-fünf GmbH & Co. KG, an indirect
wholly-owned subsidiary of eResearchTechnology, Inc., and CareFusion Germany 234 GmbH, an
indirect wholly-owned subsidiary of CareFusion Corporation, dated April 29, 2010. |
|
|
|
|
|
|
10.10 |
|
|
Reciprocal Guaranty between CareFusion Corporation, in favor of Blitz F10-acht-drei-fünf
GmbH & Co. KG, and eResearchTechnology, Inc., in favor of
CareFusion Germany 234 GmbH, dated April 29, 2010. |
|
|
|
|
|
|
10.13 |
|
|
2010 Bonus Plan.* |
|
|
|
|
|
|
10.42 |
|
|
Management Employment Agreement effective March 1, 2010 between Dr. Joel Morganroth and the
Company.* |
|
|
|
|
|
|
10.46 |
|
|
Consultant Agreement effective March 1, 2010 between Joel Morganroth, M.D., P.C. and the
Company.* |
|
|
|
|
|
|
10.49 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Michael
McKelvey and the Company.* |
|
|
|
|
|
|
10.50 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Jeffrey S.
Litwin and the Company.* |
|
|
|
|
|
|
10.51 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Amy Furlong
and the Company.* |
|
|
|
|
|
|
10.56 |
|
|
Amendment to Management Employment Agreement effective March 17, 2010 between Keith D.
Schneck and the Company.* |
|
|
|
|
|
|
31.1 |
|
|
Certification of Chief Executive Officer. |
|
|
|
|
|
|
31.2 |
|
|
Certification of Chief Financial Officer. |
|
|
|
|
|
|
32.1 |
|
|
Statement of Chief Executive Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
|
|
|
|
|
|
32.2 |
|
|
Statement of Chief Financial Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
|
|
|
* |
|
Management contract or compensatory plan or arrangement. |
28