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, 2009
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 |
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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 þ
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Accelerated filer o
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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, $.01 par value, outstanding as of April 24, 2009, was
49,153,788.
eResearchTechnology, Inc. and Subsidiaries
INDEX
2
Part 1. Financial Information
Item 1. Financial Statements
eResearchTechnology, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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December 31, 2008 |
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March 31, 2009 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
66,376 |
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$ |
65,518 |
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Short-term investments |
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50 |
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50 |
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Accounts receivable, net |
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29,177 |
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21,676 |
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Prepaid income taxes |
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1,892 |
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1,818 |
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Prepaid expenses and other |
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2,885 |
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3,285 |
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Deferred income taxes |
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1,831 |
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1,703 |
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Total current assets |
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102,211 |
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94,050 |
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Property and equipment, net |
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29,639 |
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27,105 |
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Goodwill |
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34,603 |
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34,653 |
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Long-term investments |
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Intangible assets |
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2,149 |
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2,012 |
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Deferred income taxes |
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Other assets |
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520 |
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447 |
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Total assets |
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$ |
169,122 |
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$ |
158,267 |
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Liabilities and Stockholders Equity |
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Current Liabilities: |
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Accounts payable |
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$ |
3,971 |
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$ |
5,153 |
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Accrued expenses |
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8,140 |
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4,690 |
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Income taxes payable |
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2,492 |
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805 |
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Current portion of capital lease obligations |
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43 |
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Deferred revenues |
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12,276 |
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12,608 |
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Total current liabilities |
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26,922 |
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23,256 |
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Capital lease obligations, excluding current portion |
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Deferred rent |
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2,183 |
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2,296 |
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Deferred income taxes |
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1,332 |
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1,326 |
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Other liabilities |
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1,257 |
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1,117 |
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Total liabilities |
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31,694 |
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27,995 |
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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 $.01 par value, 175,000,000 shares authorized,
59,950,257 and 59,974,108 shares issued, respectively |
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600 |
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600 |
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Additional paid-in capital |
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93,828 |
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94,826 |
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Accumulated other comprehensive income (loss) |
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(2,716 |
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(2,948 |
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Retained earnings |
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110,479 |
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112,549 |
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Treasury stock, 8,686,868 and 10,652,320 shares at cost, respectively |
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(64,763 |
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(74,755 |
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Total stockholders equity |
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137,428 |
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130,272 |
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Total liabilities and stockholders equity |
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$ |
169,122 |
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$ |
158,267 |
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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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2008 |
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2009 |
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Net revenues: |
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Licenses |
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$ |
625 |
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$ |
709 |
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Services |
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25,273 |
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16,817 |
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Site support |
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7,775 |
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6,260 |
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Total net revenues |
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33,673 |
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23,786 |
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Costs of revenues: |
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Cost of licenses |
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200 |
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205 |
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Cost of services |
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10,514 |
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7,954 |
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Cost of site support |
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5,268 |
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3,635 |
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Total costs of revenues |
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15,982 |
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11,794 |
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Gross margin |
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17,691 |
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11,992 |
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Operating expenses: |
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Selling and marketing |
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3,323 |
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3,426 |
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General and administrative |
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4,873 |
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4,077 |
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Research and development |
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999 |
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1,149 |
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Total operating expenses |
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9,195 |
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8,652 |
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Operating income |
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8,496 |
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3,340 |
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Other income, net |
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427 |
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116 |
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Income before income taxes |
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8,923 |
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3,456 |
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Income tax provision |
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3,177 |
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1,386 |
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Net income |
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$ |
5,746 |
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$ |
2,070 |
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Basic net income per share |
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$ |
0.11 |
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$ |
0.04 |
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Diluted net income per share |
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$ |
0.11 |
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$ |
0.04 |
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Shares used to calculate basic net
income per share |
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50,638 |
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50,879 |
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Shares used to calculate diluted net
income per share |
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51,894 |
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51,164 |
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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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2008 |
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2009 |
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Operating activities: |
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Net income |
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$ |
5,746 |
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$ |
2,070 |
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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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4,344 |
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3,404 |
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Cost of sales of equipment |
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414 |
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7 |
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Provision for uncollectible accounts |
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30 |
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105 |
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Share-based compensation |
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470 |
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901 |
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Deferred income taxes |
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(362 |
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111 |
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Changes in
operating assets and liabilities: |
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Accounts receivable |
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(222 |
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7,331 |
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Prepaid expenses and other |
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(11 |
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(459 |
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Accounts payable |
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(984 |
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143 |
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Accrued expenses |
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(1,413 |
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(3,436 |
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Income taxes |
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63 |
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(1,601 |
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Deferred revenues |
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(344 |
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384 |
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Deferred rent |
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(135 |
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107 |
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Net cash provided by operating activities |
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7,596 |
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9,067 |
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Investing activities: |
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Purchases of property and equipment |
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(1,430 |
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(1,613 |
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Proceeds from sales of investments |
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455 |
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Payments for acquisition |
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(3,673 |
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Net cash used in investing activities |
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(4,648 |
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(1,613 |
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Financing activities: |
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Repayment of capital lease obligations |
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(751 |
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(43 |
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Proceeds from exercise of stock options |
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189 |
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59 |
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Stock option income tax benefit |
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103 |
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38 |
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Repurchase of common stock for treasury |
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(8,190 |
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Net cash used in financing activities |
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(459 |
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(8,136 |
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Effect of exchange rate changes on cash |
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(3 |
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(176 |
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Net increase (decrease) in cash and cash equivalents |
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2,486 |
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(858 |
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Cash and cash equivalents, beginning of period |
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38,082 |
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66,376 |
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Cash and cash equivalents, end of period |
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$ |
40,568 |
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$ |
65,518 |
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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, 2009 are not necessarily
indicative of the results that may be expected for the year ending December 31, 2009. 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, 2008 filed with the Securities and Exchange Commission
(SEC) and in this Form 10-Q.
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. Based upon managements view of our operations, we consider our business to consist of
one segment.
Reclassifications
The consolidated financial statements for prior periods have been reclassified to conform to
the current periods presentation.
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
We recognize revenues primarily from three sources: license fees, services and site support.
Our license revenues consist of license fees for perpetual license sales and monthly and annual
term license sales. Our services revenues consist of Cardiac Safety services and consulting,
technology consulting and training services and software maintenance services. Our site support
revenues consist of cardiac safety equipment rentals and sales along with related supplies and
freight.
We recognize software revenues in accordance with the Accounting Standards Executive Committee
Statement of Position (SOP) 97-2, Software Revenue Recognition, as amended by SOP 98-9,
Modification of SOP 97-2, Software Revenue Recognition, With Respect to Certain Transactions.
Accordingly, we recognize up-front license fee revenues under the residual method when a formal
agreement exists, delivery of the software and related documentation has occurred, collectability
is probable and the license fee is fixed or determinable. We recognize monthly and annual term
license fee revenues over the term of the arrangement. Hosting service fees are recognized evenly
over the term of the service. Cardiac Safety services revenues consist of services that we provide
on a fee for services basis and are recognized as the services are performed. We recognize
revenues from software maintenance contracts on a straight-line basis over the term of the
maintenance contract, which is typically twelve months. We provide consulting and training services
on a time and materials basis and recognize revenues as we perform the services. Site support
revenues are recognized over the rental period or at the time of sale.
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.
In these cases, 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 in
accordance with Emerging Issues Task Force (EITF) Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables. 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 in accordance with Emerging Issues Task Force (EITF)
Issue No. 01-14, Income Statement Characterization of Reimbursements Received for Out-of-Pocket
Expenses.
Revenue is recognized on unbilled services and relates to amounts that are currently not
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.
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, 2008 and 2009,
one client accounted for approximately 25% and 16% 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.
Short-term Investments
At March 31, 2009, short-term investments consisted of an auction rate security issued by a
government-sponsored agency. Pursuant to Statement of Financial Accounting Standards (SFAS) No.
115, Accounting for Certain Investments in Debt and Equity Securities, 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
investment at December 31, 2008 and March 31, 2009 as available-for-sale. At December 31, 2008 and
March 31, 2009, unrealized gains and losses were immaterial. Realized gains and losses during the
three months ended March 31, 2008 and 2009 were immaterial. For purposes of determining realized
gains and losses, the cost of the securities sold is based upon specific identification.
Property and Equipment
Pursuant to SOP 98-1, Accounting for the Costs of Computer Software Developed or Obtained for
Internal Use, 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 $0.7 million and $0.9 million for the
three-month periods ended March 31, 2008 and 2009, respectively. For the three-month periods ended
March 31, 2008 and 2009, we capitalized $0.6 million and $0.5 million, respectively, of software
development costs. As of March 31, 2009, $0.6 million of capitalized costs have not yet been
placed in service and are therefore not being amortized.
7
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 $35.2 million and $34.7 million at December
31, 2008 and March 31, 2009, respectively. The accumulated depreciation for cardiac safety
equipment was $25.0 million and $26.4 million at December 31, 2008 and March 31, 2009,
respectively.
Prior to 2007, a portion of our cardiac safety equipment was obtained under operating leases.
During the first quarter of 2007, we entered into an agreement to purchase all of our leased
cardiac safety equipment at an established price at the end of each lease schedules term, rather
than return the equipment at that time. As a result, in accordance with SFAS No. 13, Accounting
for Leases, we re-evaluated the classification of the leases and determined that the
classification should be converted from operating leases to capital leases. As a result, we
recorded a non-cash addition to property and equipment of $3.6 million and $3.6 million of capital
lease obligations. The final payment under these capital lease obligations was in March 2009.
Goodwill
We carry a significant amount of goodwill. In accordance with the provisions of SFAS No. 142,
Goodwill and Other Intangible Assets, 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 2008 or during the three months ended March
31, 2009.
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.
The carrying value of goodwill was $34.6 million and $34.7 million as of December 31, 2008 and
March 31, 2009, respectively. During the first three months of 2009, goodwill increased
approximately $0.1 million due to contingent payments related to the CCSS acquisition. Contingent
payments of approximately $0.1 million are included in accrued expenses at March 31, 2009. See
Note 4 for additional disclosure regarding the CCSS acquisition.
Long-lived Assets
In accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal
of 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, 2008 or March 31,
2009.
Software Development Costs
Research and development expenditures related to software development are charged to
operations as incurred. SFAS No. 86, Accounting for the Costs of Computer Software to be Sold,
Leased, or Otherwise Marketed, requires the capitalization of certain software development costs
subsequent to the establishment of technological feasibility. Since software development costs
have not been significant after the establishment of technological feasibility, all such costs have
been charged to expense as incurred.
8
Stock-Based Compensation
Accounting for Stock-Based Compensation
We apply the provisions of SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123R),
which requires that the costs resulting from all share-based payment transactions be recognized in
the financial statements at their fair values. The aggregate share-based compensation expense
recorded in the Consolidated Statements of Operations for the three month periods ended March 31,
2008 and 2009 under SFAS No. 123R were $0.5 million and $0.9 million, respectively.
Valuation Assumptions for Options Granted
The fair value of each stock option granted during the three months ended March 31, 2008 and
2009 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. 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.
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2009 |
|
Risk-free interest rate |
|
|
2.10 |
% |
|
|
1.33 |
% |
Expected life |
|
3.5 years |
|
|
3.5 years |
|
Expected volatility |
|
|
52.03 |
% |
|
|
63.97 |
% |
The above assumptions were used to determine the weighted-average per share fair value of
$4.76 and $2.13 for stock options granted during the first three months of 2008 and 2009,
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 3,375,000 shares of the Companys common
stock. 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. In May 1999, the stockholders approved an amendment to the 1996 Plan
that increased the number of shares which could be acquired through option grants under the 1996
Plan by 4,050,000 to 7,425,000 and provided for an annual option grant of 5,000 shares to each
outside director. In April 2001, the stockholders approved an amendment to the 1996 Plan that
increased the number of shares which could be acquired through option grants under the 1996 Plan by
2,025,000 to 9,450,000. 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.
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 2,151,980 shares available for grant as of March 31, 2009. The Company
normally issues new shares to satisfy option exercises under these plans.
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. On February 26, 2009,
concurrent with the approval of the annual grant of stock options to the executive officers and other employees, the
Board of Directors approved the award to each outside director of non-qualified options to purchase 22,000 shares
pursuant to the 2003 Equity Incentive Plan which were granted on March 2, 2009.
9
Information with respect to outstanding options under our plans is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
|
|
|
|
Average |
|
|
Term |
|
|
Value |
|
|
|
Shares |
|
|
Exercise Price |
|
|
(in years) |
|
|
(in thousands) |
|
Outstanding as of January 1, 2009 |
|
|
3,635,860 |
|
|
$ |
11.03 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,218,150 |
|
|
|
4.60 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(23,851 |
) |
|
|
2.49 |
|
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
(48,401 |
) |
|
|
18.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2009 |
|
|
4,781,758 |
|
|
$ |
9.37 |
|
|
|
5.3 |
|
|
$ |
2,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable or expected to vest at March 31, 2009 |
|
|
4,481,091 |
|
|
$ |
9.48 |
|
|
|
5.3 |
|
|
$ |
2,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at March 31, 2009 |
|
|
2,777,308 |
|
|
$ |
10.64 |
|
|
|
4.5 |
|
|
$ |
1,488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value in the 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 2009 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, 2009. 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, 2008 and 2009
was $0.4 million and $0.1 million, respectively.
As of March 31, 2009, 2,777,308 options with a weighted average exercise price of $10.64 per
share were exercisable under the 1996 Plan and the 2003 Plan.
As of March 31, 2009, there was $5.8 million of total unrecognized compensation cost related
to non-vested stock options granted under the plans. That cost is expected to be recognized over a
weighted-average period of 2.5 years.
Tax Effect Related to Stock-based Compensation Expense
SFAS No. 123R provides that 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, 2008 and
2009 related to stock-based compensation expense was approximately $0.1 million.
Note 3. Fair Value of Financial Instruments
SFAS No. 157, Fair Value Measurements, defines fair value, establishes a framework for
measuring fair value and expands the related disclosure requirements. This statement applies under
other accounting pronouncements that require or permit fair value measurements. The statement
indicates, among other things, that 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. SFAS
No. 157 defines fair value based upon an exit price model.
We adopted SFAS No. 157 as of January 1, 2008, with the exception of the application of the
statement to non-recurring nonfinancial assets and nonfinancial liabilities, which was delayed by
FSP FAS 157-2 to fiscal years beginning after November 15, 2008, which we therefore adopted as of
January 1, 2009. As of March 31, 2009, we do not have any significant non-recurring measurements of
nonfinancial assets and nonfinancial liabilities.
10
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, 2009
consisted of an auction rate security, or ARS, issued by a municipality. This security is included
in short-term investments in our consolidated balance sheets. SFAS No. 157 classifies the inputs
used to measure fair value into the following hierarchy:
|
|
|
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 |
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, 2008 and March 31,
2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at December 31, 2008 |
|
|
|
|
|
|
|
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 |
|
$ |
66,376 |
|
|
$ |
66,376 |
|
|
$ |
|
|
|
$ |
|
|
Auction rate securities |
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
66,426 |
|
|
$ |
66,376 |
|
|
$ |
|
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at March 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 |
|
$ |
65,518 |
|
|
$ |
65,518 |
|
|
$ |
|
|
|
$ |
|
|
Auction rate securities |
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
65,568 |
|
|
$ |
65,518 |
|
|
$ |
|
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 4. Business Combination
On November 28, 2007, we completed the acquisition of Covance Cardiac Safety Services, Inc.
(CCSS) from Covance Inc. (Covance). We have included CCSSs operating results in our Consolidated Statements of Operations
from the date of the acquisition. 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. We have additionally incurred approximately $1.1 million in
transaction costs. Through March 31, 2009, Covance earned $5.1 million of this contingent amount,
of which $3.0 million was recognized in 2007, $2.0 million in 2008 and $0.1 in the three months
ended March 31, 2009. At March 31, 2009, approximately $0.7 million of the contingent amount
earned remained to be paid to Covance which we recorded in accounts payable. These contingent
amounts increased goodwill by $5.1 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.
11
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
balances of our accrued liabilities relating to severance and lease costs associated with the
closing of CCSS operations, which are included in Accrued expenses and Other liabilities on our
Consolidated Balance Sheets (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease |
|
|
|
Severance |
|
|
Liability |
|
Balance at acquisition at November 28, 2007 |
|
$ |
1,165 |
|
|
$ |
900 |
|
Adjustments to previous estimates |
|
|
16 |
|
|
|
|
|
Cash payments |
|
|
(55 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
1,126 |
|
|
|
900 |
|
Additional reserve recorded |
|
|
21 |
|
|
|
|
|
Adjustments to previous estimates |
|
|
(255 |
) |
|
|
1,183 |
|
Cash payments |
|
|
(801 |
) |
|
|
(327 |
) |
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
91 |
|
|
|
1,756 |
|
Cash payments |
|
|
(61 |
) |
|
|
(140 |
) |
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
$ |
30 |
|
|
$ |
1,616 |
|
|
|
|
|
|
|
|
During the first three months of 2008 and 2009, goodwill was increased by $0.8 million and
$0.1 million, respectively. The $0.8 million was comprised of contingent payments to Covance of
$0.4 million and additional transaction costs of $0.4 million. The $0.1 million was comprised of
contingent payments to Covance. 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.
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, 2008 and 2009 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
Net Book |
|
|
Useful Life |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Value |
|
|
(in years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,269 |
|
|
$ |
631 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
182 |
|
|
|
1,518 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
1,851 |
|
|
$ |
2,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
Net Book |
|
|
Useful Life |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Value |
|
|
(in years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,364 |
|
|
$ |
536 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
224 |
|
|
$ |
1,476 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
$ |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
1,988 |
|
|
$ |
2,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
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, 2008 and 2009 was $451 and $137, respectively.
12
Estimated amortization expense for the remaining estimated useful life of the acquired
intangible assets is as follows for the years ending December 31 (the 2009 amount represents the
amortization expense to be recognized over the last nine months of the year):
|
|
|
|
|
|
|
Amortization of |
|
Years ending December 31, |
|
Intangible Assets |
|
2009 |
|
$ |
405 |
|
2010 |
|
|
431 |
|
2011 |
|
|
170 |
|
2012 |
|
|
170 |
|
2013 |
|
|
170 |
|
Thereafter |
|
|
666 |
|
|
|
|
|
Total |
|
$ |
2,012 |
|
|
|
|
|
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.
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 |
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
5,746 |
|
|
|
50,638 |
|
|
$ |
0.11 |
|
Effect of dilutive shares |
|
|
|
|
|
|
1,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
5,746 |
|
|
|
51,894 |
|
|
$ |
0.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
2,070 |
|
|
|
50,879 |
|
|
$ |
0.04 |
|
Effect of dilutive shares |
|
|
|
|
|
|
285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
2,070 |
|
|
|
51,164 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
In computing diluted net income per share, options to purchase 1,969,000 and 3,083,000 shares
of common stock were excluded from the computations for the three months ended March 31, 2008 and
2009, 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
SFAS No. 130, Reporting Comprehensive Income, requires companies 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 foreign currency translation as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2008 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
5,746 |
|
|
$ |
2,070 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
|
(3 |
) |
|
|
(232 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income, net of tax |
|
$ |
5,743 |
|
|
$ |
1,838 |
|
|
|
|
|
|
|
|
13
Note 8. Recent Accounting Pronouncements
In December of 2007, the FASB issued SFAS No. 141R, Business Combinations. SFAS 141R
requires the acquiring entity in a business combination to recognize all the assets acquired and
liabilities assumed in the transaction at fair value as of the acquisition date. SFAS 141R is
effective for business combinations for which the acquisition date is on or after the beginning of
the first annual reporting period beginning on or after December 15, 2008. We were required to
adopt SFAS No. 141R in the first quarter of 2009 prospectively. The impact of adopting SFAS 141R
will depend on the nature and terms of future acquisitions.
In April 2008, the FASB issued FASB Staff Position (FSP) No. 142-3, Determination of the
Useful Life of Intangible Assets. FSP 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. FSP 142-3 is
effective for fiscal years beginning after December 15, 2008. The adoption of FSP 142-3 did not
have an impact on our consolidated financial position, results of operations or cash flows.
Note 9. Income Taxes
We apply the provisions of FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (FIN 48) an interpretation of SFAS 109. We did not recognize any adjustment in the
liability for unrecognized income tax benefits as a result of the implementation of FIN 48. At the
adoption date, we had $0.8 million of unrecognized tax benefits, all of which would affect our
effective tax rate if recognized. At March 31, 2009, we had $0.5 million of unrecognized tax
benefits under the provisions of FIN 48. We recognize interest and penalties related to
unrecognized tax benefits in income tax expense. The tax years 2004 through 2007 remain open to
examination by the major taxing jurisdictions to which we are subject.
Our effective tax rate was 35.6% and 40.1% for the three months ended March 31, 2008 and 2009,
respectively. We had historically provided deferred taxes under APB 23 for the presumed ultimate
repatriation to the United States of earnings from our UK subsidiary. The indefinite reversal
criterion of APB 23 allows us to overcome that presumption to the extent the earnings are
indefinitely reinvested outside the United States. As of January 1, 2008, we determined that a
portion of our UK subsidiarys current undistributed net earnings, as well as the future net
earnings, will be permanently reinvested. As a result of the APB 23 change in assertion, we
reduced our deferred tax liabilities related to undistributed foreign earnings by $0.3 million
during the first quarter of 2008.
Note 10. Related Party Transactions
Our Chairman, Dr. Morganroth, is a cardiologist who provides medical professional services to
the Company as an independent contractor through his wholly-owned professional corporation.
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 ERT. 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 of the net amounts billed by ERT for Dr. Morganroths services to
our customers. That percentage was 80% beginning January 1, 2008. Revenues recorded in connection
with this consulting arrangement approximated $0.5 million and $0.4 million in the three months
ended March, 2008 and 2009, respectively. Fees incurred under this consulting arrangement
approximated $0.4 million and $0.3 million in the three months ended March, 2008 and 2009,
respectively. Total amounts payable incurred under this consulting arrangement approximated $0.5
million and $0.4 million in the three months ended March 31, 2008 and 2009, respectively. At March
31, 2008 and 2009, $0.1 million and $0.2 million, respectively, was owed to the professional
corporation in connection with the consulting agreement.
Note 11. Commitments and Contingencies
In the second quarter of 2007, we entered into 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, 2009, we paid HTS $1.5 million for
the license and $0.5 million in advanced payments against future royalties. As of March 31, 2009,
HTS earned royalties of $0.1 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. An additional $0.5 million royalty payment is guaranteed, and will be made in May
2009. Any royalties earned by HTS will be applied against these payments. After this May 2009
payment is made, all future payments to HTS will be solely based on royalty payments based on
revenues received from electronic patient reported outcomes (ePRO) sales.
On November 28, 2007, we completed the acquisition of CCSS. 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,
2009, Covance earned $5.1 million of this contingent amount, of which $3.0 million was recognized
in 2007, $2.0 million in the year ended December 31, 2008 and $0.1 million in the three months
ended March 31, 2009. At March 31, 2009, approximately $0.7 million of the contingent amount
earned remained to be paid to Covance, which we recorded in accounts payable. These contingent
payments increased goodwill by $5.1 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.
14
We fully integrated the operations of CCSS into our existing operations in the third quarter
of 2008. We did so by merging CCSSs Reno, Nevada based operations into our existing operations
and closing the operations in Reno. Costs identified at the date of the acquisition as part of this
closing were estimated to be $1.2 million for severance and $0.9 million for lease costs. The
actual final severance amount was $0.9 million. The estimated lease costs have been adjusted to
$2.1 million based on further analysis in 2008. In accordance with Emerging Issues Task Force
(EITF) No. 95-3, Recognition of Liabilities in Connection with a Purchase Business Combination,
these amounts have been recognized as a liability as of the date of the acquisition and included in
the cost of the acquisition. Other costs such as stay pay incentive arrangements and other related
period costs associated with the closing of the Reno location were expensed in the period when such
costs were incurred. The stay pay incentive arrangements of $1.2 million were recognized as expense
over the required service period of the employees. The expense recognized for the stay pay
incentive for the year ended December 31, 2008 was $1.0 million.
Note 12. Operating Segments / Geographic Information
We consider our business to consist of one segment as this represents managements view of our
operations. Until we closed the Reno operation in the third quarter of 2008, we operated on a
worldwide basis with three 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, 2008 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
America |
|
|
Europe |
|
|
Total |
|
License revenues |
|
$ |
625 |
|
|
$ |
|
|
|
$ |
625 |
|
Service revenues |
|
|
21,210 |
|
|
|
4,063 |
|
|
|
25,273 |
|
Site support revenues |
|
|
5,131 |
|
|
|
2,644 |
|
|
|
7,775 |
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
$ |
26,966 |
|
|
$ |
6,707 |
|
|
$ |
33,673 |
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
6,850 |
|
|
$ |
1,646 |
|
|
$ |
8,496 |
|
Long-lived assets |
|
$ |
24,424 |
|
|
$ |
6,402 |
|
|
$ |
30,826 |
|
Total assets |
|
$ |
131,325 |
|
|
$ |
16,077 |
|
|
$ |
147,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2009 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
America |
|
|
Europe |
|
|
Total |
|
License revenues |
|
$ |
709 |
|
|
$ |
|
|
|
$ |
709 |
|
Service revenues |
|
|
14,595 |
|
|
|
2,222 |
|
|
|
16,817 |
|
Site support revenues |
|
|
4,443 |
|
|
|
1,817 |
|
|
|
6,260 |
|
|
|
|
|
|
|
|
|
|
|
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 |
|
15
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Statement for Forward-Looking Information
The following discussion and analysis should be read in conjunction with our consolidated
financial statements and the related notes to the consolidated financial statements appearing
elsewhere in this Form 10-Q. The following discussion and analysis includes forward-looking
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; integration of future acquisitions;
competitive factors; 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
We were founded in 1977 to provide Cardiac Safety solutions to evaluate the safety of new
drugs. 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 EDC and ePRO products and solutions.
Our license revenues consist of license fees for perpetual license sales and monthly and
annual term license sales for our software products offered under our EDC solutions and ePRO
solutions. Our services revenues consist of our services offered under our Cardiac Safety
solutions, technology consulting and training services and software maintenance services. The
technology consulting and training services and software maintenance services are related to our
EDC and ePRO solutions. Our site support revenue consists of cardiac safety equipment rentals and
sales along with related supplies and logistics management.
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 companies,
biotechnology companies, 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 generally required 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. Additionally, under our EDC
solutions, we offer the licensing and, at the clients option, hosting of our proprietary software
products and the provision of maintenance and consulting services in support of these products. We
also offer ePRO solutions along with proprietary clinical assessments. 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.
16
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.
EDC. The process of designing, implementing and managing a clinical trial requires a well
defined process and set of supporting products to effectively handle the variety of tasks and
information comprising a clinical trial. We provide a suite of products to address the
capture, management and dissemination of clinical trial data. Our integrated suite is
comprised of the following:
Portal is an easy to use portal application enabling clinical trial researchers and
staff to gain real-time access to study dashboards, progress reports, folders and forums
enabling efficient management and communication of study progress.
EDC Now! technology provides a comprehensive electronic data capture (EDC) system
comprised of technology and consulting services formulated to deliver rapid time to start for
electronic trial initiatives.
Data Management is a clinical data management application for collecting, cleaning and
managing clinical trial data.
Adverse Event Reporting is an adverse event management system enabling the generation
of key regulatory reports, including CIOMS and Medwatch.
Trial Management is a clinical trial management technology that can be used to set up
clinical trials, establish standards, track study activities, plan resources, distribute
supplies, manage the financial aspects of a trial and electronically view clinical trial data.
ePRO. Our electronic patient reported outcome (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.
We recognize software revenues in accordance with Statement of Position (SOP) 97-2, Software
Revenue Recognition, as amended by SOP 98-9, Modification of SOP 97-2, Software Revenue
Recognition, With Respect to Certain Transactions. Accordingly, we recognize up-front license fee
revenues under the residual method when a formal agreement exists, delivery of the software and
related documentation has occurred, collectability is probable and the license fee is fixed or
determinable. We recognize monthly and annual license fee revenues over the term of the
arrangement. Hosting service fees are recognized evenly over the term of service. Cardiac Safety
services revenues consist of services that we provide on a fee for services basis and are
recognized as the services are performed. We recognize revenues from software maintenance
contracts on a straight-line basis over the term of the maintenance contract, which is typically
twelve months. We provide consulting and training 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.
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 in
accordance with Emerging Issues Task Force (EITF) Issue No. 00-21, Revenue Arrangements with
Multiple Deliverables. 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 in accordance with EITF Issue No. 01-14, Income
Statement Characterization of Reimbursements Received for Out-of-Pocket Expenses.
17
Revenue is recognized on unbilled services and relates to amounts that are currently not
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.
Cost of licenses consists primarily of application service provider (ASP) fees for those
clients that choose hosting, the cost of producing compact disks and related documentation and
royalties paid to third parties in connection with their contributions to our product development.
Cost of services includes the cost of Cardiac Safety services and the cost of technology
consulting, training and maintenance services. Cost of Cardiac Safety 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
technology consulting, training and maintenance services consists primarily of wages, fees paid to
outside consultants and other direct operating costs related to our consulting and client support
functions. 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, legal 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 direct costs associated with the development of our technology products.
We conduct our operations through offices in the United States (U.S.) and the United Kingdom
(UK). Our international net revenues represented approximately 20% and 17% of total net revenues
for the three months ended March 31, 2008 and 2009, respectively. The majority of our revenues are
allocated among our geographic segments based upon the profit split transfer pricing methodology,
and revenues are generally attributed to the geographic segment where the work is performed. The
profit split methodology equalizes gross margins for each legal entity based upon its respective
direct costs.
18
Results of Operations
Executive Overview
Net revenues were $23.8 million for the first quarter of 2009, a decrease of $9.9 million or
29.4% from $33.7 million in the first quarter of 2008. The year over year revenue decline is due
to a decline in transaction volumes in both Thorough QTc and routine studies, lower revenue from
acquired backlog of Covance Cardiac Safety Services, Inc. (CCSS) as this backlog nears completion
and less equipment sales in the first quarter of 2009 than in the first quarter of 2008.
Gross margin percentage in the first quarter of 2009 was 50.4% compared to 52.5% in the first
quarter of 2008. Gross margin percentage is significantly impacted by volume. The negative
impacts of volume on the gross margin percentage compared to the prior years quarter was partially
offset by the elimination of legacy costs associated with processing the CCSS backlog during the
period we integrated their operations and lower depreciation and amortization.
Operating income for the first quarter of 2009 was $3.3 million or 14.0% of total net revenues
as compared to $8.5 million or 25.2% of total net revenues in the first quarter of 2008. Total
expenses were $20.4 million in the first quarter of 2009, a decrease of $4.8 million from $25.2
million in the first quarter of 2008. Our tax rate for the first quarter of 2009 was 40.1% as
compared to 35.6% in the first quarter of 2008.
Net income for the first quarter of 2009 was $2.1 million as compared to $5.7 million in the
first quarter of 2008. This resulted in net income per diluted share of $0.04 in the first quarter
of 2009 as compared to $0.11 in the first quarter of 2008.
General business and economic conditions have deteriorated globally since the fourth quarter
of 2008. Starting in the fourth quarter of 2008, we have experienced an increased focus in Phase
III opportunities, a decline in the number of Thorough QTc bookings, and a delay in starts for
certain Thorough QTc trials and we believe these trends will continue through at least the first
half of fiscal 2009. We believe the increase in Phase III opportunities will provide us with a
base of business into the future, however this business will take longer to turn into revenue. We
believe that the delays in Thorough QTc trials are related to timing as the result of the uncertain
economic environment, especially in small to midsize customers. Thorough QTc trials are generally required to be
performed due to regulatory guidance, however the timing of when these trials are done is
discretionary. We also experienced an increase in awards of new and expanded exclusive or
near-exclusive long-term enterprise relationships with large pharmaceutical companies during the
latter portion of fiscal 2008 and also continuing into the first quarter of 2009, including several
that we had very little business with in the past. Overall, we believe the fundamental drivers of
our core business remain positive. However, a continued weakened global economy could have a
negative impact on future results of operations.
19
The following table presents certain financial data as a percentage of total net revenues:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2008 |
|
|
2009 |
|
Net revenues: |
|
|
|
|
|
|
|
|
Licenses |
|
|
1.9 |
% |
|
|
3.0 |
% |
Services |
|
|
75.0 |
|
|
|
70.7 |
|
Site support |
|
|
23.1 |
|
|
|
26.3 |
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
|
|
|
100.0 |
|
|
|
|
|
|
|
|
Costs of revenues: |
|
|
|
|
|
|
|
|
Cost of licenses |
|
|
0.6 |
|
|
|
0.9 |
|
Cost of services |
|
|
31.2 |
|
|
|
33.4 |
|
Cost of site support |
|
|
15.7 |
|
|
|
15.3 |
|
|
|
|
|
|
|
|
Total costs of revenues |
|
|
47.5 |
|
|
|
49.6 |
|
|
|
|
|
|
|
|
Gross margin |
|
|
52.5 |
|
|
|
50.4 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
9.9 |
|
|
|
14.4 |
|
General and administrative |
|
|
14.4 |
|
|
|
17.2 |
|
Research and development |
|
|
3.0 |
|
|
|
4.8 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
27.3 |
|
|
|
36.4 |
|
|
|
|
|
|
|
|
Operating income |
|
|
25.2 |
|
|
|
14.0 |
|
Other income, net |
|
|
1.3 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
26.5 |
|
|
|
14.5 |
|
Income tax provision |
|
|
9.4 |
|
|
|
5.8 |
|
|
|
|
|
|
|
|
Net income |
|
|
17.1 |
% |
|
|
8.7 |
% |
|
|
|
|
|
|
|
20
Three Months Ended March 31, 2008 Compared to Three Months Ended March 31, 2009.
The following table presents our consolidated statements of operations with product line
detail (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
2008 |
|
|
2009 |
|
|
Increase (Decrease) |
|
Licenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
625 |
|
|
$ |
709 |
|
|
$ |
84 |
|
|
|
13.4 |
% |
Costs of revenues |
|
|
200 |
|
|
|
205 |
|
|
|
5 |
|
|
|
2.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
425 |
|
|
$ |
504 |
|
|
$ |
79 |
|
|
|
18.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac Safety |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
23,784 |
|
|
$ |
15,617 |
|
|
$ |
(8,167 |
) |
|
|
(34.3 |
%) |
Costs of revenues |
|
|
9,865 |
|
|
|
7,377 |
|
|
|
(2,488 |
) |
|
|
(25.2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
13,919 |
|
|
$ |
8,240 |
|
|
$ |
(5,679 |
) |
|
|
(40.8 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Technology consulting and training |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
706 |
|
|
$ |
398 |
|
|
$ |
(308 |
) |
|
|
(43.6 |
%) |
Costs of revenues |
|
|
427 |
|
|
|
363 |
|
|
|
(64 |
) |
|
|
(15.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
279 |
|
|
$ |
35 |
|
|
$ |
(244 |
) |
|
|
(87.5 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Software maintenance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
783 |
|
|
$ |
802 |
|
|
$ |
19 |
|
|
|
2.4 |
% |
Costs of revenues |
|
|
222 |
|
|
|
214 |
|
|
|
(8 |
) |
|
|
(3.6 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
561 |
|
|
$ |
588 |
|
|
$ |
27 |
|
|
|
4.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
25,273 |
|
|
$ |
16,817 |
|
|
$ |
(8,456 |
) |
|
|
(33.5 |
%) |
Costs of revenues |
|
|
10,514 |
|
|
|
7,954 |
|
|
|
(2,560 |
) |
|
|
(24.3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
14,759 |
|
|
$ |
8,863 |
|
|
$ |
(5,896 |
) |
|
|
(39.9 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Site support: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
7,775 |
|
|
$ |
6,260 |
|
|
$ |
(1,515 |
) |
|
|
(19.5 |
%) |
Costs of revenues |
|
|
5,268 |
|
|
|
3,635 |
|
|
|
(1,633 |
) |
|
|
(31.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
2,507 |
|
|
$ |
2,625 |
|
|
$ |
118 |
|
|
|
4.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
33,673 |
|
|
$ |
23,786 |
|
|
$ |
(9,887 |
) |
|
|
(29.4 |
%) |
Costs of revenues |
|
|
15,982 |
|
|
|
11,794 |
|
|
|
(4,188 |
) |
|
|
(26.2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
17,691 |
|
|
|
11,992 |
|
|
|
(5,699 |
) |
|
|
(32.2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
3,323 |
|
|
|
3,426 |
|
|
|
103 |
|
|
|
3.1 |
% |
General and administrative |
|
|
4,873 |
|
|
|
4,077 |
|
|
|
(796 |
) |
|
|
(16.3 |
%) |
Research and development |
|
|
999 |
|
|
|
1,149 |
|
|
|
150 |
|
|
|
15.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
9,195 |
|
|
|
8,652 |
|
|
|
(543 |
) |
|
|
(5.9 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
8,496 |
|
|
|
3,340 |
|
|
|
(5,156 |
) |
|
|
(60.7 |
%) |
Other income, net |
|
|
427 |
|
|
|
116 |
|
|
|
(311 |
) |
|
|
(72.8 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
8,923 |
|
|
|
3,456 |
|
|
|
(5,467 |
) |
|
|
(61.3 |
%) |
Income tax provision |
|
|
3,177 |
|
|
|
1,386 |
|
|
|
(1,791 |
) |
|
|
(56.4 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
5,746 |
|
|
$ |
2,070 |
|
|
$ |
(3,676 |
) |
|
|
(64.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21
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, |
|
|
Increase |
|
|
|
2008 |
|
|
2009 |
|
|
(Decrease) |
|
Cost of licenses |
|
|
32.0 |
% |
|
|
28.9 |
% |
|
|
(3.1 |
%) |
Cost of services: |
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac Safety |
|
|
41.5 |
% |
|
|
47.2 |
% |
|
|
5.7 |
% |
Technology consulting and training |
|
|
60.5 |
% |
|
|
91.2 |
% |
|
|
30.7 |
% |
Software maintenance |
|
|
28.4 |
% |
|
|
26.7 |
% |
|
|
(1.7 |
%) |
Total cost of services |
|
|
41.6 |
% |
|
|
47.3 |
% |
|
|
5.7 |
% |
Cost of site support |
|
|
67.8 |
% |
|
|
58.1 |
% |
|
|
(9.7 |
%) |
Total costs of revenues |
|
|
47.5 |
% |
|
|
49.6 |
% |
|
|
2.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
9.9 |
% |
|
|
14.4 |
% |
|
|
4.5 |
% |
General and administrative |
|
|
14.4 |
% |
|
|
17.1 |
% |
|
|
2.7 |
% |
Research and development |
|
|
3.0 |
% |
|
|
4.8 |
% |
|
|
1.8 |
% |
Revenues
The decrease in Cardiac Safety services revenues was primarily due to a $6.3 million reduction
in transactions performed in the three months ended March 31, 2009 as compared to the three months
ended March 31, 2008 and due to a decrease of $1.8 million of CCSS backlog revenue recognized as
these studies reach completion. The impact of CCSS backlog revenue is expected to continue to
decrease in significance as these studies reach completion. There was also a decrease in average
revenue per transaction that was largely due to a heavier weighting of semi-automatic studies which
carry lower transaction prices which resulted in a decrease in revenue of approximately $0.6
million. Partially offsetting these decreases was $0.5 million resulting from a change in
classification of reporting configuration revenue that was previously included in technology
consulting and training revenue. As of January 1, 2009, we include reporting configuration as
part of our package of Cardiac Safety services.
Technology consulting and training revenues decreased due to a change in revenue
classification as discussed above.
Site support revenues decreased primarily due to a $0.8 million decrease in equipment sales as
more customers choose to rent cardiac safety equipment and a $0.5 million decrease in rental
revenue from cardiac safety equipment due to a lower average price per unit. The lower average price per unit is a result of planned
actions that we have recently taken to improve our competitiveness with regard to this component of our revenue.
Costs of Revenues
The decrease in the cost of Cardiac Safety services was primarily due to $2.1 million of costs
recognized in the first quarter of 2008 associated with the CCSS operations. We successfully
completed the integration of the CCSS acquisition in the third quarter of 2008 with the complete
transfer of all operating activities from the CCSS Reno facility into our operations in
Philadelphia and Peterborough. Additionally, amortization of intangible assets decreased $0.3
million as result of certain assets becoming fully amortized, telecommunications costs decreased
$0.2 million due to negotiated adjustments related to contract renewals and bonus expense decreased
$0.2 million due to reduced accruals based on operating results. Partially offsetting the decrease
was a $0.4 million increase in labor costs related to additional staff added in 2008 and market
adjustments to salaries made in 2009. The increase in the cost of Cardiac Safety services as a
percentage of Cardiac Safety 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 $0.8 million decrease in depreciation expense as older,
more expensive ECG equipment has become fully depreciated and a $0.4 million decrease in the cost
of equipment sold due to lower equipment sales. Additional decreases totaling $0.4 million
occurred in freight, costs associated with the CCSS operations in 2008, supplies and other
expenses.
Operating Expenses
The increase in selling and marketing expenses, both in absolute terms and as a percentage of
total net revenue, was due primarily to a $0.2 million increase in advertising and marketing, $0.1
million of consulting costs and $0.1 million comprised of a number of smaller cost increases,
partially offset by a $0.3 million decrease in incentive compensation consistent with lower levels
of revenue.
The decrease in general and administrative expenses was due primarily to $1.3 million of costs
recognized in the first quarter of 2008 resulting from including the administrative costs of CCSS
in 2008 for which there were no corresponding costs in the first quarter of 2009. This decrease
was partially offset by a $0.4 million increase in stock option compensation expense which was
largely the result of
a grant of stock options to directors in the first quarter of 2009. The 2008 stock option
grant to directors occurred in the second quarter of 2008. The increase in general and
administrative expenses as a percentage of total net revenues reflects the fact that the costs do
not necessarily change in direct relation with changes in revenue.
22
The increase in research and development expenses, both in absolute terms and as a percentage
of total net revenues, was primarily due to $0.1 million reduction in the capitalization of
salaries for internal-use software projects and a $0.1 million increase in expense for third-party
consultants. Partially offsetting the increase was a $0.1 million decrease in bonus expense.
Other income, net, consisted primarily of interest income of $0.3 million and $0.0 million for
the three months ended March 31, 2008 and 2009, respectively, realized from our cash, cash
equivalents and investments and foreign exchange gains of $0.1 million in each of the three months
ended March 31, 2008 and 2009. Interest income decreased primarily due to significantly lower
average interest rates in the three months ended March 31, 2009 as compared to the three months
ended March 31, 2008.
Our effective tax rate for the three months ended March 31, 2009 was 40.1% compared to 35.6%
for the three months ended March 31, 2008. The effective tax rate for the three months ended March
31, 2008 included a benefit of $0.3 million related to our determination that a portion of our UK
subsidiarys current undistributed net earnings, as well as the future net earnings, will be
permanently reinvested. The effective tax rate for the three months ended March 31, 2008 also
included a benefit from tax-free interest income which declined significantly in the three months
ended March 31, 2009.
Liquidity and Capital Resources
At March 31, 2009, we had $65.6 million of cash, cash equivalents and short-term investments.
We had historically placed our investments in 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. Due to the current financial market conditions, we have invested
primarily in liquid money market funds.
For the three months ended March 31, 2009, our operations provided cash of $9.1 million
compared to $7.6 million during the three months ended March 31, 2008. The change was primarily the
result of a decrease in accounts receivable in the three months ended March 31, 2009 of $7.3
million as compared to an increase of $0.2 million in the three months ended March 31, 2008 related
to focused collection efforts and a decrease in revenue. Partially offsetting this positive
impacts on cash flow was $3.7 million of lower net income in the three months ended March 31, 2009
as compared to the three months ended March 31, 2008 and a $2.0 million larger decrease in accrued
expenses in the three months ended March 31, 2009 as compared to the three months ended March 31,
2008 which was largely the result of the payment of a greater amount in 2009 for bonuses related to
the prior years results. Changes in income taxes, including deferred income taxes, are due to the
timing and size of income tax payments and provision. The tax provision decreased in 2009 due to
lower taxable income, but at a higher effective tax rate.
For the three months ended March 31, 2009, our investing activities used cash of $1.6 million
as compared to $4.6 million during the three months ended March 31, 2008. $3.7 million was
incurred in the first three months of 2008 for contingent payments and transaction costs related to
the CCSS acquisition for which there were no corresponding amounts in the first three months of
2009.
During the three months ended March 31, 2009 and 2008, we purchased $1.6 million and $1.4
million, respectively, of property and equipment. Included in property and equipment is $0.5
million and $0.6 million for the three months ended March 31, 2009 and 2008, respectively, of
internal use software including software associated with the development of a data and
communications management services software product (EXPERT®) used in connection with our
centralized core cardiac safety ECG services. We capitalize certain internal use software costs in
accordance with Statement of Position (SOP) 98-1, Accounting for Costs of Computer Software for
Internal Use. The amortization is charged to the cost of Cardiac Safety services beginning at the
time the software is ready for its intended use.
For the three months ended March 31, 2009, our financing activities used cash of $8.1 million
compared to $0.5 million for the three months ended March 31, 2008. In 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, 2008.
We have a line of credit arrangement with Wachovia Bank, National Association totaling $3.0
million which expires on June 1, 2009. We expect to renew this line of credit at similar terms in
the second quarter of 2009. To date, we have not borrowed any amounts under our line of credit.
As of March 31, 2009, 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 expect that existing cash and cash equivalents and cash flows from operations will be
sufficient to meet our foreseeable cash needs for at least the next year. However, 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.
23
Our board of directors has authorized the repurchase of up to an aggregate of 12.5 million
shares, of which 5.9 million shares remain to be purchased as of March 31, 2009. 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, of which $1.8 million was recorded in accounts payable at
March 31, 2009. Subsequent to March 31, 2009, an additional 168,000 shares were purchased for $0.9
million. No shares were purchased during the three months ended March 31, 2008.
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
have additionally incurred approximately $1.1 million in transaction costs. 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,
2009, Covance earned $5.1 million of this contingent amount, of which $3.0 million was recognized
in 2007, $2.0 million in the year ended December 31, 2008 and $0.1 million in the three months
ended March 31, 2009. At March 31, 2009, approximately $0.7 million of the contingent amount
earned remained to be paid to Covance, which we recorded in accounts payable. These contingent
payments increased goodwill by $5.1 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.
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 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. Due to the current financial market
conditions, we have invested primarily in liquid money market funds. We will continue to monitor
conditions and look for prudent investment opportunities. 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, 2009 by approximately
$0.1 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, 2009
that have materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
24
Part II. Other Information
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table provides information regarding the stock
buy-back activity during the fiscal quarter ended March 31, 2009:
ISSUER PURCHASES OF EQUITY SECURITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(c) Total Number of |
|
|
(d) Maximum Number of |
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased as Part |
|
|
Shares that May Yet Be |
|
|
|
(a) Total Number of |
|
|
(b) Average Price |
|
|
of Publicly Announced |
|
|
Purchased Under the |
|
Period |
|
Shares Purchased |
|
|
Paid per Share |
|
|
Plans
or Programs (1) |
|
|
Plans or Programs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 2009 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
7,875,651 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
February 2009 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
7,875,651 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2009 |
|
|
1,965,452 |
|
|
$ |
5.05 |
|
|
|
1,965,452 |
|
|
|
5,910,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,965,452 |
|
|
|
|
|
|
|
1,965,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
We originally announced a
program to repurchase up to 500,000 shares on April 21, 2004,
and subsequently announced increases of 2.0 million and
10.0 million shares on October 20, 2004 and May 3,
2005, respectively. Through March 31, 2009, we have repurchased
6.6 million shares of the 12.5 million shares approved for
repurchase. |
Item 6. Exhibits
|
|
|
|
|
|
10.14 |
|
|
2009 Bonus Plan.* |
|
|
|
|
|
|
10.32 |
|
|
First
Amendment to the Amended and Restated 2003 Equity Incentive Plan.* |
|
|
|
|
|
|
10.45 |
|
|
Management Employment Agreement effective August 31, 2004 between Amy Furlong and the Company.* |
|
|
|
|
|
|
10.57 |
|
|
Management Employment Agreement effective January 1, 2009 between Dr. Joel Morganroth and the Company.* |
|
|
|
|
|
|
10.58 |
|
|
Consultant Agreement effective January 1, 2009 between Dr. Joel Morganroth 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. |
25
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.
|
|
|
|
|
|
eResearchTechnology, Inc.
(Registrant)
|
|
Date: May 8, 2009 |
By: |
/s/
Michael J. McKelvey |
|
|
|
Michael J. McKelvey |
|
|
|
President and Chief Executive Officer,
(Principal executive officer) |
|
|
|
|
Date: May 8, 2009 |
By: |
/s/
Keith D. Schneck |
|
|
|
Keith D. Schneck |
|
|
|
Executive Vice President, Chief Financial
Officer and Secretary
(Principal financial and
accounting officer) |
|
26
EXHIBIT INDEX
|
|
|
|
|
|
Exhibit No. |
|
|
Exhibit |
|
|
10.14 |
|
|
2009 Bonus Plan.* |
|
|
|
|
|
|
10.32 |
|
|
First
Amendment to the Amended and Restated 2003 Equity Incentive Plan.* |
|
|
|
|
|
|
10.45 |
|
|
Management Employment Agreement effective August 31, 2004 between Amy Furlong and the
Company.* |
|
|
|
|
|
|
10.57 |
|
|
Management Employment Agreement effective January 1, 2009 between Dr. Joel Morganroth and
the Company.* |
|
|
|
|
|
|
10.58 |
|
|
Consultant Agreement effective January 1, 2009 between Dr. Joel Morganroth 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.
27