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 September 30, 2010
or
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o |
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Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transitional period from to
Commission file number: 0-29100
eResearchTechnology, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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22-3264604 |
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(State or other jurisdiction of incorporation
or organization)
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(I.R.S. Employer Identification No.) |
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1818 Market Street
Philadelphia, PA
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19103 |
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(Address of principal executive offices)
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(Zip code) |
215-972-0420
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes
o No
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date.
The number of shares of Common Stock, $.01 par value, outstanding as of October 22, 2010, was
49,057,842.
eResearchTechnology, Inc. and Subsidiaries
INDEX
2
Part 1. Financial Information
Item 1. Financial Statements
eResearchTechnology, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(unaudited)
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December 31, 2009 |
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September 30, 2010 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
68,979 |
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$ |
19,333 |
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Short-term investments |
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9,782 |
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50 |
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Investment in marketable securities |
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1,026 |
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648 |
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Accounts receivable, less allowance for doubtful accounts of
$548 and $785, respectively |
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16,579 |
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37,225 |
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Inventory |
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3,879 |
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Prepaid income taxes |
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2,698 |
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2,989 |
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Prepaid expenses and other |
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3,308 |
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5,516 |
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Deferred income taxes |
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1,649 |
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2,411 |
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Total current assets |
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104,021 |
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72,051 |
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Property and equipment, net |
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24,205 |
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41,809 |
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Goodwill |
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34,676 |
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71,613 |
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Intangible assets |
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1,607 |
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19,565 |
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Other assets |
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352 |
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513 |
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Total assets |
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$ |
164,861 |
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$ |
205,551 |
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Liabilities and Stockholders Equity |
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Current Liabilities: |
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Accounts payable |
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$ |
3,007 |
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$ |
3,874 |
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Accrued expenses |
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5,990 |
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13,499 |
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Income taxes payable |
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346 |
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Deferred revenues |
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11,728 |
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13,283 |
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Total current liabilities |
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21,071 |
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30,656 |
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Deferred rent |
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2,357 |
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2,220 |
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Deferred income taxes |
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2,502 |
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2,098 |
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Long-term debt |
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21,000 |
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Other liabilities |
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1,259 |
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2,220 |
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Total liabilities |
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27,189 |
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58,194 |
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Commitments and contingencies |
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Stockholders Equity: |
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Preferred stock $10.00 par value, 500,000 shares authorized,
none issued and outstanding |
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Common stock $.01 par value, 175,000,000 shares authorized,
60,189,235 and 60,453,270 shares issued, respectively |
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602 |
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604 |
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Additional paid-in capital |
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97,367 |
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99,723 |
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Accumulated other comprehensive loss |
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(1,580 |
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(4 |
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Retained earnings |
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121,166 |
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126,917 |
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Treasury stock, 11,589,603 shares at cost |
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(79,883 |
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(79,883 |
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Total stockholders equity |
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137,672 |
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147,357 |
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Total liabilities and stockholders equity |
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$ |
164,861 |
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$ |
205,551 |
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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 September 30, |
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Nine Months Ended September 30, |
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2009 |
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2010 |
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2009 |
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2010 |
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Net revenues: |
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Services |
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$ |
15,969 |
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$ |
25,929 |
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$ |
48,292 |
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$ |
59,461 |
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Site support |
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6,757 |
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19,199 |
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19,895 |
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36,631 |
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EDC licenses and services |
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2,501 |
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Total net revenues |
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22,726 |
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45,128 |
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70,688 |
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96,092 |
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Costs of revenues: |
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Cost of services |
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7,577 |
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13,526 |
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22,941 |
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29,162 |
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Cost of site support |
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3,418 |
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11,505 |
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10,523 |
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19,261 |
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Cost of EDC licenses and services |
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863 |
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Total costs of revenues |
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10,995 |
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25,031 |
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34,327 |
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48,423 |
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Gross margin |
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11,731 |
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20,097 |
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36,361 |
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47,669 |
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Operating expenses: |
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Selling and marketing |
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3,056 |
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4,478 |
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9,756 |
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11,827 |
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General and administrative |
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2,977 |
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7,780 |
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10,581 |
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22,278 |
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Research and development |
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989 |
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1,250 |
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3,131 |
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3,177 |
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Total operating expenses |
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7,022 |
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13,508 |
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23,468 |
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37,282 |
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Operating income |
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4,709 |
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6,589 |
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12,893 |
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10,387 |
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Foreign exchange losses |
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(173 |
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(1,745 |
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(543 |
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(1,267 |
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Other income (expense), net |
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91 |
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(199 |
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168 |
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(181 |
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Income before income taxes |
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4,627 |
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4,645 |
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12,518 |
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8,939 |
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Income tax provision |
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1,808 |
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1,472 |
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5,081 |
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3,188 |
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Net income |
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$ |
2,819 |
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$ |
3,173 |
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$ |
7,437 |
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$ |
5,751 |
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Net income per share: |
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Basic |
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$ |
0.06 |
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$ |
0.06 |
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$ |
0.15 |
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$ |
0.12 |
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Diluted |
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$ |
0.06 |
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$ |
0.06 |
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$ |
0.15 |
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$ |
0.12 |
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Shares used in computing net income per share: |
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Basic |
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48,452 |
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48,860 |
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49,399 |
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48,789 |
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Diluted |
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48,755 |
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49,258 |
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49,698 |
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49,162 |
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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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Nine Months Ended September 30 |
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2009 |
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2010 |
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Operating activities: |
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Net income |
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$ |
7,437 |
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$ |
5,751 |
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Adjustments to reconcile net income to net cash
provided by operating activities: |
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Gain on sale of EDC operations |
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(530 |
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Depreciation and amortization |
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9,694 |
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12,753 |
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Cost of sales of equipment |
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93 |
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767 |
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Provision for uncollectible accounts |
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210 |
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Share-based compensation |
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2,145 |
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2,048 |
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Deferred income taxes |
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347 |
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(1,043 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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12,516 |
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(6,429 |
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Inventory |
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(984 |
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Prepaid expenses and other |
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(1,269 |
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(640 |
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Accounts payable |
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(69 |
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1,622 |
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Accrued expenses |
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(3,728 |
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5,145 |
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Income taxes |
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(2,955 |
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(1,125 |
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Deferred revenues |
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588 |
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1,153 |
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Deferred rent |
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211 |
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(225 |
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Net cash provided by operating activities |
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24,690 |
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18,793 |
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Investing activities: |
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Purchases of property and equipment |
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(3,567 |
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(15,987 |
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Purchases of investments |
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(999 |
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Proceeds from sales of investments |
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10,731 |
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Payment related to sale of EDC operations |
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(1,150 |
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Payments for acquisitions |
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(655 |
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(82,789 |
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Net cash used in investing activities |
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(5,372 |
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(89,044 |
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Financing activities: |
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Proceeds from long-term debt |
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23,000 |
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Repayment of long-term debt |
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(2,000 |
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Repayment of capital lease obligations |
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(43 |
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Proceeds from exercise of stock options |
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372 |
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215 |
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Stock option income tax benefit |
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134 |
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29 |
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Repurchase of common stock for treasury |
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(15,120 |
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Net cash (used in) provided by financing activities |
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(14,657 |
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21,244 |
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Effect of exchange rate changes on cash |
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1,030 |
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(639 |
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Net increase (decrease) in cash and cash equivalents |
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5,691 |
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(49,646 |
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Cash and cash equivalents, beginning of period |
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66,376 |
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68,979 |
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Cash and cash equivalents, end of period |
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$ |
72,067 |
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$ |
19,333 |
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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 nine-month period ended September 30, 2010 are not necessarily
indicative of the results that may be expected for the year ending December 31, 2010. Further
information on potential factors that could affect our financial results can be found in our Report
on Form 10-K for the year ended December 31, 2009 and in our Report on Form 10-Q for the quarter
ended June 30, 2010, in each case as filed with the Securities and Exchange Commission (SEC).
Subsequent events have been evaluated for disclosure and recognition.
ERT® and EXPeRT® are registered trademarks of eResearchTechnology, Inc.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of ERT and its
wholly-owned subsidiaries. All significant intercompany accounts and transactions have been
eliminated. We consider our business to consist of one segment which is providing technology and
service solutions to collect, interpret and distribute diagnostic data principally used by the
pharmaceutical industry as part of clinical drug trials.
Use of Estimates
The preparation of financial statements in accordance with accounting principles generally
accepted in the United States requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported revenues and expenses during the reporting
period. Actual results could differ from those estimates.
Revenue Recognition
Our services revenues consist primarily of our services offered under our Cardiac Safety,
Respiratory Services and, to a lesser extent, our electronic patient reported outcomes ( ePRO)
solutions that we provide on a fee for services basis and are recognized as the services are
performed. We also provide Cardiac Safety consulting services on a time and materials basis and
recognize revenues as we perform the services. Our site support revenue, consisting of equipment
rentals and sales along with related supplies and logistics management, are recognized at the time
of sale or over the rental period.
At the time of each transaction, management assesses whether the fee associated with the
transaction is fixed or determinable and whether or not collection is reasonably assured. The
assessment of whether the fee is fixed or determinable is based upon the payment terms of the
transaction. If a significant portion of a fee is due after our normal payment terms or upon
implementation or client acceptance, the fee is accounted for as not being fixed or determinable
and revenue is recognized as the fees become due or after implementation or client acceptance has
occurred.
Collectability is assessed based on a number of factors, including past transaction history
with the client and the creditworthiness of the client. If it is determined that collection of a
fee is not reasonably assured, the fee is deferred and revenue is recognized at the time collection
becomes reasonably assured, which is generally upon receipt of cash. Under a typical contract for
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 service contracts as the services are performed.
For arrangements with multiple deliverables where the fair value of each element is known, the
revenue is allocated to each component based on the relative fair value of each element. For
arrangements with multiple deliverables where the fair value of one or more delivered elements is
not known, revenue is allocated to each component of the arrangement using the residual method
provided that the fair value of all undelivered elements is known. Fair values for undelivered
elements are based primarily upon stated renewal rates for future products or services.
We have recorded reimbursements received for out-of-pocket expenses incurred as revenue in the
accompanying consolidated
statements of operations.
6
Unbilled revenue is revenue that is recognized but is not currently billable to the customer
pursuant to contractual terms. In general, such amounts become billable in accordance with
predetermined payment schedules, but recognized as revenue as services are performed. Amounts
included in unbilled revenue are expected to be collected within one year and are included within
current assets.
Our former electronic data capture (EDC) operations are included in EDC licenses and services
revenue and include license revenue, technology consulting and training services and software
maintenance services. We recognized up-front license fee revenues under the residual method when a
formal agreement existed, delivery of the software and related documentation occurred,
collectability was probable and the license fee was fixed or determinable. We recognized monthly
and annual term license fee revenues over the term of the arrangement. Hosting service fees were
recognized evenly over the term of the service. We recognized revenues from software maintenance
contracts on a straight-line basis over the term of the maintenance contract, which was typically
twelve months. We provided consulting and training services on a time and materials basis and
recognized revenues as we performed the services.
Business Combinations
On May 28, 2010, we acquired Research Services Germany 234 GmbH (Research Services or RS),
which was formed as a result of a demerger of CareFusion Germany 234 GmbH under German law, which
effectively divided CareFusion Germany 234 GmbH into RS and another entity. RS is comprised of the
research services division of CareFusion Germany 234 GmbH and certain research operations of
CareFusion Corporation (CareFusion). RS is a leading provider of respiratory diagnostics services
and a manufacturer of diagnostic devices and also offers cardiac safety and ePRO services. We paid
$82.6 million for RS. The acquisition and related transaction costs was financed from our existing
cash and a portion of the $23.0 million drawn from our new $40.0 million revolving credit facility
through Citizens Bank of Pennsylvania. The credit facility was established on May 27, 2010. See
Note 4 for additional disclosure on the RS acquisition and Note 7 for additional disclosure
regarding the revolving credit facility.
We allocated the purchase price to the tangible and intangible assets we acquired and
liabilities we assumed based on their estimated fair values. This valuation requires management to
make significant estimates and assumptions, especially with respect to long-lived and intangible
assets.
Critical estimates in valuing certain of the intangible assets include but are not limited to:
future expected cash flows from customer contracts, customer relationships, proprietary technology
and discount rates. Our estimates of fair value are based upon assumptions we believe to be
reasonable, but which are inherently uncertain and unpredictable. Assumptions may be incomplete or
inaccurate, and unanticipated events and circumstances may occur.
Other estimates associated with the accounting for this acquisition may change as additional
information becomes available regarding the assets we acquired and liabilities we assumed and are
subject to final working capital adjustments.
For a discussion of how we allocated the purchase price of RS, see Note 4.
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 nine months ended September 30, 2009 and
2010, one client accounted for approximately 17% and 24% of net revenues, respectively. The loss
of this client could have a material adverse effect on our operations. We maintain reserves for
potential credit losses. Such losses, in the aggregate, have not historically exceeded
managements estimates.
Cash and Cash Equivalents
We consider cash on deposit and in overnight investments and investments in money market funds
with financial institutions to be cash equivalents. At the balance sheet dates, cash equivalents
consisted primarily of investments in money market funds. At December 31, 2009 and September 30,
2010, approximately $13.1 million and $5.6 million, respectively, was held by our UK subsidiary.
At September 30, 2010, approximately $6.6 million was held by our German subsidiary.
7
Short-term Investments and Investments in Marketable Securities
At September 30, 2010, short-term investments consisted of an auction rate security issued by
a municipality while marketable securities consisted of common stock received from the buyer of
certain assets of our EDC operations. Available-for-sale securities are carried at fair value,
based on quoted market prices, with unrealized gains and losses reported as a separate component of
stockholders equity. We classified our short-term investments and investment in marketable
securities at December 31, 2009 and September 30, 2010 as available-for-sale. At December 31, 2009
and September 30, 2010, unrealized gains and losses were immaterial. Realized gains and losses
during the nine months ended September 30, 2009 and 2010 were immaterial. For purposes of
determining realized gains and losses, the cost of the securities sold is based upon specific
identification.
The following summarizes the short-term investments at December 31, 2009 and September 30,
2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
Amortized cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Municipal securities |
|
$ |
6,764 |
|
|
$ |
|
|
|
$ |
(2 |
) |
|
$ |
6,762 |
|
Corporate debt securities |
|
|
1,769 |
|
|
|
1 |
|
|
|
|
|
|
|
1,770 |
|
Bonds of government sponsored agencies |
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments as of December 31, 2009 |
|
$ |
9,783 |
|
|
$ |
1 |
|
|
$ |
(2 |
) |
|
$ |
9,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
|
|
Amortized cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Municipal securities |
|
$ |
50 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments as of September 30, 2010 |
|
$ |
50 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment are stated at cost. Depreciation is provided using the straight-line
method over the estimated useful lives of three years for computer and other equipment, two to four
years for rental equipment, five years for furniture and fixtures and three to five years for
system development costs. Leasehold improvements are amortized using the straight-line method over
the shorter of the estimated useful life of the asset or the remaining lease term. Repair and
maintenance costs are expensed as incurred. Improvements and betterments are capitalized.
Depreciation expense was $2.1 million and $3.2 million for the three months ended September 30,
2009 and 2010, respectively, and $6.7 million and $6.8 million for the nine months ended September
30, 2009 and 2010, respectively.
We capitalize costs associated with internally developed and/or purchased software systems for
new products and enhancements to existing products that have reached the application development
stage and meet recoverability tests. These costs are included in property and equipment.
Capitalized costs include external direct costs of materials and services utilized in developing or
obtaining internal-use software, and payroll and payroll-related expenses for employees who are
directly associated with and devote time to the internal-use software project.
Amortization of capitalized software development costs is charged to costs of revenues.
Amortization of capitalized software development costs was $0.8 million and $0.9 million for the
three months ended September 30, 2009 and 2010, respectively, and $2.5 million and $2.7 million for
the nine months ended September 30, 2009 and 2010, respectively. For the nine-month periods ended
September 30, 2009 and 2010, we capitalized $1.9 million and $4.3 million, respectively, of
software development costs. As of September 30, 2010, $6.2 million of capitalized costs had not
yet been placed in service and were therefore not being amortized.
The largest component of property and equipment is rental equipment which is internally
manufactured and also purchased from third parties. Our clients use the rental equipment to
perform the ECG, respiratory and ePRO tests and collect and send the related data to us. Our
clients use the respiratory diagnostic equipment to perform the centralized spirometry and
pulmonary function recordings, and it also provides the means to send such recordings to us. 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 our
services agreements with our clients and the decision to rent or buy equipment is made by our
clients prior to the start of the 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
diagnostic tests to be performed each month. The longer the study and the fewer the number of
tests performed, the more likely it is that
the client may request to purchase equipment rather than rent. Regardless of whether the
client rents or buys the 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.
8
Our 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 rental equipment was $37.3 million and $55.3 million at December 31, 2009
and September 30, 2010, respectively. The accumulated depreciation for rental equipment was $30.9
and $34.3 million at December 31, 2009 and September 30, 2010, respectively. At December 31, 2009,
rental equipment consisted solely of cardiac safety equipment, whereas at September 30, 2010,
rental equipment included cardiac safety, respiratory and ePRO equipment.
Goodwill
The carrying value of goodwill was $34.7 million as of December 31, 2009 and $71.6 million as
of September 30, 2010. During the first nine months of 2010, goodwill increased $36.8 million due
to the acquisition of RS. See Note 4 for additional disclosure regarding the RS and Covance
Cardiac Safety Services (CCSS) acquisitions. Goodwill is not amortized but is subject to an
impairment test at least annually. We perform the impairment test annually as of December 31 or
more frequently if events or circumstances indicate that the value of goodwill might be impaired.
No provisions for goodwill impairment were recorded during 2009 or during the nine months ended
September 30, 2010.
When it is determined that the carrying value of goodwill may not be recoverable, measurement
of any impairment will be based on a projected discounted cash flow method using a discount rate
commensurate with the risk inherent in the current business model.
Long-lived Assets
When events or circumstances so indicate, we assess the potential impairment of our long-lived
assets based on anticipated undiscounted cash flows from the assets. Such events and circumstances
include a sale of all or a significant part of the operations associated with the long-lived asset,
or a significant decline in the operating performance of the asset. If an impairment is indicated,
the amount of the impairment charge would be calculated by comparing the anticipated discounted
future cash flows to the carrying value of the long-lived asset. No impairment was indicated
during either of the nine-month periods ended September 30, 2009 or 2010.
Software Development Costs
Research and development expenditures related to software development are charged to
operations as incurred. We capitalize certain software development costs subsequent to the
establishment of technological feasibility. Because software development costs have not been
significant after the establishment of technological feasibility, all such costs have been charged
to expense as incurred.
Share-Based Compensation
Accounting for Share-Based Compensation
Share-based compensation expense is measured at the grant date based on the fair value of the
award and is recognized as expense over the vesting period. The aggregate share-based compensation
expense recorded in the consolidated statements of operations for each of the three month periods
ended September 30, 2009 and 2010 was $0.6 million. The aggregate share-based compensation expense
recorded in the consolidated statements of operations for each of the nine-month periods ended
September 30, 2009 and 2010 was $2.1 million.
Valuation Assumptions for Options Granted
The fair value of each stock option granted during the nine months ended September 30, 2009
and 2010 was estimated at the date of grant using Black-Scholes, assuming no dividends and using
the weighted-average valuation assumptions noted in the following table.
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2010 |
|
Risk-free interest rate |
|
|
1.34 |
% |
|
|
2.44 |
% |
Expected life |
|
3.5 years |
|
|
3.8 years |
|
Expected volatility |
|
|
63.98 |
% |
|
|
61.73 |
% |
The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant.
The expected life (estimated period of time outstanding) of the stock options granted was estimated
using the historical exercise behavior of employees. Expected volatility was based on historical
volatility for a period equal to the stock options expected life, calculated on a daily basis.
Fluctuations in the market that affect these estimates could have an impact on the resulting
compensation cost. The above assumptions were used to determine the weighted-average per share
fair value of $2.14 and $3.24 for stock options granted during the first nine months of 2009 and
2010, respectively.
9
Equity Incentive Plans
In 1996, we adopted a stock option plan (the 1996 Plan) that authorized the grant of both
incentive and non-qualified options to acquire up to 9,450,000 shares of the Companys common
stock, as subsequently amended. Our Board of Directors determined the exercise price of the
options under the 1996 Plan. The exercise price of incentive stock options was not below the
market value of the common stock on the grant date. Incentive stock options under the 1996 Plan
expire ten years from the grant date and are exercisable in accordance with vesting provisions set
by the Board, which generally are over three to five years. No additional options have been
granted under this plan, as amended, since December 31, 2003 and no additional options may be
granted thereunder in accordance with the terms of the 1996 Plan.
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.
On April 26, 2007, the stockholders approved the adoption of the Companys Amended and
Restated 2003 Equity Incentive Plan (the Amended 2003 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 Amended 2003 Plan that provides for
the inclusion of restricted stock units in addition to the other equity-based awards authorized
thereunder and eliminated the fixed option grants to outside directors. Restricted stock was
granted for the first time in 2010 and is being recorded as compensation expense over the one-year
vesting period or the four-year vesting period for grants to the Companys directors and
management, respectively. In accordance with the terms of the Amended 2003 Plan, there are a total
of 7,318,625 shares reserved for issuance under the Amended 2003 Plan and there were 1,254,321
shares available for grant as of September 30, 2010.
Information regarding the stock option and equity incentive plans for the nine months ended
September 30, 2010 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
|
|
|
|
Average |
|
|
Term |
|
|
Value |
|
Share Options |
|
Shares |
|
|
Exercise Price |
|
|
(in years) |
|
|
(in thousands) |
|
Outstanding as of January 1, 2010 |
|
|
4,406,606 |
|
|
$ |
9.62 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
877,930 |
|
|
|
6.46 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(60,256 |
) |
|
|
3.58 |
|
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
(60,087 |
) |
|
|
8.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of September 30, 2010 |
|
|
5,164,193 |
|
|
$ |
9.17 |
|
|
|
4.5 |
|
|
$ |
5,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable or expected to vest at September 30, 2010 |
|
|
4,705,272 |
|
|
$ |
9.38 |
|
|
|
4.3 |
|
|
$ |
5,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2010 |
|
|
3,107,125 |
|
|
$ |
10.80 |
|
|
|
3.6 |
|
|
$ |
2,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
Restricted Stock |
|
Shares |
|
|
Fair Value |
|
Outstanding as of January 1, 2010 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
203,779 |
|
|
|
6.22 |
|
Exercised |
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of September 30, 2010 |
|
|
203,779 |
|
|
$ |
6.22 |
|
|
|
|
|
|
|
|
|
10
The aggregate intrinsic value in the share options table above represents the total pre-tax
intrinsic value (the difference between the closing price of our common stock on the last trading
day of the third quarter of 2010 and the exercise price, multiplied by the number of in-the-money
options) that would have been received by the option holders had all option holders exercised their
options on September 30, 2010. This amount changes based on the fair market value of the Companys
common stock. The total intrinsic value of options exercised for the nine months ended September
30, 2009 and 2010 was $0.3 million and $0.2 million, respectively.
As of September 30, 2010, 3,107,125 options with a weighted average exercise price of $10.80
per share were exercisable under the 1996 Plan and the 2003 Plan.
As of September 30, 2010, there was $5.3 million of total unrecognized compensation cost
related to non-vested share-based compensation arrangements (including stock options and restricted
stock awards) granted under the plans. That cost is expected to be recognized over a
weighted-average period of 2.4 years.
Tax Effect Related to Share-based Compensation Expense
Income tax effects of share-based payments are recognized in the consolidated 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 statements 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 statements of operations for the nine months ended September 30, 2009 and 2010 related
to stock-based compensation expense was approximately $0.4 million and $0.3 million, respectively.
Note 3. Fair Value of Financial Instruments
A fair value measurement assumes that the transaction to sell an asset or transfer a liability
occurs in the principal market for the asset or liability or, in the absence of a principal market,
the most advantageous market for the asset or liability. Fair value is based upon an exit price
model.
We measure certain financial assets and liabilities at fair value on a recurring basis,
including available-for-sale securities. Available-for-sale securities as of September 30, 2010
consisted of an auction rate security, or ARS, issued by a municipality and common stock received
from the buyer of certain assets of our EDC operations. Available-for-sale securities are included
in short-term investments in our consolidated balance sheets with the exception of the common stock
which is included in investment in marketable securities. The marketable securities, which were
priced at a discount due to a restriction on trading that was in effect until June 23, 2010, are
included in investments in marketable securities in our consolidated balance sheets. The discount
on the marketable securities was valued using an option pricing model and takes into consideration
multiple inputs including quoted prices of the securities, volatility factors and discount rates.
The three levels of the fair value hierarchy are described below:
Level 1 |
|
Unadjusted quoted prices in active markets for identical assets or liabilities |
|
Level 2 |
|
Unadjusted quoted prices in active markets for similar assets or liabilities, or
Unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or
Inputs other than quoted prices that are observable for the asset or liability |
|
Level 3 |
|
Unobservable inputs for the asset or liability |
11
The following tables represent our fair value hierarchy for financial assets (cash equivalents
and investments) measured at fair value on a recurring basis as of December 31, 2009 and September
30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at December 31, 2009 |
|
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
in Active Markets |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
|
|
|
|
for Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Cash and cash equivalents |
|
$ |
68,979 |
|
|
$ |
68,979 |
|
|
$ |
|
|
|
$ |
|
|
Municipal securities |
|
|
6,762 |
|
|
|
6,712 |
|
|
|
|
|
|
|
50 |
|
Corporate debt securities |
|
|
1,770 |
|
|
|
1,770 |
|
|
|
|
|
|
|
|
|
Bonds of government sponsored agencies |
|
|
1,250 |
|
|
|
1,250 |
|
|
|
|
|
|
|
|
|
Marketable securities |
|
|
1,026 |
|
|
|
|
|
|
|
1,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
79,787 |
|
|
$ |
78,711 |
|
|
$ |
1,026 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at September 30, 2010 |
|
|
|
|
|
|
Quoted Prices |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
in Active Markets |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
|
|
|
|
for Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
|
Total |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Cash and cash equivalents |
|
$ |
19,333 |
|
|
$ |
19,333 |
|
|
$ |
|
|
|
$ |
|
|
Municipal securities |
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
50 |
|
Marketable securities |
|
|
648 |
|
|
|
|
|
|
|
648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
20,031 |
|
|
$ |
19,333 |
|
|
$ |
648 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents consist primarily of checking accounts and highly rated money market
funds with original maturities of three months or less. The original cost of these assets
approximates fair value due to their short term maturity. Bank debt consists of loans drawn under
our bank credit facility. Based on our assessment of the current financial market and
corresponding risks associated with the debt, we believe that the carrying amount of bank debt at
September 30, 2010 approximates fair value.
Note 4. Business Combinations
Research Services (RS)
On May 28, 2010, we acquired RS. See Note 2 for a summary of the terms of this acquisition.
We have included RSs operating results in our consolidated statements of operations from the date
of the acquisition. We present pro forma results of operations for RS because the effect of this
acquisition was material to ERT on a standalone basis. We paid $82.6 million for RS after giving
effect to closing balance sheet working capital adjustments of $1.9 million. We have additionally
incurred approximately $0.1 million and $4.1 million in the three and nine months ended September
30, 2010, respectively, in transaction costs which were included in general and administrative
expenses. Our actual consolidated financial results for the nine months ended September 30, 2010
included RS revenue of $27.2 million, operating income of $3.6 million and net income of $1.9
million. The tax bases of the assets acquired and liabilities assumed in the RS transaction were
stepped-up to fair value at the date of the RS acquisition.
12
The RS acquisition purchase consideration of $82.6 million has been allocated to assets
acquired and liabilities assumed based on estimated fair values at the date of acquisition, as
revised, as follows (in thousands):
|
|
|
|
|
Fair value of assets acquired: |
|
|
|
|
Cash |
|
$ |
149 |
|
Accounts receivable |
|
|
12,687 |
|
Inventory |
|
|
2,598 |
|
Other current assets |
|
|
1,142 |
|
Property and equipment, net |
|
|
11,179 |
|
Goodwill, including workforce |
|
|
36,756 |
|
Other intangible assets, net |
|
|
21,349 |
|
Other assets |
|
|
407 |
|
Liabilities assumed: |
|
|
|
|
Accrued and other liabilities |
|
|
(3,257 |
) |
Deferred revenue |
|
|
(375 |
) |
|
|
|
|
Net assets acquired |
|
$ |
82,635 |
|
|
|
|
|
During the three months ended September 30, 2010, goodwill decreased $0.4 million due to
valuation adjustments to intangible assets and deferred revenue. During the three months ended
September 30, 2010, there was a $0.6 million reduction in the completion payment to CareFusion as a
result of changes in estimates related to accounts receivable and prepaid expenses. $2.5 million
was accrued for the completion payment at June 30, 2010 and $1.9 million was actually paid during
the three months ended September 30, 2010 after the $0.6 million reduction.
Pro Forma Results
The unaudited financial information in the table below summarizes the combined results of
operations for us and RS on a pro forma basis as though the companies had been combined as of the
beginning of each of the periods presented after giving effect to certain adjustments. Our
historical results of operations for the three and nine months ended September 30, 2010, included
the results of RS since May 28, 2010, the date of acquisition. The unaudited pro forma financial
information for the three and nine months ended September 30, 2009 and the nine months ended
September 30, 2010 combines our historical results for these periods with the historical results
for the comparable reporting periods for RS. The unaudited pro forma financial information below
is for informational purposes only and is not indicative of the results of operations or financial
condition that would have been achieved if the acquisition would have taken place at the beginning
of each of the periods presented and should not be taken as indicative of our future consolidated
results of operations or financial condition. Acquisition-related transaction costs of $4.1
million were excluded from the pro forma results for the nine months ended September 30, 2010. Pro
forma adjustments are tax-effected at our effective tax rate.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2009 |
|
|
2009 |
|
|
2010 |
|
|
|
(Unaudited, in thousands except per share amounts) |
|
|
|
|
|
Revenue |
|
$ |
35,799 |
|
|
$ |
103,951 |
|
|
$ |
124,432 |
|
Operating income |
|
|
3,151 |
|
|
|
11,597 |
|
|
|
16,153 |
|
Net income |
|
|
1,601 |
|
|
|
5,945 |
|
|
|
9,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
0.20 |
|
Diluted net income per share |
|
$ |
0.03 |
|
|
$ |
0.12 |
|
|
$ |
0.20 |
|
13
Covance Cardiac Safety Services, Inc. (CCSS)
On November 28, 2007, we completed the acquisition of CCSS from Covance Inc. (Covance). Under
the terms of the Purchase
Agreement, we purchased all of the outstanding shares of capital stock of CCSS in
consideration of an upfront cash payment of $35.2 million plus additional cash payments of up to
approximately $14.0 million. We fully integrated the operations of CCSS into our existing
operations in the quarter ended September 30, 2008. We did so by merging CCSSs Reno, Nevada based
operations into our existing operations and closing the operations in Reno. The following table
sets forth the activity and balance of our accrued liability relating to lease costs associated
with the closing of CCSS operations, which is included in Accrued expenses and Other
liabilities on our Consolidated Balance Sheets (in thousands):
|
|
|
|
|
|
|
Lease |
|
|
|
Liability |
|
Balance at December 31, 2009 |
|
$ |
1,758 |
|
Adjustments to previous estimates |
|
|
593 |
|
Cash payments |
|
|
(369 |
) |
|
|
|
|
Balance at September 30, 2010 |
|
$ |
1,982 |
|
|
|
|
|
Based on the continued poor commercial rental market in Reno, we determined to increase our
reserve as of June 30, 2010 by $0.6 million to provide for any estimated costs for the remaining
lease term.
Note 5. Inventory
Inventory consisted of the following:
|
|
|
|
|
|
|
September 30, 2010 |
|
|
|
(Unaudited, in |
|
|
|
thousands) |
|
|
|
|
|
Raw materials |
|
$ |
1,575 |
|
Work in process |
|
|
756 |
|
Finished goods |
|
|
1,548 |
|
|
|
|
|
Inventory |
|
$ |
3,879 |
|
|
|
|
|
Note 6. Intangible Assets
Amortization of intangible assets represents the amortization of the intangible assets from
the RS and CCSS acquisitions. The gross and net carrying amounts of the acquired intangible assets
as of December 31, 2009 (CCSS only) and September 30, 2010 were as follows (in thousands):
RS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Useful Life (in |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Net Book Value |
|
|
years) |
|
Backlog |
|
$ |
12,782 |
|
|
$ |
2,678 |
|
|
$ |
10,104 |
* |
|
|
4 |
|
Technology |
|
|
8,248 |
|
|
|
344 |
|
|
|
7,904 |
|
|
|
8 |
|
Covenants not-to-compete |
|
|
319 |
|
|
|
28 |
|
|
|
291 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,349 |
|
|
$ |
3,050 |
|
|
$ |
18,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The backlog is being amortized over four years on an accelerated basis. |
The related amortization expense reflected in our consolidated statements of operations for
the three and nine months ended September 30, 2010 was $2.4 million and $3.1 million, respectively.
14
Estimated amortization expense for the remaining estimated useful life of the acquired
intangible assets is as follows for the years ending December 31 (the 2010 amount represents the
amortization expense to be recognized over the last three months of the year) (in thousands):
|
|
|
|
|
|
|
Amortization of |
|
|
|
Intangible |
|
Years ending December 31, |
|
Assets |
|
2010 |
|
$ |
2,288 |
|
2011 |
|
|
6,735 |
|
2012 |
|
|
3,238 |
|
2013 |
|
|
1,451 |
|
2014 |
|
|
1,064 |
|
Thereafter |
|
|
3,523 |
|
|
|
|
|
Total |
|
$ |
18,299 |
|
|
|
|
|
CCSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Useful Life (in |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Net Book Value |
|
|
years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,643 |
|
|
$ |
257 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
350 |
|
|
$ |
1,350 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
$ |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
2,393 |
|
|
$ |
1,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Useful Life (in |
|
Description |
|
Gross Value |
|
|
Amortization |
|
|
Net Book Value |
|
|
years) |
|
Backlog |
|
$ |
1,900 |
|
|
$ |
1,858 |
|
|
$ |
42 |
* |
|
|
3 |
|
Customer Relationships |
|
|
1,700 |
|
|
|
476 |
|
|
$ |
1,224 |
|
|
|
10 |
|
Technology |
|
|
400 |
|
|
|
400 |
|
|
$ |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
4,000 |
|
|
$ |
2,734 |
|
|
$ |
1,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The backlog is being amortized over three years on an accelerated basis. |
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.
The related amortization expense reflected in our consolidated statements of operations for
the three and nine months ended September 30, 2009 was $0.1 million and $0.4 million, respectively.
The related amortization expense reflected in our consolidated statements of operations for the
three and nine months ended September 30, 2010 was $0.1 million and $0.3 million, respectively.
Estimated amortization expense for the remaining estimated useful life of the acquired
intangible assets is as follows for the years ending December 31 (the 2010 amount represents the
amortization expense to be recognized over the last three months of the year (in thousands)):
|
|
|
|
|
Years ending December 31, |
|
Amortization of
Intangible
Assets |
|
2010 |
|
$ |
90 |
|
2011 |
|
|
170 |
|
2012 |
|
|
170 |
|
2013 |
|
|
170 |
|
2014 |
|
|
170 |
|
Thereafter |
|
|
496 |
|
|
|
|
|
Total |
|
$ |
1,266 |
|
|
|
|
|
15
Note 7. Credit Agreement
On May 27, 2010, we entered into a credit agreement (Credit Agreement) with Citizens Bank of
Pennsylvania (Lender) which provides for a $40 million revolving credit facility. Also on May 27,
2010, we borrowed $23.0 million under the Credit Agreement to finance a portion of the purchase
price for RS and related transaction costs and to provide working capital. At our option,
borrowings under the Credit Agreement bear interest either at the Lenders prime rate or at a rate
equal to LIBOR plus a margin ranging from 1.00% to 1.75% based on our senior leverage ratio as
calculated under the Credit Agreement. In addition, we pay a quarterly unused commitment fee
ranging from 0.10% to 0.20% of the unused commitment based on our senior leverage ratio. From the
initial borrowing on May 27, 2010 through September 30, 2010, the annual interest rate ranged from
1.35% to 1.60% and the unused commitment fee was 0.10% resulting in a payment of $0.1 million for
the three and nine months ended September 30, 2010. Borrowings under the Credit Agreement may be
prepaid at any time in whole or in part without premium or penalty, other than customary breakage
costs, if any. In the three months ended September 30, 2010, we repaid $2.0 million which reduced
the balance outstanding to $21.0 million at September 30, 2010. The Credit Agreement terminates,
and any outstanding borrowings mature, on May 27, 2013.
The Credit Agreement requires us to maintain a maximum senior leverage ratio of 2.0 to 1.0 and
a minimum debt service coverage ratio of 1.5 to 1.0, in each case as calculated under the Credit
Agreement. The Credit Agreement contains other customary affirmative and negative covenants and
customary events of default.
At September 30, 2010, we were in compliance with all debt covenants. Borrowings under the
line of credit are secured by 65% of the capital stock of certain of our foreign subsidiaries.
Note 8. Net Income per Common Share
Basic net income per common 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.
16
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 September 30, |
|
Income |
|
|
Shares |
|
|
Amount |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
2,819 |
|
|
|
48,452 |
|
|
$ |
0.06 |
|
Effect of dilutive shares |
|
|
|
|
|
|
303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
2,819 |
|
|
|
48,755 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
3,173 |
|
|
|
48,860 |
|
|
$ |
0.06 |
|
Effect of dilutive shares |
|
|
|
|
|
|
398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
3,173 |
|
|
|
49,258 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net |
|
|
|
|
|
|
Per Share |
|
Nine Months Ended September 30, |
|
Income |
|
|
Shares |
|
|
Amount |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
7,437 |
|
|
|
49,399 |
|
|
$ |
0.15 |
|
Effect of dilutive shares |
|
|
|
|
|
|
299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
7,437 |
|
|
|
49,698 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income |
|
$ |
5,751 |
|
|
|
48,789 |
|
|
$ |
0.12 |
|
Effect of dilutive shares |
|
|
|
|
|
|
373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income |
|
$ |
5,751 |
|
|
|
49,162 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
In computing diluted net income per share, options to purchase 2,926,000 and 2,609,000 shares
of common stock were excluded from the computations for the three months ended September 30, 2009
and 2010, respectively, and options to purchase 3,032,000 and 2,731,000 shares of common stock were
excluded from the computations for the nine months ended September 30, 2009 and 2010, respectively.
These options were excluded from the computations because the exercise prices of such options were
greater than the average market price of our common stock during the respective period.
Note 9. Comprehensive Income
Companies are required to classify items of other comprehensive income by their nature in the
financial statements and display the accumulated balance of other comprehensive income (loss)
separately from retained earnings and additional paid-in-capital in the stockholders equity
section of the balance sheet. Our comprehensive income (loss) includes net income and unrealized
gains and losses from marketable securities and foreign currency translation as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,819 |
|
|
$ |
3,173 |
|
|
$ |
7,437 |
|
|
$ |
5,751 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized losses on marketable securities |
|
|
(27 |
) |
|
|
(211 |
) |
|
|
(246 |
) |
|
|
(246 |
) |
Currency translation adjustment |
|
|
(561 |
) |
|
|
4,206 |
|
|
|
1,285 |
|
|
|
1,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income, net of tax |
|
$ |
2,231 |
|
|
$ |
7,168 |
|
|
$ |
8,476 |
|
|
$ |
7,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
Note 10. Recent Accounting Pronouncements
In September 2009, the FASB issued a new accounting standard regarding revenue arrangements
with multiple deliverables. As codified in ASC 605-25 (formerly Emerging Issues Task Force Issue
No. 08-1, Revenue Arrangements with Multiple Deliverables), this accounting standard sets forth
requirements that must be met for an entity to recognize revenue from the sale of a delivered item
that is part of a multiple-element arrangement when other items have not yet been delivered. One
of those current requirements is that there be objective and reliable evidence of the standalone
selling price of the undelivered items, which must be supported by either vendor-specific objective
evidence (VSOE) or third-party evidence (TPE).
This consensus eliminates the requirement that all undelivered elements have VSOE or TPE
before an entity can recognize the portion of an overall arrangement fee that is attributable to
items that already have been delivered. In the absence of VSOE or TPE of the standalone selling
price for one or more delivered or undelivered elements in a multiple-element arrangement, entities
will be required to estimate the selling prices of those elements. The overall arrangement fee
will be allocated to each element (both delivered and undelivered items) based on their relative
selling prices, regardless of whether those selling prices are evidenced by VSOE or TPE or are
based on the entitys estimated selling price. Application of the residual method of allocating
an overall arrangement fee between delivered and undelivered elements will no longer be permitted.
The accounting standard is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010. We are evaluating the
potential impact of these requirements on our consolidated financial statements.
In January 2010, the FASB issued Accounting Standard Update 2010-06 which will require
reporting entities to make new disclosures about recurring or nonrecurring fair-value measurements
including significant transfers into and out of Level 1 and Level 2 fair-value measurements and
information on purchases, sales, issuances, and settlements on a gross basis in the reconciliation
of Level 3 fair-value measurements. The FASB also clarified existing fair-value measurement
disclosure guidance about the level of disaggregation, inputs, and valuation techniques. Except
for the detailed Level 3 roll forward disclosures, we adopted this standard effective January 1,
2010. The adoption of this aspect of the accounting standard did not have any impact on our
consolidated financial statements. The new disclosures about purchases, sales, issuances, and
settlements in the roll forward activity for Level 3 fair-value measurements are effective for
interim and annual reporting periods beginning after December 15, 2010. We are evaluating the
potential impact of these requirements on our consolidated financial statements.
Note 11. Income Taxes
At December 31, 2009 and September 30, 2010, we had $0.2 million of unrecognized tax benefits,
all of which would affect our effective tax rate if recognized. We recognize interest and
penalties related to unrecognized tax benefits in income tax expense. The tax years 2006 through
2009 remain open to examination by the major taxing jurisdictions to which we are subject.
The Company or one of its subsidiaries files income tax returns in the U.S. federal
jurisdiction, and various states and foreign jurisdictions. With few exceptions, we are no longer
subject to U.S. federal, state and local, or non-U.S. income tax examinations by tax authorities
for years before 2006.
Our effective income tax rate was 39.1% and 31.7% for the three months ended September 30,
2009 and 2010, respectively, and 40.6% and 35.7% for the nine months ended September 30, 2009 and
2010, respectively. Through September 30, 2009, we calculated our transfer pricing for Cardiac
Safety services using a profit split methodology based on cost. Subsequent to September 30, 2009,
the profit split transfer pricing methodology was modified for Cardiac Safety services to allocate
costs based on revenue instead of allocating revenue based on costs. Our effective income tax
rates for the three and nine months ended September 30, 2010 were benefited by the lower tax rates
applicable to the RS operations, which operates primarily in Germany which has a lower tax rate
than our historic effective tax rate, and also from organizational restructuring activities
undertaken in the third quarter of 2010 which resulted in a reduction in the effective tax rate.
Note 12. Related Party Transactions
Our Chairman, Dr. Morganroth, is a cardiologist who, through his wholly-owned professional
corporation, provides medical professional services to the Company and receives consulting fees as
an independent contractor. Additionally, beginning in January 2007, we entered into an arrangement
with Dr. Morganroths professional corporation, relating to Dr. Morganroths initiation of a
consulting practice for us through the transition of his historic consulting services to us. In
return, Dr. Morganroths professional corporation receives a percentage fee of 80% of the net
amounts we bill for Dr. Morganroths services to our customers. 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. Beginning in March 2010, we entered into
a new arrangement with Dr. Morganroths professional corporation which eliminated the consulting
fees other than the percentage fees. We recorded revenues in connection with services billed to
customers under this consulting arrangement of approximately $0.4 million in each of the
three-month periods ended September 30, 2009 and 2010 and $1.0 million in each of the nine month
periods ended September 30, 2009 and 2010. We incurred percentage fees under this consulting
arrangement of approximately $0.3 million in each of the three-month periods ended September 30,
2009 and 2010, and $0.8 million in each of the nine-month periods ended September 30, 2009 and
2010. Total amounts payable incurred under this
consulting arrangement, including consulting fees and the percentage fees, approximated $0.4
million and $0.3 million in the three months ended September 30, 2009 and 2010, respectively, and
$1.1 million and $0.8 million in the nine months ended September 30, 2009 and 2010, respectively.
At December 31, 2009 and September 30, 2010, we owed $0.1 million to the professional corporation
in connection with this consulting agreement, which is included in accounts payable.
18
Note 13. Commitments and Contingencies
We have a long-term strategic relationship with Healthcare Technology Systems, Inc. (HTS), a
leading authority in the research, development and validation of computer administered clinical
rating instruments. The strategic relationship includes the exclusive licensing (subject to one
pre-existing license agreement) of 57 Interactive Voice Response (IVR) clinical assessments offered
by HTS along with HTSs IVR system. We placed the system into production in December 2007. As of
September 30, 2010, we had paid HTS $1.5 million for the license and $1.0 million in advanced
payments against future royalties. As of September 30, 2010, HTS had earned royalties of $0.2
million, which were offset against these advanced payments. Royalty payments will be made to
HTS based on the level of revenues received from the assessments and the IVR system. Any royalties
earned by HTS will be applied against these payments. All future payments to HTS will be solely
based on royalty payments based on revenues received from ePRO sales.
On November 28, 2007, we completed the acquisition of CCSS. Under the terms of the purchase
agreement, we purchased all of the outstanding shares of capital stock of CCSS in consideration of
an upfront cash payment of $35.2 million plus additional cash payments of up to approximately $14.0
million, based upon our potential realization of revenue from the backlog transferred and from new
contracts secured through Covances marketing activities. Through September 30, 2010, Covance
earned $5.3 million of this contingent amount with less than $0.1 million earned during the three
months ended September 30, 2010. At September 30, 2010, $0.1 million of the contingent amount
earned remained to be paid to Covance, which we recorded in accounts payable. These contingent
payments increased goodwill by $5.3 million. The period for contingent payments runs through
December 31, 2010. 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.
On
September 10, 2010, we announced that Michael McKelvey will be retiring from his positions
as President and Chief Executive Officer and a director of ERT. The Companys Board of Directors
has begun a search for a successor. Dr. McKelvey will continue in his current position until a
successor is appointed or earlier, based on mutual agreement of Dr. McKelvey and the Board. In
recognition of his service to ERT, the Board agreed that Dr. McKelvey would be entitled to
retirement benefits equal to the severance benefits to which he would have been entitled under his
employment agreement had the Company terminated his employment without cause. As a result, we have
recorded approximately $0.6 million of incremental expense in the three months ended September 30,
2010, to fully record the estimated cost of these retirement benefits.
Note 14. Operating Segments / Geographic Information
We consider our business to consist of one segment which is providing technology and service
solutions to collect, interpret and distribute diagnostic data principally used by the
pharmaceutical industry as part of clinical drug trials. We operate on a worldwide basis with two
primary locations in the United States, categorized below as North America, and one primary
location each in the United Kingdom and Germany. 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.
19
Geographic information is as follows (in thousands of dollars):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2009 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
America |
|
|
UK |
|
|
Germany |
|
|
Eliminations |
|
|
Total |
|
Service revenues |
|
$ |
13,505 |
|
|
$ |
2,464 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
15,969 |
|
Site support revenues |
|
|
4,803 |
|
|
|
1,954 |
|
|
|
|
|
|
|
|
|
|
|
6,757 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
$ |
18,308 |
|
|
$ |
4,418 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
22,726 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
4,003 |
|
|
$ |
706 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,709 |
|
Long-lived assets |
|
$ |
20,717 |
|
|
$ |
3,049 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,766 |
|
Total assets |
|
$ |
139,894 |
|
|
$ |
20,301 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
160,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2010 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
America |
|
|
UK |
|
|
Germany |
|
|
Eliminations |
|
|
Total |
|
Service revenues |
|
$ |
11,037 |
|
|
$ |
5,553 |
|
|
$ |
9,339 |
|
|
$ |
|
|
|
$ |
25,929 |
|
Site support revenues |
|
|
4,606 |
|
|
|
2,445 |
|
|
|
12,148 |
|
|
|
|
|
|
|
19,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
|
15,643 |
|
|
|
7,998 |
|
|
|
21,487 |
|
|
|
|
|
|
|
45,128 |
|
Intersegment revenues |
|
|
1,100 |
|
|
|
39 |
|
|
|
|
|
|
|
(1,139 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
16,743 |
|
|
$ |
8,037 |
|
|
$ |
21,487 |
|
|
$ |
(1,139 |
) |
|
$ |
45,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (A) |
|
$ |
1,702 |
|
|
$ |
1,835 |
|
|
$ |
3,052 |
|
|
$ |
|
|
|
$ |
6,589 |
|
Long-lived assets |
|
$ |
22,762 |
|
|
$ |
6,017 |
|
|
$ |
13,030 |
|
|
$ |
|
|
|
$ |
41,809 |
|
Total assets |
|
$ |
94,223 |
|
|
$ |
15,290 |
|
|
$ |
96,038 |
|
|
$ |
|
|
|
$ |
205,551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2009 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
America |
|
|
UK |
|
|
Germany |
|
|
Eliminations |
|
|
Total |
|
Service revenues |
|
$ |
41,109 |
|
|
$ |
7,183 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
48,292 |
|
Site support revenues |
|
|
14,175 |
|
|
|
5,720 |
|
|
|
|
|
|
|
|
|
|
|
19,895 |
|
EDC licenses and services revenues |
|
|
2,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
$ |
57,785 |
|
|
$ |
12,903 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
70,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
$ |
11,185 |
|
|
$ |
1,708 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
12,893 |
|
Long-lived assets |
|
$ |
20,717 |
|
|
$ |
3,049 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,766 |
|
Total assets |
|
$ |
139,894 |
|
|
$ |
20,301 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
160,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2010 |
|
|
|
North |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
America |
|
|
UK |
|
|
Germany |
|
|
Eliminations |
|
|
Total |
|
Service revenues |
|
$ |
31,820 |
|
|
$ |
15,728 |
|
|
$ |
11,913 |
|
|
$ |
|
|
|
$ |
59,461 |
|
Site support revenues |
|
|
14,328 |
|
|
|
7,036 |
|
|
|
15,267 |
|
|
|
|
|
|
|
36,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from external customers |
|
|
46,148 |
|
|
|
22,764 |
|
|
|
27,180 |
|
|
|
|
|
|
|
96,092 |
|
Intersegment revenues |
|
|
1,424 |
|
|
|
39 |
|
|
|
|
|
|
|
(1,463 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
47,572 |
|
|
$ |
22,803 |
|
|
$ |
27,180 |
|
|
$ |
(1,463 |
) |
|
$ |
96,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (A) |
|
$ |
8 |
|
|
$ |
6,764 |
|
|
$ |
3,615 |
|
|
$ |
|
|
|
$ |
10,387 |
|
Long-lived assets |
|
$ |
22,762 |
|
|
$ |
6,017 |
|
|
$ |
13,030 |
|
|
$ |
|
|
|
$ |
41,809 |
|
Total assets |
|
$ |
94,223 |
|
|
$ |
15,290 |
|
|
$ |
96,038 |
|
|
$ |
|
|
|
$ |
205,551 |
|
|
|
|
(A) |
|
North American and German operating income for the three and nine months ended
September 30, 2010 included the negative impact of $0.1 million and $4.1 million,
respectively, of transaction costs associated with the RS acquisition. |
Through September 30, 2009, we calculated our transfer pricing for Cardiac Safety services
using a profit split methodology based on cost. Subsequent to September 30, 2009, the profit split
transfer pricing methodology was modified for Cardiac Safety services to allocate costs based on
revenue instead of allocating revenue based on costs.
Note 15. Stock Repurchase
Our board of directors has authorized the repurchase of up to an aggregate of 12.5 million
shares, of which 5.0 million shares remain to be purchased as of September 30, 2010. The stock
buy-back authorization allows us, but does not require us, to purchase the authorized shares.
During the three months ended September 30, 2009, we purchased 196,016 shares of our common stock
at a cost of
$1.1 million. During the nine months ended September 30, 2009, we purchased 2,902,735 shares
of our common stock at a cost of $15.1 million. We did not purchase any shares during the nine
months ended September 30, 2010.
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Statement for Forward-Looking Information
Except for historical matters, the matters discussed in this Form 10-Q are forward-looking
statements that involve risks and uncertainties. Forward-looking statements include, but are not
limited to, statements within the meaning of the Private Securities Litigation Reform Act of 1995
that reflect our current views as to future events and financial performance with respect to our
operations. These statements can be identified by the fact that they do not relate strictly to
historical or current facts. They use words such as aim, anticipate, are confident,
estimate, expect, will be, will continue, will likely result, project, intend,
plan, believe, look to and other words and terms of similar meaning in conjunction with a
discussion of future operating or financial performance.
These statements are subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in the forward-looking statements. Factors that
might cause such a difference include: unfavorable economic conditions; our ability to obtain new
contracts and accurately estimate net revenues due to variability in size, scope and duration of
projects and internal issues at the sponsoring client; our ability to successfully integrate
acquisitions; competitive factors in the market for centralized
cardiac safety and respiratory services; changes in
the pharmaceutical, biotechnology and medical device industries to which we sell our solutions;
technological development; and market demand. There is no guarantee that the amounts in our backlog
will ever convert to revenue. Should the current economic conditions continue or deteriorate
further, the cancellation rates that we have historically experienced could increase. Further
information on potential factors that could affect the Companys financial results can be found in
the reports we file with the Securities and Exchange Commission.
Forward-looking statements speak only as of the date made. We undertake no obligation to
update any forward-looking statements, including prior forward-looking statements, to reflect the
events or circumstances arising after the date as of which they were made. As a result of these
risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking
statements included in this discussion or that may be made in our filings with the Securities and
Exchange Commission or elsewhere from time to time by, or on behalf of, us.
Overview
eResearchTechnology, Inc. (ERT), a Delaware corporation, was founded in 1977 to provide
Cardiac Safety solutions to evaluate the safety of new drugs. ERT and its consolidated
subsidiaries collectively are referred to as the Company or we. ERT® and EXPeRT® are
registered trademarks of eResearchTechnology, Inc. We are a global provider of technology and
services to the pharmaceutical, biotechnology and medical device industries. We are the market
leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services
(Cardiac Safety services) to evaluate cardiac safety in clinical development. We are also a
leading provider of centralized respiratory technology and services (Respiratory services) to
evaluate pulmonary function efficacy and safety in clinical development. We also provide solutions
to streamline the clinical trials process by automating the collection, analysis, and distribution
of electronic patient reported outcomes (ePRO) clinical data using multi-mode technology in all
phases of clinical development as well as providing selected medical devices for the clinical
trials and healthcare industries.
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, Respiratory and ePRO solutions, which are utilized by
pharmaceutical, biotechnology and medical device companies, clinical trial sponsors and clinical
research organizations (CROs) during all phases of the clinical trial cycle. Our centralized data
collection services include the collection, interpretation and distribution of electocardiographic
(ECG) data, respiratory data from spirometry to full pulmonary function tests (PFTs) and patient
reported outcomes such as daily symptoms, quality of life data and medication usage.
The data collected provides an assessment of the efficacy and safety of a new drug by
documenting the change of selected parameters over a defined time period.
Acquisition of RS
On May 28, 2010, we acquired Research Services Germany 234 GmbH (Research Services or RS),
which was formed as a result of a demerger of CareFusion Germany 234 GmbH under German law which
effectively divided CareFusion Germany 234 GmbH into RS and another entity. RS is comprised of the
research services division of CareFusion Germany 234 GmbH and certain research operations of
CareFusion Corporation. RS is a leading provider of respiratory diagnostics services and
manufacturer of diagnostic devices and also offers cardiac safety and ePRO services. The RS
business has been included in our financial results from the acquisition date.
RS is a business with its roots in the former Erich Jaeger GmbH which was founded in Würzburg,
Germany in 1954 as a healthcare device manufacturing and servicing operation. The business entered
the clinical research market in 2002 under VIASYS Healthcare Inc. It subsequently became part of
Cardinal Health in 2007 when Cardinal Health acquired VIASYS Healthcare Inc. In 2009, RS was part
of the businesses spun off from Cardinal Health with the creation of CareFusion, a $4 billion
healthcare company with products and services focused on improving safety and quality of care. RS
currently provides services to 16 of the 20 largest pharmaceutical companies and has
supported clinical trials in more than 75 countries and more than 25,000 investigator sites.
21
We acquired the following key products as part of the RS acquisition:
|
|
|
MasterScope® CT a PC-based device platform for centralized spirometry/ pulmonary
function tests (PFT) and Cardiac Safety featuring fully customizable workflows that is 21
CFR 11 compliant. |
|
|
|
|
Flow/CorScreen® CT a desktop-based device platform for centralized spirometry and ECG
featuring a built-in color printer that is customizable and 21 CFR 11 compliant. |
|
|
|
|
Asthma Monitor AM3® an electronic lung function monitor with text-based diary
available in a broad range of languages. |
|
|
|
|
VIAPad® a dedicated hand held ePRO device for capturing high quality patient reported
outcomes in a broad range of languages. |
|
|
|
|
VIAPen an ePRO device which utilizes digital pen technology to capture quality of
life information. |
|
|
|
|
VIAConnect® an intelligent modem solution for transferring collected data from any
patients home to the data center, using an analog or wireless connection. |
Our acquisition of RS offers multiple strategic benefits:
|
|
|
Establishes us as one of the market leaders in respiratory core lab services in the
clinical trials market. The transaction provides us with a leadership position in an
attractive clinical end market and serves to diversify ERTs revenue base. |
|
|
|
|
Provides us with a leading diagnostic device capability. RS is a leader in diagnostic
device manufacturing, having developed over 20 proprietary devices and supporting software
platforms for use in the clinical trials industry. This device manufacturing expertise
has expanded our technological capabilities, enables us to provide greater breadth of
services and technologies for clinical research, and will serve as a basis for development
of other healthcare solutions. |
|
|
|
|
Expands our revenue base in cardiac safety. RS has a significant, and growing,
business in cardiac safety services that will add to our current
position in this market. |
|
|
|
|
Provides scale for our ePRO business, as well as expands the depth and breadth of our
ePRO services. This transaction will establish us as one of the five largest providers in
the ePRO market. RSs offering is based on innovative hand-held devices. When combined
with our interactive voice response technology and our planned web-based technology, we
will be able to offer our customers a multi-modality approach for their ePRO solutions. |
|
|
|
|
Expands significantly our global footprint. RS employs more than 250 people, of whom
approximately 230 are in Germany. This increased local European presence will enable us
to bolster our already strong international presence, better serve our continental
European customers, and enable us to expand our relationships with other clients in
Europe. |
|
|
|
|
Accelerates our movement into healthcare solutions. RSs device manufacturing and
services capabilities provides us with a platform and experience for future growth in
healthcare delivery. |
Sale of EDC Assets
On June 23, 2009, we completed the sale of certain assets relating to our electronic data
capture (EDC) operations. Under the terms of the transaction, OmniComm Systems, Inc. issued to us
8.1 million shares of common stock and assumed certain liabilities including deferred revenue
relating to our EDC operations in exchange for our EDC assets which primarily included our EDC
software, applications and fixed assets and $1.15 million in cash we paid. During the nine months
ended September 30, 2009, we recorded a gain on the sale of these assets of $0.5 million within
general and administrative expenses in the consolidated statements of operations.
22
Products and Services
We offer the following products and services on a global basis:
Centralized Cardiac Safety Solutions
Our Cardiac Safety solutions include the collection, interpretation and distribution of
electrocardiographic (ECG) data and images
and are performed during clinical trials in all phases of the clinical research process. The
ECG provides an electronic map of the hearts rhythm and structure, and is performed in most
clinical trials. Our Cardiac Safety solutions permit assessments of the safety of therapies by
documenting the occurrence of cardiac electrical change. Specific trials, such as a Thorough QTc
study, focus on the cardiac safety profile of a compound. Thorough QTc studies are comprehensive
studies that typically are of large volume and short duration and are recommended by the United
States Food and Drug Administration (FDA) under guidance issued in 2005 by the International
Committee on Harmonization (ICH E14).
Cardiac Safety solutions, including our EXPERT technology platform, provide for
workflow-enabled cardiac safety data collection, interpretation and distribution of
electrocardiographic (ECG) data and images as well as for analysis and cardiologist interpretation
of ECGs performed on research subjects in connection with our clients clinical trials. EXPERT is
designed specifically to address global regulatory guidance and technical standards for digital ECG
processing to include digital collection, waveform measurements and annotations, review and output
to the regulatory standard file format. Also included in Cardiac Safety solutions is FDA XML
delivery, which provides for the delivery of ECGs in a format compliant with the United States Food
and Drug Administrations XML standard for digital ECGs. We also provide ECG equipment through
rental and sales to clients to perform the ECG recordings and give them means to send such
recordings to us. Our portal product, MyStudy Portal, provides sponsors and investigator sites
with the ability to order supplies, gain real time reports and respond to queries via a secure web
portal in lieu of less efficient means such as faxing and telephone calls.
Cardiac Safety Consulting
The centralization of electrocardiograms in clinical research has become increasingly
important to organizations involved in the development of new drugs. Global regulators each apply
their own slightly different interpretation of the ICH 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.
Centralized Spirometry / Pulmonary Function Solutions
Spirometry is the most commonly performed PFT today and measures the volume and/or flow of air
that can be inhaled and exhaled. Sponsors developing new compounds for the treatment of asthma,
cystic fibrosis and Chronic Obstructive Pulmonary Disease (COPD) use this non-invasive, cost
effective test to assess the efficacy of a drug. Lung diseases such as asthma, COPD, and emphysema
decrease a patients air flow by narrowing or blocking the airways during exhalation. Peak flow is
a simple, non-invasive and inexpensive method to measure the function of the airway and we provide
a unique electronic peak flow meter with integrated diary for clinical trials capturing peak flow
data at home.
The diffusing capacity of the lung related to carbon monoxide, which is known as DLCO,
measures the extent to which oxygen passes from the air sacs of the lungs into the blood and
involves measuring the partial pressure difference between inspired and expired carbon monoxide.
Centralized DLCO testing offers sponsors the advantage of being able to diagnose and treat lung
disorders not found by either spirometry or chest x-ray. DLCO testing is also described as
single-breath determination of carbon monoxide uptake in the lung or Lung Safety in clinical
research and is used to determine if new drugs being inhaled for pain, diabetes or multiple
sclerosis may have an effect on the lung, e.g. if the diffusion of oxygen into the bloodstream is
affected or not.
Electronic Patient Reported Outcomes (ePRO)
We offer electronic patient report outcomes (ePRO) solutions which refers to the electronic
capture of patient self-reported data pertaining to their quality of life. ePRO solutions offer
our clients higher quality data with accurate timestamps and real-time data access. ePRO provides
less variable and more reliable data enabling smaller trials and better scientific conclusions.
Our solutions include both products and services for clinical trials. We manufacture devices
which include convenient handheld electronic diaries that are designed exclusively for clinical
research or using an Interactive Voice Response (IVR) system accessible through standard telephone
lines or using an electronic pen (VIAPen). We also offer device customization, worldwide
logistics and our in-house global and local support to ensure comprehensive and efficient trial
management. Diaries, screening, recruitment and all clinical assessments can be completed directly
by the subject without requiring clinician involvement.
In December 2009 the FDA finalized PRO Guidance for Label Claims, which outlines the steps
required to develop a PRO instrument from hypothesis of a concept or claim through data item
evaluation, collection, cognitive debriefing, interpretation, revision and finalization. We
believe that our devices conform to this guidance.
23
Project Assurance
We provide a full spectrum of project assurance services that augment the study
management and implementation efforts of clients in support of their clinical research
requirements. Our project assurance methodology is a consistent framework
through which we can efficiently manage the delivery of all data, from study
initiation to completion. It also provides our clients with the standards, guidelines and
services that allow us to effectively anticipate their needs and ensure proactive
communication to meet and exceed their goals.
Integrated Product Offering
With the acquisition of the RS, we now offer a fully integrated set of products and services
for centralized cardiac safety, respiratory, and ePRO and a single point of contact for all aspects
of the electronic data collection process in clinical trials.
The protocols of many of the respiratory trials in which we participate often also require
ECGs and/or Holter monitoring. Our flagship investigator site device, MasterScope® CT, is a
comprehensive solution for standardized and centralized spirometry, full PFT, ECG and ePRO in
clinical trials. Using customized software, this innovative system combines protocol-driven
workflows (with many diagnostic applications) into a single easy-to-use clinical trial workstation.
These workflows can be specially tailored for multicentre studies. Our clients and their users
consider the availability of a fully integrated platform for respiratory, cardiac safety and ePRO a
major advantage.
Revenues
Our services revenues consist primarily of our services offered under our Cardiac Safety,
Respiratory Services and, to a lesser extent, ePRO solutions that we provide on a fee for services
basis and are recognized as the services are performed. We also provide Cardiac Safety consulting
services on a time and materials basis and recognize revenues as we perform the services. Site
support revenues, consisting of equipment rentals and sales along with related supplies and
logistics management, are recognized at the time of sale or over the rental period.
For arrangements with multiple deliverables where the fair value of each element is known, the
revenue is allocated to each component based on the relative fair values of each element. For
arrangements with multiple deliverables where the fair value of one or more delivered elements is
not known, revenue is allocated to each component of the arrangement using the residual method
provided that the fair value of all undelivered elements is known. Fair values for undelivered
elements are based primarily upon stated renewal rates for future products or services.
We have recorded reimbursements received for out-of-pocket expenses incurred as revenue in the
accompanying consolidated financial statements.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer
pursuant to contractual terms. In general, such amounts become billable in accordance with
predetermined payment schedules, but recognized as revenue as services are performed. Amounts
included in unbilled revenue are expected to be collected within one year and are included within
current assets.
Our former electronic data capture (EDC) operations were included in EDC licenses and services
revenue and included license revenue, technology consulting and training services and software
maintenance services. We recognized up-front license fee revenues under the residual method when a
formal agreement existed, delivery of the software and related documentation occurred,
collectability was probable and the license fee was fixed or determinable. We recognized monthly
and annual term license fee revenues over the term of the arrangement. Hosting service fees were
recognized evenly over the term of the service. We recognized revenues from software maintenance
contracts on a straight-line basis over the term of the maintenance contract, which was typically
twelve months. We provided consulting and training services on a time and materials basis and
recognized revenues as we performed the services.
Costs
Cost of services includes the cost of Cardiac Safety, Respiratory and ePRO services. Cost of
services consists primarily of wages, depreciation, amortization of intangible assets, fees paid to
consultants and other direct operating costs. Cost of site support consists primarily of wages,
equipment rent and depreciation, amortization of intangible assets, supplies, cost of equipment
sold, shipping expenses and other direct operating costs. Selling and marketing expenses consist
primarily of wages and incentive compensation paid to sales personnel, travel expenses and
advertising and promotional expenditures. General and administrative expenses consist primarily of
wages and direct costs for our finance, administrative, corporate information technology and
executive management functions, in addition to professional service fees and corporate insurance.
Research and development expenses consist primarily of wages paid to our product development staff,
costs paid to outside consultants and other direct costs associated with the development of our
technology.
Costs of our former EDC operations included primarily wages, fees paid to outside consultants
and other direct operating costs related to our software licensing, consulting and client support
functions.
We conduct our operations through offices in the United States (U.S.) and Europe (the United
Kingdom and Germany). Our international net revenues represented approximately 18% and 52% of
total net revenues for the nine months ended September 30, 2009
and 2010, respectively. The majority of our revenues are allocated among our geographic
segments based upon the profit split transfer pricing methodology which equalizes gross margins for
each legal entity based upon its respective direct revenue or direct costs, as determined by the
relevant revenue source. Through September 30, 2009, we calculated our transfer pricing for
Cardiac Safety services using a profit split methodology based on cost. Subsequent to September
30, 2009, the profit split transfer pricing methodology was modified for Cardiac Safety services to
allocate costs based on revenue instead of allocating revenue based on costs. This has resulted in
an increase in revenue attributed to the UK beginning in the fourth quarter of 2009.
24
Results of Operations
Executive Overview
Net revenues were $45.1 million for the third quarter of 2010, an increase of $22.4 million or
98.6% from $22.7 million in the third quarter of 2009. Net revenues were $96.1 million for the
nine months ended September 30, 2010, an increase of $25.4 million or 39.5% from $70.7 million in
the nine months ended September 30, 2009. The revenue changes were due primarily to the
contributions by our newly acquired RS business which closed on May 28, 2010. Revenue in the nine
months ended September 30, 2009 included $2.5 million of EDC revenue for which we had no
corresponding revenue in 2010 as this business was sold in June 2009. The general business
environment across all our product lines cardiac safety, respiratory, and ePRO continued to
improve with bookings of $59.1 million during the third quarter of 2010, backlog of $303.1 million
at September 30, 2010 and we experienced a relatively strong general level of business development
activities. The general business environment across all our product lines cardiac safety,
respiratory, and ePRO continued to improve, as seen in another relatively strong bookings
quarter, strong backlog and general level of business development activities. However, we have
experienced an increase in the time period between booking new business and the actual start dates
of these new studies which has resulted in slower growth in our cardiac safety business.
Gross margin percentage was 44.5% in the third quarter of 2010 compared to 51.6% in the third
quarter of 2009. The decrease in gross margin percentage was driven by (1) inclusion of three
months of RS activity in the third quarter of 2010, including amortization of acquired intangibles
of $2.3 million, and RS historically has had a lower gross margin than ERT, (2) costs associated
with integration related activities and (3) a higher mix of site support revenue to total revenue
due to RS having a higher proportion of site support revenue with a lower gross margin than
services. Our gross margin on site support was 40.1% for the third quarter, down from 49.4% a year
ago and the gross margin percentage for services was 47.8% in the third quarter of 2010 compared to
52.6% in the comparable quarter a year ago.
Operating income for the third quarter of 2010 was $6.6 million or 14.6% of total net revenues
compared to $4.7 million or 20.7% of total net revenues in the third quarter of 2009. Operating
income for the third quarter of 2010 was negatively impacted by $2.3 million of amortization of
acquisition related intangibles related to the acquisition of RS and $0.6 million of retirement
costs, which reduced our operating margin by approximately 6 percentage points. Our effective
income tax rate for the third quarter of 2010 was 31.7% compared to 39.1% in the third quarter of
2009 as we have benefited from the lower tax rates applicable to the RS operations in Germany and
also from organizational restructuring activities undertaken in the current quarter which resulted
in a reduction in the effective tax rate.
Net income for the third quarter of 2010 was $3.2 million, or $0.06 per diluted share,
compared to $2.8 million, or $0.06 per diluted share, in the third quarter of 2009. Net income in
the third quarter was positively impacted by the three months of contribution from RS and
negatively impacted by the amortization of acquired intangibles, retirement costs and foreign
exchange losses related to recent weakening of the US dollar against the euro.
25
The following table presents certain financial data as a percentage of total net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
|
|
|
|
|
|
Net revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Services |
|
|
70.3 |
% |
|
|
57.5 |
% |
|
|
68.4 |
% |
|
|
61.9 |
% |
Site support |
|
|
29.7 |
% |
|
|
42.5 |
% |
|
|
28.1 |
% |
|
|
38.1 |
% |
EDC licenses and services |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
3.5 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs of revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of services |
|
|
33.4 |
% |
|
|
30.0 |
% |
|
|
32.5 |
% |
|
|
30.4 |
% |
Cost of site support |
|
|
15.0 |
% |
|
|
25.5 |
% |
|
|
14.9 |
% |
|
|
20.0 |
% |
Cost of EDC licenses and services |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
1.2 |
% |
|
|
0.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs of revenues |
|
|
48.4 |
% |
|
|
55.5 |
% |
|
|
48.6 |
% |
|
|
50.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
51.6 |
% |
|
|
44.5 |
% |
|
|
51.4 |
% |
|
|
49.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
13.4 |
% |
|
|
9.9 |
% |
|
|
13.8 |
% |
|
|
12.3 |
% |
General and administrative |
|
|
13.1 |
% |
|
|
17.2 |
% |
|
|
15.0 |
% |
|
|
23.2 |
% |
Research and development |
|
|
4.4 |
% |
|
|
2.8 |
% |
|
|
4.4 |
% |
|
|
3.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
30.9 |
% |
|
|
29.9 |
% |
|
|
33.2 |
% |
|
|
38.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
20.7 |
% |
|
|
14.6 |
% |
|
|
18.2 |
% |
|
|
10.8 |
% |
Foreign
exchange losses |
|
|
(0.7 |
%) |
|
|
(3.9 |
%) |
|
|
(0.7 |
%) |
|
|
(1.3 |
%) |
Other income (expense), net |
|
|
0.4 |
% |
|
|
(0.4 |
%) |
|
|
0.2 |
% |
|
|
(0.2 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
20.4 |
% |
|
|
10.3 |
% |
|
|
17.7 |
% |
|
|
9.3 |
% |
Income tax provision |
|
|
8.0 |
% |
|
|
3.3 |
% |
|
|
7.2 |
% |
|
|
3.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
12.4 |
% |
|
|
7.0 |
% |
|
|
10.5 |
% |
|
|
6.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
26
Three Months Ended September 30, 2009 Compared to Three Months Ended September 30, 2010.
The following table presents our consolidated statements of operations with product line
detail (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
|
|
|
|
2009 |
|
|
2010 |
|
|
Increase (Decrease) |
|
Services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
15,969 |
|
|
$ |
25,929 |
|
|
$ |
9,960 |
|
|
|
62.4 |
% |
Costs of revenues |
|
|
7,577 |
|
|
|
13,526 |
|
|
|
5,949 |
|
|
|
78.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
8,392 |
|
|
$ |
12,403 |
|
|
$ |
4,011 |
|
|
|
47.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Site support: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
6,757 |
|
|
$ |
19,199 |
|
|
$ |
12,442 |
|
|
|
184.1 |
% |
Costs of revenues |
|
|
3,418 |
|
|
|
11,505 |
|
|
|
8,087 |
|
|
|
236.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
3,339 |
|
|
$ |
7,694 |
|
|
$ |
4,355 |
|
|
|
130.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
22,726 |
|
|
$ |
45,128 |
|
|
$ |
22,402 |
|
|
|
98.6 |
% |
Costs of revenues |
|
|
10,995 |
|
|
|
25,031 |
|
|
|
14,036 |
|
|
|
127.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
11,731 |
|
|
|
20,097 |
|
|
|
8,366 |
|
|
|
71.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
3,056 |
|
|
|
4,478 |
|
|
|
1,422 |
|
|
|
46.5 |
% |
General and administrative |
|
|
2,977 |
|
|
|
7,780 |
|
|
|
4,803 |
|
|
|
161.3 |
% |
Research and development |
|
|
989 |
|
|
|
1,250 |
|
|
|
261 |
|
|
|
26.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
7,022 |
|
|
|
13,508 |
|
|
|
6,486 |
|
|
|
92.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
4,709 |
|
|
|
6,589 |
|
|
|
1,880 |
|
|
|
39.9 |
% |
Foreign
exchange losses |
|
|
(173 |
) |
|
|
(1,745 |
) |
|
|
(1,572 |
) |
|
|
908.7 |
% |
Other income
(expense), net |
|
|
91 |
|
|
|
(199 |
) |
|
|
(290 |
) |
|
|
(318.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
4,627 |
|
|
|
4,645 |
|
|
|
18 |
|
|
|
0.4 |
% |
Income tax provision |
|
|
1,808 |
|
|
|
1,472 |
|
|
|
(336 |
) |
|
|
(18.6 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,819 |
|
|
$ |
3,173 |
|
|
$ |
354 |
|
|
|
12.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, |
|
|
Increase |
|
|
|
2009 |
|
|
2010 |
|
|
(Decrease) |
|
Cost of services |
|
|
47.4 |
% |
|
|
52.2 |
% |
|
|
4.8 |
% |
Cost of site support |
|
|
50.6 |
% |
|
|
59.9 |
% |
|
|
9.3 |
% |
Total costs of revenues |
|
|
48.4 |
% |
|
|
55.5 |
% |
|
|
7.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
13.4 |
% |
|
|
9.9 |
% |
|
|
(3.5 |
%) |
General and administrative |
|
|
13.1 |
% |
|
|
17.2 |
% |
|
|
4.1 |
% |
Research and development |
|
|
4.4 |
% |
|
|
2.8 |
% |
|
|
(1.6 |
%) |
27
Revenues
Services revenues for the three months ended September 30, 2010 included $9.3 million from the
operations of RS. Apart from the impact of RS, the increase in services revenues was primarily due
to a $0.5 million increase in revenue from our ePRO operations, an increase in average revenue per
transaction that was due to customer mix which resulted in an increase in revenue of approximately
$0.3 million and a number of other revenue increases totaling $0.6 million. This was partially
offset by a $0.7 million reduction in transaction revenue related to lower volume of transactions
performed in the three months ended September 30, 2010 as compared to the three months ended
September 30, 2009.
Site support revenues for the three months ended September 30, 2010 included $12.1 million
from the operations of RS. Apart from the impact of RS, the increase in site support revenue was
primarily due to $0.9 million associated with an increase in the number of units rented in the
three months ended September 30, 2010 as compared to the three months ended September 30, 2009 and
a $0.1 million increase in each of supplies revenue and equipment sales. Partially offsetting
these increases is a $0.6 million decrease in revenue attributable to decreases in average rental
per unit and $0.2 million of other items.
Costs of Revenues
The cost of services revenues for the three months ended September 30, 2010 included $5.6
million from the operations of RS. Apart from the impact of RS, the increase in the cost of
services, both in absolute terms and as a percentage of service revenues, was primarily due to a
$0.3 million increase in variable incentive compensation expenses and a $0.2 million increase in
royalties associated with our ePRO operations. Partially offsetting these increases was a $0.2
million reduction in labor costs as a result of transitioning the costs associated with the
customer support center to the cost of site support to better align costs with related revenue.
The cost of site support revenues for the three months ended September 30, 2010 included $7.8
million from the operations of RS. Apart from the impact of RS, the increase in the cost of site
support, both in absolute terms and as a percentage of site support revenues, was primarily due to
a $0.5 million increase in labor that was partially due to the costs associated with the customer
support center as discussed above and the costs of US operations that we assumed in conjunction
with our acquisition of RS. Partially offsetting these increases was a $0.3 million decrease in
depreciation expense as older, more expensive ECG equipment has become fully depreciated.
Operating Expenses
Selling and marketing expenses for the three months ended September 30, 2010 included $0.9
million from the operations of RS. Apart from the impact of RS, the increase in selling and
marketing expenses, both in absolute terms and as a percentage of total net revenues, was due
primarily to $0.4 million in higher labor costs due to higher commissionable revenue and the costs
of US operations that we assumed in conjunction with our acquisition of RS. The balance of the
increase was related to smaller increases in items such as variable incentive compensation expenses
and tradeshows.
General and administrative expenses for the three months ended September 30, 2010 included
$2.6 million from the operations of RS. Apart from the impact of RS, the increase in general and
administrative expenses, both in absolute terms and as a percentage of total net revenues, was due
primarily to $0.8 million increase in labor costs which included payments to be made to our Chief
Executive Officer upon his recently announced retirement from the Company. Additionally, there was
a $0.4 million increase in variable incentive compensation expenses. Several items had increases
as result of the continuing integration of the RS acquisition such as travel and professional fees
with increases of $0.2 million each. Non-income taxes increased as the result of a $0.2 million
credit that reduced non-income taxes in 2009.
Research and development expenses for the three months ended September 30, 2010 included $0.4
million from the operations of RS. Apart from the impact of RS, the decrease in research and
development expenses, both in absolute terms and as a percentage of total net revenues, was
primarily due to a an increase in the capitalization of consultant fees associated with
internal-use software development projects which offsets expenses.
Foreign exchange losses increased primarily due to the movement in the
exchange rate between the euro and U.S. dollar that impacts our
operations in Germany acquired in the RS acquisition.
Other
income (expense), net changed as we incurred interest expense on
advances under our line of credit in
2010 that we used to purchase RS and to fund related acquisition
expenses and working capital needs, while 2009 included a small
amount of interest income on our cash balance, a substantial portion
of which we used to purchase RS.
Our effective tax rate for the three months ended September 30, 2010 was 31.7% compared to
39.1% for the three months ended September 30, 2009. Through September 30, 2009, we calculated our
transfer pricing for Cardiac Safety services using a profit split methodology based on cost.
Subsequent to September 30, 2009, the profit split transfer pricing methodology was modified for
Cardiac Safety services to allocate costs based on revenue instead of allocating revenue based on
costs. Our effective tax rate for the third quarter of 2010 included the impact of the RS
acquisition, which operates primarily in Germany which has a lower tax rate than our historic
effective tax rate. Additionally, as of July 1, 2010, we reorganized our operations in the United
States to align our corporate structure along departmental business lines which has also reduced
our effective tax rate.
28
Nine
Months Ended September 30, 2009 Compared to Nine Months Ended September 30, 2010.
The following table presents our consolidated statements of operations with product line
detail (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
|
|
|
2009 |
|
|
2010 |
|
|
Increase (Decrease) |
|
Services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
48,292 |
|
|
$ |
59,461 |
|
|
$ |
11,169 |
|
|
|
23.1 |
% |
Costs of revenues |
|
|
22,941 |
|
|
|
29,162 |
|
|
|
6,221 |
|
|
|
27.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
25,351 |
|
|
$ |
30,299 |
|
|
$ |
4,948 |
|
|
|
19.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Site support: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
19,895 |
|
|
$ |
36,631 |
|
|
$ |
16,736 |
|
|
|
84.1 |
% |
Costs of revenues |
|
|
10,523 |
|
|
|
19,261 |
|
|
|
8,738 |
|
|
|
83.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
9,372 |
|
|
$ |
17,370 |
|
|
$ |
7,998 |
|
|
|
85.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EDC licenses and services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
2,501 |
|
|
$ |
|
|
|
$ |
(2,501 |
) |
|
|
(100.0 |
%) |
Costs of revenues |
|
|
863 |
|
|
|
|
|
|
|
(863 |
) |
|
|
(100.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
1,638 |
|
|
$ |
|
|
|
$ |
(1,638 |
) |
|
|
(100.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
70,688 |
|
|
$ |
96,092 |
|
|
$ |
25,404 |
|
|
|
35.9 |
% |
Costs of revenues |
|
|
34,327 |
|
|
|
48,423 |
|
|
|
14,096 |
|
|
|
41.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
|
36,361 |
|
|
|
47,669 |
|
|
|
11,308 |
|
|
|
31.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
9,756 |
|
|
|
11,827 |
|
|
|
2,071 |
|
|
|
21.2 |
% |
General and administrative |
|
|
10,581 |
|
|
|
22,278 |
|
|
|
11,697 |
|
|
|
110.5 |
% |
Research and development |
|
|
3,131 |
|
|
|
3,177 |
|
|
|
46 |
|
|
|
1.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
23,468 |
|
|
|
37,282 |
|
|
|
13,814 |
|
|
|
58.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
12,893 |
|
|
|
10,387 |
|
|
|
(2,506 |
) |
|
|
(19.4 |
%) |
Foreign
exchange losses |
|
|
(543 |
) |
|
|
(1,267 |
) |
|
|
(724 |
) |
|
|
133.3 |
% |
Other income
(expense), net |
|
|
168 |
|
|
|
(181 |
) |
|
|
(349 |
) |
|
|
(207.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
12,518 |
|
|
|
8,939 |
|
|
|
(3,579 |
) |
|
|
(28.6 |
%) |
Income tax provision |
|
|
5,081 |
|
|
|
3,188 |
|
|
|
(1,893 |
) |
|
|
(37.3 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
7,437 |
|
|
$ |
5,751 |
|
|
$ |
(1,686 |
) |
|
|
(22.7 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents costs of revenues as a percentage of related net revenues and
operating expenses as a percentage of total net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Increase |
|
|
|
2009 |
|
|
2010 |
|
|
(Decrease) |
|
Cost of services |
|
|
47.5 |
% |
|
|
49.0 |
% |
|
|
1.5 |
% |
Cost of site support |
|
|
52.9 |
% |
|
|
52.6 |
% |
|
|
(0.3 |
%) |
Cost of EDC licenses and services |
|
|
34.5 |
% |
|
|
N/A |
|
|
|
N/A |
|
Total costs of revenues |
|
|
48.6 |
% |
|
|
50.4 |
% |
|
|
1.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling and marketing |
|
|
13.8 |
% |
|
|
12.3 |
% |
|
|
(1.5 |
%) |
General and administrative |
|
|
15.0 |
% |
|
|
23.2 |
% |
|
|
8.2 |
% |
Research and development |
|
|
4.4 |
% |
|
|
3.3 |
% |
|
|
(1.1 |
%) |
29
Revenues
Services revenues for the nine months ended September 30, 2010 included $11.9 million from the
operations of RS. Apart from the impact of RS, the decrease in services revenues was primarily due
to a $1.9 million reduction in transaction revenue related to lower volume of transactions
performed in the nine months ended September 30, 2010 as compared to the nine months ended
September 30, 2009. There was also a decrease in average revenue per transaction that was largely
due to certain lower transaction prices which resulted in a decrease in revenue of approximately
$0.8 million. These decreases were partially offset by a number of revenue increases totaling $2.0
million, primarily from our ePRO operations.
Site support revenues for the nine months ended September 30, 2010 included $15.3 million from
the operations of RS. Apart from the impact of RS, the increase in site support revenue was
primarily due to $1.9 million associated with an increase in the number of units rented in the nine
months ended September 30, 2010 as compared to the nine months ended September 30, 2009 and $0.2
million increase each in supplies revenue and equipment sales. Partially offsetting these
increases was a $0.7 million decrease in revenue attributable to decreases in average rental per
unit and $0.2 million of other items.
Costs of Revenues
The cost of services revenues for the nine months ended September 30, 2010 included $6.8
million from the operations of RS. Apart from the impact of RS, the decrease in the cost of
services, both in absolute terms and as a percentage of service revenues, was primarily due to a
$1.4 million reduction in labor costs of which $1.2 million was a result of transitioning the costs
associated with the customer support center to the cost of site support in 2010 to better align
costs with related revenue. We have also realized cost savings as a result of efficiency
initiatives implemented in the latter part of 2009. Additionally, depreciation expense decreased
by $0.4 million as computer equipment purchased for the development and implementation of the
EXPERT 2 technology platform has become fully depreciated. Partially offsetting these decreases
were increases in variable incentive compensation expenses of $0.7 million and $0.2 million each
for travel, telephone and connectivity and consulting.
The cost of site support revenues for the nine months ended September 30, 2010 included $9.5
million from the operations of RS. Apart from the impact of RS, 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 $1.5 million decrease in depreciation expense as older, more expensive ECG equipment has become
fully depreciated. Partially offsetting these decreases were $0.7 million of costs in 2010
associated with the customer support center as discussed above.
Operating Expenses
Selling and marketing expenses for the nine months ended September 30, 2010 included $1.3
million from the operations of RS. Apart from the impact of RS, the increase in selling and
marketing expenses, both in absolute terms and as a percentage of total net revenues, was due
primarily to $0.4 million in higher labor costs due to higher commissionable revenue and the costs
of US operations that we assumed in conjunction with our acquisition of RS, $0.3 million in higher
variable incentive compensation expenses, $0.2 million each in higher marketing costs and
royalties. These increases were partially offset by $0.3 million lower consulting costs.
General and administrative expenses for the nine months ended September 30, 2010 included $3.8
million from the operations of RS. Apart from the impact of RS, the increase in general and
administrative expenses, both in absolute terms and as a percentage of total net revenues, was due
primarily to $4.1 million of professional fees incurred related to transaction costs associated
with our acquisition of RS. Labor costs increased $0.9 million which included payments to be made
to our Chief Executive Officer upon his recently announced retirement from the Company. We added
$0.6 million to the reserve for losses on the lease of our former Reno, Nevada facility due to
continued poor prospects for subleasing that facility. We recognized a $0.5 million gain on sale
of our former EDC business in the second quarter of 2009 which decreased our expenses in 2009.
Additionally, software costs increased $0.4 million and consultant costs increased $0.3 million as
a result of an information technology modernization and virtualization project started in late 2009
and continuing in 2010. There was a $0.4 million increase in variable incentive compensation
expenses. Travel costs increased $0.3 million as a result of continuing integration costs
associated with the RS acquisition.
Research and development expenses for the nine months ended September 30, 2010 included $0.7
million from the operations of RS. Apart from the impact of RS, the decrease in research and
development expenses, both in absolute terms and as a percentage of total net revenues, was
primarily due to a $0.5 million reduction in labor costs as a result of the sale of our former EDC
operations in June 2009 and an increase in the capitalization of salaries and consultant fees
associated with internal-use software development projects.
Foreign exchange losses increased primarily due to the movement in the
exchange rate between the euro and U.S. dollar that impacts our
operations in Germany acquired in the RS acquisition.
Other income (expense), net changed as we incurred interest expense
on advances under our line of credit in 2010 that we used to purchase
RS and to fund related acquisition expenses and working capital
needs, while 2009 included a small amount of interest income on our
cash balance, a substantial portion of which we used to purchase RS.
30
Our effective tax rate for the nine months ended September 30, 2010 was 35.7% compared to
40.6% for the nine months ended September 30, 2009. Through September 30, 2009, we calculated our
transfer pricing for Cardiac Safety services using a profit split methodology based on cost.
Subsequent to September 30, 2009, the profit split transfer pricing methodology was modified for
Cardiac
Safety services to allocate costs based on revenue instead of allocating revenue based on
costs. Our effective tax rate for the nine months ended September 30, 2010 included the impact of
the RS acquisition, which operates primarily in Germany which has a lower tax rate than our
historic effective tax rate. However, acquisition costs are not deductible for tax purposes which
increased the estimated effective tax rate for the year ended December 31, 2010 by approximately
eight percentage points. Additionally, as of July 1, 2010, we reorganized our operations in the
United States to align our corporate structure along departmental business lines which has also
reduced our effective tax rate.
Liquidity and Capital Resources
At September 30, 2010, we had $19.4 million of cash, cash equivalents and short-term
investments. We generally place our investments in highly-rated securities such as municipal
securities, bonds of government sponsored agencies, certificates of deposit with fixed rates and
maturities of less than one year, and A1P1 rated commercial bonds and paper. Of the $19.4 million,
$5.6 million and $6.6 million are held by our UK and German subsidiaries, respectively. Although a
portion of our UK subsidiarys current undistributed net earnings, as well as any future net
earnings of our UK and German subsidiaries, will be permanently reinvested, we believe that this
does not have a material impact on our overall liquidity.
For the nine months ended September 30, 2010, our operations provided cash of $18.8 million, a
decrease of $5.9 million compared to $24.7 million during the nine months ended September 30, 2009.
The decrease was primarily the result of an increase in accounts receivable in the nine months
ended September 30, 2010 of $6.4 million as compared to a decrease of $12.5 million in the nine
months ended September 30, 2009. The accounts receivable were reduced significantly during the
nine months ended September 30, 2009 as a result of focused collection efforts and a reduction in
revenue. The increase in the accounts receivable in 2010 was primarily due to an increase in the
RS accounts receivables we acquired and as RS revenue increased. Partially offsetting this
negative impact on cash flow was a $5.1 million increase in accrued expenses in the nine months
ended September 30, 2010 as compared to a $3.7 million decrease in the nine months ended September
30, 2009. The increase in the 2010 accrued expenses was largely due to an increase in the RS
accrued expenses and an increase in the 2010 accrual for incentive compensation due to expected
improved results against targets as compared to 2009. The decrease in 2009 was largely the result
of the payment of a greater amount in 2009 for variable incentive compensation related to the prior
years results. Other items with a positive impact on operating cash flow in the nine months ended
September 30, 2010 as compared to the same period in 2009 included net income before depreciation
and amortization and accounts payable.
For the nine months ended September 30, 2010, our investing activities used cash of $89.0
million as compared to $5.4 million during the nine months ended September 30, 2009. Acquisition
payments totaled $82.8 million in the nine months ended September 30, 2010, substantially all for
RS, as compared to $0.7 million related to Covance Cardiac Safety Services (CCSS) in the nine
months ended September 30, 2009. Proceeds from sales of investments net of purchases were $9.7
million during the nine months ended September 30, 2010, with no activity during the nine months
ended September 30, 2009.
During the nine months ended September 30, 2010 and 2009, we capitalized $16.0 million and
$3.6 million, respectively, of property and equipment. Included in property and equipment
acquisitions was $4.3 million and $1.9 million for the nine months ended September 30, 2010 and
2009, respectively, of internal use software. The balance of the change was primarily due to an
increase in purchases of ECG and respiratory equipment commensurate with the additional units
rented in the nine months ended September 30, 2010, which included RS for four months, as compared
to the nine month ended September 30, 2009.
For the nine months ended September 30, 2010, our financing activities provided cash of $21.2
million as compared to a $14.7 million use of cash for the nine months ended September 30, 2009.
We obtained proceeds of $23.0 million from our Citizens Bank of Pennsylvania credit facility which
we used to purchase RS on May 28, 2010 and to fund related transaction costs and working capital
needs. We subsequently repaid $2.0 million. In the nine months ended September 30, 2009, we
repurchased $15.0 million of our common stock under our stock buy-back program, with no
corresponding expenditure in the nine months ended September 30, 2010.
We have a revolving line of credit arrangement with Citizens Bank of Pennsylvania in the
aggregate amount of $40.0 million, with an additional $10.0 million increase option. As of
September 30, 2010, we have outstanding $21.0 million under our line of credit and $29.0 million
remains available for us to borrow including the increase option. The line has a three-year term
which expires May 27, 2013 and annual interest rates based upon LIBOR plus a margin of 1.00% to
1.75% based upon a total leverage ratio and unused commitment fees of 0.10% to 0.20% based upon the
same total leverage ratio. From the initial borrowing on May 27, 2010 through September 30, 2010,
the annual interest rate ranged from 1.35% to 1.60% and the unused commitment fee was 0.10%.
Financial covenants include maximum total senior funded debt to earnings before interest, income
taxes, depreciation and amortization (EBITDA) of 2.0 and minimum debt service coverage ratio of
1.5. At September 30, 2010, the Company was in compliance with all debt covenants. Borrowings
under the line of credit are secured by 65% of the capital stock in certain of our foreign
subsidiaries.
We have commitments to purchase approximately $2.8 million of private label cardiac safety
equipment from a manufacturer over a twelve-month period beginning upon completion of our user
acceptance testing, which was completed in the first quarter of 2010. We expect to purchase this
cardiac safety equipment in the normal course of business and thus this commitment does not
represent a significant commitment above our expected purchases of ECG equipment during this
period. As of September 30, 2010, approximately $1.7 million of equipment was purchased under the
commitments; accordingly the balance of such commitments as of September 30,
2010 was $1.1 million.
31
In March 2010, the Patient Protection and Affordable Care Act and the Health Care and
Education Act of 2010 became law. The provisions of the Acts are not expected to have a
significant impact to our consolidated financial statements.
We expect that existing cash and cash equivalents, cash flows from operations and amounts
available under the $40 million credit facility as discussed above will be sufficient to meet our
foreseeable cash needs for at least the next year. In addition, there may be acquisition and other
growth opportunities that require additional external financing and we may from time to time seek
to obtain additional funds from the public or private issuances of equity or debt securities.
There can be no assurance that any such acquisitions will occur or that such financing will be
available or available on terms acceptable to us, particularly in view of current capital market
uncertainty.
Our board of directors has authorized the repurchase of up to an aggregate of 12.5 million
shares, of which 5.0 million shares remain to be purchased as of September 30, 2010. The stock
buy-back authorization allows us, but does not require us, to purchase the authorized shares. The
purchase of the remaining shares authorized could require us to use a significant portion of our
cash, cash equivalents and investments and could also require us to seek additional external
financing. During the nine months ended September 30, 2009, we purchased 2,902,735 shares of our
common stock at a cost of $15.1 million. No shares were purchased during the nine months ended
September 30, 2010.
On November 28, 2007, we completed the acquisition of CCSS from Covance Inc. Under the terms
of our agreement to purchase CCSS, the total initial purchase consideration was $35.2 million. We
may also pay contingent consideration of up to approximately $14.0 million based upon our potential
realization of revenue from the backlog transferred and from new contracts secured through
Covances marketing activities. The period for contingent payments runs through December 31, 2010.
Through September 30, 2010, Covance earned $5.3 million of this contingent amount with less than
$0.1 million earned during the nine months ended September 30, 2010. At September 30, 2010, $0.1
million of the contingent amount earned remained to be paid to Covance, which we recorded in
accounts payable. These contingent payments increased goodwill by $5.3 million. Under the terms
of the marketing agreement, Covance agreed to exclusively use us as its provider of centralized
cardiac safety solutions for a ten-year period, subject to certain exceptions, and we agreed to pay
referral fees on certain revenues.
Inflation
We believe the effects of inflation and changing prices generally do not have a material
effect on our consolidated results of operations or financial condition.
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
Short-term debt
At September 30, 2010, our short-term debt was comprised of $21.0 million drawn under our
$40.0 million credit facility with Citizens Bank of Pennsylvania. We do not manage the interest
rate risk on our debt through the use of derivative instruments. Our credit facilitys interest
rates may be reset due to fluctuations in the London Interbank Offered Rate (LIBOR). A
hypothetical 100-basis-point change in the interest rate of our credit facilities would change our
annual pre-tax earnings by $0.2 million based on our current borrowings under the credit facility.
Investments
We generally place our investments in highly-rated securities such as money market funds,
municipal securities, bonds of government sponsored agencies, certificates of deposit with fixed
rates with maturities of less than one year and A1P1 rated commercial bonds and paper. We actively
manage our portfolio of cash equivalents and short-term investments, but in order to ensure
liquidity, will only invest in instruments with high credit quality where a secondary market
exists. We have not held and do not hold any derivatives related to our interest rate exposure.
Due to the average maturity and conservative nature of our investment portfolio, a sudden change in
interest rates would not have a material effect on the value of the portfolio. The impact on
interest income of future changes in investment yields will depend largely on the gross amount of
our cash, cash equivalents, short-term investments and log-term investments. See Liquidity and
Capital Resources as part of Managements Discussion and Analysis of Financial Condition and
Results of Operations.
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Foreign Currency Risk
We operate on a global basis from locations in the United States (U.S.), the United Kingdom
(UK) and Germany. All international net revenues and expenses are billed or incurred in either
U.S. dollars, pounds sterling or euros. As such, we face exposure to adverse movements in the
exchange rate of the pound sterling and euro. As the currency rate changes, translation of the
statement of operations of our UK and German subsidiaries from the local currency to U.S. dollars
affects year-to-year comparability of operating results. With the recent RS acquisition, there has
been a significant increase in activity in countries outside the U.S. As a result, while we did
not hedge translation risks through September 30, 2010, we are currently in the process of
evaluating a hedging strategy.
Management estimates that a 10% change in the exchange rate of the pound sterling and euro
would have impacted the reported operating income for the nine months ended September 30, 2010 by
approximately $1.0 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 September 30,
2010 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
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Part II. Other Information
Item 6. Exhibits
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31.1
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Certification of Chief Executive Officer. |
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31.2
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Certification of Chief Financial Officer. |
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32.1
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Statement of Chief Executive Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
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32.2
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Statement of Chief Financial Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
34
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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eResearchTechnology, Inc.
(Registrant)
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Date: November 9, 2010 |
By: |
/s/ Michael J. McKelvey
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Michael J. McKelvey |
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President and Chief Executive Officer,
(Principal executive officer) |
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Date: November 9, 2010 |
By: |
/s/ Keith D. Schneck
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Keith D. Schneck |
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Executive Vice President, Chief Financial
Officer and Secretary
(Principal financial and accounting officer) |
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35
EXHIBIT INDEX
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Exhibit No. |
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Exhibit |
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31.1
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Certification of Chief Executive Officer. |
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31.2
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Certification of Chief Financial Officer. |
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32.1
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Statement of Chief Executive Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
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32.2
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Statement of Chief Financial Officer Pursuant to Section 1350 of Title 18 of the United States Code. |
36