e10vq
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended March 31, 2011
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 transition period from _____________ to _____________
Commission File No. 001-11182
BIOCLINICA, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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11-2872047 |
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(State or Other Jurisdiction of
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(I.R.S. Employer Identification No.) |
Incorporation or Organization) |
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826 Newtown-Yardley Road, Newtown, Pennsylvania
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18940-1721 |
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(Address of Principal Executive Offices)
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(Zip Code) |
(267) 757-3000
(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.
Indicate by check mark if 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 (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
* The registrant has not yet been phased into the interactive data requirement.
Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act (check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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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).
State the number of shares outstanding of each of the registrants classes of common stock, as
of April 30, 2011:
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Class |
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Number of Shares |
Common Stock, $0.00025 par value
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15,635,635 |
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BIOCLINICA, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
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-i-
PART I. FINANCIAL INFORMATION.
Item 1. Financial Statements.
References in this Quarterly Report on Form 10-Q to BioClinica, we, us, or our refer
to BioClinica, Inc., a Delaware corporation, and its subsidiaries, doing business as BioClinica.
Certain information and footnote disclosures required under generally accepted accounting
principles (GAAP) in the United States of America have been condensed or omitted from the following
consolidated financial statements pursuant to the rules and regulations of the Securities and
Exchange Commission, although we believe that such financial disclosures are adequate so that the
information presented is not misleading in any material respect. The following consolidated
financial statements should be read in conjunction with the year-end consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2010.
The results of operations for the interim periods presented in this Quarterly Report on Form
10-Q are not necessarily indicative of the results to be expected for the entire fiscal year.
-1-
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(unaudited)
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March 31, |
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December 31, |
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(in thousands) |
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2011 |
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2010 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
10,203 |
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$ |
10,443 |
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Accounts receivable, net |
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12,644 |
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11,866 |
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Prepaid expenses and other current assets |
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2,622 |
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2,501 |
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Deferred income taxes |
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3,729 |
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3,625 |
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Total current assets |
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29,198 |
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28,435 |
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Property and equipment, net |
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14,564 |
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14,029 |
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Intangibles, net |
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2,275 |
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2,430 |
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Goodwill |
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34,302 |
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34,302 |
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Deferred income tax |
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119 |
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128 |
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Other assets |
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727 |
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705 |
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Total assets |
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$ |
81,185 |
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$ |
80,029 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
3,553 |
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$ |
1,983 |
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Accrued expenses and other current liabilities |
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3,203 |
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4,283 |
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Deferred revenue |
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13,174 |
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13,395 |
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Current maturities of capital lease obligations |
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180 |
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168 |
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Total current liabilities |
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20,110 |
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19,829 |
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Long-term capital lease obligations |
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657 |
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710 |
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Long-term liability for acquisition earn-out |
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1,943 |
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1,886 |
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Deferred income tax |
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1,990 |
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1,845 |
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Other liabilities |
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1,002 |
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880 |
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Total liabilities |
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$ |
25,702 |
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$ |
25,150 |
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Stockholders equity: |
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Preferred stock $0.00025 par value; authorized
3,000,000 shares, none issued and
outstanding at March 31, 2011 and at December
31, 2010 |
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Common stock $0.00025 par value; authorized
36,000,000 shares, issued and outstanding
15,642,177 shares at March 31, 2011 and
15,631,664 shares at December 31, 2010 |
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4 |
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4 |
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Treasury stock at cost, shares held: 41,013
at March 31, 2011 and 3,400 at December 31,
2010 |
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(204 |
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(16 |
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Additional paid-in capital |
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48,450 |
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48,074 |
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Retained earnings |
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7,143 |
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6,792 |
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Accumulated other comprehensive income |
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90 |
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25 |
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Total stockholders equity |
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$ |
55,483 |
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$ |
54,879 |
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Total liabilities and stockholders equity |
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$ |
81,185 |
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$ |
80,029 |
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See Notes to Consolidated Financial Statements
-2-
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
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For the Three Months ended |
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March 31, |
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(in thousands, except per share data) |
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2011 |
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2010 |
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Service revenues |
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$ |
16,144 |
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$ |
14,746 |
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Reimbursement revenues |
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3,521 |
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3,358 |
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Total revenues |
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19,665 |
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18,104 |
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Cost and expenses: |
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Cost of service revenues |
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10,557 |
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8,951 |
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Cost of reimbursement revenues |
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3,521 |
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3,358 |
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Sales and marketing expenses |
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1,860 |
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2,210 |
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General and administrative expenses |
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2,222 |
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2,072 |
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Amortization of intangible assets related to acquisition |
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156 |
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141 |
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Mergers and acquisitions related costs |
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103 |
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205 |
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Restructuring costs |
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679 |
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Total cost and expenses |
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19,098 |
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16,937 |
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Income from operations |
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567 |
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1,167 |
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Interest income |
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2 |
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6 |
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Interest expense |
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(9 |
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(3 |
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Income before income tax |
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560 |
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1,170 |
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Income tax provision |
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(209 |
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(459 |
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Net income |
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$ |
351 |
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$ |
711 |
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Basic income per common share |
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$ |
0.02 |
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$ |
0.05 |
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Weighted average number of common shares |
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15,652 |
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14,545 |
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Diluted income per common share |
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$ |
0.02 |
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$ |
0.05 |
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Weighted average number of diluted shares |
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16,417 |
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15,382 |
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See Notes to Consolidated Financial Statements
-3-
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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For the Three Months ended |
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March 31, |
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(in thousands) |
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2011 |
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2010 |
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Cash flows from operating activities: |
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Net income |
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$ |
351 |
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$ |
711 |
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Adjustments to reconcile net income to net cash provided by
operating activities, net of acquisition: |
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Depreciation and amortization |
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1,030 |
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728 |
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Provision for deferred income taxes |
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41 |
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163 |
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Bad debt (recovery) expense, net |
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(9 |
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Stock based compensation expense |
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341 |
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235 |
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Accretion of acquisition earn-out |
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57 |
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94 |
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Changes in operating assets and liabilities, net of acquisitions: |
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(Increase) decrease in accounts receivable |
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(778 |
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1,246 |
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Increase in prepaid expenses and other current assets |
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(111 |
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(168 |
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(Increase) decrease in other assets |
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(22 |
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11 |
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Increase (decrease) in accounts payable |
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1,435 |
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(153 |
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Decrease in accrued expenses and other current liabilities |
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(1,077 |
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(624 |
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Decrease in deferred revenue |
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(221 |
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(1,218 |
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Increase in other liabilities |
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122 |
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122 |
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Net cash provided by operating activities |
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$ |
1,168 |
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$ |
1,138 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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$ |
(303 |
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$ |
(867 |
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Capitalized software development costs |
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(977 |
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(1,388 |
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Net cash used in investing activities |
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$ |
(1,280 |
) |
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$ |
(2,255 |
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Cash flows from financing activities: |
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Payments under equipment lease obligations |
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$ |
(40 |
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Purchase of treasury stock |
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(188 |
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Excess tax benefit related to stock options |
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27 |
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Proceeds from exercise of stock options |
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35 |
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38 |
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Net cash (used in) provided by financing activities |
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$ |
(193 |
) |
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$ |
65 |
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Effect of exchange rate changes on cash |
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65 |
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(49 |
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Net decrease in cash and cash equivalents |
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(240 |
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(1,101 |
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Cash and cash equivalents at beginning of period |
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10,443 |
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14,570 |
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Cash and cash equivalents at end of period |
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$ |
10,203 |
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$ |
13,469 |
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Supplemental disclosure of cash flow information: |
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Cash paid during the period for interest |
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$ |
10 |
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$ |
3 |
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Cash paid during the period for income taxes |
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$ |
74 |
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$ |
171 |
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See Notes to Consolidated Financial Statements
-4-
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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For the Three Months Ended |
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March 31, |
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2011 |
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2010 |
Supplemental cash flow disclosure (in thousands) |
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Non cash investing and financing activities: |
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Increase in property, plant and equipment
acquisitions in accounts payable |
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$ |
132 |
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$ |
587 |
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For the Three Months Ended |
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March 30, |
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2011 |
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2010 |
Acquired business (in thousands) |
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Accounts receivable |
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$ |
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$ |
309 |
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Prepaid and other current assets |
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Property and equipment |
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91 |
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Other assets |
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58 |
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Customer relationships |
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100 |
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Technology |
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1,000 |
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Goodwill, including workforce |
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1,369 |
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Current liabilities assumed |
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(459 |
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Common stock issued |
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(2,468 |
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Cash paid for acquired business, net of cash acquired |
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$ |
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$ |
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See Notes to Consolidated Financial Statements
-5-
BIOCLINICA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
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For the Three Months Ended |
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March 31, |
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2011 |
|
2010 |
Statement of comprehensive income (in thousands) |
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Net income |
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$ |
351 |
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$ |
711 |
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Equity adjustment from foreign currency translation |
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65 |
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(77 |
) |
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Total comprehensive income |
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$ |
416 |
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$ |
634 |
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See Notes to Consolidated Financial Statements
-6-
Note 1 Interim Financial Statements
Basis of Presentation.
The financial statements included in this Quarterly Report on Form 10-Q have been prepared by
us, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and footnote disclosures normally included in financial statements prepared in
accordance with GAAP in the United States of America have been condensed or omitted pursuant to
such rules and regulations. These consolidated financial statements should be read in conjunction
with the audited consolidated financial statements and notes thereto included in our Annual Report
on Form 10-K for the year ended December 31, 2010.
In the opinion of management, the accompanying consolidated financial statements contain all
adjustments, consisting solely of those which are of a normal recurring nature, necessary for a
fair statement of the results for the interim periods.
Interim results are not necessarily indicative of results for the full fiscal year.
Acquisitions.
On March 25, 2010, the Company acquired substantially all of the assets of privately held
TranSenda International, LLC (TranSenda) for total consideration of $2,468,000. The Consolidated
Statement of Income for the three months ended March 31, 2010 excludes the financial results of
TranSenda from the acquisition date of March 25, 2010 through March 31, 2010 due to immateriality
of TranSendas results of operations for that period.
Functional Currency.
The functional currency of each of the Companys foreign operations is the local currency of
the country in which the operation is located. All assets and liabilities are translated into U.S.
dollars using exchange rates in effect at the balance sheet date. Revenue and expenses are
translated using average exchange rates during the period. Increases and decreases in net assets
resulting from foreign currency translation are reflected in stockholders equity as a component of
accumulated other comprehensive income (loss).
The equity adjustment from foreign currency translation was $65,000 and $(77,000) at March 31,
2011 and 2010, respectively.
-7-
Note 2 Restructuring charges
In
2011, the Company realigned its global resources to eliminate certain duplicate functions and expects
to take a total restructuring charge, primarily comprised of severance and facility restructuring
costs, of $1.6 million. In the first quarter of 2011, the Company incurred $679,000 of these restructuring
costs consisting of $588,000 in employee severance and $91,000 in legal and other costs.
The Company has paid $495,000 of the restructuring cost as of March 31, 2011 and $184,000
remaining to be paid is included in Accrued Expense and Other Current Liabilities on the
Consolidated Balance Sheet. The $184,000 remaining to be paid of the restructuring cost primarily
consists of the severance to employees and will all be paid out by December 31, 2011. The Company
expects the total restructuring charge for 2011 to be approximately $1.6 million and to realize an
annual savings of $1.2 million from the restructuring.
Note 3 Stockholders Equity
The following summarizes the activity of the Stockholders equity accounts for the period from
December 31, 2010 through March 31, 2011:
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Addi- |
|
|
|
|
|
Accumul |
|
Compre- |
|
|
|
|
|
|
|
|
|
|
|
|
tional |
|
Treas- |
|
ated |
|
hensive |
|
Stock- |
|
|
Common Stock |
|
Paid-in |
|
ury |
|
Retained |
|
Gain |
|
holders |
(in thousands) |
|
Shares |
|
Amount |
|
Capital |
|
Stock |
|
Earnings |
|
(Loss) |
|
Equity |
|
|
|
Balance at December 31,
2010 |
|
|
15,632 |
|
|
$ |
4 |
|
|
$ |
48,074 |
|
|
$ |
(16 |
) |
|
$ |
6,792 |
|
|
$ |
25 |
|
|
$ |
54,879 |
|
Stock options exercised |
|
|
41 |
|
|
|
|
|
|
|
35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35 |
|
Restricted shares issued |
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
341 |
|
Purchase of treasury stock |
|
|
(38 |
) |
|
|
|
|
|
|
|
|
|
|
(188 |
) |
|
|
|
|
|
|
|
|
|
|
(188 |
) |
Tax benefit on exercise
of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity adjustment from
foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65 |
|
|
|
65 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
351 |
|
|
|
|
|
|
|
351 |
|
|
|
|
Balance at March 31, 2011 |
|
|
15,642 |
|
|
$ |
4 |
|
|
$ |
48,450 |
|
|
$ |
(204 |
) |
|
$ |
7,143 |
|
|
$ |
90 |
|
|
$ |
55,483 |
|
-8-
On December 15, 2010, our Board of Directors authorized $2 million in funds for use in
our common stock repurchase program over the following 18 months from December 2010. Repurchase
under the program may be made through open market purchases or privately negotiated transactions in
accordance with applicable federal securities laws, including Rule 10b-18. Rule 10b-18 puts
limitations on this repurchase program, including but not limited to, the manner of purchase, the
time of the repurchases, the prices paid and the volume of shares repurchased. The timing of the
repurchases and the exact number of shares of common stock to be purchased will be determined by
the discretion of our management under the supervision of the audit committee of our board of
directors, and will depend upon market conditions and other factors. The program will be funded
using our cash on hand and cash generated from operations. On March 14, 2011, we entered into a
10b5-1 Stock Repurchase Agreement with our broker so we had the ability to repurchase shares of our
common stock during our standard blackout periods. The program may be extended, suspended or
discontinued at any time.
The following table provides information relating to our repurchase of common stock for the first quarter of 2011:
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
Approximate |
|
|
|
|
|
|
|
|
|
|
Shares Purchased |
|
Dollar Value of |
|
|
|
|
|
|
|
|
|
|
as Part of Publicly |
|
Shares that May |
|
|
Total Number of |
|
Average Price |
|
Announced |
|
Yet Be Purchased |
|
|
Shares Purchased |
|
Paid per Share |
|
Program |
|
Under the Program |
January 1 January 31, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,984,177 |
|
February 1 February 28, 2011 |
|
|
2,509 |
|
|
$ |
4.67 |
|
|
|
2,509 |
|
|
$ |
1,972,387 |
|
March 1 March 31, 2011 |
|
|
35,104 |
|
|
$ |
5.01 |
|
|
|
35,104 |
|
|
$ |
1,795,332 |
|
|
|
|
37,613 |
|
|
|
|
|
|
|
37,613 |
|
|
|
|
|
Note 4 Earnings Per Share
Basic income per common share for the three months ended March 31, 2011 and 2010 was
calculated by dividing the net income available to Common Stockholders by the weighted average
number of shares of Common Stock outstanding during the period. Diluted income per share for the
three months ended March 31, 2011 and 2010 was calculated by dividing net income by the weighted
average number of shares of common stock outstanding, adjusted for the effect of potentially
dilutive securities using the treasury stock method.
-9-
The computation of basic income per common share and diluted income per common share was as
follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Net income basic and diluted |
|
$ |
351 |
|
|
$ |
711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
15,652 |
|
|
|
14,545 |
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.02 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
15,652 |
|
|
|
14,545 |
|
Common share equivalents
of outstanding stock options |
|
|
428 |
|
|
|
467 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
337 |
|
|
|
370 |
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equity shares |
|
|
16,417 |
|
|
|
15,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per
common share |
|
$ |
0.02 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
Options to purchase 553,000 and 492,000 shares of BioClinicas common stock respectively,
had been excluded from the calculation of diluted earnings per common share for the three months
ended March 31, 2011 and March 31, 2010, respectively, as they were all antidilutive.
-10-
Note 5 Commitments and Contingencies
On March 4, 2009, the Company entered into an employment agreement with its President and
Chief Executive Officer effective March 1, 2009 and expires on February 28, 2012. In addition, the
Company has employment agreements with its Chief Financial Officer and the President of eClinical
Solutions. The Chief Financial Officers agreement expires January 31, 2012 and is renewable on an
annual basis. The President of eClinical Solutions agreement expires September 30, 2011 and is
renewable on an annual basis. The aggregate amount due from March 31, 2011 through the expiration
under these agreements is $784,000.
On
May 5, 2010, the Company entered into an unsecured, committed line of credit with PNC Bank expiring
May 5, 2012. In April 2011 the Company extended this line of credit for an expiration of May 4, 2013.
Under the credit agreement, the Company has the ability to borrow $7.5 million at interest rates equal to
LIBOR plus 1.75%. In addition, the Company pays a fee of 0.25% per annum on the loan commitment regardless
of usage. The credit agreement requires our compliance with certain covenants, including
maintaining a minimum stockholders equity of $35 million.
As of March 31, 2011, the Company had no
borrowings under this line of credit, and was compliant with the covenants.
Note 6 Accounts Receivable and Allowance for Doubtful Accounts
The Company maintains allowances for doubtful accounts on a specific identification method for
estimated losses resulting from the inability of its customers to make required payments. If the
financial condition of its customers were to deteriorate, resulting in an impairment of the
customers ability to make payments, additional allowances may be required. The Company does not
have any off-balance-sheet credit exposure related to its customers and the trade accounts
receivable do not bear interest.
|
|
|
|
|
|
|
|
|
(in thousands) |
|
March 31, 2011 |
|
|
December 31, 2010 |
|
Billed trade accounts receivable |
|
$ |
11,984 |
|
|
$ |
11,085 |
|
Unbilled trade accounts receivable |
|
|
654 |
|
|
|
782 |
|
Other |
|
|
21 |
|
|
|
14 |
|
|
|
|
|
|
|
|
Total Receivables |
|
$ |
12,659 |
|
|
$ |
11,881 |
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward (in thousands): |
|
|
|
|
|
|
|
|
Balance at January 1, 2011 |
|
$ |
15 |
|
|
|
|
|
Additions |
|
|
0 |
|
|
|
|
|
Write offs (Recoveries) |
|
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2011 |
|
$ |
15 |
|
|
|
|
|
-11-
Note 7 Acquisitions
2010 Acquisition
On March 25, 2010, the Company acquired substantially all of the assets of privately held
TranSenda International, LLC (TranSenda). Headquartered in Bellevue, WA, TranSenda was a provider
of clinical trial management software (CTMS) solutions. TranSendas suite of web-based,
Office-Smart CTMS solutions creates efficiencies for trial operations through interoperability with
Microsoft Office tools. With this acquisition, BioClinica enhanced its ability to serve customers
throughout the clinical research process with technologies that include improved efficiencies by
reducing study durations and costs through integrated operational management. The acquisition was
made pursuant to an Asset Purchase Agreement, dated March 25, 2010, by and between the Company and
TranSenda (the Purchase Agreement). Pursuant to the terms of the Purchase Agreement, the Company
purchased and acquired from TranSenda all rights, title and interest of TranSenda in and to the
Purchased Assets (as defined in the Purchase Agreement) and assumed the Assumed Liabilities (as
defined in the Purchase Agreement) of TranSenda.
As consideration for the Purchased Assets and Assumed Liabilities, the Company issued 577,960
shares of common stock, par value $0.00025 per share, of the Company, valued at a volume weighted
average price per share equal to $4.325560, and subject to a post-closing adjustment based on the
Final Closing Net Working Capital (as defined in the Purchase Agreement). Pursuant to the terms of
the Purchase Agreement, 15% of the aggregate consideration was held in escrow to cover any
potential indemnification claims under the Purchase Agreement for a period of 12 months following
the Closing Date (as defined in the Purchase Agreement). On March 25, 2011, the amounts held in
escrow were released and there were no indemnification claims. As part of the Purchase Agreement,
TranSenda agreed not to directly or indirectly offer, sell, contract to sell, pledge, grant any
option to purchase, make any short sale or otherwise dispose of any shares of the Companys common
stock received pursuant to the Purchase Agreement for a period beginning on the date the Purchase
Agreement was executed and continuing to and including the date 12 months after such date. The
Company recorded the fair value of the acquisition of $2,468,000 based on the Companys market
value of $4.27 for the stock consideration on March 25, 2010, the date of acquisition.
Pro Forma Results. The following schedule includes consolidated statements of income data for
the unaudited pro forma results for the three months ended March 31, 2010 as if the TranSenda
acquisition had occurred as of the beginning of the periods presented after giving effect to
certain adjustments. The unaudited pro forma information is provided for illustrative purposes
only and is not indicative of the results of operations or financial condition that would have been
achieved if the TranSenda acquisition would have taken place at the beginning of the periods
presented and should not be taken as indicative of our future consolidated results of operations or
financial condition. Pro forma adjustments are tax-effected at our effective tax rate.
|
|
|
|
|
|
|
Three Months Ended |
(in thousands except per share data) |
|
March 31, 2010 |
|
Total revenue |
|
$ |
18,335 |
|
Income from operations |
|
|
549 |
|
Net Income |
|
|
334 |
|
Basic earnings per share |
|
$ |
0.02 |
|
Diluted earnings per share |
|
$ |
0.02 |
|
-12-
In connection with the acquisition of TranSenda, the Company performed an evaluation of the
guidance included in FASB ASC 280, Segment Reporting (FASB ASC 280) and FASB ASC 350, Intangibles
- Goodwill and Other (FASB ASC 350). Based on that evaluation, the Company included TranSenda as
part of its clinical trials services reportable segment.
In accordance with FASB ASC 805, Business Combinations, the Company expensed all costs related
to the acquisition.
The following table summarizes the amounts of identified assets acquired and liabilities
assumed from TranSenda at the acquisition date fair value:
|
|
|
|
|
|
|
TranSenda |
|
Accounts Receivable |
|
$ |
309 |
|
Property and Equipment |
|
|
91 |
|
Other Assets |
|
|
58 |
|
Other Liabilities |
|
|
(459 |
) |
Customer Relationships |
|
|
100 |
|
Technology |
|
|
1,000 |
|
Goodwill, including Workforce |
|
|
1,369 |
|
|
|
|
|
Total Fair Value of Purchase Price |
|
$ |
2,468 |
|
|
|
|
|
Accounts receivable, other assets and other liabilities were stated at their historical
carrying values, which approximate fair value given the short-term nature of these assets and
liabilities. The goodwill is attributable to the workforce of the acquired business and synergies
expected to arise after the acquisition of the business.
In accordance with FASB ASC 820, Fair Value Measurements (FASB ASC 820), the Company
determined that the non-financial assets and liabilities summarized above are derived from
significant unobservable inputs (Level 3 inputs) determined by management based on various market
and income analyses and recent asset appraisals. The goodwill recorded in connection with these
acquisitions will be deductible for tax purposes over 15 years.
2009 Acquisition
On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte
Solutions, Inc. (Tourtellotte). Tourtellotte provides software applications and consulting
services which support clinical trials in the pharmaceutical industry. The purchase price for
Tourtellotte was $2.1 million in cash. Pursuant to the acquisition agreement, the Company agreed to
pay up to an additional $3.2 million in cash and 350,000 shares of our common stock based upon
achieving certain milestones, which include certain product development and revenue targets (the
earn-out). In December 2010, the Company paid the first acquisition earn-out of $1,257,000 in
cash and the issuance of 350,000 shares of the Companys Common Stock. The remaining cash
contingent consideration expected to be paid in the fair value amount of $1,943,000 was classified
as a long-term liability on the financial statements at March 31, 2011. The difference between the
fair value of the cash contingent consideration at date of
-13-
acquisition and the expected payment will be recorded as an expense in the
financial statements at the end of each reporting period. The Company recorded $57,000 and
$94,000 for the three months ended March 31, 2011 and 2010, respectively, of accretion expense in
mergers and acquisition related costs on the income statement for this difference.
The following table represents changes in assets and liabilities measured at fair value using
Level 3 inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value at |
|
|
|
|
|
|
|
|
September 15, |
|
Earn out |
|
Payment on earn- |
|
Fair value at |
|
|
2009 |
|
accretion |
|
out 1 |
|
March 31, 2011 |
Cash contingent
consideration |
|
$ |
2,747,000 |
|
|
$ |
453,000 |
|
|
$ |
(1,257,000 |
) |
|
$ |
1,943,000 |
|
Note 8 Intangible Assets
At March 31, 2011 the composition of intangible assets were as follows:
|
|
|
|
|
|
|
|
|
March 31, |
|
|
Estimated |
(in thousands) |
|
2011 |
|
|
Useful Life |
Amortized intangible assets: |
|
|
|
|
|
|
Technology |
|
$ |
1,843 |
|
|
5 years |
Trademarks |
|
|
48 |
|
|
5 years |
Customer backlog |
|
|
2,112 |
|
|
3 to 7 years |
Non-competition agreement |
|
|
349 |
|
|
2 to 3 years |
|
|
|
|
|
|
|
|
|
4,352 |
|
|
|
Accumulated amortization |
|
|
(2,077 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
2,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets: |
|
|
|
|
|
|
Goodwill |
|
$ |
34,302 |
|
|
|
|
|
|
|
|
|
Estimated future amortization of the intangible assets is as follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, |
|
|
|
|
|
Remainder of 2011 |
|
$ |
467 |
|
2012 |
|
|
534 |
|
2013 |
|
|
337 |
|
2014 |
|
|
309 |
|
2015 |
|
|
160 |
|
2016 and beyond |
|
|
468 |
|
|
|
|
|
|
|
$ |
2,275 |
|
|
|
|
|
-14-
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations. |
Overview
BioClinica provides integrated clinical research technology solutions to pharmaceutical,
biotechnology, medical device companies and other organizations such as contract research
organizations, or CROs, engaged in global clinical studies. Our products and services include:
medical image management, electronic image transport and archive solutions, electronic data
capture, clinical data management, interactive voice and web response, clinical trial supply
forecasting tools, and clinical trial management software solutions. By supplying enterprise-class
software and hosted solutions accompanied by expert services to fully utilize these tools, we
believe that our offerings provide our clients, large and small, improved speed and efficiency in
the execution of clinical studies, with reduced clinical and business risk.
Market for our Services
Our vision is to build critical mass in the complementary disciplines of clinical research
related to data collection and processing especially those which can benefit from our
information technology products and support services and to integrate them in ways that yield
efficiency and value for our clients. Our goal is to provide demonstrable benefits to sponsor
clients through this strategy, that is, faster and less expensive drug development. We believe that
the outsourcing of these services should continue to increase in the future because of increased
pressure on clients, including factors such as: the need to more tightly manage costs, capacity
limitations, reductions in marketing exclusivity periods, the desire to reduce development time,
increased globalization of clinical trials, productivity challenges, imminent patent expirations
and more stringent regulation. We believe these trends will continue to create opportunities for
companies like BioClinica that are focused on improving the efficiency of drug and medical device
development.
Sales and Backlog
Our sales cycle, referring to the period from the presentation by us to a potential client to
the engagement of us by such client, has historically ranged from three to 12 months. In addition,
the contracts under which we perform services typically cover a period of three to 60 months and
the volume and type of services performed by us generally vary during the course of a project. We
cannot assure you that our project revenues will be at levels sufficient to maintain profitability.
Our contracted/committed backlog, referred to as backlog, is the expected service revenue that
remains to be earned and recognized on both signed and verbally agreed to contracts. Our backlog
as of March 31, 2011 was $111.3 million, compared to $99.7 million at March 31, 2010. Changes in
backlog for the period reflect the net effect of new contract signings, addendums, cancellations,
expansions, and reductions in scope of existing projects, all of which impacted our backlog at
March 31, 2011.
Contracts included in backlog are subject to termination by our clients at any time. In the
event that a contract is cancelled by the client, we would be entitled to receive payment for all
services performed up to the cancellation date. The duration of the projects included in our
backlog range from less than three months to 60 months. We do not believe that backlog is a
reliable predictor of future results because service revenues may be incurred in a given period on
contracts that were not included in the previous reporting periods backlog and/or contract
cancellations or project delays may occur in a given period on contracts that were included in the
previous reporting periods backlog.
-15-
Acquisitions
On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda
International, LLC, or TranSenda. Headquartered in Bellevue, WA, TranSenda was a provider of CTMS
solutions. TranSendas suite of web-based, Office-Smart CTMS solutions create efficiencies for
trial operations through interoperability with Microsoft Office tools. The CTMS solutions enable
our clients to have their applications work together instead of being locked into a single suite
vendor and serves as the foundation for operational data interchange among different software
applications. This facilitates easier access to data with a consistent user interface and reduces
training costs. With this acquisition, we enhanced our ability to serve customers throughout the
clinical research process with technologies that include improved efficiencies by reducing study
durations and costs through integrated operational management. The acquisition was made pursuant
to an Asset Purchase Agreement, dated March 25, 2010, by and between BioClinica and TranSenda,
referred to herein as the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, we
purchased and acquired from TranSenda all right, title and interest of TranSenda in and to the
Purchased Assets (as defined in the Purchase Agreement) and assumed the Assumed Liabilities (as
defined in the Purchase Agreement) of TranSenda.
As consideration for the Purchased Assets and Assumed Liabilities, we issued 577,960 shares of
common stock, par value $0.00025 per share, of the Company, valued at a volume weighted average
price per share equal to $4.325560, and subject to a post-closing adjustment based on the Final
Closing Net Working Capital (as defined in the Purchase Agreement). Pursuant to the terms of the
Purchase Agreement, 15% of the aggregate consideration was held in escrow to cover any potential
indemnification claims under the Purchase Agreement for a period of 12 months following the Closing
Date (as defined in the Purchase Agreement). On March 25, 2011, the amounts held in escrow were
released and there were no indemnification claims. As part of the Purchase Agreement, TranSenda
agreed not to directly or indirectly offer, sell, contract to sell, pledge, grant any option to
purchase, make any short sale or otherwise dispose of any shares of BioClinicas common stock
received pursuant to the Purchase Agreement for a period beginning on the date the Purchase
Agreement was executed and continuing to and including the date 12 months after such date. We
recorded the fair value of the acquisition of $2,468,000 based on our market value of $4.27 on
March 25, 2010, the date of acquisition.
Forward Looking Statements
Certain matters discussed in this Form 10-Q are forward-looking statements intended to
qualify for the safe harbors from liability established by the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements may be identified by, among other things, the use of
forward-looking terminology such as believes, expects, may, should or anticipates or the
negative thereof or other variations thereon or comparable terminology, or by discussions of
strategy that involve risks and uncertainties. In particular, our statements regarding: our
projected financial results; the demand for our services and technologies; growing recognition for
the use of independent medical image review services; trends toward the outsourcing of imaging
services in clinical trials; realized return from our marketing efforts; increased use of digital
medical images in clinical trials; integration of our acquired companies and businesses; expansion
into new business segments; the success of any potential acquisitions and the integration of
current acquisitions; and the level of our backlog are examples of such forward-looking statements.
The forward-looking statements include risks and uncertainties, including, but not limited to, the
timing of revenues due to the variability in size, scope and duration of projects, estimates made
by management with respect to our critical accounting policies, regulatory delays, clinical study
results which lead to reductions or cancellations of projects and other factors, including general
economic
-16-
conditions and regulatory developments, not within our control. The factors discussed
in this Form 10-Q and expressed from time to time in our filings with the SEC could cause
actual results and developments to be materially different from those expressed in or implied by
such statements. The forward-looking statements are made only as of the date of this filing, and
we undertake no obligation to publicly update such forward-looking statements to reflect subsequent
events or circumstances.
Recent Accounting Pronouncements
In December 2010, the FASB issued ASU 2010-29, Business Combinations (ASC Topic 805) -
Disclosure of Supplementary Pro Forma Information for Business Combinations. This amendment
expands the supplemental pro forma disclosures required. This amendment is effective prospectively
for business combinations for which the acquisition date is on or after the beginning of the first
annual reporting period beginning on or after December 15, 2010, with earlier adoption permitted.
As the adoption of ASU 2010-29 only requires enhanced disclosures, this standard will have no
impact on our financial statements.
In October 2009, the FASB issued guidance on revenue recognition that became effective for us
beginning on January 1, 2011. Under the new guidance on arrangements that include software
elements, tangible products that have software components that are essential to the functionality
of the tangible product will no longer be within the scope of the software revenue recognition
guidance, and software-enabled products will now be subject to other relevant revenue recognition
guidance. Additionally, the FASB issued guidance on revenue arrangements with multiple deliverables
that are outside the scope of the software revenue recognition guidance. Under the new guidance,
when vendor specific objective evidence or third party evidence for deliverables in an arrangement
cannot be determined, a best estimate of the selling price is required to separate deliverables and
allocate arrangement consideration using the relative selling price method. The new guidance
includes new disclosure requirements on how application of the relative selling price method
affects the timing and amount of revenue recognition. The adoption of this new guidance did not
have a material impact on the Companys financial statements.
-17-
Results of Operations
Three Months Ended March 31, 2011 and 2010
|
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Three |
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|
Three |
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|
|
|
|
|
|
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|
Months |
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|
Months |
|
|
|
|
|
|
|
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ended |
|
% of |
|
ended |
|
% of |
|
|
|
|
|
|
|
|
March 31, |
|
Total |
|
March 31, |
|
Total |
|
|
|
|
|
% |
(in thousands) |
|
2011 |
|
Revenue |
|
2010 |
|
Revenue |
|
$ Change |
|
Change |
|
Service revenues |
|
$ |
16,144 |
|
|
|
82.1 |
% |
|
$ |
14,746 |
|
|
|
81.5 |
% |
|
$ |
1,398 |
|
|
|
9.5 |
% |
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement revenues |
|
|
3,521 |
|
|
|
17.9 |
% |
|
|
3,358 |
|
|
|
18.5 |
% |
|
|
163 |
|
|
|
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
19,665 |
|
|
|
100.0 |
% |
|
|
18,104 |
|
|
|
100.0 |
% |
|
|
1,561 |
|
|
|
8.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
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|
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|
|
Cost and expenses: |
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|
|
|
|
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
10,557 |
|
|
|
53.7 |
% |
|
|
8,951 |
|
|
|
49.4 |
% |
|
|
1,606 |
|
|
|
17.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of reimbursement revenues |
|
|
3,521 |
|
|
|
17.9 |
% |
|
|
3,358 |
|
|
|
18.5 |
% |
|
|
163 |
|
|
|
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing expenses |
|
|
1,860 |
|
|
|
9.5 |
% |
|
|
2,210 |
|
|
|
12.2 |
% |
|
|
(350 |
) |
|
|
(15.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
2,222 |
|
|
|
11.3 |
% |
|
|
2,072 |
|
|
|
11.4 |
% |
|
|
150 |
|
|
|
7.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of intangible assets
related to
acquisitions |
|
|
156 |
|
|
|
0.8 |
% |
|
|
141 |
|
|
|
0.8 |
% |
|
|
15 |
|
|
|
10.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mergers and acquisitions related costs |
|
|
103 |
|
|
|
0.5 |
% |
|
|
205 |
|
|
|
1.1 |
% |
|
|
(102 |
) |
|
|
(49.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring costs |
|
|
679 |
|
|
|
3.5 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
679 |
|
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
19,098 |
|
|
|
97.1 |
% |
|
|
16,937 |
|
|
|
93.6 |
% |
|
|
2,161 |
|
|
|
12.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
567 |
|
|
|
2.9 |
% |
|
|
1,167 |
|
|
|
6.4 |
% |
|
|
(600 |
) |
|
|
(51.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
0.0 |
% |
|
|
6 |
|
|
|
0.0 |
% |
|
|
(4 |
) |
|
|
(66.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(9 |
) |
|
|
0.0 |
% |
|
|
(3 |
) |
|
|
0.0 |
% |
|
|
(6 |
) |
|
|
200.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax |
|
|
560 |
|
|
|
2.8 |
% |
|
|
1,170 |
|
|
|
6.5 |
% |
|
|
(610 |
) |
|
|
(52.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
(209 |
) |
|
|
(1.1 |
)% |
|
|
(459 |
) |
|
|
(2.5 |
)% |
|
|
250 |
|
|
|
(54.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
351 |
|
|
|
1.8 |
% |
|
$ |
711 |
|
|
|
3.9 |
% |
|
$ |
(360 |
) |
|
|
(50.6 |
)% |
|
Service revenues were $16.1 million for the three months ended March 31, 2011 and $14.7
million for the same period in 2010, an increase of $1.4 million, or 9.5%. The increase in service
revenues was due to an increase in work performed on the increased backlog from the prior year.
Pfizer, Inc., encompassing 17 projects (including legacy projects with Wyeth Pharmaceuticals),
represented 19.7% of our service revenue for the three months ended March 31, 2011. For the three
months ended
-18-
March 31, 2010, Pfizer Inc., encompassing 15 distinct projects, represented 18.3% of
our service revenues.
Reimbursement revenues and cost of reimbursement revenues were $3.5 million for the three
months ended March 31, 2011 and $3.4 million for the same period in 2010, an increase of $163,000,
or 4.9%. Reimbursement revenues and cost of reimbursement revenues consist of payments received
from the customer for reimbursable costs. Reimbursement revenues and cost of reimbursement
revenues fluctuate significantly over the course of any given project, and quarter to quarter
variations are a reflection of this project timing. Therefore, our management believes that
reimbursement revenues and cost of reimbursement revenues are not a significant indicator of our
overall performance trends. At the request of our clients, we may directly pay the independent
radiologists who review our clients imaging data. In such cases, per contractual arrangement,
these costs are billed to our clients and are included in reimbursement revenues and cost of
reimbursement revenues.
Cost of service revenues were $10.6 million for the three months ended March 31, 2011 and $8.9
million for the same period in 2010, an increase of $1.6 million, or 18.2%. Cost of service
revenues for the three months ended March 31, 2011 and 2010 were comprised of professional salaries
and benefits and allocated overhead. The increase is primarily attributable to the progressive
increase in personnel throughout 2010 to build operational readiness for our eClinical offerings,
including supporting the operational launch of our Trident IWR product, increase in consulting
activities and additional personnel assumed with the TranSenda acquisition. The cost of revenues as
a percentage of total revenues also fluctuates due to work-flow variations in the utilization of
staff and the mix of services provided by us in any given period. We expect that our cost of
service revenues will increase in fiscal 2011 to service our newly released products.
Sales and marketing expenses were $1.9 million for the three months ended March 31, 2011 and
$2.2 million for the same period in 2010, a decrease of $350,000, or 15.8%. Sales and marketing
expenses for the three months ended March 31, 2011 and 2010 were comprised of direct sales and
marketing costs, salaries and benefits and allocated overhead. The decrease is primarily due to
less tradeshow and marketing costs. We expect that our sales and marketing expenses will increase
in fiscal 2011.
General and administrative expenses were $2.2 million for the three months ended March 31,
2011 and $2.1 million for the same period in 2010, an increase of $150,000, or 7.2%. General and
administrative expenses for the three months ended March 31, 2011 and 2010 consisted primarily of
salaries and benefits, allocated overhead, professional and consulting services and corporate
insurance. The increase is due to the inclusion of costs from the acquisition of TranSenda and
increased professional fees. We expect that our general and administrative expenses will increase
in fiscal 2011.
Amortization of intangible assets related to acquisitions was $156,000 for the three months
ended March 31, 2011 and $141,000 for the same period in 2010, an increase of $15,000, or 10.6%.
Amortization of intangible assets related to acquisitions consisted primarily of amortization of
customer backlog, customer relationships, software and non-compete intangibles acquired from the
acquisitions of PDS, Tourtellotte, TranSenda and Theralys. The increase is primarily due to the
acquisition of TranSenda. We expect that the amortization of intangible assets related to
acquisitions will remain relatively flat in fiscal 2011.
Merger and acquisition related costs were $103,000 for the three months ended March 31, 2011
and $205,000 for the same period in 2010, a decrease of $102,000, or 49.8%. The three months ended
March 31, 2010 included expenses resulting directly from merger and acquisition activities for the
-19-
TranSenda acquisition such as legal, accounting and other due diligence and integration costs. The
three months ended March 31, 2011 includes $57,000 for the accretion related to the change in the
fair value of the second earn-out payment associated with the Tourtellotte acquisition. It also
includes professional fees associated with the TranSenda acquisition.
The launch of our BioPacs imaging management system and the release of our integrated BioRead
image review software further enhances the quality of our imaging corelab service offering and has
enabled us to gain efficiencies by better utilizing resources across our U.S. and European
operations.
As a result, in 2011, we are realigning our global resources to eliminate certain duplicate
functions and expect to take a total restructuring charge, primarily comprised of severance and
facility restructuring costs, of $1.6 million. In the first quarter of 2011, we incurred $679,000
of this restructuring costs consisting of $588,000 in employee severance and $91,000 in legal and
other costs. We have paid $495,000 of these restructuring costs at March 31, 2011.
Net interest expense was $7,000 for the three months ended March 31, 2011 and $3,000 interest
income for the three months ended March 31, 2010, an increase of $10,000, or 333%. Interest income
is comprised of interest income earned on our cash balance and interest expense is comprised of
interest expense incurred on equipment lease obligations. The increase is due to the capital lease
obligation we entered into in December 2010.
Our income tax provision was $209,000 for the three months ended March 31, 2011 and $459,000
for the same period in 2010, a decrease of $243,000, or 52.9%. The effective tax rate for the
three months ended March 31, 2011 was approximately 37.3% and 39.2% for the three months ended
March 31, 2010. The lower effective tax rate in fiscal 2011 was due to the decreased operating
income from the restructuring costs as well as credits for increasing
research activities.
-20-
Business Segments and Geographic Information
We view our operations and manage our business as one operating segment, clinical trials
services.
Our corporate headquarters and operational facilities are in Pennsylvania, in the United
States. We also have a European facility in Leiden, the Netherlands. We manage our services for
European-based clinical trials from the Leiden facility. Our European facility has similar
processing and analysis capabilities as our United States headquarters. We also have a facility in
Lyon, France that provides product development and research activities. We have an office in
Bhubaneshwar, India to provide information technology support.
Liquidity and Capital Resources
Our principal liquidity requirements have been, and we expect will be, for working capital and
general corporate purposes, including capital expenditures.
Statement of Cash Flow for the three months ended March 31, 2011 compared to March 31, 2010
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Three Months |
|
|
Ended |
|
Ended |
(in thousands) |
|
March 31, 2011 |
|
March 31, 2010 |
Net cash provided by operating activities |
|
$ |
1,168 |
|
|
$ |
1,138 |
|
Net cash used in investing activities |
|
$ |
(1,280 |
) |
|
$ |
(2,255 |
) |
Net cash (used in) provided by financing activities |
|
$ |
(193 |
) |
|
$ |
65 |
|
At March 31, 2011, we had cash and cash equivalents of $10.2 million. Working capital,
defined as current assets minus current liabilities, at March 31, 2011 was $9.1 million.
Net cash provided by operating activities for the three months ended March 31, 2011 was $1.2
million as compared to $1.1 million for the three months ended March 31, 2010. This increase from
the prior year is primarily due to the increase in accounts payable.
Net cash used in investing activities for the three months ended March 31, 2011 was $1.3
million as compared to net cash used in investing activities of $2.3 million for the three months
ended March 31, 2010. This decrease is primarily due to less capitalized software for the three
months ended March 31, 2011 as compared to the three months ended March 31, 2010. We currently
anticipate that capital expenditures for fiscal 2011 will be approximately $6.0 million, funded by
cash from operations, as compared to $7.2 million for fiscal 2010. These expenditures primarily
represent capitalization of software costs and network and data center computer equipment.
Net cash used in financing activities for the three months ended March 31, 2011 was $193,000
as compared to net cash provided by financing activities of $65,000 for the three months ended
March 31, 2010. The change to the use of cash for financing activities was primarily due to our
purchase of treasury shares for the three months ended March 31, 2011.
-21-
The following table lists our cash contractual obligations as of March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Payments Due By Period |
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
More than |
|
Contractual obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Facility rent operating
leases |
|
$ |
19,884 |
|
|
$ |
2,616 |
|
|
$ |
5,730 |
|
|
$ |
4,979 |
|
|
$ |
6,559 |
|
Capital lease |
|
|
834 |
|
|
|
166 |
|
|
|
353 |
|
|
|
315 |
|
|
|
|
|
Employment agreements |
|
|
784 |
|
|
|
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earn-outs
for Tourtellotte
acquisition |
|
|
2,000 |
|
|
|
|
|
|
|
2,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
23,502 |
|
|
$ |
3,566 |
|
|
$ |
8,083 |
|
|
$ |
5,294 |
|
|
$ |
6,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank expiring
May 5, 2012. In April 2011 we extended this line of credit for an expiration of May 4, 2013. Under
the credit agreement, we have the ability to borrow $7.5 million at interest rates equal to LIBOR
plus 1.75%. In addition, we pay a fee of 0.25% per annum on the loan commitment regardless of
usage. The credit agreement requires our compliance with certain covenants, including maintaining
a minimum stockholders equity of $35 million. As of March 31, 2011, we had no borrowings under
this line of credit, and we were compliant with the covenants.
Capital lease obligations consist of one equipment lease obligation at March 31, 2011. In
December 2010, we entered into a capital lease with a bank totaling $892,000, which included a
$194,000 sale-leaseback transaction that we entered into with the same bank in September 2010 and
$698,000 of equipment lease obligation, the lease term is 5 years with an interest rate of 3.87%
per annum.
We have neither paid nor declared dividends on our common stock since our inception and do not
plan to pay dividends on our common stock in the foreseeable future.
We have not entered into any off-balance sheet transactions, arrangements or other
relationships with unconsolidated entities or other persons that are likely to affect liquidity or
the availability of or requirements for capital resources.
We anticipate that our existing capital resources together with cash flow from operations will
be sufficient to meet our cash needs for the next 12 months. However, we cannot assure you that
our operating results will maintain profitability on an annual basis in the future. The inherent
operational risks associated with the following factors may have a material adverse effect on our
future liquidity:
|
|
|
our ability to gain new client contracts; |
|
|
|
the variability of the timing of payments on existing client contracts; and |
|
|
|
other changes in our operating assets and liabilities. |
We may seek to raise additional capital from equity or debt sources in order to take advantage
of unanticipated opportunities, such as more rapid expansion, acquisitions of complementary
businesses or the development of new services. We cannot assure you that additional financing will
be available, if at all, on terms acceptable to us.
-22-
Changes to Critical Accounting Policies and Estimates
Our critical accounting policies and estimates are set forth in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2010. As of March 31, 2011, there have been no changes to
such critical accounting policies and estimates.
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk. |
Interest Rate Risk
We invest in high-quality financial instruments, comprised of savings accounts, certificate of
deposits and money market funds. Due to the short-term nature of our investments, we do not
believe that we have any material exposure to interest rate risk arising from our investments.
Foreign Currency Risk
In accordance with our foreign exchange rate risk management policy, we had purchased monthly
Euro call options in prior years. These options were intended to hedge against the exposure to
variability in our cash flows resulting from the Euro denominated costs for our Netherlands and
France subsidiaries. During the three months ended March 31, 2011 and 2010, we have not purchased
any Euro call options, because our foreign currency needs are generally being met by the cash flow
generated by Euro denominated contracts. As of March 31, 2011, there were no outstanding
derivative positions.
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of any derivatives, we will record a gain or loss from such derivatives that are
deferred in stockholders equity to cost of revenues and general and administrative expenses in the
Consolidated Statement of Income based on the nature of the underlying cash flow hedged.
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Item 4. |
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Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures. We evaluated, under the supervision and
with the participation of the Chief Executive Officer and Chief Financial Officer, the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934 (Exchange Act), as
amended) as of March 31, 2011, the end of the period covered by this report on Form 10-Q. Based on
this evaluation, our Chief Executive Officer (principal executive officer) and our Chief Financial
Officer (principal accounting and financial officer) have concluded that our disclosure controls
and procedures were effective at March 31, 2011. Disclosure controls and procedures are designed
to ensure that information required to be disclosed by us in the reports that we file or submit
under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods
specified in the SECs rules and forms, and were operating in an effective manner for the period
covered by this report, and (ii) is accumulated and communicated to management, including the Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding
required disclosures.
Changes in internal control over financial reporting. There was no change in our internal
controls over financial reporting that occurred during the first quarter of 2011 that has
materially affected, or is reasonably likely to materially affect, our internal controls over
financial reporting.
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PART II. OTHER INFORMATION.
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Item 1. |
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Legal Proceedings. |
In the normal course of business, we may be a party to legal proceedings. We are not
currently a party to any material legal proceedings.
The more prominent risks and uncertainties inherent in our business are described below.
However, additional risks and uncertainties may also impair our business operations. If any of the
following risks actually occur, our business, financial condition or results of operations may
suffer. Any of the following factors could harm our business and future results of operations, and
you could lose all or part of your investment.
Risks Related to Our Company and Business
We may incur financial losses because contracts may be delayed or terminated or reduced in scope
for reasons beyond our control.
Our clients may terminate or delay their contracts for a variety of reasons, including, but
not limited to:
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unexpected or undesired clinical results; |
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the clients decision to terminate the development of a particular product or to end a
particular study; |
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insufficient patient enrollment in a study; |
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insufficient investigator recruitment; |
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failure to perform our obligations under the contract; or |
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the failure of products to satisfy safety requirements. |
In addition, we believe that companies that are regulated by the United States Food and Drug
Administration, or FDA, may proceed with fewer clinical trials or conduct them without assistance
of contract service organizations if they are trying to reduce costs as a result of cost
containment pressures associated with healthcare reform, budgetary limits or changing priorities.
These factors may cause such companies to cancel contracts with contract service organizations.
We cannot assure you that our clients will continue to use our services or that we will be
able to replace, in a timely or effective manner, departing clients with new clients that generate
comparable revenues. Further, we cannot assure you that our clients will continue to generate
consistent amounts of revenues over time.
The loss, reduction in scope or delay of a large contract or the loss or delay of multiple
contracts could materially adversely affect our business.
The recent economic downturn may adversely impact our ability to grow our business.
-25-
The recent economic downturn and adverse conditions in the national and global markets may
negatively affect our operations in the future. The fallen equity markets and adverse credit
markets may make it difficult for us to raise capital or procure credit in the future to fund the
growth of our business, which could have a negative impact on our business and results of
operations and limit our ability to pursue acquisitions.
We depend on a small number of industries and clients for all of our business, and the loss of one
such significant client could cause revenues to drop quickly and unexpectedly.
We depend on research and development expenditures by pharmaceutical, biotechnology and
medical device companies to sustain our business. Our operations could be materially and adversely
affected if:
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our clients businesses experience financial problems or are affected by a general
economic downturn; |
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consolidation in the pharmaceutical, biotechnology or medical device industries leads to
a smaller client base for us; or |
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clients reduce their research and development expenditures. |
Contracts with one client, Pfizer, Inc., which encompassed 17 projects, represented 19.7% of
our service revenues for the three months ended March 31, 2011. For the three months ended March
31, 2010, Pfizer, Inc. represented 18.3% of our service revenue, encompassing 15 projects. The
loss of business from a significant client or our failure to continue to obtain new business to
replace completed or canceled projects would have a material adverse effect on our business and
revenues.
Our contracted/committed backlog may not be indicative of future results.
Our reported contracted/committed backlog of $111.3 million at March 31, 2011 is based on
anticipated service revenue from uncompleted projects with clients. Backlog is the expected service
revenue that remains to be earned and recognized on signed and verbally agreed to contracts.
Contracts included in backlog are subject to termination by our clients at any time. In the event
that a client cancels a contract, we would be entitled to receive payment for all services
performed up to the cancellation date and subsequent client authorized services related to the
cancellation of the project. The duration of the projects included in our backlog range from less
than three months to seven years. We cannot assure you that this backlog will be indicative of
future results. A number of factors may affect backlog, including:
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the variable size and duration of the projects (some are performed over several years); |
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the loss or delay of projects; |
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the change in the scope of work during the course of a project; and |
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the cancellation of such contracts by our clients. |
Also, if clients delay projects, the projects will remain in backlog, but will not generate
revenue at the rate originally expected. Accordingly, the historical relationship of backlog to
revenues may not be indicative of future results.
We made one acquisition in the first quarter 2010, two acquisitions in the third quarter of 2009,
and may engage in future acquisitions, which may be expensive and time consuming, and from which we
may not realize anticipated benefits.
On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda
International, LLC, headquartered in Bellevue, WA. In the third quarter of 2009, we acquired the
-26-
CardioNow unit from AGFA Healthcare and substantially all of the assets of Tourtellotte Solutions,
Inc. and may acquire additional businesses, technologies and products if we determine that these
additional businesses, technologies and products complement our existing business, or otherwise
serve our strategic goals. Either as a result of the recent acquisitions or future acquisitions
undertaken, the process of integrating the acquired business, technology or product may result in
operating difficulties and expenditures, and may absorb significant management attention that would
otherwise be available for ongoing development of our business. Moreover, we may never realize the
anticipated benefits of any such acquisition. Such acquisitions could result in potentially
dilutive issuances of our securities, the incurrence of debt and contingent liabilities and
amortization expenses related to intangible assets, all of which could adversely affect our results
of operations and financial condition.
Loss of key personnel, or failure to attract and retain additional personnel, may cause the success
and growth of our business to suffer.
Future success depends on the personal efforts and abilities of the principal members of our
senior management to provide strategic direction, develop business, manage operations and maintain
a cohesive and stable environment. Specifically, we are dependent upon Mark L. Weinstein, President
and Chief Executive Officer, Ted I. Kaminer, Executive Vice President of Finance and Administration
and Chief Financial Officer, David A. Pitler, Executive Vice President, President of Medical
Imaging Solutions, and Peter Benton, Executive Vice President, President of eClinical Solutions.
Although we have employment agreements with Mr. Weinstein, Mr. Kaminer and Mr. Benton, this does
not necessarily mean that they will remain with us. Although we have executive retention agreements
with our officers, we do not have employment agreements with any other key personnel. Furthermore,
our performance also depends on our ability to attract and retain management and qualified
professional and technical operating staff. Competition for these skilled personnel is intense. The
loss of services of any key executive, or inability to continue to attract and retain qualified
staff, could have a material adverse effect on our business, results of operations and financial
condition. We do not maintain any key employee insurance on any of our executives.
We may not be able to effectively manage our international operations.
We maintain facilities in France, the Netherlands and India, and we may continue to expand our
international operations in the future. There are significant risks associated with the
establishment of foreign operations, including, but not limited to: geopolitical risks, foreign
currency exchange rates and the impact of shifts in the U.S. and local economies on those rates,
compliance with local laws and regulations, the protection of our intellectual property and that of
our customers, the ability to integrate our corporate culture with local customs and cultures, and
the ability to effectively and efficiently supply our international facilities with the required
equipment and materials. If we are unable to effectively manage these risks, these locations may
not produce the revenues, earnings, or strategic benefits that we anticipate which could have a
material adverse affect on our business.
Our revenues, earnings and operating costs are exposed to exchange rate fluctuations.
During the three months ended March 31, 2011, a portion of our service revenues were
denominated in foreign currency. Our financial statements are denominated in United States
dollars. In the event a greater portion of our service revenues are denominated in a foreign
currency, changes in
foreign currency exchange rates could affect our results of operations and financial
condition. Fluctuations in foreign currency exchange rates could materially impact the operating
costs of our European facilities in Leiden, the Netherlands and Lyon, France, which are primarily
Euro denominated. We hedge our foreign currency exposure when and as appropriate to mitigate the
adverse impact of
fluctuating exchange rates.
-27-
We may be required to record additional significant charges to earnings if our goodwill becomes
impaired.
Under accounting principles generally accepted in the United States, we review our goodwill
for impairment each year as of December 31 and when events or changes in circumstances indicate the
carrying value may not be recoverable. The carrying value of our goodwill may not be recoverable
due to factors such as a decline in stock price and market capitalization, reduced estimates of
future cash flows and slower growth rates in our industry. Estimates of future cash flows are based
on an updated long-term financial outlook of our operations. However, actual performance in the
near-term or long-term could be materially different from these forecasts, which could impact
future estimates. For example, a significant decline in our stock price and/or market
capitalization may result in impairment of our goodwill valuation. We may be required to record a
charge to earnings in our financial statements during a period in which an impairment of our
goodwill is determined to exist, which may negatively impact our results of operations.
Our software products and hosted solutions are at varying stages of market acceptance and the
failure of any of our products to achieve or maintain wide acceptance would harm our operating
results.
We began offering our electronic data capture software solution for clinical trials in March
2008. Continued use of our current electronic data capture software products, and broad and timely
acceptance of newly-introduced electronic data capture software products, as well as integrated
solutions combining one or more of our software products, is critical to our future success and is
subject to a number of significant risks, some of which are outside our control. These risks
include:
our customers and prospective customers desire for and acceptance of our electronic data
capture, clinical data management, drug safety and interactive response technology
solutions;
our ability to meet product development and release schedules;
our software products and hosted solutions ability to support large numbers of users and
manage vast amounts of data;
our ability to significantly expand our internal resources and increase our capital and
operating expenses to support the anticipated growth and continued integration of our
software products, services and hosted solutions; and
our customers ability to use our software products and hosted solutions, train their
employees and successfully deploy our technology in their clinical trial and safety
evaluation and monitoring activities.
Our failure to address, mitigate or manage these risks would seriously harm our business,
particularly if the failure of any or all of our software products or hosted solutions to achieve
market acceptance negatively affects our sales of our other products and services.
-28-
We may be unable to adequately protect, and we may incur significant costs in defending, our
intellectual property and other proprietary rights or in defending claims that we are infringing
upon the intellectual property rights of others.
Our success depends on our ability to protect our intellectual property and other proprietary
rights. We rely upon a combination of trademark, trade secret, copyright, patent and unfair
competition laws, as well as license agreements and other contractual provisions, to protect our
intellectual property and other proprietary rights. In addition, we attempt to protect our
intellectual property and proprietary information by requiring certain of our employees and
consultants to enter into confidentiality, non-competition and assignment of inventions agreements.
To the extent that our intellectual property and other proprietary rights are not adequately
protected, third parties might gain access to our proprietary information, develop and market
products or services similar to ours or use trademarks similar to ours, each of which could
materially harm our business. Existing U.S. federal and state intellectual property laws offer only
limited protection. Moreover, the laws of other countries in which we market our software products,
services and hosted solutions may afford little or no effective protection of our intellectual
property. If we are involved in legal proceedings to enforce our intellectual property rights, to
determine the validity and scope of the intellectual property or other proprietary rights of others
or to defend against claims of infringement by third parties, the proceedings could be burdensome
and expensive, even if we were to prevail. Any potential infringement actions brought against us
could require us to stop using the product or service which incorporates such third party
intellectual property, obtain a license to use such third party intellectual property (which could
be costly or unavailable) or redesign our products or services that incorporate such third party
intellectual property (which could be time consuming and costly and affect the market acceptance of
such product or service). The failure to adequately protect our intellectual property and other
proprietary rights or acknowledge third party intellectual property rights may have a material
adverse effect on our business, results of operations or financial condition.
Risks Related to Our Industry
Our failure to compete effectively in our industry could cause our revenues to decline.
Significant factors in determining whether we will be able to compete successfully include:
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consultative and clinical trials design capabilities; |
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reputation for on-time quality performance; |
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expertise and experience in specific therapeutic areas; |
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the scope of service offerings; |
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strength in various geographic markets; |
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ability to acquire, process, analyze and report data in a time-saving and accurate
manner; |
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ability to manage large-scale clinical trials both domestically and internationally; |
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the service and product offerings of our competitors; and |
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our ability to upgrade our products, services and hosted solutions so such offerings are
not deemed obsolete in comparison to the service and product offerings of our competitors. |
If our services are not competitive based on these or other factors, our business, financial
condition and results of operations could be materially harmed.
The biopharmaceutical services industry is highly competitive, and we face numerous
competitors in
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our business, including hundreds of CROs. If we fail to compete effectively, we will
lose clients, which would cause our business to suffer. We primarily compete against in-house
departments of pharmaceutical companies, full service CROs, small specialty CROs, and to a lesser
extent, universities and teaching hospitals. Some of these competitors have substantially greater
capital, technical and other resources than we do. In addition, certain of our competitors that are
smaller specialized companies may compete effectively against us because of their concentrated size
and focus.
Changes in outsourcing trends in the pharmaceutical and biotechnology industries could adversely
affect our operating results and growth rate.
Service revenues depend greatly on the expenditures made by the pharmaceutical and
biotechnology industries in research and development. Accordingly, economic factors and industry
trends that affect our clients in these industries also affect our business. For example, the
practice of many companies in these industries has been to hire outside organizations like us to
conduct clinical research projects. This practice has grown significantly in the last decade, and
we have benefited from this trend. However, if this trend were to change and companies in these
industries were to reduce the number of research and development projects they outsource, our
business could be materially adversely affected.
Additionally, numerous governments have undertaken efforts to control growing healthcare costs
through legislation, regulation and voluntary agreements with medical care providers and
pharmaceutical companies. If future regulatory cost containment efforts limit the profits that can
be derived from new drug sales, our clients might reduce their research and development spending,
which could reduce our business.
Consolidation among our customers could cause us to lose customers, decrease the market for our
products and result in a reduction of our revenues.
Our customer base could decline because of industry consolidation, and we may not be able to
expand sales of our products and services to new customers. Consolidation in the pharmaceutical,
biotechnology and medical device industries has accelerated in recent years, and we expect this
trend to continue. As these industries consolidate, competition to provide products and services
to industry participants will become more intense and the importance of establishing relationships
with large industry participants will become greater. These industry participants may try to use
their market power to negotiate price reductions for our products and services. Also, if
consolidation of larger current customers occurs, the combined organization may represent a larger
percentage of business for us and, as a result, we are likely to rely more significantly on the
combined organizations revenues to continue to achieve growth.
The recent economic downturn coupled with the current regulatory environment could have a negative
impact on the pharmaceutical, biotechnology and medical device industries.
The recent economic downturn and adverse conditions in the national and global markets may
negatively affect our operations in the future. Our revenues are contingent upon the research and
development expenditures by pharmaceutical, biotechnology and medical device companies. Some
companies in these industries have found it difficult to raise capital in the equity and debt
markets or through traditional credit markets to fund research and development. In addition,
increased regulatory scrutiny from the FDA may have increased the costs of research and development
for these companies. These companies have responded to the recent economic downturn and regulatory
environment by
-30-
postponing, attenuating or cancelling clinical trials projects, or portions thereof,
which may reduce the need for our services. As a result, our revenues may be similarly decreased.
Furthermore, while our revenues may decrease, our costs may remain relatively fixed, resulting in
decreased earnings.
Failure to comply with existing regulations could result in increased costs to complete clinical
trials.
Our business is subject to numerous governmental regulations, primarily relating to
pharmaceutical product development and the conduct of clinical trials. In particular, we are
subject to 21 CFR Part 11 of the Code of Federal Regulations that provides the criteria for
acceptance by the FDA of electronic records. If we fail to comply with these governmental
regulations, it could result in the termination of ongoing clinical research or the
disqualification of data for submission to regulatory authorities. We also could be barred from
providing clinical trial services in the future or be subjected to fines. Any of these consequences
would harm our reputation, our prospects for future work and our operating results.
We may be affected by health care reform.
In March 2010, the United States Congress enacted health care reform legislation intended over
time to expand health insurance coverage and impose health industry cost containment measures.
This legislation may significantly impact the pharmaceutical and biotechnology industries. In
addition, the U.S. Congress, various state legislatures and European and Asian governments may
consider various types of health care reform in order to control growing health care costs. We are
presently uncertain as to the effects of the recently enacted legislation on our business and are
unable to predict what legislative proposals will be adopted in the future, if any.
Implementation of health care reform legislation may have certain benefits but also may
contain costs that could limit the profits that can be made from the development of new drugs. This
could adversely affect research and development expenditures by pharmaceutical and biotechnology
companies, which could in turn decrease the business opportunities available to us both in the
United States and abroad. In addition, new laws or regulations may create a risk of liability,
increase our costs or limit our service offerings.
In addition to healthcare reform legislation, the expansion of managed care organizations in
the healthcare market may result in reduced spending on research and development. Managed care
organizations efforts to cut costs by limiting expenditures on pharmaceuticals and medical devices
could result in pharmaceutical, biotechnology and medical device companies spending less on
research and development. If this were to occur, we would have fewer business opportunities and our
revenues could decrease, possibly materially.
Changes in governmental regulation could decrease the need for the services we provide, which would
negatively affect our future business opportunities.
Governmental agencies throughout the world, but particularly in the United States, strictly
regulate the drug development/approval process. Our business involves helping pharmaceutical and
biotechnology companies navigate the regulatory drug approval process. Changes in regulation, such
as
relaxation in regulatory requirements or the introduction of simplified drug approval
procedures or an increase in regulatory requirements that we may have difficulty satisfying could
eliminate or substantially reduce the need for our services. If these changes in regulations were
to occur, our business, results of operations and financial condition could be materially adversely
affected. These and other changes in regulation could have a material adverse impact on our
available business opportunities.
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If governmental agencies do not accept the data and analyses generated by our services, the need
for our services would be eliminated or substantially reduced.
The success of our business is dependent upon continued acceptance by the FDA and other
regulatory authorities of the data and analyses generated by our services in connection with the
evaluation of the safety and efficacy of new drugs and devices. The FDA has formal guidelines that
encourage the use of surrogate measures through submission of digital image data, for evaluation
of drugs to treat life-threatening or debilitating conditions. We cannot assure you that the FDA or
other regulatory authorities will accept the data or analyses generated by us in the future and,
even assuming acceptance, the FDA or other regulatory authorities may not require the application
of imaging techniques to the number of patients and over time periods substantially similar to
those required of traditional safety and efficacy techniques. If the governmental agencies do not
accept data and analyses generated by our services in connection with the evaluation of new drugs
and devices, the need for our services would be eliminated or substantially reduced, and, as a
result, our business, results of operations and financial condition could be materially adversely
affected.
In the course of conducting our business, we possess or could be deemed to possess personal medical
information in connection with the conduct of clinical trials. If we fail to keep this information
properly protected we could be subject to significant liability.
Our software solutions are used to collect, manage and report information in connection with
the conduct of clinical trial and safety evaluation and monitoring activities. This information is
or could be considered to be personal medical information of the clinical trial participants or
patients. Regulation of the use and disclosure of personal medical information is complex and
growing. Increased focus on individuals rights to confidentiality of their personal information,
including personal medical information, could lead to an increase of existing and future
legislative or regulatory initiatives giving direct legal remedies to individuals, including rights
to damages, against entities deemed responsible for not adequately securing such personal
information. In addition, courts may look to regulatory standards in identifying or applying a
common law theory of liability, whether or not that law affords a private right of action. Since we
receive and process personal information of clinical trial participants and patients from customers
utilizing our hosted solutions, there is a risk that we could be liable if there were a breach of
any obligation to a protected person under contract, standard of practice or regulatory
requirement. If we fail to properly protect this personal information that is in our possession or
deemed to be in our possession, we could be subjected to significant liability.
We may be exposed to liability claims as a result of our involvement in clinical trials.
We may be exposed to liability claims as a result of our involvement in clinical trials. We
cannot assure you that liability claims will not be asserted against us as a result of work
performed for our clients. We maintain liability insurance coverage in amounts that we believe are
sufficient for the pharmaceutical services industry. Furthermore, we cannot assure you that our
clients will agree to indemnify us, or that we will have sufficient insurance to satisfy any such
liability claims. If a claim is
brought against us and the outcome is unfavorable to us, such outcome could have a material
adverse impact on us.
In the event we are unable to satisfy regulatory requirements relating to internal control over
financial reporting, or if these internal controls are not effective, our business and financial
results may suffer.
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Effective internal controls are necessary for us to provide reasonable assurance with respect
to our financial reports and to effectively prevent fraud. If we cannot provide reasonable
assurance with respect to our financial reports and effectively prevent fraud, our brand and
operating results could be harmed. Pursuant to the Sarbanes-Oxley Act of 2002, we are required to
furnish a report by management on internal control over financial reporting, including managements
assessment of the effectiveness of such control. Internal control over financial reporting may not
prevent or detect misstatements because of its inherent limitations, including the possibility of
human error, the circumvention or overriding of controls, or fraud. Therefore, even effective
internal controls can provide only reasonable assurance with respect to the preparation and fair
presentation of financial statements. In addition, projections of any evaluation of the
effectiveness of internal control over financial reporting to future periods are subject to the
risk that the control may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate. If we fail to maintain the adequacy of
our internal controls, including any failure to implement required new or improved controls, or if
we experience difficulties in their implementation, our business and operating results could be
harmed, we could fail to meet our reporting obligations, and there could also be a material adverse
effect on our stock price.
Risks Related to Our Common Stock
Your percentage ownership and voting power and the price of our common stock may decrease as a
result of events that increase the number of our outstanding shares.
As of March 31, 2011, we had the following capital structure (in thousands):
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Common stock outstanding |
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15,642 |
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Common stock issuable upon: |
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Exercise of options which are outstanding |
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1,844 |
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Restricted stock units outstanding |
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509 |
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Number of shares remaining under equity plan which have
not been granted |
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804 |
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Total common stock outstanding assuming exercise or conversion of
all of the above |
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18,799 |
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As of March 31, 2011, we had outstanding options to purchase 1.8 million shares of common
stock at exercise prices ranging from $0.72 to $8.06 per share (exercisable at a weighted average
of $4.88 per share), of which 1.2 million options were then exercisable. Exercise of our
outstanding options into shares of our common stock may significantly and negatively affect the
market price for our common stock as well as decrease your percentage ownership and voting power.
In addition, we may conduct
future offerings of our common stock or other securities with rights to convert the securities
into shares of our common stock. As a result of these and other events, such as future
acquisitions, that increase the number of our outstanding shares, your percentage ownership and
voting power and the price of our common stock may decrease.
Shares of our common stock eligible for public sale may have a negative impact on its market price.
Future sales of shares of our common stock by existing holders of our common stock or by
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holders of outstanding options, upon the exercise thereof, could have a negative impact on the
market price of our common stock. As of March 31, 2011, we had 15.6 million shares of our common
stock issued and outstanding, substantially all of which are currently freely tradable. As
additional shares of common stock become available for resale in the public market pursuant to
registration statements and releases of lock-up agreements, the market supply of shares of common
stock will increase, which could also decrease its market price.
We are unable to estimate the number of shares that may be sold because this will depend on
the market price for our common stock, the personal circumstances of the sellers and other factors.
Any sale of substantial amounts of our common stock or other securities in the open market may
adversely affect the market price of our securities and may adversely affect our ability to obtain
future financing in the capital markets as well as create a potential market overhang.
There are a limited number of stockholders who have significant control over our common stock,
allowing them to have significant influence over the outcome of all matters submitted to our
stockholders for approval, which may conflict with our interests and the interests of our other
stockholders.
Our directors, officers and principal stockholders (stockholders owning 10% or more of our
common stock), including Covance Inc., beneficially owned 23% of the outstanding shares of common
stock and stock options that could have been converted to common stock at March 31, 2011, and such
stockholders will have significant influence over the outcome of all matters submitted to our
stockholders for approval, including the election of our directors and other corporate actions. In
addition, such influence by these affiliates could have the effect of discouraging others from
attempting to take us over, thereby increasing the likelihood that the market price of the common
stock will not reflect a premium for control.
Because we do not intend to pay dividends, stockholders will benefit from an investment in our
common stock only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to
retain our future earnings, if any, to finance further research and development and do not expect
to pay any cash dividends in the foreseeable future. As a result, the success of an investment in
our common stock will depend upon any future appreciation in its value. There is no guarantee that
our common stock will appreciate in value or even maintain the price at which stockholders have
purchased their shares.
Trading in our common stock may be volatile, which may result in substantial declines in its market
price.
The market price of our common stock has experienced historical volatility and might continue
to experience volatility in the future in response to quarter-to-quarter variations in:
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market conditions in the industry; |
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changes in governmental regulations; and |
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changes in general conditions in the economy or the financial markets. |
The overall market (including the market for our common stock) has also experienced
significant decreases in value in the past. This volatility and potential market decline could
affect the market prices
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of securities issued by many companies, often for reasons unrelated to
their operating performance, and may adversely affect the price of our common stock. Between
January 1, 2011 and March 31, 2011, our common stock has traded at a low of $4.20 per share and a
high of $5.60 per share.
Our common stock began trading on the NASDAQ Global Market, formerly called the NASDAQ
National Market, on December 18, 2003 and has a limited trading market. We cannot assure that an
active trading market will develop or, if developed, will be maintained. As a result, our
stockholders may find it difficult to dispose of shares of our common stock and, as a result, may
suffer a loss of all or a substantial portion of their investment.
Certain provisions of our charter and Delaware law could make a takeover difficult and may prevent
or frustrate attempts by our stockholders to replace or remove our management team.
We have an authorized class of 3,000,000 shares of undesignated preferred stock, of which
1,250,000 shares were previously issued and converted to common stock and 36,000 shares designated
as Series A Junior Participating Preferred Stock under our stockholder rights plan as previously
disclosed. The remaining 1,714,000 shares may be issued by our board of directors, on such terms
and with such rights, preferences and designation as the board of directors may determine. Issuance
of such preferred stock, depending upon the rights, preferences and designations thereof, may have
the effect of delaying, deterring or preventing a change in control of our company. In addition, we
are subject to provisions of Delaware corporate law which, subject to certain exceptions, will
prohibit us from engaging in any business combination with a person who, together with affiliates
and associates, owns 15% or more of our common stock for a period of three years following the date
that the person came to own 15% or more of our common stock, unless the business combination is
approved in a prescribed manner. Our board of directors also adopted a stockholder rights plan,
dated as of July 20, 2009, as amended and restated on March 23, 2011, similar to plans adopted by
many other publicly traded companies. The stockholder rights plan is intended to protect
stockholders against unsolicited attempts to acquire control of us that do not offer a fair price
to our stockholders as determined by our board of directors.
These provisions of our certificate of incorporation, stockholders rights plan and of Delaware
law, may have the effect of delaying, deterring or preventing a change in control of our company,
may discourage bids for our common stock at a premium over market price and may adversely affect
the market price, and the voting and other rights of the holders, of our common stock. In addition,
these provisions make it more difficult to replace or remove our current management team in the
event our stockholders believe this would be in the best interest of our company and our
stockholders.
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds. |
On December 15, 2010, our Board of Directors authorized $2 million in funds for use in
our common stock repurchase program over the following 18 months from December 2010. Repurchase
under the program may be made through open market purchases or privately negotiated transactions in
accordance with applicable federal securities laws, including Rule 10b-18. Rule 10b-18 puts
limitations on this repurchase program, including but not limited to, the manner of purchase, the
time of the repurchases, the prices paid and the volume of shares repurchased. The timing of the
repurchases and the exact number of shares of common stock to be purchased will be determined by
the discretion of our management under the supervision of the audit committee of our board of
directors, and will depend upon market conditions and other factors. The program will be funded
using our cash on hand and cash generated from operations. On March 14, 2011, we entered into a
10b5-1 Stock Repurchase Agreement with our broker so we had the ability to repurchase shares of our
common stock during our standard blackout periods. The program may be extended, suspended or
discontinued at any time.
The following table provides information relating to our repurchase of common stock for the
first quarter of 2011:
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Total Number of |
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Approximate |
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Shares Purchased |
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Dollar Value of |
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|
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as Part of Publicly |
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Shares that May |
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Total Number of |
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Average Price |
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Announced |
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Yet Be Purchased |
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Shares Purchased |
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Paid per Share |
|
Program |
|
Under the Program |
January 1 January 31, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,984,177 |
|
February 1 February 28, 2011 |
|
|
2,509 |
|
|
$ |
4.67 |
|
|
|
2,509 |
|
|
$ |
1,972,387 |
|
March 1 March 31, 2011 |
|
|
35,104 |
|
|
$ |
5.01 |
|
|
|
35,104 |
|
|
$ |
1,795,332 |
|
|
|
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37,613 |
|
|
|
|
|
|
|
37,613 |
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Item 3. |
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Defaults Upon Senior Securities. |
None.
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Item 4. |
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(Removed and Reserved) |
-35-
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Item 5. |
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Other Information. |
None.
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4.1
|
|
Amended and Restated Rights Agreement, dated as
of March 23, 2011, between BioClinica, Inc. and Computershare Trust
Company, N.A. Incorporated by reference to Exhibit 4.1 of our Current
Report on Form 8-K, dated March 25, 2011. |
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31.1
|
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Certification of principal executive officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
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31.2
|
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Certification of principal financial and
accounting officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith). |
|
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32.1
|
|
Certification of principal executive officer
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C.
1350 (furnished herewith). |
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32.2
|
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Certification of principal financial and
accounting officer pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, 18 U.S.C. 1350 (furnished herewith). |
-36-
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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BIOCLINICA, INC.
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DATE: May 6, 2011 |
By: |
/s/ Mark L. Weinstein
|
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|
Mark L. Weinstein, President and Chief Executive |
|
|
Officer (Principal Executive Officer) |
|
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|
|
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DATE: May 6, 2011 |
By: |
/s/ Ted I. Kaminer
|
|
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Ted I. Kaminer, Executive Vice President of Finance |
|
|
and Administration and Chief Financial Officer
(Principal Financial and Accounting Officer) |
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|
-37-