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, 2010
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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
Incorporation or Organization)
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(I.R.S. Employer Identification No.) |
826 Newtown-Yardley Road, Newtown, Pennsylvania 18940-1721
(Address of Principal Executive Offices) (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.
Yes: þ
No: o
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).
Yes: o
No: o
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* |
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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):
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer o (do not check if a smaller reporting company) |
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes: o
No: þ
State the number of shares outstanding of each of the registrants classes of common stock, as
of April 30, 2010:
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Class |
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Number of Shares |
Common Stock, $0.00025 par value |
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15,149,187 |
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BIOCLINICA, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
-i-
PART I. FINANCIAL INFORMATION.
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Item 1. |
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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, 2009.
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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2010 |
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2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
13,469 |
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$ |
14,570 |
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Accounts receivable, net |
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10,107 |
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10,966 |
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Prepaid expenses and other current assets |
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1,963 |
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1,869 |
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Deferred income taxes |
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2,970 |
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3,370 |
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Total current assets |
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28,509 |
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30,775 |
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Property and equipment, net |
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11,118 |
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9,040 |
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Intangibles, net |
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2,928 |
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1,969 |
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Goodwill |
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34,327 |
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32,933 |
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Deferred income tax |
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35 |
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Other assets |
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622 |
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620 |
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Total assets |
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$ |
77,539 |
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$ |
75,337 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
4,229 |
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$ |
3,899 |
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Accrued expenses and other current liabilities |
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3,787 |
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4,134 |
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Deferred revenue |
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13,031 |
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14,256 |
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Current liability for acquisition earn-out |
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1,220 |
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1,184 |
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Total current liabilities |
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22,267 |
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23,473 |
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Long-term liability for acquisition earn-out |
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1,715 |
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1,657 |
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Deferred income tax |
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1,034 |
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1,167 |
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Other liabilities |
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586 |
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505 |
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Total liabilities |
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$ |
25,602 |
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$ |
26,802 |
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Stockholders equity: |
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Preferred stock $0.00025 par value;
authorized 3,000,000 shares, 0 issued and
outstanding at March 31, 2010 and at December
31, 2009 |
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Common stock $0.00025 par value; authorized
36,000,000 shares, issued and outstanding
15,149,187 shares at March 31, 2010 and
14,394,374 shares at December 31, 2009 |
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4 |
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4 |
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Common stock consideration for earn-out |
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1,309 |
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1,309 |
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Additional paid-in capital |
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45,872 |
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43,104 |
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Retained earnings |
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4,750 |
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4,039 |
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Accumulated other comprehensive income |
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2 |
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79 |
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Total stockholders equity |
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$ |
51,937 |
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$ |
48,535 |
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Total liabilities and stockholders equity |
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$ |
77,539 |
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$ |
75,337 |
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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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2010 |
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2009 |
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Service revenues |
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$ |
14,746 |
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$ |
14,475 |
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Reimbursement revenues |
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3,358 |
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2,595 |
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Total revenues |
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18,104 |
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17,070 |
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Cost and expenses: |
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Cost of service revenues |
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8,951 |
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9,061 |
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Cost of reimbursement revenues |
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3,358 |
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2,595 |
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Sales and marketing expenses |
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2,210 |
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2,156 |
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General and administrative expenses |
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2,072 |
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1,917 |
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Amortization of intangible assets
related to acquisitions |
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141 |
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119 |
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Mergers and acquisitions related costs |
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205 |
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Total cost and expenses |
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16,937 |
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15,848 |
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Income from operations |
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1,167 |
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1,222 |
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Interest income |
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6 |
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22 |
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Interest expense |
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(3 |
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(2 |
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Income before income tax |
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1,170 |
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1,242 |
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Income tax provision |
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(459 |
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(456 |
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Net income |
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$ |
711 |
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$ |
786 |
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Basic income per common share |
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$ |
0.05 |
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$ |
0.05 |
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Weighted average number of common shares |
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14,545 |
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14,341 |
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Diluted income per common share |
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$ |
0.05 |
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$ |
0.05 |
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Weighted average number of diluted shares |
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15,382 |
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15,085 |
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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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2010 |
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2009 |
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Cash flows from operating activities: |
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Net income |
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$ |
711 |
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$ |
786 |
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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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728 |
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486 |
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Provision for deferred income taxes |
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163 |
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854 |
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Bad debt recovery |
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(9 |
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(11 |
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Stock based compensation expense |
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235 |
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204 |
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Accretion of acquisition earn-out |
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94 |
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Changes in operating assets and liabilities, net of acquisitions: |
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Decrease in accounts receivable |
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1,246 |
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2,268 |
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(Increase) decrease in prepaid expenses and other current assets |
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(168 |
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268 |
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Decrease in other assets |
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11 |
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90 |
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Decrease in accounts payable |
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(153 |
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(365 |
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Decrease in accrued expenses and other current liabilities |
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(624 |
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(2,287 |
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Decrease in deferred revenue |
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(1,218 |
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(1,723 |
) |
Increase (decrease) in other liabilities |
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122 |
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(1 |
) |
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Net cash provided by operating activities |
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$ |
1,138 |
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$ |
569 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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$ |
(2,255 |
) |
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$ |
(397 |
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Net cash received for sale of assets of discontinued operations |
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500 |
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Net cash (used in) provided by investing activities |
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$ |
(2,255 |
) |
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$ |
103 |
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Cash flows from financing activities: |
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Payments under equipment lease obligations |
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$ |
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$ |
(19 |
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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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38 |
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Net cash provided by (used in) financing activities |
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$ |
65 |
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$ |
(19 |
) |
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Effect of exchange rate changes on cash |
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(49 |
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(35 |
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Net (decrease) increase in cash and cash equivalents |
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(1,101 |
) |
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618 |
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Cash and cash equivalents at beginning of period |
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14,570 |
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14,265 |
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Cash and cash equivalents at end of period |
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$ |
13,469 |
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$ |
14,883 |
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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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$ |
3 |
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$ |
2 |
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Cash paid during the period for income taxes |
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$ |
171 |
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$ |
158 |
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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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2010 |
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2009 |
Supplemental cash flow disclosure (in thousands) |
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Schedule of non cash investing and financing activities: |
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Increase in property, plant and equipment acquisitions
in accounts payable |
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$ |
587 |
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$ |
127 |
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For the Three Months Ended |
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March 31, |
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2010 |
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2009 |
Acquired business (in thousands) |
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Accounts receivable |
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$ |
309 |
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$ |
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Property and equipment |
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91 |
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Other assets |
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33 |
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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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1,394 |
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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 for the three months ended
March 31, 2010 of $0 |
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$ |
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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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2010 |
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2009 |
Statement of comprehensive income (in thousands) |
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Net income |
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$ |
711 |
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$ |
786 |
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Equity adjustment from foreign currency translation |
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(77 |
) |
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(170 |
) |
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Total comprehensive income |
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$ |
634 |
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$ |
616 |
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See Notes to Consolidated Financial Statements
-6-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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, 2009.
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 opening
balance sheet of TranSenda has been recorded on a preliminary basis as of March 31, 2010. 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 for our French and Netherlands operations is the Euro based on our
initial and periodic evaluations of economic factors as set forth in FASB ASC 830 Foreign Currency
Matters
-7-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 2 Stockholders Equity Rollforward
The following summarizes the activity of the Stockholders equity accounts for the period from
December 31, 2009 through March 31, 2010:
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Common |
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Stock |
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Accumu- |
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Other |
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Consid- |
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lated |
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Compre- |
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Additional |
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eration |
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(Deficit) |
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hensive |
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Stock- |
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Common Stock |
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Paid-in |
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for |
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Retained |
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Gain |
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holders |
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(in thousands) |
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Shares |
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Amount |
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Capital |
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Earn-out |
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Earnings |
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(Loss) |
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Equity |
|
Balance at December 31, 2009 |
|
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14,394 |
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|
$ |
4 |
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|
$ |
43,104 |
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|
$ |
1,309 |
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|
$ |
4,039 |
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$ |
79 |
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|
$ |
48,535 |
|
Stock options exercised |
|
|
177 |
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|
|
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|
38 |
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|
|
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|
|
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|
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|
38 |
|
Stock consideration for acquisitions |
|
|
578 |
|
|
|
|
|
|
|
2,468 |
|
|
|
|
|
|
|
|
|
|
|
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2,468 |
|
Stock based compensation |
|
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|
|
|
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|
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|
235 |
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|
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|
|
|
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|
|
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|
235 |
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Tax benefit on exercise of stock options |
|
|
|
|
|
|
|
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27 |
|
Equity adjustment from foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(77 |
) |
|
|
(77 |
) |
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
711 |
|
|
|
|
|
|
|
711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2010 |
|
|
15,149 |
|
|
$ |
4 |
|
|
$ |
45,872 |
|
|
$ |
1,309 |
|
|
$ |
4,750 |
|
|
$ |
2 |
|
|
$ |
51,937 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 3 Earnings Per Share
Basic income per common share for the three months ended March 31, 2010 and 2009 was
calculated based upon net income divided by the weighted average number of shares of our common
stock outstanding during the period. Diluted income per share for the three months ended March 31,
2010 and 2009 was calculated based upon net income divided by the weighted average number of shares
of our common stock outstanding during the period, adjusted for dilutive securities using the
treasury method.
-8-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The computation of basic income per common share and diluted income per common
share was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(in thousands except share data) |
|
2010 |
|
|
2009 |
|
Net income basic and diluted |
|
$ |
711 |
|
|
$ |
786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
14,545 |
|
|
|
14,341 |
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.05 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
14,545 |
|
|
|
14,341 |
|
Common share equivalents
of outstanding stock options |
|
|
467 |
|
|
|
434 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
370 |
|
|
|
310 |
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equivalent shares |
|
|
15,382 |
|
|
|
15,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per
common share |
|
$ |
0.05 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
Options to purchase 492,000 and 630,000 shares of our common stock respectively, had been
excluded from the calculation of diluted earnings per common share for the three months ended March
31, 2010 and March 31, 2009, respectively, as they were all antidilutive.
Note 4 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 both its Chief Financial Officer and the President of
eClinical division. The Chief Financial Officers agreement expires February 5, 2011 and is
renewable on an annual basis. The President of eClinical divisions agreement expires September
30, 2010 and is renewable on an annual basis. The aggregate amount due from January 1, 2010
through the expiration under these agreements was $1.3 million.
Note 5 Accounts Receivable and Allowance for Doubtful Accounts
-9-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
We maintain allowances for doubtful accounts on a specific identification method for
estimated losses resulting from the inability of our customers to make required payments. If the
financial condition of our customers were to deteriorate, resulting in an impairment of our
customers ability to make payments, additional allowances may be required. We do not have any
off-balance-sheet credit exposure related to our customers, and the trade accounts receivable do
not bear interest.
|
|
|
|
|
|
|
|
|
(in thousands) |
|
March 31, 2010 |
|
|
December 31, 2009 |
|
Billed trade accounts receivable |
|
$ |
9,305 |
|
|
$ |
10,164 |
|
Unbilled trade accounts receivable |
|
|
784 |
|
|
|
747 |
|
Other |
|
|
18 |
|
|
|
55 |
|
|
|
|
|
|
|
|
Total Receivables |
|
$ |
10,107 |
|
|
$ |
10,966 |
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward (in thousands): |
|
|
|
|
|
|
|
|
Balance at January 1, 2010 |
|
$ |
9 |
|
|
|
|
|
Additions |
|
|
0 |
|
|
|
|
|
Write offs (Recoveries) |
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2010 |
|
$ |
0 |
|
|
|
|
|
Note 6 Income Taxes
The Company records a valuation allowance to reduce its deferred tax assets to an amount that
is more likely than not to be realized. In assessing the need for the valuation allowance, the
Company considers future taxable income and on-going prudent and feasible tax planning strategies.
In the event that the Company was to determine that, in the future, they would be able to realize
the deferred tax assets in excess of its net recorded amount, an adjustment to the deferred tax
asset would be made, thereby increasing net income in the period such determination was made.
Likewise, should the Company determine that it is more likely than not that it will be unable to
realize all or part of the net deferred tax asset in the future, an adjustment to the deferred tax
asset would be charged, thereby decreasing net income in the period such determination was made.
As of December 31, 2008, the Company had $1.3 million in accumulated tax losses in the United
States, which included allowable deductions related to exercised employee stock options, generating
federal and state net operating loss (NOL) credit carryforwards. Under limitations imposed by
Internal Revenue Code Section 382, certain potential changes in ownership of the Company, which may
be outside the Companys knowledge or control, may restrict future utilization of these
carryforwards. Due to such ownership changes that have occurred in prior years, the Company
estimated that $1.1 million of the federal net operating loss would likely expire unused, in the
years 2010 through 2022, due to Internal Revenue Code Section 382 limitations. The Company has
foreign NOL carryforwards from its French subsidiary of $364,000 as of March 31, 2010 and $575,000
as of December 31, 2009. GAAP requires that the Company establish a valuation allowance for any
portion of its deferred tax assets for which management believes that it is more likely than not
the Company will be unable to utilize the asset to offset future taxes. The Company will continue
to evaluate the potential use of its deferred tax assets and
-10-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
the need for a valuation allowance by considering future taxable income and on-going prudent
and feasible tax planning strategies. Subsequent revisions to the estimated realizable value of
the deferred tax assets could cause the provision for income taxes to vary significantly from
period to period, although the cash tax payments would remain unaffected until the NOL credit
carryforward is fully utilized or has expired. Our deferred tax assets are primarily comprised of
the temporary book to tax differences related to deferred revenue.
The tax benefit of the stock option deductions have been recorded to additional paid-in
capital in the amount of $27,000 and $0 for the three months ended March 31, 2010 and 2009,
respectively.
The Company recognizes contingent liabilities for any tax related exposures when those
exposures are more likely than not to occur.
The Company has not provided for U.S. federal income and foreign withholding taxes on
approximately $1.9 million of undistributed earnings from its non-U.S. operations as of March 31,
2010 because such earnings are intended to be reinvested indefinitely outside of the United States.
There were no material unrecognized tax benefits as of March 31, 2010 and December 31, 2009.
We do not expect the unrecognized tax benefit to materially change during the next 12 months. Any
interest and penalties incurred on settlements of outstanding tax positions would be recorded as a
component of tax expense. We file our tax returns as prescribed by the tax laws of the
jurisdictions in which we operate. Our federal tax return for the 2009 year is subject to
examination. Our state taxes for years 2000 through 2008 are subject to examination. Our foreign
taxes for years 2002 through 2008 are subject to examination by the respective authorities.
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 is a provider
of clinical trial management software (CTMS) solutions. TranSendas suite of web-based,
Office-Smart CTMS solutions create 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 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, the Company paid 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
-11-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Purchase Agreement, 15% of the aggregate consideration is to be 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). 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 and 2009 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 |
|
|
March 31, |
(in thousands except per share data) |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,335 |
|
|
$ |
17,278 |
|
Income from operations |
|
|
549 |
|
|
|
525 |
|
Net Income |
|
|
334 |
|
|
|
349 |
|
Basic earnings per share |
|
$ |
0.02 |
|
|
$ |
0.02 |
|
Diluted earnings per share |
|
$ |
0.02 |
|
|
$ |
0.02 |
|
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, the Company expensed all costs related to the acquisitions.
The total costs incurred to date related to the acquisition were $111,000 and included in mergers
and acquisition related costs on the consolidated statement of income for the three months ended
March 31, 2010.
The following table summarizes the preliminary amounts of identified assets acquired and
liabilities assumed from TranSenda at the acquisition date fair value:
-12-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
|
|
TranSenda |
|
|
|
|
|
|
Accounts Receivable |
|
$ |
309 |
|
Property and Equipment |
|
|
91 |
|
Other Assets |
|
|
33 |
|
Other Liabilities |
|
|
(459 |
) |
Customer Relationships |
|
|
100 |
|
Technology |
|
|
1,000 |
|
Goodwill, including Workforce |
|
|
1,394 |
|
|
|
|
|
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.
In accordance with FASB ASC 820, Fair Value Measurements (FASB ASC 820) the Company
determined that the preliminary 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 purchase price allocation will remain
preliminary until the Company completes its review of third-party valuations and determines the
fair market values of assets acquired and liabilities assumed and could differ significantly from
preliminary recorded amounts. The goodwill recorded in connection with these acquisitions will be
deductible for tax purposes over 15 years.
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.
2009 Acquisitions
On August 27, 2009, BioClinica acquired the CardioNow unit of Agfa Healthcare (CardioNow).
CardioNow has developed a web-based system for the secure transmission of medical cardiac images.
The software was specifically developed for and marketed to the invasive cardiology departments of
hospitals within the United States. BioClinica will integrate and enhance the current CardioNow
software and service to offer our clients a streamlined electronic transport solution to facilitate
the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as
part of our suite of imaging services. The purchase price for CardioNow consisted of cash
consideration paid to Agfa Healthcare of $1 million. The Company paid the purchase price for
CardioNow with cash from operations. The pro forma impact of the CardioNow acquisition on 2009
results was immaterial.
On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte
Solutions, Inc. (Tourtellotte). Tourtellotte provided 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). The fair value of the cash earn-out of $2.8 million has been recorded as a liability
and the fair value of the 350,000 shares of $1.3 million has been classified separately within
stockholders equity as contingent consideration for a total purchase price of $6.2 million as of
March 31, 2010. The Company used cash from operations to
-13-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
fund the cash purchase price for Tourtellotte.
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, 2009 as if the Tourtellotte
acquisition had occurred as of the beginning of the period 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 Tourtellotte acquisition would have taken place at the beginning of the period 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 March |
(in thousands except per share data) |
|
31, 2009 |
|
|
|
|
|
Total revenue |
|
$ |
18,095 |
|
Income from operations |
|
|
1,301 |
|
Net income |
|
|
835 |
|
Basic earnings per share |
|
$ |
0.06 |
|
Diluted earnings per share: |
|
$ |
0.06 |
|
In connection with the acquisitions of CardioNow and Tourtellotte, 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 CardioNow and Tourtellotte as part of its clinical trials services reportable segment.
In accordance with FASB ASC 805, the Company expensed all costs related to the acquisitions.
The total costs related to the acquisitions were $560,000 and included in mergers and acquisition
related costs on the consolidated statement of income in fiscal 2009.
-14-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
The following table summarizes the consideration transferred to acquire CardioNow and
Tourtolette at the respective acquisition dates:
|
|
|
|
|
|
|
|
|
|
|
CardioNow |
|
|
Tourtellotte |
|
Cash |
|
$ |
1,000 |
|
|
$ |
2,144 |
|
Estimated earnout payments: |
|
|
|
|
|
|
|
|
Contingent consideration to be settled in cash |
|
|
|
|
|
|
2,656 |
|
Contingent consideration to be settled in stock |
|
|
|
|
|
|
1,300 |
|
Working capital adjustment |
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
|
Total purchase price |
|
$ |
1,000 |
|
|
$ |
6,194 |
|
|
|
|
|
|
|
|
The following table summarizes the amounts of identified assets acquired and liabilities
assumed from CardioNow and Tourtellotte at the respective acquisition date fair value:
|
|
|
|
|
|
|
|
|
|
|
CardioNow |
|
|
Tourtellotte |
|
Accounts Receivable |
|
|
|
|
|
$ |
934 |
|
Other Assets |
|
|
|
|
|
|
55 |
|
Other Liabilities |
|
|
|
|
|
|
(93 |
) |
Customer Relationships |
|
|
|
|
|
|
393 |
|
Goodwill, including Workforce |
|
$ |
1,000 |
|
|
|
4,905 |
|
|
|
|
|
|
|
|
Total Fair Value of Purchase Price |
|
$ |
1,000 |
|
|
$ |
6,194 |
|
|
|
|
|
|
|
|
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 cash contingent consideration expected to be paid within one year from March 31, 2010 of
$1,220,000 was classified as a short-term liability and the remaining cash contingent consideration
of $1,714,000 was classified as a long-term liability on the financial statements. The contingent
consideration expected to be paid in stock of $1,309,000 is recorded in the equity section of the
financial statements. The difference between the fair value of the cash contingent consideration
at the date of acquisition and the expected payment will be recorded as an expense in the financial
statements at the end of each reporting period. For the three months ended March 31, 2010, the
Company recorded $94,000 of accretion expense in mergers and acquisition related costs on the
income statement for this difference.
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.
The results of operations of CardioNow and Tourtellotte are included in our financial
statements from the respective acquisition dates.
-15-
BIOCLINICA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 8 Intangible Assets
At March 31, 2010 the composition of intangible assets were as follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
Estimated |
|
(in thousands) |
|
2010 |
|
|
Useful Life |
|
Amortized intangible assets: |
|
|
|
|
|
|
|
|
Technology |
|
$ |
1,843 |
|
|
5 years |
Trademarks |
|
|
48 |
|
|
5 years |
Customer backlog |
|
|
2,113 |
|
|
|
3 to 7 years |
|
Non-competition agreement |
|
|
349 |
|
|
|
2 to 3 years |
|
|
|
|
|
|
|
|
|
|
|
|
4,353 |
|
|
|
|
|
Accumulated amortization |
|
|
(1,425 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized intangible assets: |
|
|
|
|
|
|
|
|
Goodwill |
|
$ |
34,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated future amortization of the intangible assets is as follows:
|
|
|
|
|
|
|
Year Ending |
|
(in thousands) |
|
December 31, |
|
2010 |
|
$ |
590 |
|
2011 |
|
|
746 |
|
2012 |
|
|
660 |
|
2013 |
|
|
432 |
|
2014 |
|
|
399 |
|
2015 |
|
|
101 |
|
|
|
|
|
|
|
$ |
2,928 |
|
|
|
|
|
The following table details the changes in the carrying amount of goodwill:
|
|
|
|
|
(in thousands) |
|
|
|
|
Balance at December 31, 2009 |
|
$ |
32,933 |
|
Acquisition of business |
|
|
1,394 |
|
|
|
|
|
Balance at March 31, 2010 |
|
$ |
34,327 |
|
|
|
|
|
Note 9 Subsequent Events
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank, expiring
May 5, 2012. Under the credit agreement, we have the ability to
borrow up to $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 unused line of credit. The credit agreement requires our compliance with certain
covenants, including maintaining a minimum stockholders equity of $35 million.
-16-
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of
Operations. |
Overview
BioClinica, provides integrated clinical research services including imaging core lab and
eClinical technologies and services to pharmaceutical, biotechnology, medical device companies and
other organizations such as contract research organizations (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, 2010, which includes our medical image management and eClinical services, was $99.7
million compared to $93.3 million at March 31, 2009. 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, 2010.
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 seven years. 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.
-17-
Acquisitions
On March 25, 2010, the Company acquired substantially all of the assets of privately held
TranSenda International, LLC (TranSenda). Headquartered in Bellevue, WA, TranSenda is a provider
of clinical trial management software (CTMS) solutions. TranSendas suite of web-based,
Office-Smart CTMS solutions create efficiencies for trial operations through interoperability with
Microsoft Office tools. With this acquisition, BioClinica enhances 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 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, the Company paid 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 is to be 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). 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 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 centralized core laboratories; 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 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
-18-
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 October 2009, the FASB issued guidance on revenue recognition that will become effective
for us beginning January 1, 2011, with earlier adoption permitted. 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 the
application of the relative selling price method affects the timing and amount of revenue
recognition. Management believes the adoption of this new guidance will not have a material impact
on our financial statements.
-19-
Results of Operations
Three Months Ended March 31, 2010 and 2009
|
|
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|
|
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Three |
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|
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Three |
|
|
|
|
|
|
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Months |
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|
Months |
|
|
|
|
|
|
|
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ended |
|
% of |
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ended |
|
% of |
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|
|
|
|
|
|
March |
|
Total |
|
March |
|
Total |
|
|
|
|
|
% |
(in thousands) |
|
31, 2010 |
|
Revenue |
|
31, 2009 |
|
Revenue |
|
$ Change |
|
Change |
|
Service revenues |
|
$ |
14,746 |
|
|
|
81.5 |
% |
|
$ |
14,475 |
|
|
|
84.8 |
% |
|
$ |
271 |
|
|
|
1.9 |
% |
Reimbursement revenues |
|
|
3,358 |
|
|
|
18.5 |
% |
|
|
2,595 |
|
|
|
15.2 |
% |
|
|
763 |
|
|
|
29.4 |
% |
|
Total revenues |
|
|
18,104 |
|
|
|
100.0 |
% |
|
|
17,070 |
|
|
|
100.0 |
% |
|
|
1,034 |
|
|
|
6.1 |
% |
|
Cost and expenses: |
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
8,951 |
|
|
|
49.4 |
% |
|
|
9,061 |
|
|
|
53.1 |
% |
|
|
(110 |
) |
|
|
-1.2 |
% |
Cost of reimbursement revenues |
|
|
3,358 |
|
|
|
18.5 |
% |
|
|
2,595 |
|
|
|
15.2 |
% |
|
|
763 |
|
|
|
29.4 |
% |
Sales and marketing expenses |
|
|
2,210 |
|
|
|
12.2 |
% |
|
|
2,156 |
|
|
|
12.6 |
% |
|
|
54 |
|
|
|
2.5 |
% |
General and administrative expenses |
|
|
2,072 |
|
|
|
11.4 |
% |
|
|
1,917 |
|
|
|
11.2 |
% |
|
|
155 |
|
|
|
8.1 |
% |
Amortization of intangible assets
related to
acquisitions |
|
|
141 |
|
|
|
0.8 |
% |
|
|
119 |
|
|
|
0.7 |
% |
|
|
22 |
|
|
|
18.5 |
% |
Mergers and acquisitions related costs |
|
|
205 |
|
|
|
1.1 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
205 |
|
|
|
|
|
|
Total cost and expenses |
|
|
16,937 |
|
|
|
93.6 |
% |
|
|
15,848 |
|
|
|
92.8 |
% |
|
|
1,089 |
|
|
|
6.9 |
% |
|
Income from operations |
|
|
1,167 |
|
|
|
6.4 |
% |
|
|
1,222 |
|
|
|
7.2 |
% |
|
|
(55 |
) |
|
|
-4.5 |
% |
|
Interest income |
|
|
6 |
|
|
|
0.0 |
% |
|
|
22 |
|
|
|
0.1 |
% |
|
|
(16 |
) |
|
|
-72.7 |
% |
Interest expense |
|
|
(3 |
) |
|
|
0.0 |
% |
|
|
(2 |
) |
|
|
0.0 |
% |
|
|
(1 |
) |
|
|
50.0 |
% |
|
Income before income tax |
|
|
1,170 |
|
|
|
6.5 |
% |
|
|
1,242 |
|
|
|
7.3 |
% |
|
|
(72 |
) |
|
|
-5.8 |
% |
|
Income tax provision |
|
|
(459 |
) |
|
|
-2.5 |
% |
|
|
(456 |
) |
|
|
-2.7 |
% |
|
|
(3 |
) |
|
|
0.7 |
% |
|
Net income |
|
$ |
711 |
|
|
|
3.9 |
% |
|
$ |
786 |
|
|
|
4.6 |
% |
|
$ |
(75 |
) |
|
|
-9.5 |
% |
|
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.
Service revenues for the three months ended March 31, 2010 and 2009 were $14.7 million and
$14.5 million, respectively, an increase of $271,000, or 1.9%. The increase in service revenues
was due to an increase in work performed on the increased backlog from the prior year. One client,
Pfizer Inc.
-20-
encompassing 15 projects represented 18.3% of our service revenue for the three months
ended March 31, 2010. One client, Centocor Ortho Biotech, Inc., encompassing 23 projects
represented 12.0% of our service revenue for the three months ended March 31, 2009.
Reimbursement revenues and cost of reimbursement revenues for the three months ended March 31,
2010 and 2009 were $3.4 million and $2.6 million, respectively, an increase of $763,000, or 29.4%.
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 for the three months ended March 31, 2010 and 2009 were $9.0 million
and $9.1 million, respectively, a decrease of $110,000, or 1.2%. Cost of service revenues for the
three months ended March 31, 2010 and 2009 were comprised of professional salaries and benefits and
allocated overhead. The cost of service revenue remained relatively flat due to the increase in
personnel from the Tourtellotte acquisition offset by the savings resulting from the reduction in
force implemented in the second quarter of 2009. 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 2010 due to the personnel costs from the acquisition of TranSenda.
Sales and marketing expenses remained flat at $2.2M for the three months ended March 31, 2010
and 2009. Sales and marketing expenses for the three months ended March 31, 2010 and 2009 were
comprised of direct sales and marketing costs, salaries and benefits and allocated overhead. We
expect that sales and marketing expenses will increase in fiscal 2010 due to increased marketing
for our product launches and as we continue to expand our market presence in the United States and
Europe.
General and administrative expenses for the three months ended March 31, 2010 and 2009 were
$2.1 million and $1.9 million, respectively, an increase of $155,000, or 8.1%. General and
administrative expenses for the three months ended March 31, 2010 and three months ended March 31,
2009 consisted primarily of salaries and benefits, allocated overhead, professional and consulting
services and corporate insurance. The increase is primarily due to an increase in professional
fees. We expect that our general and administrative expenses will remain relatively flat for the
remainder of 2010.
Amortization of intangible assets related to acquisitions for the three months ended March 31,
2010 and 2009 were $141,000 and $119,000, respectively, an increase of $22,000, or 18.5%.
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 and Theralys. The increase is primarily due to the acquisition
of Tourtellotte. We expect that the amortization of intangible assets related to acquisitions will
increase with the acquisition of TranSenda and as we look to continue to expand our pharmaceutical
contract services through potential acquisitions.
Merger and acquisition related costs of $205,000 for the three months ended March 31, 2010
include expenses of $111,000 consisting of costs resulting directly from merger and acquisition
activities for the TranSenda acquisition such as legal, accounting and other due diligence and
integration costs.
-21-
Also included in this cost is $94,000 of earn-out accretion for the three
months ended March 31, 2010 from the Tourtellotte acquisition due to the difference in the fair
value from the purchase price recorded at the date of acquisition to March 31, 2010.
Net interest income was $3,000 for the three months ended March 31, 2010 and $20,000 for the
three months ended March 31, 2009, a decrease of $17,000, or 85%. Net interest income and expense
for the three months ended March 31, 2009 is comprised of interest income earned on our cash
balance and interest expense incurred on equipment lease obligations. Net interest income for the
three months ended March 31, 2010 is comprised of interest income earned on our cash and has decreased due to lower
average daily cash balances.
Our income tax provision for the three months ended March 31, 2010 and 2009 was $459,000 and
$456,000, respectively. Our effective tax rate is approximately 39.2% for fiscal 2010. Our
effective tax rate was approximately 36.7% for fiscal 2009. The higher effective tax rate in
fiscal 2010 was due to a larger mix of pre-tax income in the U.S. than in the Netherlands, which
has a lower corporate income tax rate than the U.S., and the changes affecting state tax rates.
-22-
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. In January 2010, we
incorporated BioClinica Private Limited in Bhubaneshwar, India to provide information technology
support services.
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, 2010 compared to March 31, 2009
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Three Months |
|
|
Ended |
|
Ended |
(in thousands) |
|
March 31, 2010 |
|
March 31, 2009 |
|
|
|
Net cash provided by operating activities |
|
$ |
1,138 |
|
|
$ |
569 |
|
Net cash (used in) provided by investing activities |
|
$ |
(2,255 |
) |
|
$ |
103 |
|
Net cash provided by (used in) financing activities |
|
$ |
65 |
|
|
$ |
(19 |
) |
At March 31, 2010, we had cash and cash equivalents of $13.5 million. Working capital,
defined as current assets minus current liabilities, at March 31, 2010 was $6.2 million.
Net cash provided by operating activities for the three months ended March 31, 2010 was
$1,138,000 as compared to $569,000 for the three months ended March 31, 2009. This increase from
the prior year is primarily due to the lesser change in accrued expenses in 2010.
Net cash used in investing activities for the three months ended March 31, 2010 was
$(2,255,000) as compared to net cash provided by investing activities of $103,000 for the three
months ended March 31, 2009. We currently anticipate that capital expenditures for the remainder
of the fiscal year ending December 31, 2010 will be approximately $3 million. These expenditures
primarily represent capitalization of software costs.
Net cash provided by financing activities from continuing operations for the three months
ended March 31, 2010 was $65,000 as compared to net cash used in financing activities of $19,000
for the three months ended March 31, 2009. Net cash provided by financing activities represents
cash proceeds from exercise of stock options for the three months ended March 31, 2010.
-23-
The following table lists our cash contractual obligations as of March 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
(in thousands) |
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
More than |
|
Contractual obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Facility rent operating
leases |
|
$ |
18,987,000 |
|
|
$ |
1,624,000 |
|
|
$ |
3,884,000 |
|
|
$ |
4,594,000 |
|
|
$ |
8,885,000 |
|
Employment agreements |
|
|
1,064,000 |
|
|
|
725,000 |
|
|
|
339,000 |
|
|
|
|
|
|
|
|
|
Earn-outs for
Tourtellotte
acquisition |
|
|
3,258,000 |
|
|
|
1,258,000 |
|
|
|
2,000,000 |
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
23,309,000 |
|
|
$ |
3,607,000 |
|
|
$ |
6,223,000 |
|
|
$ |
4,594,000 |
|
|
$ |
8,885,000 |
|
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank, expiring
May 5, 2012. Under the credit agreement, we have the ability to
borrow up to $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 unused line of credit. The credit agreement requires our compliance with certain
covenants, including maintaining a minimum stockholders equity of $35 million.
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 affect on our
future liquidity:
|
|
|
our ability to gain new client contracts; |
|
|
|
|
project cancellations; |
|
|
|
|
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.
Our fiscal year 2010 operating plan contains assumptions regarding revenue and expenses. The
achievement of our operating plan depends heavily on the timing of work performed by us on existing
projects and our ability to gain and perform work on new projects. Project cancellations, delays
in the timing of work performed by us on existing projects or our inability to gain and perform
work on new projects could have an adverse impact on our ability to execute our operating plan and
maintain adequate
-24-
cash flow. In the event actual results do not meet the operating plan, our
management believes it could
execute contingency plans to mitigate these effects. Our plans include additional financing,
to the extent available. Considering the cash on hand and based on the achievement of the operating
plan and managements actions taken to date, management believes it has the ability to continue to
generate sufficient cash to satisfy our operating requirements in the normal course of business for
at least the next 12 months and the foreseeable future.
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, 2009. As of March 31, 2010, there have been no changes to
such critical accounting policies and estimates.
Item 3. 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
Our financial statements are denominated in U.S. dollars. Fluctuations in foreign currency
exchange rates could materially increase the operating costs of our facilities in the Netherlands
and France, which are Euro denominated. A ten percent increase or decrease in the Euro to U.S.
dollar spot exchange rate would result in a change of $211,000 and $215,000 to our net asset
position, at March 31, 2010 and March 31, 2009, respectively. In addition, certain of our
contracts are denominated in foreign currency. We believe that any adverse fluctuation in the
foreign currency markets relating to these costs will not result in any material adverse effect on
our financial condition or results of operations. In the event we derive a greater portion of our
service revenues from international operations, factors associated with international operations,
including changes in foreign currency exchange rates, could affect our results of operations and
financial condition.
Our foreign currency financial assets and liabilities primarily consist of cash, trade
receivables, prepaid expenses, fixed assets, trade payables and accrued expenses. We were in a net
asset position at March 31, 2010 and March 31, 2009. An increase in the exchange rate would result
in less net assets when converted to U.S. dollars. Conversely, if we were in a net liability
position, a decrease in the exchange rate would result in more net liabilities when converted to
U.S. dollars.
We hedge our foreign currency exposure when and as appropriate to mitigate the adverse impact
of fluctuating exchange rates. As of March 31, 2010, there are no outstanding derivative
positions.
-25-
Item 4T. 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, 2010, the end of the period covered by this report on Form 10-Q. Based on this evaluation, our
President and 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, 2010. 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 quarter ended March 31, 2010 that has
materially affected, or is reasonably likely to materially affect, our internal controls over
financial reporting.
-26-
PART II. OTHER INFORMATION.
Item 1. 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.
Item 1A. Risk Factors.
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. Investing in our common stock involves a high degree of risk. 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 FDA-regulated companies 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, although our contracts entitle us to
receive all fees earned up to the time of termination.
The recent economic downturn may adversely impact our ability to raise capital.
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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. |
One client, Pfizer Inc. encompassing 15 projects represented 18.3% of our service revenue for
the three months ended March 31, 2010. One client, Centocor Ortho Biotech, Inc., encompassing 23
projects represented 12.0% of our service revenue for the three months ended March 31, 2009. 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 $99.7 at March 31, 2010 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, the Company acquired substantially all of the assets of privately held
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TranSenda International, LLC (TranSenda), headquartered in Bellevue, WA. We acquired the
CardioNow unit from AGFA Healthcare and substantially all of the assets of Tourtellotte Solutions,
Inc. in the third quarter of 2009 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 BioImaging
Services, and Peter Benton, Executive Vice President, President eClinical. 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.
Our revenues, earnings and operating costs are exposed to exchange rate fluctuations.
During the first quarter of 2010, 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.
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
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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.
We may be unable to adequately protect, and we may incur significant costs in defending, our
intellectual property and other proprietary rights.
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 resort to legal proceedings to enforce our intellectual property rights or to
determine the validity and scope of the intellectual property or other proprietary rights of
others, the proceedings could be burdensome and expensive, even if we were to prevail. The failure
to adequately protect our intellectual property and other proprietary 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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the price of services; |
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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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our size; and |
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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 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
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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 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.
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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.
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.
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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.
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:
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our customers and prospective customers desire for and acceptance of our electronic data
capture, clinical data management, drug safety and interactive response technology
solutions; |
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our ability to meet product development and release schedules; |
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our software products and hosted solutions ability to support large numbers of users and
manage vast amounts of data; |
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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 |
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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.
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.
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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, 2010, we had the following capital structure (in thousands):
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Common stock outstanding |
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15,149 |
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Common stock issuable upon: |
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Exercise of options which are outstanding |
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1,803 |
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Exercise of options which have not been granted |
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432 |
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Restricted stock units outstanding |
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332 |
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Total common stock outstanding assuming exercise or conversion of
all of the above |
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17,716 |
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As of March 31, 2010, 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 $4.65 per share), of which 1.1 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
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, 2010, we had 15.1 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
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common stock), including Covance Inc., beneficially owned 24% of the outstanding shares of common
stock and stock options that could have been converted to common stock at March 31, 2010, 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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operating results; |
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analysts reports; |
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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 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, 2010 and March 31, 2010, our common stock has traded at a low of $4.08 per share and a
high of $5.93 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. The remaining 1,750,000
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
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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. In July 2009,
our board of directors also adopted a stockholder rights plan, 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. |
None.
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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) |
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Item 5. |
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Other Information. |
On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank, expiring
May 5, 2012. Under the credit agreement, we have the ability to
borrow up to $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 unused line of credit. The credit agreement requires our compliance with certain
covenants, including maintaining a minimum stockholders equity of $35 million.
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4.1
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Committed Line of Credit Note dated May 5,
2010, by and between BioClinica, Inc. and Oxford Bio-Imaging Research,
Inc. and PNC Bank, National Association. |
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10.1
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Loan Agreement dated May 5, 2010, by and
between BioClinica, Inc. and Oxford Bio-Imaging Research, Inc. and PNC
Bank, National Association. |
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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
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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). |
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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, 2010 |
By: |
/s/ Mark L. Weinstein
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Mark L. Weinstein, President and Chief Executive Officer (Principal Executive Officer) |
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DATE: May 6, 2010 |
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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