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
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For
the quarterly period ended March 31, 2008
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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
BIO-IMAGING TECHNOLOGIES, 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.) |
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826 Newtown-Yardley Road, Newtown, Pennsylvania
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18940-1721 |
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(Address of Principal
Executive Offices) |
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(Zip Code) |
(267) 757-3000
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes: þ No: o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (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, 2008:
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Class |
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Number of Shares |
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Common Stock, $0.00025 par value |
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14,252,425 |
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BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
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Page |
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PART I. |
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FINANCIAL INFORMATION. |
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Item 1. |
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Consolidated Financial Statements (unaudited) |
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BALANCE SHEETS |
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as of March 31, 2008 and December 31, 2007 |
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2 |
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STATEMENTS OF OPERATIONS |
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For the Three Months Ended March 31, 2008 and 2007 |
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3 |
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STATEMENTS OF CASH FLOWS |
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For the Three Months Ended March 31, 2008 and 2007 |
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4 |
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited) |
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6 |
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Item 2. |
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Managements Discussion and
Analysis of Financial Condition and Results of Operations |
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15 |
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Results of Operations |
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19 |
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Business Segments |
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22 |
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Liquidity and Capital Resources |
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22 |
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Changes to Critical Accounting Policies and Estimates |
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24 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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25 |
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Item 4T. |
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Controls and Procedures |
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25 |
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PART II. |
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OTHER INFORMATION. |
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Item 1. |
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Legal Proceedings |
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27 |
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Item 1A. |
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Risk Factors |
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27 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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34 |
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Item 3. |
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Defaults Upon Senior Securities |
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35 |
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Item 4. |
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Submission of Matters to a Vote of Security Holders |
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35 |
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Item 5. |
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Other Information |
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35 |
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Item 6. |
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Exhibits |
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35 |
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SIGNATURES |
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36 |
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-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 Bio-Imaging, we, us, or our refer
to Bio-Imaging Technologies, Inc., a Delaware corporation, and its subsidiaries.
Certain information and footnote disclosures required under generally accepted accounting
principles 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, 2007.
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-
BIO-IMAGING TECHNOLOGIES, 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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2008 |
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2007 |
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ASSETS
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Current assets: |
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Cash and cash equivalents |
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$ |
11,109 |
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$ |
17,915 |
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Accounts receivable, net |
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11,807 |
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5,881 |
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Prepaid expenses and other current assets |
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1,600 |
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1,235 |
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Deferred income taxes |
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3,033 |
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2,930 |
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Total current assets |
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27,549 |
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27,961 |
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Property and equipment, net |
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9,067 |
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7,980 |
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Intangibles, net |
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2,525 |
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450 |
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Goodwill |
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27,840 |
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6,025 |
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Deferred income taxes |
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108 |
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Other assets |
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657 |
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641 |
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Total assets |
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$ |
67,746 |
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$ |
43,057 |
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities: |
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Accounts payable |
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$ |
2,836 |
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$ |
1,864 |
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Accrued expenses and other current liabilities |
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5,051 |
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4,616 |
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Deferred revenue |
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17,038 |
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11,663 |
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Current maturities of capital lease obligations |
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114 |
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97 |
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Total current liabilities |
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25,039 |
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18,240 |
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Long-term capital lease obligations |
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101 |
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Deferred income tax non-current |
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1,270 |
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691 |
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Other liability |
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617 |
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597 |
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Total liabilities |
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27,027 |
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19,528 |
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Commitments and Contingencies |
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Stockholders equity: |
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Preferred stock- $.00025 par value; authorized
3,000,000 shares, 0 issued and outstanding at
March 31, 2008 and at December 31, 2007 |
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Common stock $.00025 par value; authorized
18,000,000 shares, issued and outstanding
14,238,300 shares at March 31, 2008 and
11,765,483 shares at December 31, 2007 |
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4 |
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3 |
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Additional paid-in capital |
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41,348 |
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25,084 |
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Accumulated deficit |
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(886 |
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(1,709 |
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Accumulated other comprehensive income |
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253 |
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151 |
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Stockholders equity |
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40,719 |
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23,529 |
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Total liabilities and stockholders equity |
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$ |
67,746 |
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$ |
43,057 |
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See Notes to Consolidated Financial Statements
-2-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
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For the Three Months Ended |
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(in thousands, except per share data) |
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March 31, |
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2008 |
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2007 |
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Service revenues |
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$ |
11,161 |
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$ |
8,810 |
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Reimbursement revenues |
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3,078 |
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2,265 |
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Total revenues |
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14,239 |
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11,075 |
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Cost and expenses: |
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Cost of service revenues |
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6,324 |
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5,276 |
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Cost of reimbursement revenues |
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3,078 |
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2,265 |
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Sales and marketing expenses |
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2,011 |
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1,561 |
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General and administrative expenses |
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1,673 |
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1,472 |
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Total cost and expenses |
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13,086 |
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10,574 |
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Income from operations |
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1,153 |
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501 |
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Interest income, net |
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153 |
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157 |
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Income before income tax provision |
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1,306 |
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658 |
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Income tax provision |
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483 |
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263 |
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Net income |
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$ |
823 |
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$ |
395 |
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Basic income per common share |
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$ |
0.07 |
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$ |
0.03 |
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Weighted average number of common shares |
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12,021 |
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11,467 |
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Diluted income per common share |
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$ |
0.06 |
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$ |
0.03 |
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Weighted average number of dilutive common
equivalent shares |
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12,964 |
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12,657 |
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See Notes to Consolidated Financial Statements
-3-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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For the Three Months Ended |
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(in thousands) |
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March 31, |
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2008 |
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2007 |
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Cash flows from operating activities: |
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Net income |
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$ |
823 |
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$ |
395 |
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Adjustments to reconcile net income to net cash provided by operating
activities: |
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Depreciation and amortization |
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843 |
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534 |
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Provision for deferred income taxes |
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242 |
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240 |
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Bad debt provision |
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(17 |
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Stock based compensation expense |
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145 |
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75 |
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Gain on foreign currency options |
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(10 |
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Changes in operating assets and liabilities, net of acquisitions: |
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Increase in accounts receivable |
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(795 |
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(249 |
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(Increase) decrease in prepaid expenses and other current assets |
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(129 |
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6 |
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Decrease (increase) in other assets |
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15 |
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(108 |
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Decrease (increase) in accounts payable |
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526 |
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(85 |
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Decrease in accrued expenses and other current liabilities |
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(308 |
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(385 |
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Increase in deferred revenue |
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1,065 |
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1,760 |
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(Decrease) increase in other liabilities |
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(9 |
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5 |
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Net cash provided by operating activities |
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2,401 |
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2,178 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(1,205 |
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(902 |
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Net cash paid for acquisition |
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(8,257 |
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(3,507 |
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Net cash used in investing activities |
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(9,462 |
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(4,409 |
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Cash flows from financing activities: |
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Payments under equipment lease obligations |
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(56 |
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(140 |
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Excess tax benefit related to stock options |
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63 |
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Proceeds from exercise of stock options |
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39 |
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106 |
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Net cash provided by (used in) financing activities |
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46 |
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(34 |
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Effect of exchange rate changes on cash |
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209 |
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6 |
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Net decrease in cash and cash equivalents |
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(6,806 |
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(2,259 |
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Cash and cash equivalents at beginning of period |
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17,915 |
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16,166 |
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Cash and cash equivalents at end of period |
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$ |
11,109 |
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$ |
13,907 |
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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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$ |
1 |
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$ |
8 |
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Cash paid during the period for income taxes |
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$ |
1,034 |
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$ |
185 |
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See Notes to Consolidated Financial Statements
-4-
BIO-IMAGING TECHNOLOGIES, 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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2008 |
|
2007 |
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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$ |
64 |
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$ |
244 |
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For the Three Months Ended |
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March 31, |
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2008 |
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2007 |
Acquired business (in thousands) |
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Accounts receivable |
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$ |
4,926 |
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$ |
228 |
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Prepaid and other current assets |
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|
258 |
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Property and equipment |
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|
701 |
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185 |
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Other assets |
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37 |
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52 |
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Intangible assets and goodwill |
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23,975 |
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4,532 |
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Net current liabilities assumed |
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(1,062 |
) |
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(377 |
) |
Other liabilities assumed |
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(4,474 |
) |
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(353 |
) |
Common stock issued |
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(16,104 |
) |
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(760 |
) |
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Cash paid for acquired business, net of cash acquired of $418 |
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$ |
8,257 |
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$ |
3,507 |
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For the Three Months Ended |
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|
March 31, |
|
|
2008 |
|
2007 |
Statement of comprehensive income (in thousands) |
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Net income |
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$ |
823 |
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$ |
395 |
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Equity adjustment from foreign currency translation |
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|
253 |
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|
|
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Total comprehensive income |
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$ |
1,076 |
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$ |
395 |
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See Notes to Consolidated Financial Statements
-5-
BIO-IMAGING TECHNOLOGIES, 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 generally accepted accounting principles 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, 2007.
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.
Certain reclassifications have been made to the 2007 financial statements to conform to the
2008 financial statement presentation. We have reclassed certain reimbursable items and have
changed the presentation of our service revenues, reimbursement revenues, cost of service revenues
and cost of reimbursement revenues.
The Balance Sheet at March 31, 2008 includes Phoenix Data Systems, Inc., a Pennsylvania
corporation, hereinafter referred to as PDS, due to the acquisition on March 24, 2008. The
Consolidated Statement of Income for the three months ended March 31, 2008 excludes the financial
results of PDS from the acquisition date of March 24, 2008 through March 31, 2008 due to
immateriality of PDSs results of operations for that period.
Functional Currency.
Historically, the functional currency for our Netherlands operations was the US Dollar based
on an initial evaluation of economic factors as set forth in Financial Accounting Standards Board
Statement No. 52, Foreign Currency Translation (SFAS 52).
We periodically evaluate the economic facts and circumstances that led to the initial
conclusion that the functional currency of the Netherlands operation was the US Dollar for any
significant changes that might indicate that the functional currency of the Netherlands operation
had changed. Based on our evaluation performed in connection with the commencement of our quarter
ended September 30, 2007, we concluded that, effective July 1, 2007, the functional currency of our
Netherlands operation is the Euro. The primary economic factor change was the increase in the
sales price and market indicator of significantly more contracts in Euros as well as the cash flow
and financing indicator of the US Dollar to the Euro in our Netherlands operation.
The functional currency for our French operations is the Euro based on our initial and
periodic evaluations of economic factors as set forth in SFAS 52.
-6-
BIO-IMAGING TECHNOLOGIES, 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, 2007 through March 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Income |
|
|
Equity |
|
Balance at December 31,
2007 |
|
|
11,765 |
|
|
$ |
3 |
|
|
$ |
25,084 |
|
|
$ |
(1,709 |
) |
|
$ |
151 |
|
|
$ |
23,529 |
|
Stock options exercised |
|
|
169 |
|
|
|
|
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
39 |
|
Restricted shares issued |
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
|
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
59 |
|
Stock issued for
acquisitions |
|
|
2,288 |
|
|
|
1 |
|
|
|
16,103 |
|
|
|
|
|
|
|
|
|
|
|
16,104 |
|
Tax benefit on exercise
of stock options |
|
|
|
|
|
|
|
|
|
|
63 |
|
|
|
|
|
|
|
|
|
|
|
63 |
|
Equity adjustment from
foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102 |
|
|
|
102 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
823 |
|
|
|
|
|
|
|
823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31,
2008 |
|
|
14,238 |
|
|
$ |
4 |
|
|
$ |
41,348 |
|
|
$ |
(886 |
) |
|
$ |
253 |
|
|
$ |
40,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 3 Earnings Per Share:
Basic income per common share for the three months ended March 31, 2008 and 2007 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,
2008 and 2007 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.
-7-
BIO-IMAGING TECHNOLOGIES, 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) |
|
2008 |
|
|
2007 |
|
Net income basic and diluted |
|
$ |
823 |
|
|
$ |
395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
12,021 |
|
|
|
11,467 |
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.07 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
12,021 |
|
|
|
11,467 |
|
Common share equivalents
of outstanding stock options |
|
|
815 |
|
|
|
1,094 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
129 |
|
|
|
97 |
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equity shares |
|
|
12,965 |
|
|
|
12,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per
common share |
|
$ |
0.06 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
Options to purchase 312,000 shares of our common stock had been excluded from the calculation
of diluted earnings per common share for the three months ended March 31, 2008, as they were all
antidilutive. Options to purchase 140,000 shares of our common stock had been excluded from the
calculation of diluted earnings per common share for the three months ended March 31, 2007, as they
were all antidilutive. For the three months ended March 31,2008, the 2,287,582 shares issued in
the PDS acquisition were proratably included in weighted average number of common shares from March
24, 2008, the acquisition date, through the end of the quarter, March 31, 2008.
Note 4 Commitments and Contingencies:
On March 1, 2006, we entered into an employment agreement with our President and Chief
Executive Officer that expires on February 28, 2009. This agreement amended and restated the prior
agreement that originally expired January 31, 2007. In addition, we have an employment agreement
with our Senior Vice President and Chief Financial Officer that expires February 5, 2009 and is
renewable on
-8-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
an annual basis. Pursuant to this employment agreement, our President and Chief Executive Officer can potentially receive up to 25,000 shares of the companys common stock each
fiscal year. Based on managements assumptions, we recognized the related proportionate expense of
$44,000 for these restricted shares for the three months ended March 31, 2008. These restricted
shares are service and performance-based, and the value is determined by its fair value (as if
underlying shares were vested and issued). The aggregate amount due under these employment
agreements from January 1, 2008 through the expiration under these agreements is $716,000.
Note 5 Business Segments
FASB Statement No. 131, Disclosures about Segments of an Enterprise and Related Information,
requires companies to provide certain information about their operating segments. In November 2003,
we acquired the intellectual property of CapMed Corporation. We have two reportable segments:
pharmaceutical contract services and the CapMed division. Our pharmaceutical contract service
segment provides services that support the product development process of the pharmaceutical,
biotechnology and medical device industries. Our CapMed segment offers a software application that
enables users to manage and store personal health information, including their medical images, on
the privacy of their desktop computer, while linking directly to sponsor-directed resources such as
drug information, patient education or disease guidelines. The operating segments are managed
separately because each offers different services and applications to different markets. Our
management evaluates the performance of each segment based upon operating earnings or losses before
interest and income taxes.
-9-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Summarized financial information concerning our operational segments is shown in the following
table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceutical |
|
|
|
|
(in thousands) |
|
Contract Services |
|
CapMed Division |
|
Consolidated Total |
For the three months ended
March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14,101 |
|
|
$ |
138 |
|
|
$ |
14,239 |
|
Total cost and expenses |
|
$ |
12,404 |
|
|
$ |
682 |
|
|
$ |
13,086 |
|
Income (loss) from operations |
|
$ |
1,697 |
|
|
$ |
(544 |
) |
|
$ |
1,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended
March 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
10,941 |
|
|
$ |
134 |
|
|
$ |
11,075 |
|
Total cost and expenses |
|
$ |
10,060 |
|
|
$ |
514 |
|
|
$ |
10,574 |
|
Income (loss) from operations |
|
$ |
881 |
|
|
$ |
(380 |
) |
|
$ |
501 |
|
Our foreign customers accounted for approximately 38% and 34% of service revenues for the
three months ended March 31, 2008 and 2007, respectively.
Note 6 Accounts Receivable and Allowance for Doubtful Accounts
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, 2008 |
|
|
December 31, 2007 |
|
Billed trade accounts receivable |
|
$ |
9,917 |
|
|
$ |
5,090 |
|
Unbilled trade accounts receivable |
|
|
1,465 |
|
|
|
746 |
|
Other |
|
|
425 |
|
|
|
45 |
|
|
|
|
|
|
|
|
Total Receivables |
|
$ |
11,807 |
|
|
$ |
5,881 |
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward (in thousands): |
|
|
|
|
|
|
|
|
Balance at January 1, 2008 |
|
$ |
29 |
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(17 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
$ |
12 |
|
|
|
|
|
-10-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 7 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.
The Company has accumulated tax losses, which include allowable deductions related to
exercised employee stock options, generating federal net operating loss (NOL) credit carryforwards
of $1.1 million as of March 31, 2008. These losses will expire, if unused, in the years 2009
through 2022. 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 NOL credit carryforwards. The current and long-term deferred
tax assets are comprised of the NOL credit carryforwards with a tax effected value of $408,000 as
of March 31, 2008. Generally accepted accounting principles require 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 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 Company recognizes contingent liabilities for any tax related exposures when those
exposures are reasonably possible.
The tax benefit of the stock option deductions has been recorded to additional paid in capital
in the amount of $63,000 and $0 for the three months ended March 31, 2008 and 2007, respectively.
On January 1, 2007, we adopted Financial Accounting Standards Board Interpretation No. 48
Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes a recognition threshold
that a tax position is required to meet before being recognized in the financial statements.
Historically, our tax provision for financial statement purposes and the actual tax returns have
been prepared using consistent methodologies. There were no material unrecognized tax benefits as
of December 31, 2006. Accordingly, the adoption did not have a material impact on the financial
statements. 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 returns for years 2005 and 2006 are
subject to
-11-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
examination. Our state taxes for years 2000 through 2006 are subject to examination.
Our foreign taxes for years 2002 through 2006 are subject to examination by the respective
authorities.
Note 8 Acquisition
Phoenix Data Systems, Inc. Acquisition
On March 24, 2008, Bio-Imaging acquired PDS (the Acquisition) to expand our pharmaceutical
services in the area of electronic data capture and other eClinical data solutions to our clients.
The Acquisition was made pursuant to an Agreement and Plan of Merger (the Merger Agreement),
dated March 24, 2008, by and among the Company, Bio-Imaging Acquisition Corporation, a Pennsylvania
corporation and wholly-owned subsidiary of the Company (Merger Sub), and PDS and its
Stockholders Representative. Pursuant to the terms of the Merger Agreement, PDS merged with and
into Merger Sub. Following the consummation of the Acquisition, PDS ceased to exist and Merger Sub
became a wholly-owned subsidiary of the Company. The directors and officers of the Merger Sub
continue to be the officers and directors of the surviving corporation. In connection with the
Acquisition, the Company also entered into employment agreements with members of the senior
management team of PDS. These individuals continue to be members of the senior management of the
surviving corporation; however, none of these individuals are executive officers of the Company.
Under the terms of the Merger Agreement, the Company acquired all of PDSs outstanding capital
stock. The total consideration paid by the Company to PDSs stockholders was $23,973,858 comprised
of $7,000,000 in cash and 2,287,582 shares of common stock, par value $0.00025 per share, of the
Company, with an average closing price per share over the last 30 trading days ending and including
March 19, 2008 of $7.42 (Common Stock). The aggregate purchase price is subject to a
post-closing adjustment based on the Tangible Net Worth (as defined in the Merger Agreement) of PDS
on the Closing Date (as defined in the Merger Agreement). Pursuant to the terms of the Merger
Agreement, five percent of the aggregate consideration is to be held in escrow for a period not to
exceed three business days following the finalization of the Closing Tangible Net Worth Statement
(as defined in the Merger Agreement), which should take place within 60-90 days from the Closing
Date. Additionally, ten percent of the aggregate consideration is to be held in escrow to cover
any potential indemnification claims under the Merger Agreement for a period ending no later than
March 31, 2009. We also incurred approximately $1,076,000 in
acquisition costs and assumed $181,000 of working capital. After the
acquisition, the stock was recorded at an average price of $7.04 per share.
In connection with the Acquisition, the stockholders of PDS entered into various agreements. The
stockholders of PDS executed stockholders agreements, whereby each stockholder agreed, among other
things, to approve the Acquisition and not to compete in the business area occupied by PDS at the
time of the Acquisition for a reasonable period of time. All stockholders executed lockup
agreements, whereby all stockholders 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 Merger Agreement for a period beginning on the date the
Merger Agreement was executed and continuing to and including the date 180 days after the Closing
Date (the Initial Lockup Period Date), and certain additional stockholders 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 67 percent of the shares of the Companys Common Stock received
pursuant to the Merger Agreement
-12-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
for a period beginning on the Initial Lockup Period Date and
continuing to and including the date of the first anniversary of the Closing Date.
The Company has not finalized the purchase price allocation and the acquisition costs of the
Acquisition have been allocated to assets acquired and liabilities assumed based on preliminary
estimates of fair value as follows (in thousands):
|
|
|
|
|
Net Working Capital |
|
$ |
181 |
|
Fixed Assets |
|
|
590 |
|
Other Assets |
|
|
164 |
|
Other Liabilities |
|
|
(101 |
) |
Software |
|
|
500 |
|
Trademark |
|
|
50 |
|
Customer Backlog |
|
|
600 |
|
Customer Relationships |
|
|
300 |
|
Non-Compete Agreements |
|
|
100 |
|
Goodwill, including Workforce |
|
|
21,816 |
|
Deferred Tax Liabilities |
|
|
579 |
|
|
|
|
|
Total Purchase Price |
|
$ |
24,779 |
|
|
|
|
|
The results of operations of PDS from the acquisition date, March 24, 2008 to March 31, 2008
were immaterial, therefore, the Company did not include them in the Consolidated Statement of
Income for the three months ended March 31, 2008.
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, 2008 and 2007 as if the
Acquisition had occurred as of the beginning of each of the periods presented after giving effect
to certain adjustments including the exclusion of Phoenixs transaction related costs of $721,000.
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
acquisition would have taken place at the beginning of each of the periods presented and should not
be taken as indicative of our future consolidated results of operations or financial condition.
Pro forma adjustments are tax-effected at our effective tax rate.
-13-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
(in thousands) |
|
2008 |
|
2007 |
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
18,697 |
|
|
$ |
13,372 |
|
Operating income |
|
|
1,348 |
|
|
|
661 |
|
Net income |
|
|
924 |
|
|
|
484 |
|
Basic net income per share |
|
$ |
0.07 |
|
|
$ |
0.04 |
|
Diluted net income per share |
|
$ |
0.06 |
|
|
$ |
0.03 |
|
Theralys S.A. Acquisition
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys, a company
headquartered in Lyon, France to expand our therapeutic expertise in the Central Nervous System and
Neurovascular areas. The aggregate purchase price was 2,958,000 Euros ($3,853,000 as determined by
an agreed upon exchange rate), of which 2,375,000 Euros ($3,093,000) was paid in cash and $760,000
in value was paid with 93,000 shares of our common stock. We also incurred approximately $678,000
in acquisition costs. The purchase of the business was accounted for under the purchase method of
accounting. The result of operations of Theralys were included in our financial statements at the
acquisition date in our pharmaceutical contract services business segment. The assets acquired
primarily consisted of $4,153,000 goodwill, $291,000 software, $52,000 customer relationship and
$36,000 non-compete. The pro forma impact of the Theralys acquisition on 2007 results was
immaterial.
-14-
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations.
Overview
Pharmaceutical Contract Services
We are a global pharmaceutical contract service organization, providing services that support
the product development process of the pharmaceutical, biotechnology and medical device industries.
We specialize in assisting our clients in the design and management of the medical imaging
component of clinical trials for all modalities, which includes computerized tomography (CT),
magnetic resonance imaging (MRI), radiography, dual energy x-ray absorptiometry (DXA/DEXA),
positron emission tomography (PET), single photon emission computerized tomography (SPECT),
quantitative coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound (IVUS),
peripheral quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound. We
provide services that include the processing and analysis of medical images and the data-basing and
regulatory submission of medical images, quantitative data and text.
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 been approximately three months to 12 months.
In addition, the contracts under which we perform services typically cover a period of 12 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. Service revenues were generated from 94 clients encompassing 202 distinct projects
for the three months ended March 31, 2008. This compares to 101 clients encompassing 213 distinct
projects for the three months ended March 31, 2007.
Our contracted/committed backlog, referred to as backlog, is the amount of service revenue
that remains to be earned and recognized on both signed and verbally agreed to contracts. Our
backlog was $96.3 million as of March 31, 2008. This compares to $77.6 million as of March 31,
2007. These amounts do not include any backlog associated with PDS. Contracts included in backlog
are subject to termination by our clients at any time. In the event that a contract is canceled 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 7 years. We believe that our backlog assists our management as a general indicator of
our long-term business. However, we do not believe that backlog is a reliable predictor of
near-term 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.
During the first quarter of 2008, we completed the acquisition of PDS, a provider of
electronic data capture (EDC) services offering a comprehensive array of eClinical data solutions
to the pharmaceutical and biotechnology industries. PDS is engaged in providing full service EDC,
a unique combination of electronic data capture, interactive voice response, reporting and data
management solutions. PDS has developed a variety of software applications that allow
pharmaceutical and biotech companies to enhance their ability to process and store clinical data
through the use of PDSs proprietary software and hosting service. PDS is focused on making the
process of collecting and analyzing data from clinical trials faster, easier and more reliable.
This transaction met our acquisition criteria in that it expands our capabilities in the clinical
trials arena, leverages our global operating capabilities, leverages
our brand reputation for quality client service and utilizes our existing relationships with
major players in the pharmaceutical, biotech and medical device industries. We see this
acquisition as a very logical extension of our core offerings in image management. It not only
expands our addressable market but
-15-
gives us access to what we believe to be a very large and
rapidly growing space, intimately related to our clinical trials expertise.
We believe that demand for our services and technologies will continue to grow as the use of
digital technologies for data acquisition and management increases in the radiology and drug
development communities. We also believe that there is a growing recognition within the
bio-pharmaceutical industry of the advantages in using an independent centralized core laboratory
for analysis of medical-imaging data and compliance with the regulatory demands for the submission
of such data. The FDA is also requiring more robust studies and additional data for clinical
trials. In addition, the FDA continues to develop sophisticated guidelines for computerized
submission of clinical trial data, including medical images. Furthermore, we believe that the
increased use of digital medical images in clinical trials, especially for important drug classes
such as anti-inflammatory, neurologic and oncologic therapeutics and diagnostic image agents,
generate large amounts of image data from a large number of imaging sources. These studies require
processing, analysis, data management and submission services best handled by vendors with scalable
logistical capabilities and extensive experience working with research facilities worldwide.
However, due to several factors, including, without limitation, competition from commercial
competitors and academic research centers and the risk of project cancellations, slowing of patient
enrollment in on-going studies or delay of future project awards, among others, we cannot assure
you that demand for our services and technologies will grow, sustain growth or that additional
revenue generating opportunities will be realized by us.
CapMed Division
Our CapMed division offers the Personal Health Record software, referred to as PHR, and the
patent-pending Personal HealthKey technology. The PHR is a software application that enables
users to manage and store personal health information, including their medical images, on the
privacy of their desktop computer, while linking directly to sponsor-directed resources such as
drug information, patient education, or disease guidelines. The Personal HealthKey plugs into a
computers USB port, allowing doctors and patients easy access to the patients medical record
without the need for additional hardware or software, and it is password protected. Our hybrid
product offering also includes patient access to personal health information on line and via cell
phone and is interoperable with a wide range of third party vendors.
We intend to expand our CapMed division through partnerships and marketing efforts devoted to
the PHR and Personal HealthKey products. We continue to pursue alliances and evaluate strategic
alternatives to maximize shareholder value. We believe that continued emphasis on improving
patient care and reducing costs will contribute to the growth of the personal electronic medical
records market. We also have developed an In Case of Emergency (icePHR) designed especially for
use in emergencies to provide consumers with private and timely access to personal health
information in a security-enhanced environment. CapMed also offers icePHR Mobile that will allow
access to the information on cell phones and personal digital assistants (PDA) and a comprehensive
PHR Online product that will capture and maintain all aspects of personal health management. The
markets for our CapMed division continue to
evolve favorably. We continue to be encouraged by the long-term prospects for this division
although the revenue generating adoption rate has been slower than anticipated.
-16-
Forward Looking Statements
Certain matters discussed in this Quarterly Report on 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,
will, 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; growth potential for our CapMed
division; 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 Quarterly Report on Form 10-Q and expressed from time to time in our filings with the SEC, as
well as the risk factors set forth in our Annual Report on Form 10-K for the year ended December
31, 2007, could cause actual results and developments to be materially different from those
expressed in or implied by such statements. The forward-looking statements are made only as of the
date of this filing, and we undertake no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
Application of Critical Accounting Policies and Estimates
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles, and expands disclosures about fair value measurements. The provisions of
this standard apply to other accounting pronouncements that require or permit fair value
measurements. SFAS 157, as it relates to financial assets and financial liabilities, became
effective for Bio-Imaging Technologies, Inc. on January 1, 2008. On February 12, 2008, the FASB
issued FSP No. FAS 157-2, Effective Date of FASB Statement No. 157, which delays the effective
date of SFAS 157 for all nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on at least an annual basis,
until January 1, 2009 for calendar year-end entities. Upon adoption, the provisions of SFAS 157 are
to be applied prospectively with limited exceptions. We have determined that the adoption of SFAS
157, as it relates to financial assets and financial liabilities does not have an impact on the
Consolidated Financial Statements. We are currently evaluating the potential impact of SFAS 157, as
it relates to nonfinancial assets and nonfinancial liabilities, on the Consolidated Financial
Statements as we have elected the deferral of FAS 157-2.
On January 1, 2008, we adopted the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards (SFAS) No. 159, Fair Value Option for Financial Assets
and Financial Liabilities, (SFAS 159) which permits companies to use fair value for reporting
purposes under generally accepted accounting principles (GAAP). We have determined that the
adoption of SFAS 159 does not have an impact on the Consolidated Financial Statements.
In December 2007, the Financial Accounting Standards Board (FASB) issued Statement of
-17-
Financial Accounting Standards (SFAS) No. 141R, Business Combinations (Revised 2007), (SFAS 141R)
which addresses ways to improve the relevance, representational faithfulness and comparability of
the information that a reporting entity provides in its financial reports about a business
combination. This statement applies prospectively to business combinations for which the
acquisition date is on or after fiscal years beginning December 15, 2008. Retrospective application
is not permitted. The Company is currently evaluating SFAS 141R and the related impact on our
financial position and results of operations.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statementsan amendment of ARB No. 51, (SFAS 160). SFAS 160 amends Accounting Research
Bulletin No. 51, Consolidated Financial Statements, to establish accounting and reporting
standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. This standard defines a noncontrolling interest, sometimes called a minority interest,
as the portion of equity in a subsidiary not attributable, directly or indirectly, to a parent.
SFAS 160 requires, among other items, that a noncontrolling interest be included in the
consolidated statement of financial position within equity separate from the parents equity;
consolidated net income to be reported at amounts inclusive of both the parents and noncontrolling
interests shares and, separately, the amounts of consolidated net income attributable to the
parent and noncontrolling interest all on the consolidated statement of income; and if a subsidiary
is deconsolidated, any retained noncontrolling equity investment in the former subsidiary be
measured at fair value and a gain or loss be recognized in net income based on such fair value.
SFAS 160 becomes effective for Bio-Imaging Technologies, Inc. on January 1, 2009. Management is
currently evaluating the potential impact of SFAS 160 on the Financial Statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activitiesan amendment of FASB Statement No. 133, (SFAS 161). SFAS 161 requires enhanced
disclosures about an entitys derivative and hedging activities, including (i) how and why an
entity uses derivative instruments, (ii) how derivative instruments and related hedged items are
accounted for under SFAS 133, and (iii) how derivative instruments and related hedged items affect
an entitys financial position, financial performance, and cash flows. This standard becomes
effective for Bio-Imaging Technologies, Inc. on January 1, 2009. Earlier adoption of SFAS 161 and,
separately, comparative disclosures for earlier periods at initial adoption are encouraged. As SFAS
161 only requires enhanced disclosures, this standard will have no impact on the Financial
Statements.
-18-
Results of Operations
Three Months Ended March 31, 2008 and 2007
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Three |
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Three |
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Months |
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Months |
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Ended |
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|
Ended |
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|
|
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|
March 31, |
|
% of Total |
|
March 31, |
|
% of Total |
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|
|
|
(in thousands) |
|
2008 |
|
Revenue |
|
2007 |
|
Revenue |
|
$ Change |
|
% Change |
|
Service revenues |
|
$ |
11,161 |
|
|
|
78.4 |
% |
|
$ |
8,810 |
|
|
|
79.5 |
% |
|
$ |
2,351 |
|
|
|
26.7 |
% |
Reimbursement
revenues |
|
|
3,078 |
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|
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21.6 |
% |
|
|
2,265 |
|
|
|
20.5 |
% |
|
|
813 |
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|
|
35.9 |
% |
|
Total revenues |
|
|
14,239 |
|
|
|
100.0 |
% |
|
|
11,075 |
|
|
|
100.0 |
% |
|
|
3,164 |
|
|
|
28.6 |
% |
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Cost and expenses: |
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Cost of service revenue |
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6,324 |
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44.4 |
% |
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5,276 |
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|
|
47.6 |
% |
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|
1,048 |
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|
|
19.9 |
% |
Cost of reimbursement
revenue |
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|
3,078 |
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|
|
21.6 |
% |
|
|
2,265 |
|
|
|
20.5 |
% |
|
|
813 |
|
|
|
35.9 |
% |
Sales and marketing
expenses |
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|
2,011 |
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|
|
14.1 |
% |
|
|
1,561 |
|
|
|
14.1 |
% |
|
|
450 |
|
|
|
28.8 |
% |
General and administrative
expenses |
|
|
1,673 |
|
|
|
11.8 |
% |
|
|
1,472 |
|
|
|
13.3 |
% |
|
|
201 |
|
|
|
13.7 |
% |
|
Total cost and expenses |
|
|
13,086 |
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|
|
91.9 |
% |
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|
10,574 |
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|
|
95.5 |
% |
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|
2,512 |
|
|
|
23.8 |
% |
|
Income from operations |
|
|
1,153 |
|
|
|
8.1 |
% |
|
|
501 |
|
|
|
4.5 |
% |
|
|
652 |
|
|
|
130.1 |
% |
Interest income |
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|
153 |
|
|
|
1.1 |
% |
|
|
161 |
|
|
|
1.5 |
% |
|
|
(8 |
) |
|
|
(5.0 |
)% |
Interest expense |
|
|
|
|
|
|
0.0 |
% |
|
|
(4 |
) |
|
|
0.0 |
% |
|
|
4 |
|
|
|
100.0 |
% |
|
Income before
income tax provision |
|
|
1,306 |
|
|
|
9.2 |
% |
|
|
658 |
|
|
|
5.9 |
% |
|
|
648 |
|
|
|
98.5 |
% |
|
|
|
|
|
|
|
|
|
|
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|
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|
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Income tax provision |
|
|
483 |
|
|
|
3.4 |
% |
|
|
263 |
|
|
|
2.4 |
% |
|
|
220 |
|
|
|
83.7 |
% |
|
|
|
|
|
|
|
|
|
|
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|
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Net income |
|
$ |
823 |
|
|
|
5.8 |
% |
|
$ |
395 |
|
|
|
3.6 |
% |
|
$ |
428 |
|
|
|
108.4 |
% |
|
The Consolidated Statement of Income for the three months ended March 31, 2008 excludes the
financial results of PDS from the acquisition date of March 24, 2008 through March 31, 2008 due to
immateriality of PDSs results of operations for that period.
Service revenues for the three months ended March 31, 2008 and 2007 were $11,161,000 and
$8,810,000 respectively, an increase of $2,351,000 or 26.7%. The increase in service revenues was
due to an increase in work performed from our increased backlog. Our backlog at March 31, 2008 was
$96.3 million compared to $77.6 million at March 31, 2007, an increase of 24.1%. We believe this
increase in backlog is an indicator that the overall market growth for medical-imaging related
services for clinical trials continues to be positive, subject to project cancellations, slowing of
patient enrollment in on-going studies and delays of future project awards.
Service revenues were generated from 94 clients encompassing 202 distinct projects for the
three months ended March 31, 2008. This compares to 101 clients encompassing 213 distinct projects
for the three months ended March 31, 2007. One client, Hoffmann-LaRoche,
encompassing 11 projects represented 10.2% of our service revenues for the three months ended March
31, 2008. No one client accounted for more than 10% of our service revenues for the three months
ended March 31,
-19-
2007. Service revenues generated from our client base, while still concentrated as
measured by the number of clients, is more dispersed when revenue concentration is measured by the
number of individual projects. Our primary scope of work in both periods included medical-imaging
core laboratory services and image-based information management services.
Reimbursement revenues and cost of reimbursement revenues for the three months ended March 31,
2008 and 2007 were $3,078,000 and $2,265,000 respectively, an increase of $813,000, or 35.9%.
Reimbursement revenues and cost of reimbursement revenues consist of payments received from the
customer for reimbursable costs. Reimbursement revenues and cost of reimbursement revenues
fluctuate significantly over the course of any given project, and quarter to quarter variations are
a reflection of this project timing. Therefore, our management believes that reimbursement
revenues and cost of reimbursement revenues are not a significant indicator of our overall
performance trends. At the request of our clients, we may directly pay the independent
radiologists who review our clients imaging data. In such cases, per contractual arrangement,
these costs are billed to our clients and are included in reimbursement revenues and cost of
reimbursement revenues.
Cost of service revenues for the three months ended March 31, 2008 and 2007 were $6,324,000
and $5,276,000 respectively, an increase of $1,048,000, or 19.9%. The increase in cost of revenues
is primarily due to the increase in the costs of our European facilities along with an increase in
operational personnel. Cost of service revenues for the three months ended March 31, 2008 and 2007
were comprised of professional salaries and benefits and allocated overhead. 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
revenues will continue to increase in fiscal 2008 as service revenues increase.
Sales and marketing expenses for the three months ended March 31, 2008 and 2007 were
$2,011,000 and $1,561,000 respectively, an increase of $450,000, or 28.8%. Sales and marketing
expenses for the three months ended March 31, 2008 and 2007 were comprised of direct sales and
marketing costs, salaries and benefits and allocated overhead. The increase is primarily due to an
increase in our CapMed divisions sales and marketing expenses of $146,000 and an increase in
tradeshow attendance and marketing expenditures. We expect that sales and marketing expenses will
increase in fiscal 2008 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, 2008 and 2007 were
$1,673,000 and $1,472,000 respectively, an increase of $201,000, or 13.7%. General and
administrative expenses for the three months ended March 31, 2008 and three months ended March 31,
2007 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 and
consulting services. We expect that our general and administrative expenses will increase in 2008
due to increased professional fees and general corporate matters.
Net interest income was $153,000 for the three months ended March 31, 2008 and $157,000 for
the three months ended March 31, 2007, a decrease of $4,000, or 2.5%. Net interest income and
expense for the three months ended March 31, 2008 and 2007 is comprised of interest income earned
on our cash balance and interest expense incurred on equipment lease obligations. We expect
interest income to decline in 2008 due to the reduction in cash balance as a result of the cash
used during the first quarter
2008 for the acquisition of PDS and the decline in interest rates for short-term investments.
Income before income taxes was $1,306,000 for the three months ended March 31, 2008, and
$658,000 for the three months ended March 31, 2007. The increase was due to greater service
revenue
-20-
while cost of service revenues increased at a slower rate due to our process improvement
efforts.
Our income tax provision for the three months ended March 31, 2008 and 2007 was $483,000 and
$263,000, respectively. Our effective tax rate is approximately 37% for fiscal 2008. Our
effective tax rate was approximately 39% for fiscal 2007. The lower effective tax rate in fiscal
2008 was due to the mix of pre-tax income in the U.S. and in the Netherlands, which has a lower
corporate income tax rate than the U.S.
-21-
Business Segments
We have set forth certain financial information with respect to our two business segments,
pharmaceutical contract services and the CapMed division, in Note 4 Business Segments to our
Consolidated Financial Statements in this Quarterly Report on Form 10-Q.
During the three months ended March 31, 2008, we had CapMed segment sales of $138,000 and
total costs and expenses of $682,000, consisting of $545,000 of sales and marketing expenses,
$136,000 of general and administrative expenses and $1,000 of cost of revenues. This compares to
the three months ended March 31, 2007, whereby we had CapMed segment sales of $134,000 and total
costs and expenses of $515,000, consisting of $399,000 of sales and marketing expenses, $100,000 of
general and administrative expenses and $16,000 of cost of revenues. The increase in sales and
marketing expenses was primarily due to increased tradeshow attendance and marketing expenses.
Liquidity and Capital Resources
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|
Three Months |
|
Three Months |
|
|
Ended |
|
Ended |
(in thousands) |
|
March 31, 2008 |
|
March 31, 2007 |
|
|
|
Net cash provided by operating activities |
|
$ |
2,401 |
|
|
$ |
2,178 |
|
Net cash used in investing activities |
|
$ |
(9,462 |
) |
|
$ |
(4,409 |
) |
Net cash provided by (used in) financing activities |
|
$ |
46 |
|
|
$ |
(34 |
) |
At March 31, 2008, we had cash and cash equivalents of $11,109,000. Working capital, defined
as current assets minus current liabilities, at March 31, 2008 was $2,510,000.
Net cash provided by operating activities for the three months ended March 31, 2008 was
$2,401,000 as compared to $2,178,000 for the three months ended March 31, 2007. This increase from
the prior year is primarily due to the increase in accounts
receivable of $546,000 from the
increase in the monthly service revenues and the increase in net income of $428,000 offset by the
decrease in deferred revenue of $695,000.
Net
cash used in investing activities for the three months ended
March 31, 2008 was $9,462,000 as compared to $4,409,000 for the three months ended March 31, 2007. The increase was primarily
due to $8,257,000 used for the acquisition of PDS on March 24, 2008. We currently anticipate that
capital expenditures for the remainder of the fiscal year ending December 31, 2008 will be
approximately $2.7 million. These expenditures primarily represent additional upgrades in our
networking, data storage and core laboratory capabilities for both our U. S. and European
operations, as well as capitalization of software costs.
Net cash provided by financing activities for the three months ended March 31, 2008 was
$46,000 as compared to net cash used in financing activities of $34,000 for the three months ended
March 31, 2007. The change is primarily attributable to fewer payments under equipment lease
obligations for the three months ended March 30, 2008 due to not entering into any new capital
leases and the expiration of existing capital leases in 2008.
-22-
The following table lists our cash contractual obligations as of March 31, 2008 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
More than |
|
Contractual obligations |
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
5 years |
|
Capital lease obligations |
|
$ |
215,000 |
|
|
$ |
151,000 |
|
|
$ |
47,000 |
|
|
$ |
17,000 |
|
|
$ |
|
|
Facility rent operating
leases |
|
$ |
6,094,000 |
|
|
$ |
2,371,000 |
|
|
$ |
2,918,000 |
|
|
$ |
805,000 |
|
|
$ |
|
|
Employment agreements |
|
$ |
564,000 |
|
|
$ |
564,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
6,873,000 |
|
|
$ |
3,086,000 |
|
|
$ |
2,965,000 |
|
|
$ |
822,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
In accordance with our foreign exchange rate risk management policy, we had purchased monthly
Euro call options in prior years. These options were intended to hedge against the exposure to
variability in our cash flows resulting from the Euro denominated costs for our Netherlands
subsidiary. During the three months ended March 31, 2008, we have not purchased any Euro call
options, because our foreign currency needs are generally being met by the cash flow generated by
Euro denominated contracts. As of March 31, 2008, there are no outstanding derivative positions.
During the three months ended March 31, 2008, we did not exercise any options. During the three
months ended March 31, 2007, we exercised two options and a gain of $10,398 was recognized in the
Consolidated Statement of Income.
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:
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|
|
our ability to gain new client contracts; |
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|
|
|
project cancellations; |
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|
|
|
the variability of the timing of payments on existing client contracts; and |
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|
|
|
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 2008 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
-23-
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 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, through the line of credit discussed above.
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, 2007. As of March 31, 2008, there have been no changes to
such critical accounting policies and estimates.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value in generally accepted
accounting principles, and expands disclosures about fair value measurements. The provisions of
this standard apply to other accounting pronouncements that require or permit fair value
measurements. SFAS 157, as it relates to financial assets and financial liabilities, becomes
effective for Bio-Imaging Technologies, Inc. on January 1, 2008. On February 12, 2008, the FASB
issued FSP No. FAS 157-2, Effective Date of FASB Statement No. 157, which delays the effective
date of SFAS 157 for all nonfinancial assets and nonfinancial liabilities, except those that are
recognized or disclosed at fair value in the financial statements on at least an annual basis,
until January 1, 2009 for calendar year-end entities. Upon adoption, the provisions of SFAS 157 are
to be applied prospectively with limited exceptions. We have determined that the adoption of SFAS
157, as it relates to financial assets and financial liabilities does not have an impact on the
Consolidated Financial Statements. We are currently evaluating the potential impact of SFAS 157, as
it relates nonfinancial assets and nonfinancial liabilities, on the Consolidated Financial
Statements.
On January 1, 2008, we adopted the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards (SFAS) No. 159, Fair Value Option for Financial Assets
and Financial Liabilities, (SFAS 159) which permits companies to use fair value for reporting
purposes under GAAP. We have determined that the adoption of SFAS 159 does not have an impact on
the Consolidated Financial Statements.
-24-
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
We invest in high-quality financial instruments, primarily money market funds, federal agency
notes, asset backed securities, corporate debt securities and U.S. treasury notes, with an
effective duration of less than three months and no security with an effective duration in excess
of two years, which we believe are subject to limited credit risk. We currently do not hedge our
interest rate exposure. 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 10 percent increase or decrease in the Euro to U.S.
dollar spot exchange rate would result in a change of $400,000 and $546,000 to our net asset
position at March 31, 2008 and December 31, 2007, 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 contracts 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.
We hedge our foreign currency exposure when and as appropriate to mitigate the adverse impact
of fluctuating exchange rates. 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, 2008 and December 31, 2007. 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.
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, 2008, the end of the period covered by this Quarterly 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, 2008. 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
-25-
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, 2008 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.
None.
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 loss of business from our client,
Novartis Pharmaceutical, Inc., would have a material adverse effect on our financial condition.
We depend on a small number of industries and clients for all of our business, and the loss of one
such
-27-
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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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, Hoffmann-La Roche, encompassing 11 projects represented 10.2% of our service
revenues for the three months ended March 31, 2008. No one client accounted for more than 10% of
our service revenue for the three months ended March 31, 2007. 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 $96.3 million at March 31, 2008, excluding PDS
backlog, 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 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 have experienced substantial expansion in the past, and if we fail to properly manage that
expansion, our business may suffer.
Our business has expanded substantially in the past. Our continuing sales and marketing
efforts have resulted in increased revenues. The number of projects under management was 202,
excluding PDS projects, in the first quarter of 2008. In addition, we acquired Phoenix Data
Systems in March 2008, Theralys in February 2007, HeartCore in December 2004 and CapMed in November
2003.
Rapid expansion, internally or through acquisitions, could strain our operational, human and
financial resources. If we fail to properly manage this expansion, our results of operations and
financial condition might be adversely affected. In order to manage our expansion, we must:
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effectively market our services to pharmaceutical, biotechnology and medical device
companies; |
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continue to improve operating, administrative and information systems; |
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accurately predict future personnel and resource needs to meet client contract
commitments; |
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successfully integrate our acquired companies and businesses; |
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track the progress of on-going client projects; and |
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attract and retain qualified management, sales, professional and technical operating
personnel. |
We will face additional risks in expanding foreign operations. Specifically, we might find it
difficult to:
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assimilate differences in foreign business practices and regulations; |
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hire and retain qualified personnel; and |
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overcome language and cultural barriers. |
We recently acquired PDS and may engage in future acquisitions, which may be expensive and time
consuming and from which we may not realize anticipated benefits.
We recently acquired PDS 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 acquisition of PDS 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, 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, David A. Pitler, Senior Vice President Operations, Colin G. Miller,
Ph.D., Senior Vice President Medical Affairs and Ted I. Kaminer, Senior Vice President and Chief
Financial Officer. Although we have employment agreements with Mr. Weinstein and Mr. Kaminer, 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 2008, 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
-29-
currency exchange rates could materially impact the operating costs of our
European facility in Leiden, the Netherlands, which are primarily Euro denominated.
Our investments may be exposed to credit risk.
Financial instruments that potentially subject us to significant credit risk consist
principally of cash, investments and derivatives. As part of our risk management processes, we
continuously evaluate the relative credit standing of all of the financial institutions that
service us and monitor actual exposures versus established limits. We have not sustained credit
losses from instruments held at financial institutions. We maintain cash and cash equivalents,
comprised of savings accounts, short-term certificate of deposits and money market funds with
various financial institutions. These financial institutions are generally highly rated and the
company has a policy to limit the dollar amount of credit exposure with any one institution.
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 will be materially harmed.
The biopharmaceutical services industry is highly competitive, and we face numerous
competitors in our business, including hundreds of contract research organizations. If we fail to
compete effectively, we will lose clients, which would cause our business to suffer. We primarily
compete against in-house departments of pharmaceutical companies, full service contract research
organizations, or 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
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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 on new drugs, our clients might reduce their research and development spending, which
could reduce our business.
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.
Our CapMed division may not reach profitability.
Our CapMed division had a loss from operations for the three months ended March 31, 2008 of
$544,000. If our CapMed division continues to incur such losses, our business, results of
operations and financial condition will be materially adversely affected.
Changes in governmental regulation could decrease the need for the services we provide, which would
negatively affect our future business opportunities.
In recent years, the United States Congress and state legislatures have considered various
types of healthcare reform in order to control growing healthcare costs. The United States Congress
and state legislatures may again address healthcare reform in the future. We are unable to predict
what legislative proposals will be adopted in the future, if any. Similar reform movements have
occurred in Europe and Asia.
Implementation of healthcare reform legislation that results in additional costs could limit
the profits that can be made by clients from the development of new products. This could adversely
affect our clients research and development expenditures, 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 costs or limit service offerings. We cannot
predict the likelihood of any of these events.
In addition to healthcare reform proposals, 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.
Governmental agencies throughout the world, but particularly in the United States, strictly
-31-
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.
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 numbers 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.
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.
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, 2008, we had the following capital structure:
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Common stock outstanding |
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14,238,300 |
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Common stock issuable upon: |
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Exercise of options which are outstanding |
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1,621,229 |
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Exercise of options which have not been granted |
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280,378 |
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Total common stock outstanding assuming exercise or conversion
of all of the above |
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16,139,907 |
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As of March 31, 2008, we had outstanding options to purchase 1,621,229 shares of common stock
at exercise prices ranging from $0.63 to $8.06 per share (exercisable at a weighted average of
$3.24 per share), of which 1,224,889 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, 2008, we had 14,238,300 shares of our common
stock issued and outstanding, all of which are currently freely tradable. In addition, the sale of
a significant number of shares of our common stock in the public market following the effectiveness
of the registration statement we recently filed to register shares issued in connection with our
acquisition of PDS could harm the market price of our common stock. As additional shares of common
stock become available for resale in the public market pursuant to the registration statement 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 the securities offered hereby 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 influence may conflict with our interests and the interests of our
other stockholders.
Our directors, officers and principal stockholders (stockholders owning 10% or more of our
common stock), including Covance Inc., beneficially owned 20% of the outstanding shares of common
stock and stock options that could have been converted to common stock at March 31, 2008, 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
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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, 2008 and March 31, 2008, our common stock has traded at a low of $6.57 per share and a
high of $8.98 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 may determine. Issuance of such preferred stock, depending upon the
rights, preferences and designations thereof, may have the effect of delaying, deterring or
preventing a change in control of our company. In addition, we are subject to provisions of
Delaware corporate law which, subject to certain exceptions, will prohibit us from engaging in any
business combination with a person who, together with affiliates and associates, owns 15% or more
of our common stock for a period of three years following the date that the person came to own 15%
or more of our common stock unless the business combination is approved in a prescribed manner.
These provisions of our certificate of incorporation, 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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
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Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
None.
Item 5. Other Information.
None.
Item 6. Exhibits.
10.1 |
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Agreement and Plan of Merger, dated March 24,
2008, by and among the Company, Bio-Imaging Acquisition Corporation and
Phoenix Data Systems, Inc. and its Stockholders Representative.
Incorporated by reference to Exhibit 10.1 on our Current Report on Form
8-K/A dated March 24, 2008. |
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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
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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BIO-IMAGING TECHNOLOGIES, INC.
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DATE: May 13, 2008 |
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 13, 2008 |
By: |
/s/ Ted I. Kaminer
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Ted I. Kaminer, Senior Vice President and
Chief
Financial Officer
(Principal Financial and Accounting Officer) |
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