e10vq
United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 30, 2007
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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. 1-11182
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)
(267) 757-3000
(Registrants
Telephone Number,
Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of
1934).
Large accelerated filer: o Accelerated filer: o Non-accelerated filer: þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
State the number of shares outstanding of each of the registrants classes of common stock, as
of July 31, 2007:
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Class
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Number of Shares |
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Common Stock, $0.00025 par value
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11,656,922 |
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
- i -
PART I. FINANCIAL INFORMATION.
Item 1. Financial Statements.
References in this Quarterly Report on Form 10-Q to Bio-Imaging, we, us, or our refer
to Bio-Imaging Technologies, Inc., a Delaware corporation, and its subsidiaries.
Certain information and footnote disclosures required under generally accepted accounting
principles in the United States of America have been condensed or omitted from the following
consolidated financial statements pursuant to the rules and regulations of the Securities and
Exchange Commission, although we believe that such financial disclosures are adequate so that the
information presented is not misleading in any material respect. The following consolidated
financial statements should be read in conjunction with the year-end consolidated financial
statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2006.
The results of operations for the interim periods presented in this Quarterly Report on Form
10-Q are not necessarily indicative of the results to be expected for the entire fiscal year.
1
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
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2007 |
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2006 |
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(unaudited) |
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ASSETS
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Current assets: |
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Cash and cash equivalents |
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$ |
14,482,754 |
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$ |
16,166,264 |
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Accounts receivable, net |
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6,280,987 |
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5,564,748 |
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Prepaid expenses and other current assets |
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1,143,510 |
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1,237,405 |
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Deferred income taxes |
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3,002,291 |
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2,210,800 |
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Total current assets |
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24,909,542 |
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25,179,217 |
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Property and equipment, net |
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7,115,639 |
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5,908,281 |
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Intangibles and goodwill |
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6,622,959 |
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2,227,438 |
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Deferred income taxes |
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272,954 |
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Other assets |
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647,034 |
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519,821 |
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Total assets |
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$ |
39,295,174 |
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$ |
34,107,711 |
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities: |
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Accounts payable |
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$ |
1,543,163 |
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$ |
1,720,481 |
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Accrued expenses and other current liabilities |
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4,325,174 |
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3,334,554 |
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Deferred revenue |
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11,756,544 |
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9,451,219 |
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Current maturities of capital lease obligations |
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272,451 |
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454,458 |
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Total current liabilities |
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17,897,332 |
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14,960,712 |
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Long-term capital lease obligations |
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5,532 |
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97,036 |
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Other liability |
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579,467 |
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208,208 |
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Total liabilities |
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18,482,331 |
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15,265,956 |
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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
June 30, 2007 and at December 31, 2006 |
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Common stock $.00025 par value; authorized
18,000,000 shares, issued and outstanding
11,620,867 shares at June 30, 2007 and
11,309,550 shares at December 31, 2006 |
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2,907 |
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2,827 |
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Additional paid-in capital |
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23,968,599 |
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22,864,390 |
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Accumulated deficit |
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(3,153,837 |
) |
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(4,042,619 |
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Accumulated other comprehensive (loss) gain |
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(4,826 |
) |
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17,157 |
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Stockholders equity |
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20,812,843 |
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18,841,755 |
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Total liabilities and stockholders equity |
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$ |
39,295,174 |
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$ |
34,107,711 |
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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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June 30, |
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2007 |
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2006 |
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Service revenues |
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$ |
9,403,388 |
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$ |
7,970,354 |
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Reimbursement revenues |
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2,282,816 |
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2,244,387 |
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Total revenues |
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11,686,204 |
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10,214,741 |
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Cost and expenses: |
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Cost of revenues |
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7,706,325 |
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7,363,466 |
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General and administrative expenses |
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1,567,145 |
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1,391,816 |
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Sales and marketing expenses |
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1,738,989 |
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1,441,108 |
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Total cost and expenses |
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11,012,459 |
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10,196,390 |
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Income from operations |
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673,745 |
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18,351 |
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Interest income |
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155,496 |
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128,912 |
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Interest expense |
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(6,401 |
) |
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(13,693 |
) |
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Income before income tax provision |
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822,840 |
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133,570 |
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Income tax provision |
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329,136 |
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53,428 |
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Net income |
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$ |
493,704 |
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$ |
80,142 |
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Basic income per common share |
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$ |
0.04 |
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$ |
0.01 |
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Weighted average number of common shares |
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11,602,176 |
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11,202,712 |
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Diluted income per common share |
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$ |
0.04 |
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$ |
0.01 |
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Weighted average number of dilutive common equivalent shares |
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12,653,589 |
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12,171,375 |
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See Notes to Consolidated Financial Statements
-3-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
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For the Six Months Ended |
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June 30, |
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2007 |
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2006 |
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Service revenues |
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$ |
18,162,809 |
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$ |
15,212,945 |
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Reimbursement revenues |
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4,598,850 |
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4,311,547 |
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Total revenues |
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22,761,659 |
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19,524,492 |
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Cost and expenses: |
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Cost of revenues |
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|
15,247,834 |
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|
|
14,048,306 |
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|
|
|
|
|
|
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General and administrative expenses |
|
|
3,039,423 |
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|
2,763,062 |
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|
|
|
|
|
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Sales and marketing expenses |
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|
3,299,015 |
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|
|
2,888,836 |
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|
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|
|
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Total cost and expenses |
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|
21,586,272 |
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|
19,700,204 |
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Income (loss) from operations |
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|
1,175,387 |
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|
(175,712 |
) |
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|
|
|
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|
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Interest income |
|
|
316,048 |
|
|
|
246,445 |
|
|
|
|
|
|
|
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Interest expense |
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|
(10,131 |
) |
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|
(30,876 |
) |
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|
|
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Income before income tax provision |
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1,481,304 |
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|
|
39,857 |
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|
|
|
|
|
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Income tax provision |
|
|
592,522 |
|
|
|
15,943 |
|
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|
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Net income |
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$ |
888,782 |
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$ |
23,914 |
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|
|
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|
|
|
|
|
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|
Basic income per common share |
|
$ |
0.08 |
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|
$ |
0.00 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average number of common shares |
|
|
11,535,242 |
|
|
|
11,128,185 |
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|
|
|
|
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|
|
|
|
|
|
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|
Diluted income per common share |
|
$ |
0.07 |
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$ |
0.00 |
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|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average number of dilutive common
equivalent shares |
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|
12,668,110 |
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|
|
12,082,635 |
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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 Six Months Ended |
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June 30, |
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2007 |
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|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
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|
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|
Net income |
|
$ |
888,782 |
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|
$ |
23,914 |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,073,195 |
|
|
|
1,053,803 |
|
Provision for deferred income taxes |
|
|
(363,949 |
) |
|
|
16,113 |
|
Bad debt benefit |
|
|
|
|
|
|
(3,295 |
) |
Non-cash stock based compensation expense |
|
|
196,413 |
|
|
|
148,081 |
|
(Gain) loss on foreign currency options |
|
|
(10,398 |
) |
|
|
40,606 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
|
(488,472 |
) |
|
|
58,774 |
|
Decrease (increase) in prepaid expenses and other current assets |
|
|
58,368 |
|
|
|
(253,173 |
) |
Increase in other assets |
|
|
(45,013 |
) |
|
|
(2,752 |
) |
Decrease in accounts payable |
|
|
(445,044 |
) |
|
|
(532,549 |
) |
(Decrease) increase in accrued expenses and other current
liabilities |
|
|
756,543 |
|
|
|
(45,522 |
) |
Increase in deferred revenue |
|
|
2,163,559 |
|
|
|
3,010,208 |
|
Increase in other liabilities |
|
|
5,320 |
|
|
|
8,007 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
3,789,304 |
|
|
|
3,522,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(1,783,505 |
) |
|
|
(1,041,262 |
) |
Net cash paid for acquisition, net of cash acquired |
|
|
(3,565,725 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(5,349,230 |
) |
|
|
(1,041,262 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments under equipment lease obligations |
|
|
(273,511 |
) |
|
|
(459,576 |
) |
Premium paid for foreign currency options |
|
|
|
|
|
|
(14,077 |
) |
Proceeds from exercise of stock options |
|
|
149,927 |
|
|
|
32,001 |
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(123,584 |
) |
|
|
(441,652 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(1,683,510 |
) |
|
|
2,039,301 |
|
Cash and cash equivalents at beginning of period |
|
|
16,166,264 |
|
|
|
10,553,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
14,482,754 |
|
|
$ |
12,592,969 |
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
-5-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Supplemental cash flow disclosure
Schedule of non cash investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
2007 |
|
2006 |
Increase in property, plant and equipment
acquisitions in accounts payable |
|
|
184,633 |
|
|
|
132,945 |
|
Acquired business
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
2007 |
|
2006 |
Accounts receivable |
|
|
227,767 |
|
|
|
|
|
Property and equipment, net |
|
|
185,261 |
|
|
|
|
|
Other assets |
|
|
53,432 |
|
|
|
|
|
Intangible assets and goodwill |
|
|
4,590,000 |
|
|
|
|
|
Net current liabilities assumed |
|
|
(377,131 |
) |
|
|
|
|
Other liabilities assumed |
|
|
(353,263 |
) |
|
|
|
|
Common stock issued |
|
|
(760,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for acquired business, net of cash acquired of $200,972 |
|
|
3,565,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statement of comprehensive income
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
2007 |
|
2006 |
Net income |
|
|
888,782 |
|
|
|
23,914 |
|
Net unrealized income on derivative instruments |
|
|
|
|
|
|
15,996 |
|
Foreign currency translation adjustment |
|
|
(4,826 |
) |
|
|
|
|
|
|
|
Total comprehensive income |
|
|
883,956 |
|
|
|
39,910 |
|
See Notes to Consolidated Financial Statements
-6-
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, 2006.
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.
Note 2 Earnings Per Share:
Basic income per common share for the three and six months ended June 30, 2007 and 2006 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 and six months ended
June 30, 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income basic and diluted |
|
$ |
888,782 |
|
|
$ |
23,914 |
|
|
$ |
493,704 |
|
|
$ |
80,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
11,535,242 |
|
|
|
11,128,185 |
|
|
|
11,602,176 |
|
|
|
11,202,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.08 |
|
|
$ |
0.00 |
|
|
$ |
0.04 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
11,535,242 |
|
|
|
11,128,185 |
|
|
|
11,602,176 |
|
|
|
11,202,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share equivalents
of outstanding stock options |
|
|
1,067,952 |
|
|
|
954,450 |
|
|
|
987,947 |
|
|
|
968,663 |
|
Common share equivalents of
unrecognized compensation expense |
|
|
64,916 |
|
|
|
|
|
|
|
63,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equity shares |
|
|
12,668,110 |
|
|
|
12,082,635 |
|
|
|
12,653,589 |
|
|
|
12,171,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per
common share |
|
$ |
0.07 |
|
|
$ |
0.00 |
|
|
$ |
0.04 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to purchase 330,800 and 140,000 shares of our common stock had been excluded
from the calculation of diluted loss per common share for the three and six months ended June 30,
2007, as they were all antidilutive. Options to purchase 470,750 and 666,850 shares of our common
stock had been excluded from the calculation of diluted loss per common share for the three and six
months ended June 30, 2006, as they were all antidilutive.
Note 3 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. Pursuant to this employment agreement, our
President and Chief Executive Officer can potentially receive up to
-8-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
25,000 shares
of the companys common stock each fiscal year. Based on managements assumptions, we
recognized the related proportionate expense for these stock units for the six months ended June
30, 2007. The aggregate amount due from January 1, 2007 through the expiration under these
agreements was $981,333. On February 27, 2007, in connection with his employment agreement related
to fiscal year 2006, we issued 14,850 shares of common stock to our President and Chief Executive
Officer, this was net of 10,150 shares withheld for withholding taxes associated with the issuance
of the shares. In addition, we have an employment agreement with our Chief Financial Officer that
expires February 5, 2008.
Note 4 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. Accordingly, we now have two operating
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 |
|
|
|
|
|
|
Contract |
|
CapMed |
|
Consolidated |
|
|
Services |
|
Division |
|
Total |
For the three months ended
June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
11,487,166 |
|
|
$ |
199,038 |
|
|
$ |
11,686,204 |
|
Total cost and expenses |
|
$ |
10,398,199 |
|
|
$ |
614,260 |
|
|
$ |
11,012,459 |
|
Income (loss) from operations |
|
$ |
1,088,967 |
|
|
$ |
(415,222 |
) |
|
$ |
673,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended
June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
10,090,609 |
|
|
$ |
124,132 |
|
|
$ |
10,214,741 |
|
Total cost and expenses |
|
$ |
9,733,325 |
|
|
$ |
463,065 |
|
|
$ |
10,196,390 |
|
Income (loss) from operations |
|
$ |
357,284 |
|
|
$ |
(338,933 |
) |
|
$ |
18,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended
June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
22,428,505 |
|
|
$ |
333,154 |
|
|
$ |
22,761,659 |
|
Total cost and expenses |
|
$ |
20,457,484 |
|
|
$ |
1,128,788 |
|
|
$ |
21,586,272 |
|
Income (loss) from operations |
|
$ |
1,971,021 |
|
|
$ |
(795,634 |
) |
|
$ |
1,175,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended
June 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
19,314,345 |
|
|
$ |
210,147 |
|
|
$ |
19,524,492 |
|
Total cost and expenses |
|
$ |
18,667,564 |
|
|
$ |
1,032,640 |
|
|
$ |
19,700,204 |
|
Income (loss) from operations |
|
$ |
646,781 |
|
|
$ |
(822,493 |
) |
|
$ |
(175,712 |
) |
Our foreign customers accounted for approximately 36% and 26% of service revenues for the six
months ended June 30, 2007 and 2006, respectively. For the three months ended June 30, 2007 and
2006, our foreign customers accounted for approximately 38% and 23% of service revenues,
respectively.
Note 5 Accounts Receivable and Allowance for Doubtful Accounts
We maintain allowances for doubtful accounts on a specific identification method for
-10-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 does
not bear interest.
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Billed trade accounts receivable |
|
$ |
5,183,346 |
|
|
$ |
4,781,682 |
|
Unbilled trade accounts receivable |
|
|
1,086,069 |
|
|
|
771,818 |
|
Other |
|
|
11,572 |
|
|
|
11,248 |
|
|
|
|
|
|
|
|
Total Receivables |
|
$ |
6,280,987 |
|
|
$ |
5,564,748 |
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward: |
|
|
|
|
|
|
|
|
Balance at January 1, 2007 |
|
$ |
14,000 |
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(14,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
$ |
|
|
|
|
|
|
Note 6 Income Taxes
We record a valuation allowance to reduce our deferred tax assets to an amount that is more
likely than not to be realized. In assessing the need for the valuation allowance, we consider our
future taxable income and on-going prudent and feasible tax planning strategies. In the event that
we were to determine that, in the future, we would be able to realize our 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 we determine
that it is more likely than not that we will be unable to realize all or part of our 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. Subsequent revisions to the
estimated realizable value of our deferred tax assets could cause our provision for income taxes to
vary significantly from period to period, although our cash tax payments would remain unaffected
until our net operating loss (NOL) carryforwards is fully utilized or has expired. Our current and
long-term deferred tax assets are primarily comprised of the temporary book to tax differences
related to deferred revenue and our NOL carryforwards. We have determined that there will be
sufficient future taxable income to more likely than not utilize the unlimited net operating loss
carryforward at June 30, 2007.
We have accumulated tax losses, which include allowable deductions related to exercised
employee stock options, generating federal net operating loss (NOL) carryforwards of $1.5 million
as of June 30, 2007. The losses will expire, if unused in the years 2009-2022. Under limitations
imposed by Internal Revenue Code Section 382, certain potential changes in our
-11-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
ownership, which may be outside our knowledge or control, may restrict future utilization of
these carryforwards. Due to such ownership changes that have occurred in prior years, we have
estimated that $1.1 million of our current federal net operating loss will likely expire unused due
to Internal Revenue Code Section 382 limitations and have a valuation allowance of $408,000 for
this limitation at December 31, 2006 and June 30, 2007.
On January 1, 2007, we adopted Financial Accounting Standards Board Interpretation No. 48
Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes 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 change during the next
twelve 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 taxes for years 2005 and 2006 are
subject to examination. Our state taxes for years 2000 through 2006 are subject to examination.
Our foreign taxes have never been reviewed and are subject to examination by the respective
authorities since the inception of our foreign subsidiaries.
Note 7 Derivatives and Other Hedging Instruments
All derivatives are recognized in our Consolidated Statement of Operations at fair value and
are reported in prepaid expenses and other current assets on the Balance Sheet. To qualify for
hedge accounting in accordance with SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities, as amended by SFAS No. 138, Accounting for Certain Derivative Instruments and
Certain Hedging Activities, (SFAS No. 133), we require that the instruments are effective in
reducing the risk exposure that they are designated to hedge. For instruments that are associated
with the hedge of cash flows, hedge effectiveness criteria also require that it be probable that
the underlying transaction will occur. Instruments that meet established accounting criteria are
formally designated as hedges at the inception of the contract. These criteria demonstrate that the
derivative is expected to be highly effective at offsetting changes in fair value or cash flows of
the underlying exposure both at inception of the hedging relationship and on an ongoing basis. The
assessment for effectiveness is formally documented at hedge inception and reviewed at least
quarterly throughout the designated hedge period.
In accordance with our current foreign exchange rate risk management policy, since inception,
we have purchased twenty monthly Euro call options. Nineteen monthly call options were in the
amount of 250,000 Euros each and one call option was for 200,000 Euros for anticipated additional
costs in May, 2006. The first expiration was on July 27, 2005 and the last
expiration was in March 2007 with a strike price ranging from $1.26 to $1.27. These options
-12-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
were to hedge against the exposure to variability in our cash flows resulting from Euro denominated
costs for our Netherlands subsidiary. We paid a total premium of $132,109 for the options.
During the three months ended March 31, 2007, we exercised the remaining two options and a
gain of $10,398 was recognized in the Consolidated Statement of Operations on the exercised
options. We did not exercise or enter into any foreign currency options for the three months ended
June 30, 2007. During the six months ended June 30, 2006, we exercised 2 options and a loss of
$4,966 was recognized in the Consolidated Statement of Operations.
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of the derivative, we will record a gain or loss from the derivative that is
deferred in stockholders equity to cost of revenues and general and administrative expenses in the
Consolidated Statement of Operations based on the nature of the underlying cash flow hedged. As of
June 30, 2007, there are no outstanding derivative positions because our Euro denominated cash
flows have risen to a level commensurate with Euro denominated costs for our European subsidiaries
in France and the Netherlands, and thereby substantially mitigating our foreign exchange rate risk
exposure.
Note 8 Acquisition
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys, a privately
held company headquartered in Lyon, France to expand our therapeutic expertise in the Central
Nervous System and Neurovascular areas. The aggregate purchase price was 2,958,285 Euros
($3,853,462 as determined by an agreed upon exchange rate), of which 2,375,484 Euros ($3,093,122)
was paid in cash and $760,340 was paid in 93,408 shares of our common stock. We also incurred
approximately $673,000 in acquisition costs. The result of operations of Theralys were included in
our Consolidated Statements of Income, Cash Flows and Balance Sheet at the acquisition date. The
assets acquired primarily consisted of $4,221,000 goodwill, $291,000 software, $52,000 customer
relationship and $26,000 non-compete. The purchase price allocation of Theralys used in the
preparation of these financial statements is preliminary due to the continuing analyses relating to
the determination of the fair values of the assets acquired and liabilities assumed. Any changes to
the fair value of net assets acquired, based on information as of the acquisition date, will result
in an adjustment to the fair value of the assets acquired and liabilities assumed. We do not expect
the finalization of these matters to have a material effect on the allocation.
-13-
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 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 110 clients encompassing 229 distinct projects for the six
months ended June 30, 2007. This compares to 115 clients encompassing 241 distinct projects for
the six months ended June 30, 2006.
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 $80.1 million as of June 30, 2007. This compares to $65.6 million as of June 30, 2006.
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 3 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.
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 and this may lead to a growth in our market share for these services.
-14-
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 cost will contribute to the growth of the personal electronic medical
records market. CapMed continues to progress towards the completion of its dot-net conversion and
development of its web portal strategy, which includes a web-based PHR. Once completed, our
customers will have the choice of managing their health through an on-line PHR, from their desktop
PC or from our patent-pending USB Healthkey, which we believe will further enhance value in the
marketplace and reduce the lengthy sales cycle typical in this space. We continue to be encouraged
by the long-term prospects for this division although the revenue generating adoption rate has been
slower than anticipated, a number of favorable important partnerships are coming much closer to
fruition.
Forward Looking Statements
Certain matters discussed in this Form 10-Q are forward-looking statements intended to
qualify for the safe harbors from liability established by the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements may be identified by, among other things, the use of
forward-looking terminology such as believes, expects, may, will,
-15-
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, 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
On January 1, 2007, we adopted Financial Accounting Standards Board Interpretation No. 48
Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes 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 change during the next
twelve 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 taxes for years 2005 and 2006 are
subject to examination. Our state taxes for years 2000 through 2006 are subject to examination.
Our foreign taxes have never been reviewed and are subject to examination by the respective
authorities since the inception of our foreign subsidiaries.
-16-
Results of Operations
Three Months Ended June 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three |
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
|
Months |
|
|
|
|
|
|
|
|
Ended |
|
|
|
|
|
Ended |
|
|
|
|
|
|
|
|
June 30, |
|
% of Total |
|
June 30, |
|
% of Total |
|
|
|
|
|
|
2007 |
|
Revenue |
|
2006 |
|
Revenue |
|
$ Change |
|
% Change |
|
Service revenues |
|
$ |
9,403,388 |
|
|
|
80.5 |
% |
|
$ |
7,970,354 |
|
|
|
78.0 |
% |
|
$ |
1,433,034 |
|
|
|
18.0 |
% |
Reimbursement
revenues |
|
|
2,282,816 |
|
|
|
19.5 |
% |
|
|
2,244,387 |
|
|
|
22.0 |
% |
|
|
38,429 |
|
|
|
1.7 |
% |
|
Total revenues |
|
|
11,686,204 |
|
|
|
100.0 |
% |
|
|
10,214,741 |
|
|
|
100.0 |
% |
|
|
1,471,463 |
|
|
|
14.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
7,706,325 |
|
|
|
65.9 |
% |
|
|
7,363,466 |
|
|
|
72.1 |
% |
|
|
342,859 |
|
|
|
4.7 |
% |
General and
administrative
expenses |
|
|
1,567,145 |
|
|
|
13.4 |
% |
|
|
1,391,816 |
|
|
|
13.6 |
% |
|
|
175,329 |
|
|
|
12.6 |
% |
Sales and marketing
expenses |
|
|
1,738,989 |
|
|
|
14.9 |
% |
|
|
1,441,108 |
|
|
|
14.1 |
% |
|
|
297,881 |
|
|
|
20.7 |
% |
|
Total cost and
expenses |
|
|
11,012,459 |
|
|
|
94.2 |
% |
|
|
10,196,390 |
|
|
|
99.8 |
% |
|
|
816,069 |
|
|
|
8.0 |
% |
|
Income from operations |
|
|
673,745 |
|
|
|
5.8 |
% |
|
|
18,351 |
|
|
|
0.2 |
% |
|
|
655,394 |
|
|
|
3,571.4 |
% |
Interest income |
|
|
155,496 |
|
|
|
1.3 |
% |
|
|
128,912 |
|
|
|
1.3 |
% |
|
|
26,584 |
|
|
|
20.6 |
% |
Interest expense |
|
|
(6,401 |
) |
|
|
(0.1 |
)% |
|
|
(13,693 |
) |
|
|
(0.1 |
)% |
|
|
7,292 |
|
|
|
(53.3 |
)% |
|
Income before
income tax benefit |
|
|
822,840 |
|
|
|
7.0 |
% |
|
|
133,570 |
|
|
|
1.3 |
% |
|
|
689,270 |
|
|
|
516.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
329,136 |
|
|
|
2.8 |
% |
|
|
53,428 |
|
|
|
0.5 |
% |
|
|
275,708 |
|
|
|
516.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
493,704 |
|
|
|
4.2 |
% |
|
$ |
80,142 |
|
|
|
0.8 |
% |
|
$ |
413,562 |
|
|
|
516.0 |
% |
|
Service revenues for the three months ended June 30, 2007 and 2006 were $9,403,388 and
$7,970,354 respectively, an increase of $1,433,034, or 18.0%. The increase in service revenues was
due to an increase in work performed from our increased backlog. Our backlog at June 30, 2007 was
$80.1 million compared to $65.6 million at June 30, 2006, an increase of 22.1%. 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 104 clients encompassing 213 distinct projects for the
three months ended June 30, 2007. This compares to 102 clients encompassing 222 distinct projects
for the three months ended June 30, 2006. This decrease in the number of projects is in part due
to a marketing focus on larger clinical trials projects. No one client accounted for more than 10%
of our service revenue for the three months ended June 30, 2007. One client, Novartis
Pharmaceuticals, Inc., encompassing 13 projects represented 14.5% of our service revenues for
-17-
the
three months ended June 30, 2006. 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 consist of payments received from the customer for reimbursable costs.
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 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 Revenue and Cost of Revenues.
Cost of revenues for the three months ended June 30, 2007 and 2006 was $7,706,325 and
$7,363,466 respectively, an increase of $342,859, or 4.7%. The increase in cost of revenues is
primarily due to the addition of operating costs from Theralys S.A. Cost of revenues for the three
months ended June 30, 2007 and three months ended June 30, 2006 were comprised of professional
salaries and benefits, allocated overhead and pass-through costs. 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 2007 as reimbursement revenues and service revenues
increase.
General and administrative expenses for the three months ended June 30, 2007 and 2006 was
$1,567,145 and $1,391,816 respectively, an increase of $175,329, or 12.6%. General and
administrative expenses for the three months ended June 30, 2007 and three months ended June 30,
2006 consisted primarily of salaries and benefits, depreciation and amortization, professional and
consulting services, office rent and corporate insurance. The increase is primarily due to an
increase in professional and consulting services. We expect that our general and administrative
expense will increase in 2007 due to anticipated additional expenditures for compliance with the
Sarbanes-Oxley Act of 2002. General and administrative expenses as a percentage of total revenues
decreased slightly for the three months ended June 30, 2007 from the three months ended June 30,
2006 primarily due to a greater increase in our total revenues for the three months ended June 30,
2007.
Sales and marketing expenses for the three months ended June 30, 2007 and 2006 was $1,738,989
and $1,441,108 respectively, an increase of $297,881, or 20.7%. Sales and marketing expenses for
the three months ended June 30, 2007 and three months ended June 30, 2006 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 $165,000 and an
increase in tradeshow attendance and marketing expenditures. We expect that sales and marketing
expenses will increase in fiscal 2007 as we continue to expand our market presence in the United
States and Europe. The increase in sales and marketing expenses as a
percentage of total revenues to 14.9% for the three months ended
-18-
June 30, 2007 from 14.1% for
the three months ended June 30, 2006 is primarily due to the increase in CapMed costs.
Net interest income was $149,095 for the three months ended June 30, 2007 and net interest
income was $115,219 for the three months ended June 30, 2006, an increase of $33,876 or 29.4%.
This increase is primarily due to earning higher rates of return on short term investments. Also,
interest expense has decreased as our capital leases are maturing. Net interest income and expense
for the three months ended June 30, 2007 and 2006 is comprised of interest income earned on our
cash balance and interest expense incurred on equipment lease obligations. Interest income may
decrease in fiscal 2007 if we utilize cash for acquisitions.
Income before income taxes was $822,840 for the three months ended June 30, 2007, and $133,570
for the three months ended June 30, 2006. The increase was due to greater service revenue while
expenses increased at a slower rate due to our process improvement efforts.
Our income tax provision for the three months ended June 30, 2007 and 2006 was $329,136 and
$53,428, respectively. Our effective tax rate is approximately 40% for fiscal 2007 and fiscal
2006.
-19-
Six Months Ended June 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
|
Six Months |
|
|
|
|
|
|
|
|
Ended |
|
|
|
|
|
Ended |
|
|
|
|
|
|
|
|
June 30, |
|
% of Total |
|
June 30, |
|
% of Total |
|
|
|
|
|
|
2007 |
|
Revenue |
|
2006 |
|
Revenue |
|
$ Change |
|
% Change |
|
Service revenues |
|
$ |
18,162,809 |
|
|
|
79.8 |
% |
|
$ |
15,212,945 |
|
|
|
77.9 |
% |
|
$ |
2,949,864 |
|
|
|
19.4 |
% |
Reimbursement
revenues |
|
|
4,598,850 |
|
|
|
20.2 |
% |
|
|
4,311,547 |
|
|
|
22.1 |
% |
|
|
287,303 |
|
|
|
6.7 |
% |
|
Total revenues |
|
|
22,761,659 |
|
|
|
100.0 |
% |
|
|
19,524,492 |
|
|
|
100.0 |
% |
|
|
3,237,167 |
|
|
|
16.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
|
15,247,834 |
|
|
|
67.0 |
% |
|
|
14,048,306 |
|
|
|
72.0 |
% |
|
|
1,199,528 |
|
|
|
8.5 |
% |
General and
administrative
expenses |
|
|
3,039,423 |
|
|
|
13.4 |
% |
|
|
2,763,062 |
|
|
|
14.2 |
% |
|
|
276,361 |
|
|
|
10.0 |
% |
Sales and marketing
expenses |
|
|
3,299,015 |
|
|
|
14.5 |
% |
|
|
2,888,836 |
|
|
|
14.8 |
% |
|
|
410,179 |
|
|
|
14.2 |
% |
|
Total cost and
expenses |
|
|
21,586,272 |
|
|
|
94.9 |
% |
|
|
19,700,204 |
|
|
|
100.9 |
% |
|
|
1,886,068 |
|
|
|
9.6 |
% |
|
Income (loss) from
operations |
|
|
1,175,387 |
|
|
|
5.1 |
% |
|
|
(175,712 |
) |
|
|
(0.9 |
)% |
|
|
1,351,099 |
|
|
|
(768.9 |
)% |
Interest income |
|
|
316,048 |
|
|
|
1.4 |
% |
|
|
246,445 |
|
|
|
1.3 |
% |
|
|
69,603 |
|
|
|
28.2 |
% |
Interest expense |
|
|
(10,131 |
) |
|
|
0 |
% |
|
|
(30,876 |
) |
|
|
(0.2 |
)% |
|
|
20,745 |
|
|
|
(67.2 |
)% |
|
Income before
income tax benefit |
|
|
1,481,304 |
|
|
|
6.5 |
% |
|
|
39,857 |
|
|
|
0.2 |
% |
|
|
1,441,447 |
|
|
|
3616.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
592,522 |
|
|
|
2.6 |
% |
|
|
15,943 |
|
|
|
0.1 |
% |
|
|
576,579 |
|
|
|
3616.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
888,782 |
|
|
|
3.9 |
% |
|
$ |
23,914 |
|
|
|
0.1 |
% |
|
$ |
864,868 |
|
|
|
3616.5 |
% |
|
Service revenues for the six months ended June 30, 2007 and 2006 were $18,162,809 and
$15,212,945 respectively, an increase of $2,949,864, or 19.4%. The increase in service revenues
was due to an increase in work performed from our increased backlog. Our backlog at June 30, 2007
was $80.1 million compared to $65.6 million at June 30, 2006, an increase of 22.1%. 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 110 clients encompassing 229 distinct projects for the
six months ended June 30, 2007. This compares to 115 clients encompassing 241 distinct projects
for the six months ended June 30, 2006. This decrease in the number of projects is in part due to
a marketing focus on larger clinical trials projects. No one client accounted for more than 10% of
our service revenue for the six months ended June 30, 2007. One client, Novartis Pharmaceuticals,
Inc., encompassing 13 projects represented 13.1% of our service revenues for the six months ended
June 30, 2006. Service revenues generated from our client base, while still concentrated as
measured by the number of clients, is more dispersed when revenue
-20-
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 consist of payments received from the customer for reimbursable costs.
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 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 Revenue and Cost of Revenues.
Cost of revenues for the six months ended June 30, 2007 and 2006 was $15,247,834 and
$14,048,306 respectively, an increase of $1,199,528, or 8.5%. The increase in cost of revenues is
primarily due to the increase in reimbursement revenues of $287,000, the addition of operating
costs from Theralys S.A. of $550,000 and an overall increase in costs to support our higher revenue
base. Cost of revenues for the six months ended June 30, 2007 and six months ended June 30, 2006
were comprised of professional salaries and benefits, allocated overhead and pass-through costs.
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 2007 as reimbursement revenues and
service revenues increase.
General and administrative expenses for the six months ended June 30, 2007 and 2006 was
$3,039,423 and $2,763,062 respectively, an increase of $276,361, or 10.0%. General and
administrative expenses for the six months ended June 30, 2007 and six months ended June 30, 2006
consisted primarily of salaries and benefits, depreciation and amortization, professional and
consulting services, office rent and corporate insurance. The increase is primarily due to an
increase in professional and consulting services. We expect that our general and administrative
expense will increase in 2007 due to anticipated additional expenditures for compliance with the
Sarbanes-Oxley Act of 2002. The decrease in general and administrative expenses as a percentage of
total revenues to 13.4% for the six months ended June 30, 2007 from 14.2% for the six months ended
June 30, 2006 is primarily due to a greater increase in our total revenues for the six months ended
June 30, 2007.
Sales and marketing expenses for the six months ended June 30, 2007 and 2006 was $3,299,015
and $2,888,836 respectively, an increase of $410,179, or 14.2%. Sales and marketing expenses for
the six months ended June 30, 2007 and six months ended June 30, 2006 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 $131,000 and an
increase in tradeshow attendance and marketing expenditures. We expect that sales and marketing
expenses will increase in fiscal 2007 as we continue to expand our market presence in the United
States and Europe. The decrease in sales and marketing expenses as a percentage of total revenues
to 14.5% for the six months ended June 30, 2007 from 14.8% for the six months ended June 30, 2006
is primarily due to a greater increase in our total
-21-
revenues for the
six months ended June 30, 2007.
Net interest income was $305,917 for the six months ended June 30, 2007 and net interest
income was $215,569 for the six months ended June 30, 2006, an increase of $90,348 or 41.9%. This
increase is primarily due to having a higher cash balance to invest and earning higher rates of
return on short term investments. Also, interest expense has decreased as our capital leases are
maturing. Net interest income and expense for the six months ended June 30, 2007 and 2006 is
comprised of interest income earned on our cash balance and interest expense incurred on equipment
lease obligations. Interest income may decrease in fiscal 2007 if we utilize cash for
acquisitions.
Income before income taxes was $1,481,304 for the six months ended June 30, 2007, and $39,857
for the six months ended June 30, 2006. The increase was due to greater service revenue while
expenses increased at a slower rate due to our process improvement efforts.
Our income tax provision for the six months ended June 30, 2007 and 2006 was $592,522 and
$15,943, respectively. Our effective tax rate is approximately 40% for fiscal 2007 and fiscal
2006.
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 5 Business Segments to our
Consolidated Financial Statements in this Quarterly Report on Form 10-Q. During the three months
ended June 30, 2007, we had CapMed segment sales of $199,038 and total costs and expenses of
$614,260, consisting of $483,166 of sales and marketing expenses, $120,791 of general and
administrative expenses and $10,303 of cost of revenues. During the six months ended June 30,
2007, we had CapMed segment sales of $333,154 and total costs and expenses of $1,128,788,
consisting of $882,325 of sales and marketing expenses, $220,582 of general and administrative
expenses and $25,881 of cost of revenues.
-22-
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
Six Months |
|
|
Ended |
|
Ended |
|
|
June 30, 2007 |
|
June 30, 2006 |
|
|
|
Net cash provided by operating activities |
|
$ |
3,789,304 |
|
|
$ |
3,522,215 |
|
Net cash used in investing activities |
|
$ |
(5,349,230 |
) |
|
$ |
(1,041,262 |
) |
Net cash used in financing activities |
|
$ |
(123,584 |
) |
|
$ |
(441,652 |
) |
At June 30, 2007, we had cash and cash equivalents of $14,482,754. Working capital at June
30, 2007 was $7,012,210.
Net cash provided by operating activities for the six months ended June 30, 2007 was
$3,789,304 as compared to $3,522,215 for the six months ended June 30, 2006. This increase from
the prior year is primarily due to the increase in net income.
Net cash used in investing activities for the six months ended June 30, 2007 was $(5,349,230)
as compared to $(1,041,262) for the six months ended June 30, 2006. The increase was primarily due
to $3,565,725 used for the acquisition of Theralys, S.A. on February 6, 2007. We currently
anticipate that capital expenditures for the remainder of the fiscal year ending December 31, 2007
will be approximately $1 million. These expenditures primarily represent additional upgrades in our
networking, data storage and core laboratory capabilities for both our United States and European
operations as well as capitalization of software costs.
Net cash used in financing activities for the six months ended June 30, 2007 was $(123,584) as
compared to $(441,652) for the six months ended June 30, 2006. The change is primarily
attributable to the payments under equipment lease obligations of $273,511 offset by cash received
from the exercise of stock options of $149,927.
-23-
The following table lists our cash contractual obligations as of June 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
More |
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
than 5 |
Contractual obligations |
|
Total |
|
year |
|
1-3 years |
|
3-5 years |
|
years |
|
Capital lease obligations |
|
$ |
277,983 |
|
|
$ |
237,433 |
|
|
$ |
40,550 |
|
|
$ |
|
|
|
$ |
|
|
|
Facility rent operating
leases |
|
$ |
5,732,505 |
|
|
$ |
1,448,577 |
|
|
$ |
3,188,210 |
|
|
$ |
1,095,718 |
|
|
$ |
|
|
|
Employment agreements |
|
$ |
698,333 |
|
|
$ |
475,000 |
|
|
$ |
223,333 |
|
|
$ |
|
|
|
$ |
|
|
|
Total contractual cash
obligations |
|
$ |
6,708,821 |
|
|
$ |
2,161,010 |
|
|
$ |
3,452,093 |
|
|
$ |
1,095,718 |
|
|
$ |
|
|
|
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 current foreign exchange rate risk management policy, since inception,
we have purchased twenty monthly Euro call options. Nineteen monthly call options were in the
amount of 250,000 Euros each and one call option was for 200,000 Euros for anticipated additional
costs in May, 2006. The first expiration was on July 27, 2005 and the last expiration was in March
2007 with a strike price ranging from $1.26 to $1.27. 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. We paid a total premium of $132,109 for the options.
During the six months ended June 30, 2007, we exercised the remaining two options and a gain
of $10,398 was recognized in the Consolidated Statement of Income on the exercised options. During
the six months ended June 30, 2006, we exercised two options and a loss of $4,966 was recognized in
the Consolidated Statement of Income.
Under our current foreign exchange rate risk management policy, and upon expiration or
ineffectiveness of the derivative, we will record a gain or loss from the derivative that is
deferred in stockholders equity to cost of revenues and general and administrative expenses in the
Consolidated Statement of Income based on the nature of the underlying cash flow hedged.
As of June 30, 2007, we have not purchased any additional such Euro call options, because our
foreign currency needs are generally being met by the cash flow generated by Euro denominated
contracts.
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.
-24-
We anticipate that our existing capital resources together with cash flow from operations will
be sufficient to meet our cash needs. However, we cannot assure you that our operating results will
maintain profitability on an annual basis in the future. The inherent operational risks associated
with the following factors may have a material adverse affect on our future liquidity:
|
|
|
our ability to gain new client contracts; |
|
|
|
|
project cancellations; |
|
|
|
|
the variability of the timing of payments on existing client contracts; and |
|
|
|
|
other changes in our operating assets and liabilities. |
We may seek to raise additional capital from equity or debt sources in order to take advantage
of unanticipated opportunities, such as more rapid expansion, acquisitions of complementary
businesses or the development of new services. We cannot assure you that additional financing will
be available, if at all, on terms acceptable to us.
Our fiscal year 2007 operating plan contains assumptions regarding revenue and expenses. The
achievement of our operating plan depends heavily on the timing of work performed by us on existing
projects and our ability to gain and perform work on new projects. Project cancellations, or
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
twelve 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, 2006. As of June 30, 2007, there have been no changes to
such critical accounting policies and estimates, except for the adoption of Financial Standards
Accounting Board Interpretation No. 48 Accounting for Uncertainty in Income Taxes (FIN 48) an
interpretation of FASB Statement No. 109 (SFAS 109) on January 1, 2007.
-25-
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 United States treasury notes, with an
effective duration of the portfolio of less than nine 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 United States dollars. Fluctuations in foreign
currency exchange rates could materially increase the operating costs of our facilities in the
Netherlands and France, which are primarily EURO denominated. At June 30, 2007 and December 31,
2006, a 10% increase or decrease in the EURO to U.S. dollar spot exchange rate would result in a
change of $53,300 and $41,600 to our net asset position at June 30, 2007 and December 31, 2006,
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 instruments primarily consist of
cash, trade receivables, prepaid expenses, fixed assets, trade payables and accrued expenses. We
were in a net asset position at June 30, 2007 and December 31, 2006.
Item 4T. Controls and Procedures.
Evaluation of disclosure controls and procedures. Based on their evaluation of our disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of
March 31, 2007, 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 are effective to ensure that (i) information required to be
disclosed by us in the reports that we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the Securities and Exchange
Commissions rules and forms and are operating in an effective manner for the period covered by
this report; and (ii) information is accumulated and communicated to
management, including the chief executive officer and chief financial officer, as appropriate,
to allow timely decisions regarding required disclosures.
-26-
Changes in internal control over financial reporting. There was no change in our internal
controls over financial reporting that occurred during the quarter ended June 30, 2007 that has
materially affected, or is reasonably likely to materially affect, our internal controls over
financial reporting.
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:
|
|
|
unexpected or undesired clinical results; |
|
|
|
|
the clients decision to terminate the development of a particular product or to end a
particular study; |
|
|
|
|
insufficient patient enrollment in a study; |
|
|
|
|
insufficient investigator recruitment; |
|
|
|
|
failure to perform our obligations under the contract; or |
|
|
|
|
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
-27-
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 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:
|
|
|
clients businesses experience financial problems or are affected by a general economic
downturn; |
|
|
|
|
consolidation in the pharmaceutical, biotechnology or medical device industries leads to
a smaller client base for us; or |
|
|
|
|
clients reduce their research and development expenditures. |
No one client represented 10% of our service revenue for the six months ended June 30, 2007.
One client, Novartis Pharmaceuticals, Inc., encompassing 13 projects represented 13.1% of our
service revenue for the six months ended June 30, 2006. 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 $80.1 million at June 30, 2007 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:
|
|
|
the variable size and duration of the projects (some are performed over several years); |
|
|
|
|
the loss or delay of projects; |
|
|
|
|
the change in the scope of work during the course of a project; and |
|
|
|
|
the cancellation of such contracts by our clients. |
Also, if clients delay projects, the projects will remain in backlog, but will not generate
-28-
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 213 in the second
quarter of 2007. In addition, we acquired 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:
|
|
|
effectively market our services to pharmaceutical, biotechnology and medical device
companies; |
|
|
|
|
continue to improve operating, administrative and information systems; |
|
|
|
|
accurately predict future personnel and resource needs to meet client contract
commitments; |
|
|
|
|
successfully integrate our acquired companies and businesses; |
|
|
|
|
track the progress of on-going client projects; and |
|
|
|
|
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:
|
|
|
assimilate differences in foreign business practices and regulations; |
|
|
|
|
hire and retain qualified personnel; and |
|
|
|
|
overcome language and cultural barriers. |
We may engage in future acquisitions, which may be expensive and time consuming and from which we
may not realize anticipated benefits.
We 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. If we do undertake transactions of this sort, the process of integrating
an 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
acquisition. Future 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.
-29-
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys, a privately
held company headquartered in Lyon, France. The aggregate purchase price was 2,958,285 Euros
($3,853,462 as determined by an agreed upon exchange rate), of which 2,375,484 Euros ($3,093,122)
was paid in cash and $760,340 was paid in 93,408 shares of our common stock. We also incurred
approximately $673,000 in acquisition costs.
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 second quarter of 2007, a portion of our service revenues were denominated in
foreign currency. Our financial statements are denominated in United States dollars. In the event
a greater portion of our service revenues are denominated in a foreign currency, changes in foreign
currency exchange rates could affect our results of operations and financial condition.
Fluctuations in foreign currency exchange rates could materially impact the operating costs of our
European facility in Leiden, the Netherlands, which are primarily Euro denominated.
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:
|
|
|
consultative and clinical trials design capabilities; |
|
|
|
|
reputation for on-time quality performance; |
|
|
|
|
expertise and experience in specific therapeutic areas; |
|
|
|
|
the scope of service offerings; |
|
|
|
|
strength in various geographic markets; |
|
|
|
|
the price of services; |
-30-
|
|
|
ability to acquire, process, analyze and report data in a time-saving and accurate
manner; |
|
|
|
|
ability to manage large-scale clinical trials both domestically and internationally; |
|
|
|
|
our size; and |
|
|
|
|
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 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.
-31-
Our CapMed division may not reach profitability.
Our CapMed division had a loss from operations for the three months ended June 30, 2007 of
$415,222 and a loss of operations of $795,634 for the six months ended June 30, 2007. 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
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.
-32-
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 June 30, 2007, we had the following capital structure:
|
|
|
|
|
Common stock outstanding |
|
|
11,620,867 |
|
|
|
|
|
|
Common stock issuable upon: |
|
|
|
|
Exercise of options which are outstanding |
|
|
1,768,025 |
|
|
|
|
|
|
Exercise of options which have not been granted |
|
|
598,944 |
|
|
|
|
|
|
Total common stock outstanding assuming exercise
or conversion of all of the above |
|
|
13,987,836 |
|
As of June 30, 2007, we had outstanding options to purchase 1,768,025 shares of common stock
at exercise prices ranging from $0.63 to $8.06 per share (exercisable at a weighted average of
$2.54 per share), of which 1,528,775 options were then exercisable. Exercise of our outstanding
options into shares of our common stock may significantly and negatively affect the
-33-
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 June 30, 2007, we had 11,620,867 shares of our common stock
issued and outstanding, all of which are currently freely tradable. On February 27, 2007, in
connection with his employment agreement dated March 28, 2005, we issued 14,850 shares of
restricted stock to our President and Chief Executive Officer, this was net of 10,150 shares
withheld for withholding taxes associated with the issuance of the shares.
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 shareholders 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 25% of the outstanding shares of common
stock and stock options that could have been converted to common stock at June 30, 2007, and such
stockholders will have significant influence over the outcome of all matters submitted to our
stockholders for approval, including the election of our directors and other corporate actions. In
addition, such influence by these affiliates could have the effect of discouraging others from
attempting to take us over, thereby increasing the likelihood that the market price of the common
stock will not reflect a premium for control.
Because we do not intend to pay dividends, stockholders will benefit from an investment in our
common stock only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to
retain our future earnings, if any, to finance further research and development and do not expect
to pay any cash dividends in the foreseeable future. As a result, the success of an investment in
our common stock will depend upon any future appreciation in its value. There is no guarantee that
our common stock will appreciate in value or even maintain the price at which
-34-
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:
|
|
|
operating results; |
|
|
|
|
analysts reports; |
|
|
|
|
market conditions in the industry; |
|
|
|
|
changes in governmental regulations; and |
|
|
|
|
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, 2007 and June 30, 2007, our common stock has traded at a low of $5.75 per share and a
high of $9.40 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 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
-35-
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.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
|
(a) |
|
Our annual meeting of stockholders was held on May 9, 2007. |
|
|
(b) |
|
The following is a list of all of the nominees for Director of our company
who were elected at the annual meeting and whose term of office continued after the
meeting: |
|
(i) |
|
Mark L. Weinstein |
|
|
(ii) |
|
Jeffrey H. Berg, Ph.D. |
|
|
(iii) |
|
Richard F. Cimino |
|
|
(iv) |
|
E. Martin Davidoff, CPA, Esq. |
|
|
(v) |
|
David E. Nowicki, D.M.D. |
|
|
(vi) |
|
David M. Stack |
|
|
(vii) |
|
Paula B. Stafford |
|
|
(viii) |
|
James A. Taylor, Ph.D. |
|
(c) |
|
There were present at the annual meeting, in person or by proxy, 10,522,112
shares of common stock out of a total of 11,582,342 shares of our common stock issued
and outstanding and entitled to vote at the annual meeting. |
|
|
(d) |
|
The results of the vote of the stockholders taken at the annual meeting by
ballot and by proxy as solicited by us on behalf of the board of directors were as
follows: |
-36-
|
(i) |
|
The results of the vote taken at the meeting for the election
of the nominees for our board of directors were as follows: |
|
|
|
|
|
|
|
|
|
Nominee |
|
For |
|
Withheld |
|
Mark L. Weinstein |
|
|
10,416,459 |
|
|
|
105,653 |
|
|
|
|
|
|
|
|
|
|
Jeffrey H. Berg, Ph.D. |
|
|
10,416,964 |
|
|
|
105,148 |
|
|
|
|
|
|
|
|
|
|
Richard F. Cimino |
|
|
10,425,053 |
|
|
|
97,059 |
|
|
|
|
|
|
|
|
|
|
E. Martin Davidoff, CPA, Esq. |
|
|
10,421,914 |
|
|
|
100,198 |
|
|
|
|
|
|
|
|
|
|
David E. Nowicki, D.M.D. |
|
|
10,423,064 |
|
|
|
99,048 |
|
|
|
|
|
|
|
|
|
|
David M. Stack |
|
|
10,423,064 |
|
|
|
99,048 |
|
|
|
|
|
|
|
|
|
|
Paula B. Stafford |
|
|
10,426,264 |
|
|
|
95,848 |
|
|
|
|
|
|
|
|
|
|
James A. Taylor, Ph.D. |
|
|
10,416,464 |
|
|
|
105,648 |
|
|
(ii) |
|
A vote was taken on the proposal to ratify the appointment of
PricewaterhouseCoopers LLP as our independent registered public accounting firm
for the fiscal year ending December 31, 2007. The results of the vote taken at
the annual meeting with respect to such appointment
were as follows: |
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
10,460,298 |
|
|
60,439 |
|
|
|
1,375 |
|
-37-
Item 5. Other Information.
None.
Item 6. Exhibits.
31.1 |
|
Certification of principal executive officer
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed
herewith). |
|
31.2 |
|
Certification of principal financial and
accounting officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith). |
|
32.1 |
|
Certification of principal executive officer
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C.
1350 (furnished herewith). |
|
32.2 |
|
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). |
-38-
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.
|
|
|
|
|
|
|
|
|
BIO-IMAGING TECHNOLOGIES, INC. |
|
|
|
|
|
|
|
|
|
DATE: August 9, 2007
|
|
By:
|
|
/s/ Mark L. Weinstein
|
|
|
|
|
Mark L. Weinstein, President and Chief Executive |
|
|
|
|
Officer (Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
DATE: August 9, 2007
|
|
By:
|
|
/s/ Ted I. Kaminer
|
|
|
|
|
Ted I. Kaminer, Senior Vice President and Chief |
|
|
|
|
Financial Officer |
|
|
|
|
(Principal Financial and Accounting Officer) |
|
|
-39-