e10vq
United States
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
|
|
|
þ |
|
Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For
the quarterly period ended September 30, 2007
|
|
|
o |
|
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)
|
|
|
Delaware
|
|
11-2872047 |
|
|
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer Identification No.) |
|
|
|
826 Newtown-Yardley Road, Newtown, Pennsylvania
|
|
18940-1721 |
|
|
|
(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.
Yes: þ No: o
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).
Yes: o No:þ
State the number of shares outstanding of each of the registrants classes of common stock, as
of October 31, 2007:
|
|
|
Class
|
|
Number of Shares |
|
|
|
Common Stock, $0.00025 par value
|
|
11,696,108 |
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
|
|
|
|
|
|
|
Page |
PART I. FINANCIAL INFORMATION. |
|
|
|
|
Item 1. Consolidated Financial Statements (unaudited) |
|
|
1 |
|
BALANCE SHEETS
as of September 30, 2007 and
December 31, 2006 |
|
|
2 |
|
STATEMENTS OF OPERATIONS
For the Three Months Ended September 30, 2007 and 2006 |
|
|
3 |
|
STATEMENTS OF OPERATIONS
For the Nine Months Ended September 30, 2007 and 2006 |
|
|
4 |
|
STATEMENTS OF CASH FLOWS
For the Nine Months Ended September 30, 2007 and 2006 |
|
|
5 |
|
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS (unaudited) |
|
|
7 |
|
Item 2. Managements Discussion and Analysis of Financial |
|
|
|
|
Condition and Results of Operations |
|
|
15 |
|
Results of Operations |
|
|
19 |
|
Business Segments |
|
|
24 |
|
Liquidity and Capital Resources |
|
|
25 |
|
Changes to Critical Accounting Policies and Estimates |
|
|
27 |
|
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
|
|
28 |
|
Item 4T. Controls and Procedures |
|
|
28 |
|
PART II. OTHER INFORMATION. |
|
|
|
|
Item 1. Legal Proceedings |
|
|
30 |
|
Item 1A. Risk Factors |
|
|
30 |
|
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
|
|
39 |
|
Item 3. Defaults Upon Senior Securities |
|
|
39 |
|
Item 4. Submission of Matters to a Vote of Security Holders |
|
|
39 |
|
Item 5. Other Information |
|
|
39 |
|
Item 6. Exhibits |
|
|
39 |
|
SIGNATURES |
|
|
40 |
|
- 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
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,702,980 |
|
|
$ |
16,166,264 |
|
Accounts receivable, net |
|
|
7,359,179 |
|
|
|
5,564,748 |
|
Prepaid expenses and other current assets |
|
|
1,120,860 |
|
|
|
1,237,405 |
|
Deferred income taxes |
|
|
3,188,475 |
|
|
|
2,210,800 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
26,371,494 |
|
|
|
25,179,217 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
7,624,611 |
|
|
|
5,908,281 |
|
|
|
|
|
|
|
|
|
|
Intangibles |
|
|
497,941 |
|
|
|
354,972 |
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
|
6,093,466 |
|
|
|
1,872,466 |
|
|
|
|
|
|
|
|
|
|
Deferred income taxes |
|
|
|
|
|
|
272,954 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
557,220 |
|
|
|
519,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
41,144,732 |
|
|
$ |
34,107,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,756,609 |
|
|
$ |
1,720,481 |
|
Accrued expenses and other current liabilities |
|
|
4,792,745 |
|
|
|
3,334,554 |
|
Deferred revenue |
|
|
11,689,858 |
|
|
|
9,451,219 |
|
Current maturities of capital lease obligations |
|
|
173,573 |
|
|
|
454,458 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
18,412,785 |
|
|
|
14,960,712 |
|
Long-term capital lease obligations |
|
|
|
|
|
|
97,036 |
|
Deferred income taxes |
|
|
579,605 |
|
|
|
|
|
Other liability |
|
|
593,028 |
|
|
|
208,208 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
19,585,418 |
|
|
|
15,265,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock- $.00025 par value; authorized
3,000,000 shares, 0 issued and outstanding at
September 30, 2007 and at December 31, 2006 |
|
|
|
|
|
|
|
|
Common stock $.00025 par value; authorized
18,000,000 shares, issued and outstanding
11,674,113 shares at September 30, 2007 and
11,309,550 shares at December 31, 2006 |
|
|
2,920 |
|
|
|
2,827 |
|
Additional paid-in capital |
|
|
24,053,074 |
|
|
|
22,864,390 |
|
Accumulated deficit |
|
|
(2,506,975 |
) |
|
|
(4,042,619 |
) |
Accumulated other comprehensive gain |
|
|
10,295 |
|
|
|
17,157 |
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
21,559,314 |
|
|
|
18,841,755 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
41,144,732 |
|
|
$ |
34,107,711 |
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
-2-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Service revenues |
|
$ |
9,563,241 |
|
|
$ |
8,094,141 |
|
Reimbursement revenues |
|
|
2,893,342 |
|
|
|
2,211,783 |
|
|
|
|
|
|
|
|
Total revenues |
|
|
12,456,583 |
|
|
|
10,305,924 |
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
5,392,924 |
|
|
|
4,903,640 |
|
Cost of reimbursement revenues |
|
|
2,893,342 |
|
|
|
2,211,783 |
|
Sales and marketing expenses |
|
|
1,724,134 |
|
|
|
1,358,641 |
|
General and administrative expenses |
|
|
1,558,060 |
|
|
|
1,401,852 |
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
11,568,460 |
|
|
|
9,875,916 |
|
|
|
|
|
|
|
|
Income from operations |
|
|
888,123 |
|
|
|
430,008 |
|
Interest income |
|
|
168,295 |
|
|
|
146,904 |
|
Interest expense |
|
|
(1,144 |
) |
|
|
(10,154 |
) |
|
|
|
|
|
|
|
Income before income tax provision |
|
|
1,055,274 |
|
|
|
566,758 |
|
Income tax provision |
|
|
408,412 |
|
|
|
200,082 |
|
|
|
|
|
|
|
|
Net income |
|
$ |
646,862 |
|
|
$ |
366,676 |
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.06 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
11,658,035 |
|
|
|
11,213,887 |
|
|
|
|
|
|
|
|
Diluted income per common share |
|
$ |
0.05 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
Weighted average number of dilutive common
equivalent shares |
|
|
12,677,704 |
|
|
|
12,125,613 |
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
-3-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Service revenues |
|
$ |
27,829,986 |
|
|
$ |
23,452,033 |
|
Reimbursement revenues |
|
|
7,388,256 |
|
|
|
6,378,383 |
|
|
|
|
|
|
|
|
Total revenues |
|
|
35,218,242 |
|
|
|
29,830,416 |
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
Cost of service revenues |
|
|
16,145,845 |
|
|
|
14,785,346 |
|
Cost of reimbursement revenues |
|
|
7,388,256 |
|
|
|
6,378,383 |
|
Sales and marketing expenses |
|
|
5,023,149 |
|
|
|
4,247,477 |
|
General and administrative expenses |
|
|
4,597,481 |
|
|
|
4,164,914 |
|
|
|
|
|
|
|
|
Total cost and expenses |
|
|
33,154,731 |
|
|
|
29,576,120 |
|
|
|
|
|
|
|
|
Income from operations |
|
|
2,063,511 |
|
|
|
254,296 |
|
Interest income |
|
|
484,343 |
|
|
|
393,349 |
|
Interest expense |
|
|
(11,276 |
) |
|
|
(41,030 |
) |
|
|
|
|
|
|
|
Income before income tax provision |
|
|
2,536,578 |
|
|
|
606,615 |
|
Income tax provision |
|
|
1,000,934 |
|
|
|
215,472 |
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,535,644 |
|
|
$ |
391,143 |
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.13 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
11,576,638 |
|
|
|
11,197,985 |
|
|
|
|
|
|
|
|
Diluted income per common share |
|
$ |
0.12 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
Weighted average number of dilutive common
equivalent shares |
|
|
12,669,302 |
|
|
|
12,121,454 |
|
|
|
|
|
|
|
|
See Notes to Consolidated Financial Statements
-4-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,535,644 |
|
|
$ |
391,143 |
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,721,584 |
|
|
|
1,535,422 |
|
Benefit for deferred income taxes |
|
|
(125,116 |
) |
|
|
(274,874 |
) |
Bad debt benefit |
|
|
|
|
|
|
1,245 |
|
Non-cash stock based compensation expense |
|
|
365,398 |
|
|
|
200,630 |
|
(Gain) loss on foreign currency options |
|
|
(10,398 |
) |
|
|
51,656 |
|
Changes in operating assets and liabilities, net of acquisitions: |
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable |
|
|
(1,597,389 |
) |
|
|
884,520 |
|
Decrease (increase) in prepaid expenses and other current assets |
|
|
81,018 |
|
|
|
(81,104 |
) |
Decrease (increase) in other assets |
|
|
44,801 |
|
|
|
(68,943 |
) |
Decrease in accounts payable |
|
|
(135,399 |
) |
|
|
(665,486 |
) |
Increase in accrued expenses and other current liabilities |
|
|
1,224,114 |
|
|
|
837,025 |
|
Increase in deferred revenue |
|
|
2,096,872 |
|
|
|
2,613,393 |
|
Increase in other liabilities |
|
|
18,881 |
|
|
|
5,214 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
5,220,010 |
|
|
|
5,429,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(2,959,666 |
) |
|
|
(1,627,672 |
) |
Cash paid for acquisition, net of cash acquired |
|
|
(3,565,725 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(6,525,391 |
) |
|
|
(1,627,672 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Payments under equipment lease obligations |
|
|
(377,921 |
) |
|
|
(694,648 |
) |
Premium paid for foreign currency options |
|
|
|
|
|
|
(14,077 |
) |
Proceeds from exercise of stock options |
|
|
220,018 |
|
|
|
62,279 |
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(157,903 |
) |
|
|
(646,446 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(1,463,284 |
) |
|
|
3,155,723 |
|
Cash and cash equivalents at beginning of period |
|
|
16,166,264 |
|
|
|
10,553,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
14,702,980 |
|
|
$ |
13,709,391 |
|
|
|
|
|
|
|
|
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 Nine Months Ended |
|
|
September 30, |
|
|
2007 |
|
2006 |
Increase in property, plant and equipment acquisitions in
accounts payable |
|
$ |
88,434 |
|
|
$ |
198,439 |
|
Acquired business
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
September 30, |
|
|
2007 |
|
2006 |
|
|
|
|
|
Accounts receivable |
|
$ |
227,767 |
|
|
|
|
|
Property and equipment |
|
|
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 Nine Months Ended |
|
|
September 30, |
|
|
2007 |
|
2006 |
|
|
|
|
|
Net income |
|
$ |
1,535,644 |
|
|
$ |
391,143 |
|
Net unrealized income on derivative instruments |
|
|
|
|
|
|
(8,191 |
) |
Equity adjustment from foreign currency translation |
|
|
10,295 |
|
|
|
|
|
|
|
|
Total comprehensive income |
|
$ |
1,545,939 |
|
|
$ |
382,952 |
|
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.
Certain reclassifications have been made to the 2006 financial statements to conform to the
2007 financial statement presentation. We have reclassed certain reimbursable items and have
changed the presentation of our service revenues, reimbursement revenues, cost of service revenues
and cost of reimbursement revenues.
Functional Currency.
Historically, the functional currency for our Netherlands operations was the US Dollar based on an
initial evaluation of economic factors as set forth in SFAS 52.
We periodically evaluate the economic facts and circumstances that led to the initial conclusion
that the functional currency of the Netherlands operation was the US Dollar for any significant
changes that might indicate that the functional currency of the Netherlands operation had changed.
Based on our most recent evaluation performed in connection with the commencement of our quarter
ended September 30, 2007, we concluded that, effective July 1, 2007, the functional currency of our
Netherlands operation is the Euro. The primary economic factor change was the increase in the
sales price and market indicator of significantly more contracts in EUROs as well as the cash flow
and financing indicator of US Dollar to Euro in our Netherlands operation. The equity adjustment
from this foreign currency translation was $10,295 at September 30, 2007.
Note 2 Earnings Per Share:
-7-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Basic income per common share for the three and nine months ended September 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 nine months ended
September 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.
-8-
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Three Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income basic and diluted |
|
$ |
1,535,644 |
|
|
$ |
391,143 |
|
|
$ |
646,862 |
|
|
$ |
366,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator basic: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
11,576,638 |
|
|
|
11,197,985 |
|
|
|
11,658,035 |
|
|
|
11,213,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income per common share |
|
$ |
0.13 |
|
|
$ |
0.03 |
|
|
$ |
0.06 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares |
|
|
11,576,638 |
|
|
|
11,197,985 |
|
|
|
11,658,035 |
|
|
|
11,213,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share equivalents
of outstanding stock options |
|
|
1,025,897 |
|
|
|
923,469 |
|
|
|
950,320 |
|
|
|
911,726 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share equivalents of
unrecognized compensation expense |
|
|
66,767 |
|
|
|
|
|
|
|
69,349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
dilutive common equity shares |
|
|
12,669,302 |
|
|
|
12,121,454 |
|
|
|
12,677,704 |
|
|
|
12,125,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income per
common share |
|
$ |
0.12 |
|
|
$ |
0.03 |
|
|
$ |
0.05 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options to purchase 322,800 and 137,000 shares of our common stock had been excluded from the
calculation of diluted earnings per common share for the three and nine months ended September 30,
2007, as they were all antidilutive. Options to purchase 665,100 shares of our common stock had
been excluded from the calculation of diluted earnings per common share for the three and nine
months ended September 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
-9-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
employment agreement, our President and Chief Executive Officer can potentially receive up to
25,000 shares of the companys common stock each fiscal year. Based on managements assumptions,
we recognized the related proportionate expense for these stock units for the nine months ended
September 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.
-10-
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
September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
12,393,906 |
|
|
$ |
62,677 |
|
|
$ |
12,456,583 |
|
Total cost and expenses |
|
$ |
10,828,548 |
|
|
$ |
739,912 |
|
|
$ |
11,568,460 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
$ |
1,565,358 |
|
|
$ |
(677,235 |
) |
|
$ |
888,123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended
September 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
10,285,894 |
|
|
$ |
20,030 |
|
|
$ |
10,305,924 |
|
Total cost and expenses |
|
$ |
9,488,345 |
|
|
$ |
387,571 |
|
|
$ |
9,875,916 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
$ |
797,549 |
|
|
$ |
(367,541 |
) |
|
$ |
430,008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended
September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
34,822,411 |
|
|
$ |
395,831 |
|
|
$ |
35,218,242 |
|
Total cost and expenses |
|
$ |
31,321,419 |
|
|
$ |
1,833,312 |
|
|
$ |
33,154,731 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
$ |
3,500,992 |
|
|
$ |
(1,437,481 |
) |
|
$ |
2,063,511 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended
September 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
29,600,239 |
|
|
$ |
230,177 |
|
|
$ |
29,830,416 |
|
Total cost and expenses |
|
$ |
28,154,036 |
|
|
$ |
1,422,084 |
|
|
$ |
29,576,120 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
$ |
1,446,203 |
|
|
$ |
(1,191,907 |
) |
|
$ |
254,296 |
|
|
|
|
|
|
|
|
|
|
|
Our foreign customers accounted for approximately 41% and 29% of service revenues for the nine
months ended September 30, 2007 and 2006, respectively. For the three months ended September 30,
2007 and 2006, our foreign customers accounted for approximately 50% and 31% of service revenues,
respectively.
Note 5 Accounts Receivable and Allowance for Doubtful Accounts
-11-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
We maintain allowances for doubtful accounts on a specific identification method for
estimated losses resulting from the inability of our customers to make required payments. If
the financial condition of our customers were to deteriorate, resulting in an impairment of our
customers ability to make payments, additional allowances may be required. We do not have any
off-balance-sheet credit exposure related to our customers and the trade accounts receivable does
not bear interest.
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
Billed trade accounts receivable |
|
$ |
5,681,280 |
|
|
$ |
4,781,682 |
|
Unbilled trade accounts receivable |
|
|
1,658,364 |
|
|
|
771,818 |
|
Other |
|
|
19,535 |
|
|
|
11,248 |
|
|
|
|
|
|
|
|
Total Receivables |
|
$ |
7,359,179 |
|
|
$ |
5,564,748 |
|
|
|
|
|
|
|
|
|
|
Allowance Rollforward: |
|
|
|
|
|
|
|
|
Balance at January 1, 2007 |
|
$ |
14,000 |
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Write offs (net of recoveries) |
|
|
(14,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
$ |
0 |
|
|
|
|
|
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 deferred
tax assets are primarily comprised of the temporary book to tax differences related to deferred
revenue.
We have accumulated tax losses, which include allowable deductions related to exercised
employee stock options, generating federal net operating loss (NOL) carryforwards of $1.1 million
as of September 30, 2007. Under limitations imposed by Internal Revenue Code Section 382, certain
potential changes in our ownership, which may be outside our knowledge or control,
-12-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
may restrict
future utilization of these carryforwards. Due to such ownership changes that have occurred in
prior years, we have estimated that this $1.1 million of remaining 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 September
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 tax returns for years 2005 and 2006 are
subject to examination. Our state taxes for years 2000 through 2006 are subject to examination.
Our foreign taxes for years 2002 through 2006 are subject to examination by the respective
authorities.
Note 7 Derivatives and Other Hedging Instruments
We have not entered into any derivatives or other hedging instruments during the nine months
ended September 30, 2007. As of September 30, 2007, there are no outstanding derivative positions.
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, 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 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 to hedge
-13-
BIO-IMAGING TECHNOLOGIES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
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 six months ended
September 30, 2007. During the nine months ended September 30, 2006, we exercised 4 options and a
loss of $16,516 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 record a gain or loss from the derivative that is deferred in
stockholders equity to the Consolidated Statement of Operations based on the nature of the
underlying cash flow hedged.
Note 8 Acquisition
On February 6, 2007, we acquired 100% of the outstanding securities of Theralys, a company
headquartered in Lyon, France to expand our therapeutic expertise in the Central Nervous System and
Neurovascular areas. The aggregate purchase price was 2,958,285 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
in value was paid with 93,408 shares of our common stock. We also incurred approximately $673,000
in acquisition costs. The purchase of the business was accounted for under the purchase method of
accounting. The result of operations of Theralys were included in our financial statements at the
acquisition date in our pharmaceutical contract services business segment. The assets acquired
primarily consisted of $4,221,000 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.
-14-
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations.
Overview
Pharmaceutical Contract Services
We are a global pharmaceutical contract service organization, providing services that support
the product development process of the pharmaceutical, biotechnology and medical device industries.
We specialize in assisting our clients in the design and management of the medical imaging
component of clinical trials for all modalities, which includes computerized tomography (CT),
magnetic resonance imaging (MRI), radiography, dual energy x-ray absorptiometry (DXA/DEXA),
positron emission tomography (PET), single photon emission computerized tomography (SPECT),
quantitative coronary angiography (QCA), cardiac MRI and CT, intravascular ultrasound (IVUS),
peripheral quantitative angiography (QVA), central nervous system (CNS) MRI and ultrasound. We
provide services that include the processing and analysis of medical images and the data-basing and
regulatory submission of medical images, quantitative data and text.
Our sales cycle, referring to the period from the presentation by us to a potential client to
the engagement of us by such client, has historically been approximately 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 118 clients encompassing 251 distinct projects for the nine
months ended September 30, 2007. This compares to 119 clients encompassing 267 distinct projects
for the nine months ended September 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 $88.7 million as of September 30, 2007. This compares to $70.6 million as of September
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.
-15-
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. We also have developed an In Case of Emergency (ICEphr) designed especially for
use in emergencies to provide consumers with private and timely access to personal health
information in a security-enhanced environment. In coming months, CapMed will be launching icePHR
Mobile that will allow access to the information on cell phones and PDAs and the comprehensive PHR
Online product that will capture and maintain all aspects of personal health management. The
markets for our CapMed division continue to evolve favorably. We continue to be encouraged by the
long-term prospects for this division although the revenue generating adoption rate has been slower
than anticipated,
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,
-16-
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 for years 2002 through 2006 are subject to examination by the respective
authorities.
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements, (SFAS 157) which
addresses how companies should measure fair value when required for recognition or disclosure
purposes under GAAP. SFAS 157 is effective for fiscal years beginning after November 15, 2007. We
are currently evaluating SFAS 157 and the related impact on our
financial position and results of operations.
-17-
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 159, Fair Value Option for Financial Assets and
Financial Liabilities, (SFAS 159) which permits companies to use fair value for reporting purposes
under GAAP. SFAS 159 is effective for fiscal years beginning after November 15, 2007. We are
currently evaluating SFAS 157 and the related impact on our financial position and results of
operations.
-18-
Results of Operations
Three Months Ended September 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three |
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
|
Months |
|
|
|
|
|
|
|
|
Ended |
|
|
|
|
|
Ended |
|
|
|
|
|
|
|
|
September 30, |
|
% of Total |
|
September 30, |
|
% of Total |
|
|
|
|
|
|
2007 |
|
Revenue |
|
2006 |
|
Revenue |
|
$ Change |
|
% Change |
|
Service revenues |
|
$ |
9,563,241 |
|
|
|
76.8 |
% |
|
$ |
8,094,141 |
|
|
|
78.5 |
% |
|
$ |
1,469,100 |
|
|
|
18.2 |
% |
Reimbursement
revenues |
|
|
2,893,342 |
|
|
|
23.2 |
% |
|
|
2,211,783 |
|
|
|
21.5 |
% |
|
|
681,559 |
|
|
|
30.8 |
% |
|
Total revenues |
|
|
12,456,583 |
|
|
|
100.0 |
% |
|
|
10,305,924 |
|
|
|
100.0 |
% |
|
|
2,150,659 |
|
|
|
20.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service
revenue |
|
|
5,392,924 |
|
|
|
43.3 |
% |
|
|
4,903,640 |
|
|
|
47.6 |
% |
|
|
489,284 |
|
|
|
10.0 |
% |
Cost of
reimbursement
revenue |
|
|
2,893,342 |
|
|
|
23.2 |
% |
|
|
2,211,783 |
|
|
|
21.5 |
% |
|
|
681,559 |
|
|
|
30.8 |
% |
Sales and
marketing expenses |
|
|
1,724,134 |
|
|
|
13.8 |
% |
|
|
1,358,641 |
|
|
|
13.2 |
% |
|
|
365,493 |
|
|
|
26.9 |
% |
General and
administrative
expenses |
|
|
1,558,060 |
|
|
|
12.5 |
% |
|
|
1,401,852 |
|
|
|
13.6 |
% |
|
|
156,208 |
|
|
|
11.1 |
% |
|
Total cost and expenses |
|
|
11,568,460 |
|
|
|
92.9 |
% |
|
|
9,875,916 |
|
|
|
95.9 |
% |
|
|
1,692,544 |
|
|
|
17.1 |
% |
|
Income from operations |
|
|
888,123 |
|
|
|
7.1 |
% |
|
|
430,008 |
|
|
|
4.2 |
% |
|
|
458,115 |
|
|
|
106.5 |
% |
Interest income |
|
|
168,295 |
|
|
|
1.4 |
% |
|
|
146,904 |
|
|
|
1.4 |
% |
|
|
21,391 |
|
|
|
14.6 |
% |
Interest expense |
|
|
(1,144 |
) |
|
|
(0.0 |
)% |
|
|
(10,154 |
) |
|
|
(0.1 |
)% |
|
|
9,010 |
|
|
|
(88.7 |
)% |
|
Income before
income tax provision |
|
|
1,055,274 |
|
|
|
8.5 |
% |
|
|
566,758 |
|
|
|
5.5 |
% |
|
|
488,516 |
|
|
|
86.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
408,412 |
|
|
|
3.3 |
% |
|
|
200,082 |
|
|
|
1.9 |
% |
|
|
208,330 |
|
|
|
104.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
646,862 |
|
|
|
5.2 |
% |
|
$ |
366,676 |
|
|
|
3.6 |
% |
|
$ |
280,186 |
|
|
|
76.4 |
% |
|
Service revenues for the three months ended September 30, 2007 and 2006 were $9,563,241 and
$8,094,141 respectively, an increase of $1,469,100, or 18.2%. The increase in service revenues was
due to an increase in work performed from our increased backlog. Our backlog at September 30, 2007
was $88.7 million compared to $70.6 million at September 30, 2006, an increase of 25.6%. 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 96 clients encompassing 221 distinct projects for the
three months ended September 30, 2007. This compares to 100 clients encompassing 223 distinct
projects for the three months ended September 30, 2006. This decrease in the number of
-19-
projects is in part due to a marketing focus on larger clinical trials projects. One client,
Hoffmann-LaRoche, encompassing nine projects represented 22.48% of our service revenues for the
three months ended September 30, 2007. No one client accounted for more than 10% of our service
revenue for the three months ended September 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 and cost of reimbursement revenues for the three months ended September
30, 2007 and 2006 were $2,893,342 and $2,211,783 respectively, an increase of $681,559, or 30.8%.
Reimbursement revenues and cost of reimbursement revenues consist of payments received from the
customer for reimbursable costs. Reimbursement revenues and cost of reimbursement revenues
fluctuate significantly over the course of any given project and quarter to quarter variations are
a reflection of this project timing. Therefore, our management believes that reimbursement
revenues and cost of reimbursement revenues are not a significant indicator of our overall
performance trends. At the request of our clients, we may directly pay the independent
radiologists who review our clients imaging data. In such cases, per contractual arrangement,
these costs are billed to our clients and are included in reimbursement revenues and cost of
reimbursement revenues.
Cost of service revenues for the three months ended September 30, 2007 and 2006 were
$5,392,924 and $4,903,640 respectively, an increase of $489,284, or 10.0%. The increase in cost of
revenues is primarily due to the addition of operating costs from Theralys S.A. Cost of service
revenues for the three months ended September 30, 2007 and three months ended September 30, 2006
were comprised of professional salaries and benefits and allocated overhead. The cost of revenues
as a percentage of total revenues also fluctuates due to work-flow variations in the utilization of
staff and the mix of services provided by us in any given period. We expect that our cost of
revenues will continue to increase in fiscal 2007 as service revenues increase.
Sales and marketing expenses for the three months ended September 30, 2007 and 2006 were
$1,724,134 and $1,358,641 respectively, an increase of $365,493, or 26.9%. Sales and marketing
expenses for the three months ended September 30, 2007 and three months ended September 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 $273,000 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 13.8% for the three months ended September 30, 2007 from 13.2% for
the three months ended September 30, 2006 is primarily due to the increase in CapMed costs.
General and administrative expenses for the three months ended September 30, 2007 and 2006
were $1,558,060 and $1,401,852 respectively, an increase of $156,208, or 11.1%. General and
administrative expenses for the three months ended September 30, 2007 and three months
-20-
ended September 30, 2006 consisted primarily of salaries and benefits, allocated overhead,
professional and consulting services, and corporate insurance. The increase is primarily due to an
increase in professional and consulting services. We expect that our general and administrative
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 to 12.5% for the three months ended September 30, 2007 from 13.6% for the three months
ended September 30, 2006 primarily due to a greater increase in our total revenues for the three
months ended September 30, 2007.
Net interest income was $167,151 for the three months ended September 30, 2007 and $136,750
for the three months ended September 30, 2006, an increase of $30,401 or 22.2%. 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 September 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 further acquisitions.
Income before income taxes was $1,055,274 for the three months ended September 30, 2007, and
$566,758 for the three months ended September 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 September 30, 2007 and 2006 was $408,412
and $200,082, respectively. Our effective tax rate is approximately 40% for fiscal 2007. Our
effective tax rate is approximately 37% for fiscal 2006. The lower effective tax rate in fiscal
2006 was due to the mix of pre-tax income in the U.S. versus the Netherlands. The Netherlands has
a lower corporate income tax rate.
-21-
Nine Months Ended September 30, 2007 and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
|
|
|
|
Nine Months |
|
|
|
|
|
|
|
|
Ended |
|
|
|
|
|
Ended |
|
|
|
|
|
|
|
|
September 30, |
|
% of Total |
|
September 30, |
|
% of Total |
|
|
|
|
|
|
2007 |
|
Revenue |
|
2006 |
|
Revenue |
|
$ Change |
|
% Change |
|
Service revenues |
|
$ |
27,829,986 |
|
|
|
79.0 |
% |
|
$ |
23,452,033 |
|
|
|
78.6 |
% |
|
$ |
4,377,953 |
|
|
|
18.7 |
% |
Reimbursement
revenues |
|
|
7,388,256 |
|
|
|
21.0 |
% |
|
|
6,378,383 |
|
|
|
21.4 |
% |
|
|
1,009,873 |
|
|
|
15.8 |
% |
|
Total revenues |
|
|
35,218,242 |
|
|
|
100.0 |
% |
|
|
29,830,416 |
|
|
|
100.0 |
% |
|
|
5,387,826 |
|
|
|
18.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of service
revenue |
|
|
16,145,845 |
|
|
|
45.8 |
% |
|
|
14,785,346 |
|
|
|
49.6 |
% |
|
|
1,360,499 |
|
|
|
9.2 |
% |
Cost of reimbursement
revenue |
|
|
7,388,256 |
|
|
|
21.0 |
% |
|
|
6,378,383 |
|
|
|
21.4 |
% |
|
|
1,009,873 |
|
|
|
15.8 |
% |
Sales and
marketing expenses |
|
|
5,023,149 |
|
|
|
14.3 |
% |
|
|
4,247,477 |
|
|
|
14.2 |
% |
|
|
775,672 |
|
|
|
18.3 |
% |
General and
administrative
expenses |
|
|
4,597,481 |
|
|
|
13.1 |
% |
|
|
4,164,914 |
|
|
|
14.0 |
% |
|
|
432,567 |
|
|
|
10.4 |
% |
|
Total cost and expenses |
|
|
33,154,731 |
|
|
|
94.1 |
% |
|
|
29,576,120 |
|
|
|
99.1 |
% |
|
|
3,578,611 |
|
|
|
12.1 |
% |
|
Income (loss) from
operations |
|
|
2,063,511 |
|
|
|
5.9 |
% |
|
|
254,296 |
|
|
|
0.9 |
% |
|
|
1,809,215 |
|
|
|
711.5 |
% |
Interest income |
|
|
484,343 |
|
|
|
1.4 |
% |
|
|
393,349 |
|
|
|
1.3 |
% |
|
|
90,994 |
|
|
|
23.1 |
% |
Interest expense |
|
|
(11,276 |
) |
|
|
(0.0 |
)% |
|
|
(41,030 |
) |
|
|
(0.1 |
)% |
|
|
29,754 |
|
|
|
(72.5 |
)% |
|
Income before
income tax provision |
|
|
2,536,578 |
|
|
|
7.2 |
% |
|
|
606,615 |
|
|
|
2.0 |
% |
|
|
1,929,963 |
|
|
|
318.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
1,000,934 |
|
|
|
2.8 |
% |
|
|
215,472 |
|
|
|
0.7 |
% |
|
|
758,462 |
|
|
|
364.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,535,644 |
|
|
|
4.4 |
% |
|
$ |
391,143 |
|
|
|
1.3 |
% |
|
$ |
1,144,501 |
|
|
|
292.6 |
% |
|
Service revenues for the nine months ended September 30, 2007 and 2006 were $27,829,986 and
$23,452,033 respectively, an increase of $4,377,953, or 18.7%. The increase in service revenues
was due to an increase in work performed from our increased backlog. Our backlog at September 30,
2007 was $88.7 million compared to $70.6 million at September 30, 2006, an increase of 25.6%. 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 118 clients encompassing 251 distinct projects for the
nine months ended September 30, 2007. This compares to 119 clients encompassing 267 distinct
projects for the nine months ended September 30, 2006. This decrease in the number of projects is
in part due to a marketing focus on larger clinical trials projects. One client, Hoffmann-LaRoche,
encompassing nine projects represented 11.1% of our service revenues for
-22-
the nine months ended September 30, 2007. One client, Novartis Pharmaceuticals, Inc., encompassing
14 projects represented 11.4% of our service revenues for the nine months ended September 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 and cost of reimbursement revenues for the nine months ended September
30, 2007 and 2006 were $7,388,256 and $6,378,383 respectively, an increase of $1,009,873, or 15.8%.
Reimbursement revenues and cost of reimbursement revenues consist of payments received from the
customer for reimbursable costs. Reimbursement revenues and cost of reimbursement revenues
fluctuate significantly over the course of any given project and quarter to quarter variations are
a reflection of this project timing. Therefore, our management believes that reimbursement
revenues and cost of reimbursement revenues are not a significant indicator of our overall
performance trends. At the request of our clients, we may directly pay the independent
radiologists who review our clients imaging data. In such cases, per contractual arrangement,
these costs are billed to our clients and are included in reimbursement revenues and cost of
reimbursement revenues.
Cost of service revenues for the nine months ended September 30, 2007 and 2006 were
$16,145,845 and $14,785,346 respectively, an increase of $1,360,499, or 9.2%. The increase in cost
of revenues is primarily due to the addition of operating costs from Theralys S.A. Cost of service
revenues for the nine months ended September 30, 2007 and nine months ended September 30, 2006 were
comprised of professional salaries and benefits and allocated overhead. The cost of revenues as a
percentage of total revenues also fluctuates due to work-flow variations in the utilization of
staff and the mix of services provided by us in any given period. We expect that our cost of
revenues will continue to increase in fiscal 2007 as service revenues increase.
Sales and marketing expenses for the nine months ended September 30, 2007 and 2006 were
$5,023,149 and $4,247,477 respectively, an increase of $775,672, or 18.3%. Sales and marketing
expenses for the nine months ended September 30, 2007 and nine months ended September 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
$375,000 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. Sales and marketing expenses as a percentage of total revenues for
the nine months ended September 30, 2007 remained consistent at 14.3% from nine months ended
September 30, 2006 at 14.2%.
General and administrative expenses for the nine months ended September 30, 2007 and 2006 were
$4,597,481 and $4,164,914 respectively, an increase of $432,567, or 10.4%. General and
administrative expenses for the nine months ended September 30, 2007 and nine months ended
September 30, 2006 consisted primarily of salaries and benefits, allocated overhead, professional
and consulting services, and corporate insurance. The increase is primarily due to
an increase in professional and consulting services. We expect that our general and
-23-
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 to 13.1% for the nine months ended September 30, 2007 from
14.0% for the nine months ended September 30, 2006 primarily due to a greater increase in our total
revenues for the nine months ended September 30, 2007.
Net interest income was $473,067 for the nine months ended September 30, 2007 and $352,319 for
the nine months ended September 30, 2006, an increase of $120,748 or 34.3%. 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 nine months ended September 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 further
acquisitions.
Income before income taxes was $2,536,578 for the nine months ended September 30, 2007, and
$606,615 for the nine months ended September 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 nine months ended September 30, 2007 and 2006 was $1,000,934
and $215,472, respectively. Our effective tax rate is approximately 40% for fiscal 2007. Our
effective tax rate is approximately 37% for fiscal 2006. The lower effective tax rate in fiscal
2006 was due to the mix of pre-tax income in the U.S. versus the Netherlands. The Netherlands has
a lower corporate income tax rate.
Business Segments
We have set forth certain financial information with respect to our two business segments,
pharmaceutical contract services and the CapMed division, in Note 4 Business Segments to our
Consolidated Financial Statements in this Quarterly Report on Form 10-Q.
During the three months ended September 30, 2007, we had CapMed segment sales of $62,677 and
total costs and expenses of $739,912, consisting of $574,779 of sales and marketing expenses,
$143,695 of general and administrative expenses and $21,438 of cost of revenues. This compares to
the three months ended September 30, 2006 whereby we had CapMed segment sales of $20,030 and total
costs and expenses of $387,571, consisting of $301,573 of sales and marketing expenses, $75,393 of
general and administrative expenses and $10,606 of cost of revenues. The increase in sales and
marketing expense was primarily due to increased tradeshow attendance, website re-design and a
general marketing and public relations cost increase.
During the nine months ended September 30, 2007, we had CapMed segment sales of $395,831 and
total costs and expenses of $1,833,312, consisting of $1,428,794 of sales and marketing expenses,
$357,199 of general and administrative expenses and $47,319 of cost of revenues. This compares to
the nine months ended September 30, 2006 whereby we had
-24-
CapMed segment sales of $230,177 and total costs and expenses of $1,422,084, consisting of
$1,054,235 of sales and marketing expenses, $263,559 of general and administrative expenses and
$104,291 of cost of revenues. The increase in sales and marketing expense was primarily due to
increased tradeshow attendance, website re-design and a general marketing and public relations cost
increase.
Liquidity and Capital Resources
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
Nine Months |
|
|
Ended |
|
Ended |
|
|
September 30, 2007 |
|
September 30, 2006 |
Net cash provided by operating activities |
|
$ |
5,220,010 |
|
|
$ |
5,429,841 |
|
Net cash used in investing activities |
|
$ |
(6,525,391 |
) |
|
$ |
(1,627,672 |
) |
Net cash used in financing activities |
|
$ |
(157,903 |
) |
|
$ |
(646,446 |
) |
At September 30, 2007, we had cash and cash equivalents of $14,702,980. Working capital,
defined as current assets minus current liabilities, at September 30, 2007 was $7,958,709.
Net cash provided by operating activities for the nine months ended September 30, 2007 was
$5,220,010 as compared to $5,429,841 for the nine months ended September 30, 2006. This increase
from the prior year is primarily due to the increase in net income, offset by the increase in
accounts receivables.
Net cash used in investing activities for the nine months ended September 30, 2007 was
$6,525,391 as compared to $1,627,672 for the nine months ended September 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 nine months ended September 30, 2007 was
$157,903 as compared to $646,446 for the nine months ended September 30, 2006. The change is
primarily attributable to lesser payments under equipment lease obligations for the nine months
ended September 30, 2007 due to not entering into any new capital leases and the expiration of
existing capital leases in 2007.
-25-
The following table lists our cash contractual obligations as of September 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 |
|
$ |
173,573 |
|
|
$ |
173,573 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facility rent operating
leases |
|
$ |
5,373,539 |
|
|
$ |
1,483,942 |
|
|
$ |
2,890,560 |
|
|
$ |
999,037 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employment agreements |
|
$ |
554,583 |
|
|
$ |
415,000 |
|
|
$ |
139,583 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash
obligations |
|
$ |
6,101,695 |
|
|
$ |
2,072,515 |
|
|
$ |
3,030,143 |
|
|
$ |
999,037 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended September 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 nine months ended September 30, 2006, we exercised four options and a loss of $16,516
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.
During the nine months ended September 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. As of September 30, 2007, there are no outstanding
derivative positions.
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.
-26-
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 September 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.
-27-
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 EURO denominated. At September 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
$223,596 and $41,600 to our net asset position at September 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 September 30, 2007 and December 31, 2006.
Item 4T. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures. We evaluated, under the supervision and with the
participation of the Chief Executive Officer and Chief Financial Officer, the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Securities and Exchange Act of 1934 (Exchange Act), as amended) as of
September 30, 2007, the end of the period covered by this report on Form 10-Q. Based on this
evaluation, our President and Chief Executive Officer (principal executive officer) and our Chief
Financial Officer (principal accounting and financial officer) have concluded that, as a result of
the material weakness described below, our disclosure controls and procedures were not effective as
of September 30, 2007. Disclosure controls and procedures are
designed to ensure that information required to be disclosed by us in the reports
-28-
that we file or
submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and were not operating in an effective manner for
the period covered by this report, and (ii) is accumulated and communicated to management,
including the chief executive officer and chief financial officer, as appropriate, to allow timely
decisions regarding required disclosures. Notwithstanding the material weakness described below,
we have concluded that the consolidated financial statements included in this Quarterly Report on
Form 10-Q present fairly, in all material respects, our financial position, results of operations
and cash flows in accordance with accounting principles generally accepted in the United States of
America.
A material weakness is a control deficiency, or combination of control deficiencies in internal
control over financial reporting such that there is a reasonable possibility that a material
misstatement of the interim or annual consolidated financial statements will not be prevented or
detected on a timely basis.
As of September 30, 2007, we identified the following material weakness:
We did not maintain effective controls over the accuracy of service revenues. Specifically, we did
not maintain effective controls to review the accuracy of manual calculations for our monthly
service revenues made within a spreadsheet application. This control deficiency resulted in audit
adjustments that were material to the September 30, 2007 consolidated financial statements. In
addition, this control deficiency could result in a misstatement of service revenues that would
result in a material misstatement of the annual or interim financial statements that would not be
prevented or detected. Accordingly, we have determined that this control deficiency constitutes a
material weakness.
Remediation of Material Weakness. In the fourth quarter of 2007 we migrated the manual revenue
calculation from spreadsheet applications into automated functions within the accounting system
thereby eliminating the use of spreadsheets in the monthly revenue calculation. Also, during the
fourth quarter of 2007 we implemented additional revenue reporting and disclosure controls. We
will consider the design and operating effectiveness of these actions and will make additional
changes as determined appropriate.
Changes in internal control over financial reporting. The material weakness discussed above
constituted a change in our internal control over financial reporting during the period covered by
this Quarterly Report on Form 10-Q that materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
-29-
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
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
-30-
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. |
One client, Hoffmann-LaRoche, encompassing 9 projects represented 11.1% of our service
revenues for the nine months ended September 30, 2007. One client, Novartis Pharmaceuticals, Inc.,
encompassing 14 projects represented 11.4% of our service revenue for the nine months ended
September 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 $88.7 million at September 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
revenue at the rate originally expected. Accordingly, the historical relationship of backlog to
revenues may not be indicative of future results.
-31-
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 221 in the third
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.
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
-32-
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 third 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; |
|
|
|
|
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; |
-33-
|
|
|
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.
-34-
Our CapMed division may not reach profitability.
Our CapMed division had a loss from operations for the three months ended September 30, 2007
of $677,235 and a loss of operations of $1,437,481 for the nine months ended September 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.
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
-35-
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 September 30, 2007, we had the following capital structure:
|
|
|
|
|
Common stock outstanding |
|
|
11,674,113 |
|
|
|
|
|
|
Common stock issuable upon: |
|
|
|
|
Exercise of options which are outstanding |
|
|
1,734,379 |
|
|
|
|
|
|
Exercise of options which have not been granted |
|
|
585,344 |
|
|
|
|
|
|
Total common stock outstanding assuming exercise
or conversion of all of the above |
|
|
13,993,836 |
|
|
|
|
|
|
As of September 30, 2007, we had outstanding options to purchase 1,734,379 shares of common
stock at exercise prices ranging from $0.63 to $8.06 per share (exercisable at a weighted average
of $2.60 per share), of which 1,506,869 options were then exercisable. Exercise of our outstanding
options into shares of our common stock may significantly and negatively affect the
market price for our common stock as well as decrease your percentage ownership and voting
power. In addition, we may conduct future offerings of our common stock or other securities with
rights to convert the securities into shares of our common stock. As a result of these and other
events, such as future acquisitions, that increase the number of our
-36-
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 September 30, 2007, we had 11,674,113 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 24% of the outstanding shares of common
stock and stock options that could have been converted to common stock at September 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 stockholders have purchased their shares.
-37-
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 September 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
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.
-38-
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.
None.
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). |
-39-
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: November 14, 2007
|
|
By:
|
|
/s/ Mark L. Weinstein |
|
|
|
|
|
|
|
|
|
|
|
Mark L. Weinstein, President and Chief Executive
Officer (Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
DATE: November 14, 2007
|
|
By:
|
|
/s/ Ted I. Kaminer |
|
|
|
|
|
|
|
|
|
|
|
Ted I. Kaminer, Senior Vice President and Chief
Financial Officer |
|
|
|
|
(Principal Financial and Accounting Officer) |
|
|
-40-