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  • 10-K (Feb 28, 2011)
  • 10-K (Mar 30, 2010)
  • 10-K (Apr 30, 2009)
  • 10-K (Mar 5, 2009)

 
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BIOCEPT INC 10-Q 2011

Documents found in this filing:

  1. 10-Q
  2. Ex-31.1
  3. Ex-31.2
  4. Ex-32.1
  5. Ex-32.2
  6. Ex-32.2

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

 

x           Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended September 30, 2011

 

or

 

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. 001-11182

 

BIOCLINICA, INC.

 (Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

11-2872047

(State or Other Jurisdiction of

 

(I.R.S. Employer Identification No.)

Incorporation or Organization)

 

 

 

826 Newtown-Yardley Road, Newtown, Pennsylvania 18940-1721

(Address of Principal Executive Offices) (Zip Code)

 

(267) 757-3000

(Registrant’s 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: x  No: o

 

Indicate by check mark if the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes: x  No: o

 

Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer o
(do not check if a smaller reporting company)

 

Smaller reporting company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes: o  No: x

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of October 31, 2011:

 

Class

 

Number of Shares

Common Stock, $0.00025 par value

 

15,659,975

 

 

 



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

TABLE OF CONTENTS

 

 

 

Page

 

 

 

PART I.

FINANCIAL INFORMATION.

 

 

 

 

Item 1.

Financial Statements (unaudited)

1

 

 

 

 

CONSOLIDATED BALANCE SHEETS
as of September 30, 2011 and December 31, 2010

2

 

 

 

 

CONSOLIDATED STATEMENTS OF INCOME
For the Three Months Ended September 30, 2011 and 2010

3

 

 

 

 

CONSOLIDATED STATEMENTS OF INCOME
For the Nine Months Ended September 30, 2011 and 2010

4

 

 

 

 

CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Nine Months Ended September 30, 2011 and 2010

5

 

 

 

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
For the Three and Nine Months Ended September 30, 2011 and 2010

7

 

 

 

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

8

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

 

 

 

 

Overview

17

 

 

 

 

Forward Looking Statements

18

 

 

 

 

Recent Accounting Pronouncements

19

 

 

 

 

Results of Operations

20

 

 

 

 

Business Segments

25

 

 

 

 

Liquidity and Capital Resources

26

 

 

 

 

Changes to Critical Accounting Policies and Estimates

28

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

 

 

 

Item 4.

Controls and Procedures

28

 

 

 

PART II.

OTHER INFORMATION.

 

 

 

 

Item 1.

Legal Proceedings

29

 

 

 

Item 1A.

Risk Factors

29

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

40

 

 

 

Item 3.

Defaults Upon Senior Securities

40

 

 

 

Item 4.

(REMOVED AND RESERVED)

40

 

 

 

Item 5.

Other Information

40

 

 

 

Item 6.

Exhibits

41

 

 

 

SIGNATURES

 

42

 

i



Table of Contents

 

PART I.  FINANCIAL INFORMATION.

 

Item 1.                                                           Financial Statements.

 

References in this Quarterly Report on Form 10-Q to “BioClinica,” “we,” “us,” or “our” refer to BioClinica, Inc., a Delaware corporation, and its subsidiaries, doing business as BioClinica.

 

Certain information and footnote disclosures required under generally accepted accounting principles (GAAP) in the United States of America have been condensed or omitted from the following consolidated financial statements pursuant to the rules and regulations of the Securities and Exchange Commission, although we believe that such financial disclosures are adequate so that the information presented is not misleading in any material respect.  The following consolidated financial statements should be read in conjunction with the year-end consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

 

The results of operations for the interim periods presented in this Quarterly Report on Form 10-Q are not necessarily indicative of the results to be expected for the entire fiscal year.

 

1



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED BALANCE SHEETS

(unaudited)

 

 

 

September 30,

 

December 31,

 

(in thousands)

 

2011

 

2010

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

12,292

 

$

10,443

 

Accounts receivable, net

 

13,482

 

11,866

 

Prepaid expenses and other current assets

 

2,594

 

2,501

 

Deferred income taxes

 

4,098

 

3,625

 

Total current assets

 

32,466

 

28,435

 

 

 

 

 

 

 

Property and equipment, net

 

15,459

 

14,029

 

Intangibles, net

 

1,963

 

2,430

 

Goodwill

 

34,302

 

34,302

 

Deferred income tax

 

87

 

128

 

Other assets

 

748

 

705

 

 

 

 

 

 

 

Total assets

 

$

85,025

 

$

80,029

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,168

 

$

1,983

 

Accrued expenses and other current liabilities

 

4,185

 

4,283

 

Deferred revenue

 

13,377

 

13,395

 

Current maturities of capital lease obligations

 

342

 

168

 

Current liability for acquisition earn-out

 

2,000

 

 

Total current liabilities

 

22,072

 

19,829

 

Long-term capital lease obligations

 

1,296

 

710

 

Long-term liability for acquisition earn-out

 

 

1,886

 

Deferred income tax

 

3,107

 

1,845

 

Other liabilities

 

1,621

 

880

 

Total liabilities

 

$

28,096

 

$

25,150

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock - $0.00025 par value; authorized 3,000,000 shares, none issued and outstanding at September 30, 2011 and at December 31, 2010

 

 

 

Common stock - $0.00025 par value; authorized 36,000,000 shares, issued and outstanding 15,662,550 shares at September 30, 2011 and 15,631,664 shares at December 31, 2010

 

4

 

4

 

Treasury stock — at cost, shares held: 160,113 at September 30, 2011 and 3,400 at December 31, 2010

 

(800

)

(16

)

Additional paid-in capital

 

49,231

 

48,074

 

Retained earnings

 

8,425

 

6,792

 

Accumulated other comprehensive income

 

69

 

25

 

Total stockholders’ equity

 

$

56,929

 

$

54,879

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

85,025

 

$

80,029

 

 

See Notes to Consolidated Financial Statements

 

2



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF INCOME

(unaudited)

 

 

 

For the Three Months ended
September 30,

 

(in thousands, except per share data)

 

2011

 

2010

 

Service revenues

 

$

16,623

 

$

15,969

 

Reimbursement revenues

 

4,847

 

2,352

 

Total revenues

 

21,470

 

18,321

 

 

 

 

 

 

 

Cost and expenses:

 

 

 

 

 

Cost of service revenues

 

10,434

 

10,212

 

Cost of reimbursement revenues

 

4,847

 

2,352

 

Sales and marketing expenses

 

2,081

 

2,090

 

General and administrative expenses

 

2,434

 

2,069

 

Amortization of intangible assets related to acquisition

 

155

 

194

 

Mergers and acquisitions related costs

 

 

119

 

Restructuring costs

 

1,040

 

 

Total cost and expenses

 

20,991

 

17,036

 

 

 

 

 

 

 

Operating income

 

479

 

1,285

 

 

 

 

 

 

 

Interest income

 

2

 

10

 

Interest expense

 

(14

)

 

Income before income tax

 

467

 

1,295

 

 

 

 

 

 

 

Income tax provision

 

(109

)

(487

)

Net income

 

$

358

 

$

808

 

 

 

 

 

 

 

Basic income per common share

 

$

0.02

 

$

0.05

 

Weighted average number of common shares

 

15,640

 

15,174

 

 

 

 

 

 

 

Diluted income per common share

 

$

0.02

 

$

0.05

 

Weighted average number of diluted shares

 

16,383

 

15,796

 

 

See Notes to Consolidated Financial Statements

 

3



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF INCOME

 

(unaudited)

 

 

 

For the Nine Months ended
September 30,

 

(in thousands, except per share data)

 

2011

 

2010

 

Service revenues

 

$

49,658

 

$

46,248

 

Reimbursement revenues

 

11,887

 

9,413

 

Total revenues

 

61,545

 

55,661

 

 

 

 

 

 

 

Cost and expenses:

 

 

 

 

 

Cost of service revenues

 

31,432

 

29,109

 

Cost of reimbursement revenues

 

11,887

 

9,413

 

Sales and marketing expenses

 

6,324

 

6,865

 

General and administrative expenses

 

7,027

 

6,057

 

Amortization of intangible assets related to acquisition

 

467

 

473

 

Mergers and acquisitions related costs

 

162

 

635

 

Restructuring costs

 

1,719

 

 

Total cost and expenses

 

59,018

 

52,552

 

 

 

 

 

 

 

Operating income

 

2,527

 

3,109

 

 

 

 

 

 

 

Interest income

 

6

 

18

 

Interest expense

 

(32

)

(7

)

Income before income tax

 

2,501

 

3,120

 

 

 

 

 

 

 

Income tax provision

 

(868

)

(1,198

)

Net income

 

$

1,633

 

$

1,922

 

 

 

 

 

 

 

Basic income per common share

 

$

0.10

 

$

0.13

 

Weighted average number of common shares

 

15,645

 

14,958

 

 

 

 

 

 

 

Diluted income per common share

 

$

0.10

 

$

0.12

 

Weighted average number of diluted shares

 

16,515

 

15,730

 

 

See Notes to Consolidated Financial Statements

 

4



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

 

 

For the Nine Months ended

 

 

 

September 30,

 

(in thousands)

 

2011

 

2010

 

Cash flows from operating activities:

 

 

 

 

 

Net income

 

$

1,633

 

$

1,922

 

Adjustments to reconcile net income to net cash provided by operating activities, net of acquisition:

 

 

 

 

 

Depreciation and amortization

 

3,310

 

2,501

 

Provision for deferred income taxes

 

829

 

47

 

Bad debt recovery, net

 

(15

)

(9

)

Stock based compensation expense

 

1,019

 

791

 

Accretion of acquisition earn-out

 

114

 

245

 

Changes in operating assets and liabilities, net of acquisitions:

 

 

 

 

 

(Increase) decrease in accounts receivable

 

(1,603

)

278

 

Increase in prepaid expenses and other current assets

 

(89

)

(625

)

(Increase) decrease in other assets

 

(42

)

17

 

Increase (decrease) in accounts payable

 

113

 

(199

)

Decrease in accrued expenses and other current liabilities

 

(89

)

(1,136

)

Decrease in deferred revenue

 

(19

)

(1,127

)

Increase in other liabilities

 

742

 

368

 

Net cash provided by operating activities

 

$

5,903

 

$

3,073

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of property and equipment

 

$

(1,352

)

$

(2,296

)

Capitalized software development costs

 

(2,843

)

(3,783

)

Net cash used in investing activities

 

$

(4,195

)

$

(6,079

)

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from sale/leaseback

 

918

 

195

 

Payments under equipment lease obligations

 

(157

)

 

Purchase of treasury stock

 

(784

)

 

Excess tax benefit related to stock options

 

 

35

 

Proceeds from exercise of stock options

 

138

 

21

 

Net cash provided by financing activities

 

$

115

 

$

251

 

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

26

 

1

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

1,849

 

(2,754

)

Cash and cash equivalents at beginning of period

 

10,443

 

14,570

 

Cash and cash equivalents at end of period

 

$

12,292

 

$

11,816

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

Cash paid during the period for interest

 

$

32

 

$

7

 

Cash paid during the period for income taxes

 

$

736

 

$

1,802

 

 

See Notes to Consolidated Financial Statements

 

5



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

 

 

For the Nine Months Ended
September 30,

 

 

 

2011

 

2010

 

Supplemental cash flow disclosure (in thousands)

 

 

 

 

 

Non cash investing and financing activities:

 

 

 

 

 

Increase in property, plant and equipment acquisitions in accounts payable

 

$

74

 

$

125

 

Equipment purchases under capital lease obligations

 

$

918

 

 

 

 

 

For the Nine Months Ended
September 30,

 

 

 

2011

 

2010

 

Acquired business (in thousands)

 

 

 

 

 

Accounts receivable

 

 

$

309

 

Property and equipment

 

 

91

 

Other assets

 

 

58

 

Other Liabilities

 

 

(459

)

Customer Relationships

 

 

100

 

Technology

 

 

1,000

 

Goodwill, including Workforce

 

 

1,369

 

Total Fair Value of Purchase Price

 

 

$

2,468

 

 

See Notes to Consolidated Financial Statements

 

6



Table of Contents

 

BIOCLINICA, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(unaudited)

 

 

 

For the Three Months Ended
September 30,

 

 

 

2011

 

2010

 

Statement of comprehensive income (in thousands)

 

 

 

 

 

Net income

 

$

358

 

$

808

 

Equity adjustment from foreign currency translation

 

(47

)

166

 

Total comprehensive income

 

$

311

 

$

974

 

 

 

 

For the Nine Months Ended
September 30,

 

 

 

2011

 

2010

 

Statement of comprehensive income (in thousands)

 

 

 

 

 

Net income

 

$

1,633

 

$

1,922

 

Equity adjustment from foreign currency translation

 

44

 

(37

)

Total comprehensive income

 

$

1,677

 

$

1,885

 

 

See Notes to Consolidated Financial Statements

 

7



Table of Contents

 

Note 1 - Interim Financial Statements

 

Basis of Presentation.

 

The financial statements included in this Quarterly Report on Form 10-Q have been prepared by us, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP in the United States of America have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2010.

 

In the opinion of management, the accompanying consolidated financial statements contain all adjustments, consisting solely of those which are of a normal recurring nature, necessary for a fair statement of the results for the interim periods.

 

Interim results are not necessarily indicative of results for the full fiscal year.

 

As  previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010, the Company identified and corrected clerical billing errors in the quarter ending June 30, 2010 that overstated service revenue and income from operations by $155,000 ($94,000 net of tax) and understated the quarter ending September 30, 2010 service revenue and income from operations by $155,000 ($94,000 net of tax). The Company determined that these adjustments were not material to its consolidated financial statements for any of the quarterly periods affected. The Company has revised the financial statements for the quarter ended September 30, 2010 presented herein.

 

Functional Currency.

 

The functional currency of each of the Company’s foreign operations is the local currency of the country in which the operation is located. All assets and liabilities are translated into U.S. dollars using exchange rates in effect at the balance sheet date. Revenue and expenses are translated using average exchange rates during the period. Increases and decreases in net assets resulting from foreign currency translation are reflected in stockholder’s equity as a component of accumulated other comprehensive income (loss).

 

The equity adjustment from foreign currency translation was $44,000 and $(37,000) for the nine months ended September 30, 2011 and 2010, respectively.

 

Recently Issued Accounting Pronouncements.

 

In May 2011, the FASB issued Accounting Standards Update (ASU) No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standards (Topic 820)—Fair Value Measurement (ASU 2011-04), to provide a consistent definition of fair value and ensure that the fair value measurement and disclosure requirements are similar between U.S. GAAP and International Financial Reporting Standards. ASU 2011-04 changes certain fair value measurement principles and enhances the disclosure requirements particularly for level 3 fair value measurements. ASU 2011-04 is effective for the Company in the first quarter of fiscal 2012 and should be applied prospectively. The Company is currently evaluating the impact of the pending adoption of ASU 2011-04 on its consolidated financial statements.

 

In June 2011, the FASB issued authoritative guidance that eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders’ equity, among other

 

8



Table of Contents

 

updates to the presentation of comprehensive income. Under this guidance, an entity has the option to present the total of comprehensive income, the components of net income and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In addition, an entity is required to present on the face of the financial statements reclassification adjustments for items that are reclassified from other comprehensive income to net income in the statement(s) where the components of net income and the components of other comprehensive income are presented. This guidance will be effective for BioClinica, Inc. on January 1, 2012 and will impact the presentation of the Company’s consolidated financial statements.

 

In September 2011, the FASB issued authoritative guidance that allows an entity to use a qualitative approach to test goodwill for impairment. Under this guidance, an entity has the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is unnecessary. In addition, an entity has the option to bypass the qualitative assessment for any reporting unit in any period and proceed directly to performing the first step of the two-step goodwill impairment test. This guidance will be effective for BioClinica’s goodwill impairment tests performed after December 31, 2011 and is not expected to have a material impact on the Company’s consolidated financial statements.

 

9



Table of Contents

 

Note 2 — Restructuring charges

 

In 2011, the Company realigned its global resources to eliminate certain duplicate functions and took a total restructuring charge of $1.7 million for the nine months ended September 30, 2011.  This restructuring charge was comprised of $656,000 in employee severance, $884,000 write-off of facility lease obligations and $179,000 in legal and other costs.

 

The Company has paid $715,000 of the restructuring cost as of September 30, 2011 and the $1,004,000 remaining to be paid is included in Accrued Expense and Other Current Liabilities on the Consolidated Balance Sheet.  $120,000 of the unpaid restructuring costs will be paid by December 31, 2011 and the remaining $884,000 of the unpaid restructuring cost consists of the facility lease obligations that will be paid out over the remaining term of the leases with the last lease payment in May 2014.

 

Note 3 — Stockholders’ Equity

 

The following summarizes the activity of the Stockholders’ equity accounts for the period from December 31, 2009 through September 30, 2011:

 

 

 

Common Stock

 

Additional
Paid-in

 

Treasury

 

Common
Stock
Consideration
for

 

Accumulated
Retained

 

Other
Comprehensive
Gain

 

Stockholders’

 

(in thousands)

 

Shares

 

Amount

 

Capital

 

Stock

 

Earnout

 

Earnings

 

(Loss)

 

Equity

 

Balance at December 31, 2009

 

14,394

 

$

4

 

$

43,104

 

 

$

1,309

 

4,039

 

79

 

48,535

 

Stock options exercised

 

265

 

 

122

 

 

 

 

 

 

122

 

Restricted shares issued

 

48

 

 

(55

)

 

 

 

 

 

(55

)

Stock consideration for acquisition

 

350

 

 

1,309

 

 

(1,309

)

 

 

 

Stock issues for acquisitions

 

578

 

 

2,468

 

 

 

 

 

 

2,468

 

Stock based compensation

 

 

 

1,080

 

 

 

 

 

 

1,080

 

Purchase of treasury stock

 

(3

)

 

 

(16

)

 

 

 

 

(16

)

Tax benefit on exercise of stock options

 

 

 

46

 

 

 

 

 

 

46

 

Equity adjustment from foreign currency translation

 

 

 

 

 

 

 

 

(54

)

(54

)

Net income

 

 

 

 

 

 

 

2,753

 

 

2,753

 

Balance at December 31, 2010

 

15,632

 

$

4

 

$

48,074

 

$

(16

)

 

$

6,792

 

$

25

 

$

54,879

 

Stock options exercised

 

124

 

 

216

 

 

 

 

 

216

 

Restricted shares issued

 

64

 

 

(78

)

 

 

 

 

(78

)

Stock based compensation

 

 

 

1,019

 

 

 

 

 

1,019

 

Purchase of treasury stock

 

(157

)

 

 

 

(784

)

 

 

 

(784

)

Equity adjustment from foreign currency translation

 

 

 

 

 

 

 

44

 

44

 

Net income

 

 

 

 

 

 

1,633

 

 

1,633

 

Balance at September 30, 2011

 

15,663

 

$

4

 

$

49,231

 

$

(800

)

 

$

8,425

 

$

69

 

$

56,929

 

 

On December 15, 2010, our Board of Directors authorized $2 million in funds for use in our common stock repurchase program over 18 months from December 2010.  Repurchases under the program may be made through open market purchases or privately negotiated transactions in accordance with applicable

 

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federal securities laws, including Rule 10b-18.  Rule 10b-18 puts limitations on this repurchase program, including but not limited to, the manner of purchase, the time of the repurchases, the prices paid and the volume of shares repurchased. The timing of the repurchases and the exact number of shares of common stock to be purchased will be determined by the discretion of our management under the supervision of the audit committee of our board of directors, and will depend upon market conditions and other factors.  The program will be funded using our cash on hand and cash generated from operations.  On March 14, 2011, we entered into a 10b5-1 Stock Repurchase Agreement with our broker so we had the ability to repurchase shares of our common stock during our standard blackout periods.  The program may be extended, suspended or discontinued at any time.

 

The following table provides information relating to our repurchase of common stock for the three months ended September 30, 2011:

 

 

 

Total Number
of Shares
Purchased

 

Average Price
Paid per
Share

 

Total Number of
Shares Purchased as
Part of Publicly
Announced Program

 

Approximate Dollar
Value of Shares that
May Yet Be
Purchased Under the
Program

 

July 1 — July 31, 2011

 

26,200

 

$

4.78

 

26,200

 

$

1,317,507

 

August 1 — August 31, 2011

 

19,000

 

$

4.75

 

19,000

 

$

1,226,614

 

September 1 — September 30, 2011

 

6,500

 

$

4.84

 

6,500

 

$

1,194,918

 

Total

 

51,700

 

 

 

51,700

 

 

 

 

Note 4 — Earnings Per Share

 

Basic income per common share for the three and nine months ended September 30, 2011 and 2010 was calculated by dividing the net income available to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period.  Diluted income per share for the three and nine months ended September 30, 2011 and 2010 was calculated by dividing net income by the weighted average number of shares of Common Sstock outstanding, adjusted for the effect of potentially dilutive securities using the treasury stock method.

 

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The computation of basic income per common share and diluted income per common share was as follows:

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(in thousands, except per share data)

 

2011

 

2010

 

2011

 

2010

 

Net income — basic and diluted

 

$

358

 

$

808

 

$

1,633

 

$

1,922

 

 

 

 

 

 

 

 

 

 

 

Denominator — basic:

 

 

 

 

 

 

 

 

 

Weighted average number of common shares

 

15,640

 

15,174

 

15,645

 

14,958

 

 

 

 

 

 

 

 

 

 

 

Basic income per common share

 

$

0.02

 

$

0.05

 

$

0.10

 

$

0.13

 

 

 

 

 

 

 

 

 

 

 

Denominator — diluted:

 

 

 

 

 

 

 

 

 

Weighted average number of common shares

 

15,640

 

15,174

 

15,645

 

14,958

 

Common share equivalents of outstanding convertible equity and unrecognized compensation expense

 

743

 

622

 

870

 

772

 

Weighted average number of dilutive common equity shares

 

16,383

 

15,796

 

16,515

 

15,730

 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share

 

$

0.02

 

$

0.05

 

$

0.10

 

$

0.12

 

 

Options to purchase 536,000 and 576,000 shares of BioClinica’s common stock respectively, had been excluded from the calculation of diluted earnings per common share for the nine months ended September 30, 2011 and September 30, 2010, respectively, as they were all antidilutive. Options to purchase 563,000 and 779,000 shares of BioClinica’s common stock respectively, had been excluded from the calculation of diluted earnings per common share for the three months ended September 30, 2011 and September 30, 2010, respectively, as they were all antidilutive.

 

Note 5 — Commitments and Contingencies

 

On May 5, 2010, the Company entered into an unsecured, committed line of credit with PNC Bank expiring May 5, 2012.  In April 2011, the Company extended the expiration date of this line of credit to May 4, 2013.    Under the credit agreement, the Company has the ability to borrow $7.5 million at interest rates equal to LIBOR plus 1.75%.  In addition, the Company pays a fee of 0.25% per annum on the loan commitment regardless of usage.  The credit agreement requires our compliance with certain

 

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covenants, including maintaining a minimum stockholders’ equity of $35 million.  As of September 30, 2011, the Company had no borrowings under this line of credit and was compliant with the covenants.

 

Note 6 — Accounts Receivable and Allowance for Doubtful Accounts

 

The Company maintains allowances for doubtful accounts on a specific identification method for estimated losses resulting from the inability of its customers to make required payments.  If the financial condition of its customers were to deteriorate, resulting in an impairment of the customers’ ability to make payments, additional allowances may be required.  The Company does not have any off-balance-sheet credit exposure related to its customers, and the trade accounts receivable do not bear interest.

 

(in thousands)

 

September 30, 2011

 

December 31, 2010

 

Billed trade accounts receivable

 

$

12,703

 

$

11,085

 

Unbilled trade accounts receivable

 

779

 

782

 

Other

 

 

14

 

Total Receivables

 

$

13,482

 

$

11,881

 

 

Allowance Rollforward (in thousands):

 

 

 

Balance at January 1, 2011

 

$

15

 

Additions

 

 

Write offs (Recoveries)

 

(15

)

Balance at September 30, 2011

 

$

0

 

 

Note 7 — Acquisitions

 

2010 Acquisition

 

On March 25, 2010, the Company acquired substantially all of the assets of privately held TranSenda International, LLC (“TranSenda”). Headquartered in Bellevue, WA, TranSenda was a provider of clinical trial management software (CTMS) solutions.  TranSenda’s suite of web-based, Office-Smart CTMS solutions creates efficiencies for trial operations through interoperability with Microsoft Office tools.  With this acquisition, BioClinica enhanced its ability to serve customers throughout the clinical research process with technologies that include improved efficiencies by reducing study durations and costs through integrated operational management.  The acquisition was made pursuant to an Asset Purchase Agreement, dated March 25, 2010, by and between the Company and TranSenda (the “Purchase Agreement”). Pursuant to the terms of the Purchase Agreement, the Company purchased and acquired from TranSenda all rights, title and interest of TranSenda in and to the Purchased Assets (as defined in the Purchase Agreement) and assumed the Assumed Liabilities (as defined in the Purchase Agreement) of TranSenda.

 

As consideration for the Purchased Assets and Assumed Liabilities, the Company issued 577,960 shares of common stock, par value $0.00025 per share, of the Company, valued at a volume weighted average price per share equal to $4.325560, and subject to a post-closing adjustment based on the Final Closing Net Working Capital (as defined in the Purchase Agreement).  Pursuant to the terms of the Purchase Agreement, 15% of the aggregate consideration was held in escrow to cover any potential indemnification claims under the Purchase Agreement for a period of 12 months following the Closing Date (as defined in the Purchase Agreement). On March 25, 2011, the amounts held in escrow were

 

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released and there were no indemnification claims.  As part of the Purchase Agreement, TranSenda agreed not to directly or indirectly offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of any shares of the Company’s common stock received pursuant to the Purchase Agreement for a period beginning on the date the Purchase Agreement was executed and continuing to and including the date 12 months after such date.  The Company recorded the fair value of the acquisition of $2,468,000 based on the Company’s market value per share of $4.27 for the stock consideration on March 25, 2010, the date of acquisition.

 

Pro Forma Results.  The following schedule includes consolidated statements of income data for the unaudited pro forma results for the nine months ended September 30, 2010 as if the TranSenda acquisition had occurred as of the beginning of the periods presented after giving effect to certain adjustments.  The unaudited pro forma information is provided for illustrative purposes only and is not indicative of the results of operations or financial condition that would have been achieved if the TranSenda acquisition would have taken place at the beginning of the periods presented and should not be taken as indicative of our future consolidated results of operations or financial condition.  Pro forma adjustments are tax-effected at our effective tax rate.

 

(in thousands except per share data)

 

Nine Months Ended
September 30, 2010

 

 

 

 

 

Total revenue

 

$

55,834

 

 

 

 

 

Income from operations

 

2,577

 

 

 

 

 

Net Income

 

1,583

 

 

 

 

 

Basic earnings per share

 

$

0.05

 

 

 

 

 

Diluted earnings per share

 

$

0.05

 

 

In connection with the acquisition of TranSenda, the Company performed an evaluation of the guidance included in FASB ASC 280, Segment Reporting (“FASB ASC 280”) and FASB ASC 350, Intangibles - Goodwill and Other (“FASB ASC 350”). Based on that evaluation, the Company included TranSenda as part of its clinical trials services reportable segment.

 

In accordance with FASB ASC 805, Business Combinations, the Company expensed all costs related to the acquisition.

 

The following table summarizes the amounts of identified assets acquired and liabilities assumed from TranSenda at the acquisition date fair value:

 

 

 

TranSenda

 

Accounts Receivable

 

$

309

 

Property and Equipment

 

91

 

Other Assets

 

58

 

Other Liabilities

 

(459

)

Customer Relationships

 

100

 

Technology

 

1,000

 

Goodwill, including Workforce

 

1,369

 

Total Fair Value of Purchase Price

 

$

2,468

 

 

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Accounts receivable, other assets and other liabilities were stated at their historical carrying values, which approximate fair value given the short-term nature of these assets and liabilities.  The goodwill is attributable to the workforce of the acquired business and synergies expected to arise after the acquisition of the business.

 

In accordance with FASB ASC 820, Fair Value Measurements (“FASB ASC 820”), the Company determined that the non-financial assets and liabilities summarized above are derived from significant unobservable inputs (“Level 3 inputs”) determined by management based on various market and income analyses and recent asset appraisals. The goodwill recorded in connection with these acquisitions will be deductible for tax purposes over 15 years.

 

2009 Acquisition

 

On September 15, 2009, BioClinica acquired substantially all of the assets of Tourtellotte Solutions, Inc. (“Tourtellotte”). Tourtellotte provides software applications and consulting services which support clinical trials in the pharmaceutical industry.   The purchase price for Tourtellotte was $2.1 million in cash. Pursuant to the acquisition agreement, the Company agreed to pay up to an additional $3.2 million in cash and 350,000 shares of our common stock based upon achieving certain milestones, which include certain product development and revenue targets (the “earn-out”).  In December 2010, the Company paid the first acquisition earn-out of $1,257,000 in cash and the issuance of 350,000 shares of the Company’s Common Stock.  The remaining cash contingent consideration expected to be paid in the fair value amount of $2,000,000 was classified as a short-term liability on the financial statements at September 30, 2011.  The difference between the fair value of the cash contingent consideration at date of acquisition and the expected payment will be recorded as an expense in the financial statements at the end of each reporting period.  The Company recorded $114,000 and $245,000 for the nine months ended September 30, 2011 and 2010, respectively, of accretion expense in mergers and acquisition related costs on the income statement for this difference.

 

The following table represents changes in assets and liabilities measured at fair value using Level 3 inputs:

 

Fair value at September 15, 2009

 

$

2,747,000

 

Earn-out accretion

 

396,000

 

Payment on earn-out one

 

(1,257,000

)

Fair value at December 31, 2010

 

1,886,000

 

Earn-out accretion

 

114,000

 

Fair value at September 30, 2011

 

$

2,000,000

 

 

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Table of Contents

 

Note 8 — Intangible Assets

 

At September 30, 2011, the composition of intangible assets were as follows:

 

(in thousands)

 

September 30,
2011

 

Estimated
Useful Life

 

Amortized intangible assets:

 

 

 

 

 

Technology

 

$

1,843

 

5 years

 

Trademarks

 

48

 

5 years

 

Customer backlog

 

2,112

 

3 to 7 years

 

Non-competition agreement

 

349

 

2 to 3 years

 

 

 

$

4,352

 

 

 

Accumulated amortization

 

(2,389

)

 

 

 

 

$

1,963

 

 

 

 

 

 

 

 

 

Unamortized intangible assets:

 

 

 

 

 

 

 

 

 

 

 

Goodwill

 

$

34,302

 

 

 

 

Estimated future amortization of the intangible assets is as follows:

 

(in thousands)

 

Year Ending
December 31,

 

Remainder of 2011

 

$

156

 

2012

 

534

 

2013

 

337

 

2014

 

309

 

2015

 

160

 

2016 and beyond

 

467

 

 

 

$

1,963

 

 

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Table of Contents

 

Item 2.                                             Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

Overview

 

BioClinica provides integrated clinical research technology solutions to pharmaceutical, biotechnology, medical device companies and other organizations such as contract research organizations, or CROs, engaged in global clinical studies. Our products and services include: medical image management, electronic image transport and archive solutions, electronic data capture, clinical data management, interactive voice and web response, clinical trial supply forecasting tools and clinical trial management software solutions. By supplying enterprise-class software and hosted solutions accompanied by expert services to fully utilize these tools, we believe that our offerings provide our clients, large and small, improved speed and efficiency in the execution of clinical studies, with reduced clinical and business risk.

 

Market for our Services

 

Our vision is to build critical mass in the complementary disciplines of clinical research related to data collection and processing — especially those which can benefit from our information technology products and support services — and to integrate them in ways that yield efficiency and value for our clients. Our goal is to provide demonstrable benefits to sponsor clients through this strategy, that is, faster and less expensive drug development. We believe that the outsourcing of these services should continue to increase in the future because of increased pressure on clients, including factors such as: the need to more tightly manage costs, capacity limitations, reductions in marketing exclusivity periods, the desire to reduce development time, increased globalization of clinical trials, productivity challenges, imminent patent expirations and more stringent regulation. We believe these trends will continue to create opportunities for companies like BioClinica that are focused on improving the efficiency of drug and medical device development.

 

Sales and Backlog

 

Our sales cycle, referring to the period from the presentation by us to a potential client to the engagement of us by such client, has historically ranged from three to 12 months.  In addition, the contracts under which we perform services typically cover a period of three months to seven years, and the volume and type of services performed by us generally vary during the course of a project. We cannot assure you that our project revenues will be at levels sufficient to maintain profitability.

 

Our contracted/committed backlog, referred to as backlog, is the expected service revenue that remains to be earned and recognized on both signed and verbally agreed to contracts.  In addition, our costs may increase to service our increased backlog.  Our backlog as of September 30, 2011 was $115.6 million, compared to $106.3 million at September 30, 2010.  Changes in backlog for the period reflect the net effect of new contract signings, addendums, cancellations, expansions, and reductions in scope of existing projects, all of which impacted our backlog at September 30, 2011.

 

Contracts included in backlog are subject to termination by our clients at any time.  In the event that a contract is cancelled by the client, we would be entitled to receive payment for all services performed up to the cancellation date.  The duration of the projects included in our backlog range from less than three months to 60 months.  We do not believe that backlog is a reliable predictor of future results because service revenues may be incurred in a given period on contracts that were not included in the previous reporting period’s backlog and/or contract cancellations or project delays may occur in a given period on

 

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contracts that were included in the previous reporting period’s backlog.

 

Acquisitions

 

On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda International, LLC, or TranSenda. Headquartered in Bellevue, WA, TranSenda was a provider of CTMS solutions.  TranSenda’s suite of web-based, Office-Smart CTMS solutions create efficiencies for trial operations through interoperability with Microsoft Office tools.  The CTMS solutions enable our clients to have their applications work together instead of being locked into a single suite vendor and serves as the foundation for operational data interchange among different software applications.  This facilitates easier access to data with a consistent user interface and reduces training costs.  With this acquisition, we enhanced our ability to serve customers throughout the clinical research process with technologies that include improved efficiencies by reducing study durations and costs through integrated operational management.  The acquisition was made pursuant to an Asset Purchase Agreement, dated March 25, 2010, by and between BioClinica and TranSenda, referred to herein as the Purchase Agreement. Pursuant to the terms of the Purchase Agreement, we purchased and acquired from TranSenda all right, title and interest of TranSenda in and to the Purchased Assets (as defined in the Purchase Agreement) and assumed the Assumed Liabilities (as defined in the Purchase Agreement) of TranSenda.

 

As consideration for the Purchased Assets and Assumed Liabilities, we issued 577,960 shares of our common stock, par value $0.00025 per share, valued at a volume weighted average price per share equal to $4.325560, and subject to a post-closing adjustment based on the Final Closing Net Working Capital (as defined in the Purchase Agreement).  Pursuant to the terms of the Purchase Agreement, 15% of the aggregate consideration was held in escrow to cover any potential indemnification claims under the Purchase Agreement for a period of 12 months following the Closing Date (as defined in the Purchase Agreement). On March 25, 2011, the amounts held in escrow were released and there were no indemnification claims.  As part of the Purchase Agreement, TranSenda agreed not to directly or indirectly offer, sell, contract to sell, pledge, grant any option to purchase, make any short sale or otherwise dispose of any shares of BioClinica’s common stock received pursuant to the Purchase Agreement for a period beginning on the date the Purchase Agreement was executed and continuing to and including the date 12 months after such date.  We recorded the fair value of the acquisition of $2,468,000 based on our market value per share of $4.27 on March 25, 2010, the date of acquisition.

 

Forward Looking Statements

 

Certain matters discussed in this Form 10-Q are “forward-looking statements” intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as “believes”, “expects”, “may”, “should” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties.  In particular, our statements regarding:  our projected financial results; the demand for our services and technologies; growing recognition for the use of independent medical image review services; trends toward the outsourcing of imaging services in clinical trials; realized return from our marketing efforts; increased use of digital medical images in clinical trials; integration of our acquired companies and businesses; expansion into new business segments; the success of any potential acquisitions and the integration of current acquisitions; and the level of our backlog are examples of such forward-looking statements.  The forward-looking statements include risks and uncertainties, including, but not limited to, the timing of revenues due to the variability in size, scope and duration of projects,

 

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Table of Contents

 

estimates made by management with respect to our critical accounting policies, regulatory delays, clinical study results which lead to reductions or cancellations of projects and other factors, including general economic conditions and regulatory developments, not within our control.  The factors discussed in this Form 10-Q and expressed from time to time in our filings with the SEC could cause actual results and developments to be materially different from those expressed in or implied by such statements.  The forward-looking statements are made only as of the date of this filing, and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

 

Recent Accounting Pronouncements

 

In May 2011, the FASB issued Accounting Standards Update (ASU) No. 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standards (Topic 820)—Fair Value Measurement (ASU 2011-04), to provide a consistent definition of fair value and ensure that the fair value measurement and disclosure requirements are similar between U.S. GAAP and International Financial Reporting Standards. ASU 2011-04 changes certain fair value measurement principles and enhances the disclosure requirements particularly for level 3 fair value measurements. ASU 2011-04 is effective for us in our first quarter of fiscal 2012 and should be applied prospectively. We are currently evaluating the impact of our pending adoption of ASU 2011-04 on our consolidated financial statements.

 

In June 2011, the FASB issued authoritative guidance that eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders’ equity, among other updates to the presentation of comprehensive income. Under this guidance, an entity has the option to present the total of comprehensive income, the components of net income and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In addition, an entity is required to present on the face of the financial statements reclassification adjustments for items that are reclassified from other comprehensive income to net income in the statement(s) where the components of net income and the components of other comprehensive income are presented. This guidance will be effective for BioClinica, Inc. on January 1, 2012 and will impact the presentation of the our consolidated financial statements.

 

In September 2011, the FASB issued authoritative guidance that allows an entity to use a qualitative approach to test goodwill for impairment. Under this guidance, an entity has the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step impairment test is unnecessary. In addition, an entity has the option to bypass the qualitative assessment for any reporting unit in any period and proceed directly to performing the first step of the two-step goodwill impairment test. This guidance will be effective for BioClinica’s goodwill impairment tests performed after December 31, 2011 and is not expected to have a material impact on our consolidated financial statements.

 

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Table of Contents

 

Results of Operations

 

Three Months Ended September 30, 2011 and 2010

 

(in thousands)

 

Three
Months
ended
September
30, 2011

 

% of Total
Revenue

 

Three
Months
ended
September
30, 2010

 

% of
Total
Revenue

 

$ Change

 

% Change

 

Service revenues

 

$

16,623

 

77.4

%

$

15,969

 

87.2

%

$

654

 

4.1

%

Reimbursement revenues

 

4,847

 

22.6

%

2,352

 

12.8

%

2,495

 

106.1

%

Total revenues

 

21,470

 

100.0

%

18,321

 

100.0

%

3,149

 

17.2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of service revenues

 

10,434

 

48.6

%

10,212

 

55.7

%

222

 

2.2

%

Cost of reimbursement revenues

 

4,847

 

22.6

%

2,352

 

12.8

%

2,495

 

106.1

%

Sales and marketing expenses

 

2,081

 

9.7

%

2,090

 

11.4

%

(9

)

(0.4

)%

General and administrative expenses

 

2,434

 

11.3

%

2,069

 

11.3

%

365

 

17.6

%

Amortization of intangible assets related to acquisitions

 

155

 

0.7

%

194

 

1.1

%

(39

)

(20.1

)%

Mergers and acquisitions related costs

 

 

0.0

%

119

 

0.6

%

(119

)

(100.0

)%

Restructuring costs

 

1,040

 

4.8

%

 

 

1,040

 

 

Total cost and expenses

 

20,991

 

97.8

%

17,036

 

93.0

%

3,955

 

23.2

%

Income from operations

 

479

 

2.2

%

1,285

 

7.0

%

(806

)

(62.7

)%

Interest income

 

2

 

0.0

%

10

 

0.1

%

(8

)

(80.0

)%

Interest expense

 

(14

)

(0.1

)%

 

 

(14

)

 

Income before income tax

 

467

 

2.2

%

1,295

 

7.1

%

(828

)

(63.9

)%

Income tax provision

 

(109

)

(0.5

)%

(487

)

(2.7

)%

378

 

(77.6

)%

Net income

 

$

358

 

1.7

%

$

808

 

4.4

%

$

(450

)

(55.7

)%

 

Service revenues were $16.6 million for the three months ended September 30, 2011 and $16.0 million for the same period in 2010, an increase of $654,000, or 4.1%.  The increase in service revenues was due to an increase in work performed on the increased backlog from the prior year.  Pfizer, Inc., encompassing 18 projects, represented 19.2% of our service revenue for the three months ended

 

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September 30, 2011.  For the three months ended September 30, 2010, Pfizer Inc., encompassing 20 distinct projects, represented 19.7% of our service revenues.

 

Reimbursement revenues and cost of reimbursement revenues were $4.8 million for the three months ended September 30, 2011 and $2.3 million for the same period in 2010, an increase of $2.5 million, or 106.1%.  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 client’s imaging data.  In such cases, per contractual arrangement, these costs are billed to our clients and are included in reimbursement revenues and cost of reimbursement revenues.

 

Cost of service revenues were $10.4 million for the three months ended September 30, 2011 and $10.2 million for the same period in 2010, an increase of $222,000, or 2.2%.  Cost of service revenues for the three months ended September 30, 2011 and 2010 were comprised of professional salaries and benefits and allocated overhead. The increase is primarily attributable to the additional personnel to support the growth of our Trident IWR and OnPoint CTMS products. The cost of revenues as a percentage of total revenues also fluctuates due to work-flow variations in the utilization of staff and the mix of services provided by us in any given period. We expect that our cost of service revenues will increase for the remainder of fiscal 2011 due to increased servicing costs for our growth products.

 

Sales and marketing expenses were flat at $2.1 million for the three months ended September 30, 2011 and for the same period in 2010.  Sales and marketing expenses for the three months ended September 30, 2011 and 2010 were comprised of direct sales and marketing costs, salaries and benefits and allocated overhead.  We expect that our sales and marketing expenses will remain relatively flat for the remainder of fiscal 2011.

 

General and administrative expenses were $2.4 million for the three months ended September 30, 2011 and $2.1 million for the same period in 2010, an increase of $365,000, or 17.6%.  General and administrative expenses for the three months ended September 30, 2011 and 2010 consisted primarily of salaries and benefits, allocated overhead, professional and consulting services and corporate insurance.  The increase is due to increased information technology infrastructure costs to support our suite of clinical research solutions and increased professional fees.  We expect that our general and administrative expenses will increase for the remainder of fiscal 2011 but decrease as a percentage of total revenue going forward.

 

Amortization of intangible assets related to acquisitions was $155,000 for the three months ended September 30, 2011 and $194,000 for the same period in 2010, a decrease of $39,000, or 20.1%.  Amortization of intangible assets related to acquisitions consisted primarily of amortization of customer backlog, customer relationships, software and non-compete intangibles acquired from the acquisitions of PDS, Tourtellotte, TranSenda and Theralys.  The decrease is primarily due to the completion of the amortization of the Theralys assets.  We expect that the amortization of intangible assets related to acquisitions will remain relatively flat for the remainder of fiscal 2011.

 

There were no merger and acquisition related costs for the three months ended September 30, 2011, as compared to $119,000 for the same period in 2010.  The three months ended September 30, 2010 included expenses resulting directly from merger and acquisition activities for the TranSenda acquisition

 

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such as legal, accounting and other due diligence and integration costs.

 

In the third quarter of 2011, we incurred $1.0 million of restructuring costs primarily related to the write-off of our office lease obligations for the facilities restructuring.  We do not anticipate any additional restructuring costs for the remainder of 2011.

 

Net interest expense was $12,000 for the three months ended September 30, 2011, and net interest income was $10,000 for the three months ended September 30, 2010, a decrease of $22,000, or 220%.  Interest income is comprised of interest income earned on our cash balance and interest expense is comprised of interest expense incurred on equipment lease obligations.  The increase is due to the capital lease obligations we entered into during 2011.

 

Our income tax provision was $109,000 for the three months ended September 30, 2011 and $487,000 for the same period in 2010, a decrease of $378,000, or 77.6%.  The effective tax rate is approximately 34.9% for fiscal 2011 as compared to 38.4% for fiscal 2010 at September 30, 2010.  The lower effective tax rate in fiscal 2011 is due to the credits for increasing research activities that was not reflected in the three months ended September 30, 2010 partially offset by a New Jersey state tax assessment related to prior years.

 

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Nine Months Ended September 30, 2011 and 2010

 

(in thousands)

 

Nine
Months
ended
September
30, 2011

 

% of
Total
Revenue

 

Nine
Months
ended
September
30, 2010

 

% of
Total
Revenue

 

$ Change

 

%
Change

 

Service revenues

 

$

49,658

 

80.7

%

$

46,248

 

83.1

%

$

3,410

 

7.4

%

Reimbursement revenues

 

11,887

 

19.3

%

9,413

 

16.9

%

2,474

 

26.3

%

Total revenues

 

61,545

 

100.0

%

55,661

 

100.0

%

5,884

 

10.6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of service revenues

 

31,432

 

51.1

%

29,109

 

52.3

%

2,323

 

8.0

%

Cost of reimbursement revenues

 

11,887

 

19.3

%

9,413

 

16.9

%

2,474

 

26.3

%

Sales and marketing expenses

 

6,324

 

10.3

%

6,865

 

12.3

%

(541

)

(7.9

)%

General and administrative expenses

 

7,027

 

11.4

%

6,057

 

10.9

%

970

 

16.0

%

Amortization of intangible assets related to acquisitions

 

467

 

0.8

%

473

 

0.8

%

(6

)

(1.3

)%

Mergers and acquisitions related costs

 

162

 

0.3

%

635

 

1.1

%

(473

)

(74.5

)%

Restructuring costs

 

1,719

 

2.8

%

 

 

1,719

 

 

Total cost and expenses

 

59,018

 

95.9

%

52,552

 

94.4

%

6,466

 

12.3

%

Income from operations

 

2,527

 

4.1

%

3,109

 

5.6

%

(582

)

(18.7

)%

Interest income

 

6

 

 

18

 

 

(12

)

(66.7

)%

Interest expense

 

(32

)

(0.1

)%

(7

)

 

(25

)

357.1

%

Income before income tax

 

2,501

 

4.1

%

3,120

 

5.6

%

(619

)

(19.8

)%

Income tax provision

 

(868

)

(1.4

)%

(1,198

)

(2.2

)%

330

 

(27.5

)%

Net income

 

$

1,633

 

2.7

%

$

1,922

 

3.4

%

$

(289

)

(15.0

)%

 

Service revenues were $49.7 million for the nine months ended September 30, 2011 and $46.2 million for the same period in 2010, an increase of $3.4 million, or 7.4%.  The increase in service revenues was due to an increase in work performed on the increased backlog from the prior year.  Pfizer, Inc. encompassing 19 projects, represented 20.3% of our service revenue for the nine months ended September 30, 2011.   For the nine months ended September 30, 2010, Pfizer Inc., encompassing 21 distinct projects, represented 19.7% of our service revenues.

 

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Reimbursement revenues and cost of reimbursement revenues were $11.9 million for the nine months ended September 30, 2011 and $9.4 million for the same period in 2010, an increase of $2.5 million, or 26.3%.  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 client’s imaging data.  In such cases, per contractual arrangement, these costs are billed to our clients and are included in reimbursement revenues and cost of reimbursement revenues.

 

Cost of service revenues were $31.4 million for the nine months ended September 30, 2011 and $29.1 million for the same period in 2010, an increase of $2.3 million, or 8.0%.  Cost of service revenues for the nine months ended September 30, 2011 and 2010 were comprised of professional salaries and benefits and allocated overhead. The increase is primarily attributable to the progressive increase in personnel throughout 2010 to build operational readiness for our eClinical offerings, including supporting the operational launch of our Trident IVR/IWR product, increase in consulting activities and additional personnel assumed with the TranSenda acquisition and to support the growth of our OnPoint CTMS product. The cost of revenues as a percentage of total revenues also fluctuates due to work-flow variations in the utilization of staff and the mix of services provided by us in any given period. We expect that our cost of service revenues will increase for the remainder of fiscal 2011 due to increased servicing costs for our newly released products.

 

Sales and marketing expenses were $6.3 million for the nine months ended September 30, 2011 and $6.9 million for the same period in 2010, a decrease of $541,000, or 7.9%.  Sales and marketing expenses for the nine months ended September 30, 2011 and 2010 were comprised of direct sales and marketing costs, salaries and benefits and allocated overhead.  The decrease is primarily due to the higher marketing expenditures incurred last year to launch our OnPoint CTMS product and to ready the launch of our Trident IVR/IWR product.  We expect that our sales and marketing expenses will remain relatively flat for the remainder of fiscal 2011.

 

General and administrative expenses were $7.0 million for the nine months ended September 30, 2011 and $6.1 million for the same period in 2010, an increase of $970,000, or 16.0%.  General and administrative expenses for the nine months ended September 30, 2011 and 2010 consisted primarily of salaries and benefits, allocated overhead, professional and consulting services and corporate insurance.  The increase is due to the inclusion of costs from the acquisition of TranSenda, increased professional fees and increased technology infrastructure costs to support our suite of clinical research solutions.  We expect that our general and administrative expenses will increase for the remainder of fiscal 2011 but decrease as a percentage of total revenue going forward..

 

Amortization of intangible assets related to acquisitions were $467,000 for the nine months ended September 30, 2011 and $473,000 for the nine months ended September 30, 2010, a decrease of $6,000, or 1.3%.  Amortization of intangible assets related to acquisitions consisted primarily of amortization of customer backlog, customer relationships, software and non-compete intangibles acquired from the acquisitions of PDS, Tourtellotte, TranSenda and Theralys.  We expect that the amortization of intangible assets related to acquisitions will remain relatively flat for the remainder of fiscal 2011.

 

Mergers and acquisition related costs were $162,000 for the nine months ended September 30, 2011, and

 

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$635,000 for the same period in 2010, a decrease of $473,000, or 74.5%.  The nine months ended September 30, 2010 included expenses resulting directly from merger and acquisition activities for the TranSenda acquisition such as legal, accounting and other due diligence and integration costs.  The nine months ended September 30, 2011 includes $114,000 for the accretion related to the change in the fair value of the second earn-out payment associated with the Tourtellotte acquisition.

 

Restructuring costs were $1.7 million for the nine months ended September 30, 2011 and there were no restructuring costs for the nine months ended September 30, 2010.  The launch of our BioPacs imaging management system and the release of our  integrated BioRead image review software further enhances the quality of our imaging corelab service offering and has enabled us to gain efficiencies by better utilizing resources across our U.S. and European operations.  As a result, in 2011, we realigned our global resources to eliminate certain duplicate functions and took a total restructuring charge of $1.7 million for the nine months ended September 30, 2011.  This restructuring charge was comprised of $656,000 in employee severance, $884,000 write-off of facility lease obligations and $179,000 in legal and other costs.  We do not anticipate any additional restructuring costs for the remainder of 2011.

 

Net interest expense was $26,000 for the nine months ended September 30, 2011, and net interest income was $11,000 for the nine months ended September 30, 2010, a decrease of $37,000, or 336%.  Interest income is comprised of interest income earned on our cash balance and interest expense is comprised of interest expense incurred on equipment lease obligations.  The increase in net interest expense is due to the capital lease obligations we entered into during 2011.

 

Our income tax provision was $868,000 for the nine months ended September 30, 2011 and $1.2 million for the nine months ended September 30, 2010, a decrease of $330,000, or 27.5%.  The effective tax rate is approximately 34.9% for fiscal 2011 as compared to 38.4% for fiscal 2010 at September 30, 2010.  The lower effective tax rate in fiscal 2011 is due to the credits for increasing research activities that was not reflected in the nine months ended September 30, 2010 partially offset by a New Jersey state tax assessment related to prior years.

 

Business Segments and Geographic Information

 

We view our operation and manage our business as one operating segment, clinical trials services.

 

Our corporate headquarters and operational facilities are in Pennsylvania, in the United States.  We also have a European facility in Leiden, the Netherlands. We manage our services for European-based clinical trials from the Leiden facility. Our European facility has similar processing and analysis capabilities as our United States headquarters.  We also have a facility in Lyon, France that provides product development and research activities. We have an office in Bhubaneshwar, India to provide information technology support.

 

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Liquidity and Capital Resources

 

Our principal liquidity requirements have been, and we expect will be, for working capital and general corporate purposes, including capital expenditures.

 

Statement of Cash Flow for the nine months ended September 30, 2011 compared to September 30, 2010

 

(in thousands)

 

Nine Months
Ended
September 30,
2011

 

Nine Months
Ended
September 30,
2010

 

Net cash provided by operating activities

 

$

5,903

 

$

3,073

 

Net cash used in investing activities

 

$

(4,195

)

$

(6,079

)

Net cash provided by financing activities

 

$

115

 

$

251

 

 

At September 30, 2011, we had cash and cash equivalents of $12.3 million.  Working capital, defined as current assets minus current liabilities, at September 30, 2011 was $10.4 million.

 

Net cash provided by operating activities for the nine months ended September 30, 2011 was $5.9 million as compared to $3.1 million for the nine months ended September 30, 2010.  This increase from the prior year is primarily due to the increase in accrued expenses and accounts payable as compared to the decrease in the same period in the prior year.

 

Net cash used in investing activities for the nine months ended September 30, 2011 was $4.2 million as compared to net cash used in investing activities of $6.1 million for the nine months ended September 30, 2010.  This decrease is primarily due to less capitalized software costs for the nine months ended September 30, 2011 as compared to the nine months ended September 30, 2010.  We currently anticipate that capital expenditures for fiscal 2011 will be approximately $6.0 million, funded by cash from operations, as compared to $7.2 million for fiscal 2010. These expenditures primarily represent capitalization of software costs and network and data center computer equipment.

 

Net cash provided by financing activities for the nine months ended September 30, 2011 was $115,000 as compared to $251,000 for the nine months ended September 30, 2010.  The difference from the prior year was primarily due to our purchase of treasury shares for $784,000 for the nine months ended September 30, 2011 along with entering into $918,000 of sale/leaseback transactions to finance the purchase of property and equipment in 2011.

 

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The following table lists our cash contractual obligations as of September 30, 2011:

 

 

 

Payments Due By Period

 

(in thousands)
Contractual obligations

 

Total

 

Less than 1
year

 

1-3 years

 

3-5 years

 

More than
5 years

 

Facility rent operating leases

 

$

18,427

 

$

2,748

 

$

5,348

 

$

5,003

 

$

5,328

 

Capital lease

 

1,633

 

342

 

722

 

569

 

 

Employment agreements

 

1,291

 

1,015

 

276

 

 

 

Earn-out for Tourtellotte acquisition

 

2,000

 

2,000

 

 

 

 

Total contractual cash obligations

 

$

23,351

 

$

6,105

 

$

6,346

 

$

5,572

 

$

5,328

 

 

On May 5, 2010, we entered into an unsecured, committed line of credit with PNC Bank expiring May 5, 2012.  In April 2011, we extended the expiration date of this line of credit to May 4, 2013. Under the credit agreement, we have the ability to borrow $7.5 million at interest rates equal to LIBOR plus 1.75%.  In addition, we pay a fee of 0.25% per annum on the loan commitment regardless of usage.  The credit agreement requires our compliance with certain covenants, including maintaining a minimum stockholders’ equity of $35 million.  As of September 30, 2011, we had no borrowings under this line of credit, and we were compliant with the covenants.

 

Capital lease obligations consist of four equipment lease obligations with the same bank at September 30, 2011. In 2011, we entered into three capital lease obligations totaling $918,000 consisting of sale/leaseback transactions.  The lease terms are for five years with interest rates ranging from 3.04% to 3.87% per annum.

 

We have neither paid nor declared dividends on our common stock since our inception and do not plan to pay dividends on our common stock in the foreseeable future.

 

We have not entered into any off-balance sheet transactions, arrangements or other relationships with unconsolidated entities or other persons that are likely to affect liquidity or the availability of or requirements for capital resources.

 

We anticipate that our existing capital resources together with cash flow from operations will be sufficient to meet our cash needs for the next 12 months.  However, we cannot assure you that our operating results will maintain profitability on an annual basis in the future.  The inherent operational risks associated with the following factors may have a material adverse effect on our future liquidity:

 

·                  our ability to gain new client contracts;

·                  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.

 

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Changes to Critical Accounting Policies and Estimates

 

Our critical accounting policies and estimates are set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2010.  As of September 30, 2011, there have been no changes to such critical accounting policies and estimates.

 

Item 3.               Quantitative and Qualitative Disclosures About Market Risk.

 

Interest Rate Risk

 

We invest in high-quality financial instruments, comprised of savings accounts, certificate of deposits and money market funds.  Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.

 

Foreign Currency Risk

 

Under our current foreign exchange rate risk management policy, we monitor our exposure to variability in our cash flows resulting from the Euro denominated costs for our Netherlands and France subsidiaries.  Accordingly, we had purchased monthly Euro call options in prior years and may purchase them in the future to hedge against this exposure.  During the nine months ended September 30, 2011 and 2010, we did not purchase any Euro call options, because our foreign currency needs were generally met by the cash flow generated by our Euro denominated contracts.  As of September 30, 2011, there were no outstanding derivative positions.

 

Upon expiration or ineffectiveness of any derivatives, we would record a gain or loss from such derivatives that are deferred in stockholders’ equity to cost of revenues and general and administrative expenses in the Consolidated Statement of Income based on the nature of the underlying cash flow hedged.

 

Item 4.               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, 2011, the end of the period covered by this report on Form 10-Q.  Based on this evaluation, our Chief Executive Officer (principal executive officer) and our Chief Financial Officer (principal accounting and financial officer) have concluded that our disclosure controls and procedures were effective at September 30, 2011.  Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and were operating in an effective manner for the period covered by this report, and (ii) is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

 

Changes in internal control over financial reporting.  There was no change in our internal controls over financial reporting that occurred during the third quarter of 2011 that materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

 

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PART II. OTHER INFORMATION.

 

Item 1.               Legal Proceedings.

 

In the normal course of business, we may be a party to legal proceedings.  We are not currently a party to any material legal proceedings.

 

Item 1A.            Risk Factors.

 

The more prominent risks and uncertainties inherent in our business are described below. However, additional risks and uncertainties may also impair our business operations.  If any of the following risks actually occur, our business, financial condition or results of operations may suffer.  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 client’s 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 companies that are regulated by the United States Food and Drug Administration, or FDA, may proceed with fewer clinical trials or conduct them without assistance of contract service organizations if they are trying to reduce costs as a result of cost containment pressures associated with healthcare reform, budgetary limits or changing priorities. These factors may cause such companies to cancel contracts with contract service organizations.

 

We cannot assure you that our clients will continue to use our services or that we will be able to replace, in a timely or effective manner, departing clients with new clients that generate comparable revenues. Further, we cannot assure you that our clients will continue to generate consistent amounts of revenues over time.

 

The loss, reduction in scope or delay of a large contract or the loss or delay of multiple contracts could materially adversely affect our business.

 

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The recent economic downturn may adversely impact our ability to grow our business.

 

The recent economic downturn and adverse conditions in the national and global markets may negatively affect our operations in the future.  The fallen equity markets and adverse credit markets may make it difficult for us to raise capital or procure credit in the future to fund the growth of our business, which could have a negative impact on our business and results of operations and limit our ability to pursue acquisitions.

 

We depend on a small number of industries and clients for all of our business, and the loss of one such significant client could cause revenues to drop quickly and unexpectedly.

 

We depend on research and development expenditures by pharmaceutical, biotechnology and medical device companies to sustain our business. Our operations could be materially and adversely affected if:

 

·                  our 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.

 

Contracts with one client, Pfizer, Inc., which encompassed 19 projects, represented 20.3% of our service revenues for the nine months ended September 30, 2011.  For the nine months ended September 30, 2010, Pfizer, Inc. represented 29.7% of our service revenue, encompassing 21 projects.  The loss of business from a significant client or our failure to continue to obtain new business to replace completed or canceled projects would have a material adverse effect on our business and revenues.

 

Our contracted/committed backlog may not be indicative of future results.

 

Our reported contracted/committed backlog of $115.6 million at September 30, 2011 is based on anticipated service revenue from uncompleted projects with clients. Backlog is the expected service revenue that remains to be earned and recognized on signed and verbally agreed to contracts. Contracts included in backlog are subject to termination by our clients at any time. In the event that a client cancels a contract, we would be entitled to receive payment for all services performed up to the cancellation date and subsequent client authorized services related to the cancellation of the project. The duration of the projects included in our backlog range from less than three months to seven years. We cannot assure you that this backlog will be indicative of future results. A number of factors may affect backlog, including:

 

·                  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.

 

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We made one acquisition in the first quarter of 2010, two acquisitions in the third quarter of 2009, and may engage in future acquisitions, which may be expensive and time consuming, and from which we may not realize anticipated benefits.

 

On March 25, 2010, we acquired substantially all of the assets of privately held TranSenda International, LLC, headquartered in Bellevue, WA.  In the third quarter of 2009, we acquired the CardioNow unit from AGFA Healthcare and substantially all of the assets of Tourtellotte Solutions, Inc. 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. Either as a result of the recent acquisitions or future acquisitions undertaken, the process of integrating the acquired business, technology or product may result in operating difficulties and expenditures, and may absorb significant management attention that would otherwise be available for ongoing development of our business. Moreover, we may never realize the anticipated benefits of any such acquisition. Such acquisitions could result in potentially dilutive issuances of our securities, the incurrence of debt and contingent liabilities and amortization expenses related to intangible assets, all of which could adversely affect our results of operations and financial condition.

 

Loss of key personnel, or failure to attract and retain additional personnel, may cause the success and growth of our business to suffer.

 

Future success depends on the personal efforts and abilities of the principal members of our senior management to provide strategic direction, develop business, manage operations and maintain a cohesive and stable environment. Specifically, we are dependent upon Mark L. Weinstein, President and Chief Executive Officer, Ted I. Kaminer, Executive Vice President of Finance and Administration and Chief Financial Officer, and Peter Benton, Executive Vice President, President of eClinical Solutions. Although we have employment agreements with Mr. Weinstein, Mr. Kaminer and Mr. Benton, this does not necessarily mean that they will remain with us. Although we have executive retention agreements with our officers, we do not have employment agreements with any other key personnel. Furthermore, our performance also depends on our ability to attract and retain management and qualified professional and technical operating staff. Competition for these skilled personnel is intense. The loss of services of any key executive, or inability to continue to attract and retain qualified staff, could have a material adverse effect on our business, results of operations and financial condition. We do not maintain any key employee insurance on any of our executives.

 

We may not be able to effectively manage our international operations.

 

We maintain facilities in France, the Netherlands and India, and we may continue to expand our international operations in the future. There are significant risks associated with the establishment of foreign operations, including, but not limited to: geopolitical risks, foreign currency exchange rates and the impact of shifts in the U.S. and local economies on those rates, compliance with local laws and regulations, the protection of our intellectual property and that of our customers, the ability to integrate our corporate culture with local customs and cultures, and the ability to effectively and efficiently supply our international facilities with the required equipment and materials. If we are unable to effectively manage these risks, these locations may not produce the revenues, earnings, or strategic benefits that we anticipate which could have a material adverse affect on our business.

 

Our revenues, earnings and operating costs are exposed to exchange rate fluctuations.

 

During the nine months ended September 30, 2011, a portion of our service revenues were denominated in foreign currency.  Our financial statements are denominated in United States dollars. In the event a greater portion of our service revenues are denominated in a foreign currency, changes in foreign currency exchange rates could affect our results of operations and financial condition. Fluctuations in

 

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foreign currency exchange rates could materially impact the operating costs of our European facilities in Leiden, the Netherlands and Lyon, France, which are primarily Euro denominated.

 

We may be required to record additional significant charges to earnings if our goodwill becomes impaired.

 

Under accounting principles generally accepted in the United States, we review our goodwill for impairment each year as of December 31 and when events or changes in circumstances indicate the carrying value may not be recoverable. The carrying value of our goodwill may not be recoverable due to factors such as a decline in stock price and market capitalization, reduced estimates of future cash flows and slower growth rates in our industry. Estimates of future cash flows are based on an updated long-term financial outlook of our operations. However, actual performance in the near-term or long-term could be materially different from these forecasts, which could impact future estimates. For example, a significant decline in our stock price and/or market capitalization may result in impairment of our goodwill valuation. We may be required to record a charge to earnings in our financial statements during a period in which an impairment of our goodwill is determined to exist, which may negatively impact our results of operations.

 

Our software products and hosted solutions are at varying stages of market acceptance and the failure of any of our products to achieve or maintain wide acceptance would harm our operating results.

 

We began offering our electronic data capture software solution for clinical trials in March 2008. Continued use of our current electronic data capture software products, and broad and timely acceptance of newly-introduced electronic data capture software products, as well as integrated solutions combining one or more of our software products, is critical to our future success and is subject to a number of significant risks, some of which are outside our control. These risks include:

 

· our customers’ and prospective customers’ desire for and acceptance of our electronic data capture, clinical data management, drug safety and interactive response technology solutions;

 

· our ability to meet product development and release schedules;

 

· our software products and hosted solutions’ ability to support large numbers of users and manage vast amounts of data;

 

· our ability to significantly expand our internal resources and increase our capital and operating expenses to support the anticipated growth and continued integration of our software products, services and hosted solutions; and

 

· our customers’ ability to use our software products and hosted solutions, train their employees and successfully deploy our technology in their clinical trial and safety evaluation and monitoring activities.

 

Our failure to address, mitigate or manage these risks would seriously harm our business, particularly if the failure of any or all of our software products or hosted solutions to achieve market acceptance negatively affects our sales of our other products and services.

 

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We may be unable to adequately protect, and we may incur significant costs in defending, our intellectual property and other proprietary rights or in defending claims that we are infringing upon the intellectual property rights of others.

 

Our success depends on our ability to protect our intellectual property and other proprietary rights. We rely upon a combination of trademark, trade secret, copyright, patent and unfair competition laws, as well as license agreements and other contractual provisions, to protect our intellectual property and other proprietary rights. In addition, we attempt to protect our intellectual property and proprietary information by requiring certain of our employees and consultants to enter into confidentiality, non-competition and assignment of inventions agreements. To the extent that our intellectual property and other proprietary rights are not adequately protected, third parties might gain access to our proprietary information, develop and market products or services similar to ours or use trademarks similar to ours, each of which could materially harm our business. Existing U.S. federal and state intellectual property laws offer only limited protection. Moreover, the laws of other countries in which we market our software products, services and hosted solutions may afford little or no effective protection of our intellectual property. If we are involved in legal proceedings to enforce our intellectual property rights, to determine the validity and scope of the intellectual property or other proprietary rights of others or to defend against claims of infringement by third parties, the proceedings could be burdensome and expensive, even if we were to prevail. Any potential infringement actions brought against us could require us to stop using the product or service which incorporates such third party intellectual property, obtain a license to use such third party intellectual property (which could be costly or unavailable) or redesign our products or services that incorporate such third party intellectual property (which could be time consuming and costly and affect the market acceptance of such product or service).  The failure to adequately protect our intellectual property and other proprietary rights or acknowledge third party intellectual property rights may have a material adverse effect on our business, results of operations or financial condition.

 

Risks Related to Our Industry

 

Our failure to compete effectively in our industry could cause our revenues to decline.

 

Significant factors in determining whether we will be able to compete successfully include:

 

·                  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;

·               &