e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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| þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT
OF 1934 |
For the quarterly period ended September 30, 2006
OR
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| o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT
OF 1934 |
For the transition period from to
Commission File No. 0-12716
CLINICAL DATA, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
(State or Other Jurisdiction of Incorporation or Organization)
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04-2573920
(I.R.S. Employer Identification No.) |
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One Gateway Center, Newton, Massachusetts
(Address of Principal Executive Offices)
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02458
(Zip Code) |
Registrants telephone number, including area code: (617) 527-9933
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES þ NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES o NO þ
The number of shares outstanding of the registrants common stock as of November 6, 2006 was
9,676,450.
CLINICAL DATA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands, except share and per share amounts)
| |
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September 30, |
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March 31, |
|
| |
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2006 |
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2006 |
|
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,810 |
|
|
$ |
7,225 |
|
Accounts receivable, net |
|
|
13,884 |
|
|
|
16,160 |
|
Inventories, net |
|
|
14,339 |
|
|
|
13,180 |
|
Prepaid expenses and other current assets |
|
|
5,137 |
|
|
|
4,991 |
|
Assets of discontinued operations |
|
|
2,316 |
|
|
|
2,646 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
52,486 |
|
|
|
44,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROPERTY, PLANT AND EQUIPMENT, Net |
|
|
10,267 |
|
|
|
10,564 |
|
GOODWILL |
|
|
26,373 |
|
|
|
27,547 |
|
INTANGIBLE ASSETS, Net |
|
|
19,304 |
|
|
|
24,268 |
|
OTHER ASSETS, Net |
|
|
986 |
|
|
|
1,646 |
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
109,416 |
|
|
$ |
108,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
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|
|
|
|
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|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
Revolving credit facility |
|
$ |
4,187 |
|
|
$ |
3,980 |
|
Current portion of capital leases and long-term debt |
|
|
2,266 |
|
|
|
3,868 |
|
Accounts payable |
|
|
9,782 |
|
|
|
10,245 |
|
Accrued expenses |
|
|
10,662 |
|
|
|
14,230 |
|
Customer advances and deferred revenue |
|
|
4,192 |
|
|
|
3,543 |
|
Other current liabilities |
|
|
1,536 |
|
|
|
1,708 |
|
Liabilities of and minority interest in discontinued operations |
|
|
1,265 |
|
|
|
1,661 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
33,890 |
|
|
|
39,235 |
|
|
|
|
|
|
|
|
|
|
CAPITAL LEASES AND LONG-TERM DEBT, NET OF CURRENT PORTION |
|
|
7,381 |
|
|
|
6,889 |
|
OTHER LONG-TERM LIABILITIES |
|
|
2,223 |
|
|
|
2,314 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY: |
|
|
|
|
|
|
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|
Preferred Stock, $.01 par value, 1,500,000 shares authorized Series A voting, convertible preferred
stock, 234,000 shares issued and outstanding at September 30, 2006 and March 31, 2006,
liquidation preference of $3,358,000 at September 30, 2006 |
|
|
2 |
|
|
|
2 |
|
Common stock, $.01 par value, 14,000,000 shares authorized; 9,685,000 and 8,520,000 shares
issued at September 30, 2006 and March 31, 2006, respectively; 9,675,000 shares and 8,510,000
shares outstanding at September 30, 2006 and March 31, 2006, respectively |
|
|
97 |
|
|
|
85 |
|
Additional paid-in capital |
|
|
124,734 |
|
|
|
105,145 |
|
Accumulated deficit |
|
|
(60,078 |
) |
|
|
(45,810 |
) |
Treasury stock, 10,000 shares at cost |
|
|
(47 |
) |
|
|
(47 |
) |
Deferred compensation |
|
|
|
|
|
|
(318 |
) |
Accumulated other comprehensive income |
|
|
1,214 |
|
|
|
732 |
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
65,922 |
|
|
|
59,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
|
$ |
109,416 |
|
|
$ |
108,227 |
|
|
|
|
|
|
|
|
See notes to unaudited condensed consolidated financial statements.
- 3 -
CLINICAL DATA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share amounts)
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|
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|
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|
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Three Months Ended |
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Six Months Ended |
|
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September 30, |
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September 30, |
|
| |
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2006 |
|
|
2005 |
|
|
2006 |
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|
2005 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products |
|
$ |
10,618 |
|
|
$ |
10,075 |
|
|
$ |
23,058 |
|
|
$ |
20,251 |
|
Services |
|
|
8,576 |
|
|
|
1,629 |
|
|
|
19,189 |
|
|
|
3,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
19,194 |
|
|
|
11,704 |
|
|
|
42,247 |
|
|
|
23,414 |
|
COST OF REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Products |
|
|
7,489 |
|
|
|
6,545 |
|
|
|
15,327 |
|
|
|
13,062 |
|
Services |
|
|
5,394 |
|
|
|
926 |
|
|
|
12,098 |
|
|
|
1,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
12,883 |
|
|
|
7,471 |
|
|
|
27,425 |
|
|
|
15,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
6,311 |
|
|
|
4,233 |
|
|
|
14,822 |
|
|
|
8,355 |
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
2,346 |
|
|
|
1,366 |
|
|
|
4,896 |
|
|
|
2,760 |
|
Research and development |
|
|
3,809 |
|
|
|
631 |
|
|
|
7,038 |
|
|
|
1,338 |
|
General and administrative |
|
|
7,969 |
|
|
|
1,645 |
|
|
|
16,410 |
|
|
|
3,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
14,124 |
|
|
|
3,642 |
|
|
|
28,344 |
|
|
|
7,174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(7,813 |
) |
|
|
591 |
|
|
|
(13,522 |
) |
|
|
1,181 |
|
Interest expense |
|
|
(316 |
) |
|
|
(85 |
) |
|
|
(555 |
) |
|
|
(160 |
) |
Interest income |
|
|
155 |
|
|
|
20 |
|
|
|
254 |
|
|
|
45 |
|
Other income (expense), net |
|
|
(66 |
) |
|
|
17 |
|
|
|
(22 |
) |
|
|
23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from continuing operations before taxes |
|
|
(8,040 |
) |
|
|
543 |
|
|
|
(13,845 |
) |
|
|
1,089 |
|
Benefit from (provision for) income taxes |
|
|
29 |
|
|
|
(211 |
) |
|
|
(430 |
) |
|
|
(392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from continuing operations |
|
|
(8,011 |
) |
|
|
332 |
|
|
|
(14,275 |
) |
|
|
697 |
|
(Loss) income from discontinued operations, net of taxes |
|
|
(109 |
) |
|
|
45 |
|
|
|
(30 |
) |
|
|
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
|
(8,120 |
) |
|
|
377 |
|
|
|
(14,305 |
) |
|
|
784 |
|
Preferred stock dividend |
|
|
(27 |
) |
|
|
|
|
|
|
(50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income applicable to common stockholders |
|
$ |
(8,147 |
) |
|
$ |
377 |
|
|
$ |
(14,355 |
) |
|
$ |
784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from continuing operations per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.84 |
) |
|
$ |
0.08 |
|
|
$ |
(1.56 |
) |
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.84 |
) |
|
$ |
0.07 |
|
|
$ |
(1.56 |
) |
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from discontinuing operations per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.01 |
) |
|
$ |
0.01 |
|
|
$ |
(0.00 |
) |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.01 |
) |
|
$ |
0.01 |
|
|
$ |
(0.00 |
) |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.85 |
) |
|
$ |
0.09 |
|
|
$ |
(1.57 |
) |
|
$ |
0.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
(0.85 |
) |
|
$ |
0.08 |
|
|
$ |
(1.57 |
) |
|
$ |
0.17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
9,612 |
|
|
|
4,395 |
|
|
|
9,158 |
|
|
|
4,395 |
|
Diluted |
|
|
9,612 |
|
|
|
4,531 |
|
|
|
9,158 |
|
|
|
4,526 |
|
See notes to unaudited condensed consolidated financial statements.
- 4 -
CLINICAL DATA, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)
| |
|
|
|
|
|
|
|
|
| |
|
Six Months Ended |
|
| |
|
September 30, |
|
| |
|
2006 |
|
|
2005 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(14,305 |
) |
|
$ |
784 |
|
(Income) loss from discontinued operations |
|
|
30 |
|
|
|
(87 |
) |
|
|
|
|
|
|
|
Net (loss) income from continuing operations |
|
|
(14,275 |
) |
|
|
697 |
|
Adjustments
to reconcile net (loss) income from continuing operations to net cash (used in) provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
6,178 |
|
|
|
816 |
|
Allowance for bad debts |
|
|
657 |
|
|
|
|
|
Stock based compensation and expense |
|
|
2,630 |
|
|
|
|
|
Gain on sales of equipment |
|
|
(101 |
) |
|
|
|
|
Changes in current assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,847 |
|
|
|
(26 |
) |
Inventories |
|
|
(829 |
) |
|
|
(1,178 |
) |
Prepaid expenses and other current assets |
|
|
(30 |
) |
|
|
(425 |
) |
Other assets |
|
|
560 |
|
|
|
(163 |
) |
Accounts payable and accrued liabilities |
|
|
(3,226 |
) |
|
|
164 |
|
Customer advances and deferred revenue |
|
|
512 |
|
|
|
62 |
|
Other current liabilities |
|
|
(70 |
) |
|
|
211 |
|
|
|
|
|
|
|
|
Cash (used in) provided by continuing operations |
|
|
(6,147 |
) |
|
|
158 |
|
Cash (used in) provided by discontinued operations |
|
|
(14 |
) |
|
|
536 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by operating activities |
|
|
(6,161 |
) |
|
|
694 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of equipment |
|
|
(607 |
) |
|
|
(213 |
) |
Proceeds from sales of equipment |
|
|
124 |
|
|
|
|
|
Cash used in business combinations |
|
|
(184 |
) |
|
|
(447 |
) |
Capitalization of software development costs |
|
|
|
|
|
|
(108 |
) |
|
|
|
|
|
|
|
Cash used in investing activities continuing operations |
|
|
(667 |
) |
|
|
(768 |
) |
Cash used in investing activities discontinued operations |
|
|
(21 |
) |
|
|
(199 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(688 |
) |
|
|
(967 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net proceeds from revolving credit facility |
|
|
207 |
|
|
|
1,781 |
|
Borrowings under other debt arrangements |
|
|
231 |
|
|
|
121 |
|
Payment on debt and capital leases |
|
|
(1,438 |
) |
|
|
(411 |
) |
Proceeds from the sale of common stock and warrants, net of transaction costs |
|
|
16,622 |
|
|
|
|
|
Exercise of stock options |
|
|
547 |
|
|
|
|
|
Stockholder dividends |
|
|
(56 |
) |
|
|
(176 |
) |
|
|
|
|
|
|
|
Cash provided by financing activities continuing operations |
|
|
16,113 |
|
|
|
1,315 |
|
Cash (used in) provided by financing activities discontinued operations |
|
|
(18 |
) |
|
|
141 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
16,095 |
|
|
|
1,456 |
|
|
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS |
|
|
339 |
|
|
|
(401 |
) |
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
9,585 |
|
|
|
695 |
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
|
7,225 |
|
|
|
4,171 |
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
|
$ |
16,810 |
|
|
$ |
4,953 |
|
|
|
|
|
|
|
|
See notes to unaudited condensed consolidated financial statements.
- 5 -
CLINICAL DATA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR SEPTEMBER 30, 2006
(1) Operations and Basis of Presentation
Clinical Data, Inc. (the Company) is a Delaware corporation headquartered in Newton,
Massachusetts. The Company manages its business as four operating
segments: Molecular Services (which includes Cogenics,
PGxHealth and Vilazodone); sales of instruments and consumables to
Clinics and Small Hospitals; sales of instruments,
consumables and services to Physicians Office
Laboratories; and All Other.
Through its CogenicsTM brand name and division, the Company offers a wide range of
molecular and pharmacogenomic services which are provided and marketed to pharmaceutical, biotech,
academia, agricultural and government clients.
Under the PGxHealthTM brand name and division, the Company focuses on genetic tests and
biomarker development, validation and commercialization activities aimed at improving the efficacy
and safety of drugs. The Company is also seeking to develop and commercialize Vilazodone, a novel
dual serotonergic antidepressant compound being studied for treatment of depression, along with a
potential companion pharmacogenetic test that will be developed and marketed by the PGxHealth
division.
The Company also designs, distributes, and manufactures scientific instrumentation and supplies as
well as a range of products and services, from equipment and reagents to lab management and
consulting services to physicians office laboratories (POLs) and small- and medium-sized medical
laboratories.
The Company established its molecular and pharmacogenomics services business in the third and
fourth quarters of fiscal 2006 by acquiring Genaissance Pharmaceuticals, Inc. (Genaissance),
Icoria, Inc. (Icoria) and Genome Express S.A. (Genome Express). The acquired businesses had a
significant impact on the reported results of operations and financial position for fiscal 2006,
the first half of fiscal 2007 and will have a significant impact on future operations and cash
flows. Prior to the acquisitions, Genaissance, Icoria and Genome Express reported significant
operating losses and used significant cash in their respective operations. These operating losses
may continue for the next twelve months or longer depending upon the business developments and
research and development efforts, particularly those related to Vilazodone and PGxHealth.
The accompanying financial statements have been prepared on a basis which assumes that the Company
will continue as a going concern and which contemplates the realization of assets and the
satisfaction of liabilities and commitments in the normal course of business.
As of September 30, 2006, the Companys current and future sources of cash include cash
balances of approximately $16.8 million, existing lines of credit, cash flows from operations of
certain divisions, plus net cash proceeds of approximately $1.1 million from the sale of our
discontinued operations (see Note 3) received November 13, 2006, and possible future equity and/or
debt financings. The Companys projected uses of cash include cash used in operations of certain
operating divisions, capital expenditures, existing debt service costs and continued development of
potential products through internal research, collaborations and possibly through strategic
acquisitions. The Company has undertaken several steps to improve liquidity and reduce its
projected uses of cash, including completion of a private placement of common stock on June 13,
2006 for net proceeds of approximately $16.9 million, the restructuring of certain long-term debt
and lease obligations, and the consolidation of facilities and the resultant reductions in head
count. At currently projected rates of expenditure, management believes that additional funding
will be required to operate the Company through the first quarter of fiscal 2008, including the
funding of Phase III clinical trials for Vilazodone, which was acquired in the Genaissance
transaction. During the three and six months ended September 30, 2006, research and development
expense included approximately $2.0 million and $3.3 million, respectively, of costs related to the
Phase III clinical trials of Vilazodone. To reduce its cash utilization, the Company is working to
accelerate the integration of the businesses acquired during fiscal 2006 into the Companys
operations, improve operating efficiencies, reduce administrative costs and grow revenues in key
business lines. The Company may seek financing from among other sources, public or private
issuances of equity or debt securities, and/or from collaborations with third parties or government
grants. If the Company is unable to obtain any required additional financing or further improve
its cash position from its operating activities, it may be required to reduce the scope of its
planned research, development and commercialization activities,
- 6 -
(1) Operations and Basis of Presentation (continued)
including those efforts related to Vilazodone, which would reduce the use of cash but could harm
the Companys long-term financial condition and operating results.
(2) Summary of Significant Accounting Policies
Inventories
Inventories are stated at the lower of cost (first-in, first-out) or market and consist of the
following:
| |
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
|
March 31, |
|
| (in thousands) |
|
2006 |
|
|
2006 |
|
Raw materials |
|
$ |
5,918 |
|
|
$ |
6,300 |
|
Work-in-process |
|
|
2,462 |
|
|
|
1,589 |
|
Finished goods |
|
|
5,959 |
|
|
|
5,291 |
|
|
|
|
|
|
|
|
|
|
$ |
14,339 |
|
|
$ |
13,180 |
|
|
|
|
|
|
|
|
(Loss) Income per Share
Basic (loss) income per share is determined by dividing (loss) income applicable to common
stockholders by the weighted average shares of common stock outstanding during the period. Diluted
earnings per share are determined by dividing (loss) income applicable to common stockholders by
diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive
effect, if any, of potentially dilutive common shares, such as common stock options, warrants,
convertible debt, restricted common stock convertible preferred stock calculated using the treasury
stock method and convertible preferred stock using the if-converted method.
The number of basic and diluted weighted average common shares outstanding is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
|
Six Months Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| (in thousands) |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Basic weighted average shares outstanding |
|
|
9,612 |
|
|
|
4,395 |
|
|
|
9,158 |
|
|
|
4,395 |
|
Dilutive effect of common stock options |
|
|
|
|
|
|
136 |
|
|
|
|
|
|
|
131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average shares outstanding |
|
|
9,612 |
|
|
|
4,531 |
|
|
|
9,158 |
|
|
|
4,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following dilutive securities were not included in the diluted earnings per share
calculations for the periods ended September 30, 2006 because the inclusion of these amounts would have been
anti-dilutive because the Company reported a net loss.
| |
|
|
|
|
| (in thousands) |
|
|
|
|
Common stock options |
|
|
1,344 |
|
Common stock warrants |
|
|
972 |
|
Convertible loan |
|
|
100 |
|
Voting convertible series A preferred stock |
|
|
234 |
|
|
|
|
|
Potentially dilutive securities outstanding |
|
|
2,650 |
|
|
|
|
|
- 7 -
(2) Summary of Significant Accounting Policies (continued)
Comprehensive (Loss) Income
The components of other comprehensive (loss) income for the three and six months ended September
30, 2006 and 2005 are as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
|
Six Months Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| (in thousands) |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net (loss) income from
continuing operations |
|
$ |
(8,120 |
) |
|
$ |
377 |
|
|
$ |
(14,305 |
) |
|
$ |
784 |
|
Translation adjustment |
|
|
222 |
|
|
|
(7 |
) |
|
|
482 |
|
|
|
(670 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive (loss) income |
|
$ |
(7,898 |
) |
|
$ |
370 |
|
|
$ |
(13,823 |
) |
|
$ |
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash transactions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants in connections with debt agreements |
|
$ |
120 |
|
|
$ |
|
|
Equipment acquired through capital leases and long term debt |
|
|
|
|
|
|
135 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash transactions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
555 |
|
|
$ |
160 |
|
Recent Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board issued Interpretation No. 48, Accounting for
Uncertainty in Income Taxes-an interpretation of FASB Statement No. 109, which will be effective
for the Company beginning April 1, 2007. The interpretation provides that a tax position is
recognized if the enterprise determines that it is more likely than not that a tax position will be
sustained based on the technical merits of the position, on the presumption that the position will
be examined by the appropriate taxing authority that would have full knowledge of all relevant
information. The tax position is measured at the largest amount of benefit that is greater than
50% likely of being realized upon ultimate settlement. The interpretation also provides guidance
on derecognition, classification, interest and penalties, accounting for interim periods and
transition. The Company is in the process of evaluating the impact that adoption of the
interpretation will have on its financial statements.
(3) Discontinued Operations
During the second quarter of fiscal 2007, the Board of Directors approved a plan to sell Vital
Diagnostics, Pty. Ltd., the Companys Australian subsidiary (Vital Diagnostics). The
transaction, structured as a share purchase of the Companys 92.5% equity interest for net cash proceeds of $1.1
million, closed on November 13, 2006.
Vital Diagnostics was a member of the Vital Diagnostics Division group of companies and a part of
our Clinics and Small Hospitals segment, and acted as a distributor in Australia focused on selling
scientific instrumentation, equipment and reagents to POLs and small- and medium-sized medical
laboratories primarily in Australia and New Zealand. As a distributor, Vital Diagnostics did not
manufacture or design any of the Companys products.
The Company received offers from two groups to purchase Vital Diagnostics, and accepted the most
favorable offer. Vital Diagnostics general manager and holder of the 7.5% minority interest,
Adrian Tennyenhuis, in partnership with New River Management IV, LP, invested the cash used by
Vital Diagnostics to fund the purchase price of the buy-back. New River Management, IV is an
affiliate of Third Security, which is funded and controlled by Third Security, LLC. Third
Security, LLC is controlled by Randal J. Kirk, the Chairman of the Board of the Company. The
Company recorded a loss of approximately $153,000 net of taxes in
connection with the sale to reduce the asset to the net realizable
value. The Company has
classified the results of the operations of Vital Diagnostics as discontinued operations in the
accompanying financial statements. There was approximately $417,000 of cash reported by Vital
Diagnostics at September 30, 2006.
Prior to seeking a buyer for Vital Diagnostics, the Company determined that the Vital Diagnostics
business did not fit strategically with its operating segments. Vital Diagnostics also had few
synergies to leverage across the
- 8 -
(3) Discontinued Operations (continued)
Companys other operations, and had been experiencing significant business challenges with its
client base over the past 12 months. The Company also determined that its capital resources could
be better allocated among those businesses in our other operations segments that offer us better
opportunities for growth in our strategic markets.
Summarized financial information for Vital Diagnostics is set forth below. The loss on disposal
reflects the estimated effect of the planned sale.
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
|
Six Months Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| (in thousands) |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Discontinued Operations Before Disposal: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
992 |
|
|
$ |
1,184 |
|
|
$ |
2,756 |
|
|
$ |
2,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before taxes and minority interest |
|
|
66 |
|
|
|
70 |
|
|
|
184 |
|
|
|
134 |
|
Minority interest |
|
|
(4 |
) |
|
|
(3 |
) |
|
|
(9 |
) |
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before taxes |
|
|
62 |
|
|
|
67 |
|
|
|
175 |
|
|
|
127 |
|
Income taxes |
|
|
(18 |
) |
|
|
(22 |
) |
|
|
(52 |
) |
|
|
(40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
operations, net of taxes |
|
|
44 |
|
|
|
45 |
|
|
|
123 |
|
|
|
87 |
|
Disposal: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment
loss, before taxes |
|
|
(221 |
) |
|
|
|
|
|
|
(221 |
) |
|
|
|
|
Income tax benefit |
|
|
68 |
|
|
|
|
|
|
|
68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on disposal, net of taxes |
|
|
(153 |
) |
|
|
|
|
|
|
(153 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income from discontinued
operations, net of
taxes |
|
$ |
(109 |
) |
|
$ |
45 |
|
|
$ |
(30 |
) |
|
$ |
87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
|
March 31, |
|
| (in thousands) |
|
2006 |
|
|
2006 |
|
Accounts receivable, net |
|
$ |
1,168 |
|
|
$ |
1,131 |
|
Inventory, net |
|
|
728 |
|
|
|
910 |
|
Prepaid expenses and other current assets |
|
|
182 |
|
|
|
198 |
|
Property, plant and equipment, net |
|
|
171 |
|
|
|
340 |
|
Other assets |
|
|
67 |
|
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets of discontinued operations |
|
$ |
2,316 |
|
|
$ |
2,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of capital leases and long-term debt |
|
$ |
69 |
|
|
$ |
61 |
|
Accounts payable |
|
|
327 |
|
|
|
593 |
|
Accrued expenses |
|
|
327 |
|
|
|
448 |
|
Customer advances |
|
|
259 |
|
|
|
270 |
|
Capital leases and long-term debt, net of current portion |
|
|
159 |
|
|
|
174 |
|
Minority interest |
|
|
124 |
|
|
|
115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities of and minority interest in discontinued operations |
|
$ |
1,265 |
|
|
$ |
1,661 |
|
|
|
|
|
|
|
|
- 9 -
(4) Goodwill and Intangible Assets
Goodwill balances, by segment, are as follows:
| |
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
|
March 31, |
|
| (in thousands) |
|
2006 |
|
|
2006 |
|
Molecular services |
|
$ |
18,870 |
|
|
$ |
20,044 |
|
Physicians office laboratories |
|
|
6,350 |
|
|
|
6,350 |
|
Clinics and small hospitals |
|
|
1,153 |
|
|
|
1,153 |
|
|
|
|
|
|
|
|
|
|
$ |
26,373 |
|
|
$ |
27,547 |
|
|
|
|
|
|
|
|
The reduction in goodwill in the Molecular Services segment during the six months ended September
30, 2006 was primarily related to a $1.2 million reduction in accrued expenses recorded for the
favorable resolution of a pre-acquisition contingency.
The other identifiable intangible asset balances are as follows:
| |
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
|
March 31, |
|
| (in thousands) |
|
2006 |
|
|
2006 |
|
Purchased intangibles: |
|
|
|
|
|
|
|
|
Completed technology |
|
$ |
12,310 |
|
|
$ |
12,400 |
|
Customer relationships |
|
|
12,245 |
|
|
|
12,245 |
|
Other |
|
|
803 |
|
|
|
803 |
|
|
|
|
|
|
|
|
|
|
|
25,358 |
|
|
|
25,448 |
|
Less: accumulated amortization |
|
|
(7,694 |
) |
|
|
(4,123 |
) |
|
|
|
|
|
|
|
Purchased intangibles, net |
|
|
17,664 |
|
|
|
21,325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized software |
|
|
1,696 |
|
|
|
1,609 |
|
Less: accumulated amortization |
|
|
(642 |
) |
|
|
(443 |
) |
|
|
|
|
|
|
|
Capitalized software, net |
|
|
1,054 |
|
|
|
1,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ERP implementation and software |
|
|
586 |
|
|
|
1,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
$ |
19,304 |
|
|
$ |
24,268 |
|
|
|
|
|
|
|
|
(5) Restructuring and Integration Reserves
In connection with the acquisitions of Genaissance, Icoria and Genome Express, the Company recorded
restructuring and integration reserves totaling approximately $4.6 million, representing severance
of $3.1 million and a lease termination of $1.5 million. A summary of the severance and lease
termination activity as of September 30, 2006 is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Balance |
|
|
|
|
|
|
|
|
|
|
Balance |
|
| |
|
March 31, |
|
|
Fiscal 2007 |
|
|
September 30, |
|
| |
|
2006 |
|
|
Accrual |
|
|
Payments |
|
|
2006 |
|
Severance |
|
$ |
2,350 |
|
|
$ |
125 |
|
|
$ |
(1,532 |
) |
|
$ |
943 |
|
Lease termination costs |
|
|
1,090 |
|
|
|
|
|
|
|
(1,090 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,440 |
|
|
$ |
125 |
|
|
$ |
(2,622 |
) |
|
$ |
943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company expects the severance costs will be fully paid during the third quarter of fiscal 2007.
- 10 -
(6) Debt
Laurus Note
On August 31, 2006, the Company, Icoria and Laurus Master Fund, Ltd. (Laurus), amended and
restated the secured convertible term note payable to Laurus in the aggregate principal amount of
approximately $3.0 million (the Note), which the Company assumed as part of its acquisition of
Icoria in December 2005.
The Note
is now due in semi-annual installments of approximately $334,070 beginning December 1, 2006
with final maturity on October 19, 2010, representing a three-year extension of the original term.
The semi-annual installments may be paid in common stock if the market value of the common stock is
equal to or greater than $27.50 per share, subject to certain terms and conditions in the Amended
and Restated Securities Purchase Agreement (the Purchase Agreement) and the Note. The Note may
be prepaid at a rate of 115% of the then outstanding principal balance, plus accrued and unpaid
interest and fees, if any, subject to Laurus election to convert such amounts into common stock at
$25.00 per share. The Note carries interest at prime plus 2.5% per annum, of which 6.0% is payable
monthly in cash. As defined by the agreement, quarterly, the borrower may elect to take the
difference and: (i) capitalize it into the principal amount of the Note, (ii) pay it in cash, (iii)
pay it in common stock or (iv) pay it in a combination of both cash and common stock. The price of
the common stock would be equal to 90% of the average closing price of the common stock for the
five trading days prior to a payment date, at the option of the Company, subject to the terms and
conditions of the Purchase Agreement. The payment of the non-cash portion of the interest is due
quarterly.
The Note is convertible into shares of the Companys common stock at an initial price of $25.00 per
share at the option of Laurus, and is mandatorily convertible if the market value of the common
stock is equal to or greater than $27.50 per share for six consecutive trading days as specified
per the terms of the Note.
The Note is secured by all of Icorias assets, including but not limited to accounts receivable,
inventory, equipment, intellectual property and general intangibles.
Under the terms of the Note, the entire principal balance, plus any accrued and unpaid interest and
fees, could be accelerated if: (i) principal and interest payments are not timely made; (ii) any
covenants of Icoria contained in the Note and the Purchase Agreement are breached; or (iii) Icoria
declares bankruptcy, makes an assignment for the benefit of creditors or applies for the
appointment of a receiver or trustee for a substantial part of its assets and properties. In
addition, upon the occurrence and during the continuance of an event of default (as defined in the
Note), Laurus may accelerate payment due under the Note and, in the event of such an acceleration,
the amount due and owing to Laurus shall be 100% of the then outstanding principal amount of the
Note, plus accrued and unpaid interest and fees, if any. The interest rate on the Note shall also
be increased by 2.0% during the continuance of an event of default.
In connection with the terms of the amendment, the Company issued warrants to Laurus. The warrants
consist of the right to purchase 25,622 shares of the Companys common stock at an exercise price
of $30.00 per share. Of the 25,622 warrants, 12,811 terminate in August 2008 and 12,811 will
terminate in August 2011. The fair value of the warrants at the date of issuance totaled
approximately $120,000, which has been recorded as an increase to unamortized discount on the Note
and an increase to additional paid-in capital. The discount will be amortized and recorded as
additional interest expense on a straight-line basis over a period equal to the life of the
warrants or maturity date of the Note, whichever is lesser.
Debt Compliance for LaSalle Bank and Line of Credit Agreements
In June 2006, CDSS reduced its line of credit from $10.0 million to $7.5 million in order to lower
the fees paid to the lender on the unused portion of the line. Since CDSS borrowing capacity is
based on certain of its receivables and inventories, which have allowed maximum outstanding
borrowing levels of approximately $5.5 million to date, the reduction in the line of credit does
not impact our expected liquidity. The line of credit bears interest at the rate of either 0.25%
in excess of prime or 300 basis points above the LIBOR rate (8.50% at September 30, 2006).
Approximately $4.2 million of principal was outstanding at September 30, 2006. The credit facility
requires us to comply with certain financial covenants, including tangible net worth, capital
expenditure limitations, and fixed
- 11 -
(6) Debt (continued)
charge coverage. As of March 31, 2006, we did not meet the fixed charge coverage covenant and
were granted a waiver of the non-compliance. As of September 30, 2006, we did not meet certain
balance sheet and income statement covenants and were granted a waiver of non-compliance. The
revolving credit facility was automatically renewed for one year in March 2006.
(7) Equity-Based Compensation
The Company adopted the provisions of Statement of Financial Accounting Standards No. 123(R),
Share-Based Payment (SFAS 123R), using the modified prospective application method effective
April 1, 2006. SFAS 123R establishes accounting for stock-based awards exchanged for employee
services and other stock-based transactions. Stock-based compensation cost is measured at the grant
date, based on the fair value of the award, and is recognized as compensation cost over the
requisite service period. The Company previously applied Accounting Principles Board, or APB,
Opinion No. 25, Accounting for Stock Issued to Employees, and its interpretations and provided the
required pro forma disclosures of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS
123). The effect of adopting SFAS 123R was to increase the net loss for the three and six months
ended September 30, 2006 by $910,000 (or $0.09 per share) and $2.1 million (or $0.23 per share),
respectively, reflecting the compensation expense of stock options at fair value.
Stock-based compensation expense including options and restricted stock totaled approximately $1.1
million and $0 during the three months ended September 30, 2006 and 2005, respectively and $2.3
million and $0 during the six months ended September 30, 2006 and 2005, respectively. In May 2006,
the Company granted 70,000 options to Kevin Rakin, a member of the Companys Board of Directors, in
connection with the settlement of an employment agreement. The options were exercisable
immediately and had a fair value of approximately $896,000, which was expensed on the date of
grant.
The following table presents the stock-based compensation expense in the three and six months ended
September 30, 2006:
| |
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
|
Six Months Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| (in thousands, except per share amouts) |
|
2006 |
|
|
2006 |
|
Cost of revenues |
|
$ |
3 |
|
|
$ |
10 |
|
Sales and marketing |
|
|
16 |
|
|
|
16 |
|
Research and development |
|
|
144 |
|
|
|
227 |
|
General and administrative |
|
|
913 |
|
|
|
2,057 |
|
|
|
|
|
|
|
|
Pre-tax stock-based compensation expense |
|
|
1,076 |
|
|
|
2,310 |
|
Income tax benefits |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense, net |
|
$ |
1,076 |
|
|
$ |
2,310 |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
0.09 |
|
|
$ |
0.23 |
|
|
|
|
|
|
|
|
Since the Company realized no tax benefits related to the stock-based compensation expense,
the adoption of SFAS 123R had no impact on the reported net cash flows provided from operating or
financing activities during the three month and six month periods ended September 30, 2006.
- 12 -
(7) Equity-Based Compensation (continued)
The following table illustrates the effect on net income and earnings per share if the Company had
applied the fair value recognition provisions of SFAS 123R to stock-based employee awards for the
three and six months ended September 30, 2005:
| |
|
|
|
|
|
|
|
|
| |
|
Three Months |
|
|
Six Months |
|
| |
|
Ended |
|
|
Ended |
|
| |
|
September 30, |
|
|
September 30, |
|
| (in thousands, except per share amounts) |
|
2005 |
|
|
2005 |
|
Net income from continuing operations, as reported |
|
$ |
332 |
|
|
$ |
697 |
|
Add: Stock-based employee compensation
expense included in reported net income,
net of related tax effects |
|
|
|
|
|
|
|
|
Deduct: Total stock-based compensation
expense determined under the fair value
method, net of related tax effects |
|
|
(52 |
) |
|
|
(71 |
) |
|
|
|
|
|
|
|
Pro forma net income |
|
$ |
280 |
|
|
$ |
626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported basic income per share |
|
$ |
0.09 |
|
|
$ |
0.18 |
|
As reported diluted income per share |
|
$ |
0.08 |
|
|
$ |
0.17 |
|
|
|
|
|
|
|
|
|
|
Pro-forma income per share |
|
$ |
0.07 |
|
|
$ |
0.16 |
|
Pro-forma diluted income per share |
|
$ |
0.07 |
|
|
$ |
0.15 |
|
The fair value of options on the date of grant was estimated using the Black-Scholes option pricing
model. The fair value is then amortized on a straight-line basis over the requisite service
periods of the awards, which is generally the vesting period. Use of a valuation model requires
management to make certain assumptions with respect to selected model inputs. Expected stock price
volatility was calculated based on the historical volatility of our common stock over the expected
life of the option. The average expected life in 2006 was based on an average of the vesting
period and the contractual term of the option in accordance with SEC Staff Accounting Bulletin No.
107. The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity
term approximating the expected life of the option at the date of
grant. Exclusive of the options assumed in connection with the recent
business combinations, forfeitures
have historically been minimal and are estimated to be 0% per annum.
The assumptions used to calculate the grant-date fair value of the options for the three and six
months ended September 30, 2006 and 2005 were as follows:
| |
|
|
|
|
|
|
|
|
| |
|
Three Months Ended |
|
Six Months Ended |
| |
|
September 30, |
|
September 30, |
| |
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
4.88 - 5.13% |
|
3.88 - 4.00% |
|
4.88 - 5.18% |
|
3.88 - 4.00% |
Expected life of the options |
|
6-7 years |
|
3 years |
|
6-7 years |
|
3 years |
Expected volatility |
|
73 - 82% |
|
38% |
|
73 - 82% |
|
38% |
Expected dividend yield |
|
0% |
|
0% |
|
0% |
|
0% |
Fair value of awards |
|
$10.00 |
|
$6.23 |
|
$10.16 |
|
$6.23 |
Incentive Plans - The Company established a 1991 Stock Option Plan (the 1991 Plan) and a 1991
Directors Stock Option Plan (the Directors Plan) under which an aggregate of 150,000 shares and
75,000 shares of common stock were reserved, respectively, for the purpose of granting incentive
and nonstatutory stock options. In September 2002, the stockholders approved the establishment of
the 2002 Incentive and Stock Option Plan (the 2002 Plan)
- 13 -
(7) Equity-Based Compensation (continued)
under which an aggregate of 250,000 shares of common stock were reserved. In October 2005, the
stockholders approved the establishment of the 2005 Equity Incentive Plan (the 2005 Plan) under
which an aggregate of 1.0 million shares of common stock were reserved. On September 21, 2006, the
stockholders approved an amendment to the 2005 Plan which (a) increased the aggregate number of
shares issuable from 1.0 million to 2.0 million and (b) increased the maximum number of shares that
may be awarded to any participant in any tax year from 150,000 to 500,000 shares. All options are
granted at not less than the fair market value of the stock on the date of grant.
Under the terms of the 1991 Plan and the Directors Plan, options are exercisable over various
periods not exceeding four years. The options under the 1991 Plan expire no later than seven years
after the date of grant whereas the options granted under the Directors Plan expire no later than
ten years after the date of grant.
Under the terms of the 2002 Plan and 2005 Plan, options are exercisable at various periods and
expire as set forth in the grant document. In the case where an incentive stock option is granted,
the maximum expiration date is not later than 10 years from the date of grant unless made to a more
than 10% stockholder, in which case, such incentive stock options expire no later than 5 years from
the date of grant.
A summary of option activity during for the six months ended September 30, 2006 was as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
| |
|
|
|
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
| |
|
Number of |
|
|
Average |
|
|
Remaining |
|
|
Intrinsic |
|
| |
|
Options |
|
|
Exercise |
|
|
Contractual |
|
|
Value |
|
| |
|
(in thousands) |
|
|
Price |
|
|
Term (in years) |
|
|
(in thousands) |
|
Outstanding at April 1, 2006 |
|
|
612 |
|
|
$ |
30.17 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
868 |
|
|
|
16.43 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(99 |
) |
|
|
5.51 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(36 |
) |
|
|
30.43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
1,345 |
|
|
$ |
22.57 |
|
|
|
8.51 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2006 |
|
|
441 |
|
|
$ |
33.59 |
|
|
|
6.47 |
|
|
$ |
0 |
|
The
intrinsic value of options exercised is $1.1 million.
As of September 30, 2006, there was $8.1 million of total unrecognized compensation cost related to
unvested stock-based compensation arrangements granted under our stock plans. That cost is
expected to be recognized over a weighted average period of 4.1 years.
(8) Equity
On August 16, 2006, the Company issued 24,947 shares of common stock to Merck to purchase a
license. The value of the shares (approximately $320,000 based on the quoted price of the
Companys stock on August 16, 2006) was recorded as a research and development expense in the
Molecular Services division.
On June 13, 2006, the Company closed a private placement of common stock in which it sold 1,039,783
shares of common stock and warrants to purchase an additional 519,889 shares of common stock for
net proceeds of approximately $16.9 million, after transaction expenses of approximately $26,000,
to certain institutional and other qualified investors, including certain members of the Companys
board of directors. The unit price was $16.27, which equaled the closing bid price of its common
stock on NASDAQ on the closing date, plus $0.06. The exercise
price of the warrants is $19.45. The warrants are exercisable beginning December 14, 2006 and
expire on June 13, 2011.
- 14 -
(9) Related Party Transactions
As described in Note 3, the Company received offers from two groups to purchase the Companys 92.5%
majority interest in Vital Diagnostics. The Company accepted the more favorable offer. Pursuant
to such offer, Vital Diagnostics general manager, Adrian Tennyenhuis, in partnership with New
River Management IV, LP, invested $1.5 million into Vital Diagnostics which Vital Diagnostics used
to fund the transaction. New River Management, IV is an affiliate of Third Security, which is
funded and controlled by Third Security, LLC. Third Security, LLC is controlled by Randal J. Kirk,
the Chairman of the Board of the Company. This transaction closed on November 13, 2006.
On June 9, 2006, the Company issued $2.0 million of convertible promissory notes to two affiliates
of Randal J. Kirk. The notes, which were payable at thirty days from the date of issuance, accrued
interest at a rate of 12% per annum and were convertible at the option of the holders into the same
type of security sold by the Company to investors in the first financing following issuance. On
June 13, 2006, the notes plus accrued interest of approximately $4,000 were converted as part of
the private placement of common stock discussed in Note 6 above.
(10) Segment Information
The Company manages its business as four operating segments: Molecular Services (which includes
Cogenics, PGxHealth and Vilazodone); sales of instruments and consumables to Clinics and Small
Hospitals; sales of instruments, consumables and services to Physicians Office Laboratories;
and All Other. All Other includes corporate related items, results of insignificant operations
and, as it relates to segment profit (loss), income and expense not allocated to reportable
segments.
Segment information for the three months ended September 30, 2006 and 2005 is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Clinics and |
|
Physicians |
|
|
|
|
|
|
| |
|
Small |
|
Office |
|
Molecular |
|
All |
|
|
| (in thousands) |
|
Hospitals |
|
Laboratories |
|
Services |
|
Other |
|
Total |
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
$ |
6,731 |
|
|
$ |
5,201 |
|
|
$ |
7,262 |
|
|
$ |
|
|
|
$ |
19,194 |
|
2005 |
|
|
5,609 |
|
|
|
6,095 |
|
|
|
|
|
|
|
|
|
|
|
11,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues and operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
6,213 |
|
|
|
5,528 |
|
|
|
12,456 |
|
|
|
2,810 |
|
|
|
27,007 |
|
2005 |
|
|
4,816 |
|
|
|
5,971 |
|
|
|
|
|
|
|
326 |
|
|
|
11,113 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
14 |
|
|
|
|
|
|
|
10 |
|
|
|
131 |
|
|
|
155 |
|
2005 |
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
11 |
|
|
|
124 |
|
|
|
166 |
|
|
|
15 |
|
|
|
316 |
|
2005 |
|
|
|
|
|
|
70 |
|
|
|
|
|
|
|
15 |
|
|
|
85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
193 |
|
|
|
|
|
|
|
(233 |
) |
|
|
11 |
|
|
|
(29 |
) |
2005 |
|
|
280 |
|
|
|
(61 |
) |
|
|
|
|
|
|
(8 |
) |
|
|
211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income from continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
399 |
|
|
|
(422 |
) |
|
|
(5,530 |
) |
|
|
(2,458 |
) |
|
|
(8,011 |
) |
2005 |
|
|
538 |
|
|
|
95 |
|
|
|
|
|
|
|
(301 |
) |
|
|
332 |
|
- 15 -
(10) Segment Information (continued)
Segment information for the six months ended September 30, 2006 and 2005 is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Clinics and |
|
Physicians |
|
|
|
|
|
|
| |
|
Small |
|
Office |
|
Molecular |
|
All |
|
|
| (in thousands) |
|
Hospitals |
|
Laboratories |
|
Services |
|
Other |
|
Total |
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
$ |
15,178 |
|
|
$ |
10,605 |
|
|
$ |
16,464 |
|
|
$ |
|
|
|
$ |
42,247 |
|
2005 |
|
|
10,424 |
|
|
|
12,986 |
|
|
|
|
|
|
|
4 |
|
|
|
23,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues and operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
13,329 |
|
|
|
11,455 |
|
|
|
27,253 |
|
|
|
3,732 |
|
|
|
55,769 |
|
2005 |
|
|
9,208 |
|
|
|
12,462 |
|
|
|
|
|
|
|
563 |
|
|
|
22,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
27 |
|
|
|
|
|
|
|
52 |
|
|
|
175 |
|
|
|
254 |
|
2005 |
|
|
44 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
11 |
|
|
|
248 |
|
|
|
279 |
|
|
|
17 |
|
|
|
555 |
|
2005 |
|
|
6 |
|
|
|
130 |
|
|
|
|
|
|
|
24 |
|
|
|
160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
660 |
|
|
|
|
|
|
|
(257 |
) |
|
|
27 |
|
|
|
430 |
|
2005 |
|
|
437 |
|
|
|
(24 |
) |
|
|
|
|
|
|
(21 |
) |
|
|
392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income from continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
1,320 |
|
|
|
(1,063 |
) |
|
|
(11,097 |
) |
|
|
(3,435 |
) |
|
|
(14,275 |
) |
2005 |
|
|
842 |
|
|
|
391 |
|
|
|
|
|
|
|
(536 |
) |
|
|
697 |
|
Revenue information by geographic area for the three and six months ended September 30, 2006 and
2005 is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
North |
|
|
|
|
|
|
| (in thousands) |
|
America |
|
Europe |
|
All Other |
|
Total |
Three Months Ended September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
$ |
4,754 |
|
|
$ |
11,257 |
|
|
$ |
3,183 |
|
|
$ |
19,194 |
|
2005 |
|
|
6,170 |
|
|
|
2,999 |
|
|
|
2,535 |
|
|
|
11,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended September 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
$ |
11,091 |
|
|
$ |
24,173 |
|
|
$ |
6,983 |
|
|
$ |
42,247 |
|
2005 |
|
|
12,709 |
|
|
|
6,104 |
|
|
|
4,601 |
|
|
|
23,414 |
|
- 16 -
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward Looking Statements and Risk Factors
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. The forward-looking statements reflect our plans, estimates and
beliefs. These statements involve known and unknown risks, uncertainties and other factors which
may cause our actual results, performance or achievements to be materially different from any
future results, performances or achievements expressed or implied by the forward-looking
statements. In some cases, you can identify forward-looking statements by terms such as
anticipates, believes, could, estimates, expects, intends, may, plans, potential,
predicts, projects, should, will, would and similar expressions intended to identify
forward-looking statements. Forward-looking statements reflect our current views with respect to
future events and are based on assumptions and subject to risks and uncertainties. Because of
these risks and uncertainties, the forward-looking events and circumstances discussed in this
report may not transpire. We discuss many of these risks in Item 1A under the heading Risk
Factors of our Annual Report on Form 10-K for the year ended March 31, 2006.
Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Also, forward-looking statements represent our estimates and assumptions only as of the date of
this document. You should read this document with the understanding that our actual future results
may be materially different from what we expect. Except as required by law, we do not undertake
any obligation to publicly update or revise any forward-looking statements contained in this
report, whether as a result of new information, future events or otherwise.
Overview
Our business activities are reported in four operating segments: (i) Molecular Services, which
is comprised of the recently acquired operations of Genaissance, Icoria and Genome Express
(molecular services segment); (ii) sales of diagnostic equipment, consumables and services to
small-to-medium-sized clinics, hospitals and laboratories (clinics and small hospitals segment);
(iii) sales of diagnostic equipment, consumables and services to Physicians Office Laboratories
(POL segment); and (iv) all other activities, which includes corporate-related items, results of
insignificant operations and income and expense not allocated to reportable segments. The
molecular services segment, at the present, is the principal segment contributing to our reported
loss.
We believe we are a leading provider of molecular services, pharmacogenomics, genetic testing and
clinical diagnostics. Our molecular services segment is among the largest independent providers of
pharmacogenomics, molecular and metabolomics services globally. Our pharmacogenomics, molecular
and metabolomics services are marketed to the pharmaceutical, biotechnology, clinical, academic,
government and agricultural marketplaces. We are utilizing pharmacogenomics to develop
genetic-based tests and diagnostics and more efficacious therapeutics by finding genetic markers to
guide drug development and utilization through out PGxHealth division. Our therapeutic product,
Vilazodone, for depression, is in Phase III clinical development.
Our future success in molecular services will depend in large part on maintaining a competitive
position in the genomics field, a field that has undergone, and is expected to continue to undergo,
rapid and significant change as well as price pressure. In addition, the competition in the
pharmacogenomic and molecular services market is intense and includes companies providing similar
services, pharmaceutical, biotechnology and diagnostic companies, academic and research
institutions and government and other publicly funded agencies, both in the U.S. and abroad. Our
future success in this highly competitive market depends on our ability to demonstrate that our
recently acquired technology platforms, know how, and informatics technologies and capabilities are
superior to those of such competitors and our ability to advance technologies and genetic testing
franchises. We must continue to advance our intellectual property and that which we in-license in
order to develop and commercialize a new generation of genetic tests. In addition, we must
continue to contain costs and move toward profitability while growing revenues wherever possible.
- 17 -
Funding the continued development of Vilazodone, our depression drug currently in its first pivotal
trials, is another challenge that we face in our molecular services business. We currently do not
have the cash reserves or the revenue and related cash flows from other sources to fund such
development and our operations simultaneously beyond the first quarter of fiscal 2008. In order to
successfully commercialize this drug candidate, we will be required to either partner with a third
party that has sufficient resources or raise capital through the sale of our debt or equity
securities. Establishing a partnership with another company could have an impact on the future
revenues we can expect to receive from Vilazodone if we have to share some portion of such revenues
with a development partner. Additionally, fund raising could serve to dilute our existing
stockholders ownership.
While we continue to face challenges with respect to our recent acquisitions, we are now focused on
improving the operational performance of these acquisitions. As integration risks are minimized,
we are focusing on improving our cash flow and have taken actions to restructure and streamline the
operations of these businesses. Integrating the operations and personnel of Genaissance and Icoria
will still require management attention. Efforts to coordinate product development, sales and
marketing efforts and administrative operations are progressing. Given that both Genaissance and
Icoria have a history of incurring significant net losses, we face the challenge of successfully
integrating Genaissance and Icoria into businesses that will generate sufficient revenue to become
profitable and that will sustain profitability if they do become profitable alleviating the need
for ongoing efforts to raise capital. We have added seasoned management to assist in this
transition and these efforts.
With respect to our Vital Diagnostics Division, revenues from clinical laboratory testing worldwide
are anticipated to grow as a result of the aging of the population, increased healthcare awareness
and expanding insurance coverage. The present focus, however, on greater efficiency in disease
management and on reducing health care costs exposes our customers to a constant pressure to
contain costs. Consequently, in order to remain competitive and gain market share in these growing
markets, it is essential for us to continue to provide cost-effective technologies and services.
Competition in the medical products industry, which includes our diagnostic instrumentation,
reagent and consulting services businesses, is intense and expected to increase as new products,
technologies and services become available and new competitors enter the market. Our competitors
in the United States and Europe are numerous and include, among others, large, multi-national
diagnostic testing and medical products companies. Our future success depends upon maintaining a
competitive position in the development and distribution of products, technologies and services in
its areas of focus in POLs and smaller clinical laboratories. In order to grow, gain market share
and remain competitive, we must continue to introduce new products, technologies and services, and
invest in research and development.
Financial Operations Overview
Revenues. Our product revenues are generated primarily from the sale of diagnostic
equipment, reagents and other consumables to POLs and small-to-medium sized clinics, hospitals and
laboratories.
Our service revenues are generated primarily from (i) service fees, milestone achievements and
deliveries of molecular services data and assays; (ii) maintenance services provided on diagnostic
equipment sold by us; and (iii) laboratory management fees and consulting services provided to POLs
and to small-to-medium size clinics, hospitals and laboratories.
Cost of Revenues. Cost of product revenues primarily represent costs to purchase or
manufacture the diagnostic equipment, reagents and consumables, including equipment, parts and
other materials, salaries and related expenses for personnel, including stock-based compensation
expenses, and manufacturing overhead costs, such as depreciation, rent, utilities and other
facilities costs.
Cost of service revenues consist primarily of salaries and related expenses for personnel,
including stock-based compensation expenses, laboratory expenses, depreciation, travel and
facilities expenses, including rent, utilities and other facilities costs.
- 18 -
Sales and Marketing Expense. Sales and marketing expense consists primarily of
salaries, commissions and other related personnel costs, including stock-based compensation
expenses, in our sales and marketing functions. Other costs primarily include advertising and
promotion expenses, direct mailings, trade shows, facility costs and travel and related expenses.
In the POL segment, sales and marketing expenses also include costs for technical support and
customer service.
Research and Development Expense. Research and development expense consists
primarily of expenses incurred in developing and testing products and product candidates, including
salaries and related expenses for personnel, including stock-based compensation expenses, costs of
materials, depreciation, rent, utilities and other facilities costs, fees paid to professional
service providers in conjunction with independently monitoring our clinical trials and acquiring
and evaluating data in conjunction with our clinical trials and costs of contract manufacturing
services. We expense research and development costs as incurred.
General and Administrative Expense. General and administrative expense consists
primarily of salaries and other related costs for personnel, including stock-based compensation
expenses, in our executive, finance, accounting, information technology and human resource
functions. Other costs primarily include facility costs and professional fees for accounting,
consulting and legal services, including patent-related expenses.
Interest and Other Income (Expense), Net. Interest expense consists of interest incurred under
the revolving credit facility, notes payable and other debt financings and capital lease
obligations. Interest income consists of interest earned on our cash and cash equivalents and
short-term investments. Other income (expense), net consists primarily of foreign currency gains
(losses).
Preferred Stock Dividend. Preferred stock dividends consists of dividends accrued at a
rate of 2% per year on the outstanding shares of Series A Voting Convertible Preferred Stock (the
Series A Preferred Stock) issued in connection with the acquisition of Genaissance on October 6,
2005. Dividends on outstanding shares are payable on January 5th and July
5th of each year, when and if declared by the Board of Directors. As of September 30,
2006, the cumulative dividends accrued on the Series A Preferred Stock totaled $92,000.
Changes in Foreign Currency Rates
A portion of our balance sheet is denominated in Euros, the functional currency of our Dutch,
French and Italian operations, and a minor portion of our balance sheet is denominated in
Australian dollars and British pounds. The effect of translation of these local currencies into
U.S. dollars for reporting purposes is reflected as a separate component of stockholders equity.
The gains or losses from foreign currency transactions, which have not been material to the
financial statements, are included in other income (expense), except for those denominated in
Australian dollars which are included in discontinued operations. The Euro strengthened against
the U.S. dollar by 4.2% during the first half of fiscal 2007 and 5.9% during fiscal 2006 from the
respective prior fiscal years closing rates. The results of our European operations can be
significantly impacted by changes in these foreign exchange rates.
Periodically, we enter into foreign exchange forward contracts to reduce the exposure to currency
fluctuations on customer accounts receivable denominated in foreign currency. The objective of
these contracts is to minimize the impact of foreign currency exchange rate fluctuations on
operating results. Derivative financial instruments are not used for speculative or trading
purposes. There were foreign exchange forward contracts with a notional value of $0.9 million
outstanding at September 30, 2006. The fair value of these instruments at September 30, 2006 was
de minimis. Gains and losses related to these derivative instruments during the first half of
fiscal 2007 and fiscal 2006 were not significant. We do not anticipate any material adverse effect
on our consolidated financial position, results of operations, or cash flows resulting from the use
of these instruments. However, there can be no assurance that these strategies will be effective
or that transaction losses can be minimized or forecasted accurately.
- 19 -
Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our
consolidated financial statements and notes, which have been prepared in accordance with accounting
principles generally accepted in the U.S. The preparation of these financial statements requires
us to make estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments, including
those related to revenue, allowances for doubtful accounts, inventory, intangibles, goodwill,
accrued expenses and income taxes. We base our estimates on historical experience and on various
other assumptions that we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ from these estimates under
different assumptions or conditions.
A summary of our significant accounting policies is contained in Note 1 to our consolidated
financial statements included in our Annual Report on Form 10-K. We believe the following critical
accounting policies affect our more significant judgments and estimates used in the preparation of
our consolidated financial statements.
Revenue Recognition Our revenues from the sale of diagnostic equipment and consumables are
recognized at the time when persuasive evidence of an arrangement exists, delivery has occurred,
the price to the buyer is fixed or determinable and collectibility is reasonably assured. Revenue
from maintenance services on equipment is recognized ratably over the term of the maintenance
agreement. Revenue from maintenance services performed for customers who do not have a maintenance
agreement is recognized using the completed contract method. Revenues from consulting services
provided to POLs are generally fixed fee arrangements and such revenues are recognized ratably over
the term of the consulting contract as services are delivered. Along with the sale of products,
training and installation services are provided to the end-user customer, and such revenues are
recognized as the products are delivered or as service are provided, with all revenue measured
using objective fair value.
Revenues from the molecular services segment are derived from fees for services, reimbursement from
health insurers, licenses of intellectual property, commercial partnerships and government
contracts and grants. Payments from commercial contracts are generally related to service fees,
milestone achievements and deliveries of molecular services data or assays. Payments for service
fees and milestone achievements are recognized as revenues on a progress-to-completion basis over
the term of the respective contract, except with respect to refundable fees for which revenue
recognition does not commence until the refund right expires. Revenues recognized under the
progress-to-completion method are calculated based on applicable output measures, such as a
comparison of the number of genes analyzed to the total number of genes to be analyzed, assessed on
a contract-by-contract basis. To the extent payments received exceed revenue recognized for each
contract or grant, the excess portion of such payments is recorded as deferred revenues. To the
extent revenues recognized exceed payments received for each contract or grant, the excess revenues
are recorded as accounts receivable.
Revenue related to molecular services deliveries are recognized upon the later of delivery or, if
applicable, customer acceptance. Payments received under the Companys commercial contracts and
government contracts and grants are generally non-refundable regardless of the outcome of the
future research and development activities to be performed by the Company. Payments from
government contracts and grants, which are typically cost plus arrangements, are recognized as
revenues as related expenses are incurred over the term of each contract or grant.
Allowance for Doubtful Accounts Allowances for doubtful accounts are maintained for
estimated losses resulting from the inability of our customers to make required payments. These
estimated allowances are periodically reviewed, analyzing the customers payment history and
information known to us regarding customers credit worthiness. If the financial condition of our
customers were to deteriorate, resulting in an impairment of their ability to make payments,
additional allowances may be required.
Inventory Valuation Inventories are stated at the lower of cost (first-in, first-out) or
market. Inventory quantities are periodically reviewed and, when necessary, provisions for excess
and obsolete inventories are provided. On an ongoing basis, we review the carrying value of the
inventory and record an inventory impairment charge at such time as it is believed that the
carrying value exceeds the inventorys net realizable value. Such
- 20 -
assessments are based upon historical sales, forecasted sales, market conditions and information
derived from our sales and marketing professionals.
In addition, certain of our products are perishable, and in the event that the product is not sold
before the expiration date, a full valuation reserve against such inventory is provided as soon as
it is determined that the product is no longer marketable due to the expiration date. The product
is then disposed and written off.
Valuation of Intangibles As discussed in Note 3 to the consolidated financial statements in
our Annual Report on Form 10K, we completed four business combinations during fiscal 2006. We also
completed three business combinations during fiscal 2004. In accordance with Statement of
Financial Accounting Standard (SFAS) No. 141, Business Combinations, the transactions have been
accounted for based on the fair value of the assets purchased. As a result of the purchase price
allocations, we recorded purchased intangibles of $63.6 million and goodwill totaling $18.8 million
in the molecular services segment, goodwill of $1.2 million in clinics and small hospitals segment
and purchased intangibles of $1.5 million and goodwill totaling $6.3 million in the POL segment
relating to these acquisitions.
In accordance with the requirements of SFAS No. 142, Goodwill and Intangible Assets, we perform an
annual impairment test of the carrying value of goodwill using December 31 as our selected annual
evaluation date. The fair value of our recorded intangibles can be impacted by economic
conditions, market risks, and the volatility in the markets in which we and our customers operate.
Changes in fair value could result in future impairment charges if the fair value of the reporting
units or asset groups to which these long-lived assets are associated are determined to be less
than the carrying value of such assets. As of December 31, 2005, the most recent evaluation date,
there was no impairment of such goodwill.
In accordance with the requirements of SFAS No. 144, Accounting for the Impairment or Disposal of
Long-Lived Assets, when facts and circumstances suggest that there may be an impairment, we will
assess the carrying value of amortizing intangibles, including purchased intangibles and
capitalized software. When a potential impairment has been identified, forecasted undiscounted net
cash flows of the operations to which the asset relates are compared to the current carrying value
of the assets present in that operations. If such cash flows are less than such carrying amounts,
such intangibles are written down to their respective fair values. The results of these periodic
impairment tests can be impacted by our future expected operating results and cash flows, economic
conditions, market risks, and the volatility in the markets in which Clinical Data and its
customers operate. No impairment charges have been recognized for the periods presented in this
report.
Accrued Expenses As part of the process of preparing consolidated financial statements we
are required to estimate accrued expenses. This process involves identifying services which have
been performed on our behalf and estimating the level of service performed and the associated cost
incurred for such service as of each balance sheet date in our consolidated financial statements.
Examples of estimated expenses for which we accrue include contract service fees, such as amounts
paid to clinical monitors, data management organizations, clinical sites and investigators in
conjunction with clinical trials, and fees paid to contract manufacturers in conjunction with the
production of materials for clinical and non-clinical trials, and professional service fees. In
connection with these service fees, our estimates are most affected by our understanding of the
status and timing of services provided relative to the actual levels of services incurred by such
service providers. In the event that we do not identify costs which have begun to be incurred or
we under- or over-estimate the level of services performed or the costs of such services, our
reported expenses for such period would be too low or too high, and revenue may be overstated or
understated to the extent such expenses relate to collaborations accounted for using the
progress-to-completion method. The date on which specified services commence, the level of
services performed on or before a given date and the cost of such services is often judgmental. We
attempt to mitigate the risk of inaccurate estimates, in part, by communicating with our service
providers when other evidence of costs incurred is unavailable.
Income Taxes As part of the process of preparing our consolidated financial statements, we
are required to estimate our income taxes in each of the jurisdictions in which we operate. This
process involves estimating our actual current tax exposure together with assessing temporary
differences resulting from differing treatments of items for tax and accounting purposes. These
differences result in deferred tax assets and liabilities. As of March 31, 2006, we had federal
tax net operating loss carryforwards, after limitation for the change in ownership, of $74.5
million, which expire starting in 2011, federal research and development credit carryforwards of
$6.5 million and
- 21 -
total net deferred tax assets of $140.8 million. We have recorded a valuation allowance of $141.1
million as an offset against these otherwise recognizable net deferred tax assets due to the
uncertainty surrounding the timing of the realization of the tax benefit. In the event that we
determine in the future that we will be able to realize all or a portion of our net deferred tax
asset, an adjustment to the deferred tax valuation allowance would increase net income in the
period in which such a determination is made. The Tax Reform Act of 1986 contains provisions that
may limit the utilization of net operating loss carryforwards and credits available to be used in
any given year in the event of a change in ownership; this occurred when we purchased Genaissance
and Icoria.
Results of Operations
Three Months Ended September 30, 2006 Compared to Three Months Ended September 30, 2005
Revenues. Consolidated revenues increased $7.5 million, or 64%, to $19.2 million in the three
months ended September 30, 2006 from $11.7 million in the three months ended September 30, 2005.
Product revenues increased $543,000, or 5%, to $10.6 million in 2006 from $10.1 million in 2005 due
primarily to increased sales in Clinics and Small Hospitals.
Services revenue increased $7.0 million, or 437%, to $8.6 million in 2006 from $1.6 million in
2005. The increase was due to approximately $7.3 million of services revenue, including
approximately $1.0 million received from a customer in settlement of a prior years collaboration,
generated by the molecular services operations acquired in the second half of last fiscal year.
Service revenues in the POL segment decreased $315,000, or 19%, to $1.3 million in 2006 from $1.6
million in 2005 due to fewer units under service contracts.
Gross Profit. Gross profit on product sales was 30% in 2006 compared to 35% in 2005. The
decrease was due to a change in the revenue mix as sales of reagents and consumables, which have a
higher gross margin, declined.
Gross profit from services revenues decreased to 37% in 2006 from 43% in 2005. The decrease was
primarily due to the inclusion of the molecular services operations acquired in the second half of
last fiscal year which generate lower gross margins than those in the POL segment.
Sales and Marketing Expense. Sales and marketing expenses increased $980,000, or 70%, to $2.3
million in 2006 from $1.4 million in 2005. The increase was due to the inclusion of approximately
$993,000 of sales and marketing expenses incurred by the molecular services operations acquired in
the second half of last fiscal year. Sales and marketing expenses in the POL and Clinics and Small
Hospitals segments in 2006 were approximately the same as the prior year.
Research and Development Expense. Research and development expenses increased $3.2 million, or
507%, to $3.8 million in 2006 from $631,000 in 2005. The increase was due to the inclusion of
approximately $3.2 million of research and development expenses incurred by the molecular services
operations acquired in the second half of last fiscal year, which includes approximately $2.0
million of expenses related to the Phase III clinical trials of Vilazodone. Research and
development expenses in the POL and Clinics and Small Hospitals segments in 2006 approximated the
prior year. Our research and development expenses for molecular services are significantly
impacted by the Vilazodone Phase III clinical trials.
General and Administrative Expense. General and administrative expenses increased $6.3
million, or 393%, to $8.0 million in 2006 from $1.6 million in 2005. The increase was due
primarily to (i) the inclusion of approximately $3.6 million of general and administrative
expenses, incurred by the molecular services operations acquired in the second half of last fiscal
year; (ii) approximately $0.7 million in stock-based compensation expenses; and (iii) approximately
$350,000 of salary and related costs incurred in connection with the resignation of our former CEO
and then Executive Vice Chairman. We expect our stock-based compensation expenses to increase in
future periods as new options are granted and recently granted options become vested.
- 22 -
Interest and Other Income (Expense), Net. Interest expense increased to $316,000 in 2006 from
$85,000 in 2005 due primarily to increased average borrowings under our revolving credit facility,
debt assumed in the acquisitions of Genaissance and Icoria and to higher average interest rates.
Interest income increased to $155,000 in 2006 from $20,000 in 2005 due primarily to higher average
cash balances as a result of the private placement completed on June 13, 2006 and to higher average
interest rates.
Other income (expense), net of ($66,000) in 2006 and $17,000 in 2005 primarily represents foreign
currency (losses) and gains.
Provision For Income Taxes. The effective tax rate was (0.4%) in 2006 compared to 39% in 2005.
Although we incurred a loss in 2006, no tax benefit was recorded on the operating losses in the
United States as the deferred tax asset may not be realized. In addition, we recorded a tax
provision for the income from our foreign operations. We expect that for the foreseeable future
that we will not be able to provide a tax benefit from our losses in the United States.
Six Months Ended September 30, 2006 Compared to Six Months Ended September 30, 2005
Revenues. Consolidated revenues increased $18.8 million, or 80%, to $42.2 million in the six
months ended September 30, 2006 from $23.4 million in the six months ended September 30, 2005.
Product revenues increased $2.8 million, or 14%, to $23.1 million in 2006 from $20.3 million in
2005 due primarily to increased sales in Clinics and Small Hospitals.
Services revenue increased $16.0 million, or 500%, to $19.2 million in 2006 from $3.2 million in
2005. The increase was due to approximately $16.5 million of services revenue, including
approximately $1.0 million received from a customer in settlement of a prior years collaboration,
generated by the molecular services operations acquired in the second half of last fiscal year.
Service revenues in the POL segment decreased approximately $438,000, or 14%, to $2.7 million in
2006 from $3.2 million in 2005 due to fewer units under service contracts.
Gross Profit. Gross profit on product sales was 34% in 2006 compared to 35% in 2005. The
decrease was due to a change in the revenue mix as sales of reagents and consumables, which have a
higher gross margin, declined.
Gross profit from services revenues of 37% was the same in 2006 and 2005.
Sales and Marketing Expense. Sales and marketing expenses increased $2.1 million, or 75%, to
$4.9 million in 2006 from $2.8 million in 2005. The increase was due to the inclusion of
approximately $2.3 million of sales and marketing expenses incurred by the molecular services
operations acquired in the second half of last fiscal year. Sales and marketing expenses in the
POL and Clinics and Small Hospitals segments in 2006 were approximately $152,000 lower than in 2005
due to a reorganization of sales staff and reduced marketing activities.
Research and Development Expense. Research and development expenses increased $5.7 million, or
438%, to $7.0 million in 2006 from $1.3 million in 2005. The increase was due to the inclusion of
approximately $5.7 million of research and development expenses incurred by the molecular services
operations acquired in the second half of last fiscal year, which includes approximately $3.3
million of expenses related to the Phase III clinical trials of Vilazodone. Research and
development expenses in the POL and Clinics and Small Hospitals segments in 2006 were approximately
the same as the prior year. Our research and development expenses for molecular services are
significantly impacted by the Vilazodone Phase III clinical trials.
General and Administrative Expense. General and administrative expenses increased $13.3
million, or 429%, to $16.4 million in 2006 from $3.1 million in 2005. The increase was due
primarily to (i) the inclusion of approximately $9.5 million of general and administrative
expenses, including an increase in allowance for uncollectible accounts of $0.6 million, incurred
by the molecular services operations acquired in the second half of last fiscal year and (ii)
approximately $1.8 million in stock-based compensation expenses. We expect our stock-
- 23 -
based compensation expenses to increase in future periods as new options are granted and
recently granted options become vested.
Interest and Other Income (Expense), Net. Interest expense increased to $555,000 in 2006 from
$160,000 in 2005 due primarily to increased average borrowings under our revolving credit facility,
debt assumed in the acquisitions of Genaissance and Icoria and to higher average interest rates.
Interest income increased to $254,000 in 2006 from $45,000 in 2005 due primarily to higher average
cash balances as a result of the private placement completed on June 13, 2006 and to higher average
interest rates.
Other income (expense), net of ($22,000) in 2006 and $23,000 in 2005 primarily represents foreign
currency (losses) and gains.
Provision For Income Taxes. The effective tax rate was (3.2%) in 2006 compared to 36% in 2005.
Although we incurred a loss in 2006, no tax benefit was recorded on the operating losses in the
United States as the deferred tax asset may not be realized. In addition, we recorded a tax
provision for the income from our foreign operations. We expect that for the foreseeable future
that we will not be able to provide a tax benefit from our losses in the United States.
Liquidity and Capital Resources
We had
cash and cash equivalents of approximately $16.8 million at September 30, 2006. We
generated net cash flow of $9.6 million in the six months ended September 30, 2006 as compared to
$869,000 in the prior year. The increased net cash flow in 2006 was due to the issuance of common
stock and other equity instruments partially offset by our operating losses, debt repayments and
purchases of equipment.
At currently projected rates of expenditure, we believe that additional funding will be required to
operate the Company through the end of the first quarter fiscal 2008, including the funding of
Phase III clinical trials for Vilazodone. To reduce our cash utilization, we continue to identify
areas to rationalize our cost base and streamline our organization as we integrate Genaissance and
Icoria into our operations. We are considering several options for raising additional funds such
as public or private offerings of equity or debt, or other financing arrangements. The sale of any
equity or debt securities may result in additional dilution to our stockholders, and we cannot be
certain that additional financing will be available in amounts or on terms acceptable to us, if at
all. If we are unable to obtain any required additional financing, we may be required to reduce
the scope of our planned research, development and commercialization activities, including our
efforts related to Vilazodone, genetic testing and marker development and other new technologies,
which would reduce our use of cash but could harm our long-term financial condition and operating
results. Additional equity financing may be dilutive to the holders of our common stock and debt
financing, if available, may involve significant cash payment obligations and covenants that
restrict our ability to operate our business.
On June 13, 2006, we closed a private placement of common stock in which we sold 1,039,783 shares
of common stock and warrants to purchase an additional 519,889 shares of common stock for net
proceeds of approximately $16.9 million, after transaction expenses of approximately $26,000, to
certain institutional and other qualified investors, including certain members of our board of
directors. The unit price was $16.27, which equaled the closing bid price of our common stock on
NASDAQ on the Closing Date, plus $0.06. The exercise price of the warrants is $19.45. The
warrants are exercisable beginning December 14, 2006 and expire on June 13, 2011.
On August 31, 2006, we amended the terms of a secured convertible note, with an outstanding
principal balance of approximately $2.9 million plus accrued interest of $103,000, issued by Icoria
to Laurus Master Fund, Ltd. (the Note). The Note was assumed as part of our acquisition of
Icoria in December 2005.
The Note is due in semi-annual installments of approximately $334,070 beginning December 1, 2006
with final maturity on October 19, 2010, representing a three-year extension of the original term.
The semi-annual installments may be paid in common stock if the market value of our common stock is
equal to or greater than $27.50 per share, subject to certain terms and conditions in the Amended
and Restated Securities Purchase Agreement (the Purchase Agreement) and the Note. The Note may
be prepaid at a rate of 115% of the then outstanding principal balance,
- 24 -
plus accrued and unpaid interest and fees, if any, subject to Laurus election to convert such
amounts into our common stock at $25.00 per share. The Note carries interest at prime plus 2.5%
per annum, of which 6.0% is payable monthly in cash. As defined by the agreement, quarterly, the
borrower may elect to take the difference: and (i) capitalize it into the principal amount of the
Note, (ii) pay it in cash, (iii) pay it in common stock, or (iv) pay it in a combination of both
cash and common stock. The price of the common stock would be equal to 90% of the average closing
price of our common stock for the five trading days prior to a payment date, at our option, subject
to the terms and conditions of the Purchase Agreement. The payment of the non-cash portion of the
interest is due quarterly.
The Note is convertible into shares of our common stock at an initial price of $25.00 per share at
the option of Laurus, and is mandatory convertible if the market value of our common stock is equal
to or greater than $27.50 per share for six consecutive trading days as specified per the terms of
the Note.
The Note is secured by all of Icorias assets, including but not limited to accounts receivable,
inventory, equipment, intellectual property and general intangibles, and payments due under the
Note are guaranteed by us up to $760,000.
The entire principal balance, plus any accrued and unpaid interest and fees, could be accelerated
if: (i) principal and interest payments are not timely made; (ii) any covenants of Icoria contained
in the Note and the Purchase Agreement are breached; or (iii) Icoria declares bankruptcy, makes an
assignment for the benefit of creditors or applies for the appointment of a receiver or trustee for
a substantial part of its assets and properties. In addition, upon the occurrence and during the
continuance of an event of default (as defined in the Note), Laurus may accelerate payment due
under the Note and, in the event of such an acceleration, the amount due and owing to Laurus shall
be 100% of the then outstanding principal amount of the Note, plus accrued and unpaid interest and
fees, if any. The interest rate on the Note shall also be increased by 2.0% during the continuance
of an event of default.
Our long-term debt obligations at September 30, 2006 and March 31, 2006 were as follows:
- 25 -
| |
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
|
March 31, |
|
| (in thousands) |
|
2006 |
|
|
2006 |
|
Notes payable, bearing interest at 4.0%-10.4%, with maturities between April
2008 and December 2009 and secured by related equipment |
|
$ |
220 |
|
|
$ |
66 |
|
Note payable, bearing interest at 4.0%, with maturity on January 2010 and
monthly payments of $17 and secured by related software |
|
|
636 |
|
|
|
724 |
|
Euro note payable, bearing interest at 5.5%, with maturity on September 2007
and quarterly payments of $76 and secured by a bank guarantee |
|
|
396 |
|
|
|
452 |
|
Capital lease obligations with final maturity on January 2010 |
|
|
1,129 |
|
|
|
1,294 |
|
|
|
|
|
|
|
|
|
|
Icoria Acquired Debt |
|
|
|
|
|
|
|
|
Convertible note payable, bearing interest at 10.75% at September 30, 2006
(10.0% at March 31, 2006) with maturity on October 19, 2010; secured by
all of Icorias assets |
|
|
2,887 |
|
|
|
3,227 |
|
|
|
|
|
|
|
|
|
|
Genaissance Acquired Debt |
|
|
|
|
|
|
|
|
Notes payable, bearing interest at 6.5%, with maturities between February
2009 and May 2011 and secured by certain of Genaissances leasehold
improvements |
|
|
3,282 |
|
|
|
3,520 |
|
|
|
|
|
|
|
|
|
|
Genome Express Acquired Debt |
|
|
|
|
|
|
|
|
Interest-free advance from French government under a program to stimulate
national innovation, with maturities between September 2007 and
September 2008 |
|
|
1,097 |
|
|
|
1,134 |
|
Interest-free advance from lending institution with respect to research tax
credits, with maturity in May 2006 |
|
|
|
|
|
|
340 |
|
|
|
|
|
|
|
|
|
|
|
9,647 |
|
|
|
10,757 |
|
|
|
|
|
|
|
|
|
|
Less: |
|
|
|
|
|
|
|
|
Current portion |
|
|
(2,266 |
) |
|
|
(3,868 |
) |
|
|
|
|
|
|
|
|
|
$ |
7,381 |
|
|
$ |
6,889 |
|
|
|
|
|
|
|
|
Line of Credit Agreements
In June 2006, CDSS reduced its line of credit from $10.0 million to $7.5 million in order to lower
the fees paid to the lender on the unused portion of the line. Since CDSS borrowing capacity is
based on certain of its receivables and inventories, which have allowed maximum outstanding
borrowing levels of approximately $5.5 million to date, the reduction in the line of credit does
not impact our expected liquidity. The line of credit bears interest at the rate of either 0.25%
in excess of prime or 300 basis points above the LIBOR rate (8.50% at September 30, 2006).
Approximately $4.2 million of principal was outstanding at September 30, 2006. The borrowings
under the credit facility are secured by certain trade receivables and inventories. Approximately
$523,000 of additional borrowing capacity was available to us as of September 30, 2006. The credit
facility requires us to comply with certain financial covenants, including tangible net worth,
capital expenditure limitations, and fixed charge coverage. As of March 31, 2006, we did not meet
the fixed charge coverage covenant and were granted a waiver of the non-compliance. As of
September 30, 2006, we did not meet certain balance sheet and income statement covenants and were
granted a waiver of non-compliance. The revolving credit facility was automatically renewed for
one year in March 2006.
We maintain a line of credit agreement with a financial institution which provides for 1.8
million (approximately $2.3 million) of available credit at September 30, 2006. The line of credit
bears interest at 1.25%
above the base rate as reported by the Netherlands Central Bank with a minimum base rate of 3.25%
(4.00% at September 30, 2006). The line of credit is collateralized by certain trade receivables
and inventories, and contains certain financial
- 26 -
covenants relating to solvency, which are not
considered restrictive to our operations. As of September 30, 2006, no amounts were outstanding
under the agreement.
The following table summarizes our contractual obligations at September 30, 2006 and the effects
such obligations are expected to have on our liquidity and cash flows in future periods:
Payments Due by Period
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
October 1, 2006 |
|
|
Fiscal 2008 |
|
|
Fiscal 2010 |
|
|
|
|
| |
|
|
|
|
|
to March 31, |
|
|
Through |
|
|
Through |
|
|
After |
|
| (In thousands) |
|
Total |
|
|
2007 |
|
|
Fiscal 2009 |
|
|
Fiscal 2011 |
|
|
Fiscal 2011 |
|
Contractual Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short and long-term debt (1) |
|
$ |
8,911 |
|
|
$ |
1,095 |
|
|
$ |
3,568 |
|
|
$ |
4,019 |
|
|
$ |
229 |
|
Capital lease obligations (1) |
|
|
1,447 |
|
|
|
408 |
|
|
|
830 |
|
|
|
209 |
|
|
|
|
|
Operating lease obligations |
|
|
12,405 |
|
|
|
1,766 |
|
|
|
5,582 |
|
|
|
2,881 |
|
|
|
2,176 |
|
Government funded development
credits |
|
|
215 |
|
|
|
41 |
|
|
|
174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations |
|
$ |
22,978 |
|
|
$ |
3,310 |
|
|
$ |
10,154 |
|
|
$ |
7,109 |
|
|
$ |
2,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| (1) |
|
Includes interest expense |
We entered into a financing arrangement with a Netherlands governmental agency in connection with
the development of a new product. The grant is to be repaid as a percentage (13.6%) of the
products gross revenues as long as the product is a commercial success. We began to ship this
product during fiscal year 1998, evidencing its commercial success. We have deferred all funding
received and reported those amounts as development credits included in accrued expenses ($215,000
at September 30, 2006). When we make a payment to the Netherlands government, the recorded
liability is reduced. There is no obligation to repay any remaining amounts after 2008.
In connection with the acquisitions of Genaissance, Icoria and Genome Express we recorded
restructuring and integration reserves totaling approximately $4.6 million, representing severance
of $3.1 million and lease termination of $1.5 million. A summary of the severance and lease
termination activity as of September 30, 2006 is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Balance |
|
|
|
|
|
|
|
|
|
|
Balance |
|
| |
|
March 31, |
|
|
Fiscal 2007 |
|
|
September 30, |
|
| |
|
2006 |
|
|
Accrual |
|
|
Payments |
|
|
2006 |
|
Severance |
|
$ |
2,350 |
|
|
$ |
125 |
|
|
$ |
(1,532 |
) |
|
$ |
943 |
|
Lease termination costs |
|
|
1,090 |
|
|
|
|
|
|
|
(1,090 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,440 |
|
|
$ |
125 |
|
|
$ |
(2,622 |
) |
|
$ |
943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We expect the severance costs will be fully paid during the third quarter of fiscal 2007.
Capital expenditures totaled $607,000 and $213,000 in the six months ended September 30, 2006 and
2005, respectively and were primarily related to the Enterprise Resource Planning System. During
fiscal 2007, we expect to make capital expenditures of approximately $1.5 million primarily to
introduce new products, and improve production of existing products. We expect to use our
available cash, credit lines and capital leases to fund these expenditures.
As of September 30, 2006 our current and future sources of cash include our cash and cash
equivalents balance of approximately $16.8 million, existing lines of credit, cash flows from
certain operations of certain divisions, plus net cash proceeds from the sale of our
discontinued operations of approximately $1.1 million and possible future equity and/or debt
financings. Our projected uses of cash include cash used in operations of certain operating
divisions, capital expenditures, existing debt service costs and continued development of potential
products through internal research, collaborations and, possibly through strategic acquisitions.
As described in Note
- 27 -
3 to the consolidated financial statements in our Annual Report on Form 10K for the year ended
March 31, 2006, we have completed four business combinations since October 6, 2005. As part of our
strategy, we continually evaluate possible mergers, acquisitions and investments. The financing of
such activities is evaluated as part of our review of any opportunity.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risks, which include changes in interest rates, as well as changes in
foreign currency exchange rates as measured against the U.S. dollar and each other. We attempt to
minimize some of these risks by using foreign currency forward and swap contracts. These hedging
activities provide only limited protection against interest rate and currency exchange risks.
Factors that could influence the effectiveness of our programs include volatility of the interest
rate and currency markets and availability of hedging instruments. Any contracts that we enter
into are components of hedging programs and are entered into for the sole purpose of hedging an
existing or anticipated interest rate and currency exposure, not for speculation.
Interest Rate Risk
We use a combination of fixed rate term loans, variable rate lines of credit and fixed rate leases
to finance our activities. Our term loans and leases are all at fixed rates over their lives and
carry no interest rate risk. As a result of our existing variable rate credit lines and loan
agreements, we are exposed to risk from changes in interest rates. As of September 30, 2006, we
had $4.2 million outstanding on our domestic line of credit carrying an interest rate of 0.25% over
Prime (8.50%) and a convertible note with an outstanding balance of $3.0 million carrying an
interest rate of 2.5% over Prime (10.75%). A hypothetical 10% change in interest rates would not
materially impact our annual interest expense.
Foreign Currency Exchange Rate Risk
The value of certain foreign currencies as compared to the U.S. dollar may affect our financial
results. Fluctuations in exchange rates may positively or negatively affect our revenues, gross
margins, operating expenses, assets, liabilities and retained earnings, all of which are expressed
in U.S. dollars. Where we deem it prudent, we engage in hedging programs, using primarily foreign
currency forward and swap contracts, aimed at limiting the impact of foreign currency exchange rate
fluctuations on earnings. We purchase short-term foreign currency forward and swap contracts to
protect against currency exchange risks associated with long-term intercompany loans due to our
international subsidiaries and the payment of merchandise purchases to foreign vendors. We do not
hedge the translation of foreign currency profits into U.S. dollars, as we regard this as an
accounting and not an economic exposure.
As of September 30, 2006, we had outstanding foreign currency forward contracts with a notional
amount aggregating $900,000, all of which related to intercompany debt. The fair value of the
forward contracts and the related gains and losses were not material as of and for the six months
ended September 30, 2006.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer, or CEO, and Chief Financial
Officer, or CFO, evaluated the effectiveness of our disclosure controls and procedures (as defined
in Rules 13a-15(b) under the Securities and Exchange Act) as of September 30, 2006. Based on their
evaluation, our CEO and CFO concluded that, as of September 30, 2006, our disclosure controls and
procedures were (1) designed to ensure that material information relating to us is made known to
our CEO and CFO by others within the Company, particularly during the period in which this report
was being prepared and (2) effective, in that they provide reasonable assurance that information
required to be disclosed by us in reports that we file or submit under the Securities and Exchange
Act is recorded, processed, summarized, and reported with in the time periods specified in the
Securities and Exchange Commissions rules and forms.
Changes in Internal Controls
- 28 -
No change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Securities and Exchange Act) occurred during the period covered by this report
that materially affected, or is reasonably likely to materially affect, our internal controls over
financial reporting.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are, from time to time, subject to disputes arising in the normal course of our business. While
the ultimate results of any such disputes cannot be predicted with certainty, at September 30,
2006, there were no asserted claims against us which, in the opinion of management, if adversely
decided, would have a material adverse effect on our financial position and cash flows.
ITEM 1A. RISK FACTORS
Investment in our securities involves a high degree of risk. Our Annual Report on Form 10-K for
the year ended March 31, 2006, which was filed with the SEC on June 29, 2006, contains numerous
risk factors relating to our business and operations and ownership of common stock. We updated our
Risk Factors since June 29, 2006 as set fourth in our quarterly report Form 10-Q which was filed
with the SEC on August 14, 2006. Investors should carefully consider the Risk Factors.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
| a) |
|
The Companys annual meeting of stockholders was held on September 21, 2006. |
| |
| b) |
|
The following matters were voted on at the annual meeting: |
| |
1. |
|
The stockholders elected all of managements nominees for election as Directors. The
results of the vote taken were as follows: |
| |
|
|
|
|
|
|
|
|
| Directors: |
|
For |
|
Withheld |
| |
Randal J. Kirk |
|
|
7,638,225 |
|
|
|
649,574 |
|
|
|
|
|
|
|
|
|
|
Andrew J. Fromkin |
|
|
7,657,461 |
|
|
|
630,338 |
|
|
|
|
|
|
|
|
|
|
Larry D. Horner |
|
|
7,658,435 |
|
|
|
629,634 |
|
|
|
|
|
|
|
|
|
|
Arthur B. Malman |
|
|
7,659,572 |
|
|
|
628,227 |
|
|
|
|
|
|
|
|
|
|
Kevin L. Rakin |
|
|
7,659,764 |
|
|
|
628,035 |
|
|
|
|
|
|
|
|
|
|
Burton E. Sobel, M.D. |
|
|
7,660,329 |
|
|
|
627,470 |
|
| |
2. |
|
The stockholders approved the amendments to the Clinical Datas 2005 equity incentive plan.
The results of the votes were as follows: |
| |
|
|
|
|
For: |
|
|
4,183,971 |
|
Against: |
|
|
820,962 |
|
Abstain: |
|
|
19,082 |
|
Broker Non-Votes: |
|
|
3,263,784 |
|
- 29 -
| |
|
|
The proposal was approved by a majority of the shares represented and entitled to vote
(including abstentions) with respect to this proposal which shares voting affirmatively also
constituted a majority of the required quorum. |
| |
| |
3. |
|
The stockholders ratified the selection, by the Audit Committee of the Board of Directors,
of Deloitte & Touche LLP, independent certified public accountants, as auditors of the
Company for the year ending March 31, 2007. The results of the vote taken were as follows: |
| |
|
|
|
|
For: |
|
|
8,258,766 |
|
Against: |
|
|
21,282 |
|
Abstain: |
|
|
7,751 |
|
Broker Non-Votes: |
|
|
0 |
|
| |
|
|
The proposal was approved by a majority of the outstanding shares. |
ITEM 5. OTHER INFORMATION
The Current Report on Form 8-K filed with the Commission on August 7, 2006 which, among other
things, reported under Item 5.02 Departure of Directors or Principal Officers; Election of
Directors; Appointment of Principal Officers that the Company had appointed C. Evan Ballantyne as
its Senior Vice President and Chief Financial Officer, should also have reported the terms of Mr.
Ballantynes offer letter under Item 1.01 Entry into a Material Definitive Agreement. Such terms
were disclosed in detail in the Current Report, but only under Item 5.02.
ITEM 6. EXHIBITS
See Exhibit Index on the page immediately following the signature page for a list of the exhibits
filed as part of this quarterly report, which Exhibit Index is incorporated by reference.
- 30 -
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized, on November 14, 2006.
| |
|
|
|
|
|
|
CLINICAL DATA, INC. |
|
|
|
|
|
|
|
|
|
/s/ Andrew J. Fromkin |
|
|
Dated: November 14, 2006
|
|
Andrew J. Fromkin
|
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
Principal Executive Officer |
|
|
|
|
|
|
|
|
|
/s/ C. Evan Ballantyne |
|
|
Dated: November 14, 2006
|
|
C. Evan Ballantyne
|
|
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
|
Principal Financial and Accounting Officer |
|
|
- 31 -
EXHIBIT INDEX
| |
|
|
| Exhibit |
|
|
| Number |
|
Description |
3.1
|
|
Certificate of Incorporation. Filed as Exhibit 3.1 to the
Companys Registration Statement on Form S-1 (File No. 2-82494),
as filed with the Commission on March 17, 1983, and incorporated
herein by reference. |
|
|
|
3.2
|
|
Certificate of Amendment of Certificate of Incorporation filed
with the Secretary of State of the State of Delaware on October
1, 2003. Filed as Exhibit 3.1 to the Companys Quarterly Report
on Form 10-Q, as filed with the Commission on February 17, 2004,
and incorporated herein by reference. |
|
|
|
3.3
|
|
Certificate of Elimination of the Series A Nonvoting Convertible
Preferred Stock filed with the Secretary of State of the State of
Delaware on July 7, 2005. Filed as Exhibit 3.1 to the Companys
Current Report on Form 8-K, as filed with the Commission on July
11, 2005, and incorporated herein by reference. |
|
|
|
3.4
|
|
Certificate of Designation of the Series A Preferred Stock filed
with the Secretary of State of the State of Delaware on October
4, 2005. Filed as Exhibit 3.2 to the Companys Current Report on
Form 8-K, filed with the Commission on October 11, 2005, and
incorporated herein by reference. |
|
|
|
3.5
|
|
Certificate of Amendment of Certificate of Incorporation filed
with the Secretary of State of the State of Delaware on October
6, 2005. Filed as Exhibit 3.1 to the Companys Current Report on
Form 8-K, filed with the Commission on October 11, 2005, and
incorporated herein by reference. |
|
|
|
3.6
|
|
Amended and Restated By-laws of the Company, as of June 20, 2005.
Filed as Exhibit 3.1 to the Companys Current Report on Form
8-K, filed with the Commission on June 24, 2005, and incorporated
herein by reference. |
|
|
|
4.1
|
|
Specimen Common Stock Certificate. Filed as Exhibit 4.1 to the
Companys Registration Statement on Form S-1 (File No. 2-82494),
as filed with the Commission on March 17, 1983, and incorporated
herein by reference. |
|
|
|
10.1
|
|
Selective Share Buy-Back Agreement among Vital Diagnostics Pty.
Ltd., Clinical Data, B.V., and Clinical Data, Inc. (with respect
to Sections 4.4, 6 and 7 only) dated November 13, 2006. Filed
herewith. |
|
|
|
10.2
|
|
Employment Offer Letter between the Company and C. Evan
Ballantyne dated August 7, 2006. Filed herewith. |
|
|
|
10.3
|
|
Amended and Restated 2005 Equity Incentive Plan. Filed herewith |
|
|
|
31.1
|
|
Certification of Chief Executive Officer Pursuant to §240.13a-14
or §240.15d-14 of the Securities Exchange Act of 1934, as
amended. Filed herewith. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer Pursuant to §240.13a-14
or §240.15d-14 of the Securities Exchange Act of 1934, as
amended. Filed herewith. |
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32.1
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Certification of Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350. Filed
herewith. |