Aspira Women's Health Inc. - Quarter Report: 2006 June (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2006
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 000-31617
CIPHERGEN BIOSYSTEMS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE | 33-0595156 | |
(State or other jurisdiction | (I.R.S. Employer | |
of incorporation of organization) | Identification Number) | |
6611 DUMBARTON CIRCLE, FREMONT, | ||
CALIFORNIA | 94555 | |
(Address of principal executive offices) | (ZIP Code) |
Registrants telephone number, including area code: 510-505-2100
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 Exchange Act.
Yes o No þ
Number of shares of common stock, $0.001 par value, outstanding as of July 31, 2006: 36,075,017
CIPHERGEN BIOSYSTEMS, INC.
INDEX FOR FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2006
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6 | ||||||||
13 | ||||||||
20 | ||||||||
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30 | ||||||||
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31 | ||||||||
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34 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32 |
Ciphergen, ProteinChip and Biomarker Discovery Center are registered trademarks of Ciphergen
Biosystems, Inc. Biomek is a registered trademark of Beckman Coulter Inc. BioSepra is a registered
trademark of Pall Corporation.
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CIPHERGEN BIOSYSTEMS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, | December 31, | |||||||
2006 | 2005 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 20,576 | $ | 25,738 | ||||
Short-term investment |
| 2,240 | ||||||
Accounts receivable, net of allowance for doubtful accounts of $458 and $238, respectively |
4,185 | 5,828 | ||||||
Prepaid expenses and other current assets |
1,798 | 1,746 | ||||||
Inventories |
4,661 | 5,594 | ||||||
Total current assets |
31,220 | 41,146 | ||||||
Property, plant and equipment, net |
5,910 | 7,320 | ||||||
Goodwill |
76 | 76 | ||||||
Other intangible assets, net |
2,055 | 2,417 | ||||||
Other long-term assets |
1,691 | 1,852 | ||||||
Total assets |
$ | 40,952 | $ | 52,811 | ||||
LIABILITIES
AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,647 | $ | 3,188 | ||||
Accrued liabilities |
6,212 | 6,298 | ||||||
Deferred revenue |
3,753 | 4,132 | ||||||
Current portion of capital lease obligations |
22 | 21 | ||||||
Equipment financing loan |
| 377 | ||||||
Total current liabilities |
11,634 | 14,016 | ||||||
Deferred revenue |
439 | 508 | ||||||
Capital lease obligations, net of current portion |
16 | 28 | ||||||
Long-term debt owed to related party |
5,000 | 2,500 | ||||||
Convertible senior notes, net of discount |
28,851 | 28,586 | ||||||
Other long-term liabilities |
539 | 650 | ||||||
Total liabilities |
46,479 | 46,288 | ||||||
Commitments and contingencies (note 6) |
||||||||
Stockholders
equity (deficit): |
||||||||
Common stock |
36 | 36 | ||||||
Additional paid-in capital |
203,509 | 202,485 | ||||||
Accumulated other comprehensive loss |
(79 | ) | (204 | ) | ||||
Accumulated deficit |
(208,993 | ) | (195,794 | ) | ||||
Total
stockholders equity (deficit) |
(5,527 | ) | 6,523 | |||||
Total
liabilities and stockholders equity (deficit) |
$ | 40,952 | $ | 52,811 | ||||
See notes to unaudited condensed consolidated financial statements.
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CIPHERGEN BIOSYSTEMS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenue: |
||||||||||||||||
Products |
$ | 3,196 | $ | 4,886 | $ | 8,005 | $ | 9,367 | ||||||||
Services |
2,077 | 2,055 | 4,332 | 4,222 | ||||||||||||
Total revenue |
5,273 | 6,941 | 12,337 | 13,589 | ||||||||||||
Cost of revenue: |
||||||||||||||||
Products |
1,871 | 2,570 | 4,144 | 4,682 | ||||||||||||
Services |
1,077 | 1,013 | 2,208 | 2,036 | ||||||||||||
Total cost of revenue |
2,948 | 3,583 | 6,352 | 6,718 | ||||||||||||
Gross profit |
2,325 | 3,358 | 5,985 | 6,871 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
2,874 | 3,626 | 5,866 | 7,133 | ||||||||||||
Sales and marketing |
3,945 | 4,792 | 7,448 | 10,065 | ||||||||||||
General and administrative |
2,729 | 3,742 | 5,008 | 7,246 | ||||||||||||
Total operating expenses |
9,548 | 12,160 | 18,322 | 24,444 | ||||||||||||
Loss from operations |
(7,223 | ) | (8,802 | ) | (12,337 | ) | (17,573 | ) | ||||||||
Interest and other income (expense), net |
(456 | ) | (537 | ) | (692 | ) | (948 | ) | ||||||||
Loss before income taxes |
(7,679 | ) | (9,339 | ) | (13,029 | ) | (18,521 | ) | ||||||||
Income tax provision |
56 | (11 | ) | 170 | 139 | |||||||||||
Net loss from continuing operations |
(7,735 | ) | $ | (9,328 | ) | (13,199 | ) | $ | (18,660 | ) | ||||||
Loss from sale of discontinued operations, net of tax |
| (67 | ) | | (67 | ) | ||||||||||
Net loss |
$ | (7,735 | ) | $ | (9,395 | ) | $ | (13,199 | ) | $ | (18,727 | ) | ||||
Net loss per share, basic and diluted: |
||||||||||||||||
Net loss per share from continuing operations |
$ | (0.21 | ) | $ | (0.32 | ) | $ | (0.37 | ) | $ | (0.63 | ) | ||||
Net loss per share from discontinued operations |
0.00 | (0.00 | ) | 0.00 | (0.00 | ) | ||||||||||
Net loss |
$ | (0.21 | ) | $ | (0.32 | ) | $ | (0.37 | ) | $ | (0.63 | ) | ||||
Shares used in computing basic and diluted net loss per share |
36,048 | 29,575 | 36,024 | 29,524 | ||||||||||||
See notes to unaudited condensed consolidated financial statements.
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CIPHERGEN BIOSYSTEMS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(in thousands)
Six Months Ended | ||||||||
June 30, | ||||||||
2006 | 2005 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net loss |
$ | (13,199 | ) | $ | (18,727 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
2,442 | 2,895 | ||||||
Stock-based compensation expense |
924 | | ||||||
Amortization of debt discount associated with beneficial conversion
feature of convertible senior notes |
265 | 265 | ||||||
Accrued investment income |
(5 | ) | (31 | ) | ||||
Interest accrued on notes receivable from related parties |
| (6 | ) | |||||
Gain from sale of BioSepra business |
| 67 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable, net |
1,707 | 4,557 | ||||||
Prepaid expenses and other current assets |
(45 | ) | 449 | |||||
Inventories |
1,044 | 278 | ||||||
Other long-term assets |
168 | 140 | ||||||
Accounts payable and accrued liabilities |
(1,624 | ) | 9 | |||||
Deferred revenue |
(460 | ) | (885 | ) | ||||
Other long-term liabilities |
(155 | ) | (107 | ) | ||||
Net cash used in operating activities |
(8,938 | ) | (11,096 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||
Purchase of property, plant and equipment, net |
(530 | ) | (1,322 | ) | ||||
Liquidation of short-term investment |
2,245 | | ||||||
Payment for license related to litigation settlement |
(242 | ) | (325 | ) | ||||
Cash paid for post-closing adjustment related to sale of BioSepra business |
| (1,111 | ) | |||||
Net cash provided by (used in) investing activities |
1,473 | (2,758 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Proceeds from issuance of common stock, net |
99 | 201 | ||||||
Repayments of notes receivable from stockholders |
| 314 | ||||||
Proceeds of loan from Quest Diagnostics |
2,500 | | ||||||
Principal payments on capital lease obligations |
(12 | ) | (12 | ) | ||||
Repayments of long-term debt |
(377 | ) | (561 | ) | ||||
Net cash provided by (used in) financing activities |
2,210 | (58 | ) | |||||
Effect of exchange rate changes |
93 | (224 | ) | |||||
Net decrease in cash and cash equivalents |
(5,162 | ) | (14,136 | ) | ||||
Cash and cash equivalents, beginning of period |
25,738 | 35,392 | ||||||
Cash and cash equivalents, end of period |
$ | 20,576 | $ | 21,256 | ||||
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: |
||||||||
Transfer of fixed assets to inventory |
$ | 101 | $ | 126 | ||||
Acquisition of property and equipment under capital leases |
1 | 48 |
See notes to unaudited condensed consolidated financial statements.
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CIPHERGEN BIOSYSTEMS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
June 30, 2006
1. ORGANIZATION AND BASIS OF PRESENTATION
The Company
Ciphergen Biosystems, Inc. (the Company or Ciphergen) is dedicated to translating protein
biomarkers and panels of biomarkers into protein molecular diagnostic tests that improve patient
care. The Company is also focused on providing collaborative research services through its
Biomarker Discovery Center® laboratories for biomarker discovery for new diagnostic tests as well
as pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays. In
addition, Ciphergen develops, manufactures and sells a family of ProteinChip® Systems for life
science researchers. These systems enable protein discovery, validation, identification and assay
development to provide researchers with predictive, multi-marker assay capabilities and a better
understanding of biological function at the protein level. The core technology, which is patented,
is Surface Enhanced Laser Desorption/Ionization (SELDI). The systems consist of ProteinChip
Readers, ProteinChip Software and related accessories, which are used in conjunction with
consumable ProteinChip Arrays. These products are sold primarily to biologists at pharmaceutical
and biotechnology companies, and academic and government research laboratories. The Company also
offers consulting services, customer support services and training classes to its customers and
collaborators.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of America for
interim financial information and with the interim reporting requirements of Form 10-Q and Rule
10-01 of Regulation S-X. Accordingly, they do not include all of the information required by
accounting principles generally accepted in the United States of America for complete financial
statements. Therefore, this unaudited financial data should be read in conjunction with the audited
consolidated financial statements and accompanying notes contained in the Companys Annual Report
on Form 10-K for the fiscal year ended December 31, 2005, filed with the Securities and Exchange
Commission on March 17, 2006. The unaudited interim financial statements have been prepared on the
same basis as the annual financial statements and, in the opinion of management, all adjustments
(consisting of normal recurring adjustments) considered necessary for a fair statement have been
included. In addition, the Company adopted Statement of Financial Accounting Standards No. 123
(Revised), Share-Based Payment, in January 2006 as discussed in note 8. The accompanying
unaudited condensed consolidated financial statements include the accounts of the Company and its
subsidiaries. All intercompany transactions have been eliminated in consolidation. The results of
operations for the interim periods shown herein are not necessarily indicative of operating results
for the entire year or any other future interim period.
Liquidity
From its inception through June 30, 2006, the Company has financed its operations principally
with $223.4 million from the sales of products and services to customers and net proceeds from
equity financings totaling approximately $160.8 million including $15.0 million from the sale of
6,225,000 shares of Ciphergens common stock and a warrant to purchase up to 2,200,000 shares of
Ciphergens common stock to Quest Diagnostics Incorporated (Quest Diagnostics) on July 22, 2005.
Ciphergen received $28.1 million of net proceeds from the sale of 4.5% convertible senior notes on
August 22, 2003. These notes are due September 1, 2008. In addition, in July 2005, Quest
Diagnostics agreed to loan the Company up to $10 million with interest accrued at the prime rate
plus 0.5% and paid monthly, solely to fund certain development activities related to the strategic
alliance between Ciphergen and Quest Diagnostics, against which the Company had borrowed
approximately $5.0 million as of June 30, 2006. Borrowings may be made by the Company in monthly
increments of up to approximately $417,000 during the first two years of the alliance, and the loan
will be forgiven upon Ciphergens achievement of certain milestones. Otherwise, amounts outstanding
on the loan must be repaid on or before July 22, 2010. (See note 7.) The Company also received
$28.0 million from the sale of its BioSepra® business in November 2004. The Company has incurred
significant net losses and negative cash flows from operations since inception. At June 30, 2006,
the Company had an accumulated deficit of $209.0 million.
Management believes that currently available resources will provide sufficient funds to enable
the Company to meet its obligations for at least the next 12 months. Ciphergen currently expects to
fund its liquidity needs as well as expenditures for its obligations related to the strategic
alliance with Quest Diagnostics and for capital requirements from a combination of available cash,
borrowings from Quest Diagnostics, and potential sales of assets and additional equity and/or debt
securities. If anticipated operating results are
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not achieved, however, management believes that planned expenditures may need to be reduced in
order to extend the time period over which the currently available resources will be adequate to
fund the Companys operations. At such time as the Company requires additional funding, the Company
may seek to raise such additional funding from various possible sources, including the public
equity market, private financings, sales of assets, collaborative arrangements and debt. If
additional capital is raised through the issuance of equity or securities convertible into equity,
stockholders may experience dilution, and such securities may have rights, preferences or
privileges senior to those of the holders of its common stock or convertible senior notes. If the
Company obtains additional funds through arrangements with collaborators or strategic partners, it
may be required to relinquish its rights to certain technologies or products that it might
otherwise seek to retain. There can be no assurance that the Company will be able to obtain such
financing, or obtain it on acceptable terms. If Ciphergen is unable to obtain financing on
acceptable terms, it may be unable to execute its business plan, it could be required to delay or
reduce the scope of its operations, and it may not be able to pay off the convertible senior notes
or the loans from Quest Diagnostics if and when they come due.
2. RECENT ACCOUNTING PRONOUNCEMENTS
In November 2004, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 151, Inventory Costs, an amendment of ARB 43, Chapter
4. SFAS 151 requires certain inventory costs to be recognized as current period expenses. This
standard also provides guidance for the allocation of fixed production overhead costs. This
standard is effective for inventory costs incurred during fiscal years beginning after June 15,
2005. The Company adopted this standard beginning in 2006, but its adoption did not have a material
impact on the Companys consolidated financial position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123 (Revised), Share-Based Payment. This standard
requires the measurement of all stock-based compensation, including stock options, using the fair
value method and the recording of such expense in the Companys consolidated statements of income.
Beginning in the first quarter of 2006, Ciphergen adopted SFAS 123(R) under the modified
prospective transition method using the Black-Scholes pricing model. Under this new standard, the
Companys estimate of compensation expense requires a number of complex and subjective assumptions,
including the price volatility of Ciphergens common stock, employee exercise patterns (expected
life of the options), future forfeitures and related tax effects. Although the adoption of SFAS
123(R) had no adverse impact to the Companys balance sheet and cash flows, it adversely affected
the Companys net loss and net loss per share. See (note 8).
In March 2005, the Securities and Exchange Commission (SEC) issued Staff Accounting Bulletin
(SAB) No. 107, Share-Based Payment. SAB 107 provides guidance on the initial implementation of
SFAS 123(R). In particular, the statement includes guidance related to share-based payment awards
for non-employees, valuation methods and selecting underlying assumptions such as expected
volatility and expected term. It also provides guidance on the classification of compensation
expense associated with such awards and accounting for the income tax effects of those awards upon
the adoption of SFAS 123(R). The Company adopted this standard concurrent with its adoption of SFAS
123(R).
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections. SFAS
154 is a replacement of Accounting Principles Board Opinion (APB) No. 20 and SFAS 3. SFAS 154
provides guidance on the accounting for and reporting of accounting changes and error corrections.
It establishes retrospective application as the required method for reporting a change in
accounting principle. SFAS 154 provides guidance for determining whether retrospective application
of a change in accounting principle is impracticable and for reporting a change when retrospective
application is impracticable. The reporting of a correction of an error by restating previously
issued financial statements is also addressed by SFAS 154. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005. The
Company adopted this standard beginning in 2006.
In September 2005, the FASB issued EITF Issue No. 04-13, Accounting for Purchases and Sales
of Inventory with the Same Counterparty (EITF 04-13). The issue provides guidance on the
circumstances under which two or more inventory transactions with the same counterparty should be
viewed as a single nonmonetary transaction within the scope of APB Opinion No. 29, Accounting for
Nonmonetary Transactions. The issue also provides guidance on circumstances under which
nonmonetary exchanges of inventory within the same line of business should be recognized at fair
value. EITF 04-13 is effective for transactions completed in reporting periods beginning after
March 15, 2006. Adoption of this standard did not have a material impact on the
Companys consolidated financial position, results of operations or cash flows.
In
July 2006, the FASB issued FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
Interpretation of FASB Statement No. 109 (FIN 48), which
clarifies the accounting for uncertainty in tax positions. This
Interpretation requires that we recognize in our financial statements
the impact of a tax position if that position is more likely than not
of being sustained on audit, based on the technical merits of the
position. The provisions of FIN 48 are effective as of the beginning
of our 2007 fiscal year, with the cumulative effect, if any, of the
change in accounting principle recorded as an adjustment to opening
retained earnings. We are currently evaluating the impact of adopting
FIN 48 on our condensed consolidated financial statements.
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In October 2005, the FASB issued FSP FAS 123(R)-2, Practical Accommodation to the Application
of Grant Date as Defined in FAS 123(R) (FSP 123(R)-2). FSP 123(R)-2 provides guidance on the
application of grant date as defined in SFAS 123(R). In accordance with this standard, a grant date
of an award exists if (a) the award is a unilateral grant, and (b) the key terms and conditions of
the award are expected to be communicated to an individual recipient within a relatively short
time period from the date of approval. The Companys adoption of this standard concurrent with its
adoption of SFAS 123(R) did not have a material impact on the Companys consolidated financial
position, results of operations or cash flows.
In November 2005, the FASB issued FSP FAS 123(R)-3, Transition Election Related to Accounting
for the Tax Effects of Share-Based Payment Awards (FSP 123(R)-3). FSP 123(R)-3 provides an
elective alternative method that establishes a computational component to arrive at the beginning
balance of the accumulated paid-in capital pool related to employee compensation and a simplified
method to determine the subsequent impact on the accumulated paid-in capital pool of employee
awards that are fully vested and outstanding upon the adoption of SFAS 123(R). The Company adopted
this transition method concurrent with its adoption of SFAS 123(R).
3. INVENTORIES
Inventories consisted of the following (in thousands):
June 30, | December 31, | |||||||
2006 | 2005 | |||||||
Raw materials |
$ | 1,632 | $ | 1,775 | ||||
Work in process |
1,240 | 1,241 | ||||||
Finished goods |
1,789 | 2,578 | ||||||
$ | 4,661 | $ | 5,594 | |||||
4. GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill and other intangible assets consisted of the following (in thousands):
June 30, 2006 | December 31, 2005 | |||||||||||||||||||||||
Gross | Gross | |||||||||||||||||||||||
Carrying | Accumulated | Carrying | Accumulated | |||||||||||||||||||||
Amount | Amortization | Total | Amount | Amortization | Total | |||||||||||||||||||
Non-amortizing: |
||||||||||||||||||||||||
Goodwill |
$ | 76 | $ | | $ | 76 | $ | 76 | $ | | $ | 76 | ||||||||||||
Amortizing: |
||||||||||||||||||||||||
Acquired license related to litigation settlement |
5,985 | 3,930 | 2,055 | 5,743 | 3,326 | 2,417 | ||||||||||||||||||
$ | 6,061 | $ | 3,930 | $ | 2,131 | $ | 5,819 | $ | 3,326 | $ | 2,493 | |||||||||||||
During the first six months of 2006, the acquired license related to the Companys litigation
settlement in 2003 increased $242,000 as a result of cash payments made by the Company for license
fees. Amortization expense for this acquired license for the six month periods ended June 30, 2006
and 2005 was $604,000 and $605,000, respectively. Amortization expense for the acquired license,
based on its gross carrying amount at June 30, 2006, is expected to total approximately $605,000
for the remaining six months of 2006, $1.2 million in 2007, $241,000 in 2008 and zero thereafter.
Amortization expense for the acquired license is charged to cost of revenue.
5. WARRANTIES AND MAINTENANCE CONTRACTS
Ciphergen has a direct field service organization that provides service for its products. The
Company generally includes a standard 12 month warranty on its ProteinChip Systems, ProteinChip
Tandem MS Interfaces and accessories in the form of a maintenance contract upon initial sale, after
which maintenance and support may be provided under a separately priced contract or on an
individual call basis. The Company substitutes a maintenance contract in place of a standard
12-month warranty on its instruments and accessories upon initial sale. Ciphergen also sells
separately priced maintenance (extended warranty) contracts, which are generally for 12 or 24
months, upon expiration of the initial maintenance contract. Coverage under both the standard and
extended maintenance contracts is identical. Revenue for both the standard and extended maintenance
contracts is deferred and recognized on a straight line basis over the period of the applicable
maintenance contract. Related costs are recognized as incurred.
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Changes in product warranty obligations, including separately priced maintenance obligations,
were as follows (in thousands):
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Balance at beginning of period |
$ | 2,884 | $ | 3,439 | $ | 2,831 | $ | 3,778 | ||||||||
Add: Costs incurred for maintenance contracts |
614 | 680 | 1,178 | 1,386 | ||||||||||||
Revenue deferred for maintenance contracts |
989 | 1,252 | 2,216 | 2,231 | ||||||||||||
Less: Settlements made under maintenance contracts |
(614 | ) | (680 | ) | (1,178 | ) | (1,386 | ) | ||||||||
Revenue recognized for maintenance contracts |
(1,125 | ) | (1,271 | ) | (2,299 | ) | (2,589 | ) | ||||||||
Balance at end of period |
$ | 2,748 | $ | 3,420 | $ | 2,748 | $ | 3,420 | ||||||||
6. COMMITMENTS AND CONTINGENCIES
On October 3, 2005,
the Company entered into a two year research and license agreement with
University College London and UCL BioMedica Plc. (together, UCL) to utilize Ciphergens suite of
proteomic solutions (Deep Proteome, Pattern Track Process and ProteinChip System) to further
UCLs ongoing research in ovarian cancer and breast cancer. Under the terms of the agreement,
Ciphergen has exclusive rights to license intellectual property resulting from discoveries made
during the course of this collaboration for use in developing, manufacturing and selling products
and services utilizing the intellectual property. Additionally, Ciphergen will contribute
approximately $2.1 million in cash and $652,000 in the form of Ciphergen equipment, software,
arrays and consumable supplies as requested by UCL, valued at Ciphergens list selling price, to
cover part of the costs incurred by UCL specifically for this research program. $1.1 million of the
cash obligation is to be paid in the first year of the agreement and is non-cancelable. The
remainder is to be paid in the second year of the agreement and is cancelable with three months
advance notice. As of June 30, 2006, the Company expensed $874,000, of which $75,000
represented the Companys cost for the arrays and consumables it
had provided, cash payment of $217,000 and the remaining
$582,000 was recorded as an accrued liability.
The Company has extended its agreement to fund a Biomarker Discovery Center collaboration with
The Johns Hopkins University School of Medicine. Under this agreement, Ciphergen has an obligation
to fund a total of $305,000, of which $76,000 of this commitment
had been accrued but not yet paid.
On June 26, 2006, Health Discovery Corporation filed a lawsuit against us in the U.S. District Court
for the Eastern District of Texas (Marshall Division), claiming that
software used in certain of Ciphergens
ProteinChip® Systems infringes on three of its United States patents. Health Discovery Corporation is
seeking injunctive relief as well as unspecified compensatory and
enhanced damages, reasonable attorneys
fees, prejudgment interest and other costs. On August 1, 2006 Ciphergen filed an unopposed motion with
the Court to extend the deadline for Ciphergen to answer or otherwise respond until September 2, 2006.
Given the early stage of this action, the Company cannot predict the ultimate outcome of this matter at this
time. As a result, in accordance with Statement of Financial
Accounting Standard No. 5 Accounting for
Contingencies, the Company has disclosed the existence of this lawsuit; however, no accrual for potential
losses, if any, has been recorded.
7. STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS
On July 22, 2005, the Company entered into a strategic alliance agreement with Quest
Diagnostics covering a three year period during which the parties will strive to develop and
commercialize up to three diagnostic tests based on Ciphergens proprietary SELDI ProteinChip
technology. Pursuant to the agreement, Quest Diagnostics will have the non-exclusive right to
commercialize these tests on a worldwide basis, with exclusive commercialization rights in
territories where Quest Diagnostics has a significant presence for up to five years following
commercialization. As part of the strategic alliance, there is a royalty arrangement under which
Quest Diagnostics will pay royalties to Ciphergen based on fees earned by Quest Diagnostics for
applicable diagnostics services, and Ciphergen will pay royalties to Quest Diagnostics based on
Ciphergens revenue from applicable diagnostics products. To date, no such royalties have been
earned by either party. Quest Diagnostics and Ciphergen have also entered into a supply agreement
under which Ciphergen will sell instruments and consumable supplies to Quest Diagnostics to be used
for performing diagnostics services. In addition, for an aggregate purchase price of $15 million,
Quest Diagnostics purchased 6,225,000 shares of Ciphergens common stock, or approximately 17.4% of
shares outstanding after the transaction, and a warrant having a term of five years to purchase up
to an additional 2,200,000 shares for $3.50 per share. The warrant was valued at approximately $2.2
million based on the fair value as determined by a Black-Scholes model using the following
assumptions: risk-free interest rate, 4.04%; expected life, 5 years; expected volatility 69%. While
the warrant is exercisable for up to 2,200,000 shares, Ciphergen and Quest Diagnostics have
clarified that the total number of shares of Common Stock issuable upon exercise of the warrant
could at no time cause Quest Diagnostics total holdings of Ciphergens Common Stock to exceed
19.9% of the total number of outstanding shares of Ciphergen Common Stock (provided that Quest
Diagnostics may, prior to or concurrently with the exercise of their warrant, sell such number of
shares of Ciphergen Common Stock so that, after the exercise of the warrant and such sale of
shares, Quest Diagnostics would not own more than 19.9% of Ciphergens Common Stock). Quest
Diagnostics also agreed to loan Ciphergen up to $10 million with interest accrued at the prime rate
plus 0.5% and paid monthly, solely to fund certain development activities related to the strategic
alliance. Borrowings may be made by Ciphergen in monthly increments of up to approximately $417,000
on the last day of each month during the first two years of the alliance, and at June 30, 2006,
such borrowings amounted to $5 million. This loan, collateralized by certain intellectual property
of Ciphergen, will be forgiven based on Ciphergens achievement of certain milestones related to
development, regulatory approval and commercialization of certain diagnostic tests. Should the
Company fail to achieve these milestones, the outstanding principal amount of any such loans will
become due and payable on July 22, 2010. From the inception of the strategic alliance through
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June 30, 2006, the Company had spent approximately $4.8 million of the loan proceeds on
in-house research and development, as well as collaborations with others, directed towards
achieving the milestones.
8. STOCK-BASED COMPENSATION
The Company currently has one equity-based compensation plan, the 2000 Stock Plan (2000
Plan), from which stock-based compensation awards can be granted to eligible employees, officers,
directors and other service providers. This plan is administered by, and each award grant must be
approved by, the Board of Directors or a committee of the Board, which determines the number of
shares and/or options subject to each award, the purchase price for any shares of the Companys
common stock subject to an award, the vesting schedule (if any) applicable to each award, the term
of each award, and the other terms and conditions of each award, subject to the limitations of the
plan. Under the 2000 Plan, options may be granted at prices not lower than 85% and 100% of the fair
market value of the common stock for nonstatutory and statutory stock options, respectively.
Options generally vest monthly over a period of five years and unexercised options generally expire
ten years from the date of grant. The Company issues new shares of common stock upon exercise of
stock options. There were 911,519 shares available for future stock option grants under the 2000
Plan at June 30, 2006.
The Company also has an employee stock purchase plan, the 2000 Employee Stock Purchase Plan
(ESPP). The ESPP is administered by the Board of Directors or a committee of the Board. Subject
to limits, all of the Companys officers and employees in the U.S. and Canada are eligible to participate in
the ESPP. The ESPP generally operates in successive six month offering and purchase periods.
Participants in the ESPP may purchase common stock at the end of each six month period at a
purchase price equal to 85% of the lower of the fair market value of the stock at the beginning of
the six month period or the end of the six month period. The administrator of the ESPP may allow
participants to contribute up to 15% of their eligible compensation to purchase stock under the
plan. At June 30, 2006, the Company had 260,612 shares of common stock reserved for purchase by
employees under the ESPP.
Effective January 1, 2006, the Company adopted SFAS No. 123 (revised), Share-Based Payment
(SFAS 123(R)), using the modified prospective transition method. Under this new standard, the
Companys estimate of compensation expense requires a number of complex and subjective assumptions,
including the price volatility of Ciphergens common stock, employee exercise patterns (expected
life of the options), future forfeitures and related tax effects. Prior to the adoption of SFAS
123(R), the Company accounted for stock option grants using the intrinsic value method, in
accordance with APB Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and
accordingly, recognized no compensation expense for stock option grants.
Under the modified prospective approach, SFAS 123(R) applies to new awards and to awards that
were outstanding on January 1, 2006 that are subsequently modified, repurchased or cancelled. Under
the modified prospective approach, compensation cost recognized in the first six months of 2006
includes compensation cost for all stock-based payments granted prior to, but not yet vested as of,
January 1, 2006, based on the grant-date fair value estimated in accordance with the original
provisions of SFAS 123, and compensation cost for all stock-based payments granted subsequent to
January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of
SFAS 123(R). Prior periods were not restated to reflect the impact of adopting the new standard.
As a result of adopting SFAS 123(R) on January 1, 2006, the Companys net loss and basic and
diluted net loss per share for the three months ended June 30,
2006 were $464,000 and $0.01 higher,
respectively, than if the Company had continued to account for stock-based compensation under APB
25 for its stock option grants. The Companys net loss and basic and diluted net loss per share for
the six months ended June 30, 2006 were $924,000 and $0.03
higher, respectively than if the Company had continued to account for
stock-based compensation under APB 25 for its stock option grants. The Company has a
100% valuation allowance recorded against its deferred tax assets. Therefore SFAS 123(R) had no
effect on the income tax provision in the consolidated statement of operations or the consolidated
statement of cash flows.
Prior to 2006, the Company accounted for its stock-based employee compensation arrangements
using the intrinsic value method of accounting. Unearned compensation expense was based on the
difference, if any, on the date of the grant between the fair value of the Companys stock and the
exercise price. Unearned compensation was amortized and expensed using an accelerated method. The
Company accounted for stock issued to non-employees using the fair value method of accounting. The
following table illustrates the effect on the Companys net loss and net loss per share had
compensation expense for stock-based compensation been determined in accordance with SFAS 123 for
the three and six months ended June 30, 2005 (in thousands, except per share amounts):
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Three Months Ended | Six Months Ended | |||||||
June 30, 2005 | June 30, 2005 | |||||||
Net loss as reported |
$ | (9,395 | ) | $ | (18,727 | ) | ||
Add: Employee stock-based compensation expense in reported net loss, net of tax |
| | ||||||
Less: Employee stock-based compensation expense determined under the fair
value method, net of tax |
(819 | ) | (1,882 | ) | ||||
Pro forma net loss |
$ | (10,214 | ) | $ | (20,609 | ) | ||
Basic and diluted net loss per share: |
||||||||
As reported |
$ | (0.32 | ) | $ | (0.63 | ) | ||
Pro forma |
$ | (0.35 | ) | $ | (0.70 | ) |
The Company used the Black-Scholes option pricing model to estimate the fair value of
stock-based awards with the following weighted-average assumptions for the indicated periods.
Employee Stock | ||||||||||||||||
Stock Option Plan | Purchase Plan | |||||||||||||||
Three Months Ended | Three Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Assumptions: |
||||||||||||||||
Risk-free interest rate |
5.19 | % | 3.99 | % | 4.93 | % | 3.26 | % | ||||||||
Expected term (in years) |
5.9 | 5.0 | 0.5 | 0.5 | ||||||||||||
Expected volatility |
86 | % | 94 | % | 84 | % | 94 | % | ||||||||
Expected dividend yield |
| % | | % | | % | | % | ||||||||
Weighted-average grant-date fair values: |
||||||||||||||||
Exercise price less than market price |
$ | | $ | | $ | 0.68 | $ | 0.62 | ||||||||
Exercise price equal to market price |
0.90 | 1.38 | | | ||||||||||||
Exercise price greater than market price |
| | | |
The expected term of stock options represents the weighted-average period the stock options
are expected to remain outstanding. Prior to January 1, 2006, the expected term was developed based
on observed and expected time to post-vesting exercise or forfeiture of an option. After January 1,
2006, the expected term of options granted was derived using the simplified method allowed by SAB
107. Prior to January 1, 2006, expected volatility was derived exclusively from an analysis of the
Companys historical stock prices. After January 1, 2006, expected volatility was derived from the
Companys historical stock prices and peer group analysis. The risk-free interest rate is based on
the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent
remaining term. The expected dividend assumption is based on the Companys history and expectation
of dividend payouts.
The Company recognizes stock-based compensation costs for grants made after January 1, 2006 on
a straight-line basis over the requisite service period of the award, which is generally the option
vesting term. These costs should reflect awards ultimately expected to vest, and have therefore
been reduced for estimated forfeitures. SFAS 123(R) requires forfeitures to be estimated at the
time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from
those estimates. Prior to January 1, 2006, the Company accounted for forfeitures as they occurred.
Stock-based compensation costs for grants made prior to January 1, 2006 are recognized on an
accelerated basis over the option vesting term, generally five years, consistent with prior years
footnote presentations under SFAS 123.
The following table represents stock option activity for the six months ended June 30, 2006
(numbers of shares stated in thousands):
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Total Options Outstanding | ||||||||||||
Weighted | Weighted-Average | |||||||||||
Number | -Average | Remaining | ||||||||||
of | Exercise | Contract | ||||||||||
Shares | Price | Life (Years) | ||||||||||
Outstanding options at beginning of period |
6,334 | $ | 4.46 | 7.7 | ||||||||
Granted |
1,325 | 1.20 | ||||||||||
Exercised |
| | ||||||||||
Forfeited |
822 | 4.89 | ||||||||||
Outstanding options at end of period |
6,837 | $ | 3.78 | 7.8 | ||||||||
Outstanding options exercisable at end of period |
3,972 | $ | 5.36 | 6.7 |
At June 30, 2006, the aggregate intrinsic value of options outstanding was $157,000 and the
aggregate intrinsic value of outstanding options exercisable was $42,000. Also, there was $2.6
million of unrecognized compensation cost related to stock option grants to employees which is
expected to be recognized over a weighted average period of 1.6 years.
The allocation of stock-based compensation expense by functional area for the three and six
months ended June 30, 2006 was as follows (in thousands):
Three Months Ended | Six Months Ended | |||||||
June 30, 2006 | June 30, 2006 | |||||||
Cost of products revenue |
$ | 49 | $ | 94 | ||||
Research and development |
94 | 194 | ||||||
Sales and marketing |
83 | 186 | ||||||
General and administrative |
238 | 450 | ||||||
Total |
$ | 464 | $ | 924 | ||||
9. INCOME TAXES
Based on the available objective evidence, management believes it is more likely than not that
the net deferred tax assets related to the Companys operations will not be fully realizable.
Accordingly, the Company has provided a full valuation allowance against its net deferred tax
assets at June 30, 2006. The Company incurs income tax liabilities in most of the countries outside
the U.S. in which it operates.
10. COMPREHENSIVE LOSS
Comprehensive
income (loss) generally represents all changes in
stockholders equity (deficit) except
those resulting from investments or contributions by stockholders. The only component of
comprehensive income (loss) that is excluded from the net loss during the periods presented is the
Companys cumulative translation adjustments.
11. NET LOSS PER SHARE
Basic net loss per share is calculated using the weighted average number of common shares
outstanding during the period. Because the Company is in a net loss position, diluted earnings per
share is calculated using the weighted average number of common shares outstanding and excludes the
effects of 12.4 million and 9.1 million potential common shares as of June 30, 2006 and 2005,
respectively, that are antidilutive. Potential common shares include shares that could be issued if
all convertible senior notes were converted into common stock, shares of common stock issuable upon
the exercise of an outstanding warrant held by Quest Diagnostics, common stock subject to
repurchase, common stock issuable under the Companys 2000 Employee Stock Purchase Plan, and shares
of common stock potentially issuable upon the exercise of outstanding stock options.
12. SEGMENT INFORMATION AND GEOGRAPHIC DATA
Ciphergens revenue is derived from the sales of related products and services on a worldwide
basis. The chief operating decision maker evaluates resource allocation not on a product or
geographic basis, but rather on an enterprise-wide basis. Therefore, management has determined that
Ciphergen operates in only one reportable segment, which is the protein research tools and
collaborative services business.
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The Company sells most of its products and services directly to customers in North America,
Western Europe and Japan, and through distributors in other parts of
Europe, Asia and in
Australia. Revenue for geographic regions reported below is based upon the customers locations.
Following is a summary of the geographic information related to revenue for the three and six month
periods ended June 30, 2006 and 2005 (in thousands):
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenue |
||||||||||||||||
United States |
$ | 1,510 | $ | 1,923 | $ | 3,328 | $ | 5,253 | ||||||||
Canada |
244 | 290 | 641 | 623 | ||||||||||||
Europe |
2,267 | 2,491 | 4,962 | 4,008 | ||||||||||||
Asia-Pacific |
1,252 | 2,237 | 3,406 | 3,705 | ||||||||||||
Total |
$ | 5,273 | $ | 6,941 | $ | 12,337 | $ | 13,589 | ||||||||
During the three month periods ended June 30, 2006 and 2005, sales to customers in Japan
represented 19% and 30% of revenue, respectively. During the six month periods ended June 30, 2006
and 2005, sales to customers in Japan represented 24% and 26% of revenue, respectively.
In addition, during the three month and six month periods ended June 30, 2006, sales to customers in the U.K. represented 13% and 11%, respectively. No other
country outside the U.S. accounted for 10% or more of total revenue during these periods.
Long-lived assets, primarily machinery and equipment, are reported based on the location of
the assets. Long-lived asset information by geographic area as of June 30, 2006 and December 31,
2005 is presented in the following table (in thousands):
June 30, | December 31, | |||||||
2006 | 2005 | |||||||
Long lived assets |
||||||||
United States |
$ | 5,160 | $ | 6,256 | ||||
Canada |
4 | 20 | ||||||
Europe |
372 | 561 | ||||||
Asia-Pacific |
374 | 483 | ||||||
Total |
$ | 5,910 | $ | 7,320 | ||||
13. SUBSEQUENT EVENTS
On May 24, 2006,
the Nasdaq Listings Qualification Department notified Ciphergen that the
Company had failed to comply with the continued
listing requirements of The Nasdaq Global Market because the
market value of the Companys listed securities had
fallen below $50,000,000 for 10 consecutive business
days (pursuant to Rule 4450(b)(1)(A) of the Nasdaq Marketplace Rules).
Pursuant to Nasdaq Marketplace Rule 4450(e)(4), the Company was provided a period of 30
calendar days, or until June 23, 2006, to regain compliance. The
Company requested a hearing for purposes of appealing this delisting
determination on July 3, 2006.
On August 14, 2006, the Company signed a definitive agreement with Bio-Rad Laboratories, Inc.
related to Bio-Rads purchase of the Companys proteomics instrument business, which includes
the Companys SELDI technology,
ProteinChip® Arrays and accompanying software. The Company would
retain exclusive rights to the diagnostics market. In addition, upon closing the Company would
agree to purchase SELDI instruments and consumables from Bio-Rad for the continued development
of its diagnostics business. Subject to approval by the Companys stockholders, and other
customary closing conditions, Bio-Rad will purchase this business for approximately $20 million
in cash and will make a $3 million equity investment in Ciphergen.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
We have made statements under the captions Managements Discussion and Analysis of Financial
Condition and Results of Operations, Factors That May Affect Our Results and in other sections
of this Form 10-Q that are forward-looking statements for purposes of the safe harbor provisions
under the Private Securities Litigation Reform Act of 1995. We claim the protection of such safe
harbor, and disclaim any intent or obligation to update any forward-looking statement. You can
identify these statements by forward-looking words such as may, will, expect, intend,
anticipate, believe, estimate, plan, could, should and continue or similar words.
These forward-looking statements may also use different phrases. We have based these
forward-looking statements on our current expectations and projections about future events.
Examples of forward-looking statements include statements about projections of our future revenue,
gross margin, expenses, losses, results of operations and financial condition; anticipated
deployment, capabilities and uses of our products and our product development activities and
product innovations; the importance of proteomics as a major focus of biology research; the ability
of our products to enable proteomics research; competition and competitive pricing pressure in the
markets in which we compete; existing and future collaborations and partnerships; our ability to
operate our Biomarker Discovery Center® laboratories and secure the commercial rights to biomarkers
discovered at our Biomarker Discovery Center laboratories; the utility of biomarker discoveries and
the effectiveness of our Biomarker Discovery Center laboratories; our plans to develop and
commercialize diagnostic tests through our strategic alliance with Quest Diagnostics; our ability
to comply with applicable government regulations; our ability to expand and protect our
intellectual property portfolio; our ability to decrease research and development costs; our
ability to decrease sales and marketing costs; our ability to decrease general and administrative
costs; expected stock-based compensation costs following our adoption of Statement of Financial
Accounting Standards No. 123 (Revised), Share-Based Payment, (SFAS 123(R)); anticipated future
losses; expected levels of capital expenditures; our ability to meet development milestones in
order to achieve the forgiveness of loan obligations to Quest Diagnostics; the rating of our
convertible notes and the value of the related put options; the period of time for which our
existing financial resources, debt facilities and interest income will be sufficient to enable us
to maintain current and planned operations; foreign currency exchange rate fluctuations and our
plans for mitigating foreign currency exchange risks; and the market risk of our investments. These
statements are subject to risks and uncertainties that could cause actual results to differ
materially, including the
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risks set forth under the caption Risk Factors in this Form 10-Q and the similar factors and
risks outlined in our other filings with the Securities and Exchange Commission (SEC).
OVERVIEW
Ciphergen is dedicated to translating protein biomarkers and panels of biomarkers into protein
molecular diagnostic tests that improve patient care. We are also focused on providing
collaborative research services through our Biomarker Discovery Center laboratories for biomarker
discovery for new diagnostic tests as well as pharmacoproteomic services for improved drug
toxicology, efficacy and theranostic assays. We develop, manufacture and sell our family of
ProteinChip® Systems, which use patented Surface Enhanced Laser Desorption/Ionization (SELDI)
technology. ProteinChip Systems enable protein discovery, validation, identification and assay
development to provide researchers with predictive, multi-marker assay capabilities and a better
understanding of biological function at the protein level. These systems consist of a ProteinChip
Reader, ProteinChip Software and related accessories which are used in conjunction with our
consumable ProteinChip Arrays. We also offer consulting services, customer support services and
training classes to further our customers success in using SELDI technology. We market and sell
our products primarily to research biologists in pharmaceutical and biotechnology companies, and
academic and government research laboratories.
Through a series of acquisitions and license agreements executed in 1997, 1998 and 2003, we
acquired an exclusive, worldwide license and right to sublicense the SELDI technology and to
commercialize any and all products, information and services derived from the technology without
limitation. Our first designed and manufactured system, the ProteinChip System, Series PBS I, was
available for shipment in the third quarter of 1997. In 1997, we also established a subsidiary in
the U.K. and began direct selling in Europe. During 1999, we initiated an expanded marketing
program and in May 1999 began shipping the ProteinChip System, Series PBS II, the latest version of
which is now referred to as the ProteinChip Biology System. In 1999, we also established a joint
venture with Sumitomo Corporation to distribute our products in Japan. During 2000, we began
offering research services and established Biomarker Discovery Center laboratories in Fremont,
California; Copenhagen, Denmark; and Malvern, Pennsylvania.
In 2001, we introduced the ProteinChip Biomarker System, which utilizes sophisticated
third-party software to automate pattern recognition-based statistical analysis methods and
correlate protein expression patterns from clinical samples with disease phenotypes. We also began
selling the Biomek(R) 2000 Workstation, later superseded by the Biomek 3000 workstation, a robotic
accessory which is manufactured by Beckman Coulter and which has been optimized for use with our
ProteinChip Biomarker System to increase sample throughput and reproducibility. In addition, we
expanded our product offering with a SELDI ProteinChip interface to high-end tandem mass
spectrometers. On July 31, 2001, Ciphergen acquired the BioSepra® process chromatography business
from Invitrogen Corporation; this business was subsequently sold to Pall Corporation on November
30, 2004.
On August 31, 2002, we increased our ownership interest in Ciphergen Biosystems KK, the
Japanese joint venture we formed with Sumitomo Corporation in 1999, from 30% to 70%. Shortly
thereafter, we opened a Biomarker Discovery Center laboratory at the Yokohama facility of Ciphergen
Biosystems KK. In October 2002, we launched the ProteinChip AutoBiomarker System, an automated
version of our ProteinChip Biomarker System, which incorporates an autoloader and a Biomek robot to
increase sample throughput and automate the reading of ProteinChip Arrays. On March 23, 2004, we
purchased the remaining 30% ownership interest in Ciphergen Biosystems KK. In July 2004, we
launched the ProteinChip System, Series 4000, our next generation ProteinChip System.
We have used our resources primarily to develop and improve our proprietary ProteinChip
Systems and related consumables and to establish a marketing and sales organization for
commercialization of our products. We have also used our funds to establish a joint venture to
distribute our products in Japan and to increase our ownership in the joint venture to 100%. In
addition, we acquired the BioSepra process chromatography business in 2001, which we sold for a
gain in 2004. We have also used our resources to establish Biomarker Discovery Center laboratories
to provide research services to our clients, to foster further adoption of our products and
technology, and to discover biomarkers that we seek to patent for diagnostic and other purposes. In
early 2004, we increased our efforts to discover and commercialize protein biomarkers and panels of
biomarkers that we expect can be developed into protein molecular diagnostic tests that improve
patient care; to date, these efforts have not generated commercialized products or any revenue from
diagnostic tests. Since our inception we have incurred significant losses and as of June 30, 2006,
we had an accumulated deficit of $209 million.
Our sales are currently driven by the need for new and better tools to perform protein
discovery, characterization, purification, identification and assay development. Many of the
ProteinChip Systems sold to our customers also generate a recurring revenue stream from the sale of
consumables and maintenance contracts. In addition, some of our customers later enhance their
ProteinChip Systems by adding our automation accessories and advanced software.
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Our expenses have consisted primarily of materials, contracted manufacturing services, labor
and overhead costs to manufacture our ProteinChip Systems and ProteinChip Arrays and to provide
customer services; marketing and sales activities; research and development programs; litigation;
and general and administrative costs associated with our operations. We expect to incur losses for
at least the next year. Our current level of revenue is insufficient for us to become profitable.
To become profitable, we will need to increase sales of our ProteinChip Systems, Arrays and
collaborative services into the research and development market as well as begin achieving revenue
from our diagnostic efforts.
We anticipate that our quarterly results of operations will fluctuate for the foreseeable
future due to several factors, including market acceptance of current and new products and
services, the length of the sales cycle and timing of significant orders, the timing and results of
our research and development efforts, the introduction of new products by our competitors and
possible patent or license issues. Our limited operating history makes accurate prediction of
future results of operations difficult.
RECENT DEVELOPMENTS
RESULTS OF OPERATIONS
Effective January 1, 2006, we adopted SFAS 123(R) using the modified prospective transition
method. As a result, compensation costs in the first six months of 2006 include compensation cost
for stock-based payments granted prior to, but not yet vested as of, January 1, 2006, as well
as compensation cost for stock-based payments granted during 2006. Prior
periods were not restated to reflect the impact of adopting the new standard.
COMPARISON OF THE THREE AND SIX MONTH PERIODS ENDED JUNE 30, 2006 AND JUNE 30, 2005
PRODUCTS REVENUE. Products revenue decreased to $3.2 million in the second quarter of 2006
from $4.9 million in the same period of 2005, a decrease of $1.7 million or 35%. The decrease was
primarily the result of $934,000 or 33% decline in revenue from sales of our ProteinChip Systems, accessories and software
and a $756,000 or 37% decline in revenue from arrays and consumables.
The decrease was largely due to the reductions in our sales force in
July 2005. The decline in revenue from sales of our ProteinChip Systems, accessories and software was largely
due to a 27% decline in unit sales of ProteinChip Systems, as well as a decrease in average revenue
per system of approximately 8% mainly due to the decrease in sales of
accessories comparing the second quarter of 2006 to the
same period in 2005.
Products revenue decreased to $8.0 million in the first six months of 2006 from $9.4 million
in the same period of 2005, a decrease of $1.4 million or 15%. The decrease was primarily the
result of a $1.3 million or 29% decline in revenue from arrays and consumables and a $103,000 or 2%
decline in revenue from sales of our ProteinChip Systems, accessories and software. The decrease
in products sales was largely due to the reductions in our sales force in July 2005. In addition,
the decrease in unit sales of systems from prior quarters, which typically include a significant
initial purchase of consumables, also adversely impacted our array and consumable
sales.
SERVICES REVENUE. Services revenue was approximately $2.1 million in both the second quarter of
2006 and second quarter of 2005. Revenue from Biomarker Discovery Center projects increased
approximately $288,000 due to completion of several large projects in the second quarter of 2006.
This increase was partly offset by a decrease in revenue from training and consulting services of
approximately $120,000, which was mainly due to the reduction in the number of field scientists
on our staff, and a decrease in revenue from maintenance contracts of $146,000 due to having
fewer instruments under contract.
Services revenue increased to $4.3 million in the first six months of 2006 from $4.2 million
in the same period of 2005, an increase of $110,000 or 3%. This increase was primarily due to an
increase of approximately $755,000 in revenue from Biomarker Discovery Center projects due to
completion of several large contracts in the first six months of 2006. This increase was partly
offset by a decrease in revenue from training and consulting services of approximately $355,000,
which was primarily due to the reduction in the number of field scientists on our staff, and a
decrease in revenue from maintenance contracts of $290,000 due to having fewer instruments
under contract.
We expect that future revenues for our business will be affected by, among other things, our
ability to develop and commercialize diagnostic tests based on the ProteinChip platform, demand for
our ProteinChip Systems and Arrays, the degree of acceptance by the market of our Series 4000
platform, the level of continuing purchases of arrays by existing customers, new product and
application introductions, customer budgets, competitive conditions and government funding for
research in our field.
COST OF PRODUCTS REVENUE. Cost of products revenue decreased to $1.9 million in the second
quarter of 2006 from $2.6 million in the same period of 2005, a
decrease of $699,000 or 27%. The decrease was primarily due to the
decrease in unit sales of our ProteinChip Systems. The
gross margin for products revenue decreased to 41% in the second quarter of 2006, compared to 47%
in the second quarter of 2005. The decrease in gross margin was a result of higher
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unit costs
resulting from lower production volumes, for both systems and consumables manufacturing, in the
second quarter of 2006. This resulted in a decrease of the
gross margin of approximately 15% expressed as a percentage of revenue. However, a reduction in the provision for excess and obsolete
inventories, due to a decrease in the number of PBS II systems in
inventory, increased gross margin of approximately 5%. Finally, a reduction in the
amount of under absorbed overhead, due to a decrease in salary
related expenses, resulted in an improvement in the
gross margin of an additional
6%.
Cost of products revenue decreased to $4.1 million in the first six months of 2006 from $4.7
million in the same period of 2005, a decrease of $538,000 or 11%.
The decrease was primarily due to the decrease in unit sales of our
ProteinChip Systems. The gross margin for products
revenue decreased to 48% in the first six months of 2006, compared to 50% in the first six months
of 2005. Higher absorption variances for consumables manufacturing contributed to a decrease in the
gross margin of 7% expressed as a percentage of revenue. However,
this was partially offset by a reduction in the provisions for obsolete
inventory for consumables and a reduction in scrap which increased in the gross
margin by 3%.
COST OF SERVICES REVENUE. Cost of services revenue increased to $1.1 million in the second
quarter of 2006 from $1.0 million in the same period of 2005, an increase of $64,000 or 6%. The
largest component of this increase came from Biomarker Discovery
Center projects, whose costs vary
based on the complexity and difficulty of the project being undertaken. The gross margin for services
revenue decreased to 48% in the second quarter of 2006 compared to 51% in the same period of 2005.
The decrease was mainly due to lower margins realized from our training classes.
Cost of services revenue increased to $2.2 million in the first six months of 2006 from $2.0
million in the same period of 2005, an increase of $172,000 or 8%. The largest component of this
increase came from Biomarker Discovery Center projects, whose costs vary based on the complexity
and difficulty of the work being undertaken. The gross margin for services revenue decreased to 49%
in the first six months of 2006 compared to 52% in the same period of 2005. This decrease was
mainly due to a cost reimbursement contract with a government agency
which yielded no profit for the first six months of 2006.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses decreased to $2.9 million
in the second quarter of 2006 from $3.6 million in the same period of 2005, a decrease of $752,000
or 21%. The decrease was largely due to a 48% decrease in headcount comparing June 30, 2006 to June
30, 2005, resulting in a decrease in payroll and related costs of approximately $640,000.
Cancelling or scaling back selected early-stage research and development projects related to new
instrumentation platforms as part of our efforts to control expenses resulted in a decrease of
$294,000 for materials and supplies used in new product development. In addition, allocation of
occupancy costs declined by $88,000 due to the shift in employee mix following reduction in
research and development headcount. These decreases were partly offset by an increase in
collaboration costs of $229,000, largely due to our collaboration with University College London,
which began in October 2005. Stock-based compensation expense included in research and development
expenses was $94,000 in the second quarter of 2006.
Research and development expenses decreased to $5.9 million in the first six months of 2006
from $7.1 million in the same period of 2005, a decrease of $1.2 million or 18%. The decrease was
largely due to a 48% decrease in headcount comparing June 30, 2006 to June 30, 2005, resulting in a
decrease in payroll and related costs of approximately $1.4 million. As a result of headcount
reduction, allocation of occupancy costs also decreased by $131,000 due to the shift in employee
mix. Cancelling or scaling back selected early-stage research and development projects related to
new instrumentation platforms as part of our efforts to control expenses resulted in a decrease of
$412,000 for materials and supplies used in new product development. These decreases were partly
offset by an increase in collaboration costs of $494,000, largely due to our collaboration with
University College London, which began in October 2005. Stock-based compensation expense included
in research and development expenses was $194,000 in the first six months of 2006.
We expect research and development expenses to decline in 2006 relative to 2005 due to having
fewer research and development employees in 2006 as well as slowing or canceling selected
early-stage research and development programs related to new instrumentation platforms as part of
our efforts to control expenses, partially offset by an increase in our research and development
activities associated with developing and commercializing diagnostic tests as part of our strategic
alliance with Quest Diagnostics, and discovering biomarkers that could potentially be developed
into additional diagnostic products. The decline in research and development expenses will also be
partly offset by stock-based compensation expense.
SALES AND MARKETING EXPENSES. Sales and marketing expenses decreased to $3.9 million in the
second quarter of 2006 from $4.8 million in the same period of 2005, a decrease of $847,000 or 18%.
The decrease was largely due to a 27% decrease in headcount comparing June 30, 2006 to June 30,
2005, resulting in a decrease in payroll and related costs of approximately $222,000. This also
resulted in reductions in travel and other operating expenses in sales and marketing of
approximately $360,000. Equipment costs, consisting primarily of depreciation on demonstration
ProteinChip Systems, declined approximately $347,000, as we have fewer demonstration systems in
service. Costs for trade shows, advertising and other marketing activities declined approximately
$172,000. Internal consumption of ProteinChip Arrays and other consumables for customer
demonstrations and support decreased approximately $122,000. These decreases were partly offset by
an increase of $289,000 in the portion of occupancy costs allocated to
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sales and marketing departments largely due to the shift in employee mix following reductions
in research and development headcount. Stock-based compensation expense included in sales and
marketing expenses was $83,000 in the second quarter of 2006.
Sales and marketing expenses decreased to $7.5 million in the first six months of 2006 from
$10.1 million in the same period of 2005, a decrease of $2.6 million or 26%. The decrease was
largely due to a 27% decrease in headcount comparing June 30, 2006 to June 30, 2005, resulting in a
decrease in payroll and related costs of approximately $1.2 million. This also resulted in
reductions in travel and other operating expenses in sales and marketing of approximately $606,000.
Internal consumption of ProteinChip Arrays and other consumables for customer demonstrations and
support decreased approximately $367,000. Equipment costs, consisting primarily of depreciation on
demonstration ProteinChip Systems, declined approximately $566,000, as we have fewer demonstration
systems in service. Costs for trade shows, advertising and other marketing activities declined
approximately $303,000. These decreases were partly offset by an increase of $202,000 in the
portion of occupancy costs allocated to sales and marketing departments largely due to the shift in
employee mix following reductions in research and development headcount. Stock-based compensation
expense included in sales and marketing expenses was $186,000 in the first six months of 2006.
We expect sales and marketing expenses to decrease in 2006 relative to 2005 as a result of a
smaller sales force and reduced associated selling expenses. The decline in sales and marketing
expenses will be partly offset by stock-based compensation expense.
GENERAL AND ADMINISTRATIVE EXPENSES. General and administrative expenses decreased to $2.7 million in the second
quarter of 2006 from $3.7 million in the same period of 2005, a decrease of $1.0 million or 27%. The decrease was largely due to a
43% reduction in headcount comparing June 30, 2006 to June 30, 2005, resulting in a decrease in payroll and related costs of
approximately $463,000. This
decrease was accompanied by decreases of $336,000 in legal fees primarily due to being more selective in patent activities, $336,000
in consulting and outside services due in part by the absence of Sarbanes-Oxley compliance fees as the company is no longer an
accelerated filer, and $109,000 in travel and other operating expenses. Stock-based compensation expense
included in general and administrative expenses was $238,000 in the second quarter of 2006.
General and administrative expenses decreased to $5.0 million in the first six months of 2006 from $7.2 million in the same period of
2005, a decrease of $2.2 million or 31%. The decrease was largely due to a 43% reduction in headcount comparing June 30, 2006 to
June 30, 2005, resulting in a decrease in payroll and related costs of approximately $1.1 million. This decrease was accompanied by
decreases of $514,000 in legal fees primarily related to patent activities, $868,000 in consulting and outside services due in part by the
absence of Sarbanes-Oxley compliance fees as the company is no longer an accelerated filer, and $251,000 in travel and other
operating expenses. Stock-based compensation expense included in general and administrative expenses was $450,000 in the first six
months of 2006.
We expect general and administrative expenses to decrease in 2006 relative to 2005 due to
lower headcount in administrative functions and because certain large expenses incurred in 2005,
such as severance payments to former executives and outside professional fees related to the
restatement of our financial results for the second quarter of 2005, are not expected to recur. In
addition, we expect our costs related to compliance with Section 404 of the Sarbanes-Oxley Act of
2002 to decrease significantly as we are now deemed to be a non-accelerated filer and thus not
subject to the full requirements of Section 404. However, these reductions are expected to be
partly offset by stock-based compensation expense.
INTEREST AND OTHER INCOME (EXPENSE), NET. Interest income in the second quarter of 2006 was
$226,000 compared to $170,000 in the same period of 2005. Interest income increased due to higher
interest rates in the second quarter of 2006 compared to the same period in 2005. Interest expense
in the second quarter of 2006 was $566,000 compared to $491,000 in the same period of 2005.
Interest expense in both periods consisted largely of interest accrued for our convertible senior
notes, borrowings from Quest Diagnostics, equipment-financing loan and capital leases.
Approximately $133,000 of the interest expense in the second quarters of 2006 and 2005 was
non-cash, attributable to amortization of the beneficial conversion feature associated with the
convertible senior notes. Other income (expense) in the second quarter of 2006 was net expense of
$116,000 compared to net expense of $216,000 in the same period of
2005. The change was mainly due to favorable foreign currency
variances. The net expense in the
second quarters of both 2006 and 2005 resulted primarily from amortization of the offering costs
related to the convertible senior notes.
Interest income in the first six months of 2006 was $464,000 compared to $352,000 in the same
period of 2005. Interest income increased due to higher interest rates in the second quarter of
2006 compared to the same period in 2005. Interest expense in the first six months of 2006 was $1.1
million compared to $983,000 in the same period of 2005. Interest expense in both periods consisted
largely of interest accrued for our convertible senior notes, borrowings from Quest Diagnostics,
equipment-financing loan and capital leases. Approximately $265,000 of the interest expense in the
first six months of 2006 and 2005 was non-cash, attributable to amortization of the beneficial
conversion feature associated with the convertible senior notes. Other income (expense) in the
first six
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months of 2006 was net expense of $57,000 compared to net expense of $317,000 in the same
period of 2005. The net expense in the first six months of 2006 resulted primarily from $160,000
received in settlement of a claim against a service provider, partly offset by $187,000 for
amortization of the offering costs related to the convertible senior notes. The net expense in the
six months of 2005 resulted largely from the amortization of the offering costs related to the
convertible senior notes.
INCOME TAX PROVISION (BENEFIT). The provision for income taxes in the second quarter of 2006
was an expense of $56,000 compared to a benefit of $11,000 in the same period of 2005. The
increase in expense was primarily due to a tax benefit of $59,000 recorded in 2005 compared to no
such tax benefit recorded for our Japanese subsidiary, Ciphergen Biosystems KK.
The provision for income tax from continuing operations in the first six months of 2006 was an
expense of $170,000, compared to an expense of $139,000 in the same period of 2005. The increase
was primarily due to higher income tax provision resulting from higher projected income from our UK
subsidiary, Ciphergen Biosystems Ltd. in 2006. In addition, in 2005, the UK subsidiary had
net operating loss carryforwards to offset its income. These net
operating loss carryforwards were completely utilized at the end of 2005.
LIQUIDITY AND CAPITAL RESOURCES
From our inception through June 30, 2006, we have financed our operations principally with
$223.4 million from the sales of products and services to customers and net proceeds from equity
financings totaling approximately $160.8 million, including $15.0 million from the sale to Quest
Diagnostics on July 22, 2005 of 6,225,000 shares of Ciphergens common stock and a warrant to
purchase up to 2,200,000 shares of Ciphergens common stock. We received $28.1 million of net
proceeds from the sale of 4.5% convertible senior notes on August 22, 2003. These notes are due
September 1, 2008. In addition, in July 2005 Quest Diagnostics agreed to loan us up to $10 million
with interest accrued at the prime rate plus 0.5% and paid monthly, solely to fund certain
development activities related to our strategic alliance, against which we had borrowed
approximately $5.0 million as of June 30, 2006. We also received net proceeds of $28.0 million from
the sale of our BioSepra business in November 2004. Cash, cash equivalents and a short-term
investment at June 30, 2006 were $20.6 million, compared to $28.0 million at December 31, 2005.
Working capital at June 30, 2006 was $19.6 million, compared to $27.1 million at December 31, 2005.
The decrease in working capital was principally due to a net $7.4 million decrease in cash and
short-term investments to fund our operating losses, a $1.6 million decrease in accounts
receivable, and a $933,000 decrease in inventory, partly offset by a $1.6 million decrease in
payables, accrued liabilities and payroll, a $379,000 decrease in deferred revenue, and a $377,000
decrease in current portion of the long-term debt. Long-term debt and capital lease balances at
June 30, 2006 totaled $33.9 million compared to $31.5 million at December 31, 2005.
Net cash used in operating activities was $8.9 million in the first six months of 2006
compared to $11.1 million in the same period of 2005. Reductions in other operating and
manufacturing overhead expenditures of $3.9 million, payroll expense of $3.1 million, and raw
materials inventory purchases of $2.2 million, comparing the first six months of 2006 to the same
period of 2005, were offset by approximately $8.6 million less in collections from customers in the
first six months of 2006 than in the comparable period of 2005.
Net cash provided by investing activities was $1.5 million in the first six months of 2006
compared to net cash used in investing activities of $2.8 million in the first six months of 2005.
Net cash provided by investing activities in the first six months of 2006 consisted of $2.2 million
from the liquidation of an investment in a fixed rate annuity, partly offset by net purchases of
property and equipment of approximately $530,000 and payments totaling $242,000 for a technology
license related to our litigation which was settled in 2003. Net cash used in investing activities
in the first six months of 2005 consisted of net purchases of property and equipment of
approximately $1.3 million, a payment of $1.1 million to Pall Corporation for post-closing
adjustments related to the sale of our BioSepra business, and payments totaling $325,000 for a
technology license related to our litigation which was settled in 2003. We anticipate capital
expenditures of approximately $1 to $2 million in 2006.
Net cash provided by financing activities was $2.2 million in the first six months of 2006
compared to net cash used in financing activities of $58,000 in the first six months of 2005. Net
cash provided by financing activities in the first six months of 2006 consisted of $2.5 million in
loans from Quest Diagnostics and $99,000 received from the issuance of common stock under our
employee stock purchase plan, partly offset by $388,000 for repayments of an equipment financing
loan. Net cash used in financing activities in the first six months of 2005 was used primarily for
debt repayments amounting to $573,000, largely offset by $314,000 received from the repayment of
stockholder loans and $201,000 received from the issuance of common stock under our employee stock
purchase plan.
We believe that current cash resources will be sufficient to maintain our operations at least
for the next 12 months. We currently expect to fund our liquidity needs as well as expenditures for
our obligations related to the strategic alliance with Quest Diagnostics
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and for capital requirements from a combination of available cash, borrowings from Quest
Diagnostics, and potential sales of assets and additional equity and/or debt securities. We will be
required to raise additional capital at some point in the future, which might be achieved through a
variety of sources, including the public equity market, private financings, sales of assets,
collaborative arrangements and debt. If additional capital is raised through the issuance of equity
or securities convertible into equity, our stockholders may experience dilution, and such
securities may have rights, preferences or privileges senior to those of the holders of our common
stock or the notes. If we obtain additional funds through arrangements with collaborators or
strategic partners, we may be required to relinquish our rights to certain technologies or products
that we might otherwise seek to retain. Additional financing may not be available to us on
favorable terms, if at all. If we are unable to obtain financing on acceptable terms, we may be
unable to execute our business plan and we could be required to delay, reduce the scope of, or
eliminate our operations and we may not be able to pay off the convertible senior notes or the
loans from Quest Diagnostics if and when they come due.
The following summarizes Ciphergens contractual cash obligations at June 30, 2006 and the
effect such obligations are expected to have on our liquidity and cash flow in future periods (in
thousands, except the footnotes).
Less than | Beyond | |||||||||||||||||||
Total | 1 Year | 1-3 Years | 4-5 Years | 5 Years | ||||||||||||||||
Contractual cash obligations: |
||||||||||||||||||||
Capital lease obligations (1) |
$ | 38 | $ | 22 | $ | 16 | $ | | $ | | ||||||||||
Interest payable on capital lease obligations |
2 | 2 | | | ||||||||||||||||
Loan from Quest Diagnostics (1) |
5,000 | | | 5,000 | | |||||||||||||||
Interest payable on loan from Quest Diagnostics (2) |
1,776 | 437 | 875 | 464 | | |||||||||||||||
Convertible senior notes (3) |
30,000 | | 30,000 | | | |||||||||||||||
Interest payable on convertible senior notes |
3,038 | 1,350 | 1,688 | | | |||||||||||||||
Non-cancelable collaboration obligation (4)(5) |
1,405 | 1,405 | | | | |||||||||||||||
Non-cancelable operating lease obligations |
9,971 | 5,003 | 4,633 | 335 | | |||||||||||||||
Purchase obligations (6) |
402 | 402 | | | | |||||||||||||||
Total contractual cash obligations |
$ | 51,632 | $ | 8,621 | $ | 37,212 | $ | 5,799 | $ | | ||||||||||
(1) | Principal amounts, not including interest. | |
(2) | Based on outstanding principal balance and interest rate as of June 30, 2006. | |
(3) | Excludes the beneficial conversion feature amounting to $2.7 million, less related amortization of $1.5 million. | |
(4) | On October 3, 2005, the Company entered into a two year research and license agreement with University College London and UCL BioMedica Plc. (together, UCL) to utilize Ciphergens suite of proteomic solutions (Deep Proteome, Pattern Track Process and ProteinChip System) to further UCLs ongoing research in ovarian cancer and breast cancer. Under the terms of the agreement, Ciphergen will have exclusive rights to license intellectual property resulting from discoveries made during the course of this collaboration for use in developing, manufacturing and selling products and services utilizing the intellectual property. Ciphergen is obligated to make contributions of approximately $2.1 million in cash and $652,000 in the form of Ciphergen equipment, software, arrays and consumable supplies as requested by UCL, valued at Ciphergens list selling price, to cover part of the costs incurred by UCL specifically for this research program. $1.1 million of the cash obligation is to be paid in the first year of the agreement and is non-cancelable. The remainder is to be paid in the second year of the agreement and is cancelable with three months advance notice. As of June 30, 2006, Ciphergen expensed $874,000, of which $75,000 represented our cost for the arrays and consumables we had provided, cash payment of $217,000 and the remaining $582,000 was recorded as an accrued liability. | |
(5) | We have made a commitment to fund a Biomarker Discovery Center laboratory at The Johns Hopkins University School of Medicine which totals $305,000 for the period June 2006 to September 2006, of which $305,000 was non-cancelable at June 30, 2006. | |
(6) | Purchase obligations include agreements to purchase inventory that are enforceable and legally binding on Ciphergen and that specify all significant terms, including: fixed or minimum quantities to be purchased; fixed, minimum or variable price provisions; and the approximate timing of the transaction. Purchase obligations exclude agreements that are cancelable without penalty. |
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RECENT ACCOUNTING PRONOUNCEMENTS
See note 2 of the Unaudited Condensed Consolidated Financial Statements for a description of
recent accounting pronouncements, including the respective dates of adoption and effects on results
of operations and financial condition.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We have classified our short-term investments as available-for-sale, and have accordingly
recorded them on the balance sheet at fair value with unrealized gains and losses reported as a
separate component of accumulated other comprehensive income (loss). These investments are not
leveraged and are held for purposes other than trading.
The following discussion about our market risk involves forward-looking statements. We are
exposed to market risk related mainly to changes in interest rates. We do not invest in derivative
financial instruments.
INTEREST RATE SENSITIVITY
As of June 30, 2006, our cash was held primarily in money market accounts. We believe that, in
the near-term, we will maintain our available funds in money market accounts.
The primary objective of our investment activities is to preserve principal, maintain proper
liquidity to meet operating needs and maximize yields. Our investment policy, which has been
approved by our Board of Directors, specifies credit quality standards for our investments and
limits the amount of credit exposure to any single issue, issuer or type of investment.
Our exposure to market risk for changes in interest rates relates primarily to the increase or
decrease in the amount of interest income we can earn on our available funds for investment. Our
long-term debt and capital lease agreements are at fixed interest rates. We do not plan to use
derivative financial instruments in our investment portfolio.
FOREIGN CURRENCY EXCHANGE RISK
Most of our revenue is realized in U.S. dollars. However, all our revenue in Japan is realized
in Japanese yen. As a result, our financial results could be affected by factors such as changes in
foreign currency exchange rates or weak economic conditions in foreign markets. Because most of our
revenue is currently denominated in U.S. dollars, an increase in the value of the U.S. dollar
relative to foreign currencies could make our products less competitive in foreign markets.
The functional currency of Ciphergen Biosystems KK is the Japanese yen. Accordingly, the
accounts of this operation are translated from yen to the U.S. dollar using the current exchange
rate in effect at the balance sheet date for the balance sheet accounts, and using the average
exchange rate during the period for revenue and expense accounts. The effects of translation are
recorded as a separate component of stockholders equity.
The accounts of all other non-U.S. operations are remeasured to the U.S. dollar, which is the
functional currency. Accordingly, all monetary assets and liabilities of these foreign operations
are translated into U.S. dollars at current period-end exchange rates, and non-monetary assets and
related elements of expense are translated using historical rates of exchange. Income and expense
elements are translated to U.S. dollars using average exchange rates in effect during the period.
Gains and losses from the foreign currency transactions of these subsidiaries are recorded as other
income (expense), net in the statement of operations.
The net tangible assets of our non-U.S. operations, excluding intercompany debt, were $2.8
million at June 30, 2006.
We did not enter into any forward contracts during the six month periods ended June 30, 2005
and 2006. Although we will continue to monitor our exposure to currency fluctuations, we cannot
provide assurance that exchange rate fluctuations will not harm our business in the future.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
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We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934) designed to ensure that information required to be
disclosed in our filings under the Exchange Act is recorded, processed, summarized and reported
accurately and within the time periods specified in the SECs rules and forms. As of June 30, 2006,
an evaluation was carried out under the supervision and with the participation of our management,
including Gail Page, our Chief Executive Officer and interim Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures. Based upon that evaluation, the
Chief Executive Officer and interim Chief Financial Officer concluded that, as of June 30, 2006, the design
and operation of these disclosure controls and procedures were effective to provide reasonable
assurance of the achievement of the objectives described above.
Changes in Internal Control Over Financial Reporting
During the quarter ended June 30, 2006, there were no changes in internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On June
26, 2006, Health Discovery Corporation filed a lawsuit against us in the U.S. District Court
for the Eastern District of Texas (Marshall Division), claiming that software used in certain
of Ciphergens ProteinChip® Systems infringes on three of its United States patents.
Health Discovery Corporation is seeking injunctive relief as well as unspecified compensatory
and enhanced damages, reasonable attorneys fees, prejudgment interest and other costs. On
August 1, 2006 Ciphergen filed an unopposed motion with the Court to extend the deadline for
Ciphergen to answer or otherwise respond until September 2, 2006.
Given the early stage of this action, the Company cannot predict the
ultimate outcome of this matter at this time.
ITEM 1A. RISK FACTORS
The reader should carefully consider each of the risks and uncertainties we describe below, as
well as all of the other information in this report. The risks and uncertainties we describe below
are not the only ones we face. Additional risks and uncertainties which we are currently unaware of
or that we currently believe to be immaterial could also adversely affect our business.
We expect to continue to incur net losses in 2006 and 2007. If we are unable to significantly
increase our revenues or significantly decrease our expenses, we may never achieve profitability.
From our inception in December 1993 through June 30, 2006, we have generated cumulative
revenue from continuing operations of approximately $187.5 million and have incurred net losses of
approximately $209.0 million. We have experienced significant operating losses each year since our
inception and expect these losses to continue for at least the next several quarters. For example,
we experienced net losses of approximately $25.8 million in 2001, $29.1 million in 2002, $36.7
million in 2003, $19.8 million in 2004, $35.4 million in 2005 and $13.2 million in the first six
months of 2006. Our losses have resulted principally from costs incurred in research and
development, sales and marketing, litigation, and general and administrative costs associated with
our operations. These costs have exceeded our gross profit which, to date, has been generated
principally from product sales. We expect to incur additional operating losses and these losses may
be substantial. We may never achieve profitability. Even if we do achieve profitability, we may not
be able to sustain or increase profitability on a quarterly or annual basis.
If we are unable to further establish the utility of our products, our products and services may
not achieve market acceptance.
The commercial success of our ProteinChip Systems and Arrays depends upon validating their
utility for important biological applications and increasing their market acceptance by researchers
in pharmaceutical and biotechnology companies, academic and government research centers and
clinical reference laboratories. If our products are not demonstrated to be more effective in
providing commercially useful protein information than other existing technologies, or if we are
unable to develop diagnostic tests using our ProteinChip technology, it could seriously undermine
market acceptance of our products and reduce the likelihood that we will ever achieve
profitability.
If we fail to successfully market the Series 4000, expand sales of our ProteinChip Systems, and
develop new and improved applications for our products, our revenue will not increase and we will
not achieve profitability.
Our success depends on our ability to expand commercial sales of our ProteinChip Systems and
Arrays, and develop new and improved applications for this platform. In particular, our success
will depend on our success in marketing and growing sales of our ProteinChip System, Series 4000.
If the performance of our system does not meet or exceed competitive offerings, it is unlikely that
we will be able to expand our sales. We may encounter difficulties in developing new, higher
performance products or producing our
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current proteomic systems on a timely basis, we may not be able to produce them economically,
we may fail to achieve expected performance levels, or we may fail to gain industry acceptance of
such products.
We may experience increased manufacturing costs or failure rates for our ProteinChip Systems and
Arrays that are higher than we anticipated, particularly for new products that are introduced.
Our products and the components used in our products are based on complex technologies and we
are currently in the process of developing new versions of certain products. We may not be able to
cost effectively manufacture such new products. In addition, it is difficult to predict the failure
rate of new products. If our manufacturing costs are higher than anticipated or if the failure
rates for our products are higher than anticipated, resulting in increased warranty claims and
increased costs associated with servicing those claims, our gross profit will decrease.
We may not succeed in developing diagnostic products and even if we do succeed in developing
diagnostic products, they may never achieve significant commercial market acceptance.
There is considerable risk in developing diagnostic products based on our biomarker discovery
efforts as potential tests may fail to validate results in larger clinical studies and may not
achieve acceptable levels of clinical sensitivity and specificity. If we do succeed in developing
diagnostic tests with acceptable performance characteristics, we may not succeed in achieving
significant commercial market acceptance for those tests. Our ability to successfully commercialize
diagnostic products that we may develop, such as tests, kits and devices, will depend on several
factors, including:
| our ability to convince the medical community of the safety and clinical efficacy of our products and their advantages over existing diagnostic products; | ||
| our ability to further establish business relationships with other diagnostic companies that can assist in the commercialization of these products; and | ||
| the agreement by Medicare and third-party payers to provide full or partial reimbursement coverage for our products, the scope and extent of which will affect patients willingness to pay for our products and will likely heavily influence physicians decisions to recommend our products. |
These factors present obstacles to significant commercial acceptance of our potential
diagnostic products, which we will have to spend substantial time and money to overcome, if we can
do so at all. Our inability to successfully do so would prevent us from generating additional
revenue from diagnostic products and we could be unable to develop a profitable business.
Our ability to commercialize our potential diagnostic tests is heavily dependent on our strategic
alliance with Quest Diagnostics.
On July 22, 2005, Ciphergen and Quest Diagnostics entered into a strategic alliance which will
focus on commercializing up to three assays chosen from Ciphergens pipeline over the next three
years. If this strategic alliance does not continue for its full term or if Quest Diagnostics fails
to proceed to diligently perform its obligations as part of the strategic alliance, such as
independently developing, validating and commercializing potential diagnostics tests, our ability
to commercialize our potential diagnostic tests would be seriously harmed. If we elect to increase
our expenditures to fund diagnostic development programs or research programs on our own, we will
need to obtain additional capital, which may not be available on acceptable terms, or at all. If we
fail to develop diagnostic tests, our ability to expand our business beyond the sale of ProteinChip
Systems and Arrays would be seriously harmed.
Our Common Stock is currently subject to proceedings to delist it
from the Nasdaq Global Market. If we continue to fail to meet all applicable
Nasdaq Global Market requirements and Nasdaq determines to delist our common
stock, the delisting could adversely affect the market liquidity of our common stock
and the market price of our common stock could decrease.
Our common stock is listed on the Nasdaq Global Market.
In order to maintain that listing, we must satisfy minimum
financial and other requirements. On May 24, 2006, we received notice from the
Nasdaq Listings Qualification Department that our common stock had
not met the continued listing requirements of The Nasdaq Global Market because the
market value of the Companys listed securities had fallen below $50,000,000 for 10 consecutive
business days. After failing to regain compliance in the 30 calendar day grace period, the
Company has appealed this delisting determination. We have not received the final Listing Qualifications Panel determination with respect to our appeal. In the interim, our common stock will remain
listed on the Nasdaq Global Market while our appeal is pending before the Listing Qualifications Panel. We have not requested that, should our appeal be denied, our common stock would be delisted from the Nasdaq Global Market and our common stock would be traded on the Over the Counter (OTC) Bulletin Board of the National Association of Securities Dealers, Inc. If we fail to continue to meet all applicable Nasdaq Global Market requirements in the future and the Nasdaq Global Market determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease. Such delisting could also adversely affect our results of operations, our ability to obtain financing for the continuation of our operations and also result in the loss of confidence by investors, customers, suppliers and employees.
If we are unable to attract additional clients for our Biomarker Discovery Center services and
satisfy these clients, we may not be successful in furthering adoption of our products and
technology or generating additional revenue through commercial rights related to biomarker
discoveries.
One element of our business strategy is to operate Biomarker Discovery Center laboratories in
part through partnerships with pharmaceutical and biotechnology companies as well as academic and
government research centers in order to increase adoption of our products and technology. Although
we are currently in negotiation with additional potential partners and clients, to date we have
entered into only a few such arrangements. Failure to enter into additional arrangements or expand
existing relationships could limit adoption of our products and prevent us from generating
additional revenue through commercialization of biomarker discoveries.
New product introductions can result in disruptions to our revenue patterns and increased sales and
marketing costs, and may
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involve manufacturing challenges that can negatively impact our gross margin.
We have introduced, and we may introduce in the future, new versions of our ProteinChip
Systems, Arrays and Software. New product introductions entail training and educating our customers
and prospective customers about the new features, protocols and technology encompassed by the new
products. This could disrupt our revenue patterns or temporarily lengthen our sales cycles to a
greater extent than it would at larger companies with broader product offerings. New product
introductions may temporarily increase our sales and marketing costs. Manufacturing new products
inherently runs the risk that initial costs may be high as new production processes are introduced,
and it is possible that new products may involve quality issues that negatively impact our gross
margins. In addition, the introduction of new products makes the continuing sales of previous
product versions difficult and may require significant price discounts on such products.
If we fail to continue to develop the technologies we base our products on, we may not be able to
successfully foster further adoption of our products and services as an industry standard or
develop new product offerings.
The technologies we use for our ProteinChip Systems and related product offerings are new and
complex technologies, which are subject to change as new discoveries are made. New discoveries and
further progress in our field are essential if we are to maintain and expand the adoption of our
product offerings. Development of these technologies remains a substantial risk to us due to
various factors including the scientific challenges involved, our ability to find and collaborate
with others working in our field, and competing technologies, which may prove more successful than
ours. In addition, we have reduced our research and development headcount and expenditures, which
may adversely affect our ability to further develop our technology.
If we are unable to provide our customers with software that enables the integration and analysis
of large volumes of data, the acceptance and use of our products may be limited.
The successful commercial research application of our products requires that they enable
researchers to process and analyze large volumes of data and to integrate the results into other
phases of their research. The nature of our software enables a level of integration and analysis
that is adequate for many projects. However, if we do not continue to develop and improve the
capabilities of our ProteinChip Software to perform more complex analyses of customer samples and
to meet increasing customer expectations, market acceptance of our products may not increase and we
could lose our current customers, which might adversely impact our revenues and we could be unable
to develop a profitable business.
Our quarterly operating results may fluctuate significantly due to a number of causes outside our
control.
Because the timing of our product orders can vary, we may not be able to reliably predict
quarterly revenue and profitability. Our operating results can also vary substantially in any
period depending on the mix of products sold. Our quarterly sales and operating results are highly
dependent on the volume and timing of orders received during the quarter, as well as the seasonal
and cyclical nature of our markets. Historically, a relatively large percentage of our sales have
arrived in the last month of each quarter, and often towards the end of such month. Accordingly, a
short delay in receiving an order, shipping product, or recognizing revenue from such order may
result in substantial quarterly fluctuations in revenue and earnings.
A significant portion of our operating expenses is relatively fixed in nature due to our
significant sales, research and development, administration and manufacturing costs. If we cannot
adjust spending quickly enough to compensate for a revenue shortfall, this may magnify the adverse
impact of such revenue shortfall on our results of operations. As a result, our quarterly operating
results could fluctuate, and such fluctuation could cause the market price of our common stock and
convertible senior notes to decline. Results from one quarter should not be used as an indication
of future performance.
If we are unable to reduce our lengthy sales cycle, our ability to become profitable will be
harmed.
Our ability to obtain customers for our products depends in significant part upon the
perception that our products and services can help enable protein biomarker discovery,
characterization and assay development. From the time we make initial contact with a potential
customer until we receive a binding purchase order typically takes between a few weeks to a year or
more. Our sales effort requires the effective demonstration of the benefits of our products and may
require significant training, sometimes of many different departments within a potential customer.
These departments might include research and development personnel and key management. In addition,
we may be required to negotiate agreements containing terms unique to each customer. We may expend
substantial funds and management effort and may not be able to successfully sell our products or
services in a short enough time to achieve profitability.
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We will need to raise additional capital in the future, and if we are unable to secure adequate
funds on terms acceptable to us, we may be unable to execute our business plan.
We currently believe that current cash resources together with existing debt facilities will
be sufficient to meet our anticipated needs for the next 12 months. However, we may need to raise
additional capital sooner in order to develop new or enhanced products or services, increase our
efforts to discover biomarkers and develop them into diagnostic products, or acquire complementary
products, businesses or technologies. If we are unable to obtain financing, or to obtain it on
acceptable terms, we may be unable to successfully execute our business plan.
Because our business is highly dependent on key executives, scientists, engineers and sales people,
our inability to recruit and retain these people could hinder our business expansion plans.
We are highly dependent on our executive officers, senior scientists, engineers and sales
people. In certain countries, a few key individuals are important to our local success. Our product
development and marketing efforts could be delayed or curtailed if we lose the services of any of
these people. To expand our research, product development and sales efforts, we need people skilled
in areas such as bioinformatics, biochemistry, information services, manufacturing, sales,
marketing and technical support. Competition for qualified employees is intense. We will not be
able to expand our business if we are unable to hire, train and retain a sufficient number of
qualified employees. During 2004, 2005 and 2006, we took steps to reduce our headcount and our voluntary
employee turnover has increased from historic levels. In addition, the adoption of Statement of
Financial Accounting Standards No. 123 (Revised), Share-Based Payment, on January 1, 2006, which
requires us to expense all stock-based compensation, may cause us to change the manner in which we
compensate our employees, which could negatively impact our ability to recruit and retain qualified
employees.
We face intense competition in our current and potential markets and if our competitors develop new
technologies or products, our products may not achieve market acceptance and may fail to capture
market share.
Competition in our existing and potential markets is intense and we expect it to increase.
Currently, our principal competition comes from other technologies that are used to perform many of
the same functions for which we market our ProteinChip System. The major technologies that compete
with our ProteinChip System are liquid chromatography-mass spectrometry and 2D-gel
electrophoresis-mass spectrometry. In the life science research market, competitive protein
research tools and services are currently provided by a number of companies, including several
which are larger than Ciphergen. In the diagnostics market, there are several larger direct
competitors. In many instances, our competitors may have substantially greater financial,
technical, research and other resources and larger, more established marketing, sales, distribution
and service organizations. Additionally, our potential customers may internally develop competing
technologies. If we fail to compete effectively with these technologies and products, or if
competitors develop significant improvements in protein detection systems, develop systems that are
easier to use, or introduce comparable products that are less expensive, our products may not
achieve market acceptance and our sales may decrease.
If we are unable to maintain our licensed rights to the SELDI technology, we may lose the right to
produce ProteinChip Systems and products based on the SELDI technology and the right to provide
services and information related thereto.
Our commercial success depends on our ability to maintain our sublicenses to the SELDI
technology. All of our revenue from continuing operations was derived from SELDI-based products
within the scope of the Baylor SELDI patents. Pursuant to the settlement of the litigation between
Ciphergen, Molecular Analytical Systems (MAS), LumiCyte and T. William Hutchens, MAS cannot
terminate Ciphergens rights under the sublicenses. However, Baylor College of Medicine has the
right to terminate its license with MAS in case of material breach by MAS. If the agreements
between Baylor College of Medicine and MAS were terminated and we were unable to obtain a license
to these rights from Baylor College of Medicine, we would be precluded from selling any SELDI-based
products within the scope of the Baylor SELDI patents, we would no longer generate revenue from the
sale of these products and we would have to revise our business direction and strategy.
If the government grants a license to the SELDI technology to others, it may harm our business.
Some of the inventions covered by our sublicense agreements with MAS were developed under a
grant from an agency of the U.S. government and therefore, pursuant to the Bayh-Dole Act and
regulations promulgated thereunder, the government has a paid-up, nonexclusive nontransferable
license to those inventions and will be able in limited circumstances to grant a license to others
on reasonable terms. We are not aware of any basis for the government to exercise such rights, but
if circumstances change and the government exercises such rights, our business could be harmed.
If we fail to maintain our rights to utilize intellectual property directed to diagnostic
biomarkers, we may not be able to offer
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diagnostic tests using those biomarkers.
One aspect of our business plan is to develop diagnostic tests based on certain biomarkers
which we have the right to utilize through licenses with our academic collaborators, such as The
Johns Hopkins School of Medicine and the University of Texas M.D. Anderson Cancer Center. In some
cases, our collaborators own the entire right to the biomarkers. In other cases we co-own the
biomarkers with our collaborator. If, for some reason, we lose our license to biomarkers owned
entirely by our collaborators, we may not be able to use those biomarkers in diagnostic tests. If
we lose our exclusive license to biomarkers co-owned by us and our collaborators, our collaborators
may license their share of the intellectual property to a third party that may compete with us in
offering the diagnostic test.
We have drawn funds from the $10 million secured line of credit provided by Quest Diagnostics. If
we fail to achieve the loan forgiveness milestones set forth therein, we will be responsible for
full repayment of the loan.
In connection with the strategic alliance with Quest Diagnostics, Quest Diagnostics agreed to
provide us with a $10 million secured line of credit, from which we had drawn a total of
approximately $5 million as of June 30, 2006. Borrowings may be made in monthly increments of up to
approximately $417,000 over a two year period, with accrued interest to be paid monthly. Funds from
this collateralized line of credit may only be used to pay certain costs and expenses directly
related to the strategic alliance, with forgiveness of the repayment obligations based upon our
achievement of milestones related to the development, regulatory approval and commercialization of
laboratory tests. Should we fail to achieve these milestones, we would be responsible for the
repayment of the outstanding principal amount of any such loans on or before July 22, 2010.
If a competitor infringes our proprietary rights, we may lose any competitive advantage we may have
as a result of diversion of management time, enforcement costs and the loss of the exclusivity of
our proprietary rights.
Our commercial success depends in part on our ability to maintain and enforce our proprietary
rights. We rely on a combination of patents, trademarks, copyrights and trade secrets to protect
our technology and brand. In addition to our licensed SELDI technology, we also have submitted
patent applications directed to subsequent technological improvements and application of the SELDI
technology, including patent applications covering biomarkers that may have diagnostic or
therapeutic utility. Our patent applications may not result in additional patents being issued.
If competitors engage in activities that infringe our proprietary rights, our managements
focus will be diverted and we may incur significant costs in asserting our rights. We may not be
successful in asserting our proprietary rights, which could result in our patents being held
invalid or a court holding that the competitor is not infringing, either of which would harm our
competitive position. We cannot be sure that competitors will not design around our patented
technology.
We also rely upon the skills, knowledge and experience of our technical personnel. To help
protect our rights, we require all employees and consultants to enter into confidentiality
agreements that prohibit the disclosure of confidential information. These agreements may not
provide adequate protection for our trade secrets, know-how or other proprietary information in the
event of any unauthorized use or disclosure.
If others successfully assert their proprietary rights against us, we may be precluded from making
and selling our products or we may be required to obtain licenses to use their technology.
Our success also depends on avoiding infringing on the proprietary technologies of others. If
a third party were to assert claims that we are violating their patents, we might incur substantial
costs defending ourselves in lawsuits against charges of patent infringement or other unlawful use
of anothers proprietary technology. Any such lawsuit may not be decided in our favor, and if we
are found liable, we may be subject to monetary damages or injunction against using their
technology. We may also be required to obtain licenses under their patents and such licenses may
not be available on commercially reasonable terms, if at all.
We rely on single-source suppliers for many components of our ProteinChip Systems as well as
processing services for our ProteinChip Arrays, and if we are unable to obtain these components and
processing services, we would be harmed and our operating results would suffer.
We depend on many single-source suppliers for the necessary raw materials and components
required to manufacture our products. We also rely on some single-source subcontractors for certain
outsourced manufacturing services. Some of these suppliers are small companies without extensive
financial resources. Because of the limited quantities of products we currently manufacture, it is
not
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economically feasible to qualify and maintain alternate vendors for most components of our
ProteinChip Readers and processing services for our ProteinChip Arrays. We have occasionally
experienced delays in receiving raw materials, components and services, resulting in manufacturing
delays. If we are unable to procure the necessary raw materials, components or services from our
current vendors, we will have to arrange new sources of supply and our raw materials and components
shipments could be delayed, harming our ability to manufacture our products, and our ability to
sustain or increase revenue could be harmed. As a result, our costs could increase and our
profitability could be harmed.
If we fail to maintain certain distribution and patent license agreements, we may have to stop
selling certain products and this may harm our revenue.
We sell certain products under either OEM or distribution or patent license agreements. These
include arrangements with Beckman Coulter with respect to selling a customized version of the
Biomek 3000 Workstation, with Salford Systems with respect to selling Biomarker Patterns software,
and with Applied Biosystems / MDS Sciex with respect to selling our ProteinChip Tandem MS
Interfaces. If we fail to maintain or extend after their expiration the underlying agreements with
these companies, we would have to stop selling these particular products and may have to seek
alternate products to sell, as a result of which our sales may be harmed.
If there are reductions in research funding, the ability of our existing and prospective customers
to purchase our products could be seriously harmed.
A significant portion of our products are sold to universities, government research
laboratories, private foundations and other institutions where funding is dependent upon grants
from government agencies, such as the National Institutes of Health. Government funding for
research and development has fluctuated significantly in the past due to changes in congressional
appropriations. Research funding by the U.S. government or the governments of other countries may
be significantly reduced in the future. Any such reductions may seriously harm the ability of our
existing and prospective research customers to purchase our products or may reduce the number of
ProteinChip Arrays used. Limitations in funding for commercial, biotechnology and pharmaceutical
companies and academic institutions that are the potential customers for our ProteinChip Systems
and Arrays, and general cost containment pressures for biomedical research may limit our ability to
sell our products and services.
If we or our future potential partners fail to comply with FDA requirements, we may not be able to
market our products and services and may be subject to stringent penalties; further improvements to
our manufacturing operations may be required that would entail additional costs.
Currently, the FDA does not actively regulate clinical laboratory tests, or home brews, that
have been developed and used by the laboratory to conduct in-house testing. Active ingredients
(known as analyte specific reagents or ASRs) that are sold to laboratories for use in tests
developed in-house by clinical laboratories are generally exempt from the FDAs pre-market review
requirements. We believe that ASRs that we may provide will fall within those exemptions. However,
the FDA has publicly stated it is reevaluating its ASR policy and we expect that revisions to FDA
policies may be implemented in the future that may have the effect of increasing the regulatory
burden on manufacturers of these devices. The commercialization of our products could be impacted
by being delayed, halted or prevented. If the FDA were to view any of our actions as non-compliant,
it could initiate enforcement action such as a warning letter and possible imposition of penalties.
Finally, ASRs that we may provide will be subject to a number of FDA requirements, including
compliance with the FDAs QSRs, which establish extensive regulations for quality assurance and
control as well as manufacturing procedures. Failure to comply with these regulations could result
in enforcement action for us or our potential partners. Adverse FDA action in any of these areas
could significantly increase our expenses and limit our revenue and profitability. Although we are
ISO 9001:2000 certified in our ProteinChip manufacturing processes, we will need to undertake
additional steps to maintain our operations in line with FDA QSR requirements. Our manufacturing
facilities will be subject to periodic regulatory inspections by the FDA and other federal and
state regulatory agencies. We have not yet been subject to an FDA inspection. We may not satisfy
such regulatory requirements, and any such failure to do so would have an adverse effect on our
diagnostics efforts.
Our diagnostic efforts may cause us to have significant product liability exposure.
The testing, manufacturing and marketing of medical diagnostics entails an inherent risk of
product liability claims. Potential product liability claims may exceed the amount of our insurance
coverage or may be excluded from coverage under the terms of the policy. Our existing insurance
will have to be increased in the future if we are successful at introducing diagnostic products and
this will increase our costs. In the event that we are held liable for a claim against which we are
not indemnified or for damages exceeding the limits of our insurance coverage, our liabilities
could exceed our total assets.
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Business interruptions could limit our ability to operate our business.
Our operations as well as those of the collaborators on which we depend are vulnerable to
damage or interruption from fire, natural disasters, computer viruses, human error, power
shortages, telecommunication failures, international acts of terror and similar events. Our only
production facility is located in Fremont, California, where we also have laboratories. Although we
have certain business continuity plans in place, we have not established a formal comprehensive
disaster recovery plan, and our back-up operations and our business interruption insurance may not
be adequate to compensate us for losses we may suffer. A significant business interruption could
result in losses or damages incurred by us and require us to cease or curtail our operations.
Legislative actions resulting in higher compliance costs are likely to adversely impact our future
financial position, cash flows and results of operations.
Compliance with changing regulation of corporate governance and public disclosure will result
in additional expenses. Changing laws, regulations and standards relating to corporate governance
and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and Nasdaq
Global Market listing requirements, are resulting in increased compliance costs. Compliance with
these evolving standards will result in increased general and administrative expenses and may cause
a diversion of management time and attention from revenue-generating activities to compliance
activities.
Our business is subject to risks from international operations.
We conduct business globally. Accordingly, our future results could be materially adversely
affected by a variety of uncontrollable and changing factors including, among others, foreign
currency exchange rates; regulatory, political, or economic conditions in a specific country or
region; trade protection measures and other regulatory requirements; and natural disasters. Any or
all of these factors could have a material adverse impact on our future international business. In
certain countries, a few key individuals are important to our local success. In addition, China
does not currently have a comprehensive and highly developed legal system, particularly with
respect to the protection of intellectual property rights. As a result, enforcement of existing and
future laws and contracts is uncertain, and the implementation and interpretation of such laws may
be inconsistent. Such inconsistency could lead to piracy and degradation of our intellectual
property protection.
We are exposed to fluctuations in the exchange rates of foreign currency.
As a global concern, we face exposure to adverse movements in foreign currency exchange rates.
With our ownership of Ciphergen Biosystems KK, a significant percentage of our net sales are
exposed to foreign currency risk. These exposures may change over time as business practices evolve
and could have a material adverse impact on our financial results.
We are subject to environmental laws and potential exposure to environmental liabilities.
We are subject to various international, federal, state and local environmental laws and
regulations that govern our operations, including the handling and disposal of nonhazardous and
hazardous wastes, the recycling and treatment of electrical and electronic equipment, and emissions
and discharges into the environment. Failure to comply with such laws and regulations could result
in costs for corrective action, penalties or the imposition of other liabilities. We also are
subject to laws and regulations that impose liability and clean-up responsibility for releases of
hazardous substances into the environment. Under certain of these laws and regulations, a current
or previous owner or operator of property may be liable for the costs of remediating hazardous
substances or petroleum products on or from its property, without regard to whether the owner or
operator knew of, or caused, the contamination, as well as incur liability to third parties
impacted by such contamination. The presence of, or failure to remediate properly, such substances
could adversely affect the value and the ability to transfer or encumber such property. Based on
currently available information, although there can be no assurance, we believe that such costs and
liabilities have not had and will not have a material adverse impact on our financial results.
Anti-takeover provisions in our charter, bylaws and Stockholder Rights Plan and under Delaware law
could make a third party acquisition of us difficult.
Our certificate of incorporation, bylaws and Stockholder Rights Plan contain provisions that
could make it more difficult for a third party to acquire us, even if doing so might be deemed
beneficial by our stockholders. These provisions could limit the price that investors might be
willing to pay in the future for shares of our common stock. We are also subject to certain
provisions of Delaware law that could delay, deter or prevent a change in control of us.
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The rights issued pursuant to our Stockholder Rights Plan will become exercisable the tenth
day after a person or group announces acquisition of 15% or more of our common stock or announces
commencement of a tender or exchange offer the consummation of which would result in ownership by
the person or group of 15% or more of our common stock. If the rights become exercisable, the
holders of the rights (other than the person acquiring 15% or more of our common stock) will be
entitled to acquire, in exchange for the rights exercise price, shares of our common stock or
shares of any company in which we are merged, with a value equal to twice the rights exercise
price.
Because we do not intend to pay dividends, our stockholders will benefit from an investment in our
common stock only if it appreciates in value.
We have never declared or paid any cash dividends on our common stock. We currently intend to
retain our future earnings, if any, to finance the expansion of our business and do not expect to
pay any cash dividends in the foreseeable future. As a result, the success of an investment in our
common stock will depend entirely upon any future appreciation. There is no guarantee that our
common stock will appreciate in value or even maintain the price at which our investor purchased
his shares.
Risks Related to Our Convertible Senior Notes and Common Stock
Substantial leverage and debt service obligations may adversely affect our cash flows.
In connection with the sale of the convertible senior notes (the notes), we incurred $30
million of indebtedness. As a result of this indebtedness, our principal and interest payment
obligations increased substantially. The degree to which we are leveraged could, among other
things:
| make it difficult for us to make payments on the notes; | ||
| make it difficult for us to obtain financing for working capital, acquisitions or other purposes on favorable terms, if at all; | ||
| make us more vulnerable to industry downturns and competitive pressures; and | ||
| limit our flexibility in planning for, or reacting to changes in, our business. |
Our ability to meet our debt service obligations will depend upon our future performance,
which will be subject to financial, business and other factors affecting our operations, many of
which are beyond our control.
The notes are unsecured, and future indebtedness could effectively rank senior to the notes.
The notes are unsecured and will rank equal in right of payment with our existing and future
unsecured and unsubordinated indebtedness. The notes will be effectively subordinated to any
secured debt to the extent of the value of the assets that secure the indebtedness. The notes will
also be structurally subordinated to all indebtedness and other liabilities, including trade
payables and lease obligations, of our existing and future subsidiaries. In the event of our
bankruptcy, liquidation or reorganization or upon acceleration of the notes, payment on the notes
could be less, ratably, than on any secured indebtedness. We may not have sufficient assets
remaining to pay amounts due on any or all of the notes then outstanding.
The indenture governing the notes does not prohibit or limit us or our subsidiaries from
incurring additional indebtedness and other liabilities, or from pledging assets to secure such
indebtedness and liabilities. The incurrence of additional indebtedness and, in particular, the
granting of a security interest to secure the indebtedness, could adversely affect our ability to
pay our obligations on the notes. We anticipate that we may incur additional indebtedness from time
to time in the future.
The notes are not protected by restrictive covenants, including financial covenants.
Neither we nor our subsidiaries are restricted from incurring additional debt, including
senior debt, or liabilities under the indenture. In addition, the indenture does not restrict us or
any of our subsidiaries from paying dividends or issuing or repurchasing securities. If we or our
subsidiaries were to incur additional debt or liabilities, our ability to pay our obligations on
the notes could be adversely affected.
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We may be unable to repay, repurchase or redeem the notes.
At maturity, the entire outstanding principal amount of the notes will become due and payable
by us. Upon a change in control, as defined in the indenture, note holders may require us to
repurchase all or a portion of their notes. We may not have enough funds or be able to arrange for
additional financing to pay the principal at maturity or to repurchase the notes on a change in
control. Future credit agreements or other agreements relating to our indebtedness may restrict the
redemption or repurchase of the notes and provide that a change in control constitutes an event of
default. If the maturity date or a change in control occurs at a time when we are prohibited from
repaying or repurchasing the notes, we could seek the consent of our lenders to purchase the notes
or we could attempt to refinance this debt. If we do not obtain the necessary consents or cannot
refinance the debt on favorable terms, or at all, we will be unable to repay or repurchase the
notes. Our failure to repay the notes at maturity or repurchase tendered notes would constitute an
event of default under the indenture, which might constitute a default under the terms of our other
debt. Our obligation to offer to purchase the notes upon a change in control would not necessarily
afford note holders protection in the event of a highly leveraged transaction, reorganization,
merger or similar transaction involving us.
There may not be an active, liquid market for our common stock or the notes.
There is no guarantee that an active trading market for our common stock will be maintained on
the Nasdaq Stock Markets Global Market. Investors may not be able to sell their shares quickly or
at the latest market price if trading in our stock is not active. An active trading market for the
notes may not be maintained. If an active market for the notes is not sustained, the trading price
of the notes could decline significantly. The notes are eligible for trading on the PORTAL Market.
We do not intend to apply for listing of the notes on any securities exchange.
The notes and the common stock issuable upon conversion of the notes may be subject to restrictions
on resale.
We entered into a registration rights agreement with the initial purchasers of the notes,
pursuant to which we filed a shelf registration statement covering the resale of the notes and the
common stock issuable upon conversion of the notes. If the effectiveness of the registration
statement is not maintained, the liquidity and price of the notes and common stock issuable upon
conversion of the notes would be adversely affected and note holders could lose all or part of
their investment.
During significant periods from 2003 to 2006, the price at which our common stock could be
purchased on the Nasdaq National Market was lower than the conversion price of the notes, and our
stock price may be lower than the conversion price in the future.
Prior to electing to convert notes, the note holder should compare the price at which our
common stock is trading in the market to the conversion price of the notes. Our common stock trades
on the Nasdaq Global Market under the symbol CIPH. The initial conversion price of the notes is
approximately $9.19 per share. The market prices of our securities are subject to significant
fluctuations. Such fluctuations, as well as economic conditions generally, may adversely affect the
market price of our securities, including our common stock and the notes.
The notes may not be rated or may receive a lower rating than anticipated.
We believe it is unlikely that the notes will be rated. However, if one or more rating
agencies rates the notes and assigns the notes a rating lower than the rating expected by
investors, reduces their rating in the future or indicates that it will have their ratings on the
notes under surveillance or review with possible negative implications, the market price of the
notes and our common stock would be harmed. In addition, a ratings downgrade could adversely affect
our ability to access capital.
Our stock price has been highly volatile, and an investment in our stock could suffer a decline in
value, adversely affecting the value of the notes or the shares into which those notes may be
converted.
The trading price of our common stock has been highly volatile and could continue to be
subject to wide fluctuations in price in response to various factors, many of which are beyond our
control, including:
| actual or anticipated period-to-period fluctuations in financial results; | ||
| failure to achieve, or changes in, financial estimates by securities analysts; |
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| announcements of new products or services or technological innovations by us or our competitors; | ||
| developments regarding actual or potential discoveries of biomarkers by us or others; | ||
| comments or opinions by securities analysts or major stockholders; | ||
| conditions or trends in the pharmaceutical, biotechnology and life science industries; | ||
| announcements by us of significant acquisitions, strategic partnerships, joint ventures or capital commitments; | ||
| developments regarding our patents or other intellectual property or that of our competitors; | ||
| litigation or threat of litigation; | ||
| additions or departures of key personnel; | ||
| sales of our common stock; | ||
| limited daily trading volume; and | ||
| economic and other external factors or disasters or crises. |
In addition, the stock market in general, and the Nasdaq Global Market and the market for
technology companies in particular, have experienced significant price and volume fluctuations that
have often been unrelated or disproportionate to the operating performance of those companies.
Further, there has been significant volatility in the market prices of securities of life science
companies. These broad market and industry factors may seriously harm the market price of our
common stock, regardless of our operating performance. In the past, following periods of volatility
in the market price of a companys securities, securities class action litigation has often been
instituted. A securities class action suit against us could result in substantial costs, potential
liabilities and the diversion of managements attention and resources.
Future sales of our common stock in the public market could adversely affect the trading price of
our common stock, the value of the notes and our ability to raise funds in new stock offerings.
Future sales of substantial amounts of our common stock in the public market, or the
perception that such sales are likely to occur, could affect prevailing trading prices of our
common stock and the value of the notes. As of June 30, 2006, we had:
| 36,075,017 shares of common stock outstanding; | ||
| 6,836,577 shares of common stock reserved for issuance upon exercise of options outstanding under our stock option plans with a weighted average exercise price of $3.78 per share; | ||
| in addition to the shares reserved for issuance upon the exercise of options referred to in the preceding bullet point, 1,172,131 shares reserved for future issuance under our stock option and employee stock purchase plans; | ||
| a warrant outstanding for 2,200,000 shares of common stock at a purchase price of $3.50 per share; and | ||
| 25,000 shares of common stock potentially issuable to Gail S. Page, President and Chief Executive Officer of Ciphergen, contingent upon the achievement of a specific diagnostic milestone. |
Because the notes are convertible into common stock only at a specific conversion price, a decline
in our common stock price may cause the value of the notes to decline.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Our Annual Meeting of Stockholders was held on June 7, 2006 in Fremont, California. Of the
35,999,131 shares outstanding as of the record date, April 12, 2006, 30,654,599 were present or
represented by proxy at the meeting. The results of the voting on the matters submitted to the
stockholders were as follows:
1. | To elect two (2) Class III directors to serve until the 2009 Annual Meeting of Stockholders and until their successors are duly elected and qualified. |
Name | Votes For | Votes Withheld | ||||||
Judy Bruner |
30,513,392 | 141,207 | ||||||
Gail S. Page |
30,521,054 | 133,545 |
2. | To ratify the selection of PricewaterhouseCoopers LLP as the independent registered public accounting firm of the Company for the fiscal year ending December 31, 2006. |
Votes for: |
30,150,356 | |||
Votes against: |
433,966 | |||
Votes abstaining: |
70,277 |
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
The following exhibits have been filed with this report:
2.1(1)
|
Share Purchase Agreement between Ciphergen Biosystems, Inc. and LumiCyte, Inc. dated May 28, 2003 | |
2.2(2)
|
Asset Purchase Agreement between Ciphergen Biosystems, Inc. and Pall Corporation dated October 27, 2004 | |
3.2(3)
|
Amended and Restated Certificate of Incorporation of Registrant | |
3.4(3)
|
Amended and Restated Bylaws of Registrant | |
3.5(4)
|
Certificate of Designation of Rights, Preferences and Privileges of Series A Participating Preferred Stock of Ciphergen Biosystems, Inc. | |
4.1(3)
|
Form of Registrants Common Stock Certificate | |
4.2(4)
|
Preferred Shares Rights Agreement dated March 20, 2002 between Ciphergen Biosystems, Inc. and Continental Stock Transfer & Trust Company | |
4.3(5)
|
Indenture between Ciphergen Biosystems, Inc. and U.S. Bank National Association dated August 22, 2003 | |
4.4(6)
|
Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated July 22, 2005 | |
4.5(7)
|
Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated September 30, 2005 | |
31.1
|
Certification of the Chief Executive Officer Pursuant to Section 302 (a) of the Sarbanes-Oxley Act of 2002 | |
31.2
|
Certification of the Chief Financial Officer Pursuant to Section 302 (a) of the Sarbanes-Oxley Act of 2002 | |
32
|
Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(1) | Incorporated by reference to the corresponding exhibits in our Form 8-K filed with the Securities and Exchange Commission on June 11, 2003. | |
(2) | Incorporated by reference to the corresponding exhibit in our Form 8-K filed with the Securities and Exchange Commission on December 6, 2004. | |
(3) | Incorporated by reference to exhibits (with same exhibit number) to Ciphergen Biosystems Registration Statement on Form | |
S-1 (File No. 333-32812) declared effective on September 28, 2000. | ||
(4) | Incorporated by reference to our Registration Statement on Form 8-A filed with the Securities and Exchange Commission on March 21, 2002. | |
(5) | Incorporated by reference to our Registration Statement on Form S-3 filed with the Securities and Exchange Commission on October 8, 2003. | |
(6) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on July 28, 2005. | |
(7) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on October 4, 2005. | |
(8) | Incorporated by reference to exhibit (with same exhibit number) in our Form 8-K filed with the Securities and Exchange Commission on March 23, 2006. |
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SIGNATURES
Pursuant to the requirements 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.
August 16, 2006
CIPHERGEN BIOSYSTEMS, INC.
(Registrant)
/s/ Gail S. Page |
||
Gail S. Page |
||
President, Chief Executive Officer and Director |
||
/s/ Gail S. Page |
||
Gail
S. Page |
||
Interim Chief Financial Officer |
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EXHIBIT INDEX
Exhibit No. | Exhibit Title | |
2.1(1)
|
Share Purchase Agreement between Ciphergen Biosystems, Inc. and LumiCyte, Inc. dated May 28, 2003 | |
2.2(2)
|
Asset Purchase Agreement between Ciphergen Biosystems, Inc. and Pall Corporation dated October 27, 2004 | |
3.2(3)
|
Amended and Restated Certificate of Incorporation of Registrant | |
3.4(3)
|
Amended and Restated Bylaws of Registrant | |
3.5(4)
|
Certificate of Designation of Rights, Preferences and Privileges of Series A Participating Preferred Stock of Ciphergen Biosystems, Inc. | |
4.1(3)
|
Form of Registrants Common Stock Certificate | |
4.2(4)
|
Preferred Shares Rights Agreement dated March 20, 2002 between Ciphergen Biosystems, Inc. and Continental Stock Transfer & Trust Company | |
4.3(5)
|
Indenture between Ciphergen Biosystems, Inc. and U.S. Bank National Association dated August 22, 2003 | |
4.4(6)
|
Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated July 22, 2005 | |
4.5(7)
|
Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated September 30, 2005 | |
31.1
|
Certification of the Chief Executive Officer Pursuant to Section 302 (a) of the Sarbanes-Oxley Act of 2002 | |
31.2
|
Certification of the Chief Financial Officer Pursuant to Section 302 (a) of the Sarbanes-Oxley Act of 2002 | |
32
|
Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(1) | Incorporated by reference to the corresponding exhibits in our Form 8-K filed with the Securities and Exchange Commission on June 11, 2003. | |
(2) | Incorporated by reference to the corresponding exhibit in our Form 8-K filed with the Securities and Exchange Commission on December 6, 2004. | |
(3) | Incorporated by reference to exhibits (with same exhibit number) to Ciphergen Biosystems Registration Statement on Form S-1 (File No. 333-32812) declared effective on September 28, 2000. | |
(4) | Incorporated by reference to our Registration Statement on Form 8-A filed with the Securities and Exchange Commission on March 21, 2002. | |
(5) | Incorporated by reference to our Registration Statement on Form S-3 filed with the Securities and Exchange Commission on October 8, 2003. | |
(6) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on July 28, 2005. | |
(7) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on October 4, 2005. | |
(8) | Incorporated by reference to exhibit (with same exhibit number) in our Form 8-K filed with the Securities and Exchange Commission on March 23, 2006. |
34