Aspira Women's Health Inc. - Quarter Report: 2006 September (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 SEPTEMBER 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 (State or other jurisdiction of incorporation of organization) |
33-0595156 (I.R.S. Employer Identification Number) |
|
6611 DUMBARTON CIRCLE, FREMONT, | ||
CALIFORNIA (Address of principal executive offices) |
94555 (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 October 31, 2006: 36,083,612
CIPHERGEN BIOSYSTEMS, INC.
INDEX FOR FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2006
3 | ||||||||
3 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
6 | ||||||||
14 | ||||||||
22 | ||||||||
23 | ||||||||
23 | ||||||||
23 | ||||||||
23 | ||||||||
29 | ||||||||
29 | ||||||||
29 | ||||||||
29 | ||||||||
29 | ||||||||
31 | ||||||||
32 | ||||||||
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)
(in thousands)
September 30, | December 31, | |||||||
2006 | 2005 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 15,024 | $ | 25,738 | ||||
Short-term investment |
| 2,240 | ||||||
Accounts receivable, net of allowance for doubtful accounts of $458 and $238, respectively |
3,985 | 5,828 | ||||||
Prepaid expenses and other current assets |
2,526 | 1,746 | ||||||
Inventories |
4,255 | 5,594 | ||||||
Total current assets |
25,790 | 41,146 | ||||||
Property, plant and equipment, net |
5,435 | 7,320 | ||||||
Goodwill |
76 | 76 | ||||||
Other intangible assets, net |
1,856 | 2,417 | ||||||
Other long-term assets |
1,486 | 1,852 | ||||||
Total assets |
$ | 34,643 | $ | 52,811 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,223 | $ | 3,188 | ||||
Accrued liabilities |
4,934 | 6,298 | ||||||
Deferred revenue |
3,569 | 4,132 | ||||||
Current portion of capital lease obligations |
12 | 21 | ||||||
Equipment financing loan |
| 377 | ||||||
Total current liabilities |
10,738 | 14,016 | ||||||
Deferred revenue |
320 | 508 | ||||||
Capital lease obligations, net of current portion |
3 | 28 | ||||||
Long-term debt owed to related party |
6,250 | 2,500 | ||||||
Convertible senior notes, net of discount |
28,986 | 28,586 | ||||||
Other long-term liabilities |
470 | 650 | ||||||
Total liabilities |
46,767 | 46,288 | ||||||
Commitments and contingencies (note 6) |
||||||||
Stockholders equity (deficit): |
||||||||
Common stock |
36 | 36 | ||||||
Additional paid-in capital |
203,925 | 202,485 | ||||||
Accumulated other comprehensive loss |
(76 | ) | (204 | ) | ||||
Accumulated deficit |
(216,009 | ) | (195,794 | ) | ||||
Total stockholders equity (deficit) |
(12,124 | ) | 6,523 | |||||
Total liabilities and stockholders equity (deficit) |
$ | 34,643 | $ | 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)
(in thousands, except per share amounts)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenue: |
||||||||||||||||
Products |
$ | 2,697 | $ | 4,491 | $ | 10,702 | $ | 13,858 | ||||||||
Services |
1,965 | 2,565 | 6,297 | 6,787 | ||||||||||||
Total revenue |
4,662 | 7,056 | 16,999 | 20,645 | ||||||||||||
Cost of revenue: |
||||||||||||||||
Products |
1,571 | 2,158 | 5,715 | 6,840 | ||||||||||||
Services |
909 | 1,191 | 3,117 | 3,227 | ||||||||||||
Total cost of revenue |
2,480 | 3,349 | 8,832 | 10,067 | ||||||||||||
Gross profit |
2,182 | 3,707 | 8,167 | 10,578 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
2,914 | 3,098 | 8,780 | 10,231 | ||||||||||||
Sales and marketing |
3,203 | 4,136 | 10,651 | 14,201 | ||||||||||||
General and administrative |
2,542 | 3,482 | 7,550 | 10,728 | ||||||||||||
Total operating expenses |
8,659 | 10,716 | 26,981 | 35,160 | ||||||||||||
Loss from operations |
(6,477 | ) | (7,009 | ) | (18,814 | ) | (24,582 | ) | ||||||||
Interest and other income (expense), net |
(519 | ) | (503 | ) | (1,211 | ) | (1,451 | ) | ||||||||
Loss before income taxes |
(6,996 | ) | (7,512 | ) | (20,025 | ) | (26,033 | ) | ||||||||
Income tax provision (benefit) |
20 | (36 | ) | 190 | 103 | |||||||||||
Net loss from continuing operations |
(7,016 | ) | $ | (7,476 | ) | (20,215 | ) | $ | (26,136 | ) | ||||||
Loss from sale of discontinued operations, net of tax |
| | | (67 | ) | |||||||||||
Net loss |
$ | (7,016 | ) | $ | (7,476 | ) | $ | (20,215 | ) | $ | (26,203 | ) | ||||
Net loss per share, basic and diluted: |
||||||||||||||||
Net loss per share from continuing operations |
$ | (0.19 | ) | $ | (0.23 | ) | $ | (0.56 | ) | $ | (0.84 | ) | ||||
Net loss per share from discontinued operations |
0.00 | 0.00 | 0.00 | 0.00 | ||||||||||||
Net loss |
$ | (0.19 | ) | $ | (0.23 | ) | $ | (0.56 | ) | $ | (0.84 | ) | ||||
Shares used in computing basic and diluted net loss per share |
36,075 | 32,282 | 36,042 | 31,328 | ||||||||||||
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)
Nine Months Ended | ||||||||
September 30, | ||||||||
2006 | 2005 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net loss |
$ | (20,215 | ) | $ | (26,203 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
3,550 | 4,126 | ||||||
Stock-based compensation expense |
1,339 | | ||||||
Amortization of debt discount associated with beneficial conversion feature of convertible
senior notes |
400 | 399 | ||||||
Accrued investment income |
(5 | ) | (49 | ) | ||||
Interest accrued on notes receivable from related parties |
| (6 | ) | |||||
Gain from sale of BioSepra business |
| 67 | ||||||
Common stock issued to company officer as compensation |
| 55 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable, net |
1,898 | 4,423 | ||||||
Prepaid expenses and other current assets |
(779 | ) | 474 | |||||
Inventories |
1,445 | 961 | ||||||
Other long-term assets |
95 | (44 | ) | |||||
Accounts payable and accrued liabilities |
(2,317 | ) | (1,813 | ) | ||||
Deferred revenue |
(760 | ) | (1,480 | ) | ||||
Other long-term liabilities |
92 | 204 | ||||||
Net cash used in operating activities |
(15,257 | ) | (18,886 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||
Purchase of property, plant and equipment, net |
(881 | ) | (1,732 | ) | ||||
Liquidation of short-term investment |
2,245 | | ||||||
Payment for license related to litigation settlement |
(346 | ) | (463 | ) | ||||
Cash paid for post-closing adjustment related to sale of BioSepra business |
| (1,111 | ) | |||||
Net cash provided by (used in) investing activities |
1,018 | (3,306 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Proceeds from issuance of common stock, net |
99 | 212 | ||||||
Repayments of notes receivable from stockholders |
| 350 | ||||||
Proceeds of loan from Quest Diagnostics |
3,749 | 1,250 | ||||||
Principal payments on capital lease obligations |
(12 | ) | (18 | ) | ||||
Repayments of long-term debt |
(377 | ) | (740 | ) | ||||
Net proceeds from sale of common stock to Quest Diagnostics |
| 14,954 | ||||||
Net cash provided by financing activities |
3,459 | 16,008 | ||||||
Effect of exchange rate changes |
66 | (295 | ) | |||||
Net decrease in cash and cash equivalents |
(10,714 | ) | (6,479 | ) | ||||
Cash and cash equivalents, beginning of period |
25,738 | 35,392 | ||||||
Cash and cash equivalents, end of period |
$ | 15,024 | $ | 28,913 | ||||
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: |
||||||||
Transfer of fixed assets to inventory |
$ | 100 | $ | 178 | ||||
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)
September 30, 2006
September 30, 2006
1. ORGANIZATION AND BASIS OF PRESENTATION
The Company
Ciphergen Biosystems, Inc. (the Company or Ciphergen) is dedicated to translating disease
indicators, known as protein biomarkers, into protein molecular diagnostic tests that can improve
the identification or prognosis of various diseases in order to improve patient care. The Company
is also focused on providing collaborative research services through its Biomarker Discovery
Centers® for discovery of new biomarkers and diagnostic tests, as well as biomarker
research services with pharmaceutical and biotechnology companies to improve the safety and
efficacy of developmental and FDA-approved drugs.
Ciphergen also 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 Companys patented core technology
is based on Surface Enhanced Laser Desorption/Ionization (SELDI), a technique that allows the
identification and quantification of proteins that may be present in low concentrations but
important in the pathology of certain diseases such as cancer. The ProteinChip® Systems consist of
ProteinChip® Readers, ProteinChip® Software and related accessories, which are used in conjunction
with consumable ProteinChip® Arrays. These products collectively comprise our proteomics research
instrument business and are sold primarily to researchers at pharmaceutical companies and
biotechnology companies, as well as academic and government research laboratories. The Company also
offers consulting services, customer support services and training classes to its customers and
collaborators.
On November 13, 2006 the Company sold certain assets and liabilities of its protein research
tools and collaborative services business (the proteomics research instrument business) to
Bio-Rad Laboratories, Inc. through an asset purchase transaction (the Asset Sale) in order to
concentrate its resources on developing clinical protein biomarker diagnostic products and services
(see Note 13. Subsequent Events describing the asset purchase agreement for the Asset Sale).
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 September 30, 2006, the Company has financed its operations
principally with $228.1 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 November 2006, the Company
entered into separate privately negotiated agreements with certain holders to amend the terms of
the notes (See Note 13: Subsequent Events). 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
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alliance between Ciphergen and Quest Diagnostics, against which the Company had borrowed
approximately $6.3 million as of September 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
September 30, 2006, the Company had an accumulated deficit of $216.0 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, the sale of the proteomics research instrument business to
Bio-Rad Laboratories, Inc., other potential sales of assets, and additional equity and/or debt
securities. If anticipated operating results are 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 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.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value in accordance with
generally accepted accounting principles and expands disclosures about fair value measurements. The
provisions of SFAS 157 are effective for fiscal years beginning after November 15, 2007. We are
currently evaluating the impact, if any, of the adoption of SFAS 157 will have on our financial
reporting.
In September 2006, the SEC issued Staff Accounting Bulletin No. 108 (SAB 108) in order to
eliminate the diversity of practice surrounding how public companies quantify financial statement
misstatements. Traditionally, there have been two widely-recognized methods for quantifying the
effects of financial statement misstatements: the roll-over method and the iron curtain
method. The roll-over method focuses primarily on the impact of a misstatement on the income
statement, including the reversing effect of prior period misstatements; but its use can lead to
the accumulation of misstatements in the balance sheet. The iron-curtain method, on the other
hand, focuses primarily on the effect of correcting the period-end balance sheet with less emphasis
on the reversing effects of prior period errors on the income statement. We currently use the
iron-curtain method for quantifying identified financial statement misstatements. In SAB 108,
the SEC staff established an approach that requires quantification of financial statement
misstatements based on the effects of the misstatements on each of the Companys financial
statements and the related financial statement disclosures. This model is commonly referred to as
a dual approach because it requires quantification of errors under both the iron curtain and
the roll-over methods. SAB 108 permits existing public companies to initially apply its
provisions either by (i) restating prior financial statements as if the dual approach had always
been used or (ii) recording the cumulative effect of initially applying the dual approach as
adjustments to the carrying values of assets and liabilities as of the beginning of the current
fiscal year with an offsetting adjustment to the opening balance of retained earnings in the year
of adoption. Use of the cumulative effect transition method requires detailed disclosure of the
nature and amount of each individual error being corrected through the cumulative adjustment and
how and when it arose. The provisions of SAB 108 must be applied to annual financial statements no
later
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than the first fiscal year ending after November 15, 2006. We have evaluated the effect of
adopting this guidance and have determined that there will be no impact at adoption on our
financial statements or related disclosures.
3. INVENTORIES
Inventories consisted of the following (in thousands):
September 30, | December 31, | |||||||
2006 | 2005 | |||||||
Raw materials |
$ | 1,381 | $ | 1,775 | ||||
Work in process |
989 | 1,241 | ||||||
Finished goods |
1,885 | 2,578 | ||||||
$ | 4,255 | $ | 5,594 | |||||
4. GOODWILL AND OTHER INTANGIBLE ASSETS
Goodwill and other intangible assets consisted of the following (in thousands):
September 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 |
6,089 | 4,233 | 1,856 | 5,743 | 3,326 | 2,417 | ||||||||||||||||||
$ | 6,165 | $ | 4,233 | $ | 1,932 | $ | 5,819 | $ | 3,326 | $ | 2,493 | |||||||||||||
During the first nine months of 2006, the acquired license related to the Companys litigation
settlement in 2003 increased $346,000 as a result of cash payments made by the Company for license
fees. Amortization expense for this acquired license for the nine month periods ended September 30,
2006 and 2005 was $907,000 and $908,000, respectively. Amortization expense for the acquired
license, based on its gross carrying amount at September 30, 2006, is expected to total
approximately $302,000 for the remaining three months of 2006, $1.2 million in 2007, $344,000 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.
Changes in product warranty obligations, including separately priced maintenance obligations,
were as follows (in thousands):
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Balance at beginning of period |
$ | 2,748 | $ | 3,420 | $ | 2,831 | $ | 3,778 | ||||||||
Add: Costs incurred for maintenance contracts |
509 | 673 | 1,687 | 2,059 | ||||||||||||
Revenue deferred for maintenance contracts |
851 | 1,074 | 3,067 | 3,305 | ||||||||||||
Less: Settlements made under maintenance contracts |
(509 | ) | (673 | ) | (1,687 | ) | (2,059 | ) | ||||||||
Revenue recognized for maintenance contracts |
(1,138 | ) | (1,347 | ) | (3,437 | ) | (3,936 | ) | ||||||||
Balance at end of period |
$ | 2,461 | $ | 3,147 | $ | 2,461 | $ | 3,147 | ||||||||
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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 September 30, 2006, the Company had incurred expenses totaling $1,152,000
comprised of $87,000 for the Companys cost for the contributed arrays and consumables, $442,000
paid in cash, and $623,000 in accrued liabilities.
On June 26, 2006, Health Discovery Corporation filed a lawsuit against the Company 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. Ciphergen subsequently filed its Answer and
Counterclaim to the Complaint with the Court on September 1, 2006. Given the early stage of this
action, the Company cannot predict the ultimate outcome of this matter at this time, but believes
that it does not infringe any Health Discovery Corporation patents. 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. At September 30, 2006,
such borrowings amounted to $6,250,000. 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
September 30, 2006, the Company had spent approximately $6.3 million of the loan proceeds on
in-house research and development, as well as collaborations with others, directed towards
achieving the milestones.
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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 1,228,868 shares available for future stock option grants under the 2000
Plan at September 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 nine month offering and purchase
periods. Participants in the ESPP may purchase common stock at the end of each nine 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 nine month period or the end of the nine 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 September 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 nine 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 September 30, 2006 were $414,000 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 nine months ended September 30, 2006 were $1,338,000 and $0.04 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 nine months ended September 30, 2005 (in thousands, except per share amounts):
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Three Months Ended | Nine Months Ended | |||||||
September 30, 2005 | September 30, 2005 | |||||||
Net loss as reported |
$ | (7,476 | ) | $ | (26,203 | ) | ||
Add: Employee stock-based compensation expense in reported net loss, net of tax |
55 | 55 | ||||||
Less: Employee stock-based compensation expense determined under the fair
value method, net of tax |
(619 | ) | (2,501 | ) | ||||
Pro forma net loss |
$ | (8,040 | ) | $ | (28,649 | ) | ||
Basic and diluted net loss per share: |
||||||||
As reported |
$ | (0.23 | ) | $ | (0.84 | ) | ||
Pro forma |
$ | (0.25 | ) | $ | (0.91 | ) |
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 | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Assumptions: |
||||||||||||||||
Risk-free interest rate |
4.595 | % | 4.24 | % | 4.93 | % | 3.26 | % | ||||||||
Expected term (in years) |
6.1 | 5.0 | 0.5 | 0.5 | ||||||||||||
Expected volatility |
88 | % | 90 | % | 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 |
0.80 | 2.19 | | | ||||||||||||
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 nine months ended September 30,
2006 (numbers of shares stated in thousands):
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 |
1,409 | 1.23 | ||||||||||
Exercised |
2 | 0.94 | ||||||||||
Forfeited |
1,281 | 4.60 | ||||||||||
Outstanding options at end of period |
6,460 | $ | 3.73 | 7.7 | ||||||||
Outstanding options exercisable at end of period |
3,963 | $ | 5.11 | 6.7 |
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At September 30, 2006, the aggregate intrinsic value of options outstanding was $154,000 and
the aggregate intrinsic value of outstanding options exercisable was $53,000. Also, there was $2.3
million of unrecognized compensation cost related to stock option grants to employees which is
expected to be recognized over a weighted average period of 1.5 years.
The allocation of stock-based compensation expense by functional area for the three and nine
months ended September 30, 2006 was as follows (in thousands):
Three Months Ended | Nine Months Ended | |||||||
September 30, 2006 | September 30, 2006 | |||||||
Cost of products revenue |
$ | 46 | $ | 140 | ||||
Research and development |
79 | 273 | ||||||
Sales and marketing |
66 | 252 | ||||||
General and administrative |
223 | 673 | ||||||
Total |
$ | 414 | $ | 1,338 | ||||
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 September 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 11.9 million and 11.6 million potential common shares as of September 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.
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 nine month periods
ended September 30, 2006 and 2005 (in thousands):
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenue |
||||||||||||||||
United States |
$ | 1,393 | $ | 3,578 | $ | 4,706 | $ | 9,011 | ||||||||
Canada |
300 | 111 | 926 | 734 | ||||||||||||
Europe |
1,652 | 1,395 | 6,651 | 5,403 | ||||||||||||
Asia-Pacific |
1,317 | 1,792 | 4,716 | 5,497 | ||||||||||||
Total |
$ | 4,662 | $ | 7,056 | $ | 16,999 | $ | 20,645 | ||||||||
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During the three month periods ended September 30, 2006 and 2005, sales to customers in Japan
represented 25% and 13% of revenue, respectively. During the nine month periods ended September 30,
2006 and 2005, sales to customers in Japan represented 24% and 21% of revenue, respectively. In
addition, during the nine months ended September 30, 2006, sales to customers in the U.K.
represented 10%. 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 September 30, 2006 and December
31, 2005 is presented in the following table (in thousands):
September 30, | December 31, | |||||||
2006 | 2005 | |||||||
Long lived assets |
||||||||
United States |
$ | 4,802 | $ | 6,256 | ||||
Canada |
2 | 20 | ||||||
Europe |
283 | 561 | ||||||
Asia-Pacific |
348 | 483 | ||||||
Total |
$ | 5,435 | $ | 7,320 | ||||
13. SUBSEQUENT EVENTS
On November 13, 2006, the Company sold the assets and liabilities of its proteomics research
instrument business, which includes the Companys SELDI technology, ProteinChip® Arrays and
accompanying software to Bio-Rad Laboratories, Inc. through an Asset Purchase Agreement. The
Company retains certain exclusive rights in the clinical and consumer diagnostics market. Bio-Rad
purchased the proteomics research instrument business for approximately $16 million in cash at
closing. An additional $4.0 million of cash consideration includes $2.0 million, subject to
certain adjustments, to be held in escrow for three years as security for certain obligations, and
another $2.0 million as a holdback amount until the issuance of a re-examination certificate
confirming the Surface Enhanced Laser Desorption/Ionization (SELDI) patent
Pursuant to the Asset Purchase Agreement, assets and liabilities of approximately $15 million and
$7 million, respectively were sold to BioRad. Furthermore, the Company expects to record a gain of
approximately $7 million in the fourth quarter of 2006.
As a result of the sale to BioRad, there will be no significant sales until the first of the
diagnostic tests is launched.
On November 13, 2006, Bio-Rad and Ciphergen closed a Stock Purchase Agreement (the Purchase
Agreement) for the private sale of shares of the Companys common stock to Bio-Rad for an
aggregate purchase price of $3,000,000. The Purchase Agreement also provides for certain
registration rights such that if the Company files a registration statement under the Securities
Act of 1933, as amended, Bio-Rad may elect to include its shares in that registration, subject to
various conditions
In connection with the Asset Sale, the Company also agreed to enter into a Manufacturing
Services Agreement with Bio-Rad whereby the Company would agree to purchase SELDI instruments and
consumables from Bio-Rad for the continued development of its diagnostics business.
In connection with the Asset Sale, the Company also agreed to enter into a Cross-License
Agreement with Bio-Rad whereby the Company retains certain rights to exploit existing technology
commercially, including SELDI technology, in the clinical diagnostics market, which market includes
the development and sale of clinical laboratory products and services, as well as home-use
diagnostic tests.
On November 15, 2006 the Company exchanged $27.5 million aggregate principal amount of its
4.50% Convertible Senior Notes due 2008 (the Outstanding Notes) for $16.5 million aggregate
principal amount of a new series of 7.00% Convertible Senior Notes due 2011 (the New Notes) and
$11.0 million in cash, plus accrued and unpaid interest. The New Notes will mature on September 1,
2011, and bear interest at a rate of 7.00% per year, which may be reduced to 4.00% per year if the
Company receives approval or clearance for commercial sale of any of its ovarian cancer tests by
the U.S. Food and Drug Administration (FDA). The New Notes are convertible into the Companys
common stock at an initial conversion price of $2.00 per share. On or after September 1, 2009, the
Company may, at its option, redeem the Notes for cash in whole at any time or in part from time to
time, on any date prior to maturity if, beginning on September 1, 2009, the volume-weighted average
price per share of the Common Stock equals or exceeds 200% of
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the Conversion Price then in effect for at least 20 Trading Days in any consecutive 30 Trading Day
period ending on the Trading Day prior to the date the notice of the redemption. $2.5 million of
the Outstanding Notes remain outstanding and are due in 2008.
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 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 can improve the identification or prognosis of various diseases in
order to improve patient care. We have a three-pronged approach to development and
commercialization of our molecular diagnostics products. The first prong is to develop high-value
diagnostic tests that help physicians stratify patients according to their risk of developing a
particular disease. Secondly, we are seeking to facilitate more efficient clinical trials of new
therapeutics by identifying and developing biomarkers that stratify patients according to the
likelihood of response to new therapeutics. Thirdly, we are seeking to identify biomarkers that can
form the basis for molecular imaging diagnostics.
The Companys current pipeline of new biomarker diagnostic products includes a gynecological
diagnostic biomarker test for ovarian cancer to complement other approved diagnostic methods in
order to enhance physicians ability to make an earlier and correct differential diagnosis of
ovarian cancer vs. a persistent benign pelvic mass, to stratify patients into higher risk for
ovarian cancer versus those with benign disease, as well as identify those patients who should
receive surgical or other intervention. We plan to submit an application to the FDA for approval of
an in vitro diagnostic ovarian biomarker product in the US during the second half of 2007 and also
plan to launch the product in a second country during 2007. In addition, our strategic alliance
with Quest Diagnostics provides the Company with the ability to market the ovarian biomarker test
broadly to reference laboratory customers in the U.S. and internationally. Other diagnostic
biomarker products in the pipeline include biomarkers for peripheral arterial disease (PAD) and
thrombotic thrombocytopenic purpura (TTP).
We are also focused on providing collaborative research services through our Biomarker
Discovery Centers® for biomarker discovery of new diagnostic tests as well as drug
safety and efficacy assays for pharmaceutical and biotechnology companies. 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
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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® 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
September 30, 2006, we had an accumulated deficit of $216 million.
Upon closing of the Bio-Rad Asset Sale in November 2006, the Companys proteomics research
instrument business, which included the Companys SELDI technology, ProteinChip® Arrays and
accompanying software was sold and transferred to Bio-Rad. However, the Company retained certain
exclusive rights to the diagnostics market, including products and services for clinical
laboratories, reference laboratories, and in-home use. The Company will continue to focus on
translating protein biomarkers and panels of biomarkers into protein molecular diagnostic tests
that can improve the identification or prognosis of various diseases in order to improve patient
care.
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 will enhance their
ProteinChip Systems by adding our automation accessories and advanced software. However, as a
result of the Bio-Rad transaction, there will be no significant sales until the first of the
diagnostic tests is launched.
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
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development programs; litigation; and general and administrative costs associated with our
operations. We expect to incur losses for at least the next year. To become profitable, we will
need to 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 timing of introduction of new diagnostic biomarker
products into the market, market acceptance of current and new products and services, the length of
the sales cycle and timing of significant orders, the cost to manufacture new products, 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
On November 13, 2006, the Company sold the assets and liabilities of its proteomics research
instrument business, which includes the Companys SELDI technology, ProteinChip® Arrays and
accompanying software to Bio-Rad Laboratories, Inc. through an Asset Purchase Agreement. The
Company retains certain exclusive rights in the clinical and consumer diagnostics market. Bio-Rad
purchased the proteomics research instrument business for approximately $16 million in cash at
closing. An additional $4.0 million of cash consideration includes $2.0 million, subject to
certain adjustments, to be held in escrow for three years as security for certain obligations, and
another $2.0 million as a holdback amount until the issuance of a re-examination certificate
confirming the Surface Enhanced Laser Desorption/Ionization (SELDI) patent
Pursuant to the Asset Purchase Agreement, assets and liabilities of approximately $15 million and
$7 million, respectively were sold to BioRad. Furthermore, the Company expects to record a gain of
approximately $7 million in the fourth quarter of 2006.
As a result of the sale to BioRad, there will be no significant sales until the first of the
diagnostic tests is launched.
On November 13, 2006, Bio-Rad and Ciphergen closed a Stock Purchase Agreement (the Purchase
Agreement) for the private sale of shares of the Companys common stock to Bio-Rad for an
aggregate purchase price of $3,000,000. . The Purchase Agreement also provides for certain
registration rights such that if the Company files a registration statement under the Securities
Act of 1933, as amended, Bio-Rad may elect to include its shares in that registration, subject to
various conditions
In connection with the Asset Sale, the Company also agreed to enter into a Manufacturing
Services Agreement with Bio-Rad whereby the Company would agree to purchase SELDI instruments and
consumables from Bio-Rad for the continued development of its diagnostics business.
In connection with the Asset Sale, the Company also agreed to enter into a Cross-License
Agreement with Bio-Rad whereby the Company retains certain rights to exploit existing technology
commercially, including SELDI technology, in the clinical diagnostics market, which market includes
the development and sale of clinical laboratory products and services, as well as home-use
diagnostic tests.
On November 15, 2006 the Company exchanged $27.5 million aggregate principal amount of its
4.50% Convertible Senior Notes due 2008 (the Outstanding Notes) for $16.5 million aggregate
principal amount of a new series of 7.00% Convertible Senior Notes due 2011 (the New Notes) and
$11.0 million in cash, plus accrued and unpaid interest. The New Notes will mature on September 1,
2011, and bear interest at a rate of 7.00% per year, which may be reduced to 4.00% per year if the
Company receives approval or clearance for commercial sale of any of its ovarian cancer tests by
the U.S. Food and Drug Administration (FDA). The New Notes are convertible into the Companys
common stock at an initial conversion price of $2.00 per share. On or after September 1, 2009, the
Company may, at its option, redeem the Notes for cash in whole at any time or in part from time to
time, on any date prior to maturity if, beginning on September 1, 2009, the volume-weighted average
price per share of the Common Stock equals or exceeds 200% of the Conversion Price then in effect
for at least 20 Trading Days in any consecutive 30 Trading Day period ending on the Trading Day
prior to the date the notice of the redemption. $2.5 million of the Outstanding Notes remain
outstanding and are due in 2008.
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 September 23, 2006, to regain compliance. The Company requested a hearing for
purposes of appealing this delisting determination on July 3, 2006.
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On August 17, 2006, the Company attended a hearing before a Nasdaq Listing Qualifications
Panel and requested the Companys listing be transferred from the Nasdaq Global Market to the
Nasdaq Capital Market. On August 24, 2006 the Company was notified the transfer was approved
effective Monday, August 28, 2006. The Companys trading symbol remains CIPH.
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 nine 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 NINE MONTH PERIODS ENDED SEPTEMBER 30, 2006 AND SEPTEMBER 30, 2005
PRODUCTS REVENUE. Products revenue decreased to $2.7 million in the third quarter of 2006 from $4.5
million in the same period of 2005, a decrease of $1.8 million or 40%. The decrease was primarily
the result of a decline of $1.1 million or 46% in revenue from sales of our ProteinChip Systems,
accessories and software, and a $713,000 or 34% decline in revenue from arrays and consumables.
The reductions in our sales force in July, 2005 was the major factor in these declines.
The number of ProteinChip systems sold in the third quarter declined by 59% to 9 from 22 in the
same period in 2005. This decline was only partially offset by an improvement in product mix in
favor of our PCS 4000 systems. The PCS 4000 systems in the third quarter of 2006 comprised 78% of
our total system sales versus 50% in the same period of 2005. The improvement in the product mix
resulted in an increase in average revenue per system of 33% or $35,000 per average sale.
Products revenue decreased to $10.7 million in the first nine months of 2006 from $13.9
million in the same period of 2005, a decrease of $3.2 million or 23%. The decrease was primarily
the result of a $2.0 million or 30% decline in revenue from arrays and consumables and a $1.2
million or 16% 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, we experienced a 30% decline in system unit sales during the first 9 months of 2006 as
compared to the first nine months of the prior year, with most of the decline being experienced in the
third quarter.
SERVICES REVENUE. Services revenue was approximately $2.0 million in the third quarter of 2006
as compared to $2.6 million in the third quarter of 2005. Revenue from Biomarker Discovery Center
projects declined approximately $365,000 due to completion of several large projects in the second
quarter of 2006. We also had a decrease in revenue from training and consulting services of
approximately $26,000, 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 $209,000 due to fewer
maintenance contracts being renewed by our customers.
Services revenue decreased to $6.3 million in the first nine months of 2006 from $6.8 million
in the same period of 2005, a decrease of $490,000 or 7%. This decrease was primarily due to a
decrease in revenue from training and consulting services of approximately $381,000, 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 $499,000 due to having fewer instruments under contract,
partially offset by an increase of approximately $390,000 in revenue from Biomarker Discovery
Center projects due to completion of several large contracts in the first nine months of 2006.
As
a result of the closing of the sale of our proteomics research instrument business to
Bio-Rad in November 2006, we expect our future revenues to be primarily affected by our ability to
develop and commercialize diagnostic biomarker tests based on the ProteinChip platform.
COST OF PRODUCTS REVENUE. Cost of products revenue decreased to $1.6 million in the third
quarter of 2006 from $2.2 million in the same period of 2005, a decrease of $587,000 or 27%. The
Consumables line experienced a reduction in sales for the third quarter of this year compared to
the same period for 2005 of approximately 34%. Also, our ProteinChip Systems experienced a
reduction in sales for the third quarter of 2006 compared to the same period in 2005. The gross
margin for product revenue decreased
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to 42% in the third quarter of 2006, compared to 52% in the third quarter of 2005. The
decrease in the gross margin is primarily a result of the under absorption of manufacturing
overhead costs due to lower production volumes.
Cost of products revenue decreased to $5.7 million in the first nine months of 2006 from $6.8
million in the same period of 2005, a decrease of $1.1 million or 16%. The decrease during the nine
month period was concentrated in the third quarter and was related to the decline in unit sales
during that period. Overall, the Company experienced a 23% reduction in product revenue during the
first nine months of 2006 as compared to the same period in 2005. The gross margin for products
revenue decreased to 47% in the first nine months of 2006, compared to 51% in the first nine months
of 2005. The decrease in the gross margin is primarily a result of the under absorption of
manufacturing overhead costs due to lower production volumes.
COST OF SERVICES REVENUE. Cost of services revenue decreased to $0.9 million in the third
quarter of 2006 from $1.2 million in the same period of 2005, a decrease of $283,000 or 24%,
primarily due to lower revenue from Biomarker Discovery Center projects. The gross margin for
services revenue was 54% in the third quarter of 2006, the same as in the third quarter of 2005.
Cost of services revenue decreased to $3.1 million in the first nine months of 2006 from $3.2
million in the same period of 2005, a decrease of $111,000 or 3%. The largest component of this
decrease 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 was slightly
down at 51% in the first nine months of 2006 compared to 52% in the same period of 2005.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses decreased to $2.9 million
in the third quarter of 2006 from $3.1 million in the same period of 2005, a decrease of $184,000
or 6%. The decrease was largely due to a 21% decrease in headcount comparing September 30, 2006 to
September 30, 2005, resulting in a decrease in payroll and related costs of approximately $620,000.
This also resulted in reductions in travel and other operating expenses of approximately $53,000.
These decreases were offset by an increase in collaboration costs of $252,000, largely due to our
collaboration with University College London, which began in October 2005 and material usage in
early stage diagnostic research and development projects in the amount of $180,000. Stock-based
compensation expense included in research and development expenses was $79,000 in the third quarter
of 2006.
Research and development expenses decreased to $8.8 million in the first nine months of 2006
from $10.2 million in the same period of 2005, a decrease of $1.4 million or 14%. The decrease was
largely due to a 21% decrease in headcount comparing September 30, 2006 to September 30, 2005,
resulting in a decrease in payroll and related costs of approximately $2.0 million. This also
resulted in reductions in travel and other operating expenses of approximately $115,000. Canceling
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
$233,000 for materials and supplies used in new product development. These decreases were partly
offset by an increase in collaboration costs of $756,000, 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 $273,000 in the first nine months of 2006.
We expect research and development expenses to decline for the remainder of 2006 relative to
2005 due to a reduction in the number of research and development employees in 2006, as well as
slowing or canceling selected early-stage research and development programs related to new
instrumentation platforms, 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, together with biomarker discovery research for new diagnostic
biomarker products. The decline in research and development expenses will be partly offset by
stock-based compensation expense.
SALES AND MARKETING EXPENSES. Sales and marketing expenses decreased to $3.2 million in the
third quarter of 2006 from $4.1 million in the same period of 2005, a decrease of $933,000 or 23%.
The decrease was largely due to a 22% decrease in headcount comparing September 30, 2006 to
September 30, 2005, resulting in a decrease in payroll and related costs of approximately $616,000.
The decreased staffing also resulted in reductions in travel and other operating expenses in sales
and marketing of approximately $279,000. Equipment costs, consisting primarily of depreciation on
demonstration ProteinChip Systems, declined approximately $210,000, as we have fewer demonstration
systems in service. Costs for trade shows, demonstration consumables, advertising and other
marketing activities declined approximately $177,000. These reductions were offset by costs
remaining in the department. Sales and marketing personnel typically provide support activities to
the BDCs, Field Service, and Training and the associated costs are transferred from Sales &
Marketing to COGS. The reduced revenue levels resulted in lower support costs for BDCs and Field
Service being transferred to COGS, such that costs remaining in the department were $377,000 higher
compared to the third quarter of 2005.
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Stock-based compensation expense included in sales and marketing
expenses was $66,000 in the third quarter of 2006.
Sales and marketing expenses decreased to $10.7 million in the first nine months of 2006 from
$14.2 million in the same period of 2005, a decrease of $3.6 million or 25%. The decrease was
largely due to a 22% decrease in headcount comparing September 30, 2006 to September 30, 2005,
resulting in a decrease in payroll and related costs of approximately $1.8 million. The decreased
staffing also resulted in reductions in travel and other operating expenses in sales and marketing
of approximately $892,000. Internal consumption of ProteinChip Arrays and other consumables for
customer demonstrations and support decreased approximately $454,000. Equipment costs, consisting
primarily of depreciation on demonstration ProteinChip Systems, declined approximately $776,000, as
we have fewer demonstration systems in service. Costs for trade shows, advertising and other
marketing activities declined approximately $393,000. These reductions were offset by costs
remaining in the department. Sales and marketing personnel typically provide support activities to
the BDCs, Field Service, and Training and the associated costs are transferred from Sales &
Marketing to COGS. The reduced revenue levels resulted in lower support costs for Training and
Field Service being transferred to COGS, such that costs remaining in the department were $361,000
higher compared to the first nine months of 2005. Stock-based compensation expense included in sales
and marketing expenses was $252,000 in the first nine months of 2006.
We expect sales and marketing expenses to decrease for the remainder of 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 $2.5
million in the third quarter of 2006 from $3.5 million in the same period of 2005, a decrease of
$1.0 million or 27%. The decrease was largely due to a 36% reduction in headcount comparing
September 30, 2006 to September 30, 2005, resulting in a decrease in payroll and related costs of
approximately $700,000. This decrease was accompanied by decreases of $344,000 in legal fees
primarily due to being more selective in patent activities, $73,000 in travel expenses, and $64,000
in directors and officers insurance. Stock-based compensation expense included in general and
administrative expenses was $223,000 in the third quarter of 2006.
General and administrative expenses decreased to $7.5 million in the first nine months of 2006
from $10.7 million in the same period of 2005, a decrease of $3.2 million or 30%. The decrease was
largely due to a 36% reduction in headcount comparing September 30, 2006 to September 30, 2005,
resulting in a decrease in payroll and related costs of approximately $1.8 million. This decrease
was accompanied by decreases of $859,000 in legal fees primarily due to being more selective in
patent activities, $876,000 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, $192,000 in
directors and officers insurance, and $196,000 in travel expenses. Stock-based compensation
expense included in general and administrative expenses was $673,000 in the first nine months of
2006.
We expect general and administrative expenses to decrease for the remainder of 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 during 2006. However, these
reductions are expected to be partly offset by stock-based compensation expense.
INTEREST AND OTHER INCOME (EXPENSE), NET. Interest income in the third quarter of 2006 was
$190,000 compared to $239,000 in the same period of 2005. Interest income decreased because we
continue to use invested funds to maintain our operation. Interest expense in the third quarter of
2006 was $592,000 compared to $495,000 in the same period of 2005. Interest expense increased as we
increased our loan balance from Quest Diagnostics. Approximately $135,000 of the interest
expense in the third quarters of 2006 and 2005 was non-cash, attributable to amortization of the
beneficial conversion feature associated with the convertible senior notes. Other expense in the
third quarter of 2006 was $116,000 compared to expense of $247,000 in the same period of 2005. The
change was mainly due to favorable foreign currency variances.
Interest income in the first nine months of 2006 was $654,000 compared to $591,000 in the same
period of 2005. Interest income increased due to higher interest rates in first nine months of
2006, partially offset by lower balances in interest earning instruments as we continue to draw
down balances to fund operations. Interest expense in the first nine months of 2006 was $1.7
million compared to $1.5 million in the same period of 2005. Interest expense in both periods
consisted largely of interest accrued for our convertible
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senior notes, borrowings from Quest Diagnostics, equipment-financing loan and capital leases.
Approximately $400,000 of the interest expense in the first nine months of 2006 and 2005 was
non-cash, attributable to amortization of the beneficial conversion feature associated with the
convertible senior notes. Other expense in the first nine months of 2006 was net expense of
$173,000 compared to expense of $564,000 in the same period of 2005. The net expense in the first
nine months of 2006 resulted primarily from $160,000 received in settlement of a claim against a
service provider, offset by $280,000 for amortization of the offering costs related to the
convertible senior notes. The net expense in the nine 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 third quarter of 2006
was an expense of $20,000 compared to a benefit of $36,000 in the same period of 2005. The increase
in expense was primarily due to a tax benefit of $42,000 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 nine months of 2006 was
an expense of $190,000, compared to an expense of $103,000 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 September 30, 2006, we have financed our operations principally
with $228.1 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 $30.0 million 4.5% convertible senior notes on August 22, 2003. These
notes are due September 1, 2008 but in November 2006, the Company entered into separate privately
negotiated agreements with certain holders to amend the terms of the notes, such that only $2.5
million remains due September, 2008. (See Note 13: Subsequent Events). 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 $6.3 million as of September 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 September 30, 2006 were $15.0 million,
compared to $28.0 million at December 31, 2005. Working capital at September 30, 2006 was $15.0
million, compared to $27.1 million at December 31, 2005. The decrease in working capital was
principally due to a net $13.0 million decrease in cash and short-term investments to fund our
operating losses, a $1.8 million decrease in accounts receivable, and a $1.3 million decrease in
inventory, partly offset by a $2.3 million decrease in payables, accrued liabilities and payroll, a
$563,000 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 September 30, 2006 totaled $35.3 million
compared to $31.5 million at December 31, 2005.
Net cash used in operating activities was $15.3 million in the first nine months of 2006
compared to $18.9 million in the same period of 2005. Reductions in other operating and
manufacturing overhead expenditures of $6.0 million, payroll expense of $4.0 million, and raw
materials inventory purchases of $3.2 million, comparing the first nine months of 2006 to the same
period of 2005, were offset by approximately $4.9 million less in collections from customers in the
first nine months of 2006 than in the comparable period of 2005 due to lower revenues.
Net cash provided by investing activities was $1.0 million in the first nine months of 2006
compared to net cash used in investing activities of $3.3 million in the first nine months of 2005.
Net cash provided by investing activities in the first nine 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 $881,000 and payments totaling $346,000 for a
technology license related to our litigation which was settled in 2003. Net cash used in investing
activities in the first nine months of 2005 consisted of net purchases of property and equipment of
approximately $1.7 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 $463,000 for a
technology license related to our litigation which was settled in 2003. We anticipate capital
expenditures of approximately $1.4 million during the next 12 months of operations.
Net cash provided by financing activities was $3.5 million in the first nine months of 2006
compared to net cash provided by financing activities of $16.0 million in the first nine months of
2005. Net cash provided by financing activities in the first nine months of 2006 consisted of $3.7
million in loans from Quest Diagnostics and $99,000 from the issuance of common stock under our
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employee stock purchase plan, partly offset by $377,000 for repayments of an equipment
financing loan. Net cash used in financing activities in the first nine months of 2005 was used
primarily for debt repayments amounting to $740,000, largely offset by $15.0 million from issuance
of common stock to Quest Diagnostics, $350,000 from the repayment of stockholder loans, $1.3
million in loans from Quest Diagnostics and $212,000 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 for at
least the next 12 months. We currently expect to fund our liquidity needs, our obligations related
to the strategic alliance with Quest Diagnostics and for capital requirements from a combination of
available cash, borrowings from Quest Diagnostics, the sale of assets and additional equity (see
Note 13), and/or the sale 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 September 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) |
$ | 15 | $ | 12 | $ | 3 | $ | | $ | | ||||||||||
Interest payable on capital lease obligations |
1 | 1 | | | ||||||||||||||||
Loan from Quest Diagnostics (1) |
6,250 | | | 6,250 | | |||||||||||||||
Interest payable on loan from Quest Diagnostics (2) |
2,083 | 547 | 1,094 | 442 | | |||||||||||||||
Convertible senior notes (3) |
30,000 | | 30,000 | | | |||||||||||||||
Interest payable on convertible senior notes |
2,700 | 1,350 | 1,350 | | | |||||||||||||||
Non-cancelable collaboration obligation (4)(5) |
699 | 699 | | | | |||||||||||||||
Non-cancelable operating lease obligations |
8,069 | 4,109 | 3,701 | 259 | | |||||||||||||||
Purchase obligations (6) |
667 | 667 | | | | |||||||||||||||
Total contractual cash obligations |
$ | 50,484 | $ | 7,385 | $ | 36,148 | $ | 6,951 | $ | | ||||||||||
(1) | Principal amounts, not including interest. | |
(2) | Based on outstanding principal balance and interest rate as of September 30, 2006. | |
(3) | Excludes the beneficial conversion feature amounting to $2.7 million, less related amortization of $1.7 million. As noted in Note 13. Subsequent Events, the Company has restructured this debt for $16.5 million aggregate principal amount due in 2011, and $11 million in cash. The remaining $2.5 million principal amount is due in 2008. | |
(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(TM), Pattern Track(TM) 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 September 30, 2006, Ciphergen incurred expenses totaling $1,152,000 comprised of $87,000 representing the companys cost for the contributed arrays and consumables, cash payments of $442,000 and $623,000 in accrued liabilities. | |
(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. The Company has made a cash payment of $229,000 and has an accrued liability of $76,000 at September 30, 2006. |
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(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. |
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 September 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 $2.9
million at September 30, 2006.
We did not enter into any forward contracts during the nine month periods ended September 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.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
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 September 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 September 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 September 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. Ciphergen filed its Answer and Counterclaim to the
Complaint with the Court on September 1, 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 September 30, 2006, we have generated cumulative
revenue from continuing operations of approximately $192.2 million and have incurred net losses of
approximately $216.0 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 $20.2 million in the first nine
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 derived from a business that we have now sold. 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.
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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.
Our success depends on our ability to develop and commercialize diagnostic products. 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 would be seriously harmed.
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.
If we fail to continue to develop our technologies, we may not be able to successfully foster
adoption of our products and services or develop new product offerings.
Our technologies are new and complex, and are subject to change as new discoveries are made.
New discoveries and further progress in our field are essential if we are to foster 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 technologies.
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.
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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 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 and employees, our inability to recruit
and retain these people could hinder our business plans.
We are highly dependent on our executive officers and certain key employees. Our product
development could be delayed or curtailed if we lose the services of any of these people. To expand
our research and product development efforts, we need people skilled in areas such as
bioinformatics, biochemistry, and information services. 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.
If we fail to maintain our rights to utilize intellectual property directed to diagnostic
biomarkers, we may not be able to offer
diagnostic tests using those biomarkers.
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 $6.25 million as of September 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 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
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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.
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 with respect to our manufacturing processes used for our previous
ProteinChip products, 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.
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.
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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 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.
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.
Substantial leverage and debt service obligations may adversely affect our cash flows.
As of September 30, 2006 we had $30 million of convertible senior notes outstanding. As a
result of this indebtedness, we have high principal and interest payment obligations. The degree to
which we are leveraged could, among other things:
| make it difficult for us to make payments on the notes; |
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| 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.
Our stock price has been highly volatile, and an investment in our stock could suffer a decline in
value.
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; | ||
| 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 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. As of September 30, 2006, we had:
| 36,076,437 shares of common stock outstanding; |
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| 6,460,642 shares of common stock reserved for issuance upon exercise of options outstanding under our stock option plans with a weighted average exercise price of $3.73 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. |
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
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 | |
2.3(3) | Asset Purchase Agreement between Ciphergen Biosystems, Inc. and Bio-Rad Laboratories, Inc. dated August 14, 2006. | |
3.2(4) | Amended and Restated Certificate of Incorporation of Registrant | |
3.4(4) | Amended and Restated Bylaws of Registrant | |
3.5(5) | Certificate of Designation of Rights, Preferences and Privileges of Series A Participating Preferred Stock of Ciphergen Biosystems, Inc. | |
4.1(4) | Form of Registrants Common Stock Certificate | |
4.2(5) | Preferred Shares Rights Agreement dated March 20, 2002 between Ciphergen Biosystems, Inc. and Continental Stock Transfer & Trust Company | |
4.3(6) | Indenture between Ciphergen Biosystems, Inc. and U.S. Bank National Association dated August 22, 2003 | |
4.4(7) | Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated July 22, 2005 | |
4.5(8) | Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated September 30, 2005 |
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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 September 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 our Form 8-K filed with the Securities and Exchange Commission on November 13, 2006. | |
(4) | 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. | |
(5) | Incorporated by reference to our Registration Statement on Form 8-A filed with the Securities and Exchange Commission on March 21, 2002. | |
(6) | Incorporated by reference to our Registration Statement on Form S-3 filed with the Securities and Exchange Commission on October 8, 2003. | |
(7) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on July 28, 2005. | |
(8) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on October 4, 2005. |
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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.
November 20, 2006
CIPHERGEN BIOSYSTEMS, INC.
(Registrant)
/s/ Gail S. Page |
|
Gail S. Page |
|
President, Chief Executive Officer and Director |
|
/s/ Debra A. Young |
|
Debra A. Young |
|
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 | |
2.3(3)
|
Asset Purchase Agreement between Ciphergen Biosystems, Inc. and Bio-Rad Laboratories, Inc. dated August 14, 2006. | |
3.2(4)
|
Amended and Restated Certificate of Incorporation of Registrant | |
3.4(4)
|
Amended and Restated Bylaws of Registrant | |
3.5(5)
|
Certificate of Designation of Rights, Preferences and Privileges of Series A Participating Preferred Stock of Ciphergen Biosystems, Inc. | |
4.1(4)
|
Form of Registrants Common Stock Certificate | |
4.2(5)
|
Preferred Shares Rights Agreement dated March 20, 2002 between Ciphergen Biosystems, Inc. and Continental Stock Transfer & Trust Company | |
4.3(6)
|
Indenture between Ciphergen Biosystems, Inc. and U.S. Bank National Association dated August 22, 2003 | |
4.4(7)
|
Amendment to Rights Agreement between the Company and Wells Fargo Bank, N.A. dated July 22, 2005 | |
4.5(8)
|
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 September 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 our Form 8-K filed with the Securities and Exchange Commission on November 13, 2006. | |
(4) | 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. | |
(5) | Incorporated by reference to our Registration Statement on Form 8-A filed with the Securities and Exchange Commission on March 21, 2002. | |
(6) | Incorporated by reference to our Registration Statement on Form S-3 filed with the Securities and Exchange Commission on October 8, 2003. | |
(7) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on July 28, 2005. | |
(8) | Incorporated by reference to our Form 8-K filed with the Securities and Exchange Commission on October 4, 2005. |
32