þ | Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. |
o | Transition Report under Section 13 or 15(d) of the Securities Exchange Act of 1934. |
Delaware | 33-0595156 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
6611 Dumbarton Circle, Fremont, California | 94555 | |
(Address of principal executive offices) | (Zip Code) |
Page | ||||||||
1 | ||||||||
2 | ||||||||
3 | ||||||||
4 | ||||||||
5 | ||||||||
18 | ||||||||
29 | ||||||||
30 | ||||||||
|
||||||||
31 | ||||||||
31 | ||||||||
40 | ||||||||
40 | ||||||||
40 | ||||||||
40 | ||||||||
41 | ||||||||
47 | ||||||||
EXHIBIT 10.6 | ||||||||
EXHIBIT 10.51 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.0 |
- 1 -
- 2 -
- 3 -
- 4 -
- 5 -
- 6 -
- 7 -
- 8 -
- 9 -
- 10 -
- 11 -
- 12 -
- 13 -
- 14 -
- 15 -
- 16 -
- 17 -
- 18 -
- 19 -
- 20 -
- 21 -
- 22 -
- 23 -
- 24 -
- 25 -
- 26 -
- 27 -
- 28 -
- 29 -
- 30 -
(Unaudited)
September 30,
December 31,
2007
2006
$
19,498
$
17,711
4,000
29
1,101
2,300
24,599
20,040
1,613
2,260
655
716
$
26,867
$
23,016
$
2,177
$
2,401
3,863
4,600
31
45
2,460
8,531
7,046
10,000
7,083
16,150
18,428
278
360
34,959
32,917
64
39
227,796
207,991
(235,850
)
(217,860
)
(102
)
(71
)
(8,092
)
(9,901
)
$
26,867
$
23,016
Table of Contents
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2007
2006
2007
2006
$
$
2,697
$
$
10,702
1,965
21
6,297
4,662
21
16,999
1,571
5,714
910
15
3,118
2,481
15
8,832
2,181
6
8,167
2,182
2,914
6,297
8,780
516
3,204
1,440
10,652
2,090
2,541
8,626
7,549
4,788
8,659
16,363
26,981
(382
)
(4,788
)
(6,478
)
(16,739
)
(18,814
)
169
190
458
654
(596
)
(592
)
(1,727
)
(1,691
)
95
(116
)
17
(174
)
(5,120
)
(6,996
)
(17,991
)
(20,025
)
3
(20
)
1
(190
)
$
(5,117
)
$
(7,016
)
$
(17,990
)
$
(20,215
)
$
(0.11
)
$
(0.19
)
$
(0.43
)
$
(0.56
)
48,056,582
36,075,163
42,214,245
36,041,625
Table of Contents
(Unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Accumulated
Comprehensive
Stockholders
Comprehensive
Shares
Amount
Capital
Deficit
Loss
(1)
Equity (Deficit)
Loss
35,998,881
$
36
$
202,485
$
(195,794
)
$
(204
)
$
6,523
(20,215
)
(20,215
)
$
(20,215
)
128
128
128
$
(20,087
)
1,670
2
2
75,886
100
100
1,338
1,338
36,076,437
$
36
$
203,925
$
(216,009
)
$
(76
)
$
(12,124
)
39,220,437
$
39
$
207,991
$
(217,860
)
$
(71
)
$
(9,901
)
(17,990
)
(17,990
)
$
(17,990
)
(31
)
(31
)
(31
)
$
(18,021
)
20,312
24
24
23,093
21
21
24,513,092
25
19,076
19,101
684
684
63,776,934
$
64
$
227,796
$
(235,850
)
$
(102
)
$
(8,092
)
(1)
Accumulated Other Comprehensive Loss arises solely from foreign currency cumulative
translation adjustment.
Table of Contents
(Unaudited)
Nine Months Ended
September 30,
2007
2006
$
(17,990
)
$
(20,215
)
382
882
3,551
684
1,338
182
399
54
279
(5
)
29
1,898
848
(779
)
1,445
19
95
(1,004
)
(2,317
)
(14
)
(760
)
(82
)
(187
)
(16,010
)
(15,258
)
(235
)
(881
)
2,245
(4,000
)
(346
)
(4,235
)
1,018
24
21
100
19,101
2,917
3,749
(13
)
(376
)
22,063
3,460
(31
)
66
1,787
(10,714
)
17,711
25,738
$
19,498
$
15,024
$
1,603
$
1,595
197
7
$
$
100
1
Table of Contents
1.
Organization, Basis of Presentation and Summary of Significant Accounting and Reporting
Policies
The Company
At the annual stockholders meeting on June 29, 2007, the stockholders approved an amendment to the
Certificate of Incorporation to change the name of the company from Ciphergen Biosystems, Inc. to
Vermillion, Inc. (Vermillion; Vermillion and its wholly-owned subsidiaries are collectively
referred to as the Company). The name change represented the transition of the Company from its
historical roots as a proteomics research products business to a specialty diagnostic testing
business. On August 21, 2007, the Company amended its Certificate of Incorporation to reflect the
name change.
Prior to the November 13, 2006, sale of assets and liabilities of the Companys protein research
products and collaborative services business (the Instrument Business) to Bio-Rad Laboratories,
Inc. (Bio-Rad), the Company developed, manufactured and sold ProteinChip Systems for life science
research. This patented technology is recognized as Surface Enhanced Laser Desorption/Ionization
(SELDI). The systems consist of ProteinChip Readers, ProteinChip Software and related
accessories, which were used in conjunction with consumable ProteinChip Arrays. These products
were sold primarily to pharmaceutical companies, biotechnology companies, academic research
laboratories and government research laboratories. The Company also provided research services
through its Biomarker Discovery Center laboratories, and offered consulting services, customer
support services and training classes to its customers and collaborators. As a result of the sale
of assets and liabilities of the Companys Instrument Business to Bio-Rad on November 13, 2006, the
Company does not expect to generate substantial revenues until certain diagnostic tests are cleared
by the United States Food and Drug Administration (the FDA) and commercialized.
Since the sale of assets and liabilities of the Companys Instrument Business to Bio-Rad, the
Company has dedicated itself to the discovery, development and commercialization of specialty
diagnostic tests that provide physicians with information with which to manage their patients care
and to improve patient outcomes. The Company uses translational proteomics, which is the process
of answering clinical questions by utilizing advanced protein separation methods, to identify and
resolve variants of specific biomarkers, develop assays and commercialize diagnostic tests.
The Company has incurred significant net losses and negative cash flows from operations since
inception. At September 30, 2007, the Company had an accumulated deficit of $235,850,000. After
completing the private placement sale of securities on August 29, 2007, management (we, us or
our) believes the Companys current available resources will be sufficient to maintain current
and planned operations through the next twelve months. The Company will, however, be required to
raise additional capital at some point in the future. At such time the Company requires additional
funding, the Company may seek to raise such additional funding from various 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 securities or securities convertible
into equity, stockholders will experience dilution, and such securities may have rights,
preferences or privileges senior to those of the holders of common stock or convertible senior
notes. If the Company obtains additional funds through arrangements with collaborators or
strategic partners, the Company 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 the Company is unable to
obtain financing on acceptable terms, we may be unable to execute our business plan, the Company
could be required to delay or reduce the scope of its operations, and the Company may not be able
to pay off the convertible senior notes if and when they come due.
Basis of Presentation
The unaudited consolidated financial statements of the Company have been prepared in accordance
with accounting principles generally accepted in the United States of America (GAAP) for interim
financial statements and the instructions to Form 10-Q pursuant to Rule 10-01,
Interim Financial
Statements
, of Regulation S-X promulgated by
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
the Securities and Exchange Commission (the SEC).
Accordingly, the unaudited consolidated financial statements do not include all of the disclosures
required by GAAP for complete financial statements. The December 31, 2006, consolidated balance
sheet was derived from audited consolidated financial statements, but does not include all
disclosures required by GAAP. The unaudited consolidated financial statements 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, 2006, filed with
the SEC on April 2, 2007.
In the opinion of management, the unaudited consolidated financial statements contain all
adjustments consisting only of a normal and recurring nature, which are considered necessary for a
fair presentation of the financial condition and results of operations for such periods. The
accompanying unaudited consolidated financial statements include the accounts of the Company. 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.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimated results.
Income Taxes
On January 1, 2007, the Company adopted Financial Accounting Standards Board (the FASB)
Interpretation No. (FIN) 48,
Accounting for Uncertainty in Income Taxes an Interpretation of
FASB Statement No. 109
, which clarifies the accounting for income tax uncertainties that have been
recognized in an enterprises financial statements in accordance with Statement of Financial Accounting Standards (SFAS) No. 109,
Accounting for
Income Taxe
s. The cumulative effect of adopting FIN 48 on January 1, 2007, resulted in no
liability under FIN 48 on the balance sheet. There are open statutes of limitations for taxing
authorities to audit the Company for federal and state jurisdictions from the year 2003 through the
current period. Since the Company had a full valuation on all the deferred tax assets, FIN 48 had
no impact on the Companys effective tax rate. The Company is evaluating the net operating loss
carryforwards, and research and development deferred tax assets to determine whether there is a
limit due to prior year ownership changes. It is possible that a portion of these deferred tax
assets may be limited in their use. The Company expects to complete the studies by the end of
2007.
The Company accounts for income taxes using the liability method. Under this method, deferred tax
assets and liabilities are determined based on the difference between the financial statement and
the tax bases of assets and liabilities using enacted tax rates in effect for the year in which the
differences are expected to affect taxable income. A valuation allowance is established when
necessary to reduce deferred tax assets to the amounts expected to be realized. Interest and
penalties related to income taxes are recorded to interest and other expense of the consolidated
statement of operations.
2.
Recent Accounting Pronouncements
Fair Value Option for Financial Assets and Financial Liabilities
In February 2007, the FASB issued SFAS No. 159,
The
Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of FASB
Statement No. 115
.
SFAS No. 159 provides entities with an option to report selected financial assets and liabilities
at fair value. Unrealized gains and losses on items for which the fair value option has been
elected are reported in earnings.
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
SFAS No. 159 is effective for fiscal years beginning after
November 15, 2007. The Companys adoption of SFAS No. 159 is not expected to have a material
impact on its consolidated financial statements.
Fair Value Measurements
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements
. SFAS No. 157 defines
fair value, establishes a framework for measuring fair value and expands disclosures about fair
value measurements. SFAS No. 157 clarifies the principle that fair value should be based on the
assumptions market participants would use when pricing an asset or liability and establishes a fair
value hierarchy that prioritizes the information used to develop those assumptions. Under the
standard, fair value measurements would be separately disclosed by level within the fair value
hierarchy. The provisions of SFAS No. 157 are effective for fiscal years beginning after November
15, 2007, and interim periods within those fiscal years, with early adoption permitted. The
Companys adoption of SFAS No. 157 is not expected to have a material impact on its consolidated
financial statements.
3.
Strategic Alliance with Quest Diagnostics Incorporated
On July 22, 2005, Vermillion and Quest Diagnostics Incorporated (Quest) entered into a strategic
alliance agreement, which focuses on commercializing up to three assays chosen from Vermillions
pipeline. The term of the agreement ends on the later of (i) the three-year anniversary of the
agreement and (ii) the date on which Quest commercializes the three diagnostic tests covered by
such agreement. Pursuant to the agreement, Quest will have the non-exclusive right to
commercialize these tests on a worldwide basis, with exclusive commercialization rights in
territories where Quest 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 will pay royalties to Vermillion based on fees earned by Quest for applicable diagnostics
services, and Vermillion will pay royalties to Quest based on Vermillions revenue from applicable
diagnostics products. To date, no such royalties have been earned by either party.
Quest also agreed to provide Vermillion with a $10,000,000 secured line of credit, which is
collateralized by certain intellectual property of Vermillion, that may only be used for certain
costs and expenses directly related to the strategic alliance. Under the terms of this secured
line of credit, the interest rate is at the prime rate plus 0.5% and is payable monthly.
Additionally, this secured line of credit contain provisions for Quest to forgive portions of the
amounts borrowed that corresponds to Vermillions achievement of certain milestones related to
development, regulatory approval and commercialization of certain diagnostic tests. The amounts to
be forgiven and the corresponding milestones that Vermillion must achieve are (i) $1,000,000 for
each application that allows a licensed laboratory test to be commercialized with a maximum of
$3,000,000 for three applications that allows a licensed laboratory test to be commercialized; (ii)
$3,000,000 for the commercialization of the first diagnostic test kit; and (iii) $2,000,000 for
each subsequent commercialization of diagnostic test kits with a maximum of $4,000,000 for two
subsequent commercialization of diagnostic test kits. Should Vermillion fail to achieve these
milestones, it would be responsible for the repayment of the outstanding principal amount and any
unpaid interest on the secured line of credit on or before July 22, 2010. Vermillion has drawn on
this secured line of credit in monthly increments of $417,000 on the last day of each month during
the first two years of the strategic alliance. As of September 30, 2007, and December 31, 2006,
Vermillion has drawn $10,000,000 and $7,083,000, respectively, from this secured line of credit.
From the inception of the strategic alliance through September 30, 2007, the Company had spent
$10,000,000 of the amounts drawn on in-house research and development, as well as collaborations
with others, directed towards achieving the milestones.
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
4.
Short-Term Investments
Short-term investments available-for-sale are carried at fair value based on quoted market prices.
The Company has no unrealized holding gains or losses based on the market value of the auction rate
preferred securities at September 30, 2007. Short-term investments available-for-sale consist of
the following at September 30, 2007 (in thousands):
Gross
Gross
Amortized
Unrealized
Unrealized
Market
Cost
Gain
Loss
Value
$
4,000
$
$
$
4,000
The scheduled maturity dates for short-term investments available for sale at September 30, 2007,
are as follows (in thousands):
After 1 Year
After 5 Year
Within
Through
Through
After
1 Year
5 Years
10 Years
10 Years
Total
$
4,000
$
$
$
$
4,000
5.
Receivables from and Payables to Bio-Rad
In connection with the sale of assets and liabilities of the Companys Instrument Business on
November 13, 2006, Bio-Rad withheld $2,000,000 from the sales proceeds until the issuance of a
reexamination certificate confirming United States Patent No. 6,734,022 (the 022 Patent). If the
United States Patent and Trademark Office (the USPTO) does not issue a reexamination certificate
confirming the patentability of all of the claims as originally issued in the 022 Patent, or claims
of equivalent scope, the Company will not be entitled to receive the $2,000,000 withheld by
Bio-Rad. The 022 Patent is directed to a fundamental process of SELDI that involves capturing an
analyte from a sample on the surface of a mass spectrometry probe derivatized with an affinity
reagent, applying matrix and detecting the captured analyte by laser desorption mass spectrometry.
In March 2007, the USPTO issued a final office action in the reexamination, rejecting all of the
claims of the 022 Patent. Although the office action was designated final, Vermillion, under the
USPTO rules, advocated the outstanding rejections and the patentability of the claimed invention
with the patent examiners on March 30, 2007, and April 11, 2007. In addition, on April 18, 2007,
Vermillion filed a response to the final office action with the USPTO. On June 28, 2007, the USPTO
sent to Vermillion a notice of intent to issue a reexamination certificate of the 022 Patent (see
further discussion in Note 13 Subsequent Event).
Subsequent to the sale of assets and liabilities of the Companys Instrument Business to Bio-Rad on
November 13, 2006, both the Company and Bio-Rad recognized business activities on behalf of each
other. As of September 30, 2007, the Company owed Bio-Rad $20,000 for accounts receivable the
Company collected on behalf of Bio-Rad. Similarly, Bio-Rad owed the Company $128,000, which
consisted of $83,000 of invoices processed and paid by the Company on behalf of Bio-Rad and $45,000
for Bio-Rads portion of expenses related to facilities shared by the Company. Subsequent to
September 30, 2007, the Company made no payments towards the $20,000 owed to Bio-Rad, and collected
$45,000 related to the $128,000 owed by Bio-Rad. As of December 31, 2006, the Company owed Bio-Rad
$1,571,000, which consisted of $1,511,000 for accounts receivable the Company collected on behalf
of Bio-Rad, $8,000 for invoices processed by Bio-Rad on behalf of the Company and $52,000 for
services Bio-Rad provided to the Company. Similarly, Bio-Rad owed the Company $619,000, which
consisted of $174,000 for invoices processed by the Company on behalf of Bio-Rad, $200,000 for
sales taxes on the sale of assets and $245,000 for unbilled receivables from Bio-Rad. Subsequent
to December 31, 2006, the Company paid the $1,571,000 owed to Bio-Rad, and collected the $619,000
owed by Bio-Rad. Additionally, for the nine months ended September 30, 2007, the Company recorded
a charge of $382,000 related to a post-closing adjustment resulting from the sale of assets and
liabilities of the Companys Instrument Business to Bio-Rad.
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
Additionally, as of September 30, 2007, the Company owed Bio-Rad $192,000 for laboratory supplies.
Subsequent to September 30, 2007, the Company paid $160,000 related to the $192,000 owed to
Bio-Rad.
6.
Warranties and Maintenance Contracts
Prior to the sale of assets and liabilities of the Companys Instrument Business to Bio-Rad on
November 13, 2006, the Company had product warranty activities and obligations to provide services
for its products. The Company generally included a standard 12-month warranty on its ProteinChip
Systems and certain accessories upon initial sale, after which maintenance and support was
available under a separately priced contract or on an individual call basis. The Company also sold
separately priced maintenance (extended warranty) contracts, which were generally for 12 or 24
months, upon expiration of the initial 12-month warranty. Coverage under both the standard and
extended maintenance contracts was identical. Revenue for both the standard and extended
maintenance contracts was deferred and recognized on a straight-line basis over the period of the
applicable maintenance contract. Related costs were recognized as incurred.
For the three and nine months ended September 30, 2007, the Company had no product warranty
obligations or activity, as all warranty obligations were assumed by Bio-Rad as of November 13,
2006. Changes in product warranty obligations, including separately priced maintenance
obligations, for the three and nine months ended September 30, 2006, were as follows (in
thousands):
Three Months
Nine Months
Ended
Ended
September 30,
September 30,
2006
2006
$
2,748
$
2,831
509
1,687
851
3,067
(509
)
(1,687
)
(1,138
)
(3,437
)
$
2,461
$
2,461
7.
Long-Term Debt
7.00% Convertible Senior Notes Due 2011
On November 15, 2006, the Company closed the sale of $16,500,000 of convertible senior notes due
September 1, 2011 (the New Notes). Offering costs were $104,000 and fees of $514,500, which were
paid on behalf of the debt holders, were recorded as debt discount on the New Notes. Fees paid on
behalf of debt holders included the fair value of two warrants issued to underwriters to purchase a
total of 200,000 shares of common stock at $1.26 per share. The warrant was valued at
approximately $140,000 based on the fair value as determined by a Black-Scholes model using the
following assumptions: a risk free interest rate of 4.75%, 5 year contractual life, and 88%
volatility rate. Interest on the New Notes is 7.00% per annum on the principal amount, payable
semiannually on March 1 and September 1 of each year, beginning March 1, 2007. The New Notes were
sold pursuant to separate exchange and redemption agreements between the Company and each of
Highbridge International LLC, Deerfield International Limited, Deerfield Partners, L.P., Bruce
Funds, Inc. and Professional Life & Casualty, each holders of the Companys existing 4.50%
convertible senior notes due September 1, 2008 (the Old Notes), pursuant to which holders of an
aggregate of $27,500,000 of the Old Notes agreed to exchange and redeem their Old Notes for an
aggregate of $16,500,000 in aggregate principal amount of the New Notes and $11,000,000 in cash,
plus accrued and unpaid interest on the Old Notes of $254,000 through and including the day prior
to the Closing. The transaction was treated as a debt extinguishment and accordingly, $613,000 of
unamortized prepaid offering costs
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
and $868,000 of unamortized debt discount related to the Old Notes were charged to expense as loss
on extinguishment of debt. Offering costs and debt discount related to the New Notes will be
amortized to interest expense using the effective interest method. Amortization expense in 2006
for the New Notes was $15,000.
The Company issued the New Notes pursuant to an indenture, dated November 15, 2006, between the
Company and U.S. Bank National Association, as Trustee. Following the Closing, $2,500,000 in
aggregate principal amount of the Old Notes remain outstanding.
The New Notes are unsecured senior indebtedness of the Company and bear interest at the rate of
7.00% per annum, which may be reduced to 4.00% per annum if the Company receives approval or
clearance for commercial sale of any of its ovarian cancer tests by the FDA. Interest is payable
on March 1 and September 1 of each year, commencing March 1, 2007. The effective interest rate is
7.13% per annum.
The New Notes are convertible at the option of each Holder, at any time on or prior to the close of
business on the business day immediately preceding September 1, 2011, into shares of the Companys
common stock at a conversion price of $2.00 per share, equivalent to a conversion rate equal to 500
shares of common stock per $1,000 principal of the New Notes, subject to adjustment for standard
anti-dilution provisions including distributions to common stockholders and stock splits as well as
occurrence of a change in control, in which case the conversion rate is adjusted for a make-whole
premium.
The make-whole premium shall be equal to the principal amount of New Notes to be converted divided
by $1,000 and multiplied by the applicable number of shares of common stock based upon the
Companys share prices as of the change of control date. Specifically, as the New Notes approach
their redemption date of September 2009, as discussed below, the make-whole payment decreases. The
Company is not required to make a make-whole payment if the Companys stock price is less than
$1.20 or greater than $8.00 as of the date of the change in control. The make-whole premium
associated with the New Note sets a maximum additional 15,000,001 shares that may be issued on
conversion (909.091 shares per $1,000 principal amount of New Notes).
If a holder converts all or any portion of their New Notes prior to October 31, 2008, upon such
conversion, in addition to the common stock such holder would receive, the holder will be entitled
to receive with respect to each New Note so converted an amount in cash equal to the difference of
(i) the amount of all interest that the Company would be required to pay on such New Note from the
date of the indenture through October 31, 2008, and (ii) the amount of interest actually paid on
such New Note by the Company prior to the time of conversion.
Holders of the New Notes have the option to require the Company to repurchase the New Notes under
certain circumstances, including at any time after September 1, 2009, if the Company has not
received approval or clearance for commercial sale of any of its ovarian cancer test by the FDA.
The Company may redeem the New Notes at its option, in whole or in part, at any time on or after
September 1, 2009, at specified redemption prices plus accrued and unpaid interest; provided that
the New Notes will be redeemable only if the closing price of the stock equals or exceeds 200.0% of the conversion price then in effect for at least 20 trading days within a period
of 30 consecutive trading days ending on the trading day before the date of the notice of the
optional redemption. The 8,250,000 shares that could be issued if all New Notes were converted
into common stock have not been included in the calculation of loss per share, as these potential
common shares are antidilutive. Upon a change of control, each holder of the New Notes may require
the Company to repurchase some or all of the New Notes at specified redemption prices, plus accrued
and unpaid interest. The debenture contains a put option that entitles the holder to require the
Company to redeem the New Note at a price equal to 105.0% of the principal balance upon a change in
control of the Company.
The Company identified the guaranteed interest payment for any conversion of any New Note by a
holder prior to October 31, 2008, and the written put option permitting the holder to put the debt
at 105.0% of principal plus accrued and unpaid interest upon a change of control as a compound
embedded derivative, which needs to be separated and measured at its fair value. The factors
impacting the fair value of the guaranteed interest payment for
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
any conversion of any New Note by a holder prior to October 31, 2008, is based upon certain factors
including the Companys stock price, the time value of money and the likelihood holders would
convert within the next two years. However, due to the Companys current stock price at the date
of New Note issuance and through December 31, 2006, resulting in the conversion feature being
substantially out of the money, the likelihood of conversion was deemed to be remote. The factors
impacting the fair value of the written put option permitting the holder to put the New Note at
105.0% of principal plus accrued and unpaid interest upon a change of control, is contingent upon a
change of control. However, due to significant related party holdings of the Companys common
stock shares and the presence of certain anti-takeover provisions in the bylaws of the Company, a
change of control is deemed to be remote. When the fair values of these two features are combined,
the fair value of the compound embedded derivative had de minimis fair value on the date of
inception and on December 31, 2006.
The Company and the investors entered into a registration rights agreement in which the Company
agrees to make reasonable best efforts to file a shelf registration and keep it effective
permitting the New Note holders to sell the New Notes or the underlying common stock shares. In
the circumstance of a failed registration, the Company agrees to pay interest as partial relief for
the damages (Liquidated Damages) until the earlier of (1) the day on which the Registration
Default has been cured and (2) the date the Shelf Registration Statement is no longer required to
be kept effective, in an amount in cash equal to 1.5% of the aggregate outstanding principal amount
of the New Notes until such Registration Default is cured; provided that in no event shall
Liquidated Damages exceed 10.0% of the holders initial investment in the New Notes in the
aggregate.
The Company evaluated the Liquidated Damages according to guidance under FASB Staff Position No.
Emerging Issues Task Force (FSP EITF) 00-19-2,
Accounting for Registration Payment Arrangements
, which specifies that
the contingent obligation to make future payments or otherwise transfer consideration under a
registration payment arrangement, whether issued as a separate agreement or included as a provision
of a financial instrument or other agreement, shall be recognized and measured separately in
accordance with SFAS No. 5,
Accounting for Contingencies
, and FIN 14,
Reasonable Estimation of the Amount of a Loss
. FSP EITF 00-19-2 further states that an entity
should recognize and measure a registration payment arrangement as a separate unit of account from
the financial instrument subject to that arrangement. Accordingly, the Company concluded that the
transfer of consideration under a registration payment arrangement is not probable at the time of
inception or December 31, 2006. Therefore a contingent liability under the registration payment
arrangement was not recognized.
The New Notes and common stock issuable upon conversion of the New Notes were registered with the
SEC on Form S-3 on December 15, 2006, and at December 31, 2006, all New Notes remained issued and
outstanding
8.
Commitments and Contingent Liabilities
Commitments
On November 17, 2000, the Company originally entered into a five-year research collaboration
agreement with The Johns Hopkins University School of Medicine (JHU), which expired on
November 30, 2005. The research collaboration agreement was directed at the discovery and
validation of biomarkers in human subjects, including but not limited to clinical application of
biomarkers in the understanding, diagnosis and management of human diseases. Since the expiration
on November 30, 2005, the Company had extended the research collaboration agreement with JHU on
a quarterly basis. Most recently, on September 26, 2007, the Company extended the research
collaboration agreement with JHU through December 31, 2007, while continuing to negotiate a renewal
collaboration agreement. Under the renewal collaboration agreement, it is anticipated that
Vermillion will have an obligation to provide additional noncancelable collaboration funding of
$600,000 for 2007 in addition to $73,000 owed for 2006. Under an extended research collaboration
agreement with an expiration date of December 31, 2006, Vermillion had an outstanding obligation to
pay $305,000. Subsequently, under an extended research collaboration agreement with an expiration
date of March 31, 2007, the outstanding 2006 obligation of $305,000 was reduced to $73,000 during
the three months ended March 31, 2007. For the nine months ended September 30, 2007, Vermillion
paid $373,000 of collaboration expenses and as of September 30, 2007, Vermillion accrued $150,000
for collaboration expenses to
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
JHU. Collaboration costs related to this agreement were $150,000 and $218,000 for the three and
nine months ended September 30, 2007, respectively, which reflects the $232,000 reduction in
collaboration costs resulting from the extended collaboration agreement through September 30, 2007.
Collaboration costs related to this agreement were $241,000 and $723,000 for the three and nine
months ended September 30, 2006, respectively.
On September 22, 2005, the Company entered into a two year collaborative research agreement with
University College London and UCL Biomedica Plc (together, UCL), which expired on September 30,
2007. The collaborative research agreement was directed at the utilization of Vermillions suite
of proteomic solutions (Deep Proteome, Pattern Track Process and ProteinChip System) to further
both parties ongoing research in ovarian cancer and breast cancer. Under the terms of the
agreement, Vermillion had exclusive rights to license intellectual property resulting from
discoveries made during the course of this collaboration for use in developing, manufacturing and
commercializing products and services utilizing the intellectual property. Additionally,
Vermillion had an obligation to contribute $2,131,000 in cash and $652,000 in the form of
Vermillion equipment, software, arrays and consumable supplies as mutually agreed, valued at
Vermillions list selling price, to cover part of the costs incurred by UCL specifically for this
research program. $1,065,000 of the cash obligation was to be paid in the first year of the
agreement and is noncancelable. The remaining $1,066,000 was to be paid in the second year of the
agreement and was cancelable with three months advance notice. As of September 30, 2007, the
Company had made cash contributions of $1,603,000 and accrued $567,000 related to this agreement.
Additionally, the Company provided at its cost $112,000, or $546,000 valued at Vermillions list
selling price, of equipment, software, arrays and consumable supplies. Collaboration costs, which
are included in research and development expenses, related to this agreement were $285,000 and
$832,000 for the three and nine months ended September 30, 2007, respectively, and $272,000 and
$798,000 for the three and nine months ended September 30, 2006, respectively.
On October 4, 2006, the Company entered into a one-year research and development agreement, which
has automatic renewals for two additional one-year terms, with Katholieke Universiteit Leuven,
Belgium, directed at discovery, validation and characterization of novel biomarkers related to
gynecologic disease. Under the terms of the agreement, Vermillion will have exclusive rights to
license discoveries made during the course of this collaboration. Vermillion will contribute
45,000 or $61,000 per year to fund sample collection at the Katholieke Universiteit Leuven from
patients undergoing evaluation of a persistent pelvic mass who will undergo surgical intervention.
The first year contribution of 45,000 or $61,000 is noncancelable. As of September 30, 2007,
the Company has paid $61,000 related to this agreement. Collaboration costs related to this
agreement were $15,000 and $61,000 for the three and nine months ended September 30, 2007,
respectively.
On October 13, 2006, the Company entered into a two-year research and collaboration agreement,
which has automatic renewals of additional one-year terms, with The Ohio State University Research
Foundation (OSURF) directed at discovery, purification, identification and/or validation of
biomarkers related to thrombotic thrombocytopenic purpura (TTP) and production of associated
technology. Under the terms of the agreement, Vermillion has an option to take an exclusive
license to discoveries made during the course of this collaboration. During the first fifteen
months of the agreement, Vermillion will pay a total of $150,000 in noncancelable financial
contributions to OSURF in consideration for costs incurred specifically for this research program.
There is no financial contribution obligation for the remaining initial term of the agreement. As
of September 30, 2007, the Company has paid $94,000 and accrued $34,000 related to this agreement.
Collaboration costs related to this agreement were $90,000 for the nine months ended September 30,
2007. The Company did not incur collaboration costs related to this agreement during the three
months ended September 30, 2007.
On December 11, 2006, Vermillion entered into a consulting agreement with PrecisionMed
International (PrecisionMed), which was subsequently amended on April 5, 2007. Under the terms
of the amended agreement, PrecisionMed will collect whole blood specimens from up to 1,000 research
subjects for the purposes of Vermillions whole blood collection protocol for its OvaRI Assay
clinical trial. The amended agreement provides for a maximum payment of $1,335,000 for 500
research subjects and a maximum payment of $1,788,000 for 1,000 research subjects. As of
September 30, 2007, Vermillion has paid a total of $1,103,000, including travel expenses of
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
$50,000, and accrued $329,000 related to this amended agreement. These costs, which are included
in research and development expenses, related to this agreement were $488,000 and $1,288,000 for
the three and nine months ended September 30, 2007, respectively.
On June 1, 2007, Vermillion entered into a nonexclusive license agreement with the National
Cardiovascular Center (NCVC), an entity organized and existing under the laws of Japan. Under
this agreement, Vermillion obtained a ten-year worldwide nonexclusive license with the right to
extend the term for the life of the licensed patent, which includes a United States Patent
Application, a Japan Patent and a Patent Cooperation Treaty (PCT) Application, for technology
used in our TTP diagnostic test kit that is under development. Under this agreement, Vermillion
will pay NCVC a non-refundable license fee of $50,000. The payment terms are $20,000 upon
execution of this agreement, $10,000 upon submission of an in vitro diagnostic test to the FDA for
clearance, $10,000 upon the first commercial sale of such in vitro diagnostic test kit and $10,000
upon achievement of $500,000 in net sales of such in vitro diagnostic test kits. Additionally,
Vermillion will pay royalties to NCVC for net sales to customers located in the United Sates,
Japan, Europe and China. As of September 30, 2007, Vermillion has paid $20,000 related to the
execution of this agreement.
In conjunction with the sale of assets and liabilities of the Companys Instrument Business on
November 13, 2006, Vermillion also entered into a manufacture and supply agreement with Bio-Rad.
Under the terms of the manufacture and supply agreement, Vermillion has a commitment to purchase 10
systems and 30,000 arrays in the first year, 13 systems and 30,000 arrays in the second year and 20
systems and 30,000 arrays for the third year in order to support its collaboration agreements with
Quest, which may be used as inventory for resale, fixed assets for collaboration purposes or
supplies for research and development. The Company has estimated cost to be $63,000 per system and
$20 per array. As of September 30, 2007, the Company had purchased and expensed $212,000 of
arrays.
Contingent Liabilities
On September 17, 2007, Vermillion was served with a complaint filed in the Superior Court of
California for the County of Santa Clara naming Vermillion and Bio-Rad as defendants and Molecular
Analytical Systems (MAS) as plaintiff. The complaint alleges, among other things, that
Vermillion is in breach of its license agreement with MAS relating to SELDI technology as a result
of Vermillions entry into a sublicense agreement with Bio-Rad. In connection with the sale of
assets and liabilities of the Companys Instrument Business to Bio-Rad, Vermillion sublicensed to
Bio-Rad certain rights to the SELDI technology that Vermillion obtained under the MAS license for
use outside of the clinical diagnostics field. Vermillion retained exclusive rights to the
technology for use in the field of clinical diagnostics for a five-year period, after which it will
retain nonexclusive rights in that field. Given the early stage of this action, we cannot predict
the ultimate outcome of this matter at this time.
On June 26, 2006, Health Discovery Corporation filed a lawsuit against Vermillion in the United
States District Court for the Eastern District of Texas, Marshall Division (the Court), claiming
that software used in certain of Vermillions ProteinChip Systems infringes on three of its United
States patents. Health Discovery Corporation sought injunctive relief as well as unspecified
compensatory and enhanced damages, reasonable attorneys fees, prejudgment interest and other
costs. On August 1, 2006, Vermillion filed an unopposed motion with the Court to extend the
deadline for Vermillion to answer or otherwise respond until September 2, 2006. Vermillion filed
its answer and counterclaim to the complaint with the Court on September 1, 2006. Concurrent with
its answer and counterclaims, Vermillion filed a motion to transfer the case to the Northern
District of California. On January 10, 2007, the court granted Vermillions motion to transfer the
case to the Northern District of California. The parties met for a scheduled mediation on May 7,
2007. On July 10, 2007, Vermillion entered into a license and settlement agreement with Health
Discovery Corporation (the HDC Agreement) pursuant to which it licensed more than 25 patents
covering Health Discovery Corporations support vector machine technology for use with SELDI
technology. Under the terms of the HDC Agreement, Vermillion receives a worldwide, royalty-free,
non-exclusive license for life sciences and diagnostic applications of the technology and has
access to any future patents resulting from the underlying intellectual property in conjunction
with use of SELDI systems. Pursuant to the HDC
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
Agreement, Vermillion paid $200,000 to Health Discovery Corporation upon entry into the agreement
on July 10, 2007. The remaining $400,000 under the HDC agreement is payable as follows: $100,000
three months following the date of the agreement, $150,000 twelve months following the date of the
agreement and $150,000 twenty-four months following the date of the agreement. The total
settlement of $600,000 was expensed for nine months ended September 30, 2007. The HDC Agreement
settles all disputes between Vermillion and Health Discovery Corporation.
9.
Common Stock
Authorized Shares
At the annual stockholders meeting on June 29, 2007, the stockholders approved an amendment to the
Certificate of Incorporation to increase the number of authorized shares of common stock from
80,000,000 to 150,000,000. On July 13, 2007, the Company amended and restated its Certificate of
Incorporation with the State of Delaware for the increased authorized shares.
Private Placement Sale
On August 29, 2007 (the Closing Date), Vermillion completed a private placement sale of
24,513,092 shares of its common stock and warrants to purchase up to an additional 19,610,470
shares of its common stock with an exercise price of $0.925 per share and expiration date of
August 29, 2012, to a group of new and existing investors for $20,591,000 in gross proceeds. The
net proceeds of the transaction will be used for general working capital needs. Existing investors
included affiliates of the Company, who purchased 9,642,856 shares of common stock and warrants to
purchase up to an additional 7,714,284 shares of common stock for $8,100,000. In connection with
Quests participation in this transaction, Vermillion amended a warrant originally issued to Quest
on July 22, 2005. Pursuant to the terms of the amendment, the exercise price for the purchase of
Vermillions common stock was reduced from $3.50 per share to $2.50 per share and the expiration
date of such warrant was extended from July 22, 2010, to July 22, 2011. For services as placement
agent, Vermillion paid Oppenheimer & Co. Inc. (Oppenheimer) $1,200,000 and issued a warrant to
purchase up to 921,000 shares of Vermillions common stock with an exercise price of $0.925 per
share and expiration date of August 29, 2012. The warrants issued to the investors and Oppenheimer
were valued at $7,194,000 and $581,000, respectively, based on the fair value as determined by the
Black-Scholes model. The amended value of the warrant issued to Quest on July 22, 2005, increased
by $356,000, which is reflected in additional paid-in capital. Assumptions used to value the
warrants issued to the investors and Oppenheimer, and the amended value of the warrant issued to
Quest were as follows:
Private
Amendment to
Investors and
Quest
Oppenheimer
Diagnostics
& Co. Inc.
Incorporated
0.00
%
0.00
%
80.14
%
82.92
%
4.31
%
4.24
%
5.00
3.90
Under the terms of the securities purchase agreement, the Company is required to prepare and file
with the SEC a Shelf Registration Statement and have the Registration Statement be declared
effective by the SEC. The Company shall pay each investor liquidated damages of 1/13 of 1.5% of
the aggregate purchase price with respect to any shares not previously sold or transferred for the
following events:
Each day in excess of 30 days from the Closing
Date until the Shelf Registration Statement is filed with the SEC.
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
Each day in excess of 90 days
from the Closing Date until the Registration Statement is declared effective by the SEC if no SEC review of the Shelf Registration Statement, or each day in excess of 120 days from the Closing Date until the Registration Statement is declared effective by the SEC in the event of an SEC review of the Registration Statement.
Each day for a period in excess of 20 consecutive days or 45 total days in any 12-month period that the SEC issues a stop order to suspend the effectiveness of the Registration
Statement.
The maximum cumulative liquidated damages are 10.0% of the aggregate purchase price. Payment of
liquidated damages is due 30 days after coming into compliance with above events. Interest is 1.5%
every 30 days for delinquent payments.
The Company evaluated the liquidated damages provision according to guidance under FSP EITF
00-19-2, which specifies that the contingent obligation to make future payments or otherwise
transfer consideration under a registration payment arrangement, whether issued as a separate
agreement or included as a provision of a financial instrument or other agreement, shall be
recognized and measured separately in accordance with SFAS No. 5 and FIN 14. FSP EITF 00-19-2
further states that an entity should recognize and measure a registration payment arrangement as a
separate unit of account from the financial instrument subject to that arrangement. The Company
filed a Form S-1, Shelf Registration Statement, with the SEC on September 27, 2007, and is
currently under review by the SEC. The Company considers the likelihood of the Registration
Statement not being declared effective within the prescribed timeframe and the SEC suspension of
the effectiveness of the Registration Statement for a period of 20 consecutive days or not more
than 45 days in any 12-month period to be remote. As a result, to date no contingent liability was
recorded related to this registration payment arrangement. As of September 30, 2007, the Company
has incurred costs of $290,000 in connection with the registration of these securities, which is
reflected as a reduction to additional paid-in capital.
NASDAQ Listing Requirements Compliance Notification
On August 15, 2007, Vermillion was notified by NASDAQ Listing Qualifications that it did not comply
with Marketplace Rule 4310(c)(3) for continue inclusion, and as required by Marketplace Rule
4310(c)(8)(C), Vermillion had 30 days, or until September 14, 2007, to regain compliance.
Marketplace Rule 4310(c)(3) requires Vermillion to (A) have minimum stockholders equity of
$2,500,000, (B) have a minimum common stock market value of $35,000,000 or (C) have net income from
continuing operations of $500,000 in the most recently completed fiscal year or in two of the last
three most recently completed fiscal years. Subsequently, on September 14, 2007, NASDAQ Listing
Qualifications notified Vermillion it had regained compliance with Marketplace Rule 4310(c)(3) with
the market value of Vermillion common stock exceeding $35,000,000 for 10 consecutive business days
Additionally, on September 6, 2007, Vermillion was notified by NASDAQ Listing Qualifications that
Vermillions common stock bid price closed below the minimum $1.00 per share requirement for
continued inclusion by Marketplace Rule 4310(c)(4), and as required by Marketplace Rule
4310(c)(8)(D), Vermillion had 180 days, or until March 4, 2008, to regain compliance. To regain
compliance, the bid price of Vermillions common stock must close at $1.00 per share or more for a
minimum of 10 consecutive business days.
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
10.
Stock-Based Compensation
Options for 233,500 shares were granted with an exercise price of $1.02, and options for 1,667,700
shares were granted with an average exercise price of $1.26 during the three and nine months ended
September 30, 2007, respectively. The allocation of stock-based compensation expense by functional
area for the three and nine months ended September 30, 2007 and 2006, was as follows (in
thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2007
2006
2007
2006
$
$
46
$
1
$
140
52
79
129
273
20
66
66
252
166
223
488
673
$
238
$
414
$
684
$
1,338
11.
Loss Per Share
Basic 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 loss per share is
calculated using the weighted average number of common shares outstanding and excludes the effects
of 37,440,001 and 12,173,606 potential common shares as of September 30, 2007 and 2006,
respectively, that are antidilutive. Potential common shares include common shares issuable upon
conversion of all convertible senior notes, common stock issuable under the Companys 2000 Employee
Stock Purchase Plan, and incremental shares of common stock issuable upon the exercise of
outstanding stock options and warrants.
12.
Segment Information and Geographic Data
As a result of the sale of assets and liabilities of the Companys Instrument Business to Bio-Rad
on November 13, 2006, management has determined that the Company operates one reportable segment,
specialty diagnostic tests. Prior to November 13, 2006, the Company operated one reportable
segment, which was the protein research products and collaborative services business.
Prior to November 13, 2006, the Company sold 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. The following is a summary of the geographic information related to revenue
for the three and nine months ended September 30, 2007 and 2006 (in thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2007
2006
2007
2006
$
$
1,393
$
21
$
4,706
300
926
1,652
6,651
1,317
4,716
$
$
4,662
$
21
$
16,999
Sales to customers in Japan represented 25.1% and 24.0% of revenue for the three and nine months
ended September 30, 2006. Additionally, sales to customers in the United Kingdom represented 7.7%
and 10.3% of
Table of Contents
Notes to Consolidated Financial Statements Continued
(Unaudited)
revenue for the three and nine months ended September 30, 2006. No other country outside the
United States 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, 2007, and December 31,
2006, were as follows (in thousands):
September 30,
December 31,
2007
2006
$
1,607
$
2,244
6
16
$
1,613
$
2,260
13.
Subsequent Event
On October 23, 2007, the USPTO issued a reexamination certificate of the 022 Patent to Vermillion.
Accordingly, the Company has submitted the 022 Patent reexamination certificate to Bio-Rad in order
to claim the $2,000,000 withheld from the sales proceeds. On November 9, 2007, the Company received from Bio-Rad the $2,000,000 withheld from the sales proceeds.
Table of Contents
projections of the Companys future revenue, results of operations and financial condition;
anticipated deployment, capabilities and uses of the Companys products and the Companys
product development activities and product innovations;
the importance of proteomics as a major focus of biology research;
competition and consolidation in the markets in which the Company competes;
existing and future collaborations and partnerships;
the utility of biomarker discoveries;
our belief that biomarker discoveries may have diagnostic and/or therapeutic utility;
our plans to develop and commercialize diagnostic tests through the Companys strategic
alliance with Quest Diagnostics Incorporated (Quest);
our ability to comply with applicable government regulations;
our ability to expand and protect the Companys intellectual property portfolio;
our ability to decrease general and administrative costs;
our ability to decrease sales and marketing costs;
our ability to decrease research and development costs;
anticipated future losses;
expected levels of capital expenditures;
forgiveness of the outstanding principal amounts of the secured line of credit by Quest;
the period of time for which the Companys existing financial resources, debt facilities
and interest income will be sufficient to enable the Company to maintain current and planned
operations; and
the market risk of the Companys investments.
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Three Months Ended
September 30,
Increase (Decrease)
2007
2006
Amount
%
$
$
2,697
$
(2,697
)
(100.00
)
1,965
(1,965
)
(100.00
)
4,662
(4,662
)
(100.00
)
1,571
(1,571
)
(100.00
)
910
(910
)
(100.00
)
2,481
(2,481
)
(100.00
)
2,181
(2,181
)
(100.00
)
2,182
2,914
(732
)
(25.12
)
516
3,204
(2,688
)
(83.90
)
2,090
2,541
(451
)
(17.75
)
4,788
8,659
(3,871
)
(44.70
)
(4,788
)
(6,478
)
(1,690
)
(26.09
)
169
190
(21
)
(11.05
)
(596
)
(592
)
4
0.68
95
(116
)
(211
)
(181.90
)
(5,120
)
(6,996
)
(1,876
)
(26.82
)
3
(20
)
(23
)
(115.00
)
$
(5,117
)
$
(7,016
)
$
(1,899
)
(27.07
)
Table of Contents
Table of Contents
Nine Months Ended
September 30,
Increase (Decrease)
2007
2006
Amount
%
$
$
10,702
$
(10,702
)
(100.00
)
21
6,297
(6,276
)
(99.67
)
21
16,999
(16,978
)
(99.88
)
5,714
(5,714
)
(100.00
)
15
3,118
(3,103
)
(99.52
)
15
8,832
(8,817
)
(99.83
)
6
8,167
(8,161
)
(99.93
)
6,297
8,780
(2,483
)
(28.28
)
1,440
10,652
(9,212
)
(86.48
)
8,626
7,549
1,077
14.27
16,363
26,981
(10,618
)
(39.35
)
(382
)
(382
)
(16,739
)
(18,814
)
(2,075
)
(11.03
)
458
654
(196
)
(29.97
)
(1,727
)
(1,691
)
36
2.13
17
(174
)
(191
)
(109.77
)
(17,991
)
(20,025
)
(2,034
)
(10.16
)
1
(190
)
(191
)
(100.53
)
$
(17,990
)
$
(20,215
)
$
(2,225
)
(11.01
)
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
- 31 -
- 32 -
- 33 -
- 34 -
- 35 -
- 36 -
- 37 -
- 38 -
- 39 -
- 40 -
- 41 -
- 42 -
- 43 -
- 44 -
- 45 -
- 46 -
- 47 -
Table of Contents
make it difficult for the Company to make payments on the convertible senior notes and
secured line of credit;
make it difficult for the Company to obtain financing for working capital, acquisitions or
other purposes on favorable terms, if at all;
make the Company more vulnerable to industry downturns and competitive pressures; and
limit our flexibility in planning for or reacting to changes in the Companys business.
Table of Contents
our ability to convince the medical community of the safety and clinical efficacy of the
Companys products and its 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 the Companys products, the scope and extent of which will affect patients
willingness to pay for the Companys products and will likely heavily influence physicians
decisions to recommend the Companys products.
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
failure to commercialize diagnostic tests and significantly increase revenue;
actual or anticipated period-to-period fluctuations in financial results;
failure to achieve, or changes in, financial estimates by securities analysts;
announcements or introductions of new products or services or technological innovations by
the Company or its competitors;
publicity regarding actual or potential discoveries of biomarkers by others;
comments or opinions by securities analysts or major stockholders;
conditions or trends in the pharmaceutical, biotechnology and life science industries;
announcements by the Company of significant acquisitions and divestitures, strategic
partnerships, joint ventures or capital commitments;
developments regarding the Companys patents or other intellectual property or that of the
Companys competitors;
Table of Contents
litigation or threat of litigation;
additions or departures of key personnel;
sales of Vermillion common stock;
limited daily trading volume;
delisting from NASDAQ Capital Market; and
economic and other external factors, disasters or crises.
Table of Contents
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Share Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and LumiCyte, Inc.
dated May 28, 2003
8-K
000-31617
2.1
June 11, 2003
Asset Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Pall
Corporation dated October 27, 2004
8-K
000-31617
2.1
December 6, 2004
Second Amended and Restated
Certificate of Incorporation of
Vermillion, Inc.
S-1
333-146354
3.1
September 27, 2007
Amended and Restated Bylaws of
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.)
S-1
333-32812
3.3
September 28, 2000
Certificate of Designation of
Rights, Preferences and Privileges
of Series A Participating Preferred
Stock of Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.)
8-A
000-31617
3.5
March 21, 2002
Form of Vermillion, Inc.s (formerly
Ciphergen Biosystems, Inc.) Common
Stock Certificate
S-1
333-32812
4.1
September 28, 2000
Indenture between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) and U.S. Bank National
Association dated August 22, 2003
S-3
333-109556
4.1
October 8, 2003
Preferred Shares Rights Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Continental Stock Transfer & Trust
Company dated March 20, 2002
8-A
000-31617
4.2
March 21, 2002
Amendment to Rights Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Wells Fargo Bank, N.A. dated
July 22, 2005
8-K
000-31617
4.4
July 28, 2005
Second Amendment to Rights Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Wells Fargo Bank, N.A. dated
September 30, 2005
8-K
000-31617
4.5
October 4, 2005
Third Amendment to Rights Agreement
between Vermillion, Inc. and Wells
Fargo Bank, N.A., dated
September 11, 2007
8-K
333-146354
10.1
September 12, 2007
Form of Preferred Stock Purchase
Agreement
S-1
333-32812
10.1
September 28, 2000
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Fourth Amended and Restated
Investors Rights Agreement dated
March 3, 2000
S-1
333-32812
10.2
September 28, 2000
1993 Stock Option Plan
S-1
333-32812
10.3
September 28, 2000
Form of Stock Option Agreement
S-1
333-32812
10.4
September 28, 2000
2000 Stock Plan and related form of
Stock Option Agreement
S-1
333-32812
10.5
September 28, 2000
Amended and Restated 2000 Employee Stock Purchase Plan
ü
401(k) Plan
10-K
000-31617
10.7
March 22, 2005
Form of Warrant
S-1
333-32812
10.8
September 28, 2000
Form of Proprietary Information
Agreement between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) and certain of its employees
S-1
333-32812
10.9
September 28, 2000
Lease Agreement between Vermillion,
Inc. (formerly Ciphergen Biosystems,
Inc.) and John Arrillaga, Trustee of
the John Arrillaga Survivors Trust
and Richard T. Peery, Trustee of the
Richard T. Peery Separate Property
Trust, dated January 28, 2000, and
Amendment No. 1 dated August 8, 2000
S-1
333-32812
10.12
September 28, 2000
MAS License Agreement with IllumeSys
Pacific, Inc. dated April 7, 1997
S-1
333-32812
10.23
September 28, 2000
MAS License Agreement with Ciphergen
Technologies, Inc. (formerly ISP
Acquisition Corporation) dated
April 7, 1997
S-1
333-32812
10.24
September 28, 2000
Sublicense Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.13
September 27, 2007
Joint Venture Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Sumitomo
Corporation
S-1
333-32812
10.25
September 28, 2000
Distribution and Marketing Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Ciphergen Biosystems KK dated
March 24, 1999
S-1
333-32812
10.26
September 28, 2000
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Joint Development Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Stanford
Research Systems, Inc. dated
February 2, 1995 and amendment
thereto
S-1
333-32812
10.27
September 28, 2000
Asset Purchase Agreement by and
between Invitrogen Corporation and
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) dated June 25,
2001
10-Q
000-31617
10.28
June 30, 2001
OEM Agreement between Salford
Systems and Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) dated February 27, 2001
10-K
000-31617
10.29
April 1, 2002
Supply Agreement between Beckman
Coulter, Inc. and Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) dated November 2, 2001
10-K
000-31617
10.30
April 1, 2002
Stock Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and SC
Biosciences Corporation dated
August 30, 2002
10-K
000-31617
10.32
March 31, 2003
First Amendment to the Joint Venture
Agreement between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.), Sumitomo Corporation, SC
Biosciences Corporation (a
subsidiary of Sumitomo Corporation)
and Ciphergen Biosystems KK dated
March 15, 2002
10-K
000-31617
10.33
March 31, 2003
Second Amendment to Joint Venture
Agreement between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.), Sumitomo Corporation, SC
Biosciences Corporation (a
subsidiary of Sumitomo Corporation)
and Ciphergen Biosystems KK dated
November 15, 2002
10-K
000-31617
10.34
March 31, 2003
Third Amendment to Joint Venture
Agreement between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.), Sumitomo Corporation, SC
Biosciences Corporation (a
subsidiary of Sumitomo Corporation)
and Ciphergen Biosystems KK dated
November 15, 2002
10-K
000-31617
10.35
March 31, 2003
Exhibit A, which amends the Supply
Agreement between Beckman Coulter,
Inc. and Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) dated
November 2, 2001
10-K
000-31617
10.36
March 31, 2003
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Lease Agreement between Symbion and
Ciphergen Biosystems A/S dated
February 24, 2003
10-K
000-31617
10.37
March 31, 2003
Service and Support Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Applied Biosystems/MDS Sciex dated
April 2, 2001
10-K
000-31617
10.38
March 31, 2003
Employment Agreement between Gail
Page and Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) dated
December 31, 2005
10-K
000-31617
10.39
March 17, 2006
Registration Rights Agreement dated
August 22, 2003
S-3
000-31617
10.1
October 8, 2003
Extension of Term of Service and
Support Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Applied
Biosystems/MDS Sciex dated March 10,
2004
10-K
000-31617
10.43
March 15, 2004
Asset Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Pall
Corporation dated October 27, 2004
8-K
000-31617
2.1
December 6, 2004
Stock Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Quest
Diagnostics Incorporated dated
July 22, 2005
8-K
000-31617
10.45
July 28, 2005
Letter Agreement dated August 29,
2007 between Vermillion, Inc. and
Quest Diagnostics Incorporated
S-1
333-146354
10.38
September 27, 2007
Warrant between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) and Quest Diagnostics
Incorporated dated July 22, 2005
10-K
000-31617
10.51
March 17, 2006
Memorialization Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Quest
Diagnostics Incorporated dated
January 12, 2006*
S-1
333-146354
10.41
September 27, 2007
Amendment to Warrant between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Quest
Diagnostics Incorporated dated
August 29, 2007
S-1
333-146354
10.41
September 27, 2007
Credit Agreement between Vermillion,
Inc. (formerly Ciphergen Biosystems,
Inc.) and Quest Diagnostics
Incorporated dated July 22, 2005
8-K
000-31617
10.47
July 28, 2005
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Security Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Quest
Diagnostics Incorporated dated
July 22, 2005
8-K
000-31617
10.48
July 28, 2005
Form of Exchange Agreement, dated as
of November 3, 2006 between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and certain
holders of its 4.50% Convertible
Senior Notes due September 1, 2008
8-K
000-31617
10.55
November 6, 2006
Asset Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated August 14,
2006
14a
000-31617
September 12, 2006
Amendment to Asset Purchase
Agreement between Vermillion, Inc.
(formerly Ciphergen Biosystems,
Inc.) and Bio-Rad Laboratories, Inc.
dated November 13, 2006
S-1
333-146354
10.47
September 27, 2007
Stock Purchase Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.48
September 27, 2007
Transition Services Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Bio-Rad Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.49
September 27, 2007
Amendment No. 1 to Transition
Services Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated May 11,
2007
S-1
333-146354
10.50
September 27, 2007
Amendment No. 2 to Transition
Services Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated June 15,
2007
S-1
333-146354
10.51
September 27, 2007
Manufacture and Supply Agreement
between Vermillion, Inc. (formerly
Ciphergen Biosystems, Inc.) and
Bio-Rad Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.52
September 27, 2007
Amendment No. 1 to Manufacture and
Supply Agreement between Vermillion,
Inc. and Bio-Rad Laboratories, Inc.
dated August 27, 2007
S-1
333-146354
10.53
September 27, 2007
Table of Contents
Exhibit
Incorporated by Reference
Filed
Number
Exhibit Description
Form
File No.
Exhibit
Filing Date
Herewith
Cross License Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.54
September 27, 2007
Letter Agreement between Vermillion,
Inc. (formerly Ciphergen Biosystems,
Inc.) and Bio-Rad Laboratories, Inc.
dated November 13, 2006
S-1
333-146354
10.55
September 27, 2007
Sublease Agreement between
Vermillion, Inc. (formerly Ciphergen
Biosystems, Inc.) and Bio-Rad
Laboratories, Inc. dated
November 13, 2006
S-1
333-146354
10.56
September 27, 2007
Securities Purchase Agreement, dated
as of August 23, 2007, by and among
Vermillion, Inc. and the purchasers
party thereto
S-1
333-146354
10.57
September 27, 2007
Form of Warrant
ü
Certification of the Chief Executive
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
ü
Certification of the Chief Financial
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
ü
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
)
(1)
Furnished herewith
Table of Contents
Vermillion, Inc.
/s/ Gail S. Page
Gail S. Page
Director, President and Chief Executive Officer
(Principal Executive Officer)
/s/ Qun Zhou
Qun Zhou
Corporate Controller and Interim Chief Financial
Officer
(Acting Principal Financial and Accounting Officer)
___ Original Application | Enrollment Date: | |
___ Change in Payroll Deduction Rate | ||
___ Change of Beneficiary(ies) |
1. | hereby elects to participate in the Vermillion, Inc. Employee Stock Purchase Plan (the Employee Stock Purchase Plan) and subscribes to purchase shares of the Companys Common Stock in accordance with this Subscription Agreement and the Employee Stock Purchase Plan. | |
2. | I hereby authorize payroll deductions from each paycheck in the amount of ___% of my Compensation on each payday (from 0 to 15%) during the Offering Period in accordance with the Employee Stock Purchase Plan. (Please note that no fractional percentages are permitted.) | |
3. | I understand that said payroll deductions shall be accumulated for the purchase of shares of Common Stock at the applicable Purchase Price determined in accordance with the Employee Stock Purchase Plan. I understand that if I do not withdraw from an Offering Period, any accumulated payroll deductions will be used to automatically exercise my option. | |
4. | I have received a copy of the complete Employee Stock Purchase Plan. I understand that my participation in the Employee Stock Purchase Plan is in all respects subject to the terms of the Plan. I understand that my ability to exercise the option under this Subscription Agreement is subject to stockholder approval of the Employee Stock Purchase Plan. | |
5. | Shares purchased for me under the Employee Stock Purchase Plan should be issued in the name(s) of (Employee or Employee and Spouse only). | |
6. | I understand that if I dispose of any shares received by me pursuant to the Plan within 2 years after the Enrollment Date (the first day of the Offering Period during which I purchased such shares) or one year after the Exercise Date, I will be treated for federal income tax purposes as having received ordinary income at the time of such disposition in an amount equal to the excess of the fair market value of the shares at the time such shares were purchased by me over the price which I paid for the shares. I hereby agree to notify the Company in writing within 30 days after the date of any disposition of my shares and I will make adequate provision for Federal, state or other tax withholding obligations, if any, which arise upon the |
disposition of the Common Stock . The Company may, but will not be obligated to, withhold from my compensation the amount necessary to meet any applicable withholding obligation including any withholding necessary to make available to the Company any tax deductions or benefits attributable to sale or early disposition of Common Stock by me. If I dispose of such shares at any time after the expiration of the 2-year and 1-year holding periods, I understand that I will be treated for federal income tax purposes as having received income only at the time of such disposition, and that such income will be taxed as ordinary income only to the extent of an amount equal to the lesser of (1) the excess of the fair market value of the shares at the time of such disposition over the purchase price which I paid for the shares, or (2) 15% of the fair market value of the shares on the first day of the Offering Period. The remainder of the gain, if any, recognized on such disposition will be taxed as capital gain. | ||
7. | I hereby agree to be bound by the terms of the Employee Stock Purchase Plan. The effectiveness of this Subscription Agreement is dependent upon my eligibility to participate in the Employee Stock Purchase Plan. | |
8. | In the event of my death, I hereby designate the following as my beneficiary(ies) to receive all payments and shares due me under the Employee Stock Purchase Plan: |
|
NAME: (Please print) | |||||||
|
(First) | (Middle) | (Last) |
|
||||
|
Relationship | |||
|
||||
|
(Address) |
|
Employees Social | |||||
|
Security Number: | |||||
|
|
|||||
|
Employees Address: | |||||
|
|
|||||
|
||||||
|
||||||
|
Dated:
|
|
|||||
|
||||||
|
||||||
|
||||||
|
Spouses Signature (If beneficiary other than spouse) |
Name and Address of Participant: | ||||||
|
||||||
|
||||||
|
||||||
|
||||||
Signature: | ||||||
|
||||||
|
||||||
|
Date: | |||||
|
Warrant
# of
Section 1(e)
No.
Record Holder
Shares
excluded
David I.J. Wang
285,713
Quest Diagnostics Incorporated
1,904,761
ü
Falcon Technology Partners LP
1,428,571
Phronesis Partners LP
3,895,428
ü
Kane & Co.
6,320
OFI Institutional Global Opportunities Fund
25,040
IFT Co.
20,080
IFT Co.
283,283
Oppenheimer Global Opportunities Fund
3,474,800
Highbridge International LLC
4,380,952
Fort Mason Master LP
1,788,762
Fort Mason Partners LP
116,000
Rockmore Investment Master Fund Ltd.
952,380
Iroquois Master Fund Limited
952,380
Kee Colen
96,000
Oppenheimer & Co.
921,000
ü
Warrant No. [ ]
|
Number of Shares: [ ]
(subject to adjustment) |
|
Date of Issuance: August 29, 2007
|
||
|
||
Original Issue Date (as defined in
subsection 2(a)): August 29, 2007 |
2
|
||
Where: X =
|
the number of Warrant Shares that shall be issued to the Registered Holder; | |
|
||
Y =
|
the number of Warrant Shares for which this Warrant is being exercised (which shall include both the number of Warrant Shares issued to the Registered Holder and the number of Warrant Shares subject to the portion of the Warrant being cancelled in payment of the Purchase Price); | |
|
||
A =
|
the Fair Market Value (as defined below) of one share of Common Stock, as of the date prior to the Exercise Date; and | |
|
||
B =
|
the Purchase Price then in effect. |
3
4
5
6
7
|
C | ||||||
|
|||||||
|
AP = P x | O + | P | ||||
A
|
8
9
10
11
12
13
14
VERMILLION, INC. | ||||
|
||||
|
By: | |||
|
||||
|
Name: | |||
|
Title: | |||
ATTEST:
|
||||
|
||||
|
15
To: Vermillion, Inc. | Dated: | |||||||
|
o | $___in lawful money of the United States; and/or | ||
o | o the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 1(b), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 1(b). |
|
||||
|
Signature: | |||
|
||||
|
||||
|
Address: | |||
|
||||
|
||||
|
||||
|
|
16
Name of Assignee
|
Address | No. of Shares |
17
1. | I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures [as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)] and internal control over financial reporting [as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)] for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: November 14, 2007
|
/s/ Gail S. Page | |
|
||
|
Gail S. Page | |
|
Director, President and Chief Executive Officer |
1. | I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures [as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)] and internal control over financial reporting [as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)] for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | ||
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: November 14, 2007
|
/s/ Qun Zhou | |
|
||
|
Qun Zhou | |
|
Corporate Controller and Interim Chief Financial Officer |
1. | The Companys quarterly report on Form 10-Q for the period ended September 30, 2007, (the Form 10-Q) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act); and |
2. | Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 14, 2007
|
/s/ Gail S. Page | |
|
||
|
Gail S. Page | |
|
Director, President and Chief Executive Officer | |
|
(Principal Executive Officer) | |
|
||
Date: November 14, 2007
|
/s/ Qun Zhou | |
|
||
|
Qun Zhou | |
|
Corporate Controller and Interim Chief Financial Officer | |
|
(Acting Principal Financial and Accounting Officer) |