U.
S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-QSB
T Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
For
the
quarterly period ended June 30, 2006
Transition
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
For
the
transition period from
to
.
Commission
File Number 0-8092
(Exact
name of small business issuer as specified in its charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
94-1620407
(I.R.S.
employer
identification
number)
|
323
Vintage Park Drive, Suite B, Foster City, CA 94404
(Address
of principal executive offices and zip code)
(650)
212-2568
(Registrant’s
telephone number, including area
code)
|
Check
mark whether the issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the past 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
T NO
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). YES
NO
T
At
August
11, 2006, the issuer had outstanding the indicated number of shares of common
stock: 43,066,985.
Transitional
Small Business Disclosure Format YES
NO
T
OXIS
International, Inc.
Form
10-QSB
For
the Quarter Ended June 30, 2006
Table
of Contents
PART
I - FINANCIAL INFORMATION
|
Page
|
Item
1.
|
Financial
Statements
|
|
|
Consolidated
Balance Sheets as of June 30, 2006 (Unaudited) and December 31,
2005
|
1
|
|
Consolidated
Statements of Operations for the periods ended June 30, 2006 and
2005
(Unaudited)
|
2
|
|
Consolidated
Statements of Cash Flows for the periods ended June, 2006 and 2005
(Unaudited)
|
3
|
|
Condensed
Notes to Consolidated Financial Statements
|
4
|
Item
2.
|
Management’s
Discussion and Analysis or Plan of Operation
|
14
|
Item
3.
|
Controls
and Procedures
|
38
|
PART
II - OTHER INFORMATION
|
Item
1.
|
Legal
Proceedings
|
39
|
Item
2.
|
Unregistered
Sales of Equity Securities
and Use of Proceeds
|
39
|
Item
3.
|
Defaults
Upon Senior Securities
|
39
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
39
|
Item
5.
|
Other
Information
|
39
|
Item
6.
|
Exhibits
|
39
|
SIGNATURE
|
40
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements.
OXIS
INTERNATIONAL, INC.
CONSOLIDATED
BALANCE SHEETS
|
|
June
30, 2006
(Unaudited)
|
|
December
31, 2005
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
461,000
|
|
$
|
614,000
|
|
Accounts
receivable, net
|
|
|
930,000
|
|
|
865,000
|
|
Inventories,
net
|
|
|
623,000
|
|
|
650,000
|
|
Prepaid
expenses and other current assets
|
|
|
121,000
|
|
|
238,000
|
|
Deferred
tax assets
|
|
|
13,000
|
|
|
14,000
|
|
Restricted
cash
|
|
|
3,060,000
|
|
|
3,060,000
|
|
Total
current assets
|
|
|
5,208,000
|
|
|
5,441,000
|
|
Property,
plant and equipment, net
|
|
|
259,000
|
|
|
243,000
|
|
Patents,
net
|
|
|
815,000
|
|
|
831,000
|
|
Goodwill
and other assets
|
|
|
1,299,000
|
|
|
1,291,000
|
|
|
|
$
|
7,581,000
|
|
$
|
7,806,000
|
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
778,000
|
|
$
|
505,000
|
|
Accrued
expenses
|
|
|
375,000
|
|
|
468,000
|
|
Accounts
payable to related party
|
|
|
129,000
|
|
|
194,000
|
|
Notes
payable to related party
|
|
|
200,000
|
|
|
—
|
|
Notes
payable
|
|
|
3,460,000
|
|
|
3,060,000
|
|
Total
current liabilities
|
|
|
4,942,000
|
|
|
4,227,000
|
|
Long-term
deferred taxes
|
|
|
41,000
|
|
|
41,000
|
|
Total
liabilities
|
|
|
4,983,000
|
|
|
4,268,000
|
|
Minority
interest in subsidiary
|
|
|
690,000
|
|
|
604,000
|
|
Shareholders’
equity:
|
|
|
|
|
|
|
|
Convertible
preferred stock - $0.01 par value; 15,000,000 shares authorized;
Series C
- 96,230 shares issued and outstanding
|
|
|
1,000
|
|
|
1,000
|
|
Common
stock- $0.001 par value; 95,000,000 shares authorized; 42,988,547
and
42,538,397 shares issued and outstanding at June 30, 2006 and December
31,
2005, respectively
|
|
|
43,000
|
|
|
43,000
|
|
Additional
paid-in capital
|
|
|
68,929,000
|
|
|
68,686,000
|
|
Accumulated
deficit
|
|
|
(66,648,000
|
)
|
|
(65,379,000
|
)
|
Accumulated
other comprehensive loss
|
|
|
(417,000
|
)
|
|
(417,000
|
)
|
Total
shareholders’ equity
|
|
|
1,908,000
|
|
|
2,934,000
|
|
|
|
$
|
7,581,000
|
|
$
|
7,806,000
|
|
See
accompanying condensed notes to consolidated financial statements.
OXIS
INTERNATIONAL, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
2006
|
|
2005
|
|
Product
revenues
|
|
$
|
1,356,000
|
|
$
|
555,000
|
|
$
|
2,869,000
|
|
$
|
1,186,000
|
|
Cost
of product revenues
|
|
|
833,000
|
|
|
287,000
|
|
|
1,649,000
|
|
|
573,000
|
|
Gross
profit
|
|
|
523,000
|
|
|
268,000
|
|
|
1,220,000
|
|
|
613,000
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
178,000
|
|
|
60,000
|
|
|
391,000
|
|
|
122,000
|
|
Selling,
general and administrative
|
|
|
837,000
|
|
|
545,000
|
|
|
1,901,000
|
|
|
1,081,000
|
|
Total
operating expenses
|
|
|
1,015,000
|
|
|
605,000
|
|
|
2,292,000
|
|
|
1,203,000
|
|
Loss
from operations
|
|
|
(492,000
|
)
|
|
(337,000
|
)
|
|
(1,072,000
|
)
|
|
(590,000
|
)
|
Other
income (expenses):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
11,000
|
|
|
44,000
|
|
|
31,000
|
|
|
52,000
|
|
Other
income
|
|
|
2,000
|
|
|
—
|
|
|
2,000
|
|
|
—
|
|
Interest
expense
|
|
|
(28,000
|
)
|
|
(7,000
|
)
|
|
(55,000
|
)
|
|
(11,000
|
)
|
Total
other income (expenses)
|
|
|
(15,000
|
)
|
|
37,000
|
|
|
(22,000
|
)
|
|
41,000
|
|
Allocation
to minority interest in subsidiary
|
|
|
(36,000
|
)
|
|
—
|
|
|
(86,000
|
)
|
|
|
|
Loss
before provision for income taxes
|
|
|
(543,000
|
)
|
|
(300,000
|
)
|
|
(1,180,000
|
)
|
|
(549,000
|
)
|
Provision
for income taxes
|
|
|
36,000
|
|
|
—
|
|
|
89,000
|
|
|
—
|
|
Net
loss
|
|
$
|
(579,000
|
)
|
$
|
(300,000
|
)
|
$
|
(1,269,000
|
)
|
$
|
(549,000
|
)
|
Net
loss per share - basic and diluted
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
(0.01
|
)
|
Weighted
average shares outstanding - basic
and
diluted
|
|
|
42,621,928
|
|
|
42,241,523
|
|
|
42,580,393
|
|
|
41,935,199
|
|
See
accompanying condensed notes to consolidated financial statements.
OXIS
INTERNATIONAL, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(1,269,000
|
)
|
$
|
(549,000
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Depreciation
of property, plant and equipment
|
|
|
38,000
|
|
|
14,000
|
|
Amortization
of intangible assets
|
|
|
64,000
|
|
|
24,000
|
|
Share-based
compensation expense
|
|
|
180,000
|
|
|
8,000
|
|
Minority
interest in subsidiary
|
|
|
86,000
|
|
|
—
|
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(65,000
|
)
|
|
(43,000
|
)
|
Inventories
|
|
|
27,000
|
|
|
(51,000
|
)
|
Prepaid
expenses and other current assets
|
|
|
117,000
|
|
|
(28,000
|
)
|
Deferred
tax asset
|
|
|
1,000
|
|
|
—
|
|
Other
assets
|
|
|
(8,000
|
)
|
|
—
|
|
Accounts
payable
|
|
|
241,000
|
|
|
(92,000
|
)
|
Accrued
expenses
|
|
|
(93,000
|
)
|
|
(412,000
|
)
|
Accounts
payable to related party
|
|
|
(65,000
|
)
|
|
—
|
|
Net
cash used in operating activities
|
|
|
(746,000
|
)
|
|
(1,129,000
|
)
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
Investment
in restricted certificate of deposit
|
|
|
(3,060,000
|
)
|
|
—
|
|
Purchases
of property, plant and equipment
|
|
|
(38,000
|
)
|
|
(6,000
|
)
|
Increase
in patents
|
|
|
(32,000
|
)
|
|
(131,000
|
)
|
Proceeds
from restricted certificate of deposit
|
|
|
3,060,000
|
|
|
—
|
|
Net
cash used in investing activities
|
|
|
(70,000
|
)
|
|
(137,000
|
)
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
Collection
of private placement proceeds receivable, net of registration statement
costs
|
|
|
—
|
|
|
1,958,000
|
|
Issuance
of common stock
|
|
|
—
|
|
|
239,000
|
|
Proceeds
from exercise of stock options
|
|
|
63,000
|
|
|
34,000
|
|
Proceeds
from short-term borrowing
|
|
|
3,660,000
|
|
|
—
|
|
Repayment
of short-term borrowings
|
|
|
(3,060,000
|
)
|
|
(1,200,000
|
)
|
Net
cash provided by financing activities
|
|
|
663,000
|
|
|
1,031,000
|
|
Net
decrease in cash and cash equivalents
|
|
|
(153,000
|
)
|
|
(235,000
|
)
|
Cash
and cash equivalents - beginning of period
|
|
|
614,000
|
|
|
4,687,000
|
|
Cash
and cash equivalents - end of period
|
|
$
|
461,000
|
|
$
|
4,452,000
|
|
See
accompanying condensed notes to consolidated financial statements.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June
30, 2006
1. The
Company and Summary of Significant Accounting Policies
OXIS
International, Inc. with its subsidiaries (collectively, “OXIS” or the
"Company") is a clinical diagnostics company engaged in the development of
clinical and research assays, diagnostics, nutraceutical and therapeutic
products, which include new technologies applicable to conditions and diseases
associated with oxidative stress. OXIS derives its revenues primarily from
sales
of research diagnostic assays to research laboratories. The Company’s diagnostic
products include five cardiac marker assays and 25 research assays to measure
markers of oxidative and nitrosative stress.
In
1965,
the corporate predecessor of OXIS, Diagnostic Data, Inc., was incorporated
in
the State of California. Diagnostic Data changed its incorporation to the
State
of Delaware in 1972 and changed its name to DDI Pharmaceuticals, Inc. in
1985.
In 1994, DDI Pharmaceuticals merged with International BioClinical, Inc.
and
Bioxytech S.A. and changed its name to OXIS International, Inc. The Company’s
principal executive offices were relocated to Foster City, California from
Portland, Oregon on February 15, 2006.
On
September 19, 2005, the Company entered into a stock purchase agreement with
BioCheck, Inc. (“BioCheck”) and certain stockholders of BioCheck to purchase all
of the common stock of BioCheck for $6.0 million in cash. On
December 6, 2005, the Company purchased 51% of the common stock of BioCheck
from each of the shareholders of BioCheck on a pro rata basis, for $3,060,000
in
cash. The consolidated statements of operations for the three and six months
ended June 30, 2006 include the results of operations of BioCheck and the
consolidated balance sheets at December 31, 2005 and June 30, 2006
include the assets and liabilities of BioCheck.
The
Company incurred net losses of $1.3 million in the six months ended June
30, 2006 and $3.1 million in 2005. The Company began expensing stock
options effective January 1, 2006 in accordance with the Statement of Financial
Accounting Standards No. 123 (revised 2004), “Share-Based Payments” (“SFAS
123R”). The Company is also seeking debt financing that may have related
warrants. Non-cash financing charges resulting from such financing and the
additional non-cash charges related to stock options may delay profitability.
The Company’s plan is to increase revenues to generate sufficient gross profit
in excess of selling, general and administrative, and research and development
expenses in order to achieve profitability. However, the Company cannot provide
assurances that it will accomplish this task and there are many factors that
may
prevent the Company from reaching its goal of profitability.
On
a
consolidated basis, the Company had cash and cash equivalents of $461,000
at
June 30, 2006 of which $441,000 was held by BioCheck. Since BioCheck has
been
and is expected to continue to be cash flow positive, management believes
that
its cash will be sufficient to sustain its operating activities.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
The
OXIS
parent company had cash and cash equivalents of $20,000 at June 30, 2006.
OXIS
cannot access the cash held by its majority-held subsidiary, BioCheck, to
pay
for the corporate purposes of the OXIS parent company. The Company incurred
negative operating cash flows of $0.7 million during the six months ended
June
30, 2006 and $2.1 million during 2005. The current rate of cash usage raises
substantial doubt about the OXIS parent Company’s ability to continue as a going
concern, absent any new sources of significant cash flows. In an effort to
mitigate this near-term concern, the Company is seeking debt and equity
financings to obtain sufficient funds to sustain operations, implement its
marketing campaign and purchase the remaining 49% of BioCheck for approximately
$3.0 million. The Company plans to increase revenues by executing its marketing
campaign and introducing new products. However, the Company cannot provide
assurances that it will successfully obtain debt or equity financing, if
any,
sufficient to finance its goals or that the Company will increase product
related revenues. The financial statements do not include any adjustments
relating to the recoverability and classification of recorded assets, or
the
amounts and classification of liabilities that might be necessary in the
event
the Company cannot continue in existence.
Basis
of Presentation
The
consolidated financial statements have been prepared by the Company in
accordance with the rules and regulations of the Securities and Exchange
Commission regarding interim financial information. Accordingly, these financial
statements and notes thereto do not include certain disclosures normally
associated with financial statements prepared in accordance with accounting
principles generally accepted in the United States of America. This interim
financial information should be read in conjunction with the Company’s audited
consolidated financial statements and notes thereto for the year ended December
31, 2005 included in the Company’s Annual Report on Form 10-KSB.
The
consolidated financial statements include the accounts of OXIS International,
Inc. and its subsidiaries. All intercompany balances and transactions have
been
eliminated. On December 6, 2005, the Company purchased 51% of the common
stock of BioCheck. The consolidated statements of operations for the three
and
six months ended June 30, 2006 include the results of operations of
BioCheck and the consolidated balance sheets include the assets and liabilities
of BioCheck at December 31, 2005 and June 30, 2006. BioCheck’s
revenues and expenses are not included in the consolidated statements of
operations for the three and six months ended June 30, 2005 because those
results of operations were incurred before the December 6, 2005 date
of acquisition. In the opinion of the Company’s management, the consolidated
financial statements include all adjustments (consisting of only normal
recurring adjustments) and disclosures considered necessary for a fair
presentation of the results of the interim periods presented. This interim
financial information is not necessarily indicative of the results of any
future
interim periods or for the Company’s full year ending December 31,
2006.
Segment
Reporting
The
Company operates in one reportable segment.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
Restricted
Cash
The
Company invested $3,060,000 of cash into a 30-day certificate of deposit
at
KeyBank, N.A. (“KeyBank”) and entered into a $3,060,000 non-revolving one-year
loan agreement with KeyBank on December 2, 2005 for the purpose of
completing the initial closing of the BioCheck acquisition. The Company granted
a security interest in its $3,060,000 certificate of deposit to KeyBank under
the loan agreement. The $3,060,000 loan with KeyBank was repaid during February
2006 and a new one-year loan agreement for $3,060,000 was entered into at
Bridge
Bank, N.A. (“Bridge Bank”). As part of the loan arrangement with Bridge Bank,
the Company granted a security interest in a $3,060,000 certificate of deposit
transferred from KeyBank to Bridge Bank. The certificate of deposit bears
interest at 1.0%. Consequently, these certificates of deposit were classified
as
restricted cash on the consolidated balance sheets at June 30, 2006 and December
31, 2005 as the cash is restricted as to use.
Share-Based
Compensation
The
Company has historically accounted for stock options granted to employees
and
directors and other share-based employee compensation plans using the intrinsic
value method of accounting in accordance with Accounting Principles Board
Opinion No. 25, "Accounting for Stock Issued to Employees" (“APB 25”) and
related interpretations. As such, the Company recognized compensation expense
for stock options only if the quoted market value of the Company’s common stock
exceeded the exercise price of the option on the grant date. Any compensation
expense realized using this intrinsic value method is being amortized over the
vesting period of the option.
In
December 2004, the Financial Accounting Standards Board ("FASB") issued SFAS
123R which requires a public entity to measure the cost of employee services
received in exchange for an award of equity instruments based on the fair
value
of the award on the grant date (with limited exceptions). That cost will
be
recognized in the entity’s financial statements over the period during which the
employee is required to provide services in exchange for the award.
Management
implemented SFAS 123R effective January 1, 2006, using the modified prospective
application method. Under the modified prospective application method, SFAS
123R
applies to new awards and to awards modified, repurchased or cancelled after
January 1, 2006. Additionally, compensation costs for the portion of awards
for
which the requisite service has not been rendered that are outstanding as
of
January 1, 2006 are recognized as the requisite service is rendered on or
after
January 1, 2006. The compensation cost for that portion of awards is based
on
the grant-date fair value of those awards as calculated for proforma disclosures
under Statement of Financial Accounting Standard No. 123, "Accounting for
Stock-Based Compensation" ("SFAS 123"). The compensation cost for awards
issued
prior to January 1, 2006 attributed to services performed in years after
January
1, 2006 uses the attribution method applied prior to January 1, 2006 according
to SFAS 123, except that the method of recognizing forfeitures only as they
occur was not continued.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
The
recognition of share-based employee compensation costs during 2006 had no
related tax effect since the Company provides a valuation allowance equal
to its
net deferred tax assets. The adoption of SFAS 123R had no effect on cash
flow
from operations, cash flow from financing activities and basic and diluted
earnings per share. The effect of adoption of SFAS 123R on the results of
operations for the six months ended June 30, 2006 was:
|
|
Loss
from Operations
|
|
Loss
Before Provision
for Income
Taxes
|
|
Net
Loss
|
|
Results
as reported
|
|
$
|
(1,072,000
|
)
|
$
|
(1,180,000
|
)
|
$
|
(1,269,000
|
)
|
Additional
compensation expense - effect of adoption of SFAS 123R
|
|
|
131,000
|
|
|
131,000
|
|
|
131,000
|
|
Proforma
results applying the original provisions of SFAS 123 using the
intrinsic
value method of APB
25
|
|
$
|
(941,000
|
)
|
$
|
(1,049,000
|
)
|
$
|
(1,138,000
|
)
|
The
following table presents the effect on net loss and net loss per share if
the
Company had applied the fair value recognition provisions of SFAS 123 to
share-based awards to employees prior to January 1, 2006:
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
2006
|
|
2005
|
|
Net
loss as reported
|
|
$
|
(579,000
|
)
|
$
|
(300,000
|
)
|
$
|
(1,269,000
|
)
|
$
|
(549,000
|
)
|
Share-based
employee compensation expense included in reported net loss
|
|
|
60,000
|
|
|
—
|
|
|
131,000
|
|
|
—
|
|
Share-based
employee compensation expense that would have been included in
net income
if the fair value method had been applied to all awards
|
|
|
(60,000
|
)
|
|
(41,000
|
)
|
|
(131,000
|
)
|
|
(89,000
|
)
|
Pro
forma net loss
|
|
$
|
(579,000
|
)
|
$
|
(341,000
|
)
|
$
|
(1,269,000
|
)
|
$
|
(638,000
|
)
|
Net
loss per share:
Basic
and diluted - as reported
Basic
and diluted - pro forma
|
|
$
$
|
(0.01
(0.01
|
)
)
|
$
$
|
(0.01
(0.01
|
)
)
|
$
$
|
(0.03
(0.03
|
)
)
|
$
$
|
(0.01
(0.02
|
)
)
|
The
Company undertook a comprehensive study of options issued from 1994 through
2001
to determine historical patterns of options being exercised and forfeited.
The
results of this study were used as a source to estimate expected life and
forfeiture rates. The new estimated life of 4.45 years was applied only to
determine the fair value of awards issued after January 1, 2006. The estimated
forfeiture rate of 40% was applied to all awards that vested after January
1,
2006, including awards issued prior to that date, to determine awards expected
to be exercised.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
The
Company issued no options to employees and directors during the three months
ended June 30, 2006. The Company issued options to purchase 15,000 shares
of the
Company's common stock to employees and directors during the three months
ended
June 30, 2005, and options to purchase 280,000 and 615,000 shares of the
Company's common stock during the six months ended June 30, 2006 and 2005,
respectively. The fair values of employee stock options are estimated for
the
calculation of employee compensation expense in 2006 and the pro forma
adjustments in 2005 in the above table at the date of grant using the
Black-Scholes option-pricing model with the following weighted-average
assumptions during 2006 and 2005: expected volatility of 90% and 170%,
respectively; average risk-free interest rate of 4.45% and 4.00%, respectively;
initial expected life of 4.45 years and 6 years, respectively; no expected
dividend yield; and amortization over the vesting period of typically one
to
four years.
Stock
options issued to non-employees as consideration for services provided to
the
Company have been accounted for under the fair value method in accordance
with
SFAS 123 and Emerging Issues Task Force No. 96-18, “Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services,” which requires that compensation
expense be recognized for all such options. The Company issued options to
purchase 50,000 shares of the Company's common stock to non-employees and
a
warrant to purchase 108,000 shares of the Company's common stock under a
warrant
to a director under a consulting agreement during the three and six months
ended
June 30, 2006. The Company issued no options to non-employees during the
six
months ended June 30, 2005.
Net
Loss Per Share
Basic
net
loss per share is computed by dividing the net loss for the period by the
weighted average number of common shares outstanding during the period. Diluted
net loss per share is computed by dividing the net loss for the period by
the
weighted average number of common shares outstanding during the period, plus
the
potential dilutive effect of common shares issuable upon exercise or conversion
of outstanding stock options and warrants during the period. The weighted
average number of potentially dilutive common shares were 975,052 and 908,665
for the three months ended June 30, 2006 and 2005, respectively, and 781,559
and
1,041,575 for the six months ended June 30, 2006 and 2005, respectively.
These
shares were excluded from net diluted loss per share because of their
anti-dilutive effect.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
Recent
Accounting Pronouncements
In
March
2006, the FASB issued Statement of Financial Accounting Standards No. 156,
“Accounting for Servicing of Financial Assets—an amendment of FASB Statement No.
140” (“SFAS No. 156”). SFAS No. 156 requires an entity to recognize a servicing
asset or servicing liability each time it undertakes an obligation to service
a
financial asset by entering into a servicing contract in any of the following
situations: a transfer of the servicer’s financial assets that meets the
requirements for sale accounting; a transfer of the servicer’s financial assets
to a qualifying special-purpose entity in a guaranteed mortgage securitization
in which the transferor retains all of the resulting securities and classifies
them as either available-for-sale securities or trading securities; or
an
acquisition or assumption of an obligation to service a financial asset
that
does not relate to financial assets of the servicer or its consolidated
affiliates. SFAS No. 156 also requires all separately recognized servicing
assets and servicing liabilities to be initially measured at fair value,
if
practicable and permits an entity to choose either the amortization or
fair
value method for subsequent measurement of each class of servicing assets
and
liabilities. SFAS No. 156 further permits, at its initial adoption, a one-time
reclassification of available for sale securities to trading securities
by
entities with recognized servicing rights, without calling into question
the
treatment of other available for sale securities under Statement of Financial
Accounting Standards No. 115, “Accounting for Certain Investments in Debt and
Equity Securities”, provided that the available for sale securities are
identified in some manner as offsetting the entity’s exposure to changes in fair
value of servicing assets or servicing liabilities that a servicer elects
to
subsequently measure at fair value and requires separate presentation of
servicing assets and servicing liabilities subsequently measured at fair
value
in the statement of financial position and additional disclosures for all
separately recognized servicing assets and servicing liabilities. SFAS
No. 156
is effective for fiscal years beginning after September 15, 2006, with
early
adoption permitted as of the beginning of an entity’s fiscal year. Management
believes the adoption of SFAS No. 156 will have no impact on the Company’s
financial condition or results of operations.
In
February 2006, the FASB issued Statement of Financial Accounting Standards
No.
155, “Accounting for Certain Hybrid Financial Instruments, an Amendment of FASB
Standards No. 133 and 140” (“SFAS No. 155”). SFAS No. 155 established the
accounting for certain derivatives embedded in other instruments. It simplifies
accounting for certain hybrid financial instruments by permitting fair
value
remeasurement for any hybrid instrument that contains an embedded derivative
that otherwise would require bifurcation under Statement of Financial Accounting
Standards No. 133 “Accounting for Derivative Instruments and Hedging Activities”
as well as eliminating a restriction on the passive derivative instruments
that
a qualifying special-purpose entity (“SPE”) may hold under Statement of
Financial Accounting Standards No. 140 “Accounting for Transfers and Servicing
of Financial Assets and Extinguishments of Liabilities” (“SFAS No. 140”). SFAS
No. 155 allows a public entity to irrevocably elect to initially and
subsequently measure a hybrid instrument that would be required to be separated
into a host contract and derivative in its entirety at fair value (with
changes
in fair value recognized in earnings) so long as that instrument is not
designated as a hedging instrument pursuant to the statement. SFAS No.
140
previously prohibited
a qualifying special-purpose entity from holding a derivative financial
instrument that pertains to a beneficial interest other than another derivative
financial instrument. SFAS
No.
155 is effective for fiscal years beginning after September 15, 2006, with
early
adoption permitted as of the beginning of an entity’s fiscal year. Management
believes the adoption of SFAS No. 155 will have no impact on the Company’s
financial condition or results of operations.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
In
June
2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes - an interpretation of FASB Statement No. 109” (“FIN 48”), which
prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected
to be
taken in a tax return. FIN 48 also provides guidance on de-recognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. FIN 48 is effective for fiscal years beginning
after
December 15, 2006. The Company does not expect the adoption of FIN 48 to
have a
material impact on our financial reporting, and the Company is currently
evaluating the impact, if any, the adoption of FIN 48 will have on our
disclosure requirements.
2. Acquisition
of BioCheck
On
September 19, 2005, the Company entered into a stock purchase agreement with
BioCheck and certain stockholders of BioCheck to purchase all of the common
stock of BioCheck for $6.0 million in cash. BioCheck is a privately held
California corporation engaged in the development of immunoassays, with a
number
of clinical diagnostic tests that have been approved by the United States
Food
and Drug Administration. On December 6, 2005, the Company purchased 51% of
the common stock of BioCheck from each of the shareholders of BioCheck on
a pro
rata basis, for $3,060,000 in cash. This acquisition was accounted for by
the
purchase method of accounting according to Statement of Financial Accounting
Standards No. 141, “Business Combinations” (“SFAS No. 141”).
Pursuant
to the stock purchase agreement, OXIS will use its reasonable best efforts
to
consummate a follow-on financing transaction to raise additional capital
with
which to purchase the remaining outstanding shares of BioCheck in one or
more
additional closings. The purchase price for any BioCheck shares purchased
after
the initial closing will be increased by an additional 8% per annum from
December 6, 2005. If OXIS has not purchased all of the outstanding shares
of BioCheck within twelve months of December 6, 2005, the earnings before
interest, taxes, depreciation and amortization expenses, if any, of BioCheck,
will be used to repurchase the remaining outstanding BioCheck shares at one
or
more additional closings. The purchase of the remaining outstanding shares
of
BioCheck will be accounted for the same as the initial purchase of 51% of
BioCheck using the purchase method of accounting according to SFAS No. 141.
The
additional purchase price will be allocated over the purchased assets of
BioCheck and the consolidated statements of operations will continue to include
the results of operations of BioCheck reduced by the minority interest, if
any,
in BioCheck. The Company may obtain additional independent valuations of
BioCheck’s assets related to the acquisition of the remaining 49% of BioCheck
and additional acquisition costs may be incurred. Such information and costs
may
affect the disclosures as presented herein.
On
June
23, 2006, OXIS entered into a mutual services agreement with BioCheck. Each
of
OXIS and BioCheck will provide certain services to the other corporation
to be
charged monthly at an hourly rate with an overhead surcharge. The services
that
BioCheck will provide include manufacturing the bulk of OXIS’ research assay
test kits, assisting in packaging and shipping such research assay test kits
to
OXIS customers, and undertaking research and development of certain new OXIS
research assay test kits on a case-by-case basis to be agreed upon between
the
parties. OXIS will provide services to BioCheck, including marketing and
sales,
website management and materials requirement and control
systems.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
The
agreement terminates on December 6, 2009, or earlier upon mutual consent
of the
parties, upon 90 day prior written notice by either party, by either party
if a
monthly billing is unpaid after 60 days if a 15 day notice and opportunity
to
cure has been provided, or upon a material breach of the Agreement after
30
days’ notice and opportunity to cure the breach.
3. Notes
Payable
|
|
June
30, 2006
|
|
December
31, 2005
|
|
Note
payable to KeyBank, N.A.
|
|
$
|
—
|
|
$
|
3,060,000
|
|
Note
payable to Bridge Bank, N.A.
|
|
|
3,060,000
|
|
|
—
|
|
Note
payable to the Company’s President & CEO
|
|
|
200,000
|
|
|
—
|
|
Note
payable to Fagan Capital, Inc.
|
|
|
400,000
|
|
|
—
|
|
Total
notes payable
|
|
$
|
3,660,000
|
|
$
|
3,060,000
|
|
On
December 2, 2005, the Company entered into non-revolving one-year loan
agreement with KeyBank in the amount of $3,060,000, for the purpose of
completing the initial closing of the BioCheck acquisition. The Company granted
a security interest in its $3,060,000 certificate of deposit at KeyBank under
the loan agreement. The loan bore interest at an annual rate that was 2.0%
greater than the interest rate on the certificate of deposit. The Company’s
$3,060,000 loan with KeyBank was repaid during February 2006 and a new one-year
loan agreement was entered into with Bridge Bank. The Company has granted
a
security interest in its $3,060,000 certificate of deposit transferred from
KeyBank to Bridge Bank. The loan bears interest at 3.0% and the certificate
of
deposit bears interest at 1.0%.
On
March
10, 2006, the Company received $200,000 in exchange for an unsecured promissory
note with the Company’s president and chief executive officer. The related party
note bears interest at 7.0%. Interest and principal are due on September
10,
2006 or, at the option of the holder, on the date the Company receives net
proceeds in the amount of $500,000 or more from a debt or equity financing.
In
addition, if, at any time on or before the maturity date, the Company enters
into an agreement to incur debt, the holder has the right to rollover this
note
into such debt arrangement, on the same terms and conditions offered to such
future lenders. The purpose of this loan was to provide the Company with
short
term financing as it seeks longer term financing.
On
March
31, 2006, the Company entered into a $400,000 unsecured promissory note with
Fagan Capital, Inc. ("Fagan Capital"). Interest accrues at an annual rate
of 8.0% and interest and principal were initially due on June 2, 2006. On
July
26, 2006, Fagan Capital extended the maturity date of the promissory note
to
June 1, 2007 and the Company issued to Fagan Capital a warrant to purchase
1,158,857 shares of common stock at an initial exercise price of $0.35 per
share. See Note 7. The obligation to pay all unpaid principal and accrued
interest will be accelerated upon an event of default, including failure
to pay
debt when due in an amount exceeding $200,000, the bankruptcy of the Company
or
related events. The Company covenants that it will not incur indebtedness,
other
than its current Bridge Bank loan and normal course trade debt, in excess
of $1
million. The Company also covenants that it will not pledge, grant or convey
any
new liens on the Company’s assets. The purpose of this loan was to provide the
Company with short term financing as it seeks longer term financing.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
4. Supplemental
Cash Flow Disclosures
The
Company recognized non-cash compensation expense of $49,000 and $8,000 related
to the issuance and vesting of stock options issued to consultants in the
six
months ended June 30, 2006 and 2005, respectively. The Company recognized
non-cash compensation expense of $131,000 related to the issuance and vesting
of
stock options issued to employees in the six months ended June 30, 2006.
No
employee non-cash compensation expense was recognized in the six months ended
June 30, 2005 prior to the implementation of SFAS 123R. Cash interest paid
was $58,000 and $11,000 in the six months ended June 30, 2006 and 2005,
respectively.
5. Relocation
of Operations
On
December 6, 2005, the Company committed itself to a plan to cease
operations in Portland, Oregon and relocate operations to Foster City,
California (the “Relocation”). The Company decided to effect the Relocation
after reviewing and evaluating all aspects of the Company’s operations to
determine the profitability and viability of continuing in the Portland,
Oregon
location. During the first quarter of 2006, operations were relocated to
California and on February 15, 2006 the Portland, Oregon facility was closed
with the termination of employment of all Portland based employees who did
not
relocate to California. The Company’s subsidiary, BioCheck, has commenced
shipping of the Company’s products and is manufacturing all of its research
assay kit products not manufactured by third party suppliers.
In
connection with the Relocation, the Company accrued $119,000 during 2005
for
employee severances offered to all regular full-time employees who were not
relocated to Foster City, California. Of this amount, $78,000 was paid during
the first half of 2006, resulting in $41,000 of accrued expenses at June
30,
2006. The Company expects $33,000 of this amount to be paid during the remainder
of 2006 and $8,000 is to be paid during 2007. The Company accrues for these
benefits in the period when benefits are communicated to the terminated
employees. Typically, terminated employees are not required to provide continued
service to receive termination benefits. In general, the Company uses a formula
based on the number of years of service to calculate the termination benefits
to
be provided to affected employees.
In
connection with the Relocation, the Company signed a lease agreement to occupy
4,136 square feet of space adjacent to space occupied by its BioCheck subsidiary
in Foster City, California. The lease commenced on April 1, 2006 at an annual
base rent of $62,000 per year that increases incrementally to $66,000 by
the end
of the lease term on March 31, 2009. In addition to the base rent, the Company
will be responsible for its proportionate share of the building's operating
expenses and real estate taxes. The Company has a renewal option to extend
the
lease for one three-year period at the prevailing market rental value for
rentable property in the same area.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
6.
Related Party Transactions
BioCheck
and EverNew Biotech, Inc., a California corporation (“EverNew”), entered into a
services agreement dated December 6, 2005 (the “Services Agreement”). The
holders of the shares of capital stock of EverNew are substantially the same
set
of individuals and entities who held BioCheck’s common stock immediately prior
to the initial closing of OXIS’ acquisition of BioCheck, including Dr. John
Chen, President of BioCheck, as a significant shareholder. EverNew is an
emerging point-of-care diagnostics company, with a number of products in
development. EverNew renders certain services to BioCheck, including assay
research and development work, and BioCheck renders certain administrative
services to EverNew. In consideration of services provided by EverNew, BioCheck
agreed to pay to EverNew $12,000 per month, provided, however, if the sum
of
EverNew’s gross revenues for a consecutive three month period during the term of
the Services Agreement equals or exceeds $100,000, then BioCheck shall no
longer
be obligated to pay EverNew any amounts for the remainder of the term of
the
Services Agreement. Further, in such event, EverNew shall pay BioCheck an
amount
equal to the EverNew Service Cost per month for the remainder of the term
of the
Services Agreement, and the EverNew Service Cost for such month shall be
reduced
by the amount of the BioCheck compensation paid to BioCheck for such month
under
the Services Agreement. As
used
in the Services Agreement, EverNew Service Cost means the cost of all BioCheck
Services provided by BioCheck each month under the Services Agreement, as
incurred and determined in good faith by BioCheck. Amounts due to EverNew
from BioCheck were $129,000 and $194,000 at June 30, 2006 and December 31,
2005, respectively.
7. Subsequent
Events
On
July
26, 2006, Fagan Capital extended the maturity date of the $400,000 promissory
note, as described in Note 3, which was originally issued on March 31, 2006
by
entering into a renewal and modification promissory note (“Renewal Note”). The
Renewal Note has a principal amount of $405,600, comprised of the principal
amount of the original promissory note plus accrued interest of $5,600. The
effective date of the Renewal Note is June 2, 2006. No payments of interest
or
principal are required prior to the maturity date of June 1, 2007. The
obligation to pay all unpaid principal and accrued interest will be accelerated
upon an event of default, including, after October 31, 2006, failure to pay
debt
when due in an amount exceeding $300,000, or at any time, the bankruptcy
of OXIS
or related events. The Company further agreed that, after October 31, 2006,
it
will not incur indebtedness, other than its current Bridge Bank loan and
normal
course trade debt, in excess of $1 million, and that it will not pledge,
grant
or convey any new liens on its assets. The purpose of this loan was to provide
the Company with intermediate term financing as it seeks longer term
financing.
In
conjunction with the issuance of the Renewal Note, on July 26, 2006 the Company
issued to Fagan Capital a common stock purchase warrant to purchase 1,158,857
shares of common stock at an initial exercise price of $0.35 per share. The
exercise price is adjustable pursuant to certain anti-dilution provisions
and
upon the occurrence of a stock split. The common stock purchase warrant has
an
effective date of June 2, 2006 and expires on June 1, 2014. The parties are
negotiating the terms of a registration rights agreement covering the shares
underlying the common stock purchase warrant. This warrant will be valued
using
the Black-Scholes option-pricing model and that amount will be expensed over
the
life of the loan as of the date of the agreement.
On
July
20, 2006, the Company entered into an amendment to the exclusive license
and
supply agreement originally signed on September 28, 2004 with HaptoGuard,
Inc.
(“HaptoGuard”). The Company granted HaptoGuard three-month extensions to fulfill
its obligation to begin Phase II clinical trials with a licensed product.
HaptoGuard may obtain three such extensions upon payment of $50,000 for each
extension. In addition, the Company agreed to change the timeline for initiation
of Phase IIb clinical trials with a licensed product under the license agreement
and agreed to allow the same extension arrangement for that milestone. The
Company has received a $50,000 payment from HaptoGuard on July 24, 2006 for
the
first extension ending on September 30, 2006.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
June
30, 2006
Item
2. Management’s
Discussion and Analysis or Plan of Operation.
Statement
Regarding Forward-Looking Statements
The
statements contained in this Report on Form 10-QSB that are not purely
historical are forward-looking statements within the meaning of Section
27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of
1934, or the Exchange Act, including, without limitation, statements regarding
our expectations, objectives, anticipations, plans, hopes, beliefs, intentions
or strategies regarding the future. Forward-looking statements include,
without
limitation, statements regarding:
(1)
our plan to increase revenues to generate sufficient gross profit in excess
of
selling, general and administrative, and research and development expenses
in
order to achieve profitability; (2) our expectation that BioCheck will
continue
to be cash flow positive, and that its cash will be sufficient to sustain
its
operating activities; (3) our intention to seek additional loan and equity
financings to obtain sufficient funds to sustain our operations, implement
our
marketing campaign and purchase the remaining 49% of BioCheck for approximately
$3.0 million; (4) our plan to increase revenues by our marketing campaign
and
the introduction of new products; (5) our belief that the adoption of certain
accounting standards will have no impact on our financial condition or
results
of operations; (6) our expectation that $33,000 of employee severance package
expenses will be paid during the remainder of 2006 and $8,000 will be paid
during 2007; (7) our plan to pursue the development of novel cardiac markers
intended to provide a more effective diagnostic predictor test for patients
at
risk of cardiac events before they occur, given the availability of sufficient
capital resources; (8) our plan to develop the cardiac marker product through
the combination of our MPO assay with other in-house assays; (9) our belief
that
our Ergothioneine compound may be well suited for development as a nutraceutical
supplement that can be sold over the counter and our testing of Ergothioneine;
(10) our intent to pursue the development of Ergothioneine for use in
over-the-counter markets, given the availability of sufficient capital
resources; (11) our expectation that a new myeloperoxidase research assay
will
be ready for commercial launch in the third quarter of 2006; (12) our
expectation that the ID protein assays and reagents will be ready for commercial
launch by late 2006; (13) our plan to continue to build our management
team and
enhance our Board of Directors during 2006; (14) our projections for 2006,
which
are based upon our expectations that BioCheck will incur similar revenues
and
costs in 2006 as it incurred in 2005; (15) our expectation that in the
third
quarter 2006, product revenues will increase modestly from the second quarter;
(16) our intention to develop new diagnostic test kits and evaluate our
product
offerings, pricing and distribution network in order to increase sales
volume;
(17) our expectation that third quarter 2006 product costs will increase
proportionally with any increases in revenues; (18) our expectation that
revenues and expenses will increase substantially from 2005 to 2006 with
the
consolidation of all of BioCheck’s results of operations during the first
quarter of 2006; (19) our expectation that third quarter 2006 research
and
development costs will be approximately the same as the second quarter;
(20) our
expectation that the actual amount of research and development expenses
will
fluctuate with the availability of funding; (21) our expectation that third
quarter 2006 selling, general and administrative expenses will approximately
the
same as the second quarter; (22) our expectation that interest expense
will
increase during the third quarter of 2006 with the non-cash expense incurred
from the issuance of a warrant in the third quarter 2006;
and
(23) our expectation that our cash position will not be sufficient to sustain
our operations through the third quarter of 2006 without additional
financing.
It
is
important to note that our actual results could differ materially from
those
included in such forward-looking statements due to a variety of factors
including (1) failure to complete our acquisition of BioCheck or to adequately
integrate the operations of the two companies; (2) failure to achieve any
benefits in connection with the recent changes in management or personnel;
(3)
disruption in operations due to the relocation plan and reduction in workforce;
(4) inability to hire employees or management; (5) failure to make payments
when
required under our Mutual Services Agreement with BioCheck to avoid termination;
(6) failure to find alternative suppliers; (7)
failure to develop or market products successfully; (8)
failure to obtain necessary financing; (9)
the
cost of complying with regulatory
requirements; (10)
uncertainties exist relating to issuance, validity and ability to enforce
and
protect patents, other intellectual property and certain proprietary
information; (11)
our
products may not meet product performance specifications; (12)
new
products may be unable to compete successfully in either existing or new
markets; (13)
availability and future costs of materials and other operating expenses;
(14)
weakness in the global economy and changing market conditions, together
with
general economic conditions affecting our target industries, could cause
our
operating results to fluctuate; (15) miscalculations in the assessment
of our
cash position; and (16) our failure to accurately predict the impact of
the
adoption of certain accounting standards. These and other factors could
cause
actual results to differ materially from the forward looking statements.
For a
detailed explanation of such risks, please see the section entitled “Factors
that May Affect Future Operating Results” beginning on page 23
of
this Report on Form 10-QSB. Such risks, as well as such other risks and
uncertainties as are detailed in our Securities and Exchange Commission,
or the
SEC, reports and filings for a discussion of the factors that could cause
actual
results to differ materially from the forward- looking statements. Given
these
uncertainties, readers are cautioned not to place undue reliance on the
forward-looking statements. All
forward-looking statements included in this Report
on Form 10-QSB
are
based on information available to us on the date hereof, and we assume
no
obligation to update any such forward-looking statements.
The
following discussion of our financial condition and plan of operation should
be
read in conjunction with our consolidated financial statements and related
notes
included in this Report and our audited consolidated financial statements
and
related notes for the year ended December 31, 2005 included in our Annual
Report
on Form 10-KSB.
Overview
OXIS
International, Inc. develops technologies and products to research, diagnose,
treat and prevent diseases of oxidative stress associated with damage from
free
radical and reactive oxygen species. We derive our revenues primarily from
sales
of research diagnostic assays to research laboratories. Our diagnostic products
include approximately 30 research assays to measure markers of oxidative
stress. We
hold
the rights to three therapeutic classes of compounds in the area of oxidative
stress, and have focused our commercialization programs in clinical
cardiovascular markers, including MPO (myeloperoxidase) and GPx (glutathione
peroxidase), as well as a potent antioxidant, Ergothioneine, that may be
appropriate for sale over-the-counter as a dietary supplement. OXIS has acquired
a 51% interest in and has the option to purchase the remaining 49% of BioCheck,
Inc., or BioCheck.
Our
majority-held subsidiary, BioCheck,
is a
leading producer of clinical diagnostic assays, including high quality enzyme
immunoassay research services and immunoassay kits for cardiac and tumor
markers, infectious diseases, thyroid function, steroids, and fertility hormones
designed to improve the accuracy, efficiency, and cost-effectiveness of
in
vitro
(outside
the body) diagnostic testing in clinical laboratories. BioCheck
focuses primarily on the immunoassay segment of the clinical diagnostics
market.
BioCheck
offers over 40 clinical diagnostic assays manufactured in its 15,000
square-foot, U.S. Food and Drug Administration, or FDA, certified Good
Manufacturing Practices device-manufacturing facility in Foster City,
California.
We
incurred net losses of $1.3 million in the six months ended June 30, 2006
and $3.1 million in 2005. We began expensing stock options effective
January 1, 2006 in accordance with the Statement of Financial Accounting
Standards No. 123 (revised 2004), “Share-Based Payments,” or SFAS 123R, and we
are seeking debt financing that may have related warrants. Non-cash financing
charges resulting from such financing and the additional non-cash charges
related to stock options may delay profitability. Our plan is to increase
revenues to generate sufficient gross profit in excess of selling, general
and
administrative, and research and development expenses in order to achieve
profitability. However, we cannot assure you that we will accomplish this
task
and there are many factors that may prevent us from reaching our goal of
profitability.
On
a
consolidated basis, we had cash and cash equivalents of $461,000 at June
30,
2006 of which $441,000 was held by BioCheck. Since BioCheck has been and
is
expected to continue to be cash flow positive, management believes that its
cash
will be sufficient to sustain its operating activities.
The
OXIS
parent company had cash and cash equivalents of $20,000 at June 30, 2006.
OXIS
cannot access the cash held by its majority-held subsidiary, BioCheck, to
pay
for the corporate purposes of the OXIS parent company. We have incurred negative
operating cash flows of $0.7 million during the first six months of 2006
and
$2.1 million during 2005. The current rate of cash usage raises substantial
doubt about the OXIS parent company’s ability to continue as a going concern,
absent any new sources of significant cash flows. In an effort to mitigate
this
near-term concern, we are seeking debt and equity financings to obtain
sufficient funds to sustain operations, implement our marketing campaign
and
purchase the remaining 49% of BioCheck for approximately $3.0 million. We
plan
to increase revenues by our marketing campaign and the introduction of new
products. However, we cannot assure you that we will successfully obtain
debt or
equity financing, if any, sufficient to finance our goals or that we will
increase product related revenues as such events are subject to factors beyond
our control. The financial statements do not include any adjustments relating
to
the recoverability and classification of recorded assets, or the amounts
and
classification of liabilities that might be necessary in the event OXIS cannot
continue in existence.
Recent
Developments
Current
significant financial and operating events and strategies are summarized
as
follows:
Stockholder
Approval
On
August
1, 2006, at the OXIS 2006 Annual Meeting of Stockholders, the five nominated
directors were re-elected, the proposal to amend the Company’s Certificate of
Incorporation to increase the number of authorized shares of common stock
from
95,000,000 to 150,000,000 was approved, and the proposal to increase the
number
of shares reserved for issuance under the OXIS 2003 Stock Incentive Plan,
or the
Plan, from 3,600,000 shares to 5,600,000 shares was also approved by the
stockholders.
License
Agreement Extension
On
July
20, 2006, the Company entered into an amendment to the exclusive license
and
supply agreement originally signed on September 28, 2004 with HaptoGuard,
Inc.,
or HaptoGuard. The Company granted HaptoGuard three-month extensions to fulfill
its obligation to begin Phase II clinical trials with a licensed product.
HaptoGuard may obtain three such extensions upon payment of $50,000 for each
extension. In addition, the Company agreed to change the timeline for initiation
of Phase IIb clinical trials with a licensed product under the license agreement
and agreed to allow the same extension arrangement for that milestone. The
Company has received a $50,000 payment from HaptoGuard on July 24, 2006 for
the
first extension ending on September 30, 2006.
Service
Agreement with Ambient Advisors LLC
On
May
12, 2006, we entered into an agreement with Ambient Advisors LLC, or Ambient
Advisors. Gary M. Post, a member of the board of directors, is the manager
of
Ambient Advisors. Ambient Advisors will provide certain services pertaining
to
strategic planning, investor communications and financing strategies or other
projects at the request of our chief executive officer for a one year period,
and thereafter, on a month-to-month basis. Ambient Advisors compensation
is
$5,000 per month and we granted Ambient Advisors a ten year warrant to purchase
108,000 shares of OXIS common stock at an exercise price of $0.39 per share,
with 9,000 shares becoming exercisable each month over the term of the
agreement.
Acquisition
of BioCheck
On
September 19, 2005, we entered into a stock purchase agreement with BioCheck
and
its stockholders to purchase all of its common stock for $6.0 million in
cash. BioCheck is a leading producer of enzyme immunoassay diagnostic kits
for
clinical laboratories. On December 6, 2005, we purchased 51% of the
shares of BioCheck’s common stock from each of its shareholders on a pro rata
basis for $3,060,000 in cash. This acquisition was accounted for by the purchase
method of accounting according to Statement of Financial Accounting Standards
No. 141, “Business Combinations.” The consolidated statements of operations for
the three and six months ended June 30, 2006 include the results of
operations of BioCheck and the consolidated balance sheets include the assets
and liabilities of BioCheck at December 31, 2005 and June
30, 2006. Pursuant to the stock purchase agreement, OXIS will use its
reasonable best efforts to consummate a follow-on financing transaction to
raise
additional capital with which to purchase the remaining outstanding shares
of
BioCheck in one or more additional closings.
Mutual
Services Agreement
On
June
23, 2006, we entered into a mutual services agreement with BioCheck. Each
of
OXIS and BioCheck will provide certain services to the other corporation
to be
charged monthly at an hourly rate with an overhead surcharge. The services
that
BioCheck will provide include manufacturing the bulk of OXIS’ research assay
test kits, assisting in packaging and shipping such research assay test kits
to
OXIS customers, and undertaking research and development of certain new OXIS
research assay test kits on a case-by-case basis to be agreed upon between
the
parties. OXIS will provide services to BioCheck, including marketing and
sales,
website management and materials requirement and control systems.
The
agreement terminates on December 6, 2009, or earlier upon mutual consent
of the
parties, upon 90 day prior written notice by either party, by either party
if a
monthly billing is unpaid after 60 days if a 15 day notice and opportunity
to
cure has been provided, or upon a material breach of the Agreement after
30
days’ notice and opportunity to cure the breach. OXIS owes BioCheck
approximately $73,000 for services that BioCheck had provided to OXIS prior
to
the signing of the Agreement, on or before June 30, 2006. OXIS has not made
that
payment. If OXIS receives written notice of breach of the agreement due to
this
non-payment, it will have 15 days to cure that breach. If OXIS fails to cure
the
breach during the cure period, BioCheck would have the right to terminate
the
agreement.
Product
Development
We
have
expanded our product portfolio of research assay kits for the cardiovascular
research markets with the addition of five new assay products from BioCheck
for
the measurement of biomarkers of inflammation related to cardiovascular
disease. Given the availability of sufficient capital resources, we plan
to pursue the development of novel cardiac markers intended to provide a
more
effective diagnostic predictor test for patients at risk of cardiac events
before they occur. We are planning to develop this product through the
combination of our myeloperoxidase, or MPO, assay with other in-house
assays. We also believe that our Ergothioneine compound may be well suited
for development as a nutraceutical supplement that can be sold over the
counter. We are currently testing Ergothioneine produced in bulk to ensure
that its purity level is acceptable. Given the availability of sufficient
capital resources and the successful scale-up to a bulk manufacturing process
that ensures an acceptable level of purity, we intend to pursue the development
of Ergothioneine for use in the over the counter market, however, there can
be
no assurance as to when or if we will launch Ergotheioneine on a commercial
basis as a nutraceutical.
BioCheck
currently has several products under development for cancer,
cardiac/inflammatory and angiogenesis research applications. A research
assay and reagents for the detection of HMGA2, a marker for aggressive breast
cancer, are under development. Myeloperoxidase is an inflammatory
protein that has utility as a prognostic marker for cardiac events. A new
myeloperoxidase research assay has been developed that we expect will be
ready
for commercial launch in the third quarter of 2006. Id proteins play a
central role in cell differentiation, and Id1 and Id3 play a central and
critical role in tumor related angiogenesis. BioCheck has developed
research assays and rabbit monoclonal antibodies for the detection of human
and
mouse Id proteins. We currently expect that the Id protein assays and reagents
will be ready for commercial launch by late 2006.
Loans
and Warrant
The
$3,060,000 loan with KeyBank, N.A., or KeyBank, was repaid during February
2006
and a new one-year loan agreement for $3,060,000 was entered into with Bridge
Bank, National Association, or Bridge Bank. As part of the loan arrangement
with
Bridge Bank, we granted a security interest in a $3,060,000 certificate of
deposit transferred from KeyBank to Bridge Bank. The loan bears interest
at 3.0%
and the certificate of deposit bears interest at 1.0%.
On
March
10, 2006, we received $200,000 in exchange for an unsecured promissory note
with
Steven T. Guillen, our president and chief executive officer. The related
party
note bears interest at 7.0%. Interest and principal are due on September
10,
2006 or, at the option of Mr. Guillen, on the date we receive net proceeds
in
the amount of $500,000 or more from a debt or equity financing. On March
31,
2006, we entered into a $400,000 unsecured promissory note with Fagan Capital,
Inc., or Fagan Capital. Interest accrues at an annual rate of 8.0% and
interest and principal were due on June 2, 2006. On July 26, 2006, Fagan
Capital
extended the maturity date of the promissory note to June 1, 2007 and we
issued
to Fagan Capital a warrant to purchase 1,158,857 shares of common stock at
an
initial exercise price of $0.35 per share. See Note 7 to the unaudited
consolidated financial statements included in this Report. The purpose of
these
loans was to provide us with short term financing as we seek longer term
financing.
Relocation
of Operations
On
December 6, 2005, we initiated a relocation plan to cease our operations
in
Portland, Oregon and relocate to Foster City, California. We decided to relocate
after reviewing and evaluating all aspects of our operations to determine
the
profitability and viability of continuing in the Portland, Oregon location.
During February 2006, we signed a lease agreement for 4,136
square feet of space located immediately adjacent to those of BioCheck and
relocated our manufacturing operations to Foster City, California.
On
February 15, 2006, we ceased operations at the Portland, Oregon facility
and
most of the Portland, Oregon employees were terminated. In connection with
the
relocation, we accrued $119,000 during 2005 for an employee severance package
offered to all regular full-time employees who were not relocated to Foster
City, California. Of this amount, $78,000 was paid during the first half
of
2006, resulting in $41,000 of accrued expenses at June 30, 2006. We expect
$33,000 of this amount to be paid during the remainder of 2006 and $8,000
is to
be paid during 2007.
Management
Team and Board of Directors
During
2006, we have continued to build our management team and enhance our Board
of
Directors. Michael D. Centron was appointed as our Vice President and Chief
Financial Officer during January 2006, replacing Marvin S. Hausman, M.D.
as
acting Chief Financial Officer. During February 2006, Randall Moeckli was
appointed as our Senior Director of Sales and Marketing. On March 15, 2006,
Gary
M. Post, Managing Director of Ambient Advisors, LLC, joined our Board of
Directors.
Results
of Operations
We
expect
revenues and expenses to increase substantially as described below from 2005
to
2006 with the consolidation of all of BioCheck’s results of operations during
the first and second quarters of 2006. BioCheck’s revenues and expenses are not
included in the results of operations for the first and second quarters of
2005
because they were incurred before the December 6, 2005 date of
acquisition. Our projections for 2006 are based upon our expectations that
BioCheck will incur similar revenues and costs in 2006 as it incurred in
2005.
We can give no assurances that we will be able to successfully merge
manufacturing operations without adversely affecting revenues and costs,
implement an effective marketing campaign that will increase revenues, develop
new products, finance our expansion plans and purchase the remaining 49%
of the
BioCheck common stock we do not own.
Revenues
The
following table presents the changes in revenues from 2005 to 2006:
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
Product
revenues
|
|
$
|
1,356,000
|
|
$
|
555,000
|
|
$
|
801,000
|
|
|
144%
|
|
$
|
2,869,000
|
|
$
|
1,186,000
|
|
$
|
1,683,000
|
|
|
142%
|
|
For
the
three months ended June 30, the increase in product revenues was primarily
attributable to the consolidation of $1,014,000 of revenues from BioCheck
that
was partially offset by a $213,000 decrease in sales from the OXIS parent
company. For the six months ended June 30, the increase in product revenues
was
primarily attributable to the consolidation of $2,076,000 of revenues from
BioCheck that was partially offset by a $393,000 decrease in sales from the
OXIS
parent company. The decrease in OXIS parent company sales is attributable
to
lower sales volume that was caused, in part, by the interruption arising
from
moving operations from Portland, Oregon to Foster City, California and
consolidating our product offerings. We expect third quarter 2006 product
revenues to increase modestly from the second quarter as we introduce new
products such as our improved MPO. We intend to develop new diagnostic test
kits
and evaluate our product offerings, pricing and distribution network with
the
plan of increasing sales volume.
Cost
of product revenues
The
following table presents the changes in cost of product revenues from 2005
to
2006:
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
Cost
of product revenues
|
|
$
|
833,000
|
|
$
|
287,000
|
|
$
|
546,000
|
|
|
190%
|
|
$
|
1,649,000
|
|
$
|
573,000
|
|
$
|
1,076,000
|
|
|
188%
|
|
For
the
three months ended June 30, 2006, the increase in cost of product revenues
is
attributable to the consolidation of $587,000 of costs from the operations
of
BioCheck that were partially offset by decreased labor and related costs
including contract labor of $29,000 and facility and related costs of $12,000.
For the six months ended June 30, 2006, the increase in cost of product revenues
is attributable to the consolidation of $1,108,000 of costs from the operations
of BioCheck that were partially offset by decreased labor and related costs
of
$28,000 and facility and related costs of $11,000. We expect third quarter
2006
product costs to increase proportionally with any increases in
revenues.
Gross
profit of $523,000 for the three months ended June 30, 2006 was higher
than the
gross profit of $268,000 in the comparable period of 2005 because of the
additional profits from product sales from BioCheck. Gross profit as a
percentage of revenues was 39% in the three months ended June 30, 2006,
as
compared to 48% in the three months ended June 30, 2005. Gross profit of
$1,220,000 for the six months ended June 30, 2006 was higher than the gross
profit of $613,000 in the comparable period of 2005 because of the additional
profits from product sales from BioCheck. Gross profit as a percentage
of
revenues was 43% in the six months ended June 30, 2006, as compared to
52% in
the six months ended June 30, 2005.
Research
and development expenses
The
following table presents the changes in research and development expenses
from
2005 to 2006:
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
Research
and development expenses
|
|
$
|
178,000
|
|
$
|
60,000
|
|
$
|
118,000
|
|
|
197%
|
|
$
|
391,000
|
|
$
|
122,000
|
|
$
|
269,000
|
|
|
220%
|
|
For
the
three months ended June 30, 2006, the increase in research and development
expenses is primarily attributable to the consolidation of $132,000 of costs
from the operations of BioCheck and increased patent amortization expense
of
$8,000. The increase was partially offset by decreased salary and benefits
costs
of $20,000 and direct project expenses of $10,000. For the six months ended
June
30, 2006, the increase in research and development expenses is primarily
attributable to the consolidation of $302,000 of costs from the operations
of
BioCheck and increased patent amortization expense of $40,000. The increase
was
partially offset by decreased salary and benefits costs of $42,000 and direct
project expenses of $24,000. We expect third quarter 2006 research and
development costs to be approximately the same as the second quarter. However,
the actual amount of research and development expenses will fluctuate with
the
availability of funding.
Selling,
general and administrative expenses
The
following table presents the changes in selling, general and administrative
expenses from 2005 to 2006:
|
|
Three
Months Ended June 30,
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
2006
|
|
2005
|
|
Increase
from 2005
|
|
Selling,
general and administrative expenses
|
|
$
|
837,000
|
|
$
|
545,000
|
|
$
|
292,000
|
|
|
54%
|
|
$
|
1,901,000
|
|
$
|
1,081,000
|
|
$
|
820,000
|
|
|
76%
|
|
For
the
three months ended June 30, 2006, the increase in selling, general and
administrative expenses is primarily attributed to the consolidation of costs
from the operations of BioCheck of $189,000, and increased costs for labor
and
related costs including contract labor and associated transportation costs
of
$61,000; and non-cash compensation of $85,000 which, effective January 1,
2006,
is required for employees to be included in expenses by SFAS 123R. The increase
was partially offset by decreased costs for accounting, legal, shareholder
communication and investor relations activities of $40,000. For the six months
ended June 30, 2006, the increase in selling, general and administrative
expenses is primarily attributed to the consolidation of costs from the
operations of BioCheck of $408,000, and increased costs for accounting, legal,
shareholder communication and investor relations activities of $102,000;
labor
and related costs including contract labor and associated transportation
costs
of $120,000; and non-cash compensation of $180,000. We expect third quarter
2006
selling, general and administrative expenses to be approximately the same
as the
second quarter.
Interest
Income
The
decrease in interest income from $52,000 for the six months ended June 30,
2005
to $31,000 in the same period in 2006, is primarily due to reduced cash
available for investment activities obtained in the $6,500,000 equity financing
received during December 2004 and January 2005.
Other
Income
Other
income is related to the sale of surplus equipment.
Interest
Expense
Interest
expense of $55,000 in the six months ended June 30, 2006 was primarily due
to
the loan with KeyBank that was transferred to Bridge Bank incurred in connection
with the BioCheck acquisition and the addition of new debt of $600,000 in
March
2006. We expect interest expense for the third quarter to increase from the
second quarter of 2006. Warrants were issued with the renewal of a note with
Fagan Capital that will result in non-cash financing expense over the life
of
note being recorded as interest expense. See Note 7 to the unaudited
consolidated financial statements included in this Report.
Liquidity
and Capital Resources
On
a
consolidated basis, we had cash and cash equivalents of $461,000 at June
30,
2006 of which $441,000 was held by BioCheck. Since BioCheck has been and
is
expected to continue to be cash flow positive, management believes that its
cash
will be sufficient to sustain its operating activities.
The
cash
held by the OXIS parent company was $20,000 at June 30, 2006. OXIS cannot
access
the cash held by its majority-held subsidiary, BioCheck, to pay for the
corporate purposes of the OXIS parent company. We have incurred negative
operating cash flows of $0.7 million during the six months ended June 30,
2006.
Our cash is not sufficient to sustain our operations through the third quarter
of 2006 without additional financings. We are seeking debt and equity financings
to obtain sufficient funds to sustain operations, implement our marketing
campaign and purchase the remaining 49% of BioCheck for approximately $3.0
million. We plan to increase revenues by our marketing campaign and the
introduction of new products. However, we cannot assure you that we will
successfully obtain debt or equity financing, if any, sufficient to finance
our
goals or that we will increase product related revenues as such events are
subject to factors beyond our control. If we are unable to raise additional
capital in the third quarter of 2006, we will have to curtail or cease
operations.
Net
cash used in operating activities
The
following table presents quarterly cash flows from operating activities for
2006
and 2005:
|
|
Six
Months Ended June 30,
|
|
|
|
2006
|
|
|
2005
|
|
Cash
paid to employees including benefits
|
|
$
|
(1,161,000
|
)
|
$
|
(454,000
|
)
|
Cash
paid to suppliers
|
|
|
(2,364,000
|
)
|
|
(1,859,000
|
)
|
Total
cash paid to employees and suppliers
|
|
|
(3,525,000
|
)
|
|
(2,313,000
|
)
|
Cash
received from customers
|
|
|
2,804,000
|
|
|
1,143,000
|
|
Interest
and other income received
|
|
|
33,000
|
|
|
52,000
|
|
Interest
paid
|
|
|
(58,000
|
)
|
|
(11,000
|
)
|
Net
cash used in operating activities
|
|
$
|
(746,000
|
)
|
$
|
(1,129,000
|
)
|
The
increase in cash paid to employees is primarily attributed to $0.7 million
of
cash paid by BioCheck for payroll and benefits. Cash paid to suppliers is
increased by approximately $1.1 million due to BioCheck that was offset by
2004
expenses recorded as liabilities at December 31, 2004 that were paid in the
first quarter of 2005 of approximately $0.5 million and an increase in accounts
payable and accrued expense in the first six months of 2006 of approximately
$0.1 million. The increase in cash received from customers in the first and
second quarters of 2006 is attributed to increased revenues of $1.7 million.
Interest paid increased in the first and second quarters of 2006 primarily
due
to increased debt of $3,060,000 entered into during December 2005 and $600,000
during March 2006.
Cash
used in investing activities
During
the first quarter of 2006 we transferred our $3,060,000 restricted certificate
of deposit from KeyBank to Bridge Bank. Capital expenditures during the second
quarter of 2006 were primarily for equipment and leasehold improvements at
our
new Foster City, California location. We had no commitments for capital
expenditures at June 30, 2006. We paid $32,000 and $131,000 for patent
filings that were capitalized in the first and second quarters of 2006 and 2005,
respectively.
Net
cash provided by financing activities
On
December 2, 2005, we entered into a non-revolving one-year loan agreement
with KeyBank in the amount of $3,060,000, for the purpose of completing the
initial closing of the BioCheck acquisition. This loan was repaid during
February 2006 and a new one-year loan agreement for $3,060,000 was entered
into
at Bridge Bank.
On
March
10, 2006, we received $200,000 in exchange for an unsecured promissory note
with
Steven T. Guillen, our president and chief executive officer. The related
party
note bears interest at 7.0%. Interest and principal are due on September
10,
2006 or, at the option of Mr. Guillen, on the date we receive net proceeds
in
the amount of $500,000 or more from a debt or equity financing. On March
31,
2006, we entered into a $400,000 unsecured promissory note with Fagan Capital.
Interest accrues at an annual rate of 8.0% and interest and principal were
due
on June 2, 2006. On July 26, 2006, Fagan Capital extended the maturity date
of
the promissory note to June 1, 2007 and we issued to Fagan Capital a warrant
to
purchase 1,158,857 shares of common stock at an initial exercise price of
$0.35
per share. See Note 7 to the unaudited consolidated financial statements
included in this Report. The purpose of these loans was to provide us with
short
term financing as we seek longer term financing.
The
cash
held by the OXIS parent company of $20,000 at June 30, 2006 is not sufficient
to
sustain our operations through the third quarter of 2006 without additional
financings. OXIS cannot access the cash held by its majority-held subsidiary,
BioCheck, to pay for the corporate purposes of the OXIS parent company. In
an
effort to mitigate this near-term concern, we are seeking debt and equity
financings to obtain sufficient funds to sustain operations, implement our
marketing campaign and purchase the remaining 49% of BioCheck for approximately
$3.0 million. However, we cannot assure you that we will successfully obtain
debt or equity financing.
Critical
Accounting Policies
We
consider the following accounting policies to be critical given they involve
estimates and judgments made by management and are important for our investors’
understanding of our operating results and financial condition.
Basis
of Consolidation
The
consolidated financial statements contained in this Report include the accounts
of OXIS International, Inc. and its subsidiaries. All intercompany balances
and
transactions have been eliminated. On December 6, 2005, we purchased 51% of
the common stock of BioCheck. This acquisition was accounted for by the purchase
method of accounting according to Statement of Financial Accounting Standards
No. 141, “Business Combinations.” The consolidated statements of operations for
the three and six months ended June 30, 2006 include the results of
operations of BioCheck and the consolidated balance sheets include the assets
and liabilities of BioCheck at June 30, 2006 and
December 31, 2005.
Revenue
Recognition
We
manufacture, or have manufactured on a contract basis, research and diagnostic
assays and fine chemicals, which are our primary products sold to customers.
Revenue from the sale of our products, including shipping fees, is recognized
when title to the products is transferred to the customer which usually occurs
upon shipment or delivery, depending upon the terms of the sales order and
when
collectibility is reasonably assured. Revenue from sales to distributors
of our
products is recognized, net of allowances, upon delivery of product to the
distributors. According to the terms of individual distributor contracts,
a
distributor may return product up to a maximum amount and under certain
conditions contained in its contract. Allowances are calculated based upon
historical data, current economic conditions and the underlying contractual
terms. Our mix of product sales are substantially at risk to market conditions
and demand, which may change at anytime.
We
recognize license fee revenue for licenses to our intellectual property when
earned under the terms of the agreements. Generally, revenue is recognized
upon
transfer of the license unless we have continuing obligations for which fair
value cannot be established, in which case the revenue is recognized over
the
period of the obligation. We consider all arrangements with payment terms
extending beyond twelve months not to be fixed or determinable. In certain
licensing arrangements there is provision for a variable fee as well as a
non-refundable minimum amount. In such arrangements, the amount of the
non-refundable minimum guarantee is recognized upon transfer of the license
and
collectibility is reasonably assured or over the period of the obligation,
as
applicable, and the amount of the variable fee is recognized as revenue when
it
is fixed and determinable. We recognize royalty revenue based on reported
sales
by third party licensees of products containing our materials, software and
intellectual property. Non-refundable royalties, for which there are no further
performance obligations, are recognized when due under the terms of the
agreements.
Inventories
Inventories
are stated at the lower of cost to purchase and/or manufacture the inventory
or
the current estimated market value of the inventory. We regularly review
our
inventory quantities on hand and record a provision for excess and obsolete
inventory based primarily on our estimated forecast of product demand and/or
our
ability to sell the products and production requirements. Demand for our
products can fluctuate significantly. Factors which could affect demand for
our
products include unanticipated changes in consumer preferences, general market
conditions or other factors, which may result in cancellations of advance
orders
or a reduction in the rate of reorders placed by customers and/or continued
weakening of economic conditions. Additionally, our estimates of future product
demand may be inaccurate, which could result in an understated or overstated
provision required for excess and obsolete inventory. Our estimates are based
upon our understanding of historical relationships which can change at
anytime.
Long-Lived
Assets
Our
long-lived assets include property, plant and equipment, capitalized costs
of
filing patent applications and goodwill and other assets. We evaluate our
long-lived assets for impairment in accordance with SFAS No. 144, “Accounting
for the Impairment or Disposal of Long-Lived Assets” whenever events or changes
in circumstances indicate that the carrying amount of such assets may not
be
recoverable. Estimates of future cash flows and timing of events for evaluating
long-lived assets for impairment are based upon management’s judgment. If any of
our intangible or long-lived assets are considered to be impaired, the amount
of
impairment to be recognized is the excess of the carrying amount of the assets
over its fair value.
Applicable
long-lived assets are amortized or depreciated over the shorter of their
estimated useful lives, the estimated period that the assets will generate
revenue, or the statutory or contractual term in the case of patents. Estimates
of useful lives and periods of expected revenue generation are reviewed
periodically for appropriateness and are based upon management’s judgment.
Goodwill and other assets are not amortized.
Share-Based
Compensation
In
December 2004, the Financial Accounting Standards Board, or FASB, issued
SFAS
123R. SFAS 123R replaces FASB Statement No. 123, “Accounting for Stock-Based
Compensation”, and supersedes APB Opinion No. 25, “Accounting for Stock Issued
to Employees,” or APB Opinion No. 25. SFAS 123R establishes standards for the
accounting for share-based payment transactions in which an entity exchanges
its
equity instruments for goods or services. It also addresses transactions
in
which an entity incurs liabilities in exchange for goods or services that
are
based on the fair value of the entity’s equity instruments or that may be
settled by the issuance of those equity instruments. SFAS 123R covers a
wide
range of share-based compensation arrangements including share options,
restricted share plans, performance-based awards, share appreciation rights
and
employee share purchase plans. SFAS 123R requires a public entity to measure
the
cost of employee services received in exchange for an award of equity
instruments based on the fair value of the award on the grant date (with
limited
exceptions). That cost will be recognized in the entity’s financial statements
over the period during which the employee is required to provide services
in
exchange for the award. Management implemented SFAS 123R effective January
1,
2006. Methodologies used for calculations such as the Black-Scholes
option-pricing models and variables such as volatility and expected life
are
based upon management’s judgment. Such methodologies and variables are reviewed
and updated periodically for appropriateness and affect the amount of recorded
charges. See Note 1 to the unaudited consolidated financial statements
included
in this Report for more information on the amounts, methodologies and variables
related to non-cash share-based compensation charges.
FACTORS
THAT MAY AFFECT FUTURE OPERATING RESULTS
We
operate in a rapidly changing environment that involves a number of risks,
some
of which are beyond our control. The following discussion highlights some
of
these risks and others are discussed elsewhere in this report or in our Annual
Report on Form 10-KSB for the period ended December 31, 2005 and our
Post-Effective Amendment No. 1 to Form SB-2 Registration Statement (SEC
File No. 333-123008).
Risks
Related to Our Business
We
will need to raise additional capital to fund our general and administrative
expenses, and if we are unable to raise such capital, we will have to curtail
or
cease operations.
The
cash
held by the OXIS parent company of $20,000 at June 30, 2006 is not sufficient
to
continue operations through the third quarter of 2006 without additional
financings. OXIS cannot access the cash held by its majority-held subsidiary,
BioCheck, to pay for the corporate purposes of the OXIS parent company. We
are
seeking debt and equity financings to obtain sufficient funds to sustain
operations, including our development and commercialization programs, to
implement our marketing campaign and purchase the remaining 49% of BioCheck
common stock we do not own. We have incurred significant obligations in relation
to our relocation to Foster City, California and our integration of operations
with BioCheck, including severance benefits for terminated employees, the
hiring
of new personnel, our contractual obligations to consultants and moving
expenses. We will need to repay debt in the amount of $200,000 to our chief
executive officer on or before September 10, 2006 and $405,600 to Fagan Capital
on or before June 1, 2007. On July 26, 2006, Fagan Capital extended the maturity
date of the promissory note to June 1, 2007 and the Company issued to Fagan
Capital a warrant to purchase 1,158,857 shares of common stock at an initial
exercise price of $0.35 per share. See Note 7 to the unaudited consolidated
financial statements included in this Report. If we are unable to raise
additional capital in the third quarter of 2006 we will have to curtail or
cease
operations. If we raise short term capital by incurring additional debt,
we will
have to obtain equity financing sufficient to repay such debt and accrued
interest. Further, incurring additional debt may make it more difficult for
us
to successfully consummate future equity financings.
As
we
have failed to make payments due to BioCheck under our Mutual Services
Agreement, BioCheck could exercise its rights under the default provisions
of
that agreement to terminate the agreement and cease production of many of
our
research test kit assays.
As
mentioned above, on June 23, 2006, we entered into a Mutual Services Agreement,
or Agreement, with our majority owned subsidiary, BioCheck. Pursuant to the
Agreement, OXIS agreed to pay BioCheck approximately $73,000 that it owed
to
BioCheck for services that BioCheck had provided to OXIS prior to the signing
of
the Agreement, on or before June 30, 2006. OXIS has not made that payment.
If
OXIS receives written notice of breach of the Agreement due to this non-payment,
it will have 15 days to cure that breach. If OXIS fails to cure the breach
during the cure period, BioCheck would have the right to terminate the
Agreement. Pursuant to the Agreement, BioCheck is manufacturing the bulk
of
OXIS’ research assay test kits, assisting in packaging and shipping such
research assay test kits to OXIS customers, and undertaking research and
development of certain new OXIS research assay test kits. If BioCheck ceases
to
perform services under the Agreement, OXIS will have to turn to third party
suppliers for the manufacturing of its research assay test kits, where that
is
possible, and will likely have to cease research and development of new OXIS
research assay test kits. There can be no assurance that possible third party
suppliers of research assay test kits will be willing or able to manufacture
OXIS’ research assay test kits at competitive prices or at all, or that OXIS
would be able to pay for such services. Disruption or cessation of manufacturing
due to the termination of the Agreement would have immediate and deleterious
effects on OXIS future revenues.
We
will need to raise additional capital in order to complete our acquisition
of
the outstanding shares of BioCheck.
On
September 19, 2005 we entered into a stock purchase agreement with BioCheck
and
the stockholders of BioCheck pursuant to which OXIS undertook to purchase
up to
all of the outstanding shares of common stock of BioCheck for an aggregate
purchase price of $6.0 million in cash. On December 6, 2005, pursuant to
the terms of the stock purchase agreement with BioCheck, at the initial closing,
we purchased an aggregate of fifty-one percent (51%) of the outstanding shares
of common stock of BioCheck from each of the shareholders of BioCheck on
a pro
rata basis, for an aggregate of $3,060,000 in cash. Pursuant to the stock
purchase agreement, OXIS will use its reasonable best efforts to consummate
a
follow-on financing transaction to raise additional capital with which to
purchase the remaining outstanding shares of BioCheck in one or more additional
closings. The purchase price for any BioCheck shares purchased after the
initial
closing will be increased by an additional 8% per annum from the date of
the
initial closing through the date of such purchase. If OXIS has not purchased
all
of the outstanding shares of BioCheck within twelve months of the initial
closing, the earnings before interest, taxes, depreciation and amortization
expenses, or EBITDA, if any, of BioCheck will be used to repurchase the
remaining outstanding BioCheck shares at one or more additional closings.
There
can be no assurance that there will be any EBITDA of BioCheck in the next
several years which could be utilized to purchase additional shares of BioCheck
pursuant to the stock purchase agreement. Even if there is some amount of
BioCheck EBITDA available to purchase additional shares of BioCheck, there
can
be no assurance that such EBITDA would be sufficient to complete our acquisition
of the remaining 49% of BioCheck outstanding shares.
To
avoid
an increase in the purchase price of the remaining shares of BioCheck at
the
rate of 8% per annum, we will need to consummate a financing transaction
to
complete the acquisition of the remaining 49% of the outstanding shares of
BioCheck. The successful completion of our acquisition of BioCheck is dependent
upon obtaining financing on acceptable terms. No assurances can be given
that we
will be able to complete such a financing sufficient to undertake our
acquisition of the outstanding shares of BioCheck on terms favorable to us,
or
at all. Any financing that we do undertake to finance the acquisition of
BioCheck will likely involve dilution of our common stock if it is an equity
financing or will involve the assumption of significant debt by
OXIS.
We
will need additional financing in order to complete our development and
commercialization programs.
As
of
June 30, 2006, we had an accumulated deficit of approximately $66,648,000.
We
currently do not have sufficient capital resources to complete the development
and commercialization of our antioxidant therapeutic technologies and oxidative
stress assays, and no assurances can be given that we will be able to raise
such
capital in the future on terms favorable to us, or at all. The unavailability
of
additional capital could cause us to cease or curtail our operations and/or
delay or prevent the development and marketing of our potential products.
In
addition, we may choose to abandon certain issued United States and
international patents that we deem to be of lesser importance to our strategic
direction, in an effort to preserve our financial resources.
Our
future capital requirements will depend on many factors including the following:
-
continued
scientific progress in our research and development programs and the
commercialization of additional products;
-
the
cost of our research and development and commercialization activities
and
arrangements, including sales and marketing;
-
the
costs associated with the scale-up of manufacturing;
-
the
success of pre-clinical and clinical trials;
-
the
establishment of and changes in collaborative relationships;
-
the
time and costs involved in filing, prosecuting, enforcing and defending
patent
claims;
-
the
time and costs required for regulatory approvals;
-
the
acquisition of additional technologies or businesses;
-
technological
competition and market developments; and
-
the
cost of complying with the requirements of the Autorité des Marchés
Financiers, or AMF, the French regulatory agency overseeing the Nouveau
Marché
in France.
We
will
need to raise additional capital to fund our development and commercialization
programs. Our current capital resources are not sufficient to sustain operations
and our development programs with respect to our cardiovascular predictor
product and Ergothioneine as a nutraceutical supplement. We have granted
a
licensee exclusive worldwide rights, in certain defined areas of cardiovascular
indications, to develop, manufacture and market BXT-51072 and related compounds
from our library of such antioxidant compounds. The licensee is responsible
for
worldwide product development programs with respect to the licensed compounds.
Due to the lack of financial resources, we ceased further testing of BXT-51072
but continue to review the possibility of further developing applications
for
BXT-51072 and related compounds outside of the areas defined in the license.
However, further development and commercialization of antioxidant therapeutic
technologies, oxidative stress assays or currently unidentified opportunities,
or the acquisition of additional technologies or businesses, may require
additional capital. The fact that further development and commercialization
of a
product or technology would require us to raise additional capital, would
be an
important factor in our decision to engage in such further development or
commercialization. No assurances can be given that we will be able to raise
such
funds in the future on terms favorable to us, or at all.
If
we
complete our acquisition of BioCheck, our business could be materially and
adversely affected if we fail to adequately integrate the operations of the
two
companies.
If
we
complete the acquisition of BioCheck, or the Acquisition, as planned, and
we do
not successfully integrate the operations of the two companies, or if the
benefits of the transaction do not meet the expectations of financial or
industry analysts, the market price of our common stock may decline. The
Acquisition could result in the use of significant amounts of cash, dilutive
issuances of equity securities, or the incurrence of debt or expenses related
to
goodwill and other intangible assets, any of which could materially adversely
affect our business, operating results and financial condition.
We
may
not be able to successfully integrate the BioCheck business into our existing
business in a timely and non-disruptive manner, or at all. In addition, the
Acquisition may result
in, among other things, substantial
charges
associated with acquired in-process research and development, future write-offs
of goodwill that is deemed to be impaired, restructuring charges related
to
consolidation of operations, charges associated with unknown or unforeseen
liabilities of acquired businesses and increased general and administrative
expenses. Furthermore, the Acquisition may not produce revenues, earnings
or
business synergies that we anticipate. There
can
be no assurance that BioCheck will continue to manufacture our research assay
test kits if that agreement is terminated.
In
addition, acquisitions in general involve numerous risks, including:
-
difficulties
in assimilating the operations, technologies, products and personnel
of an
acquired company;
-
risks
of entering markets in which we have either no or limited prior
experiences;
-
the
diversion of management’s attention from other business concerns; and
-
the
potential loss of key employees of an acquired company.
The
time,
capital management and other resources spent on the Acquisition, if it fails
to
meet our expectations, could cause our business and financial condition to
be
materially and adversely affected.
Our
relocation plan could adversely affect our operations.
As
part
of our decision to acquire BioCheck, we implemented a relocation and integration
plan, including a strategy to reduce our cost structure. In doing so, we
significantly reduced our employee workforce from 15 full time employees
to
four, outsourced certain company functions and have taken other steps intended
to reduce costs and improve efficiencies. Our
business may continue to be disrupted and adversely affected by this reduction
in work force until we employ new personnel to replace certain open positions.
Our business may also be disrupted due to our move to new
facilities.
The
payment of severance benefits resulting from employee terminations will cause
us
to utilize cash. There can be no assurances that we will be able to improve
efficiencies and function properly following such reductions.
We
may experience disruption or may fail to achieve any benefits in connection
with
the recent changes in executive management and in Board membership.
During
the second quarter of 2004, our former Chief Executive Officer retired, and
during the third quarter of 2004 our Chief Operating and Financial Officer
left
the employment of our company. As a result, others who had limited experience
with OXIS were appointed to serve as acting Chief Executive Officer, acting
Chief Operating Officer and acting Chief Financial Officer.
On February 28, 2005, the Board appointed Mr. Steven T. Guillen to the
positions of President and Chief Executive Officer of OXIS, and as a member
of
our board. On January 6, 2006, we hired Michael D. Centron as our Vice President
and Chief Financial Officer. In addition, during 2004 and early 2005, following
the acquisition of a then-majority interest in OXIS by Axonyx, eight directors
resigned from the board resulting in a four person board. During 2005 we
added
independent director John E. Repine, M.D., and Gary M. Post joined our Board
of
Directors on March 15, 2006, resulting in a six-person board. Timothy C.
Rodell,
M.D., declined to stand for re-election at the Annual Meeting of Stockholders
held on August 1, 2006. All five directors currently serving on the board
commenced their service on the board during the period of 2004 through the
date
hereof.
One
impact of such changes has been to delay our sales promotions in the research
assay market and in the development of Ergothioneine market opportunities.
Further, we narrowed our strategic focus to concentrate resources, including
discontinuing our Animal Health Profiling program. In addition, the decreased
OXIS parent company sales during the second quarter of 2006 are attributable
to
lower sales volume that was caused, in part, by the interruption arising
from
moving operations from Portland, Oregon to Foster City, California and
consolidating our product offerings. There can be no assurances that these
changes will not cause further disruptions in, or otherwise adversely affect,
our business and results of operations.
If
we
fail to attract and retain key personnel, our business could suffer.
Our
future depends, in part, on our ability to attract and retain key personnel.
We
may not be able to hire and retain such personnel at compensation levels
consistent with our existing compensation and salary structure. We deferred
the
hiring of senior management personnel in order to allow our newly-engaged
full
time Chief Executive Officer to select such key personnel. While we succeeded
in
engaging Mr. Steven T. Guillen as our President and Chief Executive Officer
and
Michael D. Centron as our Chief Financial Officer, we cannot predict whether
we
will be successful in finding suitable new candidates for key management
positions within OXIS. While we have entered into letter agreements of
employment with Mr. Guillen and Mr. Centron, they are free to terminate their
employment “at will.” Further, we cannot predict whether Mr.
Guillen or Mr. Centron will
be
successful in their roles as our President and Chief Executive Officer, and
Chief Financial Officer, or whether senior management personnel hires will
be
effective. The loss of services of executive officers or key personnel, any
transitional difficulties with our new Chief Financial Officer or the inability
to attract qualified personnel could have a material adverse effect on our
financial condition and business. We
do not
have any key employee life insurance policies with respect to any of our
executive officers.
The
success of our business depends upon our ability to successfully develop
and
commercialize products.
We
cannot
assure you that our efforts to develop and commercialize a cardiac predictor
product, an Ergothioneine
nutraceutical product or any other products will be successful. The cost
of such
development and commercialization efforts can be significant and the likelihood
of success of any such programs is difficult to predict. The failure to develop
or commercialize such new products could be materially harmful to us and
our
financial condition.
Our
future profitability is uncertain.
We
cannot
predict our ability to reduce our costs or achieve profitability. We may
be
required to increase our research and development expenses in order to
develop potential new products. As evidenced by the substantial net losses
during the first six months of 2006 and the fiscal year 2005, losses and
expenses may increase and fluctuate from quarter to quarter. There can be
no
assurance that we will ever achieve profitable operations.
We
have no biopharmaceutical or clinical diagnostic products available for sale
and
we may never be successful in developing products suitable for
commercialization.
All
of
our biopharmaceutical and clinical diagnostic candidates are at an early
stage
of development and all of such therapeutic and clinical diagnostic candidates
will require expensive and lengthy testing and regulatory clearances. None
of
our therapeutic or clinical diagnostic candidates have been approved by
regulatory authorities. We have no therapeutic or clinical diagnostic products
available for sale and we may not have any products commercially available
for
several years, if at all. There are many reasons we may fail in our efforts
to
develop our therapeutic and clinical diagnostic candidates,
including:
-
our
therapeutic and clinical diagnostic candidates may be ineffective, toxic
or
may not receive regulatory clearances,
-
our
therapeutic and clinical diagnostic candidates may be too expensive to
manufacture or market or may not achieve broad market acceptance,
-
third
parties may hold proprietary rights that may preclude us from developing
or
marketing our therapeutic and clinical diagnostic candidates, or
-
third
parties may market equivalent or superior products.
Clinical
development is inherently uncertain and expense levels may fluctuate
unexpectedly because we cannot accurately predict the timing and level of
such
expenses.
Our
future success may depend in part upon the results of clinical trials undertaken
by us or our licensees designed to assess the safety and efficacy of our
potential products. We do not have substantial experience in developing and
running clinical trials. The completion of clinical trials often depends
significantly upon the rate of patient enrollment, and our expense levels
will
vary depending upon the rate of enrollment. In addition, the length of time
necessary to complete clinical trials and submit an application for marketing
and manufacturing approvals varies significantly and is difficult to predict.
The expenses associated with each phase of development depend upon the design
of
the trial. The design of each phase of trials depends in part upon results
of
prior phases, and additional trials may be needed at each phase. As a result,
the expense associated with future phases cannot be predicted in advance.
Further, if we undertake clinical trials, we may decide to terminate or suspend
ongoing trials. Failure to comply with extensive FDA regulations may result
in
unanticipated delay, suspension or cancellation of a trial or the FDA's refusal
to accept test results. The FDA may also suspend our clinical trials at any
time
if it concludes that the participants are being exposed to unacceptable risks.
As a result of these factors, we cannot predict the actual expenses that
we will
incur with respect to clinical trials for any of our potential products,
and we
expect that our expense levels will fluctuate unexpectedly in the future.
Competition
in most of our primary current and potential market areas is intense and
expected to increase.
The
diagnostic, pharmaceutical and nutraceutical industries are highly competitive.
The main commercial competition at present in our research assay business
is
represented by, but not limited to, the following companies: Cayman Chemical
Company, Assay Designs and Randox Laboratories Ltd. In addition, our competitors
and potential competitors include large pharmaceutical/nutraceutical companies,
universities and research institutions. Relative to OXIS, these competitors
may
have substantially greater capital resources, research and development staffs,
facilities, as well as greater expertise manufacturing and making products.
In
addition, these companies, as well as others, may have or may develop new
technologies or use existing technologies that are, or may in the future
be, the
basis for competitive products. There can be no assurance that we can compete
successfully.
In
addition, current and potential competitors may make strategic acquisitions
or
establish cooperative relationships among themselves or with third parties,
thereby increasing the ability of their products to address the needs of
our
current and prospective customers. Accordingly, it is possible that new
competitors or alliances among current and new competitors may emerge and
rapidly gain significant market share. Such competition could materially
adversely affect our ability to commercialize existing technologies or new
technologies on terms favorable to us. Further, competitive pressures could
require us to reduce the price of our products and technologies, which could
materially adversely affect our business, operating results and financial
condition. We may not be able to compete successfully against current and
future
competitors and any failure to do so would have a material adverse effect
upon
our business, operating results and financial condition.
Axonyx
holds the voting power to influence matters affecting us.
Axonyx
currently owns approximately 33% of our issued and outstanding stock. In
addition, Dr. Marvin Hausman is a member of the board of directors of Axonyx
and
is the chairman of our board of directors, and Mr. S. Colin Neill, the Chief
Financial Officer of Axonyx, is a member of our board of directors and the
Secretary of OXIS. Given these circumstances, Axonyx may influence our business
direction and policies, and, thus, may have the ability to control certain
material decisions affecting us. In addition, such concentration of voting
power
could have the effect of delaying, deterring or preventing a change of control
or other business combination that might otherwise be beneficial to our
shareholders. Section 203 of the Delaware General Corporation Law prohibits
a
Delaware corporation from engaging in any business combination with any
interested shareholder for a period of three years unless the transaction
meets
certain conditions. Section 203 also limits the extent to which an
interested shareholder can receive benefits from our assets. These provisions
could complicate or prohibit certain transactions (including a financing
transaction between OXIS and Axonyx), or limit the price that other investors
might be willing to pay in the future for shares of our common
stock.
If
we
are unable to develop and maintain alliances with collaborative partners,
we may
have difficulty developing and selling our products and services.
Our
ability to realize significant revenues from new products and technologies
is
dependent upon, among other things, our success in developing business alliances
and licensing arrangements with nutraceutical/biopharmaceutical and/or health
related companies to develop and market these products. To date, we have
had
limited success in establishing foundations for such business alliances and
licensing arrangements and there can be no assurance that our efforts to
develop
such business relationships will progress to mature relationships or that
any
such relationships will be successful. Further, relying on these or other
alliances is risky to our future success because:
-
our
partners may develop products or technologies competitive with our products
and technologies;
-
our
partners may not devote sufficient resources to the development and sale
of
our products and technologies;
-
our
collaborations may be unsuccessful; or
-
we
may
not be able to negotiate future alliances on acceptable terms.
Our
revenues and quarterly results have fluctuated historically and may continue
to
fluctuate, which could cause our stock price to decrease.
Our
revenues and operating results may fluctuate due in part to factors that
are
beyond our control and which we cannot predict. Material shortfalls in revenues
will materially adversely affect our results and may cause us to experience
losses. In particular, our revenue growth and profitability depend on sales
of
our research assays and fine chemicals. Factors that could cause sales for
these
products and other products to fluctuate include:
-
an
inability to produce products in sufficient quantities and with appropriate
quality;
-
an
inability to obtain sufficient raw materials;
-
the
loss of or reduction in orders from key customers;
-
variable
or decreased demand from our customers;
-
the
receipt of relatively large orders with short lead times;
-
our
customers' expectations as to how long it takes us to fill future orders;
-
customers'
budgetary constraints and internal acceptance review procedures;
-
there
may be only a limited number of customers that are willing to purchase
our
research assays and fine chemicals;
-
a
long
sales cycle that involves substantial human and capital resources;
and
-
potential
downturns in general or in industry specific economic
conditions.
Each
of
these factors has impacted, and may in the future impact, the demand for
and
availability of our products and our quarterly operating results. For example,
due to the unavailability of beef liver as a source for bSOD we were unable
to
sell any bSOD during 2005 and 2004, as compared to sales of $562,000 in 2003.
We
do not
anticipate this source becoming available again within the foreseeable future
and do not anticipate any revenues from sales of this product in the foreseeable
future. In addition, a decrease in the demand for our Ergothioneine product
resulted in a reduction of sales of Ergothioneine to $18,000 in 2005 and
$87,000
in 2004, compared to $333,000 in 2003. We cannot predict with any certainty
our
future sales of Ergothioneine.
If
the
sales or development cycles for research assays and fine chemicals lengthen
unexpectedly, our revenues may decline or not grow as anticipated and our
results from operations may be harmed.
Changes
in accounting standards regarding stock option plans could increase our reported
losses, cause our stock price to decline and limit the desirability of granting
stock options.
In
December 2004, the FASB issued SFAS 123R. SFAS 123R replaces SFAS No. 123
and
supersedes APB Opinion No. 25. SFAS 123R establishes standards for the
accounting for share-based payment transactions in which an entity exchanges
its
equity instruments for goods or services. It also addresses transactions
in
which an entity incurs liabilities in exchange for goods or services that
are
based on the fair value of the entity’s equity instruments or that may be
settled by the issuance of those equity instruments. SFAS 123R covers a
wide
range of share-based compensation arrangements including share options,
restricted share plans, performance-based awards, share appreciation rights
and
employee share purchase plans. SFAS 123R requires a public entity to measure
the
cost of employee services received in exchange for an award of equity
instruments based on the fair value of the award on the grant date (with
limited
exceptions). That cost will be recognized in the entity’s financial statements
over the period during which the employee is required to provide services
in
exchange for the award. Management implemented SFAS 123R effective January
1,
2006. Expensing such stock options will add to our losses or reduce our
profits,
if any. In addition, stock options are an important employee recruitment
and
retention tool, and we may not be able to attract and retain key personnel
if we
reduce the scope of our employee stock option program.
Our
income may suffer if we receive relatively large orders with short lead times,
or our manufacturing capacity does not otherwise match our demand.
Because
we cannot immediately adapt our production capacity and related cost structures
to rapidly changing market conditions, when demand does not meet our
expectations, our manufacturing capacity will likely exceed our production
requirements. Fixed costs associated with excess manufacturing capacity could
adversely affect our income. Similarly, if we receive relatively large orders
with short lead times, we may not be able to increase our manufacturing capacity
to meet product demand, and, accordingly, we will not be able to fulfill
orders
in a timely manner. During a market upturn, we may not be able to purchase
sufficient supplies to meet increasing product demand. In addition, suppliers
may extend lead times, limit supplies or increase prices due to capacity
constraints or other factors. These factors could materially and adversely
affect our results.
Our
success will require that we establish a strong intellectual property position
and that we can defend ourselves against intellectual property claims from
others.
Maintaining
a strong patent position is important to our competitive advantage. We currently
have 81 patents either granted or applied for in 16 countries with expiration
dates ranging from 2009 to 2025. Litigation on patent-related matters has
been
prevalent in our industry and we expect that this will continue. Patent law
relating to the scope of claims in the technology fields in which we operate
is
still evolving and the extent of future protection is highly uncertain, so
there
can be no assurance that the patent rights we have or may obtain will be
valuable. Others may have filed, or may in the future file, patent applications
that are similar or identical to ours. To determine the priority of inventions,
we may have to participate in interference proceedings declared by the United
States Patent and Trademark Office that could result in substantial costs
in
legal fees and could substantially affect the scope of our patent protection.
We
cannot assure investors that any such patent applications will not have priority
over our patent applications. Further, we may choose to abandon certain issued
United States and international patents that we deem to be of lesser importance
to our strategic direction, in an effort to preserve our financial resources.
Abandonment of patents could substantially affect the scope of our patent
protection. In addition, we may in future periods incur substantial costs
in
litigation to defend against patent suits brought by third parties or if
we
initiate such suits.
In
addition to patent protection, we also rely upon trade secret protection
for our
confidential and proprietary information. There can be no assurance, however,
that such measures will provide adequate protection for our trade secrets
or
other proprietary information. In addition, there can be no assurance that
trade
secrets and other proprietary information will not be disclosed, that others
will not independently develop substantially equivalent proprietary information
and techniques or otherwise gain access to or disclose our trade secrets
and
other proprietary information. If we cannot obtain, maintain or enforce
intellectual property rights, competitors can design and commercialize competing
technologies.
We
may
face challenges from third parties regarding the validity of our patents
and
proprietary rights, or from third parties asserting that we are infringing
their
patents or proprietary rights, which could result in litigation that would
be
costly to defend and could deprive us of valuable rights.
Extensive
litigation regarding patents and other intellectual property rights has been
common in the biotechnology and pharmaceutical industries. The defense and
prosecution of intellectual property suits, United States Patent and Trademark
Office interference proceedings, and related legal and administrative
proceedings in the United States and internationally involve complex legal
and
factual questions. As a result, such proceedings are costly and time-consuming
to pursue and their outcome is uncertain. Litigation may be necessary to:
-
enforce
patents that we own or license;
-
protect
trade secrets or know-how that we own or license; or
-
determine
the enforceability, scope and validity of the proprietary rights of others.
Our
involvement in any litigation, interference or other administrative proceedings
could cause us to incur substantial expense and could significantly divert
the
efforts of our technical and management personnel. An adverse determination
may
subject us to loss of our proprietary position or to significant liabilities,
or
require us to seek licenses that may not be available from third parties.
An
adverse determination in a judicial or administrative proceeding, or a failure
to obtain necessary licenses, may restrict or prevent us from manufacturing
and
selling our products. Costs associated with these arrangements may be
substantial and may include ongoing royalties. Furthermore, we may not be
able
to obtain the necessary licenses on satisfactory terms, if at all. These
outcomes could materially harm our business, financial condition and results
of
operations.
We
may be exposed to liability due to product defects.
The
risk
of product liability claims is inherent in the testing, manufacturing, marketing
and sale of our products. We may seek to acquire additional insurance for
liability risks. We may not be able to obtain such insurance or general product
liability insurance on acceptable terms or in sufficient amounts. A product
liability claim or recall could have a serious adverse effect on our business,
financial condition and results of operations.
Disclosure
controls are no assurance that the objectives of the control system are
met.
Although
we have an extensive operating history, resources are limited for the
development and maintenance of our control environment. We have a very limited
number of personnel and therefore segregation of duties can be somewhat limited
as to their scope and effectiveness. We believe, however, that we are in
reasonable compliance with the best practices given the environment in which
we
operate. Although existing controls in place are deemed appropriate for the
prevention, detection and minimization of fraud, theft and errors, they may
result in only limited assurances, at best, that the total objectives of
the
control system are met. Because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, can be detected and/or prevented
and as such this is a risk area for investors to consider.
Risks
Related to Our Common Stock
Our
common stock is traded on the OTCBB, our stock price is highly volatile,
and you
may not be able to sell your shares of our common stock at a price greater
than
or equal to the price you paid for such shares.
Our
shares of common stock are currently traded on the Over the Counter Bulletin
Board, or OTCBB. Stocks traded on the OTCBB generally have limited trading
volume and exhibit a wide spread between the bid/ask quotation. The market
price
of our common stock is extremely volatile. To demonstrate the volatility
of our
stock price, during the six-month period ending on June 30, 2006, the volume
of
our common stock traded on any given day ranged from 0 to 2,786,900 shares.
Moreover, during that period, our common stock traded as low as
$0.26 per
share
and as high as $0.46 per share, a 77% difference. This may impact an investor’s
decision to buy or sell our common stock. As of June 30, 2006 there were
approximately 5,200 holders of our common stock. Factors affecting our stock
price include:
-
our
financial results;
-
fluctuations
in our operating results;
-
announcements
of technological innovations or new commercial health care products or
therapeutic products by us or our competitors;
-
government
regulation;
-
developments
in patents or other intellectual property rights;
-
developments
in our relationships with customers and potential customers; and
-
general
market conditions.
Furthermore,
volatility in the stock price of other companies has often led to securities
class action litigation against those companies. Any such securities litigation
against us could result in substantial costs and divert management's attention
and resources, which could seriously harm our business and financial
condition.
Our
common stock may be subject to “penny stock” rules which may be detrimental to
investors.
Our
common stock may be, or may become, subject to the regulations promulgated
by
the SEC for “penny stock”. SEC regulation relating to penny stock is presently
evolving, and the OTCBB may react to such evolving regulation in a way that
adversely affects the market liquidity of our common stock. Penny stock
currently includes any non-NASDAQ equity security that has a market price
of
less than $5.00 per share, subject to certain exceptions. The regulations
require that prior to any non-exempt buy/sell transaction in a penny stock,
a
disclosure schedule set forth by the SEC relating to the penny stock market
must
be delivered to the purchaser of such penny stock. This disclosure must include
the amount of commissions payable to both the broker-dealer and the registered
representative and current price quotations for the common stock. The
regulations also require that monthly statements be sent to holders of penny
stock that disclose recent price information for the penny stock and information
of the limited market for penny stocks. These requirements may adversely
affect
the market liquidity of our common stock.
Sales
of our common stock may require broker-dealers to make special suitability
determinations regarding prospective purchasers.
Our
common stock may be, or may become, subject to Rule 15g-1 through 15g-9 under
the Exchange Act, which imposes certain sales practice requirements on
broker-dealers which sell our common stock to persons other than established
customers and “accredited investors” (generally, individuals with a net worth in
excess of $1,000,000 or an annual income exceeding $200,000 (or $300,000
together with their spouses)). For transactions covered by this rule, a
broker-dealer must make a special suitability determination for the purchaser
and have received the purchaser’s written consent to the transaction prior to
the sale. Applicability of this rule would adversely affect the ability of
broker-dealers to sell our common stock and purchasers of our common stock
to
sell their shares of such common stock. Accordingly, the market for our common
stock may be limited and the value negatively impacted.
We
will incur expenses in connection with registration of our shares which may
be
significant.
We
are
required to pay fees and expenses incident to the registration with the SEC
of
the shares issued in the private placement of equity which closed on January
6,
2005 and maintain adequate disclosure in connection with such registration,
including updating prospectuses and under certain circumstances, filing amended
registration statements. These expenses were $302,000 in 2005, and we may
incur
significant additional expenses in the future related to maintaining effective
registration statements for prior financings and any additional registrations
related to future financings. We have also agreed to indemnify such selling
shareholders against losses, claims, damages and liabilities arising out
of
relating to any misstatements or omissions in our registration statement
and
related prospectuses, including liabilities under the Securities Act. In
the
event such a claim is made in the future, such losses, claims, damages and
liabilities arising therefrom could be significant in relation to our
revenues.
Item
3. Controls
and Procedures.
Under
the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we have evaluated
the effectiveness of the design and operation of our disclosure controls
and
procedures as of June 30, 2006, and, based on their evaluation, our principal
executive officer and principal financial officer have concluded that these
controls and procedures are effective. On
January 6, 2006, we hired Michael D. Centron as our Vice President and Chief
Financial Officer. We
relocated our headquarters on February 15, 2006 from Portland, Oregon to
Foster
City, California, and on that date we terminated the employment of our financial
controller. Temporary accounting facilities were established during this
transition period. Our accounting procedures and disclosure controls and
procedures have changed during this period, and management believes that
disclosure controls and procedures have been adequately maintained during
this
period and that reporting controls and procedures have been improved. There
has
been no change in our internal control over financial reporting that occurred
during our most recent fiscal quarter that has materially affected or is
reasonably likely to materially affect our internal control over financial
reporting.
Disclosure
controls and procedures are our controls and other procedures that are designed
to ensure that information required to be disclosed by us in the reports
that we
file or submit under the Exchange Act is recorded, processed, summarized
and
reported, within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without limitation, controls
and
procedures designed to ensure that information required to be disclosed by
us in
the reports that we file under the Exchange Act is accumulated and communicated
to our management, including our principal executive officer and principal
financial officer, as appropriate to allow timely decisions regarding required
disclosures.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
None.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds.
On
May
12, 2006, the Company entered into an Engagement Letter with Ambient
Advisors LLC. Gary M. Post, a member of the board of directors, is the manager
of Ambient Advisors LLC.
Pursuant
to the Engagement Letter, Ambient Advisors will provide certain services
pertaining to strategic planning, investor communications and financing
strategies or other projects at the request of our Chief Executive Officer
for a
one year period, thereafter on a month to month basis. Ambient Advisors will
receive monthly compensation in the amount of $5,000. As part of the
compensation under the Engagement Letter, we granted Ambient Advisors a ten
year
common stock purchase warrant to purchase 108,000 shares of OXIS common stock
at
an exercise price of $0.39 per share, with 9,000 shares becoming exercisable
each month over the term of the agreement.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Submission of Matters to a Vote of Security Holders.
Item
5. Other Information.
None.
Item
6. Exhibits
See
Index
to Exhibits on page 41.
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.
|
|
|
|
OXIS
International, Inc. |
|
|
|
Date:
August 14, 2006 |
By: |
/s/ Michael
D. Centron |
|
Michael D. Centron |
|
Title:
Chief
Financial Officer |
Exhibit
Index
|
|
|
Incorporated
by Reference
|
Exhibit
Number
|
|
Exhibit
Description
|
|
Form
|
|
Filing
Date
|
|
Number
|
|
Filed
Herewith
|
10.1
|
|
Engagement
Letter with Ambient Advisors LLC.
|
|
8-K
|
|
5/31/06
|
|
10.1
|
|
|
10.2
|
|
Mutual
Services Agreement between OXIS International, Inc. and BioCheck,
Inc.
dated June 23, 2006.
|
|
8-K
|
|
6/29/06
|
|
10.1
|
|
|
10.3
|
|
Renewal
and Modification Promissory Note dated June 2, 2006.
|
|
8-K
|
|
7/26/06
|
|
10.1
|
|
|
10.4
|
|
Common
Stock Purchase Warrant dated June 2, 2006.
|
|
8-K
|
|
7/26/06
|
|
10.2
|
|
|
10.5
|
|
Amendment
#2 to Exclusive License and Supply Agreement dated July 19,
2006.
|
|
8-K
|
|
7/26/06
|
|
10.3
|
|
|
31.1
|
|
Certification
of the Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a),
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of
2002.
|
|
|
|
|
|
|
|
X
|
31.2
|
|
Certification
of the Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a),
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of
2002.
|
|
|
|
|
|
|
|
X
|
32.1
|
|
Certification
of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
|
|
|
|
X
|
32.2
|
|
Certification
of the Principal Financial Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
|
|
|
|
X
|
41