U. S.
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-QSB
þ Quarterly
report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
For the
quarterly period ended March
31, 2008
¨
|
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 þ NO ¨
Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). YES ¨ NO þ
At May
18, 2008, the issuer had outstanding the indicated number of shares of common
stock: 46,850,809.
Transitional
Small Business Disclosure Format YES ¨ NO
þ
OXIS
INTERNATIONAL, INC.
FORM
10-QSB
For
the Quarter Ended March 31, 2008
Table
of Contents
PART
I – FINANCIAL INFORMATION
|
|
Page
|
|
Item
1.
|
Financial
Statements
|
|
|
|
|
Consolidated
Balance Sheets as of March 31, 2008 (Unaudited) and December 31,
2007
|
|
|
1 |
|
|
Consolidated
Statements of Operations for the three months ended March 31, 2008 and
2007 (Unaudited)
|
|
|
2 |
|
|
Consolidated
Statement of Stockholders’ Equity (Deficit)
|
|
|
3 |
|
|
Consolidated
Statements of Cash Flows for the three months ended March 31, 2008 and
2007 (Unaudited)
|
|
|
4 |
|
|
Condensed
Notes to Consolidated Financial Statements
|
|
|
5 |
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
|
14 |
|
Item
3A(T).
|
Controls
and Procedures
|
|
|
21 |
|
PART
II – OTHER INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
|
|
22 |
|
Item
2.
|
Unregistered
Sales of Securities and Use of Proceeds
|
|
|
22 |
|
Item
3.
|
Defaults
Upon Senior Securities
|
|
|
22 |
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
|
|
22 |
|
Item
5.
|
Other
Information
|
|
|
22 |
|
Item
6.
|
Exhibits
|
|
|
22 |
|
SIGNATURES
|
|
|
23 |
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated
Balance Sheets
As
of March 31, 2008 and December 31, 2007
|
|
March
31, 2008
(Unaudited)
|
|
|
December
31, 2007
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
1,068,000 |
|
|
$ |
1,140,000 |
|
|
|
|
885,000 |
|
|
|
830,000 |
|
|
|
|
506,000 |
|
|
|
520,000 |
|
Prepaid
expenses and other current assets
|
|
|
109,000 |
|
|
|
129,000 |
|
|
|
|
— |
|
|
|
8,000 |
|
|
|
|
2,568,000 |
|
|
|
2,627,000 |
|
Property,
plant and equipment, net
|
|
|
153,000 |
|
|
|
169,000 |
|
|
|
|
539,000 |
|
|
|
561,000 |
|
Goodwill
and other assets, net
|
|
|
1,500,000 |
|
|
|
1,500,000 |
|
|
|
|
2,192,000 |
|
|
|
2,230,000 |
|
|
|
$ |
4,760,000 |
|
|
$ |
4,857,000 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,208,000 |
|
|
$ |
1,034,000 |
|
|
|
|
1,075,000 |
|
|
|
1,039,000 |
|
|
|
|
71,000 |
|
|
|
— |
|
|
|
|
668,000 |
|
|
|
244,000 |
|
Accrued
derivative liability
|
|
|
60,000 |
|
|
|
89,000 |
|
Convertible
debentures, net of discounts of $384,000 and
$552,000
|
|
|
966,000 |
|
|
|
797,000 |
|
Total
Current Liabilities
|
|
|
4,048,000 |
|
|
|
3,203,000 |
|
|
|
|
25,000 |
|
|
|
25,000 |
|
|
|
|
4,073,000 |
|
|
|
3,228,000 |
|
|
|
|
921,000 |
|
|
|
866,000 |
|
Stockholders’
Equity (Deficit):
|
|
|
|
|
|
|
|
|
Convertible
preferred stock - $0.01 par value; 15,000,000 shares
authorized:
|
|
|
— |
|
|
|
— |
|
Series
B - 0 and 0 shares issued and outstanding at March 31, 2008 and December
31, 2007, respectively (aggregate liquidation preference of
$1,000)
|
|
|
— |
|
|
|
— |
|
Series
C - 96,230 and 96,230 shares issued and outstanding at March 31, 2008 and
December 31, 2007, respectively
|
|
|
1,000 |
|
|
|
1,000 |
|
Common
stock - $0.001 par value; 150,000,000 shares authorized; 46,850,809 and
46,850,809 shares issued and outstanding at March 31, 2008 and December
31, 2007, respectively
|
|
|
47,000 |
|
|
|
47,000 |
|
Additional
paid-in capital
|
|
|
71,077,000 |
|
|
|
70,980,000 |
|
|
|
|
(70,942,000
|
) |
|
|
(69,848,000
|
) |
Accumulated
other comprehensive loss
|
|
|
(417,000
|
) |
|
|
(417,000
|
) |
Total
Stockholders’ Equity (Deficit)
|
|
|
(234,000
|
) |
|
|
763,000 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
|
$ |
4,760,000 |
|
|
$ |
4,857,000 |
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated
Statements of Operations
For
the Three Months Ended March 31, 2008 and 2007
|
|
Three
Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Revenue
|
|
|
|
|
|
|
Product
revenues
|
|
$ |
1,484,000 |
|
|
$ |
1,268,000 |
|
License
revenues
|
|
|
44,000 |
|
|
|
123,000 |
|
TOTAL
REVENUE
|
|
|
1,528,000 |
|
|
|
1,391,000 |
|
Cost
of Product Revenue
|
|
|
856,000 |
|
|
|
729,000 |
|
Gross
profit
|
|
|
672,000 |
|
|
|
662,000 |
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Research
and
development
|
|
|
186,000 |
|
|
|
173,000 |
|
Selling,
general and
administrative
|
|
|
813,000 |
|
|
|
941,000 |
|
Total
operating
expenses
|
|
|
999,000 |
|
|
|
1,114,000 |
|
Loss
from
Operations
|
|
|
(327,000 |
) |
|
|
(452,000 |
) |
Other
Income (expenses):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
8,000 |
|
|
|
25,000 |
|
Other
income
|
|
|
12,000 |
|
|
|
21,000 |
|
Change
in value of warrant and derivative liabilities
|
|
|
(395,000 |
) |
|
|
63,000 |
|
Interest
expense
|
|
|
(257,000 |
) |
|
|
(241,000 |
) |
Other
expense
|
|
|
— |
|
|
|
(8,000 |
) |
Total
Other Income
(Expense)
|
|
|
(632,000 |
) |
|
|
(140,000 |
) |
Loss
before minority interest and provision for income taxes
|
|
|
(959,000 |
) |
|
|
(592,000 |
) |
Minority
Interest in
Subsidiary
|
|
|
(55,000 |
) |
|
|
(77,000 |
) |
Income
(loss) before provision for income taxes
|
|
|
(1,014,000 |
) |
|
|
(669,000 |
) |
Provision
for income
taxes
|
|
|
80,000 |
|
|
|
105,000 |
|
Net
income
(loss)
|
|
$ |
(1,094,000 |
) |
|
$ |
(774,000 |
) |
Earnings
(Loss) Per Share
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
Diluted
|
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
Weighted
Average Shares
Outstanding
|
|
|
|
|
|
|
|
|
Basic
|
|
|
46,850,809 |
|
|
|
44,527,476 |
|
Diluted
|
|
|
46,850,809 |
|
|
|
44,527,476 |
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated
Statement of Stockholders’ Equity (Deficit)
For
the Three Months Ended March 31, 2008 and 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
|
|
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|
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|
|
Total
|
|
|
Preferred
Stock
|
|
Common
Stock
|
|
Additional
Paid-in
|
|
Accumulated
|
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Loss
|
|
(Deficit)
|
|
Balance,
December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
compensation expense for
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
options
issued to non-employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
compensation expense for
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
options
issued to employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
Consolidated
Statements of Cash Flows
For
the Three Months Ended March 31, 2008 and 2007
|
|
Three
Months Ended March 31,
|
|
|
|
2008
(unaudited)
|
|
|
2007
(unaudited)
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,094,000 |
) |
|
$ |
(774,000 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
of property, plant and equipment
|
|
|
16,000 |
|
|
|
21,000 |
|
Amortization
of intangible
assets
|
|
|
22,000 |
|
|
|
25,000 |
|
Stock
compensation expense for options and warrants
issued
to employees and non-employees
|
|
|
97,000 |
|
|
|
228,000 |
|
Amortization
of debt discounts
|
|
|
169,000 |
|
|
|
166,000 |
|
Change
in value of warrant and derivative liabilities
|
|
|
395,000 |
|
|
|
(64,000 |
) |
Minority
interest in
subsidiary
|
|
|
55,000 |
|
|
|
77,000 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(55,000 |
) |
|
|
(88,000 |
) |
Inventory
|
|
|
14,000 |
|
|
|
55,000 |
|
Prepaid
expense and other current assets
|
|
|
20,000 |
|
|
|
26,000 |
|
Accounts
payable
|
|
|
174,000 |
|
|
|
205,000 |
|
Accrued
expenses
|
|
|
36,000 |
|
|
|
104,000 |
|
Income
tax
payable
|
|
|
79,000 |
|
|
|
— |
|
Accounts
payable to related
party
|
|
|
— |
|
|
|
5,000 |
|
Net
cash used in operating activities
|
|
|
(72,000 |
) |
|
|
(14,000 |
) |
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds
from restricted certificate of deposit
|
|
|
— |
|
|
|
3,060,000 |
|
Capital
expenditures
|
|
|
— |
|
|
|
(1,000 |
) |
Increase
in
patents
|
|
|
— |
|
|
|
— |
|
Net
cash provided by investing activities
|
|
|
— |
|
|
|
3,059,000 |
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayment
of short-term
borrowings
|
|
|
— |
|
|
|
(3,060,000 |
) |
Net
cash provided by financing activities
|
|
|
— |
|
|
|
(3,060,000 |
) |
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(72,000 |
) |
|
|
(15,000 |
) |
CASH
AND CASH EQUIVALENTS - Beginning of period
|
|
|
1,140,000 |
|
|
|
1,208,000 |
|
CASH
AND CASH EQUIVALENTS - End of period
|
|
$ |
1,068,000 |
|
|
$ |
1,193,000 |
|
The
accompanying condensed notes are an integral part of these consolidated
financial statements.
OXIS
INTERNATIONAL, INC.
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Note
1 – The Company and Summary of Significant Accounting Policies
The unaudited consolidated financial
statements have been prepared by Oxis International, Inc. (the “Company”),
pursuant to the rules and regulations of the Securities Exchange Commission
(“SEC”). The information furnished herein reflects all adjustments
(consisting of normal recurring accruals and adjustments) which are, in the
opinion of management, necessary to fairly present the operating results for the
respective periods. Certain information and footnote disclosures normally
present in annual consolidated financial statements prepared in accordance with
accounting principles generally accepted in the United States of America have
been omitted pursuant to such rules and regulations. These consolidated
financial statements should be read in conjunction with the audited consolidated
financial statements and footnotes included in the Company’s Annual Report on
Form 10-KSB filed with the SEC on April 11, 2008. The results for the
three months ended March 31, 2008 are not necessarily indicative of the results
to be expected for the full year ending December 31, 2008.
Organization and Line of
Business
OXIS International, Inc. with its
subsidiaries (collectively, “OXIS” or the “Company”) is engaged in the
development of research assays, 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
assays to research laboratories. The Company’s diagnostic products include 26
research assays to measure markers of oxidative and nitrosative
stress.
OXIS’ majority owned
subsidiary, BioCheck Inc. (“BioCheck”) offers its clinical laboratory and
in vitro diagnostics customers over 40 clinical diagnostic assays.
BioCheck’s primary product line consists of enzyme linked immunosorbentassay, or
ELISA, kits that are widely used in medical laboratory settings. These
test kits are applicable to cardiac markers, infectious disease, thyroid
function markers, fertility hormones, and other miscellaneous clinical
diagnostic markers. BioCheck currently has several products under
development for cancer, cardiac/inflammatory and angiogenesis research
applications. In addition to clinical and research assay products,
BioCheck provides various research services to pharmaceutical and diagnostic
companies worldwide.
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 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 and in the third quarter of 2007 the Company purchased
an additional 2% of BioCheck shares.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
The Company had a net loss of
$1,094,000 for the three month period ended March 31, 2008 compared to a net
loss of $774,000 for the three month period ended March 31, 2007. The
net loss in the first three months of 2008 was primarily affected by non-cash
expense relating to an increase in warrant and derivative liabilities of
$395,000, as well as interest expense associated with notes payable of
$257,000. The net loss in the first three months of 2007 was primarily
attributable to interest expense on notes payable of $241,000 and other
operating expenses.
Going
Concern
The Company incurred a loss from
operations of $327,000 and $452,000 for the three months ended March 31, 2008
and 2007, respectively. BioCheck generated a net profit of $118,000 and $82,000
for the three months ended March 31, 2008 and 2007, respectively. The Company
obtained debt financing in the amount of $1,350,000 in the fourth quarter of
2006. Such financing resulted in a non-cash financing charges of $1,674,000 in
2006. Net loss for the three months ended March 31, 2008 was primarily affected
by non-cash expenses relating to changes in value of the warrant and derivative
liabilities.
As shown in the accompanying
consolidated financial statements, the Company has incurred an accumulated
deficit of $70,942,000 through March 31, 2008. On a consolidated
basis, the Company had cash and cash equivalents of $1,068,000 at March 31, 2008
of which $944,000 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 Company will need to seek
additional loan and/or equity financing to pay for basic operating costs, or to
expand operations, implement its marketing campaign, or hire additional
personnel. As of March 31, 2008, approximately $3,230,000 would be needed
in order for OXIS to exercise its option to purchase the remaining 47% of
BioCheck. During 2007, the Company purchased an additional 2% of Bio
Check shares for $132,000.
The current rate of cash usage at the
parent level raises substantial doubt about the 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 additional
equity financing to obtain sufficient funds to sustain
operations. The Company plans to increase revenues by introducing new
products. However, the Company may not successfully obtain debt or equity
financing on terms acceptable to the Company, or at all, that will be sufficient
to finance its goals or to 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 operations.
Use of
Estimates
The financial statements and notes are
representations of the Company's management, which is responsible for their
integrity and objectivity. These accounting policies conform to accounting
principles generally accepted in the United States of America, and have been
consistently applied in the preparation of the financial statements. The
preparation of financial statements requires management to make estimates and
assumptions that affect the reported amounts of assets, liabilities revenues and
expenses and disclosures of contingent assets and liabilities at the date of the
financial statements. Actual results could differ from those
estimates.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Revenue
Recognition
Product
Revenue
The Company manufactures, or has
manufactured on a contract basis, research and clinical diagnostic assays and
fine chemicals, which are the Company’s primary products sold to customers.
Revenue from the sale of the Company’s 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 collectability is reasonably assured. Revenue from sales to
distributors of the Company’s 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. The Company’s mix of product sales are
substantially at risk to market conditions and demand, which may change at
anytime.
License
Revenue
License arrangements may consist of
non-refundable upfront license fees, exclusive licensed rights to patented or
patent pending technology, and various performance or sales milestones and
future product royalty payments. Some of these arrangements are multiple element
arrangements.
Non-refundable, up-front fees that are
not contingent on any future performance by the Company, and require no
consequential continuing involvement on its part, are recognized as revenue when
the license term commences and the licensed data, technology and/or compound is
delivered The Company defers recognition of non-refundable upfront
fees if it has continuing performance obligations without which the technology,
right, product or service conveyed in conjunction with the non-refundable fee
has no utility to the licensee that is separate and independent of the Company’s
performance under the other elements of the arrangement. In addition, if the
Company has continuing involvement through research and development services
that are required because the Company’s know-how and expertise related to the
technology is proprietary to the Company, or can only be performed by the
Company, then such up-front fees are deferred and recognized over the period of
continuing involvement.
Royalty
Revenue
The Company recognizes royalty revenues
from licensed products when earned in accordance with the terms of the license
agreements. Net sales figures used for calculating royalties include deductions
for costs of unsaleable returns, managed care chargebacks, cash discounts,
freight and warehousing, and miscellaneous write-offs.
Segment
Reporting
The Company operates in one reportable
segment.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Derivative
Instruments
In February 2006, the Financial
Accounting Standards Board issued Statement of Financial Accounting Standards
No. 155, “Accounting for Certain Hybrid Financial Instruments, an Amendment of
FASB Standards No. 133 and 140” (hereinafter “SFAS No. 155”). This statement
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 SFAS No.
133 as well as eliminating a restriction on the passive derivative instruments
that a qualifying special-purpose entity (“SPE”) may hold under SFAS No. 140.
This statement 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. This statement 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 this statement will not change the way the Company accounts for
its derivative transactions.
If certain conditions are met, a
derivative may be specifically designated as a hedge, the objective of which is
to match the timing of gain or loss recognition on the hedging derivative with
the recognition of the changes in the fair value of the hedged asset or
liability that are attributable to the hedged risk or the earnings effect of the
hedged forecasted transaction. For a derivative not designated as a hedging
instrument, the gain or loss is recognized in income in the period of change.
The Company has not entered into derivatives contracts to hedge existing risks
or for speculative purposes. The Company has not engaged in any transactions
that would be considered to contain derivative instruments, except for the
convertible debenture issued in 2006.
Stock-Based
Compensation
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 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. The Company recognized $0 and $76,000 in share-based
compensation expense for the three months ended March 31, 2008 and 2007,
respectively.
The Company issued 0 and 30,000 stock
options to employees and directors during the three months ended March 31, 2008
and 2007, respectively. The fair values of employee stock options are
estimated for the calculation of the pro forma adjustments in the above table at
the date of grant using the Black-Scholes option-pricing model with the
following weighted-average assumptions during 2007: expected volatility of 176%;
average risk-free interest rate of 5.0%; initial expected life of 4.45 years; no
expected dividend yield; and amortized over the vesting period of typically one
to four years.
The Company undertook a comprehensive
study of options issued over the life of the Company’s option plans 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.
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 recognized in
share-based compensation expense for non-employees of $97,000 and $152,000 for
the three months ended March 31, 2008 and 2007, respectively.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Earnings Per
Share
Basic earnings per share is computed by
dividing the net income or loss for the period by the weighted average number of
common shares outstanding during the period. Diluted earnings per
share is computed by dividing the earnings 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. Since
the Company incurred a net loss for the three months ended March 31, 2008 and
2007, all instruments convertible into shares of common stock are excluded from
net diluted loss per share because of their anti-dilutive effect.
On
January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements. SFAS
No. 157 defines fair value, establishes a three-level valuation hierarchy for
disclosures of fair value measurement and enhances disclosures requirements for
fair value measures. The carrying amounts reported in the balance sheets for
receivables and current liabilities each qualify as financial instruments and
are a reasonable estimate of fair value because of the short period of time
between the origination of such instruments and their expected realization and
their current market rate of interest. The three levels are defined as
follow:
·
|
Level
1 inputs to the valuation methodology are quoted prices (unadjusted) for
identical assets or liabilities in active markets. The Company’s Level 1
assets include cash equivalents, primarily institutional money market
funds, whose carrying value represents fair value because of their
short-term maturities of the investments held by these
funds.
|
·
|
Level
2 inputs to the valuation methodology include quoted prices for similar
assets and liabilities in active markets, and inputs that are observable
for the asset or liability, either directly or indirectly, for
substantially the full term of the financial instrument. The Company’s
Level 2 liabilities consist of two liabilities arising from the issuance
of a convertible debenture in 2006 and in accordance with EITF 00-19: a
warrant liability for detachable warrants, as well as an accrued
derivative liability for the beneficial conversion feature. These
liabilities are remeasured on a quarterly basis. Fair value is determined
using the Black-Scholes valuation model based on observable market inputs,
such as share price data and a discount rate consistent with that of a
government-issued security of a similar
maturity.
|
·
|
Level
3 inputs to the valuation methodology are unobservable and significant to
the fair value measurement.
|
The following table
represents our assets and liabilities by level measured at fair value on a
recurring basis at March 31, 2008.
Description
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash
equivalents
|
|
$ |
621,000 |
|
|
$ |
- |
|
|
$ |
- |
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
|
- |
|
|
|
668,000 |
|
|
|
- |
|
Accrued
derivative liability
|
|
|
- |
|
|
|
60,000 |
|
|
|
- |
|
The Company has not
applied the provisions of SFAS No. 157 to non-financial assets and liabilities
that are of a nonrecurring nature in accordance with FASB Staff Position (FSP)
Financial Accounting Standard 157-2, Effective Date of FASB Statement No. 157
(FSP 157-2). FSP 157-2 delayed the effective date of application of SFAS 157 to
non-financial assets and liabilies that are of a nonrecurring nature until
January 1, 2009. FSP 157-2 will not have a material effect on the Company’s
financial position, results of operations and cash flows.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Note
2 – Inventories
The
Company states its inventories at the lower of cost or market. Cost has been
determined by using the first-in, first-out method. The physical count of
inventory takes place at the end of the year, and the Company makes estimates of
inventory at interim dates. The Company periodically reviews its reserves for
slow moving and obsolete inventory and believes that such reserves are adequate
at March 31, 2008 and December 31, 2007. Below is a summary of inventory at
March 31, 2008 and December 31, 2007.
|
|
|
|
|
|
|
|
|
March
31, 2008
|
|
|
December
31, 2007
|
|
Raw
materials
|
|
$ |
129,000 |
|
|
$ |
129,000 |
|
Work
in process
|
|
|
174,000 |
|
|
|
174,000 |
|
Finished
goods
|
|
|
203,000 |
|
|
|
217,000 |
|
|
|
$ |
506,000 |
|
|
$ |
520,000 |
|
Convertible
Debentures
On October 25, 2006, the Company
entered into a securities purchase agreement (“purchase agreement”) with four
accredited investors (the “purchasers”). In conjunction with the signing of the
purchase agreement, the Company issued secured convertible debentures
(“debentures”) and Series A, B, C, D, and E common stock warrants (“warrants”)
to the purchasers.
Pursuant
to the terms of the purchase agreement, the Company issued the debentures in an
aggregate principal amount of $1,694,250 to the Purchasers. The debentures were
subject to an original issue discount of 20.318% resulting in proceeds to the
Company of $1,350,000 from the transaction. The debentures mature on October 25,
2008, but may be prepaid by the Company at any time provided that the common
stock issuable upon conversion and exercise of the warrants is covered by an
effective registration statement. The debentures are convertible, at the option
of the purchasers, at any time, into shares of common stock at $0.35 per share,
as adjusted pursuant to a full ratchet anti-dilution provision. Pursuant to the
terms of the debentures, beginning on February 1, 2007, we began to amortize the
debentures in equal installments on a monthly basis resulting in a complete
repayment by the maturity date (the “monthly redemption amounts”). The monthly
redemption amounts can be paid in cash or in shares, subject to certain
restrictions. If the Company chooses to make any monthly redemption amount
payment in shares of common stock, the price per share is the lesser of the
conversion price then in effect and 85% of the weighted average price for the 10
trading days prior to the due date of the monthly redemption
amount. The
Company was not allowed to make its monthly redemption payments in shares due to
contractual restrictions on its ability to do so. The Company has not
made the required monthly cash redemption amounts and as of May 1, 2008, the
Company was in default and was 16 months behind on these
payments. Pursuant to the provisions of the secured convertible
debentures, such non-payment is an event of default. Penalty interest
accrues on any unpaid redemption balance at an interest rate equal to the lesser
of 18% per annum or the maximum rate permitted by applicable law until such
amount is paid in full. Upon an event of default, each purchaser has
the right to accelerate the cash repayment of at least 130% of the outstanding
principal amount of the debenture plus accrued but unpaid liquidated damages and
interest. If the Company fails to make such payment in full, the
purchasers have the right sell substantially all of the Company’s assets
pursuant to their security interest to satisfy any such unpaid
balance. The monthly redemption amount is approximately $85,000 per
month. As of
about March 31, 2008, the Company would have to issue approximately 11,856,077
shares of common stock to satisfy the monthly redemption amount in arrears in an
amount of $1,271,000 and unpaid interest of $133,000, for a total of
approximately $1,404,000 in arrears.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Pursuant to
the debentures, the Company agreed that it will not incur additional
indebtedness for borrowed money. The Company also agreed that it will not
pledge, grant or convey any new liens on its assets. The obligation to pay all
unpaid principal will be accelerated upon an event of default, including upon
failure to perform its obligations under the debenture covenants, failure to
make required payments, default on any of the transaction documents or any other
material agreement, lease, document or instrument to which the Company is
obligated, the bankruptcy of the Company or related events. The purchasers have
a right of first refusal to participate in up to 100% of any future financing
undertaken by the Company until the later of the date that the debentures are no
longer outstanding and the one year anniversary of the effective date of the
registration statement. The Company was restricted from issuing shares of common
stock or instruments convertible into common stock for 90 days after the
effective date of the registration statement with certain exceptions. The
Company is also prohibited from effecting any subsequent financing involving a
variable rate transaction until such time as no purchaser holds any of the
debentures. In addition, until such time as any purchaser holds any of the
securities issued in the debenture transaction, if the Company issues or sells
any common stock or instruments convertible into common stock which a purchaser
reasonably believes is on terms more favorable to such investors than the terms
pursuant to the transaction documents, the Company is obligated to amend the
terms of the transaction documents to such purchaser the benefit of such better
terms. The Company may prepay the entire outstanding principal amount of the
debentures, plus accrued interest and other amounts payable, at its option at
any time without penalty, provided that a registration statement is available
for the resale of shares underlying the debentures and warrants, as more fully
described in the debentures. The purpose of this debenture transaction was to
provide the corporation with intermediate term financing as it seeks longer term
financing.
On
October 25, 2006, in conjunction with the signing of the purchase agreement, the
Company issued to the purchasers five year Series A warrants to purchase an
aggregate of 2,420,357 shares of common stock at an initial exercise price of
$0.35 per share, one year Series B warrants to purchase 2,420,357 shares of
common stock at an initial exercise price of $0.385 per share, and two year
Series C warrants to purchase an aggregate of 4,840,714 shares of common stock
at an initial exercise price of $0.35 per share. In addition, the Company issued
to the Purchasers Series D and E warrants which become exercisable on a pro-rata
basis only upon the exercise of the Series C warrants. The six year Series D
warrants to purchase 2,420,357 shares of common stock have an initial exercise
price of $0.35 per share. The six year Series E warrants to purchase 2,420,357
shares of common stock have an initial exercise price of $0.385 per share. The
initial exercise prices for each warrant are adjustable pursuant to a full
ratchet anti-dilution provision and upon the occurrence of a stock split or a
related event.
Pursuant to the registration rights
agreement, the Company must file a registration statement covering the public
resale of the shares underlying the Series A, B, C, D and E Warrants and the
Debentures within 45 days of the closing of the transaction and cause the
registration to be declared effective within 120 days of the closing date. The
registration statement was filed and declared effective within the 120 days of
the closing date. Cash liquidated damages equal to 2% of the face value of the
debentures per month are payable to the purchasers for any failure to timely
file or maintain an effective registration statement.
Pursuant to the security agreement, the
Company agreed to grant the purchasers, pari passu, a security interest in
substantially all of the Company’s assets. The Company also agreed to pledge its
respective ownership interests in its wholly-owned subsidiaries, OXIS
Therapeutics, OXIS Isle of Man, and its 53% owned subsidiary, BioCheck, Inc. In
addition, OXIS Therapeutics and OXIS Isle of Man each provided a subsidiary
guarantee to the purchasers in connection with the transaction.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Per EITF
00-19, paragraph 4, these convertible debentures do not meet the definition of a
“conventional convertible debt instrument” since the debt is not convertible
into a fixed number of shares. The monthly redemption amounts can be paid with
common stock at a conversion price that is a percentage of the market price;
therefore the number of shares that could be required to be delivered upon
“net-share settlement” is essentially indeterminate. Therefore, the
convertible debenture is considered “non-conventional,” which means that the
conversion feature must be bifurcated from the debt and shown as a separate
derivative liability. This beneficial conversion liability was calculated
to be $690,000 on October 25, 2006. In addition, since the convertible
debenture is convertible into an indeterminate number of shares of common stock,
it is assumed that the Company could never have enough authorized and unissued
shares to settle the conversion of the warrants issued in this transaction into
common stock. Therefore, the warrants issued in connection with this transaction
had a fair value of $2,334,000 at October 20, 2006. The value of the
warrants was calculated using the Black-Scholes model using the following
assumptions: Discount rate of 4.5%, volatility of 158% and expected term of one
to six years. The fair value of the beneficial conversion feature and the
warrant liability will be adjusted to fair value on each balance sheet date with
the change being shown as a component of net loss.
The fair value of the beneficial
conversion feature and the warrants at the inception of these convertible
debentures were $690,000 and $2,334,000, respectively. The first
$1,350,000 of these discounts has been shown as a discount to the convertible
debentures which will be amortized over the term of the convertible
debenture.
At March 31, 2008, the Company
determined the fair value of the beneficial conversion feature and the warrants
was $60,000 and $668,000, respectively. The fair value was calculated using the
Black-Scholes model using the following assumptions: discount rate of 3.0%,
volatility of 127%; dividend yield of 0% and expected term of one to five years.
The aggregate increase in fair value of these two liabilities from
December 31, 2007 to March 31, 2008 of $395,000 is shown as other expense in the
accompanying consolidated statements of operations for the three months ended
March 31, 2008. The fair value of beneficial conversion feature and the warrants
will be determined at each balance sheet date with the change from the prior
period being reported as other income (expense).
On January 8, 2008, the Company entered
into an agreement with Richardson & Patel LLP (“the Firm”), whereby the
Company provided the option to the Firm to convert, at their election, the
unpaid balance of $190,434 in invoices due as of October 31, 2007, or a portion
thereof of the unpaid balance. The initial conversion price will be $0.385 per
share, which conversion price is subject to adjustment based on certain terms.
The conversion price will be reduced (but not increased) to the greater of: (i)
the lowest conversion price per share under the Bristol Debentures, (ii) $0.10
per share, or (iii) the lowest price per share of common stock offered by the
Company in a bona fide financing transaction; provided however, that (i) above
shall only apply so long as the Bristol Debentures are issued and outstanding.
Further, in connection with this agreement, the Company issued to the Firm a
5-year warrant to purchase up to 879,121 shares of common stock of the Company
at an initial exercise price of $0.385 per share, which conversion price is also
subject to adjustment based on certain terms. The conversion price will be
reduced (but not increased) to the greater of: (i) the highest exercise price
per share under the Bristol Warrants or the Fagan Warrant, (ii) $0.10 per share,
or (iii) the lowest price per share of common stock offered by the Company in a
bona fide financing transaction; provided however, that (i) above shall only
apply so long as either the Bristol Warrants or the Fagan Warrant remain issued
and outstanding. At January 8, 2008, the Company determined the fair value of
the warrants was $31,000, and recorded the amount as legal expenses incurred
during the three months ended March 31, 2008 in the accompanying consolidated
statements of operations. The value of the warrants was calculated using the
Black-Scholes model using the following assumptions: Discount rate of 3%,
volatility of 121% and expected term of two years.
In addition to the warrants issued, the
Company issued to the Firm a 5-year option to four individuals of the Firm to
purchase up to a total of 1,025,217 shares of common stock of the Company at an
initial exercise price of $0.385 per share, as adjusted pursuant to the same
terms as aforementioned the warrant issue. The option expense incurred in the
three months ended March 31, 2008 related to these options was $51,000. The
value of the warrants was calculated using the Black-Scholes model using the
following assumptions: Discount rate of 3%, volatility of 121% and expected term
of two years.
OXIS
INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE
MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
Note 5
– Stock Options and Warrants
Stock
Options
Following
is a summary of the stock option activity:
|
|
Options
Outstanding
|
|
|
Weighted
Average Exercise Price
|
|
Outstanding
as of December 31, 2007
|
|
|
5,280,272 |
|
|
$ |
0.32 |
|
Granted
|
|
|
1,025,217 |
|
|
|
0.39 |
|
Forfeited
|
|
|
(128,000 |
) |
|
|
0.35 |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Outstanding
as of March 31, 2008
|
|
|
6,177,489 |
|
|
$ |
0.27 |
|
Warrants
Following is a summary of the warrant
activity:
|
|
Options
Outstanding
|
|
|
Weighted
Average Exercise Price
|
|
Outstanding
as of December 31, 2007
|
|
|
31,562,895 |
|
|
$ |
0.54 |
|
Granted
|
|
|
879,121 |
|
|
|
0.39 |
|
Forfeited
|
|
|
- |
|
|
|
- |
|
Exercised
|
|
|
- |
|
|
|
- |
|
Outstanding
as of March 31, 2008
|
|
|
32,442,016 |
|
|
$ |
0.54 |
|
The Company recognized non-cash
compensation expense of $82,000 and $152,000 related to the issuance and vesting
of stock options issued to consultants in the three months ended March 31, 2008
and 2007, respectively. The Company recognized non-cash compensation
expense of $15,000 and $76,000 related to the issuance and vesting of stock
options issued to employees in the three months ended March 31, 2008 and 2007,
respectively. Cash interest paid was $0 in the three months ended
March 31, 2008 and 2007.
On April 9, 2008, the Company received
a demand letter on behalf of Bristol
Investment Fund, Ltd, demanding immediate payment of all amounts in default
under the convertible debenture agreement dated October 25, 2006 as described in
Note 3 above. The Company is
in active discussions with this investor regarding ways to have
the notice of default withdrawn and/or have the default
cured.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
CAUTIONARY
NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This discussion contains
forward-looking statements based upon our current expectations and involves
risks and uncertainties. To the extent that the information presented
in this report discusses financial projections, information or expectations
about our business plans, results of operations, products or markets, or
otherwise makes statements about future events, such statements are
forward-looking. Such forward-looking statements can be identified by
the use of words such as “may,” “will,” “should,” “might,” “would,” “intends,”
“anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,”
“plans,” and “proposes.” Although we believe that the expectations reflected in
these forward-looking statements are based on reasonable assumptions, there are
a number of risks and uncertainties that could cause actual results to differ
materially from such forward-looking statements. These include, among
others, the cautionary statements in the “Risk Factors” and “Management’s
Discussion and Analysis and Plan of Operation” sections of this
report. These cautionary statements identify important factors that
could cause actual results to differ materially from those described in the
forward-looking statements. When considering forward-looking
statements in this report, you should keep in mind the cautionary statements in
the “Risk Factors” and “Management’s Discussion and Analysis or Plan of
Operation” sections below, and other sections of this report.
The statements contained in this
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, including, without limitation, statements
regarding our expectations, objectives, anticipations, plans, hopes, beliefs,
intentions or strategies regarding the future.
All forward-looking statements
included in this document are based on information available to us on the date
hereof, and we assume no obligation to update any such forward-looking
statements. It is important to note that our actual results could differ
materially from those included in such forward-looking statements. For a more
detailed explanation of such risks, please see “Risk Factors” below. Such risks,
as well as such other risks and uncertainties as are detailed in our SEC reports
and filings for a discussion of the factors that could cause actual results to
differ materially from the forward-looking statements.
The following discussion should be
read in conjunction with the consolidated financial statements and the notes
included in this report on Form 10-QSB.
Overview
OXIS International, Inc. focuses on the
research and development of technologies and therapeutic products in the field
of oxidative stress/inflammatory reaction, diseases that are associated with
damage from free radicals and reactive oxygen species. Biological free radicals
are the result of naturally occurring processes such as oxygen metabolism and
inflammatory reactions. Free radicals react with key organic substances such as
lipids, proteins and DNA. Oxidation of these biomolecules can damage them,
disturbing normal functions and may contribute to a variety of disease
states. Organ systems that are predisposed to oxidative stress and damage are
the pulmonary system, the brain, the eye, the circulatory and reproductive
systems. A prime objective of OXIS is to use its broad portfolio of
oxidative stress biomarkers to identify associations between reactive biomarker
signals and various disease etiologies and conditions.
We presently derive our revenues
primarily from sales of research diagnostic reagents and assays to medical
research laboratories. Our diagnostic products include approximately 45 research
reagents and 26 assays to measure markers of oxidative and nitrosative
stress. We hold the rights to
four therapeutic classes of compounds in the area of oxidative stress and
inflammation. One such compound is L-Ergothioneine, a potent antioxidant
produced by OXIS, that may be appropriate for sale over-the-counter as a dietary
supplement. In September 2005 we acquired a 51% interest in BioCheck
and in the third quarter of 2007 we purchased an additional 2% of BioCheck
shares and have the option to purchase the remaining 47% of BioCheck,
Inc. OXIS does
not have access to the funds held by BioCheck as BioCheck is not a wholly owned
subsidiary. The cash held by the OXIS parent company of $124,000 at
March 31, 2008 is not sufficient to sustain our operations through the second
quarter of 2008.
Our
majority-held subsidiary, BioCheck, Inc. 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 had a net loss of $1,094,000 and
$774,000 for the three months ended March 31, 2008 and 2007,
respectively. The net loss in the first three months of 2008 was
primarily affected by non-cash expense relating to increase in warrant and
derivative liabilities of $395,000, as well as interest expense associated with
notes payable of $257,000. The net loss in the first three months of 2007
was primarily attributable to interest expense on notes payable of $241,000 and
other operating expenses.
As shown in the accompanying
consolidated financial statements, we have incurred an accumulated deficit of
$70,942,000 through March 31, 2008. On a consolidated basis, we had cash and
cash equivalents of $1,068,000 at March 31, 2008 of which $944,000 was held by
BioCheck. Since BioCheck has been and is expected to continue to be cash flow
positive, management believes that BioCheck’s cash will be sufficient to sustain
its operating activities, however, OXIS does not have access to the funds held
by BioCheck as BioCheck is not a wholly owned subsidiary. In February
2008, we received $150,000 from BioCheck for reimbursement of management, market
research, sales efforts, accounting fees and general corporate expenses incurred
on their behalf. The cash held by the OXIS parent company was
$124,000 at March 31, 2008. We will need to seek additional loan
and/or equity financing to pay for basic operating costs, or to expand
operations, implement our marketing campaign, or hire additional
personnel. During 2007, we purchased an additional 2% of Bio Check shares
for $132,000. Additionally, we may decide to acquire the remaining
47% of BioCheck that we currently do not own, which would require additional
financing. However, we may not successfully obtain debt or equity
financing on terms acceptable to us, or at all, that will be sufficient to
finance our operating costs in 2008 and our other goals. These
consolidated 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 we cannot
continue our operations.
Results of
Operations
The following table presents the
changes in revenues from 2007 to 2008:
|
|
Three
Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Increase
(Decrease) from 2007
|
|
Product
Revenues
|
|
$ |
1,484,000 |
|
|
$ |
1,268,000 |
|
|
|
216,000 |
|
License
Revenues
|
|
$ |
44,000 |
|
|
|
123,000 |
|
|
|
(79,000 |
) |
The increase
in product revenues for the three months ended March 31, 2008 compared to the
same period in 2007 was primarily attributable to higher product sales from
Biocheck.
The decrease in license revenues was
attributable to the loss of a significant manufacturing
contract.
Cost
of Product Revenues
The following table presents the
changes in cost of product revenues from 2007 to 2008:
|
|
Three
Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Increase
(Decrease) from 2007
|
|
Cost
of product revenues
|
|
$ |
856,000 |
|
|
$ |
729,000 |
|
|
$ |
127,000 |
|
The change in cost of product
revenues is attributable to the change in product sales. Cost
of product revenue as a percentage was 57.7% for the three months ended March
31, 2008 compared to 57.5% for the same period in 2007. The change is
not significant.
Gross profit was $672,000 and
$662,000 for the three month period ended March 31, 2008 and 2007,
respectively. Gross profit as a percentage of revenues was 44.0% and
47.6% for the three months ended March 31, 2008 and 2007,
respectively. The decrease in gross profit percentage is due to the
decrease in licensing revenues.
Research
and development expenses
The following table presents the
changes in research and development expenses from 2007 to 2008:
|
|
Three
Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Increase
(Decrease) from 2007
|
|
Research
and development expenses
|
|
$ |
186,000 |
|
|
$ |
173,000 |
|
|
$ |
13,000 |
|
The increase in research and
development expenses is primarily attributable to increased salaries and higher
consulting expenses.
Selling,
general and administrative expenses
The following table presents the
changes in selling, general and administrative expenses from 2007 to
2008:
|
|
Three
Months Ended March 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Increase
(Decrease) from 2007
|
|
Selling,
general and administrative expenses
|
|
$ |
813,000 |
|
|
$ |
941,000 |
|
|
$ |
(128,000 |
) |
The decrease in selling, general and
administrative expenses is primarily attributable to a decrease in non-cash
compensation and a decrease in shareholder relations
expenses.
Interest
Income
Interest income was $8,000 and $25,000
for the three months ended March 31, 2008 and 2007, respectively. The
decrease is primarily due to the decrease in cash available for investment
activities.
Change
in value of warrant and derivative liabilities
The change in the value of warrant and
derivative liabilities relates to the change in fair value of these liabilities
recorded by us as a result of the convertible debentures issued in October
2006.
Interest
Expense
Interest expense was $257,000 and
$241,000 for the three months ended March 31, 2008 and 2007,
respectively. The increase is due to the interest on the convertible
debentures and the amortization of the debt issuance costs associated with the
convertible debentures as well as penalty interest associated with the
delinquent payment of the issued debentures.
Liquidity and Capital
Resources
On a
consolidated basis, we had cash and cash equivalents of $1,068,000 at March 31,
2008, of which $944,000 was held by BioCheck. The cash held by the
OXIS parent company was $124,000 at March 31, 2008. Cash used in
operating activities was $72,000 during the three months ended March 31,
2008. In February 2008, we received $150,000 from BioCheck for
reimbursement of management, market research, sales efforts, accounting fees and
general corporate expenses incurred on their behalf. The cash held by
the OXIS parent company of $124,000 at March 31, 2008, including the additional
$150,000 received in 2008 from BioCheck, is not sufficient to sustain our
operations through the second quarter of 2008.
Since BioCheck has been and is expected
to continue to be cash flow positive, management believes that BioCheck’s cash
will be sufficient to sustain BioCheck’s operating
activities. However, we cannot access the cash held by our
majority-held subsidiary, BioCheck, to pay for our parent level operating
expenses. The current rate of cash usage at our parent level raises substantial
doubt about our 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 additional equity financing to obtain sufficient funds to
sustain operations. We plan to increase revenues by introducing new
products. However, we cannot provide assurance that we will
successfully obtain equity or other financing, if any, sufficient to finance our
goals or that we will increase product related revenues. Our
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 that we
cannot continue in existence.
On
October 25, 2006, we completed a private placement of debentures and warrants
under a securities purchase agreement with four accredited investors. In this
financing we issued secured convertible debentures in an aggregate principal
amount of $1,694,250 (referred to in this report as the “debentures”), and
Series A, B, C, D, and E common stock warrants (referred to in this report as
the “warrants”). We also provided the investors registration rights under a
registration rights agreement, and a security interest in our assets under a
security agreement to secure performance of our duties and obligations under the
debentures. Under the warrants, the investors have the right to purchase an
aggregate of approximately 14.5 million shares of our common stock, at initial
exercise prices ranging from $0.35 to $0.385 per share, and these exercise
prices are adjustable according to a full ratchet anti-dilution provision, i.e.,
the exercise price may be adjusted downward in the event that we conduct a
financing at a price per share below $0.35 or $0.385 per share, respectively.
The Series D and E warrants are only exercisable pro rata subsequent to the
exercise of the Series C warrants. The debentures were issued with an original
issue discount of 20.318%, and resulted in proceeds to us of $1,350,000. The
debentures are convertible, at the option of the holders, at any time into
shares of common stock at $0.35 per share, as adjusted in accordance with a full
ratchet anti-dilution provision (referred to in this report as the “conversion
price”). Pursuant to the terms of the debentures, beginning on
February 1, 2007, we began to amortize the debentures in equal installments on a
monthly basis resulting in a complete repayment by the maturity date (the
“monthly redemption amounts”). The monthly redemption amounts can be
paid in cash or in shares, subject to certain restrictions. If we choose to make
any monthly redemption amount payment in shares of common stock, the price per
share is the lesser of the conversion price then in effect and 85% of the
weighted average price for the ten trading days prior to the due date of the
monthly redemption amount. The Company has not made the required monthly
redemption amounts and is currently in default on these payments. We have not
made required monthly redemption payments beginning on February 1, 2007 to
purchasers of debentures issued in October 2006. Pursuant to the
provisions of the secured convertible debentures, such non-payment is an event
of default. Penalty interest accrues on any unpaid redemption balance
at an interest rate equal to the lesser of 18% per annum or the maximum rate
permitted by applicable law until such amount is paid in full. Upon
an event of default, each purchaser has the right to accelerate the cash
repayment of at least 130% of the outstanding principal amount of the debenture
plus accrued but unpaid liquidated damages and interest. If we fail
to make such payment in full, the purchasers have the right sell substantially
all of our assets pursuant to their security interest to satisfy any such unpaid
balance. The monthly redemption amount
is approximately $85,000 and as of May 1, 2008 we were 16 months
behind. We would have to issue approximately 11,856,077 shares of
common stock to satisfy the monthly redemption amount in arrears in an amount of
$1,271,000 and unpaid interest of $133,000, for a total of approximately
$1,404,000 in arrears.
On
January 1, 2008, we adopted SFAS No. 157, Fair Value Measurements. SFAS No. 157
defines fair value, establishes a three-level valuation hierarchy for
disclosures of fair value measurement and enhances disclosures requirements for
fair value measures. The carrying amounts reported in the balance sheets for
receivables and current liabilities each qualify as financial instruments and
are a reasonable estimate of fair value because of the short period of time
between the origination of such instruments and their expected realization and
their current market rate of interest. The three levels are defined as
follow:
·
|
Level
1 inputs to the valuation methodology are quoted prices (unadjusted) for
identical assets or liabilities in active markets. Our Level 1 assets
include cash equivalents, primarily institutional money market funds,
whose carrying value represents fair value because of their short-term
maturities of the investments held by these
funds.
|
·
|
Level
2 inputs to the valuation methodology include quoted prices for similar
assets and liabilities in active markets, and inputs that are observable
for the asset or liability, either directly or indirectly, for
substantially the full term of the financial instrument. Our Level 2
liabilities consist of two liabilities arising from the issuance of a
convertible debenture in 2006 and in accordance with EITF 00-19: a warrant
liability for detachable warrants, as well as an accrued derivative
liability for the beneficial conversion feature. These liabilities are
remeasured on a quarterly basis. Fair value is determined using the
Black-Scholes valuation model based on observable market inputs, such as
share price data and a discount rate consistent with that of a
government-issued security of a similar
maturity.
|
·
|
Level
3 inputs to the valuation methodology are unobservable and significant to
the fair value measurement.
|
The following table
represents our assets and liabilities by level measured at fair value on a
recurring basis at March 31, 2008.
Description
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash
equivalents
|
|
$ |
621,000 |
|
|
$ |
- |
|
|
$ |
- |
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant
liability
|
|
|
- |
|
|
|
668,000 |
|
|
|
- |
|
Accrued
derivative liability
|
|
|
- |
|
|
|
60,000 |
|
|
|
- |
|
We have not applied the
provisions of SFAS No. 157 to non-financial assets and liabilities that are of a
nonrecurring nature in accordance with FASB Staff Position (FSP) Financial
Accounting Standard 157-2, Effective Date of FASB Statement No. 157 (FSP 157-2).
FSP 157-2 delayed the effective date of application of SFAS 157 to non-financial
assets and liabilies that are of a nonrecurring nature until January 1, 2009.
FSP 157-2 will not have a material effect on our financial position,
results of operations and cash flows.
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. In addition during the third quarter of 2007 we purchased
an additional 2% of BIoCheck. This acquisition was accounted for by
the purchase method of accounting according to Statement of Financial Accounting
Standards, or SFAS, No. 141, “Business Combinations.
Revenue
Recognition
Product
Revenue
We manufacture, or have manufactured on
a contract basis, research and clinical 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 collectability 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.
License
Revenue
License arrangements may consist of
non-refundable upfront license fees, exclusive licensed rights to patented or
patent pending technology, and various performance or sales milestones and
future product royalty payments. Some of these arrangements are multiple element
arrangements.
Non-refundable, up-front fees that are
not contingent on any future performance by us, and require no consequential
continuing involvement on our part, are recognized as revenue when the license
term commences and the licensed data, technology and/or compound is
delivered We defer recognition of non-refundable upfront fees if we
have continuing performance obligations without which the technology, right,
product or service conveyed in conjunction with the non-refundable fee has no
utility to the licensee that is separate and independent of our performance
under the other elements of the arrangement. In addition, if we have continuing
involvement through research and development services that are required because
our know-how and expertise related to the technology is proprietary to us, or
can only be performed by us, then such up-front fees are deferred and recognized
over the period of continuing involvement.
Royalty
Revenue
We recognize royalty revenues from
licensed products when earned in accordance with the terms of the license
agreements. Net sales figures used for calculating royalties include deductions
for costs of unsaleable returns, managed care chargebacks, cash discounts,
freight and warehousing, and miscellaneous write-offs.
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. See Notes 1, 4, 5 and 6 to the audited consolidated
financial statements for the year ended December 31, 2007 included in Form
10-KSB for more detail regarding our long-lived 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.
Certain Expenses and
Liabilities
On an ongoing basis, management
evaluates its estimates related to certain expenses and accrued liabilities. We
base our estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of liabilities
that are not readily apparent from other sources. Actual results may differ
materially from these estimates under different assumptions or
conditions.
Share-Based
Compensation
In December 2004, the FASB issued SFAS
123R, which 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.
Risk
Factors
There have been no material changes
from the disclosure provided in Part II, Item 6 of our Annual Report on Form
10-KSB for the year ended December 31, 2007 under the title “Risk
Factors”.
Item
3A(T). Controls
And Procedures
Evaluation of Disclosure
Controls and Procedures
In connection with the preparation of
this Quarterly Report on Form 10-QSB, an evaluation was carried out by our
management, with the participation of our Chief Executive Officer and Chief
Financial Officer, of the effectiveness of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)), as of March 31,
2008. Disclosure controls and procedures are designed to ensure that
information required to be disclosed in reports filed or submitted under the
Exchange Act is recorded, processed, summarized, and reported within the time
periods specified in SEC rules and forms and that such information is
accumulated and communicated to management, including the Chief Executive
Officer and Chief Financial Officer, to allow timely decisions regarding
required disclosures. Based on that evaluation, and in light of the
previously identified material weaknesses in internal control over financial
reporting, as of December 31, 2007, relating to ineffective control environment
and inadequate procedures for intangible impairment evaluation described in the
2007 Annual Report on Form 10-KSB, our principal executive officer and our
principal financial officer have concluded that our disclosure controls and
procedures were not effective as of March 31, 2008.
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. There was no such change in our internal control over
financial reporting because of the timing of the filing of Form 10-KSB in
relation to the filing of the Form 10-QSB, there was insufficient time for us to
implement any material changes in internal control over financial
reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
There
have been no material changes from the disclosure provided in Part I, Item 3 of
our Annual Report on Form 10-KSB for the year ended December 31,
2007.
Item
2. Unregistered Sales of Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
We have
not made required monthly redemption payments beginning on February 1, 2007 to
purchasers of debentures issued in October 2006. Pursuant to the
provisions of the Secured Convertible Debentures, such non-payment is an event
of default. Penalty interest accrues on any unpaid redemption balance
at an interest rate equal to the lesser of 18% per annum or the maximum rate
permitted by applicable law until such amount is paid in full. Upon
an event of default, each purchaser has the right to accelerate the cash
repayment of at least 130% of the outstanding principal amount of the debenture
plus accrued but unpaid liquidated damages and interest. If we fail
to make such payment in full, the purchasers have the right sell substantially
all of our assets pursuant to their security interest to satisfy any such unpaid
balance. The Monthly Redemption Amount is approximately $85,000 and
as of May 1, 2008 we were 16
months behind. We would have to issue approximately 11,856,077 shares
of common stock to satisfy the monthly redemption amount in arrears in an amount
of $1,271,000 and unpaid interest of $133,000, for a total of approximately
$1,404,000 in arrears.
On April 9, 2008, we received
a demand letter on behalf of Bristol
Investment Fund, Ltd, demanding immediate payment of all amounts in default
under the convertible debenture agreement dated October 25, 2006 as described in
Note 3 above. We have been in active discussions with
Bristol regarding ways to have the notice
of default withdrawn and/or have the default cured. No action has been taken by Bristol to
enforce the default. Until final agreement is reached on
potential amendments to our agreements with the debenture holders, we cannot
give any assurance that the debenture holders will continue to forbear from
enforcing the terms applicable in the case of
default.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
None.
Item
6. Exhibits
Exhibit
Number
|
Description
of Exhibit
|
31.1
|
Certification
of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
|
31.2
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d 14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Executive
Officer).
|
32.2
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Financial
Officer).
|
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.
|
|
|
|
May
20, 2008
|
By:
|
/s/ Marvin S.
Hausman
|
|
Marvin
S. Hausman
Chief
Executive Officer
|
|
|
|
|
|
|
|
|
May
20, 2008
|
By:
|
/s/ Marvin S.
Hausman
|
|
Marvin
S. Hausman
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|