ITEM 3. LEGAL PROCEEDINGS
On June 3, 2003, we received correspondence from counsel to an entity
purportedly known as Axiom Pharmaceutical Corporation, which alleged that we
were infringing upon its use of the trademark "Axiom Pharmaceutical
Corporation." On September 29, 2003, we entered into a settlement agreement with
Axiom Pharmaceutical Corporation, whereby we agreed to cease using the name
"Axiom Pharmaceuticals, Inc." and in consideration Axiom Pharmaceutical
Corporation agreed to release us from any claims of infringement regarding use
of the trademark "Axiom Pharmaceutical Corporation" and to pay us $5,000.
Other than as disclosed herein, we are not a party to any material
legal proceeding and no such proceeding is known to be contemplated.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company did not submit any matters to a vote to the security
holders during 2003.
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDERS MATTERS
The common stock is currently listed on the American Stock Exchange
under the symbol "AXJ." Prior to March 14, 2003, the date on which the reverse
acquisition with Werke Pharmaceuticals, Inc. occurred, the common stock was
quoted under the symbol "WICK" on the over-the-counter Bulletin Board.
The following table sets forth the quarterly high and low bid prices
for the common stock since the quarter ended March 30, 2002. The prices set
forth below represent inter-dealer quotations, without retail markup, markdown
or commission and may not be reflective of actual transactions.
Fiscal 2003 HIGH LOW
Quarter ended March 31, 2002 ............................ $0.55 $0.10
Quarter ended June 30, 2002 ............................. 7.00 0.11
Quarter ended September 30, 2002 ........................ 0.51 0.10
Quarter ended December 31, 2002 ......................... 0.51 0.09
January 1, 2003 to March 13, 2003 ....................... 0.51 0.14
Quarter ended March 30, 2003 (beginning on March 14) .... 1.85 0.14
Quarter Ended June 30, 2003 ............................. 6.69 1.05
Quarter Ended September 30, 2003 ........................ 5.68 4.20
Quarter Ended December 31, 2003 ......................... 5.10 3.30
At December 31, 2003, the closing bid price of our common stock was
$4.95. At December 31, 2003, there were approximately 118 record holders of our
common stock. This number excludes any estimate by AXM Pharma of the number of
beneficial owners of shares held in street name, the accuracy of which cannot be
guaranteed.
Starting on March 3, 2004, our common stock listed on the American
Stock Exchange, also called the AMEX, under the trading symbol "AXJ." On March
25, 2004, the closing bid for our common stock as reported on the AMEX was $5.21
per share. As of March 25, 2004 there were 14,807,780shares of common stock
outstanding, 2,425,000 shares of Series A Preferred Stock outstanding and
860,000 shares of Series B Preferred Stock outstanding.
We have not paid cash dividends on any class of common equity since
formation and we do not anticipate paying any dividends on our outstanding
common stock in the foreseeable future.
RECENT SALES OF UNREGISTERED SECURITIES
In order to accomplish the March 2003 share exchange with Werke
Pharmaceuticals, Inc., we issued an aggregate of 11,420,000 shares of common
stock in exchange for all of the issued and outstanding capital stock of Werke
Pharmaceuticals, Inc. The shares issued to the former shareholders of Werke
Pharmaceuticals, Inc. were issued to 25 accredited investors pursuant to an
exemption from registration under Section 4(2) of the Securities Act and to 33
non-U.S. persons pursuant to an exemption from registration under Regulation S
promulgated under the Securities Act.
On April 30, 2003, we issued 30,000 shares of restricted common stock
to Rabelaisian Resources, Plc. pursuant to a consulting agreement. Rabelasian
Resources' services were business and product development. The shares were
issued pursuant to the exemption from registration provided by Section 4(2) of
the Securities Act for issuances not involving a public offering. The shares
were valued at $1.80 per share, the market price for shares of our common stock
at the time of issuance. Therefore, the total aggregate value of the
consideration paid to Rabelasian Resources was $54,000.
On April 30, 2003, we issued 150,000 shares of restricted common stock
to Madden Consulting, Inc. pursuant to a consulting agreement. The services to
be provided under the consulting agreement were investor and public relations.
On September 18, 2003, we issued an additional 400,000 shares to Madden
Consulting, in connection with renewal of its consulting agreement. The shares
were issued pursuant to the exemption from registration provided by Section 4(2)
of the Securities Act for issuances not involving a public offering. The shares
issued on April 30, 2003, were valued at $1.80 per share and the shares issued
on September 18, 2003, were valued at $5.00 per share, the market price for
shares of our common stock at the respective times of issuance. Therefore, the
total aggregate value of the consideration paid to Madden Consulting was
$270,000 on April 30, 2003, and $2,000,000 on September 18, 2003.
On May 1, 2003, we issued 25,000 shares of restricted common stock to
Robert Alexander pursuant to a consulting agreement. The services to be provided
under the consulting agreement were the identification and evaluation of
pharmaceutical companies, products and licenses in Canada. The shares were
issued pursuant to the exemption from registration provided by Section 4(2) of
the Securities Act for issuances not involving a public offering. The shares
were valued at $1.50 per share, the market price for shares of our common stock
at the time of issuance. Therefore, the total aggregate value of the
consideration paid to Robert Alexander was $37,500.
On May 21, 2003, we issued 40,000 shares of restricted common stock to
Amaroq Capital, LLC pursuant to a consulting agreement. The services to be
provided under the consulting agreement were business development and financial
consulting. The shares were issued pursuant to the exemption from registration
provided by Section 4(2) of the Securities Act for issuances not involving a
public offering. The shares were valued at $1.75 per share, the market price for
shares of our common stock at the time of issuance. Therefore, the total
aggregate value of the consideration paid to Amaroq Capital was $70,000.
On May 21, 2003, we issued 15,000 shares of restricted common stock to
McCartney Multimedia, Inc. in consideration for the creation of our website and
corporate logo. The shares were issued pursuant to the exemption from
registration provided by Section 4(2) of the Securities Act for issuances not
involving a public offering. The shares were valued at $1.75 per share, the
market price for shares of our common stock at the time of issuance. Therefore,
the total aggregate value of the consideration paid to McCartney Multimedia was
$26,250.
On June 27, 2003, we issued 80,000 shares of restricted common stock to
Woodbridge Management, Ltd. pursuant to a consulting agreement. The services to
be provided under the consulting agreement were business development, corporate
strategy, and assistance with joint ventures, mergers and acquisitions. The
shares were issued pursuant to the exemption from registration provided by
Section 4(2) of the Securities Act for issuances not involving a public
offering. The shares were valued at $4.45 per share, the market price for shares
of our common stock at the time of issuance. Therefore, the total aggregate
value of the consideration paid to Woodbridge Management was $356,000.
On August 21, 2003, and September 12, 2003, we issued 2,750,000 shares
of our preferred stock at a price per share of $2.00 and 2,750,000 warrants,
each of which entitles the holder to purchase one share of our common stock for
a period of five years from the date of issuance at a price of $3.00 per share,
to two accredited investors pursuant to a private equity financing. Each share
of preferred stock is convertible, at the option of the holder, into one share
of common stock, subject to adjustment for certain occurrences. We also issued a
five-year warrant to purchase up to 275,000 units , each Unit consisting of one
share of preferred stock and one Warrant at an exercise price of $2.00 per Unit
to TN Capital Equities, Ltd., our placement agent in connection with the private
equity financing. The private equity financing described above was made pursuant
to the exemption from the registration provisions of the Securities Act provided
by Section 4(2) of the Act and Rule 506 of Regulation D promulgated thereunder.
On August 31, 2003, we issued 41,667 shares to Peter Cunningham, our
President and Chief Executive Officer, pursuant to the terms of his employment
agreement with AXM Pharma. The shares were issued pursuant to the exemption from
registration provided by Section 4(2) of the Securities Act for issuances not
involving a public offering. The shares were valued at $5.00 per share, the
market price for shares of our common stock at the time of issuance. Therefore,
the total aggregate value of the consideration paid to Peter W. Cunningham was
$208,335.
On September 18, 2003, we issued 100,000 shares to Lan Hao, our Chief
Financial Officer, pursuant to the terms of his employment agreement with AXM
Pharma. The shares were issued pursuant to the exemption from registration
provided by Section 4(2) of the Securities Act for issuances not involving a
public offering. The shares were valued at $5.00 per share, the market price for
shares of our common stock at the time of issuance. Therefore, the total
aggregate value of the consideration paid to Lan S. Hao was $500,000.
On December 31, 2003, we issued 860,000 shares of our preferred stock,
at a price per share of $2.25 and 1,000,000 warrants. Each share of preferred
stock is convertible, at the option of the holder, into one share of common
stock, subject to adjustment for certain occurrences. Each warrant entitles the
holder to purchase one share of our common stock for a period of five years from
the date of issuance at a price of $3.00 per share. Holders of our warrants may
also exercise the warrants through a cashless exercise under certain
circumstances. In addition, we issued to TN Capital Equities, our placement
agent, a five-year warrant to purchase up to 86,000 shares of our preferred
stock for $2.25 per share and up to 100,000 warrants to purchase shares of our
common stock upon exercise at $3.00 per share, on a pro-rata basis to the number
of shares of preferred stock purchased. The private equity financing described
above was made pursuant to the exemption from the registration provisions of the
Securities Act provided by Section 4(2) of the Act and Rule 506 of Regulation D
promulgated thereunder.
On January 26, 2004, the Board authorized the issuance of 100,000
shares of restricted common shares and 50,000 warrants to Great Eastern
Securities, Inc. pursuant to an investment banking agreement. The shares are to
be released quarterly based upon a vesting schedule of 25,000 shares per quarter
during the term of the agreement. Pursuant to an agreement that was executed on
December 18, 2003, Great Eastern will provide investor relations related
services and assist AXM Pharma with broker relations for our stock. The warrants
are for a term of five years and have an exercise price equal to $4.74 per
share. The shares were issued pursuant to the exemption from registration
provided by Section 4(2) of the Securities Act for issuances not involving a
public offering. The shares were valued at $5.65 per share, the market price for
shares of our common stock at the time of issuance. Therefore, the total
aggregate value of the consideration paid to Great Eastern Securities, Inc. was
$565,000.
On February 2, 2004, we issued 200,000 shares of restricted common to
the Aston Organization. We have only released 20,000 of the issued shares to the
Aston Organization. The remaining 180,000 shares are to be released monthly
based upon a vesting schedule of 15,000 shares per month during the term of the
agreement. The services to be provided under the agreement are investor
relations. The shares were issued pursuant to the exemption from registration
provided by Section 4(2) of the Securities Act for issuances not involving a
public offering. The shares were valued at $5.65 per share, the market price for
shares of our common stock at the time of issuance. Therefore, the total
aggregate value of the consideration paid to the Aston Organization was
$1,130,000.
ITEM 6. MANAGEMENT DISCUSSIONS AND ANALYSIS OR PLAN OF OPERATION
The following discussion should be read in conjunction with our financial
statements and the notes thereto which appear elsewhere in this report. The
results shown herein are not necessarily indicative of the results to be
expected in any future periods. This discussion contains forward-looking
statements based on current expectations, which involve uncertainties. Actual
results and the timing of events could differ materially from the
forward-looking statements as a result of a number of factors. Readers should
also carefully review factors set forth in other reports or documents that we
file from time to time with the Securities and Exchange Commission.
OVERVIEW
On March 14, 2003, we completed a share exchange with Werke
Pharmaceuticals, Inc., a Delaware corporation, formed to develop and finance the
growth of Chinese based pharmaceutical companies. As a result of the share
exchange, Werke became our wholly owned subsidiary. Werke's wholly owned
operating subsidiary is Shenyang Tianwei Werke Pharmaceutical Co. Ltd., a
northern China-based pharmaceutical company. The comparables discussed below
relate to the operations of Werke and its wholly owned subsidiary, Shenyang
Tianwei Werke Pharmaceutical Co., for the periods discussed.
We anticipate seeking Chinese government approval to repackage our
product line with the AXM Pharma brand during 2004 following completion of a
full redesign and reconfiguration of our packaging by our international brand
consulting firm.
Our products are currently primarily sold through one third party
distributor, Liaoning Weikang Medicine Co., Ltd. and its selected
sub-distributors, to hospital pharmacies in the key cities of Shanghai,
Guangzhou and Shenyang. We anticipate expanding our sales into retail pharmacies
within these regions during the next quarter and will make efforts to expand
both hospital and retail pharmacy sales into other regional cities such as
Beijing.
We are currently seeking to license various branded OTC products from
identifiable North American pharmaceutical and supplement companies for
distribution and manufacturing in China and Asia-Pacific. As of the date of this
filing we have not entered into any definitive agreements with any such
companies.
LIQUIDITY AND CAPITAL RESOURCES
Total assets increased from $4,312,196 at December 31, 2002 to
$11,024,738 at December 31, 2003. The increase is primarily attributable to
receipt of $4,888,502 in net proceeds from the placement of securities and
accounts receivable that increased approximately $1.7 million and a $.9 million
inventory increase. All of these increases except for cash are directly
attributable to the increase in sales of $6.9 million or 223% over the period
ended December 31, 2002.
During the third quarter, we completed a private equity financing of
$5,500,000 with two accredited investors. After payment of costs and expenses,
including fees of the placement agent, we received net proceeds of approximately
$4,888,502. Pursuant to the terms of the purchase agreements with our investors,
dated as of August 21, 2003, and September 12, 2003, we issued 2,750,000 shares
of our preferred stock, $.001 par value per share, at a price per share of $2.00
and 2,750,000 warrants. Each share of preferred stock is convertible, at the
option of the holder, into one share of common stock, subject to adjustment for
certain occurrences. Each warrant entitles the holder to purchase one share of
our common stock, $.001 par value, for a period of five years from the date of
issuance at a price of $3.00 per share.
Our total outstanding current liabilities increased to approximately
$3.4 million at December 31, 2003, as compared to approximately $1.4 million at
December 31, 2002. The current liabilities increase was the result of an
increase in value-added tax payable and accrued expenses.
From December 31, 2002, to December 31, 2003, our cash and cash
equivalents increased by approximately $2.8 million as a result of receipt of
net proceeds in the private placement offering of $4,888,502. This figure was
offset by cash general, administrative and selling expenses of approximately
$3.7 million. The sales, general and administrative expenditures were incurred
primarily for offering fees and expenses, planning and construction, legal and
accounting fees and consulting fees. Approximately $3.5 million of non-cash
general, administrative and selling expenses were incurred in 2003. The non-cash
expense is where we pay for services (e.g. financial consulting and investor
relations services) using shares of our common stock. In the past the Company
took advantage of these opportunities to conserve cash.
Assuming there is no decrease in current accounts payable, and
accounting for various one-time expenses, the Company's negative cash flow is
approximately $185,000 per month. Without a significant change in sales and
operating gross profits, our only source of significant additional funds to meet
future operating expenses is the sale of our securities. The amount of cash on
hand is sufficient to meet our operating expenses through at least December 31,
2004. Management anticipates that the future prospects and trends in our
business indicate that we may experience at least a 100 percent growth of sales
and operating gross profits during 2004.
We do expect to incur material capital expenditures for the new plant
in Shenyang. Based on discussions with engineering and design firms and
consultants for U.S. Food and Drug Administration validation and Good
Manufacturing Practices certification, the cost of the factory is budgeted at
approximately U.S.$ 5.0 million. Required future capital expenditures for
construction of the new plant, associated manufacturing equipment and staffing
of the new plant will be funded out of existing cash on hand, future revenues or
additional financing activities. There is no assurance we will be able to
generate sufficient revenues or obtain sufficient funds when needed, or whether
such funds, if available, will be obtained on terms satisfactory to us. We do
not have any long term or contingent obligations that must be satisfied.
Additionally, in order to ensure that sufficient funds are available to
develop various additional phases of the new Shenyang plant, we may in the near
future, following completing any regulatory or contractual obligations, provide
notice of redemption of the warrants sold in the private placement, which would
have the effect of forcing exercise of the warrants; provided the exercise price
of the warrants is less than the market price of our common stock at the time
the notice of redemption is provided to our investors. If one hundred percent of
these warrants were exercised, we would receive approximately $8,250,000 in
gross proceeds. Our ability to provide notice of redemption of the warrants is,
however, subject to several factors beyond our control. Such factors include,
the effectiveness of our registration statement on Form SB-2, originally filed
on September 25, 2003, at the time of the notice of redemption, and the price of
our common stock on the market on which it is listed. Therefore, there can be no
guarantee that we will be able to provide notice of redemption of the warrants
or that we will receive any proceeds from the exercise of the warrants.
If the warrants are not exercised and we are unable to provide
necessary capital for construction of the Shenyang plant from future revenues or
financing activities, this may cause delays in the construction of the Shenyang
plant. More likely, however, is that in the absence of the funds from the
exercise of the warrants, we will still be able to complete the Shenyang plant
but we will be forced to acquire manufacturing equipment that operates at lower
capacity and speed. We intend to use the additional funds from exercise of the
warrants, if any, for engineering support to increase speed of production
through improving work flow and using higher speed equipment; for higher speed
equipment for tableting and encapsulation production; and for higher volume
equipment and higher speed equipment for cream mixing and filling production.
CRITICAL ACCOUNTING POLICIES
We believe the following critical accounting policies, among others,
affect our more significant judgments and estimates used in the preparation of
our financial statements:
ALLOWANCE FOR DOUBTFUL ACCOUNTS
We maintain allowances for doubtful accounts for estimated losses
resulting from the inability of our customers to make required payments. The
allowance for doubtful accounts is based on specific identification of customer
accounts and our best estimate of the likelihood of potential loss, taking into
account such factors as the financial condition and payment history of major
customers. We evaluate the collectibility of our receivables at least quarterly.
If the financial condition of our customers were to deteriorate, resulting in an
impairment of their ability to make payments, additional allowances may be
required. The differences could be material and could significantly impact cash
flows from operating activities.
INVENTORY
We write down our inventory for estimated obsolescence or unmarketable
inventory equal to the difference between the cost of inventory and the
estimated market value based upon assumptions about future demand, future
pricing and market conditions. If actual future demand, future pricing or market
conditions are less favorable than those projected by management, additional
inventory write-downs may be required and the differences could be material.
Such differences might significantly impact cash flows from operating
activities.
ACCOUNTING FOR STOCK-BASED COMPENSATION
We account for stock-based compensation based on the provisions of
Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to
Employees," as amended by the Financial Accounting Standards Board
Interpretation No. 44, "Accounting for Certain Transactions Involving Stock
Compensation." Accounting Principles Board Opinion No. 25 and Financial
Accounting Standards Board Interpretation No. 44 state that no compensation
expense is recorded for stock options or other stock-based awards to employees
that are granted with an exercise price equal to or above the estimated fair
value per share of the company's common stock on the grant date. We adopted the
disclosure requirements of Statement of Financial Accounting Standards No. 123,
"Accounting for Stock-Based Compensation," which requires compensation expense
to be disclosed based on the fair value of the options granted at the date of
the grant.
In December 2002, the Financial Accounting Standards Board issued its
Statement No. 148, "Accounting for Stock-Based Compensation -- Transition and
Disclosure--an amendment of Financial Accounting Standards Board Statement No.
123." This Statement amends Statement of Financial Accounting Standards No. 123,
to provide alternative methods of transition for an entity that voluntarily
changes to the fair value based method of accounting for stock-based employee
compensation. It also amends the disclosure provisions of Statement of Financial
Accounting Standards No. 123 to require prominent disclosure about the effects
on reported net income of an entity's accounting policy decisions with respect
to stock-based employee compensation. The transition and annual disclosure
provisions of Statement of Financial Accounting Standards No. 148 are effective
for fiscal years ending after December 15, 2002, and the interim disclosure
provisions were effective for the first interim period beginning after December
15, 2002. We did not voluntarily change to the fair value based method of
accounting for stock-based employee compensation, therefore, the adoption of
Statement of Financial Accounting Standards No. 148 did not have a material
impact on our operations and/or financial position.
We did not issue any stock options to employees during the 2003 fiscal
year, therefore pro forma disclosures are not required for the twelve months
ended December 31, 2003.
CONVERTIBLE PREFERRED STOCK
Convertible Preferred Sock issued by AXM Pharma is initially offset by
a discount representing the relative fair value of the beneficial conversion
feature and warrants. This beneficial conversion for the preferred stock is
recorded as a dividend over the period the preferred stock is convertible and
accelerated pro-rata as the preferred stock are converted. The beneficial
conversion feature allocated to warrants is recognized over the life of the
warrants and accelerated as warrants are exercised. The fair value of the
warrants and beneficial conversion discount are calculated based on available
market data using appropriate valuation models. The beneficial conversion
feature is limited to the total proceeds received.
SALES ALLOWANCES
A portion of our business is to sell products to distributors who
resell the products to the end customers. In certain instances, these
distributors obtain discounts based on the contractual terms of these
arrangements. Sales discounts are usually based upon the volume of purchases or
by reference to a specific price in the related distribution agreement. We
recognize the amount of these discounts at the time the sale is recognized.
Additionally, sales returns allowances are estimated based on historical return
data, and recorded at the time of sale. If the quality or efficacy of our
products deteriorates or market conditions otherwise change, actual discounts
and returns could be significantly higher than estimated, resulting in
potentially material differences in cash flows from operating activities.
VALUATION OF INTANGIBLES
From time to time, we acquire intangible assets that are beneficial to
our product development processes. We periodically evaluate the carrying value
of intangibles, including the related amortization periods. In evaluating
acquired intangible assets, we determine whether there has been an impairment by
comparing the anticipated undiscounted cash flows from the operation and
eventual disposition of the product line with its carrying value. If the
undiscounted cash flows are less than the carrying value, the amount of the
impairment, if any, will be determined by comparing the carrying value of each
intangible asset with its fair value. Fair value is generally based on either a
discounted cash flows analysis or market analysis. Future operating income is
based on various assumptions, including regulatory approvals, patents being
granted, and the type and nature of competing products. If regulatory approvals
or patents are not obtained or are substantially delayed, or other competing
technologies are developed and obtain general market acceptance, or market
conditions otherwise change, our intangibles may have a substantially reduced
value, which could be material.
DEFERRED TAXES
We record a valuation allowance to reduce the deferred tax assets to
the amount that is more likely than not to be realized. We have considered
estimated future taxable income and ongoing tax planning strategies in assessing
the amount needed for the valuation allowance. Based on these estimates, all of
our deferred tax assets have been reserved. If actual results differ favorably
from those estimates used, we may be able to realize all or part of our net
deferred tax assets. Such realization could positively impact our operating
results and cash flows from operating activities.
VALUE ADDED TAX
Value added tax payable is reported as a significant liability. The
accounting policies adopted by management include full disclosure of the Value
Added Tax liability calculated at 17% of the difference between ex factory price
and the cost of raw materials, less the cost of the fees paid to the third-party
original equipment manufacturing company.
LITIGATION
We account for litigation losses in accordance with Statement of
Financial Accounting Standards (SFAS) No. 5, "Accounting for Contingencies."
Under SFAS No. 5, loss contingency provisions are recorded for probable losses
at management's best estimate of a loss, or when a best estimate cannot be made,
a minimum loss contingency amount is recorded. These estimates are often
initially developed substantially earlier than the ultimate loss is known, and
the estimates are refined each accounting period, as additional information is
known. Accordingly, we are often initially unable to develop a best estimate of
loss; therefore, the minimum amount, which could be zero, is recorded. As
information becomes known, either the minimum loss amount is increased or a best
estimate can be made, resulting in additional loss provisions. Occasionally, a
best estimate amount is changed to a lower amount when events result in an
expectation of a more favorable outcome than previously expected. Due to the
nature of current litigation matters, the factors that could lead to changes in
loss reserves might change quickly and the range of actual losses could be
significant, which could materially impact our results of operations and cash
flows from operating activities.
COMPARISON OF RESULTS FOR THE FISCAL YEAR ENDED DECEMBER 31, 2003, TO THE FISCAL
YEAR ENDED DECEMBER 31, 2002.
REVENUE. During the fiscal year ended December 31, 2003, we generated
$10,025,605 from product sales compared to revenues from product sales for the
fiscal year ended December 31, 2002, of $3,103,656. This is an increase of
$6,921,949 or approximately 223%. The increase is primarily due to more robust
sales of our product line, particularly the sales of Asarone tablets and
Weifukang cream. Domestic Chinese customers accounted for 100% of total sales.
We estimate that 45% of these sales were from the sale of Asarone Tablets and
27% were from the sale of Weifukang cream.
Management anticipates growing total revenues by as much as 100% in
2004, through broader distribution within China and the addition of one or more
new products. Despite the views of management, the statement concerning future
gross revenues is a forward-looking statement that involves certain risks and
uncertainties, which could result in a fluctuation of gross sales below those
achieved for the year ended December 31, 2003. Pricing of our products and gross
profit on product sales could change due to competitive forces, which could
negatively impact future sales and or operating profits
GROSS PROFIT. Gross profit on product sales for the fiscal year ended
December 31, 2003, was $3,497,325 compared to $621,579 for the fiscal year ended
December 31, 2002, an increase of $2,875,746 or approximately 462%. The increase
in gross profits during 2003 was due primarily to the $6.9 million increase in
sales. More efficient third party product manufacturing accounted for the
remainder of the increase in our gross profits. Assuming the product sales mix
remains the same, management anticipates future gross profit margins to increase
by as much as another 5% in 2004. This gross profit margin increase is due to
higher pricing of our products and slightly lower production and distribution
costs. We plan to achieve higher average unit prices through the introduction of
new high value products and the revision of marketing and pricing programs to
reflect the Wholly Foreign Owned Entity status of the Company. The State Food
and Drug Administration allows for higher prices to be charged in the hospital
tendering process by foreign owned enterprises as compared to locally owned
companies. We believe that lower production and distribution costs will result
from the opening of the new manufacturing facility, which will enable us to
reduce processing costs through the use of high speed equipment. Further, with
our own factory operating, we eliminate the need to pay the processing fees to
the third-party original equipment manufacturer. We also believe that the
increased unit production and sales volume being achieved will enable us to
negotiate improved raw material supply prices. Despite the views of management,
the statement concerning future gross profit margins is a forward-looking
statement that involves certain risks and uncertainties, which could result in a
fluctuation of gross margins below those achieved for the three months ended
September 30, 2003. Pricing of our products and gross profit on product sales
could change due to competitive forces that could negatively impact future sales
and or operating profits.
SALES, GENERAL AND ADMINISTRATIVE EXPENSES. We incurred Sales, General
and Administrative expenses of $7,205,392 for fiscal year ended December 31,
2003, compared to $673,936 for the fiscal year ended December 31, 2002, an
increase of $6,531,456. There were $3,522,085 in non-cash expenses in
recognition of stock issued to cover administrative services provided by
consultants in lieu of cash. The cash Selling, General and Administrative
expense was $3,683,307 for the same period, or an increase of $3,009,371 and was
the result of the increased personnel and outside services required to prepare
the Company for the increase in sales, marketing of our products, expenses
associated with our public reporting status and increased activities associated
with the proposed construction of a new plant in Shenyang.
NON-CASH CONSULTING ACTIVITIES. During the year ended December 31,
2003, our Board of Directors authorized the issuance of shares of our restricted
common stock to various consultants in lieu of cash payments. Based upon the
common stock trading price at the times of issuance, and FASB rules, we were
required to incur non-cash consulting expenses of $3,522,085 for the issuance of
these shares during the year ended December 31, 2003.
NET LOSS. We recorded a Net Loss applicable to common shareholders for
the fiscal year ended December 31, 2003, of $6,771,556 compared to a Net Loss of
$52,357 for the fiscal year ended December 31, 2002. The increase is the result
of the aforementioned increase in Selling, General and Administrative expenses
and approximately $3.1 million charged to the deemed dividend from beneficial
conversion feature embedded in the preferred stock. The net loss per share for
the year ended December 31, 2003 was $0.52 per share calculated on weighted
average shares outstanding of 12,927,956. This was compared to a net loss per
share for the year ended December 31, 2002 of $0.01 for weighted average shares
outstanding of 10,000,000.
RISK FACTORS
You should carefully consider the risks described below before making an
investment in AXM Pharma. All of these risks may impair our business operations.
If any of the following risks actually occurs our business, financial condition
or results of operations could be materially adversely affected. In such case,
the trading price of our common stock could decline, and you may lose all or
part of your investment.
RISKS RELATING TO OUR BUSINESS
We may not be able to adequately protect and maintain our intellectual property.
Our success will depend in part on our ability to protect and maintain
intellectual property rights and licensing arrangements for our products. No
assurance can be given that licenses or rights used by AXM Pharma will not be
challenged, invalidated, infringed or circumvented, or that the rights granted
thereunder will provide competitive advantages to us. There can be no assurance
that we will be able to obtain a license to any third-party technology that we
may require to conduct our business or that such technology can be licensed at a
reasonable cost. There is no certainty that we will not be challenged by our
partners for non-compliance with our licensing arrangements. Furthermore, there
can be no assurance that we will be able to remain in compliance with our
existing or future licensing arrangements. Consequently, there may be a risk
that licensing arrangements are withdrawn with no penalties to the licensor or
compensation to AXM Pharma.
We may not be able to obtain regulatory approvals for our products or
reimbursement from the sale of our products.
The manufacture and sale of pharmaceutical products in The Peoples
Republic of China is highly regulated by a number of state, regional and local
authorities. These regulations significantly increase the difficulty and costs
involved in obtaining and maintaining regulatory approval and reimbursement
listings for marketing new and existing products. In addition, our future growth
and profitability are, to a significant extent, dependent upon our ability to
obtain timely regulatory approvals and reimbursement from the relevant
authorities.
The State Food and Drug Administration of The Peoples Republic of China
recently implemented new guidelines for licensing of pharmaceutical products.
All existing manufacturers with licenses, which are currently valid under the
previous guidelines, are required to apply for Good Manufacturing Practices
certification by June 30, 2004, and to receive approval by December 31, 2004. As
a result, we plan to submit our application to the State Food and Drug
Administration within the required time period. Furthermore, we believe that our
new factory, which is currently under construction in Shenyang and which is
being constructed to meet more stringent U.S. Good Manufacturing Practices
requirements, will pass the certification process and that our current licenses
will be renewed under the new guidelines. However, should we fail to receive
certification under the new guidelines promulgated by the State Food and Drug
Administration, our business would be impacted in a materially adverse manner.
Our dependence on certain local parties may impact our ability to control
certain aspects of our operations.
Our operations may become substantially dependent on local Chinese
partners to provide marketing expertise and knowledge of the local regulatory
environment in order to facilitate the acquisition of necessary licenses and
permits. Any failure to form or maintain alliances with local partners, or the
preemption or disruption of such alliances by our competitors or otherwise,
could adversely affect our ability to penetrate and compete successfully in the
Chinese marketplace. In addition, in the uncertain legal environments in The
Peoples Republic of China, our business may be vulnerable to local government
agencies or other parties who wish to renegotiate the terms and conditions of,
or terminate, their agreements or other understandings with AXM Pharma.
We rely on third parties for the supply, manufacture and distribution of our
products.
Third parties manufacture and distribute all of our products. We do not
currently have manufacturing facilities, personnel or access to raw materials to
independently manufacture our products. Currently, our products are manufactured
by Qiqihaer Pharmaceutical Factory 2 and our products are distributed by
Liaoning Weikang Medicine Co. Ltd. Except for any contractual rights and
remedies that we may have with our manufacturer and our distributor, we have no
control over the availability of our products, their quality or cost or the
actual distribution of our products. Our current distribution agreement with
Liaoning Weikang Medicine Co. Ltd. expires at the end of March 2004. Although
Liaoning Weikang Medicine Co. Ltd. has verbally agreed to continue as our
distributor at this time, we have not yet signed a definitive written agreement
for distribution of our products with either Liaoning Weikang Medicine Co. Ltd.
or any other distributor. If for any reason we are unable to obtain or retain
third-party manufacturers and distributors on commercially acceptable terms, we
may not be able to produce and distribute our products as planned. If we
encounter delays or difficulties with our contract manufacturer in producing or
packaging our products or with our distributor in distributing our products, the
production, distribution, marketing and subsequent sales of these products would
be adversely affected, and we may have to seek alternative sources of supply or
distribution or abandon or sell product lines on unsatisfactory terms. We may
not be able to enter into alternative supply, production or distribution
arrangements on commercially acceptable terms, if at all. There can be no
assurance that the manufacturer that we have engaged will be able to provide
sufficient quantities of these products or that the products supplied will meet
with our specifications or that our distributor will be able to distribute our
products in accordance with our requirements. In addition, production of our
products may require raw materials for which the sources and quantities are
limited. An inability to obtain adequate supplies of raw materials could
significantly delay development, regulatory approval and marketing of our
products.
During the fiscal years ended December 31, 2003 and 2002, one distributor
accounted for 100% of our net revenues.
During the fiscal years ended December 31, 2003 and 2002, one
distributor, Liaoning Weikang Medicine Co., Ltd., accounted for 100% of our net
revenues during the past two fiscal years. Any dispute with Liaoning Medicine
Co. could have a material adverse effect on our ability to distribute our
products. Additionally, should Liaoning Weikang Medicine Co.'s business suffer
for any reason or if they encounter problems with their customers our business
would be adversely affected.
Additionally, our distributor, Liaoning Weikang Medicine Co. is
required to comply with new Good Sales Practices guidelines promulgated by the
State Food and Drug Administration by December 31, 2004. We have been informed
by Liaoning Weikang Medicine Co. that they are in the process of preparing for
this certification requirement and that they expect to meet the new
requirements. If, however, Liaoning Weikang Medicine Co. does not meet the new
certification requirements, we would be forced to find a new distributor for our
products that is in compliance with the new guidelines. Any delay in our
distribution caused by such an event could have a material adverse effect on our
business. Furthermore, we may not be able to obtain terms as favorable to us
from a new distributor as the terms we have currently negotiated with Liaoning
Weikang Medicine Co., which could also have an adverse effect on our business.
We may have difficulty competing with larger and better financed companies in
our sector.
The ethical and over-the-counter drug markets in The Peoples Republic
of China are very competitive and competition may increase. Products compete on
the basis of efficacy, safety, side effect profiles, price and brand
differentiation. Some of our competitors may have greater technical and
financial resources than AXM Pharma and may use these resources to pursue a
competitive position that threatens our products. Our products could be rendered
obsolete, or uneconomical by the development of new pharmaceuticals to treat
conditions addressed by our products, as a result of technological advances
affecting the cost of production, or as a result of marketing or pricing action
by one or more of our competitors.
We are dependant on certain key existing and future personnel.
Our success will depend, to a large degree, upon the efforts and
abilities of our officers and key management employees such as Peter Cunningham,
our Chief Executive Officer; Chet Howard, our Chief Financial Officer; and Wang
Wei Shi, Chief Executive Officer of Shenyang Tianwei Werke Pharmaceuticals and
Chairman of AXM Pharma. The loss of the services of one or more of our key
employees could have a material adverse effect on our operations. We currently
only have an employment agreement with Peter Cunningham . We do not currently
maintain key man life insurance on any of our key employees. In addition, as our
business plan is implemented, we will need to recruit and retain additional
management and key employees in virtually all phases of our operations. Key
employees will require not only a strong background in the pharmaceutical
industry, but a familiarity with language and culture in the markets in which we
compete. We cannot assure that we will be able to successfully attract and
retain key personnel.
Our growth is dependent on our ability to successfully develop, acquire or
license new drugs.
We must invest substantial time, resources and capital in identifying
and developing new drugs, dosage and delivery systems, either on our own or by
acquiring and licensing such products from third parties. Our growth depends, in
part, on our success in such process. Our planned expansion over time is founded
on a simple principal of introducing two new products or line extensions each
year and to expand distribution into two new territories each year. This
strategy has the advantage of building brands through geographic expansion and
line extensions, and establishing incremental capabilities for new product
introductions. We believe that our planned expansion will require $5.0 million
in total over three years, which we intend to fund out of our future revenues
and, if necessary, additional financing. If we are unable to either develop new
products on our own or acquire licenses for new products from third parties, our
ability to grow revenues and market share will be adversely affected. In
addition, we may not be able to recover our investment in the development of new
drugs, given that projects may be interrupted, unsuccessful, not as profitable
as initially contemplated or we may not be able to obtain necessary financing
for such development if we are unable to fund such development from our future
revenues. Similarly, there is no assurance that we can successfully secure such
rights from third parties on an economically feasible basis.
We may be subject to product liability claims in the future.
We face an inherent business risk of exposure to product liability
claims in the event that the use of our technologies or products are alleged to
have resulted in adverse side effects. Side effects or marketing or
manufacturing problems pertaining to any of our products could result in product
liability claims or adverse publicity. These risks will exist for those products
in clinical development and with respect to those products that receive
regulatory approval for commercial sale. Furthermore, although we have not
historically experienced any problems associated with claims by users of our
products, we do not currently maintain product liability insurance. We plan to
have a product liability insurance plan in place by the first quarter of fiscal
2004; however, there can be no assurance that we will be able to acquire product
liability insurance with terms that are commercially feasible.
RISKS RELATING TO THE PHARMACEUTICAL INDUSTRY IN THE PEOPLE'S REPUBLIC OF CHINA
Changes in the laws and regulations in The Peoples Republic of China may
adversely affect our ability to conduct our business.
The pharmaceutical industry is relatively new in the emerging markets
of The Peoples Republic of China that we are targeting, and the manner and
extent to which it is regulated in these geographical areas is evolving. As a
Chinese corporation, AXM Pharma is subject to the Company Law of The Peoples
Republic of China and more specifically to the Foreign Company provisions of the
Company Law and the Law on Foreign Capital Enterprises of the People's Republic
of China. Additionally, as a pharmaceutical company, we are subject to the
Pharmaceutical Administrative Law. Changes in existing laws or new
interpretations of such laws may have a significant impact on our methods and
costs of doing business. For example, new legislative proposals for
pharmaceutical product pricing, reimbursement levels, approval criteria and
manufacturing requirements may be proposed and adopted. Such new legislation or
regulatory requirements may have a material adverse effect on our financial
condition, results of operations or cash flows. In addition, we will be subject
to varying degrees of regulation and licensing by governmental agencies in The
Peoples Republic of China. There can be no assurance that the future regulatory,
judicial and legislative changes will not have a material adverse effect on AXM
Pharma, that regulators or third parties will not raise material issues with
regard to AXM Pharma or our compliance or non-compliance with applicable laws or
regulations or that any changes in applicable laws or regulations will not have
a material adverse effect on AXM Pharma or our operations.
We may experience barriers to conducting business due to governmental policy.
The State Food and Drug Administration of The Peoples Republic of China
set up a classification administrative system in 1999 for prescription and
over-the-counter drugs. Since then, the State Food and Drug Administration has
issued a series of guidelines for interpretation of the new classification
system for labeling, usage instructions and packaging of over-the-counter
products. The State Food and Drug Administration currently requires that
pharmaceutical manufacturers clearly label drugs for over-the-counter sales and
distinguish them from those to be sold in hospitals as ethical drugs. We have
instituted this policy as required by the State Food and Drug Administration. To
date, we have never experienced any problems with compliance with the
regulations of the State Food and Drug Administration. We have never been
investigated for noncompliance by this agency nor have we violated any
regulations of the State Food and Drug Administration.
Our business may be adversely affected by government plans to consolidate state
owned pharmaceutical companies in the Peoples Republic of China.
The Ministry of Commerce announced plans to consolidate nearly 5,000
state owned pharmaceutical companies into approximately 12 to 15 companies. The
Ministry of Commerce has stated that it targets the size of these remaining
firms to be at least U.S.$ 10.0 billion revenue per annum in the future (U.S.$
5.0 billion by the year 2010). Their primary business will be to make generic
pharmaceutical products for sale to state owned hospitals. The planned
consolidation has already commenced and is anticipated to continue until the
goals of the Ministry of Commerce have been realized. The Ministry of Commerce
has set a near term goal of having 10 large companies with annual sales of over
RMB 5 billion by 2005. We are not aware, however, at this time of how many
companies have been consolidated or when the planned consolidation will be
completed. A recent example of the consolidation amongst state owned
pharmaceutical companies is the acquisition by the conglomerate Huayuan Group of
a 40% stake in Shanghai Pharmaceutical Group. This new company will be involved
in Manufacture, distribution and research and development. An objective of the
consolidation is to establish a manufacturing standard consistent with U.S. Good
Manufacturing Practices. It is planned that all products manufactured in The
Peoples Republic of China will meet U.S. Good Manufacturing Practices standard
in the future.
AXM Pharma has initiated several programs to mitigate any potential
negative impact that this consolidation may have. These steps include commencing
construction of a U.S. Good Manufacturing Practices qualified facility that will
comply with both Chinese and U.S. requirements; seeking to license original
molecules from multi national pharmaceutical firms and specialist drug discovery
firms to participate in the patented prescription product segment of the market
which provides certain protections and pricing multiples not available in other
segments;; and pursuing expansion into the distribution segment of the
pharmaceutical business which is being opened for foreign companies at this
time. This access is supported by new government regulation. Despite these
steps, however, should The Ministry of Commerce follow through with its plans to
consolidate the many fragmented Chinese pharmaceutical companies into a smaller
number of large firms, we will face increased competition from large, well
funded, government supported companies. Our business could be adversely affected
by this increased competition.
RISKS RELATING TO THE PEOPLE'S REPUBLIC OF CHINA
Capital outflow policies in The Peoples Republic of China may hamper our ability
to remit income to the United States.
The Peoples Republic of China has adopted currency and capital transfer
regulations. These regulations may require that we comply with complex
regulations for the movement of capital. In order to comply with these
regulations we may have to revise or change the banking structure of our company
or its subsidiaries Although we believe that we are currently in compliance with
these regulations, should these regulations or the interpretation of them by
courts or regulatory agencies change we may not be able to remit all income
earned and proceeds received in connection with our operations to the U.S.
Fluctuation of the Renminbi could materially affect our financial condition and
results of operations.
The value of the Renminbi fluctuates and is subject to changes in The
Peoples Republic of China's political and economic conditions. Since 1994, the
conversion of Renminbi into foreign currencies, including United States dollars,
has been based on rates set by the People's Bank of China, which are set daily
based upon the previous day's interbank foreign exchange market rates and
current exchange rates on the world financial markets. Since 1994, the official
exchange rate for the conversion of Renminbi to United States dollars has
generally been stable. As of November 15, 2003, the exchange rate between the
Renminbi and the United States dollar was 8.26 Renminbi to every one United
States dollar.
We may face obstacles from the communist system in The Peoples Republic of
China.
Foreign companies conducting operations in The Peoples Republic of
China face significant political, economic and legal risks. The Communist regime
in The Peoples Republic of China, including a stifling bureaucracy, may hinder
Western investment. Another obstacle to foreign investment is corruption. There
is no assurance that we will be able to obtain recourse, if desired, through The
Peoples Republic of China's poorly developed and often corrupt judicial systems.
We may have difficulty establishing adequate management, legal and financial
controls in The Peoples Republic of China.
The Peoples Republic of China historically has been deficient in
Western style management and financial reporting concepts and practices, as well
as in modern banking, computer and other control systems. We may have difficulty
in hiring and retaining a sufficient number of qualified employees to work in
The Peoples Republic of China. As a result of these factors, we may experience
difficulty in establishing management, legal and financial controls, collecting
financial data and preparing financial statements, books of account and
corporate records and instituting business practices that meet Western
standards.
Trade barriers and taxes may have an adverse effect on our business and
operations.
We may experience barriers to conducting business and trade in our
targeted emerging markets in the form of delayed customs clearances, customs
duties and tariffs. In addition, we may be subject to repatriation taxes levied
upon the exchange of income from local currency into foreign currency,
substantial taxes of profits, revenues, assets and payroll, as well as
value-added tax . The markets in which we plan to operate may impose onerous and
unpredictable duties, tariffs and taxes on our business and products, and there
can be no assurance that this will not have an adverse effect on our finances
and operations.
It will be extremely difficult to acquire jurisdiction and enforce liabilities
against our officers, directors and assets based in The Peoples Republic of
China.
Because several of our directors, including Wei Shi Wang, the chairman
of our Board of Directors, are Chinese citizens it may be difficult, if not
impossible, to acquire jurisdiction over these persons in the event a lawsuit is
initiated against AXM Pharma and/or its officers and directors by a shareholder
or group of shareholders in the U.S. Also, although our executive officers are
U.S. citizens, because they may be residing in The Peoples Republic of China at
the time such a suit is initiated achieving service of process against such
persons would be extremely difficult. Furthermore, because the majority of our
assets are located in The Peoples Republic of China it would also be extremely
difficult to access those assets to satisfy an award entered against us in U.S.
court.
There can be no guarantee that The Peoples Republic of China will comply with
the membership requirements of the World Trade Organization.
Due in part to the relaxation of trade barriers following World Trade
Organization accession in January 2002, we believe The Peoples Republic of China
will become one of the world's largest pharmaceutical markets by the middle of
the twenty-first century. As a result, we believe the Chinese market presents a
significant opportunity for both domestic and foreign drug manufacturers. With
the Chinese accession to the World Trade Organization, the Chinese
pharmaceutical industry is gearing up to face the new patent regime that is
required by World Trade Organization regulation. The Chinese government has
begun to reduce its average tariff on pharmaceuticals. The Peoples Republic of
China has also agreed that foreign companies will be allowed to import most
products, including pharmaceuticals, into any part of The Peoples Republic of
China. Current trading rights and distribution restrictions are to be phased out
over a three-year period. In the sensitive area of intellectual property rights,
The Peoples Republic of China has agreed to implement the trade-related
intellectual property agreement of the Uruguay Round. There can be no assurances
that The Peoples Republic of China will implement any or all of the requirements
of its membership in the World Trade Organization in a timely manner, if at all.
The recent outbreak of Severe Acute Respiratory Syndrome (SARS) may adversely
impact our operations and the operations of our contract manufacturers and
distributors.
The SARS outbreak has been most notable in Asia, in particular The
Peoples Republic of China, Singapore and Vietnam. Our principal administrative,
sales, marketing and production development facilities are located in the
Northern portion of The Peoples Republic of China and the operations of all of
our contract manufacturers and distributors are located in The Peoples Republic
of China, as well. The development, manufacture, marketing and distribution of
our pharmaceutical products could suffer if a significant number of our
employees or the employees of our contract manufacturers or distributors
contract SARS or otherwise are unable to fulfill their responsibilities. In
addition, while we possess technology that would allow us to develop and market
products with minimal travel to or from Asia, our business could also be harmed
if travel to or from Asia and the United States is restricted or inadvisable.
Because of our relatively small size, many of our competitors may be better able
to withstand the adverse impact to their businesses resulting from the SARS
outbreak.
RISKS RELATING TO OWNERSHIP OF COMMON STOCK
There may not be sufficient liquidity in the market for our securities in order
for investors to sell their securities.
There is currently only a limited public market for our common stock,
which is listed on the American Stock Exchange, and there can be no assurance
that a trading market will develop further or be maintained in the future.
During the month of February 2004, our common stock traded an average of
approximately 55,000 shares per day. As of March 25, 2004, the closing bid price
of our common stock on the American Stock Exchange was $ 5.21 per share. As of
March 25, 2004, we had approximately 114 shareholders of record not including
shares held in street name. In addition, during the past two years our common
stock has had a trading range with a low price of $.09 per share and a high
price of $7.30 per share.
The fact that our directors and officers own approximately 38.65% of our capital
stock may decrease your influence on shareholder decisions.
Our executive officers and directors, in the aggregate, beneficially
own approximately 38.65% of our capital stock. As a result, our officers and
directors, will have the ability to influence our management and affairs and the
outcome of matters submitted to shareholders for approval, including the
election and removal of directors, amendments to our bylaws and any merger,
consolidation or sale of all or substantially all of our assets.
The outstanding warrants may adversely affect AXM Pharma in the future and cause
dilution to existing Shareholders.
The holders of the warrants have until August 21, 2008, September 12,
2008, and December 31, 2008, respectively, to exercise their warrants. There are
currently 3,333,750 warrants outstanding, which are exercisable at a price of
$3.00 per share, subject to adjustment in certain circumstances. Exercise of the
warrants may cause dilution in the interests of other shareholders as a result
of the additional common stock that would be issued upon exercise. In addition,
sales of the shares of our common stock issuable upon exercise of the warrants
could have a depressive effect on the price of our stock, particularly if there
is not a coinciding increase in demand by purchasers of our common stock.
Further, the terms on which we may obtain additional financing during the period
any of the warrants remain outstanding may be adversely affected by the
existence of these warrants as well.
ITEM 7. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The following Financial Statements required by this item appear at the end of
this report:
Report of Independent Public Accountant
Balance Sheet as of December 31, 2003
Statement of Operations - For the years ended December 31, 2002, and
2003.
Statement of Stockholders Equity - For the years ended December 31,
2002, and 2003.
Statement of Cash Flows - For the years ended December 31, 2002, and
2003.
Notes to Financial Statements
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANICAL DISCLOSURES
We have had no disagreements with our certified public accountants with respect
to accounting practices or procedures or financial disclosure.
ITEM 8A. CONTROLS AND PROCEDURES
EVALUATION AND DISCLOSURE CONTROLS AND PROCEDURES
The Company, under the supervision and with the participation of the
Company's management, including the Company's Chief Executive Officer and Chief
Financial Officer, has evaluated the effectiveness of the design and operation
of the Company's "disclosure controls and procedures," as such term is defined
in Rules 13a-15e promulgated under the Exchange Act as of this report. Based
upon the evaluation, the Chief Executive Officer and Chief Financial Officer has
concluded that the Company's disclosure controls and procedures were effective
as of the end of the period covered by this report to provide reasonable
assurance that information required to be disclosed by the Company in reports
that it files or submits under the Exchange Act is recorded, processed,
summarized and report within the time periods specified in SEC rules and forms.
CHANGES IN INTERNAL CONTROLS
There have been no changes in internal controls or in other factors
that could significantly affect those controls subsequent to the date of their
evaluation, including any corrective actions with regard to significant
deficiencies and material weaknesses.
PART III.
ITEM 9. DIRECTORS AND EXECUTIVE OFFICERS OF REGISTRANT
The following table and text set forth the names and ages of all
directors and executive officers of AXM Pharma as of March 25, 2004. The Board
of Directors is comprised of only one class. All of the directors will serve
until the next annual meeting of shareholders, which is anticipated to be held
in April of 2004, and until their successors are elected and qualified, or until
their earlier death, retirement, resignation or removal. To date we have not had
an annual meeting. There are no family relationships among directors and
executive officers. Also provided herein are brief descriptions of the business
experience of each director and executive officer during the past five years and
an indication of directorships held by each director in other companies subject
to the reporting requirements under the Federal securities laws.
NAME AGE POSITION
---- --- --------
Wang Wei Shi 45 Chairman
Douglas C. MacLellan 47 Vice Chairman
Peter W. Cunningham 47 Chief Executive Officer, President
Mark H. Elenowitz 34 Director
Mark J. Bluer 41 Director
Chet Howard 61 Chief Financial Officer
Montgomery F. Simus 36 Director
Chaoying (Charles) Li 33 Director
|
MS. WANG WEI SHI, CHAIRMAN. Ms. Wang became Chairman of AXM Pharma
when we acquired Werke Pharmaceuticals, Inc. in March 2003 and has been Chairman
of Shenyang Tianwei Werke Pharmaceuticals and Vice-Chairman of Werke
Pharmaceuticals, Inc. since December 2000. From 1999 until December 2000, Ms.
Wang was Chairman and General Manager of Shenyang Tianwei Pharmaceutical
Factory, Ltd., a predecessor to Shenyang Tianwei Werke Pharmaceuticals. Since
May 1996, she has also been Chairman of Liaoning Shenda Import and Export
Company, a Chinese import/export company. From 1984 through 1988, Ms. Wang was
the Manager of the Finance Department of the Shenyang Five Mineral Import and
Export Company, a Chinese import/export company. Ms. Wang attended Beijing
University and Shenyang University and studied financial management, accounting
and economics.
MR. DOUGLAS C. MACLELLAN, VICE-CHAIRMAN. Mr. MacLellan became
Vice-Chairman of AXM Pharma in connection with our acquisition of Werke
Pharmaceuticals, Inc. in March 2003 and has been Vice-Chairman of Werke
Pharmaceuticals, Inc. since October 2000 and Vice Charman of the Board of
Directors of Shenyang Tianwei Werke Pharmaceutical Co., Ltd. since December
2000. Mr. MacLellan is a venture capitalist and business incubation executive.
He holds significant expertise in developing and financing Chinese-based
businesses, particularly in the telecommunications, software and Internet
industries. Since May 1992, Mr. MacLellan has been President and Chief Executive
Officer of the MacLellan Group, Inc., a privately-held business incubator and
financial advisory firm. From March 1998 through October 2000, Mr. MacLellan was
the co-founder and a significant shareholder of Wireless Electronique, Ltd., a
China-based telecommunications company having joint venture operations with
China Unicom (NASDAQ: CHU) in Yunnan, Inner Mongolia and Ningxia provinces. He
is also a co-founder and, since May 1997, has been a director of Datalex
Corporation, a Canadian-based legacy software solution provider. Mr. MacLellan
is also a member of the board of directors and chairman of the audit committee
of AMDL, Inc. (AMEX: ADL), a publicly-held biotechnology firm. From November
1996 to March 1998, Mr. MacLellan was co-Chairman and an Investment Committee
member of the Strategic East European Fund. From November 1995 to March 1998,
Mr. MacLellan was President, Chief Executive Officer and a Director of PortaCom
Wireless, Inc., a company engaged as a developer and operator of cellular and
wireless telecommunications ventures in selected developing world markets. Mr.
MacLellan is a former member of the board of directors and co-founder of
FirstCom Corporation (NASDAQ: FCLX), an international telecommunications company
that operates a competitive access fiber and satellite network in Latin America,
which became AT&T Latin America (NASDAQ: ATTL) in August 2000. During 1996, he
was also the Vice-Chairman of Asia American Telecommunications (now Metromedia
China Corporation), a majority-owned subsidiary of Metromedia International
Group, Inc. (AMEX: MMG). Mr. MacLellan was educated at the University of
Southern California in economics and finance, with advanced training in
classical economic theory.
MR. PETER W. CUNNINGHAM, CHIEF EXECUTIVE OFFICER, PRESIDENT. Mr.
Cunningham was appointed as our Chief Operating Officer in August 2003 and
promoted to the positions of Chief Executive Officer and President in September
2003. He is a known pharmaceutical industry advisor with extensive experience in
creating increased market share for new and existing ethical drug and
over-the-counter pharmaceutical products. He has more than 15 years of
experience working in the healthcare industries in the Asia Pacific region.
Since 1997 Mr. Cunningham has been an independent consultant to the
pharmaceutical industry. From 1994 to 1997, he was the Principal Consultant in
the firms Marc J Consultants & Coopers & Lybrand / Marc J Consultants Healthcare
Industry Practice. He is the former General Manager of Sterling Drug Singapore
(1983 to 1985), where he was the youngest General Manager in the company's
history. He held regional management positions with Rhone Poulenc Rorer from
1987 to 1990, and Becton Dickinson from 1990 to 1994. While at Becton Dickinson,
he held additional responsibility as a member of an internal strategy advisory
team comprising headquarters staff and visionary management from various
operations worldwide. Mr. Cunningham received his MBA from The George Washington
University and a B.A. from the State University of New York and is a Research
Fellow at the American Red Cross National Headquarters.
MR. MARK H. ELENOWITZ, DIRECTOR. Mr. Elenowitz became a Director of AXM
Pharma in connection with our acquisition of Werke Pharmaceuticals, Inc. in
March 2003. Mr. Elenowitz was a co-founder and since July 2001, has been a
managing director of TriPoint Capital Advisors, LLC, a consulting firm, where he
is responsible for the overall corporate development of TriPoint and assisting
its clients with corporate and general business development. From September 2001
to March 2002, Mr. Elenowitz was a Director and President of Image World Media,
Inc. (Pink sheet: IMWI), an international media company specializing in the
production and distribution of various media content for worldwide distribution
across multiple media platforms, such as traditional television, film and the
Internet. From February 1998 to October 2001, Mr. Elenowitz was Co-Chairman and
Managing Director of GroupNow!, Inc., a financial consulting firm. He was also a
founder, and since 1996 has been the senior managing director of Investor
Communications Company, LLC, a national investor relations firm. Mr. Elenowitz
has held Series 7 and 63 licenses as a broker, and has held a Series 24 license
at a regional brokerage firm. Mr. Elenowitz is a graduate of the University of
Maryland School of Business and Management, with a BS in Finance.
MR. MARK J. BLUER, DIRECTOR. Mr. Bluer is the most recent addition to
AXM Pharma's Board of Directors; he joined the AXM Pharma team on February 25,
2004. Mr. Bluer is a founder and managing partner of Bluer and Bluer, LLP, which
was founded in 2000 and is a San Francisco bay area based law firm primarily
focused on business and employment litigation. Mr. Bluer personally represents
clients through all stages of litigation and many cases involve parties from
China or disputes involving transactions between China and the United States.
Prior to founding Bluer and Bluer, Mr. Bluer served as Deputy Chief
Representative for the Beijing Representative office of the law firm CHA & PAN
from 1997 to 1999. Mr. Bluer represented various American clients of the firm
with business interests in China. Mr. Bluer's first attorney position was with
Kern, Noda, Devine & Segal from 1992 to 1995. Mr. Bluer was enrolled in the
Taipei Language Institute where he took tutorial classes in Mandarin Chinese
from 1985 to 1986 and now has over 14 years experience speaking and reading
Mandarin Chinese. Mr. Bluer also has a BA in Business Economics and History,
from the University of California, Santa Barbara. In 1990, Mr. Bluer received
his JD from Santa Clara University School of Law and has been an active member
of the California State Bar since 1991.
MR. CHET HOWARD, CFO. Mr. Chet Howard has over 30 years of financial
management experience working with a variety of early stage and growth
companies. Since January 2000, Mr. Howard has maintained a consulting practice
that specializes in SEC reporting and Sarbanes-Oxley compliance. His clients
have included Amerimmune Pharmaceuticals, Inc., Mandalay Resorts, Inc. and Smart
Chip Technologies, Inc. From January 2001 to December 2002, Mr. Howard was
Executive Vice President and CFO of AirCard Cellular, Inc., where he organized
the finance department, implemented the accounting system and helped develop the
business plan. Prior to AirCard, he was Senior Vice President and CFO of Big
Hub.com, Inc., where he was responsible for all aspects of taking the company
public and instrumental in raising $7.5 million. Before joining Big Hub.com, he
was Executive Vice President and CFO of USA Service Systems, Inc., a marketing
and merchandising company with clients such as Sam's Club, Wal-Mart, Walgreen's
and Sears. Mr. Howard was also Executive Vice President and CFO of InterAmericas
Communication Corp (now AT&T Latin American) and Executive Vice President and
CFO of HQ Office Supplies Warehouse, Inc, where he managed the sale of the
company to Staples, Inc. Previously, he helped develop the business plan and
manage venture capital investment as Senior Vice President, CFO and a co-founder
of the Sports Authority, Inc. In addition to these corporate positions, Mr.
Howard has eight years of experience as a consultant where he has prepared
IPO's, several secondary offering documents and assisted company executives with
SEC filings on a regular basis. Mr. Howard holds both an MBA and BS degree
(Accounting Major) from California State Poly University and has attended
numerous seminars to maintain current expertise in SEC reporting and other
corporate goverence matters.
MR. MONTGOMERY FRANK SIMUS, DIRECTOR. Mr. Simus has more than nine
years of experience working in Central and Southeast Asia, including a unique
combination of information and communications technology expertise and
international development and team-building experience. Since August 2002, he
has been President, CEO and founder of Golden Asia Ventures, a management
consultancy that focuses on strategic business and technology investments
partnerships between Asian and North American organizations. From 2001 to 2002,
Mr. Simus was a Vice President at CEM Investments, where he focused on
early-stage commercial and residential real estate and mezzanine financing
opportunities. Prior to CEM Investments, he worked as an Alliance Manager in the
Institutional Business Development Group at Financial Engines, Inc. from
September 1999 to January 2001. Before joining Financial Engines, Inc., Mr.
Simus held a variety of technology and finance related positions with various
international firms, including AES Corporation, Lehman Brothers Asia Limited
(Hong Kong), Hong Kong and Shanghai Banking Corporation Limited (Hong Kong),
Oracle Corporation and EDS Limited. Mr. Simus also previously managed the
implementation of a multi-million dollar international aid project portfolio
focused on telecommunications, aviation, and parastatal reform for the United
Nations Development Program in Kenya. He graduated from Harvard University's
John F. Kennedy School of Government with a Masters Degree in Public Policy
focused on International Development. He has a BA in History from Yale
University and is functional in French, Mandarin Chinese and Russian.
MR. CHAOYING (CHARLES) LI, DIRECTOR. Mr. Li is a registered lawyer and
trademark attorney in the People's Republic of China where he specializes in
foreign investments in China, mergers and acquisitions, joint venture structure
and formations and intellectual property and technology law. Since August 2001,
he has been a partner at T&C Law Offices in Beijing. Prior to joining T&C, Mr.
Li was a founder and general counsel of Bookoo, Inc., a pioneer in the e-book
marketplace and one of the first Internet companies in Greater China that
extensively emphasized the management of intellectual property rights from
January 2000 to August 2001. Before the founding of Bookoo, Inc., Mr Li spent
over 4 years from August 1995 to December 1999 working for Cha & Cha, an
international law firm specializing in Telecom, Internet and joint venture law.
He received a Master of Laws from the University of Ottawa in 2003 and both a
Master of Laws in July 1999 and Bachelor of Laws in July 1996 from Peking
University, majoring in Intellectual Property Law. He also has earned BS in
Mathematics in July 1995 from Peking University. Mr. Li has written numerous
academic and professional articles that are widely published internationally and
in Mainland China, Hong Kong and Taiwan. Mr. Li is fluent in English and
Mandarin. He also completed an internship at Gowling Lafleur Henderson LLP in
Ottawa, Canada in 2003.
AUDIT COMMITTEE FINANCIAL EXPERT AND IDENTIFY AUDIT COMMITTEE:
The Audit Committee focuses its efforts on assisting our Board of Directors
to fulfill its oversight responsibilities with respect to AXM Pharma's:
o Quarterly and annual consolidated financial statements and financial
information filed with the Securities and Exchange Commission;
o System of internal controls;
o Financial accounting principles and policies;
o Internal and external audit processes; and
o Regulatory compliance programs.
The committee meets periodically with management to consider the
adequacy of AXM Pharma's internal controls and financial reporting process. It
also discusses these matters with AXM Pharma's independent auditors and with
appropriate financial personnel employed by AXM Pharma. The committee reviews
our financial statements and discusses them with management and our independent
auditors before those financial statements are filed with the Securities and
Exchange Commission. The committee met 3 times in fiscal 2003.
The committee has the sole authority to retain and dismiss our
independent auditors and periodically reviews their performance and independence
from management. The independent auditors have unrestricted access and report
directly to the committee.
AUDIT COMMITTEE FINANCIAL EXPERT.
The Board has determined that the Chairman of the committee, Mr.
MacLellan is an "audit committee financial expert" as that term is defined in
Item 401(e) of Regulation S-B and "independent" for purposes of currently
adopted American Stock Exchange listing standards and Section 10A(m)(3) of the
Securities Exchange Act of 1934. Mr. MacLellan is also currently the Chairman of
the Audit Committee of AMDL, Inc. a company also listed on the American Stock
Exchange. Our Board of Directors has determined that such simultaneous service
does not impair the ability of Mr. MacLellan to effectively serve as the
Chairman of AXM Pharma's Audit Committee.
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT
On December 26, 2003, our officers, Directors and 10% or greater
shareholders became subject to the requirements of Section 16(a) of the
Securities Exchange Act by virtue of our common stock becoming registered
pursuant to Section 12 of the Securities Exchange Act on such date. As a result,
each of our officers, directors and 10% or greater shareholders were required on
that date to file a Form 3 reporting their beneficial ownership of AXM Pharma's
securities at such date. Although all of the required Form 3s have now been
filed as required by the Securities Exchange Act, Peter Cunningham, Lan Hao,
Doug MacLellan, Mark Elenowitz, Tongbo Wang and Wang Wei Shi all filed their
initial statements of beneficial ownership on Form 3 late. Other than as set
forth herein, we believe that all reports, which our officers, Directors and 10%
or greater shareholders were required to file in fiscal 2003, pursuant to
Section 16(a) of the Securities Exchange Act, have been timely filed.
CODE OF ETHICS
The Company has always encouraged its employees, including officers and
directors to conduct business in an honest and ethical manner. Additionally, it
has always been our policy to comply with all applicable laws and provide
accurate and timely disclosure. Although we did not have a formal written code
of ethics for the 2003 fiscal year, due to the abundance of tasks associated
with our gaining entrance to a public stock exchange. In March 2004, our Board
adopted formal written codes of ethics for both our executive officers and for
our directors.
Our codes of ethics are designed to deter wrongdoing and promote honest
and ethical conduct and compliance with applicable laws and regulations. These
codes also incorporate our expectations of our executives that enable us to
provide accurate and timely disclosure in our filings with the Securities and
Exchange Commission and other public communications. Our codes of ethics is
posted on our website, www.axmpharma.com. Any future changes or amendments to
our code of ethics, and any waiver of our codes of ethics will also be posted on
our website when applicable.
ITEM 10. EXECUTIVE COMPENSATION
EXECUTIVE COMPENSATION
Summary Compensation Table
Long Term Compensation
----------------------------- -----------
ANNUAL COMPENSATION AWARDS Payouts
----------------------------- -----------
---------------------------------------------------------------- ----------------------------- -----------
(a) (b) (c) (d) (e) (f) (g) (h) (i)
Other Securities All
Name Annual Restricted Under- Other
And Compen- Stock lying LTIP Compen-
Principal sation Award(s) Options/ Payouts sation
($) SARs (#) ($) ($)
Position Year Salary($) Bonus($) ($)
---------------------------------------------------------------- ----------------------------- ----------- -----------
Peter W. Cunningham, 2003 $50,000 0 0 $208,335 41,667 0 0
President, CEO, 2002 0 0 0
2001 0 0 0
Lan Hao 2003 40,000 0 0 $500,000 100,000 0 0
CFO, Director, 2002 0 0 0
2001 0 0 0
Option/SAR in Last Fiscal Year
(Individual Grants)
--------------------------------------------------------------------------------------------------------------
Name Number of Percent of total Exercise or Expiration
Securities options/SARs base price date
Underlying granted to ($/Sh)
Options/SARs employees in
Granted (#) fiscal year
--------------------------------------------------------------------------------------------------------------
(a) (b) (c) (d) (e)
Peter W. Cunningham(1), 0 0 0 N/A
President, CEO
Lan S. Hao(2) 0 0 0 N/A
CFO, Director
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(1) Does not include 400,000 incentive stock options authorized by our
Board of Directors exercisable at $3.90 per share which are subject to
ratification of the "2004 Qualified and Nonstatutory Stock Option
Plan" by our Shareholders at the next annual meeting.
(2) Does not include 25,000 incentive stock options authorized by our
Board of Directors exercisable at $3.90 per share which are subject to
ratification of the "2004 Qualified and Nonstatutory Stock Option
Plan" by our Shareholders at the next annual meeting.
BOARD OF DIRECTORS
Our directors who are employees do not receive any compensation from
AXM Pharma for services rendered as directors. Outside directors receive $3,000
a month for serving on the Board of Directors. Members of the Audit Committee
receive an additional $1,500 per month and the chairman of the Audit Committee
receives an additional $9,000 per month. The chairpersons of the other two board
committees receive an additional $4,500 per month. The Vice-chairman of the
Board receives an additional $6,000 for service in such position, in addition to
any other payments to which he is entitled, and our Chairperson of the Board is
paid a flat fee of $20,000 per month. All board members are entitled to
participate in AXM Pharma's health insurance plan. In January 2004, our Board of
Directors authorized the issuance of 910,000 stock options exercisable at $3.90
per share to members of our Board of Directors and an additional 40,000 stock
options exercisable at 5.70 per share. The foregoing options are subject to
ratification of the "2004 Qualified and Nonstatutory Stock Option Plan" by our
Shareholders at the next annual meeting.
EMPLOYMENT AGREEMENTS
In August 2003, we entered into an employment agreement with Peter
Cunningham, our President and Chief Executive Officer. Although he was
originally hired to serve as our Chief Operating Officer, in September 2003, Mr.
Cunningham was promoted to the positions of President and Chief Executive
Officer. At the time of his promotion, other than the change in his
responsibilities, the terms of Mr. Cunningham's employment agreement remained
the same. Pursuant to the terms of his agreement with AXM Pharma, Mr. Cunningham
shall be paid not less than $120,000 per year for his services. In January 2004,
our Board of Directors increased Mr. Cunningham's salary from $120,000 per year
to $240,000 per year. In addition, Mr. Cunningham is entitled to receive a stock
grant of 250,000 shares of our common stock, which shall be issued and vest in
equal installments every six months (41,667 per six month period) beginning in
August 2003. Mr. Cunningham is also entitled to health insurance and such other
bonus and incentives as the Board of Directors, in its discretion, shall
authorize. Mr. Cunningham's salary, bonus and incentives shall be reviewed
yearly by our Board of Directors and compensation committee with the goal of
bringing Mr. Cunningham's salary in line with industry standards. The term of
Mr. Cunningham's agreement with AXM Pharma is one year, but the agreement shall
automatically renew on the first and second anniversary dates of the agreement
unless either AXM Pharma or Mr. Cunningham provides written notice to the other
not less than 60 days prior to the anniversary date that they do not wish to
renew the agreement, in which case the agreement shall expire on the day prior
to the anniversary date. The employment agreement may be terminated for good
cause by either party in the event of a material breach of the employment
agreement by either party or in the case of Mr. Cunningham of a change in
control of AXM Pharma. In the event of termination with good cause by Mr.
Cunningham or without good cause by AXM Pharma, Mr. Cunningham is entitled to
three months severance plus bonus and incentives earned to that date and
relocation to Los Angeles, California. In the event that Mr. Cunningham is
terminated for good cause by the Company or terminates the agreement without
good cause he will only be entitled to payment of his salary, bonus and
incentives earned to the date of termination and relocation to Los Angeles,
California. Mr. Cunningham's agreement requires that he keep confidential any
proprietary information acquired while employed and upon termination of his
employment. He is also prohibited from soliciting any employees of AXM Pharma
for a period of one year following his termination for any reason.
In September 2003, we entered into employment agreement with Lan Hao,
our former Chief Financial Officer. Pursuant to the terms of his agreement with
AXM Pharma, Mr. Hao was entitled to be paid $120,000 per year for his services.
In addition, Mr. Hao received a stock grant of 100,000 shares of our common
stock, health insurance and such other bonus and incentives as the Board of
Directors, in its discretion, shall authorize. The term of Mr. Hao's employment
agreement is one year but the agreement may be terminated by either party with
or without cause on 30 days written notice. In the event of termination with
good cause by Mr. Hao or without good cause by AXM Pharma, Mr. Hao is entitled
to three months severance pay plus bonus and incentives earned to that date. In
the event that Mr. Hao is terminated for good cause by the Company or terminates
the agreement without good cause he will only be entitled to payment of his
salary, bonus and incentives earned to the date of termination. Mr. Hao is not
subject to any restrictive covenants in his employment agreement. In March 2003
Mr. Hao voluntarily resigned from his position as our Chief Financial Officer.
He is not entitled to any severance pay as a result of his voluntary
resignation.
STOCK OPTION PLANS
In January of 2004, our Board of Directors approved the "2004 Qualified
and Nonstatutory Stock Option Plan." The Board of Directors reserved 3,000,000
shares of the Company's common stock to be issued in the form of incentive
and/or non-qualified stock options for employees, directors and consultants to
AXM. As of March 25, 2004, our Board of Directors, authorized the issuance of
2,040,000 options to employees, directors and consultants. The stock option plan
and the options authorized thereunder are subject to ratification of the stock
option plan by our Shareholders at our next annual meeting.
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