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U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

(X)QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934

For the quarterly period ended September 30, 2004

or

( )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: 001-13343

AMS HEALTH SCIENCES, INC.

(Exact name of registrant as specified in its charter)
     
Oklahoma   73-1323256
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)
     
711 NE 39th Street    
Oklahoma City, Oklahoma   73105
(Address of principal executive offices)   (Zip Code)

(405) 842-0131
(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes   (X)    No   (  )

Indicate by check mark whether the registrant is an accelerated filer as defined in Rule 12b-2 of the Exchange Act.

Yes   (  )    No   (X)

On October 25, 2004, we had outstanding 6,773,960 shares of our common stock, $.0001 par value.

 


AMS HEALTH SCIENCES, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004

Table of Contents

         
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 Amended and Restated Certificate of Incorporation
 Commercial Industrial Real Estate Purchase Contract
 Letter of Independent Accountants as to Unaudited Interim Financial Information
 Rule 13a-14(a) Certification by Chairman and CEO
 Rule 13a-14(a) Certification by CFO
 Section 1350 Certification by CEO
 Section 1350 Certification by CFO

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

     Certain statements under the caption “Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations” constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Certain, but not necessarily all, of such forward-looking statements can be identified by the use of forward-looking terminology such as “anticipates”, “believes”, “expects”, “may”, “will”, or “should” or other variations thereon, or by discussions of strategies that involve risks and uncertainties. Our actual results or industry results may be materially different from any future results expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include general economic and business conditions; our ability to implement our business and acquisition strategies; changes in the network marketing industry and changes in consumer preferences; competition; availability of key personnel; increasing operating costs; unsuccessful advertising and promotional efforts; changes in brand awareness; acceptance of new product offerings; changes in, or the failure to comply with, government regulations (especially food and drug laws and regulations); product liability matters; our ability to obtain financing for future acquisitions and other factors.

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PART I –FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

SEPTEMBER 30, 2004 AND DECEMBER 31, 2003
                 
    September 30,   December 31,
    2004
  2003
    (Unaudited)        
ASSETS
               
CURRENT ASSETS:
               
Cash and cash equivalents
  $ 234,135     $ 2,309,281  
Marketable securities, available for sale, at fair value
    4,123,388       1,876,978  
Receivables
    193,511       416,919  
Prepaid taxes and income tax receivable
    117,602       464,975  
Inventory
    1,340,487       901,529  
Deferred income taxes
    4,854       4,854  
Other assets
    157,720       41,212  
 
   
 
     
 
 
Total current assets
    6,171,697       6,015,748  
RECEIVABLES
    225,949       232,809  
PROPERTY AND EQUIPMENT, net
    3,735,101       3,461,733  
COVENANTS NOT TO COMPETE and other intangibles, net
    499,641       558,004  
DEFERRED INCOME TAXES
    2,611,645       1,883,172  
OTHER ASSETS
    41,956       52,553  
 
   
 
     
 
 
TOTAL
  $ 13,285,989     $ 12,204,019  
 
   
 
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
CURRENT LIABILITIES:
               
Accounts payable
  $ 416,087     $ 357,696  
Accrued commissions and bonuses
    466,233       215,062  
Accrued other expenses
    349,533       328,136  
Accrued sales tax liability
    126,922       130,185  
Notes payable
          485,161  
Capital lease obligations
    112,249       78,954  
 
   
 
     
 
 
Total current liabilities
    1,471,024       1,595,194  
LONG-TERM LIABILITIES:
               
Notes payable
          1,504,009  
Capital lease obligations
    195,779       142,880  
Deferred compensation
    668,073       668,073  
Lease abandonment liability
    135,320        
 
   
 
     
 
 
Total liabilities
    2,470,196       3,910,156  
 
   
 
     
 
 
COMMITMENTS AND CONTINGENCIES (NOTE 7)
               
STOCKHOLDERS’ EQUITY
               
Common stock - $.0001 par value; authorized 495,000,000 shares; issued 7,365,555 and 5,905,307 shares, outstanding 6,773,960 and 5,432,512 shares, respectively
    737       590  
Paid-in capital
    20,023,824       15,160,183  
Notes receivable for exercise of options
    (31,000 )     (31,000 )
Accumulated deficit
    (6,597,682 )     (4,687,718 )
Accumulated other comprehensive gain, net of tax
    52,693       96,284  
 
   
 
     
 
 
Total capital and accumulated deficit
    13,448,572       10,538,339  
Less cost of treasury stock (591,595 and 472,795 shares, respectively)
    (2,632,779 )     (2,244,476 )
 
   
 
     
 
 
Total stockholders’ equity
    10,815,793       8,293,863  
 
   
 
     
 
 
TOTAL
  $ 13,285,989     $ 12,204,019  
 
   
 
     
 
 

See notes to consolidated financial statements.

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE PERIODS ENDED SEPTEMBER 30, 2004 AND 2003
(UNAUDITED)
                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net sales
  $ 4,522,683     $ 4,883,055     $ 13,253,272     $ 14,183,992  
Cost of sales
    3,935,936       3,248,866       10,286,553       9,605,356  
 
   
 
     
 
     
 
     
 
 
Gross profit
    586,747       1,634,189       2,966,719       4,578,636  
Marketing, distribution and administrative expenses:
                               
Marketing
    389,464       418,812       879,891       1,214,174  
Distribution and administrative
    1,767,624       1,507,742       4,842,592       4,287,805  
 
   
 
     
 
     
 
     
 
 
Total marketing, distribution and administrative expenses
    2,157,088       1,926,554       5,722,483       5,501,979  
 
   
 
     
 
     
 
     
 
 
Loss from operations
    (1,570,341 )     (292,365 )     (2,755,764 )     (923,343 )
Other income (expense):
                               
Interest and dividends, net
    32,239       (21,637 )     107,502       (68,947 )
Other, net
    52,692       3,461       36,204       (47,928 )
 
   
 
     
 
     
 
     
 
 
Total other income (expense)
    84,931       (18,176 )     143,706       (116,875 )
 
   
 
     
 
     
 
     
 
 
Loss before taxes
    (1,485,410 )     (310,541 )     (2,612,058 )     (1,040,218 )
Income tax benefit
    (463,753 )     (121,232 )     (702,095 )     (405,806 )
 
   
 
     
 
     
 
     
 
 
Net loss
  $ (1,021,657 )   $ (189,309 )   $ (1,909,963 )   $ (634,412 )
 
   
 
     
 
     
 
     
 
 
Net loss per common share – basic
  $ (.15 )   $ (.04 )   $ (.28 )   $ (.14 )
 
   
 
     
 
     
 
     
 
 
Net loss per common share – assuming dilution
  $ (.15 )   $ (.04 )   $ (.28 )   $ (.14 )
 
   
 
     
 
     
 
     
 
 
Weighted average common shares outstanding – basic
    6,876,796       4,463,092       6,729,395       4,445,541  
 
   
 
     
 
     
 
     
 
 
Weighted average common shares outstanding - assuming dilution
    6,876,796       4,463,092       6,729,395       4,445,541  
 
   
 
     
 
     
 
     
 
 

See notes to consolidated financial statements.

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
(UNAUDITED)
                 
    September 30,   September 30,
    2004
  2003
CASH FLOWS FROM OPERATING ACTIVITIES:
               
Net loss
  $ (1,909,963 )   $ (634,412 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    630,036       743,514  
Loss on sale of assets
    17,016       12,047  
Realized (gain)/loss on sale of marketable securities
    (43,734 )     50,289  
Deferred taxes
    (702,095 )     (405,806 )
Lease abandonment liability
    135,320        
Stock issued for services
    14,000       56,500  
Employee compensation recognized upon exercise of stock options
    205,923        
Changes in assets and liabilities which provided (used) cash:
               
Receivables
    233,994       40,625  
Inventory
    (438,958 )     (277,900 )
Prepaid taxes
    347,373        
Other assets
    (96,813 )     (148,378 )
Accounts payable and accrued expenses
    327,695       421,217  
 
   
 
     
 
 
Net cash used in operating activities
    (1,280,206 )     (142,304 )
 
   
 
     
 
 
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Purchases of property and equipment
    (1,045,507 )     (509,393 )
Sales of property and equipment
    316,399       24,412  
Receipts on notes receivable
    (3,725 )      
Purchases of marketable securities, available for sale
    (7,363,901 )     (1,206,729 )
Sales of marketable securities, available for sale
    5,091,256       1,183,980  
Payments on advances to affiliates
          50,394  
 
   
 
     
 
 
Net cash used in investing activities
    (3,005,478 )     (457,336 )
 
   
 
     
 
 
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Proceeds from issuance of common stock
    665,646        
Proceeds from exercise of warrants
    3,978,218        
Purchases of treasury stock
    (388,303 )      
Principal payment on notes payable
    (1,989,170 )     (364,219 )
Principal payment on capital lease obligations
    (55,853 )     (93,027 )
 
   
 
     
 
 
Net cash provided by (used in) financing activities
    2,210,538       (457,246 )
 
   
 
     
 
 
NET DECREASE IN CASH AND CASH EQUIVALENTS
    (2,075,146 )     (1,056,886 )
CASH AND CASH EQUIVALENTS, BEGINNING
    2,309,281       1,207,299  
 
   
 
     
 
 
CASH AND CASH EQUIVALENTS, ENDING
  $ 234,135     $ 150,413  
 
   
 
     
 
 

See notes to consolidated financial statements.

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
(UNAUDITED)

1.   UNAUDITED INTERIM FINANCIAL STATEMENTS
 
         The unaudited consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote disclosures normally included in 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. The accompanying consolidated financial statements and related notes should be read in conjunction with the audited consolidated financial statements of the Company, and notes thereto, for the year ended December 31, 2003.
 
         The information furnished reflects, in the opinion of management, all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the results of the interim periods presented. Operating results of the interim period are not necessarily indicative of the amounts that will be reported for the year ending December 31, 2004.
 
2.   SIGNIFICANT ACCOUNTING POLICIES
 
         In December 2002, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standard (SFAS) No. 148, “Accounting for Stock-Based Compensation-Transition and Disclosure”, which amended SFAS No. 123, “Accounting for Stock-Based Compensation”. The standard provides alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In compliance with SFAS No. 148, the Company elected to continue to follow the intrinsic value method in accounting for its stock-based employee compensation arrangement as defined by APB No. 25. Accordingly, no compensation cost has been recognized for stock options granted in the accompanying consolidated financial statements. The Company calculated the following pro forma data, net of tax, using compensation costs for the Company’s stock-based compensation awards based upon the fair value of such awards at the grant date consistent with the methodology prescribed under SFAS No. 123.

                                 
    Three Months Ended
  Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net loss as reported
  $ (1,021,657 )   $ (189,309 )   $ (1,909,963 )   $ (634,412 )
Adjustment, net of tax
    (97,996 )     (44,241 )     (798,764 )     (113,400 )
 
   
 
     
 
     
 
     
 
 
Proforma net loss
  $ (1,119,653 )   $ (233,550 )   $ (2,708,727 )   $ (747,812 )
 
   
 
     
 
     
 
     
 
 
Net loss per common share as reported
  $ (.15 )   $ (.04 )   $ (.28 )   $ (.14 )
Adjustment, net of tax
    (.01 )     (.01 )     (.12 )     (.03 )
 
   
 
     
 
     
 
     
 
 
Proforma net loss per common share
  $ (.16 )   $ (.05 )   $ (.40 )   $ (.17 )
 
   
 
     
 
     
 
     
 
 
Proforma net loss per common share — assuming dilution
  $ (.16 )   $ (.05 )   $ (.40 )   $ (.17 )
 
   
 
     
 
     
 
     
 
 
Weighted average common shares outstanding
    6,876,796       4,463,092       6,729,395       4,445,541  
 
   
 
     
 
     
 
     
 
 
Weighted average common shares outstanding – assuming dilution
    6,876,796       4,463,092       6,729,395       4,445,541  
 
   
 
     
 
     
 
     
 
 

    The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in 2004 and 2003, respectively: risk-free interest rates of 3.24 and 2.82 percent; no dividend yield or assumed forfeitures; an expected life of five years; and volatility of 67.7 and 77.4 percent. The pro forma amounts above are not likely to be representative of future years because there is no assurance that additional awards will be made each year. In April 2003, the board of directors of the Company adopted the Advantage Marketing Systems, Inc. 2003 Stock Incentive Plan, which the shareholders approved at the 2003

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003

(UNAUDITED)

    annual meeting of shareholders. The Company issued shares under the Plan in the first nine months of 2004.
 
3.   MARKETABLE SECURITIES
 
         Securities are classified as available for sale with the related unrealized gains and losses excluded from earnings and reported net of income tax as a separate component of stockholders’ equity until realized. Realized gains and losses on sales of securities are based on the specific identification method. Declines in the fair value of investment securities below their carrying value, that are other than temporary, are recognized in earnings.
 
         Net unrealized losses, net of tax, of approximately $74,000 and $44,000 were included in accumulated other comprehensive gain/loss for the three and nine months ended September 30, 2004 and net unrealized gains, net of tax, of approximately $18,000 and $106,000 were included in other comprehensive gain/loss for the three and nine months ended September 30, 2003. Total comprehensive loss for the three and nine months ended September 30, 2004 was approximately $1,095,000 and $1,954,000 and total comprehensive loss for the three and nine months ended September 30, 2003 was approximately $171,000 and $528,000.
 
4.   NOTES PAYABLE
 
    Notes payable consists of the following:

                 
    September 30,   December 31,
    2004
  2003
Note payable to RMS Limited Partnership, 7.5% effective rate, payable in 60 monthly installments net of discount of $80,069 at December 31, 2003
  $     $ 961,606  
Note payable to bank, with interest at prime less .25% (3.75% at December 31, 2003), payable in monthly installments of principal and interest, due on September 30, 2006, collateralized by warehouse and equipment
          853,270  
Note payable to bank, with interest at prime less .25% (3.75% at December 31, 2003), payable in monthly installments of principal and interest, due on September 30, 2006, collateralized by certain assets
          145,950  
5.0% note payable to Lexus Motor Credit, payable in monthly installments of $588.59
          28,344  
 
   
 
     
 
 
Total
          1,989,170  
Less: current maturities
          485,161  
 
   
 
     
 
 
Long-term notes payable
  $     $ 1,504,009  
 
   
 
     
 
 

    The Company paid all of its notes payable and long-term debt in full in January 2004, using proceeds from the exercise of outstanding warrants by the Company’s warrant holders.
 
5.   LOSS PER SHARE
 
         Loss per common share – basic is computed based upon net loss divided by the weighted average number of common shares outstanding during each period. Loss per common share – assuming dilution is computed based upon net loss divided by the weighted average number of common shares outstanding during each period adjusted for the effect of dilutive potential common shares, calculated using the treasury stock method.

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003

(UNAUDITED)

         The following is a reconciliation of the common shares used in the calculations of loss per common share – basic and loss per common share – assuming dilution:

                         
    Income   Shares   Per Share
    (Numerator)
  (Denominator)
  Amount
Weighted average common shares outstanding:
                       
For the three months ended September 30, 2004:
                       
Loss per common share:
                       
Loss available to common stockholders
  $ (1,021,657 )     6,912,165     $ (.15 )
 
                   
 
 
Loss per common share – assuming dilution:
                       
Options
                   
 
   
 
     
 
         
Loss available to common stockholders plus assumed conversions
  $ (1,021,657 )     6,912,165     $ (.15 )
 
   
 
     
 
     
 
 
For the three months ended September 30, 2003:
                       
Loss per common share:
                       
Loss available to common stockholders
  $ (189,309 )     4,463,092     $ (.04 )
 
                   
 
 
Loss per common share – assuming dilution:
                       
Options
                   
 
   
 
     
 
         
Loss available to common stockholders plus assumed conversions
  $ (189,309 )     4,463,092     $ (.04 )
 
   
 
     
 
     
 
 
For the nine months ended September 30, 2004:
                       
Loss per common share:
  $ (1,909,963 )     6,764,764     $ (.28 )
 
                   
 
 
Loss available to common stockholders
                       
Loss per common share – assuming dilution:
                       
Options
                   
 
   
 
     
 
         
Loss available to common stockholders plus assumed conversions
  $ (1,909,963 )     6,764,764     $ (.28 )
 
   
 
     
 
     
 
 
For the nine months ended September 30, 2003:
                       
Loss per common share:
                       
Loss available to common stockholders
  $ (634,412 )     4,445,541     $ (.14 )
 
                   
 
 
Loss per common share – assuming dilution:
                       
Options
                   
 
   
 
     
 
         
Loss available to common stockholders plus assumed conversions
  $ (634,412 )     4,445,541     $ (.14 )
 
   
 
     
 
     
 
 

         Options to purchase 2,510,394 shares of common stock at exercise prices ranging from $1.30 to $6.13 per share were outstanding for the three and nine months ended September 30, 2004, but were not included in the computation of earnings (loss) per common share – assuming dilution for the three or nine months ended because there was a net loss for the periods then ended.
 
         Options to purchase 2,782,192 shares of common stock at exercise prices ranging from $1.30 to $6.13 per share were outstanding for the three and nine months ended September 30, 2003, but were not included in the computation of earnings (loss) per common share – assuming dilution for the three or nine months ended because there was a net loss for the periods then ended.
 
         Warrants to purchase 1,874,768 shares of common stock at exercise prices ranging from $3.40 to $5.40 per share were outstanding at September 30, 2003, but were not included in the computation of earnings per common share — assuming dilution for the three or nine months ended because the warrants’ exercise price was greater than the average market price of the common shares.

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AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003

(UNAUDITED)

         As part of the LifeScience Technologies Acquisition, the sellers received monthly cash payments in an amount equal to the greater of $41,667 or 5% of LifeScience Technologies product sales. The sellers had the election to take each monthly payment in shares of common stock rather than cash at $3.00 per share exercise price, but could not acquire more than 860,000 shares pursuant to such elections. The sellers did not exercise their right to receive any of the acquisition price in shares of the Company’s common stock. None of the shares of common stock subject to this election right were included in the computation of earnings (loss) per common share – assuming dilution for the three or nine months ended September 30, 2003 because there was a net loss for the three and nine months then ended. The balance of the acquisition price, including interest on an outstanding promissory note held by sellers, was paid in full on January 29, 2004.
 
6.   DEFERRED TAXES
 
         On a regular basis, management evaluates all available evidence, both positive and negative, regarding the ultimate realization of the tax benefits of its deferred tax assets. Valuation allowances have been established for certain operating loss and credit carryforwards that reduce deferred tax assets to an amount that will, more likely than not, be realized. Uncertainties that may affect the realization of these assets include tax law changes and the future level of product prices and costs. The outlook for determination of this allowance is calculated on the Company’s historical taxable income, its expectations for the future based on a three-year projection, and available tax-planning strategies. Based on this determination, management expects that the net deferred tax assets will be realized as offsets to reversing deferred tax liabilities and as offsets to the tax arising from any future taxable income. The Company has net operating loss carryforwards of $4,038,000 available to reduce future taxable income, which will begin to expire in 2023. A valuation allowance of approximately $116,000 and $274,000 was provided by management, based upon this analysis for the three months and nine months ended September 30, 2004, respectively. This valuation allowance increase caused a difference between the Company’s expected tax rate of 38% and the Company’s effective tax rate of 31% and 27% for the three months and nine months ended September 30, 2004, respectively.
 
7.   COMMITMENTS AND CONTINGENCIES
 
         Recent Regulatory Developments - As a marketer of products that are ingested by consumers, the Company is subject to the risk that one or more of the ingredients in its products may become the subject of adverse regulatory action. On February 11, 2004, the Food and Drug Administration, or FDA, issued and published in the Federal Register its Final Rule on Ephedrine-containing Supplements, stating that since an “unreasonable risk” had been determined, such supplements would be considered “adulterated” under the Federal Food, Drug and Cosmetic Act, or FFDCA, and thus may not be sold. In essence, this Final Rule (or regulation) imposed a national ban on ephedrine supplements.
 
         The effective date of this regulation was April 12, 2004. The Company complied, and ceased all sales and advertisement of AM-300 and any other ephedra-containing supplement on April 12, 2004. The FDA has indicated that it will now consider whether alternatives to Ephedra and other weight loss and energy stimulants (such as bitter orange) similarly carry an unreasonable risk. These proposals to limit stimulant ingredients, if finalized, may necessitate reformulations of some of the Company’s weight loss products.
 
         Finally, as the press, the FDA, and members of Congress and of the supplement industry have all predicted, the very issuance of the Final Rule on Ephedra may cause Congress to rethink and amend The Dietary Supplement Health and Education Act of 1994, or DSHEA, as to how safety in supplements may be ensured. In particular, there is growing sentiment (including from one herbal

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Table of Contents

AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003

(UNAUDITED)

    trade association) to make Adverse Event Reporting mandatory for all manufacturers and marketers of dietary supplements, so that FDA may take action more quickly than it did on Ephedra, when a harmful herb or other ingredient is suspected. The Company’s regulatory counsel will keep it apprised of any challenges to DSHEA, especially any proposed bills that would amend this Act.
 
    Manufacturing. On March 13, 2003, the FDA published a proposed rule in the Federal Register which proposes comprehensive requirements for the manufacturing, packing and holding of dietary supplements, also known as good manufacturing practices, or GMPs. The FDA accepted public comments on the proposed GMPs until June 11, 2003; final GMPs will be promulgated after the FDA has reviewed the public comments. Once final GMP regulations become effective, the Company’s manufacturer will be required to adhere to them. The FDA will most likely institute an effective date for the GMPs which will allow the Company’s manufacturer a reasonable amount of time to conduct this review and, if necessary, revise its manufacturing operations to comply with the final GMP regulations.
 
    Advertising and Website. The FDA considers website promotional content to constitute “labeling”, and thus the Company’s website must not contain disease claims or drug claims, but only permissible structure/function claims. The Federal Trade Commission, or FTC, governs the advertising of dietary supplements, in any medium or vehicle—print ads, radio spots, infomercials, etc.—including on Internet ads and websites. The fundamental FTC rule is that all material advertising claims, whether express (direct) or implied, must be substantiated by reliable and competent scientific evidence. Because the Company’s website must comply with both FDA and FTC regulations, management routinely asks its regulatory compliance counsel to review certain web pages, especially the content of new product promotions. When necessary, regulatory counsel also reviews the scientific substantiation for particular claims (again, especially for new products such as Prime One, an anti-stress and weight loss product) to determine if it is sufficient, and also that there are no disease claims present, the main FDA issue. Any major website revision will be reviewed by counsel.
 
         Product Liability - The Company, like other marketers of products that are intended to be ingested, faces an inherent risk of exposure to products liability claims in the event that the use of its products results in injury. The Company maintains a claims made policy, with limited liability insurance coverage. The limits of this coverage are $1,000,000 per occurrence and $2,000,000 in the aggregate. Products containing ephedra, which represented approximately 12.6% of the Company’s net revenue for the first nine months of 2004, are not covered by the Company’s product liability insurance. The Company generally does not obtain contractual indemnification from parties manufacturing its products. However, all of the manufacturers of the Company’s products carry product liability insurance, which covers the Company’s products. Such product claims against the Company could result in material losses to the Company.
 
         Legal Proceedings - The Company is currently involved in three products liability suits related to the ingestion of its ephedra-based products. Answers to these petitions have been filed and written discovery and responses have been, or soon will be, exchanged. The Company has denied, and will continue to deny, any wrongdoing, and intends to vigorously defend against the claims. The amounts of damages sought are unknown, but include compensatory and punitive damages.