U.S. SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
(X)QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
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.
| 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
(Registrants 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
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
Certain statements under the caption Item 2 Managements 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.
2
PART I FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| 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.
3
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| 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.
4
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| 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.
5
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
| 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 Companys 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 |
6
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
| 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 Companys 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. | ||||
7
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
| 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. | ||||
8
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
| 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 Companys 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 Companys 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 Companys expected tax rate of 38% and the Companys 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 Companys 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 | ||||
9
AMS HEALTH SCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2004 AND 2003
| 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 Companys 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 Companys manufacturer will be required to adhere to them. The FDA will most likely institute an effective date for the GMPs which will allow the Companys 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 Companys 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 vehicleprint 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 Companys 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 Companys net revenue for the first nine months of 2004, are not covered by the Companys product liability insurance. The Company generally does not obtain contractual indemnification from parties manufacturing its products. However, all of the manufacturers of the Companys products carry product liability insurance, which covers the Companys 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. | ||||