| NUTRACEUTICAL INTERNATIONAL CORP Item 1A Risk Factors |
| Forward-Looking Statements and Certain Risks The statements contained in this report that are not purely historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act |
| These statements regard our expectations, hopes, beliefs, commitments, intentions, and strategies regarding the future |
| They may be identified by the use of words or phrases, such as “believe,” “expect,” “anticipate,” “should,” “plan,” “estimate,” and “potential,” among others |
| Forward-looking statements include, but are not limited to, statements contained in “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our financial performance, revenue and expense levels in the future, and the sufficiency of our existing assets to fund future operations and capital spending needs |
| Actual results could differ materially from the anticipated results or other expectations expressed in these forward-looking statements or for the reasons discussed below |
| The fact that some of the risk factors may be the same or similar to past reports we have filed with the Securities and Exchange Commission means only that the risks are present in multiple periods |
| We believe that many of the risks detailed here are part of doing business in the industry in which we operate and compete and will likely be present in all periods reported |
| The fact that certain risks are endemic to the industry does not lessen their significance |
| The forward-looking statements contained in this report are made as of the date of this report, and we assume no obligation to update them or to update the reasons why actual results could differ from those projected in these forward-looking statements |
| Among others, risks and uncertainties that may affect our business, financial condition, performance, development, and results of operations include the following: Regulatory, Product Liability and Insurance Risks Our products are subject to government regulation, which could limit or prevent the sale of our products |
| The manufacture, packaging, labeling, advertising, promotion, distribution, and sale of our products are subject to regulation by numerous national and local governmental agencies in the United States and other countries |
| The primary regulatory bodies in the United States are the FDA and FTC Failure to comply with these regulatory requirements may result in various types of penalties or fines |
| These include injunctions, product withdrawals, recalls, product seizures, fines, and criminal prosecutions |
| Individual states also regulate nutritional supplements |
| A state may interpret claims or products presumptively valid under federal law as illegal under that state’s regulations |
| In markets outside the United States, we are usually required to obtain approvals, licenses, or certifications from a country’s ministry of health or comparable agency, as well as labeling and packaging regulations, all of which vary from country to country |
| Approvals or licensing may be conditioned on reformulation of products or may be unavailable with respect to certain products or product ingredients |
| Any of these government agencies, as well as legislative bodies, can change existing regulations, or impose new ones, which could cause any of the following: · requirements for the reformulation of certain or all products to meet new standards, · the recall or discontinuance of certain or all products, · additional record keeping, · expanded documentation of the properties of certain or all products, 13 ______________________________________________________________________ · expanded or different labeling, · adverse event tracking and reporting, and · additional scientific substantiation |
| Any or all of these requirements could have a material adverse effect on us |
| There can be no assurance that the regulatory environment in which we operate will not change or that such regulatory environment, or any specific action taken against us, will not result in a material adverse effect on us |
| We may experience product liability claims and litigation to prosecute such claims, and although we maintain product liability insurance, which we believe to be adequate for our needs, there can be no assurance that our insurance coverage will be adequate or that we will be able to maintain adequate insurance coverage |
| As a manufacturer and a distributor of products for human consumption, we experience product liability claims and litigation to prosecute such claims |
| Additionally, the manufacture and sale of these products involves the risk of injury to consumers as a result of tampering by unauthorized third parties or product contamination |
| We carry insurance coverage in the types and amounts that we consider reasonably adequate to cover the risks we face |
| Except for certain products that contain kava, our current third-party liability policies exclude claims related to products containing ephedra or kava, as well as additional ingredients |
| We are currently party to product liability lawsuits that involve excluded ingredients, and there can be no assurance that we will not be subject to additional lawsuits |
| We have established a captive insurance subsidiary to provide coverage for certain of our product liability risks, including excluded claims under our other policies |
| We have accrued an amount using the assistance of a third-party actuary that we believe is sufficient to cover probable and reasonably estimable liabilities related to product liability claims based on its history of such claims |
| However, the capitalization and income from premiums paid, both of which are contributed by us, could be inadequate to cover a claim, particularly a material claim that arises in the first few years of the captive’s operations |
| If insurance coverage is inadequate or unavailable or premium costs continue to rise, we may face additional claims not covered by insurance, and claims that exceed coverage limits or that are not covered could have a material adverse effect on us |
| Market and Channel Risks Our success is linked to the size and growth rate of the vitamin, mineral and supplement market and an adverse change in the size or growth rate of that market could have a material adverse effect on us |
| Some manufacturers in our industry have experienced a slow-down in sales of nutritional supplements |
| An adverse change in size or growth rate of the vitamin, mineral and supplement market could have a material adverse effect on us |
| Underlying market conditions are subject to change based on economic conditions, consumer preferences and other factors that are beyond our control, including media attention and scientific research, which may be positive or negative |
| Because a substantial majority of our sales are to or through health food stores, we are dependent to a large degree upon the success of this channel as well as the success of specific retailers in the channel |
| Over 90prca of our sales are in the United States and Canada |
| In those two markets, we sell our products primarily to or through health food stores |
| Because of this, we are dependent to a large degree upon the success of that channel as well as the success of specific retailers in the channel |
| There are some large chains of health food stores, such as Whole Foods, Wild Oats and Vitamin Shoppe, but most health food stores are individual stores or very small chains |
| We rely on these health food stores to purchase, market, and sell our products |
| Our success is dependent, to a large degree, on the growth and success of the healthy foods channel, which is outside our control |
| There can be no assurance that the healthy foods channel will be able to grow or prosper as it faces price and service pressure from other channels, including the mass market |
| There can be no assurance that retailers in the healthy foods channel, in the aggregate, will respond or continue to respond to our stated loyalty to this channel |
| 14 ______________________________________________________________________ We are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar products distributed by other companies in our industry, and adverse publicity and negative public perception regarding particular ingredients or products or our industry in general could limit our ability to increase revenue and grow our business |
| Decisions about purchasing made by consumers of our products may be affected by adverse publicity or negative public perception regarding particular ingredients or products or our industry in general |
| This negative public perception may include publicity regarding the legality or quality of particular ingredients or products in general or of other companies or our products or ingredients specifically |
| Negative public perception may also arise from regulatory investigations, regardless of whether those investigations involve us |
| We are highly dependent upon consumers’ perception of the safety and quality of our products as well as similar products distributed by other companies |
| Thus, the mere publication of reports asserting that such products may be harmful could have a material adverse effect on us, regardless of whether these reports are scientifically supported |
| Publicity related to nutritional supplements may also result in increased regulatory scrutiny of our industry and/or the healthy foods channel |
| Adverse publicity may have a material adverse effect on our business, financial condition, and results of operations |
| There can be no assurance of future favorable scientific results and media attention or of the absence of unfavorable or inconsistent findings |
| We face intense competition from competitors that are larger, more established and that possess greater resources than we do, and if we are unable to compete effectively, we may be unable to maintain sufficient market share to sustain profitability |
| Numerous manufacturers and retailers compete actively for consumers |
| There can be no assurance that we will be able to compete in this intensely competitive environment |
| In addition, nutritional supplements can be purchased in a wide variety of channels of distribution |
| These channels include mass market retail stores and the Internet |
| Because these markets generally have low barriers to entry, additional competitors could enter the market at any time |
| Private label products of our customers also provide competition to our products |
| Additional national or international companies may seek in the future to enter or to increase their presence in the healthy foods channel or the vitamin, mineral supplement market |
| Increased competition in either or both could have a material adverse effect on us |
| The nutritional supplement industry increasingly relies on intellectual property rights and although we seek to ensure that we do not infringe the intellectual property rights of others, there can be no assurance that third parties will not assert intellectual property infringement claims against us, which claims may result in substantial costs and diversion of management and other resources and could have a material adverse effect on our business, financial condition, and operating results |
| Recently it is becoming more and more common for suppliers and competitors to apply for patents or develop proprietary technologies and processes |
| We seek to ensure that we do not infringe the intellectual property rights of others, but there can be no assurance that third parties will not assert intellectual property infringement claims against us |
| These developments can prevent us from offering or supplying competitive products or ingredients in the marketplace |
| They can also result in litigation or threatened litigation against us related to alleged or actual infringement of third-party rights |
| If an infringement claim is asserted or litigation is pursued, we may be required to obtain a license of rights, pay royalties on a retrospective or prospective basis, or terminate our manufacturing and marketing of our products that are alleged to have infringed |
| Litigation with respect to such matters can result in substantial costs and diversion of management and other resources and could have a material adverse effect on our business, financial condition, and operating results |
| There can be no assurance that third-party claims will not in the future adversely affect our business, financial condition, and results of operations |
| Business Strategy and Operational Risks If we are unable to retain key personnel, our ability to manage our business effectively and continue our growth could be negatively impacted |
| Key management employees include Frank W Gay II, Bruce R 15 ______________________________________________________________________ Hough, Jeffrey A Hinrichs, Gary M Hume, Leslie M Brown, Jr, Stanley E Soper, Cory J McQueen, Christopher B Neuberger and certain other employees |
| These key management employees are primarily responsible for our day-to-day operations, and we believe our success depends in part on our ability to retain them and to continue to attract additional qualified individuals to our management team |
| We do not have an employment agreement with any of our key management employees |
| The loss or limitation of the services of any of our key management employees or the inability to attract additional qualified management personnel could have a material adverse effect on our business, financial condition, and results of operations |
| As a part of our business strategy, we have made and expect to continue to make acquisitions that could disrupt our operations and harm our operating results |
| An element of our strategy includes expanding our product offerings, gaining shelf-space and gaining access to new skills and other resources through strategic acquisitions when attractive opportunities arise |
| Acquiring additional businesses and the implementation of other elements of our business strategy are subject to various risks and uncertainties |
| These risks and uncertainties include, but are not limited to, the following: · Any acquisition may result in significant expenditures of cash, stock and/or management resources, · Acquired businesses may not perform in accordance with expectations, · We may encounter difficulties and costs with the integration of the acquired businesses, · Management’s attention may be diverted from other aspects of our business, · We may face unexpected problems entering geographic and product markets in which we have limited or no direct prior experience, · We may lose key employees of acquired or existing businesses, · We may incur liabilities and claims arising out of acquired businesses, · We may be unable to obtain financing, and · We may incur indebtedness or issue additional capital stock which could be dilutive to holders of our common stock |
| There can be no assurance that attractive acquisition opportunities will be available to us, that we will be able to obtain financing for or otherwise consummate any acquisitions or that any acquisitions which are consummated will prove to be successful |
| There can be no assurance that we can successfully execute all aspects of our business strategy |
| Because we depend on outside suppliers with whom we do not have long-term agreements for raw materials, we may be unable to obtain adequate supplies of raw materials for our products at favorable prices or at all, which could result in product shortages and back orders for our products, with a resulting loss of net sales and profitability |
| We acquire all of our raw materials for the manufacture of our products from third-party suppliers |
| We have few if any agreements for the continued supply of these materials and products |
| A number of our products contain one or more ingredients that may only be available from a single source or supplier |
| Any of our suppliers could discontinue selling to us at any time |
| Although we believe that we could establish alternate sources for most of these materials, any delay in locating and establishing relationships with other sources could result in product shortages and back orders for the products, with a resulting loss of net sales |
| We are also subject to delays associated with raw materials |
| These can be caused by conditions not within our control, including: · weather, 16 ______________________________________________________________________ · crop conditions, · transportation interruptions, · strikes by supplier employees, and · natural disasters or other catastrophic events |
| We acquire many ingredients from suppliers outside of the United States |
| Purchasing these ingredients is subject to the risks generally associated with importing raw materials from other countries, including, among other factors, delays in shipments, changes in economic and political conditions, quality assurance, tariffs, trade disputes and foreign currency fluctuations |
| These factors could result in a delay in or disruption of the supply of certain raw materials |
| Any significant delay in or disruption of the supply of raw materials could have a material adverse effect upon us |
| Our success is dependent on the accuracy, reliability, and proper use of sophisticated and dependable information processing systems and management information technology and any interruption in these systems could have a material adverse effect on our business, financial condition, and results of operations |
| Our success is dependent on the accuracy, reliability, and proper use of sophisticated and dependable information processing systems and management information technology |
| Our information technology systems are designed and selected in order to facilitate order entry and customer billing, maintain customer records, accurately track purchases and incentive payments, manage accounting, finance and manufacturing operations, generate reports, and provide customer service and technical support |
| Any interruption in these systems could have a material adverse effect on our business, financial condition, and results of operations |
| Because we manufacture over 80prca of our products, we are dependent upon the uninterrupted and efficient operation of our manufacturing facilities, which are subject to power failures, the breakdown, failure, or substandard performance of equipment, the improper installation or operation of equipment, natural or other disasters, and the need to comply with the requirements or directives of government agencies, including the FDA We manufacture over 80prca of our products |
| As a result, we are dependent upon the uninterrupted and efficient operation of our manufacturing facilities in Ogden, Utah |
| Those operations are subject to power failures, the breakdown, failure, or substandard performance of equipment, the improper installation or operation of equipment, natural or other disasters, and the need to comply with the requirements or directives of government agencies, including the FDA There can be no assurance that the occurrence of these or any other operational problems at our facility would not have a material adverse effect on our business, financial condition, and results of operations |
| We are party to a number of lawsuits that arise in the ordinary course of business and may become party to others and while none of the lawsuits in which we are involved as of the date of this filing are reasonably estimated to be material, it is possible that future litigation could arise or that developments could occur in existing litigation that could have material adverse effects on us |
| We are party to a number of lawsuits that arise in the ordinary course of business and may become party to others |
| The possibility of such litigation, and its timing, is in large part outside our control |
| While none of the current lawsuits in which we are involved are reasonably estimable to be material as of the date of this filing, it is possible that future litigation could arise, or developments could occur in existing litigation, that could have material adverse effects on us |
| If we fail to maintain adequate and effective internal control over financial reporting, our ability to manage our business, comply with Sarbanes-Oxley, obtain required auditor attestation and provide reliable financial reporting could be impaired and our management and auditors may be precluded from certifying effective internal control over financial reporting, which could harm our business reputation and cause our stock price to decline |
| As directed by Section 404 of the Sarbanes-Oxley Act of 2002, the Securities and Exchange Commission adopted rules requiring public companies to include a report of management on the 17 ______________________________________________________________________ company’s internal control over financial reporting in their Annual Reports on Form 10-K In addition, the independent registered public accounting firm auditing a public company’s financial statements must attest to and report on management’s assessment of the effectiveness of the company’s internal control over financial reporting |
| Although our auditors did so attest in connection with this Annual Report on Form 10-K, if in the future our independent registered public accounting firm is not satisfied with our internal control over financial reporting or the level at which these controls are documented, designed, operated or reviewed, or if that firm interprets the requirements, rules or regulations differently from the way we interpret them, then they may decline to attest to management’s assessment or may issue a report that is qualified or has a scope limitation |
| From time-to-time, in our ongoing effort to improve business and operational processes and our internal control over financial reporting, we or our auditors may determine that “significant deficiencies” or “material weaknesses” (as such terms are defined under accounting standards established by the Public Company Accounting Oversight Board) exist or that our internal control over financial reporting may otherwise require improvement |
| Significant deficiencies or material weaknesses could impair our ability to provide financial statements that can be relied upon |
| If this were to occur, our business reputation could be harmed and investors may lose confidence in the reliability of our financial statements and reports, either of which could have a significant negative impact on our stock price |
| Stock Market Risks The market price for our common stock may be particularly volatile, and our stockholders may be unable to resell their shares at a profit |
| The trading price of our common stock has been subject to wide fluctuations and may continue to fluctuate in the future in response to a variety of factors, including: · quarter-to-quarter variations in operating results, · material announcements by us or our competitors, · governmental regulatory action, · negative or positive publicity involving us or the nutritional supplement industry generally, · general economic downturns, · announcements by official or unofficial health and medical authorities, · consumer preferences generally, or · other events or factors, many of which are beyond our control |
| In addition, the stock market has historically experienced significant price and volume fluctuations, which have particularly affected the market prices of many nutritional supplement companies and which have, in certain cases, not had a strong correlation to the operating performance of these companies |
| General economic conditions, such as recession or interest rate or currency rate fluctuations in the United States or abroad, could negatively affect the market price of our common stock |
| In addition, our operating results in future quarters may be below the expectations of securities analysts and investors |
| In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company |
| Such litigation could result in substantial cost and a diversion of management’s attention and resources |