FITLIFE BRANDS, INC. 10-K

ITEM 1. BUSINESS Overview FitLife Brands, Inc. (the “ Company ”) is a provider of innovative and proprietary nutritional supplements and wellness products for health-conscious consumers marketed under the following brand names: (i) NDS Nutrition, PMD Sports, SirenLabs, Core Active, Nutrology, and Metis Nutrition (together, “ NDS Products ”); (ii) iSatori, BioGenetic Laboratories, and Energize (together, the " iSatori Products "); (iii) Dr. Tobias, All Natural Advice, and Maritime Naturals, each acquired as a result of the acquisition of Mimi’s Rock Corp. ( “ MRC ”) on February 28, 2023 (together, the “ MRC Products "); and (iv) MusclePharm, which was acquired on October 10, 2023 as a result of the acquisition of substantially all of the assets of MusclePharm Corporation (“ MusclePharm ”). - 2 - The Company distributes the NDS Products principally through franchised General Nutrition Centers, Inc. (“ GNC ”) stores located both domestically and internationally and, with the launch of Metis Nutrition, through corporate GNC stores in the U.S. The iSatori Products are sold through retail locations, which include specialty and mass, as well as online directly to the end consumer. The Company distributes the MRC Products primarily online through e-commerce platforms, such as Amazon, directly to the end consumer. MusclePharm’s products are sold to both wholesale customers as well as online through various e-commerce platforms directly to the end consumer. FitLife Brands is headquartered in Omaha, Nebraska. For more information on the Company, please go to www.fitlifebrands.com. The Company’s common stock, par value $0.01 per share (“ Common Stock ”), trades under the symbol “FTLF” on the Nasdaq Capital Market. Recent Developments Stock Split On February 7, 2025, the Company effected a 2-for-1 stock split of its Common Stock and proportionately increased the number of authorized shares of Common Stock. All share and per share information throughout this Annual Report on Form 10-K have been retroactively adjusted to reflect the stock split. The shares of Common Stock retain a par value of $0.01 per share. Accordingly, an amount equal to the par value of the additional shares issued in the stock split was reclassified from additional paid-in capital in excess of par value to Common Stock. Industry Overview We compete principally in the nutrition industry. The nutrition industry is generally categorized into the following segments: ● Natural & Organic Foods (products such as cereals, milk, non-dairy beverages and frozen meals); ● Functional Foods (products with added ingredients or fortification specifically for health or performance purposes); ● Natural & Organic Personal Care and Household Products; and ● Supplements. Management believes that the following factors drive growth in the nutrition industry: ● The general public’s awareness and understanding of the connection between diet and health; ● The aging population in the Company’s markets who tend to use more nutritional supplements as they age; ● Increasing healthcare costs and the consequential trend toward preventative medicine and non-traditional medicines; and ● Product introductions in response to new scientific studies. Our Products The Company currently focuses its sales and marketing efforts on its full line of sports, weight loss and general nutrition products that are currently marketed and sold both domestically and internationally. The Company currently markets more than 100 different NDS Products to approximately 700 GNC franchise locations located in the United States, as well as to additional franchise locations in other countries, most of which are distributed through GNC’s distribution system. In addition, following the launch of Metis Nutrition, we distribute products through more than 1,400 corporate GNC stores in the United States. We sell iSatori Products through specialty, mass, and online retail locations. We sell the MRC Products primarily on Amazon.com (“ Amazon ”). We sell MusclePharm products online directly to the end consumer as well as to wholesale partners. - 3 - A complete product list is available on our website at www.fitlifebrands.com . NDS Products The Company’s NDS Products consist of the following brands: ● NDS – Premium weight loss, sports nutrition, and general health products; ● PMD – Premium sports nutrition products; ● SirenLabs – Premium weight loss and sports nutrition products; ● Nutrology – Sports nutrition and general wellness products with an emphasis on natural, vegan, and organic ingredients; ● Metis Nutrition – Premium male health and weight loss products; and ● Core Active Nutrition – Value-oriented sports nutrition and weight loss products. iSatori Products The Company’s iSatori Products consist of the following brands: ● Energize – Energy products designed to boost energy through a combination of time-released caffeine, vitamins, and herbal formulations; ● iSatori – High-quality weight loss and sports nutrition products; and ● BioGenetic Laboratories – Value-oriented weight loss and general health products. MRC Products The Company acquired MRC on February 28, 2023. MRC is a dietary supplement and wellness company which markets and sells its products primarily on Amazon. The MRC Products include the following brands: ● Dr. Tobias – General health supplements; ● All Natural Advice – Natural skincare and beauty products; and ● Maritime Naturals – Natural skincare and beauty products. Products sold under the All Natural Advice and Maritime Naturals brand names are registered with Health Canada and under the EU Cosmetics Act. MusclePharm Products The MusclePharm assets were acquired by the Company on October 10, 2023. MusclePharm is a scientifically driven, performance lifestyle brand that develops, markets and distributes a variety of branded sports nutrition and general health products. MusclePharm products are sold to wholesale customers as well as online directly to the end consumer. We believe MusclePharm’s brand recognition attracts a large and engaged customer base consisting of athletes and other active individuals. - 4 - Manufacturing, Sourcing and Availability of Raw Materials All of the Company’s products are manufactured by FDA-regulated contract manufacturers within the United States. Each contract manufacturer is required by the Company to abide by current Good Manufacturing Practices (“ cGMPs ”) to ensure quality and consistency, and to manufacture its products according to the Company’s strict specifications. All our contract manufacturers are certified through a governing body such as the Natural Products Association or NSF International. In most cases, contract manufacturers purchase the raw materials based on the Company’s specifications; however, from time to time, the Company will license particular raw material ingredients and supply its own source to the manufacturer. Once produced, in addition to in-house testing performed by the contract manufacturer, the Company may also perform independent analysis and testing. The contract manufacturer either ships the finished product to one of our fulfillment centers or directly to our customers. The Company has implemented vendor qualification programs for all of its suppliers and manufacturers, including analytical testing of purchased products. As part of the vendor program, the Company also periodically inspects vendors’ facilities to monitor quality control and assurance procedures. Product Reformulations and New Product Identification From time to time, we reformulate existing products to address market developments and trends, and to respond to customer requests. We also continually expand our product line through the development of new products. New product ideas are derived from a number of sources including trade publications, scientific and health journals, consultants, distributors, and other third parties. Prior to reformulating existing products or introducing new products, we evaluate product formulations as they relate to regulatory compliance and other issues. We introduced a total of 23 new products during the year ended December 31, 2024, which included 19 completely new products and 4 product reformulations and flavor extensions, and we introduced a total of 18 new products during the year ended December 31, 2023, which included 6 completely new products and 12 product reformulations and flavor extensions. Management continually assesses and analyzes developing market trends to detect and proactively address what they believe are areas of unmet or growing demand that represent an opportunity for the Company and, where deemed appropriate, attempts to introduce new products and/or packaging solutions in direct response to meet that demand. Sales, Marketing and Distribution NDS Products NDS Products are sold through approximately 700 GNC franchise locations located throughout the United States. The Company also distributes NDS Products to additional franchise locations in other countries. In 2014, the Company transitioned distribution of NDS Products to GNC’s centralized distribution platform. For the years ended December 31, 2024 and 2023, the majority of NDS Product sales were through GNC’s centralized distribution platform. Our sales and marketing efforts are designed to expand sales of NDS Products to additional GNC franchise locations both domestically and internationally. In addition, we relaunched our Core Active brand as an online-exclusive brand. The GNC domestic franchise market remains a critical component of our operations. Management is committed to continue to work collaboratively with GNC and its franchisees to build on our established track record of innovation and operational performance. iSatori Products iSatori Products are distributed directly to consumers through the Company's own websites and through other e-commerce platforms such as Amazon , as well as through the specialty, drug and mass-market distribution channels. In some cases, iSatori utilizes independent brokers, who work in conjunction with iSatori’s sales employees and management to oversee the drug and mass-market channels. iSatori sells its products to mass-market merchandisers either directly or through distributors of nutritional supplement products. In addition to the Company’s online distribution channels for direct-to-consumer sales, major iSatori customers include Vitamin Shoppe and Walgreens. iSatori’s core strategy is to build and strengthen brands among consumers seeking nutritional supplement products with a reputation for quality and innovation. iSatori utilizes social media campaigns, coupons, and online advertising, plus cooperative and other incentive programs, to build consumer awareness and generate trial and repeat purchases. Our marketing team regularly reviews the media mix for its effectiveness in creating consumer demand and the highest return on investment dollars. - 5 - MRC Products and MusclePharm MRC Products are distributed primarily on Amazon. MusclePharm’s products are distributed via wholesale customers as well as directly to end consumers through the Company’s own websites and through other e-commerce platforms, including Amazon. Product Returns We currently have a 30-day product return policy for NDS Products, which allows for a 100% sales price refund for the return of unopened and undamaged products purchased from us online through one of our websites. Product sold to GNC may be returned from corporate store shelves or the distribution centers in the event the product is damaged, short dated, expired or recalled. GNC maintains a customer satisfaction program that allows customers to return product to the store for credit or refund. Subject to certain terms and restrictions, GNC may require reimbursement from vendors for unsaleable returned product through either direct payment or credit against a future invoice. We also support a product return policy for iSatori Products, MRC Products and MusclePharm whereby customers can return product for credit or refund. Product returns can and do occur from time to time and can be material. Competition The nutrition industry is highly competitive, and the Company has many competitors that sell products similar to the Company’s products. Many of the Company’s competitors have significantly greater financial and human resources than our own. The Company seeks to differentiate its products and marketing from its competitors based on product quality, benefits, and functional ingredients. Patent and trademark applications that protect brands, product names, and new technologies are pursued whenever possible. While we cannot assure that such measures will mitigate the potential impact of competitive products, we believe our continued emphasis on innovation and new product development targeted at the needs of the consumer will enable the Company to effectively compete in the marketplace. Regulatory Matters Our business is subject to varying degrees of regulation by a number of government authorities in the U.S., including the Federal Drug Administration (“ FDA ”), the Federal Trade Commission (“ FTC ”), the Consumer Product Safety Commission, the U.S. Department of Agriculture, and the Environmental Protection Agency. Various agencies of the states and localities in which we operate and in which our products are sold also regulate our business, such as the California Department of Health Services, Food and Drug Branch. The areas of our business that these and other authorities regulate include, among others: ● product claims and advertising; ● product labels; ● product ingredients; and ● how we manufacture, package, distribute, import, export, sell, and store our products. The FDA, in particular, regulates the formulation, manufacturing, packaging, storage, labeling, promotion, distribution and sale of vitamins and other nutritional supplements in the U.S., while the FTC regulates marketing and advertising claims. In June 2007, a new rule issued by the FDA went into effect requiring companies that manufacture, package, label, distribute or hold nutritional supplements to meet cGMPs to ensure such products are of the quality specified and are properly packaged and labeled. We are committed to meeting or exceeding the standards set by the FDA and we currently operate in compliance with all GMPS. - 6 - The FDA regulates the labeling and marketing of dietary supplements and nutritional products, including the following: ● the identification of dietary supplements or nutritional products and their nutrition and ingredient labeling; ● requirements related to the wording used for claims about nutrients, health claims, and statements of nutritional support; ● labeling requirements for dietary supplements or nutritional products for which “high potency” and “antioxidant” claims are made; ● notification procedures for statements on dietary supplements or nutritional products; and ● premarket notification procedures for new dietary ingredients in nutritional supplements. The Dietary Supplement Health and Education Act of 1994 (“ DSHEA ”) revised the provisions of the Federal Food, Drug and Cosmetic Act (“ FDCA ”) concerning the composition and labeling of dietary supplements, and defined dietary supplements to include vitamins, minerals, herbs, amino acids and other dietary substances used to supplement diets. DSHEA generally provides a regulatory framework to help ensure safe, quality dietary supplements and the dissemination of accurate information about such products. The FDA is generally prohibited from regulating active ingredients in dietary supplements as drugs unless the product makes claims in violation of DSHEA, such as claims that a product may heal, mitigate, cure or prevent an illness, disease or malady, trigger drug status. DSHEA also permits statements of nutritional support to be included in labeling for nutritional supplements without FDA premarket approval. These statements must be submitted to the FDA within 30 days of marketing and must bear a label disclosure that includes the following: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” These statements may describe a benefit related to a nutrient deficiency disease, the role of a nutrient or nutritional ingredient intended to affect the structure or function in humans, the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or the general well-being from consumption of a nutrient or dietary ingredient, but may not expressly or implicitly represent that a nutritional supplement will diagnose, cure, mitigate, treat or prevent a disease. An entity that uses a statement of nutritional support in labeling must possess scientific evidence substantiating that the statement is truthful and not misleading. If the FDA determines that a particular statement of nutritional support is an unacceptable drug claim or an unauthorized version of a disease claim for a food product, or if the FDA determines that a particular claim is not adequately supported by existing scientific data or is false or misleading, we will be prevented from using the claim. In December 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“ DSNDCPA ”) was passed, which further revised the provisions of the FDCA. Under the act, manufacturers, packers or distributors whose name appears on the product label of a dietary supplement or nonprescription drug are required to include contact information on the product label for consumers to use in reporting adverse events associated with the product’s use and are required to notify the FDA of any serious adverse event report within 15 business days of receiving such report. Events reported to the FDA would not be considered an admission from a company that its product caused or contributed to the reported event. We are committed to meeting or exceeding the requirements of the DSNDCPA. We are also subject to a variety of other regulations in the U.S., including those relating to bioterrorism, taxes, labor and employment, import and export, the environment, and intellectual property. All of these regulations require significant financial and operational resources to ensure compliance, and we cannot assure that we will always be in compliance despite our best efforts to do so. Our operations outside the U.S. are similarly regulated by various agencies and entities in the countries in which we operate and in which our products are sold. The regulations of these countries may conflict with those in the U.S. and may vary from country to country. The sale of our products in certain European countries is subject to the rules and regulations of the European Union, which may be interpreted differently among the countries within the European Union. In other markets outside the U.S., we may be required to obtain approvals or certifications from a country’s ministry of health or comparable agency before we begin operations or the marketing of products in that country. These approvals may be secured through the Company directly or through the respective distributors depending on the country. Approvals or licenses may be conditioned on the reformulation of our products for a particular market or may be unavailable for certain products or product ingredients. These regulations may limit our ability to enter certain markets outside the U.S. - 7 - Patents, Trademarks and Proprietary Rights The Company regards intellectual property, including its trademarks, service marks, website URLs (domains) and other proprietary rights, as valuable assets and part of its brand equity. The Company believes that protecting such intellectual property is crucial to its business strategy. The Company pursues registration of the registrable trademarks, service marks and patents, associated with its key products in the United States, Canada, Europe and other places it distributes its products. The Company formulates its products using proprietary ingredient formulations, flavorings and delivery systems. To further protect its product formulations and flavors, the Company may enter into agreements with manufacturers that provide exclusivity to certain products formulations and/or delivery technologies. When appropriate, the Company will seek to protect its research and development efforts by filing patent applications for proprietary product technologies or ingredient combinations. We have abandoned or not pursued efforts to register certain other patents and marks identifying other items in our product line for various reasons, including the inability of some names to qualify for registration or patent applications to qualify for patent protection, and due to our abandonment of certain such products. All trademark registrations are protected for a period of ten years and then are renewable thereafter if still in use. Employees We had 39 and 37 full-time employees as of December 31, 2024 and 2023, respectively. In addition, the Company utilizes consultants and temporary or part-time employees for certain services on an as-needed basis. We consider our employee relations to be good. Cost of Compliance with Environmental Laws We have not incurred any costs associated with compliance with environmental regulations, nor do we anticipate any future costs associated with environmental compliance; however, no assurance can be given that we will not incur such costs in the future. Available Information As a public company, we are required to file our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A and other information (including any amendments) with the Securities and Exchange Commission (the “ SEC ”). The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. You can find our SEC filings at the SEC’s website at www.sec.gov . Our Internet address is www.fitlifebrands.com . Information contained on our website is not part of this Annual Report. Our SEC filings (including any amendments) will be made available free of charge on www.fitlifebrands.com , as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.