Cosmos Health Inc.

Cosmos Health Inc. is a diversified, vertically integrated global healthcare group operating in the pharmaceutical and nutraceutical sectors, encompassing research & development, manufacturing, marketing, sales, and distribution. The company also operates a telehealth platform. Cosmos Health is focused on generic medicines, nutraceuticals, biocides, medical devices, novel oncology drugs, and drug repurposing. The global generic drugs market was valued at $424.98 billion ⁴ in 2025 and is projected to reach $874.63 billion ⁵ by 2033, growing at a CAGR of 8.35% ⁶. The global nutraceuticals market was valued at $636.31 billion ⁷ in 2025 and is projected to reach approximately $1,234 billion ⁸ by 2034, expanding at a CAGR of 7.64% ⁹. The global obesity & weight management market is calculated at $163.13 billion ¹⁰ in 2025 and is expected to be worth $362.1 billion ¹¹ by 2034, expanding at a CAGR of 8.3% ¹². The global oncology drugs market was valued at $256.46 billion ¹³ in 2025 and is projected to grow to $697.59 billion ¹⁴ by 2034, exhibiting a CAGR of 11.77% ¹⁵. The global drug repurposing market is anticipated to reach $30.1 billion ¹⁶ by 2028, up from $24.5 billion ¹⁷ in 2021, reflecting a CAGR of 2.9% ¹⁸.

The company's core business model revolves around generating revenue through its full-line pharmaceutical wholesale operations, branded pharmaceuticals and generics, healthcare distribution, and proprietary nutraceutical brands. The revenue mix includes both transactional income from product sales and recurring income streams, though the filing does not explicitly detail the split. Primary customer segments include retail pharmacies, hospitals, private clinics, and other wholesale pharmaceutical distributors. The company leverages its automated distribution facilities, including ROWA™ robotics, to achieve efficiency and accuracy in its healthcare distribution network, which exceeds 1,500 pharmacies in Greece.

Cosmos Health's product portfolio is diverse, including generics, over-the-counter (OTC) pharmaceutical products, innovative medicines, nutraceuticals, and biocides. Its generic medicine portfolio includes products like ASTO-CHOL (Pravastatin) for cholesterol, Diorium (Omeprazole) for stomach issues, HEART-FREE (Clopidogrel) for heart-related issues, LIPICHOL (Atorvastatin) for cholesterol and heart-related issues, Miltus (Donepezil) for Alzheimer's disease, Newzypra (Olanzapine) for mood disorders and psychosis, PNEUMO-KAST (Montelukast) for asthma, Sahar (Pioglitazone) for blood sugar, VIVALCID (Leucovorin) for cancer drug effects, and Diabit-is (Sitagliptin) for Type 2 diabetes. The proprietary nutraceutical brands, Sky Premium Life® ("SPL") and Mediterranation®, comprise approximately 165 SKUs, categorized by benefit (e.g., General Wellbeing, Immunity) and nutrient (e.g., Vitamins & Multivitamins, Minerals). The biocide portfolio includes C-Sept® and C-Scrub®, with C-Sept Pro 2% containing 76% Isopropyl Alcohol and 2% chlorhexidine digluconate, and C-Scrub Wash 4% CHG containing chlorhexidine digluconate. Other pharmaceutical products include Melatonin Spray®, Otikon™ ear drops, and Bio-bebe® organic infant care and nutrition brand. As of December 31, 2025, the inventory breakdown was: Pharmaceuticals $4,599,638 ¹⁹ (74.73% ²⁰), Parapharmaceuticals $1,133,686 ²¹ (18.42% ²²), Manufacturing products $4,254 ²³ (0.07% ²⁴), Raw materials $235,785 ²⁵ (3.83% ²⁶), Dairy products $38,359 ²⁷ (0.62% ²⁸), Veterinary medicine $1,265 ²⁹ (0.02% ³⁰), and Other $142,003 ³¹ (2.31% ³²), less provisions of $(376,848) ³³, totaling $5,778,142 ³⁴.

For the fiscal year ended December 31, 2025, Cosmos Health Inc. reported total revenue of $65,271,815 ³⁵, an increase of 19.9% ³⁶ from $54,426,402 ³⁷ in the prior year. Gross profit significantly increased by 83.1% ³⁸ to $7,895,575 ³⁹ from $4,311,323 ⁴⁰ in 2024, leading to a gross margin expansion to 12.1% ⁴¹ from 7.9% ⁴². Operating expenses rose by 23.9% ⁴³ to $24,599,179 ⁴⁴ from $19,856,153 ⁴⁵. The company reported a net loss of $19,144,998 ⁴⁶ for 2025, compared to a net loss of $16,183,018 ⁴⁷ in 2024. Basic and diluted EPS were both $(0.63) ⁴⁸ for 2025, compared to $(1.17) ⁴⁹ for 2024. Net cash used in operating activities increased to $8,447,614 ⁵⁰ from $7,717,034 ⁵¹. As of December 31, 2025, cash and cash equivalents stood at $715,674 ⁵², with restricted cash of $2,744,219 ⁵³. Total debt, including notes payable and convertible notes payable (current and long-term portions), was $10,181,155 ⁵⁴ ($2,191,274 ⁵⁵ current notes payable + $1,584,063 ⁵⁶ long-term notes payable + $2,137,804 ⁵⁷ current convertible notes payable + $4,267,774 ⁵⁸ long-term convertible notes payable). Net debt is not explicitly calculated in the filing.

The year-over-year revenue growth of 19.9% ⁵⁹ was primarily driven by Cosmofarm S.A.'s wholesale revenue growth of approximately 15% ⁶⁰ due to new distribution channels, CANA S.A.'s pharmaceutical manufacturing revenues nearly doubling from approximately $865,000 ⁶¹ to approximately $1.7 million ⁶², and Decahedron Ltd.'s UK revenues increasing from approximately $815,000 ⁶³ to approximately $2.6 million ⁶⁴ from Amazon sales and pharmaceutical product sales into Greece. The gross margin improved to 12.1% ⁶⁵ from 7.9% ⁶⁶ due to a favorable shift towards higher-margin business lines. Operating expenses increased, largely due to a $3,885,923 ⁶⁷ (33.1% ⁶⁸) rise in general and administrative expenses to $15,619,160 ⁶⁹, which included $5,882,393 ⁷⁰ in provisions for doubtful accounts and expected credit losses, $2,312,241 ⁷¹ in stock-based compensation, and approximately $2.0 million ⁷² in management bonuses. Salaries and wages increased by $1,084,842 ⁷³ (19.1% ⁷⁴) to $6,778,278 ⁷⁵, mainly due to workforce expansion at CANA S.A. Sales and marketing expenses decreased by $204,729 ⁷⁶ (57.7% ⁷⁷) to $150,240 ⁷⁸ due to a strategic reduction in promotional investment. The net loss increased from $16,183,018 ⁷⁹ in 2024 to $19,144,998 ⁸⁰ in 2025. Total comprehensive loss improved from $(24,093,129) ⁸¹ in 2024 to $(16,678,564) ⁸² in 2025, primarily due to a $2,466,434 ⁸³ foreign currency translation gain in 2025 compared to a $1,715,087 ⁸⁴ loss in 2024, and the absence of deemed dividends in 2025 (compared to $6,195,024 ⁸⁵ in 2024).

During 2025, Cosmos Health Inc. continued executing its "Growth Strategy," focusing on high-margin segments like Sky Premium Life®, Mediterranation®, and C-Sept® / C-Scrub® with launches into new geographical regions. The company nearly doubled revenues from its pharmaceutical manufacturing subsidiary, CANA S.A., and significantly increased revenues from its UK subsidiary, Decahedron Ltd., through Amazon sales and pharmaceutical product sales into the Greek market. The company also made a strategic investment of approximately $2,000,000 ⁸⁶ in digital assets, primarily Ethereum (ETH). In terms of R&D, the company filed patent applications for multiple sclerosis (N2039644 ⁸⁷), glioma (N2039647 ⁸⁸), and hematologic malignancies including multiple myeloma (N2039645 ⁸⁹) on February 10, 2025. It is finalizing the scale-up production phase of CCX0722, an obesity and weight management pill, targeting a market launch in the third or fourth quarter of 2026. The company also secured buy-out rights and exclusive licensing for two patented anticancer drugs targeting prostate, ovarian, and colorectal cancers, which are set to commence Clinical Phase I trials. An exclusive distribution agreement was signed with Pharmalink for Sky Premium Life® products in the UAE, with an initial purchase order for 130,000 units ⁹⁰ and expected orders exceeding 500,000 units ⁹¹ in 2026 and more than 3,000,000 units ⁹² over the next five years. Additionally, exclusive distribution agreements for Sky Premium Life® were signed in Kuwait and Jordan in September and October 2025, respectively. The company also issued 5,997,256 shares ⁹³ of common stock under its At-the-Market (ATM) sales program for gross proceeds of $5,417,396 ⁹⁴ and net proceeds of $5,254,875 ⁹⁵.

Management's plans for the upcoming period include the expansion of brand name products to the market, expanding the current product portfolio, and evaluating acquisition targets to expand distribution. The exclusive distribution agreement signed for Sky Premium Life products in the United Arab Emirates ("UAE") and the significant orders already received are expected to substantially strengthen its operating cash flow. Furthermore, the Company intends to vertically integrate its supply chain distribution network.

A major growth vector for Cosmos Health is the development of innovative products through its R&D efforts. The company is finalizing the scale-up production phase of CCX0722, an obesity and weight management pill, with human clinical trials set to be completed between the end of 2025 and the beginning of 2026, targeting a market launch in the third or fourth quarter of 2026. This product is being optimized for its physicochemical properties and effects on gut microflora through in vitro studies and simulations, and is positioned for potential classification as a class III medical device. Additionally, the company has secured buy-out rights and exclusive licensing for two patented anticancer drugs targeting prostate, ovarian, and colorectal cancers, which are protected by international patents (WIPO patent WO 2017/001439A1 ⁹⁶ and WIPO patent WO 2018/011414 A1 ⁹⁷) and are set to commence Clinical Phase I trials. These therapies are focused on major markets such as the USA, EU, Canada, Japan, China, and Australia.

Another significant growth area is the expansion of its global networks and proprietary brands. The company aims to expand and consolidate its sales distribution networks of proprietary brands through strategic agreements in new regions and territories, such as the UAE and other GCC countries, and Eastern Europe, while strengthening market share in core markets. An exclusive distribution agreement for Sky Premium Life® products in the UAE has already resulted in an initial purchase order for 130,000 units ⁹⁸, with expected orders exceeding 500,000 units ⁹⁹ during 2026 and more than 3,000,000 units ¹⁰⁰ over the next five years. Exclusive distribution agreements for the "Sky Premium Life" brand were also entered into in Kuwait and Jordan in September and October 2025, respectively.

Operationally, the company is undergoing a corporate reorganization focused on vertical integration and efficiency to streamline costs and enhance asset and resource utilization through the integration of business units. This initiative aims to achieve operational efficiencies and economies of scale through organic growth and a cost optimization initiative to significantly reduce recurring operating expenses while maintaining the company's growth outlook. The company is also improving its entity-wide infrastructure to enhance efficiency, capabilities, and speed to market, including investments in advanced information systems and automated warehouse technology to comply with future pedigree and supply chain custody requirements. The implementation of a centralized platform to consolidate data from all ERP systems across subsidiaries is aimed for completion by the end of 2026 to strengthen data accuracy, streamline consolidation, and support timely reporting.

Regarding capital allocation, the company intends to continue utilizing its At-the-Market (ATM) sales program as a source of ongoing equity capital as market conditions permit. During the period from September 22 to December 31, 2025, the ATM program generated gross proceeds of $5,417,396 ¹⁰¹ and net proceeds of $5,254,875 ¹⁰². The company also has access to the ATW Convertible Note Facility, which provides for the issuance of up to $300 million ¹⁰³ of senior secured convertible promissory notes, with an initial closing of $8 million ¹⁰⁴ completed on August 6, 2025. While not currently intending to draw additional tranches, the company may pursue subsequent closings of up to $292 million ¹⁰⁵ under this facility if additional capital needs arise. A new Shelf Registration Statement on Form S-3 was filed on November 7, 2025, registering up to $200,000,000 ¹⁰⁶ of securities, which the company intends to utilize for additional equity capital as needed. Management's plans also include postponing certain debt repayments through achieving favorable amendments to its debt facilities and making substantial efforts to secure additional debt financing, and considering postponing certain repayments to suppliers and creditors as necessary.

Management explicitly flagged several structural headwinds and execution risks to the growth plan. These include the inherent uncertainty and high degree of risk in the discovery and development of drugs, vaccines, and biological products, which are time-consuming, costly, and unpredictable. Product candidates can fail at any stage due to unfavorable preclinical or clinical trial results, or new data that does not support further development. Difficulties in recruiting and enrolling patients for clinical trials on a consistent basis, the need to amend clinical trial protocols or conduct additional trials, and challenges in successfully addressing regulatory authority comments or obtaining approvals for new products and indications are also noted. Regulatory interpretations and assessments, or other developments, could adversely affect a product's commercial potential. Additionally, continued approval for products receiving accelerated approval pathways may be contingent upon confirmatory studies.

Geographic, regulatory, and macro factors identified as constraints include the intensely competitive and highly regulated pharmaceutical markets, where competition is based on efficacy, safety, ease of use, and cost-effectiveness. The company faces competition from other pharmaceutical companies, generic drug manufacturers, and brand-name pharmaceutical companies. The maintenance of profitable operations in generic pharmaceuticals depends on the ability to select, develop, and launch new generic products in a timely and cost-efficient manner. The nutritional industry is also competitive, with factors including expertise, service, product quality, diversification, differentiation, price, and brand recognition. The majority of revenues are generated from operations in the European Union and UK, with growing contributions from the UAE and North America, all earned outside of the U.S. during 2025, and initial US operations commencing in 2026. All foreign operations are subject to risks inherent in conducting business abroad, including price and currency exchange controls, fluctuations in currency values, political and economic instability, and restrictive governmental actions.

The company faces several material risks, including regulatory and litigation risks, as laws and regulations may prohibit or restrict product sales or require business model changes. Taxation and transfer pricing could adversely affect results if regulators challenge corporate structures or methodologies. Currency exchange rate fluctuations pose a significant risk, as over 98% ¹⁰⁷ of net sales in 2025 were outside the United States, with the majority recognized in local currencies, leading to potential adverse effects from a strengthening U.S. dollar. Geopolitical issues and conflicts, such as the war in Ukraine or the conflict in the Middle East, could materially affect operations if they escalate in areas where the company does business. Inflation and rising interest rates in the EU, with an annual inflation rate of approximately 2.3% ¹⁰⁸ in December 2025 and an average annual change in HICP of approximately 2.6% ¹⁰⁹ from 2016 to 2025, adversely affect the business due to higher costs and increased financing costs from floating interest rate loan facilities. The U.S. Inflation Reduction Act of 2022 (IRA) and potential Most-Favoured-Nation (MFN) pricing agreements could significantly reduce U.S. drug prices, and Section 232 tariffs on pharmaceutical imports starting in 2026 could increase costs and disrupt supply chains. The discovery and development of drugs are time-consuming, costly, and unpredictable, with product candidates failing at any stage. Cybersecurity risks, including data loss, litigation, and liability from breaches, could adversely affect operations and financial condition, despite measures taken to protect data systems.

Management's message to shareholders emphasizes a commitment to becoming a global healthcare company through a lean, efficient, and vertically integrated operating model, expanding the portfolio of proprietary nutraceutical and pharmaceutical products, growing the customer base, and achieving growth stabilization in new markets. The company strives to maximize shareholder value by adapting to market realities and customer needs. Key strategic priorities include driving organic growth at attractive margins by improving execution, optimizing cash flow, and leveraging a strong market position while maintaining a streamlined cost structure. Management also highlights the ongoing corporate reorganization to streamline costs and enhance asset and resource utilization through business unit integration, aiming for operational efficiencies and economies of scale. Finally, a significant emphasis is placed on stepping up innovation through accelerated R&D efforts on IP-driven products like the CCX0722 obesity and weight management pill, CCDL24 for gastrointestinal disorders, CNS, Prostate, Ovarian and Colorectal cancer treatments, and the AI-driven drug repurposing platform "Cloudscreen®". Management is confident that the current liquidity position, along with ongoing financing and investment strategies, will enable the company to meet its financial obligations and continue its growth trajectory. The company intends to continue utilizing its At-the-Market (ATM) sales program as a source of ongoing equity capital and may pursue subsequent closings of up to $292 million ¹¹⁰ available under the ATW Convertible Note Facility if additional capital needs arise. A new Shelf Registration Statement on Form S-3 was filed on November 7, 2025, registering up to $200,000,000 ¹¹¹ of securities, which the company intends to utilize to raise additional equity capital as and when needed.