What changed in this filing

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Item 1. Business

2025-03-04 compared with 2024-03-06 · 78 added, 64 removed, 257 unchanged (36% of the section changed)

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In addition to age, other factors linked to NAD+ depletion include poor diet, excess alcohol consumption and a number of disease states.

NAD+ levels may be increased through supplementation with NAD+ precursors, such as nicotinamide riboside (NR), calorie restriction and moderate exercise.

NAD+ levels may be increased with administration of NAD+ precursors, calorie restriction and moderate exercise.

We are at the forefront of exploring effective methods to increase NAD+ levels and support healthy aging.

In 2013, we commercialized Niagen®, a proprietary form of NR, a novel form of vitamin B3, and one of the most well-studied and efficient NAD+ precursors on the market.

Data from numerous preclinical studies and human clinical trials show that NR is a highly efficient NAD+ precursor that significantly raises NAD+ levels in blood and tissue.

Niagen® is confirmed safe for human consumption as a dietary supplement and food ingredient.

Niagen® has twice been successfully reviewed under the U.S.

In 2013, we commercialized food-grade Niagen®, a proprietary form of nicotinamide riboside chloride (NRC), a novel form of vitamin B3, as both a dietary and food ingredient.

In 2024, we launched Niagen Plus, a product line for healthcare practitioners and clinics, featuring pharmaceutical-grade Niagen®.

We supply pharmaceutical-grade Niagen® to U.S.

FDA-registered 503B outsourcing facilities who are able to compound and distribute Niagen® intravenous (Niagen IV) and injectable Niagen®.

These pharmaceutical-grade Niagen® products are available exclusively at clinics with a prescription.

Food-grade Niagen® is authorized for human consumption as a dietary supplement and generally recognized as safe as a food ingredient.

Pharmaceutical-grade Niagen® is authorized by the FDA for compounding by 503B outsourcing facilities.

NRC remains one of the most well-studied and efficient NAD+ precursors on the market.

Data from numerous preclinical studies and human clinical trials show that orally administered food-grade NRC is a highly efficient NAD+ precursor that significantly raises NAD+ levels in blood and tissue.

Food-grade Niagen® has twice been successfully reviewed under the U.S.

Food and Drug Administration’s (FDA) new dietary ingredient (NDI) notification program, it has been successfully notified to the FDA as generally recognized as safe (GRAS), and has been approved by Health Canada, the European Commission, the Turkish Ministry of Agriculture and the Therapeutic Goods Administration (TGA) of Australia.

Niagen® has also been approved for inclusion in medical foods by both the Brazilian Health Regulatory Agency (ANVISA) and the Food Standards Australia New Zealand (FSANZ).

Clinical studies of Niagen® have demonstrated a variety of outcomes including increased NAD+ levels, altered body composition, increased cellular metabolism and increased energy production.

Niagen® is protected by patents to which we are the owner or have exclusive rights.

Food-grade Niagen® has also been approved for inclusion in medical foods by both the Brazilian Health Regulatory Agency (ANVISA) and the Food Standards Australia New Zealand (FSANZ).

Clinical studies of oral, food-grade Niagen® have demonstrated a variety of outcomes including increased NAD+ levels, altered body composition, increased cellular metabolism and increased energy production.

Food-grade Niagen®, pharmaceutical-grade Niagen® and other NAD+ precursors are protected by patents to which we are the owner or have exclusive rights.

While best known for its role in cellular energy production, NAD+ is also thought to play an important role in healthy aging.

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Through our ChromaDex External Research Program (CERP™), we have amassed more than 275 research partnerships with leading universities and research institutions around the world including the National Institutes of Health, Cornell, Dartmouth, Harvard, Massachusetts Institute of Technology, University of Cambridge, the Mayo Clinic, Chiba University and Sun Yat-sen University.

The results of the 275+ research agreements have allowed CERP™ to help produce the trusted science behind Niagen® and continue to advance the understanding of NAD+ in health, diseases, and aging.

The results of the 275+ research partnerships have allowed CERP® to help produce the trusted science behind Niagen® and continue to advance the understanding of NAD+ in health, diseases, and aging.

We value and encourage strong scientific rigor behind our products and seek to continually develop additional relationships in pursuit of this.

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Other distinguished members include Dr.

Charles Brenner, Alfred E Mann Family Foundation Chair in the Department of Diabetes & Cancer Metabolism at City of Hope and one of the world’s recognized experts in NAD+ and discoverer of NR as a NAD+ precursor;

Rudy Tanzi, co-chair of the department of neurology at Harvard Medical School;

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Brunie Felding, Associate Professor in the Department of Molecular Medicine at Scripps Research Institute, California Campus;

David Katz, Founder and former director of Yale University’s Yale-Griffin Prevention Research Center, President and Founder of the non-profit True Health Initiative, and Founder and Chief Executive Officer of Diet ID, Inc.;

Vilhelm (Will) Bohr, M.D., Ph.D., D.Sc., former Chief of the Laboratory of Molecular Genetics at the National Institute on Aging of the National Institutes of Health.

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Consumer Products Segment

Through our consumer products segment, we provide finished dietary supplement products that contain the Company's proprietary ingredients, commercialized as Tru Niagen®, directly to consumers and distributors.

As one of the world leaders on NAD+ and the science of healthy aging, we continuously strive to evolve our Tru Niagen® products through ongoing exploration, discovery and the application of patented technologies.

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Ingredients Segment

Through our ingredients segment, we provide Niagen® in ingredient form to our strategic partners, including Nestec Ltd.

(Nestlé), a global leader in pioneering quality science-based nutritional health solutions.

We also offer Immulina®, a spirulina extract with predominant active compounds of Braun-type lipoproteins which are useful for supporting human immune function.

Our mission is to continue to identify, acquire and commercialize innovative proprietary ingredients and technologies.

With an experienced team, we possess the capability to guide innovative ingredients and technologies from early development through commercialization, ensuring compliance with regulatory approvals, safety standards, toxicology assessments, and clinical trials.

Furthermore, we offer comprehensive supply chain management and manufacturing support, enabling us to either directly sell the ingredient products or license them to third parties.

Through our Ingredients segment, we develop and commercialize proprietary ingredient technologies, including food-grade Niagen® and pharmaceutical-grade Niagen®.

We supply these ingredients as raw materials to manufacturers of consumer products and U.S.

FDA-registered 503B outsourcing facilities, respectively.

Manufacturers of consumer products incorporate our food-grade Niagen® into multi-ingredient products, and U.S.

FDA-registered 503B outsourcing facilities use pharmaceutical-grade Niagen® who are able to compound and distribute intravenous (Niagen® IV) and injectable Niagen® products.

These pharmaceutical-grade products are available exclusively at clinics with a valid prescription.

Food-grade Niagen® is authorized for human consumption as a dietary supplement and has been notified as Generally Recognized as Safe (GRAS) for use as a food ingredient.

Pharmaceutical-grade Niagen® is authorized by the FDA for use in compounding by 503B outsourcing facilities.

Our mission is to identify, acquire, and commercialize innovative proprietary ingredients and technologies to drive growth and deliver value.

With an experienced team, we have the expertise to guide innovative ingredients and technologies from early-stage development through commercialization.

This includes ensuring compliance with regulatory approvals, safety standards, toxicology assessments, and clinical trial requirements.

Additionally, we provide comprehensive supply chain management and manufacturing support, enabling us to either directly sell our ingredient products or license them to third parties.

Analytical Reference Standards and Services Segment

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We have used and, to a limited extent, continue to use intellectual property harnessed from our analytical reference standards and services segment to create new proprietary ingredients to our customers.

Business Market

Business Addressable Market

According to data from Global Wellness Institute, the global wellness industry market was approximately $6.3 trillion in 2023, nearly 17% higher than its size in 2021.

In 2022, the personal care and beauty market was approximately $1,089 billion, healthy eating, nutrition and weight loss was approximately $1,079 billion and traditional and complementary medicine market was approximately $519 billion.

In 2023, the personal care and beauty market was approximately $1,213 billion, healthy eating, nutrition and weight loss was approximately $1,096 billion, traditional and complementary medicine market was approximately $553 billion and the spa market, which includes IV drips, was approximately $137 billion.

The Global Wellness Institute projects the overall wellness economy to grow approximately 7.3% annually, or 42% in total, from 2023 to 2028.

According to data from Grand View Research, the global dietary supplements market size was estimated at $164 billion in 2022, and is expected to grow at a compound annual growth rate of 8.9% from 2022 to 2030.

According to data from Grand View Research, the global dietary supplements market size was estimated at $178 billion in 2023, and is expected to grow at a compound annual growth rate of 9.1% from 2024 to 2030 and the intravenous hydration therapy market size was estimated at $2 billion in 2022, and is expected to grow at a compound annual growth rate of 8.0% from 2023 to 2030.

In 2023, our net sales grew by 16%, followed by a 19% increase in 2024.

Over the five-year period from 2019 to 2023, we achieved a compound annual growth rate of 13%.

Over the period from 2020 to 2024, we had a compound annual growth rate of 14%.

For the years ended December 31, 2024 and 2023, our net sales were approximately $99.6 million and $83.6 million, respectively.

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Major Customers

For the years ended December 31, 2023 and 2022, we had one major customer which accounted for more than 10% of our total net sales.

Watson Group, a related party, accounted for approximately 15.4% and 13.9% of our net sales for the years ended December 31, 2023 and 2022, respectively.

The loss of or deterioration in relationship with this customer would have a material adverse effect on our business and financial condition.

For the years ended December 31, 2024 and 2023, we had two major customers which accounted for more than 10% of our total net sales.

Watson Group, a related party during 2023 and part of 2024, accounted for approximately 12.5% and 15.4% of our net sales for the years ended December 31, 2024 and 2023, respectively, and Life Extension accounted for approximately 11.7% of our net sales for the year ended December 31, 2024.

The loss of or deterioration in relationship with these customers would have a material adverse effect on our business and financial condition.

Sales and Marketing Strategy

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Additionally, in August 2023, we launched a partnership with iHerb, an online global destination for supplements with access to over 180 countries, to help accelerate our global expansion.

We continue to focus on obtaining additional regulatory approvals required to expand marketing and distribution of the Tru Niagen® brand in new strategic international markets.

Currently, we are in the process of obtaining applicable regulatory approvals, including “Blue Hat” or health food registration with the Peoples Republic of China State Administration for Market Regulation for Tru Niagen® and other products containing nicotinamide riboside in our name or the name of our designee (collectively, the “Blue Hat Registration”) in connection with our joint venture agreement with Taikuk Group Ltd.

Achieving Blue Hat Registration would notably broaden our sales opportunities in China and is at the forefront of our expansion goals.

As of December 31, 2023, it is uncertain if or when Blue Hat Registration will be achieved.

For additional discussion surrounding our joint venture agreement and Blue Hat Registration see Note 15, Joint Venture , in Item 8 Financial Statements and Supplementary Data of this Form 10-K.

In January 2025, we began distributing to the United Arab Emirates.

We continue to seek opportunities to thoughtfully expand the Tru Niagen® brand into new international markets, carefully assessing the feasibility of obtaining the necessary regulatory approvals.

Ingredients Segment & Analytical and Reference Standards Segments

Our ingredients segment is supported through the development of key partnerships since we do not currently offer our ingredients to the broader public.

Our ingredients segment is supported through the development of key partnerships as we do not currently offer our ingredients to the broader public.

Sales to our partners are predominantly based in the United States, Hong Kong and Europe.

Our partners sell multi-ingredient products featuring Niagen® in the U.S.

Our food-grade Niagen® ingredient partners manufacture and sell multi-ingredient products featuring Niagen® in the U.S.

and other international markets.

Our pharmaceutical-grade Niagen® ingredient partners, which are U.S.

FDA-registered 503B outsourcing facilities, are able to compound and distribute Niagen® IV and injectable Niagen® products in the U.S.

For our analytical reference standards and services segment, we promote our products and services based on a direct, technically-oriented model.

We recruit and hire sales and marketing staff with appropriate commercial and scientific backgrounds.

Our analytical reference standards and services segment provides products and services to customers both within the United States and internationally.

We employ sales and marketing personnel with appropriate commercial experience and scientific qualifications.

Our analytical reference standards and services segment provides products and services to customers both within the U.S.

and internationally.

We offer unique and highly-characterized, phytochemicals, natural products and plant-based materials as well as tailored research services as requested through custom “Scope of Work” applications.

For our international operations, we partner with international distributors to market and sell to several foreign countries and markets.

Total sales and marketing expense for the years ended December 31, 2023 and 2022 was approximately $26.4 million and $28.3 million, respectively.

Total sales and marketing expense across all segments for the years ended December 31, 2024 and 2023 was approximately $29.5 million and $26.4 million, respectively.

Research and Development

The ChromaDex External Research Program (CERP®) is an essential component of our research and development platform.

CERP™ was established to advance the science of nicotinamide riboside and other ChromaDex products.

CERP® was established to advance the science of nicotinamide riboside chloride and other ChromaDex products.

We value and encourage strong scientific rigor behind our products and have cultivated relationships with academic institutions in pursuit of this.

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Additional relationships are currently being developed.

To date, over 375 peer-reviewed studies have been published on the science behind NR, including its NAD+ boosting properties, and there are over 475 published human clinical studies on NAD+ and its impact on health.

CERP™ has produced more than 40% of all peer-reviewed NR-focused publications and 75% of the peer-reviewed clinical NR publications so far.

To date, over 450 peer-reviewed studies have been published on the science behind NRC, including its NAD+ boosting properties, and there are over 500 published human clinical studies on NAD+ and its impact on health.

CERP® has produced more than 40% of all peer-reviewed NRC-focused publications and 75% of the peer-reviewed clinical NRC publications so far.

To date, 38 peer-reviewed human clinical trials have been published on our proprietary ingredient Niagen® demonstrating its safety and/or efficacy.

No adverse effects have been attributed to Niagen® in any of the published clinical trials.

In both 2015 and 2018, Niagen® was successfully notified to the FDA as an NDI.

Niagen® was also successfully notified to FDA as Generally Recognized as Safe in August 2016.

Through our research and development laboratory in Longmont, Colorado, and the collective efforts of our experienced team, we venture to discover, develop and evaluate new products that we aim to take to market and explore cost saving processes for existing products.

In both 2015 and 2018, food-grade Niagen® was successfully notified to the FDA as an NDI.

Food-grade Niagen® was also successfully notified to FDA as GRAS in August 2016.

Pharmaceutical-grade Niagen® is authorized by the FDA for compounding by 503B outsourcing facilities.

Through our research and development laboratory in Longmont, Colorado, and the collective efforts of our experienced team, we venture to discover, develop and evaluate new products and ingredients that we aim to take to market and explore cost saving processes for existing products.

Research and development expense for the years ended December 31, 2024 and 2023 was approximately $6.0 million and $5.0 million, respectively.

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The health and wellness, anti-aging and dietary supplement industries are highly competitive, and we have competitors that offer products similar to our products.

Many of our competitors may have greater financial and human resources than our own.

In addition to competing with companies that may have greater financial and human resources than our own, we also face competition from those selling products that are inaccurately or falsely labeled, including those that contain significantly lower amounts of active ingredients than stated on their labels.

Furthermore, some competitors may attempt to infringe on our patents, misappropriate proprietary formulations, or introduce products that imitate our innovations without adhering to the same standards of scientific rigor and quality control.

We seek to differentiate our products and marketing from our competitors by emphasizing product quality, product benefits, scientific rigor, and functional ingredients.

Patent and trademark applications that protect brands, product names, and new technologies are pursued whenever possible.

We also pursue patent and trademark protections for our brands, product names, and new technologies whenever possible.

While we cannot assure that such measures will block competitive products, we believe our continued emphasis on scientific research, innovation and new product development targeted at the needs of our consumers will enable us to effectively compete in the marketplace by building a trusted brand.

For our consumer products segment, we are in direct competition with Elysium Health who offers a similar product to Tru Niagen® as well as other providers of NAD+ boosting supplements.

For our consumer products segment, we are in direct competition with other providers of NAD+ boosting supplements.

Additionally, we have customers who are authorized resellers of Niagen® as a consumer product.

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Working Capital

ChromaDex’s working capital as of December 31, 2023 and 2022 was approximately $9.5 million and $13.5 million, respectively.

For the year ended December 31, 2023, we observed a positive impact on our supply chain lead times due to the mitigation of COVID-related disruptions and the implementation of additional efficiency initiatives.

We measure working capital by adding trade receivables and inventories and subtracting accounts payable.

The Company’s net working capital as of December 31, 2024 and 2023 was approximately $8.4 million and $9.5 million, respectively.

We measure net working capital by adding trade receivables and inventories and subtracting accounts payable.

Our working capital is primarily comprised of assets and liabilities from our consumer products segment and ingredients segment as these operations require a considerable amount of inventory on hand.

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Some of our operations are subject to regulation by various U.S.

federal agencies and similar state and international agencies, including, but not limited to, the FDA, the Federal Trade Commission (FTC), the Consumer Product Safety Commission, the Department of Commerce, the Department of Transportation and the Department of Agriculture.

These regulators govern a wide variety of production activities, from design and development to labeling, manufacturing, handling, selling and distributing of products.

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• ingredient testing;

• documentation process, batch records, specifications;

• manufacturing process, documentation, batch records, specifications;

• product labeling;

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Advertising Regulations

In addition to FDA regulations, the FTC regulates the advertising of dietary supplements, foods, cosmetics, and over-the-counter drugs.

In addition to FDA regulations, the FTC regulates the advertising of dietary supplements, foods, cosmetics, over-the-counter drugs and other consumer products.

In recent years, the FTC has instituted numerous enforcement actions against dietary supplement companies for failure to adequately substantiate claims made in advertising or for the use of false or misleading advertising claims.

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We may be subject to regulation under various state and local laws that include provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of dietary supplements, foods, cosmetics and over-the-counter drugs.

Additionally, state attorney's general and private plaintiff attorneys also regulate the advertising of dietary supplements, foods, cosmetics, and over-the-counter drugs through enforcement of state consumer protection laws.

Additionally, state attorney's general and private plaintiff attorneys also monitor the advertising of dietary supplements, foods, cosmetics, and over-the-counter drugs through enforcement of state consumer protection laws.

State attorney’s general and, to a larger extent, private lawyers specializing in consumer class action litigation have instituted numerous enforcement actions against dietary supplement companies for failure to adequately substantiate claims made in advertising, for the use of false or misleading advertising claims, for underdosed products that don’t meet label claims and allegations related to product safety.

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Typically, novel ingredients must go through an extensive safety review process (similar to the NDI notification process in the U.S.) by a regulatory or scientific authoritative body.

Finished products typically must either be notified or registered (a limited approval process) with the relevant authorities.

Finished products typically must either be registered or notified (a limited approval process) with the relevant authorities.

In some cases, new products can be brought to market without notifying the authorities.

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11,746,123 Efficient and scalable syntheses of nicotinoyl ribosides and reduced nicotinoyl ribosides, modified derivatives thereof, phosphorylated analogs thereof, adenylyl dinucleotide conjugates thereof, and novel crystalline forms thereof 6/22/2020 9/05/2023 11/10/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex

11,981,698 Methods of Preparing reduced Nicotinamide Riboside and Derivatives Thereof 5/4/2022 5/14/2024 7/24/2034 Licensed from The Queen’s University of Belfast

12,195,494 Efficient and scalable syntheses of nicotinoyl ribosides and reduced nicotinoyl ribosides, modified derivatives thereof, phosphorylated analogs thereof, adenylyl dinucleotide conjugates thereof, and novel crystalline forms thereof 8/24/2023 1/14/2025 11/10/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex

Manufacturing, Sources and Availability of Raw Materials

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These manufacturing partners uphold the standards imposed by the International Organization for Standardization, as well as the high-quality standards we require.

We utilize third-party manufacturers for the production, encapsulation, and bottling of NR as well as the manufacturing and supply of various other ingredients, products, and services.

We utilize third-party manufacturers for the production, encapsulation, and bottling of NRC as well as the manufacturing and supply of various other ingredients, products, and services.

In most cases, our contract manufacturers purchase raw materials based on our specifications;

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We believe these strategic manufacturing relationships not only mitigate our capital investment but also enable us to exercise cost control, positioning us competitively against larger-volume manufacturers in the dietary supplements, phytochemicals, and ingredients market.

Additionally, the Company has an exclusive manufacturer for the supply of NR, W.R.

Effective November 2, 2023, the Company entered into a Ninth Amendment to the Manufacturing and Supply Agreement (the "Grace Manufacturing Agreement"), initially effective in January 2016.

In January 2019, Grace was issued patents related to the crystalline form of NR chloride which limit the Company’s ability to find alternatives for supply (Grace Patents).

In December 2023, the Company and Grace executed a Limited Licensing Agreement.

Pursuant to this agreement, the Company is authorized to procure NR supply from a designated third party in explicitly defined quantities for purchase in 2024.

The Grace Manufacturing Agreement is set to expire on December 31, 2024, subject to potential renewal, the terms of which will be negotiated by both parties.

Any failure to extend the Grace Manufacturing Agreement on satisfactory terms could potentially have a material adverse impact on our financial results and strategic position, as outlined in more detail in Item 1A.

Additionally, the Company has an exclusive manufacturer for the supply of food-grade NRC, W.R.

During the third quarter of 2024, the Company entered into a Tenth Amendment (Tenth Amendment) to the Manufacturing and Supply Agreement (such agreement as amended, the “Grace Manufacturing Agreement” or “Agreement”), effective as of January 1, 2025 and originally effective in January 2016 with Grace.

In January 2019, Grace was issued patents related to the crystalline form of NRC which limit the Company’s ability to find alternatives for supply (Grace Patents).

Pursuant to the Tenth Amendment, the Company committed to purchase approximately $4.8 million of total inventory between January 1, 2025 and March 31, 2025.

The Grace Manufacturing Agreement is set to expire on March 31, 2025, subject to further renewal of the Agreement to be negotiated by the parties.

Additionally, under the Tenth Amendment, the Company and Grace maintain a binding six-month rolling forecast, which is updated monthly.

As of December 31, 2024, this forecast obligates the Company to purchase approximately $11.2 million of total inventory between January 1, 2025 and June 30, 2025.

If we are unable to extend the agreement with Grace on satisfactory terms, it could have a material adverse impact to our financial results and strategic position in the market.

Risk Factors, "We rely on a single supplier, W.R.

Grace, for NR and a limited number of third-party suppliers for the raw materials required to produce our products."

Grace, for NRC and a limited number of third-party suppliers for the raw materials required to produce our products."

In our pursuit of excellence, we believe that we have identified reliable sources and suppliers of ingredients, chemicals, phytochemicals, and reference materials.

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We believe our people are critical for our success.

We are dedicated to providing an environment where ChromaDex employees can have fulfilling careers, be happy, healthy and productive.

We are dedicated to providing an environment where our employees can have fulfilling careers, be happy, healthy and productive.

We offer attractive wage and benefit packages to take care of the needs of our employees and their families.

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We continue to invest in recruiting, developing, and rewarding talented people.

ChromaDex and its employees are dedicated to diversity, inclusion, and fairness.

We promote and support an open dialogue.

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We are subject to the reporting requirements under the Securities Exchange Act of 1934, as amended (the Exchange Act).

Consequently, we are required to file reports and information with the Securities and Exchange Commission (SEC), including reports on the following forms:

Consequently, we are required to file reports and information with the SEC, including reports on the following forms:

annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business