Item 1. Business
Item 1. Business
Unless otherwise indicated or the context otherwise requires, references to the Company, ChromaDex, we, us and our refer to ChromaDex Corporation and its consolidated subsidiaries.
Company Background
On May 21, 2008, Cody Resources, Inc., a Nevada corporation and a public company, (Cody) entered into an Agreement and Plan of Merger (Merger Agreement), by and among Cody, CDI Acquisition, Inc., a California corporation and wholly-owned subsidiary of Cody (Acquisition Sub), and ChromaDex, Inc. (Merger). Subsequent to the signing of the Merger Agreement, Cody merged with and into a Delaware corporation. On June 20, 2008, Cody amended its articles of incorporation to change its name to ChromaDex Corporation. ChromaDex Corporation was traded on the over-the-counter market under the symbol “CDXC.” On April 25, 2016, ChromaDex Corporation became listed on the Nasdaq Capital Market under the symbol “CDXC.”
ChromaDex, Inc., a wholly owned subsidiary of ChromaDex Corporation, was originally formed as a California corporation on February 19, 2000.
On March 12, 2017, ChromaDex Corporation acquired Healthspan Research LLC, a consumer product company offering Tru Niagen® branded products. This marked the strategic shift to become a global bioscience company dedicated to healthy aging. On September 5, 2017, the Company completed the sale of its operating assets that were used with the Company’s quality verification program testing and analytical chemistry business for food and food related products to Covance Laboratories Inc. On January 15, 2021, Healthspan Research LLC was dissolved. Prior to its dissolution, Healthspan Research, LLC contributed its assets and liabilities to ChromaDex, Inc.
Company Overview
ChromaDex is a global bioscience company dedicated to healthy aging. Our team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), an essential coenzyme that is a key regulator of cellular metabolism and is found in every cell of the human body. NAD+ levels in humans have been shown to decline by more than 50% from young adulthood to middle age. 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.
In 2013, we commercialized Niagen®, a proprietary form of NR, a novel form of vitamin B3. 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. 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.
While best known for its role in cellular energy production, NAD+ is also thought to play an important role in healthy aging. Many cellular functions related to health and healthy aging are sensitive to levels of locally available NAD+ and this represents an active area of research in the field of NAD+. To date, there are over 475 published human clinical studies related to NAD+ and its impact on health. These areas of study include understanding NAD+’s role in Alzheimer’s disease, Parkinson’s disease, neuropathy, sarcopenia, liver disease and heart failure.
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We are among the world leaders in the emerging NAD+ space. Through our ChromaDex External Research Program (CERP™), we have amassed more than 250 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 250+ 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. We value and encourage strong scientific rigor behind our products and seek to continually develop additional relationships in pursuit of this. CERP™ is a vital component of our research and development platform along with our scientific advisory board. Our scientific advisory board supports the technical and intellectual property needs of investigators, presents research at conferences, and helps build and support the NAD+ and healthy aging research community.
Our scientific advisory board is led by Chairman Dr. Roger Kornberg, Nobel Laureate Stanford Professor, Dr. Charles Brenner, one of the world’s recognized experts in NAD+ and discoverer of NR as a NAD+ precursor, Dr. Rudy Tanzi, the co-chair of the department of neurology at Harvard Medical School, Sir John Walker, Nobel Laureate and Emeritus Director, MRC Mitochondrial Biology Unit in the University of Cambridge, England, Dr. Bruce German, Chairman of food, nutrition and health at the University of California, Davis, Dr. Brunie Felding, Associate Professor, Department of Molecular Medicine at Scripps Research Institute, California Campus, Dr. David Katz, the 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. and Dr. 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.
Business Model, Products and Services
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 in the emerging NAD+ space and the science of healthy aging, we continuously strive to evolve our Tru Niagen® products through the exploration, discovery and enhancement of patented technologies. The Tru Niagen® brand is built on a dedication to scientific evidence and improving consumer health by safely raising NAD+ levels to help consumers age better. Our principal objective is to increase awareness of the Tru Niagen® brand worldwide including through expanded access to consumers by entering new markets, retail platforms and other opportunities.
We remain focused on expanding marketing and distribution of the Tru Niagen® brand in new strategic international markets and securing the regulatory approvals necessary to accomplish the same. We began international expansion of the Tru Niagen® brand with the launch in Hong Kong and Macau with our strategic partner, A.S. Watson Group, in 2017. Since then, we have further expanded into Singapore, New Zealand, Canada, Australia, China, Korea, Japan, the United Kingdom and other European markets. We support our international operations in various capacities which include supplying our international strategic partners with finished products manufactured in the U.S, as well as marketing materials and know-how. Simultaneously, we continue to support our proprietary e-commerce platforms and the e-commerce platforms of strategic regional and local partners within the U.S while further exploring opportunities for new domestic channels.
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 other innovative proprietary ingredients and technologies. Our experienced team is capable of advancing products through early development into commercialization with the required regulatory approval, safety, toxicology and clinical trials as well as providing supply chain management and manufacturing needs to ultimately sell the ingredient products directly or license to third parties.
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Analytical Reference Standards and Services Segment
Since 1999, we have provided research and quality-control products and services through our analytical reference standards and services segment and have positioned ourselves as a leader in the industry. Customers worldwide in the dietary supplement, food and beverage, cosmetic, pharmaceutical, and life sciences industries utilize our products, which are small quantities of highly-characterized, phytochemicals, natural products and plant-based materials, to ensure the quality of their raw materials and finished products. We also provide research services for customers exploring the frontier of natural product research and development.
We have taken advantage of both supply chain needs and regulatory requirements to build our analytical reference standards and services segment. We believe we create value throughout the supply chain of the dietary supplements, functional foods, life science research, personal care markets and associated analytical testing laboratories. We intend to capitalize on additional opportunities in product development and commercialization of various kinds of intellectual property that we have largely discovered and acquired through the sales process associated with this segment.
Business Market
According to data from Global Wellness Institute, the global wellness industry market was approximately $4.4 trillion in 2020 amidst the disruptions of COVID-19, which is down from $4.9 trillion in 2019. In 2020, the personal care, beauty and anti-aging market was approximately $960 billion, healthy eating, nutrition and weight loss was approximately $950 billion and traditional and complementary medicine market was approximately $410 billion. The Global Wellness Institute projects the overall wellness economy to grow approximately 10% annually, or 60% in total, from 2020 to 2025, with most segments projected to exceed GDP growth.
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.
For the years ended December 31, 2022 and 2021, our net sales were approximately $72.1 million and $67.4 million, respectively. The following table summarizes total net sales for each of our business segments in the last two years. Please refer to Item 8 Financial Statements and Supplementary Data of this Form 10-K for additional financial information about each of our business segments.
Year Ended December 31,
(In thousands) 2022 2021
Consumer Products Segment $ 60,110 $ 56,705
Ingredients Segment 8,736 7,407
Analytical Reference Standards and Services Segment 3,204 3,337
Total net sales $ 72,050 $ 67,449
Major Customers
For the years ended December 31, 2022 and 2021, we had one major customer which accounted for more than 10% of our total net sales. A.S. Watson Group, a related party, accounted for approximately 13.9% and 13.8% of our net sales for the years ended December 31, 2022 and 2021, respectively. The loss of or deterioration in relationship with this customer would have a material adverse effect on our business and financial condition.
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Sales and Marketing Strategy
Consumer Products Segment
We employ a variety of strategies to drive sales and consumer awareness of Tru Niagen®, including social media and internet advertising, managing affiliate marketing, influencer campaigns and marketing, paid spokespersons and talent, events and trade shows, e-mail marketing campaigns, paid search advertising and distribution of research publications and press releases. We also have a dedicated customer care department that handles day-to-day communications with our end customers addressing any needs or concerns related to our Tru Niagen® products.
United States of America: We distribute Tru Niagen® products direct to consumers through our propriety e-commerce platform TruNiagen.com, Amazon, ShopHQ and other established internet marketplaces. We also partner with specialty retailers and direct healthcare practitioners who are authorized resellers of Tru Niagen® in the United States.
International: We utilize strategic partners on a regional or local country basis to expand our distribution of Tru Niagen® products internationally. Our strategic partners offer our products through brick and mortar stores, e-commerce channels or a combination of both. With our strategic partners, we currently distribute Tru Niagen® products to the following international markets:
• Hong Kong (A.S. Watson Group);
• Macau (A.S. Watson Group);
• Singapore (A.S. Watson Group);
• New Zealand (Matakana Superfoods);
• Australia (Matakana Superfoods);
• China (Sinopharm);
• Korea (Juvenis, Coupang);
• Canada (CLM Health Group, Amazon, Fullscript Canada and www.TruNiagen.ca);
• Japan (Amazon);
• United Kingdom (Amazon);
• Germany (Amazon);
• France (Amazon);
• Italy (Amazon);
• Spain (Amazon);
• Poland (Amazon);
• Netherlands (Amazon); and
• Sweden (Amazon).
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 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, 2022, it is uncertain when Blue Hat Registration will be achieved. For additional discussion surrounding our joint venture agreement and Blue Hat Registration see Note 12, Joint Venture , in Item 8 Financial Statements and Supplementary Data of this Form 10-K.
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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. 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. and other international markets. 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 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, 2022 and 2021 was approximately $28.3 million and $28.4 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. We value and encourage strong scientific rigor behind our products and have cultivated relationships with academic institutions in pursuit of this. Thus far, CERP™ has achieved over 250 research partnership agreements 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. Additional relationships are currently being developed.
To date, over 300 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, 24 peer-reviewed human clinical trials have been published on our proprietary ingredient Niagen® demonstrating its safety and/or efficacy through CERP™. 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, we venture to discover, develop and evaluate new products 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, 2022 and 2021 was approximately $4.8 million and $3.8 million, respectively.
Competitive Business Conditions
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 significantly greater financial and human resources than our own. 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. While we cannot assure that such measures will block competitive products, we believe our continued emphasis on 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. Additionally, we have customers who are authorized resellers of Niagen® as a consumer product. We believe these resellers are focused on specific channels that we feel are complementary to our business and expand awareness of the Niagen® ingredient and benefits. We also face strong indirect competition from other ingredient suppliers who may supply alternative ingredients that may have similar characteristics to ingredients we offer. For our analytical reference standards and services segment, we face competition within the standardization and quality testing niche of the markets we serve. These competitors have already developed reference standards or services or are currently taking steps to develop them. We strive to always provide superior products and services to our competition.
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Working Capital
ChromaDex’s working capital as of December 31, 2022 and 2021 was approximately $13.5 million and $8.4 million, respectively. We measure 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. As each of these segments grow, greater working capital will likely be required to support these operations.
Government Regulation
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. From time to time, federal, state and international legislation is enacted that may materially increase our cost of doing business or may limit or expand our permissible activities. We cannot predict whether or when potential legislation or regulations will be enacted, and, if enacted, the effect of such legislation, regulation, implementation, or any implemented regulations or supervisory policies would have on our financial condition or results of operations. In addition, the outcome of any litigation, investigations or enforcement actions initiated by state or federal authorities could result in required changes to our operations and increased compliance costs.
U.S. FDA Regulation
In the U.S., dietary supplements and food are subject to FDA regulations under the Federal Food, Drug and Cosmetic Act (FDCA). Areas addressed in these regulations include:
• product safety;
• product testing;
• ingredient testing;
• documentation process, batch records, specifications;
• product labeling;
• manufacturing facility registration;
• product manufacturing and storage;
• product claims, advertising and promotion;
• product sales and distribution; and
• product post-market surveillance.
The FDCA has been amended several times with respect to dietary supplements, most notably by the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA generally provides a regulatory framework to help ensure safe, quality dietary supplements and the dissemination of accurate information about such products. In particular, one aspect of the framework established by DSHEA provides that so-called “third-party literature”, for example a reprint of a peer-reviewed scientific publication linking a particular nutritional ingredient with health benefits, may be used in connection with the sale of a nutritional supplement to consumers without the literature being subject to regulation as labeling. Such literature must not be false or misleading; the literature may not promote a particular manufacturer or brand of nutritional supplement; the literature must present a balanced view of the available scientific information on the nutritional supplement; if displayed in an establishment, the literature must be physically separate from the nutritional supplement; and the literature may not have appended to it any information by sticker or any other method. If the literature fails to satisfy each of these requirements, we may be prevented from disseminating it with our products, and any dissemination could subject our products to regulatory action as an illegal drug. Moreover, any written or verbal representation by us that would associate a nutrient in a product that we sell with an effect on a disease will be deemed evidence of intent to sell the product as an unapproved new drug, a violation of the FDCA. We are committed to meeting or exceeding all relevant FDA regulations under the FDCA.
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U.S. Advertising Regulations
In addition to FDA regulations, the FTC regulates the advertising of dietary supplements, foods, cosmetics, and over-the-counter drugs. 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. These enforcement actions have often resulted in consent decrees and the payment of civil penalties, restitution, or both, by the companies involved. 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. 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. These actions have often resulted in consent decrees and the payment of civil penalties, restitution, or both, by the companies involved. We are not aware of, or party to, any action by a state attorney general or consumer class action involving our products.
Further, The National Advertising Division of the Council of Better Business Bureaus reviews national advertising for truthfulness and accuracy. The National Advertising Division of the Council of Better Business Bureaus uses a form of alternative dispute resolution, working closely with in-house counsel, marketing executives, research and development departments and outside consultants to decide whether claims have been substantiated. We are not aware of, or party to, any action by the National Advertising Division of the Council of Better Business Bureaus involving our products.
International Regulations
Our international sales for the consumer products segment and ingredients segment are subject to foreign government regulations, which vary substantially from country to country. Most countries, in particular major markets, have established regulations for (a) authorizing the introduction of novel ingredients to market in the food and/or dietary/food/health supplement sectors and (b) for allowing finished goods to be placed on the market for consumer access. 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. In some cases, new products can be brought to market without notifying the authorities.
The time required to obtain approval by a foreign country may be longer or shorter than that required for the FDA notification process, and the requirements may differ. We may be unable to obtain on a timely basis, if at all, any foreign government approvals necessary for the marketing of our products abroad.
Regulation of foods/food supplements in Europe is exercised primarily through the European Union, which regulates the combined market of each of its member states. Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to novel foods or new dietary ingredients.
Regulation in other major and established markets, including Canada, Japan, Brazil, China, Turkey and Australia all maintain and enforce a clear regulatory framework for novel ingredients and dietary supplements (or their equivalent).
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Patents, Trademarks, Licenses, Franchises, Concessions, Royalty Agreements or Labor Contracts, Including Duration
We currently protect our intellectual property through patents, trademarks, designs and copyrights on our products and services. 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. We aim to develop these proprietary ingredients ourselves and grant licenses to external companies for their commercialization.
The following table sets forth our existing patents and those to which we have licensed rights:
Patent Number Title Filling Date Issued Date Expires Licensor
7,776,326 Methods and compositions for treating neuropathies 6/3/2005 8/17/2010 6/24/2026 Licensed from Washington University
7,846,452 Potent immunostimulatory extracts from microalgae 7/28/2005 12/7/2010 7/28/2025 Licensed from University of Mississippi
8,106,184 Nicotinyl Riboside Compositions and Methods of Use 11/17/2006 1/31/2012 9/20/2027 Licensed from Cornell University
8,114,626 Yeast strain and method for using the same to produce Nicotinamide Riboside 3/26/2009 2/14/2012 1/5/2026 Licensed from Dartmouth College
8,133,917 Pterostilbene as an agonist for the peroxisome proliferator-activated receptor alpha isoform 10/25/2010 3/13/2012 8/18/2025 Licensed from the University of Mississippi and U.S. Department of Agriculture
8,197,807 Nicotinamide Riboside Kinase compositions and Methods for using the same 4/20/2006 6/12/2012 11/19/2026 Licensed from Dartmouth College
8,252,845 Pterostilbene as an agonist for the peroxisome proliferator-activated receptor alpha isoform 2/1/2012 8/28/2012 8/18/2025 Licensed from the University of Mississippi and U.S. Department of Agriculture
8,383,086 Nicotinamide Riboside Kinase compositions and Methods for using the same 4/12/2012 2/26/2013 4/20/2026 Licensed from Dartmouth College
8,809,400 Method to Ameliorate Oxidative Stress and Improve Working Memory Via Pterostilbene Administration 8/8/2011 8/19/2014 10/2/2028 Licensed from the University of Mississippi and U.S. Department of Agriculture
8,841,350 Method for treating non-melanoma skin cancer by inducing UDP-Glucuronosyltransferase activity using pterostilbene 5/8/2012 9/23/2014 5/8/2032 Co-owned by ChromaDex and University of California
8,889,126 Methods and compositions for treating neuropathies 5/28/2010 11/18/2014 6/3/2025 Licensed from Washington University
9,000,147 Nicotyl riboside compositions and methods of use 1/17/2012 4/7/2015 11/17/2026 Licensed from Cornell University
9,028,887 Method improve spatial memory via pterostilbene administration 5/22/2014 5/12/2015 6/10/2028 Licensed from the University of Mississippi and U.S. Department of Agriculture
9,295,688 Methods and compositions for treating neuropathies 10/10/2014 3/29/2016 6/3/2025 Licensed from Washington University
9,321,797 Nicotyl riboside compositions and methods of use 11/17/2014 4/26/2016 11/17/2026 Licensed from Cornell University
9,439,875 Anxiolytic effect of pterostilbene 5/11/2011 9/13/2016 12/11/2031 Licensed from the University of Mississippi and U.S. Department of Agriculture
9,975,915 Crystalline forms of nicotinoyl ribosides, modified derivatives thereof, and phosphorylated analogs thereof, and methods of preparation thereof 11/10/2017 5/22/2018 11/10/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
10,000,519 Methods of Preparing Nicotinamide Riboside and Derivatives Thereof 7/24/2014 6/19/2018 7/24/2034 Licensed from The Queen’s University of Belfast
10,000,520 B-vitamin and amino acid conjugates of nicotinoyl ribosides and reduced nicotinoyl ribosides, derivatives thereof, and methods of preparation thereof 3/16/2017 6/19/2018 3/16/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
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Patent Number Title Filling Date Issued Date Expires Licensor
10,183,036 Use of nicotinic acid riboside or nicotinamide riboside derivatives, and reduced derivatives thereof, as NAD+ increasing precursors 4/20/2017 1/22/2019 4/20/2037 Owned by ChromaDex
10,280,190 Nicotinic acid riboside or nicotinamide riboside compositions, reduced derivatives thereof, and the use thereof to enhance skin permeation in treating skin conditions 3/16/2016 5/7/2019 5/31/2036 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
10,688,118 Nicotinamide riboside compositions for topical use in treating skin conditions 10/30/2014 6/23/2020 4/6/2035 Owned by ChromaDex
10,689,411 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 11/10/2017
6/23/2020
11/10/2037
Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
10,815,262 Methods of preparing nicotinamide riboside and derivatives thereof
2/27/2018
10/27/2020
7/24/2034
Licensed from The Queen’s University of Belfast
10,857,172
Use of nicotinamide riboside, nicotinic acid riboside, and nicotinamide mononucleotide, reduced nicotinyl compounds, and nicotinoyl compound derivatives in infant formula for healthy development
4/14/2017
12/8/2020
4/14/2037
Owned by ChromaDex
10,934,322 B-vitamin and amino acid conjugates of nicotinoyl ribosides and reduced nicotinoyl ribosides, derivatives thereof, and methods of preparation thereof
5/11/2018
3/2/2021
3/16/2037
Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
11,033,568 Nicotinamide riboside compositions for topical use in treating skin conditions
6/3/2020
6/15/2021
10/30/2034
Owned by ChromaDex
11,071,747 Use of NAD precursors for breast enhancement
11/29/2017
7/27/2021
11/29/2037
Licensed from University of Iowa
11,214,589 Crystalline forms of nicotinoyl ribosides and derivatives thereof, and methods of preparation thereof
12/10/2019
1/4/2022
8/16/2040
Owned by ChromaDex
11,242,364 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
5/18/2021
2/8/2022
11/10/2037
Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
11,274,117 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 4/30/2021 3/15/2022 11/10/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
11,345,720 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 12/15/2021 5/31/2022 11/10/2037 Co-owned with The Queen’s University of Belfast and exclusively licensed by ChromaDex
11,524,022 Use of nicotinamide riboside, nicotinic acid riboside, and nicotinamide mononucleotide, reduced nicotinyl compounds, and nicotinoyl compound derivatives in infant formula for healthy development 4/14/2017 12/13/2022 4/14/2037 Owned by ChromaDex
11,571,413 Nicotinamide riboside treatments of domesticated meat animals 6/26/2020 2/7/2023 9/27/2039 Licensed from Kansas State University
11,584,770 Methods of preparing nicotinamide riboside and derivatives thereof 5/4/2022 2/21/2023 7/24/2034 Licensed from Queen’s University Belfast
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Manufacturing, Sources and Availability of Raw Materials
Our finished products are manufactured by third-party FDA-regulated contract manufacturers in the United States with some raw materials sourced internationally. Each contract manufacturer upholds the standards imposed by the International Organization for Standardization as well as the high quality standards we require. We utilize third-party manufacturers to produce NR, encapsulate and bottle NR sold as a dietary supplement and produce and supply other ingredients, products, and services. In most cases, our contract manufacturers purchase raw materials based on our specifications; however, we may also license particular raw material ingredients and supply our own source to the manufacturer.
Following the receipt of products or product components from third-party manufacturers, in addition to in-house testing performed by the contract manufacturer, we perform independent analysis and testing to ensure conformance to our strict specifications. We continuously monitor and manage supplier performance through a corrective action program developed by us. We believe these manufacturing relationships can minimize our capital investment, help control costs, and allow us to compete with larger volume manufacturers of dietary supplements, phytochemicals and ingredients. From time to time, if our capacity permits and when demand or quality requirements make it appropriate to do so, we manufacture certain products or product components internally.
W.R. Grace & Co. -Conn. (Grace) is our exclusive manufacturer for the supply of NR. Effective as of December 14, 2022, we entered into an Eighth Amendment (Eighth Amendment) to the Manufacturing and Supply Agreement (such agreement as amended, the “Grace Manufacturing Agreement”), originally effective in January 2016 with Grace. Beginning January 2019, Grace was issued patents related to the manufacturing of the crystalline form of NR. Pursuant to the Eighth Amendment, we are committed to purchase approximately $18.0 million of total inventory during fiscal year 2023, which is our only future purchase commitment with Grace. The Grace Manufacturing Agreement will expire on December 31, 2023, subject to further renewal of the agreement to be negotiated by the parties.
We believe that we have identified reliable sources and suppliers of ingredients, chemicals, phytochemicals and reference materials that will provide products in compliance with our guidelines.
Environmental Compliance
We incur various expenses in complying with Good Manufacturing Practices and safe handling and disposal of materials used in our research and manufacturing activities. For the years ended December 31, 2022 and 2021, these expenses totaled approximately $2.1 million and $1.7 million, respectively. We do not anticipate incurring significant additional expense in our compliance with federal, state and local environmental laws and regulations.
Backlog Orders
For our consumer products segment where we ship products internationally to distributors, we may have a backlog from time to time as the production of Tru Niagen® finished bottles require up to three months lead time by our third-party contract manufacturers. As of December 31, 2022 we did not have any significant backlog orders from the distributors that have not been shipped. For products that are directly shipped to consumers, we have minimal backlog orders as we carry sufficient inventory on hand to ship upon the receipt of order.
For our ingredients segment, we also have minimal backlog orders as we carry sufficient inventory on hand for most of the products we offer and we ship upon the receipt of customer’s order.
For our analytical reference standards and services segment, we normally have a small backlog of orders. These orders amount to approximately $20,000 or less. As we list over 1,750 phytochemicals and 400 botanical reference materials in our catalog, we may not always have the items in stock at the time of customers’ orders. These backlog orders are normally fulfilled within two to six weeks.
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Culture and Workforce
We are a company of curious, talented, and passionate people who are devoted to health, well-being, and improving the way people age. We embrace collaboration and creativity and encourage the iteration of ideas to address complex challenges in all aspects of our business.
We believe our people are critical for our success. We are dedicated to providing an environment where ChromaDex employees can have fulfilling careers, and be happy, healthy and productive. We offer attractive wage and benefit packages to take care of the needs of our employees and their families. Our competitive compensation and dynamic culture help us to attract and retain top candidates. We continue to invest in recruiting and rewarding talented people.
ChromaDex and its employees are dedicated to diversity, inclusion, and fairness. We celebrate personal authenticity and expression as a catalyst to advance human health and innovation. We support healthy, open dialogue and we communicate information about the company through multiple internal channels to our employees . As of December 31, 2022, ChromaDex had 113 full-time employees, none of whom are unionized. We believe relations with our employees are good.
Facilities
For information on our facilities, see “Properties” in Item 2 of this Form 10-K.
Available Information
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: 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. These reports, proxy and information statements and other information concerning our company may be accessed through the SEC's website at www.sec.gov .
You may also find on our website at www.chromadex.com , electronic copies of our 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. Such filings are placed on our website as soon as reasonably practicable after they are filed with the SEC. All such filings are available free of charge. We also make available, free of charge, on our website our Code of Business Conduct and Ethics, and the Charters of our Audit Committee, Nominating and Corporate Governance Committee, and Compensation Committee of our Board of Directors. Information found on, or accessible through, our website is not a part of, and is not incorporated into, this Annual Report on Form 10-K.
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