The following is issued on behalf of ChromaDex (NASDAQ: CDXC).
Dear Fellow Shareholders:
I want to take this opportunity to provide an update on ChromaDex’s intellectual property portfolio, as well as perspective on why our business is not impacted by a recent court decision related to one of the Dartmouth patents slated to expire in 2026.
Last week we learned that the U.S. Court of Appeals for the Federal Circuit affirmed a prior invalidity decision regarding the 807 Dartmouth patent.1
We believe this decision has no material impact on ChromaDex’s nicotinamide riboside (“NR”) business. In anticipation of the expiration of the Dartmouth patents, we were able to obtain a series of new, critical patents last year, which, in combination with existing IP and patents from W.R. Grace, who supplies NR to ChromaDex exclusively, we expect to protect NR for at least the next 10 years. Two of ChromaDex’s recently granted patents protect methods of making NR and various salt forms. A third recently granted patent covers a crystal form of NR methanolate chloride (“NRMCl”), while a previously granted patent in 2018, covers a crystal form of NR triacetate chloride (“NRT”). NRMCl and NRTare important intermediates in the production of the final ingredient NR Chloride (“NRCl”). In addition, W.R. Grace has two crystal forms patented for NRCl and supplies NR exclusively to ChromaDex. W.R. Grace has sued Elysium Health for infringement and is rigorously defending its crystal morphology patents globally. Collectively, these patents provide strong protection for NR. To our knowledge, no other company can produce NR, including NRCl and other salt forms of NR, at a commercial scale, without violating one or more of these patents.
The debate around the wording of the patent that we license from Dartmouth will no doubt continue. As a company that invests in R&D and intellectual property, we are concerned about the precedent this decision on the Dartmouth patent could have for patents on all isolated molecules that exist in nature but impart characteristics and uses that are not present in nature. Regardless of the final outcome, there is strong protection for NR.
But the protective moat that surrounds the Chromadex Niagen® business is not solely based on intellectual property. It is also based on a brand, a strong, global brand, today one of the most respected and trusted in the industry: Tru Niagen®.
We believe the best way to build a trusted brand is to be a trustworthy company. At Chromadex, we do the science. We do the work. We take the product ourselves. And we treat our consumers, our partners, and the regulatory bodies with respect. As a result, Tru Niagen® has attracted a strong consumer base that is educated, informed and loyal. One study indicates that our consumers are 48% more likely to have a graduate degree. And, most importantly, robust science, including 24 peer reviewed, published clinical studies demonstrate that Tru Niagen® is safe, and Tru Niagen® works. We proudly have partnered with some of the finest, most respected companies in the world and our employees and scientific advisors are among the most respected and accomplished in the field. The supplements field has a reputation for prioritizing hype over truth. Scientific rigor and ground-breaking research are in our DNA. We will continue to lead by example and work to hold the industry to the same standard.
In the coming months, we hope to announce some exciting innovations that have been years in the making. Please stay tuned. In the meantime, I thank you for your time, your attention, and your continued support.
One last thing, for sake of your health and the health of those you care about, if you are not already doing so, please take Tru Niagen®.
Looking forward to connecting at earnings.
ChromaDex Corp. is a global bioscience company dedicated to healthy aging. The ChromaDex team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), levels of which decline with age. ChromaDex is the innovator behind NAD+ precursor nicotinamide riboside (NR), commercialized as the flagship ingredient Niagen®. Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio. ChromaDex maintains a website at www.chromadex.com to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company.
This letter to stockholders contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to (i) the lack of any material impact on the Company resulting from the court’s decision; (ii) the inability of other companies producing NR without violating Company patents; and (iii) that NR is protected from an IP perspective for at least 10 years. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends," "estimates," "plans," "potential," "possible," "probable," "believes," "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions. Risks that contribute to the uncertain nature of these forward-looking statements include (a) the potential for adverse publicity arising from the court’s decision, which could adversely impact the price of our stock and/or the perception of our products, (b) the need to rely on other patents to protect NR, which other patents may also be subject to challenge and which, because they have not yet been subjected to litigation, could have vulnerabilities of which we are not aware and (c) the inherent risks of relying on patents for IP protection, including risks of invalidity or other legal infirmities, potential for parties to work around patents and the very high expense of enforcement, which can be particularly challenging for a smaller company like ChromaDex. . More detailed information about ChromaDex and the risk factors (in particular, those related to our intellectual property and patents) that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
1 ChromaDex exclusively licenses two patents from Dartmouth – the 086 and 807 patents. In December 2022, an appeal on the ‘086 in an Inter Partes Review (“IPR” proceeding) was withdrawn to focus on the ‘807 patent, which was previously upheld by the Patent Trade Appeals Board (“PTAB”). Given this, the U.S. Court of Appeals for the Federal Circuit dismissed the ‘086 appeal.
Source: ChromaDex Corporation
View source version on businesswire.com: https://www.businesswire.com/news/home/20230221005434/en/
ChromaDex Media Contact:
Kendall Knysch, Director of Media Relations
310-388-6706 ext. 689
ChromaDex Investor Relations Contact:
Tom Shumaker, LifeSci Advisors, Managing Director