The following is issued on behalf of ChromaDex:
Dear Fellow Shareholders:
In January 2016, I issued a shareholder letter wherein I
described in some detail my enthusiasm surrounding the enormous
commercial opportunity we have with our patented NIAGEN®
nicotinamide riboside (NR), a next-generation form of Vitamin B3
with what I believe has blockbuster potential in the emerging
category of NAD+ (nicotinamide adenine dinucleotide)
precursors.
What makes NR unique is its scientifically proven ability to
increase production of the co-enzyme, NAD+. As we age, NAD+ levels
decline. Such declines have been implicated in mitochondrial
dysfunction and poor cellular energy metabolism, whereas increases
in NAD+ levels are consistently being linked to improved
mitochondrial function. Recent publications have reported the
beneficial impact of NAD+ on conditions as far ranging as glaucoma
to chemotherapy-induced neuropathy. This ever growing
body of evidence demonstrating the importance of NAD+ is key to
keep in mind when considering the potential value
of NIAGEN®.
2016 saw continued growth in the number of published research
studies, as well as subsequent media attention regarding NR and
NAD+ and their importance in healthy aging. In fact,
since the launch of NIAGEN®, there have been more than 60 published
studies involving NR. During the same time, there were nearly
500 studies that have published referencing NAD+ and aging. To
support the education of the general public on these new, but
growing areas of interest, we are helping to develop and curate an
educational website, www.aboutnr.com, which is devoted entirely to
education on the topics of NR and NAD+. With the help of
many of the world’s foremost research authorities on these topics,
we believe this site will become the scientifically-validated,
information hub for NR and NAD+ education.
We believe NIAGEN® will eventually become part of an
important nutrient deficiency story similar to vitamin C, vitamin
D, folic acid, Co-Enzyme Q-10, and omega-3 fatty acids (DHA and
EPA). Ingredients that address nutrient deficiencies are
among the largest in the ingredient market, and are currently
estimated to have a value between $2 billion and $2.5 billion as
reported by Nutritional Business Journal.
These blockbuster vitamins and ingredients are commonly found in
many mainstream consumer products including food, beverage,
supplements, multi-vitamins, early-life nutrition, medical food,
skin care, sports nutrition, and even pharmaceutical products. We
believe NIAGEN® is on track to become the next blockbuster
ingredient, and as such, we expect it will eventually be
incorporated in all of these types of products.
Many blockbuster vitamins and ingredients that have a high level
of customer awareness also have a substantial number of published
research and clinical studies validating their safety and health
benefits. In fact, there is a strong correlation showing that
the higher the number of published studies on an ingredient, the
higher the amount of revenue the ingredient ultimately
generates.
Over the past three years, we have established over 100
collaborative agreements with leading universities and research
institutions to study the safety and efficacy of NIAGEN®. To
put this into perspective, a typical new ingredient is fortunate to
have five or six collaborative studies in the first three
years. I am not aware of any other vitamin or ingredient in
recent history that has been the subject of such tremendous
interest at the research level at such an early stage in its
lifecycle. Simply put, I believe this level of scientific interest
in NIAGEN® may be an enormous early validation of its blockbuster
potential. It is also important to note that ChromaDex is not
bearing the cost of these studies, which we estimate could surpass
$40 million. Moreover, we expect the number of collaborative
research studies for NIAGEN® will continue to increase.
The number of studies of NIAGEN® showing positive
effects are approaching an inflection point where peer-reviewed
published clinical data are likely to result in additional
commercial opportunities for NIAGEN®.
All indications point to 2017 being a pivotal year for ChromaDex
in both continued published research and business development
activity. We believe positive data from both human and animal
studies will deepen the validation of NIAGEN® safety, function,
applications and efficacy, and become a primary driver in
ChromaDex’s striking business development deals and substantial
revenue opportunities with large consumer product
companies.
There are currently twelve human clinical studies on
nicotinamide riboside (NR) that are in various phases that can be
found on clinicaltrials.gov.
While NIAGEN® is used in all of these studies, two are
fully sponsored by ChromaDex:
- Results from ChromaDex’s (KGK Synergize) first completed human
clinical trial of NIAGEN® along with an
animal study component, were published in Nature Communications in
October 2016. The studies confirmed that NIAGEN® is safe and
can significantly elevate NAD+ more efficiently than other forms of
Vitamin B3.
- ChromaDex’s (KGK Synergize) second study is a
140 participant trial that will evaluate the effect of repeated
doses of NIAGEN® on NAD+ metabolite concentrations in blood, urine
and muscle in healthy adults. This study will evaluate the impacts
of 3 dose levels of NIAGEN® compared to a placebo. One quarter of
subjects will receive the low dose of NIAGEN® (100 mg), one quarter
will receive the moderate dose of NIAGEN® (300 mg), one quarter
will receive the higher dose of NIAGEN® (1000 mg) and one quarter
will receive the placebo. The recruitment and dosing portions of
the trial are currently in the final stages as the last participant
is currently on study.
Four studies have been completed and are awaiting
publication:
- University of Washington - to assess the
pharmacokinetics (PK) of NR at a maximum dose of 1,000 mg as well
as the safety and tolerability of NR. Also to determine if NR
significantly raises NAD levels.
- University of Colorado, Boulder - to assess
the efficacy of supplementation with the NAD+ precursor compound,
NR, for improving physiological function (vascular, motor, and
cognitive) in healthy middle-aged and older adults.
- Aarhus University Hospital/University of
Copenhagen - to assess the pharmacokinetics (PK) of
NR.
- Elysium Health/KGK Synergize - to assess the
safety, tolerability and potential health benefits of the dietary
supplement, Basis. There will be two doses of Basis compared to a
placebo. One third of subjects will receive the low dose Basis, one
third will receive the higher dose Basis and one third will receive
placebo.
Five studies are in the recruiting process:
- Mayo Clinic / Thorne Research - to asses if NR
(750 mg/day for 12 weeks) affects the levels of NAD+ in the brain
as measured by 31P MRS in collegiate football linemen.
- Maastricht University Medical Center
Netherlands - to assess the effects of 6 week NR
supplementation (1000 mg/day) on metabolic health in healthy
(pre)obese humans. The primary objective will be hepatic and whole
body insulin sensitivity. Secondary objectives, to provide
information about the underlying mechanism, will be muscle
mitochondrial function, brown fat activity, ectopic lipid
accumulation, energy metabolism, cardiovascular risk parameters,
body composition and acetylcarnitine levels.
- NIH-NHLBI - to assess if taking NR will have
the same healthy immune system effects as fasting. To further
assess if these good effects continue even after resumed
eating.
- University of Birmingham (UK) - to assess the
physiological consequences of elevating NAD+ availability using NR
supplementation in skeletal muscle tissue, and examine its effect
upon muscle metabolic phenotype.
- Aarhus University Hospital/University of
Copenhagen - to assess the effect of NIAGEN® NR on
substrate metabolism, insulin sensitivity, and body composition in
obese men.
One study is in the development stage and has yet to
beginning recruiting subjects:
- University of Texas San Antonio – to assess
the effects of NR on NAD levels and brain function, including
cognition and blood flow in people diagnosed with mild cognitive
impairment (MCI).
It should be noted that these last 10 studies each have
a varying degree of ChromaDex involvement and we will not be in
full control of recruiting, executing, reporting and publication of
the study data.
ChromaDex is one step closer to the Pharmaceutical
opportunity of NIAGEN®.
In addition to an abundance of markets in
consumer product applications for NIAGEN®, there may also be
significant opportunity in pharmaceutical applications. Numerous
pre-clinical studies have been published by distinguished
researchers which speak to the potential of NR as a therapy for a
various age-related diseases such as cancer, neuro-degenerative
diseases, mitochondrial dysfunction, obesity, and cardio vascular
disease.
We have been working closely with the NIH
under a collaborative agreement on a therapeutic indication
for NR as a treatment of a rare pediatric orphan
disease, Cockayne Syndrome. We completed a pre-IND
meeting with the U.S. Food and Drug Administration (FDA) last
November and we expect to file an IND application with
the FDA in 2017.
Yesterday, we announced that University of Iowa researchers have
published an animal study on NR in the prestigious Journal of the
International Association for the Study of Pain (PAIN) revealing NR
as an effective tool in relieving chemotherapy induced peripheral
neuropathy (CIPN) pre-, during, and post-treatment with a common
anticancer agent – paclitaxel. As the American Society of
Clinical Oncology has issued a position paper that there is an
unmet need for treatments that can alleviate CIPN, I believe this
has potential to be a very significant business opportunity for
NIAGEN®.
Revenue growth is always important, but our focus is on
the significant untapped markets for NIAGEN®.
We completed 2016 with momentum, recently announcing preliminary
revenue in Q4 2016 of approximately $5.6 million, an increase of
approximately 29% as compared to $4.4 million in Q4 2015.
Importantly, no single customer accounted for more than 11%
of total expected revenue in Q4 2016.
Full-year 2016 revenue is expected to be approximately $26.8
million, an increase of approximately 22% as compared to $22
million for full-year 2015.
While we have experienced significant revenue
growth, I want to stress that we are in the early stage of
commercial development for NIAGEN®. As we anticipated, thus
far we have only penetrated the early-adopting product companies
strictly within the dietary supplement market. While pre-clinical
[animal] studies, such as the ones mentioned above, may drive media
attention and build consumer awareness, I believe peer-reviewed
published human studies will be the key for a natural transition of
our customer base from the early adopters to large mainstream
consumer product companies. This transition has played out
many times before with other well-known blockbuster vitamins and
ingredients.
We have been actively engaged with numerous large multi-national
consumer product companies with respect to commercial opportunities
for NIAGEN® being included and featured in a number of branded
consumer products within extremely large product categories.
Following the playbook of other well-known blockbuster vitamins
and ingredients, we are progressing through the safety, clinical
and regulatory hurdles that would allow NIAGEN® to be included in
consumer products within the following segments:
- Dietary Supplements (Complete)
- Sports Nutrition (Complete)
- Functional Food & Beverage
- Medical Food
- Early-Life Nutrition
- Skincare and
Cosmetics
- Pharmaceuticals
Additionally, as studies generate more published human data, we
are developing regulatory dossiers for NR registration in key
international markets. We are in varying stages of the respective
registration processes in Canada, Australia and the EU.
I will end this letter with the same conclusion I reached in the
January 2016 shareholder letter:
I am convinced more than ever that ChromaDex has an
extraordinary opportunity to create substantial shareholder value
with our patented NIAGEN® nicotinamide riboside. I
believe a new vitamin or ingredient of this magnitude is the type
of opportunity that does not come along very often. All of
the important pieces of the puzzle are systematically falling into
place, creating a perfect storm that may allow NIAGEN® to
become the next blockbuster ingredient.
On behalf of ChromaDex's management, Board of
Directors, and employees, I want to personally thank you for your
continued support.
Sincerely,
Frank Jaksch Founder & CEO
Forward-Looking Statements: This letter
contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as
amended, including statements related to future commercial
opportunities for NIAGEN®, whether www.aboutnr.com will become the
scientifically-validated, information hub for NR and NAD+
education, the ability of NR to increase production of NAD+,
whether NIAGEN® will become the next blockbuster ingredient,
whether the number of collaborative research studies for NIAGEN®
will increase, the timing and results of future studies, whether
positive data from clinical studies will result in business
development deals and revenue opportunities, the potential for
NIAGEN® to be used in pharmaceutical applications, the timing and
results of future regulatory filings in the U.S. and other
countries, unaudited financial results, whether human studies will
grow the customer base to include large mainstream consumer product
companies, and whether NIAGEN® will be included in consumer
products in certain consumer segments. 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. More detailed information
about ChromaDex and the risk factors 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 January 2, 2016, 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 letter to reflect events or circumstances after the
date hereof.
ChromaDex Public Relations Contact:
Breah Ostendorf, Director of Marketing
949-537-4103
breaho@chromadex.com
ChromaDex Investor Relations Contact:
Andrew Johnson, Director of Investor Relations
949-419-0288
andrewj@chromadex.com
ChromaDex (NASDAQ:CDXC)
Historical Stock Chart
From Mar 2024 to Apr 2024
ChromaDex (NASDAQ:CDXC)
Historical Stock Chart
From Apr 2023 to Apr 2024