Sean Octavius Murphy Colleen Keahey
The State of CBD in Dietary Supplements
Business
Opportunities
& Market Trends

U.S. Retail Hemp Industry (5 Year CAGR)
22% Growth
U.S. Hemp Industry (2020)
$1.8B
Hemp-Derived CBD Industry (2016)
$130M

U.S. Hemp Cultivation By Type
55%
30%
15%
Seed
Fiber
Cannabidiol

Hemp as an Ag Commodity
CBD as an Ingredient
Seed Fiber Cannabidiol
Extract Isolate
De-hulled
Non-viable Whole
Viable Whole
Bast Hurd
Primary Secondary Lignin

CBD Production & Price Indexing
U.S. Domestic Production (2016)
143,880 Kilograms
U.S. Imported (2016)
24,726 Kilograms

Processing and Pricing

Trend #1: Canada Coming Online for Hemp CBD
M&A Activity

Trend #2: Wholesale Exports to Central & South America

Trend #3: Labeling CBD vs. Hemp Extract, Oil and Complex

Total U.S. CBD Sales

Trend #4: Dietary Supplement vs. Big Pharma
2016 Total U.S. CBD Sales
(hemp and marijuana combined)
2016 End of Year Cash
(GW Pharmaceutical's Balance Sheet)
$262mm
$483mm

Epidiolex Timeline
“By the end of November” is the
expected submission of the NDA.
The New Drug Application is the
vehicle in the U.S. which drug
sponsors formally propose that the
FDA approve a new pharmaceutical
for sale and marketing.
End of Year, 2017:
The FDA has 60 days to
review the NDA and accept
or reject it. The Epidiolex
NDA is “robust and well-
written.” HBJ anticipates it
will be accepted.
The Prescription Drug User Action
(PDUFA) outlines the timeline and
protocol by which drug companies
submit fees and the FDA approves
drug applications. PDUFA is typically a
one year timeline unless the drug is
“fast tracked,” and then it’s 6 months.
Epidiolex will likely be fast tracked.
GW management stated a June, 2018
PDUFA date.
Upon the FDA’s approval
under PDUFA, the DEA has
up to 90 days to reschedule
a drug. HBJ anticipates
Epidiolex will be re-schedules
on the CSA as a Schedule IV
drug in October or
November 2018.
The Greenwhich
Biosciences sales
team will take
Epidiolex to market.
HBJ estimates an
initial wave of pent
up demand at the
end of 2018. Sales
may not begin until
early 2019.
End of 2018 or
beginning of 2019.
The hemp industry
should watch for
increased FDA action
or regulation to
enforce CBD as a
drug given Epidiolex
commercialization.
Epidiolex sales ramp-up.
Continued
regulatory clashes
between FDA, DEA
and cannabis
companies (hemp
and marijuana)
concerning
labeling, marketing
and scheduling.
Note: If the DEA reschedules (to Schedule
II) or de-schedules marijuana from the
Controlled Substances Act, it will have an
impact on this timeline. HBJ estimates no
such scheduling action will occur – until at
the earliest - Epidiolex becomes a
scheduled drug and pharmaceutical
financial interests are ‘in play’ across
regulatory agencies and financial markets.
Following the U.S.
submission, we expect
the E.U. drug filing to
following shortly
thereafter.
2018 2019

• Mission & Purpose of HIA
• What’s Happening in the CBD Market
• Major Players in the CBD Market

The Big Three – Statement of Principles

Why the HIA Sued the DEA (again)
RMH Holdings
Centuria Natural Foods

HIA Member Survey and DEA Concerns

H.R. 3530 and Business Opportunities

Become a
Member
at TheHIA.org
The CBD Report and 2017 Mid-Year Update - $399
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