Sean Octavius Murphy
The Certified Business of Disruption (CBD)
Founder and Publisher
A Division of

Sometime a little
before 1994…

That’s it — we’re going
to the Naturopath!
• Family of MDs on Father’s side
• I was chronically sick: Strep
Infections, Respiratory Failure,
Pills Pills Pills
• Momma knows best!

Linda Kantor, ND, MH

1994

DSHEA

U.S. Retail Hemp Industry (5 Year CAGR)
22% Growth
U.S. Hemp Industry (2020)
$1.8B
Hemp-Derived CBD Industry (2017)
$175

disruption
Business. a radical change in an industry or business
strategy, especially involving the introduction of a
new product or service that creates a new market.

an issuing forth suddenly; outburst;
eruption

February 7, 2014

Sec. 7606, Farm Bill Amendment

9,700
3,469
3,020
3,100

0
20,000
40,000
60,000
80,000
100,000
120,000
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Global Hemp Acreage Comparison
EU Canada US
Source: US state agencies for cultivated acres, nova-Institute and EIHA for EU cultivation. Health Canada for Canadian licensed acreage (acres). 2017 unconfirmed estimates for EU and Canada

Hemp as an Ag Commodity
CBD as an “Ingredient”
Seed Fiber Cannabidiol
Extracts Isolates
De-hulled
Non-viable Whole
Viable Whole
Bast Hurd
Primary Secondary Lignin

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

Thank You

Natural & Specialty Channel
Tracked Sales Leaders

Total CBD Sales Leaders
Hemp-Derived & Marijuana-Derived

Three CBD Market
Disruptions to Watch

#1. Canada CBD
Market Coming
Online
M&A Activity
Inverell

BIG Alcohol
#2. The “BIGS” are Moving In
Criticalit
y
BIG Tobacco
BIG Pharma

#3. Exports Slowing to Central & South America:
Countries Establishing Domestic Markets

Five NPI Retail
Disruptions to Watch

“We’re not afraid to be
disruptive and pave the path
and be pioneers.”
Sandy Wise, Lucky’s Directory of Apothecary
#1. Opportunity Arrives in Large NPI Retailors

#2. BIG Hemp Joins the Dance
#3 Distribution Kicking into Gear
58 SKUs (1 Pet)

#4. Pet/Animal Market Breaks Out

#5. Synergistic Blending

Innovative? Inefficient?

Organic – Not really happening… yet.
2017
3%
2016
5%
Natural and Specialty Channel
5%
$320,000$124,000

Support H.R. 3530 !

Things to Watch – 2018 & early 2019
1. Introduction of Senate Bill: Leadership Support
2. Epidiolex® Go to Market: FDA/GW actions
3. HIA (Hoban Law) vs. DEA: Response By the Court
4. Farm Bill 2018: Sec. 7606 Update/Amendment?
5. Clarification on Statement of Principles: TBD

Keep an eye on “The Big Four”

Stated Position + Notice + More Warning Letters =
Moving ducks in a row to regulate CBD as a drug
Statement of Principles + Not stepping out of regulatory line =
Will follow FDA and DEA on CBD

New Drug Code (7350) for Marijuana Extract

Seizures, Apologies, Schedule IV’ing… oh my!

Epidiolex Timeline
The New Drug
Application (NDA) submitted
End of December, 2017:
The FDA accepts the
Epidiolex NDA
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 was fast tracked.
June 27, 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-
scheduled on the CSA as a
Schedule IV drug in
September or October 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.
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.
Application Submitted
and Accepted for
Review by the
European Medicines
Authority (EMA)
2018
2019
Management anticipates
approval decision in the
first quarter of 2019

2017 Total
U.S. CBD Sales
(hemp and marijuana)
2018 End of Q1
Cash Balance
$367mm $560mm

$52,600,000,000

• “Current information does not justify scheduling CBD”
• “CBD could have therapeutic value for seizures due to
epilepsy and related conditions”
• Postponed full review of CBD until May 2018

• Oversees World Anti-Doping Code: Used by 600+
sports organizations including International Olympic
Committee and the U.S. Anti-Doping Agency.
• “Cannabidiol is no longer prohibited”
• THC remains banned

Researchers bought 84 CBD products
online and had them tested in Colorado labs.
• 43% contained more CBD than the label claimed.
• 26% contained less CBD than promised.
• 31% were within 10 percentage points of the promise.

Labeling: “CBD” vs. Hemp Extract, Oil and Complex

Chuck “DESHEA” Norris

Hemp-
Derived CBD
Consumer
Education!

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