Presentation from a live webinar featuring Tim Gordon (Functional Remedies), Sarah Sayed (CV Sciences) and Steve Hoffman (Compass Natural). Webinar focusing on hemp data and market trends.

1. The State of CBD in the
Natural Products Industry
Live Webinar
October 10, 2017
Organizer: Sean Murphy
Panelists: Tim Gordon, Sarah Syed, Steve Hoffman
Farm Photo Credit

3. 1. CBD Market Overview – Data & Intel
2. Natural Products: Past, Present & Future
3. Vertical Integration & Product Quality
4. Marketing Best Practices
5. Q&A
Webinar Learning Topics

4. The CBD Webinar Series
1. The State of CBD in Natural Products | Today
2. CBD Regulatory and Legal Environment | December, 2017
3. 2018: Natural Product Industry Insights | March, 2018
4. Hemp-Derived CBD: Market Opportunities | April, 2018
5. Listeners’ Choice | To be scheduled

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

7. Hemp as an Agricultural Commodity
Seed Fiber Cannabidiol
Extract Isolate
De-hulled
Non-viable Whole
Viable Whole
Bast Hurd
Primary Secondary Lignin

8. CBD (Cannabinoids) Seed
55%
30%
15%
U.S. Cultivation By Type (2017 estimates)
Fiber

10. 5,922 7,500
State Acreage Growth Rates (2016/2017)
+27%
2,525 3,000
+18%
+2,262%
51 1,205
500 3,649 30 3,020
+629% +9,966%
225 200
-11%

11. U.S. Domestic
Production (2016)
143,880 Kilograms
U.S. Imported (2016)
24,726 Kilograms

12. Canada: Land of M&A

21. Labeling Trend: CBD vs. Hemp Extract, Oil & Complex

22. “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 has 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 estimates
Epidiolex will be re-
scheduled on the CSA as a
Schedule IV drug in October
or November 2018.
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, regulation or GW
litigation 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
interests are ‘in play’ across regulatory
agencies and markets.
Following the U.S.
submission, we expect
the E.U. drug filing to
following shortly
thereafter.
2018 2019
Epidiolex Commercialization Timeline
This timeline is based on Hemp Business Journal estimates, forecasts and public statements from GW
Pharmaceutical’s management (“”). It contains forward looking statements and is not investment advice.
®

23. As a new Managing Editor back in 1986 with the
Natural Foods Merchandiser, I was charged with
conducting, analyzing and reporting on the natural
products industry’s annual retail market overview
survey. I recall spending late evenings pouring over
data with New Hope Network founder Doug
Greene to determine overall sales, growth
categories and emerging trends. That was when the
industry was just breaking $5 billion in sales – a
fraction of what it is today.
Thirty years later, the natural and organic products
industry is maturing, reaching $141 billion in sales
on growth of 7.4% in 2016, according to the 2017
Market Overview, published in the July/August
2017 edition of Natural Foods Merchandiser (NFM)
in partnership with Nutrition Business Journal, with
additional data provided by SPINS and the Organic
Trade Association’s annual organic industry survey.
Steven Hoffman
Director

27. Tim Gordon
President

29. Research &
Genetics
Cultivatio
n
Processing Wholesale Retail Lifecycle & Reinvestment
Vertical Integration
Wholesale

33. Important Takeaways

34. Dates & Event to Watch – End of 2017 & 2018
1. Introduction of Senate Bill (and leadership support)
2. NDA for Epidiolex® and successive FDA actions
3. HIA, RMH, Centuria (Hoban Law) vs. DEA: Oral Arguments
4. Farm Bill 2018
5. Clarification on Statement of Principles

35. Upcoming Surveys
1. Hemp Cultivation
2. CBD Consumers: Product Use, Types, Dosing
3. Practitoners: What they’re recommending
Upcoming Market Reports
1. The CBD Report, Second Annual
2. The State of Hemp 2018

37. The CBD Report &
2017 Mid-Year Updates
Go to HempBizJournal.com and use coupon
code “webinar20” for 20% off.