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© 2020 GW Pharmaceuticals all rights reserved. NASDAQ: GWPH GW Pharmaceuticals Investor Presentation May 2020

GW Pharmaceuticals Investor Presentation

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Page 1: GW Pharmaceuticals Investor Presentation

© 2020 GW Pharmaceuticals all rights reserved.

NASDAQ: GWPH

GW Pharmaceuticals Investor Presentation

May 2020

Page 2: GW Pharmaceuticals Investor Presentation

Forward-Looking Statements

This presentation contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information about our current expectations for future events, including potential results of operations, the timing of clinical trials, the timing of regulatory filings and approvals, the timing and outcomes of regulatory or intellectual property decisions, demand for our commercially available products and products in development and the clinical benefits, safety profile and commercial potential and potential pricing of Sativex®, Epidiolex®, and any product candidates. These forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, including those associated with COVID-19 pandemic, and other factors that could cause our actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. You should read our most recent filings with the Securities and Exchange Commission including our Transition Report on Form 10-K and our Quarterly Reports on Form 10-Q, including the Risk Factors set forth therein and the exhibits thereto, and our subsequent filings with the Securities and Exchange Commission, completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

May 2020 GW Pharmaceuticals Investor Presentation 2

Page 3: GW Pharmaceuticals Investor Presentation

2019/2020 Key Achievements

May 2020 3GW Pharmaceuticals Investor Presentation

Epidiolex manufacturing and supply chain

running smoothly

Highly successful Epidiolex® launch

2019 total revenue of $296 million

Epidiolex Phase 3 study in Rett syndrome

commenced

EU approval of Epidyolex® and initial

commercial launches

Positive Epidiolex Phase 3 data for

seizures in TSC

FDA/EMA TSC submissions completed in

2020 (accepted for Priority Review by FDA

with July 31 PDUFA date)

Epidiolex exclusivity strengthened through

9 Orange Book-listed patents

Nabiximols US pivotal clinical plan

developed and ready to commence

in H2 2020

Advanced programs in schizophrenia,

autism and NHIE

✓ ✓

Page 4: GW Pharmaceuticals Investor Presentation

GW Leadership

20+ Years Expertise | Proven Track Record

CLINICAL COMMERCIALIZATION

REGULATORYMANUFACTURING PIPELINE

PEOPLE

Page 5: GW Pharmaceuticals Investor Presentation

Epidiolex® (cannabidiol) Oral Solution

• First FDA-approved plant-derived cannabinoid

• Launched in the US on November 1, 2018

• New mechanism of action in epilepsy

• Positive data from five consecutive Phase 3 RCTs

• Indicated to treat seizures associated with LGS or Dravet syndrome in patients 2 years of age and older

• Descheduled by DEA

• TSC sNDA filing accepted for Priority Review

We received a call from a mother/caregiver requesting — through tears —

that we give a BIG Thank You to all involved with the Epidiolex® Program!

“This is the most hope I’ve had

for my daughter in years!”

Page 6: GW Pharmaceuticals Investor Presentation

FDA Approves First Medicine Derived From Cannabis Plant

May 2020 GW Pharmaceuticals Investor Presentation 6

THE 50 GENIUS

COMPANIES OF 2018

In a historic first, the FDA approved the

first-ever drug containing an active

ingredient derived naturally from cannabis.

For the first time, FDA has approved a drug

derived from the marijuana plant. The

unprecedented move is designed to help

patients with a rare form of epilepsy.

The approval marks the first time patients

will have access in the U.S. to a cannabis-

derived drug that has undergone a

safety and efficacy review by the FDA.

Page 7: GW Pharmaceuticals Investor Presentation

A Strong Launch for

May 2020 7GW Pharmaceuticals Investor Presentation

• Total Q1 2020 net product sales of $116.1M

• Full-year 2019 net product sales of approximately $296.4M

• Clinical performance strong and consistent with trials

• High level of awareness and intent to prescribe

• Payer coverage

• Early coverage set foundation for strong launch

• Coverage has evolved during the year in a favorable way

Page 8: GW Pharmaceuticals Investor Presentation

GW Net Sales Revenue Growth

May 2020 8GW Pharmaceuticals Investor Presentation

0

20

40

60

80

100

120

140

Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020

$6.7 M

$39.2 M

$72.0 M

$91.0 M

$109.1 M

(Mill

ion

s)

$120.6 M

Page 9: GW Pharmaceuticals Investor Presentation

Epidiolex 2020: The Next Phase in Building a Blockbuster

May 2020 GW Pharmaceuticals Investor Presentation 9

Build on

positive

physician

experiences

to increase

prescribing to

appropriate

patients

Accelerate

adoption

across a

broader

prescriber

base

Continue

partnerships

with payers to

expand

access

Continue to

minimize

logistical

barriers to

Epidiolex

Enter long-

term care

segment

Execute on

the TSC label

expansion

Further

indication

development

Page 10: GW Pharmaceuticals Investor Presentation

Evolution of Y1 Coverage Exceeded Our Goal

May 2020 10

0

10

20

30

40

50

60

70

80

90

100

Launch 1/1/2019 6/1/2019 12/1/2019

Epidiolex Access

Open Access PA to Indication Restrictive PA Non-Formulary

97% of All US Insured Patients Have Epidiolex Coverage for LGS and Dravet Syndrome

GW Pharmaceuticals Investor Presentation

Page 11: GW Pharmaceuticals Investor Presentation

Express Scripts (ESI) Coverage of Epidiolex

• ESI is one of the two largest PBMs in the US

• Coverage was decided soon after the launch

• Epidiolex is a Preferred brand with lowest brand

copay

• Recent re-alignment of PBM clients creates

opportunities for 2020

• Model for other payers’ evolution in 2020+

May 2020 11GW Pharmaceuticals Investor Presentation

Page 12: GW Pharmaceuticals Investor Presentation

2020 Payer Focus

May 2020 GW Pharmaceuticals Investor Presentation 12

• Sharing real-world utilization trends and breadth of published evidence

• Identifying unmet medical needs in epilepsy

• Communicating clinical efficacy and safety

• Highlighting the hidden cost of therapy interruption

• Evaluating the cost of “managing” Epidiolex

• Studying the economic outcomes of controlled epilepsy

PAYER NEWSLETTER

LAUNCHED JANUARY 2020

Page 13: GW Pharmaceuticals Investor Presentation

EU Launch Update: Epidyolex® (cannabidiol)

• Approved in September 2019

• First wave of launches in 5 major markets

• German commercial launch in Q4 2019

• Secured positive NICE recommendation in the UK with commercial launch in Q1 2020

• Commercial launches in France, Spain and Italy expected later this year, following pricing and reimbursement

• Early Access Program included >1,100 patients and >400 physicians from 250 top epilepsy centers across 5 major markets

• Plans in place for progression of pricing and reimbursement in second wave of 10 EU markets

May 2020 13GW Pharmaceuticals Investor Presentation

Page 14: GW Pharmaceuticals Investor Presentation

Epidiolex in TSC: Effective and Well-Tolerated

• Safety profile observed consistent with previous studies, no new safety risks identified

• Lower incidence of known adverse events and laboratory changes in the 25 mg/kg/day group compared with 50 mg/kg/day

• Label expansion discussions with the FDA to focus on 25 mg/kg dose, close to the dose range in the US prescribing information

May 2020 GW Pharmaceuticals Investor Presentation 14

49 48

27

5250

32

Source: American Epilepsy Society Annual Meeting 2019 poster: Cannabidiol (CBD) Treatment in Patients with Seizures

Associated with Tuberous Sclerosis Complex: A Randomized, Double blind, Placebo Controlled Phase 3 Trial (GWPCARE6);

Thele et al

Page 15: GW Pharmaceuticals Investor Presentation

High Unmet Need in Patients Living With TSC

“Some of the most challenging and frustrating aspects of tuberous sclerosis complex (TSC) are seizures that cannot be effectively controlled by existing medications. Having a new safe and effective treatment option such as Epidiolex is desperately needed.”

Kari Luther RosbeckPresident and CEO

May 2020 GW Pharmaceuticals Investor Presentation 15

• sNDA submission accepted with Priority Review, July 31 PDUFA

• EMA submission accepted for review

• Epilepsy is present in >90% of patients with TSC

• TSC affects 40-50K in the US and 1-2M worldwide

• >60% of individuals with seizures associated with TSC do not achieve seizure control with standard treatments

• Leading cause of genetic epilepsy, often occurring in first year of life as focal seizures or infantile spasms

Source: Tuberous Sclerosis Alliance; Child Neurology Foundation; Infantile Spasms Project

Page 16: GW Pharmaceuticals Investor Presentation

Significant Unmet Need in Treatment Resistant Epilepsy

May 2020 GW Pharmaceuticals Investor Presentation 16

~30-50KLennox-Gastaut

syndrome

~40-50KTuberous sclerosis

complex

~160KTreatment-resistant pediatric

epilepsy patients

~1MTreatment

resistant epilepsy

seizures persisting

despite multiple

anti-epileptic drugs

(AEDs)

~15-20KDravet

syndrome

Camfield CS, et al. Epilepsia. 1996;37(1):19-23; US Department of Commerce. https://www.census.gov/prod/3/98pubs/p23-194.pdf. 1997. Accessed May 29, 2018.; Camfield P,

Camfield C. Epilepsia. 2007;48(6):1128-1132.; Berg AT, et al. Epilepsia. 2000;41(10):1269-1275.; Wu YW, et al. Pediatrics. 2015;136(5):e1310-e1315.; Centers for Disease

Control. https://www.cdc.gov/mmwr/volumes/66/wr/mm6631a1.htm. 2017. Accessed April 19, 2018.; Kwan P, Brodie MJ. N Engl J Med. 2000;342:314-319; Sander JW,

Epilepsia. 1993;34(6):1007; Picot et al, 2008 ; Kwan P, Brodie MJ. N Engl J Med. 2000;342:314-319; Kwan P, Brodie MJ, CNS Spectr. 2004;9(2):110

Approved to treat the seizures

associated with LGS and

Dravet syndrome

Page 17: GW Pharmaceuticals Investor Presentation

Epidiolex® Patent Portfolio to 2035 Aligns with Indication

9 Orange Book-listed patents to date plus formulation, TSC, and use patents in prosecution plus additional applications planned

May 2020 GW Pharmaceuticals Investor Presentation 17

FDA-approved to treat seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome in patients 2 years of age and older

US9956186

Treatment of

convulsive

seizures in LGSwith at least

10mg/kg/day of CBD

EXP

2035

US10137095

Treatment of

drop seizures in

LGS with about

20mg/kg/day of CBD

EXP

2035

US9956184

Treatment of

seizures in LGS with about at least

10mg/kg/day of CBD

and clobazam

EXP

2035

US15/183947

Treatment of

focal seizures in

Dravet syndrome with 15-20mg/kg/ day

of CBD

Awaiting Grant

EXP

TDB

US10111840

Treatment of

atonic seizures in

Dravet syndrome

LGS with about

20mg/kg/day of CBD

EXP

2035

US10195159

Formulation of

cannabinoid-rich

extract

EXP

2020

US9956185

Treatment of

convulsive

seizures in Dravet

syndrome with at

least 10mg/kg/day of

CBD

EXP

2035

US9956183

Treatment of

seizures in

Dravet syndrome

or LGS with

clobazam or CBD in

a patient previously

treated with

clobazam

EXP

2035

US10092525

Treatment of

drop seizures in

Dravet syndrome with about

20mg/kg/day of CBD

EXP

2035

PCT/GB2019/051173

Epidiolex

composition patent

application

EXP

2039

US9949937

Treatment of

seizures in

Dravet syndrome with about at least

10mg/kg/day of CBD

and clobazam

EXP

2035

US10603288

Epidiolex treatment

of seizures in LGS

w/CBD at

5mg/kg/day

increasing in

increments of 2 to

5mg/kg/day.

EXP

2035

Page 18: GW Pharmaceuticals Investor Presentation

Nabiximols (known as Sativex® ex-US)

Page 19: GW Pharmaceuticals Investor Presentation

Nabiximols: GW’s Next US Commercial Opportunity

Overlay of 24 Nabiximols Chromatograms: Standardized “Full Spectrum” Composition

May 2020 19

• Nabiximols US Adopted Name (USAN)

• A complex botanical medicine formulated from extracts of the cannabis sativa plant that contains the principal cannabinoids THC and CBD and also contains minor constituents including related cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides

• Strong exclusivity due to complex botanical formulation

• Near-term, reduced risk opportunity

• Approved in >25 countries outside the US as Sativex® for the treatment of spasticity due to multiple sclerosis (MS); sold via marketing partners

• US commercial rights owned by GW

GW Pharmaceuticals Investor Presentation

Page 20: GW Pharmaceuticals Investor Presentation

Nabiximols: Demonstrated Efficacy in MS SpasticitySupplementary Clinical Program for FDA Commencing in 2020

Efficacy demonstrated in 3 positive pivotal 3 trials conducted in Europe

May 2020 GW Pharmaceuticals Investor Presentation 20

GWMS0106

(n=189)

GWSP0604

(n=241)

SAVANT

(n=106)

Numerical Rating Scale - Spasticity (NRS) mean change from baseline

Difference vs Placebo

(95% CI)-0.52 (-1.029, -0.004) -0.84 (-1.29, -0.40) -1.90 (-2.73, -1.06)

P-value 0.048 0.0002 <0.0001

Collin, et al. Eur J Neurol 2007; 14: 290-96 Novotna, et al. Eur J Neurol 2011; 18(9): 1122-31 Markovà, et al. Int J Neursci 2019; 129(2):119-128

FDA meetings held to agree clinical and CMC requirements

• Phase 3 trial protocol finalized

• Trial to commence H2 2020

• 450 patients; Sites in US and Europe

• Two 30 patient “mechanistic” studies

• To commence H2 2020

• CMC data in place

Page 21: GW Pharmaceuticals Investor Presentation

Nabiximols US Market Opportunity in MS Spasticity

May 2020 GW Pharmaceuticals Investor Presentation 21

• Spasticity occurs in up to 84% of MS patients

• Despite current treatment, 1/3 live with uncontrolled spasticity

• No new oral anti-spasticity medicines approved in over 20 years;

MS disease modifying treatments do not relieve MS symptoms

• Spasticity significantly impacts daily function — reduced mobility

and inability to perform daily tasks, including walking and driving

• 26–50% of MS patients are self-medicating with cannabis

Nabiximols Opportunity

• Strong physician and patient enthusiasm for product use

• 90% of physicians and patients highly to moderately interested

• US market potential estimated to be >$400 million

Sources: 2014 NARCOMS survey, Rizzo et al. Mult Scler 2004, Rizzo et al. Mult Scler 2004

Page 22: GW Pharmaceuticals Investor Presentation

Significant Lifecycle Opportunities for Nabiximols

May 2020 22GW Pharmaceuticals Investor Presentation

Second target indication: Spasticity associated with Spinal Cord Injury (SCI)• Approx. 250K chronic SCI patients (~65%) suffer from spasticity

• Likely single pivotal trial required

• Sales potential >$400M

Further opportunities to address broader spasticity population• Spasticity occurs in >3M U.S. patients including spinal cord injury, post-stroke, ALS, traumatic brain

injury, cerebral palsy

Additional target indication: Post Traumatic Stress Disorder (PTSD)• PTSD is an anxiety disorder impacting ~11.7M people with ~55% diagnosed

• Approx. 65% of PTSD patients are treated with pharmacotherapy

• Approx. 75% of patients on pharmacotherapy continue to experience sleep disturbance symptoms

• Anxiety is one of the top 3 reasons for self-medication with cannabis

• Early evidence for both THC and CBD in the treatment of PTSD

• Nabiximols offers potential to reduce sleep disturbance symptoms, as well as anxiety and irritability

Sources: DiPiro. Spinal Cord. 2018; McGuire. Spasticity: Diagnosis and Management, 2011; Nicholson. Muscle Nerve. 2018; AANS Website; UpToDate;

Physician Interviews; ClearView Analysis. Goldstein. Soc Psychiatry Psychiatr Epidemiol 2016; Kessler. Arch Gen Psychiatry. 2012; Kessler. Arch Gen

Psychiatry. 2005; UpToDate; Physician Interviews; ClearView Analysis

Page 23: GW Pharmaceuticals Investor Presentation

GW’s Cannabinoid Platform: A Proprietary Growth Engine

May 2020 23

PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 SUBMIT APPROVED

EPIDIOLEX® (cannabidiol)

Dravet syndrome

Lennox-Gastaut syndrome

Tuberous Sclerosis Complex

Rett syndrome

Nabiximols (marketed as Sativex® ex-US)

MS spasticity

Spinal Cord Injury spasticity

PTSD

Other neurological conditions

CBDV

Epilepsy

Autism spectrum disorders

OTHER

Schizophrenia

Neonatal hypoxic-ischemic encephalopathy

GW Pharmaceuticals Investor Presentation

Page 24: GW Pharmaceuticals Investor Presentation

Key Financial Data

May 2020 GW Pharmaceuticals Investor Presentation 24

Q1 2020 net revenue $120.6m

Cash at March 31, 2020 $500.9m

FY 2020 R&D and SG&A expense guidance $530m–$560m

FY 2020 capital expense guidance $30m–$40m

Share Capital Current Options Fully Diluted

ADS/m 31.2 1.4 32.6

Page 25: GW Pharmaceuticals Investor Presentation

2020 Key Priorities

May 2020 GW Pharmaceuticals Investor Presentation 25

Epidiolex® commercialization:

• Continue to drive revenue growth:

• Build on positive experiences from existing physicians to increase prescribing to appropriate patients

• Accelerate adoption across a broader prescriber base

• Continue partnerships with payers to expand access

• Enter long-term care segment

• Obtain approval of TSC indication in both US and EU significantly expanding patient population

• Successful execution of EU launches of Epidyolex®

• Supplement existing Orange Book listed patents (expiry 2035) with additional use patents; progress “composition” patent application

• Advance medical literature for Epidiolex through top-tier journal publications and major scientific and medical meeting presentation

Nabiximols in the US (known as “Sativex” ex-US):

• Commence pivotal clinical program in spasticity associated with MS

• Commence clinical program to expand future label to include spasticity associated with SCI

• Commence clinical program in PTSD

Additional pipeline:

• Commence Phase 2b study for the treatment of schizophrenia

• Continue to explore CBDV in autism through a combination of open-label and investigator-led RCTs with data from one or more programs in 2020

• Execute NHIE clinical program

Page 26: GW Pharmaceuticals Investor Presentation

“Sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.

Because of this careful, scientific and evidence-based evaluation by the FDA, health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able

to deliver a predictable treatment to patients.”

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611047.htm

Former FDA Commissioner Scott Gottlieb, M.D.

June 24, 2018

Page 27: GW Pharmaceuticals Investor Presentation

© 2020 GW Pharmaceuticals all rights reserved.

NASDAQ: GWPH

PoppyLiving with Dravet syndrome

THANK YOU!

Stephen Schultz

VP Investor Relations

[email protected]

401-500-6570

www.gwpharm.com