38th Annual J.P. Morgan Healthcare Conference - NASDAQ: GWPH
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38th Annual J.P. Morgan Healthcare Conference
Justin Gover, Chief Executive Officer | January 14, 2020 NASDAQ: GWPH
© 2020 GW Pharmaceuticals all rights reserved.
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 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-KT 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. January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 2
2019 Key Achievements
✓ Highly successful Epidiolex® launch ✓ Positive Epidiolex Phase 3 data for
2019 total revenue of $296 million seizures in TSC with FDA/EMA
submissions expected in 2020
✓ EU approval of Epidyolex® and initial
commercial launches ✓ Epidiolex Phase 3 study in Rett syndrome
commenced
✓ Epidiolex manufacturing and supply chain
running smoothly
✓ Epidiolex exclusivity strengthened through
9 Orange Book-listed patents
✓ Nabiximols US pivotal clinical plan ✓ Advanced programs in schizophrenia,
developed and ready to commence in 2020 autism and NHIE
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 3
4
GW Leadership
20+ Years Expertise | Proven Track Record
MANUFACTURING REGULATORY PIPELINE
CLINICAL COMMERCIALIZATION PEOPLE
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!”
• 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
• Designated as Schedule V by DEA
Epidiolex® (cannabidiol) CV Oral Solution
FDA Approves First Medicine Derived From Cannabis Plant
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
THE 50 GENIUS will have access in the U.S. to a cannabis-
COMPANIES OF 2018 derived drug that has undergone a
safety and efficacy review by the FDA.
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 7
A Strong Launch Year for
• Q4 unaudited net product sales of approximately $104M
• Full-year unaudited net product sales of approximately $296M
• 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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 8
2019 GW Net Sales Revenue Growth
120
$108 M
100
$91.0 M
80
$72.0 M
(Millions)
60
$39.2 M
40
20
$6.7 M
0
Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 9
Epidiolex® 2020: The Next Phase in Building a Blockbuster
Build on
positive
physician Accelerate Further
experiences adoption Continue Continue to indication
to increase across a partnerships minimize development
prescribing to broader with payers to logistical Enter long- Execute on
appropriate prescriber expand barriers to term care the TSC label
patients base access Epidiolex segment expansion
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 10Evolution of Y1 Coverage Exceeded Our Goal
97% of All US Insured Patients Have Epidiolex® Coverage for LGS and Dravet Syndrome
Epidiolex Access
100
90
80
70
60
50
40
30
20
10
0
Launch 1/1/2019 6/1/2019 12/1/2019
Open Access PA to Indication Restrictive PA Non-Formulary
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 11Express 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+ January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 12
2020 Payer Focus
• 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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 13EU Launch Update: Epidyolex® (cannabidiol)
• Approved in September 2019
• First wave of launches in 5 major markets
• Commercialization underway in France and Germany
• UK NICE endorsement; funded by NHS; UK launch
expected early 2020
• Spain and Italy launches in 2020 following pricing and
reimbursement
• Early Access Program includes >1,100 patients
across 5 major markets and >400 physicians from
250 top epilepsy centers
• Plans in place for progression of pricing and
reimbursement in second wave of 10 EU markets
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 14Epidiolex® in TSC: Effective and Well-Tolerated
• Safety profile observed
consistent with previous
studies, no new safety risks
identified
52
49 50
48
• Lower incidence of known
adverse events and
laboratory changes in the 25
32 mg/kg/day group compared
27 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
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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 15High Unmet Need in Patients Living With TSC
• sNDA submission expected Q1 2020
• Epilepsy is present in >90% of patients with TSC
• TSC affects 40-80K in the US and 1-2M worldwide “Some of the most
• >60% of individuals with seizures associated with TSC challenging and frustrating
aspects of tuberous sclerosis
do not achieve seizure control with standard treatments complex (TSC) are seizures
that cannot be effectively
• Leading cause of genetic epilepsy, often occurring in first controlled by existing
year of life as focal seizures or infantile spasms medications. Having a new
safe and effective treatment
option such as Epidiolex is
desperately needed.”
Kari Luther Rosbeck
President and CEO
Source: Tuberous Sclerosis Alliance; Child Neurology Foundation; Infantile Spasms Project
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 16Significant Unmet Need in Treatment Resistant Epilepsy
~15-20K ~30-50K ~40-50K ~160K ~1M
Dravet Lennox-Gastaut Tuberous sclerosis Treatment-resistant pediatric Treatment
syndrome syndrome complex epilepsy patients resistant epilepsy
Approved to treat the seizures
associated with LGS and
Dravet syndrome
seizures persisting
despite multiple
anti-epileptic drugs
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,
(AEDs)
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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 17Epidiolex® Patent Portfolio to 2035 Aligns with Indication
FDA-approved to treat seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome in patients 2 years of age and older
US10111840 US15/183947
US9956186 US9956184
US10137095 Treatment of
US10195159 Treatment of Treatment of Treatment of
EXP EXP EXP EXP Treatment of EXP focal seizures in EXP
Formulation of convulsive seizures in LGS atonic seizures in
drop seizures in Dravet syndrome
cannabinoid-rich 2020 seizures in LGS 2035 with about at least 2035 Dravet syndrome 2035 LGS with about 2035 with 15-20mg/kg/ day
TDB
extract with at least 10mg/kg/day of CBD LGS with about
and clobazam 20mg/kg/day of CBD of CBD
10mg/kg/day of CBD 20mg/kg/day of CBD
Awaiting Grant
US9956183
US9956185 US9949937 Treatment of US10092525
Treatment of Treatment of seizures in
EXP EXP EXP Treatment of PCT/GB2019/051173 EXP
convulsive seizures in Dravet syndrome Epidiolex
drop seizures in EXP
seizures in Dravet 2035 Dravet syndrome 2035 or LGS with 2035 Dravet syndrome 2035 composition patent 2039
syndrome with at with about at least clobazam or CBD in
with about application
least 10mg/kg/day of 10mg/kg/day of CBD a patient previously
20mg/kg/day of CBD
CBD and clobazam treated with
clobazam
9 Orange Book-listed patents to date plus formulation, TSC, and use patents in
prosecution plus additional applications planned
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 18Nabiximols (known as Sativex® ex-US)
Nabiximols: GW’s Next US Commercial Opportunity
• Nabiximols US Adopted Name (USAN) Overlay of 24 Nabiximols Chromatograms:
Standardized “Full Spectrum” Composition
• A botanical drug product which is a mixture of THC and CBD
extracts 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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 20Nabiximols: Demonstrated Efficacy in MS Spasticity
Supplementary Clinical Program for FDA Commencing in 2020
Efficacy demonstrated in 3 positive pivotal 3 trials conducted in Europe
GWMS0106 GWSP0604 SAVANT
(n=189) (n=241) (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 0.0002Nabiximols US Market Opportunity in MS Spasticity
• Spasticity occurs in up to 84% of MS patients Nabiximols Opportunity
• Strong physician and
• Despite current treatment, 1/3 live with uncontrolled spasticity patient enthusiasm for
product use
• 90% of physicians and
• No new oral anti-spasticity medicines approved in over 20 years; patients highly to
MS disease modifying treatments do not relieve MS symptoms moderately interested
• US market potential
• Spasticity significantly impacts daily function — reduced mobility estimated to be >$400
and inability to perform daily tasks, including walking and driving million
• 26–50% of MS patients are self-medicating with cannabis
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 22Significant Lifecycle Opportunities for Nabiximols
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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 23GW’s Cannabinoid Platform: A Proprietary Growth Engine
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
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 24Q4 Results and Key Financial Data
Total preliminary approximate net sales revenue Q4: $108m / full-year 2019 $309m
Cash at December 31, 2019 Approx. $536m
FY 2019 operating expense guidance $415m–$430m
FY 2019 capital expense guidance $35m–$45m
Share Capital Current Options Fully Diluted
ADS/m 30.9 1.2 32.1
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 252020 Key Priorities
Epidiolex® commercialization: Nabiximols in the US (known as “Sativex” ex-US):
• Continue to drive revenue growth: • Commence pivotal clinical program in spasticity
• Build on positive experiences from existing physicians associated with MS
to increase prescribing to appropriate patients
• Commence clinical program to expand future label to
• Accelerate adoption across a broader prescriber base include spasticity associated with SCI
• Continue partnerships with payers to expand access
• Commence clinical program in PTSD
• Enter long-term care segment
• Submit/obtain approval of TSC indication in both US Additional pipeline:
and EU significantly expanding patient population
• Commence Phase 2b study for the treatment of
• Successful execution of EU launches of Epidyolex® schizophrenia
• Supplement existing 9 Orange Book listed patents • Continue to explore CBDV in autism through a
(expiry 2035) with additional use patents; obtain combination of open-label and investigator-led RCTs
grant of the “composition” patent with data from one or more programs in 2020
• Advance medical literature for Epidiolex through top- • Execute NHIE clinical program
tier journal publications and major scientific and
medical meeting presentation
January 14, 2020 38th Annual J.P. Morgan Healthcare Conference 26“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.”
Former FDA Commissioner Scott Gottlieb, M.D.
June 24, 2018
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611047.htmTHANK YOU!
Poppy
Living with Dravet syndrome
Stephen Schultz www.gwpharm.com
VP Investor Relations
sschultz@gwpharm.com
401-500-6570 NASDAQ: GWPH
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