GW Pharmaceuticals Investor Presentation
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GW Pharmaceuticals Investor Presentation May 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, 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 2019/2020 Key Achievements ✓ Positive Epidiolex Phase 3 data for ✓ Highly successful Epidiolex® launch seizures in TSC 2019 total revenue of $296 million FDA/EMA TSC submissions completed in ✓ EU approval of Epidyolex® and initial 2020 (accepted for Priority Review by FDA commercial launches with July 31 PDUFA date) ✓ 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 autism and NHIE in H2 2020 May 2020 GW Pharmaceuticals Investor Presentation 3 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 • Descheduled by DEA • TSC sNDA filing accepted for Priority Review Epidiolex® (cannabidiol) 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. May 2020 GW Pharmaceuticals Investor Presentation 6 A Strong Launch for • 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 May 2020 GW Pharmaceuticals Investor Presentation 7 GW Net Sales Revenue Growth 140 $120.6 M 120 $109.1 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 Q1 2020 May 2020 GW Pharmaceuticals Investor Presentation 8 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 May 2020 GW Pharmaceuticals Investor Presentation 9 Evolution 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 May 2020 GW Pharmaceuticals Investor Presentation 10 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 GW Pharmaceuticals Investor Presentation 11 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 May 2020 GW Pharmaceuticals Investor Presentation 12 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 GW Pharmaceuticals Investor Presentation 13 Epidiolex in TSC: Effective and Well-Tolerated • Safety profile observed consistent with previous studies, no new safety risks identified 52 50 49 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 May 2020 GW Pharmaceuticals Investor Presentation 14 High Unmet Need in Patients Living With TSC • sNDA submission accepted with Priority Review, July 31 PDUFA • EMA submission accepted for review “Some of the most • Epilepsy is present in >90% of patients with TSC challenging and frustrating aspects of tuberous sclerosis • TSC affects 40-50K in the US and 1-2M worldwide complex (TSC) are seizures that cannot be effectively • >60% of individuals with seizures associated with TSC controlled by existing do not achieve seizure control with standard treatments medications. Having a new safe and effective treatment • Leading cause of genetic epilepsy, often occurring in first option such as Epidiolex is year of life as focal seizures or infantile spasms desperately needed.” Kari Luther Rosbeck President and CEO Source: Tuberous Sclerosis Alliance; Child Neurology Foundation; Infantile Spasms Project May 2020 GW Pharmaceuticals Investor Presentation 15 Significant 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 May 2020 GW Pharmaceuticals Investor Presentation 16 Epidiolex® Patent Portfolio to 2035 Aligns with Indication FDA-approved