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Annual Report and Accounts Annual Report and Accounts 2019 Accounts and Report Annual GWPharmaceuticals plc | Annual Report and Accounts Annual Report and Accounts 2019 2019 www.gwpharm.com GW Pharmaceuticals plc | Annual Report and Accounts 2019 Contents 1 Strategic Report 15 Directors’ Report 16 Directors’ Remuneration Report 36 Directors’ Responsibilities Statement 39 Independent Auditor’s Report 45 Consolidated Income Statements 45 Consolidated Statements of Comprehensive Expense 46 Consolidated Statements of Changes in Equity 47 Consolidated Balance Sheets 48 Consolidated Cash Flow Statements 49 Notes to the Consolidated Financial Statements 78 Company Balance Sheets 79 Company Statements of Changes in Equity 80 Notes to the Company Financial Statements 85 Advisers www.gwpharm.com GWPharmaceuticals plc | Annual Report and Accounts 2019 GW Pharmaceuticals plc Sovereign House Vision Park Histon Cambridgeshire CB24 9BZ United Kingdom T: +44 (0)1223 266800 F: +44 (0)1223 235667 www.gwpharm.com GW Pharmaceuticals plc | Annual Report and Accounts 2019 Strategic Report The Directors present their Strategic Report for the Group, 25 countries outside the United States for the treatment of covering the year ended 31 December 2019. spasticity due to multiple sclerosis under the brand name Sativex. We are advancing plans to commence clinical programmes for Strategy, Objectives and Business Model nabiximols in 2020 in spasticity due to spinal cord injury and post-traumatic stress disorder, or PTSD. Overview We are a biopharmaceutical company focused on discovering, In addition to nabiximols, our pipeline includes cannabinoid developing and commercialising novel therapeutics from our product candidates for schizophrenia, autism spectrum disorder, proprietary cannabinoid product platform in a broad range of or ASD, and Neonatal Hypoxic Ischemic Encephalopathy, disease areas. In over 20 years of operations, we have established or NHIE. a world-leading position in the science, development and commercialisation of plant-derived cannabinoid therapeutics Our Marketed Products: Epidiolex through our proven drug discovery and development processes, our intellectual property portfolio, regulatory, manufacturing Epidiolex in the United States and commercial expertise. We launched Epidiolex on 1 November 2018 in the US market after FDA approval for the treatment of seizures associated with Our lead cannabinoid product is Epidiolex®, a pharmaceutical LGS or Dravet syndrome in patients two years of age and older. formulation of cannabidiol, or CBD, for which we retain global The FDA confirmed orphan drug exclusivity for Epidiolex and commercial rights. Epidiolex is approved in the United States for granted us a rare paediatric disease voucher. Following the the treatment of seizures associated with Lennox-Gastaut approval, US Drug Enforcement Administration, or DEA, placed syndrome, or LGS, and Dravet syndrome, in patients two years Epidiolex in Schedule V. of age and older. LGS and Dravet syndrome are severe childhood- onset, drug-resistant epilepsy syndromes. We launched Epidiolex Our US subsidiary, Greenwich Biosciences, Inc., markets in the United States in November 2018. In September 2019, we Epidiolex through a commercial organisation consisting of sales, received approval from the European Commission, or EC, for medical affairs, marketing, and market access/payer teams. Epidyolex® (the trade name in Europe for Epidiolex) for use as adjunctive therapy of seizures associated with LGS or Dravet The US sales team includes two National Directors, eight syndrome, in conjunction with clobazam, for patients two years Regional Managers and 65 Neurology Account Managers and is of age and older. We have launched Epidyolex in Germany and targeting approximately 6,400 physicians who treat patients with the U.K. and are planning launches in France, Italy and Spain LGS or Dravet syndrome. In 2020, we will be launching a during 2020. commercial initiative in the long-term care segment. We continue to develop Epidiolex for additional indications. In Epidyolex in Europe May 2019, we announced positive results from a Phase 3 trial for On 23 September 2019, we announced that the EC approved the the use of Epidiolex to treat seizures associated with Tuberous marketing authorisation for Epidyolex (the trade name in Europe Sclerosis Complex, or TSC, a rare genetic disorder that causes for Epidiolex) for use as adjunctive therapy of seizures associated non-malignant tumours to form in many different organs that with LGS or Dravet syndrome, in conjunction with clobazam, for affects approximately 50,000 individuals in the United States and patients two years of age and older. We have launched Epidyolex one million worldwide. On 3 February 2020, we announced that in Germany and the U.K. and are planning launches in France, we had submitted a supplemental New Drug Application, or Italy and Spain during 2020. sNDA, to the US Food and Drug Administration, or FDA, to expand the Epidiolex label to include the treatment of seizures Epidiolex Follow-On Target Indication: TSC associated with TSC. In March 2020 we filed for supplemental In May 2019, we announced positive top-line Phase 3 results in approval for the TSC indication in Europe. We have received the use of Epidiolex to treat seizures associated with TSC, and Orphan Drug Designation from the FDA and the Committee for more extensive study results from this positive trial were Orphan Medical Products (COMP) for TSC (we previously presented in December 2019 at the annual meeting of the received the same designations for Dravet syndrome and LGS). American Epilepsy Society. We have begun recruiting patients for a pivotal trial of Epidiolex In early February 2020, we submitted an sNDA to the FDA to in the treatment of Rett syndrome, a rare, non-inherited expand the Epidiolex label to include the treatment of seizures neurodevelopmental disorder affecting approximately one in associated with TSC. In March 2020, we filed for supplemental 10,000 to 15,000 live female births. This trial focuses on the approval for the TSC indication in Europe. behavioural abnormalities associated with the disorder. TSC is a genetic disorder that causes non-malignant tumours to We have a deep pipeline of additional cannabinoid product form in many different organs, primarily in the brain, eyes, heart, candidates that includes compounds in Phase 1, Phase 2, and kidney, skin and lungs. The brain and skin are the most affected Phase 3 trials. Our most advanced pipeline asset in the United organs. TSC results from a mutation in tumour suppression genes States is nabiximols, for which we expect to commence a pivotal TSC1 or TSC2. According to the Tuberous Sclerosis Alliance, clinical programme in the first half of 2020 in the treatment of TSC is estimated to affect approximately 50,000 patients in the spasticity due to multiple sclerosis. We anticipate US. The most common symptom of TSC is epilepsy, which occurs commercialising nabiximols in the US using our in-house in 75 – 90% of patients, about 70% of whom experience seizure commercial organisation. Nabiximols is already approved in over onset in their first year of life. 01 GW Pharmaceuticals plc | Annual Report and Accounts 2019 Strategic Report continued TSC patients typically have treatment-resistant seizures. The Nabiximols is already approved in over 25 countries outside seizures of TSC are typically focal in onset, meaning that they the United States for the treatment of spasticity due to multiple are localised to one region and hemisphere of the brain. There sclerosis under the brand name Sativex. To support the are significant co-morbidities associated with TSC including development and commercialisation of Sativex internationally, cognitive impairment in 50%, ASD in up to 40% and we have licence and development agreements with commercial neurobehavioural disorders in over 60% of individuals with TSC. partners. These agreements provide our collaborators with the sole right to commercialise Sativex in exclusive territories for The safety profile observed was consistent with findings from all indications. previous studies, with no new safety risks identified. On 2 March 2020 the Group announced that GW will regain Epidiolex Follow-On Target Indication: Rett Syndrome exclusive U.K. commercialisation rights for Sativex from Bayer. Rett syndrome, or RTT, is a rare, non-inherited, X-linked Under the terms of the agreement, there will be a transitional neurodevelopmental disorder affecting approximately 1 in 10,000 period until 31 December 2020 at which point GW will take over to 15,000 live female births. RTT is most commonly caused by all responsibilities for nabiximols in the U.K. heterozygous de-novo mutations in the gene encoding methyl- CpG-binding protein 2, or MeCP2, resulting in a loss of function Proprietary Cannabinoid Product Platform of the MeCP2 protein. The condition affects predominantly females and it results in abnormal neuronal development and The cannabis plant is the unique source of more than 70 function in affected children. The symptomatology of RTT is structurally related, plant-derived cannabinoids. Although one progressive, with early onset from about 6–18 months of life, cannabinoid, THC, is known to cause psychoactive effects followed by a rapid destructive phase at the age of 1 to 4 years. associated with the use of illicit herbal cannabis, none of the This stage is characterised by loss of purposeful hand skills, loss other cannabinoids are known to share this property. In recent of spoken language, breathing and cardiac irregularities, decades,
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