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Developing Novel Prescription Medicines Which Make a Real Difference to Patients’ Lives GW Pharmaceuticals Plc Annual Report and Accounts 2015 2015 Highlights

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Developing Novel Prescription Medicines Which Make a Real Difference to Patients’ Lives GW Pharmaceuticals Plc Annual Report and Accounts 2015 2015 Highlights Developing novel prescription medicines which make a real difference to patients’ lives GW Pharmaceuticals plc Annual report and accounts 2015 2015 Highlights Epidiolex® (CBD) childhood > Company sponsored Phase 3 – Additional clinical development for development programs in Dravet Epidiolex® beyond initial three epilepsy program syndrome and Lennox-Gastaut syndrome indications expected to commence in (“LGS”) H2 2016 – First Phase 3 Dravet syndrome trial fully > Expanded access program: enrolled. Data expected Q1 2016 – Latest data updated issued at – First LGS Phase 3 trial fully enrolled. the American Epilepsy Society Data expected Q2 2016 December 2015 Annual Meeting – Second LGS Phase 3 trial fully – Approximately 350 children on enrolled. Data expected Q2 2016 treatment at 32 US clinical sites – Second Phase 3 Dravet syndrome trial – Over 850 children authorised ongoing. Data expected mid 2016 for treatment by FDA under – New Drug Application (“NDA”) Expanded Access Treatment INDs submission with Food and and six US State programs Drug Administration (“FDA”) > Strategic agreement with the expected Q4 2016 Government of New South Wales in – Phase 3 Tuberous Sclerosis Complex Australia to conduct Epidiolex and (“TSC”) trial expected to commence Cannabidivarin (“CBDV”) clinical trials Q1 2016 > Cannabidiol (“CBD”) and CBDV patent portfolio strengthened Advanced clinical programs > Phase 2a CBD schizophrenia study > Phase 1b/2a study for the treatment data shows positive proof-of-concept of Recurrent Glioblastoma in multiple cannabinoid with a reassuring safety profile Multiforme (“GBM”) fully enrolled > Phase 2 CBDV epilepsy study in adults with data expected in mid-2016 pipeline product candidates under way with data expected H2 2016 – Orphan Drug Designation > Neonatal Hypoxic-Ischemic granted from FDA Encephalopathy (“NHIE”) IV CBD > Phase 2 study in type-2 diabetes fully Phase 1 clinical program expected enrolled with data expected mid 2016 to commence in H1 2016 > Phase 2 study of Sativex® in spasticity – Orphan Drug and Fast due to cerebral palsy ongoing Track Designations granted with data expected mid 2016 from FDA and EMA > Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016 Pre-clinical progress > Autism spectrum disorders, > Duchenne muscular dystrophy addressing a number of > Glioma > Ovarian and pancreatic cancers areas of unmet needs > Chemotherapy-induced cachexia US operations established > GW’s CEO, Justin Gover, relocates to the US in Carlsbad, California > Seasoned industry executive Julian Gangolli appointed as President, North America > Epilepsy specialist team build-out under way 01 GW Pharmaceuticals plc Annual report and accounts 2015 Chairman and Chief Executive Officer’s statement GW has established a world leading position in the development of plant-derived cannabinoid therapeutics. Dear Fellow Shareholders, We are proud of GW’s achievements and the build-out of a world-class U.S. Over the last 17 years since the company’s the organization that we have become. commercial organization in anticipation founding, GW has established a world In particular, highlights include: of future launch. Beyond Epidiolex, leading position in the development of > GW’s first product, Sativex®, is now we also look forward to progressing plant-derived cannabinoid therapeutics. approved in 28 countries for the clinical trials for various additional Over this past year, GW has accelerated treatment of multiple sclerosis spasticity cannabinoid pipeline products that its focus on the application of cannabinoid > GW now employs over 350 staff, have the potential to lead to valuable science to treat severe and rare diseases. including over 300 in the UK as well as commercial opportunities, especially an emerging U.S. commercial and in the field of pediatric neurology At the forefront of these efforts is the development operation to complement thorough our growing knowledge and development of our product candidate its expanding UK scientific and understanding of the developing brain. Epidiolex® in the field of treatment- manufacturing base resistant epilepsy in children. GW > We have invested approximately We believe that Epidiolex is a truly is currently supplying Epidiolex to $1 billion in R&D and the development important medicine which has the approximately 350 children in the of our organization potential to make a meaningful difference United States under a physician-led > We have research collaborations with to the lives of children suffering from FDA approved “expanded access” 36 universities around the world these very difficult forms of epilepsy. compassionate use program and is also > Our UK commercial manufacturing Indeed, our whole organization is rapidly progressing pivotal Phase 3 trials facility has been inspected and stirred by the compelling and emotional in Dravet syndrome and Lennox-Gastaut approved by multiple regulatory stories that regularly emerge from syndrome – two rare and extreme forms authorities our expanded access program as to of childhood epilepsy. We expect to > We have conducted 44 Phase 2 and how Epidiolex appears to have had carry this momentum through 2016 with Phase 3 clinical trials including over such a positive impact on the lives of a top-line data from four Epidiolex pivotal 4,379 patients number of children and their families. trials, our first NDA filing, build-out > We have undertaken post-market safety of our U.S. commercial organization, studies involving over 1,000 patients We should like to take this opportunity and ongoing data read-outs from a > Our research has led to over 80 to thank our staff for their dedication number of clinical pipeline programs. publications in peer review journals to GW, without which we would not > We have evaluated 14 distinct have been able to make such significant It is no exaggeration to say that GW cannabinoids in pre-clinical research progress over the last year. The company has seen a major transformation in > We have generated over 45,000 has grown rapidly over this period and recent years. The listing of our shares patient-years of human safety data on the pace of change has required an on the NASDAQ Global Market cannabinoid medicines extraordinary effort and commitment. in 2013 was followed by the rapid > We have exported cannabinoids to 37 We should also like to thank our scientific acceleration of our epilepsy research countries for research purposes collaborators, the physician and patient efforts, increasing recognition of the communities, and our shareholders in importance and value of GW’s science 2015 has been a particularly active supporting GW to further its important and cannabinoid platform, access to year for GW and we enter 2016 with mission to develop novel cannabinoid significant capital from U.S. investors, confidence that the coming year will therapies that have the potential to make and the resultant ambition to retain be equally as exciting. In 2016, our key a real difference to the lives of patients global commercial rights to our pipeline. objective is to successfully complete with rare and difficult to treat conditions. the Epidiolex Phase 3 clinical program, submit the NDA with FDA, and continue Dr Geoffrey W Guy and Justin Gover As filed with the Securities and Exchange Commission on December 7, 2015 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2015 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35892 GW PHARMACEUTICALS PLC (Exact name of Registrant as specified in its charter) England and Wales (Jurisdiction of incorporation or organization) Sovereign House, Vision Park Chivers Way, Histon Cambridge, CB24 9BZ United Kingdom (Address of principal executive offices) Justin D. Gover, Chief Executive Officer Sovereign House, Vision Park Chivers Way, Histon Cambridge, CB24 9BZ United Kingdom Telephone No. (44) 1223 266800 E-Mail: [email protected] Facsimile: (44) 1223 235667 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act. Title of each class Name of each exchange on which registered American Depositary Shares, each representing 12 The NASDAQ Global Market Ordinary Shares, par value £0.001 per share Securities registered or to be registered pursuant to Section 12(g) of the Act: None Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 261,180,173 ordinary shares, par value £0.001 per share. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
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