2013 H1/Q2 Financial Results AIM: GWP NASDAQ: GWPH

Transcription

1 2013 H1/Q2 Financial Results AIM: GWP NASDAQ: GWPH June 3, 2013

2 Forward Looking Statements and Disclaimer This presentation contains forward looking statements. Some of the matters discussed concerning our operations and financial performance include estimates and forward looking statements within the meaning of US federal securities laws. These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause our actual results of operations, financial condition, liquidity, performance, prospects, opportunities, achievements or industry results, as well as those of the markets we serve or intend to serve, to differ materially from those expressed in, or suggested by, these forward looking statements. These forward looking statements are based on assumptions regarding our present and future business strategies and the environment in which we expect to operate in the future. These statements are based on our current expectations and projections about future events and will be regarded by terminology such as believe, may, will, estimate, continue, anticipate, intend, expect and similar words are intended to identify estimates and forward looking statements. Estimates and forward looking statements speak only at the date they were made, and we undertake no obligation to update or to review any estimate and/or forward looking statement because of new information, future events or other factors, except as required by applicable law. Estimates and forwardlooking statements involve risks and uncertainties and are not guarantees of future performance. Our future results may differ materially from those expressed in these estimates and forward looking statements. Because of these uncertainties, you should not make any investment decision based on these estimates and forward looking statements. Although we believe that our plans, intentions and expectations are reasonable, we may not achieve our plans, intentions or expectations. You should read this presentation together with the Risk Factors section in the prospectus of GW s Nasdaq IPO and the documents that we reference and have filed as exhibits to the registration statement on Form F 1 that we have filed with the Securities and Exchange Commission completely and with the understanding that our actual future results, levels of activity, performance and achievements may be different from what we expect and that these differences may be material. We qualify all of our forward looking statements by these cautionary statements. 2

3 GW Pharma Overview World leading position in development of plant derived cannabinoid therapeutics Proprietary cannabinoid product platform in broad range of disease areas Commercialized lead product, Sativex Approved in 21 countries (ex U.S.) for MS Spasticity Significant Phase 3 opportunity in U.S. for Sativex in cancer pain Results from two Phase 3 trials expected in Trials funded by U.S. partner Additional opportunity in U.S. for Sativex in MS spasticity Collaborations with major pharmaceutical companies Otsuka, Novartis, Almirall, Bayer Promising clinical/pre clinical stage cannabinoid product pipeline Candidates in Type 2 diabetes, ulcerative colitis, epilepsy, schizophrenia, cancer 3

4 Recent Highlights Corporate Nasdaq IPO completed, raising net proceeds before expenses of $30.4m ( 19.5m) Continued recruitment of Sativex Phase 3 cancer pain trials Sativex now approved for MS spasticity in 21 countries Italy approval and reimbursement granted in May Phase 2a trial of GWP42003 in ulcerative colitis ongoing Data expected early 2014 Four Phase 1 and 2 trials in late stage preparation and expected to commence in H2 13 in epilepsy, glioma, type 2 diabetes, and schizophrenia Financial H1 13 Revenues of 12.9m ($19.6m) vs 11.1m in H H1 13 Net profit after tax 0.1m ($0.2m) vs 3.2m loss in H Cash at 31 March 2013 of 27.9m ($42.3m) Nasdaq IPO proceeds received after period end. 4

5 Product Pipeline 5

6 Sativex Commercial Partners USA $272m upfronts/milestones ($22m received) mid 20 s % supply revenue / royalty Otsuka pays all U.S. development costs Separate non Sativex research collaboration Mid East, Africa, Asia, Australasia (excl China, Hong Kong, Japan, Israel) $34m upfronts/milestones ($5m received) teens % supply revenue / royalty Europe (excl UK), Mexico 52m upfronts/milestones ( 33m received) low 20 s mid 30 s % supply revenue / royalty UK, Canada 29m upfronts/milestones ( 20m received) mid 30 s 40 % supply revenue / royalty Summary: $113m upfront fees & milestones received, further $325m potential milestones payable, attractive % supply revenues/royalties 6

7 Nasdaq Listing (GWPH) On May 1 st, GW priced IPO to U.S. investors and listed on NASDAQ 3.678m American Depository Shares ( ADSs ) issued at $8.90 per ADS Each ADS is equivalent to 12 Ordinary Shares Net proceeds before expenses of $30.4m ( 19.5m) Investors 80% from new U.S. investors 20% from existing U.K. institutional shareholders Bankers Lazard Capital Markets, Cowen and Company (Bookrunners) Canaccord Genuity (Lead manager), Roth Capital Partners (Co manager) Use of proceeds Fund new Phase 1 and Phase 2 clinical trials of multiple product candidates Expand Sativex manufacturing capabilities Discover and develop new product candidates from cannabinoid platform Fund working capital and other general corporate purposes 7

8 Sativex for Advanced Cancer Pain Initial Indication for the U.S.

9 Advanced Cancer Pain: Significant Market Opportunity in U.S. Indication: Add on treatment of persistent pain in people with advanced cancer who experience inadequate pain relief from optimized chronic opioid therapy total U.S. cancer population experience pain advanced cancer treated with opioids uncontrolled pain in U.S. 4.75m 3.3m 2.4m 2.1m 420k Sativex offers a differentiated non opioid mechanism of action and the prospect of pain relief without increasing opioid related side effects Studies in animal models of pain suggest pharmacodynamic synergy between cannabinoids and opioids 7 patent families related to Sativex, including U.S. Sativex cancer pain use patent allowed (expiry Sept. 2026) 9

10 Advanced Cancer Pain Sativex Phase 2 & 3 Clinical Program All cancer pain trials and other U.S. targeted studies funded by Otsuka Data to be used for submission to FDA and other global regulatory authorities Substantial body of positive Phase 2 data Phase 2a study (n=177) published Journal of Pain & Symptom Management Phase 2b study (n=360) published Journal of Pain Long term extension study published Journal of Pain & Symptom Management Phase 3 trials employ same key features as Phase 2b Patient population / 5 week treatment duration / Endpoint: 0 10 Pain NRS First two identical Phase 3 trials intended to form basis of NDA data expected 2014 Primary Efficacy Analysis: Cumulative Proportion of Responders Analysis Dose range: 3 10 sprays Third Phase 3 trial also underway not intended to be required for NDA Enriched study design 10

11 Two Core Phase 3 Trials: Trial Design (n=380) 35 DAYS 5 14 DAYS 14 DAYS SCREENING 5 14 days to obtain 3 day baseline period RANDOMISATION n=190 n=190 Opioid + Sativex 3 10 sprays/day Opioid + Placebo 3 10 sprays/day END OF TREATMENT EXTENSION STUDY Primary Efficacy Analysis Key Secondary Endpoints Change in Pain 0 10 NRS: Cumulative Proportion of Responders Analysis Sleep disturbance, Opioid consumption, Constipation Top line results from both Phase 3 trials expected in

12 Sativex for MS Spasticity

13 Sativex in MS Spasticity: Approved in 21 Countries Launched Approved (pending launch) Recommended for approval Launch in Italy scheduled for September. Several launches being planned in other markets 26% in market volume growth H1 13 vs H1 12 Regulatory submission filed Canada Australia Ireland Bahrain Denmark Austria Egypt Germany Belgium Kuwait Israel Czech Republic Malaysia Norway Finland Oman Spain Iceland Qatar United Kingdom Italy Luxembourg Netherlands New Zealand Poland Portugal Slovakia Sweden Saudi Arabia Switzerland United Arab Emirates Germany price reduction: Almirall pursuing all avenues, incl legal challenge 13

14 Sativex in MS Spasticity: U.S. Strategy Sativex for MS represents attractive commercial opportunity in the U.S. >400,000 MS patients in the US Spasticity affects up to 80% of MS patients over their lifetimes Current oral treatments afford only partial relief and have unpleasant side effects Pre IND meeting held with FDA in Dec 2012 GW now preparing to submit IND, including a proposed single Phase 3 trial, in mid 2013 U.S. Phase 3 trial design anticipated to be consistent with most recent completed EU Phase 3 trial 14

15 Non Sativex Pipeline: Significant Clinical Program Planned for 2013/14 Type 2 Diabetes Positive data from Phase 2a trial for GWP42004 GWP42004 Phase 2dose ranging trial to start H Ulcerative Colitis Phase 2a trial of GWP42003 on going and due to complete early 2014 (n=62) Epilepsy GWP42006 Phase 1 trial to start H Schizophrenia GWP42003 Phase 2a trial to start H Glioma Phase 1b/2a THC:CBD trial to start H

16 GWP42006 in Chronic Models of Epilepsy Seizure Score % Tonic clonic Chronic PTZ MAX SEIZURE SEVERITY % TONIC CLONIC INCIDENCE 70% 60% 50% 40% 30% 20% 10% 0% Vehicle Vehicle * Increasing dose of GWP42006 * Increasing dose of GWP42006 Chronic PTZ Model, GWP42006: Administered chronically for 7 days Treatment twice daily oral Decreases max seizure severity Decreases incidence of tonic clonic seizures Chronic Pilocarpine Model, GWP42006: Decreased all types of seizure severity Partially reverses motor function deficits in epileptic subjects with no detrimental effect in non epileptics Doesn t worsen cognitive dysfunction as experienced with other SAEDs Effective orally (as observed in acute models of seizure: p<0.05) Chronic Pilocarpine SEIZURE FREQUENCY DAY 0 VEHICLE GWP SEVERITY:

17 GWP42006 Reverts over expressed genes during epilepsy; correlates with response mrna Expression (fold change from control) Gene 1 Neuronal Firing Vehicle + Saline Vehicle + PTZ GWP Saline Gene 2 Stress Response Vehicle + Saline Vehicle + PTZ * * GWP Saline GWP PTZ GWP PTZ Acute Models Several genes are dysregulated in epileptic patients/models Revert back to normal levels in animals treatment responders Potential for modification of disease process Chronic Models GWP42006 positively effects expression of genes involved in the epilepsy process No negative effects on expression of epilepsy related genes of non epileptic animals Gene 3 Neuronal structure Gene 4 Cell Cycle Regulator These observations provide a useful biomarker for use in a clinical investigation [5] 17 Responder Non responder [5] Tang et al., 2005 Arch Neurol. 62:

18 THC:CBD Further evidence of efficacy in Glioma Additional Lab, new model: THC:CBD enhanced antitumor activity of temozolomide (TMZ) in intracranial mouse model of human glioblastoma Luciferase reporter Radiance is a function of tumour volume THC:CBD enhanced the antitumor activity of suboptimal doses of TMZ Significant increase in survival (p<0.003) Data replicates findings of Guzman group (Universidad Complutense) Formal controlled clinical study due to start imminently Radiance (x10 6 ) California Pacific Medical Center vehicle THC:CBD TMZ TMZ+THC:CBD Days Percent survival Days Tumour Volume (fold change) Complutense vehicle THC:CBD TMZ TMZ+THC:CBD Days 18

19 Financial Information

20 Overview GW s Financial Model Revenue: Sativex sales Recognized upon shipment of inventory to partners Milestones Typically recognized in full when milestone is achieved Have a significant impact on profitability in periods when they occur License fees Recognized over the term of commercial licenses R&D fee revenues Revenue recognized in line with partner funded R&D spend Expenditure: Partner funded R&D principally Sativex US Phase 3 clinical trials program GW funded R&D core research overhead plus Phase 1/2 clinical programs

21 Sativex In market Sales 6 monthly volume progression 10ml Vials sold/6mths 10ml Vials 60,000 55,000 50,000 45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 Israel Norway Denmark Sweden Germany Spain UK Canada UK Denmark H H H H H Sativex in-market sales volume in H is 26% higher than in H

22 R&D Spend Analysis GW funded R&D Partner funded R&D 16,000 14,000 12, m 15.1m ($22.9m) '000 10,000 8,000 6, m 7.4m spend 11.7m 4,000 2, m 31% 3.6m 3.4m spend H H % 22

23 Consolidated Income Statement Period ended $ 000* 31 Mar Mar Sept months 6 months 12 months Unaudited Unaudited Audited Revenue 19,605 12,915 11,078 33,120 Cost of sales (999) (658) (522) (839) R&D expenditure GW funded (5,193) (3,421) (3,944) (8,078) R&D expenditure partner funded (17,735) (11,683) (8,779) (19,500) Management & administration (2,857) (1,882) (2,035) (3,660) Operating (Loss)/profit (7,179) (4,729) (4,202) 1,043 Interest receivable (Loss)/profit before tax (7,055) (4,647) (4,100) 1,242 Tax credit 7,242 4, ,248 (Loss)/Profit after tax (3,172) 2,490 Earnings per share 0.2c 0.1p (2.4)p 1.9p *Convenience Dollar translation based on 28th March 2013 closing exchange rate of $1.518 to 1.

24 Cash Flow 6 months ended 31 March 2013 Outflow Inflow Operating cash outflow 2.8m R&D Tax credit received + 2.8m Net interest received + 0.1m Nasdaq expenses 0.7m Capital expenditure 0.9m Net Cash Outflow 1.4m ($2.1m) (8) (4) m Closing Cash at 31 March2013 of 27.9m ($42.3m) (Sept 2012: 29.3m) Additional 18.2m ($28.4m) net proceeds after expenses from Nasdaq IPO 24

25 2013 Full Year Guidance Milestones Italian 250k pricing milestone to be earned in H2 Sativex Sales Reduced supply price to Almirall and the adverse German pricing decision expected to result in 2013 Sativex sales revenues that are lower than in 2012 Italian launch expected in September. Further launches expected in FY2014 Investment in R&D GW funded R&D expected to be 10 20% higher than 2012 Profitability No major milestones expected in 2013 As previously guided, in line with market expectations, we expect to report a loss for FY2013 This loss will enable an R&D tax credit claim for the year 25

26 Anticipated Newsflow Sativex for Cancer Pain Calendar Year Progress of three Phase 3 cancer pain trials 2013 Complete recruitment in 1 st Phase III trial H st Phase 3 trial data Mid nd Phase 3 trial data H2 14 Sativex for MS Spasticity US Phase 3 IND Mid 13 Set up Phase 3 trial H2 13 Launch in Italy and other new EU countries H onwards Australia launch H2 13 Approvals/launches in Middle East Q4 13 onwards Pipeline Phase I GWP42006 trial H2 13 Phase 2 GWP42004 Diabetes trial H2 13 Phase 2a GWP42003 Schizophrenia trial H2 13 Phase 1b/2a glioma trial H2 13 Phase 2a Ulcerative Colitis trial data Early

27 GW Pharmaceuticals plc NASDAQ: GWPH AIM: GWP Stephen Schultz, VP Investor Relations