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GW Pharmaceuticals plc Reports Fourth Quarter and Year-End 2015 Financial Results and Operational Progress

- Three Phase 3 Epidiolex Clinical Trials Fully Recruited Above Target Sample Size – on Track for Initial Data in Q1 2016 -

- Significant Clinical Activity in Multiple Cannabinoid Pipeline Programs -

- Conference Call Today at 4:30 p.m. EST, 9:30 p.m. GMT -

LONDON, Dec. 7, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP), ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the fourth quarter and twelve months ended 30 September 2015.

"This last year has seen GW maintain a rapid pace in the progress of our pediatric epilepsy research program, including the start and completion of recruitment of multiple Phase 3 trials for Epidiolex, and the expansion of our expanded access program which has continued to yield promising safety and efficacy data," stated Justin Gover, GW's Chief Executive Officer. "We expect to carry this momentum through 2016 with top-line data from four Epidiolex pivotal trials, our first NDA filing, build-out of our U.S. commercial organization, and ongoing data read-outs from a number of clinical pipeline programs."

2015 HIGHLIGHTS

  • Epidiolex® (CBD) childhood epilepsy program:
    • Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome
      • First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized) data expected Q1 2016
      • First LGS Phase 3 trial fully enrolled above original target sample size (171 randomized). Data expected Q2 2016
      • Second LGS Phase 3 trial fully enrolled above original target sample size. (>210 expected to randomize). Data expected Q2 2016
      • Second Phase 3 Dravet syndrome trial ongoing. Data expected mid 2016
      • NDA submission with FDA expected Q4 2016
      • Phase 3 Tuberous Sclerosis Complex trial expected to commence Q1 2016
      • Additional clinical development for Epidiolex beyond initial three indications expected to commence in H2 2016
    • Expanded access program:
      • Separate data update announcement issued today at the American Epilepsy Society December 2015 Annual Meeting
      • Approximately 350 children on treatment at 32 U.S. clinical sites
      • Over 850 children authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
    • Strategic agreement with Government of New South Wales in Australia to conduct Epidiolex and CBDV clinical trials
    • CBD and CBDV patent portfolio strengthened
  • Advanced clinical programs in multiple cannabinoid pipeline product candidates:
    • Phase 2a CBD schizophrenia study data shows positive proof-of-concept with a reassuring safety profile
    • Phase 2 CBDV epilepsy study in adults underway with data expected H2 2016
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) IV CBD Phase 1 clinical program expected to commence in H1 2016
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
    • Clinical trials within the field of autism spectrum disorders expected to commence in H2 2016
    • Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in mid-2016
      • Orphan Drug Designation granted from FDA
    • Phase 2 study in type-2 diabetes fully enrolled with data expected mid 2016
    • Phase 2 study of Sativex in spasticity due to cerebral palsy ongoing with data expected mid 2016
  • Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers, and chemotherapy-induced cachexia
  • U.S. operations established in Carlsbad, California
    • GW's CEO, Justin Gover, relocates to the U.S.
    • Seasoned industry executive Julian Gangolli appointed as President, North America
    • Epilepsy specialist team build-out underway

FINANCIAL HIGHLIGHTS

  • Balance sheet further strengthened with successful NASDAQ follow-on offering raising net proceeds after expenses of £127.5 million ($193.3 million)
  • Revenue for the twelve months ended 30 September 2015 of £28.5 million ($43.2 million) compared to £30.0 million for the twelve months ended 30 September 2014
  • Loss for the twelve months ended 30 September 2015 of £44.6 million ($67.4 million) compared to £14.7 million for the twelve months ended 30 September 2014
  • Cash and cash equivalents at 30 September 2015 of £234.9 million ($355.3 million) compared to £164.5 million as at 30 September 2014

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 fourth quarter and year-end financial results today at 4:30 p.m. EST / 9:30 p.m. GMT. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company's website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID #13626013.

Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway + 44 20 3727 1000
GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 30 September 2015
Three months
ended
30 September
2015
$000's
Three months
ended
30 September
2015
£000's
Three months
ended
30 September
2014
£000's
Revenue 8,463 5,595 7,419
Cost of sales (1,033) (683) (419)
Research and development expenditure (38,510) (25,457) (12,269)
Sales, general and administrative expenses (7,545) (4,988) (1,844)
Net foreign exchange gain 10,399 6,874 5,411
Operating loss (28,226) (18,659) (1,702)
Interest income 125 83 50
Interest expense (22) (15) (2)
Loss before tax (28,123) (18,591) (1,654)
Tax benefit 9,618 6,358 1,936
(Loss)/profit for the period (18,505) (12,233) 282
(Loss)/profit per share – basic and diluted (7.1c) (4.7p) 0.1p
All activities relate to continuing operations.
GW Pharmaceuticals plc
Condensed consolidated income statement
Year ended 30 September 2015
Year ended
30 September
2015
$000's
Year ended
30 September
2015
£000's
Year ended
30 September
2014
£000's
Revenue 43,172 28,540 30,045
Cost of sales (3,960) (2,618) (2,060)
Research and development expenditure (116,153) (76,785) (43,475)
Sales, general and administrative expenses (19,013) (12,569) (7,337)
Net foreign exchange gain 9,382 6,202 3,188
Operating loss (86,572) (57,230) (19,639)
Interest income 369 244 130
Interest expense (113) (75) (61)
Loss before tax (86,316) (57,061) (19,570)
Tax benefit 18,906 12,498 4,911
Loss for the year (67,410) (44,563) (14,659)
Loss per share – basic and diluted (27.4)c (18.1)p (7.0)p
All activities relate to continuing operations.
Condensed consolidated statement of comprehensive loss
For the year ended 30 September 2015
Year ended
30 September
2015
£000's
Year ended
30 September
2014
£000's
Loss for the year (44,563) (14,659)
Items that may be reclassified subsequently to profit or loss
Exchange differences on translation of foreign operations (71) (2)
Other comprehensive loss for the year (71) (2)
Total comprehensive loss for the year (44,634) (14,661)
GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Year ended 30 September 2015
Called-up
share
capital
£000's
Share
premium
account
£000's
Other
reserves
£000's

Accumulated
deficit
£000's

Total
Equity
£000's
Balance at 1 October 2013 178 84,005 20,184 (68,965) 35,402
Issue of share capital 51 127,315 -- -- 127,366
Expense of new equity issue -- (1,067) -- -- (1,067)
Exercise of share options 4 5,014 -- -- 5,018
Exercise of warrants 4 5,284 (922) 922 5,288
Share-based payment transactions -- -- -- 1,238 1,238
Loss for the period -- -- -- (14,659) (14,659)
Other comprehensive expense -- -- (2) -- (2)
Balance at 30 September 2014 237 220,551 19,260 (81,464) 158,584
Balance at 1 October 2014 237 220,551 19,260 (81,464) 158,584
Issue of share capital (note 12) 22 127,812 -- -- 127,834
Expense of new equity issue -- (271) -- -- (271)
Exercise of share options 2 1,183 -- -- 1,185
Share-based payment transactions -- -- -- 2,488 2,488
Loss for the year -- -- -- (44,563) (44,563)
Deferred tax attributable to unrealized share option gains -- -- -- 84 84
Other comprehensive expense -- -- (71) -- (71)
Balance at 30 September 2015 261 349,275 19,189 (123,455) 245,270
GW Pharmaceuticals plc
Condensed consolidated balance sheet
As at 30 September 2015
As at 30
September
2015
As at 30
September
2015
As at 30
September
2014
Non-current assets $000's £000's £000's
Intangible assets - goodwill 7,881 5,210 5,210
Other intangible assets 371 245 --
Property, plant and equipment 43,464 28,733 11,639
Deferred tax asset 632 418 277
52,348 34,606 17,126
Current assets
Inventories 7,194 4,756 4,777
Taxation recoverable 19,122 12,641 5,251
Trade receivables and other assets 4,346 2,873 1,857
Cash and cash equivalents 355,292 234,872 164,491
385,954 255,142 176,376
Total assets 438,302 289,748 193,502
Current liabilities
Trade and other payables (36,338) (24,022) (12,376)
Current tax liabilities (554) (366) --
Obligations under finance leases (167) (111) (126)
Deferred revenue (4,945) (3,269) (4,827)
(42,004) (27,768) (17,329)
Non-current liabilities
Trade and other payables (12,775) (8,445) (7,927)
Obligations under finance leases (2,330) (1,540) (1,781)
Deferred revenue (10,173) (6,725) (7,881)
Total liabilities (67,282) (44,478) (34,918)
Net assets 371,020 245,270 158,584
Equity
Share capital 395 261 237
Share premium account 528,348 349,275 220,551
Other reserves 29,027 19,189 19,260
Accumulated deficit (186,750) (123,455) (81,464)
Total equity 371,020 245,270 158,584
GW Pharmaceuticals plc
Condensed consolidated cash flow statement
For the year ended 30 September 2015
Year ended
30 September
2015
$000's
Year ended
30 September
2015
£000's
Year ended
30 September
2014
£000's
Loss for the year (67,410) (44,563) (14,659)
Adjustments for:
Interest income (369) (244) (130)
Interest expense 113 75 61
Tax benefit (18,906) (12,498) (4,911)
Depreciation of property, plant and equipment 3,404 2,250 1,398
Impairment of property, plant and equipment 917 606 --
Amortization of intangible assets 79 52 --
Net foreign exchange gains (9,503) (6,282) (1,876)
Increase/(decrease) in provision for inventories 50 33 (408)
Loss on disposal of property, plant and equipment 2 1 2
Share-based payment charge 3,748 2,478 1,238
(87,875) (58,092) (19,285)
(Increase)/decrease in inventories (18) (12) 292
Increase in trade receivables and other assets (1,528) (1,010) (142)
Increase in trade and other payables and deferred revenue 10,934 7,228 3,328
Cash used in operations (78,487) (51,886) (15,807)
Research and development tax credits received 8,191 5,415 3,181
Net cash outflow from operating activities (70,296) (46,471) (12,626)
Investing activities
Interest received 357 236 145
Purchases of property, plant and equipment (27,101) (17,915) (7,254)
Purchase of intangible assets (171) (114) --
Proceeds from sales of property, plant and equipment 3 2 14
Net cash outflow from investing activities (26,912) (17,791) (7,095)
Financing activities
Proceeds on exercise of share options 1,793 1,185 5,018
Proceeds of new equity issue 193,374 127,834 127,367
Expenses of new equity issue (410) (271) (1,067)
Proceeds of warrant exercise -- -- 5,288
Interest paid (112) (74) (61)
Proceeds from fit out funding -- -- 7,822
Repayments of obligations under finance leases (386) (255) (100)
Net cash inflow from financing activities 194,259 128,419 144,267
Effect of foreign exchange rate changes on cash and cash equivalents 9,415 6,224 1,876
Net increase in cash and cash equivalents 106,466 70,381 126,422
Cash and cash equivalents at beginning of the period 248,826 164,491 38,069
Cash and cash equivalents at end of the period 355,292 234,872 164,491

Source:GW Pharmaceuticals plc