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GW Pharmaceuticals plc Reports First Quarter 2015 Financial Results and Operational Progress

LONDON, Feb. 4, 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 first quarter ended 31 December 2014.

RECENT OPERATIONAL HIGHLIGHTS

  • Rapid advance of epilepsy program and upcoming milestones:
    • Dravet Syndrome
      • Part A of Phase 2/3 trial complete
      • Part B of Phase 2/3 trial to commence Q1 2015 – top-line data expected by end of 2015
      • Second Phase 3 trial on track to start Q1 2015 and expected to complete recruitment in 2015
      • Orphan designation from European Medicines Agency for Dravet syndrome
    • Lennox-Gastaut syndrome
      • Two Phase 3 trials in Lennox-Gastaut syndrome on track to start end Q1 2015 and expected to complete recruitment in 2015
    • Expanded Access Program
      • 235 children currently on treatment in U.S. expanded access program at 13 clinical sites
      • Updated data abstract submitted to the American Academy of Neurology 2015 Annual Meeting being held in April
    • Phase 2 CBDV epilepsy trial due to commence Q1 2015
    • Notice of Allowance issued by the U.S. Patent and Trademark Office for patent application covering use of CBD in treatment of partial seizures
  • Sativex® program developments and upcoming milestones:
    • First of three Phase 3 cancer pain trials complete, results did not show a statistically significant difference for Sativex compared with placebo
    • Two additional Phase 3 cancer pain trials expected to read out in H2 2015
  • Significant additional on-going clinical trial activity for cannabinoid pipeline product candidates and upcoming 2015 milestones:
    • Phase 2a study of GWP42003 for the treatment of schizophrenia underway with data expected H2 2015
    • Second part of Phase 1b/2a study underway of GWP42002:GWP42003 for the treatment of Recurrent Glioblastoma Multiforme (GBM), first part safety cohort data reviewed by independent monitoring board with agreement to proceed
    • Phase 2b trial of GWP42004 in type-2 diabetes underway with expected completion in 2016

FINANCIAL HIGHLIGHTS

  • Revenue for the three months ended 31 December 2014 of £8.0 million ($12.4 million) compared to £7.5 million for the three months ended 31 December 2013.
  • Loss for the three months ended 31 December 2014 of £3.4 million ($5.3 million) compared to £2.8 million for the three months ended 31 December 2013.
  • Cash and cash equivalents at 31 December 2014 of £156.6 million ($243.9 million) compared to £164.5 million as at 30 September 2014.

"GW has very substantial clinical activity under way. In the next two months, we will commence all four pivotal trials of Epidiolex in Dravet syndrome and Lennox-Gastaut syndrome and we expect initial top line data from at least one of these trials by the end of the year," stated Justin Gover, GW's Chief Executive Officer. "In addition, the expanded access program continues to point to the potential for Epidiolex to treat additional forms of epilepsy and we expect to commence clinical development programs in further potential target indications during 2015. A further release of data from this expanded access program is expected to be presented during the second quarter. Beyond epilepsy, we are continuing to progress further clinical trials in a number of additional cannabinoid product candidates during the remainder of this year. With so much activity and a robust balance sheet, we are pleased with progress and confident in our prospects."

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 first quarter financial results today at 8:00 a.m. EST / 1:00 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 at least 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13599976.

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 2/3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of GW products commercially available and in development, the clinical benefits of Sativex® and Epidiolex® and the safety profile and commercial potential of Sativex and Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Enquiries:

GW Pharmaceuticals plc (Today) + 44 20 3727 1000
Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen (UK) + 44 20 3727 1000
Robert Stanislaro (U.S.) 212 850 5657
Trout Group, LLC (U.S. investor relations)
Todd James / Chad Rubin 646 378 2900
GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 31 December 2014
Three months Three months Three months
ended ended ended
31 December 31 December 31 December
2014 2014 2013
$000's £000's £000's
Revenue 12,408 7,965 7,487
Cost of sales (887) (569) (358)
Research and development expenditure (23,561) (15,126) (9,153)
Management and administrative expenses (1,250) (802) (1,275)
Net foreign exchange gain/(loss) 6,284 4,034 (236)
Operating loss (7,006) (4,498) (3,535)
Interest income 68 44 31
Interest expense (31) (20) (20)
Loss before tax (6,969) (4,474) (3,524)
Tax benefit 1,664 1,068 707
Loss for the period (5,305) (3,406) (2,817)
Loss per share – basic and diluted (2.2c) (1.4p) (1.6p)
All activities relate to continuing operations.
GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Three months ended 31 December 2014
Called-up Share
share premium Other Accumulated
capital account reserves deficit Total
£000's £000's £000's £000's £000's
Balance at 1 October 2013 178 84,005 20,184 (68,965) 35,402
Exercise of share options -- 299 -- -- 299
Share-based payment transactions -- -- -- 241 241
Loss for the period -- -- -- (2,817) (2,817)
Balance at 31 December 2013 178 84,304 20,184 (71,541) 33,125
Balance at 1 October 2014 237 220,551 19,260 (81,464) 158,584
Issue of share capital -- 59 -- -- 59
Exercise of share options -- 62 -- -- 62
Share-based payment transactions -- -- -- 269 269
Loss for the period -- -- -- (3,406) (3,406)
Other comprehensive loss -- -- (6) -- (6)
Balance at 31 December 2014 237 220,672 19,254 (84,601) 155,562
Consolidated statement of comprehensive loss
For the three months ended 31 December 2014
Three months Three months
ended ended
31 December 31 December
2014 2013
£000's £000's
Loss for the period (3,406) (2,817)
Items that may be reclassified subsequently to profit or loss
Exchange differences on retranslation of foreign operations (6) --
Other comprehensive loss for the period (6) --
Total comprehensive loss for the period (3,412) (2,817)
GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 December 2014
As at As at As at
31 December 31 December 30 September
2014 2014 2014
Non-current assets $000's £000's £000's
Intangible assets – goodwill 8,115 5,210 5,210
Property, plant and equipment 27,622 17,733 11,639
Deferred tax asset 398 255 277
36,135 23,198 17,126
Current assets
Inventories 7,243 4,649 4,777
Taxation recoverable 9,876 6,340 5,251
Trade receivables and other assets 3,192 2,049 1,857
Cash and cash equivalents 243,926 156,594 164,491
264,237 169,632 176,376
Total assets 300,372 192,830 193,502
Current liabilities
Trade and other payables (21,051) (13,514) (12,376)
Obligations under finance leases (213) (137) (126)
Deferred revenue (9,721) (6,240) (4,827)
(30,985) (19,891) (17,329)
Non-current liabilities
Trade and other payables (12,529) (8,043) (7,927)
Obligations under finance leases (2,713) (1,742) (1,781)
Deferred revenue (11,827) (7,592) (7,881)
Total liabilities (58,054) (37,268) (34,918)
Net assets 242,318 155,562 158,584
Equity
Share capital 369 237 237
Share premium account 343,743 220,672 220,551
Other reserves 29,991 19,254 19,260
Accumulated deficit (131,785) (84,601) (81,464)
Total equity 242,318 155,562 158,584
GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the three months ended 31 December 2014
Three months Three months Three months
ended ended ended
31 December 31 December 31 December
2014 2014 2013
$000's £000's £000's
Loss for the period (5,305) (3,406) (2,817)
Adjustments for:
Interest income (68) (44) (31)
Interest expense 31 20 20
Tax benefit (1,664) (1,068) (707)
Depreciation of property, plant and equipment 767 492 303
Net foreign exchange gains (6,337) (4,068) (201)
Decrease in provision for inventories (45) (29) (344)
Share-based payment charge 419 269 241
(12,202) (7,834) (3,536)
Decrease/(increase) in inventories 245 157 (373)
Increase in trade receivables and other assets (299) (192) (2,815)
Increase in trade and other payables and deferred revenue 2,630 1,689 4,279
Net cash outflow from operating activities (9,626) (6,180) (2,445)
Investing activities
Interest received 65 42 45
Purchases of property, plant and equipment (9,185) (5,897) (862)
Net cash outflow from investing activities (9,120) (5,855) (817)
Financing activities
Proceeds on exercise of share options 97 62 299
Proceeds of new equity issue 92 59 --
Interest paid (36) (23) (20)
Capital element of finance leases (44) (28) (21)
Net cash inflow from financing activities 109 70 258
Effect of foreign exchange rate changes on cash and cash equivalents 6,337 4,068 201
Net decrease in cash and cash equivalents (12,300) (7,897) (2,803)
Cash and cash equivalents at beginning of the period 256,226 164,491 38,069
Cash and cash equivalents at end of the period 243,926 156,594 35,266

Source:GW Pharmaceuticals plc