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

LONDON, May 11, 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 second quarter and half-year ended 31 March 2015.

RECENT OPERATIONAL HIGHLIGHTS

  • Epidiolex® (CBD) childhood epilepsy program:
    • Dravet syndrome - Two Phase 3 pivotal trials recently commenced with top-line data expected from the first trial by end of 2015
    • Lennox-Gastaut syndrome - First Phase 3 trial in Lennox-Gastaut syndrome commenced (see separate announcement today). Second Phase 3 trial on track to start in calendar Q2 2015
    • Tuberous Sclerosis Complex selected as additional new target indication with Phase 3 trial expected to start in H2 2015
    • Recent data on 137 patients from expanded access program presented at American Academy of Neurology further reinforces signals of clinical effect seen in previous data disclosures
    • Approx. 290 children currently on treatment in expanded access program at 17 U.S. clinical sites
    • Approx. 420 children authorized for treatment by FDA under Expanded Access Treatment INDs and additional 225 patients authorized by FDA under 4 U.S. State programs
    • Notice of Allowance issued by the U.S. Patent and Trademark Office (USPTO) covering the use of CBD in the treatment of partial seizures.
  • Cannabidivarin (CBDV) epilepsy program:
    • Phase 2 CBDV epilepsy study in 130 patients underway
    • Notice of Allowance issued by the USPTO for patent application covering use of CBDV for the treatment of epilepsy
  • Cannabinoid pipeline product candidates:
    • Orphan drug designation granted for CBD in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). Phase 1 trial expected to commence in H2 2015
    • Recruitment complete in a Phase 2a study for the treatment of schizophrenia - data expected H2 2015
    • First of three Sativex Phase 3 cancer pain trials 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
    • Phase 1b study of GWP42002:GWP42003 underway for the treatment of Recurrent Glioblastoma Multiforme (GBM)
    • Phase 2 study of GWP42004 in type-2 diabetes underway with expected completion in 2016

FINANCIAL HIGHLIGHTS

  • Follow-on offering closed 5 May 2015 raising total net proceeds after expenses of approximately $167.8 million (£110.4 million).
  • Revenue for the six months ended 31 March 2015 of £14.3 million ($21.3 million) compared to £15.0 million for the six months ended 31 March 2014.
  • Loss for the six months ended 31 March 2015 of £10.9 million ($16.2 million) compared to £8.0 million for the six months ended 31 March 2014.
  • Cash and cash equivalents at 31 March 2015 of £148.6 million ($220.7 million) compared to £164.5 million as at 30 September 2014.

"During the second quarter, we commenced our pivotal Phase 3 trials program for Epidiolex in childhood epilepsy and expect these trials to recruit rapidly with a view to reporting initial top-line data around the end of 2015. The new data presented at the American Academy of Neurology has only served to reinforce our confidence in the potential for Epidiolex to become an important advance in the field of treatment-resistant epilepsy," stated Justin Gover, GW's Chief Executive Officer. "With our successful follow-on offering, GW is in a strong position to continue to prepare for a NDA submission to the FDA in 2016 and to make necessary preparations toward a successful commercial launch."

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 second quarter and half year financial results today at 8:00 a.m. EDT / 1:00 p.m. BST. 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 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID #13609474.

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. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 3 clinical development for the treatment of Dravet syndrome and the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes Sativex in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer, as well as compounds in Phase 1 and 2 clinical development for glioma, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

Note regarding expanded access studies

Expanded access studies are uncontrolled, carried out by individual physician investigators independent from GW, and not always conducted in strict compliance with Good Clinical Practices, all of which can lead to a treatment effect which may differ from one seen in placebo-controlled trials. Data from these studies provide only anecdotal evidence of efficacy for regulatory review, although they may provide supportive safety information for regulatory review. These studies contain no control or comparator group for reference and are not designed to be aggregated or reported as study results. Moreover, data from such small numbers of patients may be highly variable. Such information, including the statistical principles that the independent physician investigators have chosen to apply to the data, may not reliably predict data collected via systematic evaluation of the efficacy in company-sponsored clinical trials or evaluated via other statistical principles that may be applied in these trials. Reliance on such information may lead to Phase 2 and/or Phase 3 clinical trials that are not adequately designed to demonstrate efficacy and could delay or prevent GW's ability to seek approval of Epidiolex.

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 in this news release 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 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 March 2015
Three months
ended
Three months
ended
Three months
ended
31 March 31 March 31 March
2015 2015 2014
$000's £000's £000's
Revenue 9,432 6,351 7,527
Cost of sales (958) (645) (640)
Research and development expenditure (22,812) (15,362) (11,885)
Management and administrative expenses (5,635) (3,794) (1,851)
Net foreign exchange gain/(loss) 6,156 4,145 (243)
Operating loss (13,817) (9,305) (7,092)
Interest income 105 71 26
Interest expense (28) (19) (19)
Loss before tax (13,740) (9,253) (7,085)
Tax benefit 2,605 1,754 1,889
Loss for the period (11,135) (7,499) (5,196)
Loss per share – basic and diluted (4.8c) (3.2p) (2.5p)

All activities relate to continuing operations.

GW Pharmaceuticals plc
Condensed consolidated income statement
Six months ended 31 March 2015
Six months
ended
Six months
ended
Six months
ended
31 March 31 March 31 March
2015 2015 2014
$000's £000's £000's
Revenue 21,261 14,317 15,015
Cost of sales (1,803) (1,214) (998)
Research and development expenditure (45,274) (30,487) (21,037)
Management and administrative expenses (6,826) (4,597) (3,126)
Net foreign exchange gain/(loss) 12,146 8,179 (479)
Operating loss (20,496) (13,802) (10,625)
Interest income 170 114 56
Interest expense (58) (39) (39)
Loss before tax (20,384) (13,727) (10,608)
Tax benefit 4,191 2,823 2,596
Loss for the period (16,193) (10,904) (8,012)
Loss per share – basic and diluted (6.8c) (4.6p) (4.1p)

All activities relate to continuing operations.

Consolidated statement of comprehensive loss
For the six months ended 31 March 2015
Six months
ended
31 March
2015
£000's
Six months
ended
31 March
2014
£000's
Loss for the period (10,904) (8,012)
Items that may be reclassified subsequently to profit or loss
Exchange differences on retranslation of foreign operations (36) --
Other comprehensive loss for the period (36) --
Total comprehensive loss for the period (10,940) (8,012)
GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Six months ended 31 March 2015
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
Issue of share capital 34 57,333 -- -- 57,367
Expense of new equity issue -- (577) -- -- (577)
Exercise of share options 1 1,708 -- -- 1,709
Exercise of warrants 3 5,284 (922) 922 5,287
Share-based payment transactions -- -- -- 566 566
Loss for the period -- -- -- (8,012) (8,012)
Balance at 31 March 2014 216 147,753 19,262 (75,489) 91,742
Balance at 1 October 2014 237 220,551 19,260 (81,464) 158,584
Issue of share capital -- 59 -- -- 59
Exercise of share options -- 379 -- -- 379
Share-based payment transactions -- -- -- 806 806
Loss for the period -- -- -- (10,904) (10,904)
Other comprehensive loss -- -- (36) -- (36)
Balance at 31 March 2015 237 220,989 19,224 (91,562) 148,888
GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 March 2015
As at
31 March
As at
31 March
As at
30 September
2015 2015 2014
Non-current assets $000's £000's £000's
Goodwill 7,736 5,210 5,210
Other intangible assets 85 57 --
Property, plant and equipment 32,381 21,805 11,639
Deferred tax asset 310 208 277
40,512 27,280 17,126
Current assets
Inventories 6,646 4,475 4,777
Taxation recoverable 4,050 2,728 5,251
Trade receivables and other assets 4,101 2,761 1,857
Cash and cash equivalents 220,719 148,632 164,491
235,516 158,596 176,376
Total assets 276,028 185,876 193,502
Current liabilities
Trade and other payables (23,493) (15,820) (12,376)
Obligations under finance leases (221) (149) (126)
Deferred revenue (5,875) (3,956) (4,827)
(29,589) (19,925) (17,329)
Non-current liabilities
Trade and other payables (11,965) (8,057) (7,927)
Obligations under finance leases (2,528) (1,703) (1,781)
Deferred revenue (10,846) (7,303) (7,881)
Total liabilities (54,928) (36,988) (34,918)
Net assets 221,100 148,888 158,584
Equity
Share capital 353 237 237
Share premium account 328,169 220,989 220,551
Other reserves 28,548 19,224 19,260
Accumulated deficit (135,970) (91,562) (81,464)
Total equity 221,100 148,888 158,584
GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the six months ended 31 March 2015
Six months ended Six months ended Six months ended
31 March 31 March 31 March
2015 2015 2014
As restated1
$000's £000's £000's
Loss for the period (16,193) (10,904) (8,012)
Adjustments for:
Interest income (170) (114) (56)
Interest expense 58 39 39
Tax benefit (4,191) (2,823) (2,596)
Depreciation of property, plant and equipment 1,509 1,016 641
Amortisation of intangible assets 3 2 --
Net foreign exchange gains (12,274) (8,265) (1,008)
Increase/(decrease) in provision for inventories 19 13 (341)
Loss on disposal of property, plant and equipment 2 1 --
Share-based payment charge 1,197 806 566
(30,040) (20,229) (10,767)
Decrease in inventories 429 289 234
(Increase)/decrease in trade receivables and other assets (1,342) (904) 197
Increase in trade and other payables and deferred revenue 1,643 1,106 1,081
Cash used in operations (29,310) (19,738) (9,255)
Research and development tax credits received 8,041 5,415 --
Net cash outflow from operating activities (21,269) (14,323) (9,255)
Investing activities
Interest received 167 113 71
Purchases of property, plant and equipment (15,094) (10,165) (2,011)
Purchase of intangible assets (88) (59) --
Proceeds from sales of property, plant and equipment 1 1 --
Net cash outflow from investing activities (15,014) (10,110) (1,940)
Financing activities
Proceeds on exercise of share options 563 379 1,708
Proceeds of new equity issue 88 59 57,367
Expenses of new equity issue -- -- (577)
Proceeds of warrant exercise -- -- 5,287
Interest paid (65) (44) (37)
Proceeds from fit out funding -- -- 4,010
Capital element of finance leases (82) (55) (48)
Net cash inflow from financing activities 504 339 67,710
Effect of foreign exchange rate changes on cash and cash equivalents 12,229 8,235 1,008
Net (decrease)/increase in cash and cash equivalents (23,550) (15,859) 57,523
Cash and cash equivalents at beginning of the period 244,269 164,491 38,069
Cash and cash equivalents at end of the period 220,719 148,632 95,592

Source:GW Pharmaceuticals plc