GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results and Operational Progress

-Three Phase 3 Epidiolex clinical trials fully recruited above target sample size – on track for initial data in March 2016-

-Conference Call Today at 8:00 a.m. EST, 1:00 p.m. GMT-

LONDON, Feb. 10, 2016 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (AIM: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 2015.

“We are on track to report topline data from four Epidiolex Phase 3 trials in the months ahead and remain very excited at the transformational potential of these data for GW. The treatment effect data from our expanded access program provide a solid basis for confidence in the outcome of these trials and the potential for Epidiolex to make a meaningful difference to the lives of patients with Dravet syndrome and Lennox-Gastaut syndrome,” stated Justin Gover, GW’s Chief Executive Officer. “We are looking forward to an active 2016, that, in addition to the Epidiolex Phase 3 data, is expected to include our first NDA filing, expansion of our U.S. commercial organization, and ongoing data read-outs from a number of clinical pipeline programs.”

RECENT OPERATIONAL HIGHLIGHTS

  • Epidiolex® (CBD) childhood epilepsy program:
    • Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)
      • First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized), data expected March 2016
      • Second Phase 3 Dravet syndrome trial ongoing, data expected H2 2016
      • Both LGS Phase 3 trials fully enrolled above original target sample sizes (171 for 2-arm, 225 for 3-arm randomized), data expected Q2 2016
      • 97% transition rate of eligible patients from Phase 3 trials to long term open label extension
      • NDA submission with FDA expected Q4 2016
      • Phase 3 Tuberous Sclerosis Complex trial due to commence Q1 2016
      • Additional clinical development for Epidiolex expected to commence in H2 2016
    • Expanded access program
      • Recent data update at the American Epilepsy Society December 2015 Annual Meeting showing promising safety and effectiveness consistent with prior updates
      • Over 375 children and young adults on treatment at 22 U.S. clinical sites
      • Over 900 children and young adults authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
  • Advanced clinical programs in multiple cannabinoid pipeline product candidates:
    • THCV Phase 2 study in type-2 diabetes data expected Q2 2016
    • THC:CBD 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 and EMA
    • Sativex® Phase 2 study in spasticity due to cerebral palsy ongoing with data expected H2 2016
    • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected around the end of 2016
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in H2 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
  • Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, Duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers

FINANCIAL HIGHLIGHTS

  • Revenue for the three months ended 31 December 2015 of £3.7 million ($5.4 million) compared to £8.0 million for the three months ended 31 December 2014
  • Loss for the three months ended 31 December 2015 of £17.7 million ($26.2 million) compared to £3.4 million for the three months ended 31 December 2014
  • Cash and cash equivalents at 31 December 2015 of £219.3 million ($324.1 million) compared to £234.9 million as at 30 September 2015

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the first quarter 2016 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 90 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13629628.

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 28 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Tuberous Sclerosis Complex. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, type 2 diabetes, schizophrenia and epilepsy. 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
Stephen Schultz, VP Investor Relations401 500 6570


FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway+44 20 3727 1000


GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 31 December 2015 and 2014

Three months
ended
Three months
ended
Three months
ended
31 December31 December31 December
Notes 2015 2015 2014
$000’s£000’s£000’s
Revenue2 5,418 3,667 7,965
Cost of sales (1,015) (687) (569)
Research and development expenditure3 (35,668) (24,139) (15,126)
Sales, general and administrative expenses (5,356) (3,625) (802)
Net foreign exchange gain 5,321 3,601 4,034
_____________________
Operating loss (31,300) (21,183) (4,498)
Interest income 93 63 44
Interest expense (28) (19) (20)
_____________________
Loss before tax (31,235) (21,139) (4,474)
Tax benefit4 5,079 3,437 1,068
_____________________
Loss for the period (26,156) (17,702) (3,406)
_____________________
Loss per share – basic and diluted5(10.0c)(6.8p)(1.4p)

All activities relate to continuing operations.

Condensed consolidated statement of comprehensive loss
For the three months ended 31 December 2015 and 2014

Three months ended
31 December
2015
£000’s
Three months ended
31 December 2014
£000’s
Loss for the period (17,702) (3,406)
Items that may be reclassified subsequently to profit or loss
Exchange differences on retranslation of foreign operations (53) (6)
Other comprehensive loss for the period (53) (6)
Total comprehensive loss for the period (17,755) (3,412)


GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Three months ended 31 December 2015 and 2014

Share
Share premium OtherAccumulated
capital account reserves deficit Total
£000’s£000’s£000’s£000’s£000’s
Balance at 1 October 2014237220,551 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 2014237220,672 19,254 (84,601) 155,562
____________________________________________
Balance at 1 October 2015 261349,275 19,189 (123,455) 245,270
Exercise of share options2562 - - 564
Share-based payment transactions-- - 1,306 1,306
Loss for the period-- - (17,702) (17,702)
Deferred tax attributable to unrealized share option gains

-


-


-


(74


)


(74


)
Other comprehensive loss-- (53) - (53)
____________________________________________
Balance at 31 December 2015263349,837 19,136 (139,925) 229,311
____________________________________________


GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 December 2015 and 30 September 2015

As at
31 December
As at
31 December
As at
30 September
2015 2015 2015
Non-current assets $000’s£000’s £000’s
Intangible assets - goodwill 7,698 5,210 5,210
Other intangible assets 408 276 245
Property, plant and equipment 46,469 31,449 28,733
Deferred tax asset 572 387 418
_____________________________
55,147 37,322 34,606
_____________________________
Current assets
Inventories 6,934 4,693 4,756
Taxation recoverable 24,056 16,281 12,641
Trade receivables and other assets 7,793 5,274 2,873
Cash and cash equivalents 324,057 219,313 234,872
_____________________________
362,840 245,561 255,142
_____________________________
Total assets 417,987 282,883 289,748
_____________________________
Current liabilities
Trade and other payables (48,561) (32,865) (24,022)
Current tax liabilities (359) (243) (366)
Obligations under finance leases (167) (113) (111)
Deferred revenue (5,706) (3,862) (3,269)
_____________________________
(54,793) (37,083) (27,768)
Non-current liabilities
Trade and other payables (12,620) (8,541) (8,445)
Obligations under finance leases (2,234) (1,512) (1,540)
Deferred revenue (9,510) (6,436) (6,725)
_____________________________
Total liabilities (79,157) (53,572) (44,478)
_____________________________
Net assets 338,830 229,311 245,270
_____________________________
Equity
Share capital 389 263 261
Share premium account 516,919 349,837 349,275
Other reserves 28,275 19,136 19,189
Accumulated deficit (206,753) (139,925) (123,455)
_____________________________
Total equity 338,830229,311245,270
___________________________


GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the three months ended 31 December 2015 and 2014


Three months endedThree months
ended
Three months
ended
31 December31 December31 December
2015 2015 2014
$000’s £000’s £000’s
Loss for the period (26,156) (17,702) (3,406)
Adjustments for:
Interest income
Interest expense
Tax benefit


(93)
28
(5,079)


(63)
19
(3,437)


(44)
20
(1,068)
Depreciation of property, plant and equipment
Amortization of intangible assets
Net foreign exchange gains
Increase/(decrease) in provision for inventories
1,088
21
(5,559)
10
736
14
(3,762)
7
492
-
(4,068)
(29)
Share-based payment charge 1,930 1,306 269
______________________________
(33,810) (22,882) (7,834)
Decrease in inventories 83 56 157
Increase in trade receivables and other assets (3,548) (2,401) (192)
Increase in trade and other payables and deferred revenue 11,292 7,642 1,689
Income taxes paid (541) (366) -
______________________________
Net cash outflow from operating activities (26,524) (17,951) (6,180)
______________________________
Investing activities
Interest received 103 70 42
Purchases of property, plant and equipment (2,633) (1,782) (5,897)
Purchases of intangible assets (176) (119) -
______________________________
Net cash outflow from investing activities (2,706) (1,831) (5,855)
______________________________
Financing activities
Proceeds on exercise of share options 833 564 62
Proceeds of new equity issue - - 59
Interest paid (30) (20) (23)
Repayments of obligations under finance leases (38) (26) (28)
______________________________
Net cash inflow from financing activities 765 518 70
______________________________
Effect of foreign exchange rate changes on cash and cash equivalents 5,475 3,705 4,068
______________________________
Net decrease in cash and cash equivalents (22,990) (15,559) (7,897)
Cash and cash equivalents at beginning of the period 347,047 234,872 164,491
______________________________
Cash and cash equivalents at end of the period324,057219,313156,594
______________________________




Source:GW Pharmaceuticals plc