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GW Pharmaceuticals plc Reports Second Quarter and Half-Year 2016 Financial Results and Operational Progress

- Positive Phase 3 Epidiolex pivotal trial in Dravet syndrome -
- Initial LGS Phase 3 pivotal data expected in June -
- Conference call today at 9:00 a.m. EDT, 2:00 p.m. BST -

LONDON, May 05, 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, announced financial results for the second quarter and half-year ended 31 March 2016.

“Following positive results in our first Phase 3 trial of Epidiolex in Dravet syndrome, GW is now entering an exciting new chapter as we start to prepare the Company’s first NDA submission to the FDA and step up plans for Epidiolex commercialization,” stated Justin Gover, GW’s Chief Executive Officer. “The robust data from this first Phase 3 trial in Dravet syndrome provides additional confidence for future clinical trials of Epidiolex and we look forward to results from our Phase 3 trials in Lennox-Gastaut syndrome in the near future. In addition, we continue to expand our research through exploring further indications for Epidiolex as well as ongoing Phase 2 clinical programs for a number of our pipeline candidates.”

RECENT OPERATIONAL HIGHLIGHTS

  • Epidiolex® (CBD) orphan epilepsy program:
    • Company sponsored Phase 3 development programs in Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC)
      • Positive results in first Phase 3 Dravet syndrome trial
        • Full publication of trial results expected in Q4 2016
        • Second Phase 3 Dravet syndrome trial ongoing
      • Pre-NDA meeting with FDA requested
      • Two LGS Phase 3 trials fully enrolled; Data from first trial expected in June
      • 98% transition rate of eligible patients from pivotal Phase 3 trials to long term open label extension
      • Phase 3 TSC trial commenced, Orphan Drug Designation received from FDA
      • Additional clinical development for Epidiolex expected to commence in H2 2016
    • Expanded access program:
      • Recent updates at the American Academy of Neurology (AAN) Annual Meeting showing consistent treatment effect and safety profile in state-sponsored clinical programs from Alabama and Georgia
      • 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:
    • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected Q1 2017
    • CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial clinical evaluation is expected to commence in H2 2016, with Phase 2 trials expected to commence in Q1 2017
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
    • THCV Phase 2 study in type-2 diabetes completed - data expected in Q2/3 2016
    • THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
      • Orphan Drug Designation granted from FDA and EMA
    • Sativex® Phase 2 study in spasticity due to cerebral palsy ongoing with data expected Q4 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

  • Cash and cash equivalents at 31 March 2016 of £192.7 million ($276.8 million) compared to £234.9 million as at 30 September 2015

  • Revenue for the six months ended 31 March 2016 of £6.3 million ($9.1 million) compared to £14.3 million for the six months ended 31 March 2015. This decrease primarily reflects the expected reduction in R&D fees associated with the conclusion of partner funded Sativex Phase 3 cancer pain trials

  • Loss for the six months ended 31 March 2016 of £34.5 million ($49.6 million) compared to £10.9 million for the six months ended 31 March 2015

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the second quarter and half-year 2016 financial results today at 9:00 a.m. EDT / 2:00 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) 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 # 13636232.

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, Lennox-Gastaut syndrome and 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
FleishmanHillard (U.S. Media)
Paddi Hurley / Adam Silverstein212 453 2382 / 917 697 9313


GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 31 March 2016
Three months
ended
Three months
ended
Three months
ended
31 March31 March31 March
2016 2016 2015
$000’s£000’s£000’s
Revenue 3,805 2,649 6,351
Cost of sales (779) (542) (645)
Research and development expenditure (36,988) (25,749) (15,362)
Sales, general and administrative expenses (4,657) (3,242) (3,794)
Net foreign exchange gain 6,448 4,488 4,145
_____________________
Operating loss (32,171) (22,396) (9,305)
Interest income 188 131 71
Interest expense (23) (16) (19)
_____________________
Loss before tax (32,006) (22,281) (9,253)
Tax benefit 7,827 5,449 1,754
_____________________
Loss for the period (24,179) (16,832) (7,499)
_____________________
Loss per share – basic and diluted (9.2c)(6.4p)(3.2p)
All activities relate to continuing operations.


Condensed consolidated statement of comprehensive loss
For the three months ended 31 March 2016
Three monthsThree months
endedended
31 March31 March
2016 2015
£000’s£000’s
Loss for the period (16,832) (7,499)
Items that may be reclassified subsequently to profit or loss
Exchange differences on retranslation of foreign operations (46) (30)
Other comprehensive loss for the period (46) (30)
Total comprehensive loss for the period (16,878) (7,529)


GW Pharmaceuticals plc
Condensed consolidated income statement
Six months ended 31 March 2016
Six months
ended
Six months
ended
Six months
ended
31 March31 March31 March
2016 2016 2015
$000’s£000’s£000’s
Revenue 9,073 6,316 14,317
Cost of sales (1,765) (1,229) (1,214)
Research and development expenditure (71,664) (49,888) (30,487)
Sales, general and administrative expenses (9,864) (6,867) (4,597)
Net foreign exchange gain 11,618 8,089 8,179
_____________________
Operating loss (62,602) (43,579) (13,802)
Interest income 279 194 114
Interest expense (50) (35) (39)
_____________________
Loss before tax (62,373) (43,420) (13,727)
Tax benefit 12,765 8,886 2,823
_____________________
Loss for the period (49,608) (34,534) (10,904)
_____________________
Loss per share – basic and diluted (18.9c)(13.2p)(4.6p)
All activities relate to continuing operations.


Condensed consolidated statement of comprehensive loss
For the six months ended 31 March 2016
Six monthsSix months
endedended
31 March31 March
2016 2015
£000’s£000’s
Loss for the period (34,534) (10,904)
Items that may be reclassified subsequently to profit or loss
Exchange differences on retranslation of foreign operations (99) (36)
Other comprehensive loss for the period (99) (36)
Total comprehensive loss for the period (34,633) (10,940)


GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Six months ended 31 March 2016
Called-up Share
share premium OtherAccumulated
capital account reserves deficit Total
£000’s£000’s£000’s£000’s£000’s
Balance at 1 October 2014 237220,551 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 2015237220,989 19,224 (91,562) 148,888
____________________________________________
Balance at 1 October 2015 261349,275 19,189 (123,455) 245,270
Exercise of share options2623 - - 625
Share-based payment transactions-- - 3,164 3,164
Loss for the period-- - (34,534) (34,534)
Deferred tax attributable to unrealized share option gains-- - 4 4
Other comprehensive loss-- (99) - (99)
____________________________________________
Balance at 31 March 2016263349,898 19,090 (154,821) 214,430
____________________________________________


GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 March 2016
As at
31 March
As at
31 March
As at
30 September
2016 2016 2015
Non-current assets $000’s£000’s £000’s
Intangible assets - goodwill 7,484 5,210 5,210
Other intangible assets 418 291 245
Property, plant and equipment 49,439 34,416 28,733
Deferred tax asset 1,006 700 418
_____________________________
58,347 40,617 34,606
_____________________________
Current assets
Inventories 6,698 4,663 4,756
Taxation recoverable 31,415 21,869 12,641
Trade receivables and other assets 4,847 3,374 2,873
Cash and cash equivalents 276,791 192,684 234,872
_____________________________
319,751 222,590 255,142
_____________________________
Total assets 378,098 263,207 289,748
_____________________________
Current liabilities
Trade and other payables (42,569) (29,633) (24,022)
Current tax liabilities (122) (85) (366)
Obligations under finance leases (164) (114) (111)
Deferred revenue (3,792) (2,640) (3,269)
_____________________________
(46,647) (32,472) (27,768)
Non-current liabilities
Trade and other payables (12,462) (8,675) (8,445)
Obligations under finance leases (2,130) (1,483) (1,540)
Deferred revenue (8,830) (6,147) (6,725)
_____________________________
Total liabilities (70,069) (48,777) (44,478)
_____________________________
Net assets 308,029 214,430 245,270
_____________________________
Equity
Share capital 378 263 261
Share premium account 502,628 349,898 349,275
Other reserves 27,423 19,090 19,189
Accumulated deficit (222,400) (154,821) (123,455)
_____________________________
Total equity 308,029214,430245,270
_____________________________


GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the six months ended 31 March 2016
Six months endedSix months endedSix months ended
31 March31 March31 March
2016 2016 2015
$000’s £000’s £000’s
Loss for the period (49,608) (34,534) (10,904)
Adjustments for:
Interest income (279) (194) (114)
Interest expense 50 35 39
Tax benefit (12,765) (8,886) (2,823)
Depreciation of property, plant and equipment 2,212 1,540 1,016
Amortisation of intangible assets 39 27 2
Net foreign exchange gains (12,034) (8,377) (8,265)
(Decrease)/increase in provision for inventories (66) (45) 13
Loss on disposal of property, plant and equipment - - 1
Share-based payment charge 4,545 3,164 806
______________________________
(67,906) (47,270) (20,229)
Decrease in inventories 200 138 289
Increase in trade receivables and other assets (715) (498) (904)
Increase in trade and other payables and deferred revenue 3,086 2,148 1,106
______________________________
Cash used in operations (65,335) (45,482) (19,738)
Income taxes paid (1,284) (894) -
Research and development tax credits received - - 5,415
______________________________
Net cash outflow from operating activities (66,619) (46,376) (14,323)
______________________________
Investing activities
Interest received 267 186 113
Purchases of property, plant and equipment (6,687) (4,655) (10,165)
Purchases of intangible assets (214) (149) (59)
Proceeds from sales of property, plant and equipment - - 1
______________________________
Net cash outflow from investing activities (6,634) (4,618) (10,110)
______________________________
Financing activities
Proceeds on exercise of share options 898 625 379
Proceeds of new equity issue - - 59
Interest paid (50) (35) (44)
Repayment of obligations under finance leases (79) (55) (55)
______________________________
Net cash inflow from financing activities 769 535 339
______________________________
Effect of foreign exchange rate changes on cash and cash equivalents 11,881 8,271 8,235
______________________________
Net decrease in cash and cash equivalents (60,603) (42,188) (15,859)
Cash and cash equivalents at beginning of the period 337,394 234,872 164,491
______________________________
Cash and cash equivalents at end of the period276,791192,684148,632
______________________________


Source:GW Pharmaceuticals plc