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

May 5, 2016

- 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
 ______________________________


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