- Epidiolex ® NDA submission process underway -  - Conference call today at 4:30 p.m. EDT -

LONDON and CARLSBAD, Calif., Aug. 07, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (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 third quarter ended 30 June 2017.                                       "I am pleased to report the NDA submission process for Epidiolex is now underway with the final sections of the submission expected to be completed in October. With a clear view now towards our anticipated approval, we are making excellent progress with preparations to ensure a highly successful launch in 2018," stated Justin Gover, GW's Chief Executive Officer. "Following the recent publication of our first Phase 3 trial in The New England Journal of Medicine, we look forward to additional Epidiolex data publications and presentations in the second half of the year. In addition to Epidiolex, we continue to keep focus on our growing and innovative cannabinoid pipeline where we have advanced a number of additional exciting clinical programs."

OPERATIONAL HIGHLIGHTS

• Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)
  • Regulatory progress: - NDA rolling submission for both Dravet and LGS indications underway. Pre-clinical module submitted;  Clinical module submission in progress; CMC module submission expected in October- EMA pre-submission meetings held. Expected EU regulatory submission in Q4 2017
  • Further clinical progress: - Phase 3 Dravet syndrome trial published in The New England Journal of Medicine - Quality of Life in Childhood Epilepsy published in Epilepsia - Phase 3 trial in Tuberous Sclerosis Complex ongoing - Part A of two-part Phase 3 trial in Infantile Spasms ongoing - Numerous abstracts submitted to American Epilepsy Society annual meeting
  • Manufacturing scale-up on track to deliver significant projected commercial launch inventory:- Preparations on track for FDA GMP inspection anticipated in early 2018
  • Expanded access program and open label extension:- Over 1,500 patients now exposed to Epidiolex treatment - 97 percent of patients who complete Phase 3 trials have entered long term extension
  • Commercial progress:- U.S. pre-launch commercial leadership team in place - Full team of epilepsy specialist Medical and Scientific Liaisons (MSLs) in place with significant medical education initiatives underway and major presence at key target congresses - EU commercial team build-out underway and increasing presence at European congresses
  • Strengthened Epidiolex exclusivity:- 14 distinct patent families in prosecution relating to the use of CBD in the treatment of epilepsy; decisions expected for several patents towards end 2017 and H1 2018- 6 patents published in the last quarter claiming various methods of treatment using CBD 
  • Life-cycle management: - Several new formulations of CBD in Phase 1 trials

• Progressed cannabinoid pipeline product candidates
  • CBDV Phase 2 partial-onset epilepsy study in adults fully enrolled. Data expected end 2017/early 2018
  • CBDV in field of autism spectrum disorders: - Expanded access IND granted by FDA for 10 patients with autism - Open label study in Rett syndrome and Phase 2 placebo-controlled trial in planning for H1 2018 - Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
  • CBD:THC in Glioblastoma:- Positive survival data from Phase 2 study presented recently at ASCO; further follow-up demonstrates continued increased survival in the CBD:THC arm
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program:- Phase 1 trial complete- Orphan Drug and Fast Track Designations granted from FDA and EMA

• Management appointments
  • Dr. Volker Knappertz appointed Chief Medical Officer
  • Douglas Snyder appointed Chief Legal Officer
  • Prof. Ben Whalley appointed as Director of Research

FINANCIAL HIGHLIGHTS

• Cash and cash equivalents at 30 June 2017 of £284.1 million ($369.5 million) compared to £374.4 million as at 30 September 2016

• Revenue for the nine months ended 30 June 2017 of £6.1 million ($7.9 million) compared to £8.6 million for the nine months ended 30 June 2016

• Loss for the nine months ended 30 June 2017 of £90.3 million ($117.5 million) compared to £46.7 million for the nine months ended 30 June 2016

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 30 June 2017 of $1.30081 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Conference Call and Webcast InformationGW Pharmaceuticals will host a conference call and webcast to discuss the third quarter 2017 financial results today at 4:30 pm EST. 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):1-877-481-4010. For both dial-in numbers please use conference ID # 13667808 and PIN: 19259.

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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), for which GW has commenced a rolling NDA submission with the FDA for the treatment of Dravet syndrome and Lennox-Gastaut syndrome. The Company continues to evaluate Epidiolex in additional epilepsy conditions and currently has ongoing Phase 3 clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. 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 30 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, 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 timing and outcomes of regulatory or intellectual property decisions, 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 including the most recent Form 20-F filed on 5 December 2016. 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.
   
GW Pharmaceuticals plcCondensed consolidated income statementThree months ended 30 June 2017  
                   
    30 June     30 June     30 June  
    2017     2017     2016  
    $000's     £000's     £000's  
Revenue   3,138     2,412     2,329  
Cost of sales   (1,444 )   (1,110 )   (711 )
Research and development expenditure   (36,339 )   (27,936 )   (25,609 )
Sales, general and administrative expenses   (15,286 )   (11,751 )   (5,603 )
Net foreign exchange (loss) / gain   (10,940 )   (8,410 )   11,190  
             
Operating loss   (60,871 )   (46,795 )   (18,404 )
Interest income   593     456     98  
Interest expense   (346 )   (266 )   (18 )
         
Loss before tax   (60,624 )   (46,605 )   (18,324 )
Tax benefit   8,126     6,247     6,109  
         
Loss for the period   (52,498 )   (40,358 )   (12,215 )
         
         
Loss per share - basic and diluted   (17.3c) (13.3p) (4.6p)
Loss per ADS - basic and diluted (1)   (207.6c) (159.6p) (55.2p)
         
Weighted average ordinary shares outstanding (in millions) - basic and diluted       303.9     262.9  
 
All activities relate to continuing operations.
(1) Each ADS represents 12 ordinary shares

Condensed consolidated statement of comprehensive loss
For the three months ended 30 June 2017    
     
  30 June 2017 £000's 30 June2016£000's
Loss for the period (40,358 ) (12,215 )
Items that may be reclassified subsequently to profit or loss    
Exchange (loss)/gain on retranslation of foreign operations (508 ) 266  
Other comprehensive (loss)/gain for the period (508 ) 266  
Total comprehensive loss for the period (40,866 ) (11,949 )

GW Pharmaceuticals plc
Condensed consolidated income statement
Nine months ended 30 June 2017
 
    30 June   30 June   30 June  
    2017   2017   2016  
    $000's   £000's   £000's  
Revenue   7,928   6,095   8,645  
Cost of sales   (3,268 ) (2,512 ) (1,940 )
Research and development expenditure   (104,074 ) (80,007 ) (75,497 )
Sales, general and administrative expenses   (36,065 ) (27,725 ) (12,470 )
Net foreign exchange (loss) / gain   (757 ) (583 ) 19,279  
               
Operating loss   (136,236 ) (104,732 ) (61,983 )
Interest income   1,355   1,042   292  
Interest expense   (662 ) (509 ) (53 )
               
Loss before tax   (135,543 ) (104,199 ) (61,744 )
Tax benefit   18,053   13,878   14,995  
               
Loss for the period   (117,490 ) (90,321 ) (46,749 )
               
               
Loss per share - basic and diluted   (38.7c)   (29.8p)   (17.8p)  
Loss per ADS - basic and diluted (1)   (464.4c)   (357.6p)   (213.6p)  
         
Weighted average ordinary shares outstanding (in millions) - basic and diluted     303.4   262.3  
 
All activities relate to continuing operations.
(1) Each ADS represents 12 ordinary shares

Condensed consolidated statement of comprehensive loss
For the nine months ended 30 June 2017    
     
  30 June 2017 £000's   30 June2016£000's  
Loss for the period (90,321 ) (46,749 )
Items that may be reclassified subsequently to profit or loss    
Exchange (loss)/gain on retranslation of foreign operations (267 ) 166  
Other comprehensive (loss)/gain for the period (267 ) 166  
Total comprehensive loss for the period (90,588 ) (46,583 )

GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Nine months ended 30 June 2017  
           
      Share      
  Share   premium   Other   Accumulated    
  capital   account   reserves     deficit     Total  
   £000's £000's £000's   £000's   £000's  
                 
Balance at 1 October 2015 261 349,275 19,189   (123,455 ) 245,270  
Exercise of share options 2 633 -   -   635  
Share-based payment transactions - - -   5,900   5,900  
Loss for the period - - -   (46,749 ) (46,749 )
Deferred tax attributable to unrealized share option gains - - -   366   366  
Other comprehensive gain - - 166   -   166  
           
Balance at 30 June 2016 263 349,908 19,355   (163,938 ) 205,588  
           
           
           
           
Balance at 1 October 2016 302 556,477 19,538   (177,827 ) 398,490  
Exercise of share options 2 88 -   -   90  
Share-based payment transactions - - -   8,141   8,141  
Loss for the period - - -   (90,321 ) (90,321 )
Deferred tax attributable to unrealized share option gains - - -   (251 ) (251 )
Other comprehensive loss - - (267 ) -   (267 )
           
Balance at 30 June 2017 304 556,565 19,271   (260,258 ) 315,882  

GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 30 June 2017
 
    As at30 June   As at 30 June   As at30 September  
    2017   2017   2016  
Non-current assets   $000's   £000's    £000's  
Goodwill   6,777   5,210   5,210  
Other intangible assets   1,232   947   629  
Property, plant and equipment   53,122   40,838   38,947  
Deferred tax asset   6,944   5,338   3,873  
               
    68,075   52,333   48,659  
               
Current assets              
Inventories   5,354   4,116   4,248  
Taxation recoverable   16,860   12,961   21,322  
Trade receivables and other assets   12,926   9,937   4,556  
Cash and cash equivalents   369,539   284,084   374,392  
               
    404,679   311,098   404,518  
Assets held for sale   1,182   909   -  
               
Total assets   473,936   364,340   453,177  
               
Current liabilities              
Trade and other payables   (34,652 ) (26,639 ) (31,170 )
Current tax liabilities   (1,131 ) (870 ) (883 )
Obligations under finance leases   (263 ) (202 ) (211 )
Deferred revenue   (3,007 ) (2,312 ) (2,686 )
               
    (39,053 ) (30,023 ) (34,950 )
               
Non-current liabilities              
Trade and other payables   (11,830 ) (9,094 ) (9,423 )
Obligations under finance leases   (6,253 ) (4,807 ) (4,959 )
Deferred revenue   (5,898 ) (4,534 ) (5,355 )
               
Total liabilities   (63,034 ) (48,458 ) (54,687 )
               
Net assets   410,902   315,882   398,490  
               
               
Equity              
Share capital   395   304   302  
Share premium account   723,985   556,565   556,477  
Other reserves   25,068   19,271   19,538  
Accumulated deficit    (338,546 ) (260,258 ) (177,827 )
               
Total equity   410,902   315,882   398,490  
               

GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the nine months ended 30 June 2017
 
  Nine months ended   Nine months ended   Nine months ended  
  30 June   30 June   30 June  
    2017   2017     2016  
  $000's     £000's     £000's  
Loss for the period (117,490 ) (90,321 ) (46,749 )
Adjustments for:            
Interest income (1,355 ) (1,042 ) (292 )
Interest expense 662   509   53  
Tax benefit (18,053 ) (13,878 ) (14,995 )
Depreciation of property, plant and equipment 4,918   3,781   2,526  
Impairment of property, plant and equipment 124   95   -  
Reversal of impairment of property, plant and equipment (281 ) (216 ) -  
Amortization of intangible assets 219   168   42  
Net foreign exchange losses/(gains) 758   583   (19,382 )
Increase/(decrease) in provision for inventories 104   80   (45 )
Decrease in deferred signature fees (1,427 ) (1,097 ) (881 )
Share-based payment charge 10,590   8,141   5,900  
Loss on disposal of property, plant and equipment 787   605   -  
             
  (120,444 ) (92,592 ) (73,823 )
Decrease in inventories 68   52   323  
(Increase)/decrease in trade receivables and other assets (2,490 ) (1,914 ) 57  
(Decrease)/increase in trade and other payables and deferred revenue (1,664 ) (1,279 ) 4,155  
             
Cash used in operations (124,530 ) (95,733 ) (69,288 )
Income taxes paid (1,661 ) (1,277 ) (1,150 )
Research and development tax credits received 28,200   21,679   13,281  
             
Net cash outflow from operating activities (97,991 ) (75,331 ) (57,157 )
             
Investing activities            
Interest received 1,262   970   290  
Purchases of property, plant and equipment (16,896 ) (12,989 ) (6,255 )
Purchase of intangible assets (609 ) (468 ) (363 )
             
Net cash outflow from investing activities (16,243 ) (12,487 ) (6,328 )
             
Financing activities            
Proceeds on exercise of share options 118   91   635  
Expenses of new equity issue (174 ) (134 ) -  
Interest paid (948 ) (729 ) (53 )
Repayment of fit out funding (973 ) (748 ) (240 )
Repayment of obligations under finance leases (208 ) (160 ) (98 )
             
Net cash (outflow)/inflow from financing activities (2,185 ) (1,680 ) 244  
             
Effect of foreign exchange rate changes on cash and cash equivalents (1,053 ) (810 ) 19,546  
             
Net decrease in cash and cash equivalents (117,472 ) (90,308 ) (43,695 )
Cash and cash equivalents at beginning of the period 487,011   374,392   234,872  
             
Cash and cash equivalents at end of the period 369,539   284,084   191,177  
             
Enquiries:GW Pharmaceuticals plc	Stephen Schultz, VP Investor Relations	401 500 6570Sam Brown (U.S. Media Enquiries)Christy Curran615 414 8668

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