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

-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
 ______________________________



 

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