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

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Aug 9, 2016

- Positive Phase 3 Epidiolex pivotal trial in Lennox-Gastaut Syndrome (LGS) -
- Positive FDA pre-NDA meeting - NDA for Dravet syndrome and LGS on track for H1 2017 submission -
            -Conference call today at 8:30 a.m. EDT, 1:30 p.m. BST -

LONDON, Aug. 09, 2016 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (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 third quarter ended 30 June 2016.

"We have now reported two positive Phase 3 trials for Epidiolex and are on track for an NDA filing that includes both the Dravet syndrome and Lennox-Gastaut Syndrome indications. We believe that these Phase 3 data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile," stated Justin Gover, GW's Chief Executive Officer. "Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch."

RECENT OPERATIONAL HIGHLIGHTS

  • Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
    • Phase 3 development programs:
      • Positive results in first Phase 3 Dravet syndrome trial
      • Positive results in first Phase 3 LGS trial
      • Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December
      • Positive Dravet syndrome Pre-NDA meeting held with FDA
      • NDA on track for H1 2017 submission for both Dravet and LGS indications
      • Data from second LGS trial expected at end of Q3
      • Second Phase 3 Dravet syndrome trial ongoing
      • Phase 3 trial in TSC ongoing
      • Phase 3 trial in IS to commence in Q4 2016
    • Expanded access program and open label extension:
      • Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial
  • 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 H1 2017
    • CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 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
    • THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
    • Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016
    • THCV Phase 2 study in type 2 diabetes completed, primary endpoint not achieved

FINANCIAL HIGHLIGHTS

  • Loss for the nine months ended 30 June 2016 of £46.7 million ($62.2 million) compared to £32.3 million for the nine months ended 30 June 2015. This increased loss primarily reflects investment in the Epidiolex Phase 3 pivotal trials program.

  • Cash and cash equivalents at 30 June 2016 of £191.2 million ($254.3 million) compared to £234.9 million as at 30 September 2015. Subsequently in July 2016 a follow-on offering raised total net proceeds after expenses of $273.1 million (£206.4 million).

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the third quarter 2016 financial results today at 8:30 a.m. EDT / 1:30 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 # 13642862.

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, 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 Relations  401 500 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 30 June 2016

  30 June30 June30 June
 Notes 2016 2016 2015
  $000's£000's£000's
Revenue2 3,097  2,329  8,629 
Cost of sales  (946) (711) (721)
Research and development expenditure3 (34,058) (25,609) (20,841)
Sales, general and administrative expenses  (7,452) (5,603) (2,984)
Net foreign exchange gain/(loss)  14,883  11,190  (8,851)
  _____________________
Operating loss  (24,476) (18,404) (24,768)
Interest income  130  98  46 
Interest expense  (24) (18) (21)
  _____________________
Loss before tax  (24,370) (18,324) (24,743)
Tax benefit4 8,125  6,109  3,318 
  _____________________
Loss for the period  (16,245) (12,215) (21,425)
  _____________________
     
Loss per share — basic and diluted5(6.1c)(4.6p)(8.5p)

All activities relate to continuing operations.


Condensed consolidated statement of comprehensive loss                         
For the three months ended 30 June 2016

 30 June
2016
£000's
30 June
2015
£000's
Loss for the period (12,215) (21,425)
Items that may be reclassified subsequently to profit or loss  
Exchange gain on retranslation of foreign operations 266  16 
Other comprehensive gain for the period 266  16 
Total comprehensive loss for the period (11,949) (21,409)
       

GW Pharmaceuticals plc
Condensed consolidated income statement
Nine months ended 30 June 2016

  30 June30 June30 June
 Notes 2016 2016 2015
  $000's£000's£000's
Revenue2 11,497  8,645  22,945 
Cost of sales  (2,580) (1,940) (1,935)
Research and development expenditure3 (100,406) (75,497) (51,328)
Sales, general and administrative expenses  (16,584) (12,470) (7,581)
Net foreign exchange gain/(loss)  25,640  19,279  (672)
  _____________________
Operating loss  (82,433) (61,983) (38,571)
Interest income  388  292  161 
Interest expense  (70) (53) (60)
  _____________________
Loss before tax  (82,115) (61,744) (38,470)
Tax benefit4 19,942  14,995  6,140 
  _____________________
Loss for the period  (62,173) (46,749) (32,330)
  _____________________
     
Loss per share — basic and diluted5(23.7c)(17.8p)(13.4p)

All activities relate to continuing operations.

Condensed consolidated statement of comprehensive loss                         
For the nine months ended 30 June 2016

 30 June
2016
£000's
30 June
2015
£000's
Loss for the period (46,749) (32,330)
Items that may be reclassified subsequently to profit or loss  
Exchange gain/(loss) on retranslation of foreign operations 166  (20)
Other comprehensive gain/(loss) for the period 166  (20)
Total comprehensive loss for the period (46,583) (32,350)
       

GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Nine months ended 30 June 2016

  Share   
 SharepremiumOtherAccumulated 
 capitalaccountreservesdeficitTotal
 £000's£000's£000's£000's£000's
Balance at 1 October 2014 237 220,551  19,260  (81,464) 158,584 
Issue of share capital22 127,812  -  -  127,834 
Expense of new equity issue- (307) -  -  (307)
Exercise of share options2 1,139  -  -  1,141 
Share-based payment transactions- -  -  1,161  1,161 
Loss for the period- -  -  (32,330) (32,330)
Other comprehensive loss- -  (20) -  (20)
 ____________________________________________
Balance at 30 June 2015261 349,195  19,240  (112,633) 256,063 
 ____________________________________________
      
      
      
Balance at 1 October 2015261 349,275  19,189  (123,455) 245,270 
Exercise of share options2 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 2016263 349,908  19,355  (163,938) 205,588 
 ____________________________________________
      

GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 30 June 2016

  As at
30 June
As at
30 June
As at
30 September
 Notes 2016 2016 2015
Non-current assets $000's£000's£000's
Goodwill  6,929  5,210  5,210 
Other intangible assets  749  563  245 
Property, plant and equipment  51,266  38,548  28,733 
Deferred tax asset  2,506  1,884  418 
  _____________________________
   61,450  46,205  34,606 
  _____________________________
Current assets    
Inventories6 5,955  4,478  4,756 
Taxation recoverable  18,912  14,220  12,641 
Trade receivables and other assets7 5,204  3,913  2,873 
Cash and cash equivalents  254,252  191,177  234,872 
  _____________________________
   284,323  213,788  255,142 
  _____________________________
Total assets  345,773  259,993  289,748 
  _____________________________
Current liabilities    
Trade and other payables8 (43,514) (32,719) (24,022)
Current tax liabilities  -  -  (366)
Obligations under finance leases10 (153) (115) (111)
Deferred revenue9 (3,028) (2,277) (3,269)
  _____________________________
   (46,695) (35,111) (27,768)
     
Non-current liabilities    
Trade and other payables8 (11,211) (8,430) (8,445)
Obligations under finance leases10 (6,658) (5,006) (1,540)
Deferred revenue9 (7,791) (5,858) (6,725)
  _____________________________
Total liabilities  (72,355) (54,405) (44,478)
  _____________________________
Net assets  273,418  205,588  245,270 
  _____________________________
     
Equity    
Share capital  350  263  261 
Share premium account  465,353  349,908  349,275 
Other reserves  25,741  19,355  19,189 
Accumulated deficit   (218,026) (163,938) (123,455)
  _____________________________
Total equity  273,418  205,588  245,270 
  _____________________________


GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the nine months ended 30 June 2016

 Nine months endedNine months endedNine months ended
 30 June30 June30 June
  2016    2016 2015
 $000's  £000's£000's
Loss for the period (62,173) (46,749) (32,330)
Adjustments for:   
Interest income (388) (292) (161)
Interest expense 70  53  60 
Tax benefit (19,942) (14,995) (6,140)
Depreciation of property, plant and equipment 3,359  2,526  1,670 
Amortization of intangible assets 56  42  2 
Net foreign exchange (gains)/losses (25,777) (19,382) 672 
(Decrease)/increase in provision for inventories (60) (45) 13 
Profit on disposal of property, plant and equipment -  -  (1)
Share-based payment charge 7,847  5,900  1,166 
 ______________________________
  (97,008) (72,942) (35,049)
Decrease in inventories 430  323  - 
Decrease/(Increase) in trade receivables and other assets 76  57  (171)
Increase in trade and other payables and deferred revenue 4,354  3,274  5,715 
 ______________________________
Cash used in operations (92,148) (69,288) (29,505)
Income taxes paid (1,529) (1,150) - 
Research and development tax credits received 17,663  13,281  5,415 
 ______________________________
Net cash outflow from operating activities (76,014) (57,157) (24,090)
 ______________________________
Investing activities   
Interest received 386  290  154 
Purchases of property, plant and equipment (8,319) (6,255) (14,136)
Purchase of intangible assets (483) (363) (59)
Proceeds from sales of property, plant and equipment -  -  2 
 ______________________________
Net cash outflow from investing activities (8,416) (6,328) (14,039)
 ______________________________
Financing activities   
Proceeds on exercise of share options 845  635  1,141 
Proceeds of new equity issue -  -  127,834 
Expenses of new equity issue -  -  (307)
Interest paid (70) (53) (63)
Repayment of fit out funding (319) (240) - 
Capital element of finance leases (130) (98) (228)
 ______________________________
Net cash inflow from financing activities 326  244  128,377 
 ______________________________
Effect of foreign exchange rate changes on cash and cash equivalents 25,993  19,546  (691)
 ______________________________
Net (decrease)/increase in cash and cash equivalents (58,111) (43,695) 89,557 
Cash and cash equivalents at beginning of the period 312,363  234,872  164,491 
  __________ __________ __________
Cash and cash equivalents at end of the period 254,252  191,177  254,048 
  __________ __________
 __________


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