GW Pharmaceuticals plc Reports Fiscal Second Quarter 2018 Financial Results and Operational Progress

May 8, 2018

- Positive unanimous vote at Epidiolex® (cannabidiol) FDA Advisory Committee meeting -
- NDA PDUFA goal date scheduled for June 27, 2018 -
- Conference call today at 4:30 p.m. EST -

LONDON and CARLSBAD, Calif., May 08, 2018 (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 second quarter ended 31 March 2018.

“The positive outcome of the Epidiolex FDA Advisory Committee meeting was a momentous event for GW. The strength and consistency of the clinical data, together with the public presentations that featured very moving personal stories of the challenges associated with managing these difficult forms of epilepsy, led to a unanimous vote in support of approval,” stated Justin Gover, GW’s Chief Executive Officer. “With our late June FDA decision date nearing, our commercial team is busy preparing to launch Epidiolex in the second half of this year. Should Epidiolex be approved, we believe that this will signal a major vote of confidence in GW’s cannabinoid platform to discover and develop prescription medicines that meet exacting regulatory standards and will serve us to accelerate a number of important pipeline programs that have the potential to offer additional value.”

OPERATIONAL HIGHLIGHTS

  • Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
    • Regulatory
      • NDA for the adjunctive treatment of seizures associated with LGS and Dravet PDUFA goal date of June 27, 2018
      • Positive, unanimous vote in support of approval by FDA Advisory Committee
      • Conditional grant of rare pediatric disease designation by FDA
      • European submission accepted for review by the EMA.  Expected decision in Q1 2019
    • Manufacturing
      • FDA pre-approval cGMP inspections successfully completed with no 483 citations
    • Clinical data
      • Second Phase 3 LGS trial accepted for publication. Paper expected to be released shortly
      • New data presented at the American Academy of Neurology (AAN) Annual Meeting
        - Long-term safety and efficacy data in patients LGS and Dravet syndrome presented
        - Abuse liability data
    • Clinical trials
      • Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019
      • Second Phase 3 trial in Dravet syndrome enrollment complete with data expected H2 2018
      • Part A of two-part Phase 2/3 trial in Infantile Spasms nearing completion; based on currently available data unlikely to proceed into Part B
    • Expanded access program and open label extension
      • Over 2,000 patients now have been exposed to Epidiolex treatment
    • Commercial
      • U.S. Sales leadership team in place and preparing for launch
      • Active engagement with U.S. payors is ongoing
      • Commercial footprint established in top 5 EU markets
    • Life-cycle management
      • Several new formulations of CBD in development including modified liquid formulations, a solid dose form and an intravenous formulation
    • Intellectual property
      • 7 key favorable patent application decisions by USPTO related to the use of CBD in epilepsy
        • 5 patent grants following March 2018 Notices of Allowance
        • 2 new Notices of Allowance issued by USPTO
        • Additional patent applications under review and being filed as new data is generated
  • Pipeline progress
    • Sativex® (nabiximols) for Multiple Sclerosis spasticity
      • U.S. development and commercialization rights wholly owned by GW
      • Three positive Phase 3 trials completed in Europe
      • Plans to engage with FDA in H2 2018 with a view to commencing a single U.S. pivotal trial
    • CBDV in Autism Spectrum Disorders
      • 10-patient investigator-initiated expanded access program for seizures associated with autism underway. Data expected Q4 2018.
      • Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q3 2018
      • Open label study in Rett syndrome due to commence Q3 and Phase 2 placebo-controlled trial in Rett syndrome due to commence in Q4 2018
        • Orphan Drug Designation from FDA and EMA for CBDV for the treatment of Rett syndrome
    • CBD:THC in Glioblastoma
      • Phase 2 study showed significant increase in one year survival compared to placebo
      • Pivotal clinical development program plans under development 
      • Orphan Drug Designation from both FDA and EMA for CBD:THC to treat glioblastoma
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
      • Phase 1 trial complete
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
      • Phase 2 trial in planning

FINANCIAL HIGHLIGHTS

  • Cash and cash equivalents at 31 March 2018 of £346.8 million ($487.2 million) compared to £241.2 million as at 30 September 2017
     
  • Revenue for the six months ended 31 March 2018 of £8.1 million ($11.4 million) compared to £3.7 million for the six months ended 31 March 2017
     
  • Loss for the six months ended 31 March 2018 of £109.6 million ($154.0 million) compared to £50.0 million for the six months ended 31 March 2017

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 31 March 2018 of $1.40495 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 Information
GW Pharmaceuticals will host a conference call and webcast to discuss the second quarter 2018 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 or 919-882-2331 (international). For both dial-in numbers please use conference ID # 13679685 and PIN: 29077.

About GW Pharmaceuticals plc and Greenwich Biosciences

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, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted regulatory applications in the U.S. and Europe for the adjunctive treatment of Lennox-Gastaut syndrome and Dravet syndrome. The Company continues to evaluate Epidiolex in additional rare epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the company is now planning a U.S. Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. 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 the Company’s regulatory processes, and the level of 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 4 December 2017. 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 (U.S.) 917 280 2424 / 401 500 6570
   
U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
 
Christy Curran
Mike Beyer
615 414 8668
312 961 2502
   
EU Media Enquiries:
FTI Consulting
 
Ben Atwell
Simon Conway
+44 (0) 3727 1000

 
     


 
GW Pharmaceuticals plc
Condensed consolidated income statement
Three months ended 31 March 2018 and 2017
               
    Three months
 ended
  Three months
 ended
  Three months
 ended
 
    31 March   31 March   31 March  
    2018   2018   2017  
    $000’s   £000’s   £000’s  
               
Revenue   3,351   2,385   1,627  
Cost of sales   (1,637 ) (1,165 ) (687 )
Research and development expenditure   (46,057 ) (32,782 ) (27,157 )
Sales, general and administrative expenses   (24,779 ) (17,637 ) (9,290 )
Net foreign exchange loss   (20,533 ) (14,615 ) (3,988 )
               
Operating loss   (89,655 ) (63,814 ) (39,495 )
Interest expense   (327 ) (233 ) (153 )
Interest and other income   1,862   1,325   313  
               
Loss before tax   (88,120 ) (62,722 ) (39,335 )
Tax benefit   80   57   4,968  
               
Loss for the period   (88,040 ) (62,665 ) (34,367 )
               
Loss per share – basic and diluted   (26.0c)   (18.5p)   (11.3p)  
Loss per ADS – basic and diluted(1)   (312.0c)   (222.0p)   (135.6p)  
               
Weighted average ordinary shares outstanding (in millions) – basic and diluted       338.2   303.7  
               

All activities relate to continuing operations.
(1) Each ADS represents 12 ordinary shares

     
Condensed consolidated statement of comprehensive loss    
For the three months ended 31 March 2018 and 2017    
     
  Three months
ended
31 March
2018
£000’s
  Three months
ended
31 March
2017
£000’s
 
Loss for the period (62,665 ) (34,367 )
Items that may be reclassified subsequently to profit or loss    
Exchange loss on retranslation of foreign operations (753 ) (177 )
Other comprehensive loss for the period (753 ) (177 )
Total comprehensive loss for the period (63,418 ) (34,544 )
         


 
GW Pharmaceuticals plc
Condensed consolidated income statement
Six months ended 31 March 2018 and 2017
               
    Six months
 ended
  Six months
 ended
  Six months
 ended
 
    31 March   31 March   31 March  
    2018   2018   2017  
    $000’s   £000’s   £000’s  
               
Revenue   11,404   8,117   3,683  
Cost of sales   (2,877 ) (2,048 ) (1,402 )
Research and development expenditure   (88,594 ) (63,058 ) (52,071 )
Sales, general and administrative expenses   (49,211 ) (35,027 ) (15,974 )
Net foreign exchange (loss)/gain   (24,120 ) (17,168 ) 7,827  
Operating loss   (153,398 ) (109,184 ) (57,937 )
Interest expense   (660 ) (470 ) (243 )
Interest and other income   3,550   2,527   586  
Loss before tax   (150,508 ) (107,127 ) (57,594 )
Tax (expense)/benefit   (3,497 ) (2,489 ) 7,631  
Loss for the period   (154,005 ) (109,616 ) (49,963 )
               
Loss per share – basic and diluted   (47.4c)   (33.7p)   (16.5p)  
Loss per ADS – basic and diluted (1)   (568.8c)   (404.4p)   (198.0p)  
               
Weighted average ordinary shares outstanding (in millions) – basic and diluted       325.0   303.2  
               

All activities relate to continuing operations.
(1) Each ADS represents 12 ordinary shares

         
Condensed consolidated statement of comprehensive loss        
For the six months ended 31 March 2018 and 2017        
         
  Six months
ended
31 March
2018
£000’s
  Six months
ended
31 March
2017
£000’s
 
Loss for the period (109,616 ) (49,963 )
Items that may be reclassified subsequently to profit or loss    
Exchange (loss)/gain on retranslation of foreign operations (940 ) 241  
Other comprehensive (loss)/gain for the period (940 ) 241  
Total comprehensive loss for the period (110,556 ) (49,722 )
         


           
GW Pharmaceuticals plc          
Condensed consolidated statement of changes in equity          
Six months ended 31 March 2018 and 2017          
           
  Called-up   Share              
  share   premium     Other   Accumulated      
  capital   account     reserves     deficit     Total  
  £000’s £000’s   £000’s   £000’s   £000’s  
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 - -   -   4,768   4,768  
Loss for the period - -   -   (49,963 ) (49,963 )
Deferred tax attributable to unrealized share option gains - -   -   595   595  
Other comprehensive income - -   241   -   241  
           
Balance at 31 March 2017 304 556,565   19,779   (222,427 ) 354,221  
           
           
           
           
Balance at 1 October 2017   304 556,570   18,822   (297,521 ) 278,175  
Exercise of share options 2 -   -   -   2  
Issue of share capital 33 223,037   -   -   223,070  
Expense of new equity issue - (926 ) -   -   (926 )
Share-based payment transactions - -   -   8,969   8,969  
Loss for the period - -   -   (109,616 ) (109,616 )
Deferred tax attributable to unrealized share option gains - -   -   675   675  
Other comprehensive loss - -   (940 ) -   (940 )
                   
Balance at 31 March 2018 339 778,681   17,882   (397,493 ) 399,409  
                   


GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 March 2018 and 30 September 2017
               
    As at
31 March
  As at
31 March
  As at
30 September
 
    2018     2018   2017  
Non-current assets   $000’s   £000’s   £000’s  
Intangible assets - goodwill   7,320   5,210   5,210  
Other intangible assets   2,723   1,938   1,049  
Property, plant and equipment   67,862   48,302   43,666  
Deferred tax asset   9,899   7,046   6,282  
    87,804   62,496   56,207  
Current assets              
Inventories   4,896   3,485   4,244  
Taxation recoverable   30,105   21,428   20,072  
Trade receivables and other current assets   19,450   13,844   11,217  
Cash and cash equivalents   487,235   346,798   241,175  
    541,686   385,555   276,708  
Total assets   629,490   448,051   332,915  
Current liabilities              
Trade and other payables   (43,071 ) (30,656 ) (33,119 )
Current tax liabilities   (3,333 ) (2,372 ) (838 )
Obligations under finance leases   (296 ) (211 ) (205 )
Deferred revenue   (1,145 ) (815 ) (2,307 )
    (47,845 ) (34,054 ) (36,469 )
               
Non-current liabilities              
Trade and other payables   (11,744 ) (8,359 ) (9,256 )
Obligations under finance leases   (6,530 ) (4,648 ) (4,755 )
Deferred revenue   (2,221 ) (1,581 ) (4,260 )
Total liabilities   (68,340 ) (48,642 ) (54,740 )
Net assets   561,150   399,409   278,175  
               
Equity              
Share capital   476   339   304  
Share premium account   1,094,010   778,681   556,570  
Other reserves   25,123   17,882   18,822  
Accumulated deficit    (558,459 ) (397,493 ) (297,521 )
               
Total equity   561,150   399,409   278,175  
               


             
GW Pharmaceuticals plc             
Condensed consolidated cash flow statements             
For the six months ended 31 March 2018 and 2017             
             
  Six months ended   Six months ended   Six months ended  
  31 March   31 March   31 March  
    2018     2018     2017  
  $000’s     £000’s     £000’s  
Loss for the period (154,005 ) (109,616 ) (49,963 )
Adjustments for:            
Interest and other income (3,550 ) (2,527 ) (586 )
Interest expense 660   470   243  
Tax expense/(benefit) 3,497   2,489   (7,631 )
Depreciation of property, plant and equipment 4,350   3,096   2,310  
Impairment of property, plant and equipment -   -   95  
Reversal of impairment of property, plant and equipment -   -   (216 )
Amortization of intangible assets 270   192   87  
Net foreign exchange losses/(gains) 24,120   17,168   (7,827 )
Increase in provision for inventories 5,292   3,767   47  
Decrease in deferred signature fees (4,159 ) (2,960 ) (823 )
Share-based payment charge 12,601   8,969   4,768  
Loss on disposal of property, plant and equipment 6   4   564  
  (110,918 ) (78,948 ) (58,932 )
Increase in inventories (4,228 ) (3,009 ) (442 )
Increase in trade receivables and other assets (586 ) (417 ) (1,667 )
Decrease in trade and other payables and deferred revenue (5,165 ) (3,676 ) (4,108 )
Research and development tax credits received 242   172   -  
Income taxes paid (1,710 ) (1,217 ) (828 )
             
Net cash outflow from operating activities (122,365 ) (87,095 ) (65,977 )
             
Investing activities            
Interest received 1,439   1,024   437  
Purchases of property, plant and equipment (15,034 ) (10,701 ) (8,995 )
Purchases of intangible assets (1,201 ) (855 ) (428 )
             
Net cash outflow from investing activities (14,796 ) (10,532 ) (8,986 )
             
Financing activities            
Proceeds on exercise of share options 1   1   90  
Proceeds of new equity issue 313,403   223,070   -  
Expenses of new equity issue (1,203 ) (856 ) (134 )
Interest paid (660 ) (470 ) (462 )
Repayments of fit out funding (270 ) (192 ) (656 )
Repayment of obligations under finance leases (142 ) (101 ) (82 )
             
Net cash inflow/(outflow) from financing activities 311,129   221,452   (1,244 )
             
Effect of foreign exchange rate changes on cash and cash equivalents (25,573 ) (18,202 ) 8,100  
             
Net increase/(decrease) in cash and cash equivalents 148,395   105,623   (68,107 )
Cash and cash equivalents at beginning of the period 338,840   241,175   374,392  
             
Cash and cash equivalents at end of the period 487,235   346,798   306,285  
             


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Source: GW Pharmaceuticals plc