- Epidiolex® (cannabidiol) oral solution approved by FDA and on track to be launched in Fall -
- Conference call today at 4:30 p.m. ET -

LONDON and CARLSBAD, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the development and commercialization of cannabinoid prescription medicines, announces financial results for the third quarter ended 30 June 2018.

“The recent FDA approval of Epidiolex represents a major medical advance for patients with Lennox-Gastaut Syndrome and Dravet syndrome. We anticipate rescheduling to be completed within 90 days of FDA approval and for product launch to take place in the Fall,” stated Justin Gover, GW’s Chief Executive Officer. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”

OPERATIONAL HIGHLIGHTS

  • Epidiolex (cannabidiol)
    • Regulatory:
      • FDA approval for the treatment of seizures associated with LGS or Dravet syndrome
      • Epidiolex rescheduling expected within 90 days of FDA approval
      • European submission under review by the EMA with decision expected in Q1 2019
      • FDA issuance of a priority review voucher (PRV) for Epidiolex.
    • Manufacturing
      • Commercial product being manufactured and prepared for shipping to the U.S.
      • Continued investment in expanded facilities to meet anticipated long-term demand  
    • Commercial:
      • U.S. sales organization fully recruited comprising two national directors, eight regional managers plus 66 Neurology Account Managers  
      • Active engagement with U.S. payors ongoing with clinical presentations to plans that cover over 80% of covered lives in the U.S. 
      • U.S. supply chain platform in place which will employ a closed model distribution network of five Specialty Pharmacy Providers (SPP’s)
      • Commercial footprint in place in 5 major European markets in readiness for 2019 European launches
    • Epilepsy Clinical trials
      • Three Phase 3 clinical trials published - two in The New England Journal of Medicine and one in The Lancet
      • Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019
    • Autism
      • Decision to expand target indications for Epidiolex beyond epilepsy to autism. IND expected to be submitted for pivotal Rett Syndrome study in Q4 18.
    • Expanded access program and open label extension:
      • Over 2,000 patients now have been exposed to Epidiolex treatment
    • Life-cycle management
      • Several new formulations of CBD in development including modified oral solution, capsule and an intravenous formulation
    • Exclusivity
      • 7-year orphan exclusivity confirmed by FDA, 6-month pediatric extension expected
      • Key favorable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam
        • Patents align directly with new Epidiolex FDA label and to be listed in Orange Book
        • Patent expiry dates to 2035
      • Additional patent applications under review and being filed as new data is generated
  • Pipeline progress
    • Sativex® (nabiximols)
      • U.S. development and commercialization rights wholly owned by GW
      • Initial U.S. target indication: Multiple Sclerosis spasticity. Three positive Phase 3 trials completed in Europe
      • Plans to meet with FDA in H2 18 to determine MS spasticity regulatory pathway in the U.S.
      • Over 20 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
    • CBDV
      • 10-patient investigator-initiated expanded access program for seizures associated with autism underway
      • Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q3 18
      • Open label study in Rett syndrome and seizures due to commence Q3 18
    • CBD:THC in Glioblastoma
      • Recent data presented from the Phase 2 study showed significant increase in median survival for patients taking CBD:THC of 662 days compared to 369 days on 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 30 June 2018 of £334.0 million ($440.2 million) compared to £241.2 million as at 30 September 2017
     
  • Revenue for the nine months ended 30 June 2018 of £10.7 million ($14.2 million) compared to £6.1 million for the nine months ended 30 June 2017
     
  • Loss for the nine months ended 30 June 2018 of £136.7 million ($180.2 million) compared to £90.3 million for the nine months ended 30 June 2017

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 30 June 2018 of $1.31792 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 third quarter 2018 financial results today at 4:30 pm ET. 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 Replay ID: 35897.

About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
Founded in 1998, GW is the world leader in the development and commercialization of cannabinoid prescription medicines. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, received U.S. FDA approval in June 2018 and is under review by European regulators. Previously, GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols) in Europe and is now advancing plans to develop this medicine in the US. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in development for epilepsy, autism, 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 EPIDIOLEX (cannabidiol) oral solution and the safety profile and commercial potential of 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 and 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 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 30 June 2018 and 2017
     
  30 June30 June30 June
  201820182017
  $000’s£000’s£000’s
Revenue 3,457  2,623  2,412 
Cost of sales (1,741) (1,321) (1,110)
Research and development expenditure (24,503) (18,592) (27,936)
Sales, general and administrative expenses (35,158) (26,677) (11,751)
Net foreign exchange gain/(loss) 21,825  16,560  (8,410)
Operating loss (36,120) (27,407) (46,795)
Interest expense (303) (230) (266)
Interest and other income 1,452  1,102  456 
Loss before tax (34,971) (26,535) (46,605)
Tax (expense)/benefit (734) (557) 6,247 
Loss for the period (35,705) (27,092) (40,358)
     
Loss per share – basic and diluted (10.5c) (8.0p) (13.3p)
Loss per ADS – basic and diluted(1) (126.0c) (96.0p) (159.6p)
     
Weighted average ordinary shares outstanding (in millions) – basic and diluted   338.6  303.9 
         
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 2018 and 2017
  
 30 June
2018
£000’s
30 June
2017
£000’s
Loss for the period(27,092)(40,358)
Items that may be reclassified subsequently to profit or loss  
Exchange gain/(loss) on retranslation of foreign operations959 (508)
Other comprehensive gain/(loss) for the period959 (508)
Total comprehensive loss for the period(26,133)(40,866)
     


     
GW Pharmaceuticals plc
Condensed consolidated income statement
Nine months ended 30 June 2018 and 2017
     
  30 June30 June30 June
  201820182017
  $000’s£000’s£000’s
Revenue 14,154  10,740  6,095 
Cost of sales (4,440) (3,369) (2,512)
Research and development expenditure (107,608) (81,650) (80,007)
Sales, general and administrative expenses (81,321) (61,704) (27,725)
Net foreign exchange loss (801) (608) (583)
Operating loss (180,016) (136,591) (104,732)
Interest expense (923) (700) (509)
Interest and other income 4,783  3,629  1,042 
Loss before tax (176,156) (133,662) (104,199)
Tax (expense)/benefit (4,014) (3,046) 13,878 
Loss for the period (180,170) (136,708) (90,321)
     
Loss per share – basic and diluted (54.7c) (41.5p) (29.8p)
Loss per ADS – basic and diluted(1) (656.4c) (498.0p) (357.6p)
     
Weighted average ordinary shares outstanding (in millions) – basic and diluted   329.6  303.4 
         
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 2018 and 2017
  
   
 30 June
2018
£000’s


30 June
2017
£000’s
Loss for the period(136,708)(90,321)
Items that may be reclassified subsequently to profit or loss  
Exchange gain/(loss) on retranslation of foreign operations19 (267)
Other comprehensive gain/(loss) for the period19 (267)
Total comprehensive loss for the period(136,689)(90,588)
     


       
GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Nine months ended 30 June 2018 and 2017
       
   Share   
 SharepremiumOtherAccumulated 
 capitalaccountreservesdeficitTotal
 £000’s£000’s£000’s£000’s£000’s
Balance at 1 October 2016302  556,477  19,538  (177,827) 398,490 
Exercise of share options2  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 2017304  556,565  19,271  (260,258) 315,882 
       
       
       
Balance at 1 October 2017304  556,570  18,822  (297,521) 278,175 
Exercise of share options2  -  -  -  2 
Issue of share capital33  223,037  -  -  223,070 
Expense of new equity issue-  (911) -  -  (911)
Share-based payment transactions-  -  -  15,742  15,742 
Loss for the period-  -  -  (136,708) (136,708)
Deferred tax attributable to unrealized share option gains-  -  -  2,202  2,202 
Other comprehensive gain-  -  19  -  19 
Balance at 30 June 2018339  778,696  18,841  (416,285) 381,591 
       


     
GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 30 June 2018 and 30 September 2017
     
  As at
30 June
As at
30 June
As at
30 September
  2018  2018  2017 
Non-current assets $000’s£000’s£000’s
Goodwill 6,866  5,210  5,210 
Other intangible assets 2,855  2,166  1,049 
Property, plant and equipment 65,768  49,903  43,666 
Deferred tax asset 11,287  8,564  6,282 
  86,776  65,843  56,207 
Current assets    
Inventories 26,333  19,981  4,244 
Taxation recoverable 2,499  1,896  20,072 
Trade receivables and other assets 23,367  17,730  11,217 
Cash and cash equivalents 440,190  334,005  241,175 
  492,389  373,612  276,708 
Total assets 579,165  439,455  332,915 
Current liabilities    
Trade and other payables (52,876) (40,121) (33,119)
Current tax liabilities (2,558) (1,941) (838)
Obligations under finance leases (282) (214) (205)
Deferred revenue (1,074) (815) (2,307)
  (56,790) (43,091) (36,469)
     
Non-current liabilities    
Trade and other payables (11,602) (8,803) (9,256)
Obligations under finance leases (6,053) (4,593) (4,755)
Deferred revenue (1,815) (1,377) (4,260)
Total liabilities (76,260) (57,864) (54,740)
Net assets 502,905  381,591  278,175 
     
Equity    
Share capital 447  339  304 
Share premium account 1,026,255  778,696  556,570 
Other reserves 24,831  18,841  18,822 
Accumulated deficit (548,628) (416,285) (297,521)
Total equity 502,905  381,591  278,175  
     
     


 
GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the nine months ended 30 June 2018 and 2017
      
 Nine months ended Nine months ended Nine months ended
 30 June 30 June 30 June
 2018   2018 2017
 $000’s   £000’s £000’s
Loss for the period(180,170) (136,708) (90,321)
Adjustments for:     
Interest and other income(4,783) (3,629) (1,042)
Interest expense923  700  509 
Tax expense/(benefit)4,014  3,046  (13,878)
Depreciation of property, plant and equipment6,190  4,697  3,781 
Impairment of property, plant and equipment-  -  95 
Reversal of impairment of property, plant and equipment-  -  (216)
Amortization of intangible assets480  364  168 
Net foreign exchange losses800  607  583 
(Decrease)/increase in provision for inventories(477) (362) 80 
Decrease in deferred signature fees(4,169) (3,163) (1,097)
Share-based payment charge20,743  15,742  8,141 
Loss on disposal of property, plant and equipment149  113  605 
 (156,300) (118,593) (92,592)
(Increase)/decrease in inventories(20,789) (15,774) 52 
Increase in trade receivables and other assets(3,033) (2,301) (1,914)
Increase/(decrease) in trade and other payables and deferred revenue9,305  7,061  (1,279)
Research and development tax credits received26,509  20,114  21,679 
Income taxes paid(2,562) (1,944) (1,277)
Net cash outflow from operating activities(146,870) (111,437) (75,331)
Investing activities             
Interest received2,205  1,673  970 
Purchases of property, plant and equipment(22,399) (16,996) (12,989)
Purchase of intangible assets(1,730) (1,313) (468)
Net cash outflow from investing activities(21,924) (16,636) (12,487)
Financing activities             
Proceeds on exercise of share options3  2  91 
Proceeds of new equity issue293,987  223,070  - 
Expenses of new equity issue(1,201) (911) (134)
Interest paid(923) (700) (729)
Repayment of fit out funding(384) (291) (748)
Repayment of obligations under finance leases(202) (153) (160)
Net cash inflow/(outflow) from financing activities291,280  221,017  (1,680)
Effect of foreign exchange rate changes on cash and cash equivalents(144) (114) (810)
Net increase/(decrease) in cash and cash equivalents122,342  92,830  (90,308)
Cash and cash equivalents at beginning of the period317,848  241,175  374,392 
Cash and cash equivalents at end of the period440,190  334,005  284,084