GW Pharmaceuticals plc Reports First Quarter 2017 Financial Results and Operational Progress

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Feb 7, 2017

- Epidiolex® NDA submission and launch preparation on track -
- New Positive Phase 2 glioma data further demonstrates value of cannabinoid pipeline - 
- Conference call today at 8:30 a.m. EST -

LONDON, Feb. 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, announced financial results for the first quarter ended 31 December 2016.

"As we look forward to 2017, our primary focus is on completing the Epidiolex NDA, which we expect to submit to the FDA in the middle of this year. With three positive Phase 3 trials delivered in 2016, we remain confident in the prospects for Epidiolex's approval and are accelerating our preparations for a highly successful launch," stated Justin Gover, GW's Chief Executive Officer. "Beyond Epidiolex, the value of GW's cannabinoid platform is further illustrated by promising new clinical data in the field of oncology and we continue to advance a number of additional clinical programs that will yield data this year."

OPERATIONAL HIGHLIGHTS

• Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
• Regulatory:
• NDA submission for both Dravet and LGS indications expected mid 2017
• Preparations advancing for expected EU regulatory submission in H2 2017
• Clinical:
• Positive results in a pivotal Phase 3 Dravet syndrome trial and in two pivotal Phase 3 LGS trials
• Substantial new data presented at the American Epilepsy Society Annual Meeting in December 2016
• Manufacturing scale-up on track to deliver significant commercial launch inventory
• Pre-NDA CMC meeting held with FDA in November 2016
• Successful UK regulatory GMP inspection of GW manufacturing facility in December 2016. On track for FDA GMP inspection anticipated in H2 2017
• Expanded access program and open label extension:
• Over 1,200 patients now on Epidiolex treatment
• 97 percent of patients who complete Phase 3 trials have entered long term extension
• Commercial:
• US commercial team build well underway and pre-launch preparations advancing well
• EU commercial team now being established
• Follow-on indications:
• Phase 3 trial in TSC ongoing
• Two part Phase 3 trial in IS commenced in December 2016
• Intellectual Property:
• Patent portfolio being prosecuted with claims directed to the use of CBD in the treatment of epilepsy seizure subtypes and epilepsy syndromes
 
• THC:CBD for Glioma
• Positive Phase 2 placebo-controlled data in Recurrent Glioblastoma Multiforme (GBM) (see separate announcement issued today)
• Orphan Drug Designation from FDA and EMA
• Multiple relevant patents granted or in process
 
• Other cannabinoid pipeline product candidates:
• CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H2 2017
• CBDV pre-clinical research ongoing within field of autism spectrum disorders. Phase 2 trials expected to commence in H2 2017
• Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
• Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
• Phase 1 trial commenced in October 2016
• Orphan Drug and Fast Track Designations granted from FDA and EMA
 

FINANCIAL HIGHLIGHTS

• Revenue for the three months ended 31 December 2016 of £2.1 million ($2.5 million) compared to £3.7 million for the three months ended 31 December 2015
 
• Loss for the three months ended 31 December 2016 of £15.6 million ($19.3 million) compared to £17.7 million for the three months ended 31 December 2015
 
• Cash and cash equivalents at 31 December 2016 of £360.2 million ($444.6 million) compared to £374.4 million as at 30 September 2016
 

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 31 December 2016 of $1.23429 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 first quarter 2017 financial results today at 8:30 a.m 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, (international):1-919-882-2331. For both dial-in numbers please use conference ID # 13654672.

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), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, 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 31 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 plc
Condensed consolidated income statement
Three months ended 31 December 2016 and 2015

  Three months
 ended
 Three months
 ended
 Three months
 ended
 
  31 December 31 December 31 December 
  2016 2016 2015 
  $000's £000's £000's 
Revenue 2,538 2,056 3,667 
Cost of sales (883)(715)(687)
Research and development expenditure (30,751)(24,914)(24,139)
Sales, general and administrative expenses (8,250)(6,684)(3,625)
Net foreign exchange gain 14,583 11,815 3,601 
  _________ _________ _________ 
Operating loss (22,763)(18,442)(21,183)
Interest income 337 273 63 
Interest expense (111)(90)(19)
  _________ _________ _________ 
Loss before tax (22,537)(18,259)(21,139)
Tax benefit 3,287 2,663 3,437 
   _________  _________  _________ 
Loss for the period (19,250)(15,596)(17,702)
   _________  _________  _________ 
     
Loss per share — basic and diluted (6.4c)(5.2p)(6.8p)
Loss per ADS — basic and diluted(1) (76.8c)(62.4p)(81.6p)
     
Weighted average ordinary shares outstanding (in millions) — basic and diluted  302.7 261.4 

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 December 2016 and 2015

 Three months
ended
31 December
2016
£000's
 Three months
ended
31 December
2015
£000's
 
Loss for the period(15,596)(17,702)
Items that may be reclassified subsequently to profit or loss  
Exchange gain/(loss) on retranslation of foreign operations418 (53)
Other comprehensive gain/(loss) for the period418 (53)
Total comprehensive loss for the period(15,178)(17,755)
     

GW Pharmaceuticals plc
Condensed consolidated statement of changes in equity
Three months ended 31 December 2016 and 2015

    Share   
 Share  premium  Other Accumulated   
 capital  account  reserves   deficit Total 
 £000's£000's£000's £000's £000's 
Balance at 1 October 2015261349,27519,189 (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 2015263349,83719,136 (139,925)229,311 
 ____________________________________________
      
      
      
Balance at 1 October 2016302556,47719,538 (177,827)398,490 
Exercise of share options288- - 90 
Share-based payment transactions--- 2,166 2,166 
Loss for the period--- (15,596)(15,596)
Deferred tax attributable to unrealized share option gains--- (255)(255)
Other comprehensive income--418 - 418 
 ___________________________________________
Balance at 31 December 2016304556,56519,956 (191,512)385,313 
  _________ _________ ________ _________ ________

GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 31 December 2016 and 30 September 2016

  As at
31 December
 As at
31 December
 As at
30 September
 
  2016   2016 2016 
Non-current assets $000's £000's  £000's 
Intangible assets - goodwill 6,431 5,210 5,210 
Other intangible assets 1,206 977 629 
Property, plant and equipment 46,647 37,792 38,947 
Deferred tax asset 5,351 4,335 3,873 
  _____________________________
  59,635 48,314 48,659 
  _____________________________
Current assets    
Inventories 5,722 4,636 4,248 
Taxation recoverable 29,272 23,716 21,322 
Trade receivables and other assets 8,488 6,877 4,556 
Cash and cash equivalents 444,649 360,247 374,392 
  _____________________________
  488,131 395,476 404,518 
Assets held for sale 1,122 909 - 
  _____________________________
Total assets 548,888 444,699 453,177 
  _____________________________
Current liabilities    
Trade and other payables (45,093)(36,534)(31,170)
Current tax liabilities (909)(736)(883)
Obligations under finance leases (204)(165)(211)
Deferred revenue (3,096)(2,508)(2,686)
  _____________________________
  (49,302)(39,943)(34,950)
     
Non-current liabilities    
Trade and other payables (11,667)(9,452)(9,423)
Obligations under finance leases (6,060)(4,910)(4,959)
Deferred revenue (6,271)(5,081)(5,355)
  _____________________________
Total liabilities (73,300)(59,386)(54,687)
  _____________________________
Net assets 475,588 385,313 398,490 
  _____________________________
     
Equity    
Share capital 375 304 302 
Share premium account 686,963 556,565 556,477 
Other reserves 24,631 19,956 19,538 
Accumulated deficit  (236,381)(191,512)(177,827)
  _____________________________
Total equity 475,588385,313398,490
   _________ __________ __________


GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the three months ended 31 December 2016 and 2015

 Three months
ended
 Three months
ended
 Three months
ended
 
 31 December 31 December 31 December 
   2016   2016   2015 
 $000's   £000's £000's 
Loss for the period(19,250)(15,596)(17,702)
Adjustments for:   
Interest income(337)(273)(63)
Interest expense111 90 19 
Tax benefit(3,287)(2,663)(3,437)
Depreciation of property, plant and equipment1,307 1,059 736 
Impairment of property, plant and equipment117 95 - 
Amortization of intangible assets22 18 14 
Net foreign exchange gains(14,583)(11,815)(3,762)
Increase in provision for inventories35 28 7 
Decrease in deferred signature fees(530)(429)(289)
Share-based payment charge2,673 2,166 1,306 
Loss on disposal of property, plant and equipment687 557 - 
 ______________________________
 (33,035)(26,763)(23,171)
(Increase)/decrease in inventories(513)(416)56 
Increase in trade receivables and other assets(2,436)(1,974)(2,401)
Increase in trade and other payables and deferred revenue6,929 5,613 7,931 
Income taxes paid(555)(450)(366)
 ______________________________
Net cash outflow from operating activities(29,610)(23,990)(17,951)
 ______________________________
Investing activities   
Interest received170 138 70 
Purchases of property, plant and equipment(1,698)(1,376)(1,782)
Purchases of intangible assets(272)(220)(119)
 ______________________________
Net cash outflow from investing activities(1,800)(1,458)(1,831)
 ______________________________
Financing activities   
Proceeds on exercise of share options111 90 564 
Expenses of new equity issue(165)(134)- 
Interest paid(305)(247)(20)
Repayments of fit out funding(696)(564)- 
Repayments of obligations under finance leases(117)(95)(26)
 ______________________________
Net cash (outflow)/inflow from financing activities(1,172)(950)518 
 ______________________________
Effect of foreign exchange rate changes on cash and cash equivalents15,123 12,253 3,705 
 ______________________________
Net decrease in cash and cash equivalents(17,459)(14,145)(15,559)
Cash and cash equivalents at beginning of the period462,108 374,392 234,872 
 ______________________________
Cash and cash equivalents at end of the period444,649 360,247 219,313 
 ______________________________

 

Enquiries:
GW Pharmaceuticals plc	
Stephen Schultz, VP Investor Relations	
401 500 6570
	
Sam Brown (U.S. Media Enquiries)	
Mike Beyer 	
312 961 2502

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