GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results and Operational Progress
February 10, 2016: 07:00 AM ET
-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 Relations
401 500 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 December
31 December
31 December
Notes
2015
2015
2014
$000’s
£000’s
£000’s
Revenue
2
5,418
3,667
7,965
Cost of sales
(1,015
)
(687
)
(569
)
Research and development expenditure
3
(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 benefit
4
5,079
3,437
1,068
_______
_______
_______
Loss for the period
(26,156
)
(17,702
)
(3,406
)
_______
_______
_______
Loss per share – basic and diluted
5
(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
Other
Accumulated
capital
account
reserves
deficit
Total
£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 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 2014
237
220,672
19,254
(84,601
)
155,562
_________
_________
________
__________
________
Balance at 1 October 2015
261
349,275
19,189
(123,455
)
245,270
Exercise of share options
2
562
-
-
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 2015
263
349,837
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
338,830
229,311
245,270
_________
_________
_________
GW Pharmaceuticals plc Condensed consolidated cash flow statements For the three months ended 31 December 2015 and 2014
Three months ended
Three months ended
Three months ended
31 December
31 December
31 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