- Three Phase 3 Epidiolex Clinical Trials Fully Recruited Above Target Sample Size – on Track for Initial Data in Q1 2016 -
- Significant Clinical Activity in Multiple Cannabinoid Pipeline Programs -
- Conference Call Today at 4:30 p.m. EST, 9:30 p.m. GMT -
LONDON, Dec. 7, 2015 (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, announces financial results for the fourth quarter and twelve months ended 30 September 2015.
"This last year has seen GW maintain a rapid pace in the progress of our pediatric epilepsy research program, including the start and completion of recruitment of multiple Phase 3 trials for Epidiolex, and the expansion of our expanded access program which has continued to yield promising safety and efficacy data," stated Justin Gover, GW's Chief Executive Officer. "We expect to carry this momentum through 2016 with top-line data from four Epidiolex pivotal trials, our first NDA filing, build-out of our U.S. commercial organization, and ongoing data read-outs from a number of clinical pipeline programs."
2015 HIGHLIGHTS
-
Epidiolex® (CBD) childhood epilepsy program:
-
Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome
- First Phase 3 Dravet syndrome trial fully enrolled above original target sample size (120 randomized) data expected Q1 2016
- First LGS Phase 3 trial fully enrolled above original target sample size (171 randomized). Data expected Q2 2016
- Second LGS Phase 3 trial fully enrolled above original target sample size. (>210 expected to randomize). Data expected Q2 2016
- Second Phase 3 Dravet syndrome trial ongoing. Data expected mid 2016
- NDA submission with FDA expected Q4 2016
- Phase 3 Tuberous Sclerosis Complex trial expected to commence Q1 2016
- Additional clinical development for Epidiolex beyond initial three indications expected to commence in H2 2016
-
Expanded access program:
- Separate data update announcement issued today at the American Epilepsy Society December 2015 Annual Meeting
- Approximately 350 children on treatment at 32 U.S. clinical sites
- Over 850 children authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
- Strategic agreement with Government of New South Wales in Australia to conduct Epidiolex and CBDV clinical trials
- CBD and CBDV patent portfolio strengthened
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Company sponsored Phase 3 development programs in Dravet syndrome and Lennox-Gastaut syndrome
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Advanced clinical programs in multiple cannabinoid pipeline product candidates:
- Phase 2a CBD schizophrenia study data shows positive proof-of-concept with a reassuring safety profile
- Phase 2 CBDV epilepsy study in adults underway with data expected H2 2016
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Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) IV CBD Phase 1 clinical program expected to commence in H1 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
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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
- Phase 2 study in type-2 diabetes fully enrolled with data expected mid 2016
- Phase 2 study of Sativex in spasticity due to cerebral palsy ongoing with data expected mid 2016
- Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers, and chemotherapy-induced cachexia
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U.S. operations established in Carlsbad, California
- GW's CEO, Justin Gover, relocates to the U.S.
- Seasoned industry executive Julian Gangolli appointed as President, North America
- Epilepsy specialist team build-out underway
FINANCIAL HIGHLIGHTS
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Balance sheet further strengthened with successful NASDAQ follow-on offering raising net proceeds after expenses of £127.5 million ($193.3 million)
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Revenue for the twelve months ended 30 September 2015 of £28.5 million ($43.2 million) compared to £30.0 million for the twelve months ended 30 September 2014
-
Loss for the twelve months ended 30 September 2015 of £44.6 million ($67.4 million) compared to £14.7 million for the twelve months ended 30 September 2014
- Cash and cash equivalents at 30 September 2015 of £234.9 million ($355.3 million) compared to £164.5 million as at 30 September 2014
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 fourth quarter and year-end financial results today at 4:30 p.m. EST / 9:30 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 #13626013.
| 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 30 September 2015 | |||
|
Three months ended 30 September 2015 $000's |
Three months ended 30 September 2015 £000's |
Three months ended 30 September 2014 £000's |
|
| Revenue | 8,463 | 5,595 | 7,419 |
| Cost of sales | (1,033) | (683) | (419) |
| Research and development expenditure | (38,510) | (25,457) | (12,269) |
| Sales, general and administrative expenses | (7,545) | (4,988) | (1,844) |
| Net foreign exchange gain | 10,399 | 6,874 | 5,411 |
| Operating loss | (28,226) | (18,659) | (1,702) |
| Interest income | 125 | 83 | 50 |
| Interest expense | (22) | (15) | (2) |
| Loss before tax | (28,123) | (18,591) | (1,654) |
| Tax benefit | 9,618 | 6,358 | 1,936 |
| (Loss)/profit for the period | (18,505) | (12,233) | 282 |
| (Loss)/profit per share – basic and diluted | (7.1c) | (4.7p) | 0.1p |
| All activities relate to continuing operations. | |||
| GW Pharmaceuticals plc | |||
| Condensed consolidated income statement | |||
| Year ended 30 September 2015 | |||
|
Year ended 30 September 2015 $000's |
Year ended 30 September 2015 £000's |
Year ended 30 September 2014 £000's |
|
| Revenue | 43,172 | 28,540 | 30,045 |
| Cost of sales | (3,960) | (2,618) | (2,060) |
| Research and development expenditure | (116,153) | (76,785) | (43,475) |
| Sales, general and administrative expenses | (19,013) | (12,569) | (7,337) |
| Net foreign exchange gain | 9,382 | 6,202 | 3,188 |
| Operating loss | (86,572) | (57,230) | (19,639) |
| Interest income | 369 | 244 | 130 |
| Interest expense | (113) | (75) | (61) |
| Loss before tax | (86,316) | (57,061) | (19,570) |
| Tax benefit | 18,906 | 12,498 | 4,911 |
| Loss for the year | (67,410) | (44,563) | (14,659) |
| Loss per share – basic and diluted | (27.4)c | (18.1)p | (7.0)p |
| All activities relate to continuing operations. | |||
| Condensed consolidated statement of comprehensive loss | ||
| For the year ended 30 September 2015 | ||
|
Year ended 30 September 2015 £000's |
Year ended 30 September 2014 £000's |
|
| Loss for the year | (44,563) | (14,659) |
| Items that may be reclassified subsequently to profit or loss | ||
| Exchange differences on translation of foreign operations | (71) | (2) |
| Other comprehensive loss for the year | (71) | (2) |
| Total comprehensive loss for the year | (44,634) | (14,661) |
| GW Pharmaceuticals plc | |||||
| Condensed consolidated statement of changes in equity | |||||
| Year ended 30 September 2015 | |||||
|
Called-up share capital £000's |
Share premium account £000's |
Other reserves £000's |
Accumulated deficit £000's |
Total Equity £000's |
|
| Balance at 1 October 2013 | 178 | 84,005 | 20,184 | (68,965) | 35,402 |
| Issue of share capital | 51 | 127,315 | -- | -- | 127,366 |
| Expense of new equity issue | -- | (1,067) | -- | -- | (1,067) |
| Exercise of share options | 4 | 5,014 | -- | -- | 5,018 |
| Exercise of warrants | 4 | 5,284 | (922) | 922 | 5,288 |
| Share-based payment transactions | -- | -- | -- | 1,238 | 1,238 |
| Loss for the period | -- | -- | -- | (14,659) | (14,659) |
| Other comprehensive expense | -- | -- | (2) | -- | (2) |
| Balance at 30 September 2014 | 237 | 220,551 | 19,260 | (81,464) | 158,584 |
| Balance at 1 October 2014 | 237 | 220,551 | 19,260 | (81,464) | 158,584 |
| Issue of share capital (note 12) | 22 | 127,812 | -- | -- | 127,834 |
| Expense of new equity issue | -- | (271) | -- | -- | (271) |
| Exercise of share options | 2 | 1,183 | -- | -- | 1,185 |
| Share-based payment transactions | -- | -- | -- | 2,488 | 2,488 |
| Loss for the year | -- | -- | -- | (44,563) | (44,563) |
| Deferred tax attributable to unrealized share option gains | -- | -- | -- | 84 | 84 |
| Other comprehensive expense | -- | -- | (71) | -- | (71) |
| Balance at 30 September 2015 | 261 | 349,275 | 19,189 | (123,455) | 245,270 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated balance sheet | |||
| As at 30 September 2015 | |||
|
As at 30 September 2015 |
As at 30 September 2015 |
As at 30 September 2014 |
|
| Non-current assets | $000's | £000's | £000's |
| Intangible assets - goodwill | 7,881 | 5,210 | 5,210 |
| Other intangible assets | 371 | 245 | -- |
| Property, plant and equipment | 43,464 | 28,733 | 11,639 |
| Deferred tax asset | 632 | 418 | 277 |
| 52,348 | 34,606 | 17,126 | |
| Current assets | |||
| Inventories | 7,194 | 4,756 | 4,777 |
| Taxation recoverable | 19,122 | 12,641 | 5,251 |
| Trade receivables and other assets | 4,346 | 2,873 | 1,857 |
| Cash and cash equivalents | 355,292 | 234,872 | 164,491 |
| 385,954 | 255,142 | 176,376 | |
| Total assets | 438,302 | 289,748 | 193,502 |
| Current liabilities | |||
| Trade and other payables | (36,338) | (24,022) | (12,376) |
| Current tax liabilities | (554) | (366) | -- |
| Obligations under finance leases | (167) | (111) | (126) |
| Deferred revenue | (4,945) | (3,269) | (4,827) |
| (42,004) | (27,768) | (17,329) | |
| Non-current liabilities | |||
| Trade and other payables | (12,775) | (8,445) | (7,927) |
| Obligations under finance leases | (2,330) | (1,540) | (1,781) |
| Deferred revenue | (10,173) | (6,725) | (7,881) |
| Total liabilities | (67,282) | (44,478) | (34,918) |
| Net assets | 371,020 | 245,270 | 158,584 |
| Equity | |||
| Share capital | 395 | 261 | 237 |
| Share premium account | 528,348 | 349,275 | 220,551 |
| Other reserves | 29,027 | 19,189 | 19,260 |
| Accumulated deficit | (186,750) | (123,455) | (81,464) |
| Total equity | 371,020 | 245,270 | 158,584 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated cash flow statement | |||
| For the year ended 30 September 2015 | |||
|
Year ended 30 September 2015 $000's |
Year ended 30 September 2015 £000's |
Year ended 30 September 2014 £000's |
|
| Loss for the year | (67,410) | (44,563) | (14,659) |
| Adjustments for: | |||
| Interest income | (369) | (244) | (130) |
| Interest expense | 113 | 75 | 61 |
| Tax benefit | (18,906) | (12,498) | (4,911) |
| Depreciation of property, plant and equipment | 3,404 | 2,250 | 1,398 |
| Impairment of property, plant and equipment | 917 | 606 | -- |
| Amortization of intangible assets | 79 | 52 | -- |
| Net foreign exchange gains | (9,503) | (6,282) | (1,876) |
| Increase/(decrease) in provision for inventories | 50 | 33 | (408) |
| Loss on disposal of property, plant and equipment | 2 | 1 | 2 |
| Share-based payment charge | 3,748 | 2,478 | 1,238 |
| (87,875) | (58,092) | (19,285) | |
| (Increase)/decrease in inventories | (18) | (12) | 292 |
| Increase in trade receivables and other assets | (1,528) | (1,010) | (142) |
| Increase in trade and other payables and deferred revenue | 10,934 | 7,228 | 3,328 |
| Cash used in operations | (78,487) | (51,886) | (15,807) |
| Research and development tax credits received | 8,191 | 5,415 | 3,181 |
| Net cash outflow from operating activities | (70,296) | (46,471) | (12,626) |
| Investing activities | |||
| Interest received | 357 | 236 | 145 |
| Purchases of property, plant and equipment | (27,101) | (17,915) | (7,254) |
| Purchase of intangible assets | (171) | (114) | -- |
| Proceeds from sales of property, plant and equipment | 3 | 2 | 14 |
| Net cash outflow from investing activities | (26,912) | (17,791) | (7,095) |
| Financing activities | |||
| Proceeds on exercise of share options | 1,793 | 1,185 | 5,018 |
| Proceeds of new equity issue | 193,374 | 127,834 | 127,367 |
| Expenses of new equity issue | (410) | (271) | (1,067) |
| Proceeds of warrant exercise | -- | -- | 5,288 |
| Interest paid | (112) | (74) | (61) |
| Proceeds from fit out funding | -- | -- | 7,822 |
| Repayments of obligations under finance leases | (386) | (255) | (100) |
| Net cash inflow from financing activities | 194,259 | 128,419 | 144,267 |
| Effect of foreign exchange rate changes on cash and cash equivalents | 9,415 | 6,224 | 1,876 |
| Net increase in cash and cash equivalents | 106,466 | 70,381 | 126,422 |
| Cash and cash equivalents at beginning of the period | 248,826 | 164,491 | 38,069 |
| Cash and cash equivalents at end of the period | 355,292 | 234,872 | 164,491 |