LONDON, May 11, 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 second quarter and half-year ended 31 March 2015.
RECENT OPERATIONAL HIGHLIGHTS
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Epidiolex® (CBD) childhood epilepsy program:
- Dravet syndrome - Two Phase 3 pivotal trials recently commenced with top-line data expected from the first trial by end of 2015
- Lennox-Gastaut syndrome - First Phase 3 trial in Lennox-Gastaut syndrome commenced (see separate announcement today). Second Phase 3 trial on track to start in calendar Q2 2015
- Tuberous Sclerosis Complex selected as additional new target indication with Phase 3 trial expected to start in H2 2015
- Recent data on 137 patients from expanded access program presented at American Academy of Neurology further reinforces signals of clinical effect seen in previous data disclosures
- Approx. 290 children currently on treatment in expanded access program at 17 U.S. clinical sites
- Approx. 420 children authorized for treatment by FDA under Expanded Access Treatment INDs and additional 225 patients authorized by FDA under 4 U.S. State programs
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Notice of Allowance issued by the U.S. Patent and Trademark Office (USPTO) covering the use of CBD in the treatment of partial seizures.
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Cannabidivarin (CBDV) epilepsy program:
- Phase 2 CBDV epilepsy study in 130 patients underway
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Notice of Allowance issued by the USPTO for patent application covering use of CBDV for the treatment of epilepsy
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Cannabinoid pipeline product candidates:
- Orphan drug designation granted for CBD in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). Phase 1 trial expected to commence in H2 2015
- Recruitment complete in a Phase 2a study for the treatment of schizophrenia - data expected H2 2015
- First of three Sativex Phase 3 cancer pain trials did not show a statistically significant difference for Sativex compared with placebo. Two additional Phase 3 cancer pain trials expected to read out in H2 2015
- Phase 1b study of GWP42002:GWP42003 underway for the treatment of Recurrent Glioblastoma Multiforme (GBM)
- Phase 2 study of GWP42004 in type-2 diabetes underway with expected completion in 2016
FINANCIAL HIGHLIGHTS
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Follow-on offering closed 5 May 2015 raising total net proceeds after expenses of approximately $167.8 million (£110.4 million).
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Revenue for the six months ended 31 March 2015 of £14.3 million ($21.3 million) compared to £15.0 million for the six months ended 31 March 2014.
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Loss for the six months ended 31 March 2015 of £10.9 million ($16.2 million) compared to £8.0 million for the six months ended 31 March 2014.
- Cash and cash equivalents at 31 March 2015 of £148.6 million ($220.7 million) compared to £164.5 million as at 30 September 2014.
"During the second quarter, we commenced our pivotal Phase 3 trials program for Epidiolex in childhood epilepsy and expect these trials to recruit rapidly with a view to reporting initial top-line data around the end of 2015. The new data presented at the American Academy of Neurology has only served to reinforce our confidence in the potential for Epidiolex to become an important advance in the field of treatment-resistant epilepsy," stated Justin Gover, GW's Chief Executive Officer. "With our successful follow-on offering, GW is in a strong position to continue to prepare for a NDA submission to the FDA in 2016 and to make necessary preparations toward a successful commercial launch."
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the 2015 second quarter and half year financial results today at 8:00 a.m. EDT / 1:00 p.m. BST. 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 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID #13609474.
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 27 countries outside the United States. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 3 clinical development for the treatment of Dravet syndrome and the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes Sativex in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer, as well as compounds in Phase 1 and 2 clinical development for glioma, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
Note regarding expanded access studies
Expanded access studies are uncontrolled, carried out by individual physician investigators independent from GW, and not always conducted in strict compliance with Good Clinical Practices, all of which can lead to a treatment effect which may differ from one seen in placebo-controlled trials. Data from these studies provide only anecdotal evidence of efficacy for regulatory review, although they may provide supportive safety information for regulatory review. These studies contain no control or comparator group for reference and are not designed to be aggregated or reported as study results. Moreover, data from such small numbers of patients may be highly variable. Such information, including the statistical principles that the independent physician investigators have chosen to apply to the data, may not reliably predict data collected via systematic evaluation of the efficacy in company-sponsored clinical trials or evaluated via other statistical principles that may be applied in these trials. Reliance on such information may lead to Phase 2 and/or Phase 3 clinical trials that are not adequately designed to demonstrate efficacy and could delay or prevent GW's ability to seek approval of Epidiolex.
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 in this news release 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 | (Today) +44 20 3727 1000 |
| Stephen Schultz, VP Investor Relations | 917 280 2424 / 401 500 6570 |
| FTI Consulting (Media Enquiries) | |
| Ben Atwell / Simon Conway / John Dineen (UK) | + 44 20 3727 1000 |
| Robert Stanislaro (U.S.) | 212 850 5657 |
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| Todd James / Chad Rubin | 646 378 2900 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated income statement | |||
| Three months ended 31 March 2015 | |||
|
Three months ended |
Three months ended |
Three months ended |
|
| 31 March | 31 March | 31 March | |
| 2015 | 2015 | 2014 | |
| $000's | £000's | £000's | |
| Revenue | 9,432 | 6,351 | 7,527 |
| Cost of sales | (958) | (645) | (640) |
| Research and development expenditure | (22,812) | (15,362) | (11,885) |
| Management and administrative expenses | (5,635) | (3,794) | (1,851) |
| Net foreign exchange gain/(loss) | 6,156 | 4,145 | (243) |
| Operating loss | (13,817) | (9,305) | (7,092) |
| Interest income | 105 | 71 | 26 |
| Interest expense | (28) | (19) | (19) |
| Loss before tax | (13,740) | (9,253) | (7,085) |
| Tax benefit | 2,605 | 1,754 | 1,889 |
| Loss for the period | (11,135) | (7,499) | (5,196) |
| Loss per share – basic and diluted | (4.8c) | (3.2p) | (2.5p) |
All activities relate to continuing operations.
| GW Pharmaceuticals plc | |||
| Condensed consolidated income statement | |||
| Six months ended 31 March 2015 | |||
|
Six months ended |
Six months ended |
Six months ended |
|
| 31 March | 31 March | 31 March | |
| 2015 | 2015 | 2014 | |
| $000's | £000's | £000's | |
| Revenue | 21,261 | 14,317 | 15,015 |
| Cost of sales | (1,803) | (1,214) | (998) |
| Research and development expenditure | (45,274) | (30,487) | (21,037) |
| Management and administrative expenses | (6,826) | (4,597) | (3,126) |
| Net foreign exchange gain/(loss) | 12,146 | 8,179 | (479) |
| Operating loss | (20,496) | (13,802) | (10,625) |
| Interest income | 170 | 114 | 56 |
| Interest expense | (58) | (39) | (39) |
| Loss before tax | (20,384) | (13,727) | (10,608) |
| Tax benefit | 4,191 | 2,823 | 2,596 |
| Loss for the period | (16,193) | (10,904) | (8,012) |
| Loss per share – basic and diluted | (6.8c) | (4.6p) | (4.1p) |
All activities relate to continuing operations.
| Consolidated statement of comprehensive loss | ||
| For the six months ended 31 March 2015 | ||
|
Six months ended 31 March 2015 £000's |
Six months ended 31 March 2014 £000's |
|
| Loss for the period | (10,904) | (8,012) |
| Items that may be reclassified subsequently to profit or loss | ||
| Exchange differences on retranslation of foreign operations | (36) | -- |
| Other comprehensive loss for the period | (36) | -- |
| Total comprehensive loss for the period | (10,940) | (8,012) |
| GW Pharmaceuticals plc | |||||
| Condensed consolidated statement of changes in equity | |||||
|
Six months ended 31 March 2015 |
|||||
| 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 2013 | 178 | 84,005 | 20,184 | (68,965) | 35,402 |
| Issue of share capital | 34 | 57,333 | -- | -- | 57,367 |
| Expense of new equity issue | -- | (577) | -- | -- | (577) |
| Exercise of share options | 1 | 1,708 | -- | -- | 1,709 |
| Exercise of warrants | 3 | 5,284 | (922) | 922 | 5,287 |
| Share-based payment transactions | -- | -- | -- | 566 | 566 |
| Loss for the period | -- | -- | -- | (8,012) | (8,012) |
| Balance at 31 March 2014 | 216 | 147,753 | 19,262 | (75,489) | 91,742 |
| Balance at 1 October 2014 | 237 | 220,551 | 19,260 | (81,464) | 158,584 |
| Issue of share capital | -- | 59 | -- | -- | 59 |
| Exercise of share options | -- | 379 | -- | -- | 379 |
| Share-based payment transactions | -- | -- | -- | 806 | 806 |
| Loss for the period | -- | -- | -- | (10,904) | (10,904) |
| Other comprehensive loss | -- | -- | (36) | -- | (36) |
| Balance at 31 March 2015 | 237 | 220,989 | 19,224 | (91,562) | 148,888 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated balance sheets | |||
| As at 31 March 2015 | |||
|
As at 31 March |
As at 31 March |
As at 30 September |
|
| 2015 | 2015 | 2014 | |
| Non-current assets | $000's | £000's | £000's |
| Goodwill | 7,736 | 5,210 | 5,210 |
| Other intangible assets | 85 | 57 | -- |
| Property, plant and equipment | 32,381 | 21,805 | 11,639 |
| Deferred tax asset | 310 | 208 | 277 |
| 40,512 | 27,280 | 17,126 | |
| Current assets | |||
| Inventories | 6,646 | 4,475 | 4,777 |
| Taxation recoverable | 4,050 | 2,728 | 5,251 |
| Trade receivables and other assets | 4,101 | 2,761 | 1,857 |
| Cash and cash equivalents | 220,719 | 148,632 | 164,491 |
| 235,516 | 158,596 | 176,376 | |
| Total assets | 276,028 | 185,876 | 193,502 |
| Current liabilities | |||
| Trade and other payables | (23,493) | (15,820) | (12,376) |
| Obligations under finance leases | (221) | (149) | (126) |
| Deferred revenue | (5,875) | (3,956) | (4,827) |
| (29,589) | (19,925) | (17,329) | |
| Non-current liabilities | |||
| Trade and other payables | (11,965) | (8,057) | (7,927) |
| Obligations under finance leases | (2,528) | (1,703) | (1,781) |
| Deferred revenue | (10,846) | (7,303) | (7,881) |
| Total liabilities | (54,928) | (36,988) | (34,918) |
| Net assets | 221,100 | 148,888 | 158,584 |
| Equity | |||
| Share capital | 353 | 237 | 237 |
| Share premium account | 328,169 | 220,989 | 220,551 |
| Other reserves | 28,548 | 19,224 | 19,260 |
| Accumulated deficit | (135,970) | (91,562) | (81,464) |
| Total equity | 221,100 | 148,888 | 158,584 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated cash flow statements | |||
| For the six months ended 31 March 2015 | |||
| Six months ended | Six months ended | Six months ended | |
| 31 March | 31 March | 31 March | |
| 2015 | 2015 | 2014 | |
| As restated1 | |||
| $000's | £000's | £000's | |
| Loss for the period | (16,193) | (10,904) | (8,012) |
| Adjustments for: | |||
| Interest income | (170) | (114) | (56) |
| Interest expense | 58 | 39 | 39 |
| Tax benefit | (4,191) | (2,823) | (2,596) |
| Depreciation of property, plant and equipment | 1,509 | 1,016 | 641 |
| Amortisation of intangible assets | 3 | 2 | -- |
| Net foreign exchange gains | (12,274) | (8,265) | (1,008) |
| Increase/(decrease) in provision for inventories | 19 | 13 | (341) |
| Loss on disposal of property, plant and equipment | 2 | 1 | -- |
| Share-based payment charge | 1,197 | 806 | 566 |
| (30,040) | (20,229) | (10,767) | |
| Decrease in inventories | 429 | 289 | 234 |
| (Increase)/decrease in trade receivables and other assets | (1,342) | (904) | 197 |
| Increase in trade and other payables and deferred revenue | 1,643 | 1,106 | 1,081 |
| Cash used in operations | (29,310) | (19,738) | (9,255) |
| Research and development tax credits received | 8,041 | 5,415 | -- |
| Net cash outflow from operating activities | (21,269) | (14,323) | (9,255) |
| Investing activities | |||
| Interest received | 167 | 113 | 71 |
| Purchases of property, plant and equipment | (15,094) | (10,165) | (2,011) |
| Purchase of intangible assets | (88) | (59) | -- |
| Proceeds from sales of property, plant and equipment | 1 | 1 | -- |
| Net cash outflow from investing activities | (15,014) | (10,110) | (1,940) |
| Financing activities | |||
| Proceeds on exercise of share options | 563 | 379 | 1,708 |
| Proceeds of new equity issue | 88 | 59 | 57,367 |
| Expenses of new equity issue | -- | -- | (577) |
| Proceeds of warrant exercise | -- | -- | 5,287 |
| Interest paid | (65) | (44) | (37) |
| Proceeds from fit out funding | -- | -- | 4,010 |
| Capital element of finance leases | (82) | (55) | (48) |
| Net cash inflow from financing activities | 504 | 339 | 67,710 |
| Effect of foreign exchange rate changes on cash and cash equivalents | 12,229 | 8,235 | 1,008 |
| Net (decrease)/increase in cash and cash equivalents | (23,550) | (15,859) | 57,523 |
| Cash and cash equivalents at beginning of the period | 244,269 | 164,491 | 38,069 |
| Cash and cash equivalents at end of the period | 220,719 | 148,632 | 95,592 |