-Recent Successful $101 Million Financing Accelerates Epidiolex® Development
in Childhood Epilepsy-
-Conference Call Today at 8:00 a.m. ET, 1:00 p.m. GMT-
LONDON, Feb. 5, 2014 (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 first quarter ended 31 December 2013.
RECENT OPERATIONAL HIGHLIGHTS
-
Follow-on offering of American Depositary Shares ("ADSs") on the NASDAQ Global Market closed in January 2014 raising total gross proceeds of $101.1 million (net proceeds after expenses of $94.0 million/£57.1 million), to be used primarily to fund the Epidiolex® development program for childhood epilepsy
- Advancement of epilepsy program:
- Orphan Drug Designation granted by the U.S. FDA for Epidiolex to treat Dravet syndrome
- Seven Expanded Access Investigational New Drug Applications (INDs) granted by the FDA to U.S. physicians to treat with Epidiolex approximately 125 children suffering from intractable epilepsy syndromes. Additional INDs recently submitted by U.S. physicians to the FDA
- Patients now commencing treatment with Epidiolex in two expanded access INDs in New York City and San Francisco - initial treatment data expected mid-2014
- Orphan Drug Designation submission to the FDA for Epidiolex to treat Lennox-Gastaut syndrome
- Additional epilepsy pipeline candidate GWP42006 (Cannabidivarin or CBDV), Phase 1 trial dosing completed with data expected in H1 2014
- Publication confirming mRNA gene expression suppressed with CBDV treatment and evidence of CBDV anticonvulsant effects
- Sativex® program developments and upcoming expected milestones:
- Phase 3 cancer pain trials in recruitment – top-line data due towards the end of 2014. Data intended to lead to a New Drug Application (NDA) filing with the FDA in the U.S.
- Phase 3 IND opened with the FDA for Sativex as a treatment for Multiple Sclerosis (MS) spasticity; request for Special Protocol Assessment (SPA) submitted to the FDA
- Recent regulatory approvals in France and Switzerland as a treatment for MS spasticity; Sativex now approved for use in 25 countries
- Agreement with Ipsen to promote and distribute Sativex in Latin America
- Significant additional on-going clinical trial activity for cannabinoid pipeline product candidates
- Phase 2a trial data of GWP42003 for the treatment of ulcerative colitis ongoing - data expected in mid-2014
- Phase 2b dose ranging trial of GWP42004 in type-2 diabetes expected to commence in H1 2014
- Phase 2a trial of GWP42003 for the treatment of schizophrenia expected to commence in H1 2014
- Phase 1b/2a clinical trial underway of GWP42002:GWP42003 for the treatment of Recurrent Glioblastoma Multiforme (GBM), with safety cohort data expected in 2014. Patent Notice of Allowance issued for the use of cannabinoids in treating GBM
FINANCIAL HIGHLIGHTS
-
Total revenue for the three months ended 31 December 2013 of £7.5 million ($12.4 million) compared to £5.2 million for the three months ended 31 December 2012.
-
Net loss after tax for the three months ended 31 December 2013 of £2.8 million ($4.7 million) compared to a profit after tax of £2.1 million for the three months ended 31 December 2012.
- Cash and cash equivalents as at 31 December 2013 of £35.3 million ($58.4 million) compared to £38.1 million as at 30 September 2013. Since the period end, this cash position has been further enhanced by receipt of the net proceeds after expenses from the follow-on offering of ADSs on the NASDAQ Global Market $94.0 million (£57.1 million) in January 2014.
"Our successful U.S. follow-on offering in early January raised $101 million and reflects excitement regarding GW's childhood epilepsy program. We believe that our lead epilepsy product candidate, Epidiolex, has the potential to meet significant unmet needs in the treatment of orphan childhood epilepsy syndromes such as Dravet syndrome and Lennox-Gastaut syndrome. With the new funds raised, we have the financial strength to accelerate this development program whilst retaining global commercial rights," stated Justin Gover, GW's Chief Executive Officer. "In addition to our orphan epilepsy program, as we move through 2014, we expect a significant amount of milestones, including Phase 3 cancer pain data for Sativex as well as important clinical progress across our robust pipeline of cannabinoid product candidates."
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the 2014 first quarter financial results today at 8:00 a.m. ET / 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 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID #13575391.
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 25 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received Orphan Drug Designation from the FDA for the treatment of Dravet syndrome, a severe infantile-onset, genetic, drug-resistant epilepsy syndrome. Our product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type‑2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
Forward-looking statements
This news release contains forward-looking statements that reflect GWs 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 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 the 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, uncertainties and other risks 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 7831 3113 |
| Justin Gover, Chief Executive Officer | (Thereafter) + 44 1980 557000 |
| Stephen Schultz, VP Investor Relations (U.S.) | 917 280 2424 / 401 500 6570 |
| FTI Consulting (Media Enquiries) | |
| Ben Atwell / Simon Conway / John Dineen (UK) | + 44 20 7831 3113 |
| Robert Stanislaro (U.S.) | 212 850 5657 |
| Trout Group, LLC (U.S. investor relations) | |
| Todd James / Chad Rubin | 646 378 2900 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated income statements | |||
| Condensed consolidated income statement for the three months ended 31 December 2013 | |||
| Three months | Three months | Three months | |
| ended | ended | ended | |
| 31 December | 31 December | 31 December | |
| 2013 | 2013 | 2012 | |
| $000's | £000's | £000's | |
| Revenue | 12,409 | 7,487 | 5,176 |
| Cost of sales | (593) | (358) | (413) |
| Research and development expenditure | (15,169) | (9,153) | (6,399) |
| Management and administrative expenses | (2,506) | (1,511) | (800) |
| Operating loss | (5,859) | (3,535) | (2,436) |
| Interest income | 51 | 31 | 46 |
| Interest payable | (33) | (20) | -- |
| Loss before tax | (5,841) | (3,524) | (2,390) |
| Tax | 1,172 | 707 | 4,441 |
| (Loss)/profit for the period | (4,669) | (2,817) | 2,051 |
| (Loss)/earnings per share | |||
| – basic | (2.6c) | (1.6p) | 1.5p |
| – diluted | (2.6c) | (1.6p) | 1.5p |
| All activities relate to continuing operations. | |||
| The Group has no recognised gains or losses other than the losses above and therefore no separate consolidated statement of comprehensive income has been presented. | |||
| GW Pharmaceuticals plc | |||||
| Condensed consolidated statements of changes in equity | |||||
| Three months ended 31 December 2013 | |||||
| Called-up | Share | ||||
| share | premium | Other | Retained | ||
| capital | account | reserves | earnings | Total | |
| £000's | £000's | £000's | £000's | £000's | |
| Balance at 1 October 2012 | 133 | 65,947 | 20,184 | (65,032) | 21,232 |
| Share-based payment transactions | -- | -- | -- | 143 | 143 |
| Profit for the period | -- | -- | -- | 2,051 | 2,051 |
| Balance at 31 December 2012 | 133 | 65,947 | 20,184 | (62,838) | 23,426 |
| Balance at 1 October 2013 | 178 | 84,005 | 20,184 | -68,965 | 35,402 |
| Exercise of share options | -- | 299 | -- | -- | 299 |
| Share-based payment transactions | -- | -- | -- | 241 | 241 |
| Loss for the period | -- | -- | -- | (2,817) | (2,817) |
| Balance at 31 December 2013 | 178 | 84,304 | 20,184 | (71,541) | 33,125 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated balance sheets | |||
| As at 31 December 2013 | |||
| As at | As at | As at | |
| 31 December | 31 December | 30 September | |
| 2013 | 2013 | 2013 | |
| Non-current assets | $000's | £000's | £000's |
| Intangible assets – goodwill | 8,634 | 5,210 | 5,210 |
| Property, plant and equipment | 10,002 | 6,035 | 5,476 |
| 18,636 | 11,245 | 10,686 | |
| Current assets | |||
| Inventories | 8,915 | 5,379 | 4,661 |
| Deferred tax asset | 1,163 | 702 | 895 |
| Taxation recoverable | 6,298 | 3,800 | 2,900 |
| Trade receivables and other current assets | 7,514 | 4,534 | 1,733 |
| Cash and cash equivalents | 58,447 | 35,266 | 38,069 |
| 82,337 | 49,681 | 48,258 | |
| Total assets | 100,973 | 60,926 | 58,944 |
| Current liabilities | |||
| Trade and other payables | (17,664) | (10,658) | (9,440) |
| Obligations under finance leases | (174) | (105) | (100) |
| Deferred revenue | (6,740) | (4,067) | (3,181) |
| (24,578) | (14,830) | (12,721) | |
| Non-current liabilities | |||
| Trade and other payables | (4,143) | (2,500) | -- |
| Obligations under finance leases | (3,113) | (1,878) | (1,905) |
| Deferred revenue | (14,241) | (8,593) | (8,916) |
| Total liabilities | (46,075) | (28,331) | (23,542) |
| Net assets | 54,898 | 33,125 | 35,402 |
| Equity | |||
| Share capital | 295 | 178 | 178 |
| Share premium account | 139,717 | 84,304 | 84,005 |
| Other reserves | 33,451 | 20,184 | 20,184 |
| Accumulated deficit | (118,565) | (71,541) | (68,965) |
| Total equity | 54,898 | 33,125 | 35,402 |
| GW Pharmaceuticals plc | |||
| Condensed consolidated cash flow statements | |||
| For the three months ended 31 December 2013 | |||
| Three months | Three months | Three months | |
| ended | ended | ended | |
| 31 December | 31 December | 31 December | |
| 2013 | 2013 | 2012 | |
| $000's | £000's | £000's | |
| (Loss)/profit for the period | (4,669) | (2,817) | 2,051 |
| Adjustments for: | |||
| Interest income | (51) | (31) | (46) |
| Interest payable | 33 | 20 | -- |
| Tax | (1,172) | (707) | (4,441) |
| Depreciation of property, plant and equipment | 503 | 303 | 209 |
| Net foreign exchange gains | (332) | (201) | (36) |
| Decrease in allowance for doubtful debts | -- | -- | (26) |
| Decrease in provision for inventories | (570) | (344) | -- |
| Share-based payment charge | 399 | 241 | 143 |
| (5,859) | (3,536) | (2,146) | |
| Decrease/(increase) in inventories | (618) | (373) | (213) |
| Increase in trade receivables and other assets | (4,666) | (2,815) | (631) |
| Increase in trade and other payables and deferred revenue | 7,092 | 4,279 | 1,461 |
| Cash used by operations | (4,051) | (2,445) | (1,529) |
| Research and development tax credits received | -- | -- | -- |
| Net cash outflow from operating activities | (4,051) | (2,445) | (1,529) |
| Investing activities | |||
| Interest received | 74 | 45 | 46 |
| Purchases of property, plant and equipment | (1,428) | (862) | (297) |
| Net cash outflow from investing activities | (1,354) | (817) | (251) |
| Financing activities | |||
| Proceeds on exercise of shares options | 496 | 299 | -- |
| Interest paid | (33) | (20) | -- |
| Capital element of finance leases | (35) | (21) | -- |
| Net cash inflow from financing activities | 428 | 258 | -- |
| Effect of foreign exchange rate changes | 332 | 201 | 36 |
| Net decrease in cash and cash equivalents | (4,645) | (2,803) | (1,744) |
| Cash and cash equivalents at beginning of the period | 63,092 | 38,069 | 29,335 |
| Cash and cash equivalents at end of the period | 58,447 | 35,266 | 27,591 |