GW Pharmaceuticals plc: 09/08/2016 GW Pharmaceuticals plc Reports Third Quarter 2016 Financial Results and Operational Progress

Tickers: GWPH
August 9, 2016

GW Pharmaceuticals plc Reports Third Quarter 2016 Financial Results and Operational Progress

- Positive Phase 3 Epidiolex pivotal trial in Lennox-Gastaut Syndrome (LGS) -

- Positive FDA pre-NDA meeting - NDA for Dravet syndrome and LGS on track for H1 2017 submission -

-Conference call today at 8:30 a.m. EDT, 1:30 p.m. BST -

LONDON, Aug. 09, 2016 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (GW, the

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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 third quarter ended 30 June 2016.

"We have now reported two positive Phase 3 trials for Epidiolex and are on track for an NDA filing that includes both the Dravet syndrome and Lennox-Gastaut Syndrome indications. We believe that these Phase 3 data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile," stated Justin Gover, GW's Chief Executive Officer. "Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch."

RECENT OPERATIONAL HIGHLIGHTS

Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)

» Phase 3 development programs:

Positive results in first Phase 3 Dravet syndrome trial Positive results in first Phase 3 LGS trial

Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December Positive Dravet syndrome Pre-NDA meeting held with FDA

NDA on track for H1 2017 submission for both Dravet and LGS indications Data from second LGS trial expected at end of Q3

Second Phase 3 Dravet syndrome trial ongoing Phase 3 trial in TSC ongoing

Phase 3 trial in IS to commence in Q4 2016

» Expanded access program and open label extension:

Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial

Advanced clinical programs in multiple cannabinoid pipeline product candidates:

» CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H1 2017

» CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 2017

» Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016

Orphan Drug and Fast Track Designations granted from FDA and EMA

» THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016

» Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016

» THCV Phase 2 study in type 2 diabetes completed, primary endpoint not achieved

FINANCIAL HIGHLIGHTS

Loss for the nine months ended 30 June 2016 of £46.7 million ($62.2 million) compared to £32.3 million for the nine months ended 30 June 2015. This increased loss primarily reflects investment in the Epidiolex Phase 3 pivotal trials program.

Cash and cash equivalents at 30 June 2016 of £191.2 million ($254.3 million) compared to £234.9 million as at 30 September 2015. Subsequently in July 2016 a follow-on offering raised total net proceeds after expenses of $273.1 million (£206.4 million).

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the third quarter 2016 financial results today at 8:30

a.m. EDT / 1:30 p.m. BST. 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):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13642862.

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, 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

FleishmanHillard (U.S. Media)

Paddi Hurley / Adam Silverstein 212 453 2382 / 917 697 9313

GW Pharmaceuticals plc

Condensed consolidated income statement Three months ended 30 June 2016

30 June 30 June 30 June

Notes 2016 2016 2015

$000's £000's £000's

Revenue 2 3,097 2,329 8,629

Cost of sales

(946)

(711) (721)

Research and development expenditure

3

(34,058)

(25,609) (20,841)

Sales, general and administrative expenses

(7,452)

(5,603) (2,984)

Net foreign exchange gain/(loss)

14,883

11,190 (8,851)

_______ _______ _______

Operating loss

(24,476)

(18,404)

(24,768)

Interest income

130

98

46

Interest expense

(24)

(18)

(21)

_______ _______ _______

Loss before tax

(24,370)

(18,324) (24,743)

Tax benefit

4

8,125

6,109 3,318

_______ _______ _______

Loss for the period (16,245) (12,215) (21,425)

_______ _______ _______

Loss per share - basic and diluted 5 (6.1c) (4.6p) (8.5p)

All activities relate to continuing operations.

Condensed consolidated statement of comprehensive loss For the three months ended 30 June 2016

30 June

2016

£000's

30 June

2015

£000's

Loss for the period

(12,215)

(21,425)

Items that may be reclassified subsequently to profit or loss

Exchange gain on retranslation of foreign operations

266

16

Other comprehensive gain for the period

266

16

Total comprehensive loss for the period

(11,949)

(21,409)

GW Pharmaceuticals plc

Condensed consolidated income statement Nine months ended 30 June 2016

30 June

30 June

30 June

Notes

2016

2016

2015

$000's

£000's

£000's

Revenue

2

11,497

8,645

22,945

Cost of sales

(2,580)

(1,940)

(1,935)

Research and development expenditure

3

(100,406)

(75,497)

(51,328)

Sales, general and administrative expenses

(16,584)

(12,470)

(7,581)

Net foreign exchange gain/(loss)

25,640

19,279

(672)

_______ _______ _______

Operating loss

(82,433)

(61,983)

(38,571)

Interest income

388

292

161

Interest expense

(70)

(53)

(60)

_______ _______ _______

Loss before tax

(82,115)

(61,744) (38,470)

Tax benefit

4

19,942

14,995 6,140

_______ _______ _______

Loss for the period (62,173) (46,749) (32,330)

_______ _______ _______

Loss per share - basic and diluted 5 (23.7c) (17.8p) (13.4p)

All activities relate to continuing operations.

Condensed consolidated statement of comprehensive loss

For the nine months ended 30 June 2016

30 June

2016

£000's

30 June

2015

£000's

Loss for the period

(46,749)

(32,330)

Items that may be reclassified subsequently to profit or loss

Exchange gain/(loss) on retranslation of foreign operations

166

(20)

Other comprehensive gain/(loss) for the period

166

(20)

Total comprehensive loss for the period

(46,583)

(32,350)

GW Pharmaceuticals plc

Condensed consolidated statement of changes in equity Nine months ended 30 June 2016

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 22 127,812 - - 127,834

Expense of new equity issue - (307) - - (307)

Exercise of share options 2 1,139 - - 1,141

Share-based payment transactions - - - 1,161 1,161

Loss for the period - - - (32,330) (32,330)

Other comprehensive loss - - (20) - (20)

_________ _________ ________ __________ ________

Balance at 30 June 2015 261 349,195 19,240 (112,633) 256,063

_________ _________ ________ __________ ________

Balance at 1 October 2015

261

349,275

19,189

(123,455)

245,270

Exercise of share options

2

633

-

-

635

Share-based payment transactions

-

-

-

5,900

5,900

Loss for the period

-

-

-

(46,749)

(46,749)

Deferred tax attributable to unrealized share option gains

-

-

-

366

366

Other comprehensive gain

-

-

166

-

166

_________ _________ ________ __________ ________

Balance at 30 June 2016 263 349,908 19,355 (163,938) 205,588

_________ _________ ________ __________ ________

GW Pharmaceuticals plc

Condensed consolidated balance sheets As at 30 June 2016

As at

As at

As at

30 June

30 June 30 September

Notes 2016 2016 2015

Non-current assets $000's £000's £000's

Goodwill 6,929 5,210 5,210

Other intangible assets 749 563 245

Property, plant and equipment 51,266 38,548 28,733

Deferred tax asset 2,506 1,884 418

GW Pharmaceuticals plc published this content on 09 August 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 09 August 2016 11:16:13 UTC.