GW Pharmaceuticals plc Reports 2013 Third Quarter Financial Results

LONDON, Aug. 5, 2013 /PRNewswire/ -- 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 third quarter ended 30 June 2013.

RECENT OPERATIONAL HIGHLIGHTS

• Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of $30.4 million (£19.6 million)
• Two pivotal Sativex^® Phase 3 cancer pain trials in recruitment. Top-line results from both trials due in 2014. Data intended to lead to a New Drug Application (NDA) filing with the FDA in the U.S.
• FDA filing of a Phase 3 Investigational New Drug Application (IND) for Sativex as a treatment for MS spasticity
• Commercial launch of Sativex in Italy as a treatment for MS spasticity, earning £250,000 milestone
• Submission of regulatory application in France for Sativex in the treatment of MS spasticity
• Positive top-line results from a 12 month, placebo-controlled study of Sativex in patients with MS spasticity confirming the reassuring safety profile and providing further evidence of efficacy
• Significant clinical trial activity for cannabinoid pipeline product candidates expected to continue in the second half of 2013
• Two new patent allowances in the U.S. protecting Sativex delivery method and delivery device

FINANCIAL HIGHLIGHTS FOR THE THREE MONTHS ENDED 30 JUNE 2013

• Sativex product sales revenues of £0.5 million ($0.8 million) for the three months ended 30 June 2013, compared to £0.1million for the three months ended 30 June 2012, reflecting increased shipments of inventory to commercial partners
• Total revenue for the three months ended 30 June 2013 of £7.3 million ($11.0 million) compared to £14.5 million for the three months ended 30 June 2012, a period in which a £9.8 million milestone payment was received
• Loss after tax for the three months ended 30 June 2013 of £2.0 million ($3.1 million) compared to a profit of £7.9 million for the three months ended 30 June 2012, which primarily reflected the impact of the £9.8 million milestone payment received in the comparable period last year
• Cash and cash equivalents at 30 June 2013 of £43.6 million ($66.3 million) compared to £29.3 million as at 30 September 2012

"Following our successful Nasdaq listing in May, GW has established an important new US shareholder base and further enhanced its robust financial position," stated Justin Gover, GW's Chief Executive Officer. "GW continues to make good progress with the U.S. Phase 3 development of Sativex as a treatment for cancer pain, and is also now advancing plans for the US development of Sativex as a treatment for MS spasticity." In addition, the recent launch of Sativex in Italy and new regulatory application in France are expected to support further commercial progress in Europe, and provide important validation for Sativex and GW's position as a world leader in cannabinoid science. As we move forward in the second half of 2013, we expect a significant amount of clinical activity to occur with respect to our cannabinoid pipeline candidates."  

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2013 third quarter financial results today at 8:00 a.m. ET / 1:00 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the US and Canada), or 00800-2246-2666 (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 # 418183.

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 22 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 established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and at least two additional programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain 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 size of Sativex market opportunities, and the development and regulatory clearance of the GW's products.  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^® 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, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. 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.

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