GWPH

GW Pharmaceuticals Plc (GWPH)

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GW Pharmaceuticals PLC (GWPH)

F3Q 2013 Results Earnings Call

August 5, 2013 8:00 AM ET

Executives

Steve Schultz - Head, Investor Relations

Justin Gover - Chief Executive Officer

Stephen Wright - Director, Research & Development

Adam George - Chief Financial Officer

Chris Tovey - Chief Operating Officer

Analysts

Phil Nadeau - Cowen and Company

Josh Schimmer - Lazard Capital Markets

Bert Hazlett - ROTH Capital Partners

Mike Aitkenhead - Edison

Ritu Baral - Canaccord Genuity

Presentation

Operator

Greetings. Welcome to the GW Pharmaceuticals Third Quarter 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions)

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Steve Schultz, Investor Relations for GW Pharmaceuticals. Thank you, Mr. Schultz. You may begin.

Steve Schultz

Thank you, Operator. Good morning and good afternoon to everyone. Welcome to GW Pharmaceuticals third quarter 2013 results conference call. Again, my name is Steve Schultz and I’m the Head of Investor Relations for GW, and I’m based in United States.

We hope you’ve had a chance to review our press release and our 6-K filing, both of which were issued earlier today. These documents provide additional details on the company’s third quarter financial and operating results.

Leading the call today will be Justin Gover, GW’s Chief Executive Officer, who will provide a corporate update. Dr. Stephen Wright, GW’s Director of Research & Development, will then provide an update focusing on the new clinical data release today, as well as an update on our pipeline. Adam George, GW’s Chief Financial Officer will then provide an overview of the financial highlights from the third quarter. Following closing remarks, we will then open the lines to answer some questions. Also joining us on the call today is Chris Tovey, our Chief Operating Officer.

As a reminder, during today’s call we will be making certain forward-looking statements. These statements reflect GW’s current expectations regarding future events, including but not limited to statements regarding financial performance, clinical and regulatory activities, including the regulatory clearance of our products, the timing of product launches, and statements related to market acceptance and commercial potential.

Forward-looking statements involve risk and uncertainties, and actual events could differ materially from those projected herein. A list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW Pharmaceuticals filings with the U.S. Securities and Exchange Commission.

Prospective investors are caution not to place undue reliance on these forward-looking statements which speak only as to the date hereof.

I’ll now turn the call over to Justin Gover, GW’s Chief Executive Officer.

Justin Gover

Thank you, Steve, and thank you to everyone for joining us on the call today. As I indicated on our last call at the time of our Q2 and half year results, by yearly presentation of results, this is standard frequency for U.K. listed companies and has been our history practice.

However, in view of our recent NASDAQ listing we have elected to provide quarterly update from now on to conform with U.S. market practice, as such this is the first time that GW has reported results for fiscal third quarter.

GW has continued to make substantial progress in the third quarter, advancing key objectives in a number of areas, including the completion in May of our IPO on NASDAQ, raising $30.4 million, the continued progress in recruitment of our two Sativex pivotal Phase 3 cancer pain trials, representing our lead U.S. indication, the filing with FDA of a Phase 3 IND for Sativex as a treatment for MS spasticity, continued commercial progress in Europe for Sativex including launch in Italy, positive topline results announcing the separate release today from the 12-month study of Sativex in MS spasticity, and the addition of two new patent allowances in the U.S. protecting Sativex.

Our financial highlights this quarter include Sativex product sales revenue of 0.5 million pounds or $800,000, reflecting increased shipment of inventory to our commercial partners. Total revenue for the quarter of 7.3 million pounds or $11 million, and we ended the quarter with cash and cash equivalents of 43.6 million pounds or $66.3 million.

With the completion of the NASDAQ IPO, GW’s cash balance at the end of this quarter is the highest reported in the company’s history. However, this NASDAQ listing represent much more than a financing exercise, we see it as a key strategic step for GW and for future value creation for our shareholders.

We expect to generate a significant portion of our future revenues in the United States and providing greater exposure for the company to the U.S. investment community is a key goal for GW moving forward.

Turning to the U.S. clinical program, we are currently evaluating Sativex in Phase 3 clinical trials for the treatment of cancer pain. This program represents the lead target indication for Sativex in the U.S. and is intended to support a regulatory filing with FDA, and with regulators in other markets around the world. GW anticipates the topline results from the two Phase 3 pivotal trials will be available in 2014 with the first reporting results around mid- ’14.

Beyond this initial cancer pain indication, an important new development for our company is the acceleration of our plans for the development of Sativex as a treatment for MS spasticity in the United States. As a reminder, this is the indication for which Sativex is currently being marketed in Europe and for which we have already obtained approval in 22 countries.

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