We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
GW Pharma (GWPH) Incurs Narrower-than-Expected Q3 Loss
Read MoreHide Full Article
GW Pharmaceuticals, Inc. reported a third-quarter fiscal 2016 (for the three months ended Jun 30, 2016) loss of 73 cents per share, much narrower than the Zacks Consensus Estimate of a loss of $1.73. The reported loss was also narrower than the year-ago loss of $1.60 per share.
The company’s total revenue in the third quarter of fiscal 2016 was $3.1 million compared with $11.4 million in the year-ago period. Revenues in the reported quarter came in below the Zacks Consensus Estimate of $3.6 million.
Research & development expenses were up 23.1% year over year to $34.1 million due to investments in pipeline. Selling, general and administrative expenses increased 87.5% year over year to $7.5 million due to pre-launch commercialization activities related to Epidiolex.
The company’s key growth driver, Sativex, is approved outside the U.S. for the treatment of spasticity associated with multiple sclerosis. Sativex revenues of just over $2 million for the quarter continued to grow steadily.
Sativex is currently being evaluated in a phase II study for spasticity due to cerebral palsy in children, with data expected in the fourth quarter of fiscal 2016.
Epidiolex in Focus
GW Pharma has made significant progress with its lead pipeline candidate, Epidiolex (cannabidiol). In Jun 2016, GW Pharma reported positive results from the first pivotal phase III study on Epidiolex for the treatment of Lennox-Gastaut syndrome (LGS). Top-line data from the second study should be out shortly.
In Mar 2016, GW Pharma reported positive data from the first pivotal phase III study on Epidiolex for the treatment of Dravet syndrome. The company continues to enrol in the second phase III study and anticipates data in fiscal 2017.
GW Pharma noted that a pre-new drug application (NDA) meeting was held with the FDA in Jul 2016 to determine the regulatory path forward for Epidiolex. GW Pharma believes the guidance received was both positive and supportive of the company’s proposed filing strategy to submit a single NDA that includes phase III data from one Dravet syndrome study and two LGS studies. The company anticipates simultaneous approval for both indications and does not expect to wait for data from the second study in Dravet syndrome prior to the submission.
GW Pharma expects to seek FDA approval for Epidiolex for both Dravet syndrome and LGS indications in the first half of fiscal 2017.
During the quarter, the company commenced a phase III study on Epidiolex for the treatment of tuberous sclerosis complex with data anticipated in fiscal 2017. Meanwhile, the company has selected infantile spasms as the fourth target indication for the development of Epidiolex. The company expects to initiate a two-part pivotal phase III study in the fourth quarter of fiscal 2016.
Apart from Epidiolex, GW Pharma has a deep pipeline of additional cannabinoid candidates with an increasing focus on orphan pediatric neurologic conditions.
GW Pharma currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Corcept Therapeutics Inc. (CORT - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corp. (GERN - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
GW Pharma (GWPH) Incurs Narrower-than-Expected Q3 Loss
GW Pharmaceuticals, Inc. reported a third-quarter fiscal 2016 (for the three months ended Jun 30, 2016) loss of 73 cents per share, much narrower than the Zacks Consensus Estimate of a loss of $1.73. The reported loss was also narrower than the year-ago loss of $1.60 per share.
The company’s total revenue in the third quarter of fiscal 2016 was $3.1 million compared with $11.4 million in the year-ago period. Revenues in the reported quarter came in below the Zacks Consensus Estimate of $3.6 million.
Research & development expenses were up 23.1% year over year to $34.1 million due to investments in pipeline. Selling, general and administrative expenses increased 87.5% year over year to $7.5 million due to pre-launch commercialization activities related to Epidiolex.
The company’s key growth driver, Sativex, is approved outside the U.S. for the treatment of spasticity associated with multiple sclerosis. Sativex revenues of just over $2 million for the quarter continued to grow steadily.
Sativex is currently being evaluated in a phase II study for spasticity due to cerebral palsy in children, with data expected in the fourth quarter of fiscal 2016.
Epidiolex in Focus
GW Pharma has made significant progress with its lead pipeline candidate, Epidiolex (cannabidiol). In Jun 2016, GW Pharma reported positive results from the first pivotal phase III study on Epidiolex for the treatment of Lennox-Gastaut syndrome (LGS). Top-line data from the second study should be out shortly.
In Mar 2016, GW Pharma reported positive data from the first pivotal phase III study on Epidiolex for the treatment of Dravet syndrome. The company continues to enrol in the second phase III study and anticipates data in fiscal 2017.
GW Pharma noted that a pre-new drug application (NDA) meeting was held with the FDA in Jul 2016 to determine the regulatory path forward for Epidiolex. GW Pharma believes the guidance received was both positive and supportive of the company’s proposed filing strategy to submit a single NDA that includes phase III data from one Dravet syndrome study and two LGS studies. The company anticipates simultaneous approval for both indications and does not expect to wait for data from the second study in Dravet syndrome prior to the submission.
GW Pharma expects to seek FDA approval for Epidiolex for both Dravet syndrome and LGS indications in the first half of fiscal 2017.
During the quarter, the company commenced a phase III study on Epidiolex for the treatment of tuberous sclerosis complex with data anticipated in fiscal 2017. Meanwhile, the company has selected infantile spasms as the fourth target indication for the development of Epidiolex. The company expects to initiate a two-part pivotal phase III study in the fourth quarter of fiscal 2016.
Apart from Epidiolex, GW Pharma has a deep pipeline of additional cannabinoid candidates with an increasing focus on orphan pediatric neurologic conditions.
GW PHARMA-ADR Price and EPS Surprise
GW PHARMA-ADR Price and EPS Surprise | GW PHARMA-ADR Quote
GW Pharma currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Corcept Therapeutics Inc. (CORT - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corp. (GERN - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>