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GW Pharma (GWPH) Posts Narrower-than-Expected Loss in Q1
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GW Pharmaceuticals plc reported first-quarter fiscal 2017 loss of 77 cents per share, much narrower than both the Zacks Consensus Estimate of a loss of $1.35 and the year-ago figure of 82 cents.
The company’s shares gained 4.6% following the release of first-quarter fiscal 2017 results. In fact, its year-to-date share price movement shows that GW Pharma gained 10.8%, outperforming the Zacks classified Medical Products industry’s increase of 5.6%.
However, despite surpassing the Zacks Consensus Estimate of $2 million, total revenue in the first quarter of fiscal 2017 came in at $2.54 million, down from $4.53 million in the year-ago period.
Research & development (R&D) expenses increased 3.7% year over year to $30.8 million. Selling, general and administrative (SG&A) expenses skyrocketed 85% to $8.3 million due to pre-launch commercialization activities related to Epidiolex.
Focus on Epidiolex
GW Pharma has made significant progress with its lead cannabinoid pipeline candidate, Epidiolex. The company expects to make a regulatory submission for the candidate in the U.S. for both Dravet syndrome and Lennox-Gastaut syndrome (LGS) around the end of the first half of 2017. The company anticipates simultaneous approval in these indications. Given the significant unmet need in the epilepsy market and the resulting opportunity, an approval would be a huge boost for the company.
In Dec 2016, GW Pharma announced additional positive phase III data on Epidiolex at the annual meeting of the American Epilepsy Society. These results included data from the pivotal phase III study for Dravet syndrome and the first pivotal phase III study for LGS, both of which were announced earlier this year. Each pivotal phase III study achieved the primary endpoint of demonstrating a statistically significant difference between Epidiolex and placebo in seizure frequency reduction during the 14-week treatment period. On the safety front, Epidiolex was found to be well tolerated.
Apart from Epidiolex, GW Pharma has a deep pipeline of other cannabinoid candidates with focus on orphan pediatric neurologic conditions. Particularly, GWP42006 (cannabidivarin) is in a phase II program for the treatment of adult epilepsy patients. Part A of the study is complete and Part B is underway with data expected in the second half of 2017.
A phase II program on the candidate for autism spectrum disorders is expected to commence in the third quarter of 2017. In addition, the company has been granted Orphan Drug status in the U.S. for an intravenous CBD formulation (GWP42003; phase I) for the treatment of neonatal hypoxic ischemic encephalopathy (NHIE). Meanwhile, a phase II study on GWP42003 in schizophrenia has been completed.
The company announced positive top-line data from a phase Ib/IIa study on the combination of GWP42002 and GWP42003 for the treatment of recurrent glioblastoma multiforme. Successful development and subsequent approval of these candidates will be a big positive for GW Pharma.
GW Pharmaceuticals PLC Price, Consensus and EPS Surprise
Eli Lilly’s earnings estimates increased from $3.99 to $4.11 for 2016 and from $4.31 to $4.37 for 2017 over the last 60 days. Its share price increased 5.8% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
GlaxoSmithKline’s earnings estimates increased from $2.52 to $2.53 for 2016 and from $2.64 to $2.66 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 8.96%. Its share price increased 2.5% year to date.
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GW Pharma (GWPH) Posts Narrower-than-Expected Loss in Q1
GW Pharmaceuticals plc reported first-quarter fiscal 2017 loss of 77 cents per share, much narrower than both the Zacks Consensus Estimate of a loss of $1.35 and the year-ago figure of 82 cents.
The company’s shares gained 4.6% following the release of first-quarter fiscal 2017 results. In fact, its year-to-date share price movement shows that GW Pharma gained 10.8%, outperforming the Zacks classified Medical Products industry’s increase of 5.6%.
However, despite surpassing the Zacks Consensus Estimate of $2 million, total revenue in the first quarter of fiscal 2017 came in at $2.54 million, down from $4.53 million in the year-ago period.
Research & development (R&D) expenses increased 3.7% year over year to $30.8 million. Selling, general and administrative (SG&A) expenses skyrocketed 85% to $8.3 million due to pre-launch commercialization activities related to Epidiolex.
Focus on Epidiolex
GW Pharma has made significant progress with its lead cannabinoid pipeline candidate, Epidiolex. The company expects to make a regulatory submission for the candidate in the U.S. for both Dravet syndrome and Lennox-Gastaut syndrome (LGS) around the end of the first half of 2017. The company anticipates simultaneous approval in these indications. Given the significant unmet need in the epilepsy market and the resulting opportunity, an approval would be a huge boost for the company.
In Dec 2016, GW Pharma announced additional positive phase III data on Epidiolex at the annual meeting of the American Epilepsy Society. These results included data from the pivotal phase III study for Dravet syndrome and the first pivotal phase III study for LGS, both of which were announced earlier this year. Each pivotal phase III study achieved the primary endpoint of demonstrating a statistically significant difference between Epidiolex and placebo in seizure frequency reduction during the 14-week treatment period. On the safety front, Epidiolex was found to be well tolerated.
Apart from Epidiolex, GW Pharma has a deep pipeline of other cannabinoid candidates with focus on orphan pediatric neurologic conditions. Particularly, GWP42006 (cannabidivarin) is in a phase II program for the treatment of adult epilepsy patients. Part A of the study is complete and Part B is underway with data expected in the second half of 2017.
A phase II program on the candidate for autism spectrum disorders is expected to commence in the third quarter of 2017. In addition, the company has been granted Orphan Drug status in the U.S. for an intravenous CBD formulation (GWP42003; phase I) for the treatment of neonatal hypoxic ischemic encephalopathy (NHIE). Meanwhile, a phase II study on GWP42003 in schizophrenia has been completed.
The company announced positive top-line data from a phase Ib/IIa study on the combination of GWP42002 and GWP42003 for the treatment of recurrent glioblastoma multiforme. Successful development and subsequent approval of these candidates will be a big positive for GW Pharma.
GW Pharmaceuticals PLC Price, Consensus and EPS Surprise
GW Pharmaceuticals PLC Price, Consensus and EPS Surprise | GW Pharmaceuticals PLC Quote
Key Picks
Some better-ranked stocks in the health care sector include Eli Lilly and Company (LLY - Free Report) , Enzo Biochem, Inc. (ENZ - Free Report) and GlaxoSmithKline plc (GSK - Free Report) . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Eli Lilly’s earnings estimates increased from $3.99 to $4.11 for 2016 and from $4.31 to $4.37 for 2017 over the last 60 days. Its share price increased 5.8% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
GlaxoSmithKline’s earnings estimates increased from $2.52 to $2.53 for 2016 and from $2.64 to $2.66 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 8.96%. Its share price increased 2.5% year to date.
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In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>