Company Update (NASDAQ:GWPH): GW Pharmaceuticals PLC- ADR Reports Second Quarter and Half-Year 2016 Financial Results and Operational Progress
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced financial results for the second quarter and half-year ended 31 March 2016.
“Following positive results in our first Phase 3 trial of Epidiolex in Dravet syndrome, GW is now entering an exciting new chapter as we start to prepare the Company’s first NDA submission to the FDA and step up plans for Epidiolex commercialization,” stated Justin Gover, GW’s Chief Executive Officer. “The robust data from this first Phase 3 trial in Dravet syndrome provides additional confidence for future clinical trials of Epidiolex and we look forward to results from our Phase 3 trials in Lennox-Gastaut syndrome in the near future. In addition, we continue to expand our research through exploring further indications for Epidiolex as well as ongoing Phase 2 clinical programs for a number of our pipeline candidates.”
RECENT OPERATIONAL HIGHLIGHTS
- Epidiolex® (CBD) orphan epilepsy program:
- Company sponsored Phase 3 development programs in Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC)
- Positive results in first Phase 3 Dravet syndrome trial
- Full publication of trial results expected in Q4 2016
- Second Phase 3 Dravet syndrome trial ongoing
- Pre-NDA meeting with FDA requested
- Two LGS Phase 3 trials fully enrolled; Data from first trial expected in June
- 98% transition rate of eligible patients from pivotal Phase 3 trials to long term open label extension
- Phase 3 TSC trial commenced, Orphan Drug Designation received from FDA
- Additional clinical development for Epidiolex expected to commence in H2 2016
- Expanded access program:
- Recent updates at the American Academy of Neurology (AAN) Annual Meeting showing consistent treatment effect and safety profile in state-sponsored clinical programs from Alabama and Georgia
- Over 900 children and young adults authorized for treatment by FDA under Expanded Access Treatment INDs and 6 U.S. State programs
- 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 Q1 2017
- CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial clinical evaluation is expected to commence in H2 2016, with Phase 2 trials expected to commence in Q1 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
- THCV Phase 2 study in type-2 diabetes completed – data expected in Q2/3 2016
- THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
- Orphan Drug Designation granted from FDA and EMA
- Sativex® Phase 2 study in spasticity due to cerebral palsy ongoing with data expected Q4 2016
- Pre-clinical progress addressing a number of areas of unmet need including autism spectrum disorders, Duchenne muscular dystrophy, glioma, ovarian and pancreatic cancers
- Cash and cash equivalents at 31 March 2016 of £192.7 million ($276.8 million) compared to £234.9 million as at 30 September 2015
- Revenue for the six months ended 31 March 2016 of £6.3 million ($9.1 million) compared to £14.3 million for the six months ended 31 March 2015. This decrease primarily reflects the expected reduction in R&D fees associated with the conclusion of partner funded Sativex Phase 3 cancer pain trials
- Loss for the six months ended 31 March 2016 of £34.5 million ($49.6 million) compared to £10.9 million for the six months ended 31 March 2015 (Original Source)
Shares of GW Pharmaceuticals are down 4% to $75.22 in after-hours trading. GWPH has a 1-year high of $133.98 and a 1-year low of $35.83. The stock’s 50-day moving average is $79.49 and its 200-day moving average is $68.90.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on April 15, Cowen analyst Phil Nadeau maintained a Buy rating on GWPH, with a price target of $135, which represents a potential upside of 71.9% from where the stock is currently trading. Separately, on March 21, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $147.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Joshua Schimmer have a total average return of -1.9% and -18.2% respectively. Nadeau has a success rate of 35.7% and is ranked #3050 out of 3827 analysts, while Schimmer has a success rate of 23.7% and is ranked #3825.
The street is mostly Bullish on GWPH stock. Out of 6 analysts who cover the stock, 6 suggest a Buy rating . The 12-month average price target assigned to the stock is $162.00, which represents a potential upside of 106.3% from where the stock is currently trading.