PINL:GRPOF - Post by User
Post by
wwmeincon Nov 05, 2019 4:23pm
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Post# 30312364
A biotech business...not "fluff" news releases...
A biotech business...not "fluff" news releases...The reality that our current shareprice of 0.205cts is due to mkt reaction to mgmt inability to actually produce something concrete to run with...in today's GWPharma release,note how they believe their CBD product is better than synthetic CBD....something to watch.
https://www.stockwatch.com/News/Item?bid=U-z7752688-U%3aGWPH-20191105&symbol=GWPH®ion=U OPERATIONAL HIGHLIGHTS
- Epidiolex® (cannabidiol)
- U.S. commercial update
- Q3 Net sales of $86.1M; $188.0M net sales in the first three quarters of 2019
- Over 15,000 patients have received Epidiolex prescriptions since launch
- Over 3,000 physicians have generated dispensed prescriptions since launch
- Strong payor coverage with approximately 93 percent of all Commercial, Medicaid and Medicare lives in the US having a coverage determination, of which 65 percent are PA to indication or less restrictive
- European launch update
- European Commission approval in September 2019
- Commercialization underway in France and Germany
- UK NICE guidance expected in Q4 2019; Spain and Italy launches to follow in 2020
- Early Access Program now includes over 1,100 patients across 5 major EU countries, and over 400 physicians from 250 top epilepsy centers
- New Indications
- Tuberous Sclerosis Complex
- TSC Phase 3 data to be presented at American Epilepsy Society annual meeting in December 2019
- TSC sNDA expected to be filed with FDA in early 2020, approval decision expected mid-2020
- TSC EMA submission expected in Q1 2020
- Rett Syndrome
- Phase 3 trial in Rett Syndrome recruiting
- Life-cycle management
- Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation
- PK data generated in 2019 supports advancing multiple new formulations into additional Phase 1 studies in 2020
- Exclusivity
- 7 years of orphan exclusivity confirmed by FDA, plus 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe plus 2 year pediatric extension expected
- 9 granted patents listed in “Orange Book” and align directly with Epidiolex FDA label
- Patent expiry dates to 2035
- Additional patent applications under review, including patents related to the use of Epidiolex in TSC and other indications
- Patent application recently published indicating that Epidiolex is more efficacious than synthetic CBD in pre-clinical epilepsy models based on the key difference that Epidiolex comprises up to 2 percent of other cannabinoids.
- Pipeline progress
- Sativex® (nabiximols)
- Initial U.S. target indication: Multiple Sclerosis spasticity
- 3 positive Phase 3 trials completed in Europe
- Clinical IND open, FDA feedback received on clinical plan
- Clinical program expected to commence in Q1 2020 to augment existing pivotal data package
- Clinical program in additional indications in planning for 2020-2021
- CBDV
- IND open for 30-patient open label study in autism expected to commence Q4 19. Initial data in 2020.
- Investigator-led 100 patient placebo-controlled trial in autism underway
- Open label study in Rett syndrome and seizures ongoing
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- Phase 1b safety study in patients expected to commence in Q4
- Orphan Drug and Fast Track Designations granted from FDA and EMA
- Schizophrenia (GWP42003)
- Positive Phase 2a trial published
- Phase 2b trial expected to commence H1 2020
FINANCIAL HIGHLIGHTS
- Revenue for the quarter ended September 30, 2019 was $91.0 million compared to $2.4 million for the quarter ended September 30, 2018
- Cash and cash equivalents at September 30, 2019 were $554.7 million compared to $591.5 million as of December 31, 2018
- Net loss for the quarter ended September 30, 2019 was $13.8 million compared to a net loss of $79.9 million for the quarter ended September 30, 2018