GW Prescribed drugs Says Epidiolex Gross sales Continued To Enhance In Fourth Quarter

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Forward of the thirty eighth Annual J.P. Morgan Healthcare Convention on Tuesday, GW Prescribed drugs plc (Nasdaq: GWPH)launched preliminary, unaudited web product gross sales for the fourth quarter and full-year 2020 and key priorities for 2021.

GW Pharma mentioned it expects whole web product gross sales to be roughly $148 million for the fourth quarter and roughly $526 million for the yr ended December 31, 2020. The corporate mentioned that whole web product gross sales of Epidiolex are anticipated to be roughly $144 million for the fourth quarter, comprising $129 million within the US and $15 million ex-US. The corporate reported that Epidiolex’s web product gross sales had been $137 million within the third quarter of 2020.

In an organization assertion revealed on Monday morning, GW Pharma mentioned that whole web product gross sales of Epidiolex for the yr ending December 31, 2020, are anticipated to be roughly $510 million in comparison with $296 million in 2019. Money and money equivalents at December 31, 2020, had been roughly $486 million.

“Epidiolex gross sales elevated by over 70% in 2020 regardless of the challenges of COVID-19, reflecting the constructive affect this drugs has on sufferers in addition to the efficiency of our industrial staff. We stay inspired by our sufferers’ expertise with this product, as demonstrated by excessive persistence and refill charges. This, mixed with our growth of payer protection and the lately authorised Tuberous Sclerosis Complicated indication, leads us to anticipate continued sturdy development in 2021 in each the US and Europe,” mentioned Justin Gover, GW’s Chief Govt Officer. “Our objectives in 2021 embrace driving additional Epidiolex development and advancing a number of US pivotal trials for nabiximols within the remedy of MS spasticity, with the primary knowledge readout anticipated this yr. Along with our beforehand introduced pipeline actions, we’re leveraging our world management in cannabinoid science to design and synthesize novel cannabinoid molecules and anticipate our first novel product candidate to enter the clinic in 2021.”

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The inventory was rising barely in premarket buying and selling on the information. 4 analysts cowl GW Pharma and have a mean worth goal of $182. The inventory was recently promoting at $128, which is beneath its one yr excessive of $144.

The corporate additionally outlined the next priorities for the approaching yr:

EPIDIOLEX commercialization:

  • Proceed to drive income development in US and Europe:

    • Execute on TSC label growth and continued penetration in Dravet and LGS

    • Construct additional on expanded payer protection achievements

    • Speed up adoption throughout a broader prescriber base

    • Enhance penetration in long-term care section

    • Proceed launches in Germany and UK and obtain profitable pricing and reimbursement, and launch execution in France, Spain and Italy, in addition to different European nations

    • Get hold of approval of the Tuberous Sclerosis Complicated indication in Europe
  • Complement present 14 Orange Guide listed patents (expiry 2035) with further use patents, and acquire grant of the Epidiolex “composition” patent
  • Begin pivotal trial in fourth goal orphan epilepsy indication

Nabiximols within the US:

  • Proceed recruitment of two ongoing pivotal MS spasticity trials and begin three further pivotal trials in MS spasticity
  • Obtain knowledge from at the least one pivotal MS spasticity trial in 2021
  • NDA submission anticipated following first constructive pivotal MS spasticity trial
  • Begin scientific program to increase future label to incorporate spasticity related to Spinal Wire Harm

Extra pipeline:

  • Proceed recruitment of ongoing Part 2b research of a cannabidiol formulation for the remedy of schizophrenia
  • Conduct placebo-controlled trials with each CBDV and CBD in autism
  • Advance NHIE scientific program using an intravenous formulation of cannabidiol
  • Full Part 1 trial for novel botanical drug candidate GW541
  • Advance first novel NCE cannabinoid candidate into Part 1
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