Ahead of the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, GW Pharmaceuticals plc (Nasdaq: GWPH)released preliminary, unaudited net product sales for the fourth quarter and full-year 2020 and key priorities for 2021.
GW Pharma said it expects total net product sales to be approximately $148 million for the fourth quarter and approximately $526 million for the year ended December 31, 2020. The company said that total net product sales of Epidiolex are expected to be approximately $144 million for the fourth quarter, comprising $129 million in the US and $15 million ex-US. The company reported that Epidiolex’s net product sales were $137 million in the third quarter of 2020.
In a company statement published on Monday morning, GW Pharma said that total net product sales of Epidiolex for the year ending December 31, 2020, are expected to be approximately $510 million compared to $296 million in 2019. Cash and cash equivalents at December 31, 2020, were approximately $486 million.
“Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients’ experience with this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved Tuberous Sclerosis Complex indication, leads us to expect continued strong growth in 2021 in both the US and Europe,” said Justin Gover, GW’s Chief Executive Officer. “Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year. In addition to our previously announced pipeline activities, we are leveraging our world leadership in cannabinoid science to design and synthesize novel cannabinoid molecules and expect our first novel product candidate to enter the clinic in 2021.”
The stock was rising slightly in premarket trading on the news. Four analysts cover GW Pharma and have an average price target of $182. The stock was lately selling at $128, which is below its one year high of $144.
The company also outlined the following priorities for the coming year:
- Continue to drive revenue growth in US and Europe:
• Execute on TSC label expansion and continued penetration in Dravet and LGS
• Build further on expanded payer coverage achievements
• Accelerate adoption across a broader prescriber base
• Increase penetration in long-term care segment
• Continue launches in Germany and UK and achieve successful pricing and reimbursement, and launch execution in France, Spain and Italy, as well as other European countries
• Obtain approval of the Tuberous Sclerosis Complex indication in Europe
- Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex “composition” patent
- Commence pivotal trial in fourth target orphan epilepsy indication
Nabiximols in the US:
- Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
- Achieve data from at least one pivotal MS spasticity trial in 2021
- NDA submission expected following first positive pivotal MS spasticity trial
- Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury
- Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
- Conduct placebo-controlled trials with both CBDV and CBD in autism
- Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
- Complete Phase 1 trial for novel botanical drug candidate GW541
- Advance first novel NCE cannabinoid candidate into Phase 1