Pharma Company Earns $311M for Cannabinoid Medicines

GW Pharmaceuticals announced last week that its cannabinoid (CBD) prescription medicines brought in total revenue of $109.1 million for the fourth quarter of 2019, and $311.3 million for the full year. 

Total revenue for Q4 2019 was $109.1 million, compared to $6.7 million for the fourth quarter of 2018. And net loss for the fourth quarter was $24.9 million compared to 2018 with a net loss of $71.9 million. 

As a biopharmaceutical company focused on discovering, developing, and commercializing therapeutics through cannabinoid products, GW Pharmaceuticals found significant profit progress with Epidiolex (cannabidiol).

Total net product sales of Epidolex was $104.5 million for the fourth quarter and $296.4 million for the 2019 year. For 2020, the company focused on broadening prescriber base, expanding payer coverage, entering long-term care segment, and expected launch of Tuberous Sclerosis Complex (TSC) indication. 

The company also saw improved intellectual property rights and exclusivity, with a current FDA label expiration date of 2035 for Epidiolex. And additional patent applications are currently under review, including patents related to the use of Epidiolex in TSC and other indications. 

“2019 was an exceptional and transformative year for GW, led by the successful launch of Epidiolex in the US and approval in Europe. The positive impact this medicine has had on thousands of patients and their families provides a compelling foundation for continued growth in 2020,” GW Pharmaceuticals CEO Justin Gover, said in the announcement. 

The company secured a positive NICE recommendation in the UK with a commercial launch expected in Q1 of this year. And later this year, commercial launches in France, Spain, and Italy are expected following pricing and reimbursement.

Additionally, TSC sNDA filed with the FDA earlier this month while marketing authorization application (MAA) submission to EMA is expected in Q1 of this year as well. And various new formulations of CBD will advance into addition Phase I studies this year, including modified oral solutions and capsules. 

Down the pipeline for GW Pharmaceuticals is a clinical program expected to take place in the second half of this year to augment existing data packages, as well as a PTSD clinical program to commence in H2 2020. 

For Schizophrenia, a positive phase 2a trial published and Phase 2b trial is expected to commence H1 2020. A 30-patient open-label study in autism is currently underway and the initial data is expected sometime this year. 

Lastly, Phase 1B of a Neonatal Hypoxic-Ischemic Encephalopathy CBD program safety study in patients is currently underway. 

“We expect 2020 to be an important year for our growing and developing product pipeline beyond Epidiolex as we build our world leadership in cannabinoid science,” Gover continued. “We are focused on advancing nabiximols in the US in several indication and clinical programs with other potential products whilst continuing to bring Epidiolex to more patients in the US and Europe.”