GW Pharmaceuticals (GWPH): Investments in manufacturing and international expansion serve as strong growth drivers

GW Pharmaceuticals plc (NASDAQ: GWPH) has seen its stock gain over 17% in the past one month. The company delivered topline growth of over 200% in the first quarter of 2020 while net loss narrowed to $8 million from $50.1 million in the prior-year period.

GW benefited from the control it has over its manufacture and supply chain and its limited reliance on other parties for production. This not only helped the company in preventing interruptions in its manufacturing but also allowed it to increase the production of Epidiolex over the past weeks.

Epidiolex

Epidiolex sales in the US totaled $106.1 million in the first quarter, reflecting an increase of over 200% year-over-year. New patient starts remained stable during the period while retention was strong. Average dosing saw a slight pickup in the quarter. The company saw growth in prescription volume and market share across all its HCP groups on a sequential basis.

Although the company was not significantly impacted by the coronavirus outbreak during the first quarter, the drop in patients visiting physicians and the limitations of telemedicine poses challenges for new patient starts looking ahead into the second quarter.

The recent decision of the DEA to deschedule Epidiolex and the expected label expansion at July-end to include seizures associated with TSC bode well for the company. The label expansion is expected to give the company access to double the addressable patient population and presents a significant growth opportunity in the latter half of this year and beyond.

European launch

On its quarterly conference call, GW stated that its main focus for this year is to achieve favorable pricing and reimbursement conditions for Epidiolex in the major European markets.

In the UK, the company received endorsement from NICE at the end of last year and central funding from the NHS in January. In Italy, Epidiolex was awarded innovation status on the basis of clinical value. This should help the product gain central funding which can be secured earlier and would remain uniform across the country as opposed to regional funding.

Epidiolex received a positive GBA benefit rating in Germany where the company holds orphan medicine status within the pricing and reimbursement process. In France, the company is seeing an increase in the number of patients in the French regulatory agency sponsored ATU early access program and it is also seeing progress in the pricing and reimbursement process with the Transparency Commission.

Looking ahead, however, GW expects to face delays in treatments and prescriptions in Europe due to the impact of the COVID-19 pandemic.

Pipeline

Nabiximols is a top priority cannabinoid product for the company. The product already has extensive safety and efficacy data and the company expects to develop at least three target indications over the coming years. Based on market research in the US, the company believes this product has vast commercial potential in MS spasticity, spinal cord injury spasticity and the broader spasticity market.

GW expects to commence a Phase III trial for MS spasticity in the second half of 2020 and a spinal cord injury spasticity clinical program towards the end of the year. The company is also advancing Phase II programs in autism, schizophrenia and neonatal hypoxic ischemic encephalopathy.