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.