Less than one month into the launch of the first cannabis-derived, US Food and Drug Administration (FDA) approved medicine in the US, GW Pharmaceuticals has announced its Q4 financial results, for the year ended September 30, 2018.
The firm reported revenue of $12.7m (€11.6m) this year, compared to $8.6m for the year ending September 30, 2017, in part due to increased Sativex sales, and R&D fee revenue from a terminated licensing agreement with Otsuka.
Sales, general and administrative (SG&A) expenses, however, rose to $52.7m in Q4 from $19.4m in Q3, totalling a year-end expense of $141.8m, compared to $58m in 2017.
According to chief financial officer Scott Giacobello, Q3’s SG&A is consistent with previous quarters: “This substantial increase is a result of continued investment in our commercial operations and prelaunch activities in both the US and Europe.”
“This has all resulted in a net loss for the quarter of $79.9m. For the year ended September 30, 2018, our net loss amounted to $295.2m,” he told investors on the company’s earnings call.
‘We are where we need to be’ for EU launch
GW Pharma’s Epidiolex received US regulatory approval in June this year to treat two types of childhood-onset epilepsy. The firm is now “moving into the final stages of the European regulatory review,” with the final decision expected in Q1, 2019.
Pending approval, the firm plans to launch Epidiolex in five major European markets.
According to GW Pharma, manufacturing capacity is ‘more than sufficient’ to meet launch requirements. “Because of the rapid timeline, [there] has been a key focus on inventory and building capacity,” said CEO Justin Gover.
“…In terms of inventory build and capacity, at this point in time looking at the US and Europe…we are most comfortably ahead of where we would need to be, even on the most aggressive of demand forecast,” he told investors.
“I don’t give patient numbers, because otherwise it provides a potential demand forecast, but we are where we need to be,” Gover added.
DEA rescheduling
While cannabis is listed as a Schedule I drug by the US Drug Enforcement Agency (DEA) – a designation which deems the drug to have no accepted medical use and a high potential for abuse – earlier this year, Epidiolex was classed a Schedule V drug.
Looking to Europe, will authorities similarly accord Epidiolex the least restrictive scheduling of controlled drug substances? “Europe, as ever, is different in each individual country,” according to COO Chris Tovey.
“The focus in the first wave of launches in Europe will be the major five countries, and each country has a slightly different approach,” Tovey explained.
In the UK, for example, Epidiolex is not considered a controlled drug, he told investors. “So we're working with each country to finalise exactly what Epidiolex will be classified as during clinical trials in the clinical phase.”
For the most part, the product is not regarded a controlled drug, Tovey continued. “We're optimistic that in the key markets, we'll be closer to that outcome than having a very, very prohibitive scheduling that will have an impact on the supply chain.”
“We are pretty optimistic that we'll end up with pretty much a high level of freedom to move the product around key markets,” he added.
