GW Pharmaceuticals (GWPH) is one of the biggest marijuana stocks on the market. Despite a recent decline in its share price, the biotech still claims a market cap of more than $2.5 billion. That's gigantic compared to most marijuana stocks.
On Wednesday, GW Pharmaceuticals executives sat down at the Goldman Sachs healthcare conference to field questions about where the company is headed. Here are the five most important questions that were asked -- and how management answered.
1. Is the company on track for regulatory filings?
Julian Gangolli, president of GW's North American operations, said that the company is on track to file for approval of Epidiolex in the U.S. in mid-2017 and in Europe later this year. He joked that the executives on stage at the Goldman Sachs conference were probably the only employees of the company not working at that moment on the New Drug Application (NDA) filing.
GW Pharmaceuticals isn't just preparing to file for regulatory approval. The company is also trying to anticipate how the U.S. Food and Drug Administration (FDA) might proceed, including the potential for an advisory panel reviewing the filing for Epidiolex, according to GW's vice president of investor relations, Steve Schultz.
2. What will the price be for Epidiolex?
GW's management basically punted on this question. In all fairness, providing details about pricing before a drug is even approved isn't something most biopharmaceutical companies would do.
However, Gangolli did at least give a hint. He stated that there are two "reference points" for pricing Epidiolex. One currently available epilepsy drug, Onfi, sells for around $18,000 per year. Another, Banzel, costs around $25,000 to $28,000 per year. As I've written before, my guess is that GW will price Epidiolex around $30,000, close to Banzel's price tag.
3. How are payer discussions going?
GW Pharmaceuticals has been working with payers since last year. Gangolli's comments seemed to indicate that he expects payers will look at Epidiolex in a similar way that they do Banzel and Onfi.
Both of these drugs require prior authorizations from some payers. Gangolli said that he "doesn't think it will be unusual" for some plans to also require prior authorizations for Epidiolex. How stringent the prior authorization processes might be, however, remains to be seen.
4. How will Epidiolex be protected from competition?
If Epidiolex is approved by the FDA, it will enjoy seven-year protection from competitors because of its orphan-drug designation. In Europe, Epidiolex's orphan-drug designation gives it exclusivity for 10 years.
GW already has been granted U.S. patent approval for Epidiolex in treating partial seizures. A total of 13 patent families have been filed. The company expects to find out either late this year or early in 2018 if those patents win approval. If they do, the intellectual property protection for Epidiolex should be solid.
5. What's next after Epidiolex?
The GW Pharmaceuticals executives were quick to point out that the primary focus for the company right now is filing for, and ultimately securing, approval for Epidiolex in treating Dravet syndrome and Lennox-Gastaut syndrome. The company also has clinical studies underway evaluating the drug in treating tuberous sclerosis and infantile spasms.
There are opportunities for GW beyond Epidiolex, though. The company has a phase 2 study of cannabidivarin (CBDV) in treating adult epilepsy and autism spectrum disorders. Gangolli also referenced data presented in poster form at the American Society of Clinical Oncology (ASCO) from a study of THC and cannibidiol (CBD) in treating glioblastoma, a form of brain cancer. He said the data was promising, but it's still early. The next steps haven't been determined yet for this potential cannabinoid cancer combo.
Gangolli stated that GW Pharmaceuticals' general approach for research and development will be to target indications with high unmet needs that provide the company with potential for orphan-drug exclusivity. This is critical for the company, since it's developing products based on naturally occurring molecules.