Anticipation is building for GW Pharmaceuticals (NASDAQ:GWPH) as the biotech prepares to hopefully launch its first product in the U.S. in 2018. The company announced its fiscal 2018 first-quarter results after the market closed on Monday. Frankly, most investors weren't too interested in the financial numbers. But there was definitely a desire to know more about what is going on with the potential launch of Epidiolex and GW's cannabinoid pipeline.
GW Pharmaceuticals executives fielded several questions on those very subjects in the company's quarterly conference call on Monday. Here are five things you'll want to know from what the world's biggest marijuana-focused biotech's management team said.
1. What are expectations for the FDA advisory committee meeting?
When GW Pharmaceuticals reported its fiscal 2017 Q4 results in early December, Chief Medical Officer Volker Knappertz stated that he thought there was "a 50-50 chance" of an advisory committee meeting to review Epidiolex. It took only a few weeks for those chances to shoot up to 100%. When the FDA accepted the New Drug Application (NDA) filing for Epidiolex, it also informed GW that it was planning to hold an advisory committee meeting.
During the company's call on Monday, Knappertz said that it was "very difficult to speculate" about what specific points the FDA advisory committee would address. He added that GW was preparing for a broad range of topics and has engaged an external consultant with significant experience in guiding drugmakers through the FDA regulatory process.
2. When could Epidiolex start generating revenue?
Julian Gangolli, GW Pharmaceuticals' president of North America, fielded what was perhaps the most important question asked during the company's conference call: When will Epidiolex make money? Of course, the premise of that question is that the FDA will approve the drug by the scheduled date of June 27, 2018. Assuming that approval is granted, Gangolli said that GW Pharmaceuticals should begin selling the drug in September. However, the quarter ending Dec. 31, 2018, will be when the company should have meaningful revenue from Epidiolex.
The gap from June to September stems from the time required for the U.S. Drug Enforcement Administration (DEA) to reschedule Epidiolex. Gangolli said that the DEA has up to 90 days to issue its interim final rule. That would put the U.S. launch of the drug in late September.
3. How are pre-launch activities going?
Obviously, GW plans to be ready to launch Epidiolex the minute both FDA approval and DEA rescheduling are completed. Gangolli said that the biotech is talking extensively with U.S. commercial, state, and federal payers that provide coverage to between 200 million and 220 million Americans. He added that GW is "not there yet on pricing," but is continuing to evaluate different pricing levels.
Gangolli stated that the U.S. sales leadership team is now fully in place. The company plans to hire around 70 sales representatives closer to the time of the Epidiolex launch. Gangolli said that there "was no shortage of interest" in these positions.
4. What's the scoop on CBDV?
While Epidiolex deservedly gets the most attention, GW Pharmaceuticals also has another intriguing cannabinoid in its pipeline -- cannabidivarin (CBDV). Data from a phase 2 study of CBDV in treating adults with partial-onset epilepsy is expected within the next couple of months. An investigator-led study of CBDV in treating autism spectrum disorders is scheduled to begin in the second quarter of 2018. GW also plans to conduct an open-label study of the drug in treating Rett syndrome in the second quarter, as well as a phase 2 study targeting the indication in the third quarter.
GW Pharmaceuticals CEO Justin Gover said that there has been considerable interest in the U.S. for CBDV following the successful clinical trials of Epidiolex. He noted that the biotech's efforts constitute a "logical response to investigator interest." Knappertz said, though, that statistical significance for some of these CBDV studies won't be as critical because they're smaller and the placebo response rate for patients in clinical studies has increased in recent years.
5. What has changed to make Sativex a more compelling asset?
The company announced on Dec. 13, 2017, that it had reacquired full rights to market Sativex in the U.S. GW currently markets the marijuana-based drug outside of the U.S. However, sales haven't been great. Gover was asked what has changed to make owning U.S. rights to Sativex more compelling now.
One reason why GW is excited about Sativex, according to Gover, stems from phase 2 study results announced in February 2017. That study evaluated the drug in treating recurrent glioblastoma multiforme, an aggressive form of brain cancer. Patients treated with Sativex had an 83% one-year survival rate compared to 53% for patients on placebo. Gover also noted that GW's position has changed dramatically from a decade ago when it licensed U.S. rights for Sativex to Otsuka Pharmaceutical.
I recently stated that if I could buy only one marijuana stock, GW Pharmaceuticals would be it. I still feel that way.
While anything can happen with the FDA regulatory process, I fully expect that Epidiolex will gain approval. I also think that GW's launch of the drug will go reasonably well. My view is that 2019 will be a better indication for just how successful Epidiolex will be, though.
There are still plenty of risks, of course. Epidiolex could disappoint. CBDV might prove to be ineffective in clinical studies. However, I continue to view the risk-reward proposition for GW Pharmaceuticals favorably. 2018 will definitely be, as Justin Gover said on Monday, "an exciting and pivotal year" for the company.