GW Pharmaceuticals PLC (NASDAQ: GWPH) was seeing some selling pressure after the company reported earnings. Its third quarter loss was actually better than expected, but revenues of $3.1 million were softer than expected. What most investors think about GW is quite mixed, and this company’s pivotal future is generally what the shares trade on rather than the miniscule revenues of today. The consensus estimate from Thomson Reuters is not calling for revenues to launch off until 2018.
What stands out so much here is when you compare an extremely bullish analyst report to the most bearish. One is calling for about 70% upside and one is calling for the stock to fall by more than half.
GW Pharma reported late on Tuesday positive Phase III Epidiolex pivotal trial data in its Lennox-Gastaut Syndrome (LGS) study. They also talked up a positive FDA pre-NDA meeting, and they said that the new drug application for Dravet syndrome and LGS are on track for the first half of 2017 submission.
An issue to consider here is that GW’s Stephen Wright notified the company that he intends to retire. Wright will step down as Chief Medical Officer and as a member of GW’s board of directors on May 1, 2017.
So, how is it that two analysts see the exact same data and have polar opposite views? Much of this may be on bias and opinions of what the market will give a future value for even if an approval is granted. Either way, one of these two analyst reports may end up looking very wrong after GW’s fate is better understood.
BofA Merrill Lynch is one of the biggest bulls for GW Pharma. The firm has a Buy rating and has a $153 price objective. That represents more than 70% upside if the firm is right. Merrill Lynch’s report shows that GW Pharma’s commercialization preparations are underway. The report said:
With the strong data from 2 phase 3 trials, we expect the second LGS study to readout positive in late September. The trial is identical to the first LGS phase 3 but includes a halfdose cohort which should lend efficacy and safety support to the NDA filing. GW believes the FDA will allow data from the LGS studies to be pooled regardless of the outcomes. Commercialization prep is underway with a focus on manufacturing scale-up, and expansion of med affairs, market access, marketing and compliance teams. Management stated that the company is assessing the federal, state and private payor landscape and conducting health economics research to support patient access to Epidiolex. We await clarity on payor expectations as regulatory processes play out.
Our valuation is mainly driven by our view on Epidiolex, for which the company has presented positive proof of concept data. We see value in investing in GW based on the potential for a scientifically validated cannabinoid therapy to have wide utility over both orphan and non-orphan indications.
Janney maintained its Sell rating and has a mere $40 fair value estimate. The firm has been quite negative here for a while and the firm also acknowledges that GW Pharma is in the early stages of building out its U.S. commercial infrastructure. This extremely cautious report from Janney said:
GW reports financial results and feedback from FDA pre-NDA meeting regarding Epidiolex. GW announced that it expects to report results of the second Phase 3 study in Lennox-Gastaut Syndrome (LGS) in late September 2016. GWPH plans to file a single NDA for both the Dravet and LGS indications in 1H17. While the company continues to make progress toward its planned NDA filing and potential NDA submission, we continue to believe valuation is highly dependent upon faultless execution of its second Phase 3 study in LGS, NDA submission, and FDA review of its NDA in the next 12-18 months, followed by commercial success of a magnitude unseen by other recent launches for highly effective drugs approved to treat LGS. While it is possible, we simply see it as way too unlikely to justify the risk. Thus, we are maintaining our Sell rating.
GW Pharma’s revenues were low as the Savitex R&D fees were lower. Again, it is not until 2018 that the pool of Thomson Reuters analysts expect a serious revenue growth.
Much of GW Pharma’s debate is that cannabinoids come from marijuana. Despite the legalization trends, there are many considerations. 24/7 Wall St. has tracked where marijuana is and is not legal. Also, here is a view of how each presidential candidate would view legalization.
GW Pharma’s stock was last seen down 4.6% at $88.35 in mid-day trading on Wednesday. Its 52-week range is $35.83 to $120.94.