GW Pharmaceuticals plc (GW) (NASDAQ: GWPH) is a British biopharmaceutical company focused on researching cannabinoids and has established a world-leading position in pioneering cannabinoid therapeutics. Founded in 1998, GW headquartered in Cambridge, UK, operates both in the EU and the US. Known as the only company with a license of cannabis cultivation in the UK, GW has developed a portfolio of cannabinoid medicines including leading products Sativex and Epidiolex®.
- First FDA & EMA approved Cannabinoid pharmaceutical
- EU approved Epidyolex aiming to expand new markets
- Fiscal year unaudited net product sale of $296 million and Q4 net product sale of $104 million
GW as the first FDA & EMA approved Cannabinoid pharmaceutical, will expand new markets and achieve revenue growth in the development and commercialization of plant-derived cannabinoid therapeutics through its proven drugs Sativex, Nabiximols, and Epidiolex.
Research & Development
Since 1998, GW has spent years researching cannabinoid therapeutics in a broad range of disease areas. It has successfully developed Sativex®, the world’s first prescription medicine derived from the cannabis plant, in great demand in Europe. Nabiximols, as a rebranded name of Sativex in the US market, is waiting for trials and supplementary clinical programs for FDA commencing for the treatment of spasticity due to multiple sclerosis (MS).
Likewise, GW has developed an oral medicine of purified cannabidiol, approved as Epidiolex® by the U.S. FDA. GW has spent four years on pre-clinical and clinical researches and has been consistently working on trials and with federations. Epidiolex is the first plant-derived cannabis medicine that has been approved by the FDA.
Upon the approval by the FDA, publications of Epidiolex in top-tier medical journals help promote it widely across the US. It specializes in the treatment of certain refractory childhood epilepsies, which are seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome. Additionally, Epidiolex is commercialized in the US as a prescription medicine by GW’s U.S. subsidiary Greenwich Biosciences for treatments on November 1, 2018. Furthermore, Epidiolex has received approval by the European Medicines Agency (EMA) for the treatments of childhood epilepsies in the EU, under the tradename EPIDYOLEX®.
GW received positive results from prescription coverage of Epidiolex throughout the year of 2019. About 97% of US insured patients with Lennox-Gastaut syndrome and Dravet Syndrome now have Epidiolex. Prescriptions made mainly are through Express Scripts (ESI) coverage, which is one of the two largest PBMs in the US.
In order to continue indicative development and expansion of Epidiolex, GW stated its strategic goals during the 38th Annual J.P. Morgan Healthcare Conference:
- Building on positive physician experiences to increase appropriate prescriptions
- Acceleration of adoption across a broader prescriber base
- Retaining partnerships with patients
- Minimization of logistical barriers to Epidiolex
Expansion to new market
As a result of the EU approval, Epidyolex has already been launched in Germany and France. Right after just two-month of post-approval, Epidyolex supported by UK NICE endorsement funded by NHS will be launched in early 2020. Following pricing and reimbursement, Spain along with other countries in the EU will launch Epidyolex throughout 2020.
Moreover, GW expects Epidiolex expansion to treatments of seizures associated with Tuberous Sclerosis Complex (TSC). Because it has shown effectiveness on primary endpoint seizure and composite focal seizures, Epidiolex is expected to include TSC label for treatments to resistant epilepsy.
Besides, GW harbors another pipeline of cannabinoid products, Nabiximols, which is the tradename of Sativex in the US. It is approved in over 25 countries outside of the US. Nabiximols in the US market faces potential opportunities in treating MS spasticity. Specifically, patients with MS spasticity make up 84% of all MS patients.
There exist further opportunities for Nabiximols to address a broader spasticity population in the US medical market. Besides that, Nabiximols has the potentials to reach PTSD patients. In the US market, 55% of 11.7M people impacted by PTSD are diagnosed with it. However, about 75% of PTSD patients treated with pharmacotherapy still experience sleep disturbance symptoms. While cannabis extract products are effective in stress relief and mind tranquilization, there is some early evidence for both THC and CBD in the treatment of PTSD. Nabiximols, as cannabis extract medicine offers potential treatments to sleep disturbance symptoms, as well as anxiety and other symptoms.
On January 12, 2020, GW preannounced Q4 2019 financial guidance that net sales revenue for the fiscal year would be approximately $309 million, as Q4 net revenue accounted for $108 million. GW generates organic growth from AD patients, mainly resulted from growing demand through US commercials and government payors to increase appropriate prescriptions. Operating expense for FY 2019 is estimated at $415 to $430 million, along with approximately $35 to $45 million of FY 2019 capital expense.
GW has always kept a high gross margin through the fiscal year 2019. In Q3 2019, gross margin accounted for 91% of net revenue, compared to 91% in Q2 2019 and 87% in Q1 2019. Although GW retains high margins of gross profits, it has difficulties in executing sales and marketing and general and administrative expenses (SG&A). SG&A in Q3 2019 was $64 million, accounting for 71% of net revenue. It is the major cause leading to GW’s operating loss and net loss.
Nonetheless, the medical market in 2020 demonstrates potentials and opportunities for GW’s revenue growth. Successful pricing and reimbursement in the EU allow Epidiolex’s launches in the major five European countries. It will undoubtedly boost GW’s sales in Q1 2020. On Feb 25, 2020, GW will announce Q4 2019 as well as presenting its annual report of 2019.
Overall, along with Sativex and Nabiximols specialized in MS spasticity and PTSD, Epidiolex for treatments to Dravet syndrome, NHIE, and others, will support GW to generate substantial revenue in the new markets of medical cannabis. While Sativex and Epidiolex are leading sales in the EU and US medical cannabis markets, Nabiximols is expected to tap the US medical market, as well as Epidyolex in the line of new market expansion in the EU.
CBD regulations in the aspect of FDA deliberation would possibly be the main concern for GW to sell its leading cannabis products. However, GW sets strategies such as building on positive physician experiences and retaining partnerships with patients to ensure prescription coverage and to gain additional sales.
Read more about GW:
- First Cannabis Medicines Epidyolex and Sativex Approved for Use On NHS to Treat Epilepsy and Multiple Sclerosis
Source: GW Pharmaceuticals plc.