GW Pharma Sales Grow 67% to $6.65 Million in December Quarter as Epidiolex Sales Commence

GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the Quarter Ended December 31, 2018
  • Epidiolex® (cannabidiol) oral solution (CV), first FDA-approved plant-derived cannabinoid medicine, launched in the U.S. in November to high awareness and demand
  • GW moves to a new fiscal year-end beginning January 1, 2019
  • Conference call today at 4:30 p.m. EST

LONDON and CARLSBAD, Calif., Feb. 26, 2019 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the development and commercialization of cannabinoid prescription medicines, announces financial results for the quarter ended December 31, 2018.

We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year.

Justin Gover, GW’s Chief Executive Officer

As we move into the New Year, prescription growth trajectory has been highly encouraging and we believe that we are on track to deliver a successful market introduction of this important new treatment. In addition to the US launch, we look forward to a positive regulatory decision in Europe in the next few months, results of a Phase 3 trial in Tuberous Sclerosis Complex, and a number of advances in the pipeline.

OPERATIONAL HIGHLIGHTS

• Epidiolex® (cannabidiol)

U.S. launch progressing to plan

– First plant-derived cannabinoid pharmaceutical ever approved by FDA and first ever approved medicine in the U.S. for Dravet syndrome
– Net sales for Nov 1 – Dec 31 launch period of $4.7m
– Approximately 4,500 new patient enrolment forms in first two month selling period
– Over 500 physicians have generated dispensed prescriptions in first two month selling period
– Filled prescription growth trend in January 2019 shows approximately 150 percent growth over December 2018
– Demand coming from major centers of excellence and local epilepsy clinics
– Pharmacy distribution network expanded from initial 5 specialty pharmacies to over 130 distribution points
– Approximately 900 expanded access program and open label extension patients expected to migrate to commercial product by end of Q2 2019

Rapid and encouraging payor coverage decisions

– Over 80 percent of all commercial lives (145 million) now have a coverage determination with 60 percent of these lives covered with either no Prior Authorization (PA) or PA to label
– 99 percent of State Fee for Service Medicaid lives now have a coverage determination
– Approximately 90 percent of Managed Medicaid lives have a coverage determination

Target physician coverage

– The sales organization has to date interacted with about 70 percent of the 5,000 target physicians including all Level 3 and 4 epilepsy centers

European progress

– European submission under review by the EMA with a CHMP recommendation expected in Q2 2019
– Commercial footprint in place in initial 5 major European markets and active preparations well underway for pricing and reimbursement to support 2019 European launches

Manufacturing

– Commercial manufacturing and supply chain running smoothly
– Production capacity sufficient to meet expected demand in both U.S. and Europe
– Continued investment in manufacturing expansion program to meet anticipated long-term demand

Clinical trials

– Second Dravet syndrome Phase 3 trial successful and incorporated into EMA regulatory process
– Phase 3 trial in Tuberous Sclerosis Complex fully recruited with data expected in Q2 2019
♦ sNDA expected in Q4 2019
– IND open for pivotal Phase 3 trial in Rett Syndrome. Expected start Q2 2019.

Life-cycle management

– Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation. PK data expected in 2019.

Exclusivity

– 7 years of orphan exclusivity confirmed by FDA, 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe with 2 year pediatric extension
– Key favorable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam
♦ Patents align directly with new Epidiolex FDA label and listed in “Orange Book”
♦ Patent expiry dates to 2035
– Additional patent applications under review and being filed as new data is generated

• Pipeline progress

Sativex® (nabiximols)

– FDA meeting in December resulted in regulatory pathway in the U.S.
♦ Initial U.S. target indication: Multiple Sclerosis spasticity
♦ Single Phase 3 pivotal study expect to commence in Q4 2019
– U.S. development and commercialization rights wholly owned by GW
– Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities

CBDV

– Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population
– Company sponsored IND open for 30-patient open label study in autism
– Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder to commence in H1 2019
– Open label study in Rett syndrome and seizures due to commence H1 2019

FINANCIAL HIGHLIGHTS

  • Fiscal year now changed to begin January 1, 2019
  • Cash and cash equivalents at December 31, 2018 were $591.5 million compared to $354.9 million as of September 30, 2018
  • Revenue for the quarter ended December 31, 2018 was $6.7 million compared to $4.0 million for the quarter ended December 31, 2017
  • Net loss for the quarter ended December 31, 2018 was $71.9 million compared to $61.8 million for the quarter ended December 31, 2017

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending December 31, 2018 financial results today at 4:30 pm EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 44354.

About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW, along with its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA approval for EPIDIOLEX (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older and which is now available by prescription in the U.S. The Company has submitted a regulatory application in Europe for the adjunctive treatment of seizures associated with LGS and Dravet syndrome. The company continues to evaluate EPIDIOLEX in additional rare epilepsy conditions and currently has an ongoing clinical trial in tuberous sclerosis complex (TSC). GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the company is now planning a U.S. Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. For further information, please visit www.gwpharm.com.

Original press release

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