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GW PHARMACEUTICALS PLC (GWPH) Q2 2019 Results – Earnings Call Transcript

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GW PHARMACEUTICALS PLC (GWPH) Q2 2019 Results – Earnings Call Transcript – RICH TV LIVE – AUGUST 6TH
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development and commercialization of cannabinoid prescription medicines, announces financial results for the second quarter ended June 30, 2019.

“We are pleased to report a strong second quarter of sales of Epidiolex in the US, reflecting high demand by US patients, increased prescribing by healthcare providers, and ongoing progress in payor coverage determinations. With the recent positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to submit an sNDA by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition,” stated Justin Gover, GW’s Chief Executive Officer. “In Europe, we are pleased to have recently received the positive opinion from the CHMP which clears the way for an expected approval in October. Our European commercial organization is in place and will be ready to launch in the first European markets upon approval, making this important new treatment option available to deserving European patients.”

OPERATIONAL HIGHLIGHTS

Epidiolex® (cannabidiol)
U.S. commercial update
Q2 Net sales of $68.4M; $101.9M net sales in the first half of 2019
Over 12,000 patients have received Epidiolex prescriptions since launch
Over 2,500 physicians have generated dispensed prescriptions since launch
Pharmacy distribution network delivering median time to fill a first prescription in approximately 2 weeks
Vast majority of patients who have received Epdiolex remain on therapy
Transition of 900 patients in expanded access program and open label extension to commercial product complete
Strong payor coverage
Approximately 93 percent of all Commercial, Medicaid and Medicare lives in the US have a coverage determination, of which 65% are PA to indication or less restrictive
European launch update
Positive CHMP opinion with European Commission approval expected in early October
Q4 launches expected in France, Germany and UK; Spain and Italy launches to follow in 2020
Early Access Program in Europe for Dravet syndrome and LGS patients now includes over 800 patients registered across 5 major EU countries
Manufacturing
Commercial manufacturing and supply chain running smoothly
Production capacity sufficient to meet expected demand in both U.S. and Europe.

FINANCIAL HIGHLIGHTS

Revenue for the quarter ended June 30, 2019 was $72.0 million compared to $3.3 million for the quarter ended June 30, 2018
Cash and cash equivalents at June 30, 2019 were $583.7 million compared to $591.5 million as of December 31, 2018
Closed on sale of Rare Pediatric Priority Review Voucher in the quarter and recognized net proceeds of $104.1 million as a gain on the sale of an intangible asset
Net income for the quarter ended June 30, 2019 was $79.7 million compared to a net loss of $84.0 million for the quarter ended June 30, 2018

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