On February 16, 2021 GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported financial results and operating progress for the fourth quarter and full-year ended December 31, 2020 (Press release, GW Pharmaceuticals, FEB 16, 2021, View Source [SID1234575093]).
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"We are very proud of our strong financial performance and operational progress in 2020, as Epidiolex sales increased by more than 70% during the year despite the challenges of COVID-19. We are well positioned to build on our success and continue to deliver strong growth in 2021 in both the U.S. and Europe, where we continue to make progress preparing for several commercial launches that are expected later this year," said Justin Gover, chief executive officer of GW. "We have commenced our Phase 3 clinical program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission. Beyond nabiximols, we are advancing a diverse and robust neuroscience pipeline with several preclinical and clinical-stage pipeline candidates as part of our commitment to patients and to developing innovative medicines that address significant unmet needs. We have strong momentum and a tremendous opportunity to continue to build on our global cannabinoid leadership position as we prepare to join Jazz Pharmaceuticals and transform the lives of even more patients and families."
FINANCIAL RESULTS
Total revenue for the quarter ended December 31, 2020 was $148.2 million compared to $109.1 million for the quarter ended December 31, 2019.
Total revenue for the full-year 2020 was $527.2 million, a 69 percent increase compared to $311.3 million for the prior year period.
Net loss for the quarter ended December 31, 2020 was $29.1 million compared to net loss of $24.9 million for the quarter ended December 31, 2019.
Cash and cash equivalents at December 31, 2020 were $486.8 million.
OPERATIONAL HIGHLIGHTS
Epidiolex (cannabidiol) progress:
Total net product sales of Epidiolex of $144.1 million for the fourth quarter and $510.5 million for the year ended December 31, 2020.
U.S. commercial update
U.S. Epidiolex net product sales of $128.8 million for the fourth quarter and $467.6 million for the year ended December 31, 2020
TSC indication launched with high prescriber awareness and near universal payer coverage
Expanded payer coverage
More than 110 million lives with no/broad prior authorization (70% increase in 2020)
Ex-U.S. commercial update
Ex-U.S. Epidyolex Q4 2020 net product sales of $15.3 million and full-year 2020 sales of $42.9 million
Continued progress expanding global reach of Epidyolex:
Pricing and reimbursement approved in Germany, Finland and Israel
Swissmedic approval received for the adjunctive therapy of seizures associated with LGS and DS
Launches in France, Spain and Italy expected in H1 2021
EMA TSC approval expected H1 2021
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
14 patents listed in Orange Book, 13 of which expire in 2035
Patents include formulation and method of use
An additional patent has been granted and will be listed in the Orange Book in Q1 2021 and a further patent is expected to be granted and listed in the Orange Book in Q2 2021
Epidiolex composition patent application filed
Nabiximols development program:
MS Spasticity trials underway
Phase 3 placebo-controlled spasm frequency study (N=450)
Phase 3 placebo-controlled muscle tone study (N=52)
MS Spasticity trials due to commence
Phase 3 placebo-controlled muscle tone studies:
N=190; Expected start: Q2 2021
N=36 (nabiximols responders); Expected start: Q2 2021
Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
First SCI trial underway
N=~100 observational clinical discovery study
SCI spasticity trials due to commence
N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021
Additional pipeline programs:
Schizophrenia (GWP42003)
Phase 2b trial now actively recruiting
Autism:
CBD formulation Phase 2 study expected to commence in Q1 2021
CBDV investigator-led 100 patient placebo-controlled trial in autism underway
New botanical cannabinoid pipeline product (GW541)
Phase 1 trial underway
Potential targets within field of neuropsychiatry
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1b safety study in patients continues to recruit
Orphan Drug and Fast Track Designations granted from FDA and EMA
Novel cannabinoid molecule synthesis and preclinical development
At least one program expected to enter Phase 1 in 2021
Several other molecules have demonstrated preclinical efficacy and are advancing towards the clinic
On Feb. 3, 2021, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and GW announced the companies had entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares (subject to limitations on the maximum and minimum number of Jazz ordinary shares issuable per ADS), for a total consideration of $7.2 billion. The transaction is subject to the approval of GW shareholders, sanction by the High Court of Justice of England and Wales and other customary closing conditions, including regulatory approvals. Subject to the satisfaction or waiver of the closing conditions, the transaction is expected to close in the second quarter of 2021.
Conference Call/Earnings Materials
Given the recently announced agreement for GW to be acquired by Jazz Pharmaceuticals, GW will no longer hold conference calls. Earnings materials are available publicly on the Investor Relations page of GW’s website at View Source Questions may be directed to Investor Relations via e-mail at the contact information below.