- Total revenue increased 51 percent to $137.1 million –
- Epidiolex for seizures associated with TSC launched in the
- Nabiximols Phase 3 program in MS spasticity now recruiting -
- Conference call today at 8:30 a.m. EST -
“We are pleased to report strong revenue growth in the 3rd quarter despite the challenges presented by COVID-19. Epidiolex meets a serious unmet need within the field of epilepsy and we expect the product to demonstrate continued strong growth in the months and years ahead. The recent expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers,” stated
FINANCIAL RESULTS
- Total revenue for the quarter ended
September 30, 2020 was$137.1 million compared to$91.0 million for the quarter endedSeptember 30, 2019 - Total revenue for the first nine months of 2020 of
$378.6 million compared to$202.3 million in the prior year period - Net loss for the quarter ended
September 30, 2020 was$12.2 million compared to net loss of$13.8 million for the quarter endedSeptember 30, 2019 - Cash and cash equivalents at
September 30, 2020 were$480.3 million
OPERATIONAL HIGHLIGHTS
- Epidiolex (cannabidiol) progress:
- Total Q3 net product sales of Epidiolex of
$132.6 million U.S. commercial updateU.S. Epidiolex Q3 net product sales of$121.6 million - TSC indication launched with high prescriber awareness and near universal payer coverage
- Expanded payer coverage
- 85 million lives with no/broad prior authorization (+47% year-to-date)
- Ex-
U.S. commercial update- Ex-
U.S. Epidyolex Q3 net product sales of$11.0 million UK pricing and reimbursement in place. Progress inGermany ,France ,Italy andSpain - TSC EMA submission under review
- Epidyolex approved in
Australia
- Ex-
- Strengthening commercial exclusivity
- Orphan exclusivity in both the
U.S. and EU - 13 patents listed in Orange Book, 12 of which expire in 2035
- Patents include formulation and method of use
- Epidiolex composition patent application in process
- Two further Orange Book listable patents to be allowed or granted by Q1 2021
- Orphan exclusivity in both the
- Total Q3 net product sales of Epidiolex of
- Nabiximols development program:
- First Phase 3 MS Spasticity trial underway
- Phase 3 placebo-controlled spasm frequency study (N=450)
- First Phase 3 MS Spasticity trial underway
- MS Spasticity trials due to commence
- Phase 3 placebo-controlled muscle tone studies:
- N=52; Expected start Q4 2020 (subject to COVID)
- N=190; Expected start: Q1 2021
N=36 (nabiximols responders); Expected start: Q1 2021
- Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
- Phase 3 placebo-controlled muscle tone studies:
- Spinal Cord Injury (SCI) spasticity clinical program
- N=~100 (observational clinical discovery study); Expected start: Q1 2021
- 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 – recruitment now resumed
- 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
- Schizophrenia (GWP42003)
Conference Call and Webcast Information
About
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. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the
Forward-looking statements
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the
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CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
(unaudited)
2020 | 2019 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 480,330 | $ | 536,933 | ||||
Accounts receivable, net | 80,424 | 48,883 | ||||||
Inventory | 115,036 | 85,528 | ||||||
Prepaid expenses and other current assets | 44,485 | 28,292 | ||||||
Total current assets | 720,275 | 699,636 | ||||||
Property, plant, and equipment, net | 131,204 | 127,765 | ||||||
Operating lease assets | 22,297 | 24,916 | ||||||
Intangible assets | 5,564 | — | ||||||
6,959 | 6,959 | |||||||
Deferred tax assets | 18,123 | 18,123 | ||||||
Other assets | 5,839 | 4,850 | ||||||
Total assets | $ | 910,261 | $ | 882,249 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 17,841 | $ | 9,990 | ||||
Accrued liabilities | 114,898 | 99,374 | ||||||
Current tax liabilities | — | 437 | ||||||
Other current liabilities | 7,549 | 7,760 | ||||||
Total current liabilities | 140,288 | 117,561 | ||||||
Long-term liabilities: | ||||||||
Finance lease liabilities | 5,219 | 5,573 | ||||||
Operating lease liabilities | 19,607 | 21,650 | ||||||
Other liabilities | 10,699 | 11,431 | ||||||
Total long-term liabilities | 35,525 | 38,654 | ||||||
Total liabilities | 175,813 | 156,215 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock - Ordinary shares par value £0.001; | ||||||||
374,169,836 shares outstanding as of 371,068,436 shares outstanding as of | 575 | 570 | ||||||
Additional paid-in capital | 1,672,237 | 1,632,046 | ||||||
Accumulated deficit | (866,940 | ) | (837,959 | ) | ||||
Accumulated other comprehensive loss | (71,424 | ) | (68,623 | ) | ||||
Total stockholders’ equity | 734,448 | 726,034 | ||||||
Total liabilities and stockholders’ equity | $ | 910,261 | $ | 882,249 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenues | ||||||||||||||||
Product net sales | $ | 136,846 | $ | 90,849 | $ | 378,608 | $ | 201,312 | ||||||||
Other revenue | 207 | 122 | 375 | 944 | ||||||||||||
Total revenues | 137,053 | 90,971 | 378,983 | 202,256 | ||||||||||||
Operating expenses | ||||||||||||||||
Cost of product sales | 7,635 | 8,150 | 27,112 | 19,901 | ||||||||||||
Research and development | 56,934 | 36,301 | 148,542 | 99,143 | ||||||||||||
Selling, general and administrative | 85,205 | 64,178 | 232,282 | 181,529 | ||||||||||||
Total operating expenses | 149,774 | 108,629 | 407,936 | 300,573 | ||||||||||||
Loss from operations | (12,721 | ) | (17,658 | ) | (28,953 | ) | (98,317 | ) | ||||||||
Interest income | 208 | 2,249 | 1,727 | 6,646 | ||||||||||||
Interest expense | (269 | ) | (272 | ) | (850 | ) | (805 | ) | ||||||||
Other income | - | - | - | 104,117 | ||||||||||||
Foreign exchange (loss) gain | (1,796 | ) | 1,889 | (430 | ) | 2,801 | ||||||||||
(Loss) income before income taxes | (14,578 | ) | (13,792 | ) | (28,506 | ) | 14,442 | |||||||||
Income tax (benefit)expense | (2,390 | ) | (35 | ) | 475 | (1,485 | ) | |||||||||
Net (loss) income | $ | (12,188 | ) | $ | (13,757 | ) | $ | (28,981 | ) | $ | 15,927 | |||||
Net (loss) income per share: | ||||||||||||||||
Basic | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.08 | ) | $ | 0.04 | |||||
Diluted | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.08 | ) | $ | 0.04 | |||||
Weighted average shares outstanding: | ||||||||||||||||
Basic | 376,281 | 372,246 | 375,218 | 371,286 | ||||||||||||
Diluted | 376,281 | 372,246 | 375,218 | 376,985 | ||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
Nine Months Ended | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (28,981 | ) | $ | 15,927 | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Foreign exchange (gain) loss | (132 | ) | (418 | ) | ||||
Share-based compensation | 40,446 | 35,633 | ||||||
Depreciation and amortization | 9,144 | 7,096 | ||||||
Gain from sale of priority review voucher | — | (104,117 | ) | |||||
Other | 27 | 39 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (31,654 | ) | (37,691 | ) | ||||
Inventory | (31,184 | ) | (37,561 | ) | ||||
Prepaid expenses and other current assets | (8,466 | ) | (14,869 | ) | ||||
Other assets | 2,369 | 2,968 | ||||||
Accounts payable | 8,116 | (1,161 | ) | |||||
Current tax liabilities | (8,570 | ) | (601 | ) | ||||
Accrued liabilities | 18,030 | 29,176 | ||||||
Other liabilities | (2,459 | ) | (1,943 | ) | ||||
Net cash used in operating activities | (33,314 | ) | (107,522 | ) | ||||
Cash flows from investing activities | ||||||||
Proceeds from sale of priority review voucher | — | 104,117 | ||||||
Additions to property, plant and equipment | (14,259 | ) | (29,915 | ) | ||||
Additions to capitalized software | (2,365 | ) | (1,183 | ) | ||||
Additions to intangible assets | (6,404 | ) | — | |||||
Net cash (used) provided by in investing activities | (23,028 | ) | 73,019 | |||||
Cash flows from financing activities | ||||||||
Proceeds from exercise of stock options | 1,577 | 2,878 | ||||||
Payments in connection with common stock withheld for employee tax obligation | (1,827 | ) | — | |||||
Payments on finance leases | (221 | ) | (317 | ) | ||||
Payments on landlord financing obligation | (430 | ) | (404 | ) | ||||
Net cash (used in) provided by financing activities | (901 | ) | 2,157 | |||||
Effect of exchange rate changes on cash | 640 | (4,469 | ) | |||||
Net decrease in cash and cash equivalents | (56,603 | ) | (36,815 | ) | ||||
Cash and cash equivalents at beginning of period | 536,933 | 591,497 | ||||||
Cash and cash equivalents at end of period | $ | 480,330 | $ | 554,682 | ||||
Supplemental disclosure of cash flow information: | ||||||||
Income taxes paid | 9,106 | 7,052 | ||||||
Interest paid | 530 | 805 | ||||||
Supplemental disclosure of noncash information: | ||||||||
Property and equipment purchases in accounts payable and accrued liabilities | 1,204 | 1,534 | ||||||
Right-of-use asset obtained in exchange for operating liabilities | 507 | — | ||||||
Source:
2020 GlobeNewswire, Inc., source