– Total revenue of
– Total Epidiolex® net product sales of
– Previously announced agreement to be acquired by
“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
FINANCIAL RESULTS
- Total revenue for the quarter ended
December 31, 2020 was$148.2 million compared to$109.1 million for the quarter endedDecember 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 endedDecember 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 endedDecember 31, 2020 . U.S. commercial updateU.S. Epidiolex net product sales of$128.8 million for the fourth quarter and$467.6 million for the year endedDecember 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 andIsrael Swissmedic approval received for the adjunctive therapy of seizures associated with LGS and DS- Launches in
France ,Spain andItaly expected in H1 2021
- Pricing and reimbursement approved in
- EMA TSC approval expected H1 2021
- Ex-
- 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
- Orphan exclusivity in both the
- 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
- Phase 3 placebo-controlled muscle tone studies:
- 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
- First SCI trial underway
- MS Spasticity trials underway
- Total net product sales of Epidiolex of
- 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
- Schizophrenia (GWP42003)
- 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 theHigh Court of Justice of England andWales 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
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 communication contains forward-looking statements regarding
Enquiries:
Investors: | |
760 795 2200 / sgiacobello@gwpharm.com | |
Media: | |
Corporate Communications | 760.579.6628 / kcardillo@gwpharm.com |
+44 (0)203 727 1000 / ben.atwell@fticonsulting.com |
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share data) (unaudited) | ||||||||
2020 | 2019 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 486,752 | $ | 536,933 | ||||
Accounts receivable, net | 71,168 | 48,883 | ||||||
Inventory | 129,138 | 85,528 | ||||||
Prepaid expenses and other current assets | 42,472 | 28,292 | ||||||
Total current assets | 729,530 | 699,636 | ||||||
Property, plant, and equipment, net | 143,767 | 127,765 | ||||||
Operating lease assets | 25,118 | 24,916 | ||||||
Intangible assets | 5,565 | — | ||||||
6,959 | 6,959 | |||||||
Deferred tax assets | 20,777 | 18,123 | ||||||
Other assets | 7,795 | 4,850 | ||||||
Total assets | $ | 939,511 | $ | 882,249 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 21,870 | $ | 9,990 | ||||
Accrued liabilities | 127,849 | 99,374 | ||||||
Current tax liabilities | 877 | 437 | ||||||
Other current liabilities | 9,210 | 7,760 | ||||||
Total current liabilities | 159,806 | 117,561 | ||||||
Long-term liabilities: | ||||||||
Finance lease liabilities | 5,454 | 5,573 | ||||||
Operating lease liabilities | 22,127 | 21,650 | ||||||
Other liabilities | 11,034 | 11,431 | ||||||
Total long-term liabilities | 38,615 | 38,654 | ||||||
Total liabilities | 198,421 | 156,215 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Ordinary shares par value £0.001; 375,196,172 and 371,068,436 shares outstanding as of | 577 | 570 | ||||||
Additional paid-in capital | 1,690,151 | 1,632,046 | ||||||
Accumulated deficit | (896,087 | ) | (837,959 | ) | ||||
Accumulated other comprehensive loss | (53,551 | ) | (68,623 | ) | ||||
Total stockholders’ equity | 741,090 | 726,034 | ||||||
Total liabilities and stockholders’ equity | $ | 939,511 | $ | 882,249 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) | ||||||||||||||||
Three Months Ended | Year Ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenues | ||||||||||||||||
Product net sales | $ | 148,222 | $ | 109,019 | $ | 526,830 | $ | 310,331 | ||||||||
Other revenue | — | 57 | 375 | 1,001 | ||||||||||||
Total revenues | 148,222 | 109,076 | 527,205 | 311,332 | ||||||||||||
Operating expenses | ||||||||||||||||
Cost of product sales | 10,419 | 7,298 | 37,531 | 27,199 | ||||||||||||
Research and development | 56,854 | 43,535 | 205,396 | 142,678 | ||||||||||||
Selling, general and administrative | 103,761 | 78,351 | 336,043 | 259,880 | ||||||||||||
Total operating expenses | 171,034 | 129,184 | 578,970 | 429,757 | ||||||||||||
Loss from operations | (22,812 | ) | (20,108 | ) | (51,765 | ) | (118,425 | ) | ||||||||
Interest income | 87 | 1,818 | 1,814 | 8,464 | ||||||||||||
Interest expense | (271 | ) | (282 | ) | (1,121 | ) | (1,087 | ) | ||||||||
Other income | — | — | — | 104,117 | ||||||||||||
Foreign exchange loss | (3,544 | ) | (5,073 | ) | (3,974 | ) | (2,272 | ) | ||||||||
Loss before income taxes | (26,540 | ) | (23,645 | ) | (55,046 | ) | (9,203 | ) | ||||||||
Income tax expense (benefit) | 2,607 | 1,301 | 3,082 | (184 | ) | |||||||||||
Net loss | $ | (29,147 | ) | $ | (24,946 | ) | $ | (58,128 | ) | $ | (9,019 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.08 | ) | $ | (0.07 | ) | $ | (0.15 | ) | $ | (0.02 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 376,680 | 372,447 | 375,586 | 371,580 | ||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) (unaudited) | ||||||||
Year Ended | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (58,128 | ) | $ | (9,019 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Foreign exchange loss | 910 | 2,709 | ||||||
Stock-based compensation | 58,359 | 48,030 | ||||||
Depreciation and amortization | 12,757 | 9,240 | ||||||
Deferred income taxes | (2,654 | ) | (9,698 | ) | ||||
Gain from sale of priority review voucher | — | (104,117 | ) | |||||
Other | 528 | 39 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (22,104 | ) | (44,623 | ) | ||||
Inventory | (39,873 | ) | (51,125 | ) | ||||
Prepaid expenses and other current assets | (9,624 | ) | (9,831 | ) | ||||
Other assets | 3,290 | 3,888 | ||||||
Accounts payable | 9,862 | 805 | ||||||
Current tax liabilities | (3,404 | ) | (963 | ) | ||||
Accrued liabilities | 24,890 | 43,110 | ||||||
Other liabilities | (2,194 | ) | (1,914 | ) | ||||
Net cash used in operating activities | (27,385 | ) | (123,469 | ) | ||||
Cash flows from investing activities | ||||||||
Proceeds from sale of priority review voucher | — | 104,117 | ||||||
Additions to property, plant and equipment | (18,585 | ) | (40,386 | ) | ||||
Additions to capitalized software | (3,018 | ) | (2,102 | ) | ||||
Additions to intangible assets - licenses | (6,404 | ) | — | |||||
Proceeds from disposal of property, plant and equipment | — | — | ||||||
Net cash (used in) provided by investing activities | (28,007 | ) | 61,629 | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of ordinary shares, Net of issuance costs | — | — | ||||||
Proceeds from exercise of stock options | 1,579 | 2,878 | ||||||
Payments in connection with common stock withheld for employee tax obligation | (1,826 | ) | — | |||||
Payments on finance leases | (299 | ) | (389 | ) | ||||
Payments on landlord financing obligation | (583 | ) | (543 | ) | ||||
Net cash (used in) provided by financing activities | (1,129 | ) | 1,946 | |||||
Effect of exchange rate changes on cash | 6,340 | 5,330 | ||||||
Net decrease in cash and cash equivalents | (50,181 | ) | (54,564 | ) | ||||
Cash and cash equivalents at beginning of period | 536,933 | 591,497 | ||||||
Cash and cash equivalents at end of period | $ | 486,752 | $ | 536,933 | ||||
Source:
2021 GlobeNewswire, Inc., source