GlobeNewswire Inc | Nov 3, 2020 07:30AM EST

November 03, 2020

- Total revenueincreased 51 percent to $137.1 million- Epidiolex for seizures associated with TSC launched in the U.S.-- Nabiximols Phase 3 program in MS spasticity now recruiting -- Conference call today at 830 a.m. EST -

LONDON and CARLSBAD, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced financial results and operating progress for the third quarter ended September 30, 2020.

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 Justin Gover, GWs Chief Executive Officer. We have also now commenced the pivotal Phase 3 program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission, including as early as next year. Beyond nabiximols, we are advancing several clinical-stage pipeline candidates, including the recent start of a Phase 2 trial in schizophrenia.

FINANCIAL RESULTS

-- Total revenue for the quarter ended September 30, 2020 was $137.1 million compared to $91.0 million for the quarter ended September 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 ended September 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 millionU.S. commercial update U.S. Epidiolex Q3 net product sales of $121.6 millionTSC indication launched with high prescriber awareness and near universal payer coverageExpanded 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 millionUK pricing and reimbursement in place. Progress in Germany, France, Italy and SpainTSC EMA submission under reviewEpidyolex approved in AustraliaStrengthening commercial exclusivity Orphan exclusivity in both the U.S. and EU13 patents listed in Orange Book, 12 of which expire in 2035 Patents include formulation and method of useEpidiolex composition patent application in processTwo further Orange Book listable patents to be allowed or granted by Q1 2021 -- Nabiximols development program: First Phase 3 MS Spasticity trial underway Phase 3 placebo-controlled spasm frequency study (N=450) -- 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 2021N=36 (nabiximols responders); Expected start: Q1 2021Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021 -- Spinal Cord Injury (SCI) spasticity clinical program N=~100 (observational clinical discovery study); Expected start: Q1 2021N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021 -- Additional pipeline programs: Schizophrenia (GWP42003) Phase 2b trial now actively recruitingAutism: CBD formulation Phase 2 study expected to commence in Q1 2021CBDV investigator-led 100 patient placebo-controlled trial in autism recruitment now resumedNew botanical cannabinoid pipeline product (GW541) Phase 1 trial underwayPotential targets within field of neuropsychiatryNeonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program Phase 1b safety study in patients continues to recruitOrphan Drug and Fast Track Designations granted from FDA and EMA

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast today at 8:30 am 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 Companys 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: 38272.

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. The Companys lead product, EPIDIOLEX(cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visitwww.gwpharm.com.

Forward-looking statementsThis 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 ofEPIDIOLEX/EPIDYOLEX(cannabidiol) oral solutionand 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 GWs 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 GWs filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Enquiries:

GW Pharmaceuticals plc Scott Giacobello, Chief Financial Officer 760 795 2200Stephen Schultz, VP Investor Relations 917 280 2424 / 401 500 6570 U.S. Media Enquiries: Sam Brown Inc. Healthcare CommunicationsChristy Curran 615 414 8668Mike Beyer 312 961 2502 Ex-U.S. media enquiries Ben Atwell, FTI Consulting +44 (0)203 727 1000

GW PHARMACEUTICALS PLCCONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share data) (unaudited)

September December 30, 31, 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 ? Goodwill 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 September30, 2020; 575 570 371,068,436 shares outstanding as of December31, 2019Additional 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

GW PHARMACEUTICALS PLCCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts)(unaudited)

Three MonthsEnded Nine MonthsEnded September 30, September 30, 2020 2019 2020 2019 Revenues Product net $ 136,846 $ 90,849 $ 378,608 $ 201,312 salesOther revenue 207 122 375 944 Total revenues 137,053 90,971 378,983 202,256 Operating expensesCost of 7,635 8,150 27,112 19,901 product salesResearch and 56,934 36,301 148,542 99,143 developmentSelling,general and 85,205 64,178 232,282 181,529 administrativeTotaloperating 149,774 108,629 407,936 300,573 expensesLoss from (12,721 ) (17,658 ) (28,953 ) (98,317 )operationsInterest 208 2,249 1,727 6,646 incomeInterest (269 ) (272 ) (850 ) (805 )expenseOther income - - - 104,117 Foreignexchange (1,796 ) 1,889 (430 ) 2,801 (loss) gain(Loss) incomebefore income (14,578 ) (13,792 ) (28,506 ) 14,442 taxesIncome tax(benefit) (2,390 ) (35 ) 475 (1,485 )expenseNet (loss) $ (12,188 ) $ (13,757 ) $ (28,981 ) $ 15,927 income Net (loss)income per share:Basic $ (0.03 ) $ (0.04 ) $ (0.08 ) $ 0.04 Diluted $ (0.03 ) $ (0.04 ) $ (0.08 ) $ 0.04 Weightedaverage shares outstanding:Basic 376,281 372,246 375,218 371,286 Diluted 376,281 372,246 375,218 376,985

GW PHARMACEUTICALS PLCCONSOLIDATED STATEMENTS OF CASH FLOWS(in thousands) (unaudited)

Nine Months Ended September 30, 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 (1,827 ) ? for employee tax obligationPayments 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 1,204 1,534 and accrued liabilitiesRight-of-use asset obtained in exchange for 507 ? operating liabilities