GW Pharmaceuticals plc Reports Third Quarter 2020 Financial Results and Operational Progress

GW Pharmaceuticals plc Reports Third Quarter 2020 Financial Results and Operational Progress

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 3 rd 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, GW’s 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 million
    • U.S. commercial update
      • U.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 in Germany, France, Italy and Spain
      • TSC EMA submission under review
      • Epidyolex approved in Australia
    • 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
  • 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 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
  • 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

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 Company’s 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 Company’s 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 visit www.gwpharm.com .

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 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
Stephen Schultz, VP Investor Relations
760 795 2200
917 280 2424 / 401 500 6570
U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
Christy Curran
Mike Beyer
615 414 8668
312 961 2502
E x-U.S. media enquiries
Ben Atwell, FTI Consulting +44 (0)203 727 1000

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

September 30, December 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 September 30, 2020;
371,068,436 shares outstanding as of December 31, 2019
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

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

Three Months Ended
September 30,
Nine Months Ended
September 30,
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

GW PHARMACEUTICALS PLC
CONSOLIDATED 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 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

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Source: GlobeNewswire (November 3, 2020 – 7:30 AM EST)

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Published at Tue, 03 Nov 2020 12:33:17 +0000

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