Press Release

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

November 3, 2020

- Total revenue increased 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 8:30 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, 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
  
Ex-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