8-K
CB24 9BZ United Kingdom 00-0000000 266800 false 0001351288 0001351288 2020-11-03 2020-11-03

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

Current Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 3, 2020

 

 

GW PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales   001-35892   Not Applicable

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

Sovereign House, Vision Park Chivers Way, Histon Cambridge, CB24 9BZ United Kingdom

(Address of principal executive offices, including zip code)

+44 1223 266 800

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol

 

Name of each exchange

on which registered

American Depositary Shares, each representing 12 Ordinary Shares, par value £0.001 per share   GWPH   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On November 3, 2020, GW Pharmaceuticals plc (the “Company”) issued a press release announcing the Company’s financial and operating results for the quarter ended September 30, 2020. A copy of the press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

The information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

 

Item 7.01

Regulation FD Disclosure.

The Company issued a press release this morning announcing that the Company along with U.S. subsidiary Greenwich Biosciences, has initiated the first U.S. Phase 3 clinical trial studying nabiximols for multiple sclerosis (MS)-associated spasticity. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

The information in this Item 7.01, and Exhibit 99.2 hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Number

  

Description

99.1    Earnings press release dated November 3, 2020.
99.2    Press release titled “GW Pharmaceuticals Initiates Pivotal Phase 3 Study of Nabiximols for Multiple Sclerosis-Associated Spasticity” dated November 3, 2020.
 104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

    GW PHARMACEUTICALS PLC
Date: November 3, 2020     By:  

/s/ Douglas B. Snyder

    Name:   Douglas B. Snyder
    Title:   Chief Legal Officer
EX-99.1

Exhibit 99.1

 

LOGO     

GW Pharmaceuticals plc Reports Third Quarter 2020 Financial Results

and Operational Progress

- 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, UK and Carlsbad, CA, Nov 3, 2020 – 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.

 

1


   

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

 

2


   

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.

 

3


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

 

4


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  
  

 

 

   

 

 

 

 

5


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  

 

6


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       —    

 

7

EX-99.2

Exhibit 99.2

 

LOGO

 

LOGO

GW Pharmaceuticals Initiates Pivotal Phase 3 Study of Nabiximols for Multiple Sclerosis-Associated Spasticity

CARLSBAD, Calif., Nov 3, 2020 - GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, today announced that the Company has initiated the first U.S. Phase 3 clinical trial studying nabiximols for multiple sclerosis (MS)-associated spasticity. Nabiximols, known as Sativex® outside of the U.S. and approved for use to treat MS spasticity in over 25 countries, is a complex botanical medicine formulated from extracts of the cannabis plant administered as an oral spray. Positive results from three previous European Phase 3 clinical studies show nabiximols was well-tolerated and provided continued reductions in patient-reported spasticity for individuals with MS.

This Phase 3 trial is one of five pivotal studies planned for nabiximols in MS spasticity, with the remaining studies on track to commence either later this year or in 2021. GW expects that a positive result in any one of these five studies will enable an NDA submission, potentially as early as mid- next year.

“We are excited that the U.S. Phase 3 clinical program evaluating nabiximols in Multiple Sclerosis spasticity is now recruiting patients, after a delay due to COVID-19. Given the rigorous studies already conducted on the medicine outside of the U.S., and positive discussions with the FDA, we believe that we have a clear path to an NDA submission, potentially as soon as next year, and a significant second product opportunity for GW in the U.S.,” stated Justin Gover, GW’s Chief Executive Officer. “Now is the ideal time to develop nabiximols in the U.S. as research shows a significant percentage of spasticity patients are today self-medicating using unapproved cannabis products to relieve their spasticity.”


“There is a significant need for new treatments to address spasticity in MS patients, a challenging condition with little therapeutic innovation in decades in the United States,” said Dr. Stephen Krieger, Associate Professor of Neurology at the Mount Sinai Hospital. “Nabiximols has the potential to be a rigorously tested and FDA-regulated cannabis-derived medicine for people living with MS. I look forward to participating as an investigator in this study which will evaluate the effect of nabiximols on the frequency of muscle spasms.”

The study is a Phase 3, double-blind, parallel, placebo-controlled study that will evaluate the safety and efficacy of nabiximols for spasm frequency over a 12-week period and is expected to enroll 446 participants. The first patient is now screened and in baseline evaluation.

Beyond this initial study, the Company intends to commence the following additional Phase 3 trials of nabiximols for MS-associated spasticity:

 

 

Phase 3 muscle tone studies – placebo-controlled cross-over design

 

   

N=52; Expected start: Q4 2020 (subject to COVID)

 

   

N=190; Expected start: Q1 2021

 

   

N=36 (nabiximols responders); Expected start: Q1 2021

 

 

Phase 3 spasm frequency studies – placebo-controlled parallel group

 

   

N=~200 (nabiximols responders); Expected start: Q2 2021

About Nabiximols

Nabiximols is in pivotal Phase 3 development in the United States for the treatment of MS spasticity. The U.S. commercial rights are owned by GW. In addition to MS spasticity, GW expects to develop nabiximols in Spinal Cord Injury spasticity.

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as an oral spray.

Nabiximols is known as Sativex® outside of the U.S. and is indicated in numerous countries as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.1 These approvals were based on multiple pivotal trials conducted in Europe.2 Sativex is currently not approved for any indication in the U.S.

 

1 

Sativex Oralmucosal Spray, SmPC, https://www.medicines.org.uk/emc/product/602.

2 

Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007About Nabiximols


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 statement

This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding the timing of clinical trials, the timing of regulatory filings and approvals, the timing and outcomes of regulatory or intellectual property decisions, and the clinical benefits and commercial potential of nabiximols (marketed as Sativex® outside the US). Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which 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 (U.S.)

  

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