The Nasdaq 00-0000000 false 0001351288 0001351288 2019-11-05 2019-11-05





Washington, D.C. 20549





Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): November 5, 2019



(Exact name of registrant as specified in its charter)


England and Wales





(State or other jurisdiction

of incorporation)



File Number)


(I.R.S. Employer

Identification No.)

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

(Address of Principal Executive Offices, including Zip Code)

Telephone: +44 1223 266 800

(Registrant’s Telephone Number, Including Area Code)


(Former Name or Former Address, if Changed Since Last Report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant 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





Name of each exchange

on which registered

American Depositary Shares, each representing 12 Ordinary Shares, par value £0.001 per share




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 Section13(a) of the Exchange Act  



Item 2.02 Results of Operations and Financial Condition.

On November 5, 2019, GW Pharmaceuticals plc (the “Company”) issued a press release announcing its financial results for the third quarter of 2019. The full text of the press release and the related attachment are 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 9.01. Financial Statements and Exhibits.

  (d) Exhibits








Press release dated November 5, 2019.




Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document


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 thereunto duly authorized.

Date: November 5, 2019









/s/ Douglas B. Snyder





Douglas B. Snyder





Chief Legal Officer


Exhibit 99.1



GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the Third Quarter Ended September 30, 2019

- Epidiolex U.S. year to date net sales of $188.0 million, including Q3 net sales of $86.1 million -

- Conference call today at 4:30 p.m. ET -

Carlsbad, CA, November 5, 2019: GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the discovery, development and commercialization of cannabinoid prescription medicines, announces financial results for the third quarter ended September 30, 2019.

“In this first year of launch, we are pleased to report continued Epidiolex revenue growth in the US. Receptivity to the introduction of this breakthrough treatment continues to be highly encouraging as a result of positive physician and patient experiences as well as strong payer coverage”, stated Justin Gover, GW’s Chief Executive Officer. “We see significant opportunity for the short, medium and long term and believe that all the fundamentals are in place to make Epidiolex a very successful brand. We can expect to see additional momentum from Europe as well as the launch of the Tuberous Sclerosis indication during 2020. On top of this, GW is ideally placed to consolidate its leadership in cannabinoid science through advancing several mid and late stage pipeline programs in the months ahead.”




Epidiolex® (cannabidiol)



U.S. commercial update



Q3 Net sales of $86.1M; $188.0M net sales in the first three quarters of 2019



Over 15,000 patients have received Epidiolex prescriptions since launch



Over 3,000 physicians have generated dispensed prescriptions since launch



Strong payor coverage with approximately 93 percent of all Commercial, Medicaid and Medicare lives in the US having a coverage determination, of which 65 percent are PA to indication or less restrictive



European launch update



European Commission approval in September 2019



Commercialization underway in France and Germany



UK NICE guidance expected in Q4 2019; Spain and Italy launches to follow in 2020



Early Access Program now includes over 1,100 patients across 5 major EU countries, and over 400 physicians from 250 top epilepsy centers



New Indications



Tuberous Sclerosis Complex



TSC Phase 3 data to be presented at American Epilespy Society annual meeting in December 2019



TSC sNDA expected to be filed with FDA in early 2020, approval decision expected mid-2020



TSC EMA submission expected in Q1 2020



Rett Syndrome



Phase 3 trial in Rett Syndrome recruiting



Life-cycle management



Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation


PK data generated in 2019 supports advancing multiple new formulations into additional Phase 1 studies in 2020






7 years of orphan exclusivity confirmed by FDA, plus 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe plus 2 year pediatric extension expected



9 granted patents listed in “Orange Book” and align directly with Epidiolex FDA label



Patent expiry dates to 2035



Additional patent applications under review, including patents related to the use of Epidiolex in TSC and other indications



Patent application recently published indicating that Epidiolex is more efficacious than synthetic CBD in pre-clinical epilepsy models based on the key difference that Epidiolex comprises up to 2 percent of other cannabinoids.



Pipeline progress



Sativex® (nabiximols)



Initial U.S. target indication: Multiple Sclerosis spasticity



3 positive Phase 3 trials completed in Europe



Clinical IND open, FDA feedback received on clinical plan



Clinical program expected to commence in Q1 2020 to augment existing pivotal data package



Clinical program in additional indications in planning for 2020-2021






IND open for 30-patient open label study in autism expected to commence Q4 19. Initial data in 2020.



Investigator-led 100 patient placebo-controlled trial in autism underway



Open label study in Rett syndrome and seizures ongoing



Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program



Phase 1b safety study in patients expected to commence in Q4



Orphan Drug and Fast Track Designations granted from FDA and EMA



Schizophrenia (GWP42003)



Positive Phase 2a trial published



Phase 2b trial expected to commence H1 2020




Revenue for the quarter ended September 30, 2019 was $91.0 million compared to $2.4 million for the quarter ended September 30, 2018



Cash and cash equivalents at September 30, 2019 were $554.7 million compared to $591.5 million as of December 31, 2018



Net loss for the quarter ended September 30, 2019 was $13.8 million compared to a net loss of $79.9 million for the quarter ended September 30, 2018

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending September 30, 2019 financial results today at 4:30 pm 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: 54868.

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. GW’s lead product, EPIDIOLEX (cannabidiol oral solution) is commercialized in the US by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in Europe under the tradename EPIDYOLEX. The Company continues to evaluate EPIDIOLEX in additional rare conditions including Tuberous Sclerosis Complex (TSC) and Rett syndrome. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the Company is now advancing a late stage program in order to seek FDA approval. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, autism, glioblastoma, 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 (cannabidiol) oral solution and Sativex (nabiximols) and the safety profile and commercial potential of EPIDIOLEX and Sativex. 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 Sativex, EPIDIOLEX 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, including the most recent Form 10-KT filed on 26 February 2019. 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.



GW Pharmaceuticals plc  
Stephen Schultz, VP Investor Relations (U.S.)   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

EU Media Enquiries:

FTI Consulting

Ben Atwell/Mike Trace   +44 (0) 203 727 1000



(in thousands, except share data)



     September 30,     December 31,  
     2019     2018  



Cash and cash equivalents

   $ 554,682     $ 591,497  

Accounts receivable, net

     41,818       4,192  


     69,288       33,030  

Prepaid expenses and other current assets

     32,196       17,903  







Total current assets

     697,984       646,622  







Property, plant, and equipment, net

     110,161       90,832  

Operating lease assets

     20,438       —    


     6,959       6,959  

Deferred tax assets

     8,425       8,720  

Other assets

     3,884       2,935  







Total assets

   $ 847,851     $ 756,068  







Liabilities and stockholders’ equity


Accounts payable

   $ 6,934     $ 9,796  

Accrued liabilities

     81,704       52,477  

Current tax liabilities

     —         2,384  

Other current liabilities

     6,627       1,559  







Total current liabilities

     95,265       66,216  







Long-term liabilities:


Finance lease liabilities

     5,297       5,690  

Operating lease liabilities

     17,007       —    

Other liabilities

     10,627       10,082  







Total long-term liabilities

     32,931       15,772  







Total liabilities

     128,196       81,988  







Commitments and contingencies


Stockholders’ equity:


Common stock - Ordinary shares par value £0.001; 370,937,744 shares outstanding as of September 30, 2019; 366,616,688 shares outstanding as of December 31, 2018

     570       564  

Additional paid-in capital

     1,619,649       1,581,144  

Accumulated deficit

     (813,013     (828,940

Accumulated other comprehensive loss

     (87,551     (78,688







Total stockholders’ equity

     719,655       674,080  







Total liabilities and stockholders’ equity

   $ 847,851     $ 756,068  









(in thousands, except per share amounts)



     Three Months Ended
September 30,
    Nine Months Ended
September 30,
     2019     2018     2019     2018  



Product net sales

   $ 90,849     $ 2,343     $ 201,312     $ 8,249  

Other revenue

     122       77       944       496  













Total revenues

     90,971       2,420       202,256       8,745  

Operating expenses


Cost of product sales

     8,150       1,399       19,901       4,815  

Research and development

     36,301       28,943       99,143       117,541  

Selling, general and administrative

     64,178       52,685       181,529       116,644  













Total operating expenses

     108,629       83,027       300,573       239,000  













Loss from operations

     (17,658     (80,607     (98,317     (230,255

Interest income

     2,249       1,283       6,646       3,041  

Interest expense

     (272     (297     (805     (935

Other income

     —         —         104,117       —    

Foreign exchange gain (loss)

     1,889       (823     2,801       (5,123













(Loss) income before income taxes

     (13,792     (80,444     14,442       (233,272

Income tax (benefit) expense

     (35     (565     (1,485     79  













Net (loss) income

   $ (13,757   $ (79,879   $ 15,927     $ (233,351













Net (loss) income per share:



   $ (0.04   $ (0.23   $ 0.04     $ (0.68














   $ (0.04   $ (0.23   $ 0.04     $ (0.68













Weighted average shares outstanding:



     372,246       341,302       371,286       340,675  


     372,246       341,302       376,985       340,675  



(in thousands)



     Nine Months Ended September 30,  
     2019     2018  

Cash flows from operating activities


Net income (loss)

   $ 15,927     $ (233,351

Adjustments to reconcile net income (loss) to net cash used in operating activities:


Foreign exchange (gain) loss

     (418     5,097  

Share-based compensation

     35,633       26,035  

Depreciation and amortization

     7,096       7,127  

Deferred income taxes

     —         835  

Gain from sale of priority review voucher

     (104,117     —    


     39       233  

Changes in operating assets and liabilities:


Accounts receivable, net

     (37,691     (581


     (37,561     (14,024

Prepaid expenses and other current assets

     (14,869     15,005  

Other assets

     2,968       (398

Accounts payable

     (1,161     4,040  

Current tax liabilities

     (601     (4,844

Accrued liabilities

     29,176       13,503  

Other liabilities

     (1,943     1,013  







Net cash used in operating activities

     (107,522     (180,310







Cash flows from investing activities


Proceeds from sale of priority review voucher

     104,117       —    

Additions to property, plant and equipment

     (29,915     (23,614

Additions to capitalized software

     (1,183     (1,049

Proceeds from disposal of property, plant and equipment

     —         517  







Net cash provided by (used in) investing activities

     73,019       (24,146







Cash flows from financing activities


Proceeds from exercise of stock options

     2,878       619  

Payments on finance leases

     (317     (211

Payments on landlord financing obligation

     (404     (397







Net cash provided by financing activities

     2,157       11  







Effect of exchange rate changes on cash

     (4,469     131  

Net decrease in cash and cash equivalents

     (36,815     (204,314

Cash and cash equivalents at beginning of period

     591,497       559,227  







Cash and cash equivalents at end of period

   $ 554,682     $ 354,913