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

 

 

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 5, 2019

 

GW PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

 

England and Wales

 

001-35892

 

N/A

(State or other jurisdiction

of incorporation)

 

(Commission

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)

N/A

(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

 

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 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

Exhibit 

    No.    

   

Description

         
 

99.1

   

Press release dated November 5, 2019.

         
 

104

   

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


SIGNATURE

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

 

 

GW PHARMACEUTICALS PLC

             

 

 

By:

 

/s/ Douglas B. Snyder

 

 

Name:

 

Douglas B. Snyder

 

 

Title:

 

Chief Legal Officer

EX-99.1

Exhibit 99.1

 

LOGO

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.”

OPERATIONAL HIGHLIGHTS

 

   

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

 

   

Exclusivity

 

   

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

 

   

CBDV

 

   

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

FINANCIAL HIGHLIGHTS

 

   

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.

Enquiries:

 

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


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     September 30,     December 31,  
     2019     2018  

Assets

    

Cash and cash equivalents

   $ 554,682     $ 591,497  

Accounts receivable, net

     41,818       4,192  

Inventory

     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       —    

Goodwill

     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  
  

 

 

   

 

 

 


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,
 
     2019     2018     2019     2018  

Revenues

        

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:

        

Basic

   $ (0.04   $ (0.23   $ 0.04     $ (0.68
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (0.04   $ (0.23   $ 0.04     $ (0.68
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

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

Diluted

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


GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     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     —    

Other

     39       233  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (37,691     (581

Inventory

     (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