8-K
00-0000000 CB24 9BZ United Kingdom, Telephone: +44 1223 266 800, Sovereign House, false 0001351288 0001351288 2020-02-25 2020-02-25

 

 

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): February 25, 2020

 

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 February 25, 2020, GW Pharmaceuticals plc (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2019. A copy of the press release is attached as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02 of Form 8-K and the information incorporated by reference herein, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

The exhibits to this Current Report on Form 8-K are as follows:

INDEX TO EXHIBITS

 

99.1

   

Press release of GW Pharmaceuticals plc dated February 25, 2020

         
 

104

   

Cover Page Interactive File (the cover page 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: February 25, 2020

 

 

          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 Fourth Quarter and Year-End 2019 Financial Results and Operational Progress

- Total revenue of $109.1 million for the fourth quarter and $311.3 million for the full year -

- Total Epidiolex® net product sales of $104.5 million for the fourth quarter and $296.4 million for the first full year of sales-

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

London, UK and Carlsbad, CA, February 25, 2020 – GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces financial results for the fourth quarter and full-year ended December 31, 2019.

“2019 was an exceptional and transformative year for GW, led by the successful launch of Epidiolex in the US and approval in Europe. The positive impact this medicine has had on thousands of patients and their families provides a compelling foundation for continued growth in 2020,” said Justin Gover, GW’s Chief Executive Officer. “We also expect 2020 to be an important year for our growing and developing product pipeline beyond Epidiolex as we build on our world leadership in cannabinoid science. We are focused on advancing nabiximols in the US in several indications and clinical programs with other potential products whilst continuing to bring Epidiolex to more patients in the US and Europe.”

OPERATIONAL HIGHLIGHTS

 

 

 

Significant progress with Epidiolex (cannabidiol)

 

 

 

Total net product sales of Epidiolex of $104.5 million for the fourth quarter and $296.4 million for the full year

 

 

 

U.S. commercial update

 

 

 

2020 focus on broadening prescriber base, expanding payer coverage, entering long term care segment, and expected launch of TSC indication

 

 

 

European launch underway

 

 

 

German commercial launch in Q4 2019

 

 

 

Secured positive NICE recommendation in the UK with commercial launch in Q1 2020

 

 

 

Commercial launches in France, Spain and Italy expected later this year, following pricing and reimbursement

 

 

 

Clinical progress with further indications – broadening addressable market

 

1


 

 

Tuberous Sclerosis Complex (TSC) sNDA filed with FDA earlier this month and MAA submission to EMA expected in Q1 2020

 

 

 

Phase 3 trial in Rett Syndrome recruiting

 

 

 

Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution, and capsule

 

 

 

Improved intellectual property rights and exclusivity

 

 

 

In addition to orphan exclusivity, 9 granted patents listed in “Orange Book” and align directly with Epidiolex FDA label with expiry dates to 2035

 

 

 

Epidiolex composition patent application recently published

 

 

 

2 new allowed patents broadly covering use in LGS and Dravet syndrome

 

 

 

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

 

 

 

Pipeline progress

 

 

 

Nabiximols (Sativex® outside of the US)

 

 

 

Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe

 

 

 

US pivotal clinical program expected to commence in Q2 2020 to augment existing data package

 

 

 

Spinal cord injury spasticity - clinical program expected to commence in H2 2020

 

 

 

PTSD – clinical program expected to commence in H2 2020

 

 

 

Schizophrenia (GWP42003)

 

 

 

Positive Phase 2a trial published and Phase 2b trial expected to commence H1 2020

 

 

 

CBDV in autism

 

 

 

30-patient open label study in autism underway. Initial data expected in 2020.

 

 

 

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

 

 

 

Open label study in Rett syndrome and seizures underway

 

 

 

Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program

 

 

 

Phase 1b safety study in patients underway

 

 

 

Orphan Drug and Fast Track Designations granted from FDA and EMA

FINANCIAL HIGHLIGHTS

 

 

 

Total revenue for the quarter ended December 31, 2019 was $109.1 million compared to $6.7 million for the quarter ended December 31, 2018

 

 

 

Net loss for the quarter ended December 31, 2019 was $24.9 million compared to a net loss of $71.9 million for the quarter ended December 31, 2018

 

 

 

Cash and cash equivalents at December 31, 2019 were $536.9 million compared to $591.5 million as of December 31, 2018

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast 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.

 

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Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 33178.

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 CV, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex, for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. 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, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 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 CV and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines. 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

  

Stephen Schultz, VP Investor Relations

  

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

 

3


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     December 31,     December 31,  
     2019     2018  

Assets

    

Cash and cash equivalents

   $ 536,933     $ 591,497  

Accounts receivable, net

     48,883       4,192  

Inventory

     85,528       33,030  

Prepaid expenses and other current assets

     28,292       17,903  
  

 

 

   

 

 

 

Total current assets

     699,636       646,622  
  

 

 

   

 

 

 

Property, plant, and equipment, net

     127,765       90,832  

Operating lease assets

     24,916       —    

Goodwill

     6,959       6,959  

Deferred tax assets

     18,123       8,720  

Other assets

     4,850       2,935  
  

 

 

   

 

 

 

Total assets

   $ 882,249     $ 756,068  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Accounts payable

   $ 9,990     $ 9,796  

Accrued liabilities

     99,374       52,477  

Current tax liabilities

     437       2,384  

Other current liabilities

     7,760       1,559  
  

 

 

   

 

 

 

Total current liabilities

     117,561       66,216  
  

 

 

   

 

 

 

Long-term liabilities:

    

Finance lease liabilities

     5,573       5,690  

Operating lease liabilities

     21,650       —    

Other liabilities

     11,431       10,082  
  

 

 

   

 

 

 

Total long-term liabilities

     38,654       15,772  
  

 

 

   

 

 

 

Total liabilities

     156,215       81,988  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Ordinary shares par value £0.001; 371,068,436 and 366,616,688 shares outstanding as of December 31, 2019 and 2018, respectively

     570       564  

Additional paid-in capital

     1,632,046       1,581,144  

Accumulated deficit

     (837,959     (828,940

Accumulated other comprehensive loss

     (68,623     (78,688
  

 

 

   

 

 

 

Total stockholders’ equity

     726,034       674,080  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 882,249     $ 756,068  
  

 

 

   

 

 

 

 

4


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended December 31,     Year Ended December 31,  
     2019     2018     2019     2018  

Revenues

        

Product net sales

   $ 109,019     $ 6,617     $ 310,331     $ 14,866  

Other revenue

     57       37       1,001       533  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     109,076       6,654       311,332       15,399  

Operating expenses

        

Cost of product sales

     7,298       1,829       27,199       6,644  

Research and development

     43,535       29,086       142,678       146,627  

Selling, general and administrative

     78,351       49,083       259,880       165,727  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     129,184       79,998       429,757       318,998  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (20,108     (73,344     (118,425     (303,599

Interest income

     1,818       2,449       8,464       5,490  

Interest expense

     (282     (295     (1,087     (1,230

Other income

     —         —         104,117       —    

Foreign exchange loss

     (5,073     (982     (2,272     (6,105
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (23,645     (72,172     (9,203     (305,444

Income tax expense (benefit)

     1,301       (266     (184     (187
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (24,946   $ (71,906   $ (9,019   $ (305,257
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share:

        

Basic

   $ (0.07   $ (0.20   $ (0.02   $ (0.88
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (0.07   $ (0.20   $ (0.02   $ (0.88
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

     372,447       366,458       371,580       347,123  

Diluted

     372,447       366,458       371,580       347,123  

 

5


GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Year Ended December 31,  
     2019     2018  

Cash flows from operating activities

    

Net loss

   $ (9,019   $ (305,257

Adjustments to reconcile net loss to net cash used in operating activities:

    

Foreign exchange loss

     2,709       5,839  

Stock-based compensation

     48,030       35,718  

Depreciation and amortization

     9,240       9,661  

Deferred income taxes

     (9,698     (430

Gain from sale of priority review voucher

     (104,117     —    

Other

     39       233  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (44,623     (2,706

Inventory

     (51,125     (28,484

Prepaid expenses and other current assets

     (9,831     11,370  

Other assets

     3,888       (445

Accounts payable

     805       2,829  

Current tax liabilities

     (963     (3,966

Accrued liabilities

     43,110       19,445  

Other liabilities

     (1,914     1,423  
  

 

 

   

 

 

 

Net cash used in operating activities

     (123,469     (254,770
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from sale of priority review voucher

     104,117       —    

Additions to property, plant and equipment

     (40,386     (42,301

Additions to capitalized software

     (2,102     (1,112

Proceeds from disposal of property, plant and equipment

           517  
  

 

 

   

 

 

 

Net cash provided by (used in) investing activities

     61,629       (42,896
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from issuance of ordinary shares, net of issuance costs

     —         324,637  

Proceeds from exercise of stock options

     2,878       620  

Payments on finance leases

     (389     (251

Payments on landlord financing obligation

     (543     (527
  

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     1,946       324,479  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     5,330       5,457  

Net increase (decrease) in cash and cash equivalents

     (54,564     32,270  

Cash and cash equivalents at beginning of period

     591,497       559,227  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 536,933     $ 591,497  
  

 

 

   

 

 

 

 

6