8-K
00-0000000 false 0001351288 0001351288 2019-08-06 2019-08-06

 

 

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): August 6, 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 August 6, 2019, GW Pharmaceuticals plc issued a press release relating to its results of operations and financial condition for the quarter ended June 30, 2019 and provided an update on its operational progress. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The press release, and the information set forth therein, is being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and 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 liabilities of that Section. Nor shall such document be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, regardless of any general incorporation language in the filing unless specifically stated so therein.

Item 9.01. Financial Statements and Exhibits.

  (d) Exhibits

Exhibit
No.

   

Description

         
 

99.1

   

Press release of GW Pharmaceuticals plc relating to its results of operations and financial condition for the quarter ended June 30, 2019 and update on its operational progress dated August 6, 2019.


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: August 6, 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 Second Quarter Ended June 30, 2019

- Epidiolex U.S. Q2 net sales of $68.4 million -

- Positive CHMP opinion clears way for an expected European approval in October -

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

Carlsbad, CA, August 6, 2019: GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development and commercialization of cannabinoid prescription medicines, announces financial results for the second quarter ended June 30, 2019.

“We are pleased to report a strong second quarter of sales of Epidiolex in the US, reflecting high demand by US patients, increased prescribing by healthcare providers, and ongoing progress in payor coverage determinations. With the recent positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to submit an sNDA by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition,” stated Justin Gover, GW’s Chief Executive Officer. “In Europe, we are pleased to have recently received the positive opinion from the CHMP which clears the way for an expected approval in October. Our European commercial organization is in place and will be ready to launch in the first European markets upon approval, making this important new treatment option available to deserving European patients.”

OPERATIONAL HIGHLIGHTS

 

   

Epidiolex® (cannabidiol)

 

   

U.S. commercial update

 

   

Q2 Net sales of $68.4M; $101.9M net sales in the first half of 2019

 

   

Over 12,000 patients have received Epidiolex prescriptions since launch

 

   

Over 2,500 physicians have generated dispensed prescriptions since launch

 

   

Pharmacy distribution network delivering median time to fill a first prescription in approximately 2 weeks

 

   

Vast majority of patients who have received Epdiolex remain on therapy

 

   

Transition of 900 patients in expanded access program and open label extension to commercial product complete

 

   

Strong payor coverage

 

   

Approximately 93 percent of all Commercial, Medicaid and Medicare lives in the US have a coverage determination, of which 65% are PA to indication or less restrictive

 

   

European launch update

 

   

Positive CHMP opinion with European Commission approval expected in early October

 

   

Q4 launches expected in France, Germany and UK; Spain and Italy launches to follow in 2020

 

   

Early Access Program in Europe for Dravet syndrome and LGS patients now includes over 800 patients registered across 5 major EU countries

 

   

Manufacturing

 

   

Commercial manufacturing and supply chain running smoothly

 

   

Production capacity sufficient to meet expected demand in both U.S. and Europe

 

   

Clinical trials

 

   

Phase 3 trial in Rett Syndrome now recruiting


   

Life-cycle management

 

   

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

 

   

PK data expected in 2019

 

   

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

 

   

Key favorable patent grants by USPTO related to the use of CBD in epilepsy

 

   

9 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

 

   

Pipeline progress

 

   

Sativex® (nabiximols)

 

   

Initial U.S. target indication: Multiple Sclerosis spasticity

 

   

Clinical program expected to commence in Q4 to augment existing pivotal data package

 

   

No new oral anti-spasticity treatments developed in the field for over 20 years

 

   

Novel mechanism of action

 

   

Potential “pipeline in a product” with over 10 placebo-controlled trials already completed in other indications

 

   

CBDV

 

   

Potential both within field of autism and epilepsy

 

   

IND open for 30-patient open label study in autism expected to begin recruitment by the end of 2019

 

   

Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder has commenced recruitment

 

   

Open label study in Rett syndrome and seizures ongoing

 

   

Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program

 

   

Phase 1 trial complete in healthy volunteers

 

   

Safety study in patients expected to commence in Q4

 

   

Orphan Drug and Fast Track Designations granted from FDA and EMA

FINANCIAL HIGHLIGHTS

 

   

Revenue for the quarter ended June 30, 2019 was $72.0 million compared to $3.3 million for the quarter ended June 30, 2018

 

   

Cash and cash equivalents at June 30, 2019 were $583.7 million compared to $591.5 million as of December 31, 2018

 

   

Closed on sale of Rare Pediatric Priority Review Voucher in the quarter and recognized net proceeds of $104.1 million as a gain on the sale of an intangible asset

 

   

Net income for the quarter ended June 30, 2019 was $79.7 million compared to a net loss of $84.0 million for the quarter ended June 30, 2018

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending June 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: 51890.

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, along with its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA approval for EPIDIOLEX (cannabidiol) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older and which is now available by prescription in the U.S. The Company has submitted a regulatory application in Europe and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). 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 planning a U.S. Phase 3 trial. 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/Andrew Ward    +44 (0) 20 727 1000


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     June 30,     December 31,  
     2019     2018  

Assets

    

Cash and cash equivalents

   $ 583,683     $ 591,497  

Accounts receivable, net

     32,113       4,192  

Inventory

     60,042       33,030  

Prepaid expenses and other current assets

     21,693       17,903  
  

 

 

   

 

 

 

Total current assets

     697,531       646,622  
  

 

 

   

 

 

 

Property, plant, and equipment, net

     107,332       90,832  

Operating lease assets

     18,739       —    

Goodwill

     6,959       6,959  

Deferred tax assets

     8,726       8,720  

Other assets

     3,490       2,935  
  

 

 

   

 

 

 

Total assets

   $ 842,777     $ 756,068  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Accounts payable

   $ 11,757     $ 9,796  

Accrued liabilities

     66,434       52,477  

Current tax liabilities

     —         2,384  

Other current liabilities

     5,757       1,559  
  

 

 

   

 

 

 

Total current liabilities

     83,948       66,216  
  

 

 

   

 

 

 

Long-term liabilities:

    

Finance lease liabilities

     5,536       5,690  

Operating lease liabilities

     15,139       —    

Other liabilities

     9,262       10,082  
  

 

 

   

 

 

 

Total long-term liabilities

     29,937       15,772  
  

 

 

   

 

 

 

Total liabilities

     113,885       81,988  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock - Ordinary shares par value £0.001; 370,621,184 shares outstanding as of June 30, 2019; 366,616,688 shares outstanding as of December 31, 2018

     570       564  

Additional paid-in capital

     1,607,346       1,581,144  

Accumulated deficit

     (799,256     (828,940

Accumulated other comprehensive loss

     (79,768     (78,688
  

 

 

   

 

 

 

Total stockholders’ equity

     728,892       674,080  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 842,777     $ 756,068  
  

 

 

   

 

 

 


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2019     2018     2019     2018  

Revenues

        

Product net sales

   $ 71,489     $ 3,094     $ 110,463     $ 5,906  

Other revenue

     549       190       822       419  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     72,038       3,284       111,285       6,325  

Operating expenses

        

Cost of product sales

     6,620       1,791       11,751       3,416  

Research and development

     32,467       45,113       62,842       88,598  

Selling, general and administrative

     62,273       37,786       117,351       63,959  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     101,360       84,690       191,944       155,973  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (29,322     (81,406     (80,659     (149,648

Interest income

     2,310       999       4,397       1,758  

Interest expense

     (268     (313     (533     (638

Other income

     104,117       —         104,117       —    

Foreign exchange gain (loss)

     2,026       (3,660     912       (4,300
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     78,863       (84,380     28,234       (152,828

Income tax (benefit) expense

     (885     (369     (1,450     644  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 79,748     $ (84,011   $ 29,684     $ (153,472
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per share:

        

Basic

   $ 0.21     $ (0.25   $ 0.08     $ (0.45
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ 0.21     $ (0.25   $ 0.08     $ (0.45
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

     371,712       340,457       370,776       340,355  

Diluted

     377,435       340,457       376,674       340,355  


GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Six Months Ended June 30,  
     2019     2018  

Cash flows from operating activities

    

Net income (loss)

   $ 29,684     $ (153,472

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

    

Foreign exchange loss

     882       3,930  

Share-based compensation

     23,330       16,426  

Depreciation and amortization

     4,808       4,720  

Deferred income taxes

     —         1,407  

Gain from sale of priority review voucher

     (104,117     —    

Other

     21       148  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (27,924     (423

Inventory

     (27,070     2,501  

Prepaid expenses and other current assets

     (6,819     22,139  

Other assets

     1,542       (249

Accounts payable

     3,488       3,156  

Current tax liabilities

     619       (3,458

Accrued liabilities

     13,887       3,599  

Other liabilities

     (2,192     1,265  
  

 

 

   

 

 

 

Net cash used in operating activities

     (89,861     (98,311
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from sale of priority review voucher

     104,117       —    

Additions to property, plant and equipment

     (22,515     (14,675

Additions to capitalized software

     (1,017     (983
  

 

 

   

 

 

 

Net cash provided by (used in) investing activities

     80,585       (15,658
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from exercise of stock options

     2,878       2  

Payments on finance leases

     (250     (143

Payments on landlord financing obligation

     (273     (271
  

 

 

   

 

 

 

Net cash provided by (used in) financing activities

     2,355       (412
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     (893     (4,906

Net decrease in cash and cash equivalents

     (7,814     (119,287

Cash and cash equivalents at beginning of period

     591,497       559,227  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 583,683     $ 439,940