8-K
00-0000000 false 0001351288 0001351288 2020-08-06 2020-08-06

 

 

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, 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 August 6, 2020, GW Pharmaceuticals plc (the “Company”) issued a press release announcing its financial results for the second quarter of 2020. 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 August 6, 2020.


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, 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 Second Quarter 2020 Financial Results and Operational Progress

- Total revenue increased 68 percent to $121.3 million -

- Epidiolex approved in the U.S. for seizures associated with TSC, launch expected this month -

- Conference call today at 4:30 p.m. EDT –

London, UK and Carlsbad, CA, Aug 6, 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 second quarter ended June 30, 2020.

“We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond,” stated Justin Gover, GW’s CEO. “We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year.”

FINANCIAL RESULTS

 

   

Total revenue for the quarter ended June 30, 2020 was $121.3 million compared to $72.0 million for the quarter ended June 30, 2019

 

   

Net loss for the quarter ended June 30, 2020 was $8.8 million compared to net income of $79.7 million for the quarter ended June 30, 2019. The prior year quarter included net proceeds of $104.1 million from the sale of a Rare Pediatric Priority Review Voucher.

 

   

Cash and cash equivalents at June 30, 2020 were $477.6 million

OPERATIONAL HIGHLIGHTS

 

   

Epidiolex (cannabidiol) progress:

 

   

Total Q2 net product sales of Epidiolex of $117.7 million

 

1


   

U.S. commercial update

 

   

U.S. Epidiolex Q2 net product sales of $111.1 million

 

   

TSC indication approved by FDA, August commercial launch planned

 

   

TSC payer reimbursement anticipated quickly following launch

 

   

European commercial update

 

   

Ex-U.S. Epidyolex Q2 net product sales of $6.6 million

 

   

Pricing & reimbursement progress in Germany, France and Italy

 

   

TSC EMA submission under review

 

   

Clinical progress with additional indications

 

   

Phase 3 trial in Rett Syndrome expected to re-commence in H2 2020

 

   

Strengthening commercial exclusivity

 

   

Orphan exclusivity in both the U.S. and EU

 

   

3 new patents granted and listed in Orange Book, bringing total of 13 patents listed in Orange Book, 12 of which expire in 2035

 

   

One recent patent listed is a non-use patent directed to the oral formulation

 

   

Epidiolex composition patent application in process

 

   

TSC patent applications under review

 

   

Nabiximols

 

   

MS Spasticity Clinical program

 

   

Three positive Phase 3 MS spasticity trials already completed outside of the U.S.

 

   

Five new MS Spasticity Phase 3 trials expected to commence in H2 2020 (2) and H1 2021 (3), any one of which could enable a NDA submission

 

   

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

 

   

N=52; Expected start: Q4 2020

 

   

N=190; Expected start: Q1 2021

 

   

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

 

   

Phase 3 spasm frequency studies – placebo-controlled parallel group

 

   

N=450; Expected start: Q4 2020

 

   

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

 

   

Spinal Cord Injury (SCI) spasticity clinical program

 

   

Three SCI trials expected to be initiated in 2020 and 2021

 

   

N=~100 (observational clinical discovery study); Expected start: Q4 2020

 

   

N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021

 

2


   

N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021

 

   

Post-Traumatic Stress Disorder (PTSD) clinical program

 

   

Phase 2/3 study in PTSD (N=~ 325); Expected start: H1 2021

 

   

Additional pipeline programs

 

   

Schizophrenia (GWP42003)

 

   

Phase 2b trial expected to commence H2 2020

 

   

CBDV in autism trials expected to recommence in H2 2020

 

   

30-patient open label study in autism

 

   

Investigator-led 100 patient placebo-controlled trial in autism

 

   

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 4:30 pm EDT. To participate in the conference call, please dial 833-937-1050 (toll free from the U.S. and Canada) or 845-403-8302 (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: 35770.

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. GW is currently 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.

 

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   
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

 

4


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     June 30,     December 31,  
     2020     2019  

Assets

    

Cash and cash equivalents

   $ 477,557     $ 536,933  

Accounts receivable, net

     80,357       48,883  

Inventory

     99,620       85,528  

Prepaid expenses and other current assets

     30,183       28,292  
  

 

 

   

 

 

 

Total current assets

     687,717       699,636  
  

 

 

   

 

 

 

Property, plant, and equipment, net

     125,106       127,765  

Operating lease assets

     22,333       24,916  

Intangible assets

     5,627       —    

Goodwill

     6,959       6,959  

Deferred tax assets

     18,123       18,123  

Other assets

     4,715       4,850  
  

 

 

   

 

 

 

Total assets

   $ 870,580     $ 882,249  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Accounts payable

   $ 16,238     $ 9,990  

Accrued liabilities

     93,313       99,374  

Current tax liabilities

     2,004       437  

Other current liabilities

     6,947       7,760  
  

 

 

   

 

 

 

Total current liabilities

     118,502       117,561  
  

 

 

   

 

 

 

Long-term liabilities:

    

Finance lease liabilities

     5,066       5,573  

Operating lease liabilities

     19,659       21,650  

Other liabilities

     10,416       11,431  
  

 

 

   

 

 

 

Total long-term liabilities

     35,141       38,654  
  

 

 

   

 

 

 

Total liabilities

     153,643       156,215  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock - Ordinary shares par value £0.001; 373,709,720 shares outstanding as of June 30, 2020; 371,068,436 shares outstanding as of December 31, 2019

     575       570  

Additional paid-in capital

     1,655,500       1,632,046  

Accumulated deficit

     (854,752     (837,959

Accumulated other comprehensive loss

     (84,386     (68,623
  

 

 

   

 

 

 

Total stockholders’ equity

     716,937       726,034  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 870,580     $ 882,249  
  

 

 

   

 

 

 

 

5


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,
 
     2020     2019     2020     2019  

Revenues

        

Product net sales

   $ 121,230     $ 71,489     $ 241,762     $ 110,463  

Other revenue

     67       549       168       822  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     121,297       72,038       241,930       111,285  

Operating expenses

        

Cost of product sales

     8,708       6,620       19,477       11,751  

Research and development

     45,734       32,467       91,608       62,842  

Selling, general and administrative

     75,894       62,273       147,077       117,351  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     130,336       101,360       258,162       191,944  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (9,039     (29,322     (16,232     (80,659

Interest income

     250       2,310       1,519       4,397  

Interest expense

     (297     (268     (581     (533

Other income

     —         104,117       —         104,117  

Foreign exchange gain

     1,386       2,026       1,366       912  
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income before income taxes

     (7,700     78,863       (13,928     28,234  

Income tax expense (benefit)

     1,128       (885     2,865       (1,450
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income

   $ (8,828   $ 79,748     $ (16,793   $ 29,684  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share:

        

Basic

   $ (0.02   $ 0.21     $ (0.04   $ 0.08  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (0.02   $ 0.21     $ (0.04   $ 0.08  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding:

        

Basic

     375,525       371,712       374,680       370,776  

Diluted

     375,525       377,435       374,680       376,674  

 

6


GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Six Months Ended June 30,  
     2020     2019  

Cash flows from operating activities

    

Net loss

   $ (16,793   $ 29,684  

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

    

Foreign exchange (gain) loss

     (488     882  

Share-based compensation

     24,677       23,330  

Depreciation and amortization

     5,514       4,808  

Gain from sale of priority review voucher

     —         (104,117

Other

     27       21  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (31,794     (27,924

Inventory

     (19,669     (27,070

Prepaid expenses and other current assets

     (4,312     (6,819

Other assets

     1,884       1,542  

Accounts payable

     6,625       3,488  

Current tax liabilities

     2,732       619  

Accrued liabilities

     (599     13,887  

Other liabilities

     (2,145     (2,192
  

 

 

   

 

 

 

Net cash used in operating activities

     (34,341     (89,861
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from sale of priority review voucher

     —         104,117  

Additions to property, plant and equipment

     (11,362     (22,515

Additions to capitalized software

     (1,455     (1,017

Additions to intangible assets

     (6,404     —    
  

 

 

   

 

 

 

Net cash (used) provided by in investing activities

     (19,221     80,585  
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from exercise of stock options

     5       2,878  

Payments in connection with common stock withheld for employee tax obligation

     (1,223     —    

Payments on finance leases

     (146     (250

Payments on landlord financing obligation

     (283     (273
  

 

 

   

 

 

 

Net cash (used in) provided by financing activities

     (1,647     2,355  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     (4,167     (893

Net decrease in cash and cash equivalents

     (59,376     (7,814

Cash and cash equivalents at beginning of period

     536,933       591,497  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 477,557     $ 583,683  
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information:

    

Income taxes paid

     251       3,907  

Interest paid

     581       533  

Supplemental disclosure of noncash information:

    

Property and equipment purchases in accounts payable and accrued liabilities

     1,727       856  

Right-of-use asset obtained in exchange for operating liabilities

     275       —    

 

7