8-K
CB24 9BZ United Kingdom 00-0000000 266800 false 0001351288 0001351288 2021-02-16 2021-02-16

 

 

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 16, 2021

 

 

GW PHARMACEUTICALS PLC

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales   001-35892   Not Applicable

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

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

(Address of principal executive offices, including zip code)

+44 1223 266 800

(Registrant’s telephone number, including area code)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under 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 Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On February 16, 2021, GW Pharmaceuticals plc (the “Company”) issued a press release announcing the Company’s financial and operating results for the fourth quarter and year ended December 31, 2020. A copy of the press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

The information in this Report, including the press release, is furnished only, is not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in that filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Number

  

Description

99.1    Press release dated February 16, 2021, reporting Fourth Quarter and Full Year 2020 Financial and Operating Results.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

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, hereunto duly authorized.

 

    GW PHARMACEUTICALS PLC
Date: February 16, 2021     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 2020 Financial Results and Operational Progress

- Total revenue of $148.2 million for the fourth quarter and $527.2 million for the full year –

- Total Epidiolex® net product sales of $144.1 million for the fourth quarter and $510.5 million for the full year –

— Previously announced agreement to be acquired by Jazz Pharmaceuticals; transaction expected to close in Q2 2021—

London, UK and Carlsbad, CA, Feb 16, 2021 – 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 fourth quarter and full-year ended December 31, 2020.

“We are very proud of our strong financial performance and operational progress in 2020, as Epidiolex sales increased by more than 70% during the year despite the challenges of COVID-19. We are well positioned to build on our success and continue to deliver strong growth in 2021 in both the U.S. and Europe, where we continue to make progress preparing for several commercial launches that are expected later this year,” said Justin Gover, chief executive officer of GW. “We have commenced our Phase 3 clinical program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission. Beyond nabiximols, we are advancing a diverse and robust neuroscience pipeline with several preclinical and clinical-stage pipeline candidates as part of our commitment to patients and to developing innovative medicines that address significant unmet needs. We have strong momentum and a tremendous opportunity to continue to build on our global cannabinoid leadership position as we prepare to join Jazz Pharmaceuticals and transform the lives of even more patients and families.”

FINANCIAL RESULTS

 

   

Total revenue for the quarter ended December 31, 2020 was $148.2 million compared to $109.1 million for the quarter ended December 31, 2019.

 

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Total revenue for the full-year 2020 was $527.2 million, a 69 percent increase compared to $311.3 million for the prior year period.

 

   

Net loss for the quarter ended December 31, 2020 was $29.1 million compared to net loss of $24.9 million for the quarter ended December 31, 2019.

 

   

Cash and cash equivalents at December 31, 2020 were $486.8 million.

OPERATIONAL HIGHLIGHTS

 

   

Epidiolex (cannabidiol) progress:

 

   

Total net product sales of Epidiolex of $144.1 million for the fourth quarter and $510.5 million for the year ended December 31, 2020.

 

   

U.S. commercial update

 

   

U.S. Epidiolex net product sales of $128.8 million for the fourth quarter and $467.6 million for the year ended December 31, 2020

 

   

TSC indication launched with high prescriber awareness and near universal payer coverage

 

   

Expanded payer coverage

 

   

More than 110 million lives with no/broad prior authorization (70% increase in 2020)

 

   

Ex-U.S. commercial update

 

   

Ex-U.S. Epidyolex Q4 2020 net product sales of $15.3 million and full-year 2020 sales of $42.9 million

 

   

Continued progress expanding global reach of Epidyolex:

 

   

Pricing and reimbursement approved in Germany, Finland and Israel

 

   

Swissmedic approval received for the adjunctive therapy of seizures associated with LGS and DS

 

   

Launches in France, Spain and Italy expected in H1 2021

 

   

EMA TSC approval expected H1 2021

 

   

Strengthening commercial exclusivity

 

   

Orphan exclusivity in both the U.S. and EU

 

   

14 patents listed in Orange Book, 13 of which expire in 2035

 

   

Patents include formulation and method of use

 

   

An additional patent has been granted and will be listed in the Orange Book in Q1 2021 and a further patent is expected to be granted and listed in the Orange Book in Q2 2021

 

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Epidiolex composition patent application filed

 

   

Nabiximols development program:

 

   

MS Spasticity trials underway

 

   

Phase 3 placebo-controlled spasm frequency study (N=450)

 

   

Phase 3 placebo-controlled muscle tone study (N=52)

   

MS Spasticity trials due to commence

 

   

Phase 3 placebo-controlled muscle tone studies:

 

   

N=190; Expected start: Q2 2021

 

   

N=36 (nabiximols responders); Expected start: Q2 2021

 

   

Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021

 

   

Spinal Cord Injury (SCI) spasticity clinical program

 

   

First SCI trial underway

 

   

N=~100 observational clinical discovery study

 

   

SCI spasticity trials due to commence

 

   

N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021

 

   

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

 

   

Additional pipeline programs:

 

   

Schizophrenia (GWP42003)

 

   

Phase 2b trial now actively recruiting

   

Autism:

 

   

CBD formulation Phase 2 study expected to commence in Q1 2021

 

   

CBDV investigator-led 100 patient placebo-controlled trial in autism underway

   

New botanical cannabinoid pipeline product (GW541)

 

   

Phase 1 trial underway

 

   

Potential targets within field of neuropsychiatry

 

   

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

 

   

Novel cannabinoid molecule synthesis and preclinical development

 

   

At least one program expected to enter Phase 1 in 2021

 

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Several other molecules have demonstrated preclinical efficacy and are advancing towards the clinic

 

   

On Feb. 3, 2021, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and GW announced the companies had entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares (subject to limitations on the maximum and minimum number of Jazz ordinary shares issuable per ADS), for a total consideration of $7.2 billion. The transaction is subject to the approval of GW shareholders, sanction by the High Court of Justice of England and Wales and other customary closing conditions, including regulatory approvals. Subject to the satisfaction or waiver of the closing conditions, the transaction is expected to close in the second quarter of 2021.

Conference Call/Earnings Materials

Given the recently announced agreement for GW to be acquired by Jazz Pharmaceuticals, GW will no longer hold conference calls. Earnings materials are available publicly on the Investor Relations page of GW’s website at http://www.gwpharm.com. Questions may be directed to Investor Relations via e-mail at the contact information below.

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. 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. The company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia.

Forward-Looking Statements

This communication contains forward-looking statements regarding Jazz Pharmaceuticals and GW Pharmaceuticals, including, but not limited to, statements related to 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 nabiximols, and the safety profile and commercial potential of both medicines, the proposed acquisition of GW Pharmaceuticals and the anticipated timing, results and benefits thereof, including the potential for Jazz Pharmaceuticals to accelerate its growth and neuroscience leadership, and for the acquisition to provide long-term growth opportunities to create shareholder value; Jazz Pharmaceuticals’ expected financing for the

 

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transaction; and other statements that are not historical facts. You can generally identify forward-looking statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative thereof or other variations thereon or comparable terminology. These forward-looking statements are based on each of the companies’ current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties, many of which are beyond Jazz Pharmaceuticals’ or GW Pharmaceuticals’ control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: Jazz Pharmaceuticals’ and GW Pharmaceuticals’ ability to complete the acquisition on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory and shareholder approvals, the sanction of the High Court of Justice of England and Wales and satisfaction of other closing conditions to consummate the acquisition; the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive transaction agreement relating to the proposed transaction; risks related to diverting the attention of GW Pharmaceuticals and Jazz Pharmaceuticals management from ongoing business operations; failure to realize the expected benefits of the acquisition; significant transaction costs and/or unknown or inestimable liabilities; the risk of shareholder litigation in connection with the proposed transaction, including resulting expense or delay; the risk that GW Pharmaceuticals’ business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected; Jazz Pharmaceuticals’ ability to obtain the expected financing to consummate the acquisition; risks related to future opportunities and plans for the combined company, including the uncertainty of expected future regulatory filings, financial performance and results of the combined company following completion of the acquisition; GW Pharmaceuticals’ dependence on the successful commercialization of Epidiolex/Epidyolex and the uncertain market potential of Epidiolex; pharmaceutical product development and the uncertainty of clinical success; the regulatory approval process, including the risks that GW Pharmaceuticals may be unable to submit anticipated regulatory filings on the timeframe anticipated, or at all, or that GW Pharmaceuticals may be unable to obtain regulatory approvals of any of its product candidates, including nabiximols and Epidiolex for additional indications, in a timely manner or at all; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; effects relating to the announcement of the acquisition or any further announcements or the consummation of the acquisition on the market price of Jazz Pharmaceuticals’ ordinary shares or GW Pharmaceuticals’ American depositary shares or ordinary shares; the possibility that, if Jazz Pharmaceuticals does not achieve the perceived benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Jazz Pharmaceuticals’ ordinary shares could decline; potential litigation associated with the possible acquisition; regulatory initiatives and changes in tax laws; market volatility; and other risks and uncertainties affecting Jazz Pharmaceuticals and GW Pharmaceuticals, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ and GW Pharmaceuticals’ Securities and Exchange Commission (SEC) filings and reports, including Jazz Pharmaceuticals’ Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, GW Pharmaceuticals’ Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and future filings and reports by either company. In addition, while Jazz

 

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Pharmaceuticals and GW Pharmaceuticals expect the COVID-19 pandemic to continue to adversely affect their respective business operations and financial results, the extent of the impact on the combined company’s ability to generate sales of and revenues from its approved products, execute on new product launches, its clinical development and regulatory efforts, its corporate development objectives and the value of and market for its ordinary shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. Moreover, other risks and uncertainties of which Jazz Pharmaceuticals or GW Pharmaceuticals are not currently aware may also affect each of the companies’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. Investors are cautioned that forward-looking statements are not guarantees of future performance. The forward-looking statements made in this communication are made only as of the date hereof or as of the dates indicated in the forward-looking statements and reflect the views stated therein with respect to future events as at such dates, even if they are subsequently made available by Jazz Pharmaceuticals or GW Pharmaceuticals on their respective websites or otherwise. Neither Jazz Pharmaceuticals nor GW Pharmaceuticals undertakes any obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Enquiries:

 

Investors:   
Scott Giacobello, Chief Financial Officer    760 795 2200 / sgiacobello@gwpharm.com
Media:   
Kristen Cardillo, VP, Corporate Communications    760.579.6628 / kcardillo@gwpharm.com
Ben Atwell, FTI Consulting    +44 (0)203 727 1000 / ben.atwell@fticonsulting.com

 

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GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     December 31,  
     2020     2019  

Assets

    

Cash and cash equivalents

   $ 486,752     $ 536,933  

Accounts receivable, net

     71,168       48,883  

Inventory

     129,138       85,528  

Prepaid expenses and other current assets

     42,472       28,292  
  

 

 

   

 

 

 

Total current assets

     729,530       699,636  
  

 

 

   

 

 

 

Property, plant, and equipment, net

     143,767       127,765  

Operating lease assets

     25,118       24,916  

Intangible assets

     5,565        

Goodwill

     6,959       6,959  

Deferred tax assets

     20,777       18,123  

Other assets

     7,795       4,850  
  

 

 

   

 

 

 

Total assets

   $ 939,511     $ 882,249  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Accounts payable

   $ 21,870     $ 9,990  

Accrued liabilities

     127,849       99,374  

Current tax liabilities

     877       437  

Other current liabilities

     9,210       7,760  
  

 

 

   

 

 

 

Total current liabilities

     159,806       117,561  
  

 

 

   

 

 

 

Long-term liabilities:

    

Finance lease liabilities

     5,454       5,573  

Operating lease liabilities

     22,127       21,650  

Other liabilities

     11,034       11,431  
  

 

 

   

 

 

 

Total long-term liabilities

     38,615       38,654  
  

 

 

   

 

 

 

Total liabilities

     198,421       156,215  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Ordinary shares par value £0.001; 375,196,172 and 371,068,436 shares outstanding as of December 31, 2020 and 2019, respectively

     577       570  

Additional paid-in capital

     1,690,151       1,632,046  

Accumulated deficit

     (896,087     (837,959

Accumulated other comprehensive loss

     (53,551     (68,623
  

 

 

   

 

 

 

Total stockholders’ equity

     741,090       726,034  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 939,511     $ 882,249  
  

 

 

   

 

 

 

 

7


GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended
December 31,
    Year Ended
December 31,
 
     2020     2019     2020     2019  

Revenues

        

Product net sales

   $ 148,222     $ 109,019     $ 526,830     $ 310,331  

Other revenue

     —         57       375       1,001  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     148,222       109,076       527,205       311,332  

Operating expenses

        

Cost of product sales

     10,419       7,298       37,531       27,199  

Research and development

     56,854       43,535       205,396       142,678  

Selling, general and administrative

     103,761       78,351       336,043       259,880  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     171,034       129,184       578,970       429,757  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (22,812     (20,108     (51,765     (118,425

Interest income

     87       1,818       1,814       8,464  

Interest expense

     (271     (282     (1,121     (1,087

Other income

           —         —         104,117  

Foreign exchange loss

     (3,544     (5,073     (3,974     (2,272
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (26,540     (23,645     (55,046     (9,203

Income tax expense (benefit)

     2,607       1,301       3,082       (184
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (29,147   $ (24,946   $ (58,128   $ (9,019
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (0.08   $ (0.07   $ (0.15   $ (0.02
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     376,680       372,447       375,586       371,580  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Year Ended
December 31,
 
     2020     2019  

Cash flows from operating activities

    

Net loss

   $ (58,128   $ (9,019

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

    

Foreign exchange loss

     910       2,709  

Stock-based compensation

     58,359       48,030  

Depreciation and amortization

     12,757       9,240  

Deferred income taxes

     (2,654     (9,698

Gain from sale of priority review voucher

     —         (104,117

Other

     528       39  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (22,104     (44,623

Inventory

     (39,873     (51,125

Prepaid expenses and other current assets

     (9,624     (9,831

Other assets

     3,290       3,888  

Accounts payable

     9,862       805  

Current tax liabilities

     (3,404     (963

Accrued liabilities

     24,890       43,110  

Other liabilities

     (2,194     (1,914
  

 

 

   

 

 

 

Net cash used in operating activities

     (27,385     (123,469
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from sale of priority review voucher

     —         104,117  

Additions to property, plant and equipment

     (18,585     (40,386

Additions to capitalized software

     (3,018     (2,102

Additions to intangible assets—licenses

     (6,404     —    

Proceeds from disposal of property, plant and equipment

     —         —    
  

 

 

   

 

 

 

Net cash (used in) provided by investing activities

     (28,007     61,629  
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from issuance of ordinary shares, Net of issuance costs

     —         —    

Proceeds from exercise of stock options

     1,579       2,878  

Payments in connection with common stock withheld for employee tax obligation

     (1,826     —    

Payments on finance leases

     (299     (389

Payments on landlord financing obligation

     (583     (543
  

 

 

   

 

 

 

Net cash (used in) provided by financing activities

     (1,129     1,946  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     6,340       5,330  

Net decrease in cash and cash equivalents

     (50,181     (54,564

Cash and cash equivalents at beginning of period

     536,933       591,497  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 486,752     $ 536,933  
  

 

 

   

 

 

 

 

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