EX-99.1 2 d931963dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

LOGO

GW Pharmaceuticals plc Reports First Quarter 2020 Financial Results

and Operational Progress

– Total revenue of $120.6 million –

– Total Epidiolex® net product sales of $116.1 million –

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

London, UK and Carlsbad, CA, May 11, 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 first quarter ended March 31, 2020.

“In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August,” stated Justin Gover, GW’s CEO. “In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science.”

FINANCIAL RESULTS

 

   

Total revenue for the quarter ended March 31, 2020 was $120.6 million compared to $39.2 million for the quarter ended March 31, 2019

 

   

Net loss for the quarter ended March 31, 2020 was $8.0 million compared to a net loss of $50.1 million for the quarter ended March 31, 2019

 

   

Cash and cash equivalents at March 31, 2020 were $500.9 million compared to $536.9 million as of December 31, 2019

OPERATIONAL HIGHLIGHTS

 

   

Epidiolex (cannabidiol) progress:

 

   

Total Q1 net product sales of Epidiolex of $116.1 million

 

   

U.S. commercial update

 

   

U.S. Epidiolex Q1 net product sales of $106.1 million

 

   

August commercial launch planned for TSC indication; July 31 PDUFA date

 

   

Epidiolex descheduled by the DEA

 

   

Payer discussions focused on pending TSC approval and expanding coverage

 

   

European commercial update

 

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Successful commercial launches in Germany and UK

 

   

Important pricing & reimbursement progress in Germany & Italy. Commercial launches in France, Spain and Italy on track for later this year

 

   

TSC EMA submission accepted for review

 

   

Clinical progress with additional indications to broaden addressable market

 

   

Phase 3 trial in Rett Syndrome (recruitment temporarily on hold)

 

   

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

 

   

Strengthening commercial exclusivity

 

   

Orphan exclusivity in both the U.S. and EU

 

   

10 granted patents listed in Orange Book with expiry dates to 2035, including 1 patent recently granted broadly covering use in LGS and Dravet syndrome

 

   

Epidiolex composition patent application in process

 

   

1 new allowed patent covering seizure sub-type use in Dravet syndrome expected to grant in Q2 2020

 

   

TSC patent applications under review with initial grant expected in 2020

 

   

Pipeline progress

 

   

Start of new clinical programs delayed until H2 2020 due to current COVID restrictions

 

   

Nabiximols (Sativex® outside of the US)

 

   

Multiple Sclerosis spasticity

 

   

US pivotal clinical program expected to commence in H2 2020 to augment existing data package

 

   

3 positive Phase 3 trials completed in Europe

 

   

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

 

   

PTSD – clinical program expected to commence in H2 2020

 

   

Schizophrenia (GWP42003)

 

   

Phase 2b trial expected to commence H2 2020

 

   

CBDV in autism

 

   

30-patient open label study in autism

 

   

Investigator-led 100 patient placebo-controlled trial in autism

 

   

Open label study in Rett syndrome and seizures

 

   

Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commenced

 

   

Phase 1b safety study in patients continues to recruit due to emergency care environment

 

   

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 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: 34479.

 

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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) 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 applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), 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 and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic, 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

 

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GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

     March 31,     December 31,  
     2020     2019  

Assets

    

Cash and cash equivalents

   $ 500,935     $ 536,933  

Accounts receivable, net

     62,209       48,883  

Inventory

     89,056       85,528  

Prepaid expenses and other current assets

     20,546       28,292  
  

 

 

   

 

 

 

Total current assets

     672,746       699,636  
  

 

 

   

 

 

 

Property, plant, and equipment, net

     122,882       127,765  

Operating lease assets

     23,199       24,916  

Intangible assets

     5,951       —    

Goodwill

     6,959       6,959  

Deferred tax assets

     18,123       18,123  

Other assets

     4,517       4,850  
  

 

 

   

 

 

 

Total assets

   $ 854,377     $ 882,249  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Accounts payable

   $ 18,345     $ 9,990  

Accrued liabilities

     77,479       99,374  

Current tax liabilities

     998       437  

Other current liabilities

     6,650       7,760  
  

 

 

   

 

 

 

Total current liabilities

     103,472       117,561  
  

 

 

   

 

 

 

Long-term liabilities:

    

Finance lease liabilities

     5,157       5,573  

Operating lease liabilities

     20,028       21,650  

Other liabilities

     10,715       11,431  
  

 

 

   

 

 

 

Total long-term liabilities

     35,900       38,654  
  

 

 

   

 

 

 

Total liabilities

     139,372       156,215  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock - Ordinary shares par value £0.001;
372,562,088 shares outstanding as of March 31, 2020;
371,068,436 shares outstanding as of December 31, 2019

     573       570  

Additional paid-in capital

     1,643,407       1,632,046  

Accumulated deficit

     (845,924     (837,959

Accumulated other comprehensive loss

     (83,051     (68,623
  

 

 

   

 

 

 

Total stockholders’ equity

     715,005       726,034  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 854,377     $ 882,249  
  

 

 

   

 

 

 

 

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GW PHARMACEUTICALS PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended March 31,  
     2020     2019  

Revenues

    

Product net sales

   $ 120,532     $ 38,974  

Other revenue

     101       273  
  

 

 

   

 

 

 

Total revenues

     120,633       39,247  

Operating expenses

    

Cost of product sales

     10,769       5,131  

Research and development

     45,874       30,375  

Selling, general and administrative

     71,183       55,078  
  

 

 

   

 

 

 

Total operating expenses

     127,826       90,584  
  

 

 

   

 

 

 

Loss from operations

     (7,193     (51,337

Interest income

     1,269       2,087  

Interest expense

     (284     (265

Foreign exchange loss

     (20     (1,114
  

 

 

   

 

 

 

Loss before income taxes

     (6,228     (50,629

Income tax expense (benefit)

     1,737       (565
  

 

 

   

 

 

 

Net loss

   $ (7,965   $ (50,064
  

 

 

   

 

 

 

Net loss per share:

    

Basic

   $ (0.02   $ (0.14
  

 

 

   

 

 

 

Diluted

   $ (0.02   $ (0.14
  

 

 

   

 

 

 

Weighted average shares outstanding:

    

Basic

     373,831       369,823  

Diluted

     373,831       369,823  

 

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GW PHARMACEUTICALS PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Three Months Ended March 31,  
     2020     2019  

Cash flows from operating activities

    

Net loss

   $ (7,965   $ (50,064

Adjustments to reconcile net income (loss) to net cash used in

operating activities:

    

Foreign exchange loss

     60       797  

Share-based compensation

     11,361       11,142  

Depreciation and amortization

     2,656       2,417  

Other

     27       —    

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (13,630     (14,998

Inventory

     (8,928     (14,295

Prepaid expenses and other current assets

     5,377       (874

Other assets

     885       659  

Accounts payable

     8,585       1,998  

Current tax liabilities

     1,726       (654

Accrued liabilities

     (16,953     6,328  

Other liabilities

     (1,799     (838
  

 

 

   

 

 

 

Net cash used in operating activities

     (18,598     (58,382
  

 

 

   

 

 

 

Cash flows from investing activities

    

Additions to property, plant and equipment

     (6,361     (12,087

Additions to capitalized software

     (535     (199

Additions to intangible assets

     (6,404     —    
  

 

 

   

 

 

 

Net cash used in investing activities

     (13,300     (12,286
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from exercise of stock options

     3       773  

Payments on finance leases

     (73     (179

Payments on landlord financing obligation

     (143     (138
  

 

 

   

 

 

 

Net cash (used in) provided by financing activities

     (213     456  
  

 

 

   

 

 

 

Effect of exchange rate changes on cash

     (3,887     384  

Net decrease in cash and cash equivalents

     (35,998     (69,828

Cash and cash equivalents at beginning of period

     536,933       591,497  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 500,935     $ 521,669  
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information:

    

Income taxes paid

     10       88  

Interest paid

     285       265  

Supplemental disclosure of noncash information:

    

Property and equipment purchases in accounts payable and accrued liabilities

     1,661       714  

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

     275       —    

 

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