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GW Pharmaceuticals plc Reports 2013 Third Quarter Financial Results

LONDON, Aug. 5, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (NASDAQ: GWPH, AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the third quarter ended 30 June 2013.


  • Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of $30.4 million (£19.6 million)
  • Two pivotal Sativex® Phase 3 cancer pain trials in recruitment. Top-line results from both trials due in 2014. Data intended to lead to a New Drug Application (NDA) filing with the FDA in the U.S.
  • FDA filing of a Phase 3 Investigational New Drug Application (IND) for Sativex as a treatment for MS spasticity
  • Commercial launch of Sativex in Italy as a treatment for MS spasticity, earning £250,000 milestone
  • Submission of regulatory application in France for Sativex in the treatment of MS spasticity
  • Positive top-line results from a 12 month, placebo-controlled study of Sativex in patients with MS spasticity confirming the reassuring safety profile and providing further evidence of efficacy
  • Significant clinical trial activity for cannabinoid pipeline product candidates expected to continue in the second half of 2013
  • Two new patent allowances in the U.S. protecting Sativex delivery method and delivery device

  • Sativex product sales revenues of £0.5 million ($0.8 million) for the three months ended 30 June 2013, compared to £0.1million for the three months ended 30 June 2012, reflecting increased shipments of inventory to commercial partners
  • Total revenue for the three months ended 30 June 2013 of £7.3 million ($11.0 million) compared to £14.5 million for the three months ended 30 June 2012, a period in which a £9.8 million milestone payment was received
  • Loss after tax for the three months ended 30 June 2013 of £2.0 million ($3.1 million) compared to a profit of £7.9 million for the three months ended 30 June 2012, which primarily reflected the impact of the £9.8 million milestone payment received in the comparable period last year
  • Cash and cash equivalents at 30 June 2013 of £43.6 million ($66.3 million) compared to £29.3 million as at 30 September 2012
  • "Following our successful Nasdaq listing in May, GW has established an important new US shareholder base and further enhanced its robust financial position," stated Justin Gover, GW's Chief Executive Officer. "GW continues to make good progress with the U.S. Phase 3 development of Sativex as a treatment for cancer pain, and is also now advancing plans for the US development of Sativex as a treatment for MS spasticity." In addition, the recent launch of Sativex in Italy and new regulatory application in France are expected to support further commercial progress in Europe, and provide important validation for Sativex and GW's position as a world leader in cannabinoid science. As we move forward in the second half of 2013, we expect a significant amount of clinical activity to occur with respect to our cannabinoid pipeline candidates."  

    Conference Call and Webcast InformationGW Pharmaceuticals will host a conference call and webcast to discuss the 2013 third quarter financial results today at 8:00 a.m. ET / 1:00 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the US and Canada), or 00800-2246-2666 (toll free from the UK) 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 A replay of the call will also be available through the GW website shortly after the call and will remain available for 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 418183.

    About GW Pharmaceuticals plc 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 commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and at least two additional programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit

    Forward-looking statementsThis news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of GW products commercially available and in development, the size of Sativex market opportunities, and the development and regulatory clearance of the GW's products.  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 the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. 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(Today) + 44 20 7831 3113Justin Gover, Chief Executive Officer

    (Thereafter) + 44 1980 557000Stephen Schultz, VP Investor Relations (US)

    401 500 6570FTI Consulting (Media Enquiries)Ben Atwell / Simon Conway / John Dineen (UK)

    + 44 20 7831 3113Robert Stanislaro (US)

    212 850 5657Trout Group, LLC (US investor relations)Seth Lewis / Todd James

    646 378 2900 GW Pharmaceuticals plc
    Condensed consolidated income statementsCondensed consolidated income statement for the three months ended 30 June 2013Three months

     endedThree months endedThree months

    ended30 June30 June30 June201320132012$000's£000's£000'sRevenue11,0387,25814,455Cost of sales(406)(267)(15)Research and development expenditure(12,826)(8,434)(5,673)Management and administrative expenses(1,322)(869)(932)Operating loss(3,516)(2,312)7,835Interest income442939Interest payable(68)(45)(1)Loss before tax(3,540)(2,328)7,873Tax456300-Profit/(loss) for the period(3,084)(2,028)7,873Earnings/(loss) per share – basic (2.0c)(1.3p)5.9p– diluted(2.0c)(1.3p)5.7p 

     Condensed consolidated income statement for the nine months ended 30 June 2013Nine months

     endedNine months endedNine  months

     ended30 June30 June30 June201320132012$000's£000's£000'sRevenue30,68020,17325,533Cost of sales(1,407)(925)(537)Research and development expenditure(35,791)(23,534)(18,396)Management and administrative expenses(4,182)(2,750)(2,967)Operating loss(10,700)(7,036)3,633Interest income169111141Interest payable(69)(45)(1)Loss before tax(10,600)(6,970)3,773Tax7,7125,071928Profit/(loss) for the period(2,888)(1,899)4,701Earnings/(loss) per share – basic (2.0c)(1.3p)3.5p– diluted(2.0c)(1.3p)3.4pAll activities relate to continuing operations.
    The Group has no recognised gains or losses other than the losses above and therefore no separate consolidated statement of comprehensive income has been presented. 

     GW Pharmaceuticals plc
    Condensed consolidated statements of changes in equity
    Nine months ended 30 June 2013Called-upSharesharepremiumOtherRetainedcapitalaccountreservesearningsTotal£000's£000's£000's£000's£000'sBalance at 1 October 201113365,86620,184(68,531)17,652Exercise of share options

    -83--83Share-based payment transactions

    ---743743Profit for the period

    ---4,7014,701Balance at 30 June 201213365,94920,184(63,087)23,179Balance at 1 October 2012 13365,94720,184(65,032)21,232Issue of share capital

    4519,567--19,612Expense of new equity issue

    -(1,759)--(1,759)Share-based payment transactions

    ---573573Loss for the period

    ---(1,899)(1,899)Balance at 30 June 201317883,75520,184(66,358)37,759 GW Pharmaceuticals plc
    Condensed consolidated balance sheets
    As at 30 June 2013As at

    30 JuneAs at30 JuneAs at

    30 September201320132012Non-current assets$000's£000's £000'sIntangible assets – goodwill7,9235,2105,210Property, plant and equipment8,1595,3652,432Deferred tax asset1,7951,180-17,87711,7557,642Current assetsInventories6,8034,4733,537Taxation recoverable2,8561,878820Trade receivables and other current assets2,3021,5141,588Cash and cash equivalents66,28143,58329,33578,24251,44835,280Total assets96,11963,20342,922Current liabilitiesTrade and other payables(16,256)(10,689)(9,114)Obligations under finance leases(129)(85)-Deferred revenue(5,297)(3,483)(2,449)(21,682)(14,257)(11,563)Non-current liabilitiesObligations under finance leases(2,961)(1,947)-Deferred revenue(14,052)(9,240)(10,127)Total liabilities(38,695)(25,444)(21,690)Net assets57,42437,75921,232EquityShare capital270178133Share premium account127,37583,75565,947Other reserves30,69620,18420,184Accumulated deficit  (100,917)(66,358)(65,032)Total equity57,42437,75921,232  

    GW Pharmaceuticals plc
    Condensed consolidated cash flow statements
    For the nine months ended 30 June 2013Nine months

    endedNine months endedNine months


    30 June 

    30 June 

    30 June201320132012$000's3;000's3;000's(Loss)/profit for the period(2,888)(1,899)4,701Adjustments for:

    Interest income

    Interest payable









    (928)Depreciation of property, plant and equipment

    Other gains and losses

    Decrease in provision for inventories




    (881)Share-based payment charge

    871573743(8,773)(5,769)3,955Increase in inventories

    (797)(524)(716)Decrease in trade receivables and other current assets

    10569808Increase/(decrease) in trade and other payables and deferred revenue




    (2,377)Cash (used)/generated by operations(7,366)(4,844)1,670Research and development tax credits received

    4,3072,832428Net cash (outflow)/inflow from operating activities(3,059)(2,012)2,098Investing activitiesInterest received

    175115104Purchases of property, plant and equipment

    (2,762)(1,816)(1,192)Net cash outflow from investing activities(2,587)(1,701)(1,088)Financing activitiesProceeds on exercise of shares options

    --83Proceeds of new equity issue

    29,82419,612-Expenses of new equity issue

    (2,153)(1,416)-Interest paid

    (68)(45)(1)Proceeds from finance leases

    342225-Net cash inflow from financing activities27,94518,37682Effect of foreign exchange rate changes(631)(415)105Net increase in cash and cash equivalents

    21,66814,2481,197Cash and cash equivalents at beginning of the period

    44,61329,33528,319Cash and cash equivalents at end of the period



    SOURCE GW Pharmaceuticals plc
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