GWPH - GW Pharmaceuticals plc

NasdaqGS - NasdaqGS Real-time price. Currency in USD
126.92
+1.67 (+1.33%)
At close: 4:00PM EDT
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Previous close125.25
Open125.32
Bid124.85 x 800
Ask128.58 x 1300
Day's range124.28 - 128.93
52-week range67.98 - 186.71
Volume331,587
Avg. volume543,069
Market cap4.063B
Beta (5Y monthly)1.87
PE ratio (TTM)119.17
EPS (TTM)1.07
Earnings date04 Aug 2020 - 10 Aug 2020
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target est184.00
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  • Globe Newswire

    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 and CARLSBAD, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- 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, 2019OPERATIONAL 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 * 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 EMAConference Call and Webcast InformationGW 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.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 Relations917 280 2424 / 401 500 6570   U.S. Media Enquiries: Sam Brown Inc. Healthcare Communications   Christy Curran Mike Beyer615 414 8668 312 961 2502   Ex-U.S. media enquiries  Ben Atwell, FTI Consulting+44 (0)203 727 1000 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  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  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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  • Globe Newswire

    GW Pharmaceuticals to Present at the Bank of America Healthcare Conference 2020

    LONDON and CARLSBAD, Calif., May 01, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that Justin Gover, GW’s Chief Executive Officer, will present a business update at the Bank of America Healthcare Conference 2020 on Tuesday, May 12th, 2020 at 1:40pm EST, which is being held virtually. Live audio webcasts of the presentation and breakout session will be available through GW’s corporate website at www.gwpharm.com on the Investors section under Events & Presentations. A replay will be available for each soon after the live presentation.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.Enquiries:GW Pharmaceuticals plc  Stephen Schultz, VP Investor Relations (U.S.)917 280 2424 / 401 500 6570

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  • Globe Newswire

    GW Pharmaceuticals plc to Report Financial Results and Operational Progress for the First Quarter Ending March 31st, 2020 and Host Conference Call on May 11th, 2020

    CARLSBAD, Calif., April 21, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, will announce on May 11th, 2020 its financial results for the first quarter ending March 31st, 2020. GW will also host a conference call the same day at 4:30 p.m. ET. Conference call information will be provided in the financial results press release. A replay of the call will also be available through the Company's website (www.gwpharm.com) shortly after the call.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 a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) 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.Enquiries:GW Pharmaceuticals plc  Stephen Schultz, VP Investor Relations (U.S.)917 280 2424 / 401 500 6570

  • Globe Newswire

    GW Pharmaceuticals plc and Its U.S. Subsidiary Greenwich Biosciences, Inc. Announce That EPIDIOLEX® (cannabidiol) Oral Solution Has Been Descheduled And Is No Longer A Controlled Substance

    \- Descheduling will enable prescribing free of the previous Schedule V requirements -CARLSBAD, Calif., April 06, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid platform, along with its U.S. subsidiary Greenwich Biosciences, Inc., announced today that it has received notification from the United States Drug Enforcement Administration (DEA) confirming that EPIDIOLEX® (cannabidiol) is no longer subject to the Controlled Substances Act (CSA).  This change takes effect immediately.“This notification from DEA fully establishes that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer a controlled substance under the federal Controlled Substances Act,” said Justin Gover, GW’s Chief Executive Officer.  “We would like to thank DEA for confirming the non-controlled status of this medicine. Importantly, the descheduling of EPIDIOLEX has the potential to further ease patient access to this important therapy for patients living with Lennox-Gastaut Syndrome and Dravet syndrome, two of the most debilitating forms of epilepsy.”EPIDIOLEX, which was launched in the United States on November 1, 2018 after approval by  FDA for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), and the first in a new category of anti-epileptic drugs.Following FDA approval, EPIDIOLEX was initially placed in Schedule V of the CSA. Following receipt of this DEA notification, GW has filed a post-approval supplement with FDA to remove Schedule V designation from EPIDIOLEX.DEA’s letter means that all federal controlled-substance restrictions have been removed for EPIDIOLEX. The Company will now begin the process of implementing these changes at the state level and through the EPIDIOLEX distribution network.  Once this process is completed in each state, prescriptions for EPIDIOLEX, like other non-controlled medicines, will be valid for one year and can be easily transferred between pharmacies. The descheduling of EPIDIOLEX also enables physicians to prescribe this breakthrough medicine free of the requirements of state prescription drug monitoring programs.The most common adverse reactions that occurred in EPIDIOLEX-treated patients were somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, and asthenia, rash, insomnia, sleep disorder and poor-quality sleep, and infections. The medicine is marketed in the United States by Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals plc. More information, including the product label, can be found at Epidiolex.com.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 a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) 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.About EPIDIOLEX® (cannabidiol) oral solutionEPIDIOLEX® (cannabidiol) oral solution, a pharmaceutical formulation of highly purified cannabidiol (CBD), is the first in a new class of anti-epileptic medications with a novel mechanism of action, and the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA). In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. A supplemental New Drug Application (sNDA) has been submitted to the FDA for the treatment of seizures associated with tuberous sclerosis complex (TSC). Epidiolex has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome. Epidiolex/Epidyolex has received Orphan Drug Designation from the FDA and the EMA for the treatment of seizures associated with Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes.Forward-looking statementsThis news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding the timing and outcomes of regulatory decisions. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the risks and uncertainties which 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 (U.S.)917 280 2424 / 401 500 6570    U.S. Media Enquiries: Sam Brown Inc. Healthcare Communications   Christy Curran Mike Beyer615 414 8668 312 961 2502

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