GWPH GW Pharmaceuticals Plc

217.93
-0.07  -0%
Previous Close 218
Open 217.55
52 Week Low 84.06
52 Week High 218.555
Market Cap $6,872,193,941
Shares 31,533,951
Float 15,557,873
Enterprise Value $6,207,346,627
Volume 169,836
Av. Daily Volume 1,207,533
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Upcoming Catalysts

Drug Stage Catalyst Date
Sativex (Nabiximols)
Spasticity due multiple sclerosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
GWP42006 (CBDV)
Autism
Phase 2
Phase 2
Phase 2 trial has resumed - noted November 3, 2020.
Epidiolex
Rett syndrome
Phase 3
Phase 3
Phase 3 trial stopped due to COVID-19 - November 12, 2020.
GWP42003
Schizophrenia
Phase 2b
Phase 2b
Phase 2b trial enrolling.
Epidiolex
Tuberous Sclerosis Complex
Approved
Approved
FDA approval announced August 3, 2020.
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
Approved
Approved
Approval announced June 25, 2018.
GWP42006 (CBDV)
Epilepsy
Phase 2
Phase 2
Phase 2 data released February 21, 2018 - primary endpoint not met.
GWP42004
Type 2 diabetes
Phase 2
Phase 2
Phase 2 trial did not meet endpoint

Latest News

  1. Investors selling PAO Group, Inc. (USOTC: PAOG) stock at current levels may be missing a big part of its story. But, as they say, there’s a buyer for every seller, so the opportunity is not going entirely unnoticed. In-play are at least two recently announced deals targeting a red-hot CBD sector at the right time. 

    The first deal is with Puration, Inc. (OTC:PURA) to accelerate a collaborative effort to develop various cannabis-centric applications through a partnership that started when PAOG acquired PURA’s cannabis cultivation business in 2020. Importantly, although taken longer than expected, a dividend distribution of PAOG stock is included in the transaction, and the company said they are awaiting FINRA approval to complete the transaction…

    Investors selling PAO Group, Inc. (USOTC: PAOG) stock at current levels may be missing a big part of its story. But, as they say, there’s a buyer for every seller, so the opportunity is not going entirely unnoticed. In-play are at least two recently announced deals targeting a red-hot CBD sector at the right time. 

    The first deal is with Puration, Inc. (OTC:PURA) to accelerate a collaborative effort to develop various cannabis-centric applications through a partnership that started when PAOG acquired PURA’s cannabis cultivation business in 2020. Importantly, although taken longer than expected, a dividend distribution of PAOG stock is included in the transaction, and the company said they are awaiting FINRA approval to complete the transaction. While the transaction may be more bullish to PURA shareholders, PAO Group still delivers expertise to the deal. Thus, it’s a long-term win-win.

    The two are already advancing a significant project to develop PURA’s Farmersville Brands project. With PAOG’s contribution, Puration is building a 70-acre facility designed to provide interactive, demonstrable education on hemp’s potential to provide environmentally sustainable alternatives to over $1 trillion in existing industrial products. The planned facility is an instrumental part of a cooperative strategy to capitalize on a hemp-derived product’s market expected $15 billion market size by 2027. Over the past several years, hemp has become far more understood in its commercial applications. Moreover, it’s considered the ideal and optimum replacement candidate for products and services currently damaging the environment due to their design. 

    PAOG’s stake is to assist in the construction and operation of indoor, pharmaceutical grade, hemp growing facilities and maintain a substantial role in the cannabis extraction lab’s operations. Notably, the two will be joined by North American Cannabis Holdings, Inc. (OTC:USMJ) and Alkame Holdings, Inc. (OTC:ALKM) to enhance PURA’s Farmersville Hemp Brand strategy.

    Thus, seller’s remorse could be in the cards. Moreover, updates on several projects could fuel a rally back toward highs set in February, especially with investors embracing risk back into portfolios after a sector-wide decline last month. 

    Record Revenues And A Transformative Acquisition

    Moreover, PAOG comes with an advantage over most of its nano-cap peers. They are generating revenues. Better still, the expected $300,000 in sales from its cannabis cultivation subsidiary puts PAOG in an enviable position to increase its exposure in other areas of the booming CBD-based therapeutics and nutraceutical sector. In fact, PAOG is already capitalizing on emerging opportunities in each market segment through recent partnerships and acquisitions.

    A big boost to its product portfolio came in 2020 when PAOG acquired RespRx. That asset has earned professional praise and puts PAOG in an enviable position to develop CBD-based therapeutics targeting the treatment of patients with symptoms associated with Chronic Obstructive Pulmonary Disorder (COPD). 

    The debilitating disease is a chronic one and affects more than 60 million people and has an addressable treatment market that surpassed $10 billion in 2016. It’s now the third leading cause of death worldwide, and the market is expected to reach $14.1 billion by 2025. CBD-based treatment could be an alternative therapy that is effective and safer than current pharmaceutical alternatives. That could bode well for PAOG. 

    Investors embraced the acquisition of RespRx from Kali-Extracts as a potentially transformative deal. And a year later, PAOG is making strides to monetize RespRx through arrangements that could deliver substantial returns in the next few quarters. Remember, like other therapeutics, time to develop is needed, and the process can be daunting. However, as seen in Jazz Pharmaceuticals’ (NASDAQ:JAZZ) purchase of GW Pharma (NASDAQ:GWPH) for $7.2 billion earlier this year, the rewards from patience can be substantial. And it’s important to note that while RespRx is currently targeting COPD, it also has the potential to treat multiple indications where a better and safer standard of care is needed. 

    Video Link: https://www.youtube.com/embed/mlG8HDv06uk

    HODL Can Be Rewarding

    Notably, holding GW Pharma stock through the years was no easy task either. But after years of trials and errors, its breakthrough CBD-based epilepsy drug, Epidiolex, took the market by storm. It also changed regulators and big pharma’s views, who initially shrugged off CBD-based pharmaceuticals as a passing fad. That’s no longer the case, and JAZZ may have started a consolidation phase where even the smallest companies can be included. But, to be included, a company needs assets. And PAOG does.

    In fact, RespRx has earned patent protection for its innovative cannabis extraction process. Thus, it could become a revenue-generating asset without the need to bring a single product to market. In fact, in a recent interview, the extraction process’s inventor said that his extraction method was professionally recognized as producing better quality CBD extracts than GW Pharma. That news shouldn’t stay unnoticed for long, especially with JAZZ potentially igniting a bidding war for patent-protected extraction processes. 

    Better still, PAOG owns other assets and agreements in place that invite multiple shots on goal. In fact, beyond its COPD pharmaceutical initiatives, PAOG is advancing a nutraceutical product line that they believe can effectively compete against already marketed, higher-priced brands. 

    Deals in place are advancing the mission.

    Nutraceuticals Program Gets A Boost

    Notable for its size, PAOG is engaging with the Puerto Rico Consortium for Clinical Investigation (PRCCI) to develop its proprietary Cannabidiol (CBD) extract into a nutraceutical product. The agreement adds value and, more importantly, positions PAOG to benefit from additional PRCCI expertise that can help accelerate potential nutraceutical marketing approvals. If they are successful in doing so, PAOG, despite its small size, could very well be positioned to market a CBD-based treatment to replace addictive and often harmful prescription drugs.

    And with CBD-based therapeutics becoming more mainstream, PAOG believes that through its association with PRCCI, it can earn expedited review and hopeful approval from regulatory agencies. 

    Thus, the roughly 340% gain in share price since the start of the year may be just the start of a more sustained move higher. Its deals with other companies could help to appreciate its value. 

    Therefore, the stock’s recent weakness could present an opportunity, especially to investors willing to invest with a long-term investment horizon. Remember, despite the significant advances and popularity, CBD-based medicine is a new science. However, interest by “big pharma” and the approval by the FDA for Epidiolex does send a message that CBD-based therapeutics work, they are safe, and they can be approved for marketing when effective. Many analysts in the space suggest that the FDA will soon embrace the totality of benefits offered by this natural compound. 

    And that puts PAOG in the right space at the right time. Moreover, like GWPH, they have a similar potential to succeed. Giving time, and having patience, could be very well rewarded.

     

    Disclaimers: Hawk Point Media is responsible for the production and distribution of this content. Hawk Point Media is not operated by a licensed broker, a dealer, or a registered investment adviser. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The information made available by Hawk Point Media is not intended to be, nor does it constitute, investment advice or recommendations. The contributors may buy and sell securities before and after any particular article, report and publication. In no event shall Hawk Point Media be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or made available by Hawk Point Media, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Hawk Point Media was compensated three-thousand-five-hundred-dollars by wire transfer to produce research, video, email, newsletters, and editorial commentary for PAO Holdings Group, Inc.. by a third party. Past performance is a poor indicator of future performance. The information in this video, article, and in its related newsletters, is not intended to be, nor does it constitute, investment advice or recommendations. Hawk Point Media strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.

    The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.

    Media Contact
    Company Name: Hawk Point Media
    Contact Person: Allie Ellis
    Email:
    City: Miami Beach
    State: Florida
    Country: United States
    Website: https://www.greenlightstocks.com

     

    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: Here\’s Why PAO Group Inc. Stock Looks Tremendously Undervalued; Dividend And CBD-Based Nutraceuticals Partnerships Are Two Reasons

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  2. Don’t let PAO Group, Inc.’s (OTC:PAOG) stock price fool you. PAOG should be worth far more than its sub-penny share price. In fact, PAOG may be doing more than many of its mid-cap competitors in the race to find an effective non-pharmaceutical treatment for COPD. And with its RespRx acquisition combined with other programs, PAOG is indeed on pace to accelerate CBD-based studies that could bring needed therapeutic relief to millions of COPD patients. 

    Moreover, PAOG is a revenue-generating company after securing an 18-month deal expected to deliver $300,000 in new revenues from its cannabis cultivation subsidiary. The first receivable may be highlighted when the company provides a Q4 update. Other deals should also help drive shareholder value…

    Don’t let PAO Group, Inc.’s (OTC:PAOG) stock price fool you. PAOG should be worth far more than its sub-penny share price. In fact, PAOG may be doing more than many of its mid-cap competitors in the race to find an effective non-pharmaceutical treatment for COPD. And with its RespRx acquisition combined with other programs, PAOG is indeed on pace to accelerate CBD-based studies that could bring needed therapeutic relief to millions of COPD patients. 

    Moreover, PAOG is a revenue-generating company after securing an 18-month deal expected to deliver $300,000 in new revenues from its cannabis cultivation subsidiary. The first receivable may be highlighted when the company provides a Q4 update. Other deals should also help drive shareholder value higher. 

    In February, PAOG announced an expansion of its CBD nutraceutical operations. That initiative, highlighted in a multimedia presentation, details PAOG’s CBD nutraceutical development expansion plans and explained how strategic engagements with Puration, Inc. (OTC:PURA), North American Cannabis Holdings, Inc. (OTC:USMJ), and Alkame Holdings, Inc. (OTC:ALKM) can accelerate growth in multiple directions.

    In fact, the breadth of news is keeping investors interested in the stock, and despite recent sector-wide weakness, PAOG has been able to hold its roughly 300% share price increase since the start of the year.

    The trend higher is likely to continue when risk makes its way back into the markets. At current share prices, the opportunity may be significant. 

    Video Link: https://www.youtube.com/embed/p48PfDlIABQ

    Targeting COPD With CBD-Based Therapeutics

    The bullish trend started after PAOG announced accelerating its initiatives to develop CBD alternatives to treat patients with symptoms associated with Chronic Obstructive Pulmonary Disorder (COPD). Investor interest spiked appreciably after PAOG announced its potentially transformative acquisition of RespRx from Kali-Extracts, Inc. That asset is a good one, and more importantly, can be commercialized to target multiple indications where a better and safer standard of care is needed.

    And not only does RespRx add substantial value to its product pipeline arsenal, but it also positions PAOG to soon monetize its opportunities through commercialization, licensing, or partnerships. Each option can add substantial value. 

    Keep in mind, too, the acquisition of RespRx does more than position PAOG as a viable competitor in the medical-grade cannabis treatment sector to treat COPD. It also allows them to leverage a patented cannabis extraction method that could be useful across many diseases. Thus, near-term revenue creation could be achieved through a licensing strategy.  

    Moving into 2021, its COPD initiatives may be taking the lead, but PAOG is far from being a one-shot company. In fact, PAOG has positioned itself for multiple shots on goal by advancing a nutraceutical product line that they believe will compete effectively against already marketed, higher-priced brands. During 2020, PAOG entered into several deals designed to monetize assets in the coming quarters.

    Nutraceuticals Can Be A Significant Opportunity

    To strengthen PAOG’s development-stage program intending to deliver a pharmaceutical-grade nutraceutical COPD treatment to market, PAOG recently announced engaging with the Puerto Rico Consortium for Clinical Investigation (PRCCI) to assist with developing its proprietary Cannabidiol (CBD) extract into a nutraceutical product. The excellent news for PAOG is that the agreement not only adds credibility and sector expertise to the initiative it can help expedite approval if the two successfully develop an effective CBD-based treatment to target COPD’s debilitating effects. 

    Moreover, with PAOG’s CBD-based treatment having the potential to replace addictive and often harmful prescription drugs, the company hopes that after proving its therapeutic value can earn fast-track approval processes through regulatory agencies accepting CBD and cannabinoid compounds as viable and effective treatment options. And don’t think that “big pharma” is not paying attention to the encroachment. Earlier this year, Jazz Pharmaceuticals’ (NASDAQ:JAZZ) purchased GW Pharma (NASDAQ:GWPH) for $7.2 billion and set the stage for further industry consolidation. And who are the attractive targets? Small companies with compelling assets…and PAOG meets that standard. 

    In addition to its assets, patents, and active programs, PAOG has something that most micro-cap companies can’t claim- REVENUES. And effective management of revenues can lead to even more. 

    Maximizing Revenues For Growth

    As noted, PAO Group is doing what most of its peers are not doing…generating revenues. And if the company can maximize that income by capitalizing on new opportunities to expand its product portfolio, the $300,000 deal may pale compared to future engagements. Progress is already showing.

    PAO Group recently announced a deal with Alkame Holdings Inc. (OTC:ALKM) to develop and distribute its CBD nutraceuticals. Alkame adds strength to development-stage companies by adding expertise on the essential logistical side of the operations. In other words, PAOG is banking on successful product development and is putting its distribution infrastructure in place now. 

    That deal does more than help push revenues toward the bottom line. It also introduced PAOG to North American Cannabis Holdings, Inc. (OTC Pink: USMJ), which is expected to take on the distributor’s role. The read-between-the-lines moment is that in reasonably quick succession, PAOG aligned itself with two other sector companies that add a specific skill set. Moreover, with all three actively making deals to expand their own market presence, consolidation and additional value-generating agreements among the three is likely over the coming quarters. 

    Thus, a sum of the parts analysis indicates on almost any measure that this emerging develop-stage company is substantially undervalued. And with shares trading at sub-penny prices per share, there are justifiable reasons for investors to take an interest in the stock. 

    In particular, increasing revenues, accretive deals, and access to a patented CBD extraction technology each add an independent layer of value. Stocks trading 10X higher lack the assets at PAOG, and most have far less in development. But, being under-the-radar has its drawbacks, and PAOG is hard at work to change that view.

    Growth In 2021 Is Happening Already

    Updates from PAOG tell a story of growth and program development. They are making strategic deals with industry companies to help expedite their near-term plans, they are generating revenues, and are positioned to leverage its patented CBD extraction process to capitalize on substantial market opportunities. 

    Therefore, from any valuation model, the current share price does not fairly reflect the inherent value in the PAOG product portfolio or pipeline. Moreover, by factoring in what the company can do in the next 3-12 months, inclusive of its deal with PRCCI that can accelerate product commercialization, PAOG is fueled and ready to create shareholder value. 

    Thus, the coming quarters can produce transformative value-creation at PAOG. And for the high-risk, high-reward investor, taking a position in PAO Group at these levels may also help transform one’s investment portfolio.

     

    Disclaimers: Hawk Point Media is responsible for the production and distribution of this content. Hawk Point Media is not operated by a licensed broker, a dealer, or a registered investment adviser. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The information made available by Hawk Point Media is not intended to be, nor does it constitute, investment advice or recommendations. The contributors may buy and sell securities before and after any particular article, report and publication. In no event shall Hawk Point Media be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or made available by Hawk Point Media, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Hawk Point Media was compensated three-thousand-five-hundred-dollars by wire transfer to produce research, video, email, newsletters, and editorial commentary for PAO Holdings Group, Inc.. by a third party. Past performance is a poor indicator of future performance. The information in this video, article, and in its related newsletters, is not intended to be, nor does it constitute, investment advice or recommendations. Hawk Point Media strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.

    The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. 

    Media Contact
    Company Name: Hawk Point Media
    Contact Person: Jake Ellis
    Email:
    City: Miami Beach
    State: Florida
    Country: United States
    Website: https://www.greenlightstocks.com

     

    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: PAO Group Inc.\’s CBD-Based Nutraceutical Shows Promise In Treating COPD… And Could Create Massive Shareholder Value

    View Full Article Hide Full Article
  3. LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) ("GW", "the Company" or "the Group"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company's Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC), for patients two years of age and older.

    TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the…

    LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) ("GW", "the Company" or "the Group"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company's Type II variation application for EPIDYOLEX® (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC), for patients two years of age and older.

    TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.1

    "Epilepsy is reported in more than 90% of individuals with Tuberous Sclerosis Complex (TSC), and over 60% of those with seizures associated with TSC do not respond to standard anti-epileptic medicines.2,3 Today's positive CHMP opinion brings us one step closer to a potentially life-improving new treatment option for these patients for whom EPIDYOLEX may be appropriate," said Justin Gover, GW's Chief Executive Officer. "This decision represents another important step for GW as we look to expand the medicine's label in Europe. If approved, this represents the third licensed indication for GW's medicine, broadening patient access to this rigorously tested cannabis-based medicine."

    Professor Helen Cross, Honorary Consultant in Paediatric Neurology at Great Ormond Street Hospital for Children NHS Foundation Trust, said, "This debilitating disease affects tens of thousands of patients in Europe, many of whom may benefit from alternative treatment options to achieve adequate seizure control. This decision, and the clinical data supporting the use of EPIDYOLEX in this challenging condition, offers real hope to the patients, their parents and physicians that battle this condition and the seizures it brings every day."

    Carla Fladrowski and Micaela Rozenberg, Co-Chairs of the European Tuberous Sclerosis Complex Association, added, "The lives of individuals with TSC and their families are seriously impacted by drug-resistant epilepsy; TSC Associations together are therefore resolute in their search for successful therapies to help manage a condition that is so difficult to control. We are extremely hopeful of the potential benefits that this desperately needed new treatment option could bring to our community, including the positive impact it could have not only on quality of life but also the burden of the disease itself."

    The CHMP's positive opinion is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW's cannabidiol (oral solution). The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of cannabidiol vs placebo, with seizure reduction of 49% in patients taking cannabidiol 25 mg/kg/day compared with 24% for placebo (p=0.0009). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified.

    Dr. Volker Knappertz, GW's Chief Medical Officer, said, "We are delighted to have been able to demonstrate the potential EPIDYOLEX has in treating seizures associated with TSC through this regulatory review and in our conversations with the CHMP. We now look forward to working with the European Commission to gain approval for this label expansion to broaden access to this medicine across the thousands of European patients who need new treatment options."

    The CHMP's recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 countries of the European Union (EU) alongside Norway, Iceland and Liechtenstein. The EC is expected to make a final decision on the Type II Variation Application in approximately two months.

    GW's cannabidiol (oral solution) was originally approved by the EMA and received marketing authorisation in September 2019 under the trade name EPIDYOLEX® as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older.

    ADDITIONAL INFORMATION

    About GW Pharmaceuticals plc

    GW Pharmaceuticals (GW), and U.S. subsidiary Greenwich Biosciences, is a UK-based global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicine. Founded over two decades ago in response to significant unmet patient need, patients remain our key focus and improving their quality of life, our motivation. GW's pioneering work has led to the regulatory approval of world first, potentially life improving, cannabis-based medicines. Our continued dedication has resulted in the treatment of thousands of patients with our medicines around the world. For further information, please visit www.gwpharm.co.uk

    About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)

    EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Commission (EC) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., EPIDIOLEX® is indicated 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. 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 in patients two years and older. In September 2020, EPIDYOLEX® was approved by the Australian Therapeutic Goods Administration (TGA) for use in Australia for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. EPIDYOLEX® has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of seizures associated TSC.

    About Tuberous Sclerosis Complex (TSC)

    Tuberous Sclerosis Complex (TSC) is a rare genetic condition that has an estimated prevalence in the EU of 10 in 100,000.4 The condition causes mostly benign tumours to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs and is a leading cause of genetic epilepsy.1,5 TSC often occurs in the first year of life with patients suffering from either focal seizures or infantile spasms. It is associated with an increased risk of autism and intellectual disability.1 The severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.6

    Enquiries
    All investor and media enquiries


    GW Pharmaceuticals plc
     
    Scott Giacobello, Chief Financial Officer+1 760 795 2200


    UK, EU and ex-U.S. media enquiries
     
    FTI Consulting 
    Michael Trace / Ben Atwell+44 (0)203 727 1000


    U.S. media enquiries
     
    Kristen Cardillo, Corporate Communications+1 760 579 6628

    1 NIH Tuberous Sclerosis Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.

    2 Nabbout R, Belousova E, Benedik MP, et al. Epilepsy in tuberous sclerosis complex: Findings from the TOSCA Study. Epilepsia Open. 2019 Mar; 4(1): 73–84.

    3 Boston Children's Hospital. https://www.childrenshospital.org/conditions-and-treatments/conditions/t/tuberous-sclerosis-tsc/symptoms-and-causes. Accessed November 2020.

    4 Prevalence and incidence or rare diseases: Bibliographic data. https://www.orpha.net/orphacom/cahiers/docs/GB/Prevalence_of_rare_diseases_by_alphabetical_list.pdf

    5 TS Alliance Website. https://www.tsalliance.org/. Accessed November 2020.

    6 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157. 



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  4. PAO Group, Inc. (OTC:PAOG) shares are trading higher by roughly 63% since the start of February. The jump in value comes after a series of announcements showing PAOG positioning itself to benefit from multiple near-term initiatives. They are also set to become a revenue-generating company, with its first tranche of receivables expected to be announced in its Q4 update.

    Last Thursday, in fact, PAOG highlighted its anticipated revenue expected from that CBD nutraceutical expansion initiative. They also published an online, multimedia presentation detailing the company’s CBD nutraceutical development expansion plans, detailing its strategic engagements with Puration, Inc. (OTC:PURA), North American Cannabis Holdings, Inc. (OTC:USMJ), and Alkame…

    PAO Group, Inc. (OTC:PAOG) shares are trading higher by roughly 63% since the start of February. The jump in value comes after a series of announcements showing PAOG positioning itself to benefit from multiple near-term initiatives. They are also set to become a revenue-generating company, with its first tranche of receivables expected to be announced in its Q4 update.

    Last Thursday, in fact, PAOG highlighted its anticipated revenue expected from that CBD nutraceutical expansion initiative. They also published an online, multimedia presentation detailing the company’s CBD nutraceutical development expansion plans, detailing its strategic engagements with Puration, Inc. (OTC:PURA), North American Cannabis Holdings, Inc. (OTC:USMJ), and Alkame Holdings, Inc. (OTC:ALKM). That presentation kept shares in demand.

    PAOG shares remain actively traded, and investors appear to be positioning ahead of several expected updates. Its focus on CBD-based treatments targeting COPD is certainly attracting attention.

    Video Link: https://www.youtube.com/embed/WL_PixD5Ln4

    The Trend Is A Friend

    The increase in February is a continuation of a bias that started at the beginning of the new year. To date, shares are higher by roughly 328%. Better still, the trend is staying bullish after PAOG announced accelerating its initiatives to develop CBD alternatives to treat patients with symptoms associated with Chronic Obstructive Pulmonary Disorder (COPD). 

    The bullish sentiment took a shot of adrenaline after a multimedia presentation showed how PAOG plans to capitalize on emerging opportunities in the booming nutraceutical product sector. And even at roughly a penny, PAOG is already positioned to advance a nutraceutical product line that can potentially compete against more established, higher-priced companies. To its credit, PAOG completed several transformative deals that clear a path to monetize assets in the coming quarters. 

    More specifically, the expected benefits from an acquisition made last year are coming into focus. It involved PAOG acquiring RespRx from Kali-Extracts, Inc. The asset is a valuable one and makes PAOG an immediate contender in the medical-grade cannabis treatment sector to treat COPD. Notably, PAOG also acquired the ability to leverage a patented cannabis extraction method that shows tremendous promise to treat many diseases. COPD is the first in line. 

    The addition of RespRx adds immediate fire-power to its product pipeline. It also sets the stage for PAOG to target additional indications where a better and safer standard of care is needed. And while RespRx might be getting credit for the recent surge, it’s more likely that a combination of strategic accomplishments is responsible for driving shareholder value higher. 

    Advancing Nutraceuticals With Help From PRCCI

    In addition to PAOG’s promising development-stage program that could bring a pharmaceutical-grade nutraceutical COPD treatment to market, PAOG also announced engaging with the Puerto Rico Consortium for Clinical Investigation (PRCCI) to assist with developing its proprietary Cannabidiol (CBD) extract into a nutraceutical product. The intention of that joint effort is to again find and develop an effective CBD-based treatment to target COPD’s debilitating effects. The alliance adds tremendous credibility and sector expertise to the initiative. 

    Moreover, with PAOG’s CBD-based treatment being a potentially better treatment option that can replace addictive prescription drugs with severe side effects, the company hopes to receive expedited approval processes from a growing willingness by regulatory agencies to accept CBD and cannabinoid compounds as viable and effective treatment options. And “big pharma” is watching the action, evidenced by Jazz Pharmaceuticals’ (NASDAQ:JAZZ) purchase of GW Pharma (NASDAQ:GWPH) for $7.2 billion earlier this month. 

    Perhaps the biggest surprise is that in addition to its impressive development-stage portfolio, PAOG has something that most nano-cap stocks don’t- REVENUES. 

    Revenues Are Value…Investors Take Notice

    PAO Group is doing what most of its peers are not doing…generating revenues. It’s obviously an important consideration to any stock purchase, but for development-stage companies like PAOG, it can be a deciding factor. 

    Earlier this month, PAOG said it expects to announce revenues during Q4 2020. Those results are expected to ger reported soon. However, within its update, PAOG guided that revenues are expected to continue through 2021 by capitalizing on multiple nutraceutical-focused initiatives. They will also benefit from a sales order agreement of $300,000 made through its cannabis cultivation subsidiary acquired from Puration, Inc. in 2020. 

    Going out further, PAOG expects to receive approximately $50,000 in revenue per quarter for six quarters, with its first $50,000 in revenue expected to be reported for Q4 2020. And there’s more.

    A deal is also in place with Alkame Holdings Inc. to develop and distribute its CBD nutraceuticals. That deal not only will help drive additional revenues toward the bottom line, but it also brings in North American Cannabis Holdings, Inc. to take on the distributor’s role. Now, PAOG is in an alliance with two other sector companies with a specific skill set. And with the propensity of all three to make accretive deals, the likelihood for consolidation or additional beneficial agreements among the three is more than likely over the coming months. 

    By assembling the pieces of this emerging develop-stage company, it’s logical to assume that its valuation falls short of its intrinsic value. And while the stock is surging on a percentage basis, with shares trading at roughly two-cents a share, there are justifiable reasons for the shares to continue higher. 

    Increasing revenues, accretive deals, and access to powerful and innovative technology are only a few of the reasons to like the stock at these levels. Even at levels 3X higher, PAOG can substantiate its value. Of course, longer-term, 3X its current price should be a small drop in a large bucket. 

    PAOG Can Transform In 2021

    With the updates from PAOG exposing blue sky, investors have been right to send shares higher. For this stock, “selling on the news” makes little sense as the deals usually create immediate value. Moreover, PAOG appears to be making deals only with industry companies to help expedite its near-term plans. Thus, focusing on where PAOG is going is a better strategy than evaluating a fair price for what they have just done. 

    Indeed, PAOG is doing the things necessary for growth. First, they have multiple and active development-stage programs. Second, PAOG is making excellent strategic decisions to partner with industry players who add specific expertise to accelerate its plans. And, third, the company has positioned itself to receive revenues over the next six quarters, an accomplishment that some mid-cap biotechs can’t claim. 

    One thing is clear- the current share price does not fairly reflect the value that PAOG is creating. Moreover, a valuation of its assets, combined with what the company can do in the next 3-6 months, is ample fuel to drive prices considerably higher. The great news is that PAOG is transparent with its shareholders, and it’s likely that more information to detail growth is on the way. There are just too many moving parts to think otherwise. 

    It’s been said many times by traders- Share price rarely tells the truth. But, despite the need for smaller companies to earn its recognition rather than have it handed to them by paid CNBC commentary, its stock prices eventually catch up with fundamentals. Knowing that, PAOG may not be a stock to trade but rather a stock to hold and watch mature.

    And with several programs in action and partnerships developing, the wait for higher stock price levels may not take as long as some investors may think. PAO Group, Inc. is definitely out to impress in 2021.

     

    Disclaimers: Hawk Point Media is responsible for the production and distribution of this content. Hawk Point Media is not operated by a licensed broker, a dealer, or a registered investment adviser. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The information made available by Hawk Point Media is not intended to be, nor does it constitute, investment advice or recommendations. The contributors may buy and sell securities before and after any particular article, report and publication. In no event shall Hawk Point Media be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or made available by Hawk Point Media, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Hawk Point Media was compensated three-thousand-five-hundred-dollars by wire transfer to produce research, video, email, newsletters, and editorial commentary for PAO Holdings Group, Inc.. by a third party. Past performance is a poor indicator of future performance. The information in this video, article, and in its related newsletters, is not intended to be, nor does it constitute, investment advice or recommendations. Hawk Point Media strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.

    The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results.Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.

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    To view the original version on ABNewswire visit: PAO Group, Inc. Positions To Accelerate Growth; Investor Interest Pushes Shares 328% Higher YTD

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  5. – 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 and CARLSBAD, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- 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…

    – 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 and CARLSBAD, Calif., Feb. 16, 2021 (GLOBE NEWSWIRE) -- 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.
    • 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
        • 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
        • 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 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 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 /  







    Media:
     
    Kristen Cardillo, VP,

    Corporate Communications



    760.579.6628 /  
      
    Ben Atwell, FTI Consulting+44 (0)203 727 1000 /  



     
    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 
             



     
    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 
                     



     
    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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