GW Pharmaceuticals Archives - Green Market Report

Debra BorchardtDebra BorchardtFebruary 16, 2021
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5min3190

GW Pharmaceuticals plc (Nasdaq: GWPH) announced that the total revenue for the fourth quarter ending December 31, 2020, was $148.2 million versus $109.1 million for the quarter ended December 31, 2019. This beat the analyst estimates according to Yahoo Finance by $3.66 million. The net loss for the quarter ended December 31, 2020, was $29.1 million versus a net loss of $24.9 million for the quarter ended December 31, 2019. The fourth quarter GAAP EPS for GW Pharmaceuticals was -$0.08 which missed analyst estimates by two cents.

The total revenue for the full-year 2020 was $527.2 million, a 69% increase compared to $311.3 million for the prior-year period. The company said in a statement that cash and cash equivalents on December 31, 2020, were $486.8 million.

“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.”

The company noted that total net product sales of Epidiolex were $144.1 million for the fourth quarter and $510.5 million for the year ended December 31, 2020.

GW Pharmaceuticals also outlined the company’s pipeline as follows:

    • 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 that the companies had entered into an 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 a 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.


StaffStaffFebruary 4, 2021
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9min5900

Editors Note: This story is reprinted with permission from Streetwise Reports.

Biopharmaceutical firm GW Pharmaceuticals Plc (GWPH:NASDAQ), which utilizes its proprietary cannabinoid product platform to develop and commercialize new medicines across a broad range of disease areas, and global biopharmaceutical company Jazz Pharmaceuticals Plc (JAZZ:NASDAQ)announced that the companies have entered into a definitive agreement for Jazz Pharmaceuticals to acquire GW Pharmaceuticals.

The companies stated that “the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.”

The report advised that the agreement terms provide that Jazz will acquire GW for $220.00 per American Depositary Share (ADS) for $200.00 in cash and $20.00 in Jazz ordinary shares, which equates to a total purchase price of $7.2 billion. Both companies respective Boards of Directors have already unanimously approved the transaction, which is expected to close in Q2/21. The companies advised that the offer price represents about a 50% premium over GW’s $146.25 closing stock price on February 2, 2021. The firms indicated that the transaction remains subject to approval by GW shareholders, other customary closing conditions and various regulatory approvals including sanction by the High Court of Justice of England and Wales.

GW is a large manufacturer and marketer of new regulatory approved therapeutics created from using its proprietary cannabinoid product platform to address a wide range of diseases. GW’s lead product, Epidiolex® (cannabidiol) holds the distinction of being “the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA).”

In addition to Epidiolex, the company’s product pipeline includes nabiximols. The company is presently active in Phase 3 studies for these potential drugs and is investigating and seeking FDA approval for use in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The firm also is developing earlier-stage cannabinoid product candidates for autism and schizophrenia treatment applications.

GW Pharmaceuticals CEO Justin Gover commented, “Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs…We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

Jazz Pharmaceuticals’ Chairman and CEO Bruce Cozadd remarked, “Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities…Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients.”

For Jazz Pharmaceuticals, the benefits of acquiring GW is that this will serve to add a third high-growth commercial franchise: that enhances product diversification in its key areas of addressing sleep disorders, oncology and epilepsies. Specifically, the GW acquisition will build upon Jazz’s growing neuroscience business by adding Epidiolex which offers near-term blockbuster potential. The company noted that within two years after commercial launch, Epidiolex now brings in around $510 million in annual sales.

Jazz Pharmaceuticals is a global biopharmaceutical company headquartered in Dublin, Ireland. The firm’s portfolio of medicines and product candidates are concentrated in the areas of neuroscience such as sleep and movement disorders and oncology including hematologic malignancies and solid tumors. JAZZ serves patients in greater than 90 countries and has market cap of approximately $9 billion.

GW Pharmaceuticals is a biopharmaceutical company that uses its proprietary cannabinoid product platform to develop novel medicines to address unmet medical needs in a broad range of disease areas. The firm’s Epidiolex oral solution has been approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of tuberous sclerosis complex (TSC).

GW Pharmaceuticals began the day with a market capitalization of around $4.6 billion with approximately 31.18 million shares outstanding and a short interest of about 8.3%. GWPH shares opened 47% higher today at $215.00 (+$68.75, +47.01%) over yesterday’s $146.25 closing price and reached a new 52-week high this morning of $217.50. The stock has traded today between $212.15 and $217.50 per share and is currently trading at $212.88 (+$66.63, +45.56%).

Disclosure:
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Debra BorchardtDebra BorchardtFebruary 3, 2021
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5min5330

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is buying GW Pharmaceuticals plc (Nasdaq: GWPH) in a deal valued at $7.2 billion or $6.7 billion net of GW cash. Jazz will 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. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

The stock is jumping over 46% in early trading to lately sell at $213.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline, and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman, and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

Jazz is a global biopharmaceutical company dedicated to developing and commercializing life-changing medicines that transform the lives of patients with serious diseases — often with limited or no options. The company’s focus is in neuroscience, including sleep and movement disorders, and in oncology, including hematologic malignancies and solid tumors.

GW Pharm is well known to the cannabis community. It is a global leader in discovering, developing, manufacturing, and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome, and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”


Debra BorchardtDebra BorchardtJanuary 11, 2021
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5min5960

Ahead of the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, GW Pharmaceuticals plc (Nasdaq: GWPH)released preliminary, unaudited net product sales for the fourth quarter and full-year 2020 and key priorities for 2021.

GW Pharma said it expects total net product sales to be approximately $148 million for the fourth quarter and approximately $526 million for the year ended December 31, 2020. The company said that total net product sales of Epidiolex are expected to be approximately $144 million for the fourth quarter, comprising $129 million in the US and $15 million ex-US. The company reported that Epidiolex’s net product sales were $137 million in the third quarter of 2020.

In a company statement published on Monday morning, GW Pharma said that total net product sales of Epidiolex for the year ending December 31, 2020, are expected to be approximately $510 million compared to $296 million in 2019. Cash and cash equivalents at December 31, 2020, were approximately $486 million.

“Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients’ experience with this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved Tuberous Sclerosis Complex indication, leads us to expect continued strong growth in 2021 in both the US and Europe,” said Justin Gover, GW’s Chief Executive Officer. “Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year. In addition to our previously announced pipeline activities, we are leveraging our world leadership in cannabinoid science to design and synthesize novel cannabinoid molecules and expect our first novel product candidate to enter the clinic in 2021.”

The stock was rising slightly in premarket trading on the news. Four analysts cover GW Pharma and have an average price target of $182. The stock was lately selling at $128, which is below its one year high of $144.

The company also outlined the following priorities for the coming year:

EPIDIOLEX commercialization:

  • Continue to drive revenue growth in US and Europe:
    • Execute on TSC label expansion and continued penetration in Dravet and LGS
    • Build further on expanded payer coverage achievements
    • Accelerate adoption across a broader prescriber base
    • Increase penetration in long-term care segment
    • Continue launches in Germany and UK and achieve successful pricing and reimbursement, and launch execution in France, Spain and Italy, as well as other European countries
    • Obtain approval of the Tuberous Sclerosis Complex indication in Europe
  • Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex “composition” patent
  • Commence pivotal trial in fourth target orphan epilepsy indication

Nabiximols in the US:

  • Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
  • Achieve data from at least one pivotal MS spasticity trial in 2021
  • NDA submission expected following first positive pivotal MS spasticity trial
  • Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury

Additional pipeline:

  • Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
  • Conduct placebo-controlled trials with both CBDV and CBD in autism
  • Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
  • Complete Phase 1 trial for novel botanical drug candidate GW541
  • Advance first novel NCE cannabinoid candidate into Phase 1

Debra BorchardtDebra BorchardtNovember 3, 2020
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4min9090

GW Pharmaceuticals plc (Nasdaq: GWPH) stock was rising over 6% in early trading as the company delivered solid third-quarter results.  The company reported total revenue of $137.1 million for the quarter ending September 30, 2020, a big jump over the $91.0 million for the same time period in 2019. This beat the Yahoo Finance average analyst estimates of $127 million for revenue.

The market was cheered by the drop in net losses to $12.2 million versus last year’s net loss of $13.8 million for the 2019 third quarter. The net loss per share was ($0.03), which also beat the analyst estimate for a loss of ($0.83).  GW Pharmaceuticals said it had cash and cash equivalents of $480.3 million.

“We are pleased to report strong revenue growth in the 3rd quarter despite the challenges presented by COVID-19. Epidiolex meets a serious unmet need within the field of epilepsy and we expect the product to demonstrate continued strong growth in the months and years ahead. The recently expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers,” stated Justin Gover, GW’s Chief Executive Officer. “We have also now commenced the pivotal Phase 3 program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission, including as early as next year. Beyond nabiximols, we are advancing several clinical-stage pipeline candidates, including the recent start of a Phase 2 trial in schizophrenia.”

The cannabidiol epilepsy drug Epidiolex is having great results. Total third-quarter net product sales of Epidiolex were $132.6 million and U.S. Epidiolex third-quarter net product sales were $121.6 million. TSC indication launched with high prescriber awareness and near-universal payer coverage.

Additional study updates provided by the company were as follows:

  • Nabiximols development program:
    • First Phase 3 MS Spasticity trial underway
      • Phase 3 placebo-controlled spasm frequency study (N=450)
  • MS Spasticity trials due to commence
    • Phase 3 placebo-controlled muscle tone studies:
      • N=52; Expected start Q4 2020 (subject to COVID)
      • N=190; Expected start: Q1 2021
      • N=36 (nabiximols responders); Expected start: Q1 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
    • N=~100 (observational clinical discovery study); Expected start: Q1 2021
    • 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 – recruitment now resumed
    • 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

StaffStaffJuly 1, 2020
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8min33130

Editors Note: This is a guest post.

More and more countries decide to legalize cannabis and give entrepreneurs a chance to make money and keep the economy. 

In 2019, the marihuana stocks were supposed to prove their worth on Wall Street by generating steady profits. However, things didn’t go according to the plan. Many investors missed opportunities due to high tax rates and supply issues in the United States and Canada. These obstacles helped the black market to thrive and left marijuana stock investors just heart-broken – no one could predict the government’s roadblocks. 

Despite all these setbacks, some pot stocks still have good market value. Do you want to learn how entrepreneurs legally make money on selling cannabis these days? Just keep reading:

Canopy Growth And Its Bright Start

Canopy Growth Corporation (NYSE: CGC) (also known as Tweed Marijuana) was founded by two friends – Chuck Rifici and Bruce Linton, in 2013. 

In 2019, the company became the largest cannabis company in the world thanks to its value of shares and market capitalization. The company has even survived all challenges in 2019 without losing a single employee. During the crisis, there were 3200 employees in Canopy Growth. 

These days, Canopy Growth is legally selling their products to 16 other countries (Spain, Germany, Australia, Canada, Jamaica, Czech Republic, Chile, etc.). At the end of 2019, the company set up a partnership with a UK-based think-tank called Beckley Foundations, which will allow them to start selling medical cannabis all around the UK as well.

David Klei, the new CEO of Canopy Growth Corporation, says that it is only the beginning of their company. In 2019, they also announced the release of edible cannabis products such as chocolates and beverages. The company might show even more surprises at the end of 2020. Mr. Klei has a point – it is only the beginning.

Curaleaf Holdings and its Cannabis King named Boris 

Curaleaf Holdings (CURLF) is a Canadian company that produces and distributes cannabis-based products around the world. There is one special thing about the company. As the owners of the company state on their website and in numerous interviews, research and advocacy help them to become leaders in the competitive industry.

In 2020, Curaleaf operated more than 57 dispensaries around the US and Canada. No wonder, Boris Jordan, the chairman of Curaleaf, is called a Cannabis King in the American mass media. 

GW Pharmaceuticals 

GW Pharmaceuticals (NASDAQ:GWPH) is a pharmaceutical company based in the UK. It helps to treat patients with multiple sclerosis with the help of natural cannabis. 

In 2018, their cannabis-based products such as Sativex and Epidiolex were approved by the US Food and Drug Administration. We can find their products in London, Prague, and Las Vegas dispensaries

In 2020, the net worth of the company is $3.21 billion. At the moment, the company has its branches in Germany, France, Spain, Italy, and the US. 

Cronos Group

Cronos Group (CRON) is an innovative global cannabinoid company with an office in New York. In 2019, the company received a $2.4 billion equity investment from Altria Group ( the largest producer of tobacco).

Investors consider Cronos Group one of the most cash-rich pot stock in the industry. The company was founded in 2016 and was run by only 2o employees at the beginning. Right now, there are almost 1000 employees in Cronos Group. Mike Gorenstein, CEO of the company, says that they have even more ambitious plans for the future. 

Tilray 

Tilray (TLRY) is another cannabis company that has a great place in the stock market. Tilray is a Canadian pharmaceutical company that has operations in the unites States, New Zeland, Portugal, Australia, Germany, and Latin America. 

All you need to know about Tilray is that it is one of the first medical cannabis producers in North America. 

Once marijuana was legalized in the United States, Tilray was the first cannabis company legally exporting their products to Americans. The company debuted on the Nasqad Stock Market with $17 per share.

In 2018, the price increased to $214 per share. However, the crisis in August 2019 brought Tilray’s founder Brendan Kennedy back to Earth – the price crashed to $29 per share. Despite such a failure, the company is still afloat, with the capital of $1.18 billion. 

The Bottom Line 

The cannabis industry is growing rapidly around the world. We might expect even more companies on the market in the near future. However, at this point, entrepreneurs need more support from the government. 

Politicians might not be interested in helping the pot business. On the other hand, they should be the ones wanting to fight the illegal drug trade. Supporting local cannabis companies will not only help to generate the requisite public revenues and provide jobs but will also help to protect users from poor quality cannabis-based products. 

 


Debra BorchardtDebra BorchardtJune 30, 2020
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5min15670

GW Pharmaceuticals plc (NASDAQ:GWPH) has pushed the legalization of cannabis ahead with its work on the drug Epidiolex. Now the company is making its plans for its other cannabis drug Sativex known and it’s impressive and hopeful.

The company is announcing its plans for its pipeline product nabiximols to the U.S. market. This strategy includes multiple opportunities for the submission of an initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the earliest of which could occur in 2021.

“We are excited to present the details of our clinical program and regulatory strategy for nabiximols, which we believe support the potential for a substantial near-term commercial opportunity in the U.S. Following constructive meetings with the FDA, we are now commencing a Phase 3 clinical program that provides multiple opportunities for an NDA submission, including as early as 2021”, stated Justin Gover, GW’s Chief Executive Officer. “Beyond the initial target indication of MS spasticity, our Phase 3 clinical program is designed to achieve a broad spasticity label over time. This development strategy, together with the long-term exclusivity potential of nabiximols, provides GW with confidence that this product should represent a significant value driver for GW.”

What Is Nabiximols?

According to GW Pharma, Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as a mouth spray. The commercial name outside the U.S. is Sativex and it is commercially available for the treatment of MS spasticity in numerous countries.

The biotech company outlined the following plans for Sativex:

MS Spasticity Clinical program

  • Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
  • Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which we believe could enable a NDA submission
    • Phase 3 muscle tone studies – placebo-controlled cross-over design
      • N=52; Expected start: Q4 2020
      • N=190; Expected start: Q1 2021
      • N=36 (nabiximols responders); Expected start: Q1 2021
    • Phase 3 spasm frequency studies – placebo-controlled parallel group
      • N=450; Expected start: Q4 2020
      • N=~200 (nabiximols responders); Expected start: Q2 2021

Spinal Cord Injury (SCI) spasticity clinical program

  • Three SCI trials are expected to be initiated in 2020 and 2021
    • N=~100 (observational clinical discovery study); Expected start: Q4 2020
    • N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
    • N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021

            This second spasticity indication may lead to broad anti-spasticity labeling and usage.

Post Traumatic Stress Disorder (PTSD) clinical program

  • We are also exploring the potential of nabiximols to reduce sleep disturbance symptoms, as well as anxiety and irritability, in patients with PTSD
  • A Phase 2/3 study in PTSD will have approximately 325 subjects and is anticipated to be initiated in H1 2021

Stock Performance

GW Pharmaceuticals stock has moved higher over the past six months. The stock hit a low of $72 in March and was recently trading at $121. It looks to be moving higher based on the news for Sativex.


StaffStaffJune 24, 2020
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5min13730

GW Pharmaceuticals plc (Nasdaq: GWPH) said that the UK Home Office has reclassified Epidiolex, the company’s cannabidiol medicine as a Schedule 5 drug. The company said that the change will take effect immediately in all four of the constituent nations of the UK – with Northern Ireland enacting separate legislation – and sees the medicine move from Schedule 2 to Schedule 5 under the Misuse of Drugs Regulations 2001.

“The decision to move Epidiolex to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” said Chris Tovey, GW Pharmaceutical‘s Chief Operating Officer. “The extensive pre-clinical and clinical data that GW developed to support the medicine’s approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA, ACMD, and Home Office for scrutinizing this data and making this change in such a short timeframe. We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling.”

GW Pharmaceuticals said that the ACMD and its Technical Committee recommended the schedule change to Kit Malthouse MP, Minister of State for Crime and Policing late in January 2020. The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from 2 years of age and older.

In its recommendation to the Minister, the ACMD cited the “low risk of abuse potential, low risk of dependency and low risk of diversion” as reasons for the reclassification from a schedule 2 controlled drug to a schedule 5 controlled drug. The ACMD also cautioned that GW’s medicine is “distinct from other commercially available CBD containing supplements that have not sought marketing authorization as a medicine” and that the schedule change, therefore, applies exclusively to Epidiolex

This now means that GW Pharmaceutical’s medicine is now exempt from virtually all controlled drug requirements. At a practical level, patients will have more flexibility in the quantity of medicine they can purchase and be able to order repeat prescriptions. Prior to this, the patients faced restrictions every time they ordered a prescription. The benefits also extend to the pharmacists and pharmacies that will have reduced controls around the storage and reporting requirements.

Analyst Response

JP Morgan Cory Kasimov wrote, “Given the Epidyolex’s favorable efficacy/safety profile, the significant unmet need in these diseases, and positive physician feedback, we believe adoption could be both rapid and substantial,” He believes that near-term label expansion opportunities (Tuberous Sclerosis) and the potential for off-label use in the broader population of general epilepsy patients could contribute significantly to the top line. “A respectable pipeline of additional assets across an array of therapeutic indications and a proprietary research/manufacturing platform should enable the company to sustain further growth” the analyst added. He currently has a $187 price target on GWPH

According to CNN Business, 16 analysts offering 12-month price forecasts for GW Pharmaceuticals PLC have a median target of $188.50, with a high estimate of $260.00 and a low estimate of $150.00. The median estimate represents a +49.97% increase from the last price of 125.69. All 16 analysts have a Buy rating on the stock.


StaffStaffMay 11, 2020
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GW Pharmaceuticals plc (Nasdaq: GWPH) delivered total revenue of $120.6 million for the first quarter ending March 31, 2020, versus last year’s $39.2 million for the same time period. The net loss for the quarter was $8 million versus last year’s net loss of $50.1 million for the same time period.

“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 Pharma said that the start of new clinical programs would be delayed until the second half of 2020 due to current COVID restrictions. Still, the company outlined the following items in the pipeline:

  • Nabiximols (Sativex outside of the US)
    • Multiple Sclerosis spasticity
      • US pivotal clinical program expected to commence in H2 2020 to augment existing data package
      • 3 positive Phase 3 trials completed in Europe
    • Spinal cord injury spasticity – clinical program expected to commence in H2 2020
    • PTSD – clinical program expected to commence in H2 2020
  • Schizophrenia (GWP42003)
    • Phase 2b trial expected to commence H2 2020
  • CBDV in autism
    • 30-patient open label study in autism
    • Investigator-led 100 patient placebo-controlled trial in autism
    • Open label study in Rett syndrome and seizures
  • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commenced
    • Phase 1b safety study in patients continues to recruit due to emergency care environment
    • Orphan Drug and Fast Track Designations granted from FDA and EMA

Debra BorchardtDebra BorchardtMarch 13, 2020
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GW Pharmaceuticals plc (Nasdaq: GWPH)  has submitted a Type II Variation Application to the European Medicines Agency (EMA) seeking approval of EPIDYOLEX, (cannabidiol) oral solution, for the treatment of seizures associated with Tuberous Sclerosis Complex. TSC is a rare genetic condition and a leading cause of genetic epilepsy. The stock was moving higher by 7% in early trading to sell at $82, not much higher than the stock’s 52-week low of $72.

“We look forward to working with the EMA to demonstrate GW’s cannabidiol oral solution’s potential in this new indication and hope to make this rigorously tested cannabis-based medicine available to a new group of patients through a potential approval in due course. If approved, this will be the third licensed indication for GW’s cannabidiol oral solution in Europe,” said Chris Tovey, GW’s Chief Operating Officer.

TSC Disease

TSC is a condition that causes mostly benign tumors 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. 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. The severity of the condition can vary widely. In some children, the disease is very mild, while others may experience life-threatening complications.

The Type II Variation Application is based on data from a positive Phase 3 safety and efficacy study. The study met its primary endpoint with patients treated with GW’s cannabidiol oral solution 25 mg/kg/day experiencing a significantly greater reduction from baseline in TSC-associated seizures compared to placebo (49% vs 27%; p=0.0009). Results for the 50 mg/kg/day dose group were similar, with seizure reductions of 48% from baseline vs 26.5% for placebo (p=0.0018). 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.


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