GW Pharmaceutical Archives - Page 2 of 3

William SumnerAugust 7, 2018

The London-based pharmaceutical company, GW Pharmaceuticals (GWPH), today announced the release of its financial results for the quarter ending on June 30, 2018.

During the last quarter, the company earned FDA approval for its cannabis-based drug Epidiolex in the treatment of seizures associated with LGS or Dravet syndrome. The company expects the FDA to reschedule Epidiolex within the next 90 days. Additionally, the company submitted Epidiolex for approval by the European Medicines Agency and a decision on the drug is expected to occur by the first quarter of 2017. The EMA has already granted Epidiolex Orphan Drug Status, so expectations are high.

With FDA approval, the company is currently gearing up for expanded facilities to meet expected long-term demand and commercial products are already being manufactured and shipped to the United States.

The company currently holds approximately $440 million in cash and cash equivalents, up from $312 million as of September 30, 2017. Revenue for the nine months ending on June 30, 2018, was $14.2 million, compared to $7.8 million during the same period in the previous year. Losses for the period rose from roughly $112 million to $180 million.

Earlier during the day, the company held a conference call to go over the financial results, and a recording of the call will be made available on GW’s website for the next 90 days. In a statement, Justin Gover, the Chief Executive Officer for GW Pharmaceuticals, hailed the FDA’s approval of Epidiolex as a major medical breakthrough.

“We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” said Gover. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”

StaffAugust 7, 2018

It’s time for your Daily Hit of cannabis financial news for August 7, 2018.

On The Site:

Aurora Cannabis Inc.

Aurora Cannabis Inc. (ACBFF) today announced that it has entered into a letter of intent to acquire HotHouse Consulting Inc. Founded in 2004, HotHouse provides greenhouse consulting services and specializes in hybrid greenhouse growing techniques. Initially, the company focused primarily on agricultural clients, but in the ensuing years has shifted towards the cannabis industry. Under the agreement, the company has granted 1,940,000 options to buy shares of Aurora to officers of HotHouse, which will vest annually over the next three years and are exercisable at $7.39 per common share.

Navy Capital

New York-based cannabis-focused institutional fund Navy Capital Green International Ltd. invested $3 million of equity into Nevada-based Oasis Cannabis. Oasis is an integrated cannabis producer and retailer in Nevada. It is also a subsidiary of CLS Holdings USA Inc., which operates as Cannabis Life Sciences.

Navy Capital said that it has an extreme interest in the CLS patented extraction and processing technology. According to the company statement, Navy Capital or select others may invest an additional two million with a 15% overallotment for a total of up to $5,750,000 by August 15, 2018.

In Other News

GW Pharmaceuticals plc

GW Pharmaceuticals plc (GWPH) reported its fiscal Q3 results for the quarter ending June 30, 2018, with revenue rising 34.6% to $3.5 million. The net loss fell 31.7% to a loss of $35.7 million. The company will be meeting with FDA in the back half of the year to clarify regulatory pathway for Sativex (nabiximols) in MS spasticity. GW Pharma will also begin to study CBDV in autism this quarter.

“The recent FDA approval of Epidiolex represents a major medical advance for patients with Lennox-Gastaut Syndrome and Dravet syndrome. We anticipate rescheduling to be completed within 90 days of FDA approval and for the product launch to take place in the Fall,” stated Justin Gover, GW’s Chief Executive Officer. “In preparation for launch, we have now completed the hiring of our U.S. sales organization and are engaged with patient organizations, physicians and managed care organizations/payors. This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”

22nd Century Group, Inc.

22nd Century Group, Inc. (XXII), a plant biotechnology company that is focused on tobacco harm reduction, Very Low Nicotine tobacco, and hemp/cannabis research, announced its second quarter 2018 financial results. The company posted net sales revenue of more than $6.9 million and significantly increased spending – to more than $2.7 million this quarter – on the Company’s Modified Risk Tobacco Product (“MRTP”) application to the U.S. Food and Drug Administration (“FDA”) for “BRAND A” Very Low Nicotine cigarettes. As of June 30, 2018, the Company had more than $53 million in cash and short-term investments, which are sufficient reserves to meet regular operating expenses for a number of years.

The company had a net loss for the three months ended June 30, 2018, of $6,739,000, or ($0.05) per share, as compared to a net loss of $3,356,000, or ($0.04) per share, for the three months ended June 30, 2017. The increase in the net loss for the second quarter of 2018 of $3,383,000, or 100.8%, was due primarily to the net increase in the operating loss of $3,758,000.

Arena Pharmaceuticals, Inc.

Arena Pharmaceuticals, Inc. (ARNA) reported a net loss of 65 cents per share or $31.8 million for the second quarter of 2018 versus last year’s loss of 77 cents per share. It was wider than the Zacks Consensus Estimate of a loss of 62 cents. Revenues totaled $4.0 million, consisting of $3.1 million in collaboration revenue, and $0.9 million in royalty revenue. At June 30, 2018, Arena’s cash, cash equivalents, and investments balance were $592.4 million and approximately 49.3 million shares of Arena common stock were outstanding.

“We have made significant progress over the past three months across our clinical programs, including the initiation of our ADVANCE Phase 3 program for ralinepag in patients with PAH. We are excited for the opportunity to potentially advance the treatment paradigm for patients suffering from this critical illness,” said Amit D. Munshi, President and CEO of Arena. “Additionally, we are pleased to have submitted our meeting request to the FDA for etrasimod in UC, and look forward to the data readout from our Phase 2 study of olorinab for pain associated with Crohn’s disease in September.”

NUGL Inc.

NUGL Inc. (NUGL) announces its North American Marketing Strategy. NUGL’s platform delivers exclusive profiles and features for brands and listings in the cannabis space leading search app offers every type of cannabis company and professional service the ability to create individual profiles for marketing, connecting and expanding client bases in and out of the NUGL community. NUGL’s platform also gives brands and listings cutting-edge software that helps their business expand their client base and network.

Debra BorchardtJune 25, 2018

It’s time for your Daily Hit of financial cannabis news for June 25, 2018.

On The Site

GW Pharmaceuticals

If any other company released any news today, then it went basically unnoticed because the FDA approved GW Pharmaceutical’s (GWPH) cannabidiol drug Epidiolex. The news was expected sometime this week, so it was nice of the FDA to just get it out of the way on Monday. According to the press release, this is the first FDA-approved drug that contains a purified drug substance derived from marijuana and it is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.

Even though the FDA has now approved the use of Epidiolex as a real treatment for these diseases, it doesn’t immediately change the status of cannabis as a controlled substance. The FDA did not say in its release whether it had delivered a recommendation to the DEA regarding Epidiolex and its schedule status.

However, in GW Pharmaceutical’s statement, the company said it would have to be rescheduled before it could be made available to patients. “Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded AEDs and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.

Marapharm Ventures

Marapharm Ventures Inc. (MRPHF) announced that it has entered into a Letter of Intent dated June 21, 2018 to purchase all the shares of Full Spectrum Medicinal Inc. Marapharm will have until September 30, 2018, to conduct due diligence on Full Spectrum, with a view to negotiating the terms of a definitive agreement in order to complete the transaction. The company did not provide a valuation for the proposed transaction.

In Other News

Harvest One Cannabis Inc.

Harvest One Cannabis Inc. (TSXV: HVT) has signed a binding Share Sale Agreement with Australian-based MMJ PhytoTech Limited for the purchase of 100% of Israeli-based PhytoTech Therapeutics Ltd. The transaction will be a combination of cash and shares. Upon completion, $1 million in cash and $7 million in Harvest One common shares issued at the then 10-day volume weighted average closing price, will be paid to MMJ.

Cronos Group Inc.

Cronos Group Inc. (CRON) announced that it entered into a strategic distribution partnership with privately owned pharmaceutical wholesaler Delfarma Sp. Zo.o. Founded in 2004, Delfarma was the first company in Poland to introduce international parallel import of medicinal products from European Economic Area countries. Delfarma distributes directly to over 5,000 pharmacies and more than 200 hospitals, a distribution network that reaches approximately 40% of the Polish domestic market.

Hiku Brands

Hiku Brands (HIKU.CN) announced that it has been granted permission for ten stores by the Province of Manitoba. Four of the stores will be located in Winnipeg and one in Brandon, all of which will be opened under our award-winning cannabis retail brand Tokyo Smoke, winner of Cannabis Brand of the Year at the 2017 Canadian Cannabis Awards.

Hiku is actively working with various regulators, provincial and municipal governments in the Province of Manitoba to obtain the necessary permits for our proposed Tokyo Smoke stores and will ensure location specific permission prior to announcing our chosen locations. This announcement is in addition to Hiku’s announcement on June 22, 2018 on the update for Alberta retail storefronts which detailed how Hiku has filed applications for more than a dozen storefronts in Calgary and are at the top of the list to be considered in each of those locations following Calgary’s first come, first serve approach to licensing. As previously announced, Hiku has also entered into a letter of intent with Oceanic Releaf Inc., a late-stage applicant under the ACMPR in Newfoundland & Labrador, pursuant to which Oceanic and Hiku are working with the government on the approval for Oceanic of up to 5 additional stores in that province.

Debra BorchardtJune 25, 2018

The U.S. Food and Drug Administration (FDA) approved GW Pharmaceuticals’ (GWPH) cannabidiol (CBD) drug Epidiolex as an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. According to the press release, this is the first FDA-approved drug that contains a purified drug substance derived from marijuana and it is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.

“Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older,” said FDA Commission Scott Gottlieb, M.D.

He went on to add, “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”

Gottlieb cautioned though that he remains concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. The FDA has taken action against companies making unsupported CBD claims in the past couple of years and the agency said it would continue to do so.

GW Says Rescheduling Within 90 Days

Even though the FDA has now approved the use of Epidiolex as a real treatment for these diseases, it doesn’t immediately change the status of cannabis as a controlled substance. The two defining factors of the schedule one designation include not having a medicinal purpose and being a highly addictive drug.

The FDA release stated, “Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD. The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.”

The FDA did not say in its release whether it had delivered a recommendation to the DEA regarding Epidiolex and its schedule status.

“While we applaud the FDA for confirming what many of us have long known–that the benefits of cannabis are immense–we do find it a bit comical that the federal government now contradicts itself once again,” said Chris Driessen, President of Organa Brands U.S. “While the FDA touts the benefits of this new drug, the DEA maintains a Schedule One classification for cannabis, stating that it has no medical application and a high potential for abuse. We have to ask–does the left hand know what the right hand is doing?

Management Comments

“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s Chief Executive Officer. “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” said Orrin Devinsky, M.D., of NYU Langone Health’s Comprehensive Epilepsy Center and a lead investigator in the EPIDIOLEX clinical program. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”

“For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a true medical advancement,” said Philip Gattone, president and CEO of the Epilepsy Foundation. “Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures.”

Epidiolex

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. It uses CBD, which is a chemical component of the Cannabis sativa plant. CBD does not give patients a psychotropic effect like getting “high” that comes from the other part of the cannabis plant – tetrahydrocannabinol (THC).

William SumnerMay 17, 2018

The biopharmaceutical company GW Pharmaceuticals (GWPH), along with its U.S. subsidiary Greenwich Biosciences, announced the publication of its Phase 3 study of cannabidiol oral solution in patients with Lennox-Gastaut syndrome (LGS) in The New England Journal of Medicine.

Announcing positive results, GW CEO Justin Gover hailed the study’s publication as another landmark moment for the company and touted its results as further proof of the cannabidiol’s potential in the treatment of LGS.

“We are now in the latter stages of the FDA`s review of our New Drug Application and look forward to a decision from FDA in late June,” stated Gover. “If approved, we expect to make this important potential new medicine available to U.S. patients with LGS in the second half of the year.”

In a double-blind, placebo-controlled trial conducted at 30 clinical centers, researchers randomly selected 225 patients diagnosed with LGS, with an age range of 2 to 55 years, who had two or more drop seizures per week. The patients were divided into three groups. One group comprised of 76 patients would receive a 20mg dose of Epidiolex, the company’s proprietary cannabidiol-based medicine, twice a day for two weeks. The second group, which was comprised of 73 patients, would receive a 10mg of Epidiolex twice a day for two weeks,. The third group, which had 76 patients, was given a placebo.

During the 28-day baseline observation period, the combined average of drop seizures for all groups combined was 85. After treatment, the group treated with 20mg of Epidiolex experienced a 41.9% reduction in seizures, while the group that received a 10mg does experience a 37.2% reduction. The placebo group only saw a 17.2% reduction in drop seizures. Sides effects from taking Epidiolex included drowsiness, reduced appetite, and diarrhea; all of which were more pronounced in the group taking the higher dose. A total of six patients from the 20mg group and one patient from the 10mg had to withdraw from the study due to the side effect. Additionally, 14 patients who received Epidiolex had elevated liver aminotransferase concentrations.

Stock Performance

News of the study’s positive results has created a surge in GW’s stock price at the open only to trim those gains as the morning went on. The stock is currently trading at an all-time high of $150.68 per share. It is nearing the average analyst price target of $155.50 according to Yahoo Finance.

Video StaffApril 20, 2018

Happy 4/20 everyone. It’s the day the cannabis industry likes to celebrate as their special holiday. It’s become a huge business deal for the industry.

A recent study done by LeafLink predicts that this 4/20 will be the first ever to have retail sales top $1B, even reaching as high as $1.2B, based on their wholesale marketplace figures. According to Flowhub, in 2017, total sales of cannabis by consumers on 4/20 represented a 44 percent increase from an average Thursday and 30 percent more than an average Friday.

The big news this week had to do with biotech company GW Pharmaceuticals. The company received very positive comments from the FDA. That left many market watchers with the feeling that the FDA will ultimately approve GW’s drug epidiolex for pharmaceutical sales in the U.S. While some believe this means that marijuana would immediately be removed from the controlled substances list. Think again. That still has to be done by Congress. However, it’s hard to argue that marijuana has no medicinal purposes, which is part of the schedule 1 designation if you can get a legal prescription for it.

Green Bits, headquartered in San Jose, announced it has raised a $17 million Series A funding round, led by Tiger Global, the New York-based investment firm, along with participation by Snoop Dogg’s Casa Verde Capital.

Medicine Man Technologies (MDCL) announced today the preliminary financial results for the quarter The company reported approximately $1.2 million in revenue for the quarter, a 122% increase over the same quarter last year and representing the fifth consecutive quarter of revenue growth.

Ontario-based Aphria Inc. (APHQF) reported that its revenues for the third quarter ending February 28 were C$10.2 million versus last year’ C$5.1 million for the same time period, an increase of 100%. Revenue increased 20% sequentially from C$8.5 million.

MassRoots filed its annual report on Tuesday but didn’t get around to the company’s financials in the filing until page 24. Gross revenue for the year fell 54% to $319,242, while the net losses ballooned 146% to $44 million. In all of this mess, CEO Isaac Dietrich awarded himself a bonus of $190,659 on top of his salary of $96,971. While Mr. Dietrich’s monthly salary was decreased from 2016, his total compensation jumped from $107,917 in 2016 to $287,630 in 2017.

Lots of acquisitions to report…..

MPX Bioceutical Corporation (MPXEF) signed a letter of intent to acquire all the issued and outstanding shares of private company Canveda Inc., a Licensed Producer under Health Canada’s Access to Cannabis.

CannaRoyalty is buying FloraCal Farms (“FloraCal”), a licensed ultra-premium craft cannabis producer located in Sonoma County, California for US$1 million and 3,million + CannaRoyalty shares

Livewell Foods Canada announced that it entered into a C$10 million private placement deal.

Civilized Worldwide Inc. announced that it executed a strategic investment and collaboration agreement with Canopy Rivers Corporation where they will invest C$5 million in Civilized via a convertible debenture and the companies will work together on various online, media and event mandates relating to the cannabis industry.

Debra BorchardtApril 19, 2018

GW Pharmaceuticals Inc. (GWPH) continues to get closer and closer to FDA approval of its drug Epidiolex for the rare forms of epilepsy Lennox-Gastaut and Dravet Syndrome. Epidiolex is GW’s lead cannabinoid product candidate and is a pharmaceutical formulation of purified cannabidiol or CBD.

Following a live hearing on Thursday, the company announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended supporting the approval of the New Drug Application (NDA) for the investigational cannabidiol oral solution (CBD) for treatment in patients two years old and up.

“We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA.”

Today’s recommendation doesn’t mean that the FDA will definitely approve it, but it is a positive sign. The FDA Advisory Committees is an independent expert panel. Their votes are not binding but are considered by the FDA when deciding whether to approve a new medicine. The next event for GW Pharma is June 27 which is the goal date for PDUFA (Prescription Drug User Fee Act) completion of the NDA review of the cannabidiol oral solution and if approved, the medicine is expected to be available by prescription in the second half of 2018.

“GW Pharmaceuticals’ efforts and success with Epidiolex proves several important facts on several fronts. I believe the most important is this… to refer to a product as ‘medicine,’ the time-tested process of clearing a new therapeutic treatment through the FDA is sacrosanct and essential to making that claim. Congratulations to GW Pharmaceuticals for finishing that race,” said Dean Petkanas, CEO of Kannalife Sciences.

GW has also submitted a Marketing Authorization Application to the European Medicines Agency with an expected decision date in early 2019.

Stock Performance

GW Pharmaceuticals stock was lately trading at $134. The stock popped earlier this week upon positive comments about Epidiolex.

Debra BorchardtFebruary 5, 2018

epidiolex-cannabidiol-or-cbd-bottle-and-packaging-1280x853.jpg

GW Pharmaceuticals (GWPH) saw its stock slip in after-hours trading after the UK-based biotech company reported its first-quarter earnings and positive news out of Europe. First, revenue for the first quarter rose 203% to $7.7 million beating estimates by $5.4 million and topping last year’s revenue for the same period.

However, losses increased to $63.3 million or 47 million pounds, higher than last years 15.6 million pounds. The earnings per share for the quarter were -$2.44 a miss of 31 cents.

“With the Epidiolex regulatory applications accepted for review in both the US and Europe and an assigned mid-year FDA decision date, 2018 is expected to be an exciting year for our Company with an anticipated first U.S. approval and launch. The commercial teams are making great progress toward launching Epidiolex with full conviction,” stated Justin Gover, GW’s Chief Executive Officer. “We also continue to see a significant flow of clinical data from the Epidiolex program through both medical meetings such as the American Epilepsy Society and in publication including our recent Lennox-Gastaut syndrome results in The Lancet. Beyond Epidiolex, we expect to progress a number of important pipeline programs during 2018 that have the potential to offer additional value.”

The company also announced that the European Medicines Agency (EMA) has decided to accept for review a marketing application seeking approval for Epidiolex (cannabidiol) for the treatment of seizures associated with the rare forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome. GW Pharma said that a final decision by the European Commission should be announced no later than the first quarter of next year. The U.S. NDA for the treatment of seizures associated with LGS and Dravet was accepted for priority review with the planned PDUFA goal date of June 27, 2018.

Earlier today, Cator Fitzgerald reiterated its buy rating on GW PHarmaceutical and a price target of $192. The stock has slipped from its 52-week high of $143 but has still had a huge move from its 52-week low of $92.

Debra BorchardtDecember 5, 2017

GW Pharmaceuticals (GWPH) fell almost 4% in after-hours trading after the British biotech company said it would sell $225 million of American Depositary Shares (ADSs) on the NASDAQ exchange in an underwritten U.S. public offering.

GW expects to grant the underwriters a 30-day option to purchase up to an additional $33.75 million of ADSs at the offering price. The price for the offering has not been set. Goldman Sachs & Co. LLC, Morgan Stanley, BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering.

The company just reported its earnings on Monday in which it said that 2018 would be pivotal year. During the company’s earnings conference call, chief financial officer Scott Giacobello said, “We expect spending to continue at a similar rate for the first six months of fiscal year 2018 and therefore anticipate total cash outflows for the first half of the year in the range of 75 million to 95 million pound sterling or $100 million to $120 million based on today’s prevailing currency exchange rates. This includes capital expenditure of $10 million to $20 million related to manufacturing expansion. Thereafter, if Epidiolex is approved, we expect cash outflows to increase in preparation for product launch and we’ll update guidance at that time.”

Chief executive officer Justin Glover gave comments on the coming year by saying, “With our NDA now submitted to the FDA, the commercial and medical affairs teams are actively preparing for the potential U.S. approval and launch in 2018. Looking out through 2018, our key priorities include continued visibility at major U.S. medical congresses, and AES being one of the best examples of this initiative. Our company has a major presence at the AES meeting including the scientific exhibit this morning where we are showcasing 22 posters on CBD, a considerable body of clinical and scientific work.”

The stock closed at approximately $119 on Tuesday before the news was announced. The stock has been recovering from a 52-week low of $92 that it hit during the summer. The 52- week high was $136.

Debra BorchardtDecember 4, 2017

London-based biotech company GW Pharmaceuticals (GWPH) reported its fourth quarter and fiscal year-end results with revenues dipping and losses rising as the company gets closer to launching its Epidiolex drug in the U.S.

GW Pharmaceuticals delivered revenue of $11 million or 8.2 million in sterling pounds for the year ending September 30. This was lower than last year’s $13.9 million or 10.3 million in pounds. The loss for the year was reported at $175 million or 131 million pounds, much higher than last year’s $85 million or 63 million in pounds. The loss per share was 58 cents or 0.43 in pounds, also higher than last year’s loss of 32 cents or 0.24 in pounds. The exchange is based on today’s approximate rate equivalent. The company’s success hinges on its ability to commercialize Sativex and Epidiolex if approved by the FDA.

“With the Epidiolex NDA for Dravet syndrome and Lennox-Gastaut syndrome submitted, we have entered a very exciting period for GW and look forward to working with the FDA to support its review process. With a decision on the NDA anticipated in mid-2018, we believe we are making excellent progress with preparations to ensure a highly successful US launch if Epidiolex is approved,” stated Justin Gover, GW’s Chief Executive Officer. “We also expect to submit a European regulatory application for Epidiolex for these indications in late 2017 and are now building a European commercial presence to prepare for a potential future launch. During 2017, a substantial body of positive clinical data on Epidiolex was published and presented, including a landmark publication in The New England Journal of Medicine, as well as a wide range of important data presentations and posters at the American Academy of Neurology and American Epilepsy Society annual meetings.”

GW Pharmaceuticals Risks

The company is dependent upon receiving FDA approval for its drugs in the U.S. and then the adoption by physicians and patients and reimbursement by insurance companies. The company said in its filing, “Even if completed Phase 3 clinical trials and/or ongoing or future Phase 3 clinical trials conducted for regulatory approval show positive results, there can be no assurance that the FDA, EMA or any other regulatory authority will approve Epidiolex or any other product candidate for any indication for several potential reasons.”

GW Pharmaceuticals also mentioned that competition is heating up in the space and noted that Insys Therapeutics and Zogenix had both announced plans to develop similar drugs.

Company Addresses Spending Levels

2018 will be a make it or break it year for the company. The company admitted it has consumed a lot of cash since inception and noted that 2018 will be a pivotal year. In the company’s filing it stated, “We expect spending to continue at current levels and anticipate total cash outflows for the first half of the year ended September 30, 2018, in the range of $100 million to $120 million (£75 million to £90 million), which includes capital expenditure of $10 million to $20 million related to manufacturing expansion. Thereafter, following NDA approval, we expect cash outflows to increase in preparation for product launch.”

GW Pharmaceutical Pipeline

The company has a deep pipeline including cannabidivarin, or CBDV, which is in Phase 2 development in the field of epilepsy and is also being researched within the field of autism spectrum disorders, or ASD. I
Received Orphan Drug Designation and Fast Track Designation from the FDA for intravenous CBD for the treatment of Neonatal Hypoxic-Ischemic Encepholapthy, or NHIE, for which a Phase 1 safety study has now been completed.
Sativex for MS spasticity – approved in numerous countries.
CBD and THC combination for Glioblastoma – Phase 2 trial complete with an open IND for clinical program
GWP42003 for schizophrenia had a positive Phase 2 proff0of-concept and next steps are under consideration.

Stock Price

The stock is up over 3% on the earnings report and was lately trading at $128, down from the company’s 52-week high of $136. The stock has recovered from its summer slide where it dipped into the mid $90’s.

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GW Pharmaceutical Archives - Page 2 of 3 - Green Market Report

GW Pharmaceuticals Releases Financial Results for the Third Quarter