Adam JacksonFebruary 17, 2023
The proposal would allow Lucy to manufacture substances for Canada's harm reduction program.
Health Canada Archives - Green Market Report
Adam JacksonFebruary 17, 2023Adam JacksonNovember 2, 2022
Tilray Brands Inc. (Nasdaq: TLRY) (TSX: TLRY) has inked a partnership with U.S.-based CBD giant Charlotte’s Web Holdings, Inc. (TSX: CWEB) (OTCQX: CWBHF) to sell hemp extract products in Canada.
Under the agreement, Charlotte’s Web’s full-spectrum CBD products will be reach dispensary shelves through Tilray’s distribution network. The company said that its products had previously only been available to those that qualified for a special access medical exemption through Health Canada for specific need-states.
“Partnering with Charlotte’s Web, the market leading CBD brand, opens new opportunities for Tilray Brands in Canada as we evolve our distribution channels from the dispensary model to natural wellness retail channels and eventually mass retail opportunities,” Tilray Canada president Blair MacNeil said.
Charlotte’s Web will sell the same core hemp extract products it has in the U.S., with Tilray handling licensing, manufacturing, quality, marketing, and distribution.
“This underscores our strategic expansion into international markets with leading domestic partners by leveraging well-established infrastructure, co-production, and route-to-market capabilities,” Charlotte’s Web CEO Jacques Tortoroli said in a news release.
The company expects Charlotte’s Web CBD products to be widely available in Canadian dispensaries by early next year.
Hemp-derived CBD falls under the same regulatory framework in Canada as cannabis, so Canadians for now can only purchase CBD products legally through a licensed cannabis retailer or through prescription by a doctor.
However, with Health Canada signaling a move toward simplifying CBD’s legal status, the company said that establishing Charlotte’s Web’s supply chain and distribution in the country also prepares for the possible introduction of natural health products regulations and potential ability to sell CBD products through traditional retailers.
Cory Pala, director of investment relations at Charlotte’s Web told Green Market Report in August that the company — which is based in the U.S. — is “particularly excited” about Health Canada’s inquiry to make CBD more accessible.
Charlotte’s Web cannot export its products to Canada under current law, “which is sort of ironic” considering it is federally legal in both countries, he said, so it has mapped out a plan to partner with cultivators in the country instead.
“In the U.S., we have 2,500 different competitors that have similar products,” Pala said. “But in Canada, we have maybe half a dozen, if that. And so it’s really, really compelling to us as a market opportunity. This is big for multiple reasons.”
Charlotte’s Web has been focused on expanding its presence in the U.S. and abroad. Last month, the company also became the “official CBD of Major League Baseball” after the two organizations struck a lucrative sponsorship deal.
Adam JacksonOctober 27, 2022
The news comes a few months after the Vancouver-based biomedical company was issued a cease trade order.
Adam JacksonSeptember 21, 2022
Havn said it is actively seeking new funding, but it might not be successful.
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The Canadian company shared several strategic plans to ensure the decline is "temporary."
Adam JacksonAugust 11, 2022
Aleafia Health Inc. (OTCQX: ALEAF) delivered positive results on Thursday as it continues to cut costs and find more profit in the Canadian legal market and overseas.
The Canadian cannabis company reported its financial results for the three months ending June 30, 2021. Aleafia Health releases its financial report card on a 15-month fiscal year with five quarters versus a standard 12-month year with four quarters.
Revenue from the fiscal year’s first quarter rose 41% from last year’s $11.7 million to this year’s $16.5 million. Much of the gains derived from the company’s Ontario brand Divvy climbing the market ladder in both pre-roll and flower products.
“Our pivot to a branded cannabis strategy is the success story driving the three pillars of company revenue: adult-use branded cannabis, a ‘sticky’ recurring medical cannabis revenue stream, and growing higher margin international sales,” said CEO Tricia Symmes. “As a result of revenue increases, the company has achieved the 2nd highest growth rate amongst top 12 Canadian LPs in retail sell-through over the prior quarter while achieving a #12 ranking for market share in our core markets for Q2 CY2022.”
Aleafia Health also reported that its net losses increased from last year’s $5.2 million to this year’s $4.5 million.
Non-GAAP income before interest, taxes, depreciation, amortization, and share-based compensation (Adjusted EBITDA) was a loss of $900,000 in the second quarter of 2022, versus a loss of $3.1 million in the same period last year. The company reaffirmed guidance of achieving run-rate breakeven Adjusted EBITDA in the 2023 fiscal year.
“Due to our successful branded growth strategy, the company continues to target a top 10 standing in our key markets and reaffirms our expectation to reach breakeven Adjusted EBITDA profitability during the second half of FY2023,” said CFO Matt Sale. “Showing continued success in retail sell-through provides us the confidence to reaffirm our guidance to deliver at least $53 million in total net revenue in fiscal year 2023, with a current run-rate of $48 million.”
Revenue Dissection
Aleafia Health saw $12 million in net revenue in the quarter and maintained its forecasted range of $53 million–$63 million.
The company continued its upward sales growth trend, with overall branded cannabis net revenue increasing 31% to a record $10.0 million, versus $7.6 million in the same quarter the previous year.
Adult-use cannabis net revenue rose 107% to $6.7 million versus $3.2 million in the same period last year.
Medical cannabis net revenue increased 4% to $2.8 million, an uptick from the previous quarter’s figure of $2.5 million — representing an $11 million run-rate net revenue base. The company said it attained a milestone 7.5% market share in the overall Canadian medical market, according to Health Canada data.
The company also said it secured new international partnerships representing approximately $4.6 million in sales commitments.
“International revenue is a competitive advantage and a differentiating factor for Aleafia, as we leverage our high quality, diversified flower supply and export it to the higher margin international sales markets,” Symmes said. “Current international agreements have led to more than $0.5 million in sales to Germany and Australia this quarter. We have also secured a new European partner with a $4.6 million sales commitment, representing further channel development. International success leverages both the company’s products and its brands.”
Sale agreed, adding “The newly signed agreement improves revenue and cash flow visibility, locks in attractive margins, and improves our overall cash conversion cycle and net working capital performance.”
Adam JacksonAugust 5, 2022Health Canada recently published a long-awaited report that experts say provides a regulatory pathway to expand the country’s cannabidiol (CBD) market.
CBD — Delta-9 THC’s chemical cousin — is a hemp-derived ingredient that can be converted into products with a variety of types and formats such as oils, gummies, capsules or topicals. It cannot produce a THC high and is typically marketed to relieve pain and anxiety, as well as insomnia.
The recommendation stems from a 2019 request by Health Canada to solicit feedback about the potential market for non-prescription health products containing cannabis.
Canadians can currently purchase CBD products through a licensed cannabis retailer or through prescription by a doctor, though the report written by the Science Advisory Committee on Health Products Containing Cannabis, an independent body, lays the foundation for purchasing them over the counter at common local retailers.
The absence of a regulated CBD regime in Canada has created confusion for consumers — fueling an illicit market that supplies unauthorized CBD products Canadians have difficulty finding at licensed dispensaries due to regulatory restrictions hemp faces under the Cannabis Act.
Retailers also have strict limits as to how they can market these products. CBD and other hemp derivatives are subject to the same restrictions as THC-oriented products, “which makes it almost impossible to build brand identity,” said Omar Khan, Senior VP of Corporate & Public Affairs at High Tide Inc.
“It is a bit of an onerous process for somebody who is not a frequent cannabis consumer,” he said. “Opening it up and allowing these products to be sold in broader retail settings I think — and we think — will help translate what is an existing demand.”
A lack of research has stifled the committee’s ability to draw conclusions on guidelines. The report said committee members agreed that “implementing a less complex regulatory framework and providing easier access to quality products to conduct studies would support the research community.”
Studying CBD in Canada currently has strict clinical trial standards and requires research and development licenses under the country’s Cannabis Act.
Sean Karl, a Vancouver-based supply-chain consultant who specializes in cannabis logistics, said that recognition for better ways to study CBD is “really encouraging.”
“We’re excited about potentially kickstarting a significant clinical trial that we had to put on ice because the sponsoring institution’s legal department won’t touch it,” he said.
CBD Is Safe
While the advisory panel concluded that CBD is “safe and tolerable for short-term use (a maximum of 30 days) at doses from 20 milligrams per day to a maximum dose of 200 mg/day,” the report recommended that separate avenues be taken to measure CBD products depending on their form and application.
“I think that the dosing guidelines reflect a fairly cautious deployment of the precautionary principle,” said George Smitherman, president of the Cannabis Council of Canada.
As stakeholders and advocates begin to provide input on the path moving forward, industry interests reflect a range of national and regional groups with varied priorities often based on the products they produce and their positions in the supply chain.
Cory Pala, Director of Investment Relations at CBD-maker Charlotte’s Web (OTC: CWBHF) said that the company — which is based in the U.S. — is “particularly excited” about the recommendation.
Charlotte’s Web cannot export its products to Canada under current law “which is sort of ironic” considering it is federally legal in both countries, he said, so it has partnered with cultivators in the country instead. The new recommendation presents a juncture for the company.
“In the US, we have 2,500 different competitors that have similar products,” Pala said. “But in Canada, we have maybe half a dozen, if that. And so it’s really, really compelling to us as a market opportunity. This is big for multiple reasons.”
Smitherman wonders how local dispensaries in Canada will feel about competing with general retailers.
“I think that there is going to be an articulation of a voice from within the currently regulated landscape that says, hey, this was an important part of my business,” he said. “Maybe it’s not the biggest part of my business, but my business is tough, so what are you going to do to actually make sure that — as this regulatory model evolves — the Canadian dispensary experience can evolve alongside it so that dispensary owners aren’t faced with loss of business in the CBD vertical.”
Such discussions will take place during stakeholder sessions in the coming months.
Despite the hefty task ahead, those with a stake in the process are excited — even if cautiously optimistic — about the future. Health Canada still has to decide on the regulations and figure out whether or not it actually wants to move in that direction before seeking approval from the Canadian government.
“Patience is the call of the day on this one,” Khan said.
Adam JacksonAugust 4, 2022
Braxia Scientific Corp. (CSE: BRAX) (OTC: BRAXF), acquired KetaMD, Inc. in a bid to expand ketamine-based psychedelic treatment for depression and other mental health challenges. The overall value of the deal is $6.2 million in a combination of common shares and convertible notes. KetaMD was founded by psychedelic pioneers Zappy Zapolin and Warren Gumpel, along with mindfulness instructor and brand experience expert Kaia Roman and the company’s President and Chief Operating Officer, Leann Taylor.
Braxia said it plans to utilize KetaMD’s end-to-end telemedicine platform to provide access to at-home ketamine treatments for people suffering from depression and related mental health conditions. Treatments are medically supervised, guided virtually by registered nurses with mental health expertise, and are backed by psychiatrists and researchers in depression.
This comes as the use of ketamine as a fast-acting antidepressant in treatment-resistant patients has piqued the interest of experts both in psychiatry and in the wider area of neuroscience.
The deal allows Braxia to offer both patient-centric in-person and digital telehealth ketamine treatments. Braxia said it plans to build upon the KetaMD platform through new clinical trials in the U.S. and Braxia’s growing patient dataset to “support potential future development of digital therapeutics in the management of depression and other related mental health conditions.”
“Today marks a notable step forward in bringing awareness, accessibility, and scalability of the benefits of ketamine and psychedelics generally for those suffering from depression and other mood disorders,” said CEO Roger McIntyre. “We’ve seen improved outcomes firsthand from ketamine treatment in our clinics and in our clinical trials. Adding digital telehealth capabilities through KetaMD’s highly anticipated online and mobile platform strengthens our position to lead the medical use of evidence-based psychedelics, while accelerating our ability to get treatment to those in need, safely and quickly across the U.S. and Canada, and globally in the future.”
KetaMD is currently available in Florida but said it plans to roll the platform out to other key states this year.
The deal comes as a growing shortage of mental health specialists in the U.S. leaves many people with unmet mental health needs.
Braxia said the acquisition of KetaMD addresses this access gap, enabling the company to reach more people in need by uniting in-person clinics with telemedicine for innovative, effective, and legal treatments.
“Following the acquisition of KetaMD, Braxia is a well-positioned vertically-integrated psychedelic medicine company,” said Zappy Zapolin, Co-Founder of KetaMD. “Combined, Braxia and KetaMD now have operations ranging from clinics to bioscience R&D to an at-home telemedicine platform, overseen by Dr. McIntyre, one of the foremost authorities in mood disorders and treatments.”
Year-end Earnings
Last week, Braxia released its year-end financial report card alongside its fourth quarter results ending March 31, 2022.
The company posted revenue of $1.49 million for the fiscal 2022 year ending March 31, 2022, a 47.5% gain versus $1.008 million in the previous year. In the fourth quarter of fiscal 2022, the company recorded revenue of $369,654, a 49.9% gain versus $246,673 in the same quarter the previous year.
The increase in revenue primarily reflects an increase in the number of treatments from the administering of ketamine at the Braxia Health clinics in Ontario, the release said.
The company saw net losses of $12.1 million for the year and an 86% decrease versus $88.8 million in a net loss in the previous year. The net loss includes a non-cash, share-based compensation of $2,422,562 (2021 – $2,874,857) and goodwill impairment of $5,275,374 (2021- $nil) related to the acquisition of the Canadian Rapid Treatment Center of Excellence CRTCE.
In the previous year, Braxia had completed a reverse-take over, the acquisition of CRTCE, and completed a brokered private placement which led to an overall increase in expenditures as the business evolved. The company’s management team said it has focused on cutting costs and reducing certain operating expenditures to focus on its core business.
Braxia’s cash and cash equivalents in the fourth quarter totaled $8.6 million, an 11.2% gain versus $7.64 million in the third quarter.
In addition to ketamine, Braxia said it has focused on researching and providing patients access to psilocybin for depression. Braxia Health, a wholly-owned subsidiary, commenced the first Health Canada approved multi-dose psilocybin-assisted therapy clinical trial last July and dosed its first participant that following November.
In connection with this clinical trial, the company reported positive preliminary results from its ongoing multi-dose psilocybin trial. The company reported meaningful improvements in depression severity observed — as measured by the Montgomery-Åsberg depression rating scale. Braxia said that the trial will be completed by December this year “at which point the full analysis will be completed and submitted for publication.”
Braxia Health also recently received approval from Health Canada for the Special Access Program (SAP) to provide psilocybin-assisted psychotherapy for a patient with Major Depressive Disorder in Ontario, according to the release. The SAP was amended on January 5 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials. Braxia Health said it has since received SAP approvals for additional patients.
The company said it has also successfully recruited and trained medical and research staff as part of Braxia Institute to provide psilocybin-assisted therapy with high-quality safety monitoring. The program included 20 therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy. All therapists were trained by the Braxia Institute and served as study therapists for the active psilocybin clinical trial, the release said.
StaffJune 28, 2021
Editors Note: This is a guest post.
October 17, 2018, was the day when Canada approved recreational cannabis as per the Canada Act. But it saw a loss in the market value initially and was waiting eagerly for Cannabis 2.0.
And guess what? The day arrived exactly one year later when Canada saw a second wave of cannabis legalization. This was the time when the country approved the sales of edibles, cannabis extracts, and topicals. And the market started cashing on this move.
So what happened in the last two years, and what does the future of cannabis in Canada look like? Let’s find out!
Cannabis Sales Doubled in 2020
Quite evidently, Cannabis 2.0 propelled the industry towards growth. But that was not the only reason that led to the rise in popularity. The increased number of brick and mortar and click and collect offerings brought upon by expanding online cannabis space helped boost sales.
But Cannabis 2.0 isn’t the only reason. Its increased acceptance and incredible therapeutic potential is making people buy weed online canada and propelling the industry to grow exponentially. Besides that, prompt adoption of new and latest methods amidst the pandemic made it an even more accessible and popular product across the country.
In fact, the market is witnessing impressive growth in adult-use cannabis, with a growth of around 118% in 2020 compared to 60% in the year 2019. The diverse supply chain and the demanding customers are helping the growth of this industry every passing day.
Enter 2021- What Changed?
The year started with so much promise for the cannabis industry. However, the sales dipped right at the beginning of the year. But as per the March sales figures, it set a record of 298.1 million Canadian dollars, rebounding from the decline that happened during the start of 2021.
In fact, Canadian retail sales saw an increase of 13.8% in March compared to the last month. That’s looking bright, isn’t it?
What next?
Health Canada started an initiative to know what consumers feel about cannabis. By this, they meant what they think about selling, labeling, and researching cannabis. This feedback is prompting a mild relaxation of rules for packaging as well as possession of infused drinks.
This consultation will impact the federal framework that will begin around the same time when the country will celebrate its third anniversary of cannabis legalization. Many cannabis experts think that Health Canada might change the equivalency rates for cannabis possession.
Other than that, there might be a change in the cannabis product labels. Currently, labels must display contents related to THC and CBD. But if the consumers want, Health Canada might ask to provide more information regarding the ingredients present in the product.
The whole idea is to develop transparency in the cannabis market and help consumers find their suitable products easily and comfortably.
Wrapping up
No one is expecting any sweeping changes this year. But the cannabis leaders want to clarify a few essential questions that are causing a stir in this industry related to advertising and celebrity endorsements.
So, will it happen any time soon? Time will tell! For now, you can enjoy the vast array of cannabis products comfortably at your home, thanks to the incredible delivery services available now.
Debra BorchardtAugust 16, 2019
The Ontario Securities Commission approved a request by CannTrust Holdings Inc. (NYSE: CTST) for a management cease trade order (“MCTO”) under National Policy 12-203 – Management Cease Trade Orders. Such a request means that the Chief Executive Officer, Chief Financial Officer and members of the board of directors or other persons who had or may have access to material information that has not been publicly disclosed can not trade shares of the company. CannTrust said that it does not affect the ability of investors who are not insiders to trade.
In addition to that, CannTrust said it will probably miss its filing deadline of August 14, 2019, to file an interim financial report for the three and six month periods ending June 30, 2019. CannTrust is now in a holding pattern waiting on decisions from Health Canada as a result of the company’s facilities not complying with the regulations as stated by law. “Health Canada has advised the Company that it is unable to provide any guidance about the timing or content of its decisions concerning the Company.”
Health Canada could order total destruction of the seized inventory, but so far hasn’t indicated if it will do so. CannTrust also said that has not had any discussions with Health Canada with regards fixing the situation it finds itself in.
NYSE
CannTrust is currently listed on the New York Stock Exchange and said it has kept the exchange up to date on its interactions with Health Canada. The company said in its statement that “The NYSE advised the Company that as a consequence of the Company’s announcements concerning its audited financial statements for the year ended December 31, 2018 and its unaudited financial statements for the quarter ended March 31, 2019, the Company is viewed as no longer having a complete annual report on Form 40-F on file for the year ended December 31, 2018.”
For now, CannTrust shares will continue to trade on both the Toronto Securities Exchange and the NYSE. “However, the NYSE advised the Company that (a) it will closely monitor the status of the Company’s late filing and any related public disclosures for up to six months from its due date, and (b) if the Company fails to file its annual report and any subsequent reports within six months of their filing due dates, the NYSE will determine, in its sole discretion, whether to halt trading in the Company’s securities or whether to allow the Company’s securities to trade for up to an additional six months, depending upon the circumstances.” The NYSE also noted that it could begin delisting the company shares at any time if the circumstances warranted it.
Financial Impact
At the beginning of the scandal, CannTrust repeatedly stated that it expected to take some sort of financial hit, but couldn’t determine what that would be. At this time, CannTrust says the estimated value of the inventory affected by the Health Canada decisions is roughly $51 million. This accounts for 53% of the total company inventory and about 30% of the total biological assets. CannTrust still has approximately $250 million in cash and cash equivalents.
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