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Why The FDA Is Wrong About CBD

Just a few months ago, the CBD and hemp industry was given added legitimacy when President Trump signed off on the Hemp Farming Act, as part of the 2018 Farm Bill. With the signing of this bill, low-THC cannabis products have been removed completely from direct review or regulation under the Controlled Substances Act. While …

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CBD FDA

Just a few months ago, the CBD and hemp industry was given added legitimacy when President Trump signed off on the Hemp Farming Act, as part of the 2018 Farm Bill. With the signing of this bill, low-THC cannabis products have been removed completely from direct review or regulation under the Controlled Substances Act. While previous legislation had already carved out exceptions for low-THC products that were under 0.3% THC-content, this new law served to clarify that hemp was legal to grow and transport across state lines. In addition, the law is also providing hemp farmers with rights and federal agricultural grants previously denied to them. They now also have access to the national banking system as well as the right to marketing, agronomy research and crop insurances, all important advantages to grow and expand the hemp industry into a legitimate agricultural commodity.

In short, the hemp industry has been formally legalized on a federal level, but problems and roadblocks still exist. Additionally, much remains murky about how products are tested, how to prove THC content below 0.3% level, what claims can be made by hemp foods and nutritional supplements, and what oversight is still held by which federal agencies. For the hemp industry to truly flourish, these products must be allowed to succeed in the market, not be restricted by inaccurate and outdated federal bureaucracy and red-tape.

ENTER THE FDA

Even though the bipartisan support for hemp resulting in the signing of the Farm Bill was a big win in the eyes of the hemp industry, the Federal Drug Agency (FDA) rained on the parade when they came out with an official FDA statement regarding cannabis shortly after. The gist of it is that:

  1. Under section 351 of the Public Health Service Act, they stated that they still hold the authority to regulate and control cannabis derived products and compounds because, as defined under this section, they consider cannabis to be a medicine. As such, cannabis and cannabis derived compounds will be subject to the same requirements as do any other FDA-regulated products (i.e. medicines), regardless of if it is being marketed or sold as a food or dietary supplement.
  2. The FDA “…continue(s) to be concerned at the number of drug claims being made…” about cannabis and cannabis derived products, and that any products making therapeutic claims need to be approved by them before they may be sold. Any cannabis and cannabis derived products that make any therapeutic claims are considered by the FDA as being a new drug, requiring registration and approval. This means that they have to go through the FDA drug approval process and clinical trials.
  3. Most critically for the hemp industry, the FDA finds it “…unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” The FDA also considers CBD products that claim to be supplements as being in violation of the FD&C Act because they were marketed as dietary supplements or involved the addition of CBD.

Basically, to boil it all down to this: the statement by the FDA makes it clear that they see CBD as a drug, or if not exactly a drug, something that they still have authority over. While the FDA has always had authority over drug-related health claims, this statement appeared to indicate that the FDA believes their authority extends even further, allowing them to pre-emptively ban CBD products or even arbitrarily reclassify them as medications.

Nice for them, but many would argue that the FDA is somewhat overreaching and that, in the greater scheme of things, they are not only wrong about CBD, but also wrong about what they are really capable of and permitted to do about CBD. While removing the DEA from having oversight under drug laws certainly freed the hemp industry from one source of regulatory risk, the FDA still remains a dangerous threat to the hemp industry if they are allowed the power to restrict the booming hemp and CBD market. The FDA’s public proclamations that they have the authority to arbitrate whether cannabidiol can be marketed as a dietary supplement or added to food for health benefits, are cause for concern. This is particularly concerning when the FDA has already been ruled against by the Supreme Court numerous times for overstepping their authority when it comes to these products, and their protection under the Dietary Supplement Health and Education Act of 1994.

THE “LOOPHOLE”

CBDPure Lab Test

Prior to 1994, a patchwork of different laws and rules governed how vitamins and supplements could be sold, and how they were treated differently than prescription medications In the late 1980’s and early 1990’s the fear was real when the Nutrition Advertising Coordination Act of 1991 was suggested. In this bill the FDA would have gained a considerable amount of power in regulating nutritional supplements – including making it illegal to advertise nutritional or therapeutic claims as well as increasing the FDA’s enforcement powers and penalties. Included in these powers would have been making common vitamin and mineral supplement go through the same approval process and federal registration as pharmaceutical drugs, with the associated cost increases being passed on to the consumer.

In response, health-food industry banded together to lobby government and Congress to vote down the laws and to “preserve the consumer’s freedom to choose dietary supplements.”

The result was the Dietary Supplement Health and Education Act of 1994 (DSHEA), a landmark piece of legislation which defined what dietary supplements are, their labelling requirements, and most importantly, that supplement manufacturers do not need to receive FDA approval before producing and selling dietary supplements that were marketed in the United States before 1994. If you have ever bought vitamins or supplements at your local grocery or health food store, and didn’t have to show a prescription or speak publicly to a doctor before you were allowed to purchase them, then you have DSHEA to thank for that freedom.

Simply put, DSHEA not only protects the rights of consumers to make their own decisions about dietary supplements like Vitamin C, melatonin or a daily multivitamin, but to a large extent, it also protects the ability of responsible CBD brands to bring their products to market. Despite the FDA’s public statements to the contrary, there is no question that hemp-based products were promoted as supplements and food products long before 1994 (media references are made to hemp farming by our founding fathers in their writings leading up to the Declaration of Independence!). There are numerous examples of hemp being used in supplements and food products prior to 1994, and for that reason alone, the FDA’s position is suspect when it comes to any outright prohibition of CBD products as dietary supplements.

SEMANTICS

On the one hand the FDA is categorizing cannabis as well as cannabis derived products such as CBD oils, lotions and gummies as drugs. That in their eyes makes CBD products subject to all the research, testing and clinical trialing that all drugs are subjected to. On the other hand, CBD manufacturers, companies and brands are labelling, distributing and marketing CBD products as a dietary supplement, and freely marketing products that contain less than 0.3% THC nationwide.

And in doing so, they are well within their rights.

According to the DSHEA, a dietary supplement may only describe the role of a nutrient or ingredient if “it affects the normal structure of function of the human body; it characterizes the means by which it acts to maintain such structure or function; the manufacturer has proof that the claim is truthful; and that the statement includes a disclaimer”. You have likely seen this disclaimer on every bottle of vitamins or supplements you have ever used, and it lays out the language that, unlike a drug or medication, the product is not intended to diagnose, treat, or cure any disease. Any dietary supplement that does not use that disclaimer, or make claims how their product can “cure cancer” or any other impermissible claim not backed by science, is and should be regulated by the FDA. These are called structure/function claims, and dietary supplements lose the protections of DSHEA when they make impermissible health claims. There is no dispute that the FDA should and does have the authority to regulate medicinal claims. In this role, the FDA can fulfill its duty to protect consumers from bad actors, while still not extending its authority over legitimate products beyond what Congress intended.

In the end it seems that the issue is partly one of semantics – is CBD a drug or a dietary supplement in the eyes of the FDA, and what actions if any will they take? If a CBD product is going to rely on the protections and freedom associated with classification as a dietary supplement, then the product cannot also make health claims reserved for drugs. Likewise, if a CBD supplement complies with all labeling requirements and the state laws in which it is sold, the FDA should maintain a “hands-off’ approach and not overreach their constitutional authority in the face of product compliance with the existing laws.

FINAL THOUGHTS

No one disputes the FDA’s passion for wanting to protect the American public’s health and safety. In many instances the hemp and CBD industry shares the same concerns of the FDA. All legitimate CBD sellers agree that there are some bad actors out there that need to be stopped, and that drug claims or promises of “cures” for serious disease have no place in the CBD supplement industry. Nor have the cannabis and hemp industries ever disputed the need for regulation in order to ensure the health and safety of the public where dangerous or mislabeled products enter the commercial market. However, the concerning issue comes in with the FDA trying to overreach, not only in their control over the industry and its products, but also in its right and ability to enforce that control. For now, the FDA seems to have adopted a wait and see approach when it comes to actual enforcement, and to their credit, have reached out to Congress for clarification on hemp and its future. While the recent sudden resignation of the FDA Commissioner will likely delay resolution of the outstanding questions, the hope remains that the FDA will retract some of their zealous positions in favor of achieving an end result that protects people’s ability to acquire the hemp products they want for their health.

The FDA is wrong about CBD, and the sooner they realize this, the better for consumers. Isn’t it maybe time they moved away from what seems more like an attempt at keeping their stranglehold over their pharmaceutical fiefdom, than a real concern for the health and safety of the American people?

Source: https://www.cbdpure.com/blog/why-the-fda-is-wrong-about-cbd/

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Fire & Flower Boosts Toronto Retail Cannabis Presence with Acquisition

Fire & Flower Enters into Agreement to Acquire College Street Cannabis Store TORONTO, Nov. 30, 2020 /CNW/ – Fire & Flower Holdings Corp. (TSX: FAF) (OTCQX: FFLWF) and its wholly-owned subsidiary Fire & Flower Inc. (collectively, “FFHC”, “Fire & Flower” or the “Company”), a leading Canadian recreational cannabis retailer, is pleased to announce that it […]

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Fire & Flower Enters into Agreement to Acquire College Street Cannabis Store

TORONTO, Nov. 30, 2020 /CNW/ – Fire & Flower Holdings Corp. (TSX: FAF) (OTCQX: FFLWF) and its wholly-owned subsidiary Fire & Flower Inc. (collectively, “FFHC”, “Fire & Flower” or the “Company”), a leading Canadian recreational cannabis retailer, is pleased to announce that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of Quad Nine Investments Inc., which owns and operates a licensed cannabis retail store at 717 College Street, Toronto, Ontario currently operating as “Blaze Cannabis”, the (“Acquisition”).

Completion of the acquisition will add Fire & Flower’s eighth fully owned, open and operating location in the province of Ontario. The Company continues to focus on the opening of additional cannabis retail stores in the province that have already completed construction.

This proposed acquisition will represent Fire & Flower’s continued strategy to further grow our omni-channel, technology-enabled retail network in the province of Ontario and across the country, both through acquisition plus organic growth.

Trevor Fencott, Chief Executive Officer of Fire & Flower

This additional store expands our operating base and brings us closer to our goal of positive operating EBITDA.

The acquisition includes a current Retail Operator License and Retail Store Authorization from the Alcohol and Gaming Commission of Ontario (the “AGCO”), which has issued a no-objection letter in respect of the Acquisition.

The total purchase price in connection with the Acquisition is $900,000 plus the net working capital of the business (including inventory) at the date of closing in cash plus 124,069 common shares of FFHC.

The Acquisition is subject to customary closing conditions, including the receipt of a no-objection letter from the AGCO and approval from the Toronto Stock Exchange, each of which has already been received.

More information on the grand opening dates and times of the store, once transitioned to the Fire & Flower brand, will be announced on the Company’s website at http://fireandflower.com/.

About Fire & Flower
Fire & Flower is a leading purpose-built, independent adult-use cannabis retailer poised to capture significant Canadian market share. The Company guides consumers through the complex world of cannabis through education-focused, best-in-class retailing while the HifyreTM digital platform and SparkTM program connect cannabis consumers with the latest cannabis products and deliver cutting edge insights into evolving consumer behaviours. The Company’s leadership team combines extensive experience in the cannabis industry with strong capabilities in retail operations.

Fire & Flower Holdings Corp. owns all issued and outstanding shares in Fire & Flower Inc., a licensed cannabis retailer that owns cannabis retail store licences in the provinces of Alberta, Saskatchewan, Manitoba and Ontario and the Yukon territory.

Through its strategic investment with Alimentation Couche-Tard Inc., the Company has set its sights on the global expansion as new cannabis markets emerge.

More information on Fire & Flower can be found at www.fireandflower.com.

Original press release

Published by NCV Newswire
NCV Newswire
The NCV Newswire by New Cannabis Ventures aims to curate high quality content and information about leading cannabis companies to help our readers filter out the noise and to stay on top of the most important cannabis business news. The NCV Newswire is hand-curated by an editor and not automated in anyway. Have a confidential news tip? Get in touch.


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Source: https://www.newcannabisventures.com/fire-flower-boosts-toronto-retail-cannabis-presence-with-acquisition/

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Organigram Fiscal Q4 Revenue Increases 13% Sequentially to $20.4 Million

Organigram Reports Fourth Quarter 2020 Results Q4 2020 net revenue increased 25% to $20.4 million from $16.3 million in Q4 2019 Q4 2020 gross revenue increased 32% to $25.4 million from $19.2 million in Q4 2019 Launched 40 new stock keeping units (“SKUs”) since July 2020, including new high THC strains, and further value segment […]

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Organigram Reports Fourth Quarter 2020 Results
  • Q4 2020 net revenue increased 25% to $20.4 million from $16.3 million in Q4 2019
  • Q4 2020 gross revenue increased 32% to $25.4 million from $19.2 million in Q4 2019
  • Launched 40 new stock keeping units (“SKUs”) since July 2020, including new high THC strains, and further value segment offerings and expect to launch up to 18 more new SKUs in Q2 2021 as part of the Company’s product portfolio revitalization
  • Subsequent to quarter-end, invested an additional $2.5 million in Hyasynth Biologicals Inc. as the biotech partner completed a milestone linked to the first commercial sale of cannabinoids produced via biosynthesis
  • Subsequent to quarter-end, raised ~$69 million in gross proceeds from an underwritten public offering including the exercise in full of the over-allotment option

MONCTON, New Brunswick, November 30, 2020–(BUSINESS WIRE)–Organigram Holdings Inc. (NASDAQ: OGI) (TSX: OGI), the parent company of Organigram Inc. (together, the “Company” or “Organigram”), a leading licensed producer of cannabis, announced its results for the fourth quarter ended August 31, 2020 (“Q4” or “Q4 2020”).

¹Adjusted gross margin, adjusted gross margin % and adjusted EBITDA are non-IFRS financial measures not defined by and do not have any standardized meaning under IFRS; please refer to the Company’s Q4 2020 MD&A for definitions and a reconciliation to IFRS.
²Sales and marketing and general and administrative expenses (“SG&A”) excluding share-based compensation
³Q4 2020 net cash used in operating activities has been calculated based on a correction of a presentation error of Q1 to Q3 Fiscal 2020 net cash used in operating activities.

“We are excited about Organigram’s prospects as we continue to reinvigorate and diversify our product portfolio with new offerings aimed at delivering the attributes that matter most to consumers,” said Greg Engel, CEO.

Overall, we are very encouraged by the initial responses to our new products and the increased awareness and traction they are receiving against a backdrop of national retail store growth and a growing legal market that continues to displace the illicit market.

Greg Engel, CEO

Our team is more focused than ever on enhancing our agility and execution to capture top-line growth and we believe we have the capital resources and liquidity to support us. We have always operated with financial discipline to pursue profitable growth which is again reflected in positive adjusted EBITDA in full-year fiscal 2020 for the second year in a row.

Key Financial Results for the Fourth Quarter Fiscal 2020

  • Net revenue:
    • Q4 2020 net revenue of $20.4 million compared to $16.3 million in Q4 2019 primarily due to:
      • Higher flower sales on higher volumes due to the large format, value segment growing and the Company having a number of offerings in this segment
      • Adult-use recreational derivative and edible (“Rec 2.0”) product sales that were not yet legal in Q4 2019 and a significant increase in international sales largely due to the supply agreement with Canndoc Ltd., leading Israeli medical cannabis producer, that did not exist in Q4 2019; and
      • A lower sales provision for returns and price adjustments in Q4 2020 compared to Q4 2019.
  • Gross revenue:
    • Q4 2020 gross revenue of $25.4 million compared to $19.2 million in Q4 2019 primarily due to similar factors impacting net revenue described above.
    • Q4 2020 gross revenue increased 32% from the prior year period compared to the 25% increase in net revenue reflecting more shipments and the increase in excise taxes as a percentage of gross revenue in Q4 2020.
  • Cost of sales:
    • Q4 2020 cost of sales of $29.0 million compared to Q4 2019 cost of sales of $15.5 million.
    • Higher cost of sales in Q4 2020 was primarily due to:
      • Increased sales volumes in Q4 2020;
      • Q4 2020 write-offs of excess and unsaleable inventories of $11.1 million, of which $8.3 million related to excess trim and concentrate; and $2.8 million of write-downs and adjustments to net realizable value and
      • $3.5 million in unabsorbed fixed overhead as a result of lower production volumes, and $0.2 million related to lump-sum payments paid to temporarily laid-off workers in Q4 2020.
  • Gross margin before fair value changes to biological assets and inventories sold:
    • Q4 2020 negative gross margin before fair value changes to biological assets and inventories sold of $8.6 million compared to positive $0.7 million in Q4 2019.
    • Negative and lower gross margin in Q4 2020 was largely due to higher cost of sales as described above.
  • Adjusted gross margin1:
    • Q4 2020 adjusted gross margin increased to $6.2 million from $1.5 million in Q4 2019 primarily due to a lower sales provision for returns and price adjustments in Q4 2020 compared to Q4 2019 as discussed above.
  • Gross margin:
    • Q4 2020 negative gross margin of $28.8 million compared to Q4 2019 negative gross margin of $11.1 million, largely due to negative Q4 2020 gross margin before fair value changes to biological assets and inventories sold as described above as well as greater net non-cash negative fair value changes to biological assets and inventories sold of $20.1 million in Q4 2020 versus $11.8 million in Q4 2019.
  • Selling, general & administrative (SG&A) expenses:
    • Q4 2020 SG&A of $10.8 million decreased 22% from Q4 2019’s amount of $13.9 million and Q4 2020 SG&A as a percentage of net revenue was 53% compared to 85% in Q4 2019.
    • Q4 2019 SG&A included approximately $2.0M of licensing and professional fees that were not expected to recur at the same level and Q4 2020 SG&A reflected the Company’s reduced spending during the ongoing COVID-19 pandemic.
    • Q4 2020 SG&A was largely in line with Q3 2020 SG&A of 10.3 million and declined from Q3 SG&A as a percentage of net revenue of 57%.
  • Adjusted EBITDA1:
    • Q4 2020 negative adjusted EBITDA of $2.7 million improved from Q4 2019 negative adjusted EBITDA of $7.2 million primarily due to higher adjusted gross margin in Q4 2020 as discussed above.
  • Net Loss:
    • Q4 2020 net loss of $38.6 million, or ($0.199) per share on a diluted basis, compared to Q4 2019 net loss of $22.5 million, or $(0.144) per share, largely due to greater negative gross margin in Q4 2020 as described above.
  • Net cash used in operating activities:
    • Q4 2020 net cash used in operating activities of $10.1 million decreased from $15.7 million used in Q4 2019 largely due to the prior period’s increase to working capital assets as the Company scaled operations ahead of Rec 2.0 legalization.

Canadian Adult-Use Recreational Market

The Company has been revitalizing its product portfolio with the launch of 40 new SKUs since July 2020 since July 2020, including new high THC strains and additional value segment offerings. Further, the Company expects to launch up to 18 new SKUs in Q2 2021.

Rec 1.0

Value Segment Offerings

  • Dried flower remains the largest category in the Canadian adult-use recreational market of all product form factors and the Company believes this category will continue to dominate for the foreseeable future based on the sales history in mature adult use recreational legal markets in the U.S. (California, Colorado, etc.).
  • The Company has noted the significant growth in the dried flower value category of the market with intensifying competition including recent entries of lower priced offerings which have caused significant market share shifts within dried flower to the value segment. In response, the Company launched “Buds”2 in Q3 2020 along with a number of other dried flower offerings in larger format sizes of 7g and 15g under the Trailblazer value brand in early Q4 2020. The Company believes Buds is a differentiated single-strain value product and it has been well-received by consumers since it is at an affordable price point but does not have to compete on price alone since it is indoor-grown, whole dried flower and strain specific.
  • Further, the Company’s value segment strategy also includes dried flower offerings that were launched in larger format sizes of 7g and 15g under our Trailblazer brand in July 2020.
  • Subsequent to quarter-end in mid-September 2020, Organigram expanded its strong value portfolio with the launch of SHRED, a high quality, high potency and affordable dried flower blend that is pre-shredded for consumer convenience. SHRED offers three pre-milled varieties, all with THC of 18% or higher. It is made from whole flower, does not contain any shake or trim and is milled to the same specifications as the Company’s existing pre-roll products. SHRED is currently Organigram’s most affordable dried flower option (on a per gram basis).

New High THC Strains

  • Cannabis consumers continue to gravitate towards both high THC dried flower products and cultivar diversity and novelty as supported by available sales data. In early August 2020, the Company announced the launch of three new strains of Edison Cannabis Co. (“Edison”) dried flower products, with higher THC: The General (Grapefruit GG4), Chemdog and limited time offering, Samurai Spy (Ninja Fruit). Going forward, the Company has decided to change naming conventions for many of its offerings to align with the street genetic names for dried flower products as it believes these names will better resonate with consumers.

Rec 2.0

Cannabis-Infused Chocolates

  • At the end of July 2020, the Company announced the launch of Trailblazer Snax, a value-priced, cannabis-infused chocolate bar which is made with premium quality ingredients including cocoa butter, all-natural flavors and distillate, while remaining an affordable cannabis-infused option. It is available in either mint or mocha flavours in a 42g bar with 10mg of THC. Each bar can be broken into five sections and is suited for both micro-dosing and full consumption.
  • Organigram’s investment in state-of-the art chocolate equipment and manufacturing processes means that each of the five sections of the Trailblazer Snax bar are filled separately, allowing for higher accuracy of infusion. The Company’s chocolate portfolio also consists of Edison Bytes truffles which are available in both milk and dark chocolate formulations. These products are available as single chocolates containing 10 mg of THC each or sets of two truffles containing 5 mg each.
  • In addition to a seasonal offering of Trailblazer Kushmas Stix, the Company is also offering Canadian cannabis consumers delicately spiced gingerbread flavours mingled with Edison Bytes’ signature rich milk chocolate. These limited time offerings are available in a two-per-pack format, with each truffle containing 5 mg THC for a total of 10 mg total in the box.

Vape Portfolio

  • The Company expects to launch Trailblazer Spark, Flicker and Glow 510-thread Torch vape cartridges in a new 1g format before the end of Q2 Fiscal 2021 which will extend Organigram’s line up to a suite of trial-size 0.5 g and full-size 1 g cartridges for the 510 vaporizer. Trailblazer Torch offers customers 510 cartridges, high-quality CO2 extract and three unique terpene-infused flavours.
  • In addition to the Trailblazer Torch value-segment offerings, the Company’s vape portfolio also includes products for the mainstream and the premium segments: Edison + Feather ready-to-go distillate pens and Edison + PAX ERA® distillate cartridges.

Powdered Beverage Launch

  • Subsequent to quarter-end in November 2020, Organigram launched Edison RE:MIX dissolvable cannabis powder. The pre-packaged powder format makes it easy to mix Edison RE:MIX into beverages quickly and discreetly, so the product can be enjoyed, based on the consumer’s own preference, in a wide variety of settings and on occasions of their choosing.
  • Edison RE:MIX is available in three formats: two sachets with 5 mg THC per sachet; two sachets with 5:5 mg THC:CBD per sachet; and five sachets with 10 mg CBD per sachet.
  • The results of a recent Organigram survey suggest a significant majority of current cannabis consumers (74%) would prefer to add cannabinoids to their beverages by themselves (vs. a pre-mixed beverage). The discreet nature of the product also addresses consumer concerns related to open cannabis consumption.
  • According to recent sales data in Colorado, cannabinoid-infused powders have rapidly risen to the top of the beverage category in popularity, representing 55% of the state’s beverage market sales. In fact, 46% of cannabis consumers reported enjoying cannabinoid-infused beverages multiple times a day (Headset – Colorado Market Insights – July 2020). In Canada, estimates suggest the recreational cannabis beverage market represents a $467M category opportunity and it is expected to increase by 15x its current market size over the next five years (Brightfield Group – Canadian Market Size Insights – July 2020).
  • As previously announced, Organigram’s researchers have developed a proprietary nano-emulsification technology that generates nano-droplets which are very small and uniform; this provides improved absorption compared to traditional edibles and beverages, potentially allowing for a more reliable and controlled experience.
  • With traditional edibles, beverages, and ingestible oil-based extracts, the body spends significant time breaking down fat soluble cannabinoid particles which are then absorbed and metabolized in the body before the effects are felt.
  • The nanoemulsion technology is also anticipated to have increased stability to temperature variations, mechanical disturbance, salinity, pH, and sweeteners. The powdered formulation holds the potential to offer consumers a measured dose of cannabinoids which they can then add to liquid, such as a beverage of their choice, while also offering the discretion, portability and shelf life expected of a dried powder formulation.

Phase 4 Expansion

  • As previously disclosed with Q3 2020 results, the Company decided to indefinitely defer final completion of Phase 4C for additional cultivation capacity (the final stage in Phase 4 cultivation expansion) as originally designed due to excess cultivation capacity versus the current demand in Canada.
  • During the quarter, Phase 4C was substantially completed such that it can be occupied, and the Company retains the option to potentially use the space for other opportunities (if and when strategic and/or market factors dictate).

Phase 5 Refurbishment

  • Phase 5, while already housing additional post-harvesting rooms (including drying rooms) and a dedicated derivatives and edibles facility, is expected to add additional functionality with expanded extraction capacity at the Moncton Campus.
  • Phase 5 was substantially complete at year end. The Company is continuing to work on the installation and commissioning of certain equipment in its edibles and extraction area including its hydrocarbon extraction equipment.

Outlook

  • Organigram remains positive on the cannabis market both in Canada and abroad. The most recent data available from Statistics Canada shows that Canadian adult use market sales (which represent the majority of legal cannabis sales in the country) tallied $256 million3 for just the month of September 2020. This represents an annualized run rate of approximately $3.1 billion, which is a record since adult use was legalized in October 2018. Month-over-month sequential growth rate was 5.2% and year-over-year growth for September was 108.5%.
  • The Company believes there are a few factors that are providing tailwinds to further industry growth. First the legalization in October of 2019 of Rec 2.0 products has attracted consumers who were not interested in smoking or vaping. New categories such as vape pens, edibles (soft chews, chocolates), beverages to name a few have significantly expanded the addressable market. Second, the number of brick and mortar retail stores has increased significantly particularly in the back half of calendar 2020. Third, the industry as a whole has made a concerted effort to match or beat illicit market pricing which has helped accelerate the conversion of consumers from illicit to legal consumption.
  • Notwithstanding the above, the cannabis industry in Canada remains highly competitive and generally oversupplied versus the current market demand considering both regulated licensed producers and the still unfettered illicit market. In early July 2020, the Company announced it had reduced its workforce by 25% in an order to better align its production capacity to prevailing market conditions. After two years of adult-use recreational legalization in Canada, consumer trends and preferences continued to solidify, including significant growth in the large format value segment, a desire for higher THC potency particularly in dried flower as well as a penchant for newness including new genetic strains and novel products. Organigram began a product portfolio revitalization earlier this year in an effort to address what it believed to be some of the biggest trends in order to grow sales and capture market share.
  • At the same time, the number of retail stores in Canada began to grow meaningfully for the first time since legalization and in September 2020, Ontario’s cannabis retail regulator began doubling the number of licenses from 10 to 20 per month and is now on pace to add up to 40 stores per month, resulting in accelerated growth for Canada’s largest adult-use cannabis market. Since July 2020, the number of retail stores in Canada’s 10 provinces grew one-third and increased approximately 140% in Ontario alone.
  • With a leaner workforce, the Company experienced some reductions in production, cultivation, processing and packaging capacity. At certain times, this contributed to delays in the product launches for its portfolio revamp and hindered consistent order fulfillment, particularly for high velocity items. The Company believes this resulted in some meaningful missed revenue opportunities in Q4 Fiscal 2020 and in Q1 Fiscal 2021. With substantial retail store growth in play, the Company is evaluating its processes and supply chain, including the benefit of gradually scaling up staffing, to help ensure improved order fulfillment rates and in turn, potentially realize greater sales opportunities. Further, as many of the Company’s product launches are recent and some are still to come, the Company believes it will still take time for the new products to reach their full potential and gain market share to drive meaningful sales growth.
  • Organigram also continues to make investments in new genetics and improved cultivation processes to increase THC potency and introduce new strains into the highly important dried flower and pre-roll categories. As discussed in the “Phase 4 Expansion” section of this press release, the Company intends to cultivate at less than its full cultivation capacity for the foreseeable future partly to help increase THC potency in its plant, which is anticipated to result in a negative non-cash adjustment to cost of sales for unabsorbed fixed overhead costs.
  • In addition to Rec 1.0, the Company plans to continue to expand on Rec 2.0, which it believes will increasingly become a larger relative category in line with mature U.S. legal markets. As indicated in previous quarters, the Company expects some production inefficiencies to persist in the near term and impact gross margin while it continues to launch new Rec 2.0 products and optimize production. Outside of Canada, the Company continues to serve international markets (Israel and Australia) from Canada via export permits and looks to augment sales channels internationally over time. International sales increased significantly in Q4 Fiscal 2020 from the prior year period as Organigram shipped its first product to Canndoc Ltd. in August 2020 under its supply agreement with the Israeli cannabis medical producer. In early Q1 Fiscal 2021, the Israeli Ministry of Health Israel amended its quality standards for imported medical cannabis. The Company has identified a pathway for demonstrating compliance with these updated standards and has initiated a process which, if completed successfully, will allow it to continue to supply product into the Israeli market.
  • Recent political changes and cannabis election ballot initiatives for both medical and recreational use in the United States suggest that the potential move to U.S. federal legalization of cannabis (THC) has increased momentum but the timing remains difficult to predict. As the Company continues to monitor and develop a potential U.S. THC strategy, it continues to evaluate CBD entry opportunities in the United States.

Liquidity and Capital Resources

  • Organigram ended the quarter with $74.7 million in cash and short-term investments compared to $47.9 million at August 31, 2019, an increase of $26.8 million which is a result of the two at-the-market (ATM) equity offerings and draws against the Company’s term loan facility, offset by investments in working capital and property, plant and equipment. During the quarter, the Company drew an additional $30 million under the term loan such that no available capacity remained at quarter-end.
  • On November 12, 2020, the Company closed an underwritten public offering (the “Offering”) of 37,375,000 units (the “Units”) at a price of $1.85 per Unit, including the full exercise of the over-allotment option. Each Unit is comprised of one common share of the Company and one-half of one common share purchase warrant of the Company (each full common share purchase warrant, a “Warrant”). Each Warrant will be exercisable to acquire one common share of the Company (a “Warrant Share”) for a period of three years following the closing date of the Offering at an exercise price of $2.50 per Warrant Share, subject to adjustment in certain events. The Company expects to use the net proceeds from the offering working capital and other general corporate purposes and to pay down its term loan balance as described below.
  • On November 27, 2020, the Company amended its Facilities pursuant to an amended and restated credit agreement (“Amended and Restated Credit Agreement”) with BMO and the syndicate of lenders to: (i) reduce the Term Loan amount from $115 million to $60 million based on a repayment of $55 million to be made on December 1, 2020 of the outstanding Term Loan balance of $115 million; (ii) have repayments on the balance of the Term Loan commence on February 28, 2021 in an amount equal to $1.5 million per quarter; (iii) reduce the Revolver commitment to $2 million from up to $25 million; (iv) adjust the minimum quarterly EBITDA covenants to be maintained by the Company commencing on February 28, 2021 and continuing through to maturity, thereby removing this covenant for the fiscal period ended November 30, 2020 and eliminating the reversion of the financial covenants to that of the original structure on November 30, 2021; (v) modify the applicable margin pricing and standby fee terms to reflect current market conditions; and (vi) reduce the minimum unrestricted cash balance requirement to $20 million, which is already inclusive of the $8 million restricted investment currently outstanding. The interest rate margin will be fixed from November 27, 2020 through to maturity on May 31, 2021.
  • As at November 29, 2020, excluding the $8.0 million of restricted investment (GIC), the Company had $135 million in cash and short-term investments. After completing the $55 million term loan repayment on December 1, 2020, on a pro forma basis the Company would have $80 million in cash and short-term investments and $60 million in long-term debt.

Capital Structure

Outstanding basic and fully diluted share count as at November 24, 2020 is as follows:

Fourth Quarter and Full Year Fiscal 2020 Conference Call

The Company will host a conference call to discuss its results with details as follows:

Date: November 30, 2020

Time: 8:00am Eastern Time

To register for the conference call, please use this link:
http://www.directeventreg.com/registration/event/4687978

To ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. After registering, a confirmation will be sent through email, including dial in details and unique conference call codes for entry. Registration is open through the live call.

To access the webcast: https://event.on24.com/wcc/r/2625442/2C164D33CA068A822C82053411FBA767

A replay of the webcast will be available within 24 hours after the conclusion of the call at https://www.organigram.ca/investors and will be archived for a period of 90 days following the call.

Non-IFRS Financial Measures

This news release refers to certain financial performance measures (including, target production capacity, and adjusted EBITDA) that are not defined by and do not have a standardized meaning under International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. These non-IFRS financial performance measures are defined below. Non-IFRS financial measures are used by management to assess the financial and operational performance of the Company. The Company believes that these non-IFRS financial measures, in addition to conventional measures prepared in accordance with IFRS, enable investors to evaluate the Company’s operating results, underlying performance and prospects in a similar manner to the Company’s management. As there are no standardized methods of calculating these non-IFRS measures, the Company’s approaches may differ from those used by others, and accordingly, the use of these measures may not be directly comparable. Accordingly, these non-IFRS measures are intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS. Please refer to the Company’s Q3 2020 MD&A for definitions and, in the case of adjusted EBITDA, a reconciliation to IFRS amounts.

About Organigram Holdings Inc.

Organigram Holdings Inc. is a NASDAQ Global Select Market and a Toronto Stock Exchange listed company whose wholly owned subsidiary, Organigram Inc., is a licensed producer of cannabis and cannabis-derived products in Canada.

Organigram is focused on producing high-quality, indoor-grown cannabis for patients and adult recreational consumers in Canada, as well as developing international business partnerships to extend the Company’s global footprint. Organigram has also developed a portfolio of adult use recreational cannabis brands including The Edison Cannabis Company, SHRED and Trailblazer. Organigram’s primary facility is located in Moncton, New Brunswick and the Company is regulated by Health Canada under the Cannabis Act (Canada) and the Cannabis Regulations (Canada).


1 Adjusted gross margin, adjusted gross margin % and adjusted EBITDA are non-IFRS financial measures not defined by and do not have any standardized meaning under IFRS; please refer to the Company’s Q4 2020 MD&A for definitions and a reconciliation to IFRS.

2 In Q3 Fiscal 2020, the Company launched its first value offering of dried flower in a large size format of 28g under Trailer Park Buds (TPB) brand. In early Q4 Fiscal 2020, the Company announced it is making changes to the TPB brand and logo but in the immediate terms has moved to a modified version of TPB, “Buds”.

3 Statistics Canada, Cannabis Stats Hub, Accessed: November 26, 2020, (https://www150.statcan.gc.ca/n1/pub/13-610-x/cannabis-eng.htm)

Original press release

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Published by NCV Newswire
NCV Newswire
The NCV Newswire by New Cannabis Ventures aims to curate high quality content and information about leading cannabis companies to help our readers filter out the noise and to stay on top of the most important cannabis business news. The NCV Newswire is hand-curated by an editor and not automated in anyway. Have a confidential news tip? Get in touch.


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Source: https://www.newcannabisventures.com/organigram-fiscal-q4-revenue-increases-13-sequentially-to-20-4-million/

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Heartland

Genetic Architecture of Flowering Time and Sex Determination in Hemp (Cannabis sativa L.): A Genome-Wide Association Study

Flowering time and sex determination in hemp (Cannabis sativa L.) strongly influence fiber quality and seed production of this crop. The control of these traits is paramount for the breeding of new cultivars. Yet, little is known about the genetics underlying such complex traits and a better understanding requires in depth knowledge of the molecular mechanisms responsible for these traits. In this report, the genetic architecture of flowering time and sex determination in hemp was studied using…

Republished by Plato

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on


. 2020 Nov 4;11:569958.

doi: 10.3389/fpls.2020.569958. eCollection 2020.

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Jordi Petit et al. Front Plant Sci. .

Abstract

Flowering time and sex determination in hemp (Cannabis sativa L.) strongly influence fiber quality and seed production of this crop. The control of these traits is paramount for the breeding of new cultivars. Yet, little is known about the genetics underlying such complex traits and a better understanding requires in depth knowledge of the molecular mechanisms responsible for these traits. In this report, the genetic architecture of flowering time and sex determination in hemp was studied using a Genome-Wide Association Studies (GWAS) approach. Association studies were performed on a panel of 123 hemp accessions, tested in three contrasting environments, using a set of 600 K SNP markers. Altogether, eight QTLs were identified across environments; six for flowering time traits and two for sex determination. These QTLs covered genomic regions with 33 transcripts predicted to be involved in flowering and sex determination as well as a microRNA, miR156. Genes related to perception and transduction of light and transcription factors well-known to regulate flowering were identified in QTLs for flowering time traits. Transcription factors and genes involved in regulating the balance of phytohormones, specially auxins and gibberellic acid, were identified in QTLs for sex determination. Sex determination QTLs were associated with the development of male flowers in female plants and thus with the stability of sex determination in monecious plants. The present study elucidates relevant knowledge on the genetic mechanisms of flowering and sex determination traits in hemp, and provides new tools for hemp breeding.

Keywords: Cannabis sativa; GWAS; QTL; flowering time; hemp; plant breeding; sex determination.

Source: https://pubmed.ncbi.nlm.nih.gov/33250906/?utm_source=no_user_agent&utm_medium=rss&utm_campaign=pubmed-2&utm_content=18gXB4q-CV5o0kQDSCt3HqwNcsXbn1PxqekJlWJaIbT8zAG16G&fc=20200804213200&ff=20201130075216&v=2.13.0

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