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Organigram Receives Health Canada’s Final Redetermination on Jolts

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Organigram Holdings Inc. announced that Health Canada has reclassified its Edison Jolts lozenge products as edible cannabis despite evidence supporting ingestible classification. The decision follows a court ruling on procedural fairness. Organigram is disappointed and is evaluating next steps.
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  • The reclassification of Organigram's Jolts lozenge products as edible cannabis by Health Canada could impact the company's product strategy and market positioning negatively.

The reclassification of Organigram's Edison Jolts lozenges by Health Canada from an ingestible extract to an edible cannabis product has significant legal and regulatory implications. The initial court decision that found a procedural breach by Health Canada indicated a potential for Organigram to maintain their product's status. However, the final redetermination by Health Canada upholds the original classification, which means that the company must now navigate a different set of regulations that apply to edibles.

This change could affect labeling, marketing, permissible THC levels and packaging requirements, potentially increasing compliance costs for Organigram. In the broader legal landscape, this decision sets a precedent for how similar products may be classified in the future, influencing the strategies of other cannabis companies. It is important for stakeholders to monitor how Organigram adapts to these regulatory changes and what legal steps they might take in response.

From a market perspective, the reclassification of Organigram's product could influence consumer perception and market dynamics within the cannabis industry. Edibles typically have a different consumer base compared to other forms of cannabis consumption and this shift might necessitate a change in Organigram's marketing strategy to target a new segment.

Furthermore, the cessation of Jolts production in its current form and the sell-through of remaining inventory may impact Organigram's short-term revenue and market share. Competitors might capitalize on this transition period to capture consumers who were loyal to the Jolts brand. Long-term, Organigram's ability to innovate and adapt to the new classification will be critical in maintaining their competitive edge in a rapidly evolving market.

From a financial viewpoint, the reclassification of Edison Jolts lozenges has immediate implications for Organigram's revenue stream and cost structure. The suspension of production suggests a potential loss in sales volume and revenue, at least temporarily. Moreover, the development and marketing of a compliant product could incur additional R&D and marketing expenses.

Investors should consider the impact of these regulatory challenges on Organigram's financial health, especially if the company faces delays in reintroducing a compliant product to the market. The ability to manage inventory levels and mitigate the costs associated with regulatory compliance will be key factors in maintaining financial stability and investor confidence during this period.

TORONTO--(BUSINESS WIRE)-- Organigram Holdings Inc. (“Organigram” or the “Company”) (TSX: OGI; NASDAQ: OGI), announced today that, despite strong evidence supporting its classification as an ingestible extract, it has received a final redetermination from Health Canada that its patented Edison Jolts lozenge products (the “Products”) are to be classified as edible cannabis.

The final redetermination follows the August 2023 decision of the Federal Court of Canada (the “Court”) to grant Organigram’s application for judicial review of a decision of Health Canada determining that the Products are to be classified as edible cannabis. The Court found there was a breach of procedural fairness by Health Canada and the matter was then remitted back to Health Canada for redetermination taking the Court’s reasons into consideration.

“We are disappointed with the outcome of Health Canada’s further review of our Jolts product,” said Beena Goldenberg, CEO of Organigram. “Our patented Jolts lozenge was launched over two years ago following significant research and development and was specifically designed to appeal to consumers looking to access regulated and tested ingestible products from the legal market that met their needs for potency and price. We are currently assessing our options to continue to meet the needs of consumers while retaining them within the legal market,” she concluded.

Organigram has stopped the production of Jolts in its current format and is currently working with Health Canada on timing to sell through remaining inventory to the provincial distributors.

About Organigram Holdings Inc.

Organigram Holdings Inc. is a NASDAQ Global Select Market and TSX listed company whose wholly owned subsidiaries include Organigram Inc. a licensed producer of cannabis, cannabis-derived products and cannabis infused edibles in Canada.

Organigram is focused on producing high-quality, cannabis for patients and adult recreational consumers, as well as developing international business partnerships to extend the Company’s global footprint. Organigram has also developed and acquired a portfolio of legal adult-use recreational cannabis brands, including Edison, Holy Mountain, Big Bag O’ Buds, SHRED, SHRED’ems, Monjour, Laurentian, Tremblant Cannabis and Trailblazer. Organigram operates facilities in Moncton, New Brunswick and Lac-Supérieur, Quebec, with a dedicated edibles manufacturing facility in Winnipeg, Manitoba. The Company is regulated by the Cannabis Act and the Cannabis Regulations (Canada).

Forward-Looking Information

This news release contains forward-looking information. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “estimates”, “intends”, “anticipates”, “believes” or variations of such words and phrases or state that certain actions, events, or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results, events, performance or achievements of Organigram to differ materially from current expectations or future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information include changes to market conditions, consumer preferences and regulatory climate and factors and risks as disclosed in the Company’s most recent annual information form, management’s discussion and analysis and other Company documents filed from time to time on SEDAR (see www.sedar.com) and filed or furnished to the Securities and Exchange Commission on EDGAR (see www.sec.gov). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information included in this news release are made as of the date of this news release and the Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

For Media enquiries:

Megan McCrae

Senior Vice President, Global Brands and Corporate Affairs

megan.mccrae@organigram.ca

Organigram

Source: Organigram Holdings Inc.

FAQ

What is the latest announcement from Organigram Holdings Inc. regarding its products?

Organigram announced that Health Canada has reclassified its Edison Jolts lozenge products as edible cannabis.

What was the court's decision related to Organigram's product classification?

The Federal Court of Canada granted Organigram's application for judicial review due to a breach of procedural fairness by Health Canada.

Who is the CEO of Organigram Holdings Inc.?

Beena Goldenberg is the CEO of Organigram.

What is Organigram's ticker symbol on the Toronto Stock Exchange and NASDAQ?

Organigram's ticker symbol is OGI on both the TSX and NASDAQ.

How is Organigram responding to Health Canada's reclassification of its products?

Organigram is evaluating its options to meet consumer needs while staying compliant with the legal market regulations.

Organigram Holdings Inc.

NASDAQ:OGI

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Medicinal and Botanical Manufacturing
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About OGI

as part of canada’s marihuana for medical purposes regulations (mmpr), organigram (tsx-v:ogi) is atlantic canada's original licensed producer of medical marijuana. we are dedicated to consistently providing our clients with the highest quality, organically grown medicine and service. if you have questions or want to learn more, visit www.organigram.ca or give our client services team a call at 1-855-961-9420.