Despite cannabis being used for various medical purposes for thousands of years (and having a safety profile that is superior to alcohol in many respects), there are surprisingly few therapeutics containing cannabis that have been approved by major regulatory authorities, with worldwide sales of only c US$600m in 2020, according to Evaluate Pharma.
GW Pharma’s Epidiolex for the treatment of certain rare epilepsies was a game-changer as the first FDA-approved cannabinoid drug in history. It was launched at the end of 2018 and soon after, the World Health Organization called for the reclassification of cannabis and its derivatives to facilitate trade for medicinal and scientific purposes, suggesting that CBD with 2% or less THC should not be subject to international controls.
This led to the United Nations Commission for Narcotic Drugs, the UN’s central drug policy-making body, in December 2020 voting to remove cannabis for medicinal purposes from a category of the world’s most dangerous drugs (Schedule IV of the 1961 Single Convention on Narcotic Drugs) to which the strictest control measures apply, which has generally discouraged its use for medical purposes. With a vote of 27 in favour (including the United States and European nations), 25 against (including China and Russia), and one abstention, UN News states that the commission ‘has opened the door to recognising the medicinal and therapeutic potential of the drug, although its use for non-medical and non-scientific purposes will continue to remain illegal’. Although governments retain jurisdiction over the classification of cannabis, the decision signalled the intent to loosen international controls.
Recreational cannabis is a large and currently mostly illegal market. In Germany, the health minister, Karl Lauterbach, estimated that around four million people had tried cannabis at least once over the last 12 months, and a quarter of all 18- to 24-year olds in the country have used it. SynBiotic estimates the cannabis black market in Germany to be worth €4bn and potentially up to €7bn. In October 2022, the German government published the final draft of a white paper (‘Eckpunktepapier’), setting out a path to legalise the purchase and possession of up to 30g of cannabis for recreational use, and to privately grow up to three plants. The paper outlines a plan allowing consumption by adults in public or in private. Advertising cannabis products would continue to be banned. The German government wants to ensure the proposed plan would be compatible with European Union (EU) law, and hence is seeking a review, but assuming the government receives assurances on this matter, a draft law is due to be presented in Q123. SynBiotic management believes the company is well-prepared for any relaxation in legislation surrounding cannabis, with its stake in Hanf Farm, which specialises in the industrial cultivation of hemp. In addition, the joint venture (JV) with Enchilada Group, announced in April 2022, is seeking to position itself as one of the first movers in the new area of stores that sell recreational cannabis. As a reminder, the JV combines SynBiotic’s deep knowledge in the cannabis space and Enchilada Group’s expertise in the food service and franchise business.
In December 2022, US President Joe Biden signed into law the ‘Medical Marijuana and Cannabidiol Research Expansion Act’, which is the first standalone cannabis-related bill approved by both chambers of US Congress. The act creates a mechanism for FDA approval of drugs derived from cannabis and protects doctors who may now discuss the harms and benefits of using cannabis and its derivatives.
Key current and prospective market applications for SynBiotic
The cannabis and CBD market can broadly be divided into three distinct segments: medical cannabis, recreational cannabis (currently illegal in most jurisdictions), and the wellness and food (CBD) segment. SynBiotic believes it is well-positioned for all three of these markets, as illustrated in Exhibit 2.
Exhibit 2: SynBiotic’s positioning across market segments
|
|
|
SynBiotic is active in this market. Medical cannabis refers to herbal or plant-derived cannabis products that are prescribed by a doctor. Products are available as herbal materials, oils, tinctures, food or capsules.
After epilepsy, pain is probably the area with the highest quantity of evidence associated with the efficacy of cannabinoids and is an enormous market. According to the Centers for Disease Control and Prevention, 20% of adults in the United States (c 50 million) have chronic pain. In Europe, the prevalence of moderate to severe pain in the adult population is estimated to be similarly high at 19% (c 80 million). Other substantial markets are the relief of sleep-related problems and anxiety. SynBiotic believes the addressable market consists of 150 million people globally with sleep-related problems, 100 million people experiencing pain and 60 million people with anxiety.
The legalisation of medical cannabis is advanced across Europe with doctors since 2017 able to offer cannabis-containing medicines to patients with a serious illness. Doctors still tend to prescribe cannabis preparations only when other therapies are ineffective against pain, as very few cannabis products have been approved for pain; however, acceptance of medicinal cannabis is increasing steadily. Over-the-counter medicinal cannabis (containing THC) is currently only legal in a few EU countries, with Germany seen as the pioneer as it currently has over 100,000 patients and the number continues to grow rapidly. The German medical cannabis market is expected to be worth €0.84bn by 2025. (source: Prohibition Partners, The European Cannabis Market, vol. 06)
SynBiotic is well-placed to enter the recreational cannabis market once legalisation takes place. Germany is seen as paving the way towards legalisation of cannabis for recreational use, and other EU countries may follow. As discussed above, SynBiotic estimates the current black market in Germany for recreational cannabis to be worth €4bn a year, and potentially up to €7bn. While initial plans were for recreational cannabis to be available for distribution in shops and pharmacies across Germany, more recent proposals have seen the scope scaled back; under current proposals, adults in Germany will be able to grow and consume recreational cannabis privately or through non-profit members’ clubs by the end of the year.
Given the inherent uncertainty in how long the legalisation process will take, SynBiotic is purposefully embracing a broader and more diversified strategy as it awaits legalisation to progress. This includes its expertise in the wider CBD space:
The vast majority of European countries allow for the sale of CDB-containing food and wellness products. However, the legalisation of recreational cannabis, as is being proposed in Germany, is likely to boost the wellness and food segment.
SynBiotic intends to move into this segment via acquisitions.
Prohibition Partners, a business consultancy for the cannabis industry, estimates the global CBD skin care market at US$710m in 2018, with projected sales of US$959m by 2024 (ie CBD cosmetics will represent about 10% of the global skin care market in the next five to 10 years). Touted as the newest super-natural ingredient, CBD is considered to have a wide range of applications in skin, body, makeup and hair care, as well as being a potential alternative to traditional cosmetic ingredients. Starting with oil-based products focused on CBD’s anti-inflammatory properties, the growth in CBD products in beauty care has extended to skin creams, lotions, serums, soaps, sun care, hair products and makeup.
According to SynBiotic, CBD can be used in cosmetics in the EU if the products are made from cannabis, cannabis resin, cannabis extracts and cannabis tinctures derived only from the seeds and leaves of the plants. The market is barely established in Germany, though CBD-containing cosmetics can be marketed in most EU countries.
SynBiotic is active in the market for CBD-based dietary supplements, which has grown steadily in recent years. SynBiotic’s Hempamed brand is present in cannabis oils, with products aimed at different markets such as improving sleep, stress reduction and muscle regeneration
SynBiotic has recently entered this market, with CBD oils for cats and dogs.
According to FEDIAF (the trade body representing the European pet food industry), Europeans spent c €18.5bn in 2019 on pet-related products and services, of which the CBD market represents a very narrow segment. In 2019, less than 0.5% of non-CBD consumers reported buying CBD for a pet (representing only 3% of CBD consumers).
Although limited by comparison with the broader CBD market, according to Frontier Financial Group, the CBD pet products market has significant growth potential.