Lexaria Bioscience (LEXX) Updates Current GLP-1 Market

Lexaria Bioscience Corp. (Nasdaq: LEXX & LEXXW) provides an update on recent glucagon-like peptide-1 ("GLP-1") receptor agonist market sector advancements.

In 2020 the total market size for GLP-1 drugs was less than $4 billion. That same year, Novo Nordisk(R) paid $1.8 billion to purchase Emisphere's(R) SNAC drug delivery technology which was subsequently incorporated into Rybelsus(R) semaglutide oral tablets, resulting in the first and only Food and Drug Administration ("FDA") approved GLP-1 drug for use as an oral tablet.

Today, the GLP-1 market is growing faster than nearly all historic forecasts had predicted. Bay Bridge Bio has published a useful interactive chart which highlights that, while there are a number of GLP-1 drug brands available today, over 95% of the current market is served by only two drugs: semaglutide (Wegovy(R), Ozempic(R), Rybelsus(R)) manufactured by Novo Nordisk(R); and the dual action GLP-1 plus glucose-dependent insulinotropic polypeptide ("GIP") receptor agonist tirzepatide (Mounjaro(R), Zepbound(R)) manufactured by Eli Lilly(R). Combined revenue of these two drugs during Q2, 2024, was $11.04 billion compared to $5.89 billion in Q2, 2023, and just $2.55 billion during Q2, 2022. As a stark comparison, these drugs generated less than $300 million during the entire year of 2018.

Despite this unprecedented growth, GLP-1/GIP drugs currently delivered by oral tablet comprise only roughly 10% of the entire market dominated by injectable delivery. The share of the market addressed with oral tablets is likely to grow aggressively as patients are expected to migrate away from injections as more available oral forms become available. Lexaria expects that its DehydraTECH drug delivery system could be a global leader in GLP-1/GIP drug delivery as oral delivery dominates in the years to come.

Analysts around the world have been trying to keep up with GLP-1 trends. Compounding the difficulty in doing so is projecting which major pharmaceutical firms will achieve approval for GLP-1/GIP and related drugs currently in the development pipeline. Tirzepatide, for example, was only approved by the FDA in May, 2022, but Eli Lilly is forecasting $15 billion in revenue from the drug during calendar 2024.

Expanding Applications For GLP-1 Drugs

The effects of GLP-1 drugs for weight loss and diabetes control are well known, but additional benefits are appearing outside of those original areas of investigation. For example, on March 8, 2024, the FDA approved Wegovy(R) (semaglutide) "to reduce the risk of cardiovascular death, heart attack and stroke". A large study of 17,600 people evidenced that weekly semaglutide injections reduced those cardiovascular risks by ~20%.

Heart disease remains the #1 leading cause of death in America, resulting in 702,880 deaths in 2022. The World Health Organization estimates that cardiovascular diseases cause 17.9 million deaths, globally, each year.

A meta-analysis of 12 studies that included ~73,000 patients has shown reduced harm experienced from chronic kidney disease when GLP-1 drugs were administered. In a large analysis of over 165,000 patients, type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs evidenced lower mortality rates and lower incidences of both major cardiovascular events and major adverse kidney events, than those patients not receiving GLP-1 drugs.

Approximately 35 million people in the US have chronic kidney disease, according to the Center for Disease Control, and it is estimated that 1.2 million people around the world die each year from the disease.

Some of the latest research seems to indicate a connection between GLP-1 drugs and the human brain, wherein inflammation models including heart disease, atherosclerosis, and liver and kidney inflammation may be mediated through the brain.

Given that heart disease and kidney disease are so widespread, and with the latest analytical study data showing that GLP-1 drugs are improving health outcomes for patients with these diseases, it seems likely that, over time, GLP-1 drugs may be approved for additional therapeutic uses in patient populations that far exceed today's regulator-approved disease indications.

GLP-1/GIP and related drugs are already one of the fastest growing sectors in the history of the pharmaceutical industry. Given that these drugs are evidencing an expansion of their therapeutic applications and are expected to be approved by national drug regulators for expanded use; and given that health insurers are increasing their coverage for these drugs, it seems possible that current growth expectations of most analysts are conservative.

Lexaria has already provided evidence that DehydraTECH seems to provide improved drug delivery kinetics and improved blood sugar control with the world's leading GLP-1 drug: semaglutide. Lexaria's interest and focus on the GLP-1/GIP and related drug sector will continue for the foreseeable future with additional studies and evaluation.

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