Market

Lipigon develops drugs for diseases caused by disturbances in the body's handling of fats. Lipigon focuses its efforts on conditions where there is a significant gap in effective treatments or where existing treatments are insufficient.

Initially, Lipigon focuses its development on advanced diseases or genetically defined patient segments where it is possible to identify a treatment effect early in the clinical development process.

Genetic stratification lays the foundation for studies with fewer patients, a more evident treatment effect and a shorter path to market approval, and thus a reduced development risk.

The market for drugs aimed at regulating blood lipids in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) was worth approximately USD 6.6 billion in 2020, according to Datamonitor. Sales in these markets are expected to rise to USD 13.9 billion by 2027.

Extensive Needs, Extensive Costs

Cardiovascular diseases consistently rank as the primary cause of death and illness in the Western world. As living standards increase, even developing countries are witnessing a surge in these diseases of affluence. Cardiovascular disease, type 2 diabetes and fatty liver disease are all linked to disturbances in the body's handling of fat, stemming from inefficient fat breakdown or imbalanced fat distribution across organs.

Cardiovascular diseases account for 45 percent of all deaths in Europe and is the predominant cause of mortality globally. In many countries, cardiovascular diseases cause the single largest health care expenditure. Lipigon addresses several niche markets within the total market for drugs aimed at regulating fats. These markets serve smaller patient groups with a pressing need for new treatments.

Business Model

Lipigon creates value for patients and shareholders by developing innovative drugs for the treatment of lipid-related diseases, either in-house or in partnership with other pharmaceutical companies. For indications that require a large sales and marketing organization, Lipigon plans to sign commercial agreements with one or more major pharmaceutical companies to ensure the most efficient route to market and commercial success. Commercial agreements are expected to provide initial payment upon contract signing and ongoing payments when important milestones are reached during development as well as royalty income upon sale of the drugs. For the commercialization of specialist drugs, Lipigon has the option of choosing to handle marketing itself in certain areas, where the number of prescribing doctors is limited.

Strategy

Lipigon's strategy is to develop a broad portfolio of drug candidates for lipid-related diseases. Initially, Lipigon focuses on advanced diseases or genetically defined patient segments where it is

possible to identify treatment effects early in the clinical development process. This approach enables studies with fewer patients, shorter development time and lower costs for market approval, which in turn leads to reduced development risk.

In certain instances, Lipigon is able to secure orphan drug status in order to reduce the development risk and create opportunities for market exclusivity and competitive pricing. In the long term, there is an opportunity for Lipigon to expand its scope to include the treatment of common diseases, such as dyslipidemia and the prevention of cardiovascular diseases, using the same medication.

The company also intends to carefully expand its project portfolio, either by initiating new projects from its in-house research, by acquiring relevant pharmaceutical projects, or both. Currently, activities are underway in both directions. Under the adopted business model, Lipigon retains ownership of the projects, while partnering companies share any future revenue.