Business concept, long-term objectives and strategies
PledPharma is recognized as an efficient and productive Nordic late phase pharmaceutical drug development company with a strong ambition to create value for patients, society and shareholders by developing a portfolio of unique products for the treatment of serious rare/niche diseases with significant unmet medical needs in the orphan drug segment.
With its unique, integrated expertise in pharmaceutical drug development, PledPharma will focus on improving the treatment of debilitating and life-threatening diseases in the orphan drug segment where there are no alternative treatments.
PledPharma will meet medical needs where there are no treatments by developing drugs in the orphan drug segment with focus on late stage development and commercialisation
PledPharma’s objective is to create value for patients, society and shareholders by developing effective new treatments for debilitating and life- threatening diseases.
PledPharma’s place in the value chain
PledPharma primarily focuses on pharmaceutical drug development in clinical phases through to market approval by pharmaceutical regulatory authorities and commercialisation. The company’s aims to commercialise its orphan drug assets through a niche and focused commercial organisation.
The Company focuses on projects in the clinical development phase in the orphan drug segment. Projects are selected based on multiple criteria, with the most important being the medical need, scientific rationale, development plan and market potential. It is considered an advantage if potential treatments are in areas with a low degree of competition.
With the company’s own resource-efficient expert organization and a small number of projects in clinical development, PledPharma is able to dedicate the necessary attention and resources to every project to ensure a successful development process. The Company has an entrepreneurial philosophy and conducts its projects in a resource-efficient manner through its own expert organization, which has long-standing experience in pharmaceutical drug development. The Company cooperates with various partners whose resources are devoted to dedicated projects. These partners include contract research organizations, contract manufacturers and legal professionals (patents, etc.).
Financing and business model
In its current situation, the Company intends to finance its operations primarily through equity and by out-licensing projects to commercial partners.
The Company intends to generate revenue primarily through sales of own products and/or licensing agreements for projects in progress as well as through royalties when products are commercialized after gaining market approval.
PledPharma’s commercial target groups are pharmaceutical companies and regional distributors with well-developed distribution networks.
License fees and royalties
License fees and royalties through strategic partnerships are the main sources of revenue for the Company. License fees are received when initiating partnerships or at defined milestones and are of a non-recurring nature. Royalties are received when a drug begins to be sold in the market. This form of revenue is of a recurring nature and is received as long as sales take place.
The first major license agreement with Solasia
The agreement with the Japanese company Solasia is an example of licensing and an agreement for royalties upon commercialization. The company signed an exclusive licensing agreement in November 2017 for PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan. License fees of up to MUSD 83 (corresponding to approximately MSEK 700) are divided into initial remuneration and partial payments linked to predefined milestones during continued development, the regulatory process and commercialization. In addition, PledPharma is also entitled to royalties on future sales of the product. Solasia has also undertaken to fully finance the expansion of the global Phase III program to additional countries in Asia.