[뉴스핌 라씨로] SK Biopharm’s ‘Sunosi’ receives royalties due to increased sales in the US… Clinical attention for expansion of indications

This article was first published on November 6th at 6:52 PM on ‘Newspim Laciro’, an investment service analyzed by AI.

[서울=뉴스핌] Reporter Kim Shin-young = As the U.S. sales of ‘Sunosi (ingredient name: solriamfetol)’, the first new drug exported by SK Biopharm, are on the rise, the proportion of royalties earned by the company is also increasing.

A U.S. partner company is conducting a clinical trial to expand the indications for Sunosi, a sleep disorder treatment, to include attention deficit hyperactivity disorder (ADHD) and depressive disorder, drawing attention to the results.

If the indications are expanded, the amount of royalties distributed to SK Biopharmaceuticals will also increase, which is expected to act as a positive factor.

According to SK Biopharm’s business report on the 6th, Sunosi’s service sales such as milestones and royalties based on sales in the United States and Europe were calculated to be 6 billion won in 2022 and 12.7 billion won in 2023. Sales in the first half of this year were 4.1 billion won.

Sunosi’s detailed sales structure and profit ratio are not disclosed according to the contract. However, an official from SK Biopharmaceuticals said, “This year’s royalty guidance for both Sunosi and Ontuzri (European cenobamate) is 15 billion won.”

It is analyzed that the reason for the increase in sales generated from Suno City is that overseas sales are trending upward.

Previously, SK Biopharmaceuticals exported Sunosi technology to Aerial Biopharma, an American bio venture company, in 2011. Afterwards, in 2014, Jazz Pharmaceuticals acquired the global distribution rights for Soleamfetol from Aerial Biopharma and proceeded with development and commercialization.

Afterwards, Sunosi was launched in the U.S. market in 2019 and the European market in 2020, and Jazz Pharmaceuticals transferred the commercialization rights to Sunosi back to Axum Therapeutics in March 2022, and royalties on sales are currently being paid by Axum. SK Biopharm holds the rights to 12 major Asian countries.

Sunosi has been on a steady rise since exceeding 10 billion won in quarterly sales in the United States in 2020. Last year, sales reached close to 100 billion won. According to Axum, sales this year are expected to reach up to $500 million.

Axum is not stopping there and is focusing on expanding the indications for Sunosi. This is to expand the scope of treatment to include ADHD, depressive disorder, and binge eating disorder in addition to sleep disorders. Phase 3 clinical trials are currently underway, and clinical results are expected to be released as early as this year or next year.

If the indications are successfully expanded, SK Biopharmaceuticals’ royalties will also increase. Although the proportion of Sunosi’s royalties in sales is still small compared to the company’s representative new drug, the epilepsy treatment ‘Cenobamate’, the market outlook for treatments for these indications is bright, so it is evaluated that there is great potential for growth.

An official from SK Biopharmaceuticals said, “As the sales of Sunosi sold by partner companies increase, the amount of royalties received by the company increases accordingly,” adding, “However, the current status of clinical trials related to expansion of indications and the timing of disclosure of results are not exactly known.” He said.

sykim@newspim.com