Pangyo, Gyeonggi Province, Korea - SK Biopharmaceuticals Co., Ltd. announced its financial results for fiscal 2021.

The company posted net sales of 418.6 billion Korean won (KRW) and an operating profit of KRW 95.3 billion in 2021.

Its annual revenue increased more than 16 times compared to a year earlier, on the back of SK Biopharmaceuticals' brisk U.S. sales growth and global licensing of its key anti-seizure medication, cenobamate (XCOPRI). Its net sales included those of XCOPRI in the U.S. at KRW 78.2 billion in 2021, up more than six times from KRW 12.7 billion in 2020.

Cenobamate obtained approval from the European Commission in early 2021, paving the way for rollouts in Germany, the UK, Denmark and Sweden under the name of ONTOZRY.

In 2021, SK Biopharmaceuticals out-licensed cenobamate in Canada and six clinical pipelines in China, further expanding its footprint in North America and Asia.

In January 2022, the company initiated a Phase 3 trial of carisbamate in Lennox-Gastaut syndrome, and got the nod from the U.S. Food and Drug Administration to begin a Phase 1 study of its anti-cancer treatment candidate.

SK Biopharmaceuticals said it will seek to double its sales of cenobamate this year from 2021, while staying the course to expand its pipeline and eyeing new investment opportunities in digital therapeutics.

'We are very pleased to have concluded 2021, achieving significant growth in U.S. sales and foraying into global top 4 pharmaceutical markets - the U.S., the EU, Japan, and China,' said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science.

'Our goal is to continue developing carisbamate, for which we will aim to submit the new drug application in 2024-2025. We will move forward with the development of cenobamate for the treatment of primary generalized tonic-clonic seizures in adults, and its Asia Phase 3 trial for the treatment of partial-onset seizures (POS) in adults, as well as its clinical study for POS in pediatrics. We have also made headway in oncology, the largest therapeutic area, gaining approval for a Phase 1 trial of SKL27969.'

Cho added, 'The company will stay the course with its key strategies by further expanding its U.S. and global businesses, pursuing inorganic growth, and open innovation, as part of efforts to boost our portfolio in the medium- to long-term.'

Contact:

Media

Hyongki Park

Director of Communications

E: h.p.comm@sk.com

Jaehee Kang

Communications Manager

E: jaeheekang@sk.com

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