Hugel wants to send its botulinum toxin around the world
Those were goals that Sohn Ji-hoon, CEO of Hugel, described during an online press conference held Friday.
“After successfully entered the Chinese market last year, we are set to launch our botulinum toxin product Letybo in the U.S. and European markets this year,” Sohn said. “In five years, we will grow into a company that holds 10 percent of the global botulinum toxin market.”
The United States, China and Europe dominate the world’s botulinum toxin market, accounting for over 80 percent of the sales.
China granted approval for the sale of Letybo in October 2020, the first for a Korean company. Hugel captured 10 percent of the market share in China in 2021, and is expected to increase that to 20 percent by the end of the year by distributing Letybo in more than 4,000 hospitals in China.
On Feb. 3, the company got marketing approval for Letybo from health regulators in France. The green light came just two days after it received an approval recommendation from the Heads of Medicines Agencies (HMA), a network of the heads of national authorities whose organizations are responsible for the regulation of medical products for human and veterinary use in the European economic area. The European Medicines Agency is an active member of the HMA.
Hugel aims to enter a total of 11 countries including Britain, Germany, Spain and Italy within the first quarter.
Hugel is currently waiting for marketing approval from the U.S. Food and Drug Administration (FDA). The FDA concluded site inspections of the company’s manufacturing plant in Chuncheon in August. Hugel has been expecting final FDA approval within the first half of the year.
The botulinum toxin maker also applied for marketing authorization from Canada and Australia in July, and is expecting approvals within the year.
Hugel is building its third factory in Chuncheon, which will have annual production capacity of 8 million vials of botulinum toxin. Construction is expected to finish in June, and start mass operation next year.
The Chuncheon, Gangwon-based company reported 60.1 billion won ($50.1 million) in 2021 net profit, according to a regulatory filing, up 32.7 percent on year but short of a market consensus of 65.8 billion won compiled by FnGuide.
Annual revenue came in at an all-time high of 245.2 billion won, up 16.2 percent on year, while operating profit rose 24.4 percent to 97 billion won.
Overseas sales rose by 36.3 percent on year, the company said, thanks to increased sales of Letybo in China.
Established in 2001, Hugel has been Korea's No. 1 botulinum toxin manufacturer in terms of sales since 2016, followed by No. 2 Medytox and Daewoong Pharmaceutical.
Last year, Bain Capital sold a 42.9-percent stake plus convertible bonds in Hugel to Aphrodite Acquisition Holdings, a special purpose company owned by CBC Group, a Singapore private equity company, Abu Dhabi-based Mubadala Investment and Dione, another special purpose company that is owned equally by GS Holdings and Seoul’s IMM Investment.
GS and IMM Investment initially were to invest $150 million each to acquire 30 percent of Aphrodite Acquisition Holdings. But GS recently increased the investment to $250 million in order to acquire 42.5 percent of the special purpose company and become the largest stakeholder of Hugel.
BY SARAH CHEA [email@example.com]