“In 2021, Hugel’s sales recorded 245.2 billion won ($ 204.4 million), the largest since its inception. In 2022, the company will go beyond the leading botulinum toxin (BTX) producer in Korea and exploit the world’s three largest BTX markets – China, Europe and the United States. “
Hugel CEO Sohn Ji-hoon said this and other remarks at an online news conference on Thursday.
According to Hugel, the global BTX market is about 6 trillion won, and BTX products for cosmetic purposes account for 49 percent. The United States, Europe and China fill 80 percent of the market among them.
Sohn said Hugel aims to release the BTX product Letybo in Europe this year and expand product distribution to 36 countries in Europe by 2023.
The company said Hugel’s cheaper BTX would be able to compete against the three leading BTX products in Europe – AbbVies Botox, Ipsen’s Dysport and Merz ‘Xeomin.
Sohn said a BTX product in Europe is highly priced at around $ 400-600, but Hugel’s product will be 20-30 percent cheaper than its competitors, just like in China.
Hugel also expects to enter the United States this year.
Han Seon-ho, Chief Marketing Officer at Hugel, said the company applied for FDA approval for BTX in March last year. The FDA completed the inspection of the Geodu plant in Chuncheon, Gangwon Province, last year.
“We expect to win FDA approval by the middle of this year,” he said.
The company also hopes to win the license in Canada and Australia by 2022.
As Hugel has Croma Canada and Croma Australia as subsidiaries for direct exports, the company expects rapid growth in the two countries, he said.
In China, Hugel Letybo rolled out last year.
The company plans to raise market share to 15-20 percent in China by holding academic events and strengthening relationships with local doctors.
The company also plans to add Letybo’s indication to reduce square jaw in China.
“Based on the Phase 1 trial conducted in Korea, we are preparing for a Phase 3 study in China,” he said.
Hugel is developing a fluid-type BTX, HG102, and will begin a Phase 3 study of “painless” HG102 in the second quarter.
Hugel is building a third factory to enter the global market and manufacture the next generation product.
Sohn said the company invested $ 56 billion won in building the four-story factory in June this year.
From 2023, the company will be able to make BTX products 2.4 times the current production with the new plant, which will also produce liquid type BTX, he said.
Last year, Hugel was on the verge of losing its license to BTX due to the dispute over the lack of government approval for exports.
At the time, the Department of Food and Drug Safety mistakenly assessed that exporting BTX through a trading company was the same as selling BTX in the local market, Sohn said.
“I feel sorry for MFDS ‘interpretation. If the government uses such an unfair measure, many Korean companies that have followed industry practices will become criminals,” he said.
This case is almost closed because the Seoul administrative court accepted the company’s request for cancellation and temporary suspension of MFDS ‘administrative order, he added.
Hugel secured MFDS ‘promise to clarify to inquiries from overseas companies that the question at Hugel was not about the quality of the product, Sohn continued.
He hoped the court would make the right decision and urged the MFDS to provide clear guidelines.
Hugel also announced its plan to switch the major shareholder.
On Thursday, GS said it would invest another $ 300 billion won in Hugel in a public application. In the process, GS secured a 62.5 percent stake in Dione.
GS established Dione, a special purpose company, to acquire a stake in Hugel from Hugel’s largest shareholder Bain Capital. As a result, Dione plans to acquire 42.89 percent of the Hugel shares. This makes GS the largest shareholder in Hugel.