Toxin Companies Resolving 'Indirect Export' Risks Show Mixed 2Q Results

The second-quarter performance of Botulinum Toxin (BTX) companies embroiled in the 'indirect export' controversy showed mixed results depending on the company.

Hugel 'Botulax', Daewoong Pharmaceutical 'Nabota', Medytox 'Coretox'. (From left) [Photo by each company]

According to the industry on the 14th, Hugel's BTX formulation 'Botulax' recorded provisional sales of 43.4 billion KRW in the second quarter of this year. This represents a 17.4% increase compared to the same period last year. Domestic sales of BTX and fillers increased by nearly 40%, driving the revenue growth. Sales of BTX and filler product lines also rose by 17.8% in overseas markets. Considering that BTX products account for about half of Hugel's total sales, it is estimated that BTX sales increased significantly.

Medyttox also achieved sales growth centered on the domestic market. Medytox's combined BTX product sales in domestic and overseas markets reached 27.9 billion KRW in the second quarter of this year. In particular, the increase in domestic sales drove the performance, with Medytox's second-quarter domestic BTX formulation sales reaching 15 billion KRW, a 50% increase compared to the same period last year. Compared to the previous quarter, domestic sales of BTX formulations surged by 198%. However, overseas sales decreased by 11% compared to the same period last year.

In contrast, Daewoong Pharmaceutical was the only major BTX company to see a decline in second-quarter BTX formulation sales. Daewoong Pharmaceutical's BTX formulation Nabota recorded sales of 32.7 billion KRW, down 11.9% from the same period last year. However, Daewoong Pharmaceutical is expanding its market by increasing the number of overseas sales countries through its North American partner Evolus. In June, Evolus also launched Nabota (European name Nuceiva) in Italy.

Companies offered different interpretations regarding the changes in toxin product sales in the second quarter of this year. A Hugel representative explained, "We showed growth due to strong performance in the Asian market and completion of entry into 23 European countries," adding, "Domestic sales also increased as we expanded sales channels by entering professional pharmaceutical online channels."

A Medytox representative said, "The impact of one-time payment fees was removed, and sales in our core business areas grew," adding, "Domestic sales were strong due to the good performance of the BTX formulation Coretox, which has become a flagship product."

Daewoong Pharmaceutical attributed the decline to a temporary shutdown of the Nabota production plant. A Daewoong Pharmaceutical representative stated, "Not only Nabota but also our bio plants regularly close for internal equipment maintenance as part of process efficiency schedules," adding, "This year, from January to April, the Nabota production base underwent process efficiency improvements, so first-half sales appear to have temporarily decreased."

Companies forecast that the BTX market will generally recover in the second half of the year. This is because the number of countries entering overseas markets is gradually increasing, and the legal risks related to indirect exports from the Ministry of Food and Drug Safety have been somewhat resolved. Previously, the Daejeon District Court ruled that the Ministry of Food and Drug Safety's manufacturing suspension order and product approval cancellation against Medytox, due to distribution issues during the indirect export process, were unjust.

A Medytox representative said, "We expect BTX formulation sales to recover in the second half of this year," adding, "With the court ruling on the Ministry of Food and Drug Safety's product approval cancellation, we aim to achieve the highest performance this year." A Daewoong Pharmaceutical representative also said, "Demand for Nabota is expected to increase mainly in overseas markets, so we decided to build a third plant in May," adding, "Sales will continue to rise not only in the second half of this year but also thereafter." A Hugel representative also stated, "Sales are doing well in major markets such as China, so we expect good performance in the second half following the first half."