[리포트 분석] Celltrion performance this year, Rekkirona shares influenced

[이데일리 김유림 기자] “The production of the Corona 19 antibody treatment Rekirona (CT-P59) resulted in less than the consensus in the fourth quarter.”

Last year, the company surpassed Yuhan Corporation, which had been the number one company in sales for the fourth consecutive year in the pharmaceutical and bio industry. The main factor below the consensus was Rekkirona.

Celltrion Corona 19 antibody treatment Rekirona. [사진=셀트리온]

KB Securities, Mirae Asset Daewoo, etc., through a performance review report on the 23rd, “With limited production capacity at the factory, the production of biosimilars declined due to the expansion of production of Rekirona, a treatment for Corona 19.” According to the analysis, the current development cost increased by 65.1 billion won (56.9% compared to the previous year) as a result of the second phase.

This year, too, with the production plan for Rekkirona, biosimilar production is expected to decrease, and the target price was only lowered or maintained. However, the situation changed when Celltrion announced on the 25th that it had begun a rolling review of’Rekirona’ at the European Medicines Agency (EMA). EMA’s Rolling Review is a system that promptly reviews prior to final application for approval in order to accelerate the evaluation of promising treatments or vaccines in crisis situations such as pandemics.

An official from Celltrion said, “After the rolling review is over, we will formally receive an application for product permission, and an emergency permission will come out immediately. We cannot predict an exact release schedule, but EMA has said that it will do it as soon as possible.” He added, “We are conducting consultations not only with Europe but also with major OECD countries in the world including the United States,” he added.

Earlier, in October of last year, the European Union (EU) granted approval after two months of starting a rolling review of Pfizer and Moder or Corona 19 vaccines. In addition, Italy has issued an emergency license for the antibody treatments Eli Lilly and Regeneron, which have not yet been approved by EMA. As can be seen in the case of approval for corona 19 drugs in Europe, it is expected that an emergency use permit for Rekkirona will be issued within two months at the latest.

An official in the bio industry said, “Considering that Eli Lily and Regeneron are still in the rolling review stage at EMA, there is ample opportunity for Rekkirona to dominate.” “Celltrion has a long history of entering the biosimilar market in Europe. Even if EMA permits are not issued by adding to, separate product permits can be issued for each European country.”

Celltrion has already completed the production of 100,000 people, and plans to produce 1.5 to 3 million additional people per year depending on demand to respond to immediate supply. The first plant produces Rekkirona and the second plant produces existing biosimilars.

Assuming that the overseas supply of Rekirona proceeds without problems, it is expected to contribute to earnings improvement of over KRW 1 trillion. Conservatively, the global supply for 1 million people, which is lower than the production target, and BIC Pharma’s antibody treatment that has been released overseas, is worth 1 trillion won, which is cheaper than the price per person of 1.5 million to 2 million won. It is not unreasonable to compare with the figures that Eli Lilly presented this year for COVID-19 treatment sales of 1 billion to 2 billion dollars (about 1.1 trillion to 2 trillion won).

In particular, it should be noted that the maximum margin can be left when the EMA officially approves for emergency use. The emergency use approval is because COVID-19 antibody treatments are supplied directly to more than 30 countries in Europe, reducing unnecessary costs such as intermediate distributors.

The investment industry also evaluated the potential of Rekkirona’s performance as important, but just entering the EMA rolling review stage. Bio Research Institute said, “By showing the achievements of developing new drugs in a short time, we have demonstrated our capabilities from a generic biopharmaceutical company to a new drug development company to the world.” “The results were less than consensus right now, but the urgent use approval process The meaning itself is extraordinary, he emphasized.