Shinbio Pharmaceutical <4582> announced its consolidated financial results for the third quarter of the fiscal year ending December 2024 (January to September 24). Revenue decreased by 57.1% year-on-year to 1.898 billion yen, operating loss was 2.791 billion yen (compared to a loss of 0.283 billion yen in the same period of the previous year), ordinary loss was 2.759 billion yen (compared to a loss of 0.156 billion yen in the same period of the previous year), and quarterly net loss attributable to the parent company shareholders was 2.845 billion yen (compared to a loss of 0.788 billion yen in the same period).

Currently, Rapid Infusion (RI) administration, which shortens the administration time of Trexim (R) intravenous infusion solution 100mg/4mL [RTD (Ready-To-Dilute) formulation] to 10 minutes, has been approved. The RTD formulation can reduce the time required for manual and laborious dissolution work compared to the conventional freeze-dried formulation (FD formulation), and further, by RI administration, the administration time can be significantly reduced from the conventional 60 minutes to 10 minutes, thus significantly reducing the burden on patients and healthcare providers. In addition, the infusion volume is also significantly reduced to 50mL from the previous 250mL, reducing the salt content. By the end of September 2024, RI administration was carried out in over 90% of medical facilities, although the erosion of generics is gradually progressing in sales activities. Concerns about the potential for delayed progression to infection or exacerbation of serious infections during or after Bendamustine therapy have slightly eased, resulting in a situation where performance is progressing as planned for the revised financial estimates. Sales promotion and general administrative expenses recorded 2.492 billion yen as research and development expenses (an increase of 36.69% year-on-year), and the total of other sales and general administrative expenses amounted to 4.235 billion yen (an increase of 12.7% year-on-year).

In February 2022, four companies obtained manufacturing and sales approval for generic pharmaceuticals based on the company's product Trexim (R) RTD formulation, with two of them commencing the sales of generic pharmaceuticals in the same year. As both companies obtained approval for Rapid Infusion (RI) and started sales, the potential for infringement of patents held by Eagle, the licensor of the product, and infringement of exclusive patent implementation rights held by the company arose. Subsequently, discussions were held with Eagle, the licensor, resulting in litigation filed in December 2022 against Pfizer and Toa Pharmaceutical <4553> for manufacturing and selling generic pharmaceuticals based on patent infringement. The case against Toa Pharmaceutical was settled in September 2024.

For the full fiscal year ending December 2024, the consolidated performance forecast announced on May 7th, maintaining the modified forecast, expects a revenue of 2.623 billion yen, operating loss of 3.702 billion yen, ordinary loss of 3.524 billion yen, and a net loss attributable to the parent company of 3.628 billion yen, a 53.1% decrease from the previous year.