INNOVATIVE PHAR(00399) issues profit warning, expecting a net loss of approximately HK$550 million to HK$600 million for the year.

INNOVATIVE PHAR(00399) announced that it is expected to incur a net loss of approximately HK$550 million to HK$600 million for the fiscal year ending on March 31, 2025, compared to a net profit of approximately HK$98.7 million for the fiscal year ending on March 31, 2024. The anticipated loss is mainly attributed to significant impairment losses of intangible assets related to the development of the oral insulin product (the product), ranging from HK$250 million to HK$350 million, and effective interest expenses of approximately HK$259 million from convertible bonds. The group is currently conducting the Phase III clinical trial Part B of the product, which began recruiting the first batch of patients in July 2020. Patient recruitment will continue. The group originally planned to commercialize the product in the first quarter of 2026. In order to ensure the timely progress of the plan, the group has implemented various measures, including evaluating and optimizing the clinical trial procedures, inviting new hospitals to participate in the trial, and expanding the sample size of existing clinical trial sites. However, the process of introducing new hospitals is complex and time-consuming, reducing the effectiveness of these measures. Additionally, the changing behavior of patients due to the COVID-19 pandemic has also increased the challenge of expanding the sample size in existing hospitals. Given the above, the group has not been able to fully implement all necessary measures. After careful consideration and based on the current situation, management expects the commercialization timeline of the product to be delayed to the third quarter of 2028.