Chugai Announces 2025 2^nd Quarter Results

• Core revenue of ¥578.5 billion (+4.6%), Core operating profit of ¥272.0 billion (+3.5%), and Core net income of ¥193.5 billion (+2.1%) (all changes year-on-year)

• Steady progress in R&D activities for in-house project GYM329 (obesity) has initiated Phase II clinical trial, and the mid-size molecule project AUBE00 (solid tumors) has entered clinical development

• To maximize the success rate of achieving TOP I 2030 goals, the management has decided to dynamically and strategically allocate resources to priority projects, thereby discontinuing the development of five in-house projects in the early-stage clinical development, LUNA18, SAIL66, SOF10, STA551, and AMY109 

TOKYO, July 24, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its financial results for the second quarter of fiscal year 2025.

<Second quarter Results (Core results, January to June 2025)>

Chugai reported increased revenue and operating profit year-on-year for the second quarter (Core-basis).

Regarding revenue, domestic sales increased by 2.8%. In the oncology field, sales decreased by 1.9%. While new products Phesgo® performed well and Lunsumio® steadily penetrated the market, this was offset by the decline in Perjeta® and Herceptin® along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin® were affected by NHI drug price revisions and biosimilars. In the specialty field, sales increased by 8.4%, driven by significant growth of the mainstay product Vabysmo® and successful market penetration of the new product PiaSky®. Overseas sales increased by 7.3%, driven by a substantial increase in exports of Actemra® to Roche. Other revenue decreased by 0.4%, despite the increase in royalty income related to Hemlibra®, mainly due to a decrease in one-time income.

Cost to sales ratio increased by 1.3 percentage points year-on-year to 34.3%, mainly due to changes in the product mix. Research and development expenses increased by 2.7% due to investments into drug discovery and early development, and increase associated with the progress of development projects, while selling, general and administrative expenses decreased by 2.6% due to efficient management of various expenses. Other operating income (expense) resulted in income of ¥0.4 billion. As a result, Core operating profit was ¥272.0 billion (+3.5%).

<R&D activities>

Chugai made good progress in both early and late-stage development activities.

In early-stage development of in-house projects that will drive mid to long-term growth, GYM329 (for obesity) and Hemlibra (for von Willebrand disease) have initiated Phase II and Phase III clinical trials, respectively. Additionally, AUBE00 (for solid tumors), the second clinical-stage project following LUNA18 in our mid-size molecule pipeline, has initiated Phase I clinical trials. In late-stage development, Alecensa® has been filed for approval for additional tumor agnostic indication in ALK fusion / rearrangement gene-positive solid tumors, including pediatric patients. In-house projects out-licensed to third parties excluding Roche also progressed steadily, with AVMAPKI™, out-licensed to Verastem Oncology, receiving approval from the U.S. Food and Drug Administration (FDA) for use in combination with FAKZYNJA™ for KRAS-mutated recurrent low-grade serous ovarian cancer, under the accelerated approval pathway* based on overall response rate and duration of response.

Chugai has made the management decision to discontinue our development of five projects from early-stage in-house clinical development pipeline; LUNA18, SAIL66, SOF10, STA551, and AMY109. Since the launch of TOP I 2030 in 2021, we have continuously generated new projects and built technological foundations through enhanced RED functions. The number of early-stage projects has been increasing, with nine in-house projects entering clinical development over the four-year period. For early-stage clinical development pipeline, we have prioritized in-house projects after considering obtained data and the current portfolio situation, resulting in the decision to discontinue these five projects. Through this decision, we aim to maximize the success rate of achieving TOP I 2030 goals through dynamic and strategic allocation of resources to priority projects.

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, Elevidys® has obtained regulatory approval as a regenerative medicine product for the treatment of Duchenne muscular dystrophy under the conditional and time-limited approval pathway in Japan. Vabysmo has received approval for an additional indication for angioid streaks, and Evrysdi® has launched a new formulation in Japan. Lunsumio has been filed for an additional indication in combination with Polivy® for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and Tecentriq® has been filed for an additional indication for unresectable thymic cancer. Additionally, Vabysmo (for non-proliferative diabetic retinopathy) and inavolisib (for PIK3CA mutated breast cancer) have initiated new clinical trials.

[2025 second quarter results]

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

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