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Chugai Pharmaceutical
1/29/2026
President and CEO, I will provide a summary of our 2025 performance and the outlook for 2026. Please refer to slide five. Regarding our full year results for 2025, revenues, operating profit, and net income all reached record highs on a core basis. Revenue reached 1,257.9 billion yen, exceeding our initial forecast by 5.7%. This was primarily driven by higher-than-expected exports of Actimura and Libra to Roche. Operating profits surpassed the 600 billion yen mark for the first time, representing our ninth consecutive year of profit growth. Operating profit margin also hit a record high of 49.5%. Moving to our 2026 earnings forecast, we anticipate another year of record-breaking results. We are projecting a revenue of ¥1,345,000,000 up 6.9% year-on-year and operating profit of ¥670,000,000 up 7.5% year-on-year. Fueled by growth in domestic product sales, royalty income, and other revenue streams. At the same time, we expect to maintain a high operating profit margin. The next slide illustrates our revenue trends. We expect revenue to increase by 87.1 billion yen or 6.9% compared to 2025. Domestic product sales are projected to raise by 25.6 billion yen, as steady growth of new and mainstay products outweighs the negative impacts of NHI price revision and generic competition. Overseas product sales are expected to remain flat year on year, while Nemluvio and Hemlibra will continue to grow. These gains will be offset by lower export unit prices and a decline in Actemra sales due to biosimilar entry. In contrast, other revenues are set to increase significantly, driven by higher royalty and profit share income from Namluvio and O4 Glupron and Hemlibra, alongside an increase in milestone payments. Next is page 8. I will discuss our dividend policy. Reflecting our strong 2025 performance, we plan a year-end dividend of 147 yen per share. This includes an ordinary dividend of 72 yen, up 22 yen from our initial forecast, and a 100th anniversary commemorative dividend of 75 yen. Combined with the interim dividend of 125 yen, the total annual dividend will be 272 yen per share. For 2026, consistent with our policy of targeting an average dividend payout ratio of 45% based on core EPS, we plan to increase the ordinary dividend by 10 yen from 2025, bringing the forecast annual dividend to 132 yen per share. Page 9. Moving on, I would like to review our 2025 management policies and priority items. Under strengthening red functions and value creation, we successfully confirmed the proof of concept for Next 007. Furthermore, we accelerated our focus strategy by deciding to collectively discontinue five in-house development projects and making go-no-go decisions on six others. Open innovation also progressed steadily, as evidenced by the conclusion of 12 new research and technical collaborations. We've seen a maximizing value of lifecycle management projects. Despite the delay in VDIS launch, we achieved several key milestones. This includes the successful Phase III results and subsequent filings for Oswald-Gluperon, and continued growth of domestic mainstay and new products and strategic in-licensing of Spar Centan from a third party. Regarding strengthening the foundation, while we face some challenges in meeting our 2030 midterm environmental goals, overall progress was smooth. Key highlights include the rollout of our new HR system and the launch of a company-wide initiative to accelerate business transformation using AI. This slide details the progress of our R&D project in early in-house development, Mint 91, and the midsize molecule of 001 transition to Phase 1, while GIN 329 for obesity moved into Phase 2. Late-stage development also saw significant progress for products expected to drive future domestic growth, including the addition of , the transition of to history, and positive trial data for . Additionally, we have successfully obtained regulatory approval for . As our project portfolio expanded through the redshift, we prioritized the selection and concentration of early-stage projects through collective discontinuations and rigorous go-no-go assistance. Consequently, the number of Phase I projects was reduced from 21 at the end of 2024 to 15, allowing us to focus our resources on high-priority candidates. With nine projects in Phase II and 28 in Phase III, we continue to maintain a robust and healthy pipeline. Three projects are currently under regulatory review with approvals expected within this year.
Next, page 11. We're going to review priority items for structuring the Hemophilia franchise development of Hemolibra autoinjector progress, and we confirmed proof of concept for next 007. We confirmed biological proof of concept and are steadily progressing toward initiating Phase II studies. Regarding RedVidis, two of our first gene therapy products, following a fatal case of acute liver failure in an overseas non-ambulatory patient, we strengthened safety measures while maintaining close coordination with relevant authorities. We aim for a prompt launch following Reimbursement approval for ambulatory patients aged 3 to 7 years. Regarding the new HR system launched last January, over 20% of all employees volunteered and proportion of job postings in annual personnel transfers exceeded initial target, reaching over 60%. We'll continue to promote employee autonomy in career development. Page 12. We will explain progress in the first five years of our 10-year top I-2030 plan regarding the first pillar, realizing global first-class drug discovery, drug discovery projects, and mid-size molecule pharmaceuticals made steady progress. We also accelerated external partnerships and investments to drive further innovation, including CDF investments and introduction of For the second pillar, building futuristic business model, we reorganized the value delivery functions of sales, medical, and safety. On the production front, we successfully supplied products to meet rapid demand fluctuations and established our own production infrastructure for the future. Simultaneously, we advanced company-wide DX, including projects for the launch of Aspire. Based on the progress over the past five years, we defined five targets for the latter half of 2030 to achieve annual launches of Chugai originated global products. We will enhance early stage development capabilities, including pharmaceuticals, while collaborating with partnering functions in Japan, U.S., Europe, and Singapore to pursue further drug discovery innovation. In production, we'll establish a stable supply system considering geopolitical risks to prepare for increased supply responsibilities accompanying the growth of in-house global products. Furthermore, in the newly entered CVM field and metabolism field, we will build systems and capabilities to enable advanced development. project management, safety, medical affairs, and sales activities that respond to the distinct characteristics of this field and changes in the external environment, thereby maximizing the value delivered to patients. To achieve these goals, we will advance the utilization of AI across the entire body chain and derive business transformation. We present the management policies and priority items for 2026, the first year of the LANA five-year period. The management policies are enhancing RET functions and creative value, maximizing value of LCM projects, and strengthening business foundations. The priority items are shown on the right. There are four of them. We'll continue to strengthen our hemophilia franchise by advancing development toward application for the Hemlibra autoinjector any initiating phase-through studies for NEXT-707. We also anticipate the highest number of domestic applications to date. These initiatives are expected to drive short- to medium-term growth in domestic sales. In particular, for Nunsunio, one of the products expected to achieve large-scale growth, we aim for early market penetration and combination therapy with Poli-B. We also ensure the successful launch of our new ERP system, Aspire, and promote the company-wide utilization of AI. Now, looking at the average annual trend in the number of Chugai-originated global products launched since 2001, the number has steadily increased in the past. Particularly over the last five years, the number of launches of in-house global products has increased, and these products will drive profit growth in the short to medium term. Furthermore, we anticipate that achieving the annual launch of in-house global products target set in top I-2030 will lead to further profit growth thereafter. Moving forward, we'll continue to leverage Shuga's unique drug discovery approach to advance drug discovery, including midsize molecules and develop new modalities, thereby expanding the creation of innovative new drugs that only Chugai can deliver. Through these efforts, we'll achieve the top I-2030 goals and realize sustainable growth beyond them. The next slide, page 16. Last but not least, regarding the opening of our U.S. partnering offices. We opened the Chugai U.S. Partnering Office in South San Francisco, commencing operations this month. It will explore, identify, evaluate, and promote collaborations with U.S. academia and venture companies. In addition to the U.S., we will strengthen our partnership network connecting Tokyo, London, and Singapore to advance global open innovation. Page 17, the last page, this shows the summary of what I said and that concludes my presentation.
We have the overview of development pipeline from Cusado. We apologize for the disturbance we had, and we will pause for a few moments at the very beginning of the session. I hope you will make use of that opportunity for a screen capture. Thank you. I am Kusano. I am with Project and Lifecycle Management Unit. Please refer to page 20 of the slides. This looks at our fourth quarter topics. I will go through these starting from the top. We secured two approvals. Tessentric obtained an indication expansion for unrespectable thymic cancer. Nunsumio was approved for a new subcutaneous injection formulation. On the filing side, there were also two key developments for our in-house product or for Glipron. Eli Lilly has filed an application in the United States for its use as an obesity treatment. Regarding Hacentric, we filed an application yesterday for its use as adjuvant therapy in MRD-positive bladder cancer. We also initiated the three phase three trials for Roche products. Tron Tinexmab for Alzheimer's disease, Xelabensiran for hypertension, and Giva Sarxuse for first-line non-small cell lung cancer. Additionally, Dibiracib received organ drug designation last December for KRAS G12C mutation positive unresectable advanced or recurrent NSCOC. There were two pipeline divisions. Based on the data accumulated to date, we have decided to discontinue the development of BRITEN for chronic diseases. Furthermore, the development of Ticentric for perioperative and SCOT was discontinued following the results of the I Am Power O30 trial. Details regarding recent publications, new contracts, and investments by Chugai Venture Fund are summarized on this slide. Moving on to the second page of topics, for our in-house product, PiaSky, we achieved positive results for Phase III trials for atypical hemolytic uremic syndrome. Orthoglyperon also met its primary endpoint in a switching trial following the administration of injectable incretins. Furthermore, I am pleased to announce that N-Spring met its primary endpoint in the phase three trial for myelin oligodendrocyte glycoprotein antibody-associated disease. Based on recent trial data, we plan to file for Ziva, Giri Desran, Daini Bisumab, and Spar-Sentan within 2026. Regarding academic conferences, there were three presentations. I will provide a more detailed update on Giri Desran later in this session. This is a summary of our major RFD events in 2025. My changes from the previous updates are underlined and shown in bold fonts. While a few items have been carried over to the next fiscal period, we consider these results to be generally highly satisfactory. In particular, looking back, the confirmation of POC for our in-house product, Next 007, a major milestone, and the decision to advance it to Phase 3 represent a significant progress. Next, I will discuss the major milestones for 2026. A key readout for our in-house portfolio is the Phase 3 trial of N-Spring for MOGAD. which, as recently announced, successfully met its primary endpoint. Regarding JIN 3-29, we will not refer to it by its international non-proprietary name, IMM, a new girl bard. We plan to announce results for three Phase II trials for amil-Globar this year. For SMA and FSHD trials, the data has already been collected, and we look forward to sharing the results with you soon. For Roche products, typical trial readouts are scheduled for Givaracid, Gira-Destran, Lunsivio and Cephexran. Regarding trial starts, we have listed those that have already been publicly disclosed. For next 007, we have the Schedule III, Phase III trials, including head-to-head comparison with the head-libra. We also plan to initiate a Phase II trial for DONC52 in celiac disease. Now I will present the results from two trials for Firi-Vestrant. First is the Evora trial, for hormone receptor positive for two negative breast cancer in patients previously treated with the CGK4-6 inhibitor. Although these results were presented at last year's ESMO Congress, I would like to review them with you today. Here, Destron is an oral selective estrogen receptor degrader, or SIRD. designed to inhibit estrogen receptor signaling regardless of the SR1 mutation status. It is expected to show efficacy even in tumors that have developed resistance to conventional endocrine therapies, including previous generation SIRS. In in vitro studies, it demonstrated higher cell proliferation inhibitory activity compared to other oral certs. Furthermore, the combination of giridescerant and mTOR inhibitor edarolimus is expected to provide superior anti-tumor activity compared to monotherapy by simultaneously inhibiting two key signaling pathways involved in hormones, receptor-positive breast cancer proliferation, and endocrine resistance. In the EVRA trial, this combination significantly improved the investigator-assessed PFS, the primary endpoint, in both the ESR1 mutation-positive and ITT populations. The therapy reduced the risk of disease progression or death by 62% in ESR mutation positive group and 44% in the ITT population. These results suggest that daguerreidespirant plus devirolimus could become a valuable new oral treatment option for patients previously treated with TDK4-6 inhibitors, a segment with limited effective alternatives regardless of their ESR1 mutation status.
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