CHUGAI PHARMACEUTICAL CO., LTD. — Call Transcript 2025

Ladies and gentlemen, thank you very much for attending the conference on FY 2025 December Q3 financial results. My name is Kae Miyata. I am in charge of today's facilitation. I am from the PR and IR department. Today we are using the Zoom webinar system. The agenda is shown on the presentation slide page 3. The presentation will be conducted in Japanese. However, we do have simultaneous interpretation service available for English speakers. Please make sure you select as you click on the language of your preference. You can choose either Japanese or English. We are going to receive questions at the end of the presentation. We have 30 minutes for Q&A. During the presentation, all of your voices and audio are muted. Now I would like to ask Dr. Osamu Okuda to give us the FY 2025 Q3 overview. Osamu Okuda, thank you. I'll be talking about 2025 Q3 performance. Please turn to page 5. 2025 Q3 performance, both domestic and external product sales, was very strong. Sales and profit both were very good. Year-on-year revenue was +5.0%. Operating profit +5.6%. Profitability for the quarter is 6.2%. Based on the Q3 results of the steady progress, we believe that we will be able to meet the target for the full year. In terms of the revenue details, I will be presenting in the next slide. Comparing to last year, the revenue is JPY 43.1 billion increase, +5.0% growth. Breakdown from the left-hand side, I would like to start. Domestic, with the NHI price revision and the generic drug, there was negative, but we have the Phesgo, PiaSky, and then Vabysmo, and Hemlibra, and N-Spring were very good. JPY 12 billion increase in revenue. Overseas, unit price for export did drop. However, volume and foreign exchange impact was large, which increased dramatically. JPY 32.2 billion increase positive. Next, main major Chugai originated products. Our growth driver in Hemlibra is driving the international markets growth. Japan, U.S., Europe, it continues to be in a growth phase. On the other, Actemra for Japan, U.S., Europe, the biosimilar remains unclear, therefore we expect sales to drop. Kaliderma, the licensed out product, the NEMLUVIO, better than expected results. Also, licensed out the orforglipron for all the readout, all phase 3 study for all of the items we have achieved. For 2025 obesity, for the type 2 diabetes, 2026 global approval submission is going to begin. Therefore, potential with great sales, third-party licensed out products are performing very well, which will drive growth for the long term. Next, Rhenalis Pharma Inc., that we bought the IgA nephropathy treatment. This is what I will talk about. This is something that we are providing value to solution to our patients so that we can give stable return to our shareholders. This is a capital allocation policy that we follow. Investing in creative and delivery of innovative medicine is a strategic investment. Outside of Roche, this is going to be the third party that we'll be working sparsely on. In Europe and the U.S., it's all been approved and launched. Rhenalis Pharma Company. has already released their press release. In Japan, phase 3 for all of the assessment, the subjected cases in all major items, status has been collected. At this moment, earliest 2026 approval submission is planned to contribute to sustainable growth domestically. First-in-class treatment, we would like to give it to our patients as soon as possible, even one day earlier. That's all I had for you tonight. Thank you very much. Next, Kusano. I will present to you the development pipeline. Yes, I am from the Project Lifecycle Management Department. I am Kusano. Please take a look at page 10 of the slide. This is the third quarter topics. I will explain in detail from top. In-house product, PiaSky, has been launched in Taiwan for PNH. Two Roche products have been approved. Tecentriq is being developed for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma needle type, which is a rare disease. It is the very first immune checkpoint inhibitor approved in Japan. CellCept submitted a finding based on public knowledge for the treatment of refractory nephrotic syndrome and received approval in September. One application was submitted for Roche Avastin for neurofibromatosis type 2 in August this year. Four Roche products have begun trials. Grafitamab has initiated a domestic phase 2 trial for relapsed or refractory diffuse large B-cell lymphoma and refractory mantle cell lymphoma. Afim Kibart has entered phase 3 trials, a trial for Crohn's disease. Additionally, Dvorasiv has entered a phase 1b trial for the first-line treatment of NSCLC, non-small cell lung cancer. Regarding pipeline exclusions, following the result of clinical trial conducted overseas, Roche discontinued the development of PiaSky for sickle cell disease, and it was therefore removed from the pipeline. Tiragolumab was approved for the treatment of NSCLC in Japan following the result of the Skyscraper 03 and Skyscraper 14 trials. Development for lung cancer and hepatocellular carcinoma has been discontinued. In the third quarter, we had many readouts for our in-house developed products. Orforglipron, which we licensed out to Eli Lilly, is being evaluated for the treatment of obesity in the ATEN-1 and ATEN-2 trials, both achieved their primary endpoints. In addition, the ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 studies for type 2 diabetes achieved pivotal results, respectively. Furthermore, the ACHIEVE-J trial conducted in Japan to evaluate safety indicated that orforglipron can be dosed in patients with type 2 diabetes safely. The result from two global phase 3 studies for N-Spring in thyroid eye disease have been obtained. I will explain about this in more details. Regarding PiaSky for sickle cell disease, we previously announced that it was removed from the pipeline, but the primary endpoint was not met in the phase 2 CROSSWALK-C study conducted overseas. Please wait for future conference presentations for detailed data. Next, we have a readout from Roche. For Vabysmo, we have two phase 3 global trials results targeting at rheumatic macular edema, RME. The SANDCAT trial, where Japan participated, did not meet its primary endpoint, while the MIRCAT trial, which Japan did not participate in, achieved its primary endpoint. In both trials, the proportion of patients whose vision improved after treatment with Vabysmo was numerically higher. Based on these results, we plan to hold consultation with regulatory authorities regarding application for approval. Tecentriq and Gildestrant Tartrate each met their primary endpoints in the indicated studies. We presented three of our in-house products and five Roche products at the medical conference. In addition to the trial results presented so far, the final OS data for the ALEX trial of Alecensa in NSCLC was also released. The company also has announced a positive result in the ALINA trial for adjuvant therapy. All Roche products have already been announced in press release. Regarding product and technology in-licensing, we have signed an agreement with Roche to license CT388, a long-acting GLP-1/GIP receptor agonist. Additionally, as announced in the news release, we collaborate with Rani Therapeutics to develop an oral formulation using RaniFIL technology. A license agreement also covers the development and commercialization of this formulation. Furthermore, as explained by Dr. Osamu Okuda earlier, with the acquisition of Rhenalis IgA nephropathy treatment for IgA nephropathy, we acquired the development and sales rights for Sparsentan. I will provide more details on the scientific aspects of Sparsentan in creating MOA. Major R&D events in 2025 are here. The bold and underlined parts indicate changes from the previous financial statement. As I mentioned earlier, N-Spring, Gildestrant Tartrate, Vabysmo, and PiaSky's study results are now available. Leucemio's cell stimulant trial and Gildestrant Tartrate's Persevere studies' readout timing is now changed to 2026. In addition, data for the GYM-329 trial for SMA and FSHD are to be presented in the first half next year, primarily for competitive reasons. Next, this is the result of a phase 3 study of N-Spring in thyroid eye disease. These results were recently presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery, ASOPRS, annual meeting. First, the study design. The SATRA-GO-1, SATRA-GO-2 studies compared N-Spring with placebo in patients with moderate to severe thyroid eye disease, verifying the usefulness of IL-6 inhibition based on existing non-clinical and clinical data. Patients with active and inactive thyroid eye disease were enrolled in studies and were randomized to either the N-Spring arm or the placebo arm in a 1:1 ratio. The results obtained this time were as follows. At week 24, as indicated in orange, we evaluated the percentage of patients with active thyroid eye disease who showed proptosis improvement. Results from the SATRA-GO-1 trial showed an improvement ratio of 49% in the N-Spring arm and 31% in the placebo arm. No statistical difference was obtained. In contrast, in the SATRA-GO-2 trial, it was 53% in the N-Spring group and 23% in the placebo group. A statistical difference was proven. Additionally, although it's not shown in the slide, both studies demonstrated clinically meaningful improvement with N-Spring in key efficacy endpoints, including proptosis, double vision, and clinical activity score in active and inactive thyroid eye disease. Safety data for N-Spring in thyroid eye disease are consistent with established data for the marketed NMOSD treatment. No new safety concerns were identified, and treatment was well tolerated. We'll continue to analyze the result of this study and plan to hold consultations with the authorities regarding future submissions. N-Spring offers convenience, subcutaneous administration once every four weeks, and a favorable safety profile, making it a promising treatment for thyroid eye disease. Next is about Sparsentan, which will be acquired through the acquisition of Rhenalis Pharma, which was announced today. Sparsentan is a drug whose efficacy in treating IgA nephropathy has been evaluated in an overseas phase 3 trial and is approved in the U.S. and Europe. A small-scale phase 3 clinical trial is currently underway in Japan, and the drug is expected to become a first-in-class treatment. This drug inhibits the renin-angiotensin system and endothelin pathway simultaneously, providing dual inhibitor effects in a single drug. Therefore, it has been shown to have a strong urinary protein reduction effect as a single drug without the need for combined use with a renin-angiotensin system inhibitor. Using the diagram on the left, I'll explain the mechanism of IgA nephropathy. First, due to a combination of genetic and environmental factors, IgA1 with abnormal glycosylation is produced. The human immune system recognizes this abnormal IgA1 as a foreign substance and produces anti-IgA1 IgG antibodies. These form immune complexes, which then deposit in the glomeruli and cause glomerular damage through the complement activity. In damaged glomeruli, the burden on the glomeruli increases and sclerosis progresses. Sparsentan suppresses blood pressure increases and vascular constriction through its dual antagonistic action, thereby suppressing nephritis, reducing the burden on the kidneys, and protecting the nephrotic function. Cefacericin, which is also being developed for IgA nephropathy, inhibits complement, and it has different MOA. Through the development of these two drugs, Sparsentan and Cefacericin, we aim to improve the complex pathology of IgA nephropathy and improve the condition of a wide range of patients. Next, I will explain the result of a phase 3 trial conducted overseas using the graph on the right. In this trial, Sparsentan was compared to the renin-angiotensin system inhibitor, irbesartan. Both drugs were administered orally once daily for 110 weeks. The primary endpoint was the mean change from baseline in urinary protein to creatinine ratio at week 36. The mean change was 15.1% in the irbesartan and 49.8% in the Sparsentan arm, demonstrating a significant reduction with Sparsentan compared to the irbesartan group. Additionally, AE were comparable between the two arms. Finally, this is the projected submissions. Projects marked with a light blue star are newly added projects. We have added a new category of in-licensed third-party products, which are shown in purple. We expect to submit an application for Sparsentan next year in 2026. The following slides are attached as reference material. That's all for my presentation. Lastly, Mr. Taniguchi will talk about the Q3 consolidated core outline. Mr. Taniguchi, so let me take over. Q3, we did JPY 43.1 billion, year-on-year 5.0%+, JPY 911 billion. Core operating profit, JPY 23.9 billion, 5.6%+, JPY 450 billion. First, I would like to say that this is how we did very well for the revenue. In terms of the revenue, in terms of the sales, JPY 794.6 billion. Year-on-year is 5.9%, JPY 44.3 billion. By region, domestic Japan, JPY 343 billion. Year-on-year, JPY 12 billion, 3.6%+. Next, this is new product and mainstay products are very well. Of course, NHI pricing revision and generic drugs are absorbed properly. Overseas, continually the Roche to Roche, we are doing JPY 450 billion. Year-on-year, JPY 32.2 billion, 7.7%+ increase. Royalty and other income and Hemlibra royalty is increasing. On the other hand, in terms of a third-party, one-time income dropped, so therefore it's JPY 117 billion. Pretty much flat as last year. In terms of costs, we have JPY 263 billion in terms of COGS, JPY 19.2 billion, year-on-year, 7.9%. Value-based sales increased, so comparatively it also increased. In terms of the cost-to-sales ratio, relatively Actemra that has high cost. The composition ratio is a bit higher. Therefore, it went up by 0.6 points to 33.1%. SG&A, with the cost of goods and HR rising, we are doing efficiency as well as other means so that it is down by JPY 3.1 billion. R&D, drug discovery, and early development projects are doing very well. That is reflected, so year-on-year, JPY 0.9 billion increase. Therefore, in terms of the profitability, year-on-year, it's JPY 2 billion that you can see. Total operating profit, year-on-year, is JPY 23.9 billion, increased JPY 450 billion in total. Operating margin is 49.4%. It's 0.3% up or 0.3 point up. In terms of net income, after taxes, JPY 320 billion and JPY 18.7 billion, 6.2% increase. Next, in terms of the sales by product, the DARC, the domestic oncology, JPY 180 billion, year-on-year, JPY 0.4 billion increase, an increase of 0.2%. Content-wise, in terms of the generic drug, Avastin dropped. On the other hand, new product, Vesigo, sales is a replacement. Ajeta is much higher, so therefore it's very good. Also, new product, Lansimil has started very well. Specialty area, JPY 163 billion, year-on-year, JPY 11.7 billion, 7.7% increase. Overall, NHI price revision impact was there, but the mainstay Hemlibra, Actemra, N-Spring, and Vabysmo are very well, and therefore, new product, PiaSky, also continuing from last year. It continues its momentum and increasing sales. Overseas, as we have explained before, especially Actemra, JPY 32.2 billion, year-on-year, 7.7% increase is what we are seeing. Hemlibra, JPY 1.1 billion is positive. Q2, next page, Hemlibra and Actemra. This is what we can see. Hemlibra, we are to have it in the end of June, the JPY 38 billion. There has been some delay because of delivery. It's going to be delayed to July. Actually, this has been accounted for Q3 cumulatively, year-on-year, JPY 0.4 billion positive. At this moment in time, year-end, the shipment schedule, if we keep this in mind, total annual full year, JPY 318.6 billion. We should be doing more than JPY 10 billion earlier, but I think we're going to do a similar more than JPY 10 billion more. Actemra, biosimilar permeation was delayed than our expectations. Q3 timing is getting closer to the full year of JPY 123 billion. From the schedule, we think we're doing very well cumulatively. Full year JPY 123 billion, we should be higher by JPY 20 billion, most likely at the end of the year. Operating profit up to September, breakdown. Left-hand side, domestic, domestic, JPY 12 billion up. Impact of the NHI price, JPY 7.5 billion. We are able to improve by volume. JPY 19 billion is the volume. We are able to accommodate the NHI price, JPY 7.5 billion. Overseas, sales JPY 32 billion. In terms of developing countries, sales expansion, unit price is down, volume is up in a big way. We have the foreign exchange impact, JPY 25.9 billion. Therefore, we are able to see such a big increase. The cost, of course, sales cost, JPY 19.2 billion. These are the main operating profit. The JPY 13.9 billion breakdown is what I just mentioned to you at this moment. Next page, please. From this point on, quarter by quarter, the sales, profit, and then the cost we're looking at. By quarter, it goes up and down somewhat. Q4, domestically, sales will improve. Overseas, export timing is not necessarily as regular as regular. This could impact in terms of timing. In terms of sales by quarter, three months at a time, we have some seasonality as well. You can confirm from these numbers. Next page, please. This is the P&L for as of September. The progress from what we mentioned to you at the beginning of the year. Three quarters, so 75%, we have already at the end of Q3. Sales, profit, both, we are coming along quite well so far. Last year, 2024. End of September. In terms of comparing us, in terms of sales, 2.4%, we are higher. Operating profit also, 2.3%. We are positive against last year's progress. We are ahead of plan. Next page, please. This is the detailed information on the status of progress per segment, per product. 75% is the benchmark, and you can tell which one is above 75% or not. If you look at the app pointing blue arrow, that means that those products are above 75% of threshold. This is an FX impact. Compared to last year, yen became cheaper by JPY 11 against the CHF. If you look at the left, you see actual JPY 34.7 billion+ on the revenue. OP-wise, JPY 30.5 billion+. Last year, we've already done 80% of the FX booking. We have some turn expected rate, but for the rest, we are affected by the FX impact. JPY 200 million is the positive impact against the 2025 expected rate in terms of revenue and -JPY 1.1 billion on OP. We had a payment of tax in December, and we had a higher special dividend payment this year. As a result, cash and deposit came down, and total asset reduced by JPY 24.8 billion. The ratio of equity attributable to Chugai's shareholder was up by 0.5% compared to December last year. Cash down by JPY 113.9 billion. The operating cash, fleet cash flow was JPY 373.2 billion, but we had to pay corporate tax and we had to pay out dividend. As a result, in the past nine months, the cash reduced by JPY 113.9 billion. This is non-core adjusted numbers. You see the difference between the core actual versus IFRS-based numbers. In-licensed, the depreciation of the in-licensed product and impairment on top of those, we are now undergoing the replacement of ERP. In the second half, we announced discontinuation of development projects, and that led to the impairment because we've had a fixed asset, which is the investigational drugs in the inventory, and we had to take impairment for those. Also, we had to pay some expenses to the CRO. We had JPY 8.4 billion sales proceed on asset. This is the property we held in Kamakura. From next pages onward, this may be the familiar slide for you. These are the status of our in-house global products. This is the current situation as of the third quarter. We've added some qualitative comments on those products. These are already approved CapEx. No major change from the last presentation. That's all from myself. Thank you. We would like to move on to Q&A. For Q&A from Sales, Mr. Takano will also be here to support. If we may kindly ask, please keep your questions up to two points so that many questions can be entertained. Similarly, we will be putting the Q&A on the website at later dates. Once again, let me explain. If you can select the language at the bottom where it says translation logo and select either Japanese or English. Unless you make the setup, you will not get the sound that you would desire. We would like to begin the questions. Zoom webinar, and click raise hand. When your name comes up, we will call your name. We would also give you the sound, and you will be unmuted. If you decide to cancel your questions, you can retract your hand. There is a number nine for the telephone. We will call your name, so give us your name and company. If you're going to cancel, you have to put the number nine after the asterisk. JPMorgan, Wakao-san, please, if you can begin your questions. Wakao from JPMorgan Chase. Can you hear me? Yes, we can hear you. Thank you. Two questions. One, Sparsentan, purchasing of this company, the buyout. Why did you decide to buy this area? Can you give me the background again? Is this the market that you have the area as well as why you want to do more of the Sparsentan? Besides Roche, are there any areas that you are interested in besides Roche? Why are you looking for outside of Roche? Sparsentan. That change, we would like to know much more about if we can. Thank you for the question, Wakao-san. If I may answer that for you, I would like to talk about Rhenalis, the Sparsentan acquisition. I think you are asking about the Sparsentan. We have decided, as the slide shows you, for we want to have the appropriate capital allocation, three areas or policies that we have. Basically, innovative area that Chugai as well as provisioning, and then value creation, R&D needs to be strengthened, and other opportunities for investment. On top of that, the basic return to shareholders of that innovative drug provision. Of course, allocating our capital is a must. Chugai, as you know, in Japan, development, marketing, sales, we are very strong and getting strong. In terms of a lot of the sales and marketing that we do, we're becoming number one. Using that power, we should use that and leverage that. Rhenalis, we bought this company. We will be buying Sparsentan. Acquisition happened in line with that. This is an area that we are strong in, in the [IPA] development, PiaSky, IgA nephropathy, Sparsentan. We have other products. The nephropathy line, we would like to increase. This is an area that we're looking into that we did it as part of the capital allocation. Sparsentan is something that we focused on this time. Number two, your question. Going forward, are we looking at other opportunities? Of course, if there's an opportunity, we will be interested. Our strength, R&D capability, and our strength are development sales in Japan. We would like to use that as our leverage so that innovative drugs could be provided to the market is what we want to do. Thank you very much. If this matches your area, are you aggressively going to do more of these same products? Am I correct? It just so happened. This opportunity, we are always searching for opportunities. We found an attractive development opportunity, as we saw, and it fits our strategy. That's why Rhenalis and Sparsentan happened this time. Understood. In terms of what we have, the IgAN, are you thinking of other options? [Foreign Language] Can you repeat your question? In terms of the Glenox and other types that you have, the anti-APRIL, do we have any other topics that you would be interested in? Thank you, Wakao-san. Thank you for the question. Of course, this kind and IgA type is a hot topic, the nephro area. What we did this time, this Sparsentan is also an attractive drug, especially many angiotensin inhibitor, endothelin. It can inhibit both at the same time. It has a double antagonist. You can start with the first line. For us, as you know, IgA nephropathy, cephalic cells, and we have, so we thought it would be a good synergy. April, we are looking at two innovative, then we would be considering. Sparsentan came up to us perfectly. Thank you. Number two question, offered the orforglipron. Lilly, what kind of communication do you have with Lilly? 2026 obesity. You want to have approval and launch. Lilly, about the approval and then the sales number. Are you given numbers from Lilly from next fiscal year? It's probably going to hit your numbers from, I want to know. What kind of communications do you have with Lilly would be my interest. Thank you very much for the question. From Lilly, as you know, for orforglipron, 2025, we want to get the submission approval, and then for diabetes, 2026 is what's going to be happening for the approval. Therefore, approval and then launch will be the flow. Week two next year, at some point in time, we want approval and then launch to happen, of course. Your company, beginning of the year, you said we'll be putting in next year's, unless it's approved, you wouldn't put it in your next year. Mr. Taniguchi can probably talk about that. Next year budget, we will talk about it in January, so we're still vigilant. If the likelihood is high, then we will put some numbers for next year. That timing and of the submission, Lilly is always keeping you up to date. Lilly communication channel, of course, we have. What kind of discussions go on between us, I don't think we can talk about it. Thank you very much. Next is from Morgan Stanley. Mr. Muraoka, please. Yes, thank you. I am Muraoka from Morgan Stanley. On top of what Wakao-san asked, normally in the third quarter, what's your outlook into next year if the approval is very probable? You said that you're going to include the compound information in the material, but next year, NEMLUVIO is doing well, and I can't think of any negative factor other than Actemra. Next year should be a good year for you in terms of the performance, correct? How do you see next year? Mr. Muraoka, thank you for your question. I would like to respond. What may happen next year is very difficult to be predicted in an accurate manner. Orforglipron is one thing, Actemra biosimilar penetration or erosion is already happening, and we can't really tell how fast this penetration will play out. NEMLUVIO, mainly in the U.S., is showing more than expected post-launch sales. All in all, at this point of time, I would say the sales we believe will be slightly higher than this year. Thank you. What about the core OP? Is there anything that you can comment? At this point of time, nothing I can comment. Please wait until next year's earnings presentation. Okay. With regard to next year's dividend, 45, am I correct to understand that dividend will come back to like a normal range of 45%? Taniguchi will respond to your question. Thank you, Muraoka-san. This time, as a 100-year anniversary, we are doing a special dividend. Basically, we make dividend payout based on our regular policy. Thank you. My second question is as follows. Gym, related to gym, yesterday's Roche had a conference call, and next year's ADA, they said that they're going to make a presentation. I thought that they're going to make a presentation on gym, you know, obesity, mainly GLP-1. Gym, obesity, I don't think they can make it by ADA. Can I ask you the timing of the presentation for gym, obesity? Yes. Mr. Muraoka, thank you for your question. Gym phase two, treating at obesity. The patient enrollment has been complete already. Next year in 2026, we are expecting readout, and that's been already announced. In terms of the academic conference presentation, we haven't made any announcement. Understood. Thank you very much. That's all. Citigroup. Mr. Yamaguchi, please. Can you hear me? Yes, we can hear you. Hello. This is Yamaguchi from Citigroup. Hemlibra, export. And the Roche number from yesterday, Roche's number from yesterday, Q2, Q3, there are different patterns. International Q2, Q3 kind of dropped a little bit, I heard. Your case, Q2, Q3, you had some numbers. Both patterns. Q4, you may be higher than expected. Our export and their sales relationship. And those single-digit dim Hyblin, you said, but is there going to be a stagger for next fiscal year? Similar questions as usual, but sorry if you can give me the narrative, please. Taniguchi-san would explain. Thank you for the question. Roche, what they sell and then our export is not necessarily in complete parallel. Still, for export, we have order forecast from Roche. It's what we receive. Six months or so, it's a commitment number. Q4, as we said, compared to last year, we will be higher. Full year too, as we said. Last year, it's going to be higher by JPY 10 billion from the JPY 318.6 billion number that we gave you. This is fiscal year for this year. Next fiscal year, we're still working on it. Yesterday's Roche call, low single-digit, of course, Roche said, but to a certain extent, that may be the dim Hyblin. There may be some positive that we have from Hemlibra. Yes. Thank you. Actemra, similar question. JPY 10 billion, JPY 20 billion higher this year. This fiscal year, under JPY 15 billion. We are very close to the full year numbers already. Q4, we already have those numbers fixed for Q4, so we will have those JPY 220 billion. Next year, biosimilar may be coming, and we don't know how far that's going to progress. Compared to this year's number, we will be impacted, but we're still looking into it. Please wait till January timing where we can give you more numbers in detail. No change. No change. Basically, it's mild. Not much drop, you have been saying. For now, as of today, by year-end, no change, but maybe next year. There is another. This time next year, whether it's mild, better, hard to say. Thank you very much. That's all I had for you. Thank you. Next is from SMBC Nikko Securities. Mr. Wada, please. Thank you. I am Wada from SMBC Nikko. With regard to N-Spring, TED, so my question is, Tepezza is already approved, and what is the point of differentiation against that drug? You have kind of one win, one lose, but what is your expectation on the approval? Like what is the most likely scenario? Thank you very much, Mr. Wada. Kusano would like to answer. Tepezza, in relation to the comparison against Tepezza, we do not have head-to-head comparison in the same study, so I can't do that. Based on the result, in terms of the safety, N-Spring has given a very good safety profile. IGF-IR inhibitor, Tepezza oftentimes shows high BP, alopecia, and low blood pressure. Those things are not observed. The proptosis improvement-wise, Tepezza has shown very high efficacy. When we look at the activity level of the disease in terms of the score, our result is comparable to Tepezza. From a safety perspective, in some cases, it's very difficult to use Tepezza in certain patients who are like a diabetic or inflammatory bowel disease or some severe AE or patients who are relapsing. IGF-1R inhibitor is different from ours, and we can offer a better safety profile. N-Spring once in four weeks, Tepezza once in three weeks IV. N-Spring convenience is very high compared to them. From that perspective, we are scrutinizing the data, and we are going to have a consultation with the regulator. Thank you very much. Very clear. Number two, Sparsentan in-licensing is something I would like to ask. What is the submission schedule? Rhenalis. For Korea, Asia, I think phase 3 has already been complete, and Japan's approach, I guess, is the bridging. Are you going to, will you be able to submit the finding in the area where you can perceive early approval? In terms of the submission timing, Japan next year, that's the plan for now. For other countries, we need to decide from now. Okay, so Japan, phase 3, can be conducted in a small number of patients because you're taking a bridging approach. Yes, we are planning to enroll 30 patients. We take a bridging approach. Thank you. Very clear. That's all from me. Next, UBS. Sakai-san, please. Thank you. This is Sakai from UBS. You didn't touch on it. Rani Therapeutics. Rani Therapeutics. Oral, Nurico, you're looking at the antibody. Which level rate you would look for discovery and tie it to your product. Looking at your contract agreement, it's a very broad milestone. The amount goes up as it goes. It must be a pretty new product lineup. You may also be paying some royalty, including your expectations if you have any comments. This is my first question. It is, thank you very much, Sakai-san, for Rani Therapeutics. Which level was your question? Give you a broad answer. This technology, drugs that cannot do oral, it's difficult antibody type within the capsule so that from digestive, it would go. It's a device, actually a device. For this device, Chugai, as you know, antibody engineering, we are very good. It's a good matching, we think. This is why we're doing this technology at this moment. Of course, it's a contract that we have. For the technology, clinical trial, the drug, it gets to the digestive and into the bloodstream. In developing our antibody, especially oral purpose type of disease that requires oral intake, we would like to promote this. Overall value, if it succeeds, the value is very high. There are five projects. We have rights to five projects. If all succeed, this will be quite a large amount that you will be looking at at the end of the day. Five projects. The first one, first pipeline, what would be the timeline or the timing? Timing, it's hard to say at this time. Which component we would apply for this technology, how we would utilize it, we haven't disclosed it yet. If you will kindly wait, it will show up eventually. It will come into our pipeline. If it does come into our pipeline, then we will be disclosing, yes. Please be patient. Thank you. Another question, nothing to do with this result. FoundationOne, the genome, what is happening here? It seems to be struggling to grow. Even if you're diagnosed, there's no treatment drug. It's not been adopted, or is it the NHI price cost? Once again, if you could sort the discussion for cancer genome. Thank you for the question. At the moment, in actual by Q3, JPY 6 billion sales we have done so far. F1 CDx, F1 Liquid, we have this liquid, so it's been the demand is growing. Further, recently, expert panel, we have some sites that can do expert panel. 38 sites, we increased to nationwide October 1, 83 sites we have total. Expert panel was the bottleneck so far. Going forward, maybe this cancer genome, F1 CDx, LCDx. Growth may be expected as of today. That's all. Thank you. Thank you very much. Unfortunately, we have come close to the end of time. The next question is going to be the last. From BofA, Mr. Mamegano, please. Hello, can you hear me? Yes. I have a question regarding a gym. SMA FSHD data readout is planned in 2026. For SMA, I think it was originally last year. It was postponed to this year, and now further postponed to next year. Is there anything that you can comment? Yes, thank you very much, Mamegano–san, for your question on gym. As of last year, we were planning readout last year, but the patient enrollment was delayed. We are still hoping to achieve this year's readout. This time, Roche commented that Gym 329, you know, there are a lot of competitive products in a timely manner, in a good timing from conference schedule and so on. First half next year will be most appropriate. That's why we have changed the readout timing into next year first half. Understood. Thank you. Is that sufficient? Thank you very much. That concludes 2025 for the Q3. Thank you very much. We apologize for any questions we couldn't answer. Please contact our IR telephone number, and the email is on this presentation last page. Thank you for making time in your busy schedule. We appreciate your attendance. That's it for today. Thank you very much.

Speaker 10: Ladies and gentlemen, thank you very much for attending the conference on FY 2025 December Q3 financial results. My name is Kae Miyata. I am in charge of today's facilitation. I am from the PR and IR department. Today we are using the Zoom webinar system. The agenda is shown on the presentation slide page 3. The presentation will be conducted in Japanese. However, we do have simultaneous interpretation service available for English speakers. Please make sure you select as you click on the language of your preference. You can choose either Japanese or English. We are going to receive questions at the end of the presentation. We have 30 minutes for Q&A. During the presentation, all of your voices and audio are muted. Now I would like to ask Dr. Osamu Okuda to give us the FY 2025 Q3 overview. Ladies and gentlemen, thank you very much for attending the conference on FY 2025 December Q3 financial results. ladies and gentlemen thank you very much for attending the conference on fy 2025 december q3 financial results My name is Kae Miyata. my name is kae miyata I am in charge of today's facilitation. i am in charge of today's facilitation I am from the PR and IR department. i am from the pr and ir department Today we are using the Zoom webinar system. today we are using the zoom webinar system The agenda is shown on the presentation slide page 3. the agenda is shown on the presentation slide page 3 The presentation will be conducted in Japanese. the presentation will be conducted in japanese However, we do have simultaneous interpretation service available for English speakers. however we do have simultaneous interpretation service available for english speakers Please make sure you select as you click on the language of your preference. please make sure you select as you click on the language of your preference You can choose either Japanese or English. you can choose either japanese or english We are going to receive questions at the end of the presentation. we are going to receive questions at the end of the presentation We have 30 minutes for Q&A. we have 30 minutes for q&a During the presentation, all of your voices and audio are muted. during the presentation all of your voices and audio are muted Now I would like to ask Dr. Osamu Okuda to give us the FY 2025 Q3 overview. now i would like to ask dr osamu okuda to give us the fy 2025 q3 overview

Speaker 9: Osamu Okuda, thank you. I'll be talking about 2025 Q3 performance. Please turn to page 5. 2025 Q3 performance, both domestic and external product sales, was very strong. Sales and profit both were very good. Year-on-year revenue was +5.0%. Operating profit +5.6%. Profitability for the quarter is 6.2%. Based on the Q3 results of the steady progress, we believe that we will be able to meet the target for the full year. In terms of the revenue details, I will be presenting in the next slide. Comparing to last year, the revenue is JPY 43.1 billion increase, +5.0% growth. Breakdown from the left-hand side, I would like to start. Domestic, with the NHI price revision and the generic drug, there was negative, but we have the Phesgo, PiaSky, and then Vabysmo, and Hemlibra, and N-Spring were very good. JPY 12 billion increase in revenue. Overseas, unit price for export did drop. Osamu Okuda, thank you. osamu okuda thank you I'll be talking about 2025 Q3 performance. i'll be talking about 2025 q3 performance Please turn to page 5. 2025 Q3 performance, both domestic and external product sales, was very strong. please turn to page 5 2025 q3 performance both domestic and external product sales was very strong Sales and profit both were very good. sales and profit both were very good Year-on-year revenue was +5.0%. year-on-year revenue was +5.0% Operating profit +5.6%. operating profit +5.6% Profitability for the quarter is 6.2%. profitability for the quarter is 6.2% Based on the Q3 results of the steady progress, we believe that we will be able to meet the target for the full year. based on the q3 results of the steady progress we believe that we will be able to meet the target for the full year In terms of the revenue details, I will be presenting in the next slide. in terms of the revenue details i will be presenting in the next slide Comparing to last year, the revenue is JPY 43.1 billion increase, +5.0% growth. comparing to last year the revenue is jpy 43.1 billion increase +5.0% growth Breakdown from the left-hand side, I would like to start. breakdown from the left-hand side i would like to start Domestic, with the NHI price revision and the generic drug, there was negative, but we have the Phesgo, PiaSky, and then Vabysmo, and Hemlibra, and N-Spring were very good. domestic with the nhi price revision and the generic drug there was negative but we have the phesgo piasky and then vabysmo and hemlibra and n-spring were very good JPY 12 billion increase in revenue. jpy 12 billion increase in revenue Overseas, unit price for export did drop. overseas unit price for export did drop However, volume and foreign exchange impact was large, which increased dramatically. JPY 32.2 billion increase positive. Next, main major Chugai originated products. Our growth driver in Hemlibra is driving the international markets growth. Japan, U.S., Europe, it continues to be in a growth phase. On the other, Actemra for Japan, U.S., Europe, the biosimilar remains unclear, therefore we expect sales to drop. Kaliderma, the licensed out product, the NEMLUVIO, better than expected results. Also, licensed out the orforglipron for all the readout, all phase 3 study for all of the items we have achieved. For 2025 obesity, for the type 2 diabetes, 2026 global approval submission is going to begin. Therefore, potential with great sales, third-party licensed out products are performing very well, which will drive growth for the long term. Next, Rhenalis Pharma Inc., that we bought the IgA nephropathy treatment. This is what I will talk about. However, volume and foreign exchange impact was large, which increased dramatically. however volume and foreign exchange impact was large which increased dramatically JPY 32.2 billion increase positive. jpy 32.2 billion increase positive Next, main major Chugai originated products. next main major chugai originated products Our growth driver in Hemlibra is driving the international markets growth. our growth driver in hemlibra is driving the international markets growth Japan, U.S., Europe, it continues to be in a growth phase. japan u.s europe it continues to be in a growth phase On the other, Actemra for Japan, U.S., Europe, the biosimilar remains unclear, therefore we expect sales to drop. on the other actemra for japan u.s europe the biosimilar remains unclear therefore we expect sales to drop Kaliderma, the licensed out product, the NEMLUVIO, better than expected results. kaliderma the licensed out product the nemluvio better than expected results Also, licensed out the orforglipron for all the readout, all phase 3 study for all of the items we have achieved. also licensed out the orforglipron for all the readout all phase 3 study for all of the items we have achieved For 2025 obesity, for the type 2 diabetes, 2026 global approval submission is going to begin. for 2025 obesity for the type 2 diabetes 2026 global approval submission is going to begin Therefore, potential with great sales, third-party licensed out products are performing very well, which will drive growth for the long term. therefore potential with great sales third-party licensed out products are performing very well which will drive growth for the long term Next, Rhenalis Pharma Inc., that we bought the IgA nephropathy treatment. next rhenalis pharma inc that we bought the iga nephropathy treatment This is what I will talk about. this is what i will talk about This is something that we are providing value to solution to our patients so that we can give stable return to our shareholders. This is a capital allocation policy that we follow. Investing in creative and delivery of innovative medicine is a strategic investment. Outside of Roche, this is going to be the third party that we'll be working sparsely on. In Europe and the U.S., it's all been approved and launched. Rhenalis Pharma Company. has already released their press release. In Japan, phase 3 for all of the assessment, the subjected cases in all major items, status has been collected. At this moment, earliest 2026 approval submission is planned to contribute to sustainable growth domestically. First-in-class treatment, we would like to give it to our patients as soon as possible, even one day earlier. That's all I had for you tonight. Thank you very much. This is something that we are providing value to solution to our patients so that we can give stable return to our shareholders. this is something that we are providing value to solution to our patients so that we can give stable return to our shareholders This is a capital allocation policy that we follow. this is a capital allocation policy that we follow Investing in creative and delivery of innovative medicine is a strategic investment. investing in creative and delivery of innovative medicine is a strategic investment Outside of Roche, this is going to be the third party that we'll be working sparsely on. outside of roche this is going to be the third party that we'll be working sparsely on In Europe and the U.S., it's all been approved and launched. in europe and the u.s it's all been approved and launched Rhenalis Pharma Company. has already released their press release. rhenalis pharma company has already released their press release In Japan, phase 3 for all of the assessment, the subjected cases in all major items, status has been collected. in japan phase 3 for all of the assessment the subjected cases in all major items status has been collected At this moment, earliest 2026 approval submission is planned to contribute to sustainable growth domestically. at this moment earliest 2026 approval submission is planned to contribute to sustainable growth domestically First-in-class treatment, we would like to give it to our patients as soon as possible, even one day earlier. first-in-class treatment we would like to give it to our patients as soon as possible even one day earlier That's all I had for you tonight. that's all i had for you tonight Thank you very much. thank you very much

Speaker 10: Next, Kusano. I will present to you the development pipeline. Next, Kusano. next kusano I will present to you the development pipeline. i will present to you the development pipeline

Speaker 4: Yes, I am from the Project Lifecycle Management Department. I am Kusano. Please take a look at page 10 of the slide. This is the third quarter topics. I will explain in detail from top. In-house product, PiaSky, has been launched in Taiwan for PNH. Two Roche products have been approved. Tecentriq is being developed for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma needle type, which is a rare disease. It is the very first immune checkpoint inhibitor approved in Japan. CellCept submitted a finding based on public knowledge for the treatment of refractory nephrotic syndrome and received approval in September. One application was submitted for Roche Avastin for neurofibromatosis type 2 in August this year. Four Roche products have begun trials. Yes, I am from the Project Lifecycle Management Department. yes i am from the project lifecycle management department I am Kusano. i am kusano Please take a look at page 10 of the slide. please take a look at page 10 of the slide This is the third quarter topics. this is the third quarter topics I will explain in detail from top. i will explain in detail from top In-house product, PiaSky, has been launched in Taiwan for PNH. in-house product piasky has been launched in taiwan for pnh Two Roche products have been approved. two roche products have been approved Tecentriq is being developed for the treatment of relapsed or refractory extranodal NK/ T-cell lymphoma needle type, which is a rare disease. tecentriq is being developed for the treatment of relapsed or refractory extranodal nk/ t-cell lymphoma needle type which is a rare disease It is the very first immune checkpoint inhibitor approved in Japan. it is the very first immune checkpoint inhibitor approved in japan CellCept submitted a finding based on public knowledge for the treatment of refractory nephrotic syndrome and received approval in September. cellcept submitted a finding based on public knowledge for the treatment of refractory nephrotic syndrome and received approval in september One application was submitted for Roche Avastin for neurofibromatosis type 2 in August this year. one application was submitted for roche avastin for neurofibromatosis type 2 in august this year Four Roche products have begun trials. four roche products have begun trials Grafitamab has initiated a domestic phase 2 trial for relapsed or refractory diffuse large B-cell lymphoma and refractory mantle cell lymphoma. Afim Kibart has entered phase 3 trials, a trial for Crohn's disease. Additionally, Dvorasiv has entered a phase 1b trial for the first-line treatment of NSCLC, non-small cell lung cancer. Regarding pipeline exclusions, following the result of clinical trial conducted overseas, Roche discontinued the development of PiaSky for sickle cell disease, and it was therefore removed from the pipeline. Tiragolumab was approved for the treatment of NSCLC in Japan following the result of the Skyscraper 03 and Skyscraper 14 trials. Development for lung cancer and hepatocellular carcinoma has been discontinued. In the third quarter, we had many readouts for our in-house developed products. Grafitamab has initiated a domestic phase 2 trial for relapsed or refractory diffuse large B-cell lymphoma and refractory mantle cell lymphoma. grafitamab has initiated a domestic phase 2 trial for relapsed or refractory diffuse large b-cell lymphoma and refractory mantle cell lymphoma Afim Kibart has entered phase 3 trials, a trial for Crohn's disease. afim kibart has entered phase 3 trials a trial for crohn's disease Additionally, Dvorasiv has entered a phase 1b trial for the first-line treatment of NSCLC, non-small cell lung cancer. additionally dvorasiv has entered a phase 1b trial for the first-line treatment of nsclc non-small cell lung cancer Regarding pipeline exclusions, following the result of clinical trial conducted overseas, Roche discontinued the development of PiaSky for sickle cell disease, and it was therefore removed from the pipeline. regarding pipeline exclusions following the result of clinical trial conducted overseas roche discontinued the development of piasky for sickle cell disease and it was therefore removed from the pipeline Tiragolumab was approved for the treatment of NSCLC in Japan following the result of the Skyscraper 03 and Skyscraper 14 trials. tiragolumab was approved for the treatment of nsclc in japan following the result of the skyscraper 03 and skyscraper 14 trials Development for lung cancer and hepatocellular carcinoma has been discontinued. development for lung cancer and hepatocellular carcinoma has been discontinued In the third quarter, we had many readouts for our in-house developed products. in the third quarter we had many readouts for our in-house developed products Orforglipron, which we licensed out to Eli Lilly, is being evaluated for the treatment of obesity in the ATEN-1 and ATEN-2 trials, both achieved their primary endpoints. In addition, the ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 studies for type 2 diabetes achieved pivotal results, respectively. Furthermore, the ACHIEVE-J trial conducted in Japan to evaluate safety indicated that orforglipron can be dosed in patients with type 2 diabetes safely. The result from two global phase 3 studies for N-Spring in thyroid eye disease have been obtained. I will explain about this in more details. Regarding PiaSky for sickle cell disease, we previously announced that it was removed from the pipeline, but the primary endpoint was not met in the phase 2 CROSSWALK-C study conducted overseas. Please wait for future conference presentations for detailed data. Next, we have a readout from Roche. Orforglipron, which we licensed out to Eli Lilly, is being evaluated for the treatment of obesity in the ATEN-1 and ATEN-2 trials, both achieved their primary endpoints. orforglipron which we licensed out to eli lilly is being evaluated for the treatment of obesity in the aten-1 and aten-2 trials both achieved their primary endpoints In addition, the ACHIEVE-2, ACHIEVE-3, and ACHIEVE-5 studies for type 2 diabetes achieved pivotal results, respectively. in addition the achieve-2 achieve-3 and achieve-5 studies for type 2 diabetes achieved pivotal results respectively Furthermore, the ACHIEVE-J trial conducted in Japan to evaluate safety indicated that orforglipron can be dosed in patients with type 2 diabetes safely. furthermore the achieve-j trial conducted in japan to evaluate safety indicated that orforglipron can be dosed in patients with type 2 diabetes safely The result from two global phase 3 studies for N-Spring in thyroid eye disease have been obtained. the result from two global phase 3 studies for n-spring in thyroid eye disease have been obtained I will explain about this in more details. i will explain about this in more details Regarding PiaSky for sickle cell disease, we previously announced that it was removed from the pipeline, but the primary endpoint was not met in the phase 2 CROSSWALK-C study conducted overseas. regarding piasky for sickle cell disease we previously announced that it was removed from the pipeline but the primary endpoint was not met in the phase 2 crosswalk-c study conducted overseas Please wait for future conference presentations for detailed data. please wait for future conference presentations for detailed data Next, we have a readout from Roche. next we have a readout from roche For Vabysmo, we have two phase 3 global trials results targeting at rheumatic macular edema, RME. The SANDCAT trial, where Japan participated, did not meet its primary endpoint, while the MIRCAT trial, which Japan did not participate in, achieved its primary endpoint. In both trials, the proportion of patients whose vision improved after treatment with Vabysmo was numerically higher. Based on these results, we plan to hold consultation with regulatory authorities regarding application for approval. Tecentriq and Gildestrant Tartrate each met their primary endpoints in the indicated studies. We presented three of our in-house products and five Roche products at the medical conference. In addition to the trial results presented so far, the final OS data for the ALEX trial of Alecensa in NSCLC was also released. The company also has announced a positive result in the ALINA trial for adjuvant therapy. For Vabysmo, we have two phase 3 global trials results targeting at rheumatic macular edema, RME. for vabysmo we have two phase 3 global trials results targeting at rheumatic macular edema rme The SANDCAT trial, where Japan participated, did not meet its primary endpoint, while the MIRCAT trial, which Japan did not participate in, achieved its primary endpoint. the sandcat trial where japan participated did not meet its primary endpoint while the mircat trial which japan did not participate in achieved its primary endpoint In both trials, the proportion of patients whose vision improved after treatment with Vabysmo was numerically higher. in both trials the proportion of patients whose vision improved after treatment with vabysmo was numerically higher Based on these results, we plan to hold consultation with regulatory authorities regarding application for approval. based on these results we plan to hold consultation with regulatory authorities regarding application for approval Tecentriq and Gildestrant Tartrate each met their primary endpoints in the indicated studies. tecentriq and gildestrant tartrate each met their primary endpoints in the indicated studies We presented three of our in-house products and five Roche products at the medical conference. we presented three of our in-house products and five roche products at the medical conference In addition to the trial results presented so far, the final OS data for the ALEX trial of Alecensa in NSCLC was also released. in addition to the trial results presented so far the final os data for the alex trial of alecensa in nsclc was also released The company also has announced a positive result in the ALINA trial for adjuvant therapy. the company also has announced a positive result in the alina trial for adjuvant therapy All Roche products have already been announced in press release. Regarding product and technology in-licensing, we have signed an agreement with Roche to license CT388, a long-acting GLP-1/GIP receptor agonist. Additionally, as announced in the news release, we collaborate with Rani Therapeutics to develop an oral formulation using RaniFIL technology. A license agreement also covers the development and commercialization of this formulation. Furthermore, as explained by Dr. Osamu Okuda earlier, with the acquisition of Rhenalis IgA nephropathy treatment for IgA nephropathy, we acquired the development and sales rights for Sparsentan. I will provide more details on the scientific aspects of Sparsentan in creating MOA. Major R&D events in 2025 are here. The bold and underlined parts indicate changes from the previous financial statement. As I mentioned earlier, N-Spring, Gildestrant Tartrate, Vabysmo, and PiaSky's study results are now available. All Roche products have already been announced in press release. all roche products have already been announced in press release Regarding product and technology in-licensing, we have signed an agreement with Roche to license CT388, a long-acting GLP-1/GIP receptor agonist. regarding product and technology in-licensing we have signed an agreement with roche to license ct388 a long-acting glp-1/gip receptor agonist Additionally, as announced in the news release, we collaborate with Rani Therapeutics to develop an oral formulation using RaniFIL technology. additionally as announced in the news release we collaborate with rani therapeutics to develop an oral formulation using ranifil technology A license agreement also covers the development and commercialization of this formulation. a license agreement also covers the development and commercialization of this formulation Furthermore, as explained by Dr. Osamu Okuda earlier, with the acquisition of Rhenalis IgA nephropathy treatment for IgA nephropathy, we acquired the development and sales rights for Sparsentan. furthermore as explained by dr. osamu okuda earlier with the acquisition of rhenalis iga nephropathy treatment for iga nephropathy we acquired the development and sales rights for sparsentan I will provide more details on the scientific aspects of Sparsentan in creating MOA. i will provide more details on the scientific aspects of sparsentan in creating moa Major R&D events in 2025 are here. major r&d events in 2025 are here The bold and underlined parts indicate changes from the previous financial statement. the bold and underlined parts indicate changes from the previous financial statement As I mentioned earlier, N-Spring, Gildestrant Tartrate, Vabysmo, and PiaSky's study results are now available. as i mentioned earlier n-spring gildestrant tartrate vabysmo and piasky's study results are now available Leucemio's cell stimulant trial and Gildestrant Tartrate's Persevere studies' readout timing is now changed to 2026. In addition, data for the GYM-329 trial for SMA and FSHD are to be presented in the first half next year, primarily for competitive reasons. Next, this is the result of a phase 3 study of N-Spring in thyroid eye disease. These results were recently presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery, ASOPRS, annual meeting. First, the study design. The SATRA-GO-1, SATRA-GO-2 studies compared N-Spring with placebo in patients with moderate to severe thyroid eye disease, verifying the usefulness of IL-6 inhibition based on existing non-clinical and clinical data. Patients with active and inactive thyroid eye disease were enrolled in studies and were randomized to either the N-Spring arm or the placebo arm in a 1:1 ratio. The results obtained this time were as follows. Leucemio's cell stimulant trial and Gildestrant Tartrate's Persevere studies' readout timing is now changed to 2026. leucemio's cell stimulant trial and gildestrant tartrate's persevere studies' readout timing is now changed to 2026 In addition, data for the GYM-329 trial for SMA and FSHD are to be presented in the first half next year, primarily for competitive reasons. in addition data for the gym-329 trial for sma and fshd are to be presented in the first half next year primarily for competitive reasons Next, this is the result of a phase 3 study of N-Spring in thyroid eye disease. next this is the result of a phase 3 study of n-spring in thyroid eye disease These results were recently presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery, ASOPRS, annual meeting. these results were recently presented at the american society of ophthalmic plastic and reconstructive surgery asoprs annual meeting First, the study design. first the study design The SATRA-GO-1, SATRA-GO-2 studies compared N-Spring with placebo in patients with moderate to severe thyroid eye disease, verifying the usefulness of IL-6 inhibition based on existing non-clinical and clinical data. the satra-go-1 satra-go-2 studies compared n-spring with placebo in patients with moderate to severe thyroid eye disease verifying the usefulness of il-6 inhibition based on existing non-clinical and clinical data Patients with active and inactive thyroid eye disease were enrolled in studies and were randomized to either the N-Spring arm or the placebo arm in a 1:1 ratio. patients with active and inactive thyroid eye disease were enrolled in studies and were randomized to either the n-spring arm or the placebo arm in a 1:1 ratio The results obtained this time were as follows. the results obtained this time were as follows At week 24, as indicated in orange, we evaluated the percentage of patients with active thyroid eye disease who showed proptosis improvement. Results from the SATRA-GO-1 trial showed an improvement ratio of 49% in the N-Spring arm and 31% in the placebo arm. No statistical difference was obtained. In contrast, in the SATRA-GO-2 trial, it was 53% in the N-Spring group and 23% in the placebo group. A statistical difference was proven. Additionally, although it's not shown in the slide, both studies demonstrated clinically meaningful improvement with N-Spring in key efficacy endpoints, including proptosis, double vision, and clinical activity score in active and inactive thyroid eye disease. Safety data for N-Spring in thyroid eye disease are consistent with established data for the marketed NMOSD treatment. No new safety concerns were identified, and treatment was well tolerated. At week 24, as indicated in orange, we evaluated the percentage of patients with active thyroid eye disease who showed proptosis improvement. at week 24 as indicated in orange we evaluated the percentage of patients with active thyroid eye disease who showed proptosis improvement Results from the SATRA-GO-1 trial showed an improvement ratio of 49% in the N-Spring arm and 31% in the placebo arm. results from the satra-go-1 trial showed an improvement ratio of 49% in the n-spring arm and 31% in the placebo arm No statistical difference was obtained. no statistical difference was obtained In contrast, in the SATRA-GO-2 trial, it was 53% in the N-Spring group and 23% in the placebo group. in contrast, in the satra-go-2 trial it was 53% in the n-spring group and 23% in the placebo group A statistical difference was proven. a statistical difference was proven Additionally, although it's not shown in the slide, both studies demonstrated clinically meaningful improvement with N-Spring in key efficacy endpoints, including proptosis, double vision, and clinical activity score in active and inactive thyroid eye disease. additionally although it's not shown in the slide both studies demonstrated clinically meaningful improvement with n-spring in key efficacy endpoints including proptosis double vision and clinical activity score in active and inactive thyroid eye disease Safety data for N-Spring in thyroid eye disease are consistent with established data for the marketed NMOSD treatment. safety data for n-spring in thyroid eye disease are consistent with established data for the marketed nmosd treatment No new safety concerns were identified, and treatment was well tolerated. no new safety concerns were identified and treatment was well tolerated We'll continue to analyze the result of this study and plan to hold consultations with the authorities regarding future submissions. N-Spring offers convenience, subcutaneous administration once every four weeks, and a favorable safety profile, making it a promising treatment for thyroid eye disease. Next is about Sparsentan, which will be acquired through the acquisition of Rhenalis Pharma, which was announced today. Sparsentan is a drug whose efficacy in treating IgA nephropathy has been evaluated in an overseas phase 3 trial and is approved in the U.S. and Europe. A small-scale phase 3 clinical trial is currently underway in Japan, and the drug is expected to become a first-in-class treatment. This drug inhibits the renin-angiotensin system and endothelin pathway simultaneously, providing dual inhibitor effects in a single drug. We'll continue to analyze the result of this study and plan to hold consultations with the authorities regarding future submissions. we'll continue to analyze the result of this study and plan to hold consultations with the authorities regarding future submissions N-Spring offers convenience, subcutaneous administration once every four weeks, and a favorable safety profile, making it a promising treatment for thyroid eye disease. n-spring offers convenience subcutaneous administration once every four weeks and a favorable safety profile making it a promising treatment for thyroid eye disease Next is about Sparsentan, which will be acquired through the acquisition of Rhenalis Pharma, which was announced today. next is about sparsentan which will be acquired through the acquisition of rhenalis pharma which was announced today Sparsentan is a drug whose efficacy in treating IgA nephropathy has been evaluated in an overseas phase 3 trial and is approved in the U.S. and Europe. sparsentan is a drug whose efficacy in treating iga nephropathy has been evaluated in an overseas phase 3 trial and is approved in the u.s and europe A small-scale phase 3 clinical trial is currently underway in Japan, and the drug is expected to become a first-in-class treatment. a small-scale phase 3 clinical trial is currently underway in japan and the drug is expected to become a first-in-class treatment This drug inhibits the renin-angiotensin system and endothelin pathway simultaneously, providing dual inhibitor effects in a single drug. this drug inhibits the renin-angiotensin system and endothelin pathway simultaneously providing dual inhibitor effects in a single drug Therefore, it has been shown to have a strong urinary protein reduction effect as a single drug without the need for combined use with a renin-angiotensin system inhibitor. Using the diagram on the left, I'll explain the mechanism of IgA nephropathy. First, due to a combination of genetic and environmental factors, IgA1 with abnormal glycosylation is produced. The human immune system recognizes this abnormal IgA1 as a foreign substance and produces anti-IgA1 IgG antibodies. These form immune complexes, which then deposit in the glomeruli and cause glomerular damage through the complement activity. In damaged glomeruli, the burden on the glomeruli increases and sclerosis progresses. Sparsentan suppresses blood pressure increases and vascular constriction through its dual antagonistic action, thereby suppressing nephritis, reducing the burden on the kidneys, and protecting the nephrotic function. Cefacericin, which is also being developed for IgA nephropathy, inhibits complement, and it has different MOA. Therefore, it has been shown to have a strong urinary protein reduction effect as a single drug without the need for combined use with a renin-angiotensin system inhibitor. therefore it has been shown to have a strong urinary protein reduction effect as a single drug without the need for combined use with a renin-angiotensin system inhibitor Using the diagram on the left, I'll explain the mechanism of IgA nephropathy. using the diagram on the left i'll explain the mechanism of iga nephropathy First, due to a combination of genetic and environmental factors, IgA1 with abnormal glycosylation is produced. first due to a combination of genetic and environmental factors iga1 with abnormal glycosylation is produced The human immune system recognizes this abnormal IgA1 as a foreign substance and produces anti-IgA1 IgG antibodies. the human immune system recognizes this abnormal iga1 as a foreign substance and produces anti-iga1 igg antibodies These form immune complexes, which then deposit in the glomeruli and cause glomerular damage through the complement activity. these form immune complexes which then deposit in the glomeruli and cause glomerular damage through the complement activity In damaged glomeruli, the burden on the glomeruli increases and sclerosis progresses. in damaged glomeruli the burden on the glomeruli increases and sclerosis progresses Sparsentan suppresses blood pressure increases and vascular constriction through its dual antagonistic action, thereby suppressing nephritis, reducing the burden on the kidneys, and protecting the nephrotic function. sparsentan suppresses blood pressure increases and vascular constriction through its dual antagonistic action thereby suppressing nephritis reducing the burden on the kidneys and protecting the nephrotic function Cefacericin, which is also being developed for IgA nephropathy, inhibits complement, and it has different MOA. cefacericin which is also being developed for iga nephropathy inhibits complement and it has different moa Through the development of these two drugs, Sparsentan and Cefacericin, we aim to improve the complex pathology of IgA nephropathy and improve the condition of a wide range of patients. Next, I will explain the result of a phase 3 trial conducted overseas using the graph on the right. In this trial, Sparsentan was compared to the renin-angiotensin system inhibitor, irbesartan. Both drugs were administered orally once daily for 110 weeks. The primary endpoint was the mean change from baseline in urinary protein to creatinine ratio at week 36. The mean change was 15.1% in the irbesartan and 49.8% in the Sparsentan arm, demonstrating a significant reduction with Sparsentan compared to the irbesartan group. Additionally, AE were comparable between the two arms. Finally, this is the projected submissions. Projects marked with a light blue star are newly added projects. Through the development of these two drugs, Sparsentan and Cefacericin, we aim to improve the complex pathology of IgA nephropathy and improve the condition of a wide range of patients. through the development of these two drugs sparsentan and cefacericin we aim to improve the complex pathology of iga nephropathy and improve the condition of a wide range of patients Next, I will explain the result of a phase 3 trial conducted overseas using the graph on the right. next i will explain the result of a phase 3 trial conducted overseas using the graph on the right In this trial, Sparsentan was compared to the renin-angiotensin system inhibitor, irbesartan. in this trial sparsentan was compared to the renin-angiotensin system inhibitor irbesartan Both drugs were administered orally once daily for 110 weeks. both drugs were administered orally once daily for 110 weeks The primary endpoint was the mean change from baseline in urinary protein to creatinine ratio at week 36. the primary endpoint was the mean change from baseline in urinary protein to creatinine ratio at week 36 The mean change was 15.1% in the irbesartan and 49.8% in the Sparsentan arm, demonstrating a significant reduction with Sparsentan compared to the irbesartan group. the mean change was 15.1% in the irbesartan and 49.8% in the sparsentan arm demonstrating a significant reduction with sparsentan compared to the irbesartan group Additionally, AE were comparable between the two arms. additionally ae were comparable between the two arms Finally, this is the projected submissions. finally this is the projected submissions Projects marked with a light blue star are newly added projects. projects marked with a light blue star are newly added projects We have added a new category of in-licensed third-party products, which are shown in purple. We expect to submit an application for Sparsentan next year in 2026. The following slides are attached as reference material. That's all for my presentation. We have added a new category of in-licensed third-party products, which are shown in purple. we have added a new category of in-licensed third-party products which are shown in purple We expect to submit an application for Sparsentan next year in 2026. we expect to submit an application for sparsentan next year in 2026 The following slides are attached as reference material. the following slides are attached as reference material That's all for my presentation. that's all for my presentation

Speaker 10: Lastly, Mr. Taniguchi will talk about the Q3 consolidated core outline. Mr. Taniguchi, Lastly, Mr. Taniguchi will talk about the Q3 consolidated core outline. lastly mr taniguchi will talk about the q3 consolidated core outline Mr. Taniguchi, mr taniguchi

Speaker 2: so let me take over. Q3, we did JPY 43.1 billion, year-on-year 5.0%+, JPY 911 billion. Core operating profit, JPY 23.9 billion, 5.6%+, JPY 450 billion. First, I would like to say that this is how we did very well for the revenue. In terms of the revenue, in terms of the sales, JPY 794.6 billion. Year-on-year is 5.9%, JPY 44.3 billion. By region, domestic Japan, JPY 343 billion. Year-on-year, JPY 12 billion, 3.6%+. Next, this is new product and mainstay products are very well. Of course, NHI pricing revision and generic drugs are absorbed properly. Overseas, continually the Roche to Roche, we are doing JPY 450 billion. Year-on-year, JPY 32.2 billion, 7.7%+ increase. Royalty and other income and Hemlibra royalty is increasing. On the other hand, in terms of a third-party, one-time income dropped, so therefore it's JPY 117 billion. so let me take over. so let me take over Q3, we did JPY 43.1 billion, year-on-year 5.0%+ , JPY 911 billion. q3 we did jpy 43.1 billion year-on-year 5.0%+ jpy 911 billion Core operating profit, JPY 23.9 billion, 5.6%+ , JPY 450 billion. core operating profit jpy 23.9 billion 5.6%+ jpy 450 billion First, I would like to say that this is how we did very well for the revenue. first i would like to say that this is how we did very well for the revenue In terms of the revenue, in terms of the sales, JPY 794.6 billion. in terms of the revenue in terms of the sales jpy 794.6 billion Year-on-year is 5.9%, JPY 44.3 billion. year-on-year is 5.9% jpy 44.3 billion By region, domestic Japan, JPY 343 billion. by region domestic japan jpy 343 billion Year-on-year, JPY 12 billion, 3.6%+ . year-on-year jpy 12 billion 3.6%+ Next, this is new product and mainstay products are very well. next this is new product and mainstay products are very well Of course, NHI pricing revision and generic drugs are absorbed properly. of course nhi pricing revision and generic drugs are absorbed properly Overseas, continually the Roche to Roche, we are doing JPY 450 billion. overseas continually the roche to roche we are doing jpy 450 billion Year-on-year, JPY 32.2 billion, 7.7%+ increase. year-on-year, jpy 32.2 billion 7.7%+ increase Royalty and other income and Hemlibra royalty is increasing. royalty and other income and hemlibra royalty is increasing On the other hand, in terms of a third-party, one-time income dropped, so therefore it's JPY 117 billion. on the other hand in terms of a third-party one-time income dropped so therefore it's jpy 117 billion Pretty much flat as last year. In terms of costs, we have JPY 263 billion in terms of COGS, JPY 19.2 billion, year-on-year, 7.9%. Value-based sales increased, so comparatively it also increased. In terms of the cost-to-sales ratio, relatively Actemra that has high cost. The composition ratio is a bit higher. Therefore, it went up by 0.6 points to 33.1%. SG&A, with the cost of goods and HR rising, we are doing efficiency as well as other means so that it is down by JPY 3.1 billion. R&D, drug discovery, and early development projects are doing very well. That is reflected, so year-on-year, JPY 0.9 billion increase. Therefore, in terms of the profitability, year-on-year, it's JPY 2 billion that you can see. Total operating profit, year-on-year, is JPY 23.9 billion, increased JPY 450 billion in total. Operating margin is 49.4%. It's 0.3% up or 0.3 point up. Pretty much flat as last year. pretty much flat as last year In terms of costs, we have JPY 263 billion in terms of COGS, JPY 19.2 billion, year-on-year, 7.9%. in terms of costs we have jpy 263 billion in terms of cogs jpy 19.2 billion year-on-year 7.9% Value-based sales increased, so comparatively it also increased. value-based sales increased so comparatively it also increased In terms of the cost-to-sales ratio, relatively Actemra that has high cost. in terms of the cost-to-sales ratio relatively actemra that has high cost The composition ratio is a bit higher. the composition ratio is a bit higher Therefore, it went up by 0.6 points to 33.1%. therefore it went up by 0.6 points to 33.1% SG&A, with the cost of goods and HR rising, we are doing efficiency as well as other means so that it is down by JPY 3.1 billion. sg&a with the cost of goods and hr rising we are doing efficiency as well as other means so that it is down by jpy 3.1 billion R&D, drug discovery, and early development projects are doing very well. r&d drug discovery and early development projects are doing very well That is reflected, so year-on-year, JPY 0.9 billion increase. that is reflected so year-on-year jpy 0.9 billion increase Therefore, in terms of the profitability, year-on-year, it's JPY 2 billion that you can see. therefore in terms of the profitability year-on-year it's jpy 2 billion that you can see Total operating profit, year-on-year, is JPY 23.9 billion, increased JPY 450 billion in total. total operating profit year-on-year is jpy 23.9 billion increased jpy 450 billion in total Operating margin is 49.4%. operating margin is 49.4% It's 0.3% up or 0.3 point up. it's 0.3% up or 0.3 point up In terms of net income, after taxes, JPY 320 billion and JPY 18.7 billion, 6.2% increase. Next, in terms of the sales by product, the DARC, the domestic oncology, JPY 180 billion, year-on-year, JPY 0.4 billion increase, an increase of 0.2%. Content-wise, in terms of the generic drug, Avastin dropped. On the other hand, new product, Vesigo, sales is a replacement. Ajeta is much higher, so therefore it's very good. Also, new product, Lansimil has started very well. Specialty area, JPY 163 billion, year-on-year, JPY 11.7 billion, 7.7% increase. Overall, NHI price revision impact was there, but the mainstay Hemlibra, Actemra, N-Spring, and Vabysmo are very well, and therefore, new product, PiaSky, also continuing from last year. It continues its momentum and increasing sales. Overseas, as we have explained before, especially Actemra, JPY 32.2 billion, year-on-year, 7.7% increase is what we are seeing. Hemlibra, JPY 1.1 billion is positive. Q2, next page, Hemlibra and Actemra. In terms of net income, after taxes, JPY 320 billion and JPY 18.7 billion, 6.2% increase. in terms of net income after taxes jpy 320 billion and jpy 18.7 billion 6.2% increase Next, in terms of the sales by product, the DARC, the domestic oncology, JPY 180 billion, year-on-year, JPY 0.4 billion increase, an increase of 0.2%. next in terms of the sales by product the darc the domestic oncology jpy 180 billion year-on-year jpy 0.4 billion increase an increase of 0.2% Content-wise, in terms of the generic drug, Avastin dropped. content-wise in terms of the generic drug avastin dropped On the other hand, new product, Vesigo, sales is a replacement. on the other hand new product vesigo sales is a replacement Ajeta is much higher, so therefore it's very good. ajeta is much higher so therefore it's very good Also, new product, Lansimil has started very well. also new product lansimil has started very well Specialty area, JPY 163 billion, year-on-year, JPY 11.7 billion, 7.7% increase. specialty area jpy 163 billion year-on-year jpy 11.7 billion 7.7% increase Overall, NHI price revision impact was there, but the mainstay Hemlibra, Actemra, N-Spring, and Vabysmo are very well, and therefore, new product, PiaSky, also continuing from last year. overall nhi price revision impact was there but the mainstay hemlibra actemra n-spring and vabysmo are very well and therefore new product piasky also continuing from last year It continues its momentum and increasing sales. it continues its momentum and increasing sales Overseas, as we have explained before, especially Actemra, JPY 32.2 billion, year-on-year, 7.7% increase is what we are seeing. overseas as we have explained before especially actemra jpy 32.2 billion year-on-year 7.7% increase is what we are seeing Hemlibra, JPY 1.1 billion is positive. hemlibra jpy 1.1 billion is positive Q2, next page, Hemlibra and Actemra. q2 next page hemlibra and actemra This is what we can see. Hemlibra, we are to have it in the end of June, the JPY 38 billion. There has been some delay because of delivery. It's going to be delayed to July. Actually, this has been accounted for Q3 cumulatively, year-on-year, JPY 0.4 billion positive. At this moment in time, year-end, the shipment schedule, if we keep this in mind, total annual full year, JPY 318.6 billion. We should be doing more than JPY 10 billion earlier, but I think we're going to do a similar more than JPY 10 billion more. Actemra, biosimilar permeation was delayed than our expectations. Q3 timing is getting closer to the full year of JPY 123 billion. From the schedule, we think we're doing very well cumulatively. Full year JPY 123 billion, we should be higher by JPY 20 billion, most likely at the end of the year. Operating profit up to September, breakdown. This is what we can see. this is what we can see Hemlibra, we are to have it in the end of June, the JPY 38 billion. hemlibra we are to have it in the end of june the jpy 38 billion There has been some delay because of delivery. there has been some delay because of delivery It's going to be delayed to July. it's going to be delayed to july Actually, this has been accounted for Q3 cumulatively, year-on-year, JPY 0.4 billion positive. actually this has been accounted for q3 cumulatively year-on-year jpy 0.4 billion positive At this moment in time, year-end, the shipment schedule, if we keep this in mind, total annual full year, JPY 318.6 billion. at this moment in time year-end the shipment schedule if we keep this in mind total annual full year jpy 318.6 billion We should be doing more than JPY 10 billion earlier, but I think we're going to do a similar more than JPY 10 billion more. we should be doing more than jpy 10 billion earlier but i think we're going to do a similar more than jpy 10 billion more Actemra, biosimilar permeation was delayed than our expectations. actemra biosimilar permeation was delayed than our expectations Q3 timing is getting closer to the full year of JPY 123 billion. q3 timing is getting closer to the full year of jpy 123 billion From the schedule, we think we're doing very well cumulatively. from the schedule we think we're doing very well cumulatively Full year JPY 123 billion, we should be higher by JPY 20 billion, most likely at the end of the year. full year jpy 123 billion we should be higher by jpy 20 billion most likely at the end of the year Operating profit up to September, breakdown. operating profit up to september breakdown Left-hand side, domestic, domestic, JPY 12 billion up. Impact of the NHI price, JPY 7.5 billion. We are able to improve by volume. JPY 19 billion is the volume. We are able to accommodate the NHI price, JPY 7.5 billion. Overseas, sales JPY 32 billion. In terms of developing countries, sales expansion, unit price is down, volume is up in a big way. We have the foreign exchange impact, JPY 25.9 billion. Therefore, we are able to see such a big increase. The cost, of course, sales cost, JPY 19.2 billion. These are the main operating profit. The JPY 13.9 billion breakdown is what I just mentioned to you at this moment. Next page, please. From this point on, quarter by quarter, the sales, profit, and then the cost we're looking at. By quarter, it goes up and down somewhat. Q4, domestically, sales will improve. Overseas, export timing is not necessarily as regular as regular. Left-hand side, domestic, domestic, JPY 12 billion up. left-hand side domestic domestic jpy 12 billion up Impact of the NHI price, JPY 7.5 billion. impact of the nhi price jpy 7.5 billion We are able to improve by volume. we are able to improve by volume JPY 19 billion is the volume. jpy 19 billion is the volume We are able to accommodate the NHI price, JPY 7.5 billion. we are able to accommodate the nhi price jpy 7.5 billion Overseas, sales JPY 32 billion. overseas sales jpy 32 billion In terms of developing countries, sales expansion, unit price is down, volume is up in a big way. in terms of developing countries sales expansion unit price is down volume is up in a big way We have the foreign exchange impact, JPY 25.9 billion. we have the foreign exchange impact jpy 25.9 billion Therefore, we are able to see such a big increase. therefore we are able to see such a big increase The cost, of course, sales cost, JPY 19.2 billion. the cost of course sales cost jpy 19.2 billion These are the main operating profit. these are the main operating profit The JPY 13.9 billion breakdown is what I just mentioned to you at this moment. the jpy 13.9 billion breakdown is what i just mentioned to you at this moment Next page, please. next page please From this point on, quarter by quarter, the sales, profit, and then the cost we're looking at. from this point on quarter by quarter the sales profit and then the cost we're looking at By quarter, it goes up and down somewhat. by quarter it goes up and down somewhat Q4, domestically, sales will improve. q4 domestically sales will improve Overseas, export timing is not necessarily as regular as regular. overseas export timing is not necessarily as regular as regular This could impact in terms of timing. In terms of sales by quarter, three months at a time, we have some seasonality as well. You can confirm from these numbers. Next page, please. This is the P&L for as of September. The progress from what we mentioned to you at the beginning of the year. Three quarters, so 75%, we have already at the end of Q3. Sales, profit, both, we are coming along quite well so far. Last year, 2024. End of September. In terms of comparing us, in terms of sales, 2.4%, we are higher. Operating profit also, 2.3%. We are positive against last year's progress. We are ahead of plan. Next page, please. This could impact in terms of timing. this could impact in terms of timing In terms of sales by quarter, three months at a time, we have some seasonality as well. in terms of sales by quarter three months at a time we have some seasonality as well You can confirm from these numbers. you can confirm from these numbers Next page, please. next page please This is the P&L for as of September. this is the p&l for as of september The progress from what we mentioned to you at the beginning of the year. the progress from what we mentioned to you at the beginning of the year Three quarters, so 75%, we have already at the end of Q3. three quarters so 75% we have already at the end of q3 Sales, profit, both, we are coming along quite well so far. sales profit both we are coming along quite well so far Last year, 2024. last year 2024 End of September. end of september In terms of comparing us, in terms of sales, 2.4%, we are higher. in terms of comparing us in terms of sales 2.4% we are higher Operating profit also, 2.3%. operating profit also 2.3% We are positive against last year's progress. we are positive against last year's progress We are ahead of plan. we are ahead of plan Next page, please. next page please This is the detailed information on the status of progress per segment, per product. 75% is the benchmark, and you can tell which one is above 75% or not. If you look at the app pointing blue arrow, that means that those products are above 75% of threshold. This is an FX impact. Compared to last year, yen became cheaper by JPY 11 against the CHF. If you look at the left, you see actual JPY 34.7 billion+ on the revenue. OP-wise, JPY 30.5 billion+. Last year, we've already done 80% of the FX booking. We have some turn expected rate, but for the rest, we are affected by the FX impact. JPY 200 million is the positive impact against the 2025 expected rate in terms of revenue and -JPY 1.1 billion on OP. We had a payment of tax in December, and we had a higher special dividend payment this year. This is the detailed information on the status of progress per segment, per product. 75% is the benchmark, and you can tell which one is above 75% or not. this is the detailed information on the status of progress per segment per product 75% is the benchmark and you can tell which one is above 75% or not If you look at the app pointing blue arrow, that means that those products are above 75% of threshold. if you look at the app pointing blue arrow that means that those products are above 75% of threshold This is an FX impact. this is an fx impact Compared to last year, yen became cheaper by JPY 11 against the CHF. compared to last year yen became cheaper by jpy 11 against the chf If you look at the left, you see actual JPY 34.7 billion+ on the revenue. if you look at the left you see actual jpy 34.7 billion+ on the revenue OP-wise, JPY 30.5 billion+ . op-wise jpy 30.5 billion+ Last year, we've already done 80% of the FX booking. last year we've already done 80% of the fx booking We have some turn expected rate, but for the rest, we are affected by the FX impact. we have some turn expected rate but for the rest we are affected by the fx impact JPY 200 million is the positive impact against the 2025 expected rate in terms of revenue and -JPY 1.1 billion on OP. jpy 200 million is the positive impact against the 2025 expected rate in terms of revenue and -jpy 1.1 billion on op We had a payment of tax in December, and we had a higher special dividend payment this year. we had a payment of tax in december and we had a higher special dividend payment this year As a result, cash and deposit came down, and total asset reduced by JPY 24.8 billion. The ratio of equity attributable to Chugai's shareholder was up by 0.5% compared to December last year. Cash down by JPY 113.9 billion. The operating cash, fleet cash flow was JPY 373.2 billion, but we had to pay corporate tax and we had to pay out dividend. As a result, in the past nine months, the cash reduced by JPY 113.9 billion. This is non-core adjusted numbers. You see the difference between the core actual versus IFRS-based numbers. In-licensed, the depreciation of the in-licensed product and impairment on top of those, we are now undergoing the replacement of ERP. In the second half, we announced discontinuation of development projects, and that led to the impairment because we've had a fixed asset, which is the investigational drugs in the inventory, and we had to take impairment for those. As a result, cash and deposit came down, and total asset reduced by JPY 24.8 billion. as a result cash and deposit came down and total asset reduced by jpy 24.8 billion The ratio of equity attributable to Chugai's shareholder was up by 0.5% compared to December last year. the ratio of equity attributable to chugai's shareholder was up by 0.5% compared to december last year Cash down by JPY 113.9 billion. cash down by jpy 113.9 billion The operating cash, fleet cash flow was JPY 373.2 billion, but we had to pay corporate tax and we had to pay out dividend. the operating cash fleet cash flow was jpy 373.2 billion but we had to pay corporate tax and we had to pay out dividend As a result, in the past nine months, the cash reduced by JPY 113.9 billion. as a result in the past nine months the cash reduced by jpy 113.9 billion This is non-core adjusted numbers. this is non-core adjusted numbers You see the difference between the core actual versus IFRS-based numbers. you see the difference between the core actual versus ifrs-based numbers In-licensed, the depreciation of the in-licensed product and impairment on top of those, we are now undergoing the replacement of ERP. in-licensed the depreciation of the in-licensed product and impairment on top of those we are now undergoing the replacement of erp In the second half, we announced discontinuation of development projects, and that led to the impairment because we've had a fixed asset, which is the investigational drugs in the inventory, and we had to take impairment for those. in the second half we announced discontinuation of development projects and that led to the impairment because we've had a fixed asset which is the investigational drugs in the inventory and we had to take impairment for those Also, we had to pay some expenses to the CRO. We had JPY 8.4 billion sales proceed on asset. This is the property we held in Kamakura. From next pages onward, this may be the familiar slide for you. These are the status of our in-house global products. This is the current situation as of the third quarter. We've added some qualitative comments on those products. These are already approved CapEx. No major change from the last presentation. That's all from myself. Thank you. Also, we had to pay some expenses to the CRO. also we had to pay some expenses to the cro We had JPY 8.4 billion sales proceed on asset. we had jpy 8.4 billion sales proceed on asset This is the property we held in Kamakura. this is the property we held in kamakura From next pages onward, this may be the familiar slide for you. from next pages onward this may be the familiar slide for you These are the status of our in-house global products. these are the status of our in-house global products This is the current situation as of the third quarter. this is the current situation as of the third quarter We've added some qualitative comments on those products. we've added some qualitative comments on those products These are already approved CapEx. these are already approved capex No major change from the last presentation. no major change from the last presentation That's all from myself. that's all from myself Thank you. thank you

Speaker 10: We would like to move on to Q&A. For Q&A from Sales, Mr. Takano will also be here to support. If we may kindly ask, please keep your questions up to two points so that many questions can be entertained. Similarly, we will be putting the Q&A on the website at later dates. Once again, let me explain. If you can select the language at the bottom where it says translation logo and select either Japanese or English. Unless you make the setup, you will not get the sound that you would desire. We would like to begin the questions. Zoom webinar, and click raise hand. When your name comes up, we will call your name. We would also give you the sound, and you will be unmuted. If you decide to cancel your questions, you can retract your hand. There is a number nine for the telephone. We would like to move on to Q&A. we would like to move on to q&a For Q&A from Sales, Mr. Takano will also be here to support. for q&a from sales mr takano will also be here to support If we may kindly ask, please keep your questions up to two points so that many questions can be entertained. if we may kindly ask please keep your questions up to two points so that many questions can be entertained Similarly, we will be putting the Q&A on the website at later dates. similarly we will be putting the q&a on the website at later dates Once again, let me explain. once again let me explain If you can select the language at the bottom where it says translation logo and select either Japanese or English. if you can select the language at the bottom where it says translation logo and select either japanese or english Unless you make the setup, you will not get the sound that you would desire. unless you make the setup you will not get the sound that you would desire We would like to begin the questions. we would like to begin the questions Zoom webinar, and click raise hand. zoom webinar and click raise hand When your name comes up, we will call your name. when your name comes up we will call your name We would also give you the sound, and you will be unmuted. we would also give you the sound and you will be unmuted If you decide to cancel your questions, you can retract your hand. if you decide to cancel your questions you can retract your hand There is a number nine for the telephone. there is a number nine for the telephone We will call your name, so give us your name and company. If you're going to cancel, you have to put the number nine after the asterisk. JPMorgan, Wakao-san, please, if you can begin your questions. We will call your name, so give us your name and company. we will call your name so give us your name and company If you're going to cancel, you have to put the number nine after the asterisk. if you're going to cancel you have to put the number nine after the asterisk JP Morgan, Wakao-san, please, if you can begin your questions. jp morgan wakao-san please if you can begin your questions

Speaker 1: Wakao from JPMorgan Chase. Can you hear me? Yes, we can hear you. Thank you. Two questions. One, Sparsentan, purchasing of this company, the buyout. Why did you decide to buy this area? Can you give me the background again? Is this the market that you have the area as well as why you want to do more of the Sparsentan? Besides Roche, are there any areas that you are interested in besides Roche? Why are you looking for outside of Roche? Sparsentan. That change, we would like to know much more about if we can. Wakao from JPMorgan Chase. wakao from jpmorgan chase Can you hear me? can you hear me Yes, we can hear you. yes we can hear you Thank you. thank you Two questions. two questions One, Sparsentan, purchasing of this company, the buyout. one sparsentan purchasing of this company the buyout Why did you decide to buy this area? why did you decide to buy this area Can you give me the background again? can you give me the background again Is this the market that you have the area as well as why you want to do more of the Sparsentan? is this the market that you have the area as well as why you want to do more of the sparsentan Besides Roche, are there any areas that you are interested in besides Roche? besides roche are there any areas that you are interested in besides roche Why are you looking for outside of Roche? why are you looking for outside of roche Sparsentan. sparsentan That change, we would like to know much more about if we can. that change we would like to know much more about if we can

Speaker 9: Thank you for the question, Wakao-san. If I may answer that for you, I would like to talk about Rhenalis, the Sparsentan acquisition. I think you are asking about the Sparsentan. Thank you for the question, Wakao-san. thank you for the question wakao-san If I may answer that for you, I would like to talk about Rhenalis, the Sparsentan acquisition. if i may answer that for you i would like to talk about rhenalis the sparsentan acquisition I think you are asking about the Sparsentan. i think you are asking about the sparsentan We have decided, as the slide shows you, for we want to have the appropriate capital allocation, three areas or policies that we have. Basically, innovative area that Chugai as well as provisioning, and then value creation, R&D needs to be strengthened, and other opportunities for investment. On top of that, the basic return to shareholders of that innovative drug provision. Of course, allocating our capital is a must. Chugai, as you know, in Japan, development, marketing, sales, we are very strong and getting strong. In terms of a lot of the sales and marketing that we do, we're becoming number one. Using that power, we should use that and leverage that. Rhenalis, we bought this company. We will be buying Sparsentan. Acquisition happened in line with that. This is an area that we are strong in, in the [IPA] development, PiaSky, IgA nephropathy, Sparsentan. We have other products. We have decided, as the slide shows you, for we want to have the appropriate capital allocation, three areas or policies that we have. we have decided as the slide shows you for we want to have the appropriate capital allocation three areas or policies that we have Basically, innovative area that Chugai as well as provisioning, and then value creation, R&D needs to be strengthened, and other opportunities for investment. basically innovative area that chugai as well as provisioning and then value creation r&d needs to be strengthened and other opportunities for investment On top of that, the basic return to shareholders of that innovative drug provision. on top of that the basic return to shareholders of that innovative drug provision Of course, allocating our capital is a must. of course allocating our capital is a must Chugai, as you know, in Japan, development, marketing, sales, we are very strong and getting strong. chugai as you know in japan development marketing sales we are very strong and getting strong In terms of a lot of the sales and marketing that we do, we're becoming number one. in terms of a lot of the sales and marketing that we do we're becoming number one Using that power, we should use that and leverage that. using that power we should use that and leverage that Rhenalis, we bought this company. rhenalis we bought this company We will be buying Sparsentan. we will be buying sparsentan Acquisition happened in line with that. acquisition happened in line with that This is an area that we are strong in, in the [IPA] development, PiaSky, IgA nephropathy, Sparsentan. this is an area that we are strong in in the [ipa] development piasky iga nephropathy sparsentan We have other products. we have other products The nephropathy line, we would like to increase. This is an area that we're looking into that we did it as part of the capital allocation. Sparsentan is something that we focused on this time. Number two, your question. Going forward, are we looking at other opportunities? Of course, if there's an opportunity, we will be interested. Our strength, R&D capability, and our strength are development sales in Japan. We would like to use that as our leverage so that innovative drugs could be provided to the market is what we want to do. Thank you very much. If this matches your area, are you aggressively going to do more of these same products? Am I correct? It just so happened. This opportunity, we are always searching for opportunities. We found an attractive development opportunity, as we saw, and it fits our strategy. The nephropathy line, we would like to increase. the nephropathy line we would like to increase This is an area that we're looking into that we did it as part of the capital allocation. this is an area that we're looking into that we did it as part of the capital allocation Sparsentan is something that we focused on this time. sparsentan is something that we focused on this time Number two, your question. number two your question Going forward, are we looking at other opportunities? going forward are we looking at other opportunities Of course, if there's an opportunity, we will be interested. of course if there's an opportunity we will be interested Our strength, R&D capability, and our strength are development sales in Japan. our strength r&d capability and our strength are development sales in japan We would like to use that as our leverage so that innovative drugs could be provided to the market is what we want to do. we would like to use that as our leverage so that innovative drugs could be provided to the market is what we want to do Thank you very much. thank you very much If this matches your area, are you aggressively going to do more of these same products? if this matches your area are you aggressively going to do more of these same products Am I correct? am i correct It just so happened. it just so happened This opportunity, we are always searching for opportunities. this opportunity we are always searching for opportunities We found an attractive development opportunity, as we saw, and it fits our strategy. we found an attractive development opportunity as we saw and it fits our strategy That's why Rhenalis and Sparsentan happened this time. That's why Rhenalis and Sparsentan happened this time. that's why rhenalis and sparsentan happened this time

Speaker 1: Understood. In terms of what we have, the IgAN, are you thinking of other options? Understood. understood In terms of what we have, the IgAN, are you thinking of other options? in terms of what we have the igan are you thinking of other options

Speaker 9: [Foreign Language] Can you repeat your question? [Foreign Language] Can you repeat your question? [foreign language] can you repeat your question

Speaker 1: In terms of the Glenox and other types that you have, the anti-APRIL, do we have any other topics that you would be interested in? In terms of the Glenox and other types that you have, the anti-APRIL, do we have any other topics that you would be interested in? in terms of the glenox and other types that you have the anti-april do we have any other topics that you would be interested in

Speaker 4: Thank you, Wakao-san. Thank you for the question. Of course, this kind and IgA type is a hot topic, the nephro area. What we did this time, this Sparsentan is also an attractive drug, especially many angiotensin inhibitor, endothelin. It can inhibit both at the same time. It has a double antagonist. You can start with the first line. For us, as you know, IgA nephropathy, cephalic cells, and we have, so we thought it would be a good synergy. April, we are looking at two innovative, then we would be considering. Thank you, Wakao-san. thank you wakao-san Thank you for the question. thank you for the question Of course, this kind and IgA type is a hot topic, the nephro area. of course this kind and iga type is a hot topic the nephro area What we did this time, this Sparsentan is also an attractive drug, especially many angiotensin inhibitor, endothelin. what we did this time this sparsentan is also an attractive drug especially many angiotensin inhibitor endothelin It can inhibit both at the same time. it can inhibit both at the same time It has a double antagonist. it has a double antagonist You can start with the first line. you can start with the first line For us, as you know, IgA nephropathy, cephalic cells, and we have, so we thought it would be a good synergy. for us as you know iga nephropathy cephalic cells and we have so we thought it would be a good synergy April, we are looking at two innovative, then we would be considering. april we are looking at two innovative then we would be considering Sparsentan came up to us perfectly. Sparsentan came up to us perfectly. sparsentan came up to us perfectly

Speaker 1: Thank you. Number two question, offered the orforglipron. Lilly, what kind of communication do you have with Lilly? 2026 obesity. You want to have approval and launch. Lilly, about the approval and then the sales number. Are you given numbers from Lilly from next fiscal year? It's probably going to hit your numbers from, I want to know. What kind of communications do you have with Lilly would be my interest. Thank you. thank you Number two question, offered the orforglipron. number two question offered the orforglipron Lilly, what kind of communication do you have with Lilly? 2026 obesity. lilly what kind of communication do you have with lilly 2026 obesity You want to have approval and launch. you want to have approval and launch Lilly, about the approval and then the sales number. lilly about the approval and then the sales number Are you given numbers from Lilly from next fiscal year? are you given numbers from lilly from next fiscal year It's probably going to hit your numbers from, I want to know. it's probably going to hit your numbers from i want to know What kind of communications do you have with Lilly would be my interest. what kind of communications do you have with lilly would be my interest

Speaker 9: Thank you very much for the question. From Lilly, as you know, for orforglipron, 2025, we want to get the submission approval, and then for diabetes, 2026 is what's going to be happening for the approval. Therefore, approval and then launch will be the flow. Week two next year, at some point in time, we want approval and then launch to happen, of course. Thank you very much for the question. thank you very much for the question From Lilly, as you know, for orforglipron, 2025, we want to get the submission approval, and then for diabetes, 2026 is what's going to be happening for the approval. from lilly as you know for orforglipron 2025 we want to get the submission approval and then for diabetes 2026 is what's going to be happening for the approval Therefore, approval and then launch will be the flow. therefore approval and then launch will be the flow Week two next year, at some point in time, we want approval and then launch to happen, of course. week two next year at some point in time we want approval and then launch to happen of course

Speaker 1: Your company, beginning of the year, you said we'll be putting in next year's, unless it's approved, you wouldn't put it in your next year. Your company, beginning of the year, you said we'll be putting in next year's, unless it's approved, you wouldn't put it in your next year. your company beginning of the year you said we'll be putting in next year's unless it's approved you wouldn't put it in your next year

Speaker 9: Mr. Taniguchi can probably talk about that. Mr. Taniguchi can probably talk about that. mr taniguchi can probably talk about that

Speaker 2: Next year budget, we will talk about it in January, so we're still vigilant. If the likelihood is high, then we will put some numbers for next year. That timing and of the submission, Lilly is always keeping you up to date. Lilly communication channel, of course, we have. What kind of discussions go on between us, I don't think we can talk about it. Next year budget, we will talk about it in January, so we're still vigilant. next year budget we will talk about it in january so we're still vigilant If the likelihood is high, then we will put some numbers for next year. if the likelihood is high then we will put some numbers for next year That timing and of the submission, Lilly is always keeping you up to date. that timing and of the submission lilly is always keeping you up to date Lilly communication channel, of course, we have. lilly communication channel of course we have What kind of discussions go on between us, I don't think we can talk about it. what kind of discussions go on between us i don't think we can talk about it Thank you very much. Thank you very much. thank you very much

Speaker 10: Next is from Morgan Stanley. Mr. Muraoka, please. Next is from Morgan Stanley. next is from morgan stanley Mr. Muraoka, please. mr muraoka please

Speaker 5: Yes, thank you. I am Muraoka from Morgan Stanley. On top of what Wakao-san asked, normally in the third quarter, what's your outlook into next year if the approval is very probable? You said that you're going to include the compound information in the material, but next year, NEMLUVIO is doing well, and I can't think of any negative factor other than Actemra. Next year should be a good year for you in terms of the performance, correct? How do you see next year? Yes, thank you. yes thank you I am Muraoka from Morgan Stanley. i am muraoka from morgan stanley On top of what Wakao-san asked, normally in the third quarter, what's your outlook into next year if the approval is very probable? on top of what wakao-san asked normally in the third quarter what's your outlook into next year if the approval is very probable You said that you're going to include the compound information in the material, but next year, NEMLUVIO is doing well, and I can't think of any negative factor other than Actemra. you said that you're going to include the compound information in the material but next year nemluvio is doing well and i can't think of any negative factor other than actemra Next year should be a good year for you in terms of the performance, correct? next year should be a good year for you in terms of the performance correct How do you see next year? how do you see next year

Speaker 9: Mr. Muraoka, thank you for your question. I would like to respond. What may happen next year is very difficult to be predicted in an accurate manner. Orforglipron is one thing, Actemra biosimilar penetration or erosion is already happening, and we can't really tell how fast this penetration will play out. Mr. Muraoka, thank you for your question. mr muraoka thank you for your question I would like to respond. i would like to respond What may happen next year is very difficult to be predicted in an accurate manner. what may happen next year is very difficult to be predicted in an accurate manner Orforglipron is one thing, Actemra biosimilar penetration or erosion is already happening, and we can't really tell how fast this penetration will play out. orforglipron is one thing actemra biosimilar penetration or erosion is already happening and we can't really tell how fast this penetration will play out

Speaker 10: NEMLUVIO, mainly in the U.S., is showing more than expected post-launch sales. All in all, at this point of time, I would say the sales we believe will be slightly higher than this year. NEMLUVIO, mainly in the U.S., is showing more than expected post-launch sales. nemluvio mainly in the u.s is showing more than expected post-launch sales All in all, at this point of time, I would say the sales we believe will be slightly higher than this year. all in all at this point of time i would say the sales we believe will be slightly higher than this year

Speaker 5: Thank you. What about the core OP? Is there anything that you can comment? Thank you. thank you What about the core OP? what about the core op Is there anything that you can comment? is there anything that you can comment

Speaker 9: At this point of time, nothing I can comment. Please wait until next year's earnings presentation. At this point of time, nothing I can comment. at this point of time nothing i can comment Please wait until next year's earnings presentation. please wait until next year's earnings presentation

Speaker 5: Okay. With regard to next year's dividend, 45, am I correct to understand that dividend will come back to like a normal range of 45%? Okay. okay With regard to next year's dividend, 45, am I correct to understand that dividend will come back to like a normal range of 45%? with regard to next year's dividend 45 am i correct to understand that dividend will come back to like a normal range of 45%

Speaker 9: Taniguchi will respond to your question. Taniguchi will respond to your question. taniguchi will respond to your question

Speaker 2: Thank you, Muraoka-san. This time, as a 100-year anniversary, we are doing a special dividend. Basically, we make dividend payout based on our regular policy. Thank you, Muraoka-san. thank you muraoka-san This time, as a 100-year anniversary, we are doing a special dividend. this time as a 100-year anniversary we are doing a special dividend Basically, we make dividend payout based on our regular policy. basically we make dividend payout based on our regular policy

Speaker 5: Thank you. My second question is as follows. Thank you. thank you My second question is as follows. my second question is as follows Gym, related to gym, yesterday's Roche had a conference call, and next year's ADA, they said that they're going to make a presentation. I thought that they're going to make a presentation on gym, you know, obesity, mainly GLP-1. Gym, obesity, I don't think they can make it by ADA. Can I ask you the timing of the presentation for gym, obesity? Gym, related to gym, yesterday's Roche had a conference call, and next year's ADA, they said that they're going to make a presentation. gym related to gym yesterday's roche had a conference call and next year's ada they said that they're going to make a presentation I thought that they're going to make a presentation on gym, you know, obesity, mainly GLP-1. i thought that they're going to make a presentation on gym you know obesity mainly glp-1 Gym, obesity, I don't think they can make it by ADA. gym obesity i don't think they can make it by ada Can I ask you the timing of the presentation for gym, obesity? can i ask you the timing of the presentation for gym obesity

Speaker 4: Yes. Mr. Muraoka, thank you for your question. Gym phase two, treating at obesity. The patient enrollment has been complete already. Next year in 2026, we are expecting readout, and that's been already announced. In terms of the academic conference presentation, we haven't made any announcement. Yes. yes Mr. Muraoka, thank you for your question. mr muraoka thank you for your question Gym phase two, treating at obesity. gym phase two treating at obesity The patient enrollment has been complete already. the patient enrollment has been complete already Next year in 2026, we are expecting readout, and that's been already announced. next year in 2026 we are expecting readout and that's been already announced In terms of the academic conference presentation, we haven't made any announcement. in terms of the academic conference presentation we haven't made any announcement

Speaker 5: Understood. Thank you very much. That's all. Understood. understood Thank you very much. thank you very much That's all. that's all

Speaker 9: Citigroup. Mr. Yamaguchi, please. Citigroup. citigroup Mr. Yamaguchi, please. mr yamaguchi please

Speaker 7: Can you hear me? Can you hear me? can you hear me

Speaker 9: Yes, we can hear you. Yes, we can hear you. yes we can hear you

Speaker 7: Hello. This is Yamaguchi from Citigroup. Hemlibra, export. And the Roche number from yesterday, Roche's number from yesterday, Q2, Q3, there are different patterns. International Q2, Q3 kind of dropped a little bit, I heard. Your case, Q2, Q3, you had some numbers. Both patterns. Q4, you may be higher than expected. Our export and their sales relationship. And those single-digit dim Hyblin, you said, but is there going to be a stagger for next fiscal year? Similar questions as usual, but sorry if you can give me the narrative, please. Hello. hello This is Yamaguchi from Citigroup. this is yamaguchi from citigroup Hemlibra, export. hemlibra export And the Roche number from yesterday, Roche's number from yesterday, Q2, Q3, there are different patterns. and the roche number from yesterday roche's number from yesterday q2 q3 there are different patterns International Q2, Q3 kind of dropped a little bit, I heard. international q2 q3 kind of dropped a little bit i heard Your case, Q2, Q3, you had some numbers. your case q2 q3 you had some numbers Both patterns. both patterns Q4, you may be higher than expected. q4 you may be higher than expected Our export and their sales relationship. our export and their sales relationship And those single-digit dim Hyblin, you said, but is there going to be a stagger for next fiscal year? and those single-digit dim hyblin you said but is there going to be a stagger for next fiscal year Similar questions as usual, but sorry if you can give me the narrative, please. similar questions as usual but sorry if you can give me the narrative please

Speaker 9: Taniguchi-san would explain. Taniguchi-san would explain. taniguchi-san would explain

Speaker 2: Thank you for the question. Roche, what they sell and then our export is not necessarily in complete parallel. Still, for export, we have order forecast from Roche. It's what we receive. Six months or so, it's a commitment number. Thank you for the question. thank you for the question Roche, what they sell and then our export is not necessarily in complete parallel. roche what they sell and then our export is not necessarily in complete parallel Still, for export, we have order forecast from Roche. still for export we have order forecast from roche It's what we receive. it's what we receive Six months or so, it's a commitment number. six months or so it's a commitment number

Speaker 9: Q4, as we said, compared to last year, we will be higher. Full year too, as we said. Last year, it's going to be higher by JPY 10 billion from the JPY 318.6 billion number that we gave you. This is fiscal year for this year. Next fiscal year, we're still working on it. Yesterday's Roche call, low single-digit, of course, Roche said, but to a certain extent, that may be the dim Hyblin. There may be some positive that we have from Hemlibra. Yes. Q4, as we said, compared to last year, we will be higher. q4 as we said compared to last year we will be higher Full year too, as we said. full year too as we said Last year, it's going to be higher by JPY 10 billion from the JPY 318.6 billion number that we gave you. last year it's going to be higher by jpy 10 billion from the jpy 318.6 billion number that we gave you This is fiscal year for this year. this is fiscal year for this year Next fiscal year, we're still working on it. next fiscal year we're still working on it Yesterday's Roche call, low single-digit, of course, Roche said, but to a certain extent, that may be the dim Hyblin. yesterday's roche call low single-digit of course roche said but to a certain extent that may be the dim hyblin There may be some positive that we have from Hemlibra. there may be some positive that we have from hemlibra Yes. yes

Speaker 7: Thank you. Actemra, similar question. JPY 10 billion, JPY 20 billion higher this year. Thank you. thank you Actemra, similar question. actemra similar question JPY 10 billion, JPY 20 billion higher this year. jpy 10 billion jpy 20 billion higher this year

Speaker 2: This fiscal year, under JPY 15 billion. We are very close to the full year numbers already. Q4, we already have those numbers fixed for Q4, so we will have those JPY 220 billion. Next year, biosimilar may be coming, and we don't know how far that's going to progress. This fiscal year, under JPY 15 billion. this fiscal year under jpy 15 billion We are very close to the full year numbers already. we are very close to the full year numbers already Q4, we already have those numbers fixed for Q4, so we will have those JPY 220 billion. q4 we already have those numbers fixed for q4 so we will have those jpy 220 billion Next year, biosimilar may be coming, and we don't know how far that's going to progress. next year biosimilar may be coming and we don't know how far that's going to progress Compared to this year's number, we will be impacted, but we're still looking into it. Please wait till January timing where we can give you more numbers in detail. No change. No change. Basically, it's mild. Not much drop, you have been saying. For now, as of today, by year-end, no change, but maybe next year. There is another. This time next year, whether it's mild, better, hard to say. Compared to this year's number, we will be impacted, but we're still looking into it. compared to this year's number we will be impacted but we're still looking into it Please wait till January timing where we can give you more numbers in detail. please wait till january timing where we can give you more numbers in detail No change. no change no change No change. no change Basically, it's mild. basically it's mild Not much drop, you have been saying. not much drop you have been saying For now, as of today, by year-end, no change, but maybe next year. for now as of today by year-end no change but maybe next year There is another. there is another This time next year, whether it's mild, better, hard to say. this time next year whether it's mild better hard to say

Speaker 7: Thank you very much. That's all I had for you. Thank you. Thank you very much. thank you very much That's all I had for you. that's all i had for you Thank you. thank you

Speaker 10: Next is from SMBC Nikko Securities. Mr. Wada, please. Next is from SMBC Nikko Securities. next is from smbc nikko securities Mr. Wada, please. mr wada please

Speaker 3: Thank you. I am Wada from SMBC Nikko. With regard to N-Spring, TED, so my question is, Tepezza is already approved, and what is the point of differentiation against that drug? You have kind of one win, one lose, but what is your expectation on the approval? Like what is the most likely scenario? Thank you. thank you I am Wada from SMBC Nikko. i am wada from smbc nikko With regard to N-Spring, TED, so my question is, Tepezza is already approved, and what is the point of differentiation against that drug? with regard to n-spring ted so my question is tepezza is already approved and what is the point of differentiation against that drug You have kind of one win, one lose, but what is your expectation on the approval? you have kind of one win one lose but what is your expectation on the approval Like what is the most likely scenario? like what is the most likely scenario

Speaker 9: Thank you very much, Mr. Wada. Kusano would like to answer. Thank you very much, Mr. Wada. thank you very much mr wada Kusano would like to answer. kusano would like to answer

Speaker 4: Tepezza, in relation to the comparison against Tepezza, we do not have head-to-head comparison in the same study, so I can't do that. Based on the result, in terms of the safety, N-Spring has given a very good safety profile. IGF-IR inhibitor, Tepezza oftentimes shows high BP, alopecia, and low blood pressure. Those things are not observed. The proptosis improvement-wise, Tepezza has shown very high efficacy. Tepezza, in relation to the comparison against Tepezza, we do not have head-to-head comparison in the same study, so I can't do that. tepezza in relation to the comparison against tepezza we do not have head-to-head comparison in the same study so i can't do that Based on the result, in terms of the safety, N-Spring has given a very good safety profile. based on the result in terms of the safety n-spring has given a very good safety profile IGF-IR inhibitor, Tepezza oftentimes shows high BP, alopecia, and low blood pressure. igf-ir inhibitor tepezza oftentimes shows high bp alopecia and low blood pressure Those things are not observed. those things are not observed The proptosis improvement-wise, Tepezza has shown very high efficacy. the proptosis improvement-wise tepezza has shown very high efficacy When we look at the activity level of the disease in terms of the score, our result is comparable to Tepezza. From a safety perspective, in some cases, it's very difficult to use Tepezza in certain patients who are like a diabetic or inflammatory bowel disease or some severe AE or patients who are relapsing. IGF-1R inhibitor is different from ours, and we can offer a better safety profile. N-Spring once in four weeks, Tepezza once in three weeks IV. N-Spring convenience is very high compared to them. From that perspective, we are scrutinizing the data, and we are going to have a consultation with the regulator. When we look at the activity level of the disease in terms of the score, our result is comparable to Tepezza. when we look at the activity level of the disease in terms of the score our result is comparable to tepezza From a safety perspective, in some cases, it's very difficult to use Tepezza in certain patients who are like a diabetic or inflammatory bowel disease or some severe AE or patients who are relapsing. from a safety perspective in some cases it's very difficult to use tepezza in certain patients who are like a diabetic or inflammatory bowel disease or some severe ae or patients who are relapsing IGF-1R inhibitor is different from ours, and we can offer a better safety profile. igf-1r inhibitor is different from ours and we can offer a better safety profile N-Spring once in four weeks, Tepezza once in three weeks IV. n-spring once in four weeks tepezza once in three weeks iv N-Spring convenience is very high compared to them. n-spring convenience is very high compared to them From that perspective, we are scrutinizing the data, and we are going to have a consultation with the regulator. from that perspective we are scrutinizing the data and we are going to have a consultation with the regulator

Speaker 3: Thank you very much. Very clear. Number two, Sparsentan in-licensing is something I would like to ask. What is the submission schedule? Rhenalis. For Korea, Asia, I think phase 3 has already been complete, and Japan's approach, I guess, is the bridging. Thank you very much. thank you very much Very clear. very clear Number two, Sparsentan in-licensing is something I would like to ask. number two sparsentan in-licensing is something i would like to ask What is the submission schedule? what is the submission schedule Rhenalis. rhenalis For Korea, Asia, I think phase 3 has already been complete, and Japan's approach, I guess, is the bridging. for korea asia i think phase 3 has already been complete and japan's approach i guess is the bridging Are you going to, will you be able to submit the finding in the area where you can perceive early approval? Are you going to, will you be able to submit the finding in the area where you can perceive early approval? are you going to will you be able to submit the finding in the area where you can perceive early approval

Speaker 4: In terms of the submission timing, Japan next year, that's the plan for now. For other countries, we need to decide from now. In terms of the submission timing, Japan next year, that's the plan for now. in terms of the submission timing japan next year that's the plan for now For other countries, we need to decide from now. for other countries we need to decide from now

Speaker 3: Okay, so Japan, phase 3, can be conducted in a small number of patients because you're taking a bridging approach. Okay, so Japan, phase 3, can be conducted in a small number of patients because you're taking a bridging approach. okay so japan phase 3 can be conducted in a small number of patients because you're taking a bridging approach

Speaker 4: Yes, we are planning to enroll 30 patients. We take a bridging approach. Yes, we are planning to enroll 30 patients. yes we are planning to enroll 30 patients We take a bridging approach. we take a bridging approach

Speaker 3: Thank you. Very clear. That's all from me. Thank you. thank you Very clear. very clear That's all from me. that's all from me

Speaker 10: Next, UBS. Sakai-san, please. Next, UBS. next ubs Sakai-san, please. sakai-san please

Speaker 8: Thank you. This is Sakai from UBS. You didn't touch on it. Rani Therapeutics. Rani Therapeutics. Oral, Nurico, you're looking at the antibody. Which level rate you would look for discovery and tie it to your product. Looking at your contract agreement, it's a very broad milestone. The amount goes up as it goes. It must be a pretty new product lineup. You may also be paying some royalty, including your expectations if you have any comments. This is my first question. Thank you. thank you This is Sakai from UBS. this is sakai from ubs You didn't touch on it. you didn't touch on it Rani Therapeutics. rani therapeutics Rani Therapeutics. rani therapeutics Oral, Nurico, you're looking at the antibody. therapeutics oral nurico you're looking at the antibody Which level rate you would look for discovery and tie it to your product. which level rate you would look for discovery and tie it to your product Looking at your contract agreement, it's a very broad milestone. looking at your contract agreement it's a very broad milestone The amount goes up as it goes. the amount goes up as it goes It must be a pretty new product lineup. it must be a pretty new product lineup You may also be paying some royalty, including your expectations if you have any comments. you may also be paying some royalty including your expectations if you have any comments This is my first question. this is my first question

Speaker 9: It is, thank you very much, Sakai-san, for Rani Therapeutics. Which level was your question? Give you a broad answer. This technology, drugs that cannot do oral, it's difficult antibody type within the capsule so that from digestive, it would go. It's a device, actually a device. For this device, Chugai, as you know, antibody engineering, we are very good. It is, thank you very much, Sakai-san, for Rani Therapeutics. it is thank you very much sakai-san for rani therapeutics Which level was your question? which level was your question Give you a broad answer. give you a broad answer This technology, drugs that cannot do oral, it's difficult antibody type within the capsule so that from digestive, it would go. this technology drugs that cannot do oral it's difficult antibody type within the capsule so that from digestive it would go It's a device, actually a device. it's a device actually a device For this device, Chugai, as you know, antibody engineering, we are very good. for this device chugai as you know antibody engineering we are very good It's a good matching, we think. This is why we're doing this technology at this moment. Of course, it's a contract that we have. For the technology, clinical trial, the drug, it gets to the digestive and into the bloodstream. In developing our antibody, especially oral purpose type of disease that requires oral intake, we would like to promote this. Overall value, if it succeeds, the value is very high. There are five projects. We have rights to five projects. If all succeed, this will be quite a large amount that you will be looking at at the end of the day. It's a good matching, we think. it's a good matching we think This is why we're doing this technology at this moment. this is why we're doing this technology at this moment Of course, it's a contract that we have. of course it's a contract that we have For the technology, clinical trial, the drug, it gets to the digestive and into the bloodstream. for the technology clinical trial the drug it gets to the digestive and into the bloodstream In developing our antibody, especially oral purpose type of disease that requires oral intake, we would like to promote this. in developing our antibody especially oral purpose type of disease that requires oral intake we would like to promote this Overall value, if it succeeds, the value is very high. overall value if it succeeds the value is very high There are five projects. there are five projects We have rights to five projects. we have rights to five projects If all succeed, this will be quite a large amount that you will be looking at at the end of the day. if all succeed this will be quite a large amount that you will be looking at at the end of the day

Speaker 8: Five projects. The first one, first pipeline, what would be the timeline or the timing? Five projects. five projects The first one, first pipeline, what would be the timeline or the timing? the first one first pipeline what would be the timeline or the timing

Speaker 9: Timing, it's hard to say at this time. Which component we would apply for this technology, how we would utilize it, we haven't disclosed it yet. Timing, it's hard to say at this time. timing it's hard to say at this time Which component we would apply for this technology, how we would utilize it, we haven't disclosed it yet. which component we would apply for this technology how we would utilize it we haven't disclosed it yet If you will kindly wait, it will show up eventually. It will come into our pipeline. If it does come into our pipeline, then we will be disclosing, yes. Please be patient. If you will kindly wait, it will show up eventually. if you will kindly wait it will show up eventually It will come into our pipeline. it will come into our pipeline If it does come into our pipeline, then we will be disclosing, yes. if it does come into our pipeline then we will be disclosing yes Please be patient. please be patient

Speaker 8: Thank you. Another question, nothing to do with this result. FoundationOne, the genome, what is happening here? It seems to be struggling to grow. Even if you're diagnosed, there's no treatment drug. It's not been adopted, or is it the NHI price cost? Once again, if you could sort the discussion for cancer genome. Thank you. thank you Another question, nothing to do with this result. another question nothing to do with this result FoundationOne, the genome, what is happening here? foundationone the genome what is happening here It seems to be struggling to grow. it seems to be struggling to grow Even if you're diagnosed, there's no treatment drug. even if you're diagnosed there's no treatment drug It's not been adopted, or is it the NHI price cost? it's not been adopted or is it the nhi price cost Once again, if you could sort the discussion for cancer genome. once again if you could sort the discussion for cancer genome

Speaker 9: Thank you for the question. At the moment, in actual by Q3, JPY 6 billion sales we have done so far. F1 CDx, F1 Liquid, we have this liquid, so it's been the demand is growing. Further, recently, expert panel, we have some sites that can do expert panel. 38 sites, we increased to nationwide October 1, 83 sites we have total. Thank you for the question. thank you for the question At the moment, in actual by Q3, JPY 6 billion sales we have done so far. F1 CDx, F1 Liquid, we have this liquid, so it's been the demand is growing. at the moment in actual by q3 jpy 6 billion sales we have done so far. f1 cdx f1 liquid we have this liquid so it's been the demand is growing Further, recently, expert panel, we have some sites that can do expert panel. 38 sites, we increased to nationwide October 1, 83 sites we have total. further recently expert panel we have some sites that can do expert panel 38 sites we increased to nationwide october 1 83 sites we have total Expert panel was the bottleneck so far. Going forward, maybe this cancer genome, F1 CDx, LCDx. Growth may be expected as of today. Expert panel was the bottleneck so far. expert panel was the bottleneck so far Going forward, maybe this cancer genome, F1 CDx, LCDx. going forward maybe this cancer genome f1 cdx lcdx Growth may be expected as of today. growth may be expected as of today

Speaker 8: That's all. Thank you. That's all. that's all Thank you. thank you

Speaker 10: Thank you very much. Unfortunately, we have come close to the end of time. The next question is going to be the last. From BofA, Mr. Mamegano, please. Thank you very much. thank you very much Unfortunately, we have come close to the end of time. unfortunately we have come close to the end of time The next question is going to be the last. the next question is going to be the last From BofA, Mr. Mameg ano, please. from bofa mr mameg ano please

Speaker 6: Hello, can you hear me? Hello, can you hear me? hello can you hear me

Speaker 9: Yes. Yes. yes

Speaker 6: I have a question regarding a gym. SMA FSHD data readout is planned in 2026. For SMA, I think it was originally last year. It was postponed to this year, and now further postponed to next year. Is there anything that you can comment? I have a question regarding a gym. i have a question regarding a gym SMA FSHD data readout is planned in 2026. sma fshd data readout is planned in 2026 For SMA, I think it was originally last year. for sma i think it was originally last year It was postponed to this year, and now further postponed to next year. it was postponed to this year and now further postponed to next year Is there anything that you can comment? is there anything that you can comment

Speaker 4: Yes, thank you very much, Mamegano–san, for your question on gym. As of last year, we were planning readout last year, but the patient enrollment was delayed. We are still hoping to achieve this year's readout. This time, Roche commented that Gym 329, you know, there are a lot of competitive products in a timely manner, in a good timing from conference schedule and so on. Yes, thank you very much, Mameg ano–san, for your question on gym. yes thank you very much mameg ano–san for your question on gym As of last year, we were planning readout last year, but the patient enrollment was delayed. as of last year we were planning readout last year but the patient enrollment was delayed We are still hoping to achieve this year's readout. we are still hoping to achieve this year's readout This time, Roche commented that Gym 329, you know, there are a lot of competitive products in a timely manner, in a good timing from conference schedule and so on. this time roche commented that gym 329 you know there are a lot of competitive products in a timely manner in a good timing from conference schedule and so on First half next year will be most appropriate. That's why we have changed the readout timing into next year first half. First half next year will be most appropriate. first half next year will be most appropriate That's why we have changed the readout timing into next year first half. that's why we have changed the readout timing into next year first half

Speaker 6: Understood. Thank you. Understood. understood Thank you. thank you

Speaker 4: Is that sufficient? Is that sufficient? is that sufficient

Speaker 10: Thank you very much. That concludes 2025 for the Q3. Thank you very much. We apologize for any questions we couldn't answer. Please contact our IR telephone number, and the email is on this presentation last page. Thank you very much. thank you very much That concludes 2025 for the Q3. that concludes 2025 for the q3 Thank you very much. thank you very much We apologize for any questions we couldn't answer. we apologize for any questions we couldn't answer Please contact our IR telephone number, and the email is on this presentation last page. please contact our ir telephone number and the email is on this presentation last page

Speaker 9: Thank you for making time in your busy schedule. We appreciate your attendance. That's it for today. Thank you very much. Thank you for making time in your busy schedule. thank you for making time in your busy schedule We appreciate your attendance. we appreciate your attendance That's it for today. that's it for today Thank you very much. thank you very much