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. JP Morgan, 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. Mameg ano, 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, Mameg ano–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.
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