Thank you very much for taking time out of your very busy schedules to attend our Q1 FY 2026 earnings call. My name is Miyata from Corporate Communication and IR department, and I'll be serving as the moderator today. Thank you for your kind attention. The session will be conducted via Zoom webinar. We will proceed according to the agenda shown on page three of the presentation materials. The briefing will be conducted in Japanese, but we will have simultaneous interpretation in English also available. Please click the interpretation icon at the bottom of your screen and select either Japanese or English for your preferred language. Questions will be taken together after all the presentations have been concluded. The Q&A session is scheduled for approximately 30 minutes. Please note that participants' microphones will remain muted during the presentation.
First, Dr. Okuda to provide an overview of the Q1 of FY 2026.
I am Okuda, President and CEO. I would like to give an overview of the Q1 of FY 2026. Please refer to slide five in the material at hand. In the Q1 of FY 2026, both domestic and overseas product sales progressed steadily, resulting in both increase in revenue and profit. Growth was driven mainly by Hemlibra exports to Roche, as well as increased Nemluvio exports to Galderma, and higher royalty income from Galderma. As a result, compared with the same period last year, revenue increased by 11.5%, operating profit by 17.1%, and quarterly profit by 19.6%. As such, Q1 got off to a smooth start in line with our initial expectations. Details of the revenue will be covered on the next slide six.
This shows the year-on-year changes in revenue compared with the same period last year. Revenue grew by JPY 33.2 billion, up 11.5%. I will walk through the items from left to right. Domestically, despite the negative impact of the NHI drug price revision and generics penetration, mainstay products as well as the new products performed well, resulting in an increase of JPY 8.4 billion. Overseas, while export unit price declined, the increase from volume and foreign exchange effects more than offset this, resulting in an increase of JPY 23.4 billion. In particular, Hemlibra exports to Roche and Nemluvio exports to Galderma increased significantly, marking solid progress. Other revenues increased year-on-year, primarily due to higher royalty income related to Nemluvio, despite a decrease in one-time income. Domestic sales, overseas sales, and other revenue all increased, achieving overall revenue growth. Please move on to the next slide.
I would like to explain about the key progress made in the Q1. Regarding NXT007, we plan to initiate two phase III trials in the Q2, aiming for a regulatory filing in 2028. Regarding emugrobart, which is GYM329, we have discontinued development for SMA and FSHD. On the other hand, based on the clinical results obtained, we believe this will not impact the development for obesity, where the target of myostatin is highly prevalent. Therefore, we will proceed with the phase II trial. As for Enspryng, we presented the result of the METEOROID study in MOGAD at the American Academy of Neurology in April. Further details will be provided later in Mr. Kusano's section. Regarding giredestrant, while numerical improvement in PFS was observed in the persevERA study for the first-line HR-positive breast cancer, the primary endpoint was not met.
Consequently, we have discontinued development for the first-line setting. Meanwhile, based on the results of the evERA and lidERA studies, which have already achieved their primary endpoints, we aim to file for the second- to third-line adjuvant treatment for HR-positive breast cancer within 2026. For DONQ52, we have commenced an in-house phase II study targeting celiac disease. Overall, progress remains on track toward achieving a record number of regulatory filings. Next is page eight. I will discuss new product launches and indications. In February, we launched ELEVIDYS, Japan's first gene therapy for DMD. In March, the combination therapy of Lunsumio and Polivy became the first in the world to receive approval in Japan for relapsed or refractory large B-cell lymphoma. We also launched a subcutaneous formulation for Lunsumio and obtained approval for an auto-injector formulation for Enspryng.
Regarding out-licensed products, orforglipron, brand name Foundayo, was approved and launched in the U.S. as a treatment for obesity. Foundayo is the only once-daily oral GLP-1 receptor agonist that can be taken at any time without any restrictions on food or water intake. Applications for approval are currently pending in over 40 countries for obesity and type II diabetes, and we look forward to contributing to patients worldwide. For Nemluvio, we anticipate further growth, especially as Galderma has raised its peak sales projection to over $4 billion. Finally, I will explain the composition of the board of directors. We have launched a new management structure, having newly appointed Ms. Kinuko Mitani, a medical expert, as an independent external director and a member of the nominating committee.
To ensure prompt and decisive management decision-making, the board maintains an appropriate balance of diversity, including expertise and gender, as well as an optimal scale. We'll continue to strive for further enhancement of our corporate governance. That's all. Thank you.
Next from Kusano. We will ask him to provide FY 2026 Q1 overview of development pipeline.
Thank you very much. I am head of Project & Lifecycle Management Unit. Please refer to slide 11 in the materials. These are the topics for Q1. I will go through them from the top. There's one launch, ELEVIDYS. A microdystrophin gene therapy has been launched as a first regenerative medicine product in Japan for DMD. For five approvals, Enspryng has received approval for a new dosage form, an auto-injector, which we expect to improve convenience for the patients. Foundayo, a once daily oral GLP-1 receptor agonist that can be taken without restrictions on food or fluid intake, is our in-house innovation. Our licensee, Eli Lilly, has received approval in the United States for obesity and has begun commercialization. Lunsumio and the Polivy combination therapy has also received approval as indication extension for relapsed or refractory large B-cell lymphoma. There's one filing.
We have submitted a regulatory application for the ocular implant for Ranibizumab, a filing for Ranibizumab formulation dedicated to ocular implant delivery is also planned within the year. Four studies have started. Inavolisib has initiated phase III studies for two types of PIK3CA mutation breast cancer, respectively. CT-388 is a long-acting GLP-1/GIP receptor agonist. Phase III study was initiated for obesity without type II diabetes. Our in-house DONQ52 started phase II study for celiac disease. There are four pipeline removals. Enspryng has been removed from the pipeline following Roche's decision to discontinue the phase II clinical trial for DMD for strategic reasons. GYM329, in light of the results of the MANATEE study, development for spinal muscular atrophy has been discontinued, and based on the result of a MANEUVER study, development of FSHD has been discontinued.
Tecentriq, based on the results of the IMbrave251 study, development for second-line hepatocellular carcinoma has been discontinued. Giredestrant, based on the result of the persevERA study, development for first-line hormone receptor-positive breast cancer has been discontinued. Moving on to the second page of the topics. First, readouts. The Foundayo ACHIEVE-4 study is a trial evaluating the risk of cardiovascular events in patients with type II diabetes at high cardiovascular risk. The results demonstrated non-inferiority versus insulin glargine, meeting the primary endpoint. Our licensee, Eli Lilly, plans to submit a filing for Foundayo for type II diabetes by the end of the Q2 under Commissioner's National Priority Voucher or CNPV. Regarding Congress publications, I will provide further details on NXT007 and Enspryng later in this presentation. For Nemluvio, results from a phase II study in children aged two to 11 with atopic dermatitis were presented at the American Academy of Dermatology.
Favorable skin clearance and itch control similar to adults and adolescents were confirmed in the pediatric population as well. Regarding orphan drug designation, glofitamab has received the designation for large B-cell lymphoma. We exercised an option right under a joint research agreement concluded in 2025 and obtained a license for Araris Biotech's proprietary ADC-linked payload technology or Araris Linker. We aim to combine this with our antibody engineering capabilities to create innovative ADC. I now would turn to key milestones for 2026. The underlined and in bold fonts reflect changes since the previous earnings announcement, and I have described them already so far. Preparation for phase III studies for NXT007 are well underway.
Next, I will present the results from part C of the phase I/II NXTAGE study for NXT007, which were announced at the European Hematology Association Congress in February. This is the first set of data for patients with hemophilia A, both with and without inhibitors, who switched from Emicizumab to NXT007 with a loading dose and no washout period. Consistent with part B, which targeted Emicizumab-naive patients, the result demonstrated a favorable tolerability when switching from Emicizumab to NXT007 without a washout period. In the high-dose cohort, blood concentrations reached levels expected to provide coagulation factor VIII activity equivalent to normal levels, and no bleeds requiring treatment were observed. The fact that the favorable tolerability was demonstrated when switching from Emicizumab to NXT007 without a washout period is a significant finding for advancing safety assessments during the switching process.
We are developing NXT007 with the ambitious goal of achieving coagulation potential equivalent to that of people without hemophilia. Working closely with Roche, we are steadily preparing for the three phase III clinical trials scheduled to begin this year, and we remain committed to delivering this treatment to patients as soon as possible. Next slide, please. I will present the study results for Enspryng, which targeted adult and adolescent patients with relapsing MOGAD. In the global phase III clinical trial for MOGAD, satralizumab significantly reduced the risk of a new MOGAD relapse achieving the primary endpoint. It demonstrated that it reduced the risk of relapse by 68% compared to placebo in the time to first relapse. Regarding safety, consistent with the data already established in the approved NMOSD indication, no new safety concerns were identified, and favorable tolerability was confirmed. Currently, there are no existing therapies approved for MOGAD.
With no established standard of care, there are high expectations for this study, as it is the first to verify efficacy in a prospective randomized controlled trial. Furthermore, for this indication, we have obtained Orphan Drug and Sakigake designations in Japan, and we plan to file for approval within this year. We look forward to delivering these new treatment options to patients as soon as possible. These data were presented at the American Academy of Neurology annual meeting held last week. In recognition of this significance and high impact, it was selected as a presentation topic for the pre-AAN press conference. Next slide, please. I will discuss our upcoming filing schedule. Projects marked with a light blue star are newly added, while those with a green star indicate a change in the scheduled filing year.
In this update, we have also subdivided projects previously disclosed as 2028 and beyond into 2028 and 2029 and beyond. For NXT007, we plan to file for hemophilia A in 2028. Regarding inebilizumab, for which two new phase III trials have been initiated, we also plan to file in 2028 for each. Additionally, for eneboparatide, we expect to file in 2029 or later. These subsequent slides are attached as reference. Please refer to them as necessary. This concludes my presentation.
Next, FY 2026 Q1 consolidated financial review provided by CFO Taniguchi.
Hello. I will discuss the financial results for the Q1 of FY 2026. I'm Taniguchi, CFO. Let me start by sharing the P&L. The Q1 revenue came to JPY 321.7 billion, up JPY 33.2 billion, or 11.5% year-over-year. Core operating profit also increased by JPY 23.8 billion, or plus 17.1% to JPY 163.3 billion. I will now walk you through the details in sequence, starting with the revenue product sales. Product sales were JPY 291.6 billion, up JPY 31.9 billion or 12.3% year-over-year. Looking at it by region, domestic sales came to JPY 111.4 billion, up JPY 8.4 billion or 8.2% year-over-year. New products and mainstay products performed well, fully absorbing the impacts of the NHI drug price revision and generic drug penetration.
Overseas, exports of mainstay products to Roche continued to perform strongly, reaching JPY 180.1 billion, up JPY 23.4 billion or 14.9% year-on-year. Hemlibra and Nemluvio have increased. Also royalty, this part, increased quite a bit. One time, slightly come down, but the royalty income from Galderma related to Nemluvio increased, and on a whole, it was positive. Moving on to cost items. Cost of sales was JPY 92.3 billion, an increase of JPY 4.8 billion, or 5.5% increase year-on-year. Now, this increase in absolute terms reflects the growth in product sales themselves. The cost of sales ratio declined by 2.0 percentage points year-on-year to 31.7%, which reflects the increase in Hemlibra, with the slightly low cost of sales. That, in the background, has had some effect.
R&D expenses increased by JPY 1.2 billion year-on-year to JPY 41.9 billion, driven by investments in drug discovery and early stage development and advancements of development projects. SG&A expenses. There was a significant increase in new product-related promotional expenses in the Q1 for Lunsumio, and others. In addition, enterprise taxes and accruals for bonuses linked to profit levels also increased. The enterprise taxes are a local tax, resulting in a year-on-year increase of JPY 3.9 billion- JPY 24.9 billion. From the Q2 onwards, however, SG&A is expected to trend lower year-on-year, and at the year-end is projected to be around JPY 1.2 billion below prior year, in line with our published forecast. As a result, operating profit increased by JPY 23.8 billion year-on-year to JPY 163.3 billion, and the operating margin rose by 2.4 percentage points year-on-year to 52.8%.
Net income after tax was JPY 118.6 billion, an increase of JPY 19.4 billion, or a 19.6% increase. This is the breakdown of changes in product sales. Domestic oncology sales was JPY 55.7 billion, up JPY 2.6 billion, or 4.9% year-on-year. The key factors increased for Polivy, following approval of the combination therapy with Lunsumio in March. A steady growth of mainstay product, Tecentriq, which more than offset the decline in Neupogen. The strong launch of new product, Lunsumio. Those were the positive drivers. On the other hand, Avastin continued to decline due to an NHI drug price revision and generics. Specialty area, JPY 55.7 billion, up JPY 5.8 billion, or 11.8% year-on-year. In addition to mainstay products, Hemlibra and Vabysmo, a new product, PiaSky, also recorded steady sales growth. Overseas product sales were JPY 180.1 billion, up by JPY 23.4 billion, or 14.9% year-on-year.
A significant increase by Hemlibra. Now, this is the quarterly trends in P&L items. Due to revenue recognition, timing differences arising from export timing, there are trends to some quarter-to-quarter ups and downs. Overseas sales as well, volume growth significantly exceeded the decline in export unit prices, and this was further supplemented by a positive foreign exchange impact contributing to the increase. That led to the total amount of the increase, JPY 23.8 billion. Breakdown. I would like to be very brief. This is a quarter-based change in profits. There are ups and downs, but compared to Q1 last year, we have a positive operating profit, and you can see the background why this is the case. This is about the revenue, a quarterly trend. Again, export not necessarily gives us the same amount each month. That leads to some variability.
If you compare Q1 with Q1, this is what we have. Overseas, domestic, we are seeing a well-balanced increase in all of those segments. As of the Q1, what has been the progress so far against the initial plan? Both revenue, profit, compared to last year, the progress rate are relatively higher. Normally, the progress tends to be low in the Q1. However, it's trending above last year's level. Next page talks about per segment, per product progress. We are showing you the progress as of last Q1. Across different products, the progress have been trending above last year's level. Next shows the impact of FX. Last year's exchange rate and this year's exchange rate shows JPY 10 difference.
Because of this JPY 10 , weaker yen, we had impact of JPY 11.6 billion in terms of revenue and JPY 9.8 billion in terms of OP, both positive. Next, moving on to the balance sheet. First of all, total assets since the end of last December, it went up by JPY 203 billion and achieved JPY 2,265.1 billion. We had a payment of tax and a payment of the special dividend. In terms of the working capital, we've had the collection of the AR in the Q1. As a result, the total assets reduced. However, in terms of the net assets, as it says here, it decreased by JPY 118 billion - JPY 1,907 billion. The rate of decrease in net assets was smaller compared to that of total assets.
Equity ratio attributable to owners of the parent rose to 84.2%. In terms of operating cash flow, it was at JPY 203.3 billion. However, we had a payment of the corporate tax and a payment of the special dividend, and it was actually negative. Next is the adjustment of core and non-core. Adjustment items would include the recognition of intangible asset, in accordance with the licensing in. Also we have some depreciation cost. Business reconstruction restructuring cost would include the replacement of ERP, SAP. Upgrading the operational platform requires JPY 4 billion. Next page lists up the CapEx that are already approved internally, and it shows plans going forward. With this, I would like to conclude my part. Thank you very much.
We will now move on to the QA session. For QA, Takano, who is the Head of Sales Division, will also join. Now, in order to accommodate as many questioners as possible, we kindly ask that each person limit their questions to two. Please note that the audio of your questions, together with the presentations, may be published on our website at a later date. Now, once again, for language selection, please click the interpretation icon at the bottom of your screen and select either English or Japanese. Now, if this setting is not selected, your voice may not be heard. We will now begin taking questions. Please click the electronic hand button at the bottom of the Zoom webinar screen. When it is your turn, your name will be called. The secretariat will request that you unmute then.
Please unmute your microphone, state your company name and your name, and then ask a question. If you wish to withdraw your question, please click the lower hand button. From Citigroup, Yamaguchi-san, you're first, please.
Hello, can you hear me?
Yes.
Yes, we can.
Hello, I am Yamaguchi with Citigroup. My first question is to Taniguchi-san. You have talked about the overall progress of the entire Q1. In comparison to your forecast, I mean, the impression is that the news were all good. Am I right to understand that the current situation is better than you had expected or is right on track?
Yes. Short response, we were right on track, and we had expected this. Of course, there are fluctuations. Hemlibra, for example, did considerably well overseas. From that point of view, there are good news. We are not, however, in the position of making any changes to published forecast.
Thank you very much. Second question has to do with Nemluvio. Export volume as well as royalty payment, both are doing well. You are not giving specific numbers, so we will have to just guess. Rozlytrek also is above the account, so locally speaking f or Q1, this was better than what you had expected, or was it what you had expected?
Well, I would say this is what we had expected because we always plan conservatively from a rational point of view. Looking at Q1 track records, it's within the range that we had expected.
If you were conservative, this seems more.
Well, we cannot really say anything definitive unless we see the situation beyond the Q2.
It wasn't bad.
Okay.
It wasn't bad for the Q1. Thank you very much.
Next from JP Morgan Securities, Mr. Wakao, please.
Hi. JP Morgan, Wakao speaking.
Yes, I am Wakao speaking from JP Morgan. Regarding the export sales, I have a question. Hemlibra for those two products. The reason why these two are doing better than your expectation, is it because the sales is trending well in the market, especially for Hemlibra? You're expecting a single-digit growth? If the actual sales is strong, I think your plan is going to be overshot. How should I look at it?
Thank you very much for your question. The Q1, every year showed some purchasing pattern, but this purchasing pattern is quite confusing every year in the Q1. Is this outperforming trend going to continue for the rest of the year? If I tell you so, I may sound too optimistic.
We say low single- digit as our expectation, and this remains unchanged. In that case, from Q2 onward, we may see some ups and downs. If a single- digit growth expectation is not becoming the reality and we expect outperformance, I think we need to look at this thing from Roche perspective and the Chugai's perspective. I can't talk about Roche number in my own position, but the Chugai's export business-wise, export can vary. We do have visibility into coming six months. Based on such, the actual result from Q2 onward will be somewhat quite similar to our current forecast.
Thank you. My second question is regarding GYM329. In your presentation, you said SMA, FSHD development didn't work out. For obesity, you said that there will be no impact. Can you give us more color on that? The Scholar Rock apitegromab, their trial is going well for obesity indication. What is the difference in your compound against the Scholar Rock's apitegromab? Is it coming from the difference in inhibition activity?
Thank you very much for your question. Kusano would like to respond to your question.
Now, development on obesity, is it going to be okay? SMA, FSHD, two trials in phase II, when we look at their results, reduction of myostatin has already been confirmed, and increase of muscle mass and improvement of motor function, we couldn't show consistent results, and we were not sure about the efficacy. Now, for FSHD and SMA, those neuromuscular diseases, when it comes to that, increase in mass does not directly link to the improvement of motor function. That's a difficult point.
Myostatin volume itself tends to be lower in the patient compared to the healthy people. That's why it's said to be very difficult to prove the efficacy of the drug in such target audience. Now when it comes to obesity, it's a chronic metabolic disease. The damage on nerve and damage on muscle, we don't believe that will lead to this disease. Incretin, which is a combination drug will induce the reduction in energy consumption. In GYM329, maintenance of muscle or increase of muscle would expect or would lead to the increase of the energy consumption. We are not looking into the improvement of motor function of muscle. We believe this obesity trial has probability of success. Regarding Scholar Rock's compound, this increase in muscle volume and improvement of motor function are not really linked directly in this type of disease.
GYM329 in phase III trial. This is phase II trial, different from Scholar Rock, and patient background is also different. We can't make head-to-head comparison. Primary endpoint and assessment for the motor function is different between us and theirs.
Thank you very much. That's all.
Thank you. From the UBS Securities, Seki-san, please.
This is Seki. Yes, thank you very much for that information. The first question has to do with what Iwaaki Taniguchi-san said. This is Galderma royalty. This seems to have had a major impact. When are you going to announce this as a separate line item?
Of course, we will be following different criteria. Also, there are criteria led by auditors, and we will follow their timing. I'm not going to give you details. I believe that, however, this year is not the best timing.
Your materiality standard is 5% or 10%?
No, we're not disclosing that.
The second question is to Dr. Okuda. This has to do with how you intend to use cash, especially late phase pipeline. Your own discovered products from the outside appears to be somewhere in a transition, which means that other companies do try to introduce licensing products to fill the gap. I do understand that you are very actively pursuing this, but maybe you should announce this more.
Seki-san, this is Okuda speaking. Thank you for your question. How we intend to use the cash at hand. Within Chugai Pharmaceutical Company, we position this as a very important strategic decision. First of all, our innovative pharmaceutical development capability, we would like to very actively invest in acquiring that kind of capacity. That's one. In addition to developing innovative drugs, we want to also invest in delivery of that. For example, what you have just mentioned, late phase development products or those close to launch. Product candidate introduction close to market is something that we're thinking about.
Now, in addition to R&D investment, there could be other CapEx for enhancing our production, and that there could be investments in order to maintain ecological aspects and also return to shareholders. Those three, we want to make sure are in balance as we make the most proper decisions. Opportunistic decisions. Being, I believe, thinking about every possible avenue from a strategic point of view.
Thank you.
Next is from Morgan Stanley MUFG Securities. Mr. Muraoka, please.
Hello. I am Muraoka from Morgan Stanley MUFG. Can you hear me okay?
Yes.
Thank you. I have a question regarding NEMO. Three months ago, I was looking at the initial guidance number three months ago, and I have a question to Mr. Taniguchi. The increase in export and the royalty income coming from non-Roche partners and Galderma, YoY, JPY 20 billion revenue increase. If I take all those numbers and do this math, royalty rate 11%-12% and the supply of product 30%-35%. It seems like the condition of this business is almost comparable to the business with Roche and it sounds really nice. Am I missing out something or am I correct?
Thank you very much, Mr. Muraoka, for your question. Now, we cannot disclose details. However, with the arm's length principle in the license agreement with Roche and contract with Galderma and the others, basically our contract are based on the arm's length principle in a very fair manner, and license transaction has been almost standardized in this pharmaceutical industry, and we've licensed this out in late-stage. In terms of the rate, it's a tiered structure, so toward the end of the year, normally revenue tends to go up and license income also tends to go up. That's all I can tell you.
In terms of the product supply, when I do my math, I get 30%-35% as a number, but it has just been launched, so the inventory in Galderma was not proactively piled up. Am I correct to understand that export has been progressing a little excessively?
Well, it depends on Galderma's policy. We have a commitment period specified in the contract. We call it firm order, and we basically follow this firm order. I can't comment on the inventory in our policy.
Thank you very much. Now, I have a question on Oley for glimepiride. I don't think I can answer, but 1,200 prescriptions in week one compared to this fiscal year's plan. How do you think of this? I know this is too early question to ask, but how do you interpret this number?
I think this is a good result, but I would like to understand how you see the result or progress so far.
Thank you.
Of course, we do have internal budget. We have assumption as well, and it's just been launched. I don't think it is appropriate to mention any interpretation of ours. When things go on and progress, we may be able to make some comment. So far, the available data or numbers are quite limited.
Understood. Thank you.
Thank you. From Macquarie Capital, Tony Ren-san, please.
Oh, can you hear me?
Hi.
Okay. Thank you for taking my question. Congratulations. Very strong Q1. My first question is for Kusano-san. Congrats that you are starting the DONQ52 phase II trial in celiac disease. Is this a phase II trial registrational? Can it be used for regulatory approval? Assuming it is not, can you explain to us your current thinking of the phase III programs for regulatory approval? How many trials are you thinking? How large are these trials? And what are the endpoints you have in mind for this disease where we don't have current approved drugs? Thank you.
Thank you very much for your question related to DONQ52. Yes, we have started our phase II study. This is for active celiac disease randomized, double-blind, placebo-controlled study. Yes, we believe that for filing. This is looking at the GI tract improvement and also celiac disease. This is looking at a reduction in symptoms. We are thinking about enrolling 90+ patients, and we hope to make sure that we get good data. For studies beyond that, we will have to wait until the outcome of the phase II to think about what we want to do for the subsequent program. I would keep from talking about that right now. Thank you.
Okay. Thank you. The phase II trial is registrational.
Again, well, this of course is phase II, so it's not that this is going to become part of the dossier. What we're saying is that we would like to look at the outcome of the phase II to think about the other program going forward.
Okay, understood. Yeah, thank you very much. The next question is for Taniguchi-san. This is about the royalty associated with Eli Lilly's Foundayo. This launch, everyone is paying a lot of attention to. Could you just remind us, has Eli Lilly indicated to you when they will pay you the Foundayo royalty? Will that be on a quarterly basis? Will there be a one-quarter lag? In other words, they will pay you the Q1 royalty in the Q2. Yeah. Thank you.
Thank you very much for the question. Details of the contract I cannot disclose, but of course, we understand that the approval came on the 6th of April. For the Q1, of course, it's not posted. Now, we of course calculate based on our own estimate, and so when we start receiving payments, that is going to be reflected in our books, too.
Okay, very good. Yeah. Thank you very much.
Next is from Daiwa Securities. Mr. Hashiguchi, please.
Hello, this is Hashiguchi. My first question is related to ELEVIDYS. On 20th of February is the launch date. Your full year guidance is targeting at JPY 12 billion. How do you see the progress so far? Initially, you had taken safety measures, or there are many things that you need to do before the actual launch. What is the feedback from the healthcare institute and the patients so far?
I am Takano, I'm the head of sales, and I would like to respond to your question. ELEVIDYS has been launched and in the Pediatric Society of Neurology , and we have been working closely, and we are always focusing on the safety. This month, we are expecting the treatment start on several cases, but we've been basically focusing on the safety measures. We have been receiving a lot of strong inquiries so far. We are now looking into the detailed feedback from the clinical practice. Including NHI drug pricing, and we believe the sales and performance will progress smoothly.
Okay. Inavolisib is the second question. On page 16, you said that 2028, there are two indications to be submitted for approval. 112, 122, and 132. There are two phase III studies, and I think their result will be used. Japan's phase I/II study and Western INAVO120 study are going to be bridged so that everolimus resistant patient targeted therapy may be filed earlier than planned. Or do you think the fastest possible timing for launch is still 2028?
Thank you very much, Hashiguchi-san, for your question regarding Inavolisib. Currently, we are conducting a bridging study and we do not disclose our plan for filing submission. Now, endocrine-resistant and HER2-positive phase III are initiated, and that's why we are disclosing the timing for the filing this time. Although you haven't disclosed, however, you're pursuing the possibility of making a filing based on the bridging study.
Hi. Are you trying to bring forward the submission timing?
Well, although I cannot comment on the timing, however, our aim is to bring this medicine to the breast cancer patients as soon as possible.
Thank you very much. That's all.
Goldman Sachs.
Thank you very much. My question is to Kusano-san. About GYM329, some other person has already asked this. It was positive in SMA phase III. Of course, patient inclusion criteria and primary endpoints were different. Can you give more details about why those differences, or how those differences in patient inclusion and endpoints have led to differences in outcome?
Well, thank you very much for asking the question. These are two separate, two different studies, so it's difficult to compare them head-to-head. For example, there were differences in primary endpoint, which is exercise tolerance. For example, Scholar Rock phase III, you're looking at the expanded Hammersmith enhanced functional assessment. In our study, we're looking at NFN30 exercise function assessment. There are differences in the motion as well as sensitivity and scope of motor function, so it's difficult to compare them. In expanded Hammersmith, the focus is more on SMA. It is more of a large, for example, trunk mobilities like standing and walking and running, very major activities as needed for daily life.
SFM32, this is more dexterity, using the fingers. That's important in day-to-day activities. This is used across myoneurological conditions, so it's quite difficult to compare the outcome of these two studies.
Thank you. I understand that. But what you have provided does tell us that these are very different assessment. Can you give us a background why you have chosen MFM32 as assessment scale?
Thank you for the question. Based on past data as well as our exchanges with key opinion leaders, we have of course, assessed what is best.
I have another question about DONQ52. Now, celiac disease. I am still learning about celiac disease, but it seems that compared between mild and severe, there's considerable differences in conditions of patients. DONQ52, what types of patient are you targeting to develop your drug?
Thank you very much for DONQ52 questions. We will be looking at the outcome of studies to decide who to target. We will be looking at very highly active celiac disease to see improvement in that gut situation.
Thank you.
We regret that time is drawing to a close, so the next question will be the final. Mr. Ueda from Goldman Sachs Securities please.
Hello, my name is Ueda from Goldman Sachs. I have just one question. In terms of the GP margin trend, I would like to understand better. In Q1, basically, cost ratio for the product is within your expectation, and for the Q4 or on full year basis, it seems like this number is expected to go up. Is that because, as of the Q1, the progress of domestic products is slow while percentage contribution coming from export to outside of Japan is high, or is there any other special factor? I feel like your export business is trending quite well within a certain range, and if trend goes on, I think your profitability will improve over time. Am I correct?
Thank you very much. This is Taniguchi speaking. Hemlibra weight, what is the percentage of Hemlibra going forward? That's very important. It's more like, how much decline do we see in Actemra? The export of Hemlibra is followed internally, and also we have an assumption for coming six months. Based on the current SG&A cost ratio, our target is 34.9% toward the end of the year, and probably this will be the most probable level.
Thank you very much. That's it.
This concludes the Q1 FY 2026 earnings briefing. For questions that we were unable to address due to time constraints, please contact Corporate Communication and IR Department. The telephone number and email address are provided on the final slide of the presentation material. Thank you very much for taking time to join us today, taking time out of your very busy schedules. Thank you.
This concludes the session.