Chugai Pharmaceutical Co., Ltd. (4519) Earnings Call Transcript & Summary

Thank you very much for taking the time out of your busy schedule to attend Chugai Pharmaceutical's financial results presentation for the First Quarter of the Fiscal Year Ending December 2025. I am Miyata from the Corporate Communications Department, and I will be your moderator today. Today's session will be conducted as a Zoom webinar. The agenda for today's meeting is displayed on the presentation material, Page 3. We will follow this agenda. This presentation will be conducted in Japanese but simultaneous English interpretation is available via the Zoom webinar. [Operator Instructions] We will take questions after the presentation is done. The Q&A time is scheduled for 30 minutes. [Operator Instructions] Now, I would like to give the floor over to Dr. Okuda to present financial year 2025 first quarter overview.

I am Okuda, the President of the company. I will give you the overview of fiscal year 2025 first quarter. Please take a look at Page 5 of the slide. The first quarter of 2025 saw increased revenue and profit, primarily driven by strong overseas export of in-house products. On a year-on-year basis, revenue increased by 21.8%. Operating profit increased by 36.6% and net income for the first quarter by 30.5%. Our operating margin remained high at 48.4%. As you can see, the first quarter started out well, in line with our initial expectations. The details of the revenue will be explained on the next slide onwards. This graph shows the increase and decrease in revenue as compared to the same period last year. Revenue grew steadily by JPY 51.6 billion or 21.8%. I will explain from the left. Domestic sales decreased by JPY 0.2 billion due to the negative impacts of NHI price revision and penetration of generics despite the strong sales of new products and main products. Overseas sales increased by JPY 55.4 billion, mainly due to an increase in export volumes and impact of foreign exchange rates, which more than offset the impacts of decrease in export unit prices with a particularly strong increase in exports of Hemlibra and Actemra to Roche. Other revenue decreased year-on-year due to a decrease in onetime income despite an increase in Hemlibra-related income. Overall, sales increased mainly due to strong overseas sales of in-house products. Next, I would like to explain the comparison of the first quarter sales of our in-house global products and domestic products with the first quarter of last year 2024 and the year before last 2023. First of all, please take a look at the graph on the left, which shows Roche's local sales volume of 4 of our in-house global products. It is on a constant currency basis. The bar graph shows the results of Hemlibra, Actemra, Alecensa and Enspryng from the bottom. Sales of Actemra are slightly decreasing, partly due to the impact of generics. On the other hand, sales of other products, including Hemlibra are steadily increasing. As a result, the total sales of the 4 products grew steadily by 5.6% from the previous year. We expect to see further progress in PiaSky to be added. The graph on the right shows sales of domestic products, excluding Ronapreve. While the NHI price revisions and generics have caused sales to decline, the growth of major products and new products has offset these declines. As a result, total domestic sales are almost flat year-on-year as compared to 2024. We expect year-on-year increase in sales for the full year of 2025, driven primarily by new products and main products. Next, I'd like to provide the latest update on one of our most important project, NXT007. NXT007 is a next-generation bispecific antibody following Hemlibra. Leveraging Chugai's proprietary antibody engineering technologies, NXT007 is designed to optimize binding affinity, extend half-life and aim for normal coagulation activity comparable to that of healthy individuals while also offering greater convenience through reduced dosing frequency. Proof of concept has been confirmed based on the results from the Phase I/II study. Please understand that the data cannot be disclosed at this time. The results will be presented at the medical conference in mid-2025. Based on the results, we have decided to initiate 3 Phase III studies during 2026. Among these 3 studies, one will include a head-to-head comparison with Hemlibra. We will continue to advance development with the goal of delivering new value to people living with hemophilia A. Next, I'd like to introduce the composition of our Board of Directors. Two new members have been appointed, and we have now commenced operations under this new structure. Mr. Thomas Schinecker and Mr. Boris L. Zaitra have joined as Non-Executive Directors from Roche. Mr. Thomas Schinecker has also been appointed as a member of the Compensation Committee. Our Board of Directors is composed of individuals with diverse knowledge, experience and expertise, ensuring that the Board as a whole maintains an appropriate diversity, including gender, international background, career history and age as well as an appropriate size. As a publicly listed company and a member of the Roche Group, we will continue to ensure our management's autonomy and independence while striving to enhance corporate governance in order to appropriately and fairly fulfill the trust placed in us by our various stakeholders. This slide summarizes our expectations for continued revenue contributions from internally developed products. Finally, I would like to briefly share the latest update on orforglipron, an innovative compound discovered by Chugai. Eli Lilly, which is currently leading the development of orforglipron, has issued a press release announcing that the drug met its primary efficacy endpoint in the Phase III ACHIEVE-1 trial for type 2 diabetes. The safety profile of orforglipron was comparable to that of injectable GLP-1 receptor agonist. As the first oral GLP receptor agonist that does not require dietary restrictions at the time of dosing, we have high expectations for orforglipron to deliver even greater value to patients. That concludes my presentation.

Next, I'd like to invite Mr. Kusano to talk about development pipeline.

I am Kusano, Head of the Project & Lifecycle Management unit. I'll explain the status of our development pipeline. Please take a look at Slide 11. These are the topics of the first quarter. As for the launches and approvals, they have already been announced, except for the approval of Vabysmo prefilled syringe. The Lunsumio launched in Japan in last month, March, is a fixed duration treatment which is predetermined according to the patient's response. A third-line treatment for relapsed or refractory follicular lymphoma that is expected to reduce the burden of treatment on patients. In terms of regulatory approvals, NEMLUVIO, an internally discovered product licensed out to Galderma was approved for atopic dermatitis and prurigo nodularis in Europe following its approval in the U.S. last December. CellCept has been filed for refractory nephrotic syndrome in the form of public knowledge-based application. 3 in-house products and 1 Roche product started the trials. Among in-house products, RAY121 entered Phase I trial for a new indication in addition to the ongoing autoimmune disease study. Enspryng started Phase II trial for Duchenne muscular dystrophy. MINT91, an in-house small molecule products and this has entered Phase I trials for the solid tumors. [ During the year ], Roche products, the anti-TL1A antibody licensed in last year entered Phase III trials last year for ulcerative colitis. Next readout, orforglipron. An in-house oral GLP-1 passive agonist achieved the primary endpoint in the Phase III study for type 2 diabetes conducted by Eli Lilly to which it had been licensed out. The good tolerability, blood glucose control and weight loss were observed with once daily oral administration. The details of the results will be presented at the American Diabetes Association meeting in June. The results of the weight control study are expected to be out later this year, and the company plans to file for approval by the end of this year. Submission for treatment of type 2 diabetes is expected sometime in 2026. We hope for further promotion of orforglipron by Eli Lilly. Lunsumio has met its primary endpoint in the SUNMO study in relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. We will accelerate preparations for submission in 2025. Next, as explained by Mr. Okuda, NXT007, which is expected to be a next-generation Hemlibra has been confirmed for its proof of concept. The results of the Phase II study, which is currently underway, will be presented at the 2025 academic conference. So please stay tuned. 3 Phase III studies are scheduled to start in the next year, including head-to-head comparison with Hemlibra, which is widely used for hemophilia A. We will continue to strengthen our hemophilia franchise. Regarding pipeline dilution, we have halted the development of Phase III study with Avastin added on top of Tecentriq for small cell lung cancer in light of the results of the study so far. The results of Phase III study of Vabysmo for angioid streaks showed the first good improvements in vision in Japanese patients for the first time, which was presented at the Japanese Society of Ophthalmology. Now, trontinemab, which is being developed for Alzheimer's disease will be explained later. Tecentriq was designated as an orphan drug for unresectable thymic carcinoma. We will proceed with application for approval. Major R&D events in 2025 are shown here. Underlying parts are changes from the previous earnings call. SUNMO study of Lunsumio and Polivy combination therapy achieved its primary endpoint and is scheduled for submission in 2025. The proof of concept of NXT007 was confirmed, and we decided to move to Phase III. We'll present the details at the conference in 2025. Trontinemab will be explained in the latter half of the slide, as I mentioned earlier. Now on Trontinemab currently under development for Alzheimer's disease, this is a novel bispecific antibody that targets amyloid beta and is designed to enhance brain penetration. Utilizing Roche's Brainshuttle technology, the antibody is expected to improve both transporting to the brain via transferring and binding affinity to its target. In the ongoing global Phase I/II study, which includes sites in Japan, PET imaging has shown that brain amyloid beta levels decrease more extensively and rapidly compared to conventional antibodies. By 7 months after administration, approximately 80% of patients in the 3.6 milligram per kg cohort achieved conversion to brain amyloid negativity. The safety profile has been favorable with a low incidence of amyloid-related imaging abnormalities or ARIA and only mild manageable infusion-related reactions. We plan to advance to Phase III trials in the second half of 2025. And we are committed to accelerating development so that we can deliver this therapy to patients as soon as possible. Next, I'd like to present the results from the Phase I study in healthy adults for RAY121, which is currently under development for autoimmune diseases. RAY121 is a recycling antibody that selectively binds to complement component C1s and inhibits the classical pathway. It is expected to provide a more favorable risk-benefit profile compared to C3 or C5 inhibitors in the downstream, particularly in classical complement pathway-driven diseases. In the Phase Ia study involving healthy adults, RAY121 demonstrated a favorable safety profile. In addition, it was confirmed that subcutaneous administration of a low dose could sufficiently suppress the classical complement pathway for over 28 days. Moving forward, we aim to develop a once-monthly subcutaneous administration using an auto-injector for self-injection. Currently, a basket trial of RAY121 involving 12-week treatment period is underway across 6 autoimmune diseases. For patients who have shown treatment response during the 12-week period, we have newly initiated an extension study that allows continued treatment for up to 1 year. Through this study, we aim to evaluate the long-term efficacy and safety of RAY121 and maximize its therapeutic value. Here are our upcoming regulatory submission plans. Projects marked with the light blue star indicate newly added programs, while those marked with the green star indicate programs for which the planned submission year has been revised. For Enspryng, our in-house developed product, the planned submission for MOGAD has been moved up from 2027 or later to 2026. Meanwhile, the submission for autoimmune encephalitis has been shifted from 2026 to 2027 in alignment with the progress of clinical trials. The following slides are provided as reference materials, so please feel free to review them as needed. That concludes my presentation.

Last but not least, I'd like to invite Mr. Taniguchi to talk about consolidated results on a core basis for the first quarter of fiscal 2025.

I'm Taniguchi, CFO. Now, I would like to explain the business results of the first quarter of fiscal year 2025. Well, the camera is not working well. Please hold-on. Now please take a look at next page. First of all, I'd like to report the consolidated revenue for the first quarter of 2025 increased by JPY 51.6 billion or 21.8% to JPY 288.5 billion, and operating profit increased by JPY 37.4 billion or 36.6% to JPY 139.5 billion year-on-year. Now, let me start from the top, the contents of the revenue, the breakdown. Among the revenue, the product sales were JPY 259.7 billion, up JPY 55.2 billion or 27%. By region, overseas and domestic, sales in Japan were JPY 103 billion, a slight decrease of JPY 0.2 billion or 0.2% year-on-year. Although new products and mainstay products performed well, results were slightly negative due to the effect of NHI drug price revisions and penetration of generics. For the full year, as already announced, we expect an increase in sales in Japan alone even on a year-on basis. Now overseas, exports of Hemlibra and Actemra, the main products were strong, growing JPY 55.4 billion or 54.7% to JPY 156.7 billion. Other revenue was JPY 28.7 billion, down JPY 3.8 billion or 11.7% year-on-year due to a decrease in onetime income despite an increase in royalty income from Hemlibra. Next, let us turn to expenses. Cost of sales was JPY 87.5 billion, up JPY 14.9 billion or 20.5% year-on-year. This was due to the increase in volume of products manufactured in line with the increase in sales. The cost to sales ratio, which is important, improved by 1.8 percentage points to 33.7% due to an increase in the proportion of products with low cost to sales ratios such as Hemlibra. With regard to SG&A expenses, due to efforts to improve efficiency despite the impact of higher prices and labor costs, it decreased by JPY 0.2 billion year-on-year. R&D expenses decreased by JPY 0.5 billion year-on-year due to the timing difference of expense recognition despite the steady progress of drug discovery research and early-stage development projects. As a result, operating profit increased JPY 37.4 billion year-on-year to JPY 139.5 billion, and operating margin increased by 5.3 percentage points to 48.4%. After-tax net income was JPY 99.2 billion, an increase of JPY 23.2 billion or 30.5%. The next page shows the breakdown of the increase and decrease in sales of products. First, in the domestic oncology field in Japan, sales declined JPY 3 billion or 5.3% to JPY 53.1 billion. Sales of Avastin decreased due to the penetration of generics, but sales of the new product, Phesgo, increased more than the decrease in sales of Perjeta, which was to be replaced by Phesgo. Sales in the specialty area increased JPY 2.9 billion to JPY 49.9 billion or up 6.2% year-on-year. While overall sales are affected by NHI drug price revision, sales of mainstay products such as Vabysmo and new products, PiaSky grew steadily. Overseas product sales increased by JPY 55.4 billion or 54.7% with all 4 mainstream products, especially Hemlibra achieving positive growth. The next page shows the breakdown of the increase in operating profit. From the left, in Japan, the negative impact of NHI drug price revision slightly exceeded the increase in volume, resulting in JPY 0.2 billion decrease in sales. On the other hand, overseas sales volume growth significantly exceeded the decrease in export unit price because of the expansion of sales in emerging countries. And this is the reason for the increase in sales. Thus the main factor for increased operating profit. As for other revenue, results decreased slightly due to the effect of onetime income from milestone payments, et cetera. In addition, a decrease in the cost of sales ratio due to a change in the product mix is an important background for boosting operating profit. The next slide shows the quarterly trends in our profit and loss items. This is by quarter or every 3 months due to factors such as the timing of exports, there tends to be some fluctuation on a quarterly basis. However, when comparing first quarter year-on-year, operating profit increased by JPY 37.4 billion, driven by a synergistic effect of higher sales and a lower cost of sales ratio. If you compare to the previous quarter, there was improvement in the cost of sales and that has led to the improvement in the operating profit. So the next slide shows the quarterly trends in the composition of revenue. And if you compare the first quarter year-on-year, this indicates a significant increase in overseas sales of products in 2025. The next slide shows the progress of our actual performance against the full year forecast figures announced in January of this year. Both revenue and operating profit are progressing at a relatively higher rate compared to the previous year. So at this point in time, it's just the first quarter. So it has to be around 25%. So I could say that the performance is generally on track with our initial projections. And this slide presents the progress against our initial forecast by segment and by individual products. And here as well, the strength of the overseas segment as a whole is clearly evident, especially Actemra has outperformed expectations in exports due in part to a slower-than-anticipated uptake of biosimilars and the resulting trend of inventory reduction. The next one is the foreign exchange rates compared to the actual rates from last year, foreign exchange had a positive impact of JPY 12.3 billion on revenue and JPY 11.8 billion on operating profit. The primary factor behind this is the depreciation of the yen, particularly against the Swiss franc, which is our largest trading currency. Looking at the Swiss franc, the actual exchange rate used for accounting purpose shifted from JPY 162.70 in the first quarter of last year to JPY 172.46 in the same period this year, an approximate JPY 10 depreciation. This has contributed to an increase in revenue when converted to yen. Next one is our balance sheet. Total assets amount to [ JPY 2.1395 trillion ], a decrease of JPY 68.9 billion from the end of the previous year. This was primarily due to a reduction in cash and cash equivalents following dividend and tax payments as well as a decrease in working capital such as accounts receivables. Meanwhile, total net assets increased by JPY 5.7 billion from the end of last year, reaching [ JPY 1.9072 trillion ], reflecting the accumulation of retained earnings from profits. As a result, the equity ratio rose to 89.1%. The next slide shows the breakdown of the change in net cash from the end of 2024. Operating free cash flow was JPY 162.4 billion, calculated by adding cash inflows from operating profit and increase due to less working capital and subtracting investment-related outflows. After deducting corporate income taxes and dividend payments, net cash decreased by JPY 51.7 billion over the 3 months period. This slide shows our near-term capital investment plan, which has been approved internally and is presented at each earnings call. Environmental investments have increased by approximately JPY 25 billion, reflecting ongoing revisions aimed at achieving our targets, and this increase is partly due to rising construction costs and other related factors. Now here, we are looking at noncore adjustment for the first quarter. And then we also have the situation of our in-house global products. That's all from me. Thank you very much for your kind attention.

Now let's move to the Q&A session. With regard to Q&A, we also have Mr. Takano, Head of Marketing & Sales to be present as well. [Operator Instructions] Matsubara-san from Nomura Securities, please.

I am Matsubara from Nomura Securities. Can you hear me?

Yes.

There are 2 questions. First of all, Actemra, so more than expected exports were achieved. That's what you said. In the second quarter, should we expect some bumps and downs or -- and supply chain situation, to what extent is it expected to continue in your view?

Taniguchi will answer the question.

Thank you for the question. Biosimilar ideally would have been launched from last year. But this year, of course, there are differences in regions, but there are some slight delays. And also, we have been conservative on the inventory, so there is some shortage in inventory. So we have seen good results in first quarter. But we can't tell about the second quarter onward. But as -- because of the delay in biosimilars, Actemra exports are performing quite well. So for the full year, there could be a slight upside. That is a trend that we've seen. With regard to prices, regardless of biosimilar coming in or not, we are maintaining the price of brand products. But of course, there are some sales in emerging countries with a totally different pricing scheme.

The second question is trontinemab. So ARIA-E generation is lower because transferrin [indiscernible] is higher. Is that correct? And also, I think this is an early treatment target for RG6289. So what is your licensing strategy?

So ARIA expression is lower. This is just a hypothesis at this moment. But with the addition of brain shuttle technology, as for trontinemab, it will pass through BBB. Especially for the capillary blood vessel, this is expected to go into the brain. So amyloid -- vascular amyloid, which is attached to the brain artery is going to be declined. So that's why we are seeing some lower expression of ARIA. RG6289 -- just a moment please. With regard to development number, trontinemab indication expansion, is that what you're asking about?

Well, secretase [ related to ] RG6289 modulator of the secretase.

Well, this is in the pipeline of Roche, and this is going to be the future development items.

So therefore, trontinemab is for the patients with Alzheimer's disease. There's already onset. And 6289 is for those who are at the early stage. Is that correct?

That information has not been received by us. So please refer that to Roche.

Next, Wakao-san from JPMorgan.

Wakao from JPMorgan. I would like to talk about the U.S. tariffs, how it's going to impact your business. According to your business model, you are exporting to Roche in Swiss, so you may not be affected by the tariffs. But then, Roche itself may be affected by the tariffs being imposed. Therefore, within the group overall, when tariffs are being imposed, what would be the negative impact? And will there be negativity sharing between the 2 companies? And what would be the stance being taken by Roche in that regard?

I'm trying to turn on my camera. Yes. Thank you very much, Wakao-san, for your question. Well, about the U.S. reciprocal tariffs that may be imposed on pharmaceuticals, there are a lot of uncertainties out there. So for the future potential impact, it would be very difficult to project such an impact going forward. Including Roche, working together with other business partners, we will try to understand what would be the potential impact and how we could appropriately respond to that kind of potential situation. We will be discussing that with the partners. This is not directly answering your question, I do understand, but there are much uncertainties. So we will see what we can do. Please understand.

So, that means that what we are looking at from your business model, you may not have a direct impact, but you will be having discussions with the partners. And depending on the outcome of the discussions, you may take responsibility for the part of the negativity by the tariffs?

I am not in a position to answer that question. In our response, we will be discussing with our business partners.

Understood. Another question is -- and this is also relevant to the previous question. Export sales situation is something I would like to ask. And Actemra, there is an upside. What about Hemlibra? And given the current situation in the world, export to the U.S., probably you should stock up in the U.S. as early as possible. And that way, you can reduce the impact of the tariff being imposed. And in terms of the impact on export, you can probably bring forward the export of your products. Is that something you are considering?

This is Taniguchi speaking. Thank you for your question. So, as of now, because we have just completed the first quarter, I can't really talk about the full year impact. We have not really revised anything from the original projection. We had a strong first quarter. But then, the firm order is not for the full year. Therefore, there are still some periods where there are some uncertainties. So I would like to carefully watch for the future development. In terms of bringing forward exports, well, generally speaking, that can be possible, but then we have to look at the supply chain and also the manufacturing capacity. So I can't really give you any confirmed answer. But generally speaking, that may be possible.

In terms of Hemlibra exports, such exports are also strong. What is the background of that favorable exports of Hemlibra?

Well, looking at different regions, international market is doing very well. It's growing more than last year in terms of the volume. So that's where we are very, very strong.

Next, Morgan Stanley MUFG Securities, Mr. Muraoka, please.

Muraoka from Morgan Stanley. Can you hear me?

Yes.

For good results, I'd like to congratulate upon that. But there are only 2 questions allowed for me. So I'd like to ask a question other than that. On tariff, the [ $5 billion ] investment has been announced by Roche yesterday already. So in this context, Chugai products -- transfer of manufacturing Chugai products to U.S., is it something that you have as an option going forward? And in that case, CapEx will be increased. So although it is unlikely, your funds for dividends could be reduced. That's something that's slightly on my mind. So can you explain more about your thoughts on that?

Muraoka-san, thank you very much for your question. So the mutual tariff from U.S. could induce us to transfer manufacturing sites to the U.S. Is there any such plan? And in that case, CapEx could increase and that would in turn -- in turn, could affect our funds for dividends. That's your question. And generally speaking, production transfer to the U.S. to avoid the impact from the tariff is a general idea, generally [ conservative ] idea. But as I said, with regard to mutual tariff, there is a great uncertainty. So it is quite difficult to see or forecast the impact as we speak. And together with Roche, the partner, we are going to address this. So CapEx increase potentially and other impacts is not something that we can refer to at this moment.

So [ $5 billion ] investment by Roche, does it include your products or not?

So [ $5 billion ] investment in the U.S. by Roche, please refer the question to Roche.

Okay. Then, the second question, NXT007. Probably, in today's material, June 23, hematology update will be held by Roche. I don't know if this coincides with the academic conference, but apart from that timing, you are going to have head-to-head study with Hemlibra, and you have a great confidence. You must have a great confidence. So there must have been quite positive response as compared to 1 year ago or half year ago. So the response has been quite positive. Is that a correct understanding?

Well, Muraoka-san, thank you very much for your question. Well, this year, there's going to be academic conference meeting. So please wait until the result to be presented there. So if we have a study in comparison with Hemlibra in the clinical study, the control is the standard of care. So what is mostly used is Hemlibra. So we have to compare our product to Hemlibra to see the result. So the results will be presented this year. So please wait for that.

Next is, from Citigroup, Yamaguchi-san, please.

I'm Yamaguchi from Citi. Can you hear me?

Yes.

First question is something about tariffs once again to avoid confusion. So you are selling to Roche, so you don't have to pay tariffs. Is my understanding correct?

Yamaguchi-san, thank you for your question. Well, as has been said already, there's great uncertainty. Tariffs will be imposed on what? That itself is not known yet. And that is another uncertainty, please understand.

I see. In relation to that, Actemra is -- has double source, Genentech and your own manufacturing site. So is it possible to transfer your manufacturing, meaning that you don't have to pay tariffs? That's my understanding right now. But partially, that product is being manufactured in the United States, but that's Genentech. So I don't know how goods are going to move around, but you have a manufacturing site in the U.S. Is that right?

This is Taniguchi speaking. Yes, it's true that in terms of production capacity, because of the problem of that, the contract manufacturing has been done, not just to Roche, but CDMO. Externally, we are actually commissioning the manufacturing to such sources. What is the volume and what is the value? That's something we are not disclosing. Please understand.

Understood. Another one is about Hemlibra exports. And I -- well, somebody else asked a similar question. Compared to the last year, there was a lot of fluctuation. Q1 was weak last year. So that's why the growth rate seems very big this year. But then, you are really selling to end users a lot, it seems. So is this expectation that there may be an update -- the upside on Hemlibra?

Well, Taniguchi speaking. Compared to first quarter last year, this year, yes, we see a great growth. Last year's first quarter, because of the previous year, the wholesale chain in the United States, towards the end of the year, there was a kind of hoarding, and that's why there was a dip in the first quarter last year. And this year, there is a similar situation. But then, it's doing very well, especially in the international market. And then, I do believe that this trend is going to continue for some time to come. And I think that this is actually leading to a very strong performance of Hemlibra. But towards the end of this year, what will happen? I think it's too early to predict at this point in time after only the first quarter being ended.

Next, Macquarie Capital, Tony Ren, please.

This is Tony Ren from Macquarie. Can you hear me?

[Foreign Language]

Okay. Perfect. Yes. So first question is also on hemophilia. So your NXT007 trial, so you are running 3 trials, 2 against the standards of care. So you mentioned already that Hemlibra is one of the standards of care. So you are doing a trial against it, and also a trial against factor VIII. Just curious, have you decided to pick standard half-life factor VIII or an extended half-life product such as ALTUVIIIO from Sanofi? So that's on the trial design on NXT007. Also, I noticed that Hemlibra appears to be losing -- I just want to confirm if Hemlibra is losing market share in the U.S. and Europe. Roche provided market share for the fourth quarter of 2025, but today, they did not, a little bit surprising. I just want to see if it's losing market share in -- Hemlibra is losing market share in U.S. and Europe? If so, to which [ competitive ] product? And also, if I could just slip in one more question is about your interaction with the FDA. There has been a lot of questions asked already about the tariffs, but we also know that there has been some changes at the U.S. FDA, to say the very least. Have you noticed any delay or disruption through your interaction with the U.S. FDA?

Thank you very much, Tony Ren-san. With regard to Hemlibra, NXT007 Phase III trial, let me answer that question first. Generally speaking, which factor VIII will be chosen has not been announced yet. But generally speaking, in Phase III study, you have to use a standard of care where the treatment has been established. That's the norm. So in the ALTUVIIIO, which has been launched just a few -- just recently, we don't know what is going to happen to that. Head-to-head comparison with that kind of drug is rare. So we have -- it is a norm to compare the trial product to the standard of care with established treatment. But for the actual choice, I would like to announce later. And Hemlibra market share, Roche has not announced it. That's what we are aware of as well. But with regard to background for that, we have yet to receive the information. We have not -- we are not aware that Hemlibra has lost share suddenly. So we'd like to wait for Roche to share with us some information. So, Kusano will answer your question about FDA.

So there are some resources -- human [indiscernible] resources reduction and how are they having impact? Well, the personnel reduction at FDA has been reported, and we are aware of that. But at the moment, any negative impact, we haven't felt that yet. That's all. Thank you.

Now, Hashiguchi-san from Daiwa Securities.

Hashiguchi. The first question is about trading conditions with your partner, with Roche. The unit price, when it change, it affects your export unit price. And when cost sharing of Roche changes, your royalty and also export business conditions may also be affected. Is that the contract that you have? In some European countries, there is a profit share scheme. And in such countries, when the cost changes, I think the profit that's being shared may also change as well. But what about in the United States? Do you also have such a clause or provision in the contract in the United States as well?

This is Taniguchi speaking. Thank you for your question. As you have pointed out, as for the export unit price, the average -- weighted average price of each region is referred to determine the price for the next year. But then, apart from that, details of the licensing agreement are not disclosed. So please understand.

Another one is, Enspryng DMD Phase II trial is going to be started. And anti-IL-6 receptor antibody against DMD, how does it modify the disease or improve symptoms? What's your expectation in going ahead with this development?

Hashiguchi-san, thank you very much for your question. Kusano would like to answer this question.

Enspryng DMD indication, Phase II trial is starting. Duchenne muscular dystrophy pediatric patients may have osteoporosis, severe one, or there may be a higher incidence of fracture, according to some reports. DMD patients, the lumbar, the bone density is declined and also absorption -- bone absorption marker, and if you look at the interleukin value, oftentimes, these values are very high, elevated. From this perspective, Enspryng anti-IL-6 antibody can have effect. And tocilizumab and Actemra, with these already, we have seen improvement in the bone density in rheumatoid arthritis, so prevention of fracture and also improvement of the muscular dystrophy. With this expectation, Roche has started the Phase II trial. That's the background.

Next, from Goldman Sachs Securities, [ Mr. ] Ueda-san, please.

Ueda from Goldman Sachs Securities. I'd like to ask about NXT007. So this time, Phase III initiation has been determined. So previously, Phase I/II healthy individuals [ anti-drug ] antibody was also looked at. So there's no such impact already. That's what you have decided? And also, head-to-head with Hemlibra, are you going to aim for superiority or non-inferiority? Which one are you going to aim for?

Well, thank you very much for your question, Ueda-san. Well, Phase I -- in Phase I, the autoantibody, we are going to announce that -- including that at the academic conference. So please wait for that. And non-inferiority or superiority in Phase III, I'm so sorry to say this, but with regard to details of protocol, I cannot answer any questions. But the study is expected to initiate early next year. So by that time, we would like to disclose that.

One follow-up question. NXT007, if there is a shift from Hemlibra to NXT007, the basic contract framework will stay the same for NXT007 as well in terms of economics?

Thank you for the question. Taniguchi speaking. As for economic terms and conditions, we are not in a position to disclose that.

From AllianceBernstein Securities, Sogi-san, please.

I have some questions. First about Roche, yesterday or the day before yesterday, $50 billion investment in the United States. Okuda-san has already said that there are a lot of uncertainties there. But then, as a possibility, I would like to ask you the following question. This $50 billion is quite a big amount. So I think this is -- the majority of that is going to go for the manufacturing site. And when that is the case, your products, especially in the United States, your products may be manufactured by Roche in the United States. Could that be the case? For PiaSky, this is your original product. However, Roche is producing this product. So this may impact your revenue model going forward. So is there such a possibility? That's something I'd like to learn. And the next one is about NXT007 head-to-head trial with Hemlibra. Is this based on the results of the discussion with FDA? And are you planning that as a pivotal trial? And Roche CEO is now your Board member, and Roche CEO was not your Board member in the past. But now, there has been a shift or a change. What is the background to that change?

Sogi-san, thank you very much for your questions. First, about Trump reciprocal tariffs, and in response, Roche announcing a large investment in the United States, and what about Chugai's manufacturing sites and whether Chugai products may be manufactured in the Roche manufacturing site in the U.S., that's the question. So PiaSky, the manufacturing right has been transferred to Roche. So Roche makes a decision as to where this product is to be produced. And as for other Chugai in-house products, we have the manufacturing rights for these products. So where we are producing, it's on us to decide. So, as I have said, there are a lot of uncertainty and certain factors. So what kind of impact is going to be seen with what kind of direction and where? That's something we need to understand so that we, Chugai, will be able to decide where to manufacture our products. And of course, one of the options is to have contract manufacturing in which country it's best to produce our products. That's something we need to consider going forward. To answer your second question, I think I would like to ask Kusano.

Thank you very much, Sogi-san, for your question. So about NXT007 Phase III trial, based on the discussions with FDA, is this going to be considered a pivotal trial? So, as for consultations with FDA, because this is something to do with the strategy, I can't really disclose what kind of discussions took place. Having said that, generally speaking, this is a Phase III trial. Whether -- you ask whether this is a pivotal trial or not, I would say, yes, this is a pivotal trial. Thank you.

To answer your third question, Sogi-san, I would like to answer your question. So Roche CEO is now a member of the Board of Chugai. So, as you have pointed out, previously, Roche CEO was not a Board member of Chugai. But if you look at the past, Roche CEO was a Board member in the past. And Mr. Schinecker, who is Roche CEO, he has a lot of wide experience and knowledge as a pharmaceutical company manager. And also, he has a good decision-making ability based on science. Therefore, he is the right person to be a Board member of Chugai. That's why we have asked him to become a member of the Board.

So, that means that you asked Mr. Schinecker to become a Board member of Chugai, is that the case?

Well, we have 3 Board members from Roche. So please understand that there was a Roche wish that is at play.

Sakai from UBS Securities, please.

Sakai from UBS Securities. Two questions. First, probably, you will ask me to ask Eli Lilly, but if you can give us some idea, that will be appreciated. Earlier this year, Novo Nordisk semaglutide oral drug application for approval or recommendation for that has been reported, and weight loss effect was 15%. That was the data that seems to have been used. So to you, was it a surprise? Or there had already been communication with Eli Lilly, and you had expected this already that this could also be the result? Can you answer that question? After this news, your share price -- I don't know if this is the only reason, the share price has dropped. So some investors might be concerned.

Thank you for the question. So semaglutide application or filing has been reported to have been made. So we are aware of that news. But there's no -- we cannot tell whether we have conducted any communication with Eli Lilly. So as you said, please ask Eli Lilly for that.

And the last question, I don't want to keep asking about tariff, but if you consider tariff issue, where the profit will be incurred? So of course, where you manufacture products is important. But if you're talking about drugs, who is holding IP in which country will become important. In your case, your U.S. subsidiary could have an IP of one product, and then the profit will be incurred there. So of course, this depends on the nature of the products. But is that kind of thought process working? I think this was slightly referred to in Roche announcement as well. So can you give us your thoughts?

Taniguchi speaking. So IP could be transferred to various parts of the world. I think that was what was discussed in 1990s in pharmaceutical companies. But in order to reach any conclusion, there's a large shortage of information. So things will be clearer. And once the information is enough, then we can act, but there is too little information to determine that at the moment.

So we have gone over the time. So I would like to have this question as the last question. [ Narita-san ] from Nikkan Yakugyo.

I am Narita. Can you hear me?

Yes.

It's a totally different topic about the pipeline exclusion, Avastin -- about Avastin. I think the development has been terminated. What is the background? What is the reason for the discontinuation of the development of Avastin?

Narita-san, thank you very much for your question. So a clinical trial for Avastin in combination with Tecentriq for non-small cell lung cancer, we had some interim analyses being done, PFS and OS extension. If you look at those endpoint results, there was no additional effect coming from Avastin. Unfortunately, that's the result. That's why at this point in time, we decided to discontinue the development of this.

So with this, we conclude the Q&A session. With this, we conclude the financial results presentation for the first quarter 2025. Due to the time limitation, we may not have been able to answer all of the questions. So please send in those questions to Corporate Communications or IR department. We have the contact numbers at the back of the presentation material. So we have those links provided as appendix to introduce our strategic alliance with Roche, as well as our R&D activities. Once again, thank you very much for taking time out of your very busy schedule to attend this. [Statements in English on this transcript were spoken by an interpreter present on the live call.]