Thank you very much for taking your time out of your busy schedule to attend the financial results and business update presentation for Q3, Fiscal 2024, by Eisai Company Limited. This is conducted in hybrid format, including in-person attendance and virtual attendance. Those of you who are attending in person, please find materials, including the presentation deck, a fact sheet. For those of you who are participating virtually, please download these materials or check the materials online. Let me introduce the presenter today: Mr. Keisuke Naito, Representative Corporate Officer, Executive Vice President, COO, and Chief Growth Officer. COO Mr. Naito, please have the floor.
Yes, thank you very much. Now, I would like to report on the financial results for the third quarter of Fiscal Year 2024. This is today's agenda. Next slide, please. As for the consolidated business results for the third quarter of FY 2024, the pharmaceutical business continued to make steady progress with an increase in revenue and double-digit profit growth from the previous year. Revenue was JPY 601.2 billion, up 9% year-on-year, and up JPY 49.9 billion from the previous year. Revenue from the pharmaceutical business, which is the organic business shown below, was JPY 569.1 billion, up 8% from the previous year due to the growth of three major products: Leqembi, Lenvima, and Dayvigo. Revenue from other businesses was JPY 32.1 billion, which was 138% of the previous year's level, mainly due to divestiture of product-related rights. Cost of sales was JPY 128.2 billion, with a cost-to-sales ratio of 21.3%, an improvement of 0.3 percentage points from the previous year due to a change in the product mix, and the gross profit was JPY 473 billion, up 9% from the previous year.
R&D expenses amounted to JPY 125.3 billion, accounting for 20.8% of the revenue, showing enhanced efficiency. After taking into account the partners' reimbursement, R&D expenses amounted to JPY 164.2 billion, 96% of the previous year's level. SG&A expenses amounted to JPY 301.5 billion, 111% of the previous year's level, including JPY 115.1 billion of shared profit by Lenvima paid to Merck, and other income and expenses amounted to JPY 9.2 billion. As a result, operating profit was JPY 55.4 billion, 148% of the previous year's level, and profit for the period was JPY 47.5 billion, 154% of the previous year's level, with a double-digit increase from the previous year. Next slide shows a breakdown of revenue migration, as shown in the top left. Revenue for the previous year was JPY 551.3 billion.
In the third quarter of FY 2024, as shown in the pink box at the top right, Leqembi grew by JPY 28.1 billion, or to 1.3 x of the previous year's level, previous quarter's level, leading the overall growth as the biggest growth driver. Lenvima grew by JPY 24.9 billion, or 11% year-on-year, and Dayvigo grew by JPY 9.3 billion, or up 30% from the previous year. In the pharmaceutical business, the growth of these three major products has overcome the impact of negative factors, including the expiration of the marketing agreement in Japan for Humira, and revenue increased by JPY 41 billion in this segment.
In addition, as shown in the box in the lower right, upfront payment for transfer of rights to Methycobal and Myonal in Pakistan and Afghanistan, as well as upfront payment for license agreement for authorized generic of Halaven, increased revenue of other businesses by JPY 8.9 billion as well. Revenue for April through December 2024 was JPY 601.2 billion, up 9% year-on-year. Next slide, please. This slide shows a breakdown of operating profit margin. Operating income also increased significantly in the pharmaceutical business due to the growth of 3 Ls, three major products, despite the proactive investment of expenses in Leqembi.
Due to the utilization of the partnership model and the promotion of efficiency by allocating resources based on priorities, as well as one-time income from the transfer of rights to certain products as positive factors, which offset the impairment loss related to BB-1701 and the increase in shared profit of Lenvima paid to Merck, operating profit increased by JPY 17.9 billion from the previous year to JPY 55.4 billion, with a double-digit increase of 48% from a year earlier. Next, I will report on the business update. First, we have a global business update on Leqembi. As an executive summary of Leqembi regarding the current status of Leqembi business, I would like to share with you five points. We are gaining confidence in our ability to meet the fiscal year targets with the progress in establishment of the pathway, including infusion capacity, and confirming steady progress in business performance.
In Japan, medical institutions' care coordination system has progressed, and actual performance has continued to exceed our plan. In China, steady progress has been made in the self-pay market and solid growth in the deliveries to medical institutions. Overall, global revenue is on track to meet our fiscal year focus. We are also making steady progress toward key events such as SC AI for subcutaneous injection and blood-based biomarker BBM, which will contribute to the improvement of pathway in the future. Based on these progresses, we believe that we are moving towards a growth expansion phase of Leqembi. Next slide, please. Let me share with you global and regional performance of Leqembi. First, let me first report on the global revenue performance of Leqembi. Global revenue totaled JPY 29.6 billion. US sales grew to 131%, Japan to 149%, and global sales to 133% compared to the second quarter.
The infusion capacity in the U.S. has expanded steadily, and follow-up facilities in Japan are also expanding. Please note that although growth in China appears flat in revenue from the second quarter to the third quarter, this is due to the timing of deliveries to wholesalers, and deliveries from wholesalers to medical institutions have continued to increase. All in all, for global revenue over Leqembi, let me share with you our view that we are steadily progressing toward achieving a forecast of JPY 42.5 billion for fiscal year 2024. Next, please. Let me now report on the performance in the United States. The company achieved JPY 18.1 billion in cumulative results through the third quarter. The number of patients currently receiving treatment is approximately 13,500, and the cumulative number of prescribing physicians is over 3,000, showing a continuous increase of 20% from the end of the previous quarter.
The number of medical institutions placing orders is approximately 1,200, confirming a 12% growth compared to the previous quarter. In addition, the number of vials sold from wholesalers to medical institutions reached 160,000 vials in the third quarter of FY 2024. This number was the record high performance. We believe that such growth in performance has been linked to the expansion of throughput of the overall pathway, including the capacity to accept patients, as we have reported earlier. Here are a few factors that have enabled this expansion. First, the number of amyloid beta PET tests has increased by 45% over the previous quarter. We believe that the increase is due to the growing awareness of the significance of early diagnosis of dementia, the spread of use of guidelines for amyloid beta PET tests that support early diagnosis, and the increasing use of BBM as a prescreening tool.
In addition, the expansion of infusion capacity is also progressing, and since January, the cap on the reimbursement has been removed. Therefore, it will contribute to the further expansion going forward. Regarding the infusion capacity, which is also increasing, expanding. As has been reported, all of the 6,000 patients on the waiting list will be able to receive Leqembi treatment by the end of this fiscal year. We expect that the infusion capacity will expand in the fourth quarter and beyond, as we anticipate further growth in the demand. As a pioneer in the new market of fundamental treatment of dementia, we will make full use of the knowledge we have accumulated through Leqembi and steadily progress towards achieving our annual forecast of JPY 26.5 billion. Next, please. Next, I would like to talk about the performance of Leqembi in Japan. The cumulative revenue through the third quarter was JPY 8.3 billion.
The number of patients treated with Leqembi has reached 6,800 since its launch, and the number of doctors prescribing this treatment has expanded to more than 1,200, showing steady penetration of the drug. In addition, the number of facilities that have initially introduced the drug has risen to 660. In Japan, the OUG describes the transfer of patients from the initial site to the follow-up site after six months of treatment. The key in Japan is to establish a system of coordination between the initial facility and the follow-up facility. We have received consent from more than 1,400 facilities to accept such coordination. We feel that the interest level by HCPs is also increasing. In addition, the DTC was aired in November to raise awareness of MCI, and we are now planning to run it again this year to further activate early medical consultation.
In Japan, awareness among both medical professionals and consumers is increasing, and we believe that we are on track to achieve our forecast of JPY 12 billion for fiscal year 2024. Next, turning to China. In China, after the launch in June last year, Leqembi is steadily growing in self-pay market. In the first three quarters, JPY 2.8 billion was achieved. The characteristic in China, a diagnostic model, which is the evidence for BBM confirmatory testing, is enhanced by academia and investigator-initiated cohort research, steadily making headway towards social implementation of BBM. As for pathway using digital platform, Yin Fa Tong , shown in orange, this is the name of the digital platform, and its user number increased to around 710,000, and the number of registered physicians increased to around 6,300, achieving further penetration. In this fiscal year, we are making good progress towards achieving forecasted revenue of JPY 4 billion in other regions, including China.
Leqembi, as we have communicated repeatedly in all regions, Leqembi sales is growing. We are receiving the voices of patients that, thanks to Leqembi treatment, they can enjoy hobbies, can spend time with family, can drive again, and QOL in daily life is improved. As for the cost of sales of Leqembi, the impact on consolidated cost of sales ratio in this fiscal year is minimal. In addition, because of rapid increase in sales from last fiscal year to this fiscal year, Leqembi production efficiency is improving, and as expected, the cost of manufacturing is steadily declining. From next fiscal year and beyond, production efficiency improvement from increasing sales and volume is expected. By promoting various cost reduction strategies, we aim to further reduce cost of sales. Now, regulatory status. Leqembi has been approved in 10 countries after it was approved in Macau.
The number of countries and regions conducting regulatory review is expected to further increase. In Europe, in November 2024, positive opinion from CHMP was received. Subsequently, the European Commission has moved to decision-making process. As a part of that decision-making process, CHMP was asked to confirm two points. First, if it is necessary to update positive opinion based on the kind of safety information which became available after the positive opinion, and second, if description on risk minimization measures in positive opinion is sufficiently clear. CHMP is scheduled to review in the regular meeting these issues in February. We believe that the review items requested by the European Commission can be sufficiently and clearly addressed with existing information and that there will be appropriate evaluation by CHMP. Towards obtaining approval in Europe, we will continue to work with the authorities. Now, turning to key events to streamline the pathway.
This is about IV maintenance administration. New method of administration, which is IV infusion maintenance dosing, was approved by FDA on January 24. By shifting to once every four weeks maintenance dosing, expectation is that clinical and biomarker benefits are maintained. After 18 months of initiation phase, the regimen of one every two weeks may be continued, or transition to the maintenance dosing of once every four weeks may be considered as a result of the approval. As a result, the maintenance dosing will help reduce the burden of clinic visits for patients and reduce the resource necessary for infusion on site at medical institutions, which we believe will also enhance pathway throughput. Next, SC AI, subcutaneous formulation autoinjector. SC AI maintenance is a submission package for 360 mg fixed dose weekly dosing. PDUFA is set for August 31.
This package was prepared using PKPD modeling based on the data from SC sub-study conducted within Clarity AD, etc. We are currently preparing submission for SC AI initiation. We plan to submit sBLA immediately after obtaining approval for SC AI maintenance treatment and aim to obtain approval in 1Q fiscal 2025 to within 1Q fiscal 2026. Based on PKPD modeling as initiation dose, more appropriate dose setting is pursued. Currently, we are steadily obtaining data necessary for submission package. With this new formulation, administration at home or outside of care becomes possible. Injection time will be substantially reduced to 15 seconds on average, leading to reduction of burden on both patients and healthcare professionals. We believe that this may also lead to lowering the hurdle for PCPs to participate in the pathway.
Next, I would like to show the roadmap for wider usage of BBM, which is the next generation confirmatory testing technology. Currently, PET or CSF is mainly used for confirmatory testing. In the U.S., as pre-screening before confirmatory testing, BBM is starting to contribute by increasing the number of A beta testing. Because of such indications, expectations for significance of BBM as confirmatory testing and its social implementation are rising. Stakeholders such as academic societies and diagnostic companies are already taking action. For example, the world's largest AD-related NPO, Alzheimer's Association, is expected to publish BBM testing clinical guideline around spring to summer this year. Several diagnostic companies have submitted IVD application for confirmatory testing using high precision composite score, including A beta and p-Tau 217 evaluation system.
To ensure that we seize these momentums, Eisai will continue to encourage each stakeholder to support establishing BBM reliability and appropriate use and adoption by authorities and in countries where approval is given. In fiscal 2026, we believe that in the U.S., IVD approval can be obtained and reimbursement will be achieved and BBM to be used widely in clinical setting. Next, turning to oncology, Lenvima continues to grow. Revenue increased by 11% to JPY 248.1 billion between April to December year-on-year. In the United States market, mainly with renal cell carcinoma, year-on-year, 15% growth was achieved, driving global sales. In the U.S., the growth is expected to outweigh the impact from Medicare Part D redesign under IRA. Lenvima has grown to become backbone therapy for multiple cancer types, with six indications across five cancer types, including endometrial carcinoma and renal cell carcinoma.
Regarding the future oncology pipeline, in addition to collaboration with Lenvima and products from other partners such as Keytruda, we will also focus on development of combination therapy of Lenvima and in-house developed products. First, about E7386. This is potential first-in-class orally available mid-molecule compound that inhibits CBP/beta-catenin protein-protein interaction. This is based on human biology findings obtained from clinical samples of Lenvima, and we hope that E7386 will reverse resistance to Lenvima. Study 102 in endometrial carcinoma is ongoing. We aim to obtain by fiscal 2030 approval for combination treatment with Lenvima. Next, MORAb-202 on the right is an ADC, which is composed of in-house developed eribulin linker and folate receptor alpha antibody, Farletuzumab, using cutting-edge process chemistry to synthesize.
Since the effect of farletuzumab on tumor microenvironment is a novel effect different from Lenvima, we hope that anti-tumor activity of Lenvima can be enhanced in combination. Study 201 in platinum-resistant ovarian cancer, as monotherapy is ongoing. In fiscal 2026, we plan to initiate a trial as a combination therapy with Lenvima, and we aim to obtain approval by fiscal 2030. This is the final slide today, which is fiscal 2024 consolidated financial forecast. One-time revenue initially expected in Q4 was carried forward to Q3. As a result, as of Q3, operating profit and net profit are about the consolidated forecast. But the forecast disclosed in May remains unchanged at this point in time. We are starting cost restructuring review with the aim of improving profitability in the next year, next fiscal year, and beyond.
We are currently reviewing the impact of that temporary increase in expenses on this year's performance. Looking at the status, we will continue to focus our efforts on 3L while controlling expenses within the range of gross profit to achieve increase in both revenue and profit. That concludes my presentation.
Thank you for your kind patience. We would like to open the floor for Q&A session. We would like to receive questions from analysts, and then we'd like to open the floor for questions from the media. If you have any questions, please mention your affiliation and name before asking your questions. Then, if you have any question, please raise your hand. In the fourth row, please have the floor. Person in the fourth row, please have the floor.
I am Yamaguchi of Citigroup. Thank you very much. To the end, you mentioned that you have moved forward the strategic options. The amount itself was almost in line with the amount expected at the beginning of the year, so there will be no changes, or have there been any changes from the plan because of the strategic option that has been moved forward?
In response to your question, Mr. Ike, who is in charge of planning, is going to respond.
Thank you very much for your question. My name is Ike. I am in charge of planning. Specifically, we are not able to mention any names of which companies, but the amount itself was larger than our expectation.
Thank you. Then specifically, there is upside to the company's forecast, right? Thank you. Understood. Now, IV maintenance, I have a question about that because IV maintenance has been approved. And for patients who are receiving treatment for over 18 months, I believe there are some. So biweekly or moving to the once every four weeks, are there many patients who are shifting or have their what size of a commercial impact of shifting to the IV maintenance do you expect?
For your question, Mr. Haruna is going to respond.
I am in charge of the Leqembi business. My name is Haruna. First, regarding the approval of IV maintenance, which is received favorably by healthcare professionals and patients that has been evaluated highly. For those patients who have received treatment for 18 months, we do not think that there are many such patients. We believe that the number is about 100. But from this fiscal year through next fiscal year, about 10,000 patients are expected to transition to the new dosing.
On a continual basis, we believe that more and more patients will continue to shift to the new formulation. Alzheimer's dementia is a continuous and progressing disease. Therefore, it requires the continuous therapy treatment. IV maintenance dosing, which has been approved in the United States, we believe which is a very significant event, which will bring about the enhanced value in clinical setting. We are confident in that. Thank you very much for your question.
Thank you. We do not see any specific numbers for next fiscal year. The Leqembi's forecast has been downwardly revised. But since then, you have been doing pretty well. But for the next fiscal year in the United States, inclusive of the factors that you have mentioned, what increase or what increasing factors do you see for the next fiscal year?
BBM will come in the next year after next and also as well, and I see initiation dosing will be also coming around in the year after next.
Yes, thank you very much for your question. Amyloid beta PET test increase and also the infusion center expansion for the pathway improvement. There will be more acceptance of more patients who can go through the pathway. That is, we believe, very important. Therefore, in order for us to achieve the forecast, which we are confident in doing so, but regarding the details, Mr. Ike is going to supplement.
Yes, as you mentioned, we are not able to give you any specific numbers for next fiscal year, but at the closing of the financial year, which will be announced in May, we will be able to share with you some numbers. But we believe that the current trend will continue for some time, which will be the basis for the planning. Our partner, Biogen, and us are having the close discussion and also expenses to be invested and also in which area or products we are going to make investment are being studied closely now.
Thank you very much.
Next question, attendee seated in the first row, please.
Thank you. I'm Wakao from JP Morgan. I have a question regarding Lenvima. Lenvima is increasing in volume, and sales are increasing strongly, and it seems that it is leading to an upside swing up to the third quarter. From January, Medicare Part D redesign started. I believe you have already incorporated that impact in this fiscal year. How would that impact next fiscal year's performance?
Medicare Part D redesign impact will be felt next fiscal year, and are you still able to achieve an increase in revenue next year?
Mr. Ike will respond.
This is Ike speaking, responsible for planning. I would like to respond to your question. I believe your question is regarding not this fiscal year, but next fiscal year. Inflation Reduction Act, there are two factors, as you are aware of. The first is the rate of inflation in excess of the rate of inflation that should be returned to the government, and this already is implemented since 2023, and the proportion of that is not expected to change next fiscal year. The second point is what you have mentioned, the one that started in January this year, which is Medicare Part D redesign out-of-pocket of $2,000 by patients.
Exceeding that amount, 20% is to be borne by the manufacturer. This fiscal year, it will be impacting only the fourth quarter, but in next year, it will be having a full year impact, and that will be of certain size. To be more specific, close to a $1 million impact in comparison to a situation without this change. However, the underlying growth trend for RCC and endometrial carcinoma in combination with Keytruda is growing despite the severe competition. So that will be substantially offsetting the impact, and we do not expect a large decline.
Thank you. Then you will be able to maintain flat growth. More or less, that is how we're developing plans. I have another question about the next fiscal year. According to the earlier presentation, you've mentioned the gross margin of the Leqembi.
Next fiscal year, well, I believe that this is improving recently, but looking at the quarter, it is not so clear yet. At what point in time will the Leqembi gross margin improve so that it will have impact on performance? When will the change be visible in next fiscal year? The Leqembi gross margin improvement and impact on increasing revenue, is that something that we can expect?
Mr. Tamura will respond.
This is Tamura, responsible for production. Is it about the cost of the cost, how much improvement in cost? As for the Leqembi cost, we are working with our partner, Biogen, regarding a cost of the Leqembi. We are working with our strategic partner, Biogen, and we are unifying our efforts. As Mr. Naito earlier explained, volume will increase in the next fiscal years, so production efficiency will improve, and the cost is expected to decline.
We are also implementing various initiatives, some of which I will share with you. First is the site of production of the drug substance. Currently, Biogen has a plant in Solothurn in Switzerland. This is a highly automated plant, and cost can be reduced by continuing to manufacture drug substance at a certain volume. That will help reduce cost, and yield of antibody can be dramatically improved with a manufacturing method, and we are trying to develop such a manufacturing method. Biogen also has a plant in North Carolina in the United States, and it is considering use of that plant for production of drug substance. This plant is in operation for quite some time, and it has been depreciated significantly. Low-cost production there may be possible, and preparations are underway for submission.
As for formulation in the second production site for formulation, a lower-cost CMO has been added, and shipment has already started from that CMO, and that is contributing to reducing the cost. As for packaging, this is for Japan and Asia, but final packaging is done by Kawashima Plant of Eisai, and we are also improving efficiency here. Through these comprehensive cost reduction strategies, we believe that we can increase the Leqembi access and stable supply of high-quality Leqembi on a continuous basis.
And regarding cost, cost is steadily being reduced. Is there any indication that you are able to give quantitatively?
As for the actual cost, we have an agreement with our partner, Biogen, and we would like to refrain from disclosing.
Finally, just briefly, based on what you have discussed, next fiscal year, what is the direction of operating profit?
The Leqembi is going to be selling strongly, and Medicare Part D impact, if it is not so significant, then it may be possible to have increasing revenue. But this year, there were some one-time revenues, and it's difficult to forecast the direction.
What is the expected direction internally?
Mr. Ike will respond.
Thank you for your question. First of all, the Leqembi is the product for which we are making the largest investment, and this also requires a commercial investment for SG&A. Fiscal 2025, SG&A is trending to be larger than in 2024, fiscal 24. As we have been stating, as an item, the Leqembi is expected to turn profitable in fiscal 2026, including in the United States. That is what we aim to achieve. As an item, loss ratio will decrease, but in fiscal 2025, investment will be made in advance.
Another backbone, Lenvima, as I've responded to the earlier question, we want to ensure sales and bottom line. Earlier, towards the end of the presentation, Mr. Naito, COO, mentioned that we will be reviewing cost structure. This has already been initiated. Some of the expenses are including expenses in this fiscal year in the fourth quarter, and some are expenses in the next fiscal year. Because of this, the target operating profit level is currently being discussed. I'm sorry, I'm not able to give a clear-cut answer, but that is the current situation.
Thank you very much.
Next question. The person in the back, please have the floor.
Thank you very much. My name is Akane of Tokai Tokyo. I have two questions about the Leqembi. I am looking at page 8. There is quite steady progress. As a catalyst, the maintenance therapy and autoinjector SCAI in August is expected to grow further, and you have made revisions, and based upon the current numbers, there is no need for such consideration of such additional events. Is this correct?
In response to your question, we have Mr. Haruna responding to you. Regarding the situation in the United States, Mr. Haruna will respond. Ms. Yusa is going to respond regarding the situation in Japan.
Thank you for your question. My name is Haruna. I am in charge of the Leqembi business in the United States. First of all, for US Leqembi, in the third quarter, there was a significant growth. We have seen the progress because of the increase in demand, particularly PET test and also BBM increasing the diagnosis. This shows the heightened expectation to the introduction of the Leqembi treatment.
Since the launch, it has been almost one year, and there has been enhanced confidence in treatment among physicians, as well as the efficacy of the treatment is being felt. Therefore, the Leqembi expansion is being accelerated. Therefore, the growth of the Leqembi is expected to grow, and we have seen further growth, and we believe that this growth will continue going forward. If I may repeat, the monthly IV maintenance has been added as an indication approved. Therefore, this has been highly evaluated by stakeholders. This is thanks to the maintenance and long-term treatment and necessity for doing this, as has been described in the label in the United States. We believe that this has been well received by physicians, prescribing physicians. Beyond these events, we believe that we will be able to continue steady growth in the United States.
Thank you very much.
That is what I have about the U.S. Mr. Yusa is going to respond to you regarding the Japanese situation in the Leqembi, and the Leqembi commercial is my area of responsibility.
As has been mentioned by Haruna-san regarding the U.S. situation, in December 2023, the Leqembi was launched. So it's now about 14 months, and the optimal use guideline has been adopted, which is a quite stringent guideline. And together with the HCPs, we have worked hard over the past one year to establish a pathway. And after completion of the pathway, we have seen a smoother flow of patients, which allowed the early diagnosis and early initiation of treatment. That is what we observed over the past 12 months. Under the OUG in Japan, every six months, efficacy has to be confirmed, and that has been done.
As COO Naito mentioned earlier, in Japan as well, there are various changes reported about patients. Some patients started the hobbies that had been stopped earlier, and also they are returning to the workplaces as well. In addition to such first-hand experience by patients, and regarding the ADR, we have disclosed the ADRs recently, the ARIA issue, which was concerned, and also infusion reaction. All of these have been disclosed compared to the clinical trial data. These ADRs have been contained lower than that was observed in clinical trial, which is controllable for the proper use by the physicians and the patients. We believe that such sense of security has spread, and going forward, a certain number of new patients who will start the treatment with the Leqembi. Therefore, we believe that the penetration of this drug will further progress in Japan as well.
Now, thank you very much. I have a question for you, Mr. Naito. In Japan, 50% growth in Japan as well on page 8, and then the 70% is the planned number, and it is difficult to foresee any drop in the fourth quarter, or rather it is expected to grow. What is the full year plan as regards to the revenue of the Leqembi?
Thank you very much for your question. As you see in this slide, for us, based upon the actual growth and the performance so far, regarding the forecast for the fourth quarter, we believe that we can be confident in achieving the forecast. In each region performance review I mentioned earlier, these are linked to a certain number of KPIs, and based upon which we are able to show our confidence in achieving this.
The last question, not only for the Leqembi, but other businesses are doing well and not bad. In Q3 and the full year number, as Mr. Naito mentioned, 103.5% in operating profit. Do you think it is going to be misleading if you consider the forecast for the fourth quarter?
As Mr. Ike mentioned in his response, there is going to be the review of the structure of the cost, and it may have an impact on the performance. If there is any potential change to the forecast for the performance, we are going to report it immediately. JPY 42.5 billion revenue is estimated for the Leqembi. If there is any upside, and there will be upside added to the, and also downside if there is any impact by the cost structure review. Mr. Ike is going to respond.
Yes, that is correct. There are other factors for increasing, as well as the one-time cost to be incurred.
Thank you very much. Understood.
Next question, attendee seated in the third row, please.
I'm Sogi from Bernstein. Your stock price is at the lowest in the past 10 years. I believe everyone from Eisai in this room understands that the stock price of Eisai movement is dependent on the Leqembi performance in the United States. It was mentioned that at the current pace, growth is expected to continue, and I believe that that may not have a positive impact on the stock price. Market participants would like to know when this product will reach $1 billion, and when can you have a certainty that it will be achieved ahead of schedule? I think that is very important, and what is the view of Eisai on this point?
Naturally, internally, I believe that you have forecast for the next three years and next five years, although I'm aware that there are various uncertainties. But what message would you like to send to the market?
Thank you for your question. As I've mentioned in the presentation, right now in each region, for example, patients are participating, and there are positive experiences related to the Leqembi, and that is beginning to be shared and presented at the academic society meetings to be shared. In that way, in this category, the significance of the product is beginning to be better understood. In this way, the Leqembi itself's fundamental value will be understood and will be reflected in the sales in major regions, including in the United States.
And looking at the future drug discovery strategy of the company, and that and our challenging attitude, our attitude to take on the challenge for the future will also be better understood. I would like to ask Mr. Haruna to make additional comment on the U.S.
Thank you. This is Haruna, responsible for the Leqembi in the U.S. Your question about sales of the Leqembi, when it will reach $1 billion in the US, I will refrain from responding, but we certainly think that the potential is greater than that, and we have a high degree of confidence. BBM and SC AI will be implemented in the society in the future, and naturally, the AD market itself will be transformed fundamentally. We believe that these will be a game changer, and the Leqembi alone has the possibility of SC AI, which is being pursued.
We are engaged in activities to increase demand and increase capacity in a multifaceted way, and primary care PCPs' participation activities are also conducted, and with that, we believe that there will be a very large increase in the future.
Thank you. One more question regarding Lenvima. In the United States, year-on-year, 15% growth was achieved in yen terms on a constant currency basis or in volume terms. How large was the increase?
That question will be addressed by Mr. Ike.
Volume, do you mean physical volume?
Not volume, but on a constant currency basis, excluding the impact of the exchange rate. I believe the growth of 15% is including the impact of the exchange rate change.
8.4% on a local currency basis. So clearly, there is also growth in terms of volume as well.
Any other questions? We would like to receive questions from participants who are participating online. Mr. Muraoka of Morgan Stanley, can you hear us?
Yes. Thank you very much. This is Muraoka of Morgan Stanley. Can you hear me?
Yes, we can.
Thank you very much. Regarding the IV maintenance treatment of the Leqembi, of course, on label for those patients who have received treatment for 18 months, who can switch to this therapy, but insurer, as well as the physicians who wish to switch to this new dosing before waiting for 18 months, of course, it will be used in off-label use. Do you think that there are such movements in the market as such?
For your question, Mr. Haruna is going to respond.
I am in charge of the Leqembi in the United States. My name is Haruna. The dosing every four weeks, there is an increasing demand for this treatment, but during the initiating period, biweekly dosing should be continued in order to have the treatment benefits, and this has been well understood in the market. Regarding the off-label, we do not recommend any off-label use, and currently, physicians understand that there is a standard to start new dosing after 18 months have passed, and therefore, we have not detected any such movements of those people who wish to switch to this new therapy or dosing earlier.
Thank you very much. I have another question about the Leqembi as regards to s.c. Up until quite recently, I think approval was expected to be in June, but PDUFA was 31st of August. So what kind of a negotiation have you had that has caused this delay compared to the original estimation of the PDUFA date?
For your question, Dr. Lynn Kramer is going to respond.
Yes. Thank you for the question. This is Lynn Kramer. I'm the Chief Clinical Officer at Eisai. Our negotiations with the FDA have been as expected, as you're aware. We have received a fast-track designation, and in this situation, we had two options. One, either to receive a rolling review, and we have received that, but we have a standard review period rather than the priority review. We do expect to achieve this in August of this year, as we've said, and that's the reason for the difference in timing. The priority review was not granted in this case, and we are having a standard review. Thank you. Does that answer your question?
Thank you very much. I have another question as a last question. The Leqembi is ramping up. We understand it very well. Trontinemab is following you with quite favorable data. Maybe there is going to be the time lag of two or three years. Do you think that there are any concerns? If you think that there is no concern, then what is the ground for you to think in that way?
For your question, Dr. Owa is going to respond.
Thank you very much, Mr. Muraoka, for your question. It's very difficult for us to respond to that question regarding any other company's products. We are not in position to make a comment, but we have the profile of the Leqembi where we have confidence, a first-in-class and a best-in-class product, and the bispecific antibodies are also developed by other companies.
But you mentioned favorable data, but we do not know any specifics about such data, efficacy, AE, and so forth, and we do not know how this balance is going to be developing. We are not in a position to make any comments on that. Currently, what we can say is that we are overwhelmingly confident in the Leqembi. Maybe that is the right way to respond to your question.
Thank you very much. Amyloid beta is clearly removed. Like the Leqembi, I think this data seems to be excellent, but do you think that this is not relevant to the future risk in terms of competition? At least for now, you do not think that this is going to be the risk in the future.
If I may continue in my response. Right. For now, in terms of efficacy, we do not think that this is going to be an overwhelming risk posed to us.
Thank you very much. Understood.
Next, we have Mr. Hashiguchi from Daiwa Securities. Can you hear me?
Yes, this is Hashiguchi. Thank you for taking my question. I have a few questions regarding Leqembi. First, CHMP opinion or European Commission's request to CHMP, what triggered this in terms of information? And what is the view of Eisai? The view of Eisai is that existing information is sufficient, but is this view already agreed to by the authorities in the United States and Japan, or is this still under review by the authorities in Japan and the U.S.?
Lynn Kramer will respond. Lynn, can you answer to the question about the.
I'm sorry. I'm still on mute. This is Lynn Kramer, Chief Clinical Officer. We were not able to tell the details of the information that became available after the adoption of the CHMP because this is a review-related matter. But the information requested is not new, and it has already been reviewed by the FDA and the MHRA. The safety profile of lecanemab in clinical practice in the United States, Japan, and other countries after its launch is consistent with the approved labels, and no new safety signals are identified. We believe that the EC's request can be addressed with existing information and will be evaluated by the CHMP because of the clear and sufficient information available, and we have provided that to them. Thank you.
Thank you very much. Regarding Kisunla, the share of lecanemab in new patients, what is the understanding of Eisai?
Mr. Haruna will respond.
Thank you for your question. This is Haruna, responsible for lecanemab in the United States. Between Kisunla, our competitive advantage we understand is very strong. The ramping up of Kisunla in the United States seems to be taking more time than lecanemab, and lecanemab introduction is being accelerated, and we believe that impact on our share is negligible. As for lecanemab infusion and ADL improvement, evidence of patients given to lecanemab, we believe that it is important to easily communicate this in an easily understandable fashion. Patients who are receiving lecanemab are saying that they are able to enjoy time with friends, family, or are able to change clothes in more than 75% of the cases, and the disease is stable. Some say that it was life-saving, and this was presented by Dr. Swanson in CTAD last year. They are able to enjoy hobby again. They are able to spend time with family.
They're able to drive again in daily life. Improvement in quality of life is also reported by patients. These are experiences that are based on lecanemab use that are actually felt by physicians, and I believe that is leading to a greater volume of prescription. To repeat, IV maintenance dosing is now approved. For patients who have progressive Alzheimer's dementia, lecanemab has the only—lecanemab is the drug with only such benefit, and we believe that this leads to—this is a future potential. Regarding the situation in Japan, Mr. Yusa will respond.
Thank you. I'm Yusa, responsible for commercial of lecanemab in Japan. First, as for Kisunla impact, at the moment, impact is almost nonexistent. As for lecanemab, we have spent much effort, time, and cooperation from various stakeholders in ramping up lecanemab since the launch in December last year, in the previous year.
MMSE 20 - 21 is required for administration of lecanemab, and for patients who have difficulty visiting on a biweekly basis, lecanemab administration has slowly begun. Two different drugs, and I see informed consent can be cumbersome. And about the differences in the safety of two drugs, we hear from healthcare professionals that they are struggling with these. But as Mr. Haruna mentioned earlier about lecanemab, we have a vast amount of experience of 7,000 patients using lecanemab. This experience and the experience of having lecanemab used safely is shared with the physicians and through physicians, through informed consent to families and patients. And that is a major advantage, and we would like to continue to further expand contribution through lecanemab.
Thank you very much. As for maintenance impact, as you mentioned just now, maintenance dosing can be a reason to select lecanemab, and that is the majority of the impact. The dose does not change. Only frequency will be reduced, and simply put, should that be understood as a negative factor for sales, especially in the United States, infusion centers and distributors, various stakeholders are being paid consideration for their expense. In maintenance and in the initial phase for the first 18 months, are there any differences in economic conditions?
Mr. Haruna will respond.
This is Haruna, responsible for lecanemab in the United States. First, lecanemab maintenance dosing with respect to that. As for the volume that is administered per administration, that remains the same, and therefore, physicians, healthcare professionals, and accounts, the burden of profit-setting will not change.
On the other hand, going forward, as you pointed out, because of IV maintenance as a value, I believe this will accelerate the introduction of this therapy by physicians. And long-term administration will also become possible, and naturally, over the longer term, patients who will continue to be treated will increase in number month by month. And therefore, maintenance dosing resulting in long-term treatment and also the value of maintenance dosing as a value that increases new patients, we believe will create another wave next year.
Thank you very much. We'd like to receive questions from the media. If you have any questions, please raise your hand. The person in the third row from the front, please have the floor.
My name is Banno. I'm from Nikkei Newspaper. If I may digress regarding the tariff policy of the United States, I have a question. The new president of the United States, Trump, is going to impose a tariff s on even on the pharmaceutical products, and the tariff rates are not determined yet, but there will be a cross-border tariff to be applied. So based upon this background, and also there will be potential tariffs against the Japanese products, what kind of potential impact do you see on your products or businesses? What is going to be the degree of impact of this tariff policy in the United States?
Mr. Tamura is going to respond.
My name is Tamura. I am responsible for manufacturing. Thank you for the question. On February 1st, Canada and Mexico, President Trump mentioned that the tariff will be 25% onto the products, and also China as well. Additional 10% will be added.
But on the 4th of February, a media report said that there has been a deferment of the additional tariffs to Canada and Mexico, and also there will be ongoing discussion with China as well regarding the sales sub in the United States of Eisai, which is trying to collect information of the U.S. government, which is conducted by the government affairs. And also we have an office in Washington as well, and through close communication with the stakeholders in Japan as well, and gathering information about the comments made by President Donald Trump, as well as the activities and movements in the U.S. government as well.
Thank you for your question. Are there any questions?
Yes, the attendee in the first row, please.
Osanai from Yomiuri Newspaper. I have two questions. First is about the maintenance dose that was approved in the United States. I heard that preparation is underway for submission in Japan as well. What is the likelihood of the submission, and what is the anticipated timing for approval?
Ogawa-san will respond.
Neurology Japan/Asia Development is my responsibility. My name is Ogawa. Thank you for your question. As for maintenance dose in Japan, looking at the situation in the U.S., which is ahead of Japan, we are in consultation with the PMDA. Specifically when, I'm not able to mention the timing right now, but maintenance dose significance and the package necessary for filing, we are having a discussion in a positive fashion.
If I may, I have one more question. I believe 6,800 patients are given lecanemab, and 7,000, I believe, was the expectation by the end of March. But what is the next step, next target, for example, 10,000 by when? Do you have any expectation?
Mr. Yusa will respond.
I'm responsible for lecanemab commercial. This is Yusa speaking. As you just mentioned, with MHLW in the initial negotiation, we have provided our market size forecast. And this year, this is the second year, and 6,800 is the number that we have provided. And we are almost in line with that. In the third year, and this is already published, 13,500 patients. And we would like to be able to provide lecanemab to as many patients as possible. We are confident that we will achieve growth in the next fiscal year, and targeting that, we will continue to engage in our activities. And thank you for your question.
Are there any questions? The person in the third row from the front, please have the floor.
Thank you very much. My name is Sakata. I am from Yakuji Nippo. I would like to ask you questions about lecanemab in Japan. There are 60 medical institutions which have initiated the treatment with lecanemab, and there are 1,400 follow-up facilities. And you mentioned that there is a smooth establishment of a pathway. And what has been working well for establishment of pathway? Have there been any bottlenecks? And the second question is a blood biomarker, SC AI. You may explain the situation in the United States, but what will be the benefits for the patient when Japanese patients will be able to receive such benefits as well?
Mr. Yusa is going to respond.
Thank you very much for your question. Regarding your first question, the initiation institutions as well as the follow-up facilities, you asked a question about that. And 660 institutions which have initiated the treatment, and we are seeing an increasing number of such institutions day by day. And first of all, the first target is to reach 1,000 institutions.
And on top of that, follow-up facilities, as Mr. Naito mentioned earlier, about 1,400 institutions have consented. And in delivery of this drug, under the OUG, we are getting the confirmatory letter exceeding the number more than 1,000 institutions who have submitted such consent form. And we need to aim at reaching 3,000 institutions because we are seeing an increasing number of new patients who will start receiving this treatment. Therefore, we would like to increase the number of institutions who will follow up. And another question is about the SC AI formulation in Japan. Or have you asked the bottlenecks in the pathway in Japan?
Yes, that is correct.
In building a pathway, rather than bottleneck, first of all, such pathway needs to be in line with the OUG. And then those institutions which are compliant with OUG, does that mean that they will immediately be able to start treatment with lecanemab? Rather than that, MRI should be regularly conducted. And with the department and the physicians which are conducting such MRI, they need to have a consultation, and you need to make appointments over six months or so, and who are going to negotiate with the follow-up facilities. Therefore, it depends on the institution as well as depending on different regions. There have been various types of bottlenecks, and over the past 12 months, we have been able to resolve this mainly because of the neurology specialists, dementia specialists. About 50 of them were assigned to prepare for the launch. And over 600 general MRs or sales reps were in charge of other products, but they deepened their understanding in the dementia as well.
The biggest factor is that 25 years ago, we were the first company which launched the drug for dementia, Aricept, and we have been able to establish a relationship with the neurologist as well in Japan.
Regarding the SC AI formulation in Japan, Mr. Ogawa is going to respond.
For SC AI formulation, I would like to respond. My name is Ogawa. I think you asked about the question. You asked the question about the schedule for introducing the SC AI. As regards to maintenance, we responded earlier. Regarding the SC AI, we will learn from the US market, and we are progressing with the negotiation discussion with PMDA as well.
Thank you very much.
Are there any other questions? Yes, Attendee who is seated in the front row, please.
Narita from Nikkan Yakugyo, thank you for taking my question. If numbers were already mentioned, I apologize, but Kisunla is now emerging as a competitor. And what is the impact? How much decrease in sales was seen? If there are numbers, please. And lecanemab is going to be given once every four weeks, and do you expect to increase the interval even longer than four weeks?
Mr. Haruna will respond.
This is Haruna, responsible for lecanemab in the U.S. We previously responded to an earlier question. Kisunla ramping up in the U.S., it seems that it's taking more time than lecanemab, and we are not seeing much impact in terms of our share. So the impact we consider to be minimal. The second question is about extending the administration interval even longer.
Yes, the second question. Mr. Ogawa will respond.
Responsible for neurology in Japan and Asia, this is Ogawa speaking. I understood the question to be about an interval that is longer than once every four weeks. We have made presentations at the academic societies, and the maintenance dose frequency is based on phase II and Clarity AD data, and based on the simulation using that data. There were several patterns that were simulated. Once every four weeks was appropriate, was deemed as appropriate to maintain efficacy, and that is why it was filed for approval. At the moment, other than that, we are not considering any different frequency for maintenance dosing.
Now, the time has come to close today's financial results briefing session. Thank you very much for participation out of your busy schedule.