My name is Toru Kimura, President and CEO of Sumitomo Pharma. Thank you for attending this briefing today. Today, as shown here, we will provide a summary of our 2024 financial results and our 2025 forecast, followed by Reboot 2027, and finally a Q&A session. Here are the financial results for FY 2024. The results were almost in line with the revised forecast announced on April 28. Revenue was JPY 398.8 billion, an increase of JPY 84.3 billion from the previous year. Growth in three key products, mainly in the U.S., contributed to the increase. We have been working to reduce R&D expenses as part of our efforts to cut costs through drastic business restructuring and as part of our selection and concentration efforts. As a result, selling, general and administrative expenses decreased by JPY 68.7 billion to JPY 167.7 billion, and R&D expenses decreased JPY 42.4 billion from the previous year to JPY 48.5 billion.
In the fiscal year under review, JPY 13.7 billion was recorded in other score bases because we spun off part of our regenerative medicine cell therapy business and transferred some of our shares to Sumitomo Chemical. As a result, core operating profit was JPY 43.2 billion, an increase of JPY 176.1 billion compared to FY 2023, which was a very difficult year. The JPY 14.3 billion recorded as adjustments includes restructuring costs in North America or Japan and a small impairment loss on TWYMEEG. As a result, operating profit was JPY 28.8 billion, an increase of JPY 383.7 billion from FY 2023. As for financial income and costs, we recorded a loss of JPY 11.2 billion due to foreign exchange losses, interest, and others.
As a result, net profit was JPY 23.6 billion, and net profit attributable to owners of the parent increased by JPY 338.6 billion compared to the previous year, far exceeding the figures announced at the Q3 results briefing on January 31st. Revenue from sales of major products is shown here. The numbers in the middle are yen-dominated figures. Revenues from ORGOVYX, MYFEMBREE, and GEMTESA increased 96.9%, 39%, and 78.6%, respectively, over the previous fiscal year, due in part to the slight impact of foreign exchange rates. Business in North America was very strong. Finally, revenue totaled JPY 251.8 billion, up JPY 92.8 billion, or 58.3%, from the same period last year. A comparison between the forecast at the beginning of the period and the actual results is shown in the upper right corner. ORGOVYX and GEMTESA results exceeded initial forecasts.
On the other hand, the results for MYFEMBREE, while growing compared to FY 2023, were a little less favorable than we had expected. With regard to MYFEMBREE, in January, we switched from co-marketing with Pfizer to solo marketing by the company. If there is any remaining in the future, deferred revenue will be recorded in a lump sum. This is included in export products one-time revenue at the bottom. In Japan, total revenue was JPY 99.8 billion, down JPY 14.8 billion from fiscal year 2023. As noted, the 12.9% decrease was due to the significant decline in sales of Equa and TRERIEF, whose exclusivity period ended during the fiscal year. In Asia, Chinese MEROPEN remained strong. Total revenue in Asia and China was JPY 47.2 billion, up JPY 6.3 billion, or 15.5%, from FY 2023.
I would like to explain about the joint venture of our Asian business and the transfer of the frontier business announced in March and April. We are in a very difficult situation, and we desperately needed to invest in growth at this time in order to further maintain and grow our Asian and frontier businesses in the future. After internal discussions, we decided to concentrate on the U.S. and Japan, which are the core markets for the new drugs. The decision was made to transfer the Chinese and Asian operations, which have a much different pipeline and product mix, to a joint venture with Marubeni Global Pharma Corporation, which is expected to invest more in growth. The frontier business was transferred to Sawai Group Holdings, which focuses on the digital healthcare business.
We have not been able to explain to you the benefits of joint ventures, especially in Asia and China, so I'm showing you the benefits here. The entire business will be transferred in two separate transactions. First, 60% will be transferred in FY 2025, and the remaining 40% in FY 2028, receiving JPY 45 billion and JPY 27 billion at each timing. In the meantime, the joint venture's dividend payout ratio will be 100% in principal, and our share will be 40%. In addition, we will continue to supply products from our company, which will benefit us in the future. This is an image of the benefits of a joint venture. Here you see the forecast for FY 2025.
If you see the middle of the table, revenue forecast is JPY 355 billion, a decrease of JPY 43.8 billion, including the impact of foreign exchange, and a decrease of JPY 30 billion, excluding the impact of foreign exchange, compared to FY 2024. Since the China and Asia business will be transferred to the joint venture, its sales will no longer be recorded from August of this fiscal year. In North America, APTIOM will soon face loss of exclusivity, and its sales will decrease significantly. The period of exclusivity for Equa/EquMet will end in Japan as well. These are the main reasons for the decrease in revenue. SG&A expenses and R&D expenses will be reduced in the same manner as the fiscal year under review, or even more so where possible. However, most of the decrease in revenue is due to the impact of foreign exchange rates.
The JPY 44.5 billion recorded as other score bases is due to the JPY 45 billion in income expected from the transfer of the Asian business. Core operating profit is expected to be JPY 56 billion, an increase of JPY 12.8 billion from the fiscal year under review. There will be no adjustment, and operating profit is expected to be JPY 54 billion. Financial costs are expected to be JPY 14 billion, including foreign exchange losses due to the difference between the actual exchange rate of JPY 152.62 for the fiscal year under review and the projected exchange rate of JPY 145 to the dollar for FY 2025. As a result of the above, net profit attributable to owners of the parent is expected to be JPY 40 billion, an increase of JPY 16.4 billion. The forecast by segment is shown here.
Since we will basically only be supplying drugs for our Asian operations from August onward, we anticipate a very large decrease in revenue and profits in Asia. In North America, APTIOM will face loss of exclusivity. Although our strategy is to offset the loss with growth in three products, we do not expect to be able to completely absorb the foreign exchange loss. This shows a breakdown of the changes in forecasted core operating profit. The actual amount for the fiscal year under review was JPY 43.2 billion. Core operating profit for the current fiscal year will no longer include the one-time recognition of deferred revenue from MYFEMBREE and a gain of JPY 26.8 billion from a change in equity interest in the regenerative medicine cell therapy business. In addition, the termination of the exclusivity period of Equa/EquMet will reduce gross profit in Japan by JPY 8.3 billion.
In contrast, gross profit in North America will increase, but on the other hand, the exclusivity period for APTIOM will end. Subtracting these items will result in a positive figure. In Asia, the company will record a gain of JPY 45 billion on the transfer but will lose sales after August. On the other hand, there are equity method profits and profits from the supply of products after the transfer of the business. Net amount related to the transfer will be JPY 31.5 billion. As a result of the above, core operating profit forecast for FY 2025 is JPY 56 billion. The revenue forecasts for our main products are shown here. Our focus is ORGOVYX, MYFEMBREE, and GEMTESA. In particular, revenues from ORGOVYX and GEMTESA are expected to increase by JPY 19.9 billion and JPY 17.1 billion, respectively, over the fiscal year under review. We expect these to continue to be our growth drivers.
On the other hand, since MYFEMBREE is to be sold solely by the company, although we do not expect an increase in revenue, we expect the profit from the product to improve so much that it to be profitable as a standalone item in the current fiscal year. This will be explained again later. We expect revenue of JPY 248.2 billion for North America as a whole. In the next fiscal year, we will receive a JPY 100 million sales milestone from Pfizer, which is also included in the JPY 38.7 billion. The following is a brief explanation of each product. First, ORGOVYX achieved an 87% increase in sales in FY 2024 compared to FY 2023. The figures in the chart below are in dollar terms. In FY 2025, we expect a 24% increase over the previous fiscal year to $710 million.
MYFEMBREE revenue was up 32% in FY 2024 compared to FY 2023, but revenue is expected to be almost flat in FY 2025. The plan is to increase profitability and profit while covering the termination of the partnership through our own sales activities alone. Next, let me explain about GEMTESA. GEMTESA revenue was very strong in FY 2024, with a 69% increase. We plan to continue to increase revenue by 26% to $572 million in the current fiscal year. On the other hand, the addition of new indications for OAB/BPH, overactive bladder with prostatic hypertrophy, was decided late last year, and a new differentiating factor from other competing products has emerged. We will continue our sales activities to make it the standard treatment of choice for both male and female patients.
We have been paying attention to the generic version of Myrbetriq, a competitor that came out in the middle of the last fiscal year. The red area shows the trend of GEMTESA, which is increasing without receiving impact. The number appears to have decreased slightly since this calendar year. This is due to the impact of our price negotiations with payers, where we were bullish because of the new indications, but we received a proposal to lower the price. Once we started activities to have them removed from the formulary, we have already seen a large payer return to us, so we are optimistic that performance will return soon. Next, let me explain about research and development. The progress since the Q3 results in January this year is shown here.
In the CNS area, or regenerative medicine cell therapy, we have made a major change in the form of a business for dopamine neuroprogenitor cells derived from other iPS cells, which will be now conducted in collaboration with RACTHERA. However, the program itself is proceeding as usual. Data from a physician-initiated clinical trial at Kyoto University made headlines when it was published in Nature on April 17th. We are already in the progress of conducting a SAKIGAKE comprehensive evaluation consultation with the PMDA and hope to obtain approval in FY 2025, preferably by the end of the year. In the area of oncology, as we have repeatedly explained, we are focusing on two products, E nzomenib and Nuvisertib. Regarding Enzomenib, we recently agreed on a study package with the FDA in April for submission and have started a pivotal study.
As for Nuvisertib, we will soon be presenting the latest data on the efficacy and safety on the single-agent cohort at the European Hematology Congress, so please stay tuned. TWYMEEG was marketed in the form of a cautiously administered dose for patients with kidney problems, but data have emerged showing no effect on renal function. Here you see the criteria. The drug can now be administered to patients with CKD 3b or 4, making this drug even more reliable. We expect to know the results of the interim analysis of the universal influenza vaccine by the end of this year. All human administration and immunization studies in clinical trials have been completed. Let me explain each product in a little more detail. I will explain about allogeneic iPS cell-derived dopaminergic neuroprogenitor cells for regenerative medicine and cell therapy.
In the lower left corner, there are three round, egg-like objects in a row. This is a PET image of the brain, and the red area is where dopamine is made. Two large red dots appear, one on each side, as indicated by the arrows, which were not there before the surgery. It can be seen that the transplanted cells made dopamine well. There's a rating index called the Hoehn and Yahr scale for patient symptoms. In this index, as noted in the upper right corner, a person living in bed or wheelchair without assistance is classified as 5, while a person with tremors or stiffness of limbs on only one side of the body is classified as 1. In Japan, people with Hoehn and Yahr, 3- 5, are eligible for designated intractable diseases. All six patients who underwent surgery were designated as intractable.
After 12 and 24 months, half of the patients moved to index 2. I think you can see that this is very impactful for patients. Patients with 3 walks in small increments and shows sagging legs. In index 2, tremors in both limbs and muscle stiffness remain, but overall movement is normal. Indicators 3 and 2 have this difference. As for Enzomenib, as I mentioned earlier, approval trials have begun. We are considering consulting with PMDA in Q2, as well as accelerating patient enrollment for the phase II part. For Nuvisertib, we are processing with a cohort of patients receiving Nuvisertib as a single agent or in combination with a JAK inhibitor. There is a European Hematology Conference coming up soon, and I heard that the abstracts will be published on May 14th. We'll be able to explain the contents tomorrow or the day after.
We are in the process of accelerating to determine the recommended clinical dose as soon as possible so that we can move to the next stage. Next, let me briefly explain about Reboot. This is our immediate action plan to restart a strong Sumitomo Pharma. With the announcement of this plan, the current midterm management plan, called Midterm Management Plan 2027, which no longer fits the current situation, has been withdrawn. First, let's look back at FY 2023 and FY 2024. As we have explained many times, our performance in FY 2023 was very difficult, and we achieved a V-shaped recovery in FY 2024. In fact, in North America, we have already undertaken a very large and fundamental structural reform in FY 2023. In Japan and the U.S., we have been promoting organizational streamlining, selection and concentration, review of R&D investments, and governance reforms.
The initiatives for FY 2023 and FY 2024 are shown here. We have thoroughly cut costs and implemented a workforce reduction of 1,200 employees in Japan and the U.S. In addition, we are conducting cap management on R&D expenses and reduced those from JPY 110 billion to JPY 50 billion. At the same time, a gain of JPY 250 billion was recorded from the sale of the entire stake in Roivant and the conversion of our agent operations into joint ventures. In addition, we promoted selection and concentration of programs in R&D too. In order to ensure that our financial situation does not hinder us from expanding our regenerative medicine and cell therapy business, we have established a new joint structure with Sumitomo Chemical as a member of the Sumitomo Chemical Group.
As a result, from FY 2023-FY 2024, we achieved a JPY 140 billion reduction in SG&A expenses and a JPY 60 billion reduction in R&D expenses compared to fiscal year 2022. With this reboot, Sumitomo Pharma is now restarted as the new Sumitomo Pharma. Despite the difficult situation, Sumitomo Pharma is determined to rebuild its foundation as an R&D-oriented pharma. We will rebuild our value creation cycles based on our own innovations and make a strong start. We would like to emphasize the value creation cycle as a key word within our company. Not only must we continuously bring innovative drugs to market through research and development, but we must also maximize their market value afterwards to contribute to better medical care and lead them to the stage of expanded sales and indications.
The resulting product branding and expansion of the next set of management resources will allow for further new strategies or new research. We have named this cycle the Value Creation Cycle. All company functions are responsible for one of these. We would strongly encourage each person or department to contribute to this cycle. As a result, we would like to rebuild the company as a global R&D-oriented company, which is our ideal albeit in a limited area as a global specialized player. In this regard, research and development have not been very successful so far. However, the next two to three years will bring major milestones in regenerative medicine, such as iPS, Parkinson's, and cancer, that will feed us in the future. For the time being, the three key products plus RETHYMIC will provide solid support for earnings while we nurture the next buds.
In this context, if we apply this Value Creation Cycle, CNS is still in the research and development stage, as we have suspended the development of a major late-stage product. As for cancer, we are finally starting to see sales, and the same is true for the regenerative medicine and cell therapy. We will strive to maximize them as soon as possible by putting them on the Value Creation Cycle that we will be strengthening. In order to implement this, we have positioned FY 2025 as the year in which we will demonstrate our true value as an R&D-oriented pharma company, as shown in the previous diagram. The results I have shown you here and have emphasized many times before will be concentrated in this fiscal year, and we hope to regain momentum through them.
We currently believe that the success of this will allow us to draw up a more concrete strategy for future growth. Here are our financial targets. These figures do not factor in the fact that sales are currently very strong and that a major milestone in research and development will come this year. We will achieve revenue of JPY 250 billion for the three key products. Core operating profit will not fall below JPY 25 billion after FY 2027. On the other hand, sales-related revenue accounts for the bulk of the current cash flow and operating profit. One of our goals for free cash flow is to quickly get the company into a position where it can generate a profit without sales-related revenues. In addition, we hope to quickly reduce interest-bearing debt to less than JPY 200 billion and resume dividend payouts as soon as possible.
For the time being, we believe that repayment of loan debt must be our priority. Here is another slide for financial targets. This image shows cash allocation. We intend to use cash flow from our core business and one-time cash flow effectively, mainly for R&D investment or repayment of interest-bearing debt. In addition to the repayment of interest-bearing debt, the recent refinancing will become due in FY 2027, and the first resumption of the existing subordinated debt will also arrive. We also see shareholder return and strategic investment as issues to be addressed. On the other hand, to start up with a focus on R&D, aggressive investment in development will be necessary, but there is a possibility that we may not be able to fully finance the cost of such investment.
We would like to place maximizing our profits through external partnerships in our development programs at the center of our strategy. We do not sell our pipeline to outside parties through licensing, but we partner to maximize our value. The business strategy overlaps with what I have already explained. The overall picture is to first maximize the value of existing products. Thorough cost control will also continue in the future. We intend to strengthen our portfolio by selecting our in-house development pipeline and pursuing partnership opportunities. First, we will focus on two oncology products and regenerative medicine, followed by strategies in the CNS and neurology fields, which are our foundation. As we work towards the launch of the two oncology products, I would like to reiterate that we will give priority to the development of three products and look for development partners as soon as possible to maximize their value.
We are currently planning to file for Enzomenib in FY 2026 and launch it in FY 2027. For Nuvisertib, we plan to file in FY 2027, although there will be a slight delay. By adhering to this schedule, we will move forward with the realization of the early market launch shown on the right side. As for regenerative medicine and cell therapy, as I have repeatedly mentioned, we have only launched RETHYMIC in the United States. We aim to obtain approval for iPS, Parkinson's disease drugs, as soon as possible this year and to start selling them in the next fiscal year. We will continue to develop the product in the United States to become one of the world leaders in this field. We aim to make this a JPY 100 billion business by the mid-2030s and JPY 300 billion thereafter. This is a regional strategy of our Value Creation Cycle.
Until now, we have focused on Japan, the U.S., China, and Asia. Our business in China and Asia, which has not been in the form of a new drug market, will be transferred to a joint venture with Marubeni Global Pharma Corporation, and we will establish our business with a focus on the U.S. and Japan. The global strategy function, or R&D, will be promoted firmly on a global basis, while sales and marketing will be managed with an emphasis on localization. I will explain our R&D efforts in more detail, but since most of these overlap with the previous explanations, I will skip some points. First, milestones for the restructuring of the value creation cycle are concentrated in the next three years, especially in the current fiscal year. Our top priority is the commercialization of iPS cell-derived products and the launch of two products, which will be followed by other products.
I hear a lot of different voices about the two cancer products. It is said that we have done many things before. We will continue to move forward with the strategy of Right target, Right plan, Right action to maximize value as soon as possible with more concrete confirmation. The policy of Right target, Right plan, Right action applies not only to cancer but also CNS. Until now, for example, when verified in a large comparative study, the results were not known until the unblinding. Rather, we will continue our R&D in areas other than oncology while firmly confirming efficacy signals even in small diseases. At the same time, the unification of the R&D and technology research divisions into a single entity was a major highlight of the December structural reform. We would like to pursue efficiency and results creation.
We show you how to maximize the value of our portfolio in oncology, CNS, and regenerative medicine. This has already been mentioned, so I will skip it. As an R&D-oriented firm, we will do our best. Finally, we are considering three steps in the restart towards a strong Sumitomo Pharma. First of all, we have almost achieved our goal of getting out of the business crisis. Next, while reforming the company to ensure that the Value Creation Cycle rotates strongly, we will work towards expanding our three key products along with R&D in oncology and regenerative medicine from now until FY 2027. After that, we would like to firmly establish our positioning as a global specialized player, which is what we are aiming for. We are considering restarting in these three phases. I have explained reboot 2027 today.
As I have just mentioned, we will withdraw the current midterm management plan, and at the same time, we would like to continue the restructuring of the company in the direction I have explained today. On the other hand, sales in North America have been very strong. We have a major milestone ahead of us this year in FY 2025. Once these are clarified, we would like to prepare a more elaborate midterm business plan and present it to you. That is all I have to say. Thank you.
Yamaguchi from Citigroup, I would like to briefly ask you a few questions. You told us about the midterm management plan, the partnership in Enzomenib, and the prompt launch, which is likely to move the corporate value in the short term.
Regarding the partnership, you have a sales team in the U.S., and of course, I do not think you are going to go into partnership for all products, but could you first tell us what you are aiming to achieve through this alliance in Japan and the U.S., and how you plan to distribute profits as a result?
Yes, naturally, it depends on the partner, but we would like to share the upfront and R&D costs in the alliance. On the other hand, in terms of commercialization, as you have just mentioned, our target markets are Japan and the U.S., so we would like to sell our products there. We hope to have such partnership.
Is the timing set already? I believe it was described in the slide as the current fiscal year.
Our R&D expenditures are sufficient for our current activities, but as you know, our R&D investment will continue to grow. We would like to do R&D with partners in the next year and beyond. We are aiming for the end of this fiscal year or second half of this fiscal year. However, we need to consider the convenience of the other party, so we are considering the possibility of a slight extension.
I understand. This time, you spoke about the next three years. We have received the figures for the fiscal year ending March 31st, 2026, but what will happen in the three years through the fiscal years ending March 31st, 2027 and 2028? In particular, you said that the fundamentals are expected to be positive in the fiscal year ending March 2026, but there will be temporary ups and downs.
It is probably a little early to ask, but beyond that, will there be no one-time revenue and profit will grow mainly through the core business in the U.S., or are the ups and downs expected to continue?
Thank you. We believe that the sale of the Asian business will be the last major one-time proceeds from the sale, so we intend to make a good profit from our own products in the fiscal year ending March 2027. Sales of the key products are performing very well compared to our initial forecast, which we hope would make up for it.
Thank you. Finally, could you briefly tell me about the relationship between dividends and interest-bearing debt, which was mentioned on the same slide? Is one shareholder when interest-bearing debt falls below JPY 200 billion, or is that not necessarily the case?
They are not linked.
We want to reinstate dividends and reduce interest-bearing debt, both of which are independent of each other. First of all, we would like to strike a balance by discussing with our shareholders what priorities we should give to the banks from which we have borrowed money, as well as to other parties.
Thank you. That's all.
Wakao from JP Morgan. Thank you for your explanation. First of all, please tell me about the results for the three key products in Q4 and the forecast for this fiscal year. I believe there has been a positive impact of Medicare Part D from Q4. I would like to know how the gross to net is improving, especially in light of the performance in Q4.
I would say that the forecast for ORGOVYX for the current fiscal year is somewhat underwhelming, and I believe perhaps it has the potential to go a little higher. For GEMTESA, on the other hand, it is difficult to understand actual revenue from the prescription trend. I believe that the high earnings forecast probably had a lot to do with the improved gross to net. In light of these points, could you please tell us about your projections for the three key products?
First, I'll give you a brief explanation, and then Mr. Nakagawa will elaborate. Regarding ORGOVYX, as you mentioned, the insurance system, a very perfect measure for us, will be implemented this year, which will reduce the burden on patients. There has been a significant change in the trend since January, and I think the difference can be read quantitatively. Mr. Nakagawa will comment on this later.
For GEMTESA, the current figure is mainly due to the improvement of gross to net. We are not particularly concerned about the lack of volume growth because Medicare coverage is now temporarily reduced. Mr. Nakagawa, do you have any additions?
Yes. I'm in charge of North America operation. I cannot go into more detail at this stage than what Mr. Kimura has just explained. There will be no major changes to the pricing strategy for ORGOVYX in Q4 or before or in FY 2025. Certain improvements resulting from changes in our IRAs are, of course, working in our favor starting in January 2025. While maintaining this, we would rather take advantage of the ease of use of this drug. The characteristics we have been advocating have led to more and more prescriptions, and the number of new patients have been increasing very steadily.
Basically, we calculated a strong sales forecast for FY 2025 based on such volume strength. On the other hand, the change in the IRA for GEMTESA, which began in January of this year, is working in our favor in terms of price. In this regard, we are considering whether to focus on price being listed in the formulae, volume, or market share in order to achieve the best balance. We would like to refrain from disclosing detailed figures. Through such strategies, we hope to achieve the significant increase in sales in FY 2025 that I explained earlier. As we have informed you, the various effects of the executive order are naturally not taken into account at this point. We have determined that nothing can be considered from the information available at this time.
Thank you very much. Could you tell us quantitatively how much the gross to net is improving?
I am sorry. We have always refrained from giving such figures by quarter. We would like to keep that information within the company.
Regarding ORGOVYX, if the gross to net is improving and the trend of the volume in Q1, which was quite strong, continues, if your plan looks conservative, if there is anything wrong with the concept, could you please point it out? As for GEMTESA, what is your volume forecast for this fiscal year?
First of all, ORGOVYX was very strong, at least in Q4. We are also seeing some very good figures in April, although still at the preliminary level. I do not think the FY 2025 forecast is conservative, but I would like to review it at the appropriate stage based on the latest information. You asked about the volume of GEMTESA.
As I mentioned earlier, we will be looking at the situation and making a strategic decision on whether we should pursue price or volume. Of course, we have included certain figures in our budget, but we would like to refrain from disclosing them. Rather than just increasing market share and volume, as I mentioned earlier, we would like to consider a variety of options, including price. This is not a straightforward answer, but we hope you understand the situation.
Thank you very much. The second is a similar theme. According to Mr. Kimura's explanation earlier, the JPY 250 billion in the midterm management plan does not factor in the recent strong performance. So can you expect to exceed the JPY 250 billion if the current situation continues?
I will answer this as well. Yes, when we made the plan, we did not fully factor in the very strong January to March situation.
We will make every effort, both strategically and operationally, to somehow surpass this.
Thank you. Finally, in terms of changes in the external environment, I would like to ask you about the impact of U.S. tariffs. For example, if a 25% tax rate were applied to pharmaceuticals, what would be the expected impact? What will be the impact regarding yesterday's executive order by the president? In fact, I believe the three key products are much higher than their original prices. Is that understanding correct?
I will answer your question. First of all, it is difficult to make a decision related to tariffs as the situation changes in many ways. Assuming the 25% condition you just mentioned, it could have an impact of about JPY 1.5 billion, as we are actually doing all kinds of things for our supply chain. That would not be a very significant impact.
Therefore, we have not incorporated the impact of tariff in our forecast for FY 2025. As for the executive order, as you said, we are analyzing it, but it is very vague and abstract. We will keep a close eye on when and in what form this will be implemented and how it will affect our business. He seems to comment that prices are high in the U.S. and low in Japan and Europe. We will keep a close eye on the future trend. In terms of actual selling price, the price at which the drug is passed on to the patient in the U.S. may be somewhat higher, but that is not something that the drug companies can control. I think this is a very difficult problem to solve.
I understand. It seems that within the next 30 days, each pharmaceutical company will receive some sort of notice.
In response to this, are there any factors that your company can work on in the short term regarding price?
We do not have specifically. In our business in the U.S., we determine the publicly listed wholesale price ourselves, which is called a work price. But then there are costs for middlemen and large rebates. Therefore, I would like to mention that prices are never changed by a single voice of a pharmaceutical company.
I understand very well. Thank you very much. That is all.
Muraoka from Morgan Stanley. In your earlier explanation about tariffs, you said that even if a 25% tariff were applied, it would only affect by about JPY 1.5 billion. Does this mean that the three key products are mainly manufactured in the U.S. and some materials are imported from outside the U.S.?
This is very complicated and difficult to explain in a few words.
We import raw materials to the U.S., but we do not import products. We have also products that are manufactured in the United States.
Yes. In a nutshell, you can say that the ratio of U.S. manufacturing is quite high then.
Yes, that is in a nutshell. Although the percentage of sales in the U.S. is very high, the impact of tariff on our company is very small.
I see. By the way, what has been the Medicare to Medicaid ratio for ORGOVYX and especially GEMTESA? And what do you expect it to be this year? There may have been several references to this in the past, but could you tell me?
I have explained the payer mix briefly so far. Roughly speaking, Medicare accounts for around 2/3 of the total for both ORGOVYX and GEMTESA.
Is Medicaid ratio small?
The Medicaid ratio is very small, yes.
I understand. Thank you very much. Let me confirm about slide 33. I have read, and you are saying that the core operating profit will be more than JPY 25 billion from FY 2027, or is it FY 2028?
You got that right. It means that we will reach JPY 25 billion in FY 2027 and will not fall below at least that amount after that. In that sense, in the sense that we will not repeat the very severe performance of the year before last, FY 2023, we have indicated that we would like to set a standard of JPY 25 billion to manage the financial performance.
I understand. Is the statement that the dividend will resume at the appropriate time an implication that the dividend will resume after FY 2027, although it will be difficult to resume by FY 2027?
We do not intend to make such a strong statement.
We have indicated that we would like to be patient in FY 2025, but that we would like to consider very seriously reinstating the dividend in FY 2026 and beyond, whether it is feasible or not.
I understand. The basic assumption for this is JPY 250 billion for the three key products. I have asked several times before, but it appears that the milestone that is triggered when the second round of ORGOVYX achieves $1 billion is not included in this JPY 25 billion. Although that figure is included in the FY 2028 and beyond, given the strong performance in January to March and April, is it possible that a second milestone will be added in FY 2027?
Thank you for your very perceptive point. The next major milestone is the promise to Pfizer of $1 billion in the calendar year.
This is $325 million U.S. dollars, which of course depends on the exchange rate, but in yen terms, it is around JPY 50 billion. We have not included it in our current plans, but we will work to make that happen as soon as possible. Looking at how well the last couple of months have been going, I do not think it is unrealistic to imagine that this can be accomplished quickly. As I said, we would like to plan based on a clear assessment of what the trend will be and incorporate those figures when we announce what we would call a midterm business plan.
Thank you. One more question. There may be upside in FY 2027, but in FY 2026, which is not mentioned here, there will be rebounds of various factors and profits will decrease slightly. Is that correct understanding?
We would like to avoid that, but we are expecting a gain of JPY 45 billion from the sale of our Asian business in the current fiscal year. We think it will be difficult to make a profit of JPY 45 billion from something else in the next fiscal year. While profit will probably decrease a little, we will make every effort not to decrease them significantly.
I understand. Thank you very much. That is all.
I'm Stephen Barker from Jefferies. Thank you very much. I would like to ask about the joint venture of the Asian business on page eight. In this pie chart, the overall value appears to be about JPY 100 billion, of which the orange portion to be about JPY 15 billion. How should this be interpreted?
Does this mean that the company expects to generate about JPY 15 billion in profits from exporting to Asia over the next three years?
This is just an image, so it is hard to explain quantitatively. We naturally place a margin on the supply of our products, and we expect to receive some income from this. Depending on sale, we believe profit will be generated. I do not think this appears to be JPY 15 billion, but if it appears to be, I think I owe you an apology.
You are saying that it will not reach JPY 15 billion?
No, that is not what I meant. This is just an image.
I understand. On page six of the supplementary financial data, the sales forecast for the Asia segment for this fiscal year is about JPY 21.1 billion.
I assume that the business will remain the same until first half, but please tell us what kind of sales we can expect from product supply in second half and beyond. I would like to know the contents of the JPY 21.1 billion.
I cannot give you any details because it would cause trouble for the customer if you knew the price of the product supply. The four-month forecast for April, May, June, and July includes the sales of products as they are under the current business structure. We hope you understand that from August onward, we disclose the projected amount of product supply.
I understand. Thank you very much. That's all.
Hashiguchi from Daiwa Securities. Thank you.
First of all, I think you mentioned that over the past year or so, you have been discussing what kind of company you would like to become in the future, given the number of people have decreased considerably and the number of pipelines have also decreased. On page 46, you show us what you are aiming for in FY 2033 and beyond. Am I correct in understanding that what is written here has not changed much from what your company has always aimed for and that you are in a condition that you are able to continue to aim for that?
Qualitatively, it is as you just said. We would like to establish a firm positioning in certain areas and products, not only in Japan but also overseas. For example, we have given up on our presence in China and Asia.
In terms of cutting the development pipeline, the number of products that can demonstrate positioning may also be slightly reduced. However, qualitatively, we want to be a company that has a strong presence in the U.S. and Japan as an R&D-oriented pharma company.
Thank you. Although the number of pipelines has been reduced as you build the Value Creation Cycle, do you ultimately aim to become a pharmaceutical company with a certain depth of pipeline or projects from early to late stage as you once did?
Yes, that's right. We aim to be a company that can do everything in-house from early to late stage. We believe that it will be difficult to run the number of late-stage programs in-house, especially at this size. We would like to use the two cancer products as a touchstone and combine them with a partnering strategy.
We will do the initial development in-house. There are some programs that we have not been able to introduce to the outside world and are now forcing us to stop. We have a number of very promising non-clinical programs at the late stage lined up. We are maintaining that and hope to bring it back as soon as possible.
Thank you very much. Second, I would like to confirm the definition of core operating profit of JPY 25 billion for FY 2027. You mentioned excluding one-time factors. What are they and what do they include? I do not think it is something like the JPY 45 billion gain from the transfer of the Asian business this quarter, for example. Are the sales milestone coming in from Pfizer not a one-time factor?
For example, I would appreciate it if you could sort out to some extent which of the pipelines that are in the late stage are temporary factors and which are not.
Yes. To give an example from this quarter, the lump sum recognition of deferred revenue for MYFEMBREE is a one-time factor, and the sales of the business is also a one-time factor. Sales milestones are also temporary factors. I hope you understand that excluding one-time factors here means, for example, the gains from ORGOVYX, GEMTESA, and MYFEMBREE.
I understand very well. Thank you very much. Finally, I would like to ask you about the data in the paper published in Nature this time regarding the iPS cell-derived products for Parkinson's disease. I believe Nature also published the results of a clinical trial of a very similar concept of embryonic stem cell-derived product.
I don't think it is fair to compare them since the number of cases is still quite small in both cases. However, the numbers looked better in terms of efficacy and safety, and the other side is already conducting tests on frozen cells. In that sense, I felt that that might have a slight advantage in terms of development progress. What do you think of the company's competitiveness against the product with such similar concepts that other groups are developing?
It is a very similar-sized clinical trial, as you mentioned. This is being implemented by an American venture called BlueRock . At first glance, the effect looks good, but in reality, the demographics of the enrolled patients are different. The Kyoto University trial is targeting patients who are considered by experts to be less likely to respond.
For example, I'm now showing you imaging data that indicates whether dopamine is being produced in the brain. The Kyoto University trial has such very solid data, but the trial of the other part has not yielded very good data. I don't think it is easy to decide between the two, but if you look at the details, I believe the Kyoto University trial has better results in terms of safety. In any case, it is not that one is better than the other since enrolled patients are very few. We are currently running clinical trials in North America for both live and frozen cells. We would like to look at that and make a firm decision on which is more advantageous. It is true that frozen cells are easier to distribute, but our stance is that it is necessary to carefully assess whether it is advantageous or not.
Do you mean that there is a possibility that frozen cells are not necessarily advantageous in a commercial sense?
Yes, that's right. I would like to say out loud that I would only say this with the word not necessarily. Frozen cells have a lower rate of viable cells, and the thawing required for actual use is not as easy. If someone is unfamiliar with the process such as this, it can cause problems. Therefore, I think it is necessary to conduct a thorough verification, including actual clinical use in the future.
Thank you very much. That's all.
Sakai from UBS. Regarding the balance sheet at the end of March, you had about JPY 260 billion in long-term debt and JPY 46 billion in short-term debt remaining. In Mr. Kimura's explanation of financial targets, he said that this figure is just an image.
In other words, you will reduce roughly JPY 100 billion by FY 2027. It says that it will be reduced to less than JPY 200 billion, although I'm not sure how much less. Now, there was talk of a lump sum or a gain on the sale. Will the JPY 100 billion be repaid in the normal cash flow? In addition, the redemption of subordinated debt is expected in FY 2027. Is this JPY 200 billion figure after redemption of subordinated debt?
Thank you for your question. I will explain first, and Mr. Sakai would like to add a few more details. First, you are correct that there is a JPY 100 billion difference between the JPY 200 billion and the current JPY 300 billion. Our goal is to reduce the JPY 100 billion over the next three years. However, this by no means means that we will do that only with non-temporary income.
Every cash in will be utilized for it. One thing that can be explained: the current situation is the gain from the sale of the China and Asia businesses that will be recorded this fiscal year. Many of those items would also be used to repay loans. Mr. Sakai, do you have anything to add?
Regarding funding sources, as Mr. Kimura just explained, the income from the sale of businesses that have been sold or those that have not yet technically been sold but will be sold in the future will also be used as a source of funds. As I mentioned earlier in relation to the R&D theme, we believe that the cash returned by the partnership could also be a source of funds. JPY 200 billion or less means total interest-bearing debt of JPY 200 billion or less. It is not intended here what to return, including subordinated debt.
We want to reduce interest-bearing debt to less than JPY 200 billion. We additionally assume that at that level, the debt-to-equity ratio will also be below one.
I understand. Does that mean that that will be one of the benchmarks for resumption of dividend in the foreseeable future?
If we say that it is a benchmark, analysts will write the timing of the resumption of dividends based on it. I would like to refrain from saying that. Naturally, the amount of debt would be one indicator for considering the timing of resumption of dividends. We would also consider other factors such as how stable the business situation is. I hope you understand that this is by no means the only indicator.
I understand. Since Mr. Kimura is an expert, I dare to ask this next question.
After various failures with anti-cancer drugs in the past, you are now in a situation where two drugs are about to move forward. Has anything changed significantly in your company's R&D, especially in drug discovery during this process? After all, I think that the development of anti-cancer drugs is still a process that requires very detailed exploration. Is there some kind of learning effect that is visible and shared within the company? You mentioned earlier that you have changed the structure. Does that mean that research and development are now integrated?
It is very difficult to answer in what way. To put it crudely, in the past, we have run as fast as we could to get a big hit. Now, as written, we are thoroughly considering the results of individual subjects or individual trials in detail and thinking scientifically with experts without wishful interpretation.
In particular, Enzomenib, one of the two cancer products, is fortunately or unfortunately a target with which several companies are competing. It is by no means the wrong target. In looking at the data objectively, there is data from industry people and clinical doctors, and of course, there are websites where multiple agents are compared under clinical physician, and such information can be taken into account. Regarding Nuvisertib, we are working with GSK on one of the current combination studies. The evaluation is being conducted not only by our own eyes but also the eyes of experts from other companies. The changes of individual subjects are also naturally checked. There is no way to explain it other than that we are doing it in such a pragmatic way.
I can tell you that replacing the leadership of cancer development has had a very significant impact on the culture and other aspects of the company. I apologize that all of this information is qualitative.
I understand. I have the impression that it has tightened up because you are doing it on a tight budget. I hope you will be able to achieve results. One last question. Is the Medicare percentage for MYFEMBREE zero?
I have heard that Medicare patients do not use MYFEMBREE very often. Mr. Nakagawa, do you have anything to add?
I think you are right. Medicare is for patients 65 years of age and older, and patients with endometriosis and uterine fibroids, which are the indications for MYFEMBREE, are much younger. So while it is not zero, you can assume that the percentage is close to zero.
Thank you.
Wakao from JP Morgan for the second time. I would like to ask questions. Please tell us about your development products. First, Enzomenib and Nuvisertib are included in the list of drugs with which you have external partnership. By partnership in Nuvisertib, do you mean the partnership with GSK, or do you mean that you will sign a contract with GSK as the development progresses?
First of all, one of the two combination studies we are running with Nuvisertib is with Momelotinib, which we are doing with GSK. We are working with GSK on this. Naturally, GSK will see the data very quickly, but there will be no obligation about future development policies and partnership strategies. Naturally, partnering with GSK is one possibility, but it is not limited to GSK.
I understand. Thank you very much. Another question is about iPS.
I was under the impression that it was proven to be safe after all. On the other hand, it seems difficult to say that it is highly effective because of the small number of cases compared to existing drugs. I would like to ask what kind of iPS positioning you are aiming for. Also, what is the current status of this in Japan? I believe that you will now apply for approval with conditions and time limits. Have there been no prior consultation with the MHLW and PMDA? Let me confirm this point.
I will answer your second question first. Strictly saying, a SAKIGAKE Comprehensive Evaluation Consultation is currently underway. You can find out what a SAKIGAKE Comprehensive Evaluation Consultation is, but this is a sort of pre-screening process. After that is done, the application is submitted, and if all goes well, it will be approved.
The SAKIGAKE designation system has a time clock for six months. If you can get your application approved sooner than usual. On the other hand, we will communicate with them in advance through a SAKIGAKE Comprehensive Evaluation Consultation. Although this is not a review, a procedural step similar to a review will proceed. Regarding the position of regenerative medicine for Parkinson's disease, all existing drugs or therapies for Parkinson's disease lose their effectiveness as the patient's dopamine nerves degenerate or drop out. All of them are. Ultimately, the patient suffers from a very difficult situation. Cell transplantation is, in principle, the process of transplanting another dopaminergic nerve when it is dying or has died. As the patient's symptoms are alleviated, the medication becomes more effective again. The description in the Nature article is also very technical and difficult to follow.
The patient's symptoms improve significantly when the drug is not present, and at the same time, the patient's symptoms improve again when the drug is added. That does not cure everything, but it varies from patient to patient. This is a new drug. This is a new treatment option offering totally different in nature. Once administered, the effect lasts for years. The trial has been following patients for two years, and the drug has been effective for patients for the entire two years.
Thank you very much. I thought that I understood the concept itself, but I was under the impression that it would not end up replacing it because its effectiveness was not necessarily high. I understood it very well. After all, has the publication in Nature this time advanced the steps towards applying for the SAKIGAKE Comprehensive Evaluation?
I think it was a tailwind in the sense that many people became interested in it after it was published in Nature. Our expectations were very high, including from patients. However, the review itself does not review Nature papers. Nature's data is data we have known for more than a year, and I believe a rigorous review will proceed based on it.
Yes, thank you. I honestly wasn't sure if there are any changes in the consultation since the data itself seems to be the same all the time. Steadily, you are advancing various discussions regardless of Nature, I believe.
Yes, that's right. However, because the approval was conditional and time-limited, the Japanese PMDA was highly criticized by foreign regulatory authorities and professional journals, particularly Nature. Nature was the spearhead of the criticism.
I imagine that it must have been psychologically very significant for the authorities to have that Nature journal look at the results of the other Japanese trial besides ours and say something like, "Although the number of cases is insufficient, it shows one scientific suggestion."
I understand. Thank you very much. That is all.
This concludes the presentation of Sumitomo Pharma's FY 2024 financial results and Reboot 2027, Reboot for a Strong Sumitomo Pharma. Thank you very much for your participation today.