Sumitomo Pharma Co., Ltd. (4506) Earnings Call Transcript & Summary

Thank you for participating in the financial results briefing for FY 2025 of Sumitomo Pharma today. I am Kimura, Representative Director, President and CEO. I will explain the summary of the FY 2025 financial results. As announced at 1:00 p.m., we are showing the business results for FY 2025 on a core basis. As shown here, revenue was JPY 453.3 billion, an increase of JPY 54.5 billion or 13.7% year-over-year. On the other hand, gross profit was JPY 256.9 Billion, An Increase Of JPY 11.2 Billion year-over-year. Regarding SG&A expenses, we are controlling them well through structural reforms, so they were JPY 159.3 billion, down JPY 8.4 billion year-over-year and R&D expenses were also controlled, decreasing by JPY 4.5 billion to JPY 43.9 billion. Although this was almost according to the budget, there was more than 30% of the budget remaining at the time of the Q3 results. So we, on the management side, expected that we would have some unused budget. On the other hand, as we have introduced for some time, we have made the research, development and technology research headquarters R&D into one department and are operating it efficiently. Cooperation in that area went well, and we were able to proceed with R&D by using the budget properly. As a result, the budget spent was slightly more than expected at the time of the Q3 results announcement at the end of January. Also, as you know, last year, there was a gain on the transfer of the China and Asia business of JPY 49 billion. So including that core operating profit was JPY 105.9 billion, an increase of JPY 62.8 billion year-over-year. On the other hand, net profit attributable to owners of the parent came in at JPY 106.9 billion, an increase of JPY 83.2 billion year-over-year. In addition, although I skipped the explanation just now, both operating profit and net profit attributable to owners of the parent were the highest ever for the company. Next slide, please. Regarding the revenue of major products, I will explain for both the U.S. and Japan. Please look at the center. In the U.S. Revenue was JPY 337.9 billion in FY 2025. This is an increase of JPY 86.1 billion or 34.2% year-over-year. Last year, there was the LOE or the end of the exclusivity period for APTIOM. So sales of the main product, APTIOM decreased significantly, but ORGOVYX more than made up for that, increasing by JPY 71.9 billion to JPY 155 billion, and GEMTESA increased by JPY 30.2 billion to JPY 96 billion. Furthermore, in the area of onetime payment income written in small letters, a sales milestone for ORGOVYX was received with USD 100 million for achieving the USD 500 million milestone. And in total, revenue was JPY 337.9 billion, which was a result well above expectations. Next slide, please. On the other hand, the revenue in Japan is shown here it was JPY 92.4 billion, a decrease of JPY 7.5 billion year-over-year. In Japan as well, during this fiscal year, the exclusive sales period for the main product, EquMet ended, leading to a significant decrease in sales. In response to this, sales growth of TWYMEEG, the introduction of XEPLION and XEPLION TRI as well as the sales of LATUDA and LONASEN Tape, which we are focusing on progressed steadily. However, due in part to the JPY 1.4 billion impact of drug price revisions, we did not reach the previous year's level. Next slide, please. This is an explanation of the results for FY 2025. Next, I will explain the business forecast for FY 2026. As you know, our company had very harsh results in the fiscal year ended March 2024. Since then, we have implemented fundamental structural reforms, specifically proceeding with rationalization, selection and concentration of businesses and reviewing R&D investment strategies. Then exactly 1 year ago, as a pharmaceutical company rooted in research and development, we announced a 3-year plan with several management goals to rebuild our value creation cycle. Fortunately, we achieved that plan in 1 year. In response to that, in early March of this year, we announced a new 3-year management policy, Boost 2028, to become a company that can provide value from that new value creation. In this, we aim for sales growth of the main products, ORGOVYX and GEMTESA, the fastest launch of 2 oncology products, the cultivation of next-generation growth engines and since our financial base had significantly deteriorated after the very difficult fiscal year ended March 2024, we conducted a public offering last month to strengthen our financial base. Next slide, please. Following the very challenging results in the fiscal year ended March 2024, our equity ratio temporarily dropped to the 10% range. There were also financial constraints, and we had to have the parent company provide debt guarantees for our loans. And for subordinated bonds, we had to replace them with capital-like funds. These issues and tasks remained. By conducting the aforementioned public offering and achieving the record high profit explained at the beginning, our equity ratio has returned to a very healthy level of around 45% at present. At the same time, we implemented refinancing for loans and have refinanced into loans without debt guarantees. In addition, regarding the subordinated bonds through this capital increase, the capital like funding for the replacement has been recognized, so the previous tasks have disappeared. With this financial reorganization, we believe we have moved from the reconstruction phase to the growth phase. Our future investment policy is shown below. We controlled R&D investment at JPY 44 billion in FY 2025. But as research and development are progressing smoothly, we plan to increase it by JPY 7 billion to JPY 51 billion this year. We have a plan to invest JPY 180 billion over 3 years, including FY 2026. Regarding regenerative medicine, since RACTHERA and S-RACMO are in the form of joint ventures, funds will be in the form of investment and loans, but including capital investment and investment and loans, we plan JPY 12 billion in FY 2026. Another point is that for the past 3 years, we have continued to pay no dividends. We aim to resume dividends as soon as possible. At this point, partly because the capital increase was just recently conducted, the amount and timing of the dividend resumption are undecided. However, we intend to proceed so as to meet the expectations of our shareholders as soon as possible. Next slide, please. Another point in our structural reform is that revenue recognition was previously disclosed by regional segment, such as Japan, the U.S. or China and Asia, according to the respective legal entity in charge. On the other hand, at present, [All IP] for main products is transferred to Japan, and we have shifted to a form where the global business is controlled from within Japan and the business operation itself is conducted globally. Based on this, we have reorganized into a single segment for the Pharmaceutical business. At the same time, we will disclose and explain the business for each market where our sales are generated, such as Japan, the U.S., Asia or Europe. We intend to change from this year to inform every one of the business situation by region. For example, in the case of Japan, there are naturally sales in the Japanese market, but there are also exports from Japan to overseas, specifically to the Asian region or to North America and Europe. Similar things happen in North America as well. We decided to change the format to aggregate such areas into a market called others. Next slide, please. This shows the business forecast for FY 2026 on a core basis. Revenue is expected to be JPY 540 billion, an increase of JPY 86.7 billion compared to FY 2025. Gross profit is expected to be JPY 295 billion, an increase of JPY 38.1 billion, while continuing to firmly control SG&A expenses. We plan to increase R&D expenses by JPY 71 billion to JPY 51 billion. As a result, it will be JPY 91 billion, a decrease of JPY 14.9 billion compared to the previous year, FY 2025. At first glance, this looks like a decrease in profit. But in reality, as I mentioned last year, we recorded JPY 49 billion from the transfer of the China and Asia business. So excluding that, it will be an increase in profit. I will explain a little more on the next slide. Operating profit is forecast at JPY 90 billion and net profit attributable to owners of the parent is forecast at JPY 77 billion. Next slide, please. This diagram explains the core operating profit in more detail. I think you remember that in the fiscal year ended March 2024, there was a deficit of JPY 130 billion at the core operating profit level. On the other hand, as I explained in the results for FY 2025, we recorded a record high of JPY 105.9 billion. I am sorry to repeat this many times, but excluding the JPY 49 billion gain from the transfer of the Asia business and JPY 8.2 billion in profit obtained from the Asia business as well as the contribution of main products whose exclusive sales periods ended in FY 2025 as the product mix changed in both Japan and the U.S., this part is our current strength as of the end of FY 2025. In contrast, profits from existing businesses such as ORGOVYX and GEMTESA will grow. So our strength will improve to this level in the fiscal year ending March 2027. 3 years ago, it was minus JPY 130 billion, and I would like you to understand that our business structure reform is progressing very rapidly. On the other hand, there is JPY 30.7 billion for sales milestones and deferred revenue for ORGOVYX. And with pluses and minuses in R&D expenses and others, it comes to JPY 91 billion. I would like you to understand that we are not simply comparing this and that. Next slide, please. I will explain the revenue of major products in the U.S. and Japan. We forecast that ORGOVYX will exceed JPY 200 billion and reach JPY 209.9 billion. This is an increase of JPY 54.9 billion compared to the previous year. Also, GEMTESA is expected to exceed JPY 100 billion with an increase of JPY 10.3 billion year-over-year. On the other hand, there is a large increase of JPY 28.7 billion in the other section. This is because there is a contract where a sales milestone of USD 325 million will be received if ORGOVYX sales reach USD 1 billion in a calendar year. In our sales forecast, we expect to hit this in the autumn, probably Q3, so a large figure appears in the other section. With that, we forecast revenue of JPY 406.4 billion, an increase of JPY 84.6 billion year-over-year. Next slide, please. I will explain the status of the main products in more detail. First is ORGOVYX. It is a treatment for prostate cancer. For the FY 2025 results, the initial budget forecast was USD 710 million, but the actual results significantly exceeded that at USD 1,029 million. Also, compared to the previous year, very strong sales were achieved, almost doubling. Even now, the number of new patients in this March reached a record high, and it continues to trend strongly. We forecast sales of USD 1,350 million. Currently, urology is our main battlefield, and it is being adopted by many urologists. On the other hand, for oncology doctors or specialized hospitals, there is a drug with a similar efficacy called Leuprolide, which is an injectable and that is still mainly used. We know that the overall market for that is larger. Our ORGOVYX is an oral drug and its features are that it is very easy to use and has few side effects. We want to proceed with promotion to tell doctors and patients that they do not need injections. However, Medicare, the U.S. insurance system has been revised and the out-of-pocket costs for patients have decreased significantly. But this is not necessarily well known, so we plan to continue promotion for that as well. Next slide, please. Moving on, we have GEMTESA. This is a drug for overactive bladder. The initial forecast was USD 572 million. But the actual result was USD 637 million, exceeding the estimated budget by 11%. Compared to the previous year, it grew by 48%, which was also very strong. We believe this is because the ease of use and excellence of our GEMTESA in the beta 3 market for overactive bladder is becoming well known. On the other hand, as I will explain on the next slide, because there were some temporary factors last year, the increase for this year FY 2025 compared to FY 2026 will be in the single digits. In this context, we want to promote clinical differentiation and also firmly promote the indication for overactive bladder associated with Benign Prostatic Hyperplasia, which is for male patients as an indication that only this drug has. Next slide, please. I mentioned that there were some temporary factors. Last year, as I mentioned several times in financial results announcements, we continued business and sales by deciding to maintain prices firmly even if it meant temporarily reducing insurance coverage. Usually, this would lead to a decrease in usage. However, there were many patients and doctors who strongly wanted to use GEMTESA even without coverage. As a result, we were able to ship large quantities and at very high prices, which combined to achieve high growth from USD 431 million to USD 637 million. This year, insurance coverage has returned, so the volume will increase sufficiently, but there will be negative factors in revenue due to rebates and other issues. If you compare both, it looks like the growth rate has slowed down. But if you look at the overall trend, I think you can see the whole picture. One way to show this is the trend of prescriptions by year, and we expect that prescription shipments will increase by more than 30% from FY 2025 to FY 2026. In the 2030s, we want to grow it to a scale of JPY 150 billion in revenue. Next slide, please. As I mentioned earlier, this shows the revenue and gross profit by segment. Japan has revenue of JPY 87.6 billion and gross profit of JPY 35.5 billion. North America has JPY 406.4 billion and JPY 253.7 billion. Others have JPY 46 billion and JPY 5.8 billion. The total is JPY 540 billion, as explained in the FY 2026 budget. On the other hand, comparing with FY 2025, North America is performing very well. But for the Japan business, although revenue will grow, gross profit will decrease slightly due to the product mix. In addition, the China and Asia business is affected by the transformation of the business structure. Next slide, please. I'll move on to R&D. The entire picture is shown here, and I will explain each topic. Next slide, please. The main R&D topics from January to May of this year are summarized here. First, in the psychiatry and neurology area, AMCHEPRY, an Allogeneic iPS cell-derived dopamine neuro progenitor cell, received approval for manufacture and marketing on March 6. Also, the drug price was decided today by the Central Social Insurance Medical Council and insurance reimbursement has been approved. Regarding the iPS cell-derived retinal sheet 3077, it received Orphan Drug Designation in March. Clinical trials are progressing in the U.S. For Lurasidone, an application for a partial change was made for the addition of pediatric dosage and administration. If this is approved, the drug price will increase and will not decrease in the future, which we are looking forward to. As for new items, the administration for the Phase Ib trial of 0051 for tremor due to Parkinson's disease and DSP-0378 has also started. Next slide, please. In the oncology area, for Enzomenib, a Phase I trial of combination therapy with Venetoclax and Azacitidine for newly diagnosed acute leukemia has started. For Nuvisertib, interim analysis data of combination therapy with momelotinib will be announced at the EHA to be held in June, and the abstract was released on May 12. Another point, which I will explain later, is that very good data is coming out for the universal influenza vaccine. Next slide, please. Regarding AMCHEPRY, which is a topic for drug price listing today, since it is a conditional and time-limited approval, we will now conduct post-marketing clinical trials, commonly known as Phase IV. Preparations for the trial are currently underway. We have promised to transplant a total of 35 patients, follow-up with each patient for 2 years and apply for full approval within 7 years. Since the follow-up period alone is 2 years, it is a very tight schedule, but we want to do our best to reach the application even 1 year earlier. Next slide, please. Another new drug is 0551, which is also for Parkinson's disease. In the case of Parkinson's disease, along with motor dysfunction, there is what is called tremor, where the patient hand shakes when they try to stop their body. We are considering a mechanism to adjust the neural circuits in the brain that cause tremor by acting on multiple ion channels, and we have started a clinical trial of 0551 for such tremor in Parkinson's disease. Next slide, please. The other is the universal influenza vaccine. As you know, the influenza virus changes constantly, so the vaccine from last year might not work this year. Influenza viruses are broadly divided into groups 1 and 2. For example, there are several types within H5. Our study showed that when immunized with a certain H1 antigen and our adjuvant, antibodies against H5 were produced along with antibodies against H1, demonstrating high universality in clinical data. By the way, this H5 is avian influenza. If an avian influenza pandemic were to occur, using our vaccine would mean we could prepare the vaccine before the virus appears. Next slide, please. Main events scheduled for FY 2026 are shown here. As an R&D-oriented pharmaceutical company, we are about to start a new journey. That said, in terms of approvals, there are not that many for a company of our size. So this is a new way we have devised to show what milestones exist in each fiscal year. Especially this year, in addition to AMCHEPRY, for the 2 oncology products, Enzomenib and Nuvisertib, we intend to restart activities to find new partners using the achievement of milestones shown here as a trigger. Then that concludes my explanation.

Dr. Kimura, thank you. We would now like to move on to the Q&A session with analysts and investors. The Q&A session will last until 4:00 p.m. . [Operator Instructions]. First, Mr. Stephen Barker from Jefferies.

I am Stephen Barker from Jefferies. I would like to ask about the outlook for the gross profit margin for this fiscal year. In the fiscal year that ended, 56.7% was achieved, but I believe the outlook for this fiscal year is 54.6%, a 2.1 percentage point deterioration. However, looking at the product mix, especially with the milestone revenues for ORGOVYX, I think the product mix is rather improving. Why is it expected to deteriorate so much?

Yes. Thank you for the question. I will give a brief explanation and Dr. Nakagawa, who is in charge of North America business, is here, so he will also explain in detail. As you mentioned, our main products, ORGOVYX and GEMTESA are growing steadily. However, as explained, while the main products grow this year or rather last fiscal year, there were products that reached LOE in the middle of the year, specially APTIOM was a product with a very high profit margin. So moving from such items to products with relatively lower profit margins is one factor. In response to the current situation in Iran, although nothing has happened yet, there are signs that costs will increase in the future. We have factored in JPY 4 billion for Japan and the U.S. for JPY 4 billion in total into the cost of sales. I recognize that it looks as if the gross profit margin has decreased more than it actually has. Dr. Nakagawa, do you have anything to add?

Yes, i will add a little. In addition to what Dr. Kimura said, we are factoring in the sales increase of ORGOVYX significantly. However, as we have explained before, this is in a co-promotion with Pfizer and regarding profits and costs, they are split 50-50. The cost of sales for ORGOVYX is not necessarily low. So since the cost of sales is high, it is one factor that relatively moves the gross profit margin in a lower direction.

Thank you. The second question, in addition to the attractive JPY 55 million drug price for the Parkinson treatment AMCHEPRY, how much is it expected to contribute to revenue this fiscal year?

Yes. Thank you for the question. Can you show Page 31 of the supplementary materials? Today, a price of JPY 55 million, including consumption tax, so over JPY 50 million was assigned, and it was decided around noon today that the drug price listing will be on May 20. The future procedures are shown here. The drug price has finally been listed. From now on, we will conduct Phase IV using this. At each hospital, there will be an IRB hospital ethics application and product contracts as well as deliberations for the adoption of the product at each hospital and university. We think it will be this autumn when it actually becomes available for sale and late autumn at that. We think that for this calendar year, doing one transplant case would be the most we can do. This will be conducted strictly as Phase IV, so it will not be at all hospitals. We want to conduct it where the system of doctors and hospitals is firmly in place. We are currently making preparations with 7 facilities in mind.

Next, Mr. Yamaguchi from Citigroup Global Markets.

I am Yamaguchi from Citigroup Global Markets. I would like to ask a follow-up to the question from Mr. Stephen. Regarding the JPY 4 billion for costs, including the situation in Iran for Japan and the U.S., I thought I heard you say it was for Japan and the U.S. Is this JPY 4 billion in total for Japan and the U.S. or JPY 4 billion each? I could not hear that part well. I'm sorry, but please confirm.

I'm sorry for the ambiguous way of speaking. We have JPY 2 billion each for Japan and the U.S. for a total of JPY 4 billion in the budget. There is not much basis for this figure itself, but I hope you understand that it is a figure we included thinking it would be sufficient to handle the situation.

Thank you. This is a repeat, but you said it was an estimate. Do you mean that you will look at that much for this period if various things come up, such as rising oil prices or logistics costs?

Yes, exactly as you said.

I understand. The second point is about Enzomenib. I think it was written that the interim analysis for Phase II would be in Q3. Regarding negotiations with partners, you said you started once and then stopped. What is the current status? For example, are you moving with the aim of completing it within the fiscal year? Or will you take a little more time to decide on a partner? Could you tell us the current status of these activities?

We believe that by showing the data from this interim analysis, the value of Enzomenib will be understood. So we intend to resume introductory activities once there is a prospect for this data. In that sense, please understand that apart from general information exchange, activities to partner for Enzomenib are currently suspended.

Thank you. Is the other one still stopped? Nuvisertib?

Nuvisertib, yes. The clinical trial itself for this is progressing smoothly. However, we are waiting for the end number to accumulate for the combination trial with momelotinib so that everyone can understand the efficacy and safety. We expect such data to come out at almost the same timing, so activities will start moving again from around Q3 as shown here. Regarding the timing of the contract conclusion, we are not thinking rigidly of it being within FY 2026, and we have factored in the possibility that it might slide into the beginning of FY 2027.

Next, Mr. Wakao from JPMorgan Securities.

Yes. I am Wakao from JPMorgan. First, regarding the question about the partnership for Yamaguchi just now. Can I understand that your explanation, Dr. Kimura, has not changed particularly from the previous timing? Previously, there was talk that it would be at the end of this fiscal year from January to March of next year or in some cases, it might slide to April to June. Is the thinking unchanged?

That is right. It is as planned. This time, we have made a table of future R&D events on Page 24, and I explained based on this, but the plan itself has not changed.

Second, I apologize as it is something I always ask, but please tell us your evaluation of the 1 3-month figures for ORGOVYX that just ended and the assumptions for this fiscal year's plan. for this 1 3-month that ended, as you said, it landed roughly as planned, I think. But basically, I want to know whether these figures had, for example, inventory buildup in 10 to 12 of 2025 and a reaction from that. And also, please tell us about your assumptions for this fiscal year. Prescription trends continue to progress steadily, I believe. And regarding gross to net 2, you told us there is no major change this fiscal year, so volume increase should connect directly to revenue. So I think it could come out a bit higher. So I would appreciate your explanation.

Thank you. On whether it might go a bit higher, we too hope it goes higher. But as we have been saying for these 2 years or so, regarding budgets or performance forecasts, rather than putting out numbers we wish for, we have a policy of putting out numbers that we can take responsibility for properly, which might be influencing the difference in recognition with Mr. Wakao perhaps, but we are absolutely not lowering them intentionally. In terms of assumptions, last fiscal year and the year before last, due to IRA impact, patient burden changed significantly. So there was a qualitative difference, but FY 2025 and FY 2026 have continuity. So I think it will become numbers very much in line with our forecast. On the other hand, since it doubled from FY 2024 to FY 2025 and the insurance situation is quite different. If you read that aggressively, it becomes a bit tough for us, too, in the current situation. Dr. Nakagawa, anything to add?

Yes, what Dr. Kimura just said covers it almost entirely, but we too strongly want to leverage the steady momentum so far and stretch further, but forecasts remain realistic, and we intend to tackle exceeding them by as much as possible.

Yes. I do not think double but felt it a bit low. The second point is GEMTESA. As you explained, the volume will grow, but the price will decrease. So the revenue for this period is USD 686 million. On the other hand, you are aiming for about USD 1 billion. To reach that, you would need to grow revenue to some extent. For example, since the price has decreased, will you not take aggressive strategies such as raising the price or increasing the volume a little more? With this plan for this period, if you simply increase it by USD 50 million each year, you will eventually reach USD 1 billion. However, as it is one of the main products, I thought you should work on it more aggressively. So I would like to know about the plan for this period.

Yes. Thank you. This is a matter of strategic thinking. As I have explained repeatedly, we are currently managing SG&A expenses very strictly. In the case of GEMTESA, we have learned from experience that it is promotion sensitive. In other words, we know that sales will grow if we put effort into promotion. On the other hand, the financial base has been significantly strengthened by this capital increase. So although we have not decided yet, as Mr. Wakao just mentioned, we want to consider strategically strengthening promotion to increase sales as one option in our future medium-term plan. We intend to take measures after doing a more detailed market forecast.

I am sorry. Let me add a little from Nakagawa regarding the question just now. Regarding the first point, the price, you mentioned that we could raise it a little more. As you know, with the IRA, the discount rate will increase every year from now on. Also, considering that generic Mirabegron will likely become full scale from now on, I think it will be difficult to bring the price up. As Dr. Kimura said, we want to rack our brains to think about how to increase volume. That is all from me.

Thank you. Regarding the generic of Mirabegron, Astellas has settled with generic manufacturers, so I think the number will increase. Am I correct in understanding that the assumption of volume increase is after factoring that in? The scale of JPY 150 billion in the 2030s that we presented in Boost 2028 is a figure that includes all of what you just pointed out.

Yes. Thank you. Finally, please tell us about shareholder returns on the eighth slide. I think the expectation of the stock market is a resumption of dividends after this capital increase. In that context, cash flow and equity ratio are written as judgment factors here. Could you be more specific about what conditions would lead to a dividend resumption? Could you tell us, including the timing? That is all from me.

Yes, I am Kimura. Regarding this, we are considering it by thinking about these things comprehensively. We believe it is already time to specifically consider resuming dividends. However, if the current assumptions were to collapse significantly, we cannot just resume once and then stop again. So we want to take a little more time to think. Please understand our intention from the fact that we wrote undecided where we had always said no dividend. I understand. So I can understand that the possibility during this period is also constantly being considered, right? That is right. We also want to consider resuming dividends at an appropriate timing since it is just after the capital increase, it is undecided.

Next, Mr. Wada from SMBC Nikko Securities.

I am Wada from SMBC Nikko Securities. I would like to ask about the impact of the segment change on Page 9. My understanding is that cost control has been conducted by region so far. I want to ask if the thinking behind cost control will change.

Sakai is here, so he will explain.

I am Sakai. Thank you for your question. The thinking behind cost control remains the same as before. Changing the segment does not mean we will change anything significantly. However, the cooperation between Japan and the U.S. has become very close. So in that sense, we are presenting this segment in a form where we control costs as a whole. I understand well.

Next is about Enzomenib and Nuvisertib. Regarding Enzomenib, looking at Page 24, I think we can see a certain trigger with the top line results of this Phase II interim analysis. For Nuvisertib, will there be any data disclosed to us at the timing of around Q3?

Yes. There is a large academic conference in Q3, so we will present it there. Regarding the partnering I mentioned earlier, we intend to talk with the latest information, including information that can be disclosed under a CDA in more detail.

Thank you. Finally, at the top of this diagram, initial POC is written for 0378, so I think patient data will come out, although it might be a very small number of cases. Similarly, 40551 on Page 22. The result determination timing for Phase I is written Q2. Is this data from patients? Or will it be safety or PK data for healthy individuals?

Ms. Sato will explain this. Ms. Sato, please explain.

I am Sato. As you asked, Q2 of FY 2027 is written in the middle. We have just started single and multiple dose administration to healthy adults, and this is the timing for those results. In addition to pharmacokinetics and safety, I think we will also obtain data to confirm brain penetration. well. Mr. Wada thank you very much.

Now with 9 minutes remaining, we have 2 people waiting, so I would like to provide quick answers. Next, Lee from Morgan Stanley MUFG Securities.

Yes. This is Lee from Morgan Stanley. This is a bit of an extension of Mr. Wakao's question on shareholder returns. Regarding the resumption of dividends, it changed from no dividend to undecided. Reading Page 8, there are equity ratio and cash flow. And in my mind, I think the outlook for cash flow is important for your company. The trigger would be that after the partnership for 2 new drugs, the outlook for cash flow and R&D spending will become much easier to formulate. Does this thinking seem wrong? Do you think it will not take that much time? Please let me follow up on this one point.

It is difficult, but we have not factored in any fees for partnerships into this year budget at all. I hope you understand that it means whether cash flow will come out as we expect in areas other than that.

I understand. Thank you. Please tell us one point about the new drugs. For SMP-3124, a checkpoint kinase 1 inhibitor, Phase I/II data for ovarian cancer or solid tumors will be released at ASCO in late May or early June. Regarding this development strategy, are you thinking of it on the premise of a partnership? Or will you do it yourself to the end? Please tell us about the development strategy here.

Yes. We have not decided on a development strategy yet. But if 3124 comes along smoothly while Enzomenib is running, we think our own resources might be a bit insufficient to maximize it. We will decide separately based on the situation at that time.

I understand. You plan to decide the Phase II dose by Q4. So can I understand that it is progressing smoothly at this point?

Yes. In terms of data coming out now and the enrollment situation, you can understand that it is progressing very smoothly.

I understand. Finally, regarding ORGOVYX, the composition of matter patent is scheduled to expire in January 2029. And in some parts of the market, there are some concerns about generic entry amid the current high growth of ORGOVYX. There is a view that generics could enter as early as FY 2029. On the other hand, your company is in ANDA litigation with other companies and recently in Boost 2028 in March, you set a goal of JPY 250 billion for ORGOVYX sales in the 2030s. Therefore, it seems to me that your company does not see generic entry in 2029 or 2030 as a concern. Could you tell us about your thinking on this again?

Yes. Thank you. Just as you mentioned, in the U.S., after 5 years and the litigation occurs for everything, and we fight in litigation with generics over how much exclusivity we can secure. Both ORGOVYX and GEMTESA have entered that phase. As you said, the composition of matter patent is January 2029, but besides that, our group of patents is listed in the FDA orange book. The results of analysis involving experts show that our patents are very strong, and we do not expect at all to reach LOE after January 2029.

Now sorry to have kept you waiting. Mr. Hashiguchi from Daiwa Securities.

I am Hashiguchi. I have 2 questions. First, you mentioned that you would strengthen promotion to oncologists, whereas it had been focused on urologists. Could you tell us the difficulty in achieving penetration among oncologists that was not there with urologists? I think one point is that they have no resistance to injectables, but is there any difference in terms of economic benefits for medical institutions?

Yes, I will explain briefly and then ask Dr. Nakagawa to add more. Exactly as you said, competing drugs are injectables. So there is a difference in what you call medical fees in Japan compared to oral drugs where you just issue a prescription. Oncology doctors consider a series of operations or treatments such as shrinking the cancer with ADT hormone ablation therapy using ORGOVYX and then surgically removing it. In that context, injectables are not so much of a problem.

On the other hand, for patients, they prefer oral drugs that have fewer side effects and work well. Our policy is to appeal to the latter. If there is a more detailed supplement, please provide it.

Yes. First, as a major trend, many patients seen by urologists are those with relatively early-stage prostate cancer. On the other hand, the segment you call oncologists sees patients at a relatively more advanced stage. Therefore, ADT is used basically, but for patients with more advanced disease, they also use various additional anticancer drugs. For oncologists, the choice of such other drugs is rather their interest, the center of their focus. Naturally, there was talk of economic incentives, but even with those drugs, they have such rewards. Relatively, the positioning of ADT, ORGOVYX and Leuprorelin is low, which is a bit of a weak point in our explanation. Dr. Kimura also mentioned that we believe ORGOVYX has superiority over Leuprorelin, which is used as a base. So we are working hard to develop that area now.

Thank you. The second question is the thinking on the number of target patients for AMCHEPRY in the future. On the slide on Page 21, you show an image of the blue circle becoming larger. In today's Central Social Insurance Medical Council materials, the expected number of patients for administration in the 10 year is written as 133. My understanding is that this peak forecast at the time of drug price calculation is predicted from the current approval content and does not consider future indications expansion or changes in approval content. However, in this case, does this 133 people assume the expansion to the far right of Page 21? Or is it an intermediate stage? Could you tell us about this relationship?

Yes, I will explain. The blue area shown in the material on Page 21 assumes the period from the application for conditional and time-limited approval to the approval. We are also thinking that the number of patients we will administer during the conditional and time-limited approval will be around 100. Then after approval is obtained, it will be 10 years later. So 3 years later, the current drug price is calculated on the premise of 133 people, as you mentioned. However, if safety or efficacy can be firmly demonstrated during this period, the target patients will expand and it will become a treatment method used by more patients. We aim for that. However, based on current data, please understand that it will be around this level.

That's all from me. Mr. Hashiguchi, thank you very much. As those are all the questions, we will end the Q&A session with analysts and investors. Thank you very much. Now the following Q&A -- now the following will be a Q&A session for the analysts and investors may leave. Thank you for your patience. We would like to move on to the Q&A session for the press. The Q&A session will end at around 4:30 p.m. [Operator Instructions] Let's start with the person in front who is the fastest.

I'm [indiscernible] from Toyo Keizai. I have 2 questions to confirm regarding the figures. On Page 11 of the materials, there is the increase or decrease in core operating profit. It says that the sales milestone for ORGOVYX for this period will be about JPY 51 billion when converted to JPY. Combined with that, the figure for the increase or decrease in deferred revenue is [indiscernible]. What does this refer to? It might have already come out, but please explain again.

Regarding deferred revenue, for example, if you look at Page 12, it says deferred revenue at the bottom. When we contracted with Pfizer, we received about JPY 50 billion as a onetime payment. In terms of accounting, we have the cash, but it is to be recorded little by little over the contract period. So we were recording about JPY 8.8 billion annually. The period for deferred recording ends this December. So JPY 8.8 billion last year will decrease to JPY 6.5 billion this year. And it will become 0 from next year onwards. Please understand that this decreased amount is included as the increase or decrease in deferred revenue. Also, since we received a USD 100 million milestone in FY 2025 compared with FY 2025, the current figure of [indiscernible] is after subtracting that amount. Also, it might be a bit early, but for this period, in comparison with the previous period, there is the disappearance of the gain on the transfer of the Asia business and this milestone part. When considering the results for FY 2027, if there is any thinking that serves as a premise for your forecast, please introduce or guide us within the range of what is known. Yes. What can be said now is that, first, the basis will be the further growth of ORGOVYX, GEMTESA and existing products. If we have a partnership in oncology, which was discussed in several questions earlier, if that enters in 2027, there is a possibility that a figure like some kind of upfront will come in. Also, for ORGOVYX, I cannot mention the amount or timing, but such sales milestones are still set. We are thinking of increasing sales so that those will also come in some year. Those are the major points.

Ms. Inami. Then the person next to you who is fast, please.

I am [ Yoshimizu ] from Iyaku Keizai. I have 2 questions. First, since you have some financial leeway now, I think you might be considering introductions. Please tell us about your thinking on that.

Yes. It is, as you said, that compared to before, things have become much more solid or rather the situation has become normal. Currently, products in oncology and regenerative medicine are close to being launched or are facing a temporary launch under conditional and time-limited approval. We want to concentrate on finishing those firmly. Eventually, like any pharmaceutical company, we will consider reinforcing our pipeline through introductions or partnerships. But for now, we want to concentrate on finishing our own products firmly.

I understand if you were to reinforce the pipeline, would it be in the same field or would it be something completely unrelated? What would be your thinking for introductions?

At present, we are not thinking specifically at all, but the most logical partner for introduction would be one where there is some kind of synergy such as being able to utilize our development capabilities or sales capabilities and system. Again, we are not thinking specifically now, and I just stated our basic thinking.

I understand. Second, you mentioned JPY 2 billion and JPY 2 billion for Iran-related costs earlier. For example, Kirin this morning mentioned that packaging would become more expensive and talked about various things. What areas do you expect will increase the most?

We have received requests from various suppliers to raise prices, including for fuel costs, but we do not think it will be anything major, so we included it just in case. We do not expect it to exceed that at all now.

Then the man in the jacket in the first row, please go ahead.

I am [ Hagiwara ] from MBS. Questions have come out several times earlier, but regarding AMCHEPRY, I believe it was approved at the meeting of the advisory body of the Ministry of Health, Labor and Welfare today. Could you give us your frank reaction to AMCHEPRY being the first product using iPS cells to be covered by insurance in the world? Also, how do you expect it to be used by patients and society in the future?

Thank you. Regarding AMCHEPRY, in the sense that it has now become possible to sell it in earnest with the drug price and insurance listing, as you know, iPS cell technology is a unique Japanese technology discovered by Professor Yamanaka of Kyoto University. With government subsidies and in reaching this point, we have consulted with university professors, various companies and government officials. I feel that we have finally reached this point. However, as was discussed at the Central Social Insurance Medical Council today, there has not yet been an example of moving from conditional and time-limited approval to full approval. So we believe it is our responsibility to firmly conduct this Phase IV and move to full approval while at the same time, demonstrating efficacy and safety more firmly. We are happy, but to be honest, we are also tightening our resolve.

Then the person with glasses in the first row of the back row.

I am [ Goto ] from The Asahi Shimbun. It is about AMCHEPRY. In your past press conferences, Dr. Kimura, you have also said that you hope for a high drug price given that it is a breakthrough treatment. Considering recent U.S. drug price policies, what did you frankly think about this drug price? Also, since you use existing iPS cells that have been stockpiled and the clinical trials were physician-led, I have an image that the burden on the company for development costs is quite small. Despite that, it is quite expensive. Could you tell us again the reason why it is expensive?

Yes. Regarding the drug price itself, we are actually incurring very high costs. Along with recovering past investments, running costs are very high. In that context, we have been asking for a higher drug price. However, due to various circumstances, the drug price announced today has been set. In that sense, it is a bit regrettable for us. But as a manufacturer, once the target value is decided, it is our strength and responsibility to finish it in a form that generates profit. With this target value decided, we intend to finish it into a business that can generate profit firmly. On the other hand, there were various discussions, including whether to set a drug price during a conditional and time-limited approval. We are relieved that a drug price was clearly presented and that it will be listed for insurance. Regarding the U.S. and other countries in the future, I think the Japanese drug price will become a kind of standard or a sense of the market. We want to make efforts so that we can sufficiently get by with that. I am very grateful that a drug price was set today, I am sorry, I forgot one thing. Although it was a physician-led clinical trial conducted at Kyoto University. For the clinical trial conducted at Kyoto University, we provided what is now AMCHEPRY at our own cost. I cannot say in detail, but we pay for the Kyoto University clinical trial costs as consideration for using the data. Please understand that development costs were by no means 0 because public funds were used and at the corporate level, development costs were firmly incurred.

When you say it is a bit regrettable, do you mean that if you were to be greedy, you wanted an even higher drug price?

It is not about being greedy, but based on the current cost structure, it is clearly a deficit. We tried to explain that and get understanding, but the Ministry of Health, Labor and Welfare was strict and it became the current price.

Then the person right at the back.

I am Sakata from Yakuji Nippo. I would also like to ask about AMCHEPRY. Regarding the post-marketing clinical trial Phase IV, there has indeed been no case that reached full approval. Regarding the implementation plan for this trial, the facilities, the number of cases, evaluation items and so on, you have made a plan. Is this a plan that you have discussed with the PMDA and reached an agreement that if you produce results with this, efficacy can be firmly confirmed rather than just estimated?

Yes. We believe that if we implement the current plan, we can firmly explain the efficacy and safety. The Ministry of Health, Labor and Welfare and PMDA have said that if such data comes out, they will grant full approval. However, in an environment where the number of facilities and patients increase, whether we can actually produce such data is something we are confident about. But if there is any laxity, a clinical trial will not go well. So we want to proceed firmly. Ms. Sato, do you have anything to add?

Thank you. As Dr. Kimura said, in the screening process, we spent a lot of time consulting with the PMDA about what kind of efficacy would be needed to confirm it, and we formulated the plan. We will work hard to obtain the planned trial results.

Then the person in front, please go ahead.

I am [ Kozaki ] from Kokusai Iyakuhin Joho. Some results for the universal influenza vaccine have been reported. I would like President Kimura to explain the feeling and future development or the schedule.

Thank you. First, the results are, as I explained, and the data I showed earlier demonstrated the possibility of a vaccine that works against a very wide range of influenza viruses, even mutant viruses that do not exist in the world yet. As the next step, as shown on Page 24, we can conduct human infection studies. This is a study where healthy people are injected with the influenza virus and are infected with influenza. This is difficult to do in Japan, but in Europe, such studies can be conducted under a firm protocol. We want to conduct that and prove that it can actually prevent infection or reduce severity as currently, we only have data that the antibody titer increased. We want to enter that trial as soon as possible. At the same time, since it is a vaccine, and as you know, vaccines are different from regular medicines, and there are only a limited number of companies that are good at vaccines. We would like to make it widely available through partnership or out-licensing. We have received interest, inquiries and requests for lectures from specialized institutions overseas or rather in the U.S.

In terms of the schedule, is it still as soon as possible?

Yes. As written on Page 24, during this fiscal year, we will start the trial I mentioned, which will likely be in Europe. The results will come out relatively quickly. With those results or if it is a specialist, they can understand the significance just by looking at the data, so we will talk to those who can understand. We think the results of this human infection studies will be the biggest trigger data.

Then the person at the front, please go ahead.

I am Takeuchi from Nikkei. I have 2 questions. First, regarding the judgment on resuming dividends this fiscal year, you said it was undecided and that you would especially emphasize cash flow. In that context, while there are ORGOVYX milestones and growth of 2 U.S. products this period, I think there are also increases in R&D expenses and repayment of loans. In forecasting cash flow for this period, what are the major factors that could cause upside or downside risks? I do not think there are many major factors.

Regarding loans, we have reached a level where we will be practically debt-free within this fiscal year. Naturally, if revenue drops more than expected due to something we cannot predict now, it will affect cash flow. But currently, the cash flow is very good, and I think operating cash flow will likely exceed JPY 100 billion.

Was that cash flow including milestones and such?

Yes. The milestone for achieving USD 1 billion that I explained today is included in that cash flow.

Regarding being debt-free, does that mean after adding and subtracting, including the possession of cash?

It is the operating cash flow for this fiscal year. We have already received nearly JPY 100 billion in cash through the public offering, but that is separate. The question was about whether debt will practically become 0, right? That is a concept where it is netted with deposits.

Thank you. Second, regarding the U.S. MFN policy at present, I think there is no major impact on your company from the U.S. government design. However, could you tell us what kind of risks you are considering for the future?

Yes. We are monitoring and constantly considering this very closely. Dr. Nakagawa is the lead. So he will explain.

Yes. Thank you. Currently, what is coming from the government is about imposing tariffs on pharmaceuticals. I think this is for reasons of U.S. national security. As someone doing business in the U.S., providing pharmaceuticals stably to U.S. patients is naturally our first objective. In that sense, the intention is the same. To achieve this, it is not just a matter of making things in the U.S. We believe we must also stabilize the business by securing stable profits and provide pharmaceuticals to patients stably. In that sense, we are also considering the optimal supply chain. Regarding tariffs, based on the information out now, considering our current supply chain and the import and export situation this year, we think it will be within a manageable range. It is impossible to read at this point what further policy changes there might be. So those are not necessarily fully factored into today's figures.

Now we have 2 people participating at the venue and online. Let's have questions in order starting from the person in front.

I am [ Abe ] from Kyodo News. I would like to ask about the table on Page 21 for AMCHEPRY. Earlier, you mentioned about 100 people until the application for full approval. As shown here, is it the case that until 2029, it will only be patients for the Phase IV trial. And after that, you expect to do about 65. Please tell us if you have a range of years.

Yes, it is exactly as you said. First, for the 35 transplant administrations until 2029, we want to prioritize the Phase IV patients since completing those administrations will be the trigger for approval. Our first goal is to achieve that as soon as possible. Once that is over, it will be possible to administer to a slightly wider range of patients outside of clinical trials since it is already approved. So the circle has become a little larger.

Regarding the number of facilities, is the image that it will be 7 facilities until FY 2029, and then you will increase them sequentially?

That is right. We will definitely proceed with clinical trials at 7 facilities until FY 2029. After that, the capacity within those 7 facilities will naturally increase. And if there are other good facilities besides those, we want to increase them sequentially. But as there is still time until full approval, we want to place more emphasis on proceeding firmly.

Then to the person on the window side of the front row.

I am Ando from Nikkei. I would like to ask about AMCHEPRY. Earlier, you mentioned in your remarks that at the current NHI price, it is clearly a deficit based on the current cost structure. If the hope was close to JPY 100 million, the price becomes almost half. I cannot quite see how you will cover that by reducing development costs. For example, will you delay capital investment for the future? Or is there some clever way?

It is not clever, but we have an intended way, which is to proceed with more mechanization and various other things. We have already started work on those, so we want to finish it in a form where we can firmly make a profit and recover investment with the JPY 55 million we received under the conditional and time-limited approval.

I understand. Do you have plan B prepared for such a possibility? And are you proceeding with that?

Well, yes. As a manufacturer, reducing costs was a basic task we had from the beginning. We are constantly making efforts to reduce costs and at the same time, reduce lot-to-lot variation. So we are thinking of achieving it as an extension of that.

Thank you. Another point is in the same regenerative medicine area, could you tell us the progress of the corporate trial for retinal pigment epithelial tears?

We have transplanted into the first patient and are firmly observing that patient. Since it is originally a very rare disease, and we have set strict entry criteria, we are currently looking for the next suitable patient.

About when would that be the next one?

I don't know when it will be, but we have built a network of several large hospitals in Japan and are ready to do it as soon as a patient is found.

Sorry to have kept you waiting. Please go ahead.

Thank you. I am [ Iwase ] from the Science Department of Yomiuri Shimbun. I have 2 major points. First, I would like to ask about AMCHEPRY. The drug price for AMCHEPRY was decided today at the Central Social Insurance Medical Council. I would like to ask about future quality control and manufacturing improvements and measures as a product. If it is iPS-derived cells, I think the risk of tumor genesis is an issue. How will you take measures against the risk of tumor genesis? I believe there were points in the screening report about looking at tumor genesis using immunodeficient mice, but how are you taking measures for safety as a product in the future?

Yes. The risk of tumor genesis has been talked about ever since iPS cells were first created. However, one reason that was said was because originally in the process of making iPS cells, what are commonly called oncogenes were introduced and it was said that this might lead to new mutations. Currently, they are not made that way. And based on the accumulation of various data, I personally recognize that the risk of canceration remains in people's minds because such words circulated from the beginning. No such situation has emerged from nonclinical safety trials or from clinical trials so far. We understand that this approval was granted because it is safe. However, once such an idea has spread widely, it remains a reality. So we think evidence that such things do not happen will increase as it is used widely in the future, we do not expect it at all, but we will monitor patients firmly so that we can take action if anything happens. Even in the Central Social Insurance Medical Council in the optimization of use promotion guidelines, there was a point about observing patients for a long time with MRI.

Will you conduct patient surveys or inspections to see if there is any canceration in the product itself?

Of course, that includes monitoring the entire health condition. To repeat, the risk of canceration was mentioned by some doctors 10 years ago, but now there are almost no people in this field who think about it. However, it is also true that such ideas remain here and there. In any case, we will monitor the health condition of patients firmly.

One last question. Within the range you can answer, could you tell us which the 7 medical institutions are?

Patient expectations are very high and the 7 facilities are already preparing in various ways. But I would like to refrain from stating which facilities they are. It is at the discretion of each medical institution and some might announce it when it actually starts. That will be the judgment of the other party.

It is the scheduled time, but if time permits, 3 reporters are waiting online, so I would like to call them in order. Mr. Ishii from Iyakutsushinsha. Sorry to have kept you waiting.

I am Ishii from Iyakutsushinsha. I would like to ask in which part you intend to utilize the benefits of strengthening the financial base.

Yes. Thank you. First, if I were to describe our situation until last month as a pharmaceutical company, equity was very low. At the same time, for loans, there were loans remaining that banks would not have lent unless Sumitomo Chemical, the parent company, provided debt guarantees. Also, we had issued JPY 120 billion in subordinated bonds, but for redeeming subordinated bonds, there was a restriction that it must be done with capital-like funds. Capital-like funds meant that even if we earned money through business activities, we could not pay them back. But by the public offering and the refinancing, those 2 were completely resolved. Also, nearly JPY 100 billion in cash has come in. So in that sense, we were able to significantly strengthen our financial base, and I hope you understand that the situation is completely different from a month ago.

I understand. What is the current amount of interest-bearing debt?

In terms of the amount of loan debt now, I think the net would be about JPY 80 billion on hand after the capital increase. Mr. Sakai is looking into it right now, is it JPY 80 billion?

The balance of loans at the end of the period is JPY 217.2 billion, but there is a fair amount of cash and deposits. So practically, it is about JPY 170 billion in net interest-bearing debt. Since we raised JPY 98 billion, I think you can consider the current net loan balance as that portion subtracted.

Can I understand that this will practically become 0 debt within this fiscal year?

Yes. It does not mean that the loans will practically disappear, but I hope you understand that net cash will practically become positive.

Now I will call the remaining 2 people. Ms. Sabokura from the Chemical Daily.

I am Tsubokura from The Chemical Daily. I have 2 questions. First, you have factored in JPY 12 billion for capital investment and investment and loans this period. What kind of investment is needed for the production quality control system and such described in the materials? Also, you mentioned that you have started working on the automation of AMCHEPRY manufacturing. Will investments related to the development of manufacturing methods for multiple patients per lot scheduled for the next 3 years or so also be included in this JPY 12 billion.

Yes. As you know, our regenerative medicine is in the form of a joint venture with Sumitomo Chemical. Production is handled by S-RACMO and R&D by RACTHERA, both joint ventures. They use money for various capital investments and to proceed with R&D. Sumitomo Pharma, SMP invests in or lends money to them. We show this in the form of capital investment and investment and loans. Within this JPY 12 billion for this fiscal year, improvements to the AMCHEPRY production method and reinforcement of production facilities that I mentioned earlier are included. On the other hand, for existing pharmaceutical factories, we also have things like promoting digitization and updating equipment. For this fiscal year, we plan for a little over JPY 6 billion in capital investment for SMP itself.

I understand. So you are thinking about half and half for Sumitomo Pharma and the regenerative cell medicine business?

Roughly speaking, the current plan is half for investment in loans to S-RACMO and RACTHERA and half for capital investment for pharma itself.

I understand. One more point. Could you give us any comments on the progress of the U.S. clinical trial for dopamine neuro progenitor cells or the plan for FY 2026?

In the U.S., which has the most patients and is a market for pharmaceuticals almost 10x that of Japan, we are proceeding with clinical trials aiming for early launch. There is no major milestone this year, so we are proceeding. How about that? So I can understand that patient enrollment and such are progressing smoothly. Personally, I want to accelerate it further. And with that desire to accelerate, I think it is still insufficient.

Now Ms. [ Nakada ] from Yomiuri Shimbun.

I am [ Nakada ] from Yomiuri Shimbun. This might be related to the previous question. I think AMCHEPRY manufacturing will be handled at the regenerative cell medicine manufacturing plant in Suita City, Osaka. Also, shares were issued in April and JPY 10 billion is to be allocated to RACTHERA and S-RACMO by the end of March 2029. Is this with a view to reinforcing the cell production line at the facility? Also, if you have specific plans for what kind of manufacturing system you aim for and by when, please tell us.

Regarding the second question, as shown in the diagram earlier, we received approval this time on the basis of moving to full approval within the 7-year period. During that period, we will enroll patients very strictly. But at the same time, we expect approval in the U.S. at almost the same timing. So we are proceeding with reinforcing the production scale around 2027 to 2028 so that more patients can receive transplants at that time. We are also thinking of further increasing the production scale in the early 2030s. The JPY 10 billion plus we are thinking of now will be allocated to both R&D expenses and equipment investment. Sumitomo Chemical is also now putting even more money than us into the regenerative cell medicine business. So as a group, we will proceed together. Please understand that we are not proceeding with just this amount.

We have exceeded the scheduled time by 10 minutes, but thank you very much to all of you for participating. Since there are no other questions, we will end the Q&A session. With that, we will end the Sumitomo Pharma FY 2025 Financial Results Briefing. Thank you very much for participating. [Statements in English on this transcript were spoken by an interpreter present on the live call.]