Earnings call transcript: Sumitomo Dainippon Pharma Q1 2025 sees strong North American sales

Sumitomo Dainippon Pharma reported robust financial performance in its Q1 2025 earnings call, driven by significant sales growth in North America. The company recorded a Q1 revenue of JPY 108 billion, a year-over-year increase of JPY 17.3 billion. This performance aligns with the company’s impressive 26.28% revenue growth over the last twelve months. The stock saw a 2.1% increase, closing at 1,714 yen, reflecting investor optimism. According to InvestingPro analysis, the stock appears slightly overvalued at current levels, despite showing strong momentum with a 160% return over the past year. Notably, the company has maintained its full-year forecast but anticipates potential revisions at the interim results.

Key Takeaways

• Strong North American sales, particularly for Orgovyx and Gemtesa.
• Decreased SG&A and R&D expenses contributed to improved profitability.
• New strategic partnership with Novo Nordisk for Ozempic in Japan.
• Restructuring efforts in Asia and rejoining the U.S. pharmaceutical industry association.
• Full-year forecast remains unchanged, with potential revisions expected.

Company Performance

Sumitomo Dainippon Pharma showcased a strong performance in the first quarter of 2025, with revenue reaching JPY 108 billion, up by JPY 17.3 billion from the previous year. The company’s growth was primarily driven by its North American operations, where sales of Orgovyx and Gemtesa significantly exceeded expectations. The company also benefited from reduced SG&A and R&D expenses, which fell by JPY 8.4 billion and JPY 4.7 billion, respectively.

Financial Highlights

• Revenue: JPY 108 billion, up JPY 17.3 billion YoY
• Core Operating Profit: JPY 20.4 billion
• Net Profit: JPY 11.2 billion
• Orgovyx sales: $226 million (135% of plan)
• Gemtesa sales: $147 million (107% of plan)

Outlook & Guidance

Sumitomo Dainippon Pharma maintains its full-year forecast but is open to potential revisions at the interim results. The company projects first-half revenue of JPY 207 billion and expects milestone income of approximately JPY 60 billion. The core operating profit is forecasted to reach JPY 70 billion for the first half of the year. Trading at a P/E ratio of 36.63, investors should note that InvestingPro analysis indicates the stock is trading at a high earnings multiple relative to peers. Access the detailed Pro Research Report, available for this and 1,400+ other top stocks, to gain comprehensive insights into the company’s valuation metrics and growth potential.

Executive Commentary

Yutaka Wakemi, a company representative, stated, "Q1 results exceeded the initial plan," highlighting the company’s strong start to the fiscal year. Another representative emphasized, "We are actively working toward partnership for both drugs," indicating ongoing strategic initiatives to expand their product portfolio.

Risks and Challenges

• Regulatory changes in the U.S. could impact future sales.
• Potential market saturation in key therapeutic areas.
• Macroeconomic pressures could affect global sales performance.
• Currency fluctuations may impact financial results.
• Dependence on North American market growth for overall performance.

Q&A

During the earnings call, analysts inquired about the potential $325 million milestone from Pfizer and the peak sales potential of Orgovyx. The company is also exploring partnership opportunities for nivisertib and enzomenev, while closely monitoring potential U.S. tariff and FDA regulatory changes.

Full transcript - Sumitomo Dainippon Pharma Co Ltd (4506) Q1 2026:

Yutaka Wakemi, Global Finance Representative, Sumitomo Pharma: Thank you very much. I’m Yutaka Wakemi from the Global Finance. Based on the presentation materials, I will now report on the first quarter results for FY twenty twenty five and the current status of clinical development. Please see Page three. We are pleased to report our Q1 financial results.

It is shown on the core IFRS basis. Revenue was JPY 108,000,000,000, an increase of JPY 17,300,000,000.0 from the same period last year. The main reasons were sales growth of Orgovyx and Gemtesa in North America. SG and A expenses and R and D expenses decreased by JPY 8,400,000,000.0 and JPY 4,700,000,000.0, respectively, from the same period last year due to the effects of business structure improvement and reorganization of the regenerative and cell medicine business. Core operating profit was JPY 20,400,000,000.0, an improvement in profit and loss over the same period last year due to increased revenue and decreased expenses.

Operating profit was likewise JPY 20,400,000,000.0. Profit before taxes were JPY 11,900,000,000.0, mainly due to a foreign exchange loss of JPY 6,700,000,000.0, resulting from the appreciation of the yen. As a result of the above, net profit attributable to owners of the parent increased to 11,200,000,000.0 yen Although revenues and profits are progressing slightly higher than the annual forecast, the full year forecast announced at the beginning of the fiscal year remains unchanged due to a number of uncertain variables at this point in time. The company has also announced a new forecast for first half of the fiscal year. This will be explained later.

Page four shows revenue for the North America segment. Sales of Orgovix and Gemtesa grew, resulting in a JPY 20,700,000,000.0 increase over the same period last year. The year on year decrease for Aptivum was due to the end of the exclusivity period in May 2025. The segment as a whole is performing well with a 29.2% progress towards the full year forecast, mainly due to the strong performance of Orgovix and a smaller than expected decline in Apteum. Starting on Page five, we will present the marketing status of our three key products.

In Q1, Orgovyx achieved $226,000,000 compared to a plan of $167,000,000 a very strong achievement rate of 135%. Prices were largely in line with expectations, mainly due to an increase in sales volume. The increase in volume is due to a cap on patient co payments under Medicare Part D in January 2024 and the further reduction in that cap from $3,250 to $2,000 beginning in January 2025. The graph on the lower left shows that in addition to the strong growth in 2024, there has been further growth in Q1 of FY 2025. As noted in the topics on the right, the number of new patients has also increased significantly.

The main factors are the increase in the number of Medicare patients due to the reduction in co payments mentioned earlier and the widespread use of Orgovix especially in urology departments that prescribe in hospital due to its advantage of being the only oral drug available. Continuing on to Mifembril, actual results were $20,000,000 compared to the Q1 plan of $21,000,000 Both volume and price were almost in line with expectations. The slight underachievement was due to the impact of the previous year’s adjustment on the price side, which is so called true up. We terminated our marketing alliance with Pfizer at the December and began marketing the product independently from January. Despite this change in structure, we have been able to maintain our sales volume and are off to a good start.

Behind this achievement is a strengthened sales structure. A new community care team was established in April in collaboration with Gemtesa’s team for general physicians. By dividing the sales representatives area more finely, we have been able to increase sales efficiency and maintain sales coverage under the independent marketing structure. In conjunction with this reorganization, we reviewed our sales strategy and optimized the use of expenses. These efforts have enabled us to achieve profitability in product earnings in 2025.

Let’s move on to Gemtesa. Actual results were $147,000,000 compared to the Q1 plan of $138,000,000 an achievement rate of 107%. This was due to an increase in volume, which allowed us to gain a larger than expected share of product in the Beta three market. From January 2025, we have changed our policy from a strategy that prioritize coverage to one that emphasize the balance in terms of price and other factors. The graph of volume trends on the left side shows that the volume also decreased due to a temporary decline in coverage in 2024.

Volumes are currently recovering as the clinical value of the product such as no warnings on elevated pressure, fewer drug interactions, etcetera, etcetera have become more prevalent in the market. Following the approval of additional indication for overactive bladder with benign prostatic hyperplasia at the end of last December, we are expanding our DTC measures for male patients. Through this initiative, we hope to further expand the volume in the future. Page eight shows revenue in the Japan segment. The sales in the Japan segment were 23,200,000,000.0 yen, down 3,800,000,000.0 yen from the same period last year.

Although the sales of Twi MIG increased, overall segment sales declined mainly due to the end of the exclusivity period for Equa. Progress against the full year forecast was 27% with the segment as a whole progressing largely in line with the expectations. Page nine shows financial results by segment. In the Japan segment, core segment profit was largely unchanged at JPY 3,800,000,000.0 due to a decrease in SG and A expenses resulting from the effect of business restructuring improvements implemented last November, including early retirement despite the decrease in gross profit due to lower revenue. In the North America segment, core segment income increased significantly by JPY 15,300,000,000.0 to JPY 17,500,000,000.0 due to an increase in gross profit from increasing Orgovyx and Gemtesa and the decrease in SG and A expenses from the effects of business structure improvement.

In the Asia segment, core segment profit increased JPY 1,500,000,000.0 to JPY 7,200,000,000.0 due to an increase in gross profit from higher sales. Please see Page 10. As for marketing and sales in Japan, we concluded the co promotion agreement with Novo Nordisk Pharma for Ozempic, a drug for Type two diabetes treatment in Japan, as announced in a press release in May 2025. This July, we began joint activities to provide information to medical institutions. In our marketing activities in Japan, we are focusing on the diabetes area and by combining our existing products such as Trimig and Metogluco for which we are currently conducting information provision activities, we will be able to offer a wide range of therapeutic proposals.

We also expect that this partnership will contribute to our midterm profits. Next, I would like to introduce our efforts to strengthen our corporate governance structure. With the approval of the annual shareholders meeting held in June, the company has transitioned to a company with an audit and supervisory committee. As a result, audit and supervisory committee members will become members of the board of directors, strengthening the supervisory function of the board. In addition, outside directors who are audit and supervisory committee members will be newly added to the nomination and compensation committee and the supervisory committee for the conflict of interest transactions between group companies.

We expect this to strengthen governance from the perspective of executive nomination and compensation as well as the protection of minority shareholders. Next, I would like to introduce the capital restructuring and asset assignment within our group. In March 2025, the company acquired the shareholders of the U. S. Subsidiary, S and P A and the Swiss subsidiary, S and P S, making them direct subsidiaries.

In addition, as of 08/01/2025, the company plans to take over patent rights and other rights related to Orgovyx, Gemtesa and other products. This will allow us to further strengthen our involvement in The U. S. Business by establishing a structure in which we as a product supplier will be directly committed to the profitability of The U. S.

Business. Next, I would like to explain the announcements of the first half financial forecasts. At the beginning of the fiscal year, we disclosed only our full year forecast, but we have now decided to announce our forecast for the first half of the fiscal year. Sales of Orgobix in Q1 were strong and milestone revenue is expected to be recorded in Q2. In addition, the timing of the split of the Asian business has been set for the July and although the amount is still undetermined, revenue recognition for Q2 has been confirmed.

As a result, significant profit items will be concentrated in the first half, leading to a significant difference in the performance between the first half and the second half. Therefore, we have decided to disclose the first half forecast at this stage. Revenue for the first half is expected to be JPY $2.00 7,000,000,000. In Q2, we expect to record a sales milestone for Orgovyx, but we expect revenues to be at the same level as in Q1 because revenues from Apteum, which has reached the end of its exclusive period and existing business in Asia will be concentrated in Q1. SG and A and R and D expenses are expected to be incurred as forecasted at the beginning of the period.

Other score basis include JPY 45,000,000,000 in transfer gains currently expected from the split of the AGM business. Based on the above, we forecast a high level of core operating profit of 70,000,000,000 and operating profit of JPY 69,000,000,000 for the first half. This includes a temporary factor of milestone income and gain on transfer of Asian business totaling approximately JPY 60,000,000,000. The full year forecast announced in May remains unchanged. As we mentioned, the initial forecast also anticipates significant fluctuations between the first half and the second half due to the concentration of major profit items in the first half, changes in the profit structure of the Asian business and other factors.

In Q1, sales, especially in North America, exceeded the plan by a wide margin. Despite the uncertain external environment, we expect this trend to continue in Q2 and beyond as we strive to improve our performance. At this point, one quarter of this year has passed and the full year forecast remains unchanged. However, we will closely examine the sales situation of our key three products and other factors and we believe we’ll be able to revise the forecast at the time of the interim results. We will now explain the status of our research and development status.

Page 15 is a list of the development stages of our development pipelines. Changes from the previous May closing are shown in red on the slide. We have previously reported the mechanism of action of Endominev as Menin and MLL inhibitor but we have decided to refer it as a Menin and KMT2A inhibitor. In addition, the proposed indication was changed from acute myeloid leukemia to acute leukemia due to the inclusion of acute lymphoblastic leukemia. For KSP1007 China was added to the development region.

Page 16 summarizes the major topics in clinical development. In the area of psychiatry and neurology, we are preparing to file for approval of allogeneic iPS cell derived dopaminergic neural progenitor cells in Japan in FY 2025. Based on data from an investigator initiated study by Kyoto University. In addition, the international non proprietary name for this product has been decided as Ragune ProCell. In The US, the first patient was dosed in June 2025 in an investigator initiated study conducted by the University of California, San Diego School of Medicine.

In the area of oncology, end of phase one meeting with the FDA has been completed for enzomineb. And based on this, the phase two part which is positioned as a confirmatory trial has been initiated. The vosertib received first track designation from the FDA and orphan drug designation from the EMA for myelofibrosis. We also gave an oral presentation of the latest monotherapy data at the European Hematology Association Annual Congress. This will be reported in detail on the slides that follow.

In other areas, we received an approval in June 2025 for rifamulin, which has been filed as a locally manufactured product. The universal influenza vaccine we released a press release today has been confirmed to be generally well tolerated in the interim analysis of post treatment follow-up conducted up to four weeks after the final dose. Immunogenicity is also being evaluated for efficacy. The next slide, slide 17 presents data from the presentation at the European Hematology Association on the nuviscertib myelofibrosis Phase onetwo trial. Efficacy showed improvement in important efficacy measures even in patients who did not respond to JAK inhibitors and in patients with prognosis with low hemoglobin and platelet counts.

In terms of safety, no dose limiting toxicities were observed. The major adverse events were grade one to two gastrointestinal toxicities with few grade three events and no clinically problematic events. This concludes my presentation. I’m Steven Baker from Jefferies. Thank you.

I would like to ask about the current situation of Orgovyx. At this point, you have achieved the progress rate of thirty two percent, but I think the current full year forecast of 103,000,000,000 yen is rather conservative. And I would like to ask you about the terms and the timing regarding the next milestone from Pfizer. The first milestone, which I believe is expected to be $100,000,000 in the first half and the second, the conditions and the timing of the three fifty million dollars payment, which I believe is expected to be paid upon achieving $1,000,000,000 in annual sales. This Q1, dollars $226,000,000 you have already achieved even more.

So there is a possibility that the second milestone will be paid next year even in your company’s next fiscal year. What do you think? Thank you for your questions. On the first point, you pointed out that the annual forecast is conservative in terms of the current situation of Orgovyx. In this regard, we consider the figures announced at the beginning of the fiscal year to be conservative.

Q1 results exceeded the initial plan. Therefore, we have not revised the current annual projections at this time, but we consider them to be conservative. Mister Nakagawa, who is in charge of North America business, if you have any comments on this point, please give us some comments. Yes. I would like to give you a few additional explanations.

As mister Wakemi just explained, we are off to a very good start this year, but we need to further examine the sales situation in the future. We are not only forecasting correctly, but we are also positively considering what measures we can take to further capitalize on this tailwind. And we will review our sales forecast for this fiscal year at the appropriate time, taking into account the extent of such effects. Therefore, for the second milestone, as for conditions, we will receive $325,000,000 when sales exceed $1,000,000,000 for the calendar year annually as predicted. Naturally, whether this will come next year or the year after depends on the forecast.

We are currently in the process of revising this forecast, so we do not have a firm answer right now as to the timing of the revision. Thank you very much. So if the second milestone is $325,000,000, how much would the third be? I am sorry, but the specific terms of the milestone after that are not disclosed. Thank you for your understanding.

I understand. Thank you. I’m Seiji Wakao from JPMorgan. Thank you for your time. Please tell us how the progress of fixed costs, SG and A and R and D expenses in Q1 compared to the full year plan.

It might be better to say compared to the internal plan. In particular, the progress of SG and A expenses seems to be a little low. And if we looked at The U. S. On a dollar basis, it appears that the progress is relatively low compared to the four year plan.

In this regard, I wonder if this is running at a reduced speed by using it efficiently. Please tell us about this point. Thank you for your question. I would like to answer your question regarding the progress of SG and A expenses in Q1. First of all, as for the actual results of SG and A expenses for Q1, the progress rate is lower than originally planned and the actual results are lower.

As a result, expenditure in Q1 were delayed compared to the original plan. Since it is the beginning of the fiscal year, we are still in the process of making progress. As for the future, as I mentioned in the Q2 forecast, we expect to catch up by Q2. The same is true for R and D expenses with the progress rate in the Q1 results slightly below the initial plan. On the other hand, we expect to catch up with our R and D expenses by Q2, although progress in some clinical trials for enrollment was a little slower than originally planned.

Thank you very much. Next question is regarding the cumulative forecast for Q2 on the Slide 13. I think the decrease in temporary revenue are as written, but could you please explain how your three key products and promotion fees are included? Thank you. I understand that your question is about the sales of our three key products and promotion fees.

First, regarding sales of our three key products, as for the actual results for Q2, we have revised our forecast based on the current situation. On the other hand, SG and A and R and D expenses have been factored in at this time, with expenditure being in line with the original plan by the end of Q2. Regarding the domestic case, I understand that you’re taking you’re talking about the Ozempic, which has being arranged most recently. We have also factored this in in the assumption that we will receive a promotion fee for this joint promotion that will begin in July. Does this mean that this is for three months?

Yes. It is after July and onward. And what kind of scale are we talking about? We are very sorry that we are not disclosing this information. Okay.

Is it correct to understand that your three key products are basically made in a way that is pulling Q1 growth? Thank you. We have made a forecast based on the recent situation, and we expect that the recent strong shipments will continue from July onward. I understand. Thank you.

By the way, Orgovyx is doing very well. And given the profile of this drug in the first place and the status of the Medicare Part D redesign, it doesn’t seem likely that the growth will slow down. Is there any chance that you will update this point and peak sales sometime in the future? This is Nakagawa speaking. In terms of your question, I believe that the product profiles and the impact of IRA will not disappear unless the system is changed as you say.

However, as I mentioned earlier, some of the results have been better than we had expected, and we are currently considering how to further optimize our estimates and strategies. In this sense, we would like to refresh our long term forecast in the near future. Therefore, we cannot give a definitive answer at this point as to when the peak will be since we have been examining the situation right now. Thank you. Finally, could you give could you give us an update on the partnership activities for nivisertib and enzomenev?

Thank you for your question. We are actively working toward partnership for both drugs. In order to maximize the values of these drugs, we have started to consider the alliance in April. As for the companies we are hoping to partner with, we are currently actively pursuing partnership with companies that agreed to promote development and joint sales. Thank you.

In terms of changes since the last time, can you give us some more feelings or tones as to whether the target companies have been narrowed down or not? We will report on the details when we are ready to announce them. I understand. Is it okay to understand that it will be ready during this fiscal year? Yes.

We hope to proceed so that we can report back to you by the end of the fiscal year. Okay. Thank you. That’s all. I am Kazakihashiguchi from Daiwa Securities.

Thank you. Regarding the full year forecast, I believe you said that you have not revised it this time due to uncertain variables. Could you tell us what kind of uncertain factors you’re currently considering? Yes, thank you. We believe that there are two major uncertain factors.

The first point is whether the current strong sales growth in Q1 will continue at the same level in the future. Orgovyx, for example, has been selling very well in Q1. We believe that it is necessary to determine how this will grow over the course of the current fiscal year. Regarding the second point, we are considering the possibility of various institutional changes, mainly in North America. One is that we believe there are uncertain factors at this point in time as as to what the situation will be like in light of the discussions on tariff policies and the drug pricing system for pharmaceuticals.

Thank you. Regarding the system, I think there are there was a certain amount of uncertainty when your forecast was announced at the beginning of the term. After three months, do you feel that the changes to the system have had a negative impact on your company’s performance? I think it could be said that the risk has not changed for the worse, but rather that the risk has decreased by taking various measures. What are your thoughts?

Thank you for your question. First of all, we believe that at least the situation is not very much worse than it was at the beginning of the year. At the beginning of the year, as for tariffs, we mentioned that would be 25%. However, currently, we have not been impacted by the application in our specific actual business operations, at least at the June. We do not expect any impact on our business by the system already in place at this time during the current fiscal year.

Of course, since various discussions are taking place on a daily basis, we do not know what kind of changes will occur in the future and what kind of systematic systemic changes there will be. We will continue to monitor the situation appropriately and incorporate changes into our forecast as necessary. I see. Thank you very much. That’s all.

My name is Fumiyoshi Sakai from UBS. I would like to know two things, but since president Kimura is not here today, I’m not sure how you can answer my question. It is about your company’s future profit calculation method. Earlier, you mentioned the milestone amount, and I also heard that the asset sales, probably the sale of the AGM business, will be the last step. If we assume that profits will increase to some extent in the so called liquid funds, will you return the increased profits from the liquid funds as profits?

Or as Mr. Kimura mentioned at the financial briefing, will you maintain r and d at the current level of 50,000,000,000 yen for the next three years or so? If this is the case, then of course, the profit from the liquid funds is recorded as profit as it should be. However, if r and d expenses are inadequate, I think it is possible to think of putting the money into this area or into sales promotion expenses in The US. What are your thoughts on this point and what plans do you have for the future?

Please tell me this point first. Thank you for your question. First of all, I would like to make a few comments on the current situation regarding our approach to profit recognition. You mentioned our various measures taken. Our view is that the various measures we have implemented since last year will have a onetime impact on profits to some extent and that this impact will largely be exhausted by second half of FY 2025.

Specifically, the various changes in the framework for the China Asia project that you mentioned earlier will be resolved by the end of FY 2025. Therefore, we basically believe that our performance will bottom out around second half of the current 2025, followed by a recovery. The first step in this process is how to consider profit. First, regarding how we plan to use the profits, we have estimated in our business plan or rather the profits we have initially planned as mister Sakai mentioned, it will be in accordance with the policy that mister Kimura announced at the beginning of the fiscal year. If the company’s performance improves at this point, how it will be used is a matter that remains to be determined as well as the extent to which it will be able to review its performance.

We will also consider where to use the funds and how to record profits in the future. I see. I apologize for asking a nitpicky question, but does 325,000,000 mean that it will be included in the second half of this fiscal year? Is that correct? Milestone from Pfizer, I’m asking.

Mr. Nakagawa mentioned it. I think this is disclosed information because Mr. Nakagawa mentioned it. Milestone from Pfizer for the second time is what I’m asking.

We apologize if our explanation was unclear. The next milestone, 325,000,000, is not expected in the current period. So it will come again as a onetime again onetime gain regardless of whether it will be in the next fiscal year or the fiscal year after that. Yes, we will work on that in the future so that it can be recorded as soon as possible. We will determine whether it will be next fiscal year or later.

I understand. Thank you. One more question. The forecast for the second half has been left unchanged at this time because of uncertain factors, and it is assumed to be negative or rather to be in the red. Will this be revised in the next quarterly financial results announcements?

Or will you make some kind of performance revision in advance? Could you tell us how you plan to time this? Thank you. First of all, we will revise our financial forecast as necessary. At this time, we have not determined whether this will be at or before the announcement of the financial results.

Okay. Yes. If this continues, second half will be in the red or rather profits will decrease in the second half. Therefore, my question was based on the premise that if the company is going to make revisions and to some extent has stated publicly that it will make revisions, then it will not be very healthy to leave it as it is. I understand as I mentioned earlier in terms of timing, we will study the issue and make an announcement when necessary.

Regarding your point that second half of the fiscal year may be in the rep based on the simple calculation, we will of course continue our efforts to make second half of the fiscal year even or in the black. I understand. Thank you. This is Hidemaru Yamaguchi from Citigroup. Thank you.

I’m a little confused on the figures, so I would like to go over them again. First of all, is my understanding correct that the 700 figure on the core basis you have given us for the Q2 cumulative total is not related to the full year, but is the latest figure for your company, which incorporates all the figures from Q1, including the Ozempic? Yes. Your understanding is correct. This q two cumulative total is our latest figure up to q two at this point.

I see. Also, as for the sales milestone for Orgovyx, the gain on transfer of the agent business was originally included, I suppose, but was the sales milestone for Orgovyx originally included in the full year? This Q2 is included, but was it originally included in the full year? Yes. For the full year, we originally included it in our plan for FY 2025.

In the first half, we were certain that we could recognize it by q two, so we factored it in. I see. So for example, at 700 core, q one was 200 and the remainder is 500, but the remainder will be mostly out by the Asian business and Orgovix. So q two at this stage is also based on the assumption that there will be almost no profit from this business base even in this latest q two forecast then. As you pointed out, the calculation exactly as you mentioned, so you are correct that one time revenue is a very large proportion of the total.

I see. So if there is no onetime profit in q three and q four, there will be almost no profit on the core basis under the current circumstances. When I look at q one, there were various irregularities, But since it was 200, I thought it will be fine. But should I assume that Q2, Q3, and Q4 will be basically nothing? Thank you.

In terms of trends, Q1 saw very strong shipments of Opteon, which I mentioned at the beginning of my presentation. In addition, the Asian business will be restructured at the July, so the figures for Q1 and Q2 and beyond will vary. Such is the case with the Q1 figures. Based on these factors, as you understand, the initial plan was that the second half would be difficult. On the other hand, there are some upside factors such as the growth of Orgovyx in Q1.

Based on these points, we will work to further improve our performance in the second half and we will closely examine the figures to see what they will be. I see. Finally, can you explain quantitatively the difference between this original figure and the actual performance of your company in Q1? In short, how much did you estimate for Q1? Thank you.

It is true that there has been an upward trend from the original plan. Sales are also higher than expected and expenses are slightly behind schedule. So they are lower than planned. Therefore, it is true that sales are higher than expected. I’m afraid I would like to refrain from giving a quantitative explanation.

Okay. Thank you very much for answering these questions. That is all. Shi from the Yakutsu Shin shop. You mentioned earlier that the sales in North America were better than expected.

Could you tell us what factors you thought contributed to this positive performance? Thank you very much. Mr. Nakagawa, who’s in charge of the North American business, will answer your questions. Yes.

Algovix exceeded our expectations, but rather than any major new factors emerging or omissions in our forecast, I think it was more of a case of our quantitative assessment of what we already understood turning out to be higher than expected. As mentioned in the previous discussion, we originally considered the drug profile to be excellent. And although there was a slight price difference compared to Luprin, which was one hurdle, there are advantages to the change in the insurance system. We hope you can understand that the way each of these upward movements was different from what we had expected. I understand.

Thank you. Yoshimizu from Eyaku Keizaisha. I have three questions. First of all, I would like mister Nakagawa to answer my question. The first point is the tariff policy in North America.

Please tell us about the impact of the tariff policy. What impact is your company seeing? And what measures are you taking? Secondly, there are reports of various issues arising from FDA reforms in North America. Could you share your impressions of the situation there from the local point of view?

Thirdly, although this is open to anyone to answer, you are aiming to submit an application for Parkinson’s disease within this fiscal year. Could you please provide an update on the current progress and outlook? That is all. Thank you very much for your question. Mr.

Nakagawa will answer the first and the second points, and Ms. Sato will answer the third question. Yes. The first and the second points overlap somewhat, but as you have heard in various news reports, information about tariffs is released from time to time, but nothing concrete has been decided yet. We are therefore considering possible measures based on the information available.

Since it is not possible to make a major move in the supply chain immediately, we need a lead time, so we are still working to gather information at this point. As for the FDA’s reforms, as you mentioned, many employees have been laid off or left, and we have heard various stories including resources shortages, but there are no particular obstacles to the FDA’s response to our current r and d pipelines or EMR. So I don’t think there will be a major impact at this point. Regarding the first and the second points, we believe that it is necessary for us to gather information quickly and understand the movements of other companies. Therefore, we have rejoined pharma, pharmaceutical company association in The United States, and I myself am attending their meetings to gather information.

I see. So specifically, you are not at the stage of considering investing in the local area like other companies. Well, we have started to consider this as a potential scenario, but we have not yet gone into concrete steps to implement it or anything like that. So are you at the stage of considering this as an option? Yes.

You’re right. I understand. Next, miss Sato will answer the question. I am Yumi Sato. As for the Parkinson’s program, as you can see in the presentation material, we are making good progress in preparation the application with the aim of obtaining approval within this fiscal year.

Are there any issues that have come up in your dealings with the authorities? There are no particular issues at this time. The product has been designated as a fast track, and we are currently working closely with CPMDA to prepare in the form of the fast track assessment consultation. I see. Thank you.

Mister Nakagawa, I’m going to go back a little, but could you tell me when you rejoined pharma? This month. So July. And when did you leave? It was last year.

You left in 2024. Yes. We left last year. Okay. I understand.

That is all. Thank you. Kada from Yakuji Nippon. You mentioned that there will be a temporary gain of 60,000,000 yen in sales profit at the end of Q2. But if there is 20,000,000,000 yen in Q1 and 60,000,000,000 yen will be added, is it correct to say that the operating income for Q2 alone will be negative?

Yes, you are correct. Your understanding is correct about the temporary gain in Q2. Thank you. Also, the international generic name for Parkinson’s disease here has been decided. Is there any reason for the name?

Thank you for your question. I will answer. This is Yumisato. The rag at the beginning of this name, ragu neprocel, comes from raku in Japanese, which means Kyoto in Japanese since this program was a collaboration with the University of Kyoto. And our company has always referred to the Office for Regenerative and Cellular Medicine Organization as ROCMO.

And we have combined Raku and ROCMO and added to the beginning of the name. And the back part is called stem, and the WHO has a standard naming rules depending on the type of the item. And there is a rule that substances derived from neural stem cells are named using the suffix neprocell, and this rule has been applied to create the name ragu neprocell. I understand. Thank you.

Say of the Asahi Shinbun, I would like to know a little more about The U. S. Tariffs. First of all, for the pharmaceuticals that were exported to The U. S.

In Q1, what percentage of tariffs were on those? Or were they zero? Could you please tell us how much it actually was? Thank you for your question. In Q1 of the actual results, there are no tariffs applied.

I understand. In The Japan US negotiations with mutual tariffs of 15% being discussed, I believe that the current understanding is that the pharmaceuticals are not excluded at this point. There were some reports a while ago that the president Trump said he was going to raise the rate to 200%, but how do you see this? How much of a risk is it considered to be? Thank you for your question.

At the present time, the pharmaceutical products are subject to tariff exclusions. As a result, the q one results are zero at this time. Yes. But it’s not going to be zero in the future. I think there were also reports that mister Akazawa said pharmaceuticals are subject to a 15% tax.

So do you have any projections as to how much those tariffs are likely to be? Is your stance such that you are not totally sure yet? Thank you for your question. Mister Nakagawa will comment on your question. Information is probably mixed up.

Therefore, we do not have a firm answer as well. As you mentioned, if it is found out that tariffs are imposed at some point, it will naturally affect us as well. But I think president Trump is still talking about lowering the price of drugs in The US as well. Raising tariffs is basically the opposite of that. As I mentioned earlier, The US pharmaceutical industry is naturally considering various measures to deal with this problem.

I think that there is no immediate risk of very high tariffs being imposed. Although this is only a guess, of course, I think that is all I can answer at this point. Thank you. Also, what percentage of the drugs that your company currently sells in The U. S.

Are imported from outside The U. S? Is that mainly Japan? Can you please tell us a little bit about how you take the medicine and what is in the supply chain as far as you can tell? Yes.

Mister Nakagawa will answer the question. We do not always disclose detailed information about our supply chain, so I will refrain from answering that question. At the very least, it is not limited to Japan, but it’s scattered across various countries. I’m going to ask from the other side, is there a certain amount of production in The US? Is there not much?

To a certain extent, there is, but the quantities are not disclosed. Thank you. That’s all. This concludes the financial results briefing of Sumitomo Pharma for 2025. Thank you very much for your participation today.

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