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

We will now begin Sumitomo Pharma's financial results briefing for Q1 FY 2026. I would like to introduce today's speakers, Sakai, Representative Director and Executive Vice President; Nakagawa, Member, Board of Directors and Managing Executive Officer; Sato, Managing Executive Officer; and Wakemi, Executive Officer. Sakai will now provide an overview of the financial results for Q1 FY 2026 and the current status of clinical development. Mr. Sakai, please proceed.

This is Sakai from Sumitomo Pharma. Thank you for joining us today. First, we would like to express our sincere sympathy to all those affected by the Reiwa 8 Kumamoto earthquake that occurred on July 28, 2026, and we sincerely pray for the swiftest possible recovery of the affected areas. I will now begin my presentation on our financial results for Q1 FY 2026. For Q1 FY 2026, revenue was JPY 129.5 billion. Core operating profit was JPY 18.1 billion, and net profit for the quarter was JPY 17.0 billion. Revenue increased by JPY 21.5 billion compared to the same period last year, including the impact of foreign exchange rate fluctuations. Although we were impacted by the sale of certain businesses in our Asian operations last year and the expiration of exclusive distribution agreements for some products, increased sales of ORGOVYX and GEMTESA in the U.S. offset that decline, enabling us to achieve revenue growth. Despite this JPY 21.5 billion increase, gross profit rose by only JPY 4.2 billion, partly due to the impact of the decline in earnings resulting from the divestiture of our Asian operations, as mentioned earlier. Selling, general and administrative expenses increased year-over-year due to higher sales promotion expenses in North America, while research and development expenses rose due to the acceleration of clinical trials in the oncology field and the advancement of development in the neuropsychiatric field, among other factors. As a result, as I mentioned earlier, core operating profit was JPY 18.1 billion, a decrease of JPY 2.2 billion compared to the same period last year. Financial income and costs improved primarily due to a favorable change in foreign exchange gains and losses, and net profit for the quarter increased by JPY 5.8 billion to JPY 17 billion. Although core operating profit decreased compared to the same period last year, we believe we have gotten off to a solid start in relation to our plan for the current fiscal year. Next, I will explain the situation in North America, Sales in the United States totaled JPY 94.3 billion, representing an increase of JPY 24.4 billion, including the impact of exchange rate fluctuations. As you can see, sales of ORGOVYX and GEMTESA have increased. I would like to explain the current status of ORGOVYX and GEMTESA. First, as shown by the figure in the upper right corner, ORGOVYX' performance was largely in line with the initial plan. Please take a look at the bar chart. Although sales temporarily declined in Q4 FY 2025 due to seasonal factors, they rebounded in Q1 with both sales and volume increasing compared to the previous year. Also, although this is not mentioned here on a calendar year basis, we have already recorded approximately USD 570 million in revenue through June, and we believe we are on track to reach the USD 1 billion milestone. Next up is GEMTESA, as shown in the upper right corner, the actual results exceeded the plan by 16%. Although sales volume was generally in line with projections, the payer mix had a positive impact, and thanks to higher prices, we exceeded our plan. As with ORGOVYX, sales declined temporarily in Q4 FY 2025 due to seasonal factors, but recovered in Q1, resulting in a year-over-year increase of nearly 30%. Next is the Japan segment. Revenue for the Japan segment was JPY 22.2 billion, an increase of JPY 1 billion compared to the same period last year. As you can see, the main factor behind the revenue increase was the recognition of sales resulting from the launch of our in-house sales of [ XEPLION ] and XEPLION TRI. On the other hand, revenue from Equa and EquMet decreased by JPY 4.2 billion because its exclusive sales period expired last year and sales were discontinued in December. Here is the gross profit by region. In the U.S. and Japan, changes in gross profit were in line with the sales figures explained earlier. In other regions, gross profit declined significantly due to the sale at the end of July last year of the Asia segment's operations, which had been included in this category until last year. I'd like to discuss one topic related to domestic sales. As announced in our press release on June 19, we have obtained additional approval for Wegovy subcutaneous injection for which we have a promotional partnership with Novo Nordisk Pharma as a treatment for obesity, as a treatment for metabolic dysfunction-associated steatohepatitis, MASH, without cirrhosis. In the field of MASH, we are now able to offer Japan's first treatment option. I would like to provide an update on the progress of our research and development. You are currently viewing a list of our main product lines. As for changes made since the announcement of our financial results in May, we have updated the development status of DSP-1083, which is intended for the treatment of Parkinson's disease and is listed in the middle of the page from in preparation to ongoing. I will now explain the main topics in clinical development starting in May. Clinical development is generally proceeding as planned. For AMCHEPRY, we have completed the necessary procedures, including the signing of a contract with Kyoto University Hospital regarding our Phase IV trial and have begun enrolling participants. In addition, AMCHEPRY was recognized for its achievements in drug discovery and received the 10th Bioindustry Grand Prize. Regarding Enzomenib in the oncology field, we have completed enrollment of the cases required for the interim analysis of the pivotal Phase II trial for acute leukemia with KMT2A rearrangements. We have begun enrolling patients with NPM1-mutated acute myeloid leukemia. We presented data from a combination therapy trial for nuvisertib at the European Hematology Association Congress and the first clinical data for SMP-3124 at the American Society of Clinical Oncology Annual Meeting. I'll explain the details on the next page. First, AMCHEPRY, preparations for the Phase IV trial of AMCHEPRY are proceeding smoothly and following the completion of various procedures and manufacturing, we plan to perform the first transplant this fall. We also plan to perform approximately 10 transplants in FY 2027 and approximately 10 to 20 transplants in FY 2028. Kyoto University Hospital began enrolling participants this July. Going forward, we will continue to prepare the necessary infrastructure at the facility scheduled to host the program in the Kanto, Kansai, Chubu and Tohoku regions. On our website, we provide information tailored to both patients and health care professionals. Today's presentation material is also available on our website in PDF format. You can view various information by clicking the here link. Let's move on to the topic of cancer. The pivotal portion of the Phase II monotherapy trial of enzomenib is proceeding as planned in the 2 patient populations, those with KMT2A rearrangements and those with NPM1 mutations as described. For the KMT2A rearrangements, we have completed patient enrollment for the interim analysis, and we aim to submit regulatory applications in Japan and the United States around Q3 FY 2026 based on the results of the interim analysis. With regard to the NPM1 mutation, we plan to complete patient enrollment for the interim analysis by Q4 FY 2026. The next topic is nuvisertib. In the nuvisertib and momelotinib combination trial presented at the European Hematology Association Congress, we obtained favorable data demonstrating efficacy and safety. The combination therapy was shown to improve systemic symptom scores and spleen volume, indicating a signal of efficacy in myelofibrosis. In terms of safety, no dose-limiting toxicity was observed, and the treatment was found to be well tolerated. Next, I'd like to move on to the topic of liposomes. Our company's strength lies in our unique drug discovery platform, which integrates compound design with liposome-based drug delivery system technology. For liposomes composed of a lipid bilayer, as shown on the left, there are implementation examples such as SMP-3124 shown in the upper right, in which a compound is encapsulated within the membrane and DSP-0546 shown by the image below, in which a compound is localized within the membrane. Liposome formulation makes it possible to control drug efficacy and pharmacokinetics. Specifically, SMP-3124 is expected to widen the safety margin, while DSP-0546 is expected to induce a strong immune response. Next up is the SMP-3124. At the American Society of Clinical Oncology 2026 Conference held in June, we presented our first-ever clinical data. We have obtained results that support the concept of liposome formulation that we previously introduced, and we are currently conducting dose optimization trials for ovarian cancer and other indications where signs of efficacy have been observed. Next up is vaccine adjuvants. Our company possesses proprietary toll-like receptor 7 adjuvant technology and is developing DSP-0546E and DSP-0546LP. The products listed on the right utilizes the liposome formulation, I mentioned earlier. Recognizing the adjuvant market, which is expected to grow as a business opportunity, we have established a new vaccine and adjuvant business development office to strengthen our commercialization capabilities. Through open innovation and external partnerships, we aim to commercialize our vaccine adjuvants. Finally, here is the schedule of major events planned for FY 2026. Please take a look at Q1. Regarding the Phase II trial of enzomenib as a monotherapy for KMT2A rearrangements, we completed enrollment for the interim analysis as planned during Q1. Also, regarding the NPM1 mutation, as I mentioned earlier, we have begun enrolling patients for the Phase II trial as planned. Although this has been a brief explanation, that concludes my remarks. We would appreciate it if you could ask us any questions you may have.

We would now like to move on to the Q&A session with analysts and investors. The question-and-answer session will end at 17:15. Mr. Wakao of JPMorgan Securities.

This is Wakao from JPMorgan. First, you mentioned the Q1 results, the full year outlook and the resumption of dividend payments if this fiscal year's targets are met. Could you please elaborate on that? In your explanation, you mentioned that actual results exceeded the company's internal projections. If this situation continues into Q2, is it likely that the full year forecast will be revised in the Q2 earnings report? Will a dividend resumption be announced in connection with that?

Thank you for your question. Mr. Wakao, as I explained, we believe the start of Q1 is proceeding smoothly compared to our plans. That said, since only 3 months have passed, I believe it is too early to revise our full year outlook at this stage. Since various factors could affect the situation, we will refrain from commenting on the full year outlook at this time. As you pointed out, I believe we got off to a very good start in Q1. As I mentioned earlier, I feel that achieving ORGOVYX' milestones has become more certain over the past 3 months. Therefore, as you mentioned, I believe we will be able to discuss shareholder returns and dividends when we release our interim financial results. Thank you.

The second point concerns GEMTESA. I think GEMTESA's Q1 results were very strong. You mentioned that sales volume is growing steadily, the payer mix has improved and prices are. I'd especially like to know about the prices. I assume the gross to net ratio has improved as a result of the improvements to the payer mix, but I'd like to know a little more about the reasons behind that improvement. Also, is this going to last? Could you tell us if levels are likely to remain similar starting in Q2?

As you said, the gross-to-net ratio improved more than we had anticipated in Q1. I believe we need to assess the situation a little further to determine whether this will continue indefinitely. As you are probably aware, GEMTESA has been removed from the coverage plans of some payers. However, I believe that in the long run, the coverage rate will increase. At this stage, I think it might be a bit too optimistic to assume that we can maintain the Q1 gross-to-net ratio going forward. Dr. Nakagawa, please let us know if you have any additional comments.

This is Nakagawa in charge of U.S. operations. As Mr. Sakai just mentioned, there have been some changes to the listings in GEMTESA's formulary. In 2025, this has been outside the coverage for many payers, but it has been steadily returning since January or April 2026 and coverage has improved. In that context, since there were a relatively large number of patients, what we might call non-formulary patients who purchased this out-of-pocket rather than using insurance, the G2N ratio, so to speak, or pricing showed a slight improvement this quarter. This is the mechanism for this period. However, as coverage expands gradually, I believe the number of such patients will gradually decrease. Therefore, the results from Q1 will not carry over into Q4. Rather, this effect will gradually fade away. However, since sales volume is expected to continue growing, we are hopeful that for the full fiscal year, we will meet our budget or perhaps even slightly exceed it. However, given that there are still some uncertainties, we are maintaining our annual forecast at this time.

I understand well. At the beginning of the period, I was quite surprised that the gross-to-net price had been lowered. So I was actually a little surprised that it went up this time. However, when I heard that there were many non-formulary patients, I understood. Finally, regarding the slides on enzomenib presented today, I believe it was mentioned that with respect to KMT2A, a submission would be made if the interim analysis data were favorable. This chart contains various expressions such as criteria met and not met. How should I interpret the terms criteria not met, final analysis and criteria met listed below? Are you simply trying to say that a scenario like this is possible?

This is Sato from R&D. When conducting an interim analysis, we strictly define the criteria for both the final analysis and the interim analysis and consult with the regulatory authorities. However, we do not disclose the criteria themselves. Therefore, as a general rule, you can submit an application if the criteria are met in the interim analysis. If the criteria are not met, we will conduct a final analysis and decide whether to submit the application based on the results. We illustrated that process.

I understand. I understood that the slide contained general information. Regarding the interim analysis of KMT2A, the criteria for the interim analysis are based on the data obtained so far, so the bar isn't set unusually high. Is it? I understood that if the data from this interim analysis was favorable, things would move forward toward a partnership with your partner next year. Does that mean conversely that if the criteria aren't met in the interim analysis, the partnering process will also be delayed.

I believe that if we can continue to achieve the results we've reported so far in the interim analysis, we'll be able to submit the application, and that's the basis for our target schedule. However, as I mentioned earlier, even if the criteria are not met at this stage, there is, of course, a possibility that satisfactory results will be obtained in the final analysis. I think how far the partnership discussions will go depends on the information that can be disclosed.

I understand. That said, your company's stance to date that you will actively pursue partnerships if the interim analysis data is favorable, hasn't changed, has it?

It hasn't changed.

Next, we'd like to hear from Mr. Lee of Morgan Stanley MUFG Securities.

This is Lee from Morgan Stanley. I'd also like to start by asking about the full year financial results. With ORGOVYX' sales milestones coming up in H2, I too felt that you've made excellent progress and gotten off to a great start. Like Mr. Wakao, I also felt that there was a possibility you might exceed your plan for the full fiscal year. However, Mr. Sakai commented that there are fluctuating factors and the fact that only 3 months have passed. Does your company currently view any particular factors as risks?

Well, I personally do not believe the risk is particularly high at this point, depending on the most severe scenario, the impact of U.S. policy could potentially begin to materialize in the 2027 calendar year, which corresponds to Q4 of our fiscal year. I said that with that in mind. However, at this point, I personally do not consider that to be such a significant risk factor.

I understand that you are making a conservative estimate. I am looking at Page 24 of the document. This time, your company has provided its forecast for H1 cumulative total for the first 6 months. Just to be sure, let me confirm this. If you subtract Q1 from the cumulative forecast for H1, it appears that Q2 will show a Q-o-Q decline. This is merely the plan at the start of the fiscal year. And as I mentioned at the beginning, since performance in Q1 has been very strong, I understand that there is a possibility that Q2 results could exceed the cumulative forecast for H1. Is this line of thinking correct?

Although I probably shouldn't say this given that we've already made this information public, our H1 plan was calculated based on an exchange rate of JPY 155. And since we cannot change our full year forecast at this stage, we are using the same basis. The actual exchange rate for Q1 averaged around JPY 160. And as you probably realize, this will likely result in an accounting discrepancy in Q2, which when factored in, will result in a negative figure. In addition, we currently expect that selling, general and administrative expenses as well as research and development expenses will be slightly higher in Q2 than in Q1. As for sales, as mentioned earlier, we did not formulate this plan on the assumption that GEMTESA's strong pricing performance in Q1 would continue at the same level. So I suppose you could certainly call this conservative.

As for individual products, and this is a minor point, I think the performance of products like MYFEMBREE and RETHYMIC in addition to GEMTESA was also solid when viewed in dollar terms. Is this just a fluke? Or is this your true ability?

Our analysis indicates that MYFEMBREE's strong performance is due to temporary factors. To add to what said about RETHYMIC, there was a surge in patients at the very beginning of the year. However, we have not revised our annual patient volume forecast. We expect patient numbers to even out over the course of the year.

I understand. Finally, I'd like to ask Ms. Sato a question about R&D. This is about enzomenib. I understand that an update for KMT2A is scheduled for this fiscal year. You said that patient enrollment for the interim analysis of the NPM1 mutation would be completed by Q4. Can we expect to see the interim data around next summer? If the data is favorable, will you proceed with the approval application using this data just as you did with KMT2A?

That is correct. For the interim analysis, we will use the data from 6 months after the last participant among those included in the interim analysis. This data is from 6 months after the completion of patient enrollment for the interim analysis. Since the analysis takes a little time, it will take a little over 6 months. That is generally correct. As you are aware, if the results of the interim analysis are favorable, we plan to submit the application afterward.

I understand. Looking at the clinical trial information, I see that the HORIZON 1 trial is being conducted even for first-line treatment in newly diagnosed patients and the primary completion date is set for June 30 of next year. If the data is good, I think we can look forward to events like next year's ASH. What do you think? This is the last question.

Regarding first-line therapy, we are also moving forward with the initial data from the Phase I study on combination therapy for first-line treatment. I believe we will make some progress on that data as well during this fiscal year, and I expect we'll be able to provide some explanation at next year's ASH meeting.

Next, we'd like to hear from Mr. Wada of SMBC Nikko Securities.

This is Wada from SMBC Nikko Securities. Could I ask you 2 questions about the development pipeline? The first one is nuvisertib. I think the data on Page 15 is from when the press release was issued in June. Compared to the R&D briefing in February, I think the number of cases has probably increased by about 6. I would like to ask for your interpretation of this data. It states that no dose-limiting toxicity was observed. The number has increased from 18 to 26 cases, but are those 6 additional cases high-dose cases? As you move forward with development, if you are able to set the dosage at a higher level, I believe you will see even stronger data on efficacy than what has been presented so far. Could you also tell us about the rationale behind the dose escalation?

Thank you for your question. Regarding the data on combination therapy with [indiscernible] that we presented at the February R&D briefing, although we did not go into detail, the data were based on administration while the patient was fasting, that is on an empty stomach. What we've explained today is known as postprandial administration, and the data presented here was collected after the subjects had eaten a meal. I apologize for not providing sufficient details. Therefore, these figures were compiled using a different method than last time. Overall, the trend is the same as when we explained it in February. In terms of the overall score, the TSS is working well and the size of the spleen has improved significantly. On the other hand, side effects such as nausea and diarrhea, commonly referred to as gastrointestinal symptoms have been less frequent this time than last time. I think the post-meal data will show slightly lower doses. As a result, adverse events related to the digestive system have been decreasing. Although the overall trend remains the same, I believe the drug continues to demonstrate good efficacy and its side effect profile has improved. We will continue in this vein, adding a few more cases and determine the specific dosage for Phase III.

I understand. Regarding efficacy, has a dose-dependent effect been observed?

We are currently accumulating data to confirm dose dependency. So it is difficult to say at this point at which specific dose that effect is observed.