4587.T4587.TJPX
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Yuko Okimoto: [Interpreted] Good afternoon, everyone. This is Okimoto from IR PR department. Thank you very much for joining PeptiDream's Financial Results briefing for the fiscal year ending December 2025. We are very sorry that the starting was delayed. Now we will begin the meeting. Today's attendees are President and CEO, Patrick Reid; Director and the CFO, Kiyofumi Kaneshiro; Chief Medical Officer and President of PDRadiopharma, Masato Murakami; and Chief Scientific Officer, Christian Cunningham. Please note that simultaneous interpretation is provided for today's briefing by selecting your language at the bottom of the screen, you can listen to the audio in your chosen language, including the interpreted audio for either the Japanese or English lines. If you do not select a language, you will hear the original. Please also note that simultaneous interpretation is not available for access via telephone lines. Today's briefing will begin with Patrick Reid presenting FY '25 summary, key topics and future outlook, followed by Mr. Kaneshiro discussing FY '25 consolidated financial results and FY '26 forecast. This will be followed by a Q&A session. Presentation materials are available on our company website. Before beginning the presentation, we would like to make a disclaimer. The explanations provided may include forward-looking statements based on current expectations. All such statements involve risks and uncertainties. Please be aware that actual results may differ from these projections. We will now begin the presentation.
Patrick Crawford Reid: Good afternoon, everyone, and good evening or good morning to those overseas that are in attendance today. Today, I'm going to provide an overview of where we are as a company, how we performed in fiscal year 2025, provide some guidance on what fiscal year 2026 and beyond will look like for PeptiDream. After this, Kiyo will provide an overview of our financial results for the 2025 fiscal year, along with guidance for the fiscal year 2026 before we move on to take questions from those in attendance. PeptiDream was founded with the dream of creating a revolutionary peptide library generation and hit finding platform that could enable us to unlock the exceptional promise and power of macrocyclic peptides to create the next generation of life-changing therapeutics for patients in need worldwide. What was only a dream 20 years ago has now become a reality. PeptiDream started as a university spin-out focused on creating our revolutionary PDPS platform and getting some of the world's largest pharmaceutical companies excited about the power of macrocyclic peptides. We spent the next 10 years focused on our discovery and development partnerships, narrowing our own focus to our 5 core therapeutic areas across RI and non-RI, creating our own internal wholly owned discovery pipeline and acquiring the exceptional Radiopharmaceutical business now known as PDRadiopharma to further accelerate all of these efforts. Today, PeptiDream on the back of an exceptional 2025 embarks on a new chapter in our history, with our first wholly owned CAXI program moving into a U.S. Phase I study in the coming weeks. This event marks the start of our evolution from a global discovery company into a truly global discovery and development company and represents the next phase toward our goal of ultimately becoming a global pharmaceutical company. Over the coming years, investors should expect to see us continue to focus on our discovery partnerships as we see the fruits of those efforts produce clinical compounds and clinical candidates that move into clinical development. In parallel to these efforts across our 5 core therapeutic areas, we will continue to grow a robust preclinical pipeline, both in-house and partnered, while in parallel moving some of the highest value programs into clinical development to both unlock further value and operational flexibility with the ultimate goal of creating exceptional value for shareholders and delivering life-changing therapeutics and diagnostics to patients. Our focus has been and will continue to be on creating a pipeline of high-value preclinical and clinical programs, both in partnerships and as in-house wholly owned programs across our 5 core therapeutic areas. The 5 core therapeutic areas represent initially in the RI side of our business, RI-PDCs. We have the goal to continue to position PDRadiopharma as the leading Radiopharmaceutical company in Japan by supplying a robust set of exciting programs for PDRadiopharma to bring to patients in need in Japan. PeptiDream also has a validated platform and track record of discovering best-in-class and first-in-class macrocyclic peptide ligands for use as targeted RI conjugates across the broad spectrum of targets and tumor types. And this is highlighted, as I'll highlight, by our Glypican-3 program and our FAP program moving into the clinic in 2025. Our second core area of focus is around oral and injectable peptide therapeutics. We have a long collaboration history in the field of injectable peptide and oral peptide therapeutics, and we've been leveraging this extensive experience and expertise to in parallel, develop a robust internal pipeline of programs. The third core area is around oligo PDCs. PeptiDream has been researching utilizing macrocyclic peptides as targeted delivery vectors for CNS delivery back since 2017 and also ex-liver oligo delivery since 2021 across a wide range of partnerships. We have extensive experience in conjugating various partners, oligo therapeutic payloads to our peptides and showing robust delivery, and I'll touch on that today. Our fourth area -- core area of focus is around cytotoxic PDCs. From our RI business, we have a growing track record of discovering and developing tumor-targeting macrocytic peptides, utilizing RI payloads for cell killing. In this area, we extend beyond RI to also cytotoxic payloads and other small molecule payloads capable of killing cells, similar to ADCs. In most of this business, the cytotoxic payloads are provided by the partner, but we have an extensive growing pipeline in this area. And lastly, is around our area of multifunctional peptide conjugates. PeptiDream has been combining our macrocytic peptide discovery capabilities with our next-generation proprietary linker architectures to allow us to create an entire new spectrum of multi-specific biologics that are capable of doing some exceptional things as both therapeutics and potentially as next-generation diagnostics. We made exceptional progress across these efforts in 2025. We had 6 programs enter clinical development in total last year, allowing us to close 2025 with a total of 13 programs in clinical development. This is an exceptional year for us, almost doubling the number of clinical programs that we have for this company. In addition to that, beyond just the 6 programs that moved into clinical development, we saw 13 programs stage advance across the entirety of our development pipeline and portfolio in 2025. We saw our ALXN2420, our GhR antagonist program partnered with Alexion and AstraZeneca moving into a global Phase II. We also saw a number of new programs in our cadherin-3 program and our IL-17 oral program also being announced. So 2025 represented a significant and exciting new phase driven by the creation of significant pipeline value, both with preclinical programs and the successful movement of clinical programs for us. More specifically, on Slide 9, we highlight some of the late-stage development pipeline that is progressing forward at PDRadiopharma. We're on target to bring these 3 late-stage exciting programs to the market between 2027 and 2029. We've announced previously on the right, the LinqMed collaboration for the Copper-64-ATSM. This continues to progress in an exciting Phase III study in malignant brain tumor patients, on path for the submission of an NDA in 2027. The 2 PSMA programs partnered with Curium, our diagnostic copper-64-PSMA-I&T entered first patients last year and is on path to progress forward for NDA submission in 2027 for the diagnostic of prostate cancer. Fast followed by the 177-lutetium-PSMA I&T therapeutic program, which has now kicked off its registrational bridging study, utilizing the data from Curium's global Phase III and are now on path toward potential submission in 2029. So these are 3 late-stage exciting programs that should contribute significantly to growing revenue at PDRadiopharma. In addition to those assets, in 2025, we saw our in-house or partnered discovery assets also moving forward into the clinic. With RayzeBio, our diagnostic and therapeutic pair of gallium-68 Glypican 3 and actinium-225 Glypican 3 as a therapeutic, moving into a Phase I, Phase B study for the treatment of hepatocellular carcinoma, liver cancer, excitingly. That was also followed by the lutetium-177 therapeutic and diagnostic gallium-68 FAP program, partnering with Novartis, that Novartis took into a Phase I study against 4 different types of cancers of solid tumors. We're looking forward to the future Phase I results to arise from those programs. In addition to excitement around the late-stage assets and our partnered programs that have been discovered at PeptiDream, as I mentioned, we're also developing a robust internally wholly owned pipeline, centered around initially our internal CAXI program. At the end of 2025, we had filed INDs for both the diagnostic Copper-64 CAXI program and the therapeutic actinium-225 program, both of which were accepted. And now we are on path to initiate a Phase I study of both of these programs here in 2026. As a second program that we had announced 2 years ago, 18.2 for gastric cancer and pancreatic cancer with a diagnostic Copper-64 agent in partnership with the actinium-225 therapeutic, we are on now path in 2026 to initiate a Phase 0 study to get an initial early look at human feasibility data in patients. In addition, we are rapidly planning a Phase I study that hopefully, we will have more news on soon, looking forward possibly to start the initiation of the Phase I in the second half of 2026. The third program, which we had announced at our R&D Day, December of 2025 was targeting cadherin-3 for potential use in head and neck squamous cell carcinoma and triple-negative breast and a few other types of solid tumors are possible. We think this is an exciting program. We currently have moved this into IND-enabling studies, and we are also now rapidly investing in the possibility of conducting a Phase I human validation study as soon as possible for this program. We look forward, of course, over the course of 2026 to update on the progress of all 3 of these exceptional programs here at PeptiDream. From the previous 3 slides, you can see we're developing a compelling targeted Radiopharmaceutical pipeline, both of exciting therapeutics and next-generation diagnostics. And we couldn't do any of this without PDRadiopharma. PDRadiopharma is Japan's leader in radiopharmaceuticals. It has a 50-year history from 1968. It is -- represents the clinical and commercial arm for PeptiDream in Japan. It has a fully integrated R&D, manufacturing and commercialized operations and a nationwide distribution and sales network. And the 450-plus people at PDRadiopharma represent a trusted partner for global companies to access the Japan market. The ongoing transformation of PDRadiopharma, that was initiated when we acquired the company in 2022, continues today under the exceptional leadership of Murakami Masato. We are very much focused on strengthening our teams across the entirety of the organization, focused on our people. We are focused on driving capacity, as we had mentioned previously, and I will touch on in a later slide, expanding our manufacturing capability and capacity and related infrastructure is a key to the growth of this business. And lastly, diversifying the product portfolio, not just across SPECT and PET and targeted therapeutics, but also from a partnering perspective, from retaining rights to the Japan rights to certain PeptiDream collaboration programs such as Glypican 3 and also PeptiDream's own wholly owned compelling programs to take forward. We believe PDRadiopharma is well positioned to see exceptional revenue growth in the many years to come, and we look forward to seeing these unfold. Beyond our Radiopharmaceutical business, the other 5 core areas of focus are, of course, spread across our non-Radiopharmaceutical business. Second core area of focus that I'll mention today, of course, is around our oral injectable peptide therapeutics. PeptiDream has numerous collaboration programs in the field of injectable and oral peptide therapeutics, and we have been leveraging this extensive experience and expertise gained over the past 10 years. At the close of 2025, PeptiDream currently has 5 programs in clinical development, but we have a robust pipeline of preclinical collaboration programs complemented by a growing number of high-value in-house programs that are setting up us for future success and future growth. In 2025, we saw significant progress across these efforts. Highlighted in part by the ALXN2420 program. As I mentioned, this moving into Phase II -- a global Phase II study is a big step forward in seeing our pipeline in our discovered macrocyclic peptide programs progressing toward the market. In addition to that, we had 2 other programs, one partnered with Asahi Kasei Pharma and one partnered with Johnson & Johnson that also reached development candidate nomination in 2025. Both of those programs, which have certain information yet to be disclosed, are progressing toward the next steps of the Phase I initiation. Dramatically -- we look forward to seeing these programs advance in that respect. Complementing our clinical pipeline, of course, has been our in-house preclinical discovery efforts, highlighted in part by our oral myostatin inhibitor program, which we have reached development candidate nomination of, and we continue to progress with IND-enabling efforts as we continue partnering activities around this program. As everyone is aware, we did not find the right partner or have yet to consummate a deal for this program, but we've had a number of exciting discussions and look forward to those continuing here in 2026 to find the ideal partner for this exciting program. At the end of 2025, we also announced our oral IL-17 dual A/F inhibitor program. This exciting program has now progressed to development candidate nomination and will be progressing into IND-enabling studies while we consider partnering activities. There's exceptional interest around this program. We continue to field such interest, and we will continue to listen and consider best partnering possibilities for this program, while we continue to drive this toward clinical development. In addition to both the oral myostatin inhibitor program and the oral IL-17 A/F inhibitor program, we have a number of other exciting preclinical oral peptide therapeutic programs ongoing, that we look forward to taking forward toward development candidate nomination in 2026. And once we do, we will, of course, make that news publicly available. From our third core area of focus is our peptide oligo conjugate efforts. We have a strong roster of peptide-oligonucleotide conjugate discovery collaboration partners from Alnylam to Takeda to Shionogi and so forth. Extensive experience in conjugating partner therapeutic oligo payloads to our peptide delivery vectors has gone exceptionally well. We're going after not only targeting CNS, but also the ex-liver organs of skeletal muscle, cardiac muscle, kidney and adipocytes. As a highlight of 2025 in December, we announced a pivotal breakthrough in our collaboration with Alnylam, demonstrating extrahepatic tissue-specific delivery of a peptide-oligo conjugate in large animals. This breakthrough paves the path for us to see multiple programs, both nominated as development candidates, and we expect to see these programs progress into the clinical development in the years to come. This represents an exceptional and transformative time for our peptide-oligo conjugate efforts. Our fourth area -- core area of focus is around peptide-cytotoxic conjugates. As I had mentioned, we have a track record of discovery and development of tumor targeting macrocyclic peptides capable of delivering both RI and cell-killing payloads, yielding similar potencies to comparable ADCs. Such exceptional efforts have gone and continued extremely well in 2025, and we are now progressing toward the nomination here in '26, potentially of the first development candidates to take forward into clinical development. This fourth area, for us, we believe is going to continue to grow in the future and yield many development candidates in clinical programs in the years to come. Lastly is around our multifunctional peptide conjugate programs, largely focused around next-generation immune engagers. We have been combining PeptiDream's macrocyclic peptide discovery capabilities with our next-generation proprietary linker architectures to create an entire new spectrum of multi-specific biologics that demonstrate all of the best qualities and best properties of their more complex protein brothers, but with the simplicity of the ease of chemistry of peptide-based therapeutics. In 2025, we had successful in vivo proof of concept of our first in-house immune engagers, which is supporting expansive -- expansion of our efforts and expansion of the programs. And at the same time, we are both considering strategic partnering of these programs and a variety of different collaboration opportunities in the MPC space. Everyone should look forward to more news to come around this area for us in 2026. As we look to our guidance of 2026 and around our clinical pipeline, I am very excited to announce that we expect to see anywhere from 6 to 12 programs enter clinical development in 2026. While we haven't broken down whether these are RI or non-RI at the moment, we expect to see these programs as they advance into clinical development, allow us to close the 2026 year with anywhere from 19 to 25 clinical programs. These 6 programs in this ratio that may not -- that may enter the clinic in 2026. If they don't, they will be on Q4 and then they will progress in the clinic in 2027. So we see very good line of sight to these 12 programs advancing and we're extremely excited about both 2026 and also 2027 and seeing our clinical pipeline, continue the trend we saw in 2025 and expand further. These amazing efforts underlie our transformation into a discovery development company. To enable this next phase of growth, the next 10 years of this company, we felt it's extremely important to create a new organizational structure and management system to enable this to occur. As announced in part last year, we have now created both an executive leadership team and also a research leadership team and a development leadership team to coordinate our research-related functions and our development-related functions and for the ELT to oversee the entire strategy of the company and all aspects thereof. To support this organizational change, we also feel it's extremely important to increase the management team. PeptiDream has relied on a very skilled but lean management team until now. To recognize the future of this company, we believe it's important to expand that team further. This is in part why we are introducing an EVP, SVP and VP system. We expect going forward to add additional EVPs, SVPs and VPs in the future. This, as is depicted on Slide 20, is not going to happen tomorrow. This is over the next 5, 10 years of our company to build out this management structure so that we can take on the future of developing a robust clinical pipeline and also advancing the many, many preclinical programs we have here at PeptiDream. To support this further, of course, is our continued investment in growing the company from a capital perspective. As we have touched on in the past, what is shown here on Slide 21, is our efforts to build and expand PeptiDream's current headquarters and R&D center at the Tonomachi site. We believe that this program is moving very well through the design phases. We had hoped that this would start construction in late '26, but that has now moved into early 2027. We're very excited about the capabilities that this new building will bring to us going forward. In addition to that, on the right side is the Kazusa manufacturing site, a further extension of PDR's current manufacturing capabilities by adding exceptional new lines to support our next-generation programs and products, both across partners and in-house, supporting lutetium-177, actinium-225 and Copper-64-related programs. This is on track to initiate construction in late 2026 and become operational sometime in 2028. So we very much look forward to providing additional news on these -- both of these exciting capital projects as they advance here in 2026. And with that, I would like to pass this over to Kiyo Kaneshiro to continue the financial presentation.
Kiyofumi Kaneshiro: [Interpreted] This is Kaneshiro speaking. In the interest of time, I'd like to highlight some of the key points to give you an overview of the consolidated performance of FY 2025 as well as the full year forecast for FY 2026. Please turn to Page 23. And this is the consolidated results for the FY 2025. For the Drug and Discovery Development (sic) [ Drug Discovery and Development ] business, oral myostatin inhibitor out-licensing was not able to conclude a deal during FY 2025 and versus the initial forecast that it was -- the business was significantly below the forecast. However, on the Radiopharmaceutical side, it is now growing into the growth stage, the PET business. And it drove this entire Radiopharmaceutical business for -- therefore, after the merger in 2022, for the 4 consecutive years, we were able to maintain the profitability and also for the clinical pipeline, which made a significant progress. So it is growing steadily. Please turn to Page 24. This is the difference from the initial forecast. Let's start with in-house programs, which is the oral myostatin inhibitor. Regarding the out-licensing, we are to maximize the value, and we are exploring a more optimum partner. That is essential. Under this strategy, we wanted to prioritize choosing the best partner. Therefore, we -- the conclusion of the deal wasn't achieved in 2025. We, however, continue the negotiation towards 2026. And we initially planned to reach an R&D milestone for the existing programs as well as new partnership agreement. Part of them were delayed and postponed to 2026. Following page describes the consolidated balance sheet for FY 2025. As you can see, in the last few years, financial soundness has been our objective, and we are making steady progress. Equity ratio is improving steadily. In addition, net cash positive was maintained. So towards FY '26 and onwards, for future growth, we'd like to continue our active investment. However, financial soundness is also very important for us. And this is -- we have a very sound finance, and therefore, equity finance is not scheduled. Please turn to 26, Page 26. This is the consolidated cash flow. As you can see in the bar chart on the right-hand side, as of the end of December 2025, the cash amounting to JPY 28.6 billion, and the operating cash flow and the investment cash flow as well as financial cash flow. As of last year, the net debt, apart from that, the income tax payment as well as the repayment of the borrowing are the main contributor here. And regarding the PeptiDream and PDR pharma, R&D as well as manufacturing-related equipments and also future CapEx are the major consumption or factors plunging the cash. Please move on to Page 27. This shows the full year forecast for 2026. In revenue, JPY 32 billion plus outsourcing upfront payment. That is our announcement. We would like to make sure that we won't repeat the same incident which took place last year. Therefore, large-scale products -- projects are taken separately, and we are planting seeds for multiple programs and accumulating to stabilize our revenue. And we'd like to maximize our asset value. Those are the basic assumptions. And based on that, we'd like to actually achieve both of these in order to actually create an upside potential strategically. Please move on to Page 28. This shows our new growth drivers as well as the midterm and long-term management goals. As I mentioned earlier and Reid-san mentioned earlier, we'd like to become a global discovery leader, focusing on 5 core therapeutic areas, whereby we'd like to accumulate our asset values. That is the most paramount growth driver that is going to be. And also, needless to say, first, the platform is going to generate a stable cash flow. Second, under these core areas, we'd like to accumulate a strategic asset value. And number three, we'd like to utilize the strength of our infrastructure so that we can solidify the competitive edge. There are many companies which may have one of them. However, but combining, it's unparalleled that it's only PeptiDream that has all 3. Therefore, we will be able to serve as a growth model that can leverage this proprietary strength. And this is my key message here. And lastly, I'd like to introduce our sustainability-related initiatives. As you can see in the diagram or slide, we'd like to ultimately pursue ESG-related initiatives, and we have been accumulating results. As a result, on the right-hand side, each rating agency rate us quite highly, and it is rising and improving. This is the propensity we'd like to maintain. And within the industry, we have reached a high level considering the industry average. We have been closely working with the old stakeholders. And once again, we'd like to express our gratitude for those of you who have supported us throughout this. That concludes my presentation. Now we'd like to entertain questions from the floor and participants.
Yuko Okimoto: [Interpreted] Thank you very much. Now, we'd like to entertain questions from those in attendance. [Operator Instructions] Now we'd like to open the floor. Yamaguchi-san, would you like to start your question.
Hidemaru Yamaguchi: [Interpreted] Citigroup, Yamaguchi is my name. For this year, you explained the forecast for 2026, and -- but you expect the lump sum payment -- upfront payment of JPY 14 billion. And then for the close to the JPY 30 billion that you were expecting, but didn't receive last year that is to be added on that. Is that a correct understanding?
Kiyofumi Kaneshiro: [Interpreted] Thank you for your question. First, yes, your understanding is correct.
Hidemaru Yamaguchi: [Interpreted] I see. And then for all the myostatin, I believe that it will be difficult for you to make a comment. But for the past 1 year, you made efforts to maximize the value, but didn't achieve that. But this year, you didn't include this in your forecast. So it seems that you can just out-license at any time. But what is the reason of the delay? And then about the expected timing of the license out this year, if you can discuss?
Patrick Crawford Reid: Thank you for the question. So you're asking in regards to whether or not we will be able to partner the myostatin program this year. And what is the current status of those efforts? As you mentioned, we started this in 2025. We continue to discuss with a number of different companies. What is a key difference for the myostatin program compared to any of our other programs is that will be combined with someone else's oral weight loss drug. As we've mentioned previously, that makes picking the right partner extremely important. With the exception of Lilly and maybe Novo, the rest of the large pharma companies are still very much working on their oral weight loss directions. And therefore, without having a strong sense of where they intend to take or say, exceptional maybe Phase II or early Phase III data, it's hard to expect them to want to combine an oral muscle preservation piece to those studies. So we think the value of this program is exceptional. One of the challenges then is that we were probably a little too early, right? The other muscle preservation agents that are in development are being developed for SMA or just early stages in combination in obesity, but being developed as injectables. There is no current oral muscle preservation agent in clinical development. So our goal, of course, is to partner this in 2026. I would really like us to be able to find the right partner. But I don't think we have -- we know exactly when that will happen or we can't comment on this time exactly who that will be with or when that will happen or what the deal economics will look like. In part, that's very similar for IL-17 program or our CAIX program. There's exceptional interest in these programs for us. But I think it would be difficult for us to disclose what we expect for upfront fees or what type of deal structures would be the best for those programs. Yes.
Hidemaru Yamaguchi: [Interpreted] Just one thing to clarify that you talk about -- you wanted to combine with the oral to oral rather than oral to injectable, right?
Patrick Crawford Reid: That's correct. From the large pharmaceutical big pharma perspective, that would be their development goal. They don't -- they -- or at least the discussions that we have to date, none of them have been around combining with their injectable. So it has been an oral-oral. Yes, that's correct.
Yuko Okimoto: [Interpreted] Next question from Wada-san, please.
Hiroshi Wada: [Interpreted] SMBC, Wada speaking. Am I clear?
Yuko Okimoto: [Interpreted] Yes, we hear you clearly.
Hiroshi Wada: [Interpreted] I'd like to actually confirm several things about the business forecast. On Page 27, that is regarding the discovery business amounting JPY 15 billion, what is included here? And what is the assumption? For R&D progress in 2026, 6 or 12 programs are anticipated, which are making -- will make a stage advance to the clinical stage. So are they included? So -- at least 6 programs, which will enter the clinical stage. Is it the assumption for the R&D piece here, which is included in the full year forecast scheduled for JPY 15 billion?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. So out of -- in terms of the breakdown of JPY 15 billion, I understand that you are actually asking the breakdown. So the revenue is comprised by milestone payment as well as R&D funding. And amounting to [ JPY 500 million ], they come. And outside that, JPY 1 billion will come from new deal or existing programs expansion. So that is the breakdown.
Hiroshi Wada: [Interpreted] I'd like to ask you one more thing regarding costs. Last year, the entire cost, including the COGS as well as SG&A amounting to JPY 23.5 billion. And this year, it was expanded, right, if I understand it correctly. But the significant surge will come from R&D costs. Is that -- am I right in thinking that? So cost-wise, what is the main driver? Or what is the major factor contributing to the significant increase in cost for 2026?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. So basically, you had the right understanding. Regarding R&D expenses last year in FY 2025, which amounted to JPY 5 billion. But this year, in 2026, FY is going to increase to JPY 6.4 billion. So it's an increase of about JPY 1.4 billion year-on-year.
Yuko Okimoto: [Interpreted] Mr. Hashiguchi, please.
Kazuaki Hashiguchi: [Interpreted] This is Hashiguchi from Daiwa. Regarding the forecast, the assumption, what Kaneshiro-san just mentioned, the remaining [ JPY 10 billion ], the new deal and also myostatin, IL-17 that is included in the plus alpha, what are the differences between those? Regarding the new deal -- so you have a good probability, including the actual value. And so those in the plus alpha like myostatin, am I correct to assume that it's possible that you will not out-license that in 2026?
Kiyofumi Kaneshiro: [Interpreted] Thank you for your question. The first -- regarding the first point, yes, your understanding is correct. So the JPY 15 billion, there are quite certain probable ones that includes those proper ones. And so our activities of this year will not actually lead to the actual revenue this year, but there will be some delay. The activities in the past may lead to the activity -- the actual revenue of this year. And also, we have a rather high certainty or the probability of receiving that amount from the activities of the last year or 2 years ago. And regarding the upfront payment, your question is what is different. And so one thing is that we have some potentially large project. So the impact on our revenue or the profit is quite large. And of course, it depends on our partner. And so it's not only the timing that is important for us, but it's important for us to maximize the value of our asset. And so the partner as well as the future development should be optimal. So including everything, we want to maximize the value of the asset. So it's possible maybe we may be able to conclude the deal within 2026, but it may be possible that our optimal solution may be to postpone it to 2026. Thus, we are separating this JPY 15 billion in the lump sum payment.
Kazuaki Hashiguchi: [Interpreted] So myostatin, IL-17, these ones, you have 4 projects here. So you will continue the clinical development in-house like myostatin and IL-17, your option is to continue the development through the registration. Is that possible?
Kiyofumi Kaneshiro: [Interpreted] Thank you for your question. And our answer is yes, especially like the CAIX and Claudin, we do have the capability to work end-to-end. But for the myostatin and IL-17, for the actual manufacturing, we will need a partner and that's our assumption. And so within that framework, we would like to consider what is the optimal time point to transfer or change the hands.
Yuko Okimoto: [Interpreted] We'd like to take next question from Ueda-san.
Akinori Ueda: [Interpreted] This is Goldman Sachs, Ueda speaking. I'd like to raise questions pertaining to your full year forecast. Currently, your basic revenue-generating ability and also what is the future outlook for mid- to long term? What is your perception here? Previously, in 2024 performance and 2024 initial forecast that about JPY 50 billion that was achievable, that was achieved. And you were to actually reach the JPY 100 billion mark in mid- to long term. That was your long-term view. However, this year, profit-wise, you are to reach JPY 5 billion level as a basic assumption, is that true? And also, if you are to reach JPY 100 billion level, do you have a concrete picture to reach that far? What is your perception right now?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. On Page 28, you are asking questions. Regarding the revenue mid- to long-term goal of achieving JPY 100 billion, we are on track of reaching this JPY 100 billion level in revenue in the long term. Of course, there will be some fluctuations and ups and downs down the road. However, broadly speaking, for us to attain this JPY 100 billion, the biggest driver here, which is described on [ Slide 28 ] are the core therapeutic areas. We are to maximize the values and accumulate values in these 5 core areas. That is most important. And to be more specific, in the first half of our presentation, in 2025, it was an exceptional year for us. It was the best in the past. And also in 2026, we'd like to surpass the 2025 results in order to maximize value in these 5 core areas, and that is our -- on our horizon. So in terms of mid- to long-term goals, we are making a steady progress and everything is on track. And to raise your -- to address your numbers -- second question, which is the profit level, profitability, JPY 32 billion plus upfront as a result of out-licensing. And if the upfront payment is on top, that will be added on top of the profitability. So there is a significant potential of upside in terms of profitability and the bottom line.
Akinori Ueda: [Interpreted] And I'd like to raise the second question. Regarding the management structure, what was the background that prompted you to change the management structure? And what was the purpose of the change in management structure? In terms of the growth that -- well, in anticipation of the growth in the size of your business. But in the last few years, in terms of revenue, the top line hasn't grown that much in the last few years. So what prompted you to actually decide in this management change? What are the factors behind this change? And also this time, in terms of the management organization, the Executive Vice President ought to be introduced and what the benefits or what is the advantages of deploying this executive...
Patrick Crawford Reid: Of course, our plans to revise management moving to the EVP, SVP and VP system. And of course, what type of individuals or what type of capabilities are we looking to expand and have covered. I think at this stage, as we want to grow into a global pharmaceutical company, we could use, I think, certain talented executives around overall operations and operational management, decision-making at PeptiDream. We are looking for individuals to focus or with strategic or expertise around strategic planning. We have many, many programs, of course, so which programs should be a priority and which programs maybe should be less of a priority. And also certain executives with portfolio management background and skill sets. Moving from a company that is just discovering drugs and passing those on to partners to develop them into a company that is going to take forward our own or certain of our own assets requires a very different operational skill set than we currently have. So I'm very much looking over the next couple of years to see us expand kind of our talent around those core areas around operations, around strategy and around the portfolio management, as we look to continue this trend of taking more of our high-value preclinical programs into clinical development to at least gain human POC before kind of out-licensing them. So I think this is a natural evolution for a company like PeptiDream I don't think this is surprising. And this is, as almost all U.S. biotech companies do, is the best path forward to maximize value for shareholders, which is, of course, the core focus of everything we're doing here at PeptiDream. And it's also the best way to see these programs drive forward toward patients in need. So with those 2 focuses in mind, those are the type of individuals we look to bring in for the next 10 years of growth here at PeptiDream.
Yuko Okimoto: [Interpreted] Next question, Kawamura-san.
Ryuta Kawamura: [Interpreted] Kawamura from SBI. I have two questions. First, some overlap of the previous question is that this year's forecast and your target last year was quite high. And so you said that it's a mind setting that needs to work. You have plan B, but you needed to do the downward revise. And so JPY 15 billion is the important point. And so you have a quite strong commitment. And for the management, it's really a must or do you rather consider the maximization of the pipeline value more important than achieving this number, particular number?
Kiyofumi Kaneshiro: [Interpreted] Thank you for your question. This is about the '26 forecast and the positioning of the JPY 15 billion. And as you mentioned, it's rather conservative. Yes, this is a very rather conservative expectation, and so probability is quite high. And -- but not only that, naturally, of course, we want to have additional one. We want to maximize the pipeline values and/or the assets. And so we will positively work on the further upside. And so we wanted to separate these 2 gears. And so we will target a high level, but with quite a high probability projects and also some projects that where we have to think about the different options. They are separate.
Ryuta Kawamura: [Interpreted] And the second question is regarding the myostatin. So I want you to do some expectation control. And so this obesity area is quite a hot area and the expectation is very high. And the player is -- there are 2 leading companies for the oral and other companies are working on the different mechanism of actions such as long-acting. And so with this trend, you want to combine the oral on the oral combination. Do you have a lot of inquiries or on the potential deal partner companies? And so can we have a very high expectation? Or could you discuss as much as possible?
Patrick Crawford Reid: Yes, Kawamura-san. I understand you're asking about, of course, our myostatin program and what is the likelihood of a deal soon, what is the size of a potential deal soon and with who. I think it's hard for us to give concrete guidance at this stage. As you mentioned, I think we have the only orally bioavailable muscle preservation agent against a very exciting pathway, the myostatin pathway, that has already shown clinical success in humans with the injectables. So that places us in a very, very strong position. As you mentioned, besides the 2 top players in the space, the rest of the companies are navigating their strategies. And I think as you well know, their strategies changed quite quickly sometimes, right? We saw some large acquisitions by Pfizer and Roche over the last couple of years. There's a number of deals coming up, of course, licensing deals coming out of China still. So it is a very fluid market space still today. Because of that, I think that's what is -- makes it difficult to give you guidance exactly when a deal will happen. But as I mentioned, I think we have an extremely valuable program. I think we will find an exceptional deal for this program. What I don't know or what we don't know is the exact timing of that yet. But we do believe it's in the future. I think just lessons learned is to not put it as a part of guidance. That's a very good lesson learned from 2025 for us. And I would echo to your earlier question, I would echo kind of Kaneshiro-san's guidance, which is, yes, we're returning to more of a conservative guidance for the company. The goal over the next 3 or 4 years is to continue to grow our clinical programs and clinical pipeline. That's how we reach the goal of the -- I don't know what it is, [ thousand-billion ] yen kind of goal that we have. We get there on the strength of the clinical pipeline. And so that's going to be our focus in -- for these next couple of years. We will, of course, intend to return to the black this year. We -- and the JPY 150 million or the [Foreign Language] gets us, of course, back into the black so that we can continue to take the proceeds or the profits from that and reinvest into the clinical pipeline. I think that is what we've been doing in the last couple of years, and that will continue to be the goal over the next 2 or 3. And we will manage our clinical programs as best we can. It was previously asked also, do we think R&D spending is going to go up every year. And yes, we budgeted for almost a -- I guess, [Foreign Language] an increase in our R&D costs for this fiscal year. That could potentially increase every year by around [Foreign Language] depending on whether we take 1 program in there into the clinic or whether we take 2 programs into the clinic. And we believe part of that is going to be guided by the revenue that we can continue to bring in. So as long as we can continue to maintain good revenue streams, good cash flow, instead operating in the black, we continue to use those proceeds to invest into taking more of our exciting preclinical programs into the clinic. And I think long term, that's how we best generate value for shareholders over the next 10 years.
Yuko Okimoto: [Interpreted] Next, we take questions from Yamakita-san.
Miyabi Yamakita: This is Yamakita speaking from Jefferies Securities. I'd like to ask you a cost-related questions. Regarding the number of headcounts, which was reported in the summary of the financial results, a slight increase to 810 from 761. Why at this timing did you increase the number of headcounts? And is it inflating your R&D, most of the R&D cost increase?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. So for the entire group, you are asking the entire headcount, PeptiDream as well as PDRadiopharma, both increased our headcount. And nearly 50 personnel was added new for this year. And mostly, the growth came from PDRadiopharma because listed products -- or excuse me, launched products are nearing the clinical late stage, and we are to make full preparation for the manufacturing and sales. So we are making preparations for the market launch. And then starting from 2026, we'd like to make necessary preparations. And in 2027 and onwards, on a gradual basis, the approval or the application will be filed, and we are to make a solid preparation that is reflected in the increase of the headcount in the PDRadiopharma.
Miyabi Yamakita: [Interpreted] Thank you very much for the detailed explanation. Second question relates to a quick confirmation. Last year, during the first half, in your presentation, you had a deal pipeline or the timing of your potential deals. In 2026, first half, the partnerships awards to be concluded for about 2 to 3 programs. There was a time line describing -- the chart describing a time line, but is it a thing of the past? Regarding the timing of each expected pipeline or deal?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. The answer is yes and no. So 6 months ago, we showed you a diagram describing the time line, and there are some ongoing items. So for those, you had the right understanding as we announced previously. And on top of that, towards the year-end as well as the beginning of this year, there are new deals that are making -- that are underway. So in terms of the revenue and the forecast of those KPIs and numerical targets, and regarding the timing and the order as well as the price -- unit price and how much time line is expected. We are actually talking with our counterparts. So at the best possible way, we'd like to actually attain our numerical targets for the revenue and both the top line and the bottom line. That is our mindset.
Yuko Okimoto: [Interpreted] Next is Matsubara-san, please.
Matsubara: [Interpreted] This is Matsubara from Nomura. Just one question from me. Again, it's about the myostatin inhibitor. Last year, the end of last year for the [ P1 ] study, so siRNA data was obtained that reduces the body weight while maintaining the muscle and the deal -- was your deal affected by that? Or because you have the combination of the -- so probably [ it ] wouldn't affect that...
Patrick Crawford Reid: With regards to recent disclosure around an siRNA to knock down myostatin or other players in the myostatin Activin signaling pathway as potential new therapeutics for muscle preservation. As you are probably well aware, manipulating the myostatin pathway is useful in a number of potential therapeutic diseases beyond just muscle preservation. It also has a key role in many of the muscular dystrophies such as DMD. As you know, there's a couple of inhibitors for myostatin that are about to be approved for SMA and again, a number of other muscular-related disorders to which inhibiting this pathway could be very effective -- clearly very effective since you have some myostatin inhibitors about to be approved for SMA and other disorders. So I think that's largely the science behind various companies moving to an siRNA-based approach to go after myostatin, of course, inhibitors. Whether this will affect our oral myostatin program, I would say, at current, no. And I think just looking at siRNA in general, I might point to one very obvious comparison, which is in the high cholesterolemia space of PCSK9. So PCSK9, of course, there is an approved siRNA drug for high cholesterolemia targeting PCSK9. But as you know, Merck is -- or may know, Merck is about to seek approval for an oral macrocyclic peptide inhibitor of PCSK9, which shows significant value to our patients different than the siRNA. So the siRNA, while can be wonderful in some cases, multiple injections over long periods of time renders them less effective. You have certain injection site issues. You can have other kind of compelling reasons why someone is not able to take an siRNA drug that actually exists for those type of therapeutics. So that's a specific example where there's an approved siRNA therapeutic against PCSK9, but now also an oral macrocyclic inhibitor, PCSK9, that will be approved, and there's actually a small molecule inhibitor PCSK9 underway, too. So I think it's a very interesting space, but we don't see siRNA, at least at this stage, causing any type of, say, loss of value for this program for us.
Kiyofumi Kaneshiro: [Interpreted] Let me add a few things here. For the myostatin, we received several questions. And I'd like to add one thing. From last year, we made various presentation and the clinical -- regarding the research and clinical. But as a market is getting warmer. I think you can understand it that way the myostatin including siRNA, there are many different approaches, and it's getting a lot of attention in the industry, and there are many players. And when the data are becoming available, then we are -- we can expect the competitive advantage of a compound as it becomes clear and clearer. And also various companies have different clinical plans. And so our compound, the positioning of clinical -- the positioning is getting clearer. And so the market is getting warmer and warmer right now. That's what we understand. On the other hand, the market potential for this compound is quite large. And so in our asset, the net present value is very large for this. And so we want to maximize the net present value for this compound. And so we are looking at the timing. And also, we are taking a little -- more time from last year to this year. And so with that, we want to really maximize the high net present value.
Yuko Okimoto: [Interpreted] We will take questions from Mizuho Securities.
Yuriko Ishida: [Interpreted] This is Ishida speaking. Regarding the full year forecast, I'd like to confirm one thing. Regarding the upfront plus alpha additional CAIX and Claudin are listed on your slide. Previously, under RI, maximization of value, you mentioned P1 data or partnership after the P1 data has become available. But regarding the [ PI ] domain, the partnership out-licensing or in-house, the decision, what is the threshold? Is it changing whether you are to out-license or conduct an in-house development?
Kiyofumi Kaneshiro: [Interpreted] Thank you very much for the question. Regarding Page 27, myostatin, IL-17, CAIX, Claudin, all of these at this point in time have inquiries in this -- so in that sense, without being selective, they can be out-licensed by tomorrow, but that is not the case. Of course, we need to ascertain when the data will become available so that we can maximize the value. In that sense, CAIX, IL-17 and Claudin, we'd like to wait until Phase I results come out. That will be the maximize sweet spot for us to initiate the out-licensing. We are actually advancing in the clinical development phase. And of course, multiple companies are interested in these products. So finally, when we reach the final decision, our ultimate goal is not to actually reach the out-license agreement. We are to commercialize so that we can keep winning in the market once these products are launched in the market. So at the best earliest timing, out-licensing at an early timing is necessary. So in that sense, for this year as well as next year, we'd like to maximize value. And that is our policy in terms of making the right decision.
Yuko Okimoto: [Interpreted] Now we'd like to entertain one more question from [ Yamada-san ].
Unknown Analyst: [Interpreted] [ Yamada from Nikkei Biotech ]. In 2026 for the clinical, the pipeline, the compounds are getting into clinical in 2026. And you mentioned that between 5 to 12 projects will go into the clinical phase. And for those -- excuse me, it's 6. And for those 6, could you discuss which area, which of these...
Patrick Crawford Reid: Thank you, [ Yamada-san ] for the question. The 6 to 12, I think we'll just comment that it's a good -- it's roughly a 50-50 mix between RI and non-RI. Again, at this stage, we're not sure exactly of the 6 that will enter the clinic. Those already, at least the 6 that we know will enter the clinic for sure in 2026 are also a mixture of both RI and non-RI programs. So last year, we had 6 programs moving into the clinic, and those were all RI related. So this year will be more of a balanced mix between our RI and non-RI programs. And of course, as far as the -- I guess you're asking if any of those are also either peptide-oligo or peptide cytotox or maybe an MPC. None of those are MPCs, we can say at this stage. But we think that could be a representative of an oligo peptide and potentially a cytotox peptide. But Again, I think it's just a better -- it's a better mix than it was in 2025 of both RI and non-RI. And we are expecting over the next 12 to 24 months to see potential clinical programs across all of our core therapeutic spaces.
Yuko Okimoto: [Interpreted] This come to conclude the session. Now we'd like to adjourn this financial results briefing for FY 2025. Additional questions, please contact IR department. Thank you very much for taking the time out of the busy schedule to attend our briefing. Thank you. The meeting is adjourned. [Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]