Peptidream Inc.

Peptidream Inc.

1,059.50
JPY
-13.00
(-1.21%)
136.86BMarket Cap
Nov 11Next Earn

Q4 FY2025 · Earnings Call TranscriptFebruary 16, 2026

Patrick 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, Kiyofumi 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 five 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 CA9 program moving into a US Phase 1 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 five 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 five core therapeutic areas.

The five 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 a broad spectrum of targets and tumor types. This is highlighted, as I'll highlight via our cadherin 3 program and our FAP program moving into the clinic in 2025.

Our second core area of focus is around oral injectable peptide therapeutics. We have a long collaboration history in the field of injectable peptide and oral peptide therapeutics, and we have 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 extrahepatic 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 core area of focus is around cytotox-PDCs.

From our RI business, we have a growing track record of discovering and developing tumor-targeting macrocyclic 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. Lastly is around our area of multifunctional peptide conjugates.

PeptiDream has been combining our macrocyclic peptide discovery capabilities with our next-generation proprietary linker architectures to allow us to create an entire new spectrum of multispecific 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 six 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 six 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 LALXN-2420, our GHSR antagonist program partnered with Alexion AstraZeneca, moving into a global Phase 2.

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 three late-stage exciting programs to the market between 2027 and 2029.

We've announced previously on the right, the LinkMed collaboration for the Copper-64 ATSM. This continues to progress in an exciting Phase 3 study in malignant brain tumor patients on path for the submission of an NDA in 2027.

The two PSMA programs partnering with Curium, our diagnostic Copper-64 PSMA I&T entered first patients last year and is on path to progress forward toward 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 3 and now on path toward potential submission in 2029. These are three 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 GPC3 and Actinium-225 GPC3 as the therapeutic moving into a Phase 1, Phase 1b 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 partnered with Novartis, that Novartis took into a Phase 1 study against four different types of cancers of solid tumors.

We're looking forward to the future Phase 1 results to arise from those programs, although we simply would note that of course those programs are run by partners and they decide when to disclose and therefore they are in control of the disclosures. 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 CA9 program.

At the end of 2025, we had filed INDs for both the diagnostic Copper-64 CA9 program and the therapeutic Actinium-225 program, both of which were accepted, and now we are on path to initiate Phase 1 study of both of these programs here in 2026. As a second program that we had announced two years ago, 18.2 for gastric cancer and pancreatic cancer with the 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 1 study that hopefully we will have more news on soon, looking forward possibly to start the initiation of the Phase 1 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, 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're also now rapidly invested in the possibility of conducting a Phase 1 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 three of these exceptional programs here at PeptiDream. In the previous three 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 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.

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.

Lastly, diversifying the product portfolio, not just across SPECT and PET and targeted therapeutics, but also from a partnering perspective, from retaining Japan rights to certain PeptiDream collaboration programs, such as the cadherin 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 five core areas of focus are, of course, spread across our non-radiopharmaceutical business. The 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 five 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 LXN-2420 program, as I mentioned, just moving into Phase 2, a global Phase 2 study. It's a big step forward in seeing our pipeline and our discovered macrocyclic peptide programs progressing toward the market.

In addition to that, we had two 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 Phase 1 initiations.

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 on, 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 AF 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 AF 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 toward peptide delivery vectors has gone exceptionally well. We're going after not only targeting CNS, but also the extrahepatic organs of skeletal muscle, cardiac muscle, kidney, and adipocytes.

As a highlight of 2025 in December, we announced the 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 clinical development in the years to come.

This represents an exceptional and transformational time for our peptide-oligo conjugate efforts. Our fourth core area of focus is around peptide-cytotox 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. These 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 multispecific 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, just supporting expansive expansion of our efforts and expansion of the programs.

At the same time, we're both considering strategic partnering of these programs in 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 toward 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.

The six programs in this ratio 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. We see very good line of sight to these 12 programs advancing.

We're extremely excited about both 2026 and also 2027 in 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 the 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.

We very much look forward to providing additional news on both of these exciting capital projects as they advance here in 2026. With that, I would like to pass this over to Kiyo Kaneshiro to continue the financial presentation.

Kiyo Kaneshiro

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. This is the consolidated results for the FY 2025.

For the drug and discovery development business, oral myostatin inhibitor out-licensing was not able to conclude a deal during FY 2025, and versus the initial forecast 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 four consecutive years, we were able to maintain the profitability, and also for the clinical pipeline, which made a significant progress, it is growing steadily. Please turn to page 24.

This is the difference from the initial forecast. Let's start with the in-house programs, which is the oral myostatin inhibitor.

Regarding the out-licensing, we are to maximize the value, and we are exploring the optimum partner, that is essential. Under this strategy, we wanted to prioritize choosing the best partner, therefore the conclusion of a deal wasn't achieved in 2025.

We, however, continue the negotiation towards 2026, and we initially planned to reach of 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 a steady progress. Equity ratio is improving steadily.

In addition, net cash positive was maintained. Towards FY 2026 and onwards, for future growth, we'd like to continue our active investment.

However, financial soundness is also very important for us, and 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 of this 2025, the cash amounting to 28.6 billion, and the operating cash flow and the investing 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.

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 the revenue, 32 billion plus outsourcing upfront payment, that is our announcement.

We'd like to make sure that we won't repeat the same incident which took place last year, for large-scale products or 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 mid-term 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 five core therapeutic areas, whereby we'd like to accumulate our asset values. That is the most paramount growth driver that is going to be.

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.

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, combining it's unparalleled that it's only PeptiDream that has all three.

Therefore, we will be able to serve as a growth model that can leverage this proprietary strength, and this is my key message here. Lastly, I'd like to introduce our sustainability-related initiatives.

As you can see in the diagram or slide, we'd like to adamantly 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 all the 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.

Operator

Thank you very much for the presentations. Now we'd like to entertain questions from those in attendance.

Please press raise your hand button, and wait. If you are to retract, then please press lower your hand button.

We can take questions in either language, either in Japanese or English. You can also send us questions in writing from the Q&A button, and this Q&A session will be posted on our corporate website, please be advised.

We'd like to limit the number of questions to two for each. Now we'd like to open floor.

Yamaguchi-san, would you like to start your question?

Hidemaru Yamaguchi

Hello.

Kiyo Kaneshiro

Yes, I can hear you.

Hidemaru Yamaguchi

Thank you. Citi Group, Yamaguchi is my name.

For this year, you explained the forecast for 2026, but you expect a lump-sum payment, upfront a payment of 14 billion, and then for the close to 30 billion that you were expecting, but didn't receive last year, that is to be added on that. Is that a correct understanding?

Kiyo Kaneshiro

Thank you for your question. First,

Hidemaru Yamaguchi

yes, your understanding is correct. I see.

Then for oral myostatin, I believe that it will be difficult for you to make a comment, but for the past one year, you made efforts to maximize the value, but didn't achieve that. This year, you didn't include this in your forecast.

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 licensing out this year, if you can discuss?

Patrick Reid

All right, thank you for the question. 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 continued 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. Therefore, without having a strong sense of where they intend to take, or say, exceptional maybe Phase 2 or early Phase 3 data, it's hard to expect them to want to combine an oral muscle preservation piece to those studies.

We think the value of this program is exceptional. One of the challenges has been 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 a combination in obesity, but being developed as injectables. There is no current oral muscle preservation agent in clinical development.

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 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 CA9 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.

Thank you. Yeah.

Hidemaru Yamaguchi

Thank you. Just one thing to clarify that you're talking about you wanted to combine with the oral to oral, rather than oral to injectable, right?

Thank you.

Patrick Reid

That's correct. From the large pharmaceutical, big pharma perspective, that would be their development goal.

Or at least the discussions that we have today, none of them have been around combining with their injectables. It has been an oral-oral.

That's correct. That's right.

Hidemaru Yamaguchi

Thank you very much.

Operator

Thank you very much. Next question from Wada-san, please.

Tomoko Wada

SMBC, Wada speaking. Am I clear?

Kiyo Kaneshiro

Yes, we hear you clearly.

Tomoko Wada

Thank you. I'd like to actually confirm several things about the business forecast.

On page 27, that is, regarding the discovery business amounting 15 billion, what is included here and what is the assumption? For R&D progress in 2026, 6 or 12 programs are anticipated which will make a steady stage advance to the clinical stage, are they included?

Six, at least six 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 15 billion?

Kiyo Kaneshiro

Thank you very much for the question. In terms of the breakdown of 15 billion, I understand that you are actually asking the breakdown.

The revenue is comprised by milestone payment as well as R&D funding. Amounting to 500 million, they come, and outside that, 1 billion will come from new deal or existing programs expansion.

That is a breakdown.

Tomoko Wada

Thank you very much. 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 23.5 billion, and this year, it was expanded, right? If I understand it correctly.

The significant surge will come from R&D costs. Am I right in thinking that?

Cost-wise, what is the main driver or what is the major factor contributing to the significant increase in costs for 2026?

Kiyo Kaneshiro

Thank you very much for the question. Basically you had the right understanding.

Regarding R&D expenses last year, in FY 2025, which amounted to 5 billion, but this year in 2026 FY is going to increase to 6.4 billion. It's an increase of about 1.4 billion year on year.

Tomoko Wada

Thank you very much. Yes, that concludes my question.

Operator

Thank you. Mr.

Hashiguchi, please.

Kazuki Hashiguchi

This is Hashiguchi from Daiwa. Thank you.

Regarding the forecast, the assumption, what Kanashiro-san just mentioned, the remaining 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, you have a good probability included in the actual value, and also 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?

Kiyo Kaneshiro

Thank you for your question. Regarding the first point, yes, your understanding is correct.

Of 15 billion, there are quite a certain or probable the ones that includes those probable one, 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 of 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 the two years ago.

Regarding the upfront payment, what is different, and so one thing is that we have some potentially a large project. 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.

The partner as well as the future development should be optimal, including everything, we want to maximize the value of the asset. 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 2026.

Thus, we are separating this 15 billion and lump-sum payment.

Kazuki Hashiguchi

Thank you very much. Myostatin, IL-17, these ones, you have four projects here.

You will continue the clinical development of the in-house like myostatin and IL-17. Your option is to continue the development through the registration, is that possible?

Kiyo Kaneshiro

Thank you for your question. Our answer is yes.

Especially like CA9 and CLDN, CA9 and CLDN, we do have the the capability to work end-to-end forward end-to-end. For the myostatin and IL-17, for the actual manufacturing, we will need a partner.

That's our assumption. Within that framework, we like to consider what is the optimal time point to transfer or the change the hands.

Thank you very much.

Operator

Thank you very much. We'd like to take next questions from Ueda-san.

Eiji Ueda

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 had that about 50 billion that was achieved, and you were to actually reach the 100 billion yen mark in mid- to long-term. That was your long-term view.

However, this year, profit-wise, you are to reach 5 billion yen level as a basic assumption. Is that true?

Also, if you are to reach the 100 billion yen level, do you have a concrete picture to reach that far? What is your perception right now?

Kiyo Kaneshiro

Thank you very much for the question. On page 28, you are asking questions.

Regarding the revenue mid- to long-term goal of achieving 100 billion yen, we are on track of reaching this 100 billion yen 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 100 billion yen, the biggest driver here, which is described on page 28, are the core therapeutic areas. We are to maximize the values and accumulate values in these five core areas.

That is most important. 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. Also in 2026, we'd like to surpass the 2025 results in order to maximize value in these five core areas, and that is on our horizon.

In terms of mid- to long-term goals, we are making a steady progress, and everything is on track. To address your second question, which is the profit level, profitability, 32 billion plus upfront as a result of out-licensing, and if upfront payment is on top, that will be added on top of the profitability.

There is a significant potential of upside in terms of profitability and the bottom line. Thank you.

Eiji Ueda

Thank you very much. I'd like to raise a 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 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.

What prompted you to actually decide this management change? What are the factors behind this change?

Also, this time, in terms of the management organization, the Executive Vice President are to be introduced, and what are benefits or what is the advantages of deploying this Executive Vice Presidents?

Patrick Reid

You're asking about, of course, our plans to revise management, moving to the EVP, SVP, 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 with expertise around strategic planning. We have many, many programs, of course, which program 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. 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, around 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.

I think this is a natural evolution for a company like PeptiDream. I don't think this is surprising.

This is, as almost all US 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. With those two focuses in mind, those are the type of individuals we look to bring in for the next 10 years of growth here at PeptiDream.

Eiji Ueda

Thank you very much for the answer.

Operator

Thank you. Next question, Kawamura-san, please.

Ryuta Kawamura

Thank you for your explanation. Kawamura from SBI.

I have two questions. First, some overlap of the previous question, it's like this year's forecast and your target last year was quite high, and so you said that if myostatin didn't work, you have plan B, but you needed to do the downward revise, and so 15 billion is the important point.

You have quite a 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 particular number?

Kiyo Kaneshiro

Thank you for your question. This is about the 2026 forecast and the positioning of the 15 billion.

As you mentioned, that's rather conservative. Yes, this is a rather conservative expectation, and so probability is quite high.

Not only that, naturally, of course, we want to have additional one. We want to maximize the pipeline values or the assets, and so we will positively work on the further upside.

We wanted to separate these two gears. We will target a high level, but with quite a high probability project, and also some project where we have to think about the different options.

They are separate. Thank you.

Ryuta Kawamura

The second question is regarding the myostatin. 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 there are two leading companies for the oral, and other companies are working on the different mechanism of actions such as long-acting.

With this trend, you want to combine the oral and oral combination. Do you have a lot of inquiries and the potential deal partner companies, and so can we have a very high expectation, or could you discuss as much as possible?

Yes, Kawamura-san, for

Patrick Reid

the question. 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.

That places us in a very, very strong position. As you mentioned, besides the two top players in the space, the rest of the companies are navigating their strategies.

I think, as you well know, their strategies change 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, of course, licensing deals coming out of China still. It is a very fluid market space still today.

Because of that, I think that's what makes difficult to give you guidance exactly when a deal will happen. As I mentioned, I think we have an extremely valuable program.

I think we will find an exceptional deal for this program. What we don't know is the exact timing of that yet.

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. To your earlier question, I would echo Kanashiro-san's guidance, which is, yes, we're returning to more of a conservative guidance for the company.

The goal over the next three or four years is to continue to grow our clinical programs and clinical pipeline. That's how we reach the goal of a 1,000 billion Japanese yen kind of goal that we have.

We get there on the strength of the clinical pipeline. That's going to be our focus for these next couple of years.

We will, of course, intend to return to the black this year. The 150 or the 150 oku 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 the last couple of years, and that will continue to be the goal over the next two or three, 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?

Yes, we budgeted for almost a I guess 15 oku increase in our R&D costs for this fiscal year. That could potentially increase every year by around 10 oku yen depending on whether we take one program into the clinic or whether we take two programs into the clinic.

We believe part of that is going to be guided by the revenue that we can continue to bring in. As long as we can continue to maintain good revenue streams, good cash flow, and stay operating in the black, we continue to use those proceeds to invest into taking more of our exciting preclinical programs into the clinic.

I think long-term, that's how we best generate value for shareholders over the next 10 years. Thank you very much.

Kiyo Kaneshiro

Let me add a few things here. For the myostatin, we receiving several questions, and I'd like to add one thing.

From last year, we made various presentation regarding the research and clinical. As a market, 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.

When the data are becoming available, then we can expect the competitive advantage of our compound becomes clearer and clearer. Also, various company have a different clinical plans, and so our compound, 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.

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. Thank you very much.

Operator

We'd like to take questions from Mizuho Securities.

Yuriko Ishida

Thank you very much for the presentations. This is Ishida speaking.

Regarding the full-year forecast, I'd like to confirm one thing. Regarding the upfront plus alpha, additional CA9 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?

Kiyo Kaneshiro

Thank you very much for the question. Regarding page 27, myostatin, IL-17, CA9, claudin, all of these at this point in time have inquiries.

In that sense, without being selective, they can be out-licensed 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, CA9, IL-17, and claudin, we'd like to wait until Phase 1 results come out. That will be the 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, 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. At the earliest timing, out-licensing at an early timing is necessary.

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. Thank you very much.

That concludes my questions.

Operator

Thank you very much. Now we'd like to entertain one more question from Yamaji-san.

Masashi Yamaji

Thank you. Yamaji from Nikkei Biotech.

In 2026, the compounds are getting into clinical in 2026, and you mentioned that between 5 to 12 project 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 Reid

Thank you, Yamaji-san, for the question. The 6 to 12, I think we'll just comment that it's roughly a 50-50 mix between RI and non-RI.

Again, at this stage, we're not sure exactly of the six that will enter the clinic. At least the six that we know will enter the clinic for sure in 2026 are also a mixture of both RI and non-RI programs.

Last year we had six programs moving to the clinic and those were all RI related, this year will be more of a balanced mix between our RI and non-RI programs. Of course, 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 there could be a representative of an oligo peptide and potentially a cytotoxic peptide. Again, I think 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.

Masashi Yamaji

Thank you. That was very clear.

Thank you very much.

Kiyo Kaneshiro

That's all. Thank you very much.

That has come to conclude the session. Now we'd like to adjourn this financial results briefing for FY 2025.

Additional questions, please contact our 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.