PeptiDream Inc. (4587) Earnings Call Transcript & Summary

February 13, 2025

Tokyo Stock Exchange JP Health Care Biotechnology earnings 84 min

Earnings Call Speaker Segments

Yen Ting Chen

executive
#1

Good morning, and welcome to PeptiDream's Full Year 2024 Earnings Call. This is Yen Ting Chen, Head of Business Development at PeptiDream. And with me today on this call is Patrick Reid, Chief Executive Officer of PeptiDream. During today's call, Patrick will provide some recent updates and perspectives. [Operator Instructions] I would like to remind you that this call will contain remarks containing PeptiDream's future expectations, plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. Today's call is recorded and will be disclosed on PeptiDream's website. And with that, I'd like to turn the call over to Patrick.

パトリック・リード

executive
#2

Thank you, Yen Ting. Good morning, everybody. Good afternoon. Good evening. Thank you to all of those who are joining the call regardless of hour. Initially, we will go over an outline of the 2024 financial and performance-related results. I'll then move on to highlight, of course, some of the key topics and discuss a little bit what 2025 potentially looks like for us. After that, of course, we'll be happy to take any questions that anyone from the audience might have. And as Yen Ting stated, we're happy to take any questions via chat whether in English and/or in Japanese. Either is okay. Initially on Slide 4. Slide 4 explains the financial performance of fiscal year 2024. As all of you are aware by now, we had all-time highs in revenue and profits. So as highlighted in the middle column, we had initially forecast in early -- in February of 2024 to have revenue around JPY 35 billion. In May of 2024, we had revised guidance upwards to JPY 45 billion, largely on the back of the Novartis expansion that happened that we initially announced in April of 2024. Final performance results for FY 2024 came in at JPY 46.676 billion, so of course, surpassing even the revised forecast that had made. More importantly, this is 163% year-over-year higher than our results in 2023, so a significant 63% jump in revenue from 2023 to 2024. I will discuss more in subsequent slides, but that revenue is broken down to JPY 31.3 billion from the Drug Discovery and Development business side and JPY 15.36 billion from the Radiopharmaceuticals side, with the Radiopharmaceuticals side largely in line with expectations and of course, the Drug Discovery and Development business significantly higher than it was in 2023. Core operating profit came in at JPY 21.2 billion, almost a 300% increase over 2023 to which we had JPY 7.1 billion in operating profits, resulting in a net income of roughly JPY 15 billion, almost a 500% increase over fiscal year 2023. We had slightly higher in comprehensive income, in part, because of the shares that we had sold in RayzeBio upon the BMS acquisition, which we'll briefly touch on. And this all resulted in earnings per share of JPY 115.85 per share, again, a 500% increase over JPY 23.41 per share we saw in fiscal year 2023. So overall, from a financial performance perspective, an absolutely fantastic banner fiscal 2024. Let's go to the next slide. On the PeptiDream-related side of the performance, as I mentioned, that came in around JPY 31.3 billion. The main driver for this was the expanded RI-PDC deal with Novartis. That deal did not only cover RI-PDC. It actually covered another type of PDCs also. So it was a multi-PDC deal in actuality and hence, really part of the large value that we saw with $180 million upfront and very significant downstream financials attached to that deal. We also had 2 milestones or a number of milestones but a number of -- a couple of important Novartis-related milestones, which I want to highlight here with the clinical candidate nomination, which actually happened in July of 2024, which was the second clinical candidate arising from the 2019 RI-PDC collaboration we had with Novartis -- we had initially started with Novartis. And then in December just of this last year, we announced what was -- the first clinical candidate actually had then moved into Phase I here in December of '24. And so really, those 2 metrics or those 2 success or achievements is -- was the genesis behind the expansion that is shown on the left here, right? So Novartis expanded in this 2024 deal with us because of the exceptional progress we've made under the 2019 deal. And you're going to see further progress here in 2025 from programs originating from that 2019 deal. So again, I think that's a really important -- that stuff that we've been doing that has maybe not been as public, those successes are actually really translating now into catalyst news and things progressing forward. And so overall revenue, of course, PeptiDream again came in at JPY 31.3 billion for fiscal 2024. On the PDRadiopharma side of the business, as has been the case, this is the -- was profitable again. The business was profitable, marginally profitable again this year. This is the third consecutive year since we've acquired the company that it's been profitable. And so we're very, of course, happy with that. But we are now setting the foundation to see actually revenue growth happen on the PDRadiopharma side of the business. And so you can see just from looking at the 2024 performance, basically, quarter-over-quarter performance has largely been in line with what we saw both in 2022 and in 2023 of roughly around JPY 4 billion, plus or minus JPY 4 billion per quarter. And now as we look forward, of course, into 2025, there was some important news in 2024. Of course, we got NIH drug price listing for our Amyvid product. We also are seeing -- we got very good reimbursement pricing. We also got insurance coverage at the end of 2023 but carried into, of course, 2024. So the Amyvid imaging project for Alzheimer's disease is in a very good position right now. At the end of last year, we also received approval for Tauvid, which is the imaging agent for, of course, tau. So this is -- has not yet received marketing approval, but it should receive that potentially here in 2025. But that gives us 2 very important Alzheimer's imaging agents, which are very much on the back of, of course, both lecanemab and donanemab, I guess, it is, or how do we say, donanemab, the Lilly, Kisunla, is it called now, Kisunla and LEQEMBI, Eisai's product, being approved in Japan. So this is something that we expect will be growth drivers in the short time -- in the short term, is our Alzheimer's-related imaging products. So a very good performance, I think, very steady performance for the PDRadiopharma business as we set products to contribute to our growth of the business, which we'll talk about in subsequent slides. On Slide 7, it's just overall the consolidated balance sheet. We saw a significant increase, of course, in overall assets in 2024. And then on the right side, it's really just the -- we're still coming in around 60% for the ratio of equity attributable to owners of the parent of the total assets. And we are aiming, of course, to slowly progress this closer to the 70% to 80% range over the medium term. And very positively, we are, of course, at current in a negative debt ratio. Very happy. On the next slide on Slide 8 is just consolidated cash flow for the business. We had significant operating positive cash flow in 2024 at JPY 23.8 billion. And so these all, of course, were contributors. We also had a significant investment cash flow from -- as I mentioned, from the sale of the -- our stake in RayzeBio upon both the acquisition by BMS, which contributed. And then we had -- as a negative is, of course, an outward cash flow being repayment of loans. We ended December, the -- I think we actually said end of June, right, end of December 2024 on the slide, should be December instead, at JPY 48.1 billion in cash. So again, very, very -- a great performance year and a very solid financial position we sit in today. In the next section, I'm going to talk on some of the key topics and highlights and progress of the business and where we're looking forward in 2025. So on Slide 10 is still the main goals of the business. As we've discussed numerous times, is a focus on the Radiopharmaceutical business and then also a large focus on the Non-Radiopharmaceutical business. The Radiopharmaceutical business continues to be focused on developing a robust pipeline of products and programs that are going to contribute to this field -- to the radiopharmaceutical field, both on the diagnostics side and on the targeted radiotherapeutics side of the equation, both in Japan, of course, through our utilization of PDRadiopharma but also globally through our collaboration and licensing agreements. On the right side, on the Non-Radiopharmaceutical side, we are still very, very much focused on peptide therapeutics with maybe a core piece of that being around oral peptide therapeutics, again, which is highlighted by one -- by our myostatin program, but there are a number of others that we are making what I would consider super exciting progress on and look forward to talking about more in 2025. On the PDC side, very much focused on, again, the delivery -- using peptides to deliver oligo drugs, using peptides to deliver small molecule drugs, again, very similar -- both these applications being very similar to the RI concept, just changing the payload. And then on the right side of actually combining our peptides with either other peptide binders or other small molecule binders to make kind of bifunctional, trifunctional type of molecules, sometimes what we refer to as MPC-like molecules, these multifunctional peptide conjugates, which is also something, I think, everyone should look forward to in 2025 to hear more about. As we move to Slide 11, this is just highlighting some of the key topics or key achievements that happened in 2024, so in the Radiopharmaceutical business. The first is, very happily, we had announced at the end of 2023 the partnership with LinqMed to develop and commercialize the 64Cu-ATSM product for gliomas, glioblastoma and a number of other types of gliomas in Japan. They announced those results in the summer, in the May time frame of 2024. And then actually, based on those results, it progressed directly into a Phase III study here in Japan or a registrational study here in Japan, which kicked off in June of 2024. So very excited about this partnership with LinqMed. The compound looks very, very promising at this stage, and we're excited to continue to watch the progress of the Phase III. We signed a strategic partnership with Curium to clinically develop and commercialize their Lu-PSMA-I&T compound and their 64Cu-PSMA-I&T compound, which both the lutetium PSMA has actually completed its Phase III overseas and the copper, the diagnostic agent, is nearing completion of its overseas Phase III. So we're happy to make that announcement. As far as progress on PeptiDream-discovered assets or peptide-based assets, as I mentioned, we announced a new clinical -- a second clinical development candidate arising from that 2019 deal with Novartis in the summer of '24. We started a Phase I here, announced the Phase I starting in December of '24 for the -- what was the first development candidate that we had picked from that collaboration. This is referred to -- there's both the lutetium product, the therapeutic; and gallium, the diagnostic. And it's referred to currently as NNS309, but I think you will expect to hear what the actual target of this molecule is around April of this year. So this will not remain a secret for that much longer. We also completed a Phase 0 study, first-in-human study of our first wholly owned internal RI-PDC program targeting CA9, which is referred to as PD-3276. This is an imaging study that was completed. We actually will be publishing or presenting this data at the ASCO GU meeting in February.

Yen Ting Chen

executive
#3

Tomorrow.

パトリック・リード

executive
#4

Tomorrow. So tomorrow. So that should show up on our website here relatively soon. Very excited to present the results of that study. We also nominated our second -- at our R&D Day, December R&D Day, we nominated our second wholly internal program targeting Claudin 18.2, which has the identifier PD-29875 for gastric cancer, was also very exciting, announced at the end of last year. We also -- again, as I had touched on, initiation of new RI-PDC program. We expanded the Novartis deal, as I mentioned, again, very, very happily to do so with them. We have continuing discussions with a number of pharmaceutical companies on new RI-PDC programs that continue. And we're actually really focused on advancing additional in-house RI-PDC programs. So the first -- so CNS, our first; 18.2 being our second; and we already have line of sight toward 3, 4 and 5. And so we're really focused on -- I don't have exact dates of when we would announce those. They're probably second half of the year. But we're a line of sight to announcing at least 1, possibly 2 new internal clinical programs per year, is an internal goal that we have. So -- in bucket 4 was the new product approval and new dosage forms of diagnostic agents, again, very, very important to the PDRadiopharma business in the short term. They actually continue to working very hard on PDRadiopharma and received a new dosage approval for the Techne Pyrophosphate product, which is also contributing to growing revenue of that product, which is fantastic. As I mentioned, we also saw an indication change or an indication expansion around the Amyvid product, which was excellent in September of '24. And then as we just caught at the end of last year was the approval of the Tauvid agent. So exciting to see how these -- I think Amyvid will be the larger -- the largest of those 3 as far as contributors in 2025, but we're very much looking forward to these products contributing in the short term. And then last is other strategic investments and/or partnerships. We did announce an R&D service agreement and master agreement for RI supply for Actinium-225 with NorthStar. NorthStar is just a fantastic company out of the Wisconsin area and has all-new infrastructure and manufacturing capabilities for Actinium-225. That has really been ramped up. They've made significant investments to ramp up their sourcing and supply, and they are the ideal partner for us to have. And they're currently backing, of course, the CA9 product program. And then we intend to also utilize them for the 18.2 program as that looks to progress forward. So excellent to have that relationship in place. And additionally, what I'm going to talk on some later slides is we announced in December actually a new state-of-the-art manufacturing facility in a location called Kazusa Akademia Park. It's in Eastern Japan, Chiba, Japan for the clinical supply, commercial production of some of our next-gen target radiopharmaceuticals, including lutetium, actinium and also copper-based agents. So exciting announcement and I have some -- a little bit more information on that in a subsequent slide. So on Slide 12 is simply just a highlight of the current pipeline as it stands. We saw new programs added this year and not only moving forward from Phase Is into Phase IIIs but also a number of programs moving into Phase I. So it's really nice to see this pipeline actually not only expanding but actually seeing programs progress. And I think everyone should very much look forward to more news across these programs in 2025, exciting. So we talk on 13, just to put a little more granularity to that. As I had mentioned, the ATSM project -- program is running through the Phase III. I don't know that we'll have any specific updates in 2025 in regards to the ongoing Phase III as it moves toward NDA filing in the future. In regards to the PSMA, the curium-related I&T programs, we are in discussions with the PMDA as far as exactly what those bridging studies are going to look like, both for the Dx, the diagnostic; and the Tx, the therapeutic, in this case. We've put in some basic benchmarks in this slide to kind of give you some idea of when we expect those to actually move into patients and start. But Merck, Kami-san and team at PDR are just doing a fantastic job of getting these 2 products all in line, working closely with Curium and the authorities here to get these into the clinic as soon as possible. So I think that's news to look forward to in the later half of 2025, as we're able to provide more details on what the time lines of those programs will look like as we bridge into Japan. The Glypican 3 program, which is partnered with RayzeBio, so BMS has acquired RayzeBio, as everyone knows. And just for those who don't know, they actually are going to continue the RayzeBio name. It will remain as a wholly owned subsidiary of BMS. So I'll continue to say RayzeBio instead of calling them BMS at this stage. As we just announced a few weeks ago, our Glypican 3 program went into initiated Phase I here at the end or earlier this year with both the therapeutic. This is the actinium-225 therapeutic and the gallium-68 diagnostic agent. As many of you are aware, we have Japan rights to this program. And right now, it started a Phase Ia, and it is slated for an escalation Phase Ia into an expansion Phase Ib. And we are looking to participate in the global study. Whether that's part of the Phase Ib or that's part of the Phase II registrational is yet to be determined. But we're very much excited about the Glypican 3 project and moving forward and us trying to actually bring this to market in Japan at the same time that Rayze is bringing this to market in overseas areas. The CA9 product, again, tomorrow, we'll be announcing those Phase 0 results. They're very positive. I'm very, very happy with the results that we actually saw. There's 2 other CA9-targeting products in development by other competitive companies. I think ours is definitely best in class from the data that we've seen and can compare to, so very excited about where we sit. We will be looking to take this. Largely, the IND-enabling package is largely almost done. And so once all of these kind of results are formulated together, we'll be in a position in the middle of the year to actually potentially file the IND with a goal toward initiating Phase I before year-end, I would say, is the current goal. And again, that will be run in the U.S. We have everything largely in line to carry out this plan. So exciting to see CA9 progress forward. 18.2, as I mentioned, our second program, will be moving into a Phase 0. We're planning a Phase 0 study in Japan. I'm not sure -- we're not sure exactly when that will start, likely toward the second half of this year, but it's very much in the works, working with the National Cancer Center Japan to align on how to do the study and what patients to do the study in because 18.2 covers a variety of different types of gastric cancers. We also will be -- existing products that we have, again, PDR folks are going to continue to work on new formulations and expand sales of the existing products that PDRadiopharma already currently sells on the market. As far as additional new clinical programs, as I mentioned, in 2024, NNS309 progressed into the clinic in December. We expect there's going to be additional compounds moving into the clinic in the future here -- in the near future here with -- again, to the extent of I'm allowed to say, we think there'll be additional products coming out of the Novartis side that should be progressing forward. So very excited to see new clinical, new programs move out of the discovery into the clinic here in 2025 also. And then the market should also expect new development candidates. So we had developed, as I mentioned, announced 18.2, but you're going to see additional development candidates come out of some of our collaboration partners and also out of PeptiDream ourselves. So I think that's also something very exciting to be looking forward to. And then the last is the potential for new collaborations. I just had attended JPM in January, and we are very much a sought-after entity, I would say, for partnering and for access actually to our own internal programs. I think there's just a huge amount of excitement. We don't have any specific plans, say, to partner on CA9 or 18.2 at this stage, but we're certainly getting a lot of offers and/or appeals, and we are certainly getting a lot of offers and appeals on earlier preclinical assets as well as new partnerships. So it remains -- it looks very much like 2025 is going to be another very robust year on the radiopharmaceutical side on the field in general across all of the various players that are now in this space. So -- and I think as you can see from the results, we had a fantastic 2024 as far as expanding our pipeline both domestically and our Discovery or PeptiDream-originating programs. And I think very much, you should consider that that's going to continue in 2025. So very excited to see, again, this pipeline coming together. The last is just on the diagnostics side, Nondisclosed other diagnostic agents that we're in discussions with. So we continue to be very active in discussions for both therapeutic products and diagnostic products that are -- have -- either on the market outside of Japan or are in late-stage development outside Japan, similar to the PSMA I&T compounds from Curium to negotiate deals to bring those products into the Japan market. And that is going to remain an important, say, part of the business of the Radiopharmaceutical business. It's not just discovering our own drugs but also partnering to bring ex-Japan drugs into the Japan market. So very excited about the progress here of our Radiopharmaceutical business. Looking to Slide 4 (sic) [ Slide 14 ] is just to see how these come together and contribute to overall revenue growth. As everyone is aware, the bottom there, the bottom yellow is really the existing diagnostics and therapeutics that we have. This is largely showing marginal growth but important for us to maintain. One of the things that the PDRadiopharma side has been doing very well, some digital solutions, so really advancing a variety of different types of data management, compound management, imaging management solutions that potentially have upside for us as the radiopharmaceutical field in Japan grows and continues to grow. The second highlighted in the pink there are the imaging agents, Amyvid and Tauvid. We expect these are going to start contributing really from 2025, I think, more to overall growth of the PDRadiopharma business. But then the real contributors, of course, to the PDRadiopharma business will be with the therapeutic and/or theranostic payers that we have. And as is mentioned on the right, the mid-term aims are really to start having 1 NDA per year from -- late 2027 onward and to be announcing 1 to 2 new clinical candidates per year. We already started last year with that but to continue that pace going forward to really have a very expansive pipeline of exciting programs. On Slide 15 is just to touch on as we announced at the end of December, but sometimes a little bit easier to actually visualize is the new manufacturing site that will be located in the Chiba, Kazusa Akademia Park. This park, to just give you some physical geography there on the lower left, you have Narita Airport, which is east of Tokyo; and then you have Haneda Airport, which is just south or very central to Tokyo. On the Chiba side, already the main manufacturing facility for PDRadiopharma is at the Chiba factory in [ Samu ]. So this is already very close -- relatively close to Narita but a little bit further from Haneda. It's probably about less than 30 minutes to Narita and maybe 1.5 hours to Haneda. And then, of course, proximal to Haneda is the PeptiDream headquarters and also our PDRadiopharma, Kawasaki PET Imaging Lab is there, too, supplying Greater Tokyo. The Kazusa Akademia Park is -- just sits across the Aqua Line under the Tokyo Bay and is roughly equal distance from both the Chiba factory and the headquarters and almost equal distance from Haneda to Narita, generally speaking. So this is, one, is an excellent geographically situated site. The academia park is loaded with very large manufacturers, so it's very easy as far as permitting and construction kind of needs. And so we actually went through quite an exhaustive process before picking this as the next site to expand our manufacturing facilities. So again, very excited, a couple of details listed there. We're expecting this overall investment to roughly be around JPY 10 billion. As this solidifies, we will be happy to provide, of course, more details. We really have just kicked off planning after we secured the purchase of the site at the end of last year. We've just been kicking off planning, of course, as far as design, anticipating completion of construction by late 2027, it seems, at this stage, again, given all situations, assuming there's no interruptions in anything with the anticipated start of operation by 2028. And this facility is going to be very important for us going forward. And it's a very nice large site, so we'll actually probably build this in stages also. So it will give us not only the potential to bring a number of products ready to go in 2028 but also give us some extra space to potentially expand further. So I think critical as a second manufacturing site for us. Very excited with this news.

Yen Ting Chen

executive
#5

Slide 17, next slide.

パトリック・リード

executive
#6

So -- yes. So on the non -- yes, yes, go. Sorry, 16, my bad. Yes. So in addition to the excellent progress around the Radiopharmaceutical side of the business in 2024, we're going to touch on some of the highlights in the Non-Radiopharmaceutical side of the business from 1 to 5 here. So one is really the GhR antagonist program. So this actually completed a Phase I study that is called AZP-3813 with Amolyt in healthy volunteers, but they presented that data in the May-June time frame at the European Congress of Endocrinology as was written in the Endocrine Society Meeting, to which they showed very -- that this agent, one, had excellent safety profile and very, very nice PK, kinetics, but also maintained IGF levels very, very well and that it looked fully promising to take this forward into acromegaly patients in a Phase II study. As that was happening, of course, AstraZeneca had announced their acquisition of Amolyt. And so Amolyt is now a unit of Alexion, which is a unit of AstraZeneca. So we've now got 3 As, Amolyt, Alexion, AstraZeneca now. I don't even know what to call them some days, to be honest, what name I'm supposed to use. But the Alexion is the rare disease unit of AstraZeneca after they had acquired them, and of course, GhR sits in the rare disease space. And so at current, the Amolyt name still remains, and so we'll continue to use either Amolyt or AstraZeneca going forward. Preparations have made for this to progress into a Phase II study in -- here in 2025, so again, excited for this program to progress forward. And the second bullet point there, MSD, MSD outside of the U.S., Merck. So this is Merck U.S., initiated a Phase I study in June of 2024 of the second peptide therapeutic. So now we have 2 in the clinic with Merck, and this is for the potential treatment of inflammatory disease. Again, these are confidential programs that are actually not listed in Merck's U.S. pipeline since they don't normally list Phase I assets. And both of these studies are being done in healthy volunteers. And therefore, there are no NCT numbers in the ClinicalTrials.gov registrational numbers either for these. So we will announce anything as soon as we're allowed to by Merck on these programs but very excited with their progress. Number three was the S2 spike protein inhibitor. This was, of course, discovered at PeptiDream in collaboration with our sister company, PeptiAID. This was an AMED-funded project that we were able to see move into a Phase I here in the fall. And right now, it's being tested in both healthy and elderly volunteers, is the current status of the program, excellent safety thus far, as we continue to dose it upwards. And I think Merck, Kami-san on our side, our CMO, is something we'll be talking about more here in 2025. I believe the Phase I data is supposed to finish by the first half. Maybe summer of 2025 is the current anticipation. So -- the fourth one is the oral myostatin program. We had presented this for the first time in regards to obesity at our R&D Day. We demonstrated very promising lean body mass preservation results in these preclinical obese animal models or the mouse obesity models that we ran these on, especially in combination with semaglutide. So this was actually really, really fantastic results in the first and only oral myostatin inhibitor that anyone is actually aware of. So excited, and I'm sure we're going to have questions about what this program looks like going forward into 2025. And then a number of other milestones. We achieved preclinical milestones with POLA CHEMICAL, who has been partners with us in the cosmetics space for some time. We achieved another leader criteria in a second program with Johnson & Johnson in December of 2024, which I'm very excited with, to be honest, and I'm hoping for more news in 2025 on this -- on some of these programs. And then, again, there was a number of preclinical milestones that we simply were not able to make press releases for that occurred in 2024 and of course, expecting that to continue in 2025. On Slide 17 is just a brief current status of the non-radiopharmaceutical pipeline for us and currently where it sits with the compounds that we actually have in the clinic, as I just described. And then, of course, on the lower part is some of the programs that we're actually looking forward to see be announced as clinical candidates and/or move forward to the clinic here in 2025 into 2026. So we can kind of highlight that in the next slide, Slide 18, with a little bit about the outlook in what 2025 looks like. As I mentioned, for the GhR antagonist program, we're -- we very much believe this will be -- move into a Phase II here in 2025. For the CD38-ARM asset that we had with -- partnered with Biohaven, they have actually just completed the phase -- the initial Phase I study that was actually run, and it was run on 7 patients that were actually enrolled in the trial. And those results are being analyzed. This was a physician-led study. We have not seen the final results, of course, but with Biohaven, we'll be working to determine next steps, development steps for the CD38-ARM program with Biohaven. So the next one is the PD-L1 inhibitor that we had partnered with BMS, of course, and we had announced in 2023 now that they were not going to continue this program forward. They had finished 1 main part -- 4 different cohorts, 1 main part of the Phase I study and -- when it was decided to not progress further. And then we've been getting the data from BMS or sharing data with BMS over the last year. It's taken considerably more time than I had maybe hoped for to get, say, the CSR. The CSR was actually written in a synoptic fashion, and so there's been a lot of good, what I'd say, back and forth on us trying to get full access to everything to make the best decision possible for this program. I would simply say, I guess, for our PD-L1 peptides or inhibitor peptides, I think we now sit in a position where there are multiple potential avenues for this program whether that's continuing it exactly as is or whether there are other potential combinations that could be looked at. I think this is -- again, PD-L1 is still very much an area of interest for us in the checkpoint inhibitor space, and we're considering all of the options to make the very best decisions for this program. So Merck programs, again, inflammatory disease. The first one was -- that went in the clinic in 2023. We didn't say what that indication was. The second program, they did allow us to be able to provide more granularity to say that's targeting inflammatory disease. We expect more news on both of these programs, I think, in 2025. So as we say in our time sheet or in our quarterly is there are certainly -- we're at the limits to what Merck will allow us to say. So we'll simply be able to report them as we are allowed, but we continue to push the Merck side to allow us to be as transparent as possible with investors and shareholders. COVID-19, as I mentioned, again, the Phase I is complete. Phase I results in the first half, phase results into summer second half of 2025. So we'll keep everybody up to date should be additional news there. And then in other areas, initial new clinical program starts. We're actually expecting new programs to move into the clinic here in 2025, and so the market should look forward to that news, actually, programs that we have not yet talked about. Other programs that we have given mention toward, [ the ] KIT inhibitor that has been partnered with Alivexis. They continue -- they have continued to actually value up the program and generate additional preclinical data, strengthening their positioning in their partnering discussions. And so we had initially thought that they would find a partnership in 2024, but again, they continue to value up the program. And so we'll look forward to 2025 and them trying to get the very best deal for this program possible. So it's hard to fault them for anything they're doing. I love what they're trying to do. On the oral myostatin, as I had mentioned, we already had previous data for DMD and then this obesity data that we had at the end of last year. We took a lot of this data to JPM and started -- kicked off really partnering discussions in January and meeting with -- as everyone knows, we have a lot of big pharma partners, so it wasn't very hard to get sit-downs and even some of those companies that are kind of partners of ours that maybe the public doesn't know that they're partners of ours but -- so we reached out to a very nice set of initial big pharmas and had sit-downs. And I think the -- it's very exciting. I think we -- the feedback certainly is very, very good. There was very high interest across the board, as you'd expect, given the data for these compounds to do a deal. And so I think we sit in a very good position toward doing a deal around these -- our myostatin inhibitors in 2025. And again, there might be questions on this -- additional questions on this that I'm happy to discuss as far as what the -- what we're looking for to a partner. It's not just about the financials. Of course, that's important, but it's also -- we believe these oral myostatin inhibitors have value not only across the obesity market but also across the muscular dystrophy markets. And so finding the right partner to, say, leverage their capabilities and potentially monetize these exciting compounds across a variety of indications, not just obesity is also an important metric for any deal that we're hoping to do. So -- but again, very exciting times as we head into 2025. I'm very confident you're going to see something in this space. The next line is other oral peptide therapeutics. We actually have a number of in-house fully owned oral peptide therapeutics ongoing. We've maybe mentioned a couple of those over the years here and there. But I think as we switch just talking less about preclinical programs with the exception of myostatin, for example, we haven't talked about those programs as much recently. But some of these programs are looking -- are also exceptional for partnering in the second half of the year. There's significant interest for a number of other programs we have in-house, but I like where we sit. And of course, as the pharmaceutical industry continues to gravitate toward oral peptide therapeutics being very much real and very much being effective, that's only drawing more interest around the programs that we have. So the second to last bar is around PDCs, oligo-peptide drug conjugates, which we have a number of partners with, as everyone is aware of, across Shionogi and Alnylam and Lilly and Novartis and probably missing somebody there and then across the cytotoxic PDC space also, which we have a very, very big deal with Merck across. I think the market should look toward news in late 2025 around some of these programs. So we've really made some exceptional progress in the peptide, utilizing macrocyclic peptides to deliver oligo drugs, exceptional in my mind. And these are going to translate to multiple clinical candidates, which I'm very excited about in the same way with the peptide cytotoxic space. So into the second half of '25 and then also into '26 is going to be -- you're going to really see these type of efforts starting to bear fruit just like our peptide RI programs for -- started to show a lot of advancement into the clinic in 2024. So really excited about this Non-Radiopharmaceutical side of our business starting to contribute a lot of excitement here in '25, and that's going to continue into '25, '26 and going forward. And the last one is just other peptide optimization across the various collaborations that we have that everyone is also aware of that we should expect additional development candidates coming out of some of these collaborations here in '25 and into 2026. So again, a big year, I think, for the Non-Radiopharmaceutical side in '25 -- late '25, into '26 for these. So as far as how these contribute to overall revenue growth, of course, as is shown on Slide 19 here, right, we have upfront fees. We have formed new collaborations across these kind of core areas and core spaces and then now also contributing by out-licensing or partnering on internal programs that we've developed with external partners to bring in those upfront fees and out-licensing, of course, and expand our shots on goal. With all of this then in the long term or mid- to long term, actually having things actually reach the market, of course, and then receiving those commercial milestones and royalties on those programs. So really looking for '25 to be a big kickoff, I think, in the expansion of our non-radiopharmaceutical product offerings and pipeline. And I would lastly touch on the lower right there, is also this immune engager and MPC area, which very much delves very closely with the oncology space, of course, and using basically tumor-binding peptides to then connect to T cell recruiting or NK cell recruiting peptides that we've developed in-house and then starting to see these exciting combinations. I think the market should look forward -- or investors should look forward to the second half of 2025, us to talk more about some of these engagers because I think we've been really developing some amazing internal assets and starting to see some fantastic preclinical results that are making me quite excited and quite optimistic for how these will position in later '25 and then into '26 and '27 as large future deal drivers for this business. So moving into consolidated financial forecasts for FY 2025 or for this year. 2023 was JPY 28.7 billion. Last year was JPY 46.6 billion. And this year, we're forecasting JPY 49 billion in overall revenue, with a core operating profit of JPY 21.7 billion and operating profit of JPY 21.6 billion and then net income coming out very similar to last year, around JPY 15.1 billion. And I'm sure there might be questions about what the -- that revenue breakdown looks like and what that comes up. I would just simply say it's very similar to last year. We believe this is a conservative estimate. This is not simply biasing to the high side. And I think we're quite confident in our ability to continue to grow the business as we are doing. So going to the next slide is just core EPS, as I mentioned, which will come out even higher than it did last year, our current forecast. So we've definitely taken a significant step-up from the 2021, '22, '23 kind of area into the JPY 100 plus earnings per share as a new foundational level for us. So that's very exciting with a good return on equity around 30%, which is, I think, is fantastic at this stage, and then return on invested capital in the low 20%. As we look maybe future beyond just fiscal year 2025, we've used this slide for a couple of years now to where we transitioned the kind of the platform business in more to the hybrid business, where we both have a platform but then also a growing clinical and commercial portfolio, especially on the Radiopharmaceutical side of the equation and the foundation that, that allows for us. This is -- we've now stepped up to almost the JPY 50 billion per year level that we had been hoping for. And I think we will be able to maintain this level over the next few years as we really look to expand and accelerate the development pipeline to get us to where we're hoping to be in 5 or 6 years at around JPY 100 billion per year. But again, this jump from the JPY 50 billion per year to the JPY 100 billion per year is going to be driven by drug approvals, which will be very, very transparent for everyone to see. But we think we should start to see, as we mentioned in earlier slides, first NDA, one NDA per year from 2027, early '28 onward and that those products then, as they hit the market, will start contributing toward us getting to this next short-term or mid-term goal. Last on Slide 23 is how we are growing the business. I guess as one of the founders of the company and the CEO, I think this is something I still take with exceptional pride that we have not accessed the capital markets, and we continue in 11 years now since IPO. And we continue to grow this business organically with free cash flow. And so this highlights kind of in 2024, with the step-up to this JPY 50 billion per year in revenue metrics, we're generating significant positive free cash flow to be able to use that money to actually fund growth of the business and also physical growth of the business by expanding our facilities as is listed here, expanding our radiopharmaceutical facilities in Chiba. And maybe in a few months, we'll start to talk more about the expansion of PeptiDream's facilities here in Kawasaki, our Tonomachi headquarters. We had mentioned a number -- about 4 years ago, I guess, 3 or 4 years ago, we had bought the land that was directly next to PeptiDream, which is about a 2x or 2.5x footprint of our current land mass and that we're actually now going to design the -- a second phase of that business. We had plans to design a large facility there in the past. But of course, with the acquisition of the PDR radiopharmaceutical company, that size of that building made less sense and potential some of the uses for that building made less sense. And so again, I congratulate my entire team for having the good sense to take a pause and reevaluate what we really, really need to grow the business, again, always conscientious of the spend. And so it's taken us a little while, but I think we have a very exciting plan for what we're going to do with the land next to us or at least one phase of that, which we'll start to talk about here through -- here in the first half of 2025. But that building, we're in the design phases now, just kicking off the design phases of that project now. And that also has, again, a goal of being completed in late 2027. The other uses, of course, for free cash flow, as the light blue, is the acceleration of the clinical pipeline, right, investing in the products that we either are in-licensing, partnering on or that we actually have, of course, internally to continue to push those forward into the clinic and maximize the value both for patients and of course, and also for stakeholders of our company and then also to use those funds to -- for future growth of pillars, right? And so this is expanded investment not only around the PDPS system but also around other -- the Non-Radiopharmaceutical side of the business also, right, expanding our peptide drug conjugate space, expanding our oral peptide therapeutic efforts and expanding our MPC programs, all of which are exceptional programs for us to be partnering on as we develop those forward. So I don't think there's any shortage of actually the type of programs that we can be focused on and be making. And I think we have a very, very clear strategy of what we're trying to actually do here and accomplish here over the next 5 to 10 years, which is, again, makes me extremely excited to be a part of this company. So lastly, on Slide 24 is really just kind of a final highlight, is just 2024 was just an exceptional year for this business in all senses. I think PeptiDream or PDRadiopharma, the PeptiDream Group is we have all of the excitement of the hottest biotech, in my mind, but with the stability of a mid-sized pharma in some ways. So we're generating all of this potential, but we're generating it without simply continuing to capital raise, continue to dilute shareholders or stakeholders, right? So I think it's very smart growth. So this platform plus portfolio model, hybrid strategy, I think, is exceptional. I think it's unique, and I don't think there's many companies that can necessarily pull this off, of course. I think the excitement around macrocyclic peptides and the clear utility of macrocyclic peptides is what allows us to drive this model. And so again, expecting another fantastic 2025 for the business. On the clinical side, we went from 11 programs to 17 programs in 2024. And as I mentioned and explained, I think we're expecting these 17 to, of course, move significantly higher in 2025. So everyone should be very excited about seeing those announcements and that progress. And lastly, as I just mentioned, is the continued asset creation to drive further growth, not just in the RI space but also across these 3 other major areas. Oral peptide therapeutics, immune engagers are things that we're making internally as wholly owned programs to then partner with companies. And really, the oligo-PDCs and cytotox PDCs are more programs that we're doing in collaboration with partner as they bring their favorite oligo or their favorite cytotox or payloads to bear to connect or conjugate to our macrocyclic peptides. So we have significant upside opportunity across asset creation, which will allow us to continue to drive -- maintain and/or drive revenue growth as this pipeline expands toward approvals, which will really then give us the maximizing revenue effect or maximizing revenue growth over the next 5 to 10 years. So with that, I'm very happy to take any questions either orally or via chat or in any format that you wish. And thank you, everybody, for your attention and time.

Yen Ting Chen

executive
#7

Thank you, Patrick. We'll now open the floor for questions. [Operator Instructions] The first question comes from James Pulsford.

Unknown Analyst

analyst
#8

It's actually [ Tom ], James' colleague. I think I've used his Zoom account. I was just wondering 2 questions. The first is about your forecast for next year, which you briefly mentioned you've made in a similar way before of being conservative. I was wondering, I mean, what visibility do you have over the pipeline this year. And are there specific areas of certainty or uncertainty that you can comment on? And secondly, a question about your new factory in Chiba that you're building. Again, is that -- the timing and the scale of that decision to build this, is that based on visibility over certain pipeline or not?

パトリック・リード

executive
#9

Thanks, [ Tom ]. Appreciate the questions. First, to the revenue guidance of the JPY 49 billion, roughly 1/3 of that is to the PDR business, give or take, and the other 2/3 is to the [ PET ] side of the business. I think last year, we maybe had a little bit better line of sight. Of course, that Novartis deal was pretty far along by that stage when we made the initial JPY 35 billion forecast, but we weren't sure of the numbers yet nor sure if they were actually going to go through with it and sign it because you never know until it's actually signed, right? And then we waited on that. I think the number this year is we have a number of assets even beyond myostatin. So myostatin is certainly a wildcard, I would guess, I would say, right? The myostatin could go from anywhere from, I don't know, JPY 50 million, I'm not sure we'd sell for JPY 50 million, JPY 50 million, JPY 100 million upfront to JPY 500 million or more upfront, right? It has a large range. And of course, also the yen is still weak, right? Basically $1 is JPY 150, and these deals are in dollars, right? And so -- and that's just one aspect, right? So that will play into it. But we actually took quite a conservative number in this guidance for that myostatin asset. So even if we don't out-license the myostatin asset, we can still attain the JPY 49 billion in revenue, we believe, right? So certainly, it would be easier if I get a huge number on the myostatin. And if I do, there might be other programs that we don't out-license in 2025 that we value up those further, right? We actually have the idea, if we didn't do the Novartis deal, we might have partnered the myostatin program in 2024, right? But because we did that Novartis deal, we actually decided to invest more and do additional studies around our myostatin compounds to value up that program and assets further, right? And so I think that's the -- I think that's a great nature for us, but that's the nature of our business. So we're already well into discussions with a variety of potential partners for myostatin, but I've been doing this game for a long time, so you never can believe anything until it's actually on paper and sign. But at the same time, for other assets, we're also very much in discussions with interested parties on just out-licensing. And then also, I'd say expansion. There's definitely going to be expansion of deals with existing partners this year. And then there potentially might be new partners this year also. So I think, overall, as a business, yes, there's -- it's February. So we have a number of things kind of moving in parallel. We'll have to see over the first half of the year what pieces of that puzzle fall in place. If we're going to drastically exceed these expectations, of course, we will revise upward. But I think if we get the deals that we're hoping that we believe we're easily going to get, then some of these deals might also shift into 2026 instead, right? So again, I'm very, very confident of where we sit at this stage given the ask from the outside companies and the interest level from the outside companies. So we could easily excel -- go way past JPY 50 billion if we wanted to if we sold everything that was in the cookie jar at this stage or everything that was in the house. But again, that's not in the best interest of us or stakeholders, right? So yes.

Unknown Analyst

analyst
#10

Sorry, just before the factory question, can I ask, the myostatin deal, is it -- have you decided that you now want to out-license that, for example, this year or this year or next year? Or is there any more you could do in-house before you do that?

パトリック・リード

executive
#11

Excellent. Thank you because I didn't mention that. So we still very much have ongoing experiments now, [ Tom ], right? So this is -- there is no pause, right? We are -- as we always do, we are developing this program like we're going to take it into the clinic. Now we don't have any plans to take it into the clinic because obesity, it would get [indiscernible] quickly possibly. Never say never, of course, right? But I think the option A is to find the right partner, and we're continuing to generate the needed data to build up the very strongest data package to do so, including monkey -- additional monkey PK studies, just really rounding out a very powerful data package. So that -- those efforts continue on our side. Nothing is being paused. We're continuing to invest in the program and developing it just as it's 100% goal for us towards the clinic. If I don't get the deal -- if we don't get the deal from big pharma that we're hoping for, which is entirely possible, yes, I think we always have to -- we have to be smart, right? We have to consider plan B. We have a plan B, and we have a plan C for this asset at this stage. Plan A is the current focus, but we very much have plan B and plan C in place to do if we need to pull the trigger and do. We've had significant private equity come to us asking us to spin up the myostatin into a NewCo into a different [ vehicle ] for example. I mean you name it. This is -- we've had every offer under the sun to kind of do something with this program. So I'm not ruling out any of those strategies, just simply trying to be -- right now, it's focused on selling to one of the big pharmas at the right numbers, knowing that they could move this the fastest given the environment, the very competitive -- they have a different environment. But if we [ can keep ] the numbers, we have to be -- we'll be thinking about others. So... On the manufacturing side of the equation, sorry, could you -- one more time, exactly what...

Unknown Analyst

analyst
#12

I was just asking, so the third site that you sort of were talking about earlier, which is going to come online in '27 in Chiba, I was wondering the decision to pull the trigger on that now and the scale of this and everything, is that driven by specific visibility of a pipeline? Or it's kind of just your generic strategy and where you see things headed with drugs going through Phase III and stuff?

パトリック・リード

executive
#13

No. So thanks, [ Tom ]. Yes. It's 100% driven by actual products that we have. So the PSMA products will move there. The CNS product will move there. The Glypican 3 product, which we have Japan rights, will move there. Everything that is lutetium or actinium-225 will be moving to that site. Some of the historic programs and copper-related programs will still be run out of the old Chiba site or let's not call it old, Chiba 1 and Chiba 2. So it is 100% a need current. In fact, we need to open by 2028 to actually be ready for those product launches as they commercialize in Japan. So this is not building for a future need. This is actually -- we need to make sure that stays on track to not delay other things. So yes, we don't build things hoping that we'll find things for them in the future, right? So that's why we're actually going to do the site now in 2 phases. So there will be a first phase that entirely will largely be booked and have very little extra capacity. It's going to cover the vast majority of projects, programs we're going to launch between now and 2030, for example. But then it will be in a position for the second phase of that site. That's why we bought a bigger site. The second phase of that site to accommodate, say, 2030 onward or 2031, '32 onward programs, and we'll build that as we see more of a clear line of sight for need.

Yen Ting Chen

executive
#14

Our next question comes from Fumiyoshi Sakai from UBS.

Fumiyoshi Sakai

analyst
#15

This is Sakai from UBS. Right. So 2 questions. I think I'm going to ask that question once again for this myostatin program. You mentioned about the likelihood of the deal, JPY 50 million to JPY 500 million. I don't know if you're referring this as an actual expectation, but this is still early stage, Phase I. And when Chugai has out-licensed orforglipron to Eli Lilly, most of the thing unnoticed because the amount was very small and Chugai really -- Chugai didn't disclose anything about the exact amount. That's my memory, if my memory serves right. So what I'm saying is it may be a bit of risk building too much expectation prior to deal completion. So expectation management could be very important. But since you mentioned this JPY 50 million to JPY 500 million, is that going to be documented in your guidance somewhere during this year? So that's my first question.

パトリック・リード

executive
#16

Yes. Thanks, Sakai-san. No, it won't be documented. I gave you a range of values actually in line with what other assets have been sold to big pharma in the obesity muscle preservation space. So I can't comment, of course, on Chugai and their decisions or them jettisoning programs from their pipeline. I don't think usually pharma is selling one thing to another pharma. Those are not usually known for being robust deals to begin with versus a biotech selling something to big pharma in a hot market. I could get JPY 50 million tomorrow for myostatin. I have 0 -- I already know that's the case. And I'm not sure that I would take JPY 500 million in 1 calendar year on the opposite side. So I very much agree with you. If someone is going to offer us JPY 500 million, we'd probably spread that over 2 years or 3 years or try to get creative there, right? So I think the value of that program is whatever someone is willing to pay me for it. And it sits as the only oral compound that's showing muscle preservation in a clearly defined myostatin pathway that is becoming increasingly validated for use in combination with the dual agonists in obesity, right, Sakai-san. So that gives us considerable leverage. But as I mentioned in today's presentation, right, we can still hit the JPY 49 billion without doing any myostatin deal at all, right? I want to make that very, very clear. So we are very much, I think, managing expectations on what the value of that program could be. But I think I'm not excited at getting JPY 50 million upfront for that myostatin program. And I think if that was the only offer, I don't think we would, in fact, sell it. I have other PE offers that are far better than that to do. So my guidance of JPY 50 million to JPY 500 million is based off of a number of discussions that I've had over the last year about where this program potentially could be, but you are very much correct. Until something is signed on paper, it's a 0, right? We don't have any money for it yet. So we'll have to see.

Fumiyoshi Sakai

analyst
#17

Right. Okay. So if it's deal, JPY 50 million, that's going to be a very, very disappointing deal. Even...

パトリック・リード

executive
#18

If it's only JPY 50 million upfront without like a second payment, third payment, right, other close payments, yes, I would think so.

Fumiyoshi Sakai

analyst
#19

Depending on the scheme, but initial payment, it's -- yes. But anyway, yes, okay, I understand. I understand what you have said. So yes, that's clear. The second question, Claudin 18.2, you mentioned several times during your presentation. Is this program something different from the existing Claudin 18.2 compound? Can you -- I mean, you said you're going to present this tomorrow. I missed the -- that part. So could you just elaborate a little bit more about this -- your compound on this one?

パトリック・リード

executive
#20

Yes. So the presentation tomorrow is the human imaging data of the CA9 program at the ASCO GU meeting in San Francisco, I believe, right? That's the CA9, the 5 patients that were imaged in the Phase 0 study that happened in '24. The 18.2 program is gastric cancer, was just announced at the R&D Day in December, and we actually have filed abstracts to present some of that data at various conferences, medical conferences here in 2025. Again, as soon as those abstracts have been accepted, we will make the announcement and put up whatever poster presentations we have, of course. But the 18.2 is -- there are no RI conjugates targeting 18.2 as of yet, but it is a target for both an ADC, which is in the clinic. And then also, of course, Astellas' antibody is approved for gastric cancer against 18.2. So 18.2 is very much a validated target in the cancer space, so we really like where we are on that compound.

Fumiyoshi Sakai

analyst
#21

Yes. Okay. Yes, Astellas bio, that's an antibody. So...

パトリック・リード

executive
#22

That's right. That's right.

Fumiyoshi Sakai

analyst
#23

That would make some differentiation, right, from there.

パトリック・リード

executive
#24

That's right. Yes. Yes.

Yen Ting Chen

executive
#25

Our next question comes from Hidemaru Yamaguchi of Citi.

Hidemaru Yamaguchi

analyst
#26

Can you hear me?

Yen Ting Chen

executive
#27

Yes.

Hidemaru Yamaguchi

analyst
#28

So this is Yamaguchi from Citi. Can I ask a question, a simple question? Can you -- I couldn't find it. But can you give me the currency assumption for this fiscal year, 2025?

パトリック・リード

executive
#29

That's a good question. I think we basically calculated mid-range, but I think we said 140 to 150. So...

Hidemaru Yamaguchi

analyst
#30

140 to 150. Because we see there's not a risk, but there's a chance that the yen is getting stronger due to the interest rates going -- that [ open it away ] from Japan and the U.S., right?

パトリック・リード

executive
#31

Very much so. Very much so.

Hidemaru Yamaguchi

analyst
#32

Okay. So 145 to 150.

パトリック・リード

executive
#33

Yes. But even within our guidance, right, our guidance actually -- we're usually picking our guidance somewhere in the mid-range. So we total all the potential deals for any year and kind of look at the low range and look at the high range, and then our guidance is really based off of a 40% success rate kind of thing, a 50% success rate. So I think that range is quite big and inherently builds in currency risk. Yes.

Hidemaru Yamaguchi

analyst
#34

The second quick question is that -- once again, regarding myostatin inhibitor. You clearly stated that the -- because you started from the JPMorgan conference in January for a deal, and it takes at least 6 months. So you are assuming it's going to be a second half this year as your kind of rough guidance for the deal itself, whether it is happening or not. Is there any chance that you can make it a little earlier or later? I mean there's a chance for the expedited because since the speed is so critical in this space and the people trying to rush into the clinical trial, including Roche and other injection players going in to do the clinical trial this year. So is there any chance -- I mean, there's always a chance. But do you see there is a chance that you can expedite it in the first half or the second half this year?

パトリック・リード

executive
#35

I think -- first, the answer is yes, right? So the -- of course, there's a chance. We have a number of interested big pharmas, more than a handful. And of course, there is the fear of missing out, right, which is very much alive and well in the pharmaceutical industry as far as dealmaking, especially in this space. And there is very much a chance that someone will just say, I'll pay you whatever you want for it now kind of thing, right, to, one, to get it but two, to stop other people from getting it, right, is how they play sometimes. I think if it was only obesity, then I do think that there's a higher likelihood of that happening because we're interested in also having a contract that stipulates how they would go after indications like DMD or SMA or other muscular dystrophies, I think that maybe adds another month or 2 to any contract negotiation, right? If it was just straight obesity licensing deal, I think we could have the deal done in a month. You could have the deal in a month or 2 months. I think if we add DMD and myostatin and those type of things, that add additional time to any deal negotiation. So I'm more comfortable suggesting that any deal that happens is probably going to be in the second half.

Hidemaru Yamaguchi

analyst
#36

Great. Finally, I think that Masu-san is going to leave the company from March. And given the -- his kind of contribution on the setting up R&D function on the platform type of the company, can you give me some ideas how you are going to, how do you say, replacement -- I don't know, replace or, how you say, how you keep R&D capability of your company after Masu-san leaving?

パトリック・リード

executive
#37

Yes. So Masu-san's role at the company was as the Head of Chemistry, and he was really facing towards domestic partnerships. He didn't have a role at PDRadiopharma, right? He sat on the Board at PDRadiopharma after we acquired the company, of course. But he wasn't involved, I would say, or not deeply involved in, say, the R&D that was actually happening at PDRadiopharma since most of those peptide products are being done internally here at PeptiDream. As we announced in the middle of 2024, Murakami, right, Masato has moved over to take on the role of also President of PDRadiopharma from June. And at that time, Masu-san steps down from the Board and Murakami-san took his place. In addition, we had additional reorganization at PDRadiopharma and the executive team that restructured slightly the PDRadiopharma. So I think PDRadiopharma is in an excellent position regardless of who's there, right? I'm very happy with the current management structure. Kiyo remains, of course, on the Board of PDRadiopharma, and we're very much in control, I think, of things there. As far as kind of we're -- on the R&D side of PeptiDream, we're actually [ having ] a little bit reorganization ourselves. Of course, it's sad to see Masu-san leave from his role in chemistry. But we have fantastic chemistry leaders in the company. We're not a young biotech anymore. So many of our directors in chemistry are in their early 50s or mid-50s anyways, and they're very much ready to lead the organization in that capacity. We also, of course, brought in Christian, right, from Genentech, who is also contributing on -- contributing to the R&D side of the equation. So I think maybe one aspect, of course, is our domestic-facing presence to which I usually -- I would -- have always handled external, right, non-Japan or international deal and partnerships and Masu-san had classically handled Japan facing. And so with Christian coming in, some of the programs and stuff that I have been handling or managing directly are actually moving over to Christian, which is going to give me additional time to focus on the Japan side. So in the short term, I think some of these things will be passed over to myself. But like I said, we have very now very capable directors in chemistry, in biology, in pharmacology here. Our teams are now very strong, very different than 5 years ago and also very capable under Yen Ting and staff, a very capable BD and alliance management function that we didn't have, right? Me and Masu-san used to have to do the -- we were the BD. We were the R&D. We were the alliance management, [ him in ] Japan and for me doing everything outside of Japan. And that's just not the situation that we're in anymore as we've grown as a company. So I think -- while I think his contributions to PeptiDream are extremely meaningful, I also don't think there is any real significant impact, say, in actual terms of operation with his departure. And I think that gave him some assurances in actually departing the company, right?

Yen Ting Chen

executive
#38

So we have one question from the chat. And the question is what is being requested by partners from myostatin data package. Do you need to run additional animal studies? And is that why you are targeting to second half 2025 instead of earlier?

パトリック・リード

executive
#39

Yes. So thank you. That's an excellent question. So as I mentioned, again, we're constantly running the study. Nothing has stopped as far as the team. So the team is really running agnostic, I guess, or -- of our deal-making efforts, which are running in parallel, right? So the team has been very much instructed to take this towards clinical candidate and IND package kind of build-out, right? And we're working on the BD side in parallel. I don't think that's the reason for it to go into 2025. I think that's more around the actual negotiations of any type of contract. We don't have any -- we haven't started drafting any contracts as of today for that program. We are expecting, of course, though, to your question, additional data readouts. In fact, data is reading out every month. There are continued new obesity mouse models going on. We have additional animal PK studies going on. We have additional oral formulation studies going on. So we have a number of things kind of running in parallel where we already have enough data certainly to substantiate the package and do a deal, but we're just continuing to add to it and again, with the goal being you just continue to add value, right? The stronger the package, the more data that's in the package, the higher that value is up. So I would say, no, I think we can do a deal right now, but I would also say, yes, in that every month, we're adding additional data that only helps us. It only helps us. So I just think we're in a stronger position overall. I do think it's probably closer to 6 months -- 3 to 6 months to negotiate a deal once you have a term sheet. And so I'd probably expect something in the term sheet maybe by the second quarter if things are going really well, and then we can have a deal closed before in the second half. Yes. Thank you for the question.

Yen Ting Chen

executive
#40

We still have a 2 more minutes for questions [Operator Instructions] [Audio Gap]

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