PeptiDream Inc. (TYO:4587)
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May 12, 2026, 3:30 PM JST
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Earnings Call: Q4 2024

Feb 13, 2025

Yen Ting Chen
Head of Business Development, PeptiDream

Good morning and welcome to PeptiDream's FY 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. At this time, all participants are in a listen-only mode. After the presentation, there will be a question-and-answer session, or we can also take questions through the chat function. 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 the PeptiDream website, and with that, I'd like to turn the call over to Patrick.

Patrick Reid
CEO, PeptiDream

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, I'd 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 four, slide four 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.

As highlighted in the middle column, we had initially forecast in early 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. 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 radiopharmaceutical side, with the radiopharmaceutical side largely in line with expectations and, of course, the drug discovery and development business significantly higher than it was in 2023. Core operating profits 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 and comprehensive income, in part because of the shares that we had sold in RayzeBio upon the BMS acquisition, which we'll briefly touch on.

This all resulted in earnings per share of JPY 115.85 per share, again, a 500% increase over the JPY 23.41 per share we saw in fiscal year 2023. 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. It was a multi-PDC deal in actuality, and hence really part of the large value that we saw with the $180 million upfront and very significant downstream financials attached to that deal.

We also had two 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 that actually had then moved into phase I here in December of 2024. And so, really, those two metrics or those two successes or achievements 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.

You're going to see further progress here in 2025 from programs originating from that 2019 deal. So, again, I think that's really important, that stuff that we've been doing that has maybe not been as public, those successes are actually really translating now into catalysts and news and things progressing forward. Overall revenue, of course, PeptiDream again came in at JPY 31.3 billion for fiscal 2024. On the radiopharma, PD Radiopharma side of the business, as has been the case, this 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. We're very, of course, happy with that. But we are now setting the foundation to see actually revenue growth happen on the PD Radiopharma side of the business.

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. 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 in the end of 2023, but carried into, of course, 2024. 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 has not yet received marketing approval, but it should receive that potentially here in 2025. But that gives us two very important Alzheimer's imaging agents, which are very much on the back of, of course, both lecanemab and the donanemab, I guess it is. How would we say donanemab? The Lilly Kisunla, is it called now? Kisunla and LEQEMBI Eisai is probably being approved in Japan. So, this is something that we expect will be growth drivers in the short term. In the short term is our Alzheimer's-related imaging products. So, very good performance, I think, very steady performance for the PDRadiopharma business as these products contribute to our growth of the business, which we'll talk about in subsequent slides. On slide seven, it's just overall the consolidated balance sheet. We saw a significant increase, of course, in overall assets in 2024.

Then on the right side is 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. We are aiming, of course, to slowly progress this closer to the 70%-80% range over the medium term. Very positively, we are, of course, currently in a negative debt ratio. Very happy. On the next slide, slide eight, is just consolidated cash flow for the business. We had significant operating positive cash flow in 2024 at JPY 23.8 billion. These all, of course, were contributors. We also had a significant investment cash flow, as I mentioned, from the sale of our stake in RayzeBio upon both the acquisition by BMS, which contributed. We had, as a negative, of course, was outward cash flow being repayment of loans.

We ended December. 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 great performance year and a very solid financial position we sit in today. In the next section, I'm going to touch on some of the key topics and highlight some 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 the field, to the radiopharmaceutical field, both on the diagnostic side and on the targeted radiotherapeutic 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 payloads. And then on the right side, I'm 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 into slide 11, this is just highlighting some of the key topics or key achievements that happened in 2024.

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 and in the May timeframe of 2024. They actually, based on those results, progressed directly into a phase III study here in Japan or a registration study here in Japan, which kicked off in June of 2024. 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 lutetium 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 2024. We started phase I here, announced a phase I starting in December of 2024 for 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.

It's referred to currently as NNF309, 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 zero study, first in human study of our first wholly owned internal RI-PDC program targeting CA9, which is referred to as PD-32766. This is an imaging study that was completed. We actually will be publishing or presenting this data at the ASCO GU meeting in February, tomorrow. So, yeah, 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 the 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. It was also very excitingly announced at the end of last year. We also, again, as I had touched on, initiation of new RI-PDC programs. 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 third, so CNS is our first, 18.2 being our second, and we already have line of sight toward three, four, and five.

We're really focused on. I don't have exact dates of when we would announce codes. They're probably second half of the year, but we have a line of sight to announcing at least one, possibly two new internal clinical programs per year, which is an internal goal that we have. In bucket four 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 continued to work very hard on PDRadiopharma and received a new dosage approval for the TechneScan 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 2024.

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 largest, the largest of those three 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-22 with NorthStar. NorthStar is just a fantastic company out of the Wisconsin area and has all new infrastructure and manufacturing capabilities for actinium-22 that has really been ramped up. They've made significant investments to ramp up their sourcing and supply and are the ideal partner for us to have. And they're currently backing, of course, the CA9 product program.

Then we intend to also utilize them for the 18.2 program as that looks to progress forward. Excellent to have that relationship in place. Additionally, I'm going to talk on some later slides as we announce 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 targeted pharmaceuticals, including lutetium, actinium, and also copper-based agents. Exciting announcement. I have a little bit more information on that in a subsequent slide. On slide 12, it's 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'll talk on 13th 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 program, 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 Murakami-san and team at PDR are just doing a fantastic job of getting these two 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 are able to provide more details on what the timelines 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.

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-22 therapeutic, and the gallium-68 diagnostic agent. As many of you are aware, we have Japan rights to this program. Right now, it started phase I-A, and it is slated for an phase I-A into an phase I-B. we are looking to participate in the global study. Whether that's part of phase I-B or that's part of the phase II registrational is yet to be determined. We're very much excited about the Glypican-3 project and it moving forward.

That's trying to actually bring this to market in Japan at the same time that RayzeBio is bringing this to market in overseas areas. The CA9 project, again, tomorrow we'll be announcing those phase zero results. They're very positive. I'm very, very happy with the results that we actually saw. There's two other CA9 targeting products in development by other competitor 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. 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.

Again, that will be run in the U.S.. We have everything largely in line to carry out this plan. Exciting to see CA9 progress forward. 18.2, as I mentioned, our second program will be moving into a phase zero. We are planning a phase zero study in Japan. I am not sure; we are not sure exactly when that will start, likely toward the second half of this year, but it is 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 this 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 had mentioned in 2024 and then NNF309 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 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. 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. 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 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.

I think as you can see from this roadmap, 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 out. The last is just on the diagnostic side, non-disclosed 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 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 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 is 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 radiopharma business will be with the therapeutic and/or theranostic pairs that we have. And as was mentioned on the right, the midterm aims are really to start having one NDA per year from late 2027 onwards and to be announcing one to two new clinical candidates per year. We already started last year with that, but continuing 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 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 Sanmu. 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 an hour and a half to Haneda. 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 across the 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. This one is an excellent geographically situated site. The Academia Park is loaded with very large manufacturers. It's very easy as far as permitting and construction kind of needs. We actually went through quite an exhaustive process before picking this as the next site to expand our manufacturing facilities. 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 interruption in anything, we'd anticipate a stop 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. We'll actually probably build this in stages also so that 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. Slide 17, next slide, so, yeah, so on the non, oh, sorry, 16, my bad. Yeah.

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 one to five here. One is really the GHR antagonist program. 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 timeframe at the European Congress of Endocrinology, as well as at the Endocrine Society meeting, to which they showed that very 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.

Amolyt is now a unit of Alexion, which is a unit of AstraZeneca. We've now got three 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. Alexion is a rare disease unit of AstraZeneca after they had acquired them. Of course, GHR sits in the rare disease space. Currently, Amolyt name still remains. We'll continue to use either Amolyt or AstraZeneca going forward. Preparations have been made for this to progress into a phase II study here in 2025. Again, excited for this program to progress forward. In the second bullet point there, MSD, MSD outside of the U.S., Merck. This is Merck U.S. initiated a phase I study in June of 2024 of the second peptide therapeutic.

So, now we have two in the clinic with Merck, and this is for the potential treatment of inflammatory disease. Again, these are confidential programs. They're actually not listed in Merck's U.S. pipeline since they don't normally list phase I assets. Both of these studies are being done in healthy volunteers. Therefore, there are no NCT numbers in the clinicaltrials.gov registration numbers either for these. 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. 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. I think Merck, Murakami 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. 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 using combination with semaglutide. 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 cosmetic space for some time. We achieved another leading 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 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, it's 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 in 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 and what 2025 looks like. As I mentioned, for the GHR antagonist program, we very much believe this will be moved into a phase II here in 2025. For the CD38 asset that we had partnered with Biohaven, they have actually just completed the initial phase I study that was actually run.

It was run on seven patients that were actually enrolled in the trial. Those results are being analyzed. This was a physician-led study. We have not seen the final results, of course. With Biohaven, we'll be working to determine next steps, development steps for the CD38 program with Biohaven. The next one is the PD-L1 inhibitor that we had partnered with BMS, of course. Hence, we had announced in 2023 now that they were not going to continue this program forward. They had finished one main part, four different cohorts, one main part of the phase I study. When it was decided to not progress further. 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 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 decision 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. As we say in our timesheet or in our quarterly, there are certainly, we're at the limits to what Merck will allow us to say. 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 phase II results in the summer, second half of 2025. 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. The market should look forward to that news, actually programs that we have not yet talked about. Other programs that we have even mentioned for it, of course, the KIT inhibitor that has been partnered with Alivexis. They have continued to actually value up the program and generate additional preclinical data, strengthening their positioning in their partnering discussions. We had initially thought that they would find a partnership in 2024. But again, they've continued to value up the program. We'll look forward to 2025 and them trying to get the very best deal for this program possible. 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.

Then this obesity data that we had at the end of last year, we took a lot of this data to JPM and kicked off really partnering discussions in January. Meeting with, as everyone knows, we have a lot of big pharma partners. It wasn't very hard to get sit-downs. 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. We reached out to a very nice set of initial big pharmas and had sit-downs. I think it's very exciting. I think the feedback certainly is very, very good. There is very high interest across the board, as you'd expect, given the data for these compounds to do a deal. We sit in a very good position for doing a deal around our myostatin inhibitors in 2025.

Again, there might be additional questions on this that I'm happy to discuss as far as what we're looking for into 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 market. 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. 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 to 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 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 that 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's aware of, across Shionogi, Alnylam, and Lilly, and Novartis, and probably missing somebody there.

And then across the cytotoxic PDC space also, which we have a 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 2025 and then also into 2026, you're going to really see these types of efforts starting to bear fruit, just like our peptide- RI programs started to show a lot of advance into the clinic in 2024. So, I'm really excited about this non-radiopharmaceutical side of our business starting to contribute a lot of excitement here in 2025.

That's going to continue into 2025, 2026, and going forward. The last one is just other peptide optimization across the various collaborations that we have that everyone's also aware of, that we should expect additional development candidates coming out of some of these collaborations here in 2025 and into 2026. So, again, a big year, I think, for the non-radiopharmaceutical side in 2025, late 2025 into 2026 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 those upfront fees, out-licensing, of course, and expand our shots on goal.

With all of this in the long term, more 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 2025 to be a big kickoff, I think, in the expansion of our non-radiopharmaceutical product offerings and pipelines, and I would lastly touch on the lower right. There is also this immune engager and MPC area, which very much deals 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 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 2025 and then into 2026 and 2027 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, an 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 that revenue breakdown looks like and what that comes off. 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, 2022, 2023 kind of area into the JPY 100+ earnings per share as a new foundational level for us. So, that's very exciting, with a good return on equity around 30%, which I think is fantastic at this stage. And then a return on invested capital in the low 20%.

As we look maybe to the future beyond just the fiscal year 2025, we've used this slide for a couple of years now to where we've transitioned the kind of the platform business into more to a 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 in the foundation that allows for us. 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 five or six years at around JPY 100 billion per year.

But again, this jump from JPY 50 billion per year to 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 on earlier slides, first one NDA per year from 2027, early 2028 onward. And that those products then, as they hit the market, will start contributing towards us getting to this next short-term or midterm goal. Last 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 this 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 four years ago, I guess, three or four 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 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 PDRadiopharma, that size of that building made less sense, and potential of 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 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.

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. Then also to use those funds for future growth of pillars, right?

This is expanded investment, not only around the PDPS system, but also around the non-radio pharmaceutical 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. I don't think there's any shortage of actually the type of programs that we can be focused on and be making. I think we have a very, very clear strategy of what we're trying to actually do here and accomplish here over the next five-to-ten years, which is, again, makes me extremely excited to be a part of this company. The last thing on slide 24 is really just kind of a final highlight. It's just 2024 was just an exceptional year for this business in all senses.

I think PeptiDream or PDRadiopharma and the PeptiDream Group is we have all of the excitement of the hottest biotech in my mind, but with the stability of a mid-size pharma in some ways. So, we're generating all of this potential, but we're generating it without simply continuing to capital raise, continuing 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.

As I mentioned and explained, I think we're expecting this 17 to, of course, move significantly higher in 2025. Everyone should be very excited about seeing those announcements and that progress. The last piece, as I just mentioned, is the continued asset creation to drive further growth, not just in the RI space, RI space, but also across these three other major areas. Oral peptide therapeutics and immune engagers are things that we're making internally as wholly owned programs to then partner with companies. Really, the oligo PDCs and cytotox PDCs are more programs that we're doing in collaboration with partners 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 five to 10 years. So, with that, I am very happy to take any questions either orally or via chat or in any format that you'd wish. And thank you, everybody, for your attention and time.

Yen Ting Chen
Head of Business Development, PeptiDream

All right. So, thank you, Patrick. We'll now open the floor for questions. If you have any questions, please tap the raise hand button. And after we call on you, please unmute and ask your question. As Patrick mentioned, you may also ask a question through the chat function in English or Japanese, whichever language you prefer. The first question comes from James Hosford.

Hi, James.

James, you are now unmuted. Please ask your question.

Hi. It's actually Tom, James's colleague. Sorry, I think I've used his Zoom account. But thanks very much for the call and for your explanations, Patrick. I was just wondering, two 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, the 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? Thank you very much.

Patrick Reid
CEO, PeptiDream

Thanks, Tom. Appreciate the question. First, to the revenue guidance of JPY 49 billion, roughly a third of that is to the PDR business, give or take. And the other two-thirds is to the PeptiDream side of the business. I think last year, we maybe had a little bit better line of sight, of course, that Novartis deal, which 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 wild card, I would guess I would say, right?

The myostatin could go for anywhere from, I don't know, $50 million. I'm not sure we'd sell it for $50 million. $50 million, $100 million upfront to $500 million or more upfront, right? It has a large range. And of course, also the yen is still weak, right? Basically, a dollar is 150 yen, and these deals are in dollars, right? 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 obtain 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 had 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 in assets further, right? And so I think that's the 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 signed. But at the same time, for other assets, we're also very much in discussion 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, yeah, 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'll 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.

We could easily exceed 50, 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 our stakeholders, right? So.

Thank you. Yeah. Sorry, just before the factory question, can I ask the myostatin deal? 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?

Excellent. Thank you, because I didn't mention that. So we still very much have ongoing experiments now, Tom, right? So there is no pause, right? 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 to the clinic because obviously, it would get infected 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 additional monkey PK studies, just really rounding out a very powerful data package. So 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% go 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, yeah, I think we always 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 new co., into a different vehicle, for example. I mean, you name it. We've had every offer under the sun to kind of do something with this program.

I'm not ruling out any of those strategies, just simply trying to be right now. It's focused on selling it to one of the big pharmas at the right numbers, knowing that they could move this the fastest, given the environment, the very competitive landscape and environment. But if we don't get the numbers we want, then we'll be thinking about others, so.

Cool. Thank you. Thank you.

Yeah. On the manufacturing side of the equation, sorry, could you one more time exactly what?

I was just asking, so the third site that you sort of were talking about earlier, which is going to come online in 2027 in Chiba, I was wondering, the decision to pull the trigger on that now and the scale of it and everything, is that driven by specific visibility over pipeline, or it's kind of just your generic strategy and where you see things headed with drugs going through phase III and stuff?

No. So thanks, Tom. Yeah. It's 100% driven by actual funds that we have. So the PSMA products will move there. The CA9 product will move there. The Glypican-3 product, which you have Japan rights, will move there. Everything that is lutetium or actinium-22 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. I don't want to say Chiba 1 and Chiba 2. So it is 100% a current need. 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 this stays on track to not delay other things.

So yeah, 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, though, in two phases. So there'll 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'll 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, 2032 onward programs. And we'll build that as we see more of a clear line of sight toward need.

Okay. Great. Thank you very much [audio distortion] .

Thank you. Thanks, Tom.

Yen Ting Chen
Head of Business Development, PeptiDream

All right. Thank you, Tom. Our next question comes from Fumiyoshi Sakai of UBS. Sakai-san, please unmute and ask your question.

Fumiyoshi Sakai
Analyst, UBS

Good morning, Patrick. This is Sakai from UBS.

Patrick Reid
CEO, PeptiDream

Hi, Sakai-san.

Fumiyoshi Sakai
Analyst, UBS

Hi. Right. So two questions. I think I'm going to have that question once again for this myostatin program. You mentioned about the likelihood of the deal, $50 million-$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 things are noticed because the amount was very small, and 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 $50 million-$500 million, is that going to be documented in your guidance somewhere during this year? So that's my first question.

Patrick Reid
CEO, PeptiDream

Yeah. Thanks, Sakai. 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 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 $50 million tomorrow for myostatin. I have zero. I already know that's the case. And I'm not sure that I would take $500 million in one calendar year on the opposite side. So I very much agree with you.

If someone's going to offer the $500 million, we'd probably spread that over two years or three 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 agonist 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 $50 million upfront for that myostatin program.

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 $50 million-$500 million is based 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 zero, right? We don't have any money for it yet. So we'll have to see.

Fumiyoshi Sakai
Analyst, UBS

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

Patrick Reid
CEO, PeptiDream

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

Fumiyoshi Sakai
Analyst, UBS

Depending on the scheme, but initial payment.

Patrick Reid
CEO, PeptiDream

Yeah.

Fumiyoshi Sakai
Analyst, UBS

Yeah. But anyway, yeah. Okay. I understand. I understand what you have said. So yeah, that's clear. The second question, Claudin 18.2, you mentioned several times during your presentations. Is this program something different from the existing Claudin 18.2 compound? I mean, you're going to present this tomorrow. I missed that part. So could you just elaborate a little bit more about your compound on this one?

Patrick Reid
CEO, PeptiDream

Yeah. 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 five patients that were imaged in the phase zero study that happened in 2024. 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 medical conferences here in 2025. Again, as soon as those abstracts have been accepted, we will make the announcements and put up whatever poster presentations we have, of course. But the 18.2, 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, Zolbetuximab antibody is approved for gastric cancer against 18.2.

18.2 is very much a validated target in the cancer space. We really like where we are on that compound.

Fumiyoshi Sakai
Analyst, UBS

[audio distortion] t hat's an antibody. So.

Patrick Reid
CEO, PeptiDream

That's right. That's right.

Fumiyoshi Sakai
Analyst, UBS

That could make some differentiation, right, from the...

Patrick Reid
CEO, PeptiDream

That's right. Yep.

Fumiyoshi Sakai
Analyst, UBS

Okay. All right, so expecting for this. Thank you very much.

Patrick Reid
CEO, PeptiDream

Thanks, Sakai-san .

Yen Ting Chen
Head of Business Development, PeptiDream

Okay. Thank you, Sakai-san. Our next question comes from Hidemaru Yamaguchi of Citi. Yamaguchi-san, please unmute and ask your question.

Hidemaru Yamaguchi
Analyst, Citi

Hi. Can you hear me?

Yen Ting Chen
Head of Business Development, PeptiDream

Yes.

Hidemaru Yamaguchi
Analyst, Citi

Thank you. So this is Yamaguchi from Citi. Thank you very much for taking my questions.

Yen Ting Chen
Head of Business Development, PeptiDream

Sure.

Hidemaru Yamaguchi
Analyst, Citi

My first question is a simple question. I couldn't find it, but can you give me the currency assumption for this fiscal year, 2025?

Patrick Reid
CEO, PeptiDream

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

Hidemaru Yamaguchi
Analyst, Citi

140-150. Because this year, there's a, not the risk, but there's a chance that the yen is getting stronger due to the interest rates going the opposite way from Japan and the U.S., right?

Patrick Reid
CEO, PeptiDream

Very much so. Very much so.

Hidemaru Yamaguchi
Analyst, Citi

Okay. Thank you. So 145, I feel, 100.

Patrick Reid
CEO, PeptiDream

Yeah, but 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.

Hidemaru Yamaguchi
Analyst, Citi

Okay. Thank you.

Patrick Reid
CEO, PeptiDream

Yeah. Yeah.

Hidemaru Yamaguchi
Analyst, Citi

Thank you. The second quick question is that, once again, regarding myostatin inhibitor.

Patrick Reid
CEO, PeptiDream

Yeah. Yeah.

Hidemaru Yamaguchi
Analyst, Citi

Yeah. You clearly stated that because you just started from the JP Morgan conference in January for a deal, and it takes at least up to six months. So you are assuming it's going to be a second half of 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 injectable players going to do the clinical trial this year. So is there any chance? I mean, there's always a chance, but do you see there's a chance that you can expedite it in the first half rather than the second half this year?

Patrick Reid
CEO, PeptiDream

I think, well, first, the answer is yes, right? So 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 deal-making, 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? It's 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 two to any contract negotiation, right? If it was a straight obesity licensing deal, I think we could have the deal done in a month. You could have the deal in a month or two months. I think if we add DMD and myostatin to those type of things, that adds 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, Citi

Great. Thank you. Finally, I think Masuya-san is going to leave the company from March. And given 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 to say, replacement? I don't know, replace or how to say, how to keep R&D capability of your company Masuya-san leaving?

Patrick Reid
CEO, PeptiDream

Yeah. Masuya-san's role at the company was as the head of chemistry. And he was really focusing 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 tests and products are being done internally here at PeptiDream.

Hidemaru Yamaguchi
Analyst, Citi

Right. Right.

Patrick Reid
CEO, PeptiDream

As we announced in the middle of 2024, Murakami-san, right, Masato has moved over to take on the role of also president of PDRadiopharma from June. And at Masuya-san stepped down from the board, and Murakami-san took his place. In addition, we had additional reorganization at PDRadiopharma in the executive team that restructured slightly to 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 undergoing a little bit of reorganization ourselves. Of course, it's sad Masuya-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 have always handled external, right, non-Japan or international deal and Masuya-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.

In the short term, I think some of these things will be passed over to myself. But like I said, we now have very capable directors in chemistry, in biology, in pharmacology here. Our teams are now very strong, very different than five years ago. And we're very capable under Yen Ting and staff, a very capable BD and alliance management function that we didn't have, right? Masuya-san used to have to do it. We were the BD, we were the R&D, we were the alliance management for him doing 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 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? Yeah.

Hidemaru Yamaguchi
Analyst, Citi

Yeah. Yeah. Thank you very much. Thank you.

Patrick Reid
CEO, PeptiDream

Yep.

Yen Ting Chen
Head of Business Development, PeptiDream

Okay. Thank you, Yamaguchi Tom. So we have one question from the chat. And the question is, "What has been requested by partners from myostatin data package? Do you need to run additional animal studies? And is that why you are targeting to the second half 2025 instead of earlier?

Patrick Reid
CEO, PeptiDream

Yes. Thank you. That's an excellent question. So as I mentioned, again, we're constantly running the studies. Nothing has stopped as far as the team. So the team is really running agnostic, I guess, of our deal-making efforts, which are running in parallel, right? So the team has been very much instructed to take this toward 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 six months, three to six 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 could have a deal closed before in the second half. Yeah. But thank you for the question.

Yen Ting Chen
Head of Business Development, PeptiDream

Okay. We still have a few more minutes for questions. If you have any additional questions, please tap the raise hand button or enter your question through the chat function.

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