PeptiDream Inc

TSE:4587

Earnings Call Analysis

Strong financial performance and positive developments for future growth

In the first half of fiscal 2024, the company reported revenues of approximately JPY 36 billion, exceeding initial estimates. Following a collaboration with Novartis, revenue guidance for the full year has been revised upward to JPY 45 billion. Core operating profits reached JPY 24 billion, with a net income of JPY 18 billion. The company is optimistic about the second half, projecting total revenues between JPY 15.4 billion and JPY 16.2 billion. Key products like Amyvid are expected to see increased sales due to higher reimbursement rates. Additionally, ongoing advancements in their clinical pipeline signal strong long-term growth potential.

Strong Financial Performance in H1 2024

The company has reported impressive first half results for fiscal year 2024, with total revenues reaching approximately JPY 36 billion. This figure consists of JPY 28.5 billion from PeptiDream operations and JPY 7.6 billion from PDRadiopharma. Importantly, both operating profit and net income surpassed expectations, achieving about 120% of initial planned targets.

Revised Revenue Guidance Reflects Confidence

The revenue guidance for the full fiscal year has been raised significantly from JPY 35 billion, prior to the partnership with Novartis, to a new estimate of JPY 45 billion, with the potential to exceed JPY 50 billion depending on performance. This revision is based on successfully finalizing strategic collaborations and robust product performance, particularly Amyvid, which is now positioned for substantial growth following a recent price increase.

Upcoming Growth Catalysts

Looking towards the second half of 2024, the company remains optimistic about outperforming guidance. Anticipated revenue contributions include expected milestones and R&D funding between JPY 1.2 billion and JPY 2.5 billion from Novartis projects. The ongoing development of their various therapeutic programs is also expected to drive additional revenue growth.

Key Product Developments and Market Opportunities

Significant advancements include the promising Phase I clinical trial results for the AZP-3813 program, a growth hormone antagonist that is moving into Phase II. Additionally, drugs like Amyvid might see increased revenues due to recognized higher reimbursement prices, and Tauvid could soon enter the market, further driving sales potential.

Strategic Positioning within the Radiopharmaceutical Sector

The company has aggressively positioned itself within the growing radiopharmaceutical market, bolstered by the Novartis partnership. The collaborative efforts have expanded their pipeline, including harboring multiple RI (Receptor-Targeted) PDC (Peptide Drug Conjugate) trials, which are essential for both diagnostic and therapeutic use, primarily focused on oncology.

Management Changes and Strategic Outlook

Recent management changes, including the appointment of Masato Murakami as the new president of PDRadiopharma, reflect the company's focus on leveraging both parties' strengths. These leadership adjustments aim to foster collaboration and drive forward strategic initiatives that enhance growth prospects.

Balance Sheet Highlights and Financial Health

By the close of the first half, the company's cash reserves increased to JPY 25 billion, augmented with an estimated JPY 50 billion post-Novartis transaction. With a net debt-negative position and a commitment to improving equity ratios, the company is in a robust financial state to support its expansion plans.

Outlook for 2025 and Beyond

While maintaining confidence in sustaining revenue levels above previous projections, the company highlights the importance of upcoming product launches and clinical trial results for ongoing growth. Many products are set for potential market entry by 2025, including advancements in therapeutic areas such as obesity and oncology, underpinning the company’s long-term strategic vision.

Earnings Call Transcript 2024-Q2

[パトリック・リード, executive]

Good morning, good afternoon and good evening to everyone joining our financial results call for the first half of the fiscal year 2024.

Slide 2. Initially, I'll give a brief outline of the first half consolidated financial results. And then we'll move on to a couple of key topics. And, of course, touch base on what the second half of 2024 looks like and a little bit of a preview into -- potentially into 2025 here. And then, of course, happy to take any questions that may arise.

So, initially, on Slide 4 is our first half performance for 2024, which was announced yesterday, of revenue of 36 -- roughly JPY 36 billion. This is divided about JPY 28.5 billion from the PeptiDream side and about JPY 7.6 billion from the PDRadiopharma, from the radiopharmaceutical business side of the equation. We, of course, now have a core operating profit at JPY 24 billion and at current net income of roughly JPY 18 billion.

As everyone is aware, we had initially forecasted in February of 2024 to have revenue for the fiscal year of JPY 35 billion, with these numbers or this revenue projection revised in May to JPY 45 billion on the announcement of the Novartis collaboration, which occurred, of course, in the end of April. When we made these forecast projections in May, there was

[Technical Difficulty]

30-day delay in being able to finalize the deal. And the deal was then finalized in, basically, mid-June. And then with the deal finalization, of course, there is a certain amount of time before we actually receive the upfront payment from Novartis. And as everyone is aware, because that was in U.S. dollars, we certainly were exposed to certain, say, currency risks, while we waited to exchange that U.S. dollar -- a significant U.S. dollar payment into Japanese yen.

And so, therefore, when we made this forecast in May, of course, we were, what I would call, intentionally conservative in our projection to, basically, be safe.

One additional aspect also is once the deal was completed in June, we had to start discussing with our auditors, our external auditors, as to what percentage of the upfront money would in fact be accounted for in our first half earnings here. And so the end result of this was, in fact, of course, we went through the HSR process smoothly. We were very fortunate to receive the U.S. dollar-based wire transfer in mid-July, and our CFO, Kiyo, did a fantastic job of actually getting us an extremely favorable, what I'd call, extremely favorable currency exchange rate in the USD 157, USD 158 per -- to Japanese yen rate, which looks fantastic, of course. Now -- and so those were all -- I think we had a lot of really nice thing to kind of happen in parallel there.

And so where we sit today, of course, is now as we look at the results through the end of June, many of you may be wondering that we're 80% of the way there as far as meeting our revenue goals for the year as at May. In addition, as you look at the core operating profit, operating profit and net income bars, all of those are, of course, exceeded the 100%, right, roughly 120% of that goal has already been achieved. And so we'll briefly touch on what the second half of 2024 looks like for us. But I would just want to make the comment that as we sit towards the second half of this year, we have a number of catalysts and/or potential additional revenue sources that may cause us to revise again these earnings upward here in the second half of 2024. And we will do so expeditiously if any of those events actually take place.

Next slide. So in regards specifically to PeptiDream, here shown on Slide 5. Of course, in the first half, the main revenue source was from the Novartis expansion, deal expansion, and this was not just around RI PDCs only. We expanded the number of programs in the RI PDC space we were doing with Novartis.

In addition to that, we, in fact, added an additional different type of PDC programs to the deal. They were announced specifically in the press release that we had sent out, but another type of peptide drug conjugate was also part of this deal. So it was, one, an expansion of our collaboration around RI PDCs and then it was also had a new component to it as far as adding additional types of peptide drug conjugate programs to the collaboration. So really just a fantastic overall results that I think really goes to show how much success we've had across the Novartis collaboration to date.

There was a small amount of money, of course, that was accounted for as milestones and other R&D funding, roughly around JPY 1 billion or so. That also happened here in the first half. As we look towards the second half, and again, I think these are our conservative projections, as we look to the second half of 2024 here, we anticipate, of course, I'll start on the right, the milestones in our R&D funding of around JPY 1.2 billion to JPY 2.5 billion. And in fact, here, just in July, we announced another Novartis milestone that will show up in the third quarter results, of course, that was around JPY 1.1 billion or JPY 1.2 billion already. So we're of course fairly comfortable or confident in achieving the high-end range, probably, on this milestone et cetera bucket on the right.

On the upfront payments, we write JPY 0 to JPY 2.4 billion. I think this is probably just at this stage some unknown. We -- this is -- we have a couple of deals that will likely close in the second half of 2024. I'll say that won't have a high likelihood of closing that would fall in this range. But I would also say, in addition to that, we're actually negotiating a number of large deals with a number of existing foreign pharmaceutical partners and also new potential pharmaceutical partners that have the potential to be quite significant.

One -- with Novartis deal happening, I think, in the first half of 2024, of course, we've done very well financially already for the year. But we really have 2 types of deal structures, as most people are probably aware. One is collaboration-type deals or discovery-based collaboration-type deals. Often, those type of deals, we might have less say on when that deal actually completes. And that is in contrast to, say, out-licensing type deals, such as finding partners for our myostatin program or our internal IL-17 program or other internal programs that we might have, those type of out-licensing deals, we have, say, much more control, of course, over when we determine or decide to, say, out-license or partner on those assets.

So with those 2 buckets in mind, I would say, as far as internal assets that we were looking to out-license potentially for 2024, I would say we're largely shifting those to 2025 at this stage. We will continue to build out, say, the data packages around myostatin and other internal assets, more with a view to value up those programs further before we maybe consummate any kind of out-licensing or partnering deals. And so those have a little bit more of a, again, I'd say, a runway toward the 2025 fiscal year.

As far as the collaboration bucket goes, again, we have a number of deals in negotiation, almost as we always do, which are quite significant. And as of today, I am not yet sure whether or not we will be able to whether those deals will consummate in 2024 or whether those deals will, in fact, be able to be moved to 2025. Our honest preference, of course, well, probably to see those moving to 2025, if we have say in that matter, but I'd say there's a very high likelihood that we, in fact, may not have a say in when those deals are consummated. As certain of these partners, of course, have certain budgets already set up for the fiscal 2024 calendar year, that might result in those deals again happening during this fiscal year.

So as soon as we see any of these deals kind of come together and/or that are announced, again, as I mentioned, we'll revise upward accordingly at that time. And so I think that's how we'll have to play by ear in the second half of 2024 from the perspective of PeptiDream.

In regards to the PDRadiopharma business, the first half of 2024 had first quarter and second quarter combined revenue of around JPY 7.7 billion. This is pretty much in line with forecast for us. Last year, I think, in the first half of last year, we saw roughly around JPY 8 billion, so this is pretty much very consistent with that. We, overall, are expecting the second half to look a little better, should actually trend potentially a little bit higher here, more towards the JPY 8 billion range of this. But total revenue for the full fiscal 2024 year should come in between JPY 15. 4 billion and JPY 16.2 billion.

As is listed here, some of the, I guess, headwinds are still the slow recovery in the SPECT business. A slow recovery, I think, just overall weakness in the SPECT business. There's just -- it's not a super area of growth and we're just trying to kind of maintain, I'd say, the status quo as far as the SPECT business goes. The PET aspects of the business, and I think partially on the back of Amyvid, is hoping to kind of maintain revenue or potentially start to see revenue growth as we head into the second half of 2024 and looking towards 2025.

I think one of the big announcements that we were quite pleased or delighted to announce was the NIH -- NHI, sorry, drug price listing for Amyvid, which happened here, I think, in May and June, where we actually saw almost a doubling of the kind of list price for Amyvid. So a very high reimbursement price for this product, which is a really fantastic news, overall, for us in this program. And so we look forward to see how Amyvid sales, which are trending in the right direction, but I still think it's extremely early days, of course, as we see how Alzheimer's and LEQEMBI sales themselves do. And of course, what impact the approval of Lilly's [ donanemab ] in the U.S. has and whether, in fact, that gets approved in Japan also in 2024.

But I'd say, certainly, there's tailwinds behind the Amyvid product going forward. And we also hope that Tauvid could potentially be approved in the relatively near future. And then that also could be a -- start contributing potentially to revenue growth at some point here.

So in a good overall position for the PDRadiopharma business. Again, as we've mentioned multiple times, the real goal is growing the pipeline of products in the portfolio of PDRadiopharma. That's our true long-term goal, of course, of the business and the real only way to see revenue growth occur. And I think we're off to an extremely favorable start in regards to that.

So continuing on Slide 7 is just the overall balance sheet. We have quite a large change in current assets. Of course, this is on the back of the -- not only the Novartis deal in the light-blue current asset bucket, but of course, not to be forgotten is the share sale of our stake in RayzeBio, which actually, of course, occurred when the deal or the acquisition of RayzeBio closed in, I don't remember when, actually, March, maybe, the March, April timeframe, I believe. And the change in the non-current assets here of the negative JPY 8 billion, of course, is actually associated with the shares being sold and then that cash proceeds actually moving into the current asset bucket above.

On the liabilities, equity side of the equation, of course, the liabilities has also gone up by JPY 8 billion, and this is really the tax liability associated with both of these events. As far as our kind of ratio of equity, we're [indiscernible] to stakeholders. We're at 61%, so a slight increase. And again, overall, medium term, the goal hasn't changed. So get us back into the 70% to 80% range for this. And very pleasantly, of course, we are net debt negative, which is a very nice position to be in.

Continuing to cash flow. So we closed the end of fiscal year 2023 with about JPY 19.5 billion in cash and/or cash equivalents, largely cash, of course.

And then the cash flow from activities be -- our largest one here, of course, was associated with the RayzeBio shares, as I mentioned. What is listed here is at the June 30 mark or the June closing of the first half, we had around JPY 25 billion in cash. And that, of course, does not account for the Novartis upfront payment, which didn't come in until July. And so actually, I think at the end of July, we roughly have -- we have JPY 50 billion plus in cash position. So we're in an extremely positive and strong -- have the strongest we've ever had, cash position for the company to start to deliver on our various goals.

Moving into Slide 10. Our key areas of focus of the company remain unchanged. On the radiopharmaceutical side, again, we continue to drive the discovery of novel peptide delivery ligands that can be used as RI conjugates for not only diagnostic purposes, but also for, of course, therapeutic purposes with the main focus being oncology. The overall goal, of course, is to grow and expand this pipeline as rapidly as possible. And I'll briefly touch on what I think are some fantastic achievements already seen to date and some of what we're looking for to going forward.

On the right side of this is all around the non-radiopharmaceutical part of the business, where is a lot of -- a lot more of this part of the business, I think, is actually happening under the surface and is maybe not as prominent, I guess, I'd say, as the radiopharmaceutical achievements that have happened of late. However, oral peptide therapeutics, in addition to a number of novel classes of peptide drug conjugate, including peptide oligos or peptide cytotox conjugates are in collaboration across a number -- and variety of collaboration partners are making fantastic progress. And I really think the non-radiopharmaceutical side of the business is going to shine quite rightly through the end of the year and actually really into 2025. And so I think that's something that I think stakeholders should look into. I look forward to seeing this part of the business also shine as brightly as the radiopharmaceutical side of the business has.

So moving to Slide 11. Additional key topics around the radiopharmaceutical side of the business. In the first half, of course, is highlighted with the Novartis expansion. But only -- in addition to that, we've now had multiple RI PDC programs from the 2019 deal are actually progressing towards clinical entry. And as I mentioned here, in July, we actually had announced IND-enabling milestone of the second program, which is I think is listed, as we'll touch on, as program #3 moving toward the clinic. And so I'll mention about those in a second. But we're very much looking forward to some of the fruits of the labor of our Novartis -- long-term Novartis relationship to be seen here.

As I mentioned, with the launch of LEQEMBI in Japan in -- the label was expanded in 2023. In addition to that, the NIH drug price standard was set as is listed here earlier this -- in the first half year of this year. And so we're really looking forward to Amyvid being in a very strong position for Amyvid in this product and seeing revenue of this product growth going forward.

The third point was actually the announcement of the LinqMed partnered 64 copper ATSM collaboration. The results of the safety and efficacy or really the safety and dose finding study in the Phase I were announced by LinqMed in concert with the National Cancer Center here in Japan, recently, happened in June. They actually presented some of this data at a conference also. And on the back of that, of course, we're seeing this product move forward here into a Phase III study going forward. I'll touch on that again in a subsequent slide.

Also is the Phase 0 initiation of our in-house CA9 program. Very happy to see this. This is our first fully-owned in-house theranostic pair or diagnostic cost therapeutic pair with initially the copper 64, so the diagnostic agent going into the Phase 0 study. We had the first patient image, I think, in roughly the June timeline. We've now since seen a second patient image. And I think we've actually already now recruited a third patient to be imaged, the end goal is to see about a total of 6 patients to be imaged here over the coming months and then we'll determine the best way to summarize and/or disclose -- provide an update on what we find from those results.

I think, thus far, and it would be premature to comment too much, but I think we're very excited about what we've seen thus far. But 2 patients does not make a study, of course, as of yet. So very positive about things and looking forward to the future when we can discuss this program more.

Lastly, I think the new management team changed. So as we announced on July 1, our Chief Medical Officer, Dr. Murakami or Masato Murakami, was also appointed as the new President of PDRadiopharma, which started from July 1, taking over from the prior President. And so we've had a little bit of a management reshuffle on the PDRadiopharma side. And I think with, one, Dr. Murakami being an MD and a PhD and an MBA, I guess if we're going to go -- he has a lot of letters after his name. But it's really the right person to be running and leading PDRadiopharma for us at this stage. And I think his appointment at PDRadiopharma really further kind of synergizes or integrate the 2 companies that will help just across the board for both companies to accelerate and expand the products and pipeline of what we're doing there. So very excited with that announcement and look forward to things to come.

So as we look towards Slide 12, the kind of current pipeline. The big changes, at least on this slide, specifically, and this is utilized, of course, in our quarterly reports, is the LinqMed copper 64 ATSM moving into the Phase III bucket now from the Phase I. So it's actually skipping the Phase II, moving directly to a Phase III, which, in Japan, they don't really use the term registrational study, and so a Phase III is referred to as a registrational study in this case, but this is the current standing. And this actually, in fact, started in June on the back of the Phase I results. So very excited again with the progress of this program that we partnered with LinqMed in the -- at the end of 2023.

The other addition that I would guess highlight is the Novartis program #3, which I touched on earlier. This was not previously in our pipeline. This has now, of course, initiated IND-enabling studies. And so we're looking forward, it's nice to see this addition to our pipeline going forward. So then I will briefly touch on each of these in the slide for [indiscernible].

So as mentioned, the ATSM product has already initiated the Phase III study. And so we will look forward to the progress of this registrational study going forward. The Glypican 3 project, which is partnered, of course, with RayzeBio. And so just for everyone's knowhow, we had thought once BMS took over RayzeBio, that the name RayzeBio impact might go away, but the BMS has decided to maintain the RayzeBio name and it will stay as RayzeBio, a BMS company, going forward. So we will continue to refer to RayzeBio as RayzeBio at least for the current or foreseeable future. And so the Glypican 3, both the therapeutic and the diagnostic, which we have Japan rights to both products we're expecting IND filings here in the second half of 2024. I don't have exact dates for you at this stage. And then, of course, subsequent to the IND filings, we expect the Phase I to start soon thereafter. This is currently being listed at, say, late 2024 and/or early 2025, I'd say at this stage of the game. That's the best we can do as far as giving you exact timelines on that.

In parallel to this, of course, PeptiDream and PDRadiopharma are working with the RayzeBio folks to allow us to prepare for global inclusion. And, two, with the end goal being that any U.S. say approval of either of these products will basically be happening at the same time as a Japan approval so that we won't have any kind of drug lag or drug gap between the 2 different regions. That's the overall goal and understanding between PeptiDream and RayzeBio and that is, of course, unchanged. So looking forward to, again, announced IND filings in Phase I starts as we are able.

On the renal cell carcinoma product, [ our CA ], [ non-product, again], as I briefly mentioned, the Phase 0 is ongoing. We are aiming -- in parallel, the IND-enabling studies are also ongoing. And we are still gearing for the initiation of a Phase I study sometime in 2025. Again, this is a fully owned product, both the therapeutic and the diagnostic. And at this stage of the game, we have no plans to out-license or partner this product. So the current goal is to take this actually into a Phase I ourselves and then we will go from there.

The second bucket down is around oncology, not disclosed, TX and DX, and it suggests in-licensing late-stage pipeline. So as everyone is aware, similar to the ATSM program, which we in-licensed or partnered with LinqMed. We've actually, as we've mentioned in our quarterly report, we've been in discussions with a number of companies outside of Japan in regards to bringing their products from outside Japan or late-stage products from outside Japan into the Japan market, and these activities are continuing. We are expecting to have news here in the second half of 2024 in regards to the in-licensing of some late-stage assets to bring into the Japan market. And so I think stakeholders should look forward to those announcements hopefully coming in the relatively near future.

In addition to that, we have other existing products that we're actually working on label expansion here through the end of the year, but I think those are more likely to happen, of course, towards the 2025 fiscal year.

The next bucket, as far as new clinical programs entering the clinic or Phase I, the Novartis program #2, we are expecting to see that move forward into a Phase I study sometime here in the near future. At this stage, I cannot comment on whether that will happen in the second half of 2024 and/or not, but it is certainly moving in that direction. And so we have certain limitations as to maybe what we'll be able to disclose as far as say IND filing in regards to that project, but I think once that project, in fact, enters Phase I, we will be able to make an announcement in regards to that achievement. So that should be something we're very much looking forward to here.

And then lastly is, of course, kind of new collaborations in the radiopharmaceutical space. And undoubtedly, of course, with the Novartis April announcement, there is growing -- continually growing interest in collaborating with PeptiDream on novel targeted radiopharmaceuticals. And so, again, a lot of discussion is actually happening at the moment in that area.

On the diagnostics space, we are, of course, also investigating or in discussions with potentially in-licensing other diagnostic products that are actually either approved outside Japan or that are also in late stage. And so, again, as I mentioned, in licensing discussions are always ongoing. And I think you'll be hearing more as we start to consummate some of those deals. And then again, we also have kind of new formulations going on with other existing products.

So I think on Slide 14, I think everyone is quite aware of this. But I don't believe we didn't have a first kind of first quarter or an earnings call, and so just for everyone's kind of review, the targeted radiotherapeutic space has just, in the last 12 months, undergone what you would call quite a dramatic change. And so this is a very nice slide kind of highlighting the history of targeted radiotherapeutics, of course, with -- from the left is, of course, Lutathera. This is the U.S. approval of Lutathera, which actually had been, of course, discovered by AAA there that Novartis had acquired way back when, I think they acquired them in 2016. And then actually moving into PSMA or the U.S. approval of Plovicto here in 2022, also a Novartis product out of Endocyte. And both of these 2 targets, SSTR2, which is the target of Lutathera and also a number of other SSTR2 compounds that are in late-stage development. In addition to that, the PSMA side. So Pluvicto is not the only compound, of course, targeting PSMA. [ Curium ] also has late-stage assets.

Point Biopharma, which has now been purchased by Lilly also has a Phase III asset targeting or targeted radiotherapeutics, targeting, sorry, PSMA for prostate cancer. And so what we saw in late 2023, of course, is Lilly coming in and buying Point Biopharma. We saw Bristol-Myers coming in buying RayzeBio and then here into 2024, AstraZeneca taking over Fusion Pharmaceutical and Novartis actually also making acquisition of Mariana Oncology. And so it's been -- it went from really just kind of 2 pharmaceutical players in the space with Novartis and Bayer up until 2023. So now having Lilly, BMS, Genentech, Genentech-Roche Group, AstraZeneca -- sorry, Novartis already being there. Also Janssen, in fact, actually has started to announce some of their targeted radiopharmaceutical compounds. So now most of the big pharma companies have actually moved into the space over the last 12 to 24 months.

So it's an extremely exciting time. And I would say still the biggest challenge of this space is the quality of the ligand you use to deliver these radio isotopes. And whether that being a small molecule, whether that being a macrocyclic peptide or whether that being an antibody delivery vehicle, I think, is the large differentiator. And just for everyone's reference, Lutathera on the left, most of the SSTR2 targeting compounds or macrocyclic peptide is really based off of the original natural peptide ligand of that receptor.

On the PSMA side, most of these are actually what you call small molecule or peptidomimetic-type compounds, which actually mimics, say, the natural ligand of PSMA itself. And so we, of course, believe, we actually believe a number of pharmaceuticals also, companies believe this, that macrocyclic peptides may be, in fact, the ideal way to target the vast majority of the relevant, say, target space for the field. This is very much an exciting time. There are just very few companies that can actually have the ability to find these macrocyclic peptide ligands and/or optimize them for this type of uses and applications. So I think with that kind of PeptiDream's role in the steel is not going to go away and it's only going to continue to increase going forward.

So on the non-radiopharmaceutical side of the business, in the first half of this year, one of the larger parts of the news was, of course, the acquisition of our partner, our strategic partner, Amolyt Pharma by AstraZeneca, which actually just closed, was announced in -- earlier in the year and just closed here in July. And now, AstraZeneca is, of course, taking over development of our partner program, AZP-3813, which is a growth hormone antagonist peptide for acromegaly. Amolyt has been doing a fantastic job of presenting the data from this exciting program, had completed a Phase I study just recently. And a lot of that data was actually presented at ECE and ENDO conferences here in June -- late May and June of 2024. So we're very much looking forward to this program continuing. I'll touch on that briefly.

We also have initiation of another Phase I from Merck, from one of our macrocyclic peptide discovered by PDPS for the treatment of inflammatory disease. This is actually the second Merck partner program to enter the clinic. The first one entered the clinic in July of 2023. So of course, this is something we're extremely delighted to be able to announce and extremely pleased to see the progress of.

The number 3 here is our PeptiAID, partnered PA-001, which will actually be, as we've announced recently, the IND application has been filed, has been accepted and actually will be progressing here into a Phase I study in healthy volunteers for the safety tolerability and PK aspects of PA-001. So we're looking forward to that.

And additionally, we also, as yesterday, achieved a second milestone with our -- from our collaboration with POLA. In addition to that, we've had a number of other preclinical milestones achieved across a number of collaboration programs that simply have either not been for financial -- or we're not able to make press releases in regards to. And so exceptional progress, I think, a lot more under -- maybe under the surface happening across the non-radio pharmaceutical side of the business.

In regards to the pipeline, specifically, the only big change, so we have -- the GhR antagonist program, AZP-3813, on this chart still remains at Phase I. We're expecting, of course, that to move into a Phase II here in the near future. And once that does, we'll account for that accordingly, of course. The other addition to this chart that wasn't there previously, of course, is the Merck program #2, which we are able to disclose, the disease areas actually for inflammatory diseases, which is one positive, although at this stage, we're still not able to disclose what the target of either program 1 or program 2 are at this stage.

And as we announced in our quarter release, there will be certain, say, certain aspects to these programs that we are not going to be able to disclose probably until they reach or ascend to Phase II-type studies, which at that point, I think we'll be able to be potentially more transparent in what we are able to discuss in regards to these specific programs as Merck classically does not list Phase I programs in their own pipeline.

So, yes, looking at Slide 17, though, as far as just what we're looking at the second half of 2024 and beyond. As I mentioned, one of the larger ones will be the AZP-3813 moving into a Phase II study. At this time, I can't give you an exact date of that happening. We will announce it as soon as we are allowed to and once AstraZeneca allows us to do so.

As far as the CD38 arm program, partnered with BioHaven, that continues in a physician-led study. Our PD-L1 inhibitor program, which, of course, we meant we had announced last year that BMS would not continue into a Phase II study. I don't have or can't make any specific updates to that program at this stage. We are still awaiting the full results or the results of the Phase I study from BMS, and there are a number of discussions around that program going on at this time. I think in all likelihood, the goal is to have a decision on the PD-L1 inhibitor program, hopefully, by the end of the year that we can potentially make available or discuss further with stakeholders.

As I mentioned, the Q2 Merck programs and also, as I mentioned, to what extent we'll be able to announce any updates in regards to those Phase I studies will be completely dependent on Merck and what they allow us to disclose and/or discuss, and so we'll have to play that very much by year. The S2-protein, so this is the FDA, of course, we'll initiate a Phase I. And then as we look more towards the end of the year and into 2025, we're, of course, expecting the additional selection of a number of clinical candidates potentially across a number of programs and also with a goal toward initiating clinical trials for those programs subsequent to those critical candidate nominations.

Lastly, as far as kind of a select internal preclinical programs, I know there's significant interest in regards to our myostatin inhibitor program. At current, our myostatin inhibitor, which we have both an injectable version and an oral version of this macrocyclic peptide series at this stage, of course, is being tested in a variety of different obesity animal models, as I have previously mentioned. It is not one -- just for clarity, it is not one single study because these are high-fat animal studies, you actually have to use quite a large N number of animals for every specific, say, compound and/or dose that you're investigating. And so it's quite challenging to actually run, say, a variety of parameters in parallel. So this is very much a sequential effort that's actually happening.

Initially, we are focused on, say, validating the obesity effect or benefit of our myostatin injectable in combination with semaglutide in these type of studies, to which then will be extended into the oral version also. So there's actually quite a variety of parameters here to work out. The real goal is, as we gear towards the end of the year to continue to build out the data package around the use of these peptides in obesity in addition to the DMD package that we have with the gear toward partnering discussions, I'd say, in 2025.

And so, again, as I mentioned earlier, in light of the Novartis deal, we're in the enviable position, I think, of not having to out-license this program in 2024, which we might have tried to do, had we had not, say, consummated the Novartis deal. And so the Novartis deal really allows us to, I think, build out the data package and puts us in a stronger position towards 2025. And there's no shortage of interest in this program, we've been reached out to by almost all of the large pharmaceutical companies in regards to this. And so it's an exciting time for this program. We want to simply make the very best decisions in regards to what we do with it.

Additionally, the as listed here, the allergic disease is -- [ key ] inhibitor. This program is in fact partnered with, I'll never say the name right, Alivexis, it used to be Modulus Discovery, now Alivexis who is actually leading the out-licensing efforts of that program, which we're expecting to happen, again, sometime in the relatively near future to which we will announce. We, of course, have a stake in that program in partnership with Alivexis, yes.

And then the last bucket is there's a number of additional programs that I think are happening as we look toward more of these probably towards 2025, Specifically, I think stakeholders should look forward to probably announcements around peptide oligo conjugates and also peptide cytotoxic conjugates into the fiscal 2025 timeframe. I think we have some very exciting announcements that should be coming around those programs in the future.

On Slide 18, it's just -- this is for completeness purposes, around the GhR antagonist, our Amolyt -- the part of the program with Amolyt in the clinical update, and just really just a summary of the Phase I clinical trial. Of course, we had announced this in the press release. And really, the AZP-3813, in fact, just showed fantastic Phase I results. Of course, these were in healthy individuals. However, they could also see that in a dose-dependent manner the AZP-3813 substantially decreased circulating IGF levels, controlled them very well in these patients and really is strongly supportive, of course, of taking this forward into patients with acromegaly in the Phase II. So I think these were as good as results as anyone could hope for and so we're very much looking forward to this program moving forward.

Lastly, on Slides 19 and 20. So 19 first, is, of course, we have revised revenue upward of JPY 45 billion and core operating profit is to JPY 20.5 billion, operating profit, is JPY 20.1 billion and then net income to JPY 14 billion. While we have of course exceeded those numbers at current, through the first half of the year already, as I mentioned, we will upward revise revenue and/or any of these numbers accordingly once we are confident where they will end up. So under, I believe, Japan listing rules for revenue, if we see revenue coming in at greater than 10% of this number, so roughly around the JPY 50 billion mark, then that would automatically trigger us to do an upward revision. And so I think that's how this is -- the second half of 2024 is going to look for us. So this could happen potentially at any time for us going forward.

Lastly, on Slide 20 is this chart, which we continue to use. It did have FY 2024 in at having about JPY 35 billion, it had this a little bit more nice slow step as we move toward our goal of JPY 50 billion in annual revenue, say, in the midterm. But of course, on the backs of the Novartis deal, we've seen that significantly jump here in 2024. As we look through '25, I guess one of the comments I'd make as we look toward fiscal year '25 and fiscal year '26, one question from stakeholders might be, do we anticipate, say, overall revenue going back down to the JPY 30 billion and JPY 35 billion mark, say, of our previous projections.

And I would like to say, I mean, you can never say you can never completely rule the possibility of that out, of course. But I think we actually have a growing number of internal assets that I think that doesn't have to happen, right? I actually have growing confidence that we hopefully could kind of maintain the kind of revenue projections depicted here in this slide over the midterm. And certainly, I think we're extremely confident in our long-term projections and our ability to meet those type of numbers. But what happens here over 2025 and 2026 as we wait to see some of these products reach market in the '27, '28, '29 timeframe, will be interesting. But again, as I mentioned, the collaboration value or the value of, say, the financial terms around any collaborations with PeptiDream has grown significantly, and I think that puts us in a significantly stronger position than we were even 12 months ago as far as, again, what we would expect for financials to do a deal with PeptiDream in 2024.

So we're at a very good position for the company. I couldn't be more excited where we stand from both a financial perspective, but more so around what we've seen in regards to both our radiopharmaceutical development pipeline and then what you're going to see, I think, from the non-radiopharmaceutical clinical pipeline that we have. So I think it's an extremely exciting time for the company and really looking forward to some fantastic announcements coming here over the second half of 2024 and beyond.