[Foreign language]
Welcome, so we will now begin the financial results briefing of the Sosei Group for FY 2023. Thank you very much for taking time out of your busy schedule to join us today. I am Nomura, Chief Financial Officer, and I will be the moderator. Today we have Chris Cargill, Chief Executive Officer; Dr. Matt Barnes, President of Heptares and Head of U.K. R&D; and Dr. Satoshi Tanaka, President of Idorsia Pharmaceuticals, Japan, and Korea. Simultaneous interpretation is provided. Please click on the "Earth" icon in the lower right corner of the screen and select either Japanese or English. If you choose "Off," you will hear the speaker's original voice. Today we will explain the progress of our business using the material in the first half, followed by a Q&A session in the second half. The presentation materials will be shown on the screen and are also available on our website.
If you want a copy, please access the website by selecting "Presentation Materials and Video" from the Investor Relations tab in the upper right corner of the website. Institutional investors, analysts, and members of the media are welcome to raise your hands and ask questions when the time comes. For all others, please submit your questions via the Q&A button. Questions can be submitted any time during the webinar and will be answered as time permits during the Q&A session later in the session. We will start the briefing. I will first explain the full year financial results, followed by Chris on the overall business update, Matt on the progress of R&D, and Tanaka on Japan and APAC business. Finally, Chris will explain our FY 2024 and medium to long-term goals. Please turn to page five of the presentation.
[Foreign language]
This is a summary of the financial results for the year ended December 31, 2023. Revenue was JPY 12.7 billion compared to JPY 15.5 billion in the same period last year, while core operating profit was a loss of JPY 3 billion compared to JPY 5.8 billion in the same period last year. This is mainly due to the absence of upfront payments for new partnerships in 2023 and the contribution of IPJ/IPK acquisition effect from the middle of the year, while the one-off costs associated with the acquisition is recorded. On the other hand, as Matt will explain later, we continue to invest in R&D for stronger future growth as planned from the beginning of the year, and with cash and cash equivalents of JPY 49 billion at the end of December, we have sufficient capacity to support these investments. Moving on to slide six.
[ Foreign language]
This overlaps with the summary I just explained, but the left side shows changes in revenue, operating profit, and core operating profit, and the right side shows the factors behind these changes. In terms of revenue, the product sales of PIVLAZ increased, whereas upfront payments, milestone, and royalty and other income decreased. This is because in 2022 there were upfront payments from the new partnerships with Lilly and AbbVie and milestone income from the start of phase II trials of Neurocrine’s M4 agonist, respectively, whereas in 2023 there were no new partnerships, and although there were a certain number of milestone revenues, the amount was lower than in 2022. The costs related to the operating profit and loss are also described, but let me explain the detailed breakdown on slide seven. slide seven, please. Here I will mainly elaborate on the breakdown of expenses.
First of all, the consolidated results on IFRS disclosed today are shown in slightly darker orange on the far right, with revenue of JPY 12.7 billion and an operating loss of JPY 9.5 billion on the IFRS basis. If you move to the left, you see non-cash and non-recurring costs at the top and A through D below, which are costs that are excluded from core operating profit in the blue section further to the left because they are one-off or do not involve actual cash expenditure. In particular, A through C are M&A-related costs, where A and C are one-off costs and B is associated with amortization of intangible assets. Excluding these costs, the core operating profit and loss in the middle, shown in slightly darker blue, is the same as IFRS in terms of revenue, but excluding such costs, the core operating loss declines to JPY 3 billion.
If you go further to the left, you can see a simplified view of the core profit and loss situation broken down into the traditional Sosei Group and the acquired IPJ/IPK. The core operating loss of the existing Sosei Group was JPY 6.2 billion, while the core operating profit of IPJ/IPK was JPY 3.1 billion. Moving on to slide eight. From here, this is mainly on 2024 guidance. Traditionally, we have not disclosed our overall sales forecast because we have no control over new alliances and milestones with partners, but regarding the sales target for PIVLAZ, which was acquired as part of the IPJ/IPK acquisition last year, we achieved sales of JPY 13.4 billion, exceeding the target of JPY 13.2 billion for 2023 that we had indicated, including our sales prior to our acquisition.
In 2024, we expect a further increase of more than 20% to more than JPY 16 billion. President Tanaka will explain this in more detail later. Moving on to slide nine. This is the last slide related to financial results. This shows the projected R&D and SG&A for 2024. You can see many factors on the slide, but the first common factor is that IPJ/IPK-related costs were only consolidated for 5.4 months after the acquisition in the year ending December 2023, but this year, ending December 2024, they will, of course, be consolidated for the full 12 months, so the costs increase accordingly. This is a very straightforward fact.
As for the rest, we expect R&D expenditure to increase by 20%-40% from approximately JPY 10 billion in 2023 to JPY 12 billion-JPY 14 billion as phase II phase I trials of Heptares-derived developments are underway, and we expect to start a further phase I trial. As you know, the value at the time of licensing a development product whose safety has been verified in phase I trials and which has some indication of efficacy is significantly higher than that of a development product where data were obtained only in animals prior to that, even if the same product is licensed. We plan to obtain such data and license the product at a higher value. In terms of SG&A, as a contribution other than full consolidation, we expect an increase in expenses of approximately JPY 2 billion, mainly as preparation costs for the marketing of Daridorexant.
This is a necessary investment for future growth as Daridorexant is scheduled to be launched as early as the end of this year. In addition, we plan to spend about JPY 1 billion on other post-merger integration activities, which are expenditure required to streamline operations, including IT-related activities, and to operate the business efficiently with appropriate personnel over the short to medium to long term. Finally, although these expenses may appear somewhat large because they are accounting figures, on an actual operating cash flow basis, Sosei is aiming to be neutral to profitable this year as before and will invest for the future without any new cash out. That concludes the summary of the financial results. Chris will now update you on the business. Chris, please.
Thank you, Nomura-san. Please kindly turn to slide 11. My name is Chris Cargill, Chief Executive Officer of Sosei Group, and I begin with a snapshot of our full pipeline of activity. For a company with less than 400 team members in total, we are extremely busy and made significant progress across in-house and partnered programs in 2023. Please turn to slide 12. 2023 was also a transformational year for the company. We executed on our mission to invest in world-leading science to deliver life-changing medicine and took several necessary steps to achieving our long-term vision of becoming a top 15 pharma company in Japan by market capitalization. Firstly, a summary of our corporate achievements. We became the first pure-play biotech company to be promoted to the Prime Segment of the Tokyo Stock Exchange, joining Japan's most prestigious listed companies.
We completed the transformational acquisition of Idorsia's pharma businesses in Japan and Korea, and we received the landmark first public investment by the Japan Investment Corporation's Opportunity Fund One, supporting our potential to be an emerging pharma champion in Japan. Next, a summary of our in-house development progress. We received marketing approval for PIVLAZ in South Korea, the second market where we plan to launch following its initial approval in Japan in April 2022. We submitted the new drug application for Daridorexant in Japan with the goal to achieve approval this year in 2024. We advanced two new in-house programs for schizophrenia and advanced solid tumors into phase II studies in the U.K. Next, a summary of the progress of our partners.
Our partner Neurocrine initiated several new phase I studies as it advances the most comprehensive portfolio of muscarinic agonists for neuropsychiatric disorders, currently a hot area of innovation globally. Pfizer initiated a phase I study of a new once-daily oral small molecule GLP-1 agonist designed using our platform. It targets metabolic diseases such as type two diabetes and obesity, currently the fastest growing area of medicine globally. Lastly, our co-owned investment Tempero Bio received clearance from the U.S. FDA to commence a phase I study for substance use disorders, an area of unprecedented unmet need in North America. 2023 was a year of action as we laid the foundations for sustainable long-term growth. Please turn to slide 13. I will now discuss our performance against our 2023 objectives, of which most were achieved.
Our first objective was to invest to enhance the discovery platform's capabilities, and this was achieved. Our research investments in data collaborations and artificial intelligence resulted in several new targets being identified and validated to advance as new drug discovery programs. This included Verily's immune profiling platform and Kallyope's gut-brain axis platform, both of which were found to be synergistic with our platform capabilities. Our second objective was to achieve at least one new high-value partnership, and this was not achieved by the end of the budget year 2023. However, I can confirm that negotiations are ongoing. For approximately 12 months, we have been in negotiation with a major global pharmaceutical company regarding an option to license agreement for one of our clinical programs. The negotiations are complex and take time.
And as I said in my New Year's message earlier this year, there is a minor difference to overall value creation if we execute a transaction in Q1 2024 versus last December 2023. Our focus is to ensure good outcomes achieved for patients and shareholders to give this potential medicine the best chance to progress. Regarding progressing existing partnerships, this was achieved with Neurocrine now advancing all M4, dual M1-M4, and M1 agonists compounds through clinical development, with a phase II clinical data result for the high-profile M4 program expected in Q4 2024. Our third objective was to achieve at least two new in-house programs into phase I studies, and this was achieved. Our next-generation schizophrenia molecule, HTL0048149, is a first-in-class once-daily oral small molecule GPR52 agonist that commenced a phase I study and recently completed the single ascending dose stage.
The interim pharmacokinetic data was in line with preclinical predictions, and the multiple ascending dose stage has recently commenced. Additionally, HTL0039732, our EP4 antagonist program, commenced a phase I/IIA study with Cancer Research U.K. Recruitment to the monotherapy arm is proceeding as planned, and the combination arm with Roche's Tecentriq, a PD-L1 checkpoint inhibitor, is also now recruiting. No dose-limiting toxicity has been reported, and pharmacokinetics are in line with preclinical predictions. Our fourth objective was to take clear steps to build a commercial pharma unit in Japan, and this was also achieved. We completed the transformational acquisition of Idorsia's Japan and Korea business, which brought us our first major commercially available medicine in PIVLAZ. We are extremely impressed by the capabilities of our new team members and look forward to investing to build our combined pharma business in Japan and Korea. Please turn to slide 14.
Here, I would like to remind the audience of our deep exposure to the fastest-growing areas of healthcare. Now, in the area of neuropsychiatry, two major acquisitions occurred in December last year that validate the excitement and potential of muscarinic agonism. Bristol Myers Squibb acquired Karuna Therapeutics to gain access to its novel M1-M4 receptor agonist for schizophrenia and other neuropsychiatric disorders. Similarly, AbbVie acquired Cerevel Therapeutics, in part to gain access to its novel M4 receptor positive allosteric modulator for schizophrenia and other neuropsychiatric disorders. As I mentioned earlier, it's worth remembering that our partner Neurocrine is advancing the largest portfolio of oral small molecule muscarinic agonists globally, with an important phase II readout for the M4 agonist expected in Q4 2024. Further to this, we are advancing our own next-generation, first-in-class oral small molecule GPR52 agonist into phase I for schizophrenia and other neuropsychiatric disorders.
We believe agonism of GPR52 could have benefits over existing and emerging schizophrenia medicines by additionally addressing the positive symptoms of the disease in addition to potentially improving cognition. So with over $20 billion of major M&A transactions last year in the neuropsychiatric space, we expect there to be significant interest in our clinical stage GPR52 agonist program. In the area of metabolic disease, the world's leading pharma companies continue to aggressively expand their franchises, including focusing on the discovery of convenient once-daily oral treatment options for patients. Notably, such options would be less expensive to manufacture than currently available complex peptide injectables and therefore more suitable for rapid uptake globally.
As such, our technologies are enabling Pfizer and Lilly to discover current and next-generation oral small molecules for type two diabetes, obesity, and potentially, in the future, expansion to other areas of unmet need such as heart, liver, and kidney disease. Further, we are advancing our own next-generation, first-in-class oral small molecule for appetite suppression. Across the fastest-growing areas of medicine, neuropsychiatry and metabolic disease, and in addition to our own next-generation programs, we are perfectly positioned with the right partners to bring potential treatments to patients. Dr. Tanaka will now discuss the performance of our Japanese and APAC businesses. Thank you, Dr. Tanaka.
As Nomura-san reported, more than JPY 13 billion sales were reported. And at the same time, PIVLAZ, which was filed in South Korea, NDA approval was acquired, and the drug price is now being negotiated.
It took about a year, and we think we'll be launching within about a year. Next page, please. So this is the sleep disorder, Daridorexant. We filed in October last year for approval. It's scheduled to be approved and commercialized by the end of this year in phase III in Japan. About 500-subject Japanese patient subject study was conducted. Total sleep hours and the latency for sleep onset, we had a good result. This product is co-developed with Mochida Pharmaceutical, co-developed and co-marketed with them. So this is where we are. Thank you, Matt. Over to you.
Thank you, Tanaka-san, and good evening, everybody. My name is Matt Barnes, and I'm the president of Heptares and head of R&D in the U.K. I will present our recent progress from the R&D area, so please turn to the next slide.
So in this first slide, I would like to provide an update on our partnered programs in the clinical stage. So firstly, I would like to update you on one of our highly successful partnerships with Neurocrine around a suite of muscarinic agonist programs for schizophrenia and other neuropsychiatric disorders. The phase II study to investigate NBI-1117568, an oral selective M4 agonist as a potential new treatment for schizophrenia, is progressing well, and we are expecting top-line data towards the end of 2024. In 2023, we were extremely pleased to see the progression of two further assets from this collaboration into phase I studies, namely NBI-1117570, a dual M1-M4 agonist, and NBI-1117569, an oral M4 preferring agonist, plus the anticipated start of a phase I study with NBI-1117567, an oral M1 preferring agonist, later in 2024.
In addition, we were also encouraged to see Pfizer detail the entry of PF522 into its phase II clinical pipeline as part of its quarterly results in 2023 Q3. PF522 is a new oral small molecule GLP-1 receptor agonist which was discovered by Pfizer scientists as part of our multi-target research collaboration. We look forward to this asset advance alongside the two other currently active clinical stage assets in Pfizer's pipeline, targeting MC4 and CCR6 for malnutrition and IBD, respectively. Furthermore, at the start of 2023, we were also very pleased to note that Tempero Bio received FDA clearance to advance clinical development of TMP-301, which is a potent selective and orally available mGlu5 NAM for the treatment of alcohol and substance use disorders, which was discovered by Sosei Heptares and out-licensed to Tempero Bio.
So in summary, we have seen significant progress in our clinical-stage partner programs, with four of these assets moving into phase I studies during 2023. Please turn to the next slide. In addition to our highly successful collaborations, we have a rich internal portfolio of programs with four wholly owned clinical and preclinical assets, plus more than 10 early stage programs. In August 2023, we were proud to confirm the initiation of a phase I/IIA clinical trial with HTL0039732, which is a selective EP4 antagonist for immunosuppression in advanced solid tumors, which is in collaboration with Cancer Research UK. HTL0039732 as a monotherapy is now being dosed to cancer patients with no dose-limiting toxicity reported to date, and a cohort in combination with a checkpoint inhibitor is now open for recruitment.
The interim pharmacokinetic profile of the asset is very encouraging and in line with predictions, and our partner CRUK will continue the progression through the clinic as planned. In June 2023, we were excited to announce the initiation of a phase I clinical trial with HTL-149, a selective GPR52 agonist, which is a novel GPCR target and presents opportunities in schizophrenia and psychosis. Again, I will provide a more detailed update on the progress of this asset in a subsequent slide. In addition, we are also making good progress with our oral potent and selective GI-restricted EP4 agonist program for IBD. All the preclinical work is now completed and submitted for regulatory approval, and we anticipate a phase I clinical start in the first half of this year.
In November 2023, we also announced our intention to regain full ownership of GSK4381061, a highly selective first-in-class oral GPR35 agonist, which is a potential new treatment for IBD. This asset was licensed to GSK in 2020 and has been further advanced, generating promising mechanistic preclinical and safety data, enabling GSK to gain MHRA approval in mid-2023 to initiate a phase I clinical study. Following the decision by GSK to discontinue its development due to changes both in its immunology research strategy and leadership, the teams have been actively engaged in the asset reversion process and making good progress to date. So in summary, we've seen significant progress in our clinical stage internal programs, with two of these assets moving into phase I studies during 2023, and we are well placed for the entry of two further assets to transition to phase I in 2024.
Please turn to the next slide. This slide provides some further context on HTL0048149, our phase I clinical stage GPR52 agonist program, which we believe represents a novel approach to treating schizophrenia. As Chris mentioned, with the recent acquisitions of both Karuna by BMS and Cerevel by AbbVie, neuropsychiatry is attracting a lot of attention right now, and we are pleased to have a clinical stage asset in this space. The unique feature of GPR52 is based on the receptor's expression profile, which leads us to a therapeutic hypothesis that GPR52 agonist may have broad efficacy to address not only positive symptoms but also negative and cognitive symptoms which are not currently addressed with antipsychotic treatments. We have strong preclinical data that supports this hypothesis.
HTL-149 was developed using our SBDD platform as a once-daily orally available small molecule drug which selectively targets the orphaned GPR52 receptor in the brain. The phase I study is proceeding as planned, with the completion of the single ascending dose and recent initiation of the multiple ascending dose study. The interim pharmacokinetic profile of the asset is excellent and in line with predictions. It has low variability, is approximately dose linear, and consistent with a once-daily dosing profile. So we're very encouraged by this data and will continue with our progression through the clinic. Please turn to the next slide. So my final slide highlights the progress we've made in 2023 in the drug discovery and platform growth area.
So firstly, we are using our current knowledge to explore other membrane protein target classes, and in mid-2023, we did initiate programs in both ion channel and transporter space in our therapeutic areas of interest. We believe an SBDD approach will offer a means of differentiation on these targets and allow us the opportunity to demonstrate technical feasibility on non-GPCR membrane drug targets. Secondly, towards the end of 2023, we completed building works on our additional laboratory space at our R&D facility in Cambridge, U.K. This will allow us to establish a new phage display lab which will be used to identify protein binders to support cryo-EM and our SBDD platform, plus a new mass spec facility to drive the advancement of our biophysical characterization of GPCRs.
In 2023, we've also continued to invest in our target identification and validation strategy, which will enable us to identify novel drug targets for the future and sustainability of our pipeline. We expanded our collaboration with PharmEnable in the AI drug discovery space, and it was fantastic to see the first discovery targets emerging from our collaborations with both Verily and Kallyope, both of whom have unique platforms for identifying new targets. And finally, I would like to highlight our progress in the drug discovery area with examples from Genentech on the progression of a first-in-class project which we announced in October 2023 and the strong preclinical data package on ORX750, a small molecule OX2 agonist which was presented by Centessa at the World Sleep Conference also in October 2023.
So that concludes my section highlighting our significant progress in U.K. R&D in 2023, and I'll now pass back to Chris for the last section. Thank you, Chris.
Thank you, Matt. Please turn to slide 26. So I'll now discuss our objectives for 2024, and we have five objectives that are designed to position us for long-term growth. Number one, we aim to continue the successful launch and adoption of PIVLAZ and achieve more than JPY 16 billion of sales. Number two, we aim to achieve the successful NDA approval for Daridorexant in Japan. Number three, we aim to acquire or enlicense at least one new late-stage medicine for patients in Japan and APAC, ex-China. Number four, we aim to execute at least one new major partnership and also advance at least one new in-house phase I study.
Number five, we aim to successfully launch our new company name and brand concept, as well as making technology investments in business systems and applications that will drive decision-making speed, operational efficiency, and allow for future scalability. All of these objectives contribute to our vision, which is to build a next generation top 15 pharma company in Japan by market capitalization. Please turn to slide 27. So 2024 will be another exciting year of growth and investment with several potential catalysts over the next 12 months. The one that we are most anticipating is the phase II completion of NBI-568, the muscarinic M4 agonist for schizophrenia. Assuming it continues to advance safely, the clinical data readout is due by the end of 2024, which if positive would be a significant catalyst event for the company. Now please turn to slide 28.
I would like to end my section with the company's Beyond 2030 vision. Now our vision is to become Japan's next generation top 15 pharma company by market capitalization. Our mission remains unchanged: to invest in world-leading science to deliver life-changing medicines. Our focus areas will be as follows: innovative specialty medicines with a particular focus on addressing drug lag and loss in Japan and APAC; tech-powered business systems and applications to drive decision-making speed, operational efficiency, and to provide for future scalability; to become the development and commercialization partner of choice for global pharma and biotech companies that do not have a presence in Japan and APAC; and lastly, to enhance our platform with new AI and machine learning capabilities to accelerate new drug discovery. Thank you for your time today, and we will now take questions.[Foreign language]
Thank you very much for the presentations. Now we would like to move on to the Q&A session. As we mentioned at the outset, for the institutional investors and the media and analysts, please make sure to press the button. The moderator will call out your name, so please unmute yourself when you would like to ask questions. As you know, we have simultaneous interpreters. Please make sure to be as synced as possible. If you have any questions, please raise your hand.[Foreign language]
So the first speaker is from Citigroup. Yamaguchi-san, can you hear us? [Foreign language] Yamaguchi-san, can you hear my voice? [Foreign language] It seems like we don't hear you, so let us move on to the next person.
The next person is from Nomura Securities, Matsubara-san. Please unmute yourself and ask your question. Matsubara from Nomura Securities, can you hear me? Yes, we can hear you. I have two questions.
The first question is about PIVLAZ. What is the current market share? In addition to that, it is now listed to the guideline and the sales are favorable. So from the peak sales that you disclosed, if there is any revision in the forecast, can you share that with us? Matsubara-san, thank you very much for all the questions. So we would like to ask Dr. Tanaka to respond to the question.
The share you mean, do you mean the number of patients? The number of patients, we have 25,000 people as the potential number of the patients, and we see the number of prescriptions as 10,000 as of now. And in principle, there is no deduction in the drug price as far as I know. So basically, from there, with respect to the revenue, Nomura-san may have some revision. Do you have any comment?
As Matsubara-san mentioned, it's slightly above our revenue forecast, and this year we have the expectation that there will be favorable growth. Having said that, from the beginning, we don't have the forecast for PIVLAZ only. As you noticed, this is a product of PIVLAZ and Daridorexant, and the total amount is JPY 35 billion. So it's premature to make revision with this factor only, but if there is a possibility in the future, we would like to do so.
Understood. So let me confirm again. Combining all the portfolio, you have over JPY 35 billion, and does this also include the sales in Korea as well?
Yes, correct. At the time of the acquisition, we slightly touched upon it. So Japan, Korea, Taiwan, PIVLAZ, and Daridorexant only. So as you pointed out, what you have mentioned are included.
What are not included include other APAC regions, and we don't have the product for Cenerimod as well. And the next question is that for the temporary factor, you are booking JPY 3 billion, and going forward, is this level of JPY 3 billion a continue or will there be more contribution from PIVLAZ? Can you give us some thoughts? Yes, understood. I think page seven is the best slide to illustrate. I will explain by using this page. You have A and C. There is a temporary amount of JPY 3 billion adjustment for revenue, and as you mentioned, the cost of goods will continue until the middle of this year, and there will no longer be M&A costs. So these can be compressed. And similarly, this year, after M&A, PMI, there are IT investments necessary for merger.
So, M&A, a one-time cost—what we have shown on the other pages—the similar amount will be required for PMI. So from that background, just by looking at this year, there won't be any impact of completely removed. But if you take a look at next year and the year after, this part will be compressed. And for R&D expenses, contrary to that, there is possibility for increase, and this is for in-licensing within Japan, which is our target this year. If that comes true, and I won't be able to state the details, but whether this will hit the P&L or not. So if we make the R&D investment, there could be possibility, but with the removal of A and C, compared to that, we are not expecting for any larger expense.
So basically, we are considering the current assets, and we are considering that there is a tendency for shrinking.
Thank you very much. That's clear now. [Foreign language] So moving to the next question. Yamaguchi-san? Can you speak now? Can you hear my voice? [Foreign language] I'm sorry, we still cannot hear you. So we may skip one more time. Next, Mizuho Securities. Suzuki-san, please. Suzuki-san from Mizuho Securities. Please unmute yourself.
Hello, this is Suzuki from Mizuho Securities. Thank you.
We hear you.
Thank you. First, one clarification in your briefing. M4 agonist data, this will be coming out around Q4? That's my first question.
So Chris, could you answer that question?
Yes, all indications suggest Q4 at the latest. Thank you.
[Foreign language] Thank you very much. So if it's Q4, then if it's successful, then will there be milestone? And that milestone, I think there's a possibility of turning positive. Will that positively impact the profitability this year? [Foreign language]
Yeah, sure. Look, I won't comment on that because we're not able to disclose the quantum of the milestone, but yes, there would be a milestone assuming success, and it is a material milestone. Thank you.
[Foreign language] Thank you. I understand. Thank you very much. And one more question is on the new collaboration, new partnership. It is delaying, you said, but around what time, if possible, could you mention the timing? And it is now a time lag. So maybe this year will be more than two. Could you say more than two? Is that the right interpretation? [Foreign language]
Chris, again, please.
I would expect to conclude in March this year, and if we are not able to complete a transaction in March, I think that you will find we will find another strategy to achieve value creation from this asset. But I am expecting that everything going well, March 2024, we will conclude a transaction. Thank you.
[Foreign language] Thank you very much. So the other transaction, is it emerging? So in your original forecast, one in 2023 and once every year, you said. And so this one in March, if there's a time lag, then there may be one more emerging this year. So is that a possibility?
It is a possibility. We are working on a number of potential transactions as we always are. Thank you.
[Foreign language Thank you very much. And just one more question. IPJ, IPK, segment, sales. Thank you very much for disclosing this number again. So this year, Daridorexant and the launch in South Korea and sales in Korea. So this operating profit margin, can this be achieved and maintained? Profit margin can be maintained?
So I will briefly answer that question. We want to maintain our operating profit margin as much as possible, like core-based. This IPJ, IPK, on a standalone basis, it's high. But if this is viewed as a standard, PIVLAZ margin is high. For Daridorexant, it is the normal average level profit margin. So it will be normally lower than this level. So that will be the level. So we want to maintain high operating profit margin, but it will not be as-is, cannot be applied to other products as-is. On the other hand, on a group-wide basis, Sosei Group, this year, on the left side, we had operating loss. But as I mentioned, cash flow positive.
On operating cash flow, we are aiming for positive. So multiple deals with milestone, this will be a different type of revenue than the product sales revenue. But as I mentioned, not all products are as high profit margin as this one.
Yes, understood. Thank you very much.
Nomura-san, Nomura-san, may I just add one more comment, please? Sure. I just think with regard to that question also, please remember that with PIVLAZ, we are looking to invest incrementally so that we can drive further market share gain of potential patients and achieve peak sales faster. And equally, with Daridorexant, we will be required to make launch investments this year as well. So what Nomura-san said regarding the products is correct. However, please note that we are trying to drive as much sales as possible of PIVLAZ and also a successful launch of Daridorexant, and that will require some investment. Thank you.
[Foreign language] Thank you for that. Does that answer your question? Please mute yourself. Now we would like to move on to the next question. So Polymer Capital, Dion-san, please mute yourself and ask your questions.
Hi, this is Dion from Polymer Capital. Can you hear me?
Yep, I can hear you.
Thank you very much for taking my question. Congratulations on fantastic presentation, exciting results. Specifically regarding PIVLAZ, can I quickly ask two questions? Firstly, regarding the other products from Idorsia, Selatogrel in particular, is it fair to say you have no further interest in Selatogrel, number one? And then secondly, just regarding Chris's comments, I think it was on slide 24, the third point regarding acquiring at least one late-stage product. Would you be— is it fair to say that it will be logical to do that in neurology, given that you've previously understood from Tanaka-san that you've got about 60 medical reps marketing PIVLAZ, something like that?
And I think they will be only marketing PIVLAZ to neurosurgeons. So would it be fair to say that you'll be looking at something complementary to PIVLAZ in terms of your in-licensing strategy? So that's just on PIVLAZ and then secondly on Selatogrel.
Thank you. Nomura-san, shall I take that? Okay. Yeah, thanks for your question. Thanks for your question, Dion. So on Selatogrel, while the product is within the purview of programs that we have options or rights around, it is fair to say that it is not high on our priority list at the moment. That's not to say that we wouldn't.
It's just not an area of focus for us right now. So that hopefully answers your first question. Second question, yeah, I mean, naturally, one of the first areas that we will look to is in-licensing more innovative product that we can put the field force to work with. However, we have a much longer-term plan to build a very successful pharma company. And so we will not just remain neurology or acute care setting focused. There are opportunities that will lend themselves well to our organization, even if they fall into other areas such as rare or orphan diseases, for example. So while you are correct, it's the most logical place to look for a bolt-on license or acquisition. We're not limiting ourselves just to that because we have a much longer-term plan to build quite a broad-based and successful organization. Hopefully, that answers your question. Thank you.
It does. Thank you very much.
[Foreign language] Thank you. Moving on to the next question. Daiwa Securities. Hashiguchi-san, please. Unmute yourself and ask your question. [Foreign language]
This is Hashiguchi speaking. Thank you very much. I have two main questions. First, IPJ, IPK, the impact on profit and loss in the first year. So JPY 16 billion on the drug price basis. So the sales you record will be smaller, I guess. But the SD&A is increasing by around JPY 10 billion. So according to what you said, most of it is IPJ, IPK related. Then this year that we just ended, so on the accounting basis, the negative seems to be pretty large. Is that correct? And for your cash flow? You said neutral to positive. When you announced in July last year, you clearly said positive. So it seems like your tone has weakened somewhat. Am I correct?
And if so, why is the reason? What is the reason? Thank you.
So your first question is if you could calculate. Hashiguchi-san, you are pretty right. So product sales, yes, you're right. But on the accounting basis, PIVLAZ costs or the one-off costs related to M&A, this will disappear within about six months. And so on the accounting basis, the operating profit will improve. And this is a partner agreement. And so the milestone, this is a sensitive matter. But last year, at the October approval, we got JPY 1.5 billion from Mochida. So if we think of the milestone type revenue in IPJ, IPK, it can sufficiently offset the SD&A. And the other is cash flow, operating cash flow neutral or positive. We're saying neutral to positive for the entire group. So of course, Heptares, last year, we're not as we expected. And it's difficult to control that.
But even based on that, we want for the entire group to be neutral to positive. So it's not just singling out IPJ, IPK.
Understood. Thank you. And my second question is GPR52. This is the receptor agonist. You mentioned Cerevel and Karuna. M&A, you mentioned that as an example and that this category is drawing more attention. What this means is the product that they're developing and the improvement in the symptom, the negative symptom, and the cognitive impairment. So the improvement in the symptom you want to improve is similar, or there is an overlap in mechanism. Is that what you mean? So what was the intent behind your remarks earlier? Thank you.
So Matt, could you start off? And then Chris, could you follow? Matt, please.
Yeah. Thank you so much for the question. So I think we're quoting the acquisitions of Karuna and Cerevel really just to highlight how attractive this space is right now. So I think, as we've mentioned before, that it's been decades since a new treatment has been approved in schizophrenia. And that's why this area is attracting a lot of attention. Karuna have done a great job, I think, in validating the muscarinic mechanism. And we're very, very well placed, I think, with our partner Neurocrine to capitalize, I think, on that interest. And a new mechanism in schizophrenia, I think, is going to be great for patients. And so that's why we're highlighting this. In reference to GPR52, so you're right. So some of these muscarinic compounds will only address certain symptomatology in schizophrenia.
What we really like about GPR52 is that it has this potential to have broad efficacy across not only positive but negative and cognitive symptomology, which is not currently served by antipsychotics at all. And that's one of the most attractive things about this. And it's completely novel. And we're the first people to take a molecule targeting this receptor into the clinic. Chris, do you want to add anything?
Thank you, Matt. I think you described that very well. I mean, the reason we're highlighting this particular area is, as Matt said, there has been no new innovation for patients in decades. And now, with the validation that's been brought forward by Karuna Therapeutics and the acquisition by BMS thereof, there's now an acceptance that there can be plenty of space for multiple players in this area because the treatments are so transformational for patients.
Now, our positioning with Neurocrine couldn't be better. There's no single program there. There's multiple programs: M4, dual M1, M4, and M1. So there's multiple shots on goal. And in many ways, we are looking forward to phase II data this year as are Cerevel with Emraclidine. And so we're looking forward to seeing how this space plays out. But certainly, with $20 billion of invested capital in December, some of the biggest pharmaceutical companies in the world are very, very excited by the potential of this mechanism. Thank you.
Thank you very much.
Thank you, Hashiguchi-san. In the interest of time, we would like to pick up two questions from the chat. The first one is from Yamaguchi-san, whose voice did not reach out to us. He jotted down in the chat, "And if we achieve our company target, our core operating profit, are we able to turn this profitable this year?"
I would like to respond to that question. Yes, that is our plan on a core basis. If we are able to achieve what we aimed, that is what we are targeting for. A new partnership and pipeline progress may be some of the factors, but that is our plan. And the second question is from the individual investor. Last November, there was capital increase. And what is the objective of this capital increase? Chris, can you respond to this question?
Yeah, sure. Thank you for the question. It was really in response to interest from the Japanese government's Opportunity Fund One wanting to make an investment in our company. And with that, we saw an opportunity to tie multiple capital markets transactions together at the same time. So in order for the JIC VGI Opportunity Fund One to make an investment, we needed to do a very small public offering to set a reference price to help them buy in at a fair price to us and at the same time took the opportunity to do some balance sheet liability management. And we refinanced our convertible bonds at the same time, which was an opportunistic thing to do.
We don't like to go to the capital markets that often. So if we have the opportunity to do it cleanly in one transaction, we will take that opportunity. But we are just very, very happy to have the JIC VGI Opportunity Fund One , who are a long-term Japanese investor, on board. And it signals the confidence that they have in us to build an emerging pharma champion in Japan. Thank you.
[Foreign language] I understand there are many questions that have been written in. We will take time to answer your question later. So one last question. So the one who raised the hand to the first. UBS [Foreign language] UBS Securities. [Foreign language] from UBS Securities. Please.
UBS [Foreign language] Haruta from UBS Securities. Thank you very much. [Foreign language] So just one question. GPR35, this receptor agonist. So the regaining of the right, you mentioned on page 25, the schedule will be for second half of the year. So what is the schedule? And once it is returned, you will conduct phase I and then outlicense. Is that a possibility? Or after it's returned, is there a possibility of outlicensing?
Thank you. So Chris, could you quickly answer this?
Yeah, sure. Thank you. As with all reversion processes, they can take time. They are dependent on the speed with which our former partner moves. However, as Matt mentioned, things are extremely cooperative between us and GSK. And so we do expect the reversion to conclude quite quickly. What we will do upon reversion is we will do what we usually do. We will conduct a thorough review of the data, and then we will make a decision whether or not we should advance this asset ourselves into the clinic for either future development or potentially outlicensing again to another partner. That is, of course, our intention.
But before we make a decision, we want to make sure that we've thoroughly reviewed the data before we make a decision on whether or not the asset should be developed further by us or with a partner. Thank you.
[Foreign language] Yes. Thank you very much.
[Foreign language] Thank you, Haruta-san, for the question. Thank you very much for many questions through text. Since it is time to conclude, we would like to conclude the meeting. For the questions we could not respond, we would like to respond by the official blogs. Please allow us for some time to respond. As for this presentation, we are planning to upload on our website. If you have interest, please make sure to look at our website. Thank you very much for your attendance today. With this, we would like to conclude the financial results of the meeting for 2023. Thank you for your attendance.