Sosei Group Corp
TSE:4565
Earnings Call Analysis
Q2-2023 Analysis
Sosei Group Corp
The company, known for its prudent financial management and strategic partnerships, is focused on maintaining a robust cash runway. Its executives conveyed the necessity of having a multiyear cash reserve to support R&D investments and sales and marketing activities that drive corporate value. This fiscal strategy enables them to aim for cash flow neutrality or positivity ideally. The executives expect to enhance their cash balance through the execution of new partnerships and the growth of sales from their flagship products, PIVLAZ and the planned launch of Daridorexant next year.
In the realm of clinical trials and product development, the company has set a goal to initiate 1 to 2 clinical study starts per year from the U.K. This year, they expect the GPR52 agonist to be the first and hope the EP4 antagonist will follow as the second. A third clinical trial for another product within this fiscal year appears unlikely. Nevertheless, they are well-prepared to scale operations if needed, leveraging external resources from partners to potentially manage more trials concurrently.
Regarding revenue streams, the company historically has a stronger financial performance in the second half of the fiscal year with milestone incomes, largely due to the timing of business developments and negotiations that initiate at the start of the year. While specific details on individual milestones are not disclosed until they materialize, the company remains optimistic about potential milestone incomes from ongoing collaborations and progression through various development phases. Additionally, active business development efforts may contribute to revenues in the latter half of the year.
The company has recently acquired an exclusive opt-in for the Cenerimod program, a compound that is safe, clean, and well-tested. While detailed comments were reserved, there was acknowledgment of the potential for indication expansion for the drug, especially for the Japanese and APAC markets. The decision on whether to pursue further development with this compound will be made in the coming months in consultation with the new partner, Idorsia.
PIVLAZ has been the subject of inquiry due to the higher incidence of Subarachnoid Hemorrhage (SAH) in Japan and Korea compared to Western countries. The company is collecting Post-Marketing Surveillance (PMS) data and planning to publish interim outcomes that elucidate the improvement in prognosis for patients prescribed PIVLAZ. While full data from a target of 2,000 cases will take time to be disclosed, the interim analysis is expected to be announced in the upcoming year.
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Time has come, so we would now like to begin the Financial Results Briefing of Sosei Group for the First Half of FY 2023. Thank you very much for taking time out of your busy schedule to join us today. I am Nomura, CFO, and I'll be the moderator. Today, we have Chris Cargill, CEO; Dr. Matt Barnes. President of Heptares and Head of UK R&D; and Dr. Satoshi Tanaka, President of Idorsia Pharma, Japan and Korea.Simultaneous interpretation is provided. [Operator Instructions]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 to the website by selecting presentation materials and video from the Investors 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 at any time during the webinar and will be answered as time permits during the Q&A session later today.So we will start the briefing. I will first explain the first half 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 2023 medium to long-term goals.Please turn to Page 5 of the presentation. Page 5. This shows the summary of financial results for the first half of the year through the end of June. Revenue was JPY 2.1 billion compared to JPY 2.4 billion in the prior year comparative period, and operating loss was JPY 4.1 billion compared to a loss of JPY 3.8 billion in the prior comparative period. This is mainly due to the almost no milestone payments from partners if we limit the scope to the end of June, plus a slight decrease in royalties from Novartis as well as accelerating R&D for stronger future growth as we had planned from the beginning of the period.On the other hand, we retained approximately JPY 65 billion in cash and deposits as of June 30 and still have approximately JPY 42 billion cash on hand after the acquisition on July 20, which Chris and Tanaka will explain in more detail later. As I've said in the past, the progress of our R&D activities over a short period of time, for example, up to the end of June, may appear slow from outside the company, depending on the timing, but please understand that our business continues to move forward steadily with steady R&D progress.Moving on to Slide 6. This basically remains unchanged from the summary I just explained, but it shows changes in revenue, operating profit and also core operating profit. As I explained earlier, overall revenue is down because milestone payments were smaller than the previous year. Royalty revenue, on the other hand, increased on a yen basis. Eli Lilly and AbbVie payment is reported on the instalment basis and so separate recording is showing up here. Cost will be explained later on, but no change from the beginning of the year.So Slide 7. This is the full year forecast for R&D expenses and other SG&A expenses in the R&D business for FY '23. Both R&D and SG&A expenses remain unchanged with R&D expenses expected to be in the range of JPY 8 billion to JPY 10 billion and SG&A expenses in the range of JPY 4.25 billion to JPY 4.75 billion. As emphasized in the presentation, this forecast excludes the impact of the acquisition of Idorsia Japan APAC Pharmaceutical business on July 20. These effects are currently being scrutinized, and we will provide a more detailed cost estimate after the Q3 results when more details will be available.That concludes the summary of the financial results. Chris will then update you on the business. Chris, please.
Thank you very much, Nomura-san. Hello, everyone, my name is Chris Cargill, CEO of Sosei Group.Please turn to Slide 9. Recently, in July, we announced the acquisition of Idorsia's Japanese and APAC business. This is a fantastic transaction that will create significant value for Sosei immediately and in the years to come. The transaction brings a highly experienced clinical development team and profitable commercial operation to our world-leading drug discovery platform. The transaction accelerates our mission to deliver life-changing medicines to patients. Sosei is now a fully integrated biopharma committed to helping patients in Japan and APAC.Please turn to Slide 10. We have 4 strategic pillars to increase corporate value, which are: having world-leading drug discovery capability; establishing new cash flow-generating partnerships; evolving our in-house R&D; and building our Japanese Japan commercial operations.Please turn to Slide 11. Against the 4 strategic pillars, we are making excellent progress. We expect to meet all FY 2023 objectives by the end of this year. Regarding world-leading drug discovery, we expect to announce technology milestones for new programs in the second half of 2023. Negotiations are active. Regarding major cash flow generating partnerships, we expect to announce a collaboration with a new major partner in the second half of 2023. Negotiations are active. Regarding in-house R&D, we have already started one Phase I trial for GPR52 agonist. We expect to start another Phase I trial very soon for the EP4 antagonist. Trial sites are active. Regarding Japanese commercial operations, as I already said, we recently completed the transformative acquisition of Idorsia Pharma, Japan and Korea. These acquired businesses provide us with a commercial platform to deliver medicines to patients in Japan and to expand throughout APAC.Please turn to Slide 12. We acquired -- the most significant operational highlight occurred after the end of the first half of 2023 in July. But as we acquired IPJ and IPK, this gives us immediate commercial sales in Japan from the third quarter 2023, plus near-term new product launch. The transaction is valued at JPY 65 billion. The transaction will achieve a double-digit rate of return. The transaction brings 2 major products PIVLAZ and Daridorexant plus rights for up to 7 more products. We have the rights to develop and commercialize all the potential products in all markets across APAC, excluding China.PIVLAZ is commercially available in Japan. PIVLAZ was launched last April and we expect fast growing sales over the next few years. To date, over 6,500 patients have been treated to PIVLAZ. And this number is growing and neurosurgeons increase usage. Next, Daridorexant is already approved in the U.S. and Europe. It is a best-in-class treatment for insomnia, a major unmet need in Japan. Positive Phase III data in Japan was achieved in 2022. Filing is expected in 2023, and launch is expected in 2024. Daridorexant will be co-promoted with Mochida. We expect the combined peak sales of both products across the territory to be more than JPY 35 billion. This transaction with Idorsia secures our business in Japan and provides a platform to expand across APAC. And we think this will generate value, which is many times bigger than the investment.Please turn to Slide 13. We are focused on executing against our 4 strategic pillars. As a result of this focus, our pipeline is now broad, diversified and balanced. We are pioneering novel therapies across multiple therapeutic areas. We are now a fully integrated biopharma business with fast-growing sales and near-term product launches. That completes my section. Thank you.
Thank you, Chris, and good evening, everyone. My name is Matt Barnes, I'm the President of Heptares and Head of R&D in the U.K., and I will present brief highlights in the R&D area.Please turn to the next slide. As highlighted in our priority objectives for 2023, we are continuing to invest in our GPCR structure-based drug design platform capability to support our world-leading drug discovery position in this area. As previously highlighted, part of this strategy involves adding complementary approaches through technology collaborations. We are continuing to make significant progress in these areas, but more specifically today, I wanted to highlight our strategic collaborations focused on choosing the right target with Kallyope and Verily, which were both initiated in 2022.Firstly, with Kallyope, we are aiming to identify and validate novel gastrointestinal GPCR targets for drug discovery in gastrointestinal diseases by leveraging Sosei Heptares' GPCR compound libraries with Kallyope's gut-brain axis platform. The collaboration is progressing extremely well, and the team have initially identified several novel GPCRs, which are now undergoing confirmation validation, and we hope to provide more information on this in the second half of the year.Secondly, with Verily, our aim is to identify new GPCR drug targets and then subsequently generate novel drug candidates for the treatment of immune-mediated diseases. This collaboration was announced in January 2022 and is focused on leveraging sophisticated computational analysis of genetic and functional genomic data provided by Verily's immune profiling technology, combined with our accumulated knowledge around the tractability of GPCRs.A list of potential drug targets with high relevance to human disease was rapidly identified as highlighted in our blog in September 2022, from which a number have subsequently been prosecuted into target validation studies to further understand the pathophysiological expression profile and functional relevance of these GPCRs using pharmacological tools.We are beginning to see some exciting data emerging from these target validation studies, and we hope to provide more information on this in the early part of the second half of this year. Importantly, identifying and validating new GPCR drug targets from these collaborations, combined with our internal capabilities, provides huge potential for maintaining sustainable early pipeline of projects in our therapeutic areas of interest.Please turn to the next slide. Next, I would like to update on one of our highly successful clinical stage partnerships with Neurocrine around a suite of muscarinic agonist programs for schizophrenia and other neuropsychiatric disorders. This slide represents an up-to-date summary of this collaboration and is taken from Neurocrine's Q2 2023 financial results presentation held earlier this week.As previously highlighted, Neurocrine initiated a placebo-controlled Phase II study in the second half of last year to investigate NBI-568, a selective M4 agonist as a potential new treatment for schizophrenia and have commented at their results presentation that they are making good progress with recruitment for this trial. In addition, Neurocrine have also confirmed the acceptance of a clinical trial application, or CTA, for NBI-570, a dual M1/M4 agonist and their intention to initiate a Phase I study in Q3 2023. To note, these are the 2 most advanced assets in this multi-program collaboration with Neurocrine, and Neurocrine also anticipate progressing additional muscarinic compounds into the clinic over time.Please turn to the next slide. So in addition to our highly successful collaborations and as Chris has previously mentioned, we have a rich internal portfolio of programs with 3 wholly owned assets to begin clinical studies in the near term. The most advanced of these is HTL-149, a GPR52 agonist program, which is a novel GPCR target and presents opportunities in schizophrenia and psychosis. HTL-149 was developed using Sosei Heptares' StaR technology and SBDD platform as a once-daily oral available small molecule drug, which selectively targets the orphan GPR52 receptor in the brain to address positive symptoms such as psychosis and hallucinations, negative symptoms such as social withdrawal, and cognitive impairment including attention and working memory, all associated with schizophrenia.In early July, we were proud to announce the dosing of a first subject in a Phase I trial evaluating HTL-149. The Phase I trial is a 2-part randomized, double-blind, placebo-controlled single and multiple ascending dose study to assess the safety, the pharmacokinetics and the pharmacodynamics of HTL-149 in healthy volunteers. The trial is being conducted in the U.K. and is expected to read out initial data in 12 to 18 months' time. The progression of this wholly owned first-in-class asset into clinical trials is a very important milestone for Sosei Heptares and it's the culmination of a rigorous internal program that began with the selection of GPR52 as the right target to address the significant unmet need of schizophrenia patients and the subsequent design of novel and potentially first-in-class agonist molecules with the right therapeutic profile.I would also like to highlight a second asset, HTL-732, which is an EP4 antagonist for immunosuppression in advanced solid tumors, which is a collaboration with Cancer Research U.K. HTL-732 was also developed, leveraging insights generated from our StaR technology and SBDD platform as a once-daily oral available small molecule drug. Details of the Phase I/IIa clinical trial sponsored by Cancer Research U.K. is now listed on clinicaltrials.gov and will involve the evaluation of HTL-732 as a monotherapy and in combination with a checkpoint inhibitor, PD-L1 antibody, in patients with advanced solid tumors across a number of sites in the U.K. We hope to announce the initiation of the trial very soon, and we'll formally communicate this event in due course.We are extremely excited about progressing these internal programs into clinical studies as they offer opportunities across our key therapeutic areas of focus and will ultimately provide Sosei Heptares with higher value creation.That concludes my section, highlighting our significant progress in research and development in the first half of 2023. I will now pass on to Tanaka-san to update our Japan APAC commercial business.
Thank you, Chris and Matt. [ I'd like ] to update activities from Japan and South Korea. So please move on to the next page. PIVLAZ, since 2022, for the first time in this cerebral vaso, we started to launch from April and the product name is PIVLAZ. In last year only, already, this is used to [ 3,200 ] patients. This year, we are planning to use for 7,300 patients for this year. We are confident about this year. And just recently, in August, in stroke guideline, for the first time, moderate events and moderate data and the Recommendation B, and this is a drug which has the highest level of recommendation, which is listed in the guideline. And we are recognizing that this drug will be further used. In Korea, already, this is being submitted. And in 1 to 2 months, we are planning to obtain approval,Please move on to the next page. Daridorexant, this was introduced by Chris earlier. Last October, in double-blind study in Japan, this was the double-blind study, which was only conducted in Japan. We have the good outcome. We're preparing for submission. This year, in Q4, we are planning to submit. As for this drug, orexin receptor, this was discovered by [ Dr. Yanagisawa ] in Japan, very eminent scientist, and this is already launched in 2022. In Japan, this is already confirmed. And we will be the third one. But looking at the clinical trial results until now, this is expected to become best-in-class.Insomnia drug allows to sleep early, but instead, there is carryover effect on the next day. There will be insomnia, and that is the biggest shortcoming. And on the following day -- the safety on the following day is something that is a concern within the guideline, but it is not allowing to have any wake in the middle and there is no carryover effect and barely any effect on the following day. We have high expectation to this drug.And if you can move on to the next page. Cenerimod, we're preparing for Phase III, and we are participating -- expecting to participate into global study in every site, the contract is already completed. And immediately, we are planning to enroll to global study. Lucerastat, unfortunately, the global study is for neuropathic pain. The primary endpoint is the target. But unfortunately, it did not meet the primary target. Instead, the comparable effect is already seen just like the drugs which are available. And with these parameters, we are planning to have additional clinical studies in Japan.Please move on to the next page. So as I explained up to now, the first PIVLAZ and Daridorexant, only in Japan, we have 400 cases of the clinical trials. Submission and marketing are something that we are already working on. As you may know, high level of a health care technology in Japan and appropriate environment for the clinical trials, thanks to that, we are able to have this platform. By conducting this clinical trial, after the launch of the product, there are physicians for participating and they're recognizing the efficacy and safety of this drug. And this is the premarketing from the clinical trials that we are targeting, and we should be able to ensure that through this platform from Sosei Group or from Idorsia Group, new products will be developed from Japan. And this is something that we would like to take the lead to.That concludes my presentation.
Please turn to Slide 24. Pipeline news flow. We now have greater control over our pipeline news flows and value catalysts. This slide shows there are several catalysts on track to be achieved in the next 18 months.Please turn to Slide 25. We are on track to achieve our 2030 vision. Thank you very much for your time. That concludes our presentation. We will now take questions.
Thank you very much for your attention. We will now move on to the Q&A session. [Operator Instructions] First, Citigroup Securities, Yamaguchi-san.
Citi's, Yamaguchi is my name. First, Daridorexant, commercialization part. So you will co-promote with Mochida and Shionogi, I think is also involved. So your take for the sales and profit in Japan will be how much? Roughly how much?
Thank you for the question. So President Tanaka?
So our sales is the hospitals of over 200 beds. That is the target for our sales. So sales, GP and, given the ratio of the hospital with over 200 beds, 30 to 40 will be our take.
And so by having Idorsia in the family, what will the scale be like? The forecast or the visibility will be -- will improve -- so the company will no longer be as deal-dependent. So maybe not this year, but from next year and onward, will the company be able to issue a forecast? What do you think?
Thank you very much. I will answer that question. As Yamaguchi-san just said, the sales and profit will come in -- will be included where we have a certain level of visibility. Now the group forecast, financial forecast that comes into the Tanshin report, we still have milestone and Heptares part is also there, and we will have new collaborations, new partnerships going on -- moving forward. So if we add all that, whether we can have a better forecast, I must say it may be a bit difficult. This year's PIVLAZ sales is presented so, of course, it's not impossible for us to show that part of the information. We don't know if we can do this [Audio Gap]. Does this answer your question?
Yes. And one last simple question. Pfizer, GLP agonist, Pfizer development stopped, but the negotiation -- if there is a negotiation, any progress there?
So Matt will respond to that question, GLP-1 agonist.
Yes. So nothing to update from the press release that we issued towards the end of June. So clearly, we were disappointed to hear Pfizer's decision to discontinue lotiglipron. We look forward to understanding the scientific and clinical data more in due course. Thank you for the question.
Did you start talking or not?
Can you hear me Yamaguchi-san?
Yes.
Okay. In summary, I'll just reiterate what Matt said.
No, no, I heard it.
You heard it? Okay.
Yes. Did you talk to Pfizer? That's a kind of follow-up question...
No.
Mr. Yamaguchi, thank you very much. It seems like there was some confusion in interpretation. Excuse us for that. And we would like to move on to the next question. Hashiguchi-san from Daiwa Securities.
This is Hashiguchi speaking. My question is about dividend. With this acquisition, your profitability structure would change, I would assume. So in the near future, is there any possibility of providing dividend? Today, drug discovery platform, you talked about the need for investment for strengthening that area. Are you planning to have the retained profit for that purpose? Do you think this situation would continue? Or in the future, are you going to be in a situation to offer a dividend? In what kind of situation do you think you can provide a dividend? What is your current thought at the moment?
Thank you very much for the question. First of all, Chris would like to respond to your question.
Yes. Thank you for the question. Our policy is not to pay dividends. We will be investing in discovery. We will be investing in development, and we'll be investing in scaling the commercial platform for many years to come. So there is no intention to pay dividend at this time or over the medium term.
If I may elaborate a little more, in Mr. Hashiguchi's question, you asked in what kind of circumstance we will be able to pay dividend. And we are currently discussing internally. But at this point in time, on a short-term basis, Idorsia is still in the growth phase, and we are not expecting to have significant profit immediately. Of course, we're going to generate profit, but JPY 35 billion or EBITDA of JPY 10 billion in order to reach the peak, whether you call it a short term or medium term, the time frame will be different, but as you know, it would require more than years. But on the other hand, we would start to generate a stable profit, milestone and also onetime payment without including the uncertain payment and if the profit becomes stable, we think it is likely to have a dividend. So from our perspective, we are hoping to achieve such circumstance as soon as possible. But as Chris said, there are difficulty on a short-term basis, as Chris said.So moving on to the next question, Mizuho Securities, Tsuzuki-san. Tsuzuki-san from Mizuho Securities.
Tsuzuki from Mizuho Securities. I have 2 questions. First, the possibility of turning profitable this fiscal year. In the second half of this year, you just had a strong message on the collaboration partnership for the second half. And Daridorexant, is there a milestone from Mochida? And including that, do you have a possibility of turning profitable this year? So that's my first question.
So Chris will answer that question.
Yes. Thank you for the question. We don't give profit guidance as we don't give revenue guidance. We always do, however, strive to run the business at cash flow neutrality, which gives us a chance of profitability, but we don't put out profit guidance or forecast. So I cannot guarantee that. Of course, we will be focused on growing the commercial sales of PIVLAZ and advancing the filing of Daridorexant. If successfully filed, there may be a modest milestone income event from Mochida, but I cannot disclose the amount at this time. Thank you for your question.
And the other question is lotiglipron, with Pfizer, GLP-1 agonist, you had a partnership. So if -- when GLP-1 Pfizer goes away, the current collaboration with Lilly, is there a possibility of an expanded partnership at all or not? So that's my second question.
So R&D head, Matt, would like to answer that question.
Yes. Thank you for the question. So we haven't disclosed the targets that we're working on with Lilly. They are in the metabolic disease area. So in terms of any discussions around being able to use GLP-1 as part of that, that's something that will unravel in time to come. So we -- there's a lot of time to go yet before we can have any discussions like that. But we generally don't disclose targets at a very early stage like that. But clearly, as you say, despite the situation with lotiglipron, we do have a very active interest in the metabolic disease area with Lilly, who are doing amazing things in the clinic at the moment in this particular therapeutic area. Thanks for the question.
Thank you for the questions. We have many hands raised, so we would like to move on to the next question, [ Stefan Markus ] from Jefferies Securities. Please wait for a moment. I think you can...
This is Miura from Jefferies Securities. I have 2 questions. The first question is about Idorsia acquisition, PPA, and according to the current forecast, this impact is not incorporated, which was explained earlier. But at the time of the financial closing, for Q3, would there be any kind of accounting-related impact?
Yes, I would like to respond to that question. Naturally, when it comes to Q3, after July 20 of Idorsia, it's not going to be 3 months on a full basis, but it will be added. So naturally, it should become more visible, and it will be reflected in P&L for the total amount. So I think you will be able to understand.
So P&L and balance sheet cash flow, would they be added?
Yes, correct.
Then the second point is on Page 11. You talked about the priority objectives for this year. And you will make investment for strengthening productivity of the platform. And what will be the scale of investment you're planning at the moment? May I confirm that point?
Thank you very much. Matt, will respond to that question.
Yes. So thank you for the question. So the scale, that's difficult to quantitate or put a dollar or yen figure on this. But I will give you some examples of what we're doing to invest in the platform. Number 1 is related to some of the collaborations that I mentioned in my part of the presentation. So we actually established these early-stage collaborations in target identification and validation. This really ensures that we're adding GPCRs to our highly productive platform that are unique, novel and have been identified and appropriately validated through those collaborations. So that's an investment. And it's -- but it's in the way of collaborations.Secondly, there's an area actually that I didn't touch on today, but maybe we can talk about this at the end of year results, is our interest and investment in non-GPCR membrane proteins. This is an area that I've highlighted previously. It's an area that we're considering very much so at the moment. We think that our technology may be applicable more broadly to other membrane protein, drug classes like ion channels and transporters. And we've been doing quite a lot of work internally -- paperwork really to try and understand if we're going to do this, which targets will we focus on. And when we push the button on this and we start wet work, we will be doing that mainly internally, but we will also be relying on some support from some collaborators as well. But that's an area that we really want to explore as well from a platform growth perspective. So there's 2 areas that I mentioned there, but they're very hard to put a yen figure on those. I hope you understand my answer. Thank you.
Okay. So why you started the investment from this fiscal year because you can get the financial [ certifying ] cash income from Idorsia, so you can start to expand for the non-GPCR targeting? Or is it -- why you started the investment from this fiscal year?
Miura-san, it's Chris here. I wouldn't say it started just from this year. We've had a plan for a long time to continually invest in the platform. And that goes all the way back to the acquisition of G7 Therapeutics in Zurich, Switzerland many years ago, and then the ongoing investments that we make in not only technology collaborations, but also this early feasibility work that Matt just discussed. When we talk about investing in the platform, it's not a specific amount of money that's just been deployed this year. It's more generally investing across multiple collaborations and technologies to ensure that our platform doesn't stand still and that it always expands. And as Matt said, the next natural area for expansion is other membrane proteins, and we hope to have something to report towards the end of the year. That is basically the fruit borne from investments not only this year but in years gone by.
Thank you very much. We will move on to the next questioner, Nomura Securities' Matsubara-san.
Matsubara from Nomura Securities. I have 2 questions. First is on PIVLAZ. So the number of patients that are being enlisted is increasing or not? And the cumulative number of patients, when I look at the trend, JPY 13.3 billion in 2023 may be a little conservative. So do you have a new forecast or projection on this?
Thank you. President Tanaka, please.
Thank you for the question. Let me answer that question. So as I said earlier, from April last year to December was 3,100; and from January this year to December, 7,300 patients is expected, prescriptions. So looking at this monthly comparison, this year, the number of prescription is increasing and as I said earlier, in August, the stroke guideline for the first time, is accepted as the standard drug at a high level. And so we think this will lead to a further increase in prescriptions.
I understand. And second question is muscarinic agonist. So M1 development status, how does it look like right now?
Thank you very much. So this will be explained by Matt, please.
Yes. So as I mentioned in my presentation, so there was -- as Hiro has on the slide right now, so Neurocrine did not specifically highlight a time line for an M1 agonist to enter the clinic. There's a more general comment there about their commitment to progressing generally muscarinic agonists from the suite of molecules that were part of the collaboration. So we have nothing specific to comment on the M1 agonist. Thank you.
Okay. So we can expect another clinical trial study the next fiscal year?
It's Chris here. We can't commit to that. As we've said, we're making a general comment regarding Neurocrine's commitment to muscarinic agonists. The programs are not within our control, given we've licensed them to a partner. So we can't disclose details that they haven't disclosed publicly. I hope you'll understand.
Thank you for the question. We would like to move on to the next question. Toyo Keizai, [ Onishi-san ].
[ Onishi ] from Toyo Keizai. I have 2 questions, very brief. After acquisition, cash at hand is JPY 40 billion and this level I'm expecting to see the increase in development fee, but the reason for retaining JPY 40 billion, are you planning to have further development and investment? And do you think this JPY 40 billion will be required for that purpose? I just want to know the criteria for retaining this JPY 40 billion. Is it the appropriate level?
Thank you very much for the question. Chris would like to respond to that question.
Sure. Thank you, [ Onishi-san ]. As a biotech, a growing biotech at that, we need to retain cash runway regardless of how our business is performing. Now we always try to manage the business to cash flow neutrality or cash flow positivity ideally. However, it's still a sensible thing to maintain a multiyear cash runway because it can be difficult to forecast and predict hard-earned milestone income, for example. That cash balance that we've retained is a prudent amount of cash to fund the business on a go-forward basis. We do expect to add to that cash balance over time as we execute new major cash flow generating partnerships and as we continue to grow sales of PIVLAZ and hopefully successfully launch Daridorexant next year. But our business always involves investment in R&D and investment in sales and marketing in order to grow corporate value over time.
Understood. So growth investment would continue to increase. So considering that the JPY 40 billion will be required, I understand your point. Now coming to the second part of my question, as the goal for this fiscal year, your own assets to enter into clinical trial, more than 2 products would enter them. And in the second half, we are expecting that you are planning to have 2, but is there a possibility for the third product to be in the clinic? And at that timing, your development capability, do you think it will be difficult to have more than 3 products in clinic at the same time? Do you have any constraints?
Matt would like to respond to that question.
Yes. Thank you so much for the question. So yes, so as reported in the slides, it's our expectation that GPR52 agonist will be #1. We hope EP4 antagonist will be #2. Your question around a third, I would say it's unlikely. I think in these slides, we are reporting EP4 agonist as being in the first half of 2024. So it's likely to be 2 this year. What we're aiming really to do from a capacity perspective is we're aiming for 1 to 2 clinical study starts per year from the U.K. We think this is well within our capacity. If we aim for 2, then at least -- we should expect to get at least 1 of those per year, but it would be great to get 2 per year. That is within our capacity to do. Hopefully, that answers the question. Thank you.
I might just add to that, Matt. If we wanted to do 3 and if we wanted to do 4, the business model that we operate makes use of flexible external resource from partners. So of course, we would be able to easily scale up and handle more if we wanted to. But it's not the current intention, as Matt said.
Thank you for the question. So we still have a few more hands, but the remaining time is limited. So I would like to take 2 more questions. First, Pathology Associates, Dion-san.
So Dion, Pathology. Can I just ask 2 questions. Number 1, regarding milestone income, the second half has historically been always much stronger for Sosei. And I am expecting some milestone income from Neurocrine on the M1/M4 combo starting Phase I in the third quarter. Is that correct? And what other milestone income should we be expecting in the remainder of this year? That's the first question. And then secondly, if I can ask on Cenerimod. That is -- that's a very large Phase III trial. And I wonder what you -- what's your expectations in terms of other indications? Can you speak a little bit about that, given the size of the Phase III and that's obviously quite advanced already? So what can we expect? What have you seen so far on Cenerimod?
Thank you very much. Matt would like to respond and then Chris to add more information.
Yes. Thank you, Hiro. So yes, thanks for the question. So I will address the first question, which is around the milestones. So I think your point is valid. So I think generally, we do probably have a stronger second half of the year. But what we would say is this that we usually don't comment on individual milestones until they've actually happened. And then we -- because they're material, then we would release them into the public domain. Generally speaking, we wouldn't refer to them ahead of time. So I'll not comment on that. We are -- we do have a number of collaborations and a number of assets that are moving through various phases; phases of discovery and clinical development. So in general, I would say our expectation is that we would hope to receive some milestones, but I won't say specifically where they're going to come from.We should also add that, as Chris mentioned as well, and Hiro, I think has mentioned, so we still continue quite actively in our business development field around identifying new collaborations. We're always open to talking to potential partners and so we're very active in that space. And that's another revenue stream that we often see that comes in towards the later half of the year as well. So that concludes my answers to the first question. Chris, I don't know if you want to add anything.
Yes. I was just going to say, Dion, you're absolutely correct. Traditionally, we are stronger in the second half when it comes to milestone income. And that's largely a fact of the way that we conduct business development strategy, and it typically starts at the beginning of the year when we all attend the JPMorgan Healthcare Conference in the second week of January. And in order to conclude a collaboration with a major pharmaceutical partner, either for a discovery collaboration or a traditional out-license, it takes time and it takes negotiation and it takes diligence visits, and that usually takes longer than 6 months, which is why the milestones have traditionally fell in the second half of the year. I won't give you a quantum to focus on, but I absolutely expect we'll be stronger in the second half when it comes to income from either new partners or existing partners.I'll now touch briefly on Cenerimod. We have, only in the last 2 weeks, obtained an exclusive opt-in to that program. So forgive me, I'm not going to comment in detail. But I do think it is fair to say your comments are correct. What we have with Cenerimod is an exclusive opt-in to a very clean, very safe compound that's been extensively tested to date, and there are certainly other indications that we would be potentially more interested in for Japan than the current trials being conducted. We are, of course, working through analysis on both of the programs. They're exclusive opt-ins. We don't have to take the programs. But Cenerimod is interesting to us because of its indication expansion potential, and we would like to spend some more time looking into the potential for that compound in Japan and APAC, and we have many months to make that decision, and we will talk with our new partner at Idorsia, if and when we come up with a new and interesting development plan for the local region.
Thank you for the question. In the interest of time, we are slightly after the scheduled time, but, [ Sakai-san ] from Credit Suisse Securities.
This is [ Sakai ] from Credit Suisse. It's about PIVLAZ and I think I should have asked this question, why in Korea and Japan, why is there higher incidence of SAH? I believe that there are clinical significances. I see that on the Internet. But since President Tanaka is in the meeting, I would like to know your thought and also PIVLAZ. The patients who are prescribed PIVLAZ, what is the prognosis? Is there any clinical data that is accumulated at some point? And would that be analyzed? And do you have any plan to disclose that? Those are the questions I have.
Thank you for the question. As you know, in Japan and Korea, in Asian countries, roughly speaking, compared to Western countries, about 20x more higher incidence of SAH. So I think you know about that. And from the ratio mechanism, we feel that there isn't any difference. And for the cerebral disease environment and natural environment, so-called high pressure, so to speak, is considered to be the cause. And with respect to this drug, it is to prevent a rupture and also the stroke infarction will be prevented. And in the clinical trial, we elucidated the improvement of the prognosis, and we are targeting for 2,000 cases, and we are collecting a PMS data. And in some time with about half of the data, we should be able to disclose the kind of information that you have asked, and we're planning to publish that.So in terms of timing, it would require another year also to be in the literature, PMS data, we don't need to disclose all cases. We just need to analyze with the collective data and to make the announcement. Ultimately, it will be 2,000 cases. So it would take us some time. But the interim analysis, we are planning to make an announcement.
Thank you for that question. Now we have many questions in the text but there are so many questions with the hands raised and we couldn't take them. It is time but if you could write in, we will follow up and answer later in official blog. So I hope you could understand. The recording of today's briefing will be made available on our website at a later date. Thank you. That concludes our financial results briefing for the first half of FY 2023. Thank you very much for your participation.[Statements in English on this transcript were spoken by an interpreter present on the live call.]