SanBio Company Limited (4592) Earnings Call Transcript & Summary

Hello. This is Keita Mori from SanBio. As usual, I and Naoki would like to provide updates on our financial results for the fiscal year ending January 31, 2024. So first page, table of contents. This is as usual, so I will skip over to Page 4 and go over the income statement. As you can see, we have, in the past year, used the R&D expense JPY 2.8 billion, and also the overall operating expense to be JPY 4.5 billion. This is quite in line with the -- our initial plan -- the initial plan. One thing to note is that the foreign exchange rate has had some impact. And we had a foreign exchange gain of about JPY 1.7 billion, which impacted the net loss to be JPY 2.6 billion. But again, in terms of the operating expense itself, it was about the amount that we forecasted at the beginning of the year. Next, I would like to go over the balance sheet. So here, I see -- I would like people to look at the cash and cash equivalent. We do have JPY 4.4 billion. And with this, we have secured working capital for the expenses related to the approval of a TBI program and the launch activities. Next slide. This is regarding the forecast for the coming year. In this, we have a forecast as -- R&D expense about JPY 2 billion and the total operating expense to be a JPY 3.3 billion. This, we expect to incur mainly for the expenses related to the approval of our product as well as the launch activities and the post-marketing period in Japan. So now I would like to go to the main topic of today, and it's the second section, SB623 Approval in Japan status and the sales structure after the approval. Page 8, this describes the overall process of the submission, approval and the launch activities. This is a slide that we have been using again and again. So I would not spend any more time on this, but let's go to the next slide. So this is the main update of this quarter, and this press release we just issued yesterday. Basically, the news is on the submission and approval process for the status. Yesterday, on March 18, Monday, there was an announcement made by the Ministry of Health, MHLW in Japan, that there will be a subcommittee meeting for regenerative medicine, something that that we have been waiting for, and I'm sure that this is something that many of the people -- paying attention to us and our new product or TBI has been watching for. So this announcement -- announces that our product candidate, AKUUGO, this used to be have the name SB623, this is equivalent, will be on the agenda of the subcommittee 1 week from today, pretty much on Monday, March 25. One thing that we would like to note is that the title of this agenda this time is -- I would like everyone to look at this press release. The title is related to AKUUGO. And the title did not include the usual title, which is regarding the approval or disapproval of the product. So this is something that we would like to highlight. And we would like people watching progress to take caution on this announcement and watch the progress through and towards -- and through March 25. So this is all we have to say today regarding the status of the SB623 or the AKUUGO, which is finally announced as one of the agendas at the subcommittee meeting. Now I would like to turn over to Naoki for what we are doing to prepare for the launch of product. So Naoki Tsukahara, please.

Yes. Thank you, Keita. So let me explain what will -- what we need to work on after we get approval of SB623. For example, listening this slide, you can see that the price listing, medical treatment fees, sales structure, logistics, promotional activities and also the internal structure to make sure the appropriate promotion activities. Those are the items that we need to work on after we got approval. And we are quite sure that we have made good progress on these preparation of these items, and we are just waiting for the approval of SB623 to move forward further. Thank you.

Now I would like to move on to the third section, maximizing the corporate value. We have 3 slides, which are the usual slides that we use. Since the approval status has not changed yet, our plan remains in the same direction for maximizing the corporate value. Let me go over briefly on each slide and our strategy in this regard. Page 12, SB623 development plans. Our priority remains our first product approval anticipation TBI in Japan. This is the highest priority, which has been the highest and which continues to be the highest at this point. Our next priority is followed by clinical trials that we are planning for Ischemic stroke in Japan. We also do not forget the importance of globalizing our product, especially from TBI, which we have a great data already and very clear and the large patient needs in the United States and elsewhere. Now I'd like to move on to the bigger picture of what's ahead of us on Page 13. This is the entire development status pipeline description of our various product candidates. As you can see, SB623 is only one of the -- finer with the 5 product candidates that we have. And so we have a lot more in our pipeline. And also, TBI is only one of the many, many 8 indications we have planned for SB623. So getting the approval for TBI, we are sure to accelerate the various activities that we have planned ahead of us, including a very important Ischemic stroke recovery and beyond. Lastly, we remain to become a global leader in regenerative medicine. We do remain as one of the leading edge or cutting-edge leading companies in the neuroregeneration space. There is no other company that we know of who is closer to the first approval of the regenerative medicine product. And as I mentioned with the announcement of the TBI AKUUGO program to the subcommittee in Japan, this is a clear step. And we would like to -- and we assure that the approval of the TBI will help in many ways in TBI patients as well as the stroke patients and beyond, and that's our vision to become the global leader and help improve the deficits of the patient and help patients live a life that they serve. Thank you very much for paying your attention to the progress of our product and what we can bring to our patients. Thank you, as always.