SanBio Company Limited (SNBIF) Q2 FY2026 Earnings Call Transcript & Summary

Good afternoon. This is Keita Mori from SanBio, and thank you very much for coming to this quarterly update meeting. Today, I have 3 agendas. First agenda is the financial results. The second agenda is the progress in the first half year 6 months. And then thirdly, I will go over future outlook. So first, financial results, and I would like to explain the consolidated statements of income. So as we are working to get obtaining approval of AKUUGO, this partial change approval, our spending pattern has been quite similar to the last quarters or last year or so. And this 6 months, we spent about JPY 1.8 billion, and this was primarily a component was the expenses related to activities for obtaining a partial change approval AKUUGO. Now I'd like to move on to the balance sheet. As always, I would like everyone to look at the cash and cash equivalents to ensure the health of -- economic health of our company. We maintain a prudent level of cash and cash equivalents. Specifically, we have JPY 2.7 billion, and this meets our foreseeable short- to medium-term needs. This time, we revised the consolidated earnings forecast. So I'd like to highlight this to our audience. The primary change is due to an increase in manufacturing-related expenses and the intent here is to secure inventory of AKUUGO at the early stage. So if you could look at this, the operating expense, the original plan or forecast was JPY 3.5 billion and now the revised forecast is at JPY 3.9 billion. Now I'd like to move on to the sort of the meat of this presentation, the progress of the -- our progress in the last 6 months. Before I dive into the actual specifics of what we accomplished in the last 6 months, I'd like to again briefly introduce what our company is about and what our product AKUUGO is. SanBio, our company is a regenerative medicine company, and we have over 20 years of history of trying to develop the new field of regenerative medicine. And primarily, we have been focusing on brain diseases. There are 2 reasons. One reason is brain diseases is one of the last frontiers of drug development, and we believe this is an important area for the patients worldwide. The second reason is brain diseases are set to have no immunorejection, and this allows us and other companies also to implement the regenerative medicine in an allogeneic cell therapy way. And allogeneic cell therapy is a -- we use a standardized product approach, large-scale manufacturing, and this allows us to make our products available to many patients around the world. So we focus on brain diseases. And after continuous efforts of pushing this regenerative medicine for brain diseases for over 20 years, last year, we finally got the world's first approval for this product AKUUGO. I'd like to also highlight that this product is the first ever -- the world's first ever therapeutic agent for regeneration or regenerating brain. Our team is very proud that we have been able to do this in this very important field and before any competitors around the world. So last July in 2024, we got an approval for this new product AKUUGO. I'd like to spend maybe just a little bit more time what this product does. And the patient population, target population is a chronic TBI, traumatic brain injury patients. Typically, these patients have more automobile or motorcycle or car accidents and resulting in a severe injury into their head and brain. And this results in patients' inability to move their arms or hands or legs, resulting in disability in like walking or daily living activities. And our product indication is the improvement of motor paralysis associated with the TBI. So we'd like to really help many patients improve their motor paralysis and get back their living once again. So I'd like to move on to the next page. AKUUGO, as I mentioned, is approved for TBI at this point, and it's very important. But for the patients who are waiting, TBI is the beginning. As a company, we intend to expand the disease areas to diseases like stroke, spinal cord injury or retinal disease or even to Parkinson's disease or Alzheimer's disease. We believe this AKUUGO has a big potential, and we like to make sure that we expand the use of this product in the future as near future as possible. So going to the next page, I just want to set the background of our company in AKUUGO. And last July, it was a very, I think, important approval. However, we were left with certain homework from the regulatory agency. And this homework was for us to conduct some runs of the manufacturing runs and submit the additional manufacturing data to the regulatory agency. This was the homework before we are allowed to ship our products to hospitals for doctors and patients to use. So in the last year, we -- our team has been working rigorously and conducting the manufacturing runs. We conducted 3 commercial manufacturing runs and of the 3, we succeeded in 2 commercial manufacturing runs. And based on the homework, we submitted this data in June of this year. So the regulatory agency is reviewing right now, and our anticipation is that the approval for this partial change will be coming in the second half fiscal year of this year, so between August of this year and January of the next year. So this is one of the accomplishments that we had in the last 6 months. We completed filing to the Japanese agency of the partial change for AKUUGO. The second, I would say, quite substantial accomplishment we got in the 6 months is the United States initiative. So as I mentioned in the last quarterly meeting, we started interacting with the FDA, the regulatory agency in the United States to discuss the Phase III clinical trial for TBI in the United States. And very recently, if you could look at this red box, we were successfully, we reached an agreement with the FDA on the Phase III clinical trial design. We are very excited about this as we -- as this is a very important progress towards the Phase III, and we're very, very happy about this. We will be continuing to discuss the details with the FDA to conduct this Phase III clinical trial. So far, I've mentioned about 2 quite substantial progresses we had in this 6 months. I'd like to move on to the -- yet the third progress we had in the last 6 months, and this is related with the financial situation. We always want to keep a financial stability or financial health of the company in order to innovate and bring innovative products to the patients. And in the last 6 months or so, we secured 3 commitment lines from major, major banks in Japan. We secured JPY 1 billion commitment line from Resona Bank in March and then another JPY 1 billion from Mizuho Bank in June and yet another JPY 1 billion from Mitsubishi, MUFG Bank in July of this year. And this gives us additional stability and the health of the finance to our company. So this marks the 3 major progresses of this 6 months, and our team is very proud of what we accomplished in this 6 months. Now based on this progress, I'd like to now move on to the future outlook. We have the mission to become the global leader in regenerative medicine, and I'd like to set the path how we get there. So in our growth strategy in the next 4 years or so, we are focusing on 3 pillars. One is Japan, and we consider Japan as a home base and Japan is an important starting point for expansion because Japan has the most innovative and proactive regulatory framework of regenerative medicine. The second pillar is obviously the biggest health care market in the United States. We always had the activities in the U.S. and operations and the network. We are restarting or we restarted the U.S. clinical initiatives. And the third pillar is ischemic stroke. TBI is an important indication, but ischemic stroke is consist with many more patients and ischemic stroke is where we started the company's initiative with, and we have lots of inquiries from patients all over the world, and we owe to the patients to make sure that we engage with ischemic stroke and get this program going eventually to the approval and commercialization. So in the next few minutes, I'd like to dive into somewhat more details of how and what the path we have in the future. But before this, I'd like to sort of step back and share with -- share with you audience our strengths in the United States. So in the United States, actually, United States is the place where we started SanBio. This was back in 2001. And since then, we have had a lot of activities in the United States. And the original idea back then was we found many innovative technologies in Japan, and we were looking for place -- best place to develop and commercialize. And at the time, United States was the best place and that's how we started in the United States. I'd like to just highlight since this is a busy slide, I'd like to highlight a few things. One is in this slide, you can see that we conducted 3 clinical trials in the United States, 2 clinical trials in ischemic stroke from 2011 to 2015 and another one 2016 to 2018. And the number of patients we treated is 18 in the first study and 163 patients in the second study. And this made us work with 65 clinical centers throughout the United States, California, New York, East Coast, West Coast, Midwest, pretty much all the major areas in the United States, we have done clinical trials. Also, we did, of course, TBI study in the United States. This was between 2016 and 2019. And the number of patients was 63 patients, and we operated 21 hospitals in the United States. So we have a lot of track record of conducting clinical trials. And we are by far the company who have done the regenerative medicine for brain regeneration. Over 200 patients is by far the most number. I'd like to also mention 3 more things just quickly. We had the recognition from the funding agency. You can see 2017, we got $20 million from California Institute for Regenerative Medicine as a research grant. This is a really, really big brand. The second recognition came from the regulatory agency. In 2019, we got the RMAT, which stands for Regenerative Medicine Advanced Therapy designation. This is a priority review, et cetera. This only goes to promising and solid programs in regenerative medicine. And the third recognition is came from the academia. In 2022, we were selected to present our clinical study results at the American Academy of Neurology at the Plenary Session. So this is a special session which our PI stood up at the podium in front of thousands of audiences wanting to hear the latest clinical outcome. So we have a lot of recognitions in the United States and a lot of the clinical experiences, including our network with key opinion leaders and all the practitioners throughout the United States. So I guess that's probably enough for today to go our strength in the United States. So next, I'd like to go over the road map for us in this near future. So here, we present the Japan initiative at the top and U.S. initiative. I'd like to go from the Japan TBI first. So from left to right, we already applied for the partial change. And so this is already done. And then this half -- this 6 months, we estimate that we will be obtaining approval for this partial exchange. And then in the first half of the next year, we anticipate getting a drug price listing and also the sales -- product sales will begin something we anticipate. And ultimately, our goal is to obtain the official approval and accelerate the commercial activities. Next, ischemic stroke in Japan. So what we estimate as the road map is the first half of next year, we estimate we will be beginning discussions with the PMDA. And ultimately, our goal is to expand the indications into this ischemic stroke. Now moving down to U.S. TBI. So in the last -- I mean, in the first half of this fiscal year, we already resumed or restarted the discussions with the FDA regarding the Phase III clinical trial. And in this 6 months, our goal was to reach an agreement with the FDA on the Phase III clinical trial. Even though this is still early part of this 6 months, we actually already obtained this agreement from the FDA, and we are very happy about this, as I mentioned. And ultimately, our goal is to commercialize in the United States, TBI as well as stroke in the United States. Now I would like to just highlight the near-term sort of the events or projected events in the next 12 months. So the left side is this 6 months and then the right-hand side is the following 6 months, which is the first 6 months of the next year. So Japan, this 6 months, we project obtaining the approval for the partial exchange. And then in the next 6 months, we anticipate the NIH drug price listing and product sales. For stroke, we estimate beginning of the discussions with the PMDA. And then going to the lower part of the slide in the United States. As I mentioned, this we already agreed. We already got an agreement from the FDA on the clinical trial study design. And then in the next 6 months of next year, we will be conducting a preparation for TBI clinical trial. I hope this gives sort of what to look for the people who are cautiously or curiously watching and looking at our company SanBio. And finally, I would like to sort of present more of the midterm view of our company to our audience, we have a big vision to become the global leader in regenerative medicine. We have done quite a substantial work getting the approval of the world's first ever brain regeneration drug, but we still think this is the beginning. We consider us as on the left-hand side, the green sphere. This is our current status, we believe. And we are about to launch our first TBI Japan product, and this is where we are today. And moving to the next stage, which we consider this current fiscal year to the next fiscal year we anticipate getting to the next phase. And this includes launching our product in Japan, seeing the patients happy, restart the TBI in the United States and the preparation for stroke. And this would give us, I think, a quite growth for our company, and we would like to get there very quickly. And then if you look at the right-hand side in the pink sphere, this is the image that we have in the 4-year time frame or so. And in this time frame, we anticipate launching our product in the U.S. We also anticipate a substantial progress in the stroke initiative. And at this point, we will be looking at many patients that total of over 10 million patients spanning from TBI to stroke and spanning from Japan to United States. I think by that time, we should be able to ready to start so many patients, and we really look forward to getting there very quickly and healthy patients. And lastly, our mission is -- we say this again and again, we would like to really create a new field of medicine, and that is the regenerative medicine. We have many patients waiting for innovative medicine products. And to do so, we put ourselves with the vision of becoming a global leader in regenerative medicine. Thank you, as always, for your attention, and thank you for your continued support. Thank you.