Earnings call transcript: SanBio Q2 2025 sees strategic moves amid EPS drop

SanBio Company Limited recently held its Q2 2025 earnings call, revealing an actual earnings per share (EPS) of -6.42, against forecasts that were not specified. The company’s stock saw a post-earnings drop of 1.57% in after-hours trading. According to InvestingPro data, the stock is currently trading above its Fair Value, following an impressive 344.07% year-to-date return. Despite the negative EPS, the company’s strategic moves in regenerative medicine and the approval of its brain regeneration therapeutic agent, AKUUGO, are noteworthy.

Key Takeaways

• SanBio’s EPS fell to -6.42, impacting its stock price negatively by 1.57% after hours.
• The company has secured significant financial backing, with commitment lines totaling ¥3 billion from major Japanese banks.
• AKUUGO, approved for chronic traumatic brain injury, marks a significant milestone in regenerative medicine.
• SanBio plans to expand AKUUGO’s indications to include stroke and other neurological conditions.
• The company is focusing on expanding its market presence in the U.S. and Japan.

Company Performance

SanBio’s performance this quarter was marked by significant strategic developments, despite the financial challenges. The company is pioneering in the field of regenerative medicine with its product AKUUGO, which is positioned to treat chronic traumatic brain injury. SanBio’s efforts to expand its therapeutic indications and its geographical reach underline its growth strategy. The company also secured financial stability through commitment lines from leading Japanese banks, which could support its ambitious plans.

Financial Highlights

• Total spending: ¥1.8 billion over six months
• Cash reserves: ¥2.7 billion
• Revised operating expense forecast: Increased from ¥3.5 billion to ¥3.9 billion

Earnings vs. Forecast

SanBio reported an EPS of -6.42, missing unspecified forecasts. The stock responded with a 1.57% decline in after-hours trading. This performance reflects ongoing investments in research and development, particularly for AKUUGO.

Market Reaction

Following the earnings release, SanBio’s stock price decreased by 1.57% in after-hours trading. The stock has experienced significant momentum, with InvestingPro data showing a remarkable 34.21% return in the past week and 98.75% over six months. This performance reflects investor optimism about AKUUGO’s potential and the company’s strategic initiatives. InvestingPro subscribers have access to 10+ additional proprietary insights about SanBio’s market performance and valuation metrics.

Outlook & Guidance

SanBio’s long-term vision includes launching products in the U.S. and making substantial progress in stroke treatment initiatives. The company is targeting a patient population exceeding 10 million, with plans to expand from traumatic brain injury to stroke treatments, and from Japan to the U.S.

Executive Commentary

"We have a mission to become the global leader in regenerative medicine," stated Keita Mori, SanBio’s representative. He emphasized that "brain diseases are one of the last frontiers of drug development," highlighting the company’s pioneering efforts in this field.

Risks and Challenges

• High R&D expenses could impact profitability.
• Regulatory hurdles in expanding AKUUGO’s indications and entering new markets.
• Competition in the regenerative medicine sector may intensify.
• Economic fluctuations could affect funding and market expansion plans.

SanBio’s Q2 2025 earnings call highlighted both the challenges and opportunities the company faces as it seeks to lead in the regenerative medicine industry. While the financial results were less than stellar, the strategic initiatives in place signal a potential for significant future growth.

Full transcript - Sanbio Company Limited (4592) Q2 2026:

Keita Mori, Company Representative/Speaker, SanBio: Good afternoon. This is Keita Mori from SanBio, and thank you very much for coming to this quarterly update meeting. Today, I have three agendas. The first agenda is the financial results. The second agenda is the progress in the first half year, six months. Thirdly, I will go over future outlook. First, financial results, and I would like to explain the consolidated statements of income. As we are working to get the notes of payee approval of AKUUGO, this partial change approval, our spending backend has been quite similar to the last quarters or last year or so. This six months, we spent about ¥1.8 billion, and this was primarily a component of the expenses related to activities for obtaining a partial change approval of 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 recoverance to ensure the health of the economic health of our company. We maintain a prudent level of cash and cash recoverance. Specifically, we have ¥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. If you could look at this, the operating expense, the original plan or forecast was ¥3.5 billion, and now the revised forecast is at ¥3.9 billion. Now, I’d like to move on to the sort of the meat of this presentation, the progress of our progress in the last six months.

Before I dive into the actual specifics of what we accomplished in the last six 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. Primarily, we have been focusing on brain diseases. There are two reasons. One reason is brain diseases are 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 said to have no immunorejection, and this allows us and other companies also to implement the regenerative medicine in an allogeneic cell therapy way.

Allogeneic cell therapy is a, we use a standardized product approach, large-scale manufacturing, and this allows us to, you know, make our products available to many patients around the world. We focus on brain diseases, and after, you know, 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. 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 on what this product does.

The patient population, target population is chronic traumatic brain injury patients. Typically, these patients have more automobile or motorcycle or, you know, car accidents resulting in a severe injury to their head and brain. This results in patients’ inability to move their arms or hands or legs, resulting in disability in, like, walking or daily living activities. Our product indication is the improvement of motor paralysis associated with the traumatic brain injury. We’d like to really help many patients improve their motor paralysis and get back their, you know, living once again. I’d like to move on to the next page. AKUUGO, as I mentioned, is approved for traumatic brain injury at this point, and it’s very important. For the patients who are waiting, traumatic brain injury 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’d like to make sure that we expand the use of this product in the future, as near future as possible. Going to the next page, I just wanted to set the background of our company and AKUUGO. Last July, it was a very, I think, important approval. However, we were left with certain homework from the regulatory agency. 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.

In the last year, our team has been working rigorously on conducting the manufacturing runs. We conducted three commercial manufacturing runs, and of the three, we succeeded in two commercial manufacturing runs. Based on the homework, we submitted this data in June of this year. 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, between August of this year and January of the next year. This is one of the accomplishments that we had in the last six 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 this six months is the United States initiative.

As I mentioned in the last quarterly meeting, we started interacting with the U.S. Food and Drug Administration, the regulatory agency in the United States, to discuss the Phase 3 clinical trial for chronic traumatic brain injury in the United States. Very recently, if you could look at this red box, we were successfully, we reached an agreement with the U.S. Food and Drug Administration on the Phase 3 clinical trial design. We are very excited about this as this is a very important progress towards the Phase 3, and we’re very, very happy about this. We will be continuing to discuss the details with the U.S. Food and Drug Administration to conduct this Phase 3 clinical trial. So far, I’ve mentioned about the two quite substantial progresses we had in this six months.

I’d like to move on to the third progress we had in the last six months, and this is related with the financial situation. We always want to keep our financial stability or financial health of the company in order to innovate and bring innovative products to the patients. In the last six months or so, we secured three commitment lines from major banks in Japan. We secured ¥1 billion commitment line from Resona Bank in March, and then another ¥1 billion from Mizuho Bank in June, and yet another ¥1 billion from Mitsubishi UFJ Financial Group (MUFG) in July of this year. This gives us additional stability and the health of the finance to our company. This marks the three major progresses of this six months, and our team is very proud of what we accomplished in this six months.

Now, based on these 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 sort of the path how we get there. In our growth strategy in the next, you know, four years or so, we are focusing on three pillars. One is Japan, and we consider Japan as a home base. Japan is an important starting point for expansion because Japan has the most innovative and proactive regulatory framework on regenerative medicine. The second pillar is obviously the biggest healthcare market, the United States. We always had the activities in the U.S. and operations and the network. We restarted the U.S. clinical initiatives. The third pillar is the ischemic stroke. TBI is an important indication, but ischemic stroke consists of many more patients.

Ischemic stroke is where we started the company’s initiative with, and we have lots of inquiries from patients all over the world. We owe it to the patients to make sure that we engage with the ischemic stroke and get this program going eventually to the approval and the commercialization. In the next few minutes, I’d like to, you know, dive into some more details of how and what the path we have in the future. Before this, I’d like to sort of, you know, sit back and share with you, audience, our strengths in the United States. In the United States, actually, the United States is the place where we started SanBio Company Limited. This was back in 2001, and since then, we have had a lot of activities in the United States.

The original idea back then was we found many innovative technologies in Japan, and we were looking for a place, best place to develop and commercialize. At the time, the 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, you know, a few things. In this slide, you can see that we conducted three clinical trials in the United States. Two clinical trials in ischemic stroke from 2011 to 2015, and another one from 2016 to 2018. The number of patients we treated is 18 in the first study and 163 patients in the second study. This, you know, made us work with 65 clinical centers throughout the United States, California, New York, you know, East Coast, West Coast, Midwest.

Pretty much, you know, all the major areas in the United States, we have done clinical trials. Also, we did the, of course, TBI study in the United States. This was between 2016 and 2019. The number of patients was 63 patients, and we operated 21 hospitals in the United States. We have a lot of track record of conducting clinical trials, and we are by far the company who has done the regenerative medicine for brain regeneration. Over 200 patients is by far the most number. I’d like to also mention three more things just quickly. We had the recognition from the funding agency. You can see in 2017, we got $20 million from California Institute for Regenerative Medicine as a research grant. This is a really, really big grant. 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, etc. This only goes to promising and solid programs in regenerative medicine. The third recognition 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. This is a special session in which our PI stood up at the podium in front of thousands of audiences wanting to hear the latest clinical outcome. We have a lot of recognitions in the United States and a lot of the clinical experiences, including our network with the key opinion leaders and all the practitioners throughout the United States. I guess that’s probably enough for today to go over our strengths in the United States. Next, I’d like to go over the roadmap for us in this near future.

Here we present the Japan initiative at the top and the US initiative. I’d like to go from the Japan TBI first. From left to right, we already applied for the partial change, and this is already done. This half, this six month, we estimate that we will be obtaining approval for this partial exchange. In the first half of the next year, we anticipate getting a drug price listing and also the sales, product sales will begin. It’s something we anticipate. Ultimately, our goal is to obtain the official approval and accelerate the commercial activities. Next, the ischemic stroke in Japan. What we estimate as the roadmap is the first half of next year, we estimate we will be beginning discussions with the PMDA. Ultimately, our goal is to expand indications into this ischemic stroke. Now, moving down to a US TBI.

In the first half of this fiscal year, we already resumed or restarted the discussions with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical trial. In this six months, our goal was to reach an agreement with the FDA on the Phase 3 clinical trial. Even though this is still an early part of this six months, we actually already obtained this agreement from the FDA, and we are very happy about this, as I mentioned. Ultimately, our goal is to commercialize in the United States, a TBI as well as a stroke in the United States. I would like to just highlight the near-term sort of the events, projected events in the next 12 months. The left side is this six months, and then the right-hand side is the following six months, which is the first six months of the next year.

In Japan, this six months, we project obtaining the approval for the partial change approval. In the next six months, we anticipate the NIH drug price listing and product sales. For stroke, we estimate the beginning of the discussions with the PMDA. Going to the lower part of the slide in the United States, as I mentioned, we already got an agreement from the FDA on the clinical trial study design. In the next six months of next year, we’ll be conducting a preparation for TBI clinical trial. I hope this gives sort of what to look for for the people who are cautiously or curiously watching and looking at our company, SanBio Company Limited. 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 approval of the world’s first ever brain regeneration drug, but we still think this is the beginning. We consider us as the, on the left-hand side, the green sphere. This is our current status, we believe. We are about to launch our first TBI Japan product, and this is where we are today. Moving to the next stage, which we consider this current fiscal year to the next fiscal year, we anticipate getting to the next phase. This includes launching our product in Japan, seeing the patients happy, restart the TBI in the United States, and the preparation for stroke. This would give us, I think, quite growth for our company, and we would like to get there very quickly.

If you could look at the right-hand side in the pink sphere, this is the image that we have in the four-year timeframe or so. In this timeframe, we anticipate launching our product in the U.S. We also anticipate substantial progress in the stroke initiative. At this point, we will be looking at many patients, the total of over 10 million patients spanning from chronic traumatic brain injury to stroke and spanning from Japan to the United States. I think by that time, we should be able to be ready to start so many patients. We really look forward to getting there very quickly and helping patients. Lastly, our mission is, we say this again and again, we would like to really create the new field of medicine, and that is regenerative medicine. We have many patients waiting for innovative medicine products.

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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.