SanBio Company Limited (4592) Earnings Call Transcript & Summary

Good afternoon. This is Keita Mori from SanBio. Thank you for all the investors and other people to attending this meeting today. It's a pleasure for us to present to this many audiences today. We met the 20 years anniversary this year, earlier this year. And we continue to strive towards developing pioneering regenerative medicine and developing the first brain regenerative medicine, which has been wanted for more than, I guess, 100 years or so. So we have 3 contents today starting from the financial results. First, I'd like to go over the income statement. As you can see, the R&D, research and development expenses increased due to higher manufacturing-related expenses in preparation for approval filing of SB623 for TBI. As you can see, our R&D expense was about $22 million in the last 6 months, and that there is some increase, again, from the additional expenses in the manufacturing. Next, I'd like to go to the balance sheet. As we are continuing to be still in the development phase, this balance sheet and cash position, these are very important to us. As you can see, in this 6 months, we have continued proactively spending to increase the value of our products towards the approval. And as a result, we have decline in the cash and cash equivalent, as you can see. However, despite the declines, we continue to have maintained a stable financial position by having about $87 million equivalent as a cash and a cash equivalent. Next, I would like to go over our lead product, SB623, our efforts to get the product approval in Japan and also the subsequent developments. So this is a slide, it's a process that we are going through towards the filing for a Japan approval. Let me back up a little bit. For the audiences who are not so familiar, we have been developing this SB623 for TBI as well as for stroke and other indications, such as Parkinson's disease, retina disease. And we have strategically chosen TBI for the area of Japan for a accelerated rapid approval by utilizing very advanced regulatory framework which is taking place in Japan. So we will focus on our efforts. I will focus our updates on our efforts in Japan and specifically, TBI first. And as many of you may have known this, we, as a company, SanBio, obtained Sakigake designation for our program TBI SB623 back in 2019. This only goes to innovative products which seeks approval in Japan earlier than any other countries throughout the world. It's an indication of how our product is innovative and important to the patient population. So this slide goes over the process under the Sakigake designation, from a Sakigake designation and all the way through the sales. As we are deep in discussions with the regulatory agency in Japan, PMDA, we cannot disclose the exact phase of our development and exact status of the regulatory discussions with the PMDA. But we will try to give you the sense of where we are as of today. Two years ago, when we first seek for the filing, we unfortunately updated the community to delay our filing timing because we identify that we need to work more on the stable supply. Since then, we have identified the issues and taken measures against these challenges. And lately, from earlier this year, we have been updating the investment community that we are working on putting together documents for the filing and discussions with the PMDA. And this is continuing in the last 3 months or 6 months, and we believe that we are making good progress. We can say that we have not observed any new challenges. And we are continuing to just work on preparing the filing by discussing with the agency in a very productive manner. So I'd like to go on to the next slide. The next 2 slides are more generic explanations or the situations of the Sakigake in general, and some of the slides we have presented in the past, for example, 3 months ago, we presented to the small meeting for the analyst community. Please excuse us for using the same slides again, but we believe it's important to provide updates at this large meeting. So this slide talks about the benefits of the Sakigake system. We have taken this document from the MHLW, Ministry of Health of Japan, and these are the major benefits. The major benefits are shortening of the time line in priority consultation from 2 months to 1 month and also a big time line reduction in the priority review from 12 months to 6 months. In order to gain these time line benefits, what we and PMDA go through is the enhanced prior assessment. This is essentially a review before the approval filing. This, in a way, takes some additional time, but this gives us the opportunity to reduce the time line in the priority review and also increases the chance of success for the approval in a substantial degree. Next slide talks about the history of the Sakigake designated products. Since 2015, we have seen 52 programs that receive the Sakigake designation. And of the 52, it depends on the programs where they are, whether they are still in Phase II or Phase III or whether they are in filing stage of approval. This is a general investigation that we did in the Sakigake system. And our investigation shows that of the 52, 17 products have gone to the filing stage. And every single one of the 17 products have been approved. Same pattern applies to the regenerative medicine, 2 products have gone to the stage of the filing and both of these products have been approved. So this again indicates the highly likelihood of the success in the review and approval as I indicated previously. Now I would like to switch over to our Executive Vice President, Mr. Aki Tsujimura, to go over our efforts in the prelaunch activities and beyond. So Aki, please.

Okay. Thank you, Keita. I'd like to go over 5 slides. With this slide, I'd like to update the product launch readiness by major items. We have been establishing the sales infrastructures complying with expected approval requirements. Especially in the last 3 months, we have been enhancing our relationships with external stakeholders. Since we believe the patient support is very, very important, we have established strong relationships with institutions, municipalities to support our patient after treatment. The next slide, this slide shows the update on our R-SAT system. Thanks to our collaboration with Suzuken, we have established the special distribution system which covers all over Japan. With respect to R-SAT system, we registered the trademark in August last year, and we have already filed the joint patent application for the system to the patent office. On the right side of this slide, there are pictures for the cases. We have already purchased these cases, which will be utilized to distribute SB623 to each institution. In the next slide, with respect to SB623, we have prioritized the TBI indication in Japan, followed by the ischemic stroke and hemorrhagic stroke indications. And in the near future, we will expand our territories to the U.S., EU and China, including the Asian regions with all of these 3 indications. Next slide, this is our pipeline. We believe SB623 has a great potential in the ophthalmic indications. And we have developed a preclinical development plan with Ocumension which allow us to get the IND as soon as possible. In addition to SB623, we have pipelines such as SB618, SB308, MSC1 and MSC2. And the most optimized development plan for these pipelines is still under development. This is the last slide. As Keita has already mentioned in his opening remarks, SanBio was established 20 years ago. Actually, this year is the 20-year anniversary of SanBio. And since then, we have been trying very hard to develop good science, technology and know-how to contribute to the patients who have been suffering from the diseases which have no effective medications and treatment. We will continue our effort to provide the effective and safety solutions to the patients to improve their quality of life. And with our innovation, we will change the world and maximize the corporate value of our company. This is the end of my slide and this is the end of our presentation. Thank you for your attention.