This is Jun Suzuki of TEIJIN. Thank you for joining us in our regenerative medicine business briefing today. It gives us a great pleasure to have so many participants. As you are aware, on January 29th of this year, TEIJIN announced the Board decision to acquire the shares in J-TEC through a tender offer. The stock purchase was carried out from February 1st to March 2nd, and was successfully completed as originally planned, making TEIJIN the parent company of J-TEC. Following the closing in March, we embarked on more detailed official studies on how best to improve the corporate value of both TEIJIN and J-TEC. When we made the internal decision to join hands with J-TEC more than a year ago, we already had a clear vision regarding the direction of the business. That is, to pursue regenerative medicine using autologous cell as the ultimate of tailor-made medicine. Furthermore, we did envision that this business could make the big leap through leveraging TEIJIN's capabilities in healthcare, materials, and engineering. Still, the plan was rather vague back then. For the six months following the completion of the TOB, both companies went through substantive talks and have now reached a stage where we are ready to discuss business plans for J-TEC and TEIJIN respectively, as well as for both companies combined. As was indicated at the earnings announcement by TEIJIN for the second quarter on November 8th, more specific business plans, including sales targets of JPY 20 billion or more in fiscal 2030, and JPY 35 billion or more in fiscal 2035, will be presented by President Hata of J-TEC and Nakano of TEIJIN today. For those analysts who have been following TEIJIN, regenerative medicine may be an unfamiliar area, and therefore, I hope this meeting will be an opportunity to deepen your understanding on what is regenerative medicine or what is CDMO, together with their business environments, and hopefully to realize that there are actually great business potentials in specific areas, and to get convinced that it is really a promising business. That is all from me. Thank you for your attention. This is Ken-ichiro Hata of J-TEC, Japan Tissue Engineering Co., Ltd., which became a new member of the TEIJIN Group in March. I would like to give the overview of our business, including the description of what regenerative medicine is, although I'm sure many of you are already familiar with this concept. I have so many things I would like to cover, so I'm afraid I will be zipping through, but you should find many details in the slide deck, so I kindly ask you to refer to them later. Please turn to the first page. This is the outline of my presentation today. First, I would like to explain a little about regenerative medicine. As many of you may already know, regenerative medicine came about in relation to tissue engineering. Tissue as in the tissue of the body. The concept is to engineer and create body tissues in others using cultured cells, which have been carried out for research purposes for medical transplantation. Please look at the video on the upper right of the slide. There, you can see cells moving like amoeba. By artificially culturing cells, the epidermal cells in the skin are multiplying in large quantities. This video clip is being fast-forwarded, so in reality it's not happening this fast, but you can see that the cells are multiplying. To use this not only for basic research, but also for medical transplantation, that's the beginning of tissue engineering. The term regenerative medicine was coined in relation to the Millennium Project of the Obuchi administration in 1999. There was a reference to the term regenerative medicine, including human genome and gene analysis. It was envisioned at this stage that various regenerative medicines be promoted such as for angiogenesis and skin grafting by 2004. In fact, J-TEC received approval for regenerative medicine for skin in 2006. Helped by the Japanese word for regenerative, [Non-English content] that gives the positive impression of some kind of new birth, this field attracted attention. What is regenerative medicine in summary? Technology that uses living cells, technology that enables regenerating organs and body tissues. These served as the source of hope and expectation. Furthermore, it also had a nuance that it may lead to curing hitherto incurable diseases. There also was a unique background in Japan. While the Organ Transplant Act was enforced right before this time frame, there were very few organ donors in Japan, which was a rather serious issue in the late 1990s. Regenerative medicine offered various advantages since tissues are made out of one's own cells, no immunological rejection, no disease transmission from other people, and no donors necessary. For these reasons, regenerative medicine attracted a lot of expectations. The Japanese Society for Regenerative Medicine stated that in regenerative medicine, cells are actively used to regenerate the functions of dysfunctional or malfunctioning tissues or organs. The regulator also expressed great expectations in terms of reconstructing structures and function, as well as treating and preventing diseases. There also was the expectation that it will become a medical treatment that uses cells to intervene from an early stage. Gene therapy is also mentioned, which indicates a great foresight. Now in addition to the nuance of regenerating human organs and tissues, there are increasing applications of enhancing the functionality of cells to fight cancer. I will talk about this later. That's the brief explanation of regenerative medicine. With the original expectations that the tissues and organs of human body can be recreated outside the body, it attracted attention, especially given the difficulty in Japan to find organ donors. Now, an overview of J-TEC itself. It was established in February 1999, just before the term regenerative medicine was defined within the Millennium Project. At that time, the term regenerative medicine was not yet major. We have 200 employees and have been active for more than 20 years with the philosophy to be a company essential and valuable to society through the industrialization of regenerative medicine. The company is listed on the JASDAQ Growth Market and is headquartered in Gamagori City, Aichi Prefecture. This is the history. At the risk of sounding presumptuous, I feel that our company has developed in line with the evolution in the business environment surrounding regenerative medicine in Japan. At that time, there was a rule requiring filing application for government approval before conducting a clinical study on skin. Likewise for cartilages. The application system was established about the same time as our company was founded. There also was a big event, Professor Shinya Yamanaka being awarded the Nobel Prize. From around this point on, the momentum to focus on regenerative medicine picked up. Many things happened, including the enactment of the Regenerative Medicine Promotion Act and revisions to the regulatory systems in 2014. The regulatory environment for regenerative medicine has improved considerably. The company began to offer cultured cartilage and skin and then expanded indications for cultured skin. In recent years, we received the approvals for the cultured corneal epithelium products, especially regarding the second corneal product. The insurance coverage was granted just yesterday on December 1st. There are four products. I will explain them really briefly. Please refer to the slides later for details. Skin is the first product. Then cartilage. Then two corneal epithelium products. First, NEPIC, and the OCURAL, corneal treatment product that uses oral mucosa cells. We have received approval for four items so far. Regarding the autologous cultured epidermis, we first received manufacturing and marketing approval for severe burns in 2007, and later the indications expanded to giant pigmented nevus and epidermolysis bullosa. Let me give you some details from here. JACE autologous cultured epidermis is the very first regenerative medicine product in Japan. It is a membranous structure made of the patient's own cells. It is so designed to be placed where the skin is lost. It does not use any artificial materials, only cultured skin cells which grow thicker. As I mentioned earlier, its first indication was for burns. The indication was expanded gradually to include giant pigmented nevus and later epidermolysis bullosa. It is provided as a sheet product with the size of about a postcard. Provision of the cultured cells in itself is not such a difficult scheme, but making sure that this is made with the patient's own cells without fail and packaging them in a way that ensures delivery to hospitals anywhere in Japan in a fresh and living state is something else. This was the very first product that realized that business model. The second product is autologous cultured cartilage, JACC, used for cartilage defects of the knee. Please look at page 14. Small amount of cartilage is taken from the patient's knee and cultured after having been mixed with collagen gel and shaped into a three-dimensional form to be transplanted. As of today, as indicated in the slide, knee osteoarthritis is excluded as its indication. It would be great if this could be used to treat many elderly people suffering from knee pains due to knee osteoporosis or osteoarthritis. At this point in time, it is targeted only for patients who need treatment due to injuries, such as athletic injuries. Furthermore, the indication is limited to fairly large defects sized 4 by 4 centimeters or larger. We are now making focused efforts in clinical studies to expand its indications to cover osteoarthritis of the knee, so as to be delivered to the patients who really need it, to more patients who are suffering as quickly as possible. The third product is for the cornea. Not the entire cornea, but the corneal epithelium, the surface or the epidermis of the cornea. This therapeutic treatment is for those who have damaged surface, for example, by having some foreign objects in the eye, say some alkaline matter in the eye. We take a small amount of tissue from the undamaged eye of the patient, culture it, and transplant it. The concept of this product is to take advantage of the corneal cell of the remaining undamaged, unaffected eye to treat the damaged cornea. The product was added to the insurance reimbursement in June 2020. Recently, another product was added. It is for patients that don't have healthy cornea in either eye. Professor Koji Nishida of Osaka University has established a wonderful technique which involves taking a mucous membrane in the mouth to create epithelium in a similar manner. True, it does not compare to the one made from the cornea, but this technique is intended for patients whose both eyes are affected, as it is confirmed that a quality corneal epithelial-like structure can be formed from the oral mucosa. Yesterday, on December first, this fourth product was granted the insurance reimbursement. There are various expressions used, such as tailor-made medicine and personalized medicine. Moving forward, in all areas of medicine, including diagnosis and treatment, medical services will be provided that would suit the specific situation of each patient. In this context, what we offer is an ultimate custom-made product where the patient's own cells are extracted, brought into the J-TEC site in Gamagori City, Aichi Prefecture, and offered with the approvals obtained as currently required by the Pharmaceuticals and Medical Devices Act, or PMD Act. The shelf lives are therefore quite short, with 56 hours for the skin and 80 hours for the cartilage. Therefore, we have established a system to get these products delivered so we can provide the ultimate custom-made products. Regenerative medical products is one of our business segments, and there are other segments that have been derived from it. This is an excerpt from the disclosed materials of J-TEC medium-term business plan. Though academic researchers and university professors have many good technological seeds, in order for them to be launched into the market, you need to package them into products that are in compliance with the regulations. In order to make them more widely available in society, you also need to establish all the business models to culture and deliver them. That is where the concept of contract development and manufacturing organizations, or CDMOs, for regenerative medicine comes into play, as will be explained by Mr. Nakano later. We provide services of establishing a business model and delivering a product. As part of our efforts to broaden the ground to be covered by our businesses, we hope to be of help in the undertakings to offer those various technological seeds. Furthermore, now that human cells can be cultured more easily, as Dr. Yamanaka says, iPS cells can be useful in drug discovery and development. We figured that if the skin cells can be cultured, they might be useful in, say, manufacturing and research and development of cosmetics, and that is what we have been providing. As the awareness of animal welfare in animal testing is increasingly heightened, needs for those products as alternatives to animals are also rising. Therefore, we are also focusing on the R&D support business. As I said, here you can see the overview of the research and development support business. We build a tissue model using the skin and provide it for use in research. Then chemical and cosmetics manufacturers can use it to study product safety, among others. This is the business model that we offer. I have rushed through the overview of our company, but from now on, I will discuss what are the future prospects of regenerative medicine and what is going on currently, especially focusing on diversity of regenerative medicine. This slide lists regenerative medical products approved as of today in Japan. This is also attached to your handout, and so I'd like you to take a look at your leisure if you are interested. Let me just hit the highlights on this table. Currently, there are 14 items in all, of which three with a star use genes instead of cells, meaning that there are 11 items using cells listed chronologically. In fiscal 2021, five new items have been approved. As I said earlier, in 2014, the regulations were revised, resulting in an environment conducive to development of regenerative medical products. Thanks to the efforts by the government of Japan, regenerative medical products are increasing rapidly, which is one noteworthy aspect. Another notable phenomenon is that it has become easier for products already approved overseas to be launched in Japan. There are relatively few Japan-originated products, of which ours account for many. There are more from overseas, especially brought in by mega pharmaceutical companies. As you can see here, cancer therapies using cells, such as those for lymphoma and leukemia, are mainstream, which indicates that regenerative medical products based on regeneration of tissues, which was what was originally expected the most of regenerative medicine, may not be complete fully yet. Let me now explain about diversity of regenerative medicine using this schematic. Therapies using patients' own cells and those using other people's cells are totally different in their business models. The latter may be closer to conventional products. What is closer to the conventional expectation on regenerative medicine is a business model where tissues of 3D organization are manufactured and transplanted. Another one is to inject cell suspension, which may be closer to the approach used for drugs. In regenerative medicine, the original expectation was to achieve transplantation medicine, which cells are turned directly into organs, and so I personally wish that would be the case. More recently, there is also expectation that physiologically active substances produced by cells can be used for treatment. In some cases, you need to live with the product for the rest of your life, while in other cases, transient effect is what is expected, as in cancer therapies. The product can be transplanted by surgery or administered by IV or injection. Therefore, regenerative medicine is so diverse that it would be a bit of a stretch to jumble them all together. Hence the need to identify an appropriate business model to provide each type of regenerative medicine. When you list up opposing approaches mentioned in the previous slide, use of allogeneic cells and cell suspension, ability to administer through IV injection, effects being created by physiologically active substances, and having transient effects are more conducive to business models similar to those for drugs. However, as in the original transplantation medicine, those that are closer to medical treatment, such as use of autologous cells and 3D organization, regeneration through engraftment by cells on cells, need for surgery, and persistent and lasting effect, do not have had solid business models universally established yet. We at J-TEC have been conducting all of our businesses, the skin, the cartilage, and cornea, with the business models closer to medical treatment. To create new medical treatments, our approach should be providing our products as part of the overall medical treatment with the cooperation from physicians instead of offering them as standalone products. This will be one of the key perspectives in this business. This slide shows the result of a survey commissioned by the Japan Agency for Medical Research and Development, or AMED, on development trend. On the left is the numbers of products on the market where there are musculoskeletal products, which includes cartilage, like the one that we offer, the skin, and cancer. On the right is the number of global development projects. Cancer is by far the largest. We can glean from this survey is that while musculoskeletal and skin products are largest in the number of those on the market, in terms of development, cancer is the largest category, including CAR T-cells. However, one thing to note is that many of them are cancer therapies using patients' own cells. How are we going to establish a business model of using the patient's own cells? We would like to closely watch and figure out how regenerative medicine and cell therapies will develop as treatments through organ and tissue transplantation. Currently, many bio-related companies are aiming for getting approval on manufacturing and marketing of their products. The question is how you can establish a business model of producing regenerative medical products stably and generating profits. We have offered our skin and cartilage and other products to more than 2,000 patients so far. We'd like to come up with a business model by performing backcasting from the profit structure to figure out what sort of development and production is required. We believe it will become important to build a mechanism to allow us to provide more cultured knee cartilage products, such as those for use by elderly patients with osteoarthritis, where there is a larger market. This is one of the materials used in our presentation to the Ministry of Education, Culture, Sports, Science and Technology. There are many different modalities for regenerative medicine, including cell therapy, gene therapy, and cancer therapy. Gene therapies come in various forms, such as those which introduce a gene using CAR T- cells and those where genes are directly infused, which are also of several different types. In particular, for those using cells, cross-modal common factors such as manufacturing and quality evaluation are just as important as different approaches by modality. We are hoping to combine J-TEC's experiences and what TEIJIN Group has, such as biomaterials and engineering, to be used in cross-modal functions, including production engineering, biomaterial development for the products themselves, and characteristic analysis, so we can seek synergistic effects while hoping that regenerative medicine itself will also develop in that manner. Let me now give you an overview of Forum for Innovative Regenerative Medicine, or FIRM, which I lead. FIRM consists of more than 200 corporations currently. What is characteristic about this organization, which was established in 2011, or 10 years ago, with 14 corporate members, is that 20% of its membership currently is in the pharmaceutical and regenerative medicine industry. In other words, even though it is a general trade organization, 1/5 of its members are companies dealing with regenerative medical products. On the other hand, there are also many in the chemistry and materials, machinery and equipment, and logistics and services. This attests to how regenerative medicine business induces discussions among diverse industries and works as a system instead of a modality basis. What these composite elements constitute is successfully what J-TEC and TEIJIN are seeking to build together, and we hope to execute the regenerative medicine business, also making use of those corporate activities of FIRM. This is a list of Directors of FIRM. As you can see, many different companies are represented. In pursuit of realizing the diversity of regenerative medicine based on the rich experiences of those corporations, the whole regenerative medicine industry is expected to move forward. In particular, our group hopes to promote regenerative medicine on the basis of systems in addition to new ecosystems and modalities. This is the summary slide. I rushed through my presentation, including what regenerative medicine is, activities of our company, and current status and issues regarding regenerative medicine, focusing on the extremely diverse forms of medical treatment. It is the establishment of this ecosystem and how that will be translated into business models that are our challenges going forward, as well as our business opportunities as well. That was a very disorderly presentation, but thank you for your attention. This is Takayuki Nakano from TEIJIN. I would like to give you an overview of the regenerative medicine business of the TEIJIN Group. This slide was shown in our second quarter financial results briefing last month. We explained that J-TEC and TEIJIN will co-create and participate in the business of CDMO services for regenerative medical products. Furthermore, TEIJIN and J-TEC will work together to promote J-TEC's existing regenerative medical products and regenerative medicine business. We aim to make the business a pillar of profit as a strategic focus of the TEIJIN Group. I will dig deeper into that aspect today. This is the outline of my presentation. I will mainly talk about the CDMO services for regenerative medical products of TEIJIN and J-TEC and the deployment of regenerative medical product lineup of J-TEC. First, the overview of the Japanese regenerative medicine market. As shown here, the size of the regenerative medicine market in Japan was about JPY 4 billion in 2018, including two products from J-TEC, JACC and JACE. We expect the market to expand to JPY 850 billion in 2030. In terms of original products, it is estimated that in 2030 products from Japan will account for about 8% and that the rest will be from overseas. We believe that there is a great need for services to be provided to venture companies and pharmaceutical companies that enter the Japanese market from overseas. In particular, in relation to compliance with Japanese pharmaceutical regulations. By treatment method, as of 2030, cell products are expected to account for the majority of the market, such as ex vivo gene therapy, cell transplantation, and tissue transplantation, as mentioned by President Hata earlier. In establishing manufacturing methods for such cell products, it is important to build solid product quality in anticipation of the many hurdles in their application for approval. Currently, development of about 700 regenerative medical products has been confirmed globally, with close to 40 of them in Japan. Autologous cell products that use the patient's own cells are the ultimate tailor-made products, as President Hata explained. For these autologous cells, it is desirable to produce locally for local consumption where the patients are located. We believe that there is a need for manufacturing in Japan. Alternatively, for allogeneic cell products that use cells from other people, it is presumed that many of allogeneic cell products launched overseas will be mass-produced overseas and imported into Japan. We believe that main needs for manufacturing in Japan will come from autologous cell products originating overseas and autologous and allogeneic cell products originating in Japan. Based on these market forecasts, TEIJIN CDMO's main battlefield for the time being is the contract manufacturing of autologous and allogeneic products originating in Japan and autologous products originating overseas in such areas as ex vivo gene therapy, primarily CAR T- cell products, cell transplantation, and tissue transplantation. Regarding the competitive landscape of the Japanese CDMO market, we assume there will be a couple of Japanese competitors. It is important to differentiate ourselves to drive this business. In TEIJIN's CDMO business, our plan is to fully leverage J-TEC's strengths, such as strong presence in Japan and high level of technology. Regarding CDO services that support product development and clinical studies, the first 1/2 of the process, we will leverage J-TEC's advantages in sophisticated product quality to ensure providing high reproducibility and scaling up to larger quantities, know-how to define product standards and quality control methods that can be applied for approval, and the ability for quick and reliable manufacturing of formulation for clinical trials. We'll make the best use of J-TEC's existing strengths to develop the CDO business and promote the development of cell products. Regarding the CMO business that offers commercial manufacturing services, we will build a solid production line based on the understanding of Japan's unique regulations and quality definitions, and provide supply chains that contribute to stable supply. Here again, we will make the most of J-TEC's strengths to participate in the CMO business. Furthermore, we believe that it is important to have a system that ensures a firm and seamless transition from the first 1/2 CDO services to the latter 1/2 CMO services. In TEIJIN Group's CDMO business, we will build a system that seamlessly transition from CDO to CMO. Changing gears, I would like to talk about the future development of J-TEC's regenerative medicine business from here. Currently, J-TEC's regenerative medicine business has sales of approximately JPY 2 billion in the three core businesses that President Hata mentioned earlier. On top of that, we will launch various products in the pipeline of J-TEC shown here over the next few years. Furthermore, we will expand the indications of JACC cartilage product already on the market, as well as expand sales of NEPIC and OCURAL, the corneal products launched recently to drive organic growth of J-TEC's business. In addition, through collaboration with TEIJIN, J-TEC's products will be expanded overseas. As I will explain later, we will expand LabCyte products in the R&D support business as animal testing alternatives. By improving on the existing products such as JACC and LabCyte and developing successors, we aim to develop and expand J-TEC itself through collaboration between TEIJIN and J-TEC. Now, on overseas development of J-TEC products. J-TEC has been only conducting its business in Japan, whereas TEIJIN has experiences of conducting business broadly through overseas licensing with overseas partners, especially in its healthcare and pharmaceutical businesses. By integrating those two approaches, we are working to bring J-TEC products overseas. A candidate for the first product in this endeavor for overseas development is the Allogeneic Cultured Epidermis product or Allo-JaCE03, which went into a clinical trial recently. As an Allogeneic Cultured Epidermis product, it can be mass-produced in a planned manner while satisfying a certain level of quality. It is a dried product with the convenience to allow for being stored and transported at room temperature. As a ready-made product, it can be stocked by medical institutions and used to patients as needed. Thus, it is suited for overseas development. Using this as the first candidate, TEIJIN and J-TEC plan to bring more J-TEC products overseas. This slide describes global development of animal testing alternative products, the LabCyte series. As President Hata said, as part of J-TEC's research and development support business, those three products of LabCyte series are already marketed in Japan. They are mainly used by cosmetics companies in the Japanese market. As you know, however, the global trend of abolishing animal testing is being accelerated. EU has already banned animal testing for cosmetics, and the ban is expected to be broadened to include pharmaceutical development in the near future, and we believe the global market for animal testing alternatives will continuously grow at a fast rate. In tackling this market with an expected fast growth rate, TEIJIN and J-TEC are aiming to expand their animal testing alternative business first in Asia with LabCyte products. We will combine TEIJIN's material technologies and J-TEC's human and tissue culture technologies to develop LabCyte's successor products, such as organ-on-a-chip, so we can aim for global development of the animal testing alternative business as TEIJIN Group as a whole. As for expanding business in the field of orthopedics through collaboration with TEIJIN Group has been conducting business in the field of orthopedics through Teijin Nakashima Medical and Teijin Pharma, while J-TEC has a cartilage products called JACC in the field of orthopedics. Again, through collaboration between TEIJIN Group and J-TEC, we hope to expand our orthopedic business. More specifically, this includes promotion of improvements of JACC cartilage products as well as collaboration in sales activities. The Teijin Nakashima Medical is already engaged in various areas of the orthopedics field, while J-TEC has its own medical network. Through joint sales activities by both parties working together, sales of JACC can be increased. We also hope to create new products and therapies in the future to preserve or reconstruct the knee joint function totally. This slide shows the total picture of the business plan through collaboration between TEIJIN and J-TEC. As was explained at the second quarter earnings announcement, we are hoping to increase the sales from the JPY 2 billion + of J-TEC alone in fiscal 2020 to over JPY 20 billion in fiscal 2030, and then to over JPY 35 billion in fiscal 2035 with CDMO business and expansion of J-TEC business. With regard to CDMO business, we have already started to work on facility startup. We plan to choose optimal locations for the facilities comparing the land sites both inside and outside of TEIJIN Group. We plan to disclose more information on this when we are ready to do so. For the next several years, we are going to start up facilities for CDO and CMO and conduct contract businesses originated from both overseas and Japan, so we can maximize the profitability as a CDMO business. On the other hand, as was explained, we will expand J-TEC business through its existing products and development pipeline items. Furthermore, through collaboration between the two parties, we will aim for business expansion by overseas development of J-TEC products such as LabCyte series and Allo-JaCE03, as well as by collaboration in the orthopedics field. This slide shows what the regenerative medicine business of the TEIJIN Group is aiming for. We will seek to realize TEIJIN's long-term vision of a company that supports society of the future, and J-TEC's vision of creating a future for regenerative medicine. Through collaboration between both parties, we will integrate the strengths of both and maximize our business through collaboration so that we can provide ultimate tailor-made therapeutics catering to the needs of each individual patient. That was my presentation on regenerative medicine as TEIJIN Group. Thank you for your attention.