CellSeed Inc. Fiscal Year 2016 Earnings Results

Transcription

1 CellSeed Inc. Fiscal Year 2016 Earnings Results February 22, 2017 CellSeed Inc. JASDAQ Growth Security Code: 7776

2 Contents Company Overview FY2016: Summary of Profit and Loss Outline of Mid-term Business Plan and Goals of Profit and Loss Cell Sheet Regenerative Medicine Business Epithelial Cell Sheet for Esophageal Regeneration Regenerated Cartilage Sheet Business Alliance in Taiwan Establishment of Cell Processing Facility (CPF) Regenerative Medicine Supporting Business Situation of Fundraising Copyright 2017 CellSeed Inc. All Rights Reserved. 1

3 CellSeed Inc. Overview Established: May 2001 Fundamental Technology: Cell Sheet Engineering Using Temperature-Responsive Polymer Listed Market: JASDAQ Growth Market, Tokyo Stock Exchange (7776), Listed in 2010 Business Description Cell Sheet Regenerative Medicine Business Commercialization of regenerative medicine using the cell sheet Regenerative Medicine Supporting Business Development, production, and sale of temperature-responsive cell cultureware Copyright 2017 CellSeed Inc. All Rights Reserved. UpCell 2

4 Regenerative Medicine: New medicine that regenerates and cures lost, damaged or malfunctioned organs University Base of innovation Seeds Collaborative research Business alliance Products Fee Hospitals Medical Treatment Medical expenses Patients Partner companies Mission We take the initiative of contributing to global health care in the valuable and innovative field of regenerative medicine. Copyright 2017 CellSeed Inc. All Rights Reserved. 3

5 Stem Cells: Key to Application of Regenerative Medicine ES cell: An embryonic stem cell derived from a zygote and can differentiate into all kinds of cells ips cell: An induced pluripotent stem cell generated by introducing a gene to a differentiated cell Somatic stem cell: A stem cell that exists in various tissues of an organism Brain Lung ips cell Zygote ES cell Liver Heart Pancreas Intestine Genitalia Blood Somatic stem cells Copyright 2017 CellSeed Inc. All Rights Reserved. 4

6 ips cell Cell sheet Protocell Stem cell Cell Tissue ips cell Somatic stem cell Epithelial cell Skin Mucous membrane Heart Cartilage ES cell Zygote Cornea ES cell Blood Copyright 2017 CellSeed Inc. All Rights Reserved. 5

7 Strategies of CellSeed Cell sheet engineering Morphogenesis Pluripotent cell Cell differentiation Cells Tissues Somatic stem cells Skin ips cell Mucous membrane Nerve ES cell Eye Heart Zygote Blood vessel Blood transfusion Blood 30-40cc Cell therapy Bone Connective tissue Various organs Blood Copyright 2017 CellSeed Inc. All Rights Reserved. 6

8 Cell Sheet Engineering Base Technology of Regenerative Medicine The world s first platform technology developed in Japan (invented by Prof. Teruo Okano of Tokyo Women s Medical University) 37 Hydrophobic 20 Hydrophilic Cells are cultured in a cell cultureware whose surface has been immobilized with temperature-responsive polymers. Possible to harvest cell sheet that retains extra cellular matrix by simply controlling temperature using CellSeed s intelligent cell culturware Copyright 2017 CellSeed Inc. All Rights Reserved. 7

9 Applications of Cell Therapy Using the Cell Sheet Engineering Periodontium Cornea Middle ear Esophagus Cartilage Cell sheet Pancreas Lung Liver Heart Time-limited approval was obtained (on Sept. 18, 2015) Copyright 2017 CellSeed Inc. All Rights Reserved. 8

10 Contents Company Overview FY2016: Summary of Profit and Loss Outline of Mid-term Business Plan and Goals of Profit and Loss Cell Sheet Regenerative Medicine Business Epithelial Cell Sheet for Esophageal Regeneration Regenerated Cartilage Sheet Business Alliance in Taiwan Establishment of Cell Processing Facility Regenerative Medicine Supporting Business Situation of Fundraising Copyright 2017 CellSeed Inc. All Rights Reserved. 9

11 Consolidated Profit and Loss (For FY2016) (Unit: Million yen; Presented with fractions less than a million yen rounded off) Sales Operating income Ordinary income Quarterly profit attributable to owners of parent Earnings per share FY2016 (A) 100-1,413-1,415-1, yen FY2015 (B) yen Divergence (B-A) Year-On-Year Change (%) Initial Full-year Estimates 100-1,200-1,150-1, yen Sales : (In 2015) Regenerative medicine supporting business : 80 million yen / Termination of the existing corneral contract :113 million yen. (In 2016) Regenerative medicine supporting business : 50 million yen / Initial retainer fee of business alliance with MetaTech(AP)Inc. : 50 million yen Regenerative medicine supporting business : Some of our existing clients (universities and research institutes) are cutting down on expenses Proactively build up new clients and develop new products Cell sheet regenerative medicine business: 524 million yen, the expense for establishing the Cell Processing Facility, was booked as facility acquisition expenses for specific research and development purposes. Copyright 2017 CellSeed Inc. All Rights Reserved. 10

12 Contents Company Overview FY2016: Summary of Profit and Loss Outline of Mid-term Business Plan and Goals of Profit and Loss Cell Sheet Regenerative Medicine Business Epithelial Cell Sheet for Esophageal Regeneration Regenerated Cartilage Sheet Business Alliance in Taiwan Establishment of Cell Processing Facility Regenerative Medicine Supporting Business Situation of Fundraising Copyright 2017 CellSeed Inc. All Rights Reserved. 11

13 Six Core Strategies of Mid-term Business Plan (From FY2017 to FY2019) Obtain sales approval for the epithelial cell sheet for esophageal regeneration Promote business alliances with overseas companies Accelerate development of the allogeneic regenerated cartilage sheet Newly develop our own supporting products and affiliated products Start development of next regenerative medicine products Establish a supply chain system Copyright 2017 CellSeed Inc. All Rights Reserved. 12

14 Mid-term Management Plan ( ) Goals of Profit and Loss (Unit: Million yen; Presented with fractions less than a million yen rounded off) Sales Operating income Ordinary income Profit attributable to owners of parent FY2017 (plan) 100-1,250-1,230-1,230 FY2018 (goal) FY2019 (goal) Major Goals of Progress in the Development Pipeline in the Future Epithelial cell sheet for esophageal regeneration: Carry out clinical trials in 2017, apply for sales approval in 2018, and obtain approval for sale in Regenerated cartilage sheet: Initiate clinical trials around the 4th quarter of FY2017 (clinical trials will be run in 2018 and 2019). Plan to proactively forge business alliances which may contribute to expansion of our cell sheet regenerative medicine business to overseas markets. *Sales related to business alliances are not contained herein, including alliances currently under discussion. Copyright 2017 CellSeed Inc. All Rights Reserved. 13

15 Contents Company Overview FY2016: Summary of Profit and Loss Outline of Mid-term Business Plan and Goals of Profit and Loss Cell Sheet Regenerative Medicine Business Epithelial Cell Sheet for Esophageal Regeneration Regenerated Cartilage Sheet Negotiations on Business Alliance in Taiwan Establishment of Cell Processing Facility Regenerative Medicine Supporting Business Situation of Fundraising Copyright 2017 CellSeed Inc. All Rights Reserved. 14

16 Esophageal Cancer in Japanese People The number of cancer morbidity by affected site (in 2010) Each year, about 22,000 people are newly diagnosed with esophageal cancer in Japan. The incidence in men is 5 times higher than that in women. Esophagus Gallbladder/Bile duct Malignant lymphoma Men Stomach Colon Rectum Liver Lung Prostate Other Large intestine Pancreas Esophagus Rectum Liver Pancreas Uterine Cervix Uterine body Ovary Leukemia Thyroid grand Other Leukemia Women Stomach Colon Lung Breast Large intestine Gallbladder/Bile duct Uterine Thyroid grand Malignant lymphoma Number of Patients Copyright 2017 CellSeed Inc. All Rights Reserved. 15

17 Epithelial Cell Sheet for Esophageal Regeneration A medical treatment developed by the Institute of Advanced BioMedical Engineering and Science, Tokyo Women s Medical University as a regenerative treatment for esophageal cancer (to heal esophageal wound and prevent stricture) Cell sheet is produced by harvesting and culturing cells from the oral mucosa of a patient on a temperatureresponsive cell cultureware to be produced in a sheet form and then transplanted into the ulcerated area in the esophagus after endoscopic surgery for esophageal cancer Harvesting the oral mucosa Drawing autologous blood Cell Processing Facility (CPF) Epithelial cell sheet Operating room Copyright 2017 CellSeed Inc. All Rights Reserved. 16

18 Path to Commercializing the Epithelial Cell Sheet for Esophageal Regeneration Clinical research at university Tokyo Women s Medical University Japan: Tokyo Women s Medical Univ. 10 cases Tokyo Women s Medical Univ. and Nagasaki Univ. 10 cases Europe: Karolinska University Hospital 10 cases Conclusion of basic development agreement Clinical trials to obtain approval Japan Conduct clinical trials CellSeed Conduct clinical trials Europe (Sweden) Completed pharmaceutical strategy consultation with the PMDA Submitted anotification of clinical trial plan on Apr. 7, 2016 Initiated clinical trials in summer of 2016 Plan to obtain approval for sale in 2019 Held a preliminary consultation with the Swedish Medical Products Agency (MPA) on Nov. 30, 2015 Consulted the European Medicines Agency (EMA) in 2016 Copyright 2017 CellSeed Inc. All Rights Reserved.

19 Simultaneous Development of Devices for Cell Sheet Transplantation Cell sheet Attach a cell sheet to a carrying device and send it to a diseased part without dilating the balloon Dilate the balloon part (to transplant the sheet) In Japan, conduct clinical trials in combination with the cell sheet. Obtain approval as medical device so that it can be used in clinical trials in Europe. Copyright 2017 CellSeed Inc. All Rights Reserved. 18

20 Development of the Regenerated Cartilage Sheet (CLS2703C) Collaborative research with Prof. Masato Sato Department of Orthopaedic Surgery, Surgical Science, Tokai University School of Medicine Chondrocyte sheet maintaining extracellular matrices Preventing proteoglycan escape Protection against catabolic factors Source of growth factors Layering Contribute to repair and regeneration of cartilage Confirmed regeneration of hyaline cartilage Three-dimensional complex (Establishment of tissue repair patch) Layered chondrocyte sheet Indications: Cartilage defects, knee osteoarthritis Copyright 2017 CellSeed Inc. All Rights Reserved. 19

21 Regenerated Cartilage Sheet From Clinical Researches to Trials, Aiming for Joint Treatment Clinical research at Tokai University Transplantation of autologous cell sheets Aug Approval was given at the 65 th Committee on Science and Technology of Health Science Council of MHLW. Oct A written opinion of the Minister of Health, Labour, and Welfare (Health Policy Publication 1003 No. 3 published by the MHLW) was issued. Nov The 1st patient was enrolled. Nov transplants were performed, evaluation was completed after 2 years from each of the 8 transplants. The post-operative course of each and every transplant more than 3 years after respective transplant operations was uneventful and made satisfactory progress. Transplantation of allogeneic cell sheet Harvest cartilage tissues from a polydactyly patient to transplant as allogeneic cell sheet, and then transplant it. The clinical research aiming for joint treatment by allogeneic cell sheet (issued by the Minister of Health, Labour, and Welfare in Aug. 2014) Feb The 1st patient was enrolled. MHLW : Ministry of Health, Labour, and Welfare Copyright 2017 CellSeed Inc. All Rights Reserved. 20

22 Regeneration of Knee Cartilage Using the Cell Sheet Data: Prof. Masato Sato of Tokai Univ. School of Medicine Before operation Immediately after transplantation 1 year after transplantation Copyright 2017 CellSeed Inc. All Rights Reserved. 21

23 Development of the Regenerated Cartilage Sheet (CLS2703C) by CellSeed Preparation underway for starting clinical trials in Japan Held a pharmaceutical strategy consultation with the PMDA (regarding safety and quality) AMED project focused on developing comprehensive evaluation technology for autologous cartilage cell sheet DNA Chip Research Inc., Tokai University, CellSeed Inc. To establish an evaluation system of the quality of cell sheet products Collaborative research with Prof. Sato of Tokai University 2004 Provided temperature-responsive cultureware 2006 Launched collaborative researches 2010 Assisted in clinical reseach 2014 Enhanced the collaborative research system (CellSeed dispatched researchers to Tokai University.) Patents: filed jointly with Tokai University Patents registered in Japan. PCT application is under examination. Plan to further enrich the patent network. Copyright 2017 CellSeed Inc. All Rights Reserved. 22

24 Contents Company Overview FY2016: Summary of Profit and Loss Outline of Mid-term Business Plan and Goals of Profit and Loss Cell Sheet Regenerative Medicine Business Epithelial Cell Sheet for Esophageal Regeneration Regenerated Cartilage Sheet Business Alliance in Taiwan Establishment of Cell Processing Facility (CPF) Regenerative Medicine Supporting Business Situation of Fundraising Copyright 2017 CellSeed Inc. All Rights Reserved. 23

25 Business Alliance in Taiwan MetaTech (AP) Inc. Founded on Sept. 17, 1998 Listed in Taipei Exchange Business description Materials for electronic components, wholesale/retail of medical cosmetic products and medical equipment, biotechnology, and other business services MetaTech desires an exclusive business development (manufacturing, approval acquisition, sale) of cell sheet products (the epithelial cell sheet for esophageal regeneration and the regenerated cartilage sheet) in Taiwan. Negotiations on a business alliance were opened in Dec CellSeed received 50 million yen to start to consider granting license (the amount received was booked to sales in FY2016). Negotiations over the alliance will be continued up to around Mar Copyright 2017 CellSeed Inc. All Rights Reserved. 24

26 CellSeed Headquarters & Cell Processing Facility Headquarters Address 15 th Floor, Telecom Center Building Aomi, Koto-ku, Tokyo Cell Processing Facility for Cell Sheets 6th Floor, Telecom Center Building Shibuya-ku Minato-ku Koto-ku Tokyo Metro Tozai Line Urayasu City Shinagawa-ku Ota-ku Haneda Airport Kawasaki City Copyright 2017 CellSeed Inc. All Rights Reserved. 25

27 CellSeed Cell Processing Facility for Cell Sheets Total floor area: 763 m 2 Automatic monitoring system Cleanliness, air pressure, temperature and humidity, operation status of equipment (incubators, reagent stockers, etc) Surveillance camera system inside the CPF 20 minutes from Haneda Airport Under application to obtain to obtain a manufacturing business license. Copyright 2017 CellSeed Inc. All Rights Reserved. 26

28 Regenerative Medicine Supporting Business Encourage development of new products and new application to increase revenue opportunities Development of new research products Development of products for clinical application; Material Transfer Agreement was concluded with Terumo Corporation. Enrichment of business strategies Strengthen the sales network both in Japan and overseas Enhance customer support services Host exhibitions and seminars Copyright 2017 CellSeed Inc. All Rights Reserved. 27

29 Resolution on the Issuance of the 16th Share Options Scheduled allotment Evolution Biotech Fund Total Options 2.2 million (Planned to be issued on Mar. 6, 2017) Total Value of Issuance Total Value of Exercise Period (In Principle) Reset Allowance (in principle) Exercise Price Total commitment First-half commitment 6.6 million yen billion yen 14.5 months 58 in total (Anticipated) 90% of VWAP (Initial exercise price : 510 yen, Minimum exercise price : 283 yen) In principle, the exercise of all the share options issued within 291 calculation days is committed. In principle, the exercise of 50% or more of the share options issued within 146 calculation days is committed. The net dilution rate compared to the previous issue (the 13th share options) is 7.9%. The number of unexercised shares at the 13th round of stock option is 1.47 million, the number of issued shares at the 16th round is million, the net increase is merely 730,000 stock options (a net dilution factor of 7.9%). The reliability of the method of funding improved (the total commitment and first-half commitment). In principle million shares shall be exercised by Oct. 5, 2017 and million shares shall be exercised by May 14, Copyright 2017 CellSeed Inc. All Rights Reserved. 28

30 We Look Forward to Your Continued Support in Our Future Endeavors! Thank You Very Much for Your Interest in CellSeed! This document contains forward looking estimates and assumptions. However, they are not meant to be guarantees of our earnings or future performance as they are influenced by various unforeseen factors and risk factors. This document has been created for the purpose of furthering the understanding of CellSeed by readers and is not meant to be a solicitation for investment in our shares. We have taken every step to ensure accuracy in the creation of this document, but we cannot guarantee that it deals with all of the factors pertinent to our Company. Therefore we will not assume responsibility for any claims of losses or damages arising from the information within this document. For investor inquiries, please contact us at our investor relation website below: Copyright 2017 CellSeed Inc. All Rights Reserved. 29