Takara Bio Inc. announced the three-year medium-term management plan from April 1st, 2013 to March 31st, 2016. The company’s goal is to achieve sales of ¥24.6 billion and an operating income of ¥2.0 billion in fiscal 2016, absorbing an increase in research and development expenses.

1. Business Target

Consolidated Financial Forecast

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(FY2014 ; Year ended March 31,2014)
Forecast of Consolidated Net Sales by Business Segment

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Forecast of Operating Profit / Loss by Business Segment

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Forecast of R&D Expenses by Business Segment

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2. Business environment

The Japanese government is instituting a wide range of measures to support development in the regenerative medicine and cell therapy fields. The amount of government funding in Japan available for conducting basic research and clinical development related to regenerative medicine and cell therapy is set to increase substantially. In addition, the National Diet and related ministries are currently undertaking deliberations in order to accelerate the development of leading-edge medical technologies. Among the measures that have been brought to the table for discussion are a quick approval system for new drugs in advanced medical fields, outsourcing of cell processing, and the development of a framework for guaranteeing safety of such advanced medical technologies in light of their inherent risks.

 

Our main business is to provide products, services, and technologies to support organizations conducting basic and clinical research. Accordingly, such government measures for accelerating the development of leading-edge medical technologies as well as the rise in government research grants for development in these fields will create a favorable business environment for the Company. Takara Bio also possesses technologies for manufacturing clinical grade gene modified cells in accordance with GMP (Good Manufacturing Practices), and is providing technical support services (cell cultivation and processing) for medical institutions practicing cancer immunotherapy. These capabilities mean that significant business opportunities will be created for us should the outsourcing of cell processing be instituted. Further, if the quick approval system for new drugs becomes applicable to gene therapy and cell therapy treatments, then we may be able to shorten the time required to commercialize the Company’s clinical development projects.

3. Strategy by each segment

Takara Bio operates 3 business segments: Genetic engineering research, Gene medicine, and AgriBio. As for the Genetic engineering business and the Gene medicine business, in order to adjust to the changing business environment as described above, the company will adopt the following business strategies with the aim to build a foundation for future growth.

 

(1) Genetic engineering research business

This business is the Takara Bio Group’s core business for generating stable revenue. The Company distributes research reagents and scientific instruments globally for biotechnology researchers in universities and companies, and also provides contract research services. The Company will accelerate the development of new products to support these growing fields, such as basic research utilizing iPS cells and research of regenerative medicine and cell therapy.

 

In fiscal 2013, DSS Takara Bio India Pvt. Ltd., distributed reagent products in the Indian market by aliquoting enzymes manufactured at Takara Biotechnology (Dalian) in China. In fiscal 2014, Takara Bio will invest in Indian facilities and conduct technology transfer from China to India in order to ensure consistent manufacturing of our reagent products. We envision that our Indian subsidiary will be able to distribute these reagent products worldwide starting from fiscal 2015.

 

We will expand our field of business from supporting basic research to drug-discovery and industry while intending to actively advance the business as follows:

  • Development of products in the field of regenerative medicine
  • Development of the applied fields market for PCR (food product analysis, environmental analysis, and molecular diagnostics), by enhancing development of new products and proactive development of customized products in Asia
  • Development of next-generation sequencing-related technologies to grow contract services business focusing on whole human genome sequence analysis and miRNA analysis
  • Enhancement of the product development capability of entire Takara Bio-group by improving the efficiency of Research and Development
  • Enhancement of the Company’s global marketing and sales organizations
  • Establishment of commercial production procedures for enzymes in India

 

Pursuing new business alliances with companies that have technologically complementary products in order to expand in-licensed products

 

(2) Gene medicine business

In the Gene medicine business, Takara Bio continues to try to advance its gene therapy projects with the aim of commercialization as soon as possible, as well as focuses its effort to sell cell culture media and gas-permeable bags in China. Taking advantage of the Japanese government’s current strong support for clinical development geared toward bringing regenerative medicine and cell therapy treatments to practical application, Takara Bio will also work to expand its contract development and manufacturing organization (CDMO) business in this section.

(Gene Therapy Projects)

  • Clinical development of oncolytic virus HF10 in the United States
  • Clinical development of HSV-TK gene therapy for patients with hematological malignancy
  • Clinical development of MAGE-A4 antigen-specific TCR gene therapy for esophageal cancer patients
  • Clinical development of MazF gene therapy for HIV in the United States
  • Clinical development of NY-ESO-1 antigen-specific TCR gene therapy for solid tumors

 

(Cell Therapy Business)

  • Clinical development of NK cell therapy
  • Acquisition of evidential data on the clinical development of RetroNectin®-induced T cell therapy (RIT) to increase sales of technical support services for clinics
  • Expansion of revenue from cell culture media and gas-permeable bags in China
  • Establishment of GMP-compliant manufacturing facility at Takara Biomedical Technology (Beijing) co., Ltd to develop GMP grade products for cell therapy

 

(Contract Development & Manufacturing Organization (CDMO) business)

The CDMO business includes not only manufacturing of biopharmaceuticals in accordance with GMP, but also performing contract research as an R&D partner, using the technologies and know-how accumulated through its own clinical development of the cell and gene therapies. Concrete examples of our CDMO business are production of GMP-grade vectors for gene therapy, safety testing services for biopharmaceuticals, development of manufacturing processes and testing methods for cells used in the regenerative medicine field.

The Company acquired new land in Kusatsu-city in Shiga prefecture to construct a new GMP-compliant manufacturing facility, which is expected to start commercial production in October 2014. This facility will be used not only to produce clinical-grade vectors for the Company’s own gene therapy projects, but also will provide GMP contract manufacturing services for gene transduced cells.

 

(3) AgriBio business

Focusing mainly on the development of functional food ingredients, Takara Bio operates a functional food business and a mushroom business.

 

In order to improve revenues in the mushroom business, Takara Bio will substantially increase production of high-value-added Honshimeji mushrooms at upgraded facilities in Mizuho Nourin Co., Ltd. In fiscal 2014, production of Hatakeshimeji mushrooms will be reduced to less than half of fiscal 2013, and production of Honshimeji mushrooms will be doubled. By this production shifting of mushrooms and collaboration with Takara Healthcare for sales of functional foods, we aim to make this business segment profitable in fiscal 2015.

  • Strengthening scientific evidence for health-oriented food ingredients through human interventional studies so as to grow sales in the B-to-B market
  • Collaboration with medical research institutes aiming to acquire basic and clinical data using health-oriented food ingredients
  • Implementation of better quality control / quality assurance systems in order to ensure the provision of safe and reliable products
  • Improvement of profitability by shifting production capacity at Mizuho Nourin Co., Ltd., from Hatakeshimeji mushrooms to Honshimeji mushrooms
  • Expansion of the licensing business for mushroom-production technology