Risk of Delays in Commercialization and Upfront Investment in the Genetically Modified Silkworm Business
First written in FY2016. 14 of 27 entries say "Worsened", first in FY2017-Q3. Latest entry: FY2024-Q1.
Immuno-Biological Laboratories moved to the "Worse" side of this theme in 2016, 9 years before the typical company in this theme (2025).
The whole theme swung hardest in 2019: 6 of 26 companies on the "Worse" side.
9 other companies' latest entry also says "Mitigated".
- FY2024-Q1MitigatedAnnual report
「Because the timing for achieving the target could not be determined and the Group decided to concentrate its limited funds on developing raw materials for in-vitro diagnostic products and other products in its antibody-related business, the Company discontinued new development aimed at producing pharmaceutical raw materials using genetically modified silkworms. Accordingly, the Company included the segment income or loss in the antibody-related business.」
Given the lack of visibility on when the target for producing pharmaceutical raw materials could be achieved, the Company discontinued new development and concentrated funds on its antibody-related business, reflecting this decision in its reportable segments as well. - FY2023MitigatedAnnual report
「Because the timing for achieving the target could not be determined and the Group decided to concentrate its limited funds on developing raw materials for in-vitro diagnostic products and other products in its antibody-related business, the Company discontinued new development aimed at producing pharmaceutical raw materials using genetically modified silkworms.」
Given the lack of visibility on when the target for producing pharmaceutical raw materials could be achieved, the Company discontinued new development and concentrated funds on its antibody-related business. - FY2023-Q3MitigatedAnnual report
「This business is focusing exclusively on basic research into developing useful proteins and improving the amount of such proteins produced in silkworm cocoons while controlling costs.」
Although the genetically modified silkworm development business recorded no sales, it is focusing on basic research while controlling costs, and the segment operating loss narrowed by ¥16.258 million year on year. - FY2023-Q2MitigatedAnnual report
「This business is focusing exclusively on basic research into developing useful proteins and improving the amount of such proteins produced in silkworm cocoons while controlling costs.」
The genetically modified silkworm development business is focusing on basic research while controlling costs. Although there were no sales, the operating loss narrowed from ¥52.616 million in the same period of the previous year to ¥40.626 million. - FY2023-Q1MitigatedAnnual report
「This business is focused exclusively on basic research into developing useful proteins and improving the amount of those proteins produced in cocoons, while controlling costs. Genetically Modified Silkworm Development Business － － － △¥18.982 million +¥10.128 million －」
The genetically modified silkworm development business is focusing on basic research while controlling costs, and the segment operating loss narrowed from ¥29.111 million in the same period of the previous year to ¥18.982 million. However, there were no sales, and the risks of commercialisation delays and upfront investment continued. - FY2022-Q2MitigatedAnnual report
「R&D expenses declined from the previous fiscal year as the Company discontinued production of pharmaceutical raw materials in compliance with GMP and focused on basic research.」
By discontinuing GMP-compliant production of pharmaceutical raw materials and focusing on basic research, the Company reduced R&D expenses from the previous fiscal year, and the operating loss in the genetically modified silkworm development business also narrowed year on year. However, cost issues related to commercialisation continued. - FY2022-Q1R&D spending continued to precede revenue generation, but the operating loss narrowedAnnual report
「However, because this business is conducting intensive basic research to increase recombinant protein yields by approximately 10 times, R&D expenses are being incurred upfront. As a result, segment sales were ¥11.233 million, down 6.7% year on year, and the operating loss was ¥43.463 million, compared with an operating loss of ¥70.127 million in the same period of the previous year.」
Upfront R&D expenses associated with research to increase recombinant protein yields continued. Meanwhile, the operating loss narrowed from the same period of the previous year, but sales declined 6.7%. - FY2021MaterialisedAnnual report
「To date, the Company has conducted R&D aimed at producing pharmaceutical raw materials by developing fibrinogen and anti-HIV antibodies produced in the cocoons of genetically modified silkworms, but it has had to abandon production of both products due to production costs and other issues.」
The Company explicitly abandoned production of fibrinogen and anti-HIV antibodies intended for use as pharmaceutical raw materials because of production costs and other factors. - FY2021-Q3MitigatedAnnual report
「As a result, segment sales were ¥25.594 million, up 16.9% year on year, and the operating loss was ¥192.296 million, compared with an operating loss of ¥237.264 million in the same period of the previous year.」
Sales in the genetically modified silkworm business increased and the operating loss narrowed from the same period of the previous year, partly reducing the realised burden of upfront investment and commercialisation delays. However, the Company stated that its testing, genetically modified silkworm, and cosmetics-related businesses had not yet reached profitable levels. - FY2021-Q2MitigatedAnnual report
「In this business, sales of laminin 511-E8, which is useful as a culture scaffold for iPS cells and other applications, as well as sales of various antibodies and contract services, were broadly in line with the same period of the previous year, with no material impact from COVID-19. The business is also focusing on the development of biopharmaceuticals and their manufacturing technologies, with an emphasis on R&D. As a result, segment sales were ¥17.575 million, up 0.6% year on year, and the operating loss was ¥130.485 million, compared with an operating loss of ¥145.773 million in the same period of the previous year.」
Sales in the genetically modified silkworm business remained broadly level, increasing 0.6% year on year, while the operating loss narrowed from ¥145.773 million to ¥130.485 million. Meanwhile, the business structure centred on R&D in biopharmaceuticals and manufacturing technologies continued. - FY2021-Q1Sales increased and the operating loss narrowed, but the focus on R&D continuedAnnual report
「In this business, sales of laminin 511-E8, which is useful as a culture scaffold for iPS cells and other applications, as well as sales of various antibodies and contract services, increased from the same period of the previous year. The business is also focusing on the development of biopharmaceuticals, including anti-HIV antibodies, and their manufacturing technologies, with an emphasis on R&D. As a result, segment sales were ¥12.034 million, up 97.6% year on year, and the operating loss was ¥70.127 million, compared with an operating loss of ¥74.723 million in the same period of the previous year.」
Sales in the genetically modified silkworm business increased 97.6% year on year, while the operating loss narrowed from ¥74.723 million to ¥70.127 million. Meanwhile, the business structure centred on R&D, including anti-HIV antibodies, continued. - FY2020WorsenedAnnual report
「The Company cannot say that it currently has sufficient equipment or expertise to comply with GMP-based regulations. Higher manufacturing costs are also an issue. In addition, expertise for developing the genetically modified silkworm business is currently insufficiently established.」
The Company specifically identified insufficient GMP-compliant equipment and expertise, manufacturing costs, and insufficient business development expertise as commercialisation risks for the genetically modified silkworm business. - FY2020-Q3WorsenedAnnual report
「As a result, segment sales were ¥21.890 million, up 30.7% year on year, and the operating loss was ¥237.264 million, compared with an operating loss of ¥166.657 million in the same period of the previous year.」
Although sales of various antibodies and contract services increased in the genetically modified silkworm business, the operating loss widened from ¥166.657 million to ¥237.264 million. As R&D continued on pharmaceutical manufacturing and anti-HIV antibodies, the burden of commercialisation and upfront investment became more pronounced. - FY2020-Q2WorsenedAnnual report
「As a result, segment sales were ¥17.473 million, up 47.5% year on year, and the operating loss was ¥145.773 million, compared with an operating loss of ¥100.378 million in the same period of the previous year.」
Although sales in the genetically modified silkworm business increased, the operating loss widened from ¥100.378 million in the same period of the previous year to ¥145.773 million, and the burden of upfront R&D and commercialisation delays continued. - FY2020-Q1WorsenedAnnual report
「As a result, segment sales were ¥6.090 million, up 56.6% year on year, and the operating loss was ¥74.723 million, compared with an operating loss of ¥48.136 million in the same period of the previous year.」
Although sales in the genetically modified silkworm business increased, the operating loss widened from ¥48.136 million in the same period of the previous year to ¥74.723 million, and the burden of commercialisation and upfront investment continued. - FY2019WorsenedAnnual report
「As a result, segment sales were ¥30.606 million, up 40.1% year on year, and the operating loss was ¥247.914 million, compared with an operating loss of ¥179.240 million in the same period of the previous year.」
Although sales in the genetically modified silkworm business increased, the operating loss widened from ¥179.240 million to ¥247.914 million, and the burden of upfront investment and commercialisation delays increased. - FY2019-Q3WorsenedAnnual report
「As a result, segment sales were ¥16.754 million, up 55.4% year on year, and the operating loss was ¥166.657 million, compared with an operating loss of ¥131.027 million in the same period of the previous year.」
Sales in the genetically modified silkworm business increased 55.4% year on year, while the operating loss widened from ¥131.027 million to ¥166.657 million. The impact of commercialisation and upfront investment risks continued, and losses worsened. - FY2019-Q2WorsenedAnnual report
「As a result, segment sales were ¥11.848 million, up 43.3% year on year, and the operating loss was ¥100.378 million, compared with an operating loss of ¥86.239 million in the same period of the previous year.」
Although sales in the genetically modified silkworm business increased, the operating loss widened from ¥86.239 million in the same period of the previous year to ¥100.378 million. The upfront burden of R&D and commercialisation toward pharmaceutical manufacturing continued. - FY2019-Q1WorsenedAnnual report
「As a result, segment sales were ¥3.890 million, down 41.0% year on year, and the operating loss was ¥48.136 million, compared with an operating loss of ¥44.728 million in the same period of the previous year.」
Sales in the genetically modified silkworm business fell 41.0% year on year, while the operating loss widened from ¥44.728 million to ¥48.136 million. The impact of commercialisation and upfront investment risks continued. - FY2018WorsenedAnnual report
「During the period, sales of antibodies used as raw materials for diagnostic reagents were recorded from a major in-vitro diagnostic company, but sales declined substantially year on year because no contract fee income or other such income was recorded from joint research partners. As a result, segment sales were ¥21.844 million, down 69.6% year on year, and the operating loss was ¥179.240 million, compared with an operating loss of ¥1,239.697 million in the same period of the previous year.」
Although the operating loss narrowed, there was no joint research contract fee income, and sales in the genetically modified silkworm business fell 69.6% year on year. The Company also stated that it had abandoned plans for the commercial production of fibrinogen, and the risks of commercialisation delays and upfront investment continued. - FY2018-Q3WorsenedAnnual report
「In this business, sales of antibodies used as raw materials for diagnostic reagents were recorded from a major in-vitro diagnostic company, but sales declined substantially year on year because no contract fee income or other such income was recorded from joint research partners. As a result, segment sales were ¥10.779 million, down 80.4% year on year, and the operating loss was ¥131.027 million, compared with an operating loss of ¥209.906 million in the same period of the previous year.」
The genetically modified silkworm business received no contract fee income, and sales declined 80.4% year on year. Although the operating loss narrowed from the same period of the previous year, revenue associated with commercialisation remained weak. - FY2018-Q2WorsenedAnnual report
「In this business, sales of antibodies used as raw materials for diagnostic reagents were recorded from a major in-vitro diagnostic company, but sales declined substantially year on year because no contract fee income or other such income was recorded from joint research partners. As a result, segment sales were ¥8.269 million, down 83.6% year on year, and the operating loss was ¥86.239 million, compared with an operating loss of ¥115.372 million in the same period of the previous year.」
Although the operating loss narrowed from the same period of the previous year, no contract fee income was received from joint research partners, and sales declined 83.6%. Revenue indicating progress toward commercialisation remained weak, and the impact of commercialisation delays continued. - FY2018-Q1WorsenedAnnual report
「As a result, segment sales were ¥6.596 million, up 25.2% year on year, and the operating loss was ¥44.728 million, compared with an operating loss of ¥42.024 million in the same period of the previous year.」
Although sales in the genetically modified silkworm business increased, the operating loss widened from ¥42.024 million to ¥44.728 million, and the impact of upfront investment and commercialisation risks continued. - FY2017WorsenedAnnual report
「As a result, segment sales were ¥71.809 million, up 6.5% year on year. Operating income and loss was affected by an increase in R&D projects for pharmaceutical raw materials, including fibrinogen and HIV treatments, which increased the facility's role as an R&D centre. Accordingly, at the end of the period, equipment and other assets previously capitalised at the facility were recognised in full as R&D expenses, amounting to ¥941.704 million. The operating loss was therefore ¥1,239.697 million, compared with an operating loss of ¥142.444 million in the same period of the previous year.」
The operating loss in the genetically modified silkworm business widened from ¥142.444 million to ¥1,239.697 million, showing a further impact from upfront R&D expenses and commercialisation delays. - FY2017-Q3WorsenedAnnual report
「As a result, segment sales were ¥54.956 million, up 2.5% year on year, and the operating loss was ¥209.906 million, compared with an operating loss of ¥104.330 million in the same period of the previous year.」
The operating loss in the genetically modified silkworm business widened from ¥104.330 million in the same period of the previous year to ¥209.906 million, showing a further impact from the upfront investment and commercialisation risks. - FY2017-Q1MaterialisedAnnual report
「Joint research with major animal health companies and major in-vitro diagnostic companies in this business has continued smoothly, but sales of candidate proteins remained limited in volume.」
Although joint research has continued, sales of candidate proteins remained limited, and part of the commercialisation delay and upfront investment risk has materialised in the form of lower sales and a segment loss in the genetically modified silkworm business. - FY2016First statedAnnual report
「Getting the genetically modified silkworm business on track requires a reasonable level of business development expertise, but the Company cannot currently say that it has sufficient expertise of this kind. In addition, as R&D expenses are expected to precede revenue generation in a newly established business, delays in commercialising this business could worsen performance.」
The Company identified insufficient business development expertise, upfront R&D expenses, and the possibility of deteriorating performance due to commercialisation delays.