A Business Model Complementing Manufacturing and Sales Through Partnerships
First written in FY2016. 16 of 36 entries say "Advanced", first in FY2017-Q3. Latest entry: 2026-09-10.
3 other companies' latest entry also says "Advanced".
- 2026-09-10AdvancedEarnings
「新規領域である泌尿器科領域においては、放射線膀胱炎を入口として医師による弊社製品の臨床使用が開始され、他の疾患領域に広げていくという取り組みが軌道に乗ってまいりました。」
従来の販売地域・領域に加え、欧州の泌尿器科領域で臨床使用と採用病院の拡大が進んだ。 - FY2026RestatedAnnual report
「For sales, we will appropriately select or combine direct sales through distributors and the licensing of sales rights to sales partners, depending on the product and region.」
The Group has reaffirmed its sales model of combining distributors, direct sales and the licensing of sales rights according to the product and region. - 2026-07-17AdvancedFinancial results presentation
「In the United States, we previously had separate teams responsible for the gastrointestinal and otolaryngology fields. From this fiscal year, we shifted to a structure in which each sales representative is responsible for a specific region and conducts sales activities in both fields.」
The U.S. sales structure shifted from field-specific teams to regional responsibility, establishing a structure for cross-field sales and cross-selling in gastrointestinal and otolaryngology. - FY2026-H1AdvancedAnnual report
「In new fields such as otolaryngology and urology, we conduct direct sales with a small-scale structure. Although sales are currently small, they continue to grow at a high rate.」
In addition to the traditional core fields, the Group operates a small-scale direct-sales structure in new European fields such as otolaryngology and urology, where high growth is continuing. The combined distributor and direct-sales model has expanded into new fields. - FY2025RestatedAnnual report
「In Europe, we entered into an exclusive distribution agreement with FUJIFILM Europe B.V. (“FUJIFILM”) in 2019 for the Hemostatic Agent in gastrointestinal endoscopy, and FUJIFILM has begun selling the product. In other fields, sales are conducted mainly through a direct-sales structure. In the United States, Japan and Australia, sales are conducted through direct-sales structures.」
The Group reaffirmed a sales structure combining exclusive distribution by FUJIFILM in European gastrointestinal endoscopy with direct sales in other European fields and in the United States, Japan and Australia. - FY2025-H1ReframedAnnual report
「In cardiovascular surgery, we reduced sales costs by reviewing the direct-sales structure and returning to a distributor-based sales model.」
In European cardiovascular surgery, the Group changed from its previous policy of maintaining and expanding direct sales to a distributor-based model in order to reduce sales costs. - FY2024-Q3ReframedAnnual report
「However, both fields have grown faster than assumed when the current fiscal-year policy was formulated, and results indicating potential profit contributions next fiscal year are beginning to emerge.」
For the direct-sales structures in European cardiovascular surgery and otolaryngology, the Group revised its previous plan for further reductions and decided to maintain current sales resources in light of the growth achieved. - FY2024-Q2AdvancedAnnual report
「In the direct-sales structures for cardiovascular surgery and otolaryngology, upfront investment in direct sales during the previous fiscal year did not contribute as expected in the short term. Accordingly, we plan to reduce upfront investment temporarily in the current fiscal year and concentrate resources on gastrointestinal endoscopy, where contribution margins are higher. However, because we have achieved growth and positive contribution margins within the minimum necessary investment, we will prepare for reinvestment in the future.」
The Group continues to reduce investment in lower-margin fields and concentrate resources on gastrointestinal endoscopy, while stating that contribution margins have turned positive within the minimum necessary investment range. - FY2023ReframedAnnual report
「For the time being, we will narrow the areas targeted by proactive sales activities to gastrointestinal endoscopy, where our Hemostatic Agent has a strong competitive advantage and sales growth is reliably expected. In other fields, we will reduce the sales structure and rebuild the team organization overall.」
The Group shifted from expanding sales structures across multiple regions and fields to rebuilding the organization by concentrating on gastrointestinal endoscopy and reducing sales capacity in other fields. - FY2023-Q3SoftenedAnnual report
「In Germany, which had the largest sales plan in Europe, the planned switch from the existing distributor to FUJIFILM EUROPE B.V. (“FUJIFILM”) around May 2022 took longer than expected and was delayed until November 2022.」
Under the European sales partnership model, the planned switch from the existing German distributor to FUJIFILM was delayed from around May 2022 to November of that year. In the United Kingdom, collaboration with the secondary distributor had not taken hold sufficiently, while the direct-sales structure was undergoing a complete personnel replacement, indicating weakening execution across the partnership and sales structures. - FY2023-Q1AdvancedAnnual report
「Through these measures, we will seek to further expand the business by establishing a stable product supply structure with multiple manufacturing sites.」
The Group is establishing a stable supply structure based on multiple manufacturing sites by combining continued manufacturing arrangements with Fuso Pharmaceutical Industries,Ltd. and outsourced production by Pharmpur. - FY2022AdvancedAnnual report
「In Japan, following the end of the exclusive distribution rights agreement with Fuso Pharmaceutical Industries,Ltd., we established a new direct-sales structure, hired sales staff, selected 23 distributors with particular strength in endoscopy-related sales by region, executed distribution agreements with them and began close collaboration with each distributor.」
The domestic sales structure became more concrete through direct sales, the hiring of sales staff and collaboration with 23 distributors. - FY2022-Q3AdvancedAnnual report
「In December 2021, we entered into a manufacturing and services agreement with Pharmpur GmbH, based in Germany, as a new contract manufacturer for our products. Pharmpur has already begun manufacturing products for the United States, and in January 2022 submitted an application to a third-party certification body for approval to add a manufacturing site for Europe.」
The manufacturing structure using partnerships became more concrete through execution of an agreement with Pharmpur as a new contract manufacturer, the start of production for the United States and submission of an application to add a European manufacturing site. - FY2022-Q2AdvancedAnnual report
「We began selling products to domestic distributors in November 2021. Regarding the transfer of the manufacturing site, the leading candidate is the counterparty manufacturing the next-generation hemostatic agent. We have already successfully completed the manufacture of the 3 batches required for manufacturing validation, and preparations for the marketing authorization application are in their final stages.」
Following the end of the agreement with Fuso Pharmaceutical Industries,Ltd., the domestic structure progressed to the start of product sales to domestic distributors and completion of 3-batch manufacturing validation at the prospective transfer site, with preparations for the marketing authorization application in their final stages. - FY2022-Q1AdvancedAnnual report
「We have already successfully completed the manufacture of the 3 batches required for manufacturing validation, and preparations for the marketing authorization application are in their final stages.」
The transfer from Fuso Pharmaceutical Industries,Ltd. to a new contract manufacturer progressed through completion of manufacturing validation for 3 batches, with preparations for the marketing authorization application in their final stages. - FY2021AdvancedAnnual report
「In Japan, we are working to secure a new domestic sales partner promptly and are considering multiple candidates. Even after securing a sales partner, we believe that a minimum level of in-house sales capability will be essential, and we are building that structure, including hiring sales personnel and establishing a sales network through wholesalers, in preparation for the start of sales.」
Domestic sales planning progressed beyond consideration of multiple candidates to hiring sales personnel and building a sales network through wholesalers. Preparations are also under way to transfer production to a new contract manufacturer. - FY2021-Q3AdvancedAnnual report
「In Japan, we are working to secure a new domestic sales partner promptly and are considering multiple candidates. Even after securing a sales partner, we believe that a minimum level of in-house sales capability will be essential, and we are building that structure in parallel. We are preparing diligently to begin sales at the start of the next fiscal year.」
Following the end of the agreement with Fuso Pharmaceutical Industries,Ltd., domestic sales planning progressed from considering multiple candidates to building in-house sales capability and preparing to begin sales at the start of the next fiscal year. The parties also agreed on the production volume required during the transition. - FY2021-Q2RestatedAnnual report
「In Japan, we are working to secure a new sales partner promptly. Regarding the transfer of manufacturing sites, we have already begun manufacturing validation with the counterparty that manufactures the next-generation hemostatic agent, which is our leading candidate.」
The Group continues efforts to secure a new domestic sales partner and transfer manufacturing sites following termination of the agreement with Fuso Pharmaceutical Industries,Ltd. - FY2021-Q1ReframedAnnual report
「We will make every effort to secure a new sales partner promptly and minimize the impact on milestones and sales.」
Following notice of termination of the domestic sales agreement with Fuso Pharmaceutical Industries,Ltd., the Group is rebuilding its structure, including the early acquisition of a new domestic sales partner and selection of a manufacturing site. - FY2020ReframedAnnual report
「We will continue discussions on establishing a transition period to smoothly terminate the contract manufacturing agreement and on having the manufacturer continue production. If the contract manufacturing agreement cannot be continued, we will need to secure a new contract manufacturer promptly.」
Following notice of termination of the contract manufacturing agreement with Fuso Pharmaceutical Industries,Ltd., the Group shifted from relying on the existing partner to rebuilding its manufacturing structure, including establishing a transition period and selecting a new contract manufacturer. - FY2020-Q3AdvancedAnnual report
「On 24 January 2020, we agreed with the company to expand the territory covered by the exclusive distribution agreement for the Hemostatic Agent to include the Middle East.」
The exclusive distribution agreement with FUJIFILM, originally covering Europe, was expanded to include the Middle East. - FY2020-Q2AdvancedAnnual report
「On 13 June 2019, our European subsidiary entered into an exclusive distribution agreement covering Europe for the Hemostatic Agent with FUJIFILM Europe B.V. (“FUJIFILM”). Sales by FUJIFILM began in October 2019. By jointly marketing the product to FUJIFILM’s broad customer base, the parties have begun working to significantly shorten the sales cycle and immediately expand customer coverage.」
The exclusive European distribution agreement with FUJIFILM progressed from execution to the start of sales in October 2019. - FY2020-Q1RestatedAnnual report
「We will sell the Hemostatic Agent exclusively through FUJIFILM in the endoscopy field across Europe.」
The Group reaffirmed the terms of its exclusive European distribution agreement with FUJIFILM for the Hemostatic Agent and its use of sales partnerships. - FY2019AdvancedAnnual report
「On 13 June 2019, our European subsidiary entered into an exclusive distribution agreement covering Europe with FUJIFILM for the Hemostatic Agent in the gastrointestinal endoscopy field.」
The comprehensive European sales partnership progressed from discussions with prospective partners to the execution of an exclusive distribution agreement with FUJIFILM in the gastrointestinal endoscopy field. Negotiations continued in the cardiovascular surgery and gastrointestinal surgery fields. - FY2019-Q3RestatedAnnual report
「Discussions with several prospective sales partners for a comprehensive sales partnership covering all of Europe have progressed. We will work toward executing an agreement during the fiscal year ending April 2019.」
The Group continues discussions with multiple prospective partners for a comprehensive European sales partnership and maintains its target of executing an agreement during the fiscal year ending April 2019. - FY2019-Q2ReframedAnnual report
「The distribution agreement with the Getinge Group is expected to end, and we plan to sell directly going forward.」
While continuing its partnership-based sales model in Europe and elsewhere, the Group indicated that it would move toward direct sales in Australia following the expected end of its distribution agreement. - FY2019-Q1RestatedAnnual report
「For a comprehensive sales partnership aimed at selling products throughout Europe, we continue discussions with prospective sales partners that have sales networks covering the target area and promotional capabilities, while building sales and usage records and working toward executing an agreement during the fiscal year ending April 2019.」
The Group continues discussions with prospective partners for a comprehensive European sales partnership, the accumulation of sales and usage records, and the target of executing an agreement during the fiscal year ending April 2019. - FY2018AdvancedAnnual report
「For a comprehensive sales partnership covering all of Europe, we have narrowed the prospective sales partners to 3 companies, each with sales networks and promotional capabilities covering the target area, and continue discussions toward forming a partnership.」
The comprehensive European sales partnership advanced to the stage of narrowing the candidates to 3 companies. However, the partnership agreement had not yet been executed. - FY2018-Q3SoftenedAnnual report
「To begin product sales across a broad area of Europe, we continue discussions toward reaching an agreement with prospective sales partners, companies with sales networks and promotional capabilities covering the entire target area. We will work toward reaching agreement during the current fiscal year by accumulating additional European sales and usage data and sales and usage records in Oceania to resolve the outstanding issues. However, depending on product sales and the progress of discussions, agreement may be delayed until the next fiscal year.」
Discussions on the comprehensive European sales partnership and the accumulation of supporting data are continuing, but agreement may be delayed from the current fiscal year to the next fiscal year, reducing certainty regarding the timetable. - FY2018-Q2RestatedAnnual report
「To begin product sales across a broad area of Europe, we continue discussions toward reaching an agreement with prospective sales partners, companies with sales networks and promotional capabilities covering the entire target area. We will work toward concluding an agreement during the current fiscal year by accumulating additional European sales and usage data and sales and usage records in Oceania to resolve the outstanding issues.」
The Group continues discussions with prospective partners for a comprehensive European sales partnership and continues to build sales and usage records in Europe and Oceania, which are required to conclude the agreement. - FY2018-Q1RestatedAnnual report
「We will work toward concluding an agreement during the current fiscal year by accumulating additional European sales and usage data and sales and usage records in Oceania to resolve the outstanding issues.」
The Group has reaffirmed its policy of continuing to build sales and usage records to resolve the outstanding issues in the comprehensive European sales partnership. - FY2018-Q1RestatedAnnual report
「To begin product sales across a broad area of Europe, we continue discussions toward reaching an agreement with prospective sales partners, companies with sales networks and promotional capabilities covering the entire target area. We will work toward concluding an agreement during the current fiscal year by accumulating additional European sales and usage data and sales and usage records in Oceania to resolve the outstanding issues.」
The Group continues discussions with prospective sales partners that have broad sales coverage and promotional capabilities, while building the sales and usage records required to conclude the agreement. - FY2017-Q3AdvancedAnnual report
「This agreement would grant the prospective partner rights relating to the development and sale of the Hemostatic Agent in China. Due diligence has been completed, and the parties are now in the final stages of negotiating the agreement. We expect to execute the agreement during the current fiscal year.」
The proposed partnership to grant rights to develop and sell TDM-621 in China progressed through due diligence to final contract negotiations. Discussions on a comprehensive European sales partnership continued. In Asia and Oceania, the Group also indicated that it would prioritize maintaining a long-term sales relationship over invoicing any shortfall in minimum purchase volumes. - FY2017-Q2RestatedAnnual report
「To begin product sales across a broad area of Europe, we continue discussions toward reaching an agreement with prospective sales partners, companies with sales networks and promotional capabilities covering the entire target area. During the second quarter, we continued to focus on building sales and usage records in Europe, Asia and Oceania, which remain challenges to concluding the agreement.」
The Group continues discussions with prospective sales partners that have broad sales networks and promotional capabilities, while working to build sales and usage records required for the agreement. - FY2017-Q1RestatedAnnual report
「To begin product sales across a broad area of Europe, we continue discussions toward reaching an agreement with prospective sales partners, companies with sales networks and promotional capabilities covering the entire target area.」
In addition to expansion through distributors, the Group continues discussions on a contract with a partner that has broad sales coverage and promotional capabilities. - FY2016First statedAnnual report
「We will further strengthen the business model in which manufacturing and sales functions are supplemented through business partnerships.」
The Group has stated that it will focus internally on planning, development and commercialization strategy, while supplementing manufacturing and sales through external partners.