reports
- Sean Conroy
SymBio Pharmaceuticals - Termination of coverage
Edison Investment Research is terminating coverage on Brooge Energy (BROG), Tyman (TYMN), SymBio Pharmaceuticals (4582), Aspire Global (0EAZ), CiiTECH and Marshall Motor Holdings (MMH). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.
- Sean Conroy
SymBio Pharmaceuticals - The first whole quarter of internal SymBio sa...
SymBio reported Q121 sales of ¥1.42bn of its drug Treakisym (bendamustine) for hematologic malignancies. This is the first quarter in which the product is being sold by SymBio directly, and it marks a substantial increase over prior sales trends. Sales have more than doubled since Q420 (¥0.6bn). Part of what is driving this is the early 2021 launch of the company’s ready-to-dilute (RTD) formulation. Moreover, SymBio recently expanded the indications approved for the drug to include diffuse large...
- Sean Conroy
SymBio Pharmaceuticals - Treakisym approved for DLBCL
SymBio announced on 23 March 2021 that it has received marketing approval for Treakisym (bendamustine) for diffuse large B-cell lymphoma (DLBCL). The drug has been approved for relapsed and refractory disease in two combinations: with rituximab and polatuzumab vedotin or with rituximab alone. We expect this approval to approximately double the addressable market for the drug in Japan.
- Sean Conroy
SymBio Pharmaceuticals - Now with commercial operations
SymBio will be undergoing a major transition in 2021 as it takes back the reigns to its Treakisym (bendamustine) franchise. The company will be making it first efforts to market the product line internally in Japan following the return of the rights from Eisai in December 2020. We expect these efforts to be bolstered by the recent launch of the ready-to-dilute (RTD) formulation of the product and the upcoming approval decision for diffuse large B-cell lymphoma (DLBCL) in May 2021.
- Sean Conroy
SymBio Pharmaceuticals - Treakisym RTD approved
SymBio announced on 23 September 2020 that it has received approval from the PMDA for the ready-to-dilute (RTD) formulation of Treakisym (bendamustine) in Japan. This formulation, licensed from Eagle Pharmaceuticals, is part of SymBio’s pipeline management strategy and the company has exclusivity on the formulation until 2031. The company intends to begin marketing the product in January 2021.
Edison Investment Research Limited: Edison issues outlook on SymBio Ph...
Edison Investment Research Limited Edison Investment Research Limited: Edison issues outlook on SymBio Pharmaceuticals (4582) 10-Sep-2020 / 08:46 GMT/BST Â London, UK, 10 September 2020 Edison issues outlook on SymBio Pharmaceuticals (4582) SymBio is approaching a major transition as it prepares to begin internal marketing of its lead product Treakisym (bendamustine), launch new liquid formulations of the drug and expand the market with new indications. At the same time, the company is moving past the recent clinical results from the Phase III study where rigosertib did not meet...
- Sean Conroy
SymBio Pharmaceuticals - At the turning point
SymBio is approaching a major transition as it prepares to begin internal marketing of its lead product Treakisym (bendamustine), launch new liquid formulations of the drug and expand the market with new indications. At the same time, the company is moving past the recent clinical results from the Phase III study where rigosertib did not meet its primary endpoint and is determining the future direction of its pipeline product brincidofovir. We are taking this time to provide our clinical and com...
- Sean Conroy
SymBio Pharmaceuticals - Top-line data from registrational DLBCL study
SymBio will be presenting data at the European Society of Hematology (EHA) meeting from its pivotal study in Japan of Treakisym (bendamustine) in combination with rituximab for the treatment of diffuse large B-cell lymphoma (DLBCL). The 38-patient, single-arm study showed a 76% overall response rate (ORR), with 47% of patients achieving a complete response (CR). This gives us a high degree of confidence in the label expansion for this population submitted in May 2020.
- Sean Conroy
SymBio Pharmaceuticals - Top-line data from registrational DLBCL study
SymBio will be presenting data at the European Society of Hematology (EHA) meeting from its pivotal study in Japan of Treakisym (bendamustine) in combination with rituximab for the treatment of diffuse large B-cell lymphoma (DLBCL). The 38-patient, single-arm study showed a 76% overall response rate (ORR), with 47% of patients achieving a complete response (CR). This gives us a high degree of confidence in the label expansion for this population submitted in May 2020.
- Sean Conroy
SymBio Pharmaceuticals - Treakisym label expansion submitted
SymBio announced on 11 May 2020 that it submitted an application to expand the label for Treakisym in Japan to include the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with rituximab. This follows the positive results seen in the Phase III study for the combination reported in November 2019. We expect this label expansion to more than double the sales potential for the drug.
- Sean Conroy
SymBio Pharmaceuticals - Treakisym label expansion submitted
SymBio announced on 11 May 2020 that it submitted an application to expand the label for Treakisym in Japan to include the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with rituximab. This follows the positive results seen in the Phase III study for the combination reported in November 2019. We expect this label expansion to more than double the sales potential for the drug.
- Sean Conroy
SymBio Pharmaceuticals - Supply issues continue
SymBio reported sales of $25.8m (Â¥2.838bn) for 2019 and an operating loss of $39.1 (Â¥4.301bn). Sales were down from 2018 due to the previously announced quality control issue for the supply of Treakisym from Astellas. We forecast sales of $31.2m (Â¥3.433bn) in 2020 as the company winds down its sales to Eisai in anticipation of the launch of its own internal salesforce and marketing effort for the drug in 2021.
- Sean Conroy
SymBio Pharmaceuticals - Supply issues continue
SymBio reported sales of ¥2.838bn for 2019 and an operating loss of ¥4.301bn. Sales were down from 2018 due to the previously announced quality control issue for the supply of Treakisym from Astellas. We forecast sales of ¥3.433bn in 2020 as the company winds down its sales to Eisai in anticipation of the launch of its own internal salesforce and marketing effort for the drug in 2021.
- Sean Conroy
SymBio Pharmaceuticals - Treakisym has positive DLBCL results
On 5 November 2019, SymBio announced it obtained positive results in its pivotal Phase III clinical trial of Treakisym (bendamustine) in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of improvement in response rates, although the company did not give detailed data in its announcement. SymBio guided toward submission of the data to the PMDA in H120 and we expect initial sales in 2021, driving sustained profitability.
- Sean Conroy
SymBio Pharmaceuticals - Treakisym has positive DLBCL results
On 5 November 2019, SymBio announced it obtained positive results in its pivotal Phase III clinical trial of Treakisym (bendamustine) in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of improvement in response rates, although the company did not give detailed data in its announcement. SymBio guided toward submission of the data to the PMDA in H120 and we expect initial sales in 2021, driving sustained profitability.
- Dr Nathaniel Calloway
SymBio Pharmaceuticals - Guidance sinks on quality control issue
In an unfortunate turn, SymBio has run into some quality control issues with its shipments of Treakisym from Astellas. During Q219, the company found an unacceptable level of ‘foreign substance or visual defects’ in the shipments of drugs, which had to be returned. The company revised its sales estimates down by a third (to ¥3.0bn from ¥4.5bn) due to the expected short supply.
- Dr Dennis Hulme
SymBio Pharmaceuticals - Looking forward to Treakisym Phase III data
Treakisym continues to generate double-digit sales growth, although 2018 sales were below our expectations. A temporary dip in revenue is expected in 2020 as inventory held by Eisai is wound down, ahead of SymBio establishing its own sales organization in Japan at the end of that year. The ongoing Phase III study of Treakisym in diffuse large B-cell lymphoma (DLBCL) is on track to allow a potential filing in Q220; we estimate that the DLBCL indication could double peak sales, if approved. SymBio...
- Dr Dennis Hulme
SymBio Pharmaceuticals - Looking forward to Treakisym Phase III data
Treakisym continues to generate double-digit sales growth, although 2018 sales were below our expectations. A temporary dip in revenue is expected in 2020 as inventory held by Eisai is wound down, ahead of SymBio establishing its own sales organisation in Japan at the end of that year. The ongoing Phase III study of Treakisym in diffuse large B-cell lymphoma (DLBCL) is on track to allow a potential filing in Q220; we estimate that the DLBCL indication could double peak sales, if approved. SymBio...
- Dr Dennis Hulme
SymBio Pharmaceuticals - Preparing to establish own sales organisation
SymBio announced in October that it has begun preparations to establish its own sales organisation to market Treakisym and other anticancer drugs in Japan after the marketing agreement with Eisai expires in December 2020. The announcement validates our decision earlier this year to adopt self-commercialisation in Japan in our base-case valuation model. Self-commercialisation will improve operating margins and allow it to establish a team of in-house experts to communicate the benefits of Treakis...
- Dr Dennis Hulme
SymBio Pharmaceuticals - Self-commercialization gains favor
With the lifecycle of Treakisym extended through the in-licensing of liquid formulations from Eagle in 2017, SymBio is refining its plans to establish its own salesforce to market Treakisym (and other drugs) in Japan. While the company has not yet made a final decision, we think it is highly likely to move to self-commercialization in order to improve operating margins after its marketing arrangement with Eisai expires. Therefore, we now model self-commercialization in our base-case valuation. T...
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