Edison Investment Research - Symbio Pharmaceuticals (4582) SymBio Pharmaceuticals - Guidance sinks on quality control issue

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Edison Investment Research

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 â€˜foreign substance or visual defectsâ€™ in the shipments of drugs, which had to be returned. The company revised its sales estimates down by a third (to Â¥3.0bn from Â¥4.5bn) due to the expected short supply.

29/08/2019 5 EN

Underlying

Symbio Pharmaceuticals

Symbio Pharmaceuticals is a specialty biopharmaceutical company based in Japan. Co. specializes in the development and commercialization of drug candidates in oncology, hematology and autoimmunity areas. Co. has built pipelines (a group of newly developed drugs) with several pharmaceuticals, as well as, newly developed drugs in these disease areas. Co.'s product pipeline includes SyB L-0501(treatment of non-Hodgkin's lymphoma and mantle cell lymphoma); SyB L-1101/SyB C-1101, a multi-kinase inhibitor for the treatment of refractory/relapse myelodysplastic syndromes and solid tumor indications; and SyB D-0701, an antiemetic transdermal patch.

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JP3383050006 Japan

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Dr Nathaniel Calloway

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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 B-cell lymphoma (DLBCL), which may also drive future sales.

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SymBio Pharmaceuticals - Treakisym approved for DLBCL

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SymBio Pharmaceuticals - Guidance sinks on quality control issue

SymBio Pharmaceuticals - Termination of coverage

SymBio Pharmaceuticals - The first whole quarter of internal SymBio sales

SymBio Pharmaceuticals - Treakisym approved for DLBCL

Accsys Technologies - Upgrading guidance for the full year

Topps Tiles - Market outperformance again in FY24

Nabaltec - Resilience and margin expansion

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