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Sep 30, 2021
Coherus Q3 2021 Earnings Report
Coherus reported a net product revenue of $82.5 million and progress in diversifying its commercial product portfolio.
Key Takeaways
Coherus BioSciences reported third-quarter 2021 financial results, with net product revenue of $82.5 million. The company is focused on expanding its commercial product portfolio, with three BLAs under FDA review and multiple additional applications expected in 2022.
UDENYCA on-body injector clinical trial expected to enable 2022 submission of a prior approval supplement to the UDENYCA BLA.
FDA accepted the BLA for CHS-201, a biosimilar Lucentis, with a target action date of August 2022.
FDA review of the BLA for CHS-1420, a biosimilar Humira, is advancing toward the target action date in December 2021.
FDA accepted the toripalimab BLA for advanced nasopharyngeal carcinoma and granted priority review with a target action date of April 2022.
Coherus
Coherus
Forward Guidance
Coherus projects full year 2021 R&D and SG&A expenses in a range of $370 million to $400 million, excluding the upfront payment made to Junshi Biosciences in the first quarter.
Positive Outlook
- R&D spending is focused on activities in preparation for the potential launch of toripalimab.
- R&D spending is focused on manufacturing-related and regulatory activities for CHS-1420 (Humira biosimilar).
- R&D spending is focused on development activities for CHS-305 (Avastin biosimilar).
- R&D spending is focused on additional presentations of UDENYCA.
- Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).