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Sep 30, 2020
Agios Q3 2020 Earnings Report
Agios reported third quarter results with TIBSOVO® net revenue of $31.7 million and narrowed 2020 TIBSOVO® net U.S. revenue guidance to $113–115 million.
Key Takeaways
Agios Pharmaceuticals reported total revenue of $34.7 million for the third quarter of 2020, which includes $31.7 million of net product revenue from sales of TIBSOVO®, $2.3 million in collaboration revenue and $0.7 million in royalty revenue. Net loss was $99.0 million for the third quarter of 2020.
TIBSOVO® net sales of $31.7 million, an increase of 15% from the second quarter of 2020.
Reported topline mature overall survival results from ClarIDHy Phase 3 study of TIBSOVO® in previously treated IDH1-mutant cholangiocarcinoma patients.
Withdrew European Marketing Authorization Application (MAA) for TIBSOVO® in IDH1-mutant relapsed or refractory acute myeloid leukemia (AML).
Initiated Phase 1 healthy volunteers study of AG-946, a next-generation, orally available, small molecule activator of the metabolic enzyme pyruvate kinase-R (PKR).
Forward Guidance
Agios expects to deliver full-year 2020 U.S. revenue for TIBSOVO® of $113-115 million.
Positive Outlook
- Report topline data from ACTIVATE trial by the end of 2020.
- Report topline data from ACTIVATE-T trial in Q1 2021.
- Finalize pivotal development plan for mitapivat in thalassemia by the end of 2020.
- Finalize pivotal development plan for mitapivat in sickle cell disease in the first half of 2021.
- Submit a supplemental new drug application for TIBSOVO® in previously treated cholangiocarcinoma in Q1 2021.
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