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Dec 31, 2020
Agios Q4 2020 Earnings Report
Agios reported strong commercial execution for the second full year of TIBSOVO® with Q4 net revenue of $39.1M.
Key Takeaways
Agios Pharmaceuticals reported Q4 2020 financial results, featuring TIBSOVO® net sales of $39.1 million. The company entered into an agreement to sell its oncology portfolio to Servier and is focusing on genetically defined diseases.
Entered into a definitive agreement to sell the oncology portfolio to Servier in December.
TIBSOVO® net sales reached $39.1 million for the quarter and $121.1 million for the year.
Topline results were announced from two Phase 3 studies of mitapivat in adults with pyruvate kinase (PK) deficiency.
Darrin Miles was appointed to the role of Chief Commercial Officer.
Forward Guidance
Agios anticipates completing the sale of its oncology portfolio to Servier, filing for regulatory approval for mitapivat in adults with PK deficiency, initiating two Phase 3 studies of mitapivat in thalassemia, and initiating a Phase 2/3 study of mitapivat in sickle cell disease by year-end.
Positive Outlook
- Complete sale of oncology portfolio to Servier and execute a meaningful portion of the planned $1.2 billion capital return by year-end.
- File for regulatory approval for mitapivat in adults with PK deficiency: submit new drug application (NDA) in the U.S. in the second quarter of 2021 and marketing authorization application (MAA) in the EU in mid-2021.
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and ENERGIZE-T, in not regularly transfused and regularly transfused adults with thalassemia in the second half of 2021.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
- Prioritize new indications for pyruvate kinase R (PKR) and pyruvate kinase M2 (PKM2) activator clinical development by year-end.
Challenges Ahead
- Risks related to the sale of the oncology portfolio, including the failure to obtain stockholder approval or satisfy other conditions.
Historical Earnings Impact
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