Loading...
•
Mar 31, 2021
Agios Q1 2021 Earnings Report
Agios reported first quarter 2021 financial results, highlighted by the closing of the oncology business sale to Servier and progress in genetically defined disease programs.
Key Takeaways
Agios reported a net income of $1.9 billion for Q1 2021, driven by the sale of its oncology business. The company is focusing on genetically defined diseases, with upcoming regulatory filings for mitapivat and initiation of Phase 3 studies.
Closed the sale of the oncology portfolio to Servier for $1.8 billion upfront.
Initiated repurchase of up to $1.2 billion of outstanding shares.
Advanced mitapivat development with presentations at the EHA 2021 Virtual Congress and planned regulatory submissions.
Focused on expanding genetically defined disease portfolio with new clinical studies.
Forward Guidance
Agios plans to finalize global regulatory filings for mitapivat, initiate Phase 3 studies in thalassemia, and advance clinical development of PKR and PKM2 activators.
Positive Outlook
- Finalize global regulatory filings for mitapivat in adults with PK deficiency.
- Submit new drug application (NDA) in the U.S. in the second quarter of 2021.
- Submit marketing authorization application (MAA) in the EU in mid-2021.
- Initiate two Phase 3 studies of mitapivat in thalassemia in the second half of 2021.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
Challenges Ahead
- Uncertainty of receiving milestone or royalty payments related to the sale of its oncology business.
- Potential impact of the COVID-19 pandemic on Agios’ business and operations.
- Risks related to clinical trials and preclinical studies outcomes.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...