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Jun 30, 2021
Agios Q2 2021 Earnings Report
Agios, now focused solely on genetically defined diseases, reported regulatory submissions for mitapivat for the treatment of adults with PK deficiency and presented data from Phase 3 studies at the European Hematology Association Virtual Congress.
Key Takeaways
Agios reported a net loss of $86.2 million for the second quarter of 2021. The company completed regulatory submissions for mitapivat in the U.S. and EU and presented data from Phase 3 studies. Cash, cash equivalents, and marketable securities totaled $1.7 billion as of June 30, 2021.
Completed U.S. and EU regulatory submissions for mitapivat for the treatment of adults with PK deficiency.
Presented data from Phase 3 ACTIVATE and ACTIVATE-T studies of mitapivat in adults with PK deficiency at the European Hematology Association Virtual Congress.
Presented data from a Phase 2 study of mitapivat in adults with non-transfusion dependent a- or b-thalassemia at the EHA Virtual Congress.
Repurchased approximately 10.5 million shares of Agios common stock at an average price of $50.41 per share.
Forward Guidance
Agios plans to initiate two Phase 3 studies of mitapivat in thalassemia and a Phase 2/3 study of mitapivat in sickle cell disease by year-end and host an investor day in the fourth quarter.
Positive Outlook
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and ENERGIZE-T, in not regularly transfused and regularly transfused adults with thalassemia, by year-end.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by year-end.
- Host investor day in fourth quarter to share more information about commercial launch planning for mitapivat in PK deficiency
- Submit data from ongoing collaborator-led clinical studies of mitapivat in sickle cell disease for presentation at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, to be held Dec. 11-14.
- Submit data from the Phase 1 healthy volunteer study of AG-946, the company’s next-generation PKR activator, for presentation at the 63rd ASH Annual Meeting & Exposition.
Historical Earnings Impact
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