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Dec 31, 2021
Agios Q4 2021 Earnings Report
Agios reported financial results for the fourth quarter and year ended December 31, 2021.
Key Takeaways
Agios Pharmaceuticals reported a net loss of $98.6 million for Q4 2021, compared to a net loss of $84.5 million for Q4 2020. The company's cash, cash equivalents, and marketable securities were $1.3 billion as of December 31, 2021.
Received FDA approval for PYRUKYND® for hemolytic anemia in adults with PK deficiency.
Dosed first patients in all three pivotal trials of PYRUKYND® in thalassemia and sickle cell disease.
Hosted investor day to share updates on the R&D pipeline.
Presented key data at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.
Forward Guidance
Agios expects to execute on key milestones and priorities in 2022, including regulatory decisions for PYRUKYND® in Europe, initiation of Phase 3 studies in pediatric patients with PK deficiency, enrollment in thalassemia studies, and completion of enrollment in the RISE UP study for sickle cell disease.
Positive Outlook
- Receive European Medicines Agency (EMA) regulatory decision for PYRUKYND® in adults with PK deficiency by year-end.
- Initiate Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of PYRUKYND® in not regularly transfused and regularly transfused pediatric patients with PK deficiency, respectively, in mid-2022.
- Enroll a meaningful portion of patients in the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® in not regularly transfused and regularly transfused adults with thalassemia, respectively, by year-end.
- Complete enrollment in the Phase 2 portion of the RISE UP study of PYRUKYND® in sickle cell disease by year-end.
- Initiate the sickle cell disease cohort of the Phase 1 study of novel PK activator AG-946 in the first half of 2022.
Historical Earnings Impact
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