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Dec 31, 2022
Agios Q4 2022 Earnings Report
Agios reported Q4 2022 financial results, highlighted by PYRUKYND® U.S. launch and progress in clinical trials.
Key Takeaways
Agios Pharmaceuticals reported Q4 2022 financial results, featuring $4.3 million in U.S. net revenue from PYRUKYND® and a net income of $36.5 million. The company completed enrollment in the Phase 2 RISE UP study and expects to complete enrollment in Phase 3 ENERGIZE and ENERGIZE-T studies by mid-2023. Agios held $1.1 billion in cash, cash equivalents, and marketable securities as of December 31, 2022.
PYRUKYND® U.S. launch generated $4.3 million in net revenue for Q4 2022.
A total of 105 unique patients have completed prescription enrollment forms, representing an increase of 25 percent over the third quarter.
Completed enrollment in the Phase 2 portion of the RISE UP study of PYRUKYND® in adults with sickle cell disease.
Net income was $36.5 million for the fourth quarter of 2022.
Forward Guidance
Agios anticipates several milestones in 2023, including completing enrollment in Phase 3 thalassemia studies and announcing data from the Phase 2 sickle cell disease study. The company expects its cash, cash equivalents and marketable securities together with anticipated product revenue and interest income will enable the company to execute its operating plan, including funding the currently planned development programs for mitapivat, AG-946 and PAH stabilization, and commercializing mitapivat outside of the U.S. through one or more partnerships, to cash-flow positivity without the need to raise additional equity.
Positive Outlook
- Complete enrollment of the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® by mid-year.
- Announce data readout from the Phase 2 portion of the RISE UP study of PYRUKUND® and go/no-go to Phase 3 decision by mid-year.
- Enroll more than half of patients in the Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of PYRUKYND® by year-end.
- Complete enrollment of the Phase 2a study of novel PK activator AG-946 by year-end.
- File investigational new drug (IND) application for phenylalanine hydroxylase (PAH) stabilizer for the treatment of phenylketonuria (PKU) by year-end.
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