AGIO · Agios Pharmaceuticals, Inc.

Agios Pharmaceuticals delivered a robust commercial performance in Q1 2026, with mitapivat (PYRUKYND® and AQVESME™) achieving $20.7 million in worldwide net revenues, up significantly from $8.7 million in Q1 2025. U.S. net revenue reached $18.8 million, propelled by the late January launch of AQVESME for thalassemia, which garnered 242 prescriptions by prescribers certified under the Risk Evaluation and Mitigation Strategy as of March 31. Ex-U.S. revenue of $1.9 million came from PYRUKYND demand in Saudi Arabia. Despite revenue growth, the company posted a GAAP net loss of $99.1 million, or $1.69 per share, compared to $89.3 million, or $1.55 per share, last year. This widening stemmed from elevated R&D expenses at $81.1 million (up from $72.7 million), tied to pipeline support and mitapivat process development, and SG&A at $48.3 million (up from $41.5 million), reflecting launch activities and higher stock compensation. Cost of sales rose modestly to $1.3 million. Balance sheet remains strong with $1.0 billion in cash, cash equivalents, and marketable securities as of quarter-end, down from $1.2 billion at year-end 2025, providing runway for the AQVESME launch, potential sickle cell entry, and clinical programs. CEO Brian Goff highlighted execution on 2026 objectives, noting community reception for AQVESME and FDA alignment for accelerated approval of mitapivat in sickle cell disease via Q2 sNDA submission, requiring confirmatory trial. Pipeline momentum includes UAE approval for PYRUKYND in thalassemia, EC review ongoing, and tebapivat Phase 2 readouts: transfusion independence in LR-MDS (H1 2026) and hemoglobin response in sickle cell (H2 2026). No formal guidance issued, but cash supports strategic independence.