Agios' Q1 Loss Narrower Than Expected, Revenues Lag Estimates

Core Viewpoint - Agios Pharmaceuticals reported a narrower loss per share in Q1 2025 compared to estimates, but revenues fell short of expectations despite a year-over-year increase Financial Performance - Agios incurred a loss of $1.55 per share in Q1 2025, better than the Zacks Consensus Estimate of a loss of $1.80, but wider than the loss of $1.45 reported in the same quarter last year [1] - Revenues for Q1 2025 were $8.7 million, missing the Zacks Consensus Estimate of $10 million, but representing a 6.1% increase from $8.2 million in the year-ago quarter [1] - The company's stock has declined 5.8% year-to-date, while the industry has seen a decrease of 1.7% [2] Product Performance - All revenues in Q1 2025 were generated from Pyrukynd, Agios' only marketed drug, which is approved for treating hemolytic anemia in adults with PK deficiency [3] - Pyrukynd revenues declined 19% sequentially due to the absence of year-end stocking benefits seen in Q4 2024 [3] - As of Q1 2025, 136 patients are on Pyrukynd therapy, reflecting a 4.6% increase from Q4 2024 [4] Expenses - Research and development expenses rose approximately 6% year-over-year to $72.7 million, attributed to higher workforce-related costs [4] - Selling, general, and administrative expenses surged 33.9% year-over-year to $41.5 million, driven by preparations for potential approval and launch of Pyrukynd for thalassemia [4] Cash Position - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $1.4 billion, down from $1.5 billion as of December 31, 2024 [5] Pipeline Developments - The FDA accepted Agios' supplemental new drug application for Pyrukynd to treat adult patients with thalassemia, with a decision expected by September 7, 2025 [9] - Agios completed enrollment in the phase III RISE UP study for SCD, with top-line data expected in late 2025 and potential regulatory filing in 2026 [10] - The company is also conducting two phase III studies for Pyrukynd in pediatric patients with PK deficiency [10] - Agios is developing tebapivat for myelodysplastic syndromes and has initiated a phase IIb study, with enrollment expected to complete in late 2025 [12]