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SEC filingRevenue accelerated 138% to $20.7M from AQVESME™ U.S. launch and PYRUKYND® volume growth plus Newbridge Agreement, driving 154% gross profit increase at 93.6% margin, though operating losses widened 3% to -$110.0M on elevated R&D investments.
Revenue increased 137.7% to $20.7 million in Q1 FY2026 from $8.7 million in the prior year quarter, primarily due to higher United States product volumes associated with AQVESME™, which launched on December 23, 2025, alongside increased PYRUKYND® volumes. Rest-of-world product revenue also rose from increased volumes tied to the Newbridge Agreement. This momentum reflects successful commercial execution post-approval, enabling Agios to capture demand for these therapies targeting rare diseases.
Gross profit expanded 154.2% to $19.4 million, yielding a robust 93.6% gross margin versus the prior period. The modest rise in direct expenses relative to revenue growth stems from higher PYRUKYND®/AQVESME™ costs driven by process development expenses, demonstrating scalable manufacturing as sales volumes grow. Expired inventory costs are recognized in cost of sales when deemed unsellable based on expiry dates, but high margins signal strong unit economics and supply chain efficiency.
Operating income reflected a -$110.0 million loss, 3.2% deeper than the -$106.6 million prior-year loss, with operating margin at -530.3%. This widening reflects increased investments in research and development, including facility-related costs, alongside selling, general and administrative expenses comprising salaries, stock-based compensation, and support for executive, finance, business development, commercial, legal, IT, and HR functions. These investments underpin pipeline advancement and commercial infrastructure expansion to support PYRUKYND® and AQVESME™ growth.
Net income showed a -$99.1 million loss, 11.0% worse than -$89.3 million last year, with diluted EPS at -$1.69 versus -$1.55. The deeper loss aligns with elevated operating expenses, partially offset by interest income though specifics are unavailable.